Bringing you the latest news, research and reviews, exclusive interviews, podcasts, quizzes, and more.

mdid
Main menu
MD Infectious Disease Main Menu
Explore menu
MD Infectious Disease Explore Menu
Proclivity ID
18856001
Unpublish
Negative Keywords Excluded Elements
header[@id='header']
div[contains(@class, 'header__large-screen')]
div[contains(@class, 'read-next-article')]
div[contains(@class, 'nav-primary')]
nav[contains(@class, 'nav-primary')]
section[contains(@class, 'footer-nav-section-wrapper')]
footer[@id='footer']
div[contains(@class, 'main-prefix')]
section[contains(@class, 'nav-hidden')]
div[contains(@class, 'ce-card-content')]
nav[contains(@class, 'nav-ce-stack')]
Altmetric
Click for Credit Button Label
Click For Credit
DSM Affiliated
Display in offset block
Disqus Exclude
Best Practices
CE/CME
Education Center
Medical Education Library
Enable Disqus
Display Author and Disclosure Link
Publication Type
News
Slot System
Featured Buckets
Disable Sticky Ads
Disable Ad Block Mitigation
Featured Buckets Admin
Publication LayerRX Default ID
972
Non-Overridden Topics
Show Ads on this Publication's Homepage
Consolidated Pub
Show Article Page Numbers on TOC
Expire Announcement Bar
Use larger logo size
On
publication_blueconic_enabled
Off
Show More Destinations Menu
Disable Adhesion on Publication
Off
Restore Menu Label on Mobile Navigation
Disable Facebook Pixel from Publication
Exclude this publication from publication selection on articles and quiz
Gating Strategy
First Peek Free
Challenge Center
Disable Inline Native ads
survey writer start date

FDA fully approves Pfizer COVID-19 vaccine

Article Type
Changed

 

The Food and Drug Administration has granted a biological license application, more commonly known as “full approval,” to the Pfizer-BioNTech COVID-19 vaccine.

It is the first COVID-19 vaccine to be fully licensed in the United States. It will be marketed under the trade name Comirnaty. 

The approval applies to individuals ages 16 years and older. The vaccine is still available for emergency use for those ages 12-15.

The FDA’s stamp of approval is somewhat anticlimactic, following months of real-world use and millions of doses doled out to the general population. It comes after months of scrutiny by the agency of the clinical trial data.

Still, the approval puts the vaccines on firmer legal footing and is expected to spur a raft of new vaccination requirements by employers, schools, and universities. 

“The FDA approval is the gold standard,” President Joe Biden said from the White House. “Those who have been waiting for full approval should go and get your shot now.”

“It could save your life or the lives of those you love,” he said.

Biden also called on businesses to mandate COVID vaccines for their employees.

Indeed, soon after the approval was announced, Defense Secretary Lloyd Austin said the vaccines would be required for all 1.4 million active duty service members.


Public health advocates have seen full approval as an important tool to increase U.S. vaccination rates and had criticized the FDA for taking so long to grant the license. 

In a news briefing on the approval, Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said the agency had not dragged its feet.

Marks noted that his team had reviewed tens of thousands of pages of clinical trial data -- down to the level of individual patients. They also inspected clinical trial sites and manufacturing facilities, and reviewed information gathered after the vaccines were authorized for use.

“It’s been 97 days since Pfizer completed the role of its [application for approval] and the clock started, which means that we completed this in about 40% of the normal clock time for a submission of this magnitude,” he said. “People worked day and night.”

The agency resisted pressure to speed up its process, saying a thorough review was necessary to ensure public confidence.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.,” acting FDA Commissioner Janet Woodcock said in a FDA news release.

Experts agreed the move would increase public confidence.

 “I don't expect a big line outside of vaccination sites this afternoon or tomorrow morning, but it will persuade some,” said William Schaffner, MD, a professor of infectious diseases at Vanderbilt University in Nashville.

A recent Kaiser Family Foundation poll found that 3 in 10 unvaccinated adults said they would be more likely to get vaccinated if the vaccines were given full approval.

More importantly, Schaffner said, the FDA’s approval would lay the groundwork for vaccine mandates. “I think those kinds of mandates are going to be necessary to get us up over 80% vaccinated.”

In granting the approval, the agency reviewed a record amount of data from more than 40,000 people who took part in clinical trials. About 12,000 recipients have been followed for at least 6 months, the agency said.

The FDA also reviewed safety data collected since it issued its emergency use authorization for the shots in December.

Based on the results from the clinical trials, the vaccine was 91% effective at preventing COVID-19 disease. But that estimate came from data collected before the Delta variant became widespread.

The most commonly reported side effects in the clinical trials were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.

The FDA said the vaccine is effective in preventing COVID-19 and potentially serious outcomes, including hospitalization and death.

Based on safety data reviewed since the two-dose vaccine was approved, the FDA said the data demonstrates a higher risk for heart inflammation -- clinically known as myocarditis or pericarditis -- especially within 7 days after the second dose of the shots. The risk is highest for men under age 40, compared to women and older men.

The prescription information includes warnings about these risks. The FDA said the drugmakers must continue to study the risks and long-term effects on people who have myocarditis after vaccination.

A version of this article first appeared on Medscape.com.

This article was updated on 8/24/21.

Publications
Topics
Sections

 

The Food and Drug Administration has granted a biological license application, more commonly known as “full approval,” to the Pfizer-BioNTech COVID-19 vaccine.

It is the first COVID-19 vaccine to be fully licensed in the United States. It will be marketed under the trade name Comirnaty. 

The approval applies to individuals ages 16 years and older. The vaccine is still available for emergency use for those ages 12-15.

The FDA’s stamp of approval is somewhat anticlimactic, following months of real-world use and millions of doses doled out to the general population. It comes after months of scrutiny by the agency of the clinical trial data.

Still, the approval puts the vaccines on firmer legal footing and is expected to spur a raft of new vaccination requirements by employers, schools, and universities. 

“The FDA approval is the gold standard,” President Joe Biden said from the White House. “Those who have been waiting for full approval should go and get your shot now.”

“It could save your life or the lives of those you love,” he said.

Biden also called on businesses to mandate COVID vaccines for their employees.

Indeed, soon after the approval was announced, Defense Secretary Lloyd Austin said the vaccines would be required for all 1.4 million active duty service members.


Public health advocates have seen full approval as an important tool to increase U.S. vaccination rates and had criticized the FDA for taking so long to grant the license. 

In a news briefing on the approval, Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said the agency had not dragged its feet.

Marks noted that his team had reviewed tens of thousands of pages of clinical trial data -- down to the level of individual patients. They also inspected clinical trial sites and manufacturing facilities, and reviewed information gathered after the vaccines were authorized for use.

“It’s been 97 days since Pfizer completed the role of its [application for approval] and the clock started, which means that we completed this in about 40% of the normal clock time for a submission of this magnitude,” he said. “People worked day and night.”

The agency resisted pressure to speed up its process, saying a thorough review was necessary to ensure public confidence.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.,” acting FDA Commissioner Janet Woodcock said in a FDA news release.

Experts agreed the move would increase public confidence.

 “I don't expect a big line outside of vaccination sites this afternoon or tomorrow morning, but it will persuade some,” said William Schaffner, MD, a professor of infectious diseases at Vanderbilt University in Nashville.

A recent Kaiser Family Foundation poll found that 3 in 10 unvaccinated adults said they would be more likely to get vaccinated if the vaccines were given full approval.

More importantly, Schaffner said, the FDA’s approval would lay the groundwork for vaccine mandates. “I think those kinds of mandates are going to be necessary to get us up over 80% vaccinated.”

In granting the approval, the agency reviewed a record amount of data from more than 40,000 people who took part in clinical trials. About 12,000 recipients have been followed for at least 6 months, the agency said.

The FDA also reviewed safety data collected since it issued its emergency use authorization for the shots in December.

Based on the results from the clinical trials, the vaccine was 91% effective at preventing COVID-19 disease. But that estimate came from data collected before the Delta variant became widespread.

The most commonly reported side effects in the clinical trials were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.

The FDA said the vaccine is effective in preventing COVID-19 and potentially serious outcomes, including hospitalization and death.

Based on safety data reviewed since the two-dose vaccine was approved, the FDA said the data demonstrates a higher risk for heart inflammation -- clinically known as myocarditis or pericarditis -- especially within 7 days after the second dose of the shots. The risk is highest for men under age 40, compared to women and older men.

The prescription information includes warnings about these risks. The FDA said the drugmakers must continue to study the risks and long-term effects on people who have myocarditis after vaccination.

A version of this article first appeared on Medscape.com.

This article was updated on 8/24/21.

 

The Food and Drug Administration has granted a biological license application, more commonly known as “full approval,” to the Pfizer-BioNTech COVID-19 vaccine.

It is the first COVID-19 vaccine to be fully licensed in the United States. It will be marketed under the trade name Comirnaty. 

The approval applies to individuals ages 16 years and older. The vaccine is still available for emergency use for those ages 12-15.

The FDA’s stamp of approval is somewhat anticlimactic, following months of real-world use and millions of doses doled out to the general population. It comes after months of scrutiny by the agency of the clinical trial data.

Still, the approval puts the vaccines on firmer legal footing and is expected to spur a raft of new vaccination requirements by employers, schools, and universities. 

“The FDA approval is the gold standard,” President Joe Biden said from the White House. “Those who have been waiting for full approval should go and get your shot now.”

“It could save your life or the lives of those you love,” he said.

Biden also called on businesses to mandate COVID vaccines for their employees.

Indeed, soon after the approval was announced, Defense Secretary Lloyd Austin said the vaccines would be required for all 1.4 million active duty service members.


Public health advocates have seen full approval as an important tool to increase U.S. vaccination rates and had criticized the FDA for taking so long to grant the license. 

In a news briefing on the approval, Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said the agency had not dragged its feet.

Marks noted that his team had reviewed tens of thousands of pages of clinical trial data -- down to the level of individual patients. They also inspected clinical trial sites and manufacturing facilities, and reviewed information gathered after the vaccines were authorized for use.

“It’s been 97 days since Pfizer completed the role of its [application for approval] and the clock started, which means that we completed this in about 40% of the normal clock time for a submission of this magnitude,” he said. “People worked day and night.”

The agency resisted pressure to speed up its process, saying a thorough review was necessary to ensure public confidence.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.,” acting FDA Commissioner Janet Woodcock said in a FDA news release.

Experts agreed the move would increase public confidence.

 “I don't expect a big line outside of vaccination sites this afternoon or tomorrow morning, but it will persuade some,” said William Schaffner, MD, a professor of infectious diseases at Vanderbilt University in Nashville.

A recent Kaiser Family Foundation poll found that 3 in 10 unvaccinated adults said they would be more likely to get vaccinated if the vaccines were given full approval.

More importantly, Schaffner said, the FDA’s approval would lay the groundwork for vaccine mandates. “I think those kinds of mandates are going to be necessary to get us up over 80% vaccinated.”

In granting the approval, the agency reviewed a record amount of data from more than 40,000 people who took part in clinical trials. About 12,000 recipients have been followed for at least 6 months, the agency said.

The FDA also reviewed safety data collected since it issued its emergency use authorization for the shots in December.

Based on the results from the clinical trials, the vaccine was 91% effective at preventing COVID-19 disease. But that estimate came from data collected before the Delta variant became widespread.

The most commonly reported side effects in the clinical trials were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.

The FDA said the vaccine is effective in preventing COVID-19 and potentially serious outcomes, including hospitalization and death.

Based on safety data reviewed since the two-dose vaccine was approved, the FDA said the data demonstrates a higher risk for heart inflammation -- clinically known as myocarditis or pericarditis -- especially within 7 days after the second dose of the shots. The risk is highest for men under age 40, compared to women and older men.

The prescription information includes warnings about these risks. The FDA said the drugmakers must continue to study the risks and long-term effects on people who have myocarditis after vaccination.

A version of this article first appeared on Medscape.com.

This article was updated on 8/24/21.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Shouldn’t docs who spread false COVID-19 info lose their licenses?

Article Type
Changed

 

A tall, distinguished-looking physician in shirtsleeves and suspenders walked to the microphone at the Mt. Vernon, Ind., school board meeting on a Friday evening in early August. He launched into an impassioned, 7-minute attack on the public health establishment’s medical guidelines for COVID-19.

“The Center for Disease Control and the Indiana State [Department] of Health are giving you very bad scientific guidance,” said Daniel Stock, MD, a primary care physician with a concierge practice in Noblesville, Ind., He described himself as a “functional family medicine physician,” though he is not board certified in family medicine.

Dr. Stock told the school board members that COVID-19 vaccines are counterproductive because they make coronavirus infections worse. He claimed his treatment of “over 15” COVID-19 patients with vitamin D, ivermectin, and zinc has kept them out of the hospital, and that those treatments reduce mortality risk from the disease by 75%. (A study released in mid-August found that ivermectin is ineffective in treating COVID-19).

In response to Dr. Stock’s remarks, the state health department quickly issued a statement reaffirming that COVID-19 vaccines “are highly effective at preventing hospitalizations and deaths.” But by then, the YouTube video of Dr. Stock’s comments had garnered nearly 600,000 views as of Aug. 12 and had been shared over 10,000 times on Facebook. Opponents of COVID-19 vaccines and masking policies across the country have been citing his comments.

Across the country, state medical licensing boards and state and national medical associations are struggling with how to respond to scientifically baseless public statements about COVID-19 by some physicians such as Dr. Stock. They fear such statements are increasing public confusion and are heightening political conflict. Physicians accused of spreading false information include public officials such as Scott Atlas, MD, who served as President Donald Trump’s COVID-19 advisor, and Kentucky Sen. Rand Paul, an ophthalmologist, whose YouTube account was temporarily suspended in August after he posted a video disputing the effectiveness of masking in stopping the spread of COVID-19.

“That’s the problem – those types of viral videos of someone somewhere who thinks they know something the rest of us don’t,” lamented Jennifer Bryan, MD, board chair of the Mississippi State Medical Association. “I don’t know any good reason why a physician should be advising against vaccination. It’s appropriate for medical boards to look into those situations.”

The Federation of State Medical Boards agrees. In July, it warned that physicians who willfully spread false information about COVID-19 risk suspension or revocation of their medical license. The federation cited a “dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians.” That’s particularly dangerous, it said, because physicians enjoy a high degree of public credibility.

Medical boards will particularly examine cases in which there is a pattern of misinformation or disinformation showing that a physician poses a continuing threat to public health, said Hank Chaudhry, DO, the federation’s CEO. In some cases, he said, boards have contacted physicians and have persuaded them to voluntarily refrain from making false public statements, without taking disciplinary action.

“Words matter,” he said. “Physicians have a really big platform, whether they realize it or not. Misinformation or disinformation in the context of COVID can not only cause harm but also death. We felt it was appropriate to remind physicians to be careful.”

Although medical leaders stress that most physicians are promoting solid science on COVID-19, the London-based Center for Countering Digital Hate, in a May report titled “The Disinformation Dozen,” named four U.S. physicians among 12 people who it said produce 65% of the misleading claims and lies about COVID-19 vaccines that abound on Facebook, Instagram, and Twitter. The leading spreader of false claims, the group said, is Joseph Mercola, MD, an Illinois-licensed osteopath living in Cape Coral, Fla. He did not respond to requests for comment.

But so far, state licensing boards and federal and state medical associations generally have been reluctant to discipline or publicly call out physicians who have spread misinformation about the causes, treatments, vaccines, and prevention strategies for COVID-19. Some of these physicians, such as Dr. Mercola, have a long history predating the COVID-19 pandemic of disseminating scientifically baseless information, often in connection with their marketing of products and services.

For instance, the Medical Licensing Board of Indiana and the state attorney general’s office, which brings medical disciplinary actions, declined to comment on Dr. Stock’s public statements at the August school board meeting. When asked about Dr. Stock, the Indiana State Medical Association, without mentioning his name, said: “We urge Hoosier physicians to share the proven facts [about public health measures recommended by the CDC and the Indiana Department of Health] with their patients and their communities.” Dr. Stock did not respond to a request for comment.

Experts say state medical boards are ill equipped and are often unwilling to address the challenge of disciplining physicians who disseminate dangerously false medical information. That enforcement gap is particularly troubling in the middle of a deadly pandemic such as this one.

“Unless you can show a harm to an individual patient, it’s pretty tough to get the boards to do much,” said Art Caplan, PhD, a professor of bioethics at New York University. “I wish they would, but they just don’t.”

That’s partly because state laws require the boards to engage in lengthy, confidential investigations and adversarial legal processes before imposing disciplinary actions. The laws generally require patients or members of the public to file a complaint before an investigation can start. Some states, however, do allow their medical boards to take rapid emergency action if a physician poses an immediate threat to patients or the public.

Another hurdle is that medical boards that seek to sanction physicians for making dangerously misleading public statements could face lawsuits alleging that such actions violate the physicians’ constitutional free speech rights or their professional autonomy.

“We have free speech, and you can get away with a lot of stuff,” said Stephen Barrett, MD, who for many years has critically documented examples of medical fraud on his website, Quackwatch. “Some doctors would sue if they were challenged by medical boards, and I’m not sure the boards would win that court fight. People have written books with advice that killed people, and I’m not aware of a single case where the author was disciplined.”

In addition, it’s not clear that U.S. physicians who are not government officials have any legal obligation – as opposed to a moral obligation – to the government or the public to promote public health, said Jonathan Moreno, PhD, a professor of medical ethics at University of Pennsylvania, Philadelphia. “Is transmitting misinformation about COVID-19 public health malpractice?” he asked. “Do we as a society see physicians having a special role as guides in an emergency? I’d like to think we do, but we don’t have a strong tradition like that in the U.S.”

But California State Sen. Richard Pan, MD, a pediatrician who represents the Sacramento area, doesn’t buy the arguments about why medical boards can’t discipline physicians for spreading misinformation. He successfully sponsored a 2019 bill that strengthens the medical board’s ability to discipline physicians who dole out medically unjustified vaccine exemptions to children.

“A medical license is a privilege. It’s an imprimatur from the state that the person is someone who upholds professional standards,” Dr. Pan said. “If someone is intentionally spreading disinformation for personal gain and that’s putting the public at risk, the medical board has a duty to act.”

There have been only a few publicly announced disciplinary actions related to COVID-19 misinformation so far.

Last December, the Oregon Medical Board, on an emergency basis, suspended the license of Steven LaTulippe, MD, of Dallas, Ore. He had publicly announced that he and his staff were not wearing masks in his clinic. In addition, he compared COVID-19 to the common cold and denied the governor’s legal authority to adopt public health protection measures. A recorded message on his office phone said he’s challenging the licensure action in court.

Last January, the Medical Board of California made Thomas Cowan, MD, of San Francisco surrender his license after Dr. Cowan posted a YouTube video, which went viral last year, that claimed that 5G Internet networks cause COVID-19. He did not respond to a request for comment.

In May, the College of Physicians and Surgeons of British Columbia reprimanded Stephen Malthouse, MD, and forbade him from speaking on issues related to COVID-19. He had written a widely circulated open letter to the province’s chief health office claiming that the pandemic was “over” and that measures to control the spread of COVID-19 were worse than the virus. He has challenged the disciplinary action in court, alleging it violates his right to free speech.

Attacking the problem from a different angle, the U.S. Federal Trade Commission has issued enforcement actions in cases in which physicians and other health care professionals engaged in deceptive business practices related to COVID-19. That approach may be applicable to a number of physicians accused of spreading COVID-19 misinformation, who allegedly have done so at least partly to sell unproven products and services to prevent or treat the disease.

In June, the FTC settled a case against Stephen Meis, MD, of Porterville, Calif. The settlement required that he stop making unsupported claims that his company’s dietary supplements effectively treat COVID-19 symptoms and that he pay $103,420 in refunds to defrauded customers.

State medical boards in the United States generally are not allowed to disclose investigations or disciplinary processes until they finalize a disciplinary action, so other investigations that have not been publicly disclosed may be pending.

A spokesperson for the Medical Board of California said the board is aware of questionable statements about COVID-19 made by several physicians and “will be looking into it.” That comment was in response to a question about statements made at a news conference last year by two Bakersfield emergency physicians, Artin Massihi, MD, and Dan Erickson, DO. They claimed that their COVID-19 testing data showed that the virus is not that dangerous. Dr. Erickson is an osteopath and is regulated by the Osteopathic Medical Board of California.

The two physicians’ news conference prompted an unusual joint statement from the American College of Emergency Medicine and the American Academy of Emergency Medicine in April 2020 declaring that they “emphatically condemn” Dr. Massihi’s and Dr. Erickson’s “reckless and untested musings.” The groups added that it appeared that the physicians issued the comments “to advance their personal financial interests without regard for the public’s health.”

Neither Dr. Massihi nor Dr. Erickson responded to a request for comment.

As for the physician dubbed by the Center for Countering Digital Hate as the world’s most influential spreader of COVID-19 misinformation on social media: No recent public complaints have been filed, and no disciplinary action has been taken against Dr. Mercola, according to a spokesman for the Illinois Department of Financial and Professional Regulation.

According to court records, Dr. Mercola faced disciplinary complaints from the Illinois board in the early 2000s for allegedly providing false and potentially harmful medical advice on his website. There is no record of any final disciplinary action taken against him.

In widely disseminated online posts, Dr. Mercola has called the COVID-19 pandemic a “scam” and said “forced vaccination” is part of a plan to re-set the global economic system. He called COVID-19 vaccines “a medical fraud,” claiming they “alter your genetic coding.” In February, the U.S. Food and Drug Administration ordered Dr. Mercola to stop saying on his website that various vitamins and dietary supplements he sells through his website are effective in preventing or treating COVID-19.

 

 

The New York Times reported in July that Dr. Mercola’s English-language Facebook page has more than 1.7 million followers, that his Spanish-language page has one million, and that he has 300,000 followers on Twitter and 400,000 on YouTube.

In August, Dr. Mercola announced that he was deleting the large archive of articles he’s written on his website but would continue to post articles every day that would be available on the site for only 48 hours. He explained his decision by saying he’s facing “blatant censorship” as part of a “McCarthyism-like attack” from “the sitting President of the United States.” He encouraged people to read his book, “The Truth about COVID-19.”

The lack of action against Dr. Mercola for his lengthy list of scientifically unfounded statements and marketing claims about COVID-19 and other medical conditions infuriates Quackwatch’s Dr. Barrett. He’s amazed that the Illinois board did not discipline Dr. Mercola despite a number of enforcement actions against him by the FTC and the FDA.

“If a doctor were to say to a patient, ‘Don’t wear a mask and don’t get vaccinated,’ the doctor would be held responsible for a bad outcome,” he said. “But if you say it to millions and as a direct result a dozen people die, shouldn’t the doctor also be held responsible for that misinformation? I think he should lose his license.”

Another of the four physicians cited in the “Disinformation Dozen” report is Sherri Tenpenny, DO, an osteopath licensed in Ohio, who has published posts on social media advocating against masking, testing, and vaccines to prevent COVID-19 infections. A spokesperson for the State Medical Board of Ohio said Dr. Tenpenny’s license expires on Oct. 1, 2021, and that any investigation would be confidential. She added that grounds for disciplinary action include “making a false, fraudulent, deceptive, or misleading statement in relation to the practice of medicine and surgery.” Dr. Tenpenny could not be reached for comment.

A third physician named in the report is Christiane Northrup, MD, an ob.gyn. formerly licensed in Maine, who has published posts advocating unproven cures for COVID-19 and claiming that vaccines increase chronic illness. Dennis Smith, executive director of the Maine Board of Licensure in Medicine, said the board received complaints about Dr. Northrup’s posts but can’t act because she withdrew her Maine license in 2015. He added that the Maine board can issue sanctions against physicians who engage in fraud, deceit, or misrepresentation or who post scientifically unfounded statements online.

The fourth physician identified in the “Disinformation Dozen” report is Rashid Buttar, DO, an osteopath practicing in Mooresville, N.C., who has claimed in social media posts that COVID-19 vaccines cause infertility and that COVID-19 tests contain living microorganisms. A spokeswoman for the North Carolina Medical Board said she could not confirm or deny the existence of any investigation of Dr. Buttar, who signed a consent order with the medical board in 2010 following charges of exorbitant fees, worthless tests and treatment, and false diagnoses. Undisclosed conditions were placed on his medical license in 2013. The spokesperson added that the board would investigate any information alleging that a physician spread false information about COVID-19.

Another physician who has caused widespread consternation over scientifically unfounded statements about COVID-19 is Simone Gold, MD, formerly an emergency department physician in Los Angeles. She founded a group called America’s Frontline Doctors, which filed a federal lawsuit in Alabama this spring to block the FDA from issuing an emergency use authorization allowing teenagers to receive COVID-19 vaccinations. She called the vaccines “an experimental biological agent whose harms are well-documented.”

Last summer, Dr. Gold and other physicians in her group held a news conference on the steps of the U.S. Supreme Court Building promoting hydroxychloroquine as a COVID-19 treatment. They declared that masks don’t work and that the virus isn’t deadly, and made other false claims. The news conference was livestreamed by conservative media outlets, was promoted on Twitter by then-President Trump and his family, and was viewed online more than 14 million times.

One of the participating physicians, Stella Immanuel, MD, of Houston, claimed in a video that went viral that she had successfully used hydroxychloroquine for more than 400 patients to cure the disease. In response, the Texas Medical Board, without naming Dr. Immanuel, warned that if it received a complaint about any physician who made a false claim about having a cure for COVID-19, it would investigate and potentially take disciplinary action.

Although no publicly known disciplinary action has been taken against Dr. Gold, she told The Washington Post last January that after participating in that July 2020 news conference, she was fired from her emergency department job at two hospitals and that she hasn’t worked as a physician since. Dr. Gold did not respond to a request for comment.

The outcome in her situation is consistent with the view of NYU’s Dr. Caplan that methods other than medical board discipline – such as action by employers, social media pressure, and reprimands from professional societies –will have to be used to hold physicians accountable for spreading COVID-19 misinformation.

“I’m disappointed to have to say it, but I don’t think medical boards are going to be effective,” he said. “We don’t know how to manage misinformation despite being in a plague. We just don’t.

A version of this article first appeared on Medscape.com.

Publications
Topics
Sections

 

A tall, distinguished-looking physician in shirtsleeves and suspenders walked to the microphone at the Mt. Vernon, Ind., school board meeting on a Friday evening in early August. He launched into an impassioned, 7-minute attack on the public health establishment’s medical guidelines for COVID-19.

“The Center for Disease Control and the Indiana State [Department] of Health are giving you very bad scientific guidance,” said Daniel Stock, MD, a primary care physician with a concierge practice in Noblesville, Ind., He described himself as a “functional family medicine physician,” though he is not board certified in family medicine.

Dr. Stock told the school board members that COVID-19 vaccines are counterproductive because they make coronavirus infections worse. He claimed his treatment of “over 15” COVID-19 patients with vitamin D, ivermectin, and zinc has kept them out of the hospital, and that those treatments reduce mortality risk from the disease by 75%. (A study released in mid-August found that ivermectin is ineffective in treating COVID-19).

In response to Dr. Stock’s remarks, the state health department quickly issued a statement reaffirming that COVID-19 vaccines “are highly effective at preventing hospitalizations and deaths.” But by then, the YouTube video of Dr. Stock’s comments had garnered nearly 600,000 views as of Aug. 12 and had been shared over 10,000 times on Facebook. Opponents of COVID-19 vaccines and masking policies across the country have been citing his comments.

Across the country, state medical licensing boards and state and national medical associations are struggling with how to respond to scientifically baseless public statements about COVID-19 by some physicians such as Dr. Stock. They fear such statements are increasing public confusion and are heightening political conflict. Physicians accused of spreading false information include public officials such as Scott Atlas, MD, who served as President Donald Trump’s COVID-19 advisor, and Kentucky Sen. Rand Paul, an ophthalmologist, whose YouTube account was temporarily suspended in August after he posted a video disputing the effectiveness of masking in stopping the spread of COVID-19.

“That’s the problem – those types of viral videos of someone somewhere who thinks they know something the rest of us don’t,” lamented Jennifer Bryan, MD, board chair of the Mississippi State Medical Association. “I don’t know any good reason why a physician should be advising against vaccination. It’s appropriate for medical boards to look into those situations.”

The Federation of State Medical Boards agrees. In July, it warned that physicians who willfully spread false information about COVID-19 risk suspension or revocation of their medical license. The federation cited a “dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians.” That’s particularly dangerous, it said, because physicians enjoy a high degree of public credibility.

Medical boards will particularly examine cases in which there is a pattern of misinformation or disinformation showing that a physician poses a continuing threat to public health, said Hank Chaudhry, DO, the federation’s CEO. In some cases, he said, boards have contacted physicians and have persuaded them to voluntarily refrain from making false public statements, without taking disciplinary action.

“Words matter,” he said. “Physicians have a really big platform, whether they realize it or not. Misinformation or disinformation in the context of COVID can not only cause harm but also death. We felt it was appropriate to remind physicians to be careful.”

Although medical leaders stress that most physicians are promoting solid science on COVID-19, the London-based Center for Countering Digital Hate, in a May report titled “The Disinformation Dozen,” named four U.S. physicians among 12 people who it said produce 65% of the misleading claims and lies about COVID-19 vaccines that abound on Facebook, Instagram, and Twitter. The leading spreader of false claims, the group said, is Joseph Mercola, MD, an Illinois-licensed osteopath living in Cape Coral, Fla. He did not respond to requests for comment.

But so far, state licensing boards and federal and state medical associations generally have been reluctant to discipline or publicly call out physicians who have spread misinformation about the causes, treatments, vaccines, and prevention strategies for COVID-19. Some of these physicians, such as Dr. Mercola, have a long history predating the COVID-19 pandemic of disseminating scientifically baseless information, often in connection with their marketing of products and services.

For instance, the Medical Licensing Board of Indiana and the state attorney general’s office, which brings medical disciplinary actions, declined to comment on Dr. Stock’s public statements at the August school board meeting. When asked about Dr. Stock, the Indiana State Medical Association, without mentioning his name, said: “We urge Hoosier physicians to share the proven facts [about public health measures recommended by the CDC and the Indiana Department of Health] with their patients and their communities.” Dr. Stock did not respond to a request for comment.

Experts say state medical boards are ill equipped and are often unwilling to address the challenge of disciplining physicians who disseminate dangerously false medical information. That enforcement gap is particularly troubling in the middle of a deadly pandemic such as this one.

“Unless you can show a harm to an individual patient, it’s pretty tough to get the boards to do much,” said Art Caplan, PhD, a professor of bioethics at New York University. “I wish they would, but they just don’t.”

That’s partly because state laws require the boards to engage in lengthy, confidential investigations and adversarial legal processes before imposing disciplinary actions. The laws generally require patients or members of the public to file a complaint before an investigation can start. Some states, however, do allow their medical boards to take rapid emergency action if a physician poses an immediate threat to patients or the public.

Another hurdle is that medical boards that seek to sanction physicians for making dangerously misleading public statements could face lawsuits alleging that such actions violate the physicians’ constitutional free speech rights or their professional autonomy.

“We have free speech, and you can get away with a lot of stuff,” said Stephen Barrett, MD, who for many years has critically documented examples of medical fraud on his website, Quackwatch. “Some doctors would sue if they were challenged by medical boards, and I’m not sure the boards would win that court fight. People have written books with advice that killed people, and I’m not aware of a single case where the author was disciplined.”

In addition, it’s not clear that U.S. physicians who are not government officials have any legal obligation – as opposed to a moral obligation – to the government or the public to promote public health, said Jonathan Moreno, PhD, a professor of medical ethics at University of Pennsylvania, Philadelphia. “Is transmitting misinformation about COVID-19 public health malpractice?” he asked. “Do we as a society see physicians having a special role as guides in an emergency? I’d like to think we do, but we don’t have a strong tradition like that in the U.S.”

But California State Sen. Richard Pan, MD, a pediatrician who represents the Sacramento area, doesn’t buy the arguments about why medical boards can’t discipline physicians for spreading misinformation. He successfully sponsored a 2019 bill that strengthens the medical board’s ability to discipline physicians who dole out medically unjustified vaccine exemptions to children.

“A medical license is a privilege. It’s an imprimatur from the state that the person is someone who upholds professional standards,” Dr. Pan said. “If someone is intentionally spreading disinformation for personal gain and that’s putting the public at risk, the medical board has a duty to act.”

There have been only a few publicly announced disciplinary actions related to COVID-19 misinformation so far.

Last December, the Oregon Medical Board, on an emergency basis, suspended the license of Steven LaTulippe, MD, of Dallas, Ore. He had publicly announced that he and his staff were not wearing masks in his clinic. In addition, he compared COVID-19 to the common cold and denied the governor’s legal authority to adopt public health protection measures. A recorded message on his office phone said he’s challenging the licensure action in court.

Last January, the Medical Board of California made Thomas Cowan, MD, of San Francisco surrender his license after Dr. Cowan posted a YouTube video, which went viral last year, that claimed that 5G Internet networks cause COVID-19. He did not respond to a request for comment.

In May, the College of Physicians and Surgeons of British Columbia reprimanded Stephen Malthouse, MD, and forbade him from speaking on issues related to COVID-19. He had written a widely circulated open letter to the province’s chief health office claiming that the pandemic was “over” and that measures to control the spread of COVID-19 were worse than the virus. He has challenged the disciplinary action in court, alleging it violates his right to free speech.

Attacking the problem from a different angle, the U.S. Federal Trade Commission has issued enforcement actions in cases in which physicians and other health care professionals engaged in deceptive business practices related to COVID-19. That approach may be applicable to a number of physicians accused of spreading COVID-19 misinformation, who allegedly have done so at least partly to sell unproven products and services to prevent or treat the disease.

In June, the FTC settled a case against Stephen Meis, MD, of Porterville, Calif. The settlement required that he stop making unsupported claims that his company’s dietary supplements effectively treat COVID-19 symptoms and that he pay $103,420 in refunds to defrauded customers.

State medical boards in the United States generally are not allowed to disclose investigations or disciplinary processes until they finalize a disciplinary action, so other investigations that have not been publicly disclosed may be pending.

A spokesperson for the Medical Board of California said the board is aware of questionable statements about COVID-19 made by several physicians and “will be looking into it.” That comment was in response to a question about statements made at a news conference last year by two Bakersfield emergency physicians, Artin Massihi, MD, and Dan Erickson, DO. They claimed that their COVID-19 testing data showed that the virus is not that dangerous. Dr. Erickson is an osteopath and is regulated by the Osteopathic Medical Board of California.

The two physicians’ news conference prompted an unusual joint statement from the American College of Emergency Medicine and the American Academy of Emergency Medicine in April 2020 declaring that they “emphatically condemn” Dr. Massihi’s and Dr. Erickson’s “reckless and untested musings.” The groups added that it appeared that the physicians issued the comments “to advance their personal financial interests without regard for the public’s health.”

Neither Dr. Massihi nor Dr. Erickson responded to a request for comment.

As for the physician dubbed by the Center for Countering Digital Hate as the world’s most influential spreader of COVID-19 misinformation on social media: No recent public complaints have been filed, and no disciplinary action has been taken against Dr. Mercola, according to a spokesman for the Illinois Department of Financial and Professional Regulation.

According to court records, Dr. Mercola faced disciplinary complaints from the Illinois board in the early 2000s for allegedly providing false and potentially harmful medical advice on his website. There is no record of any final disciplinary action taken against him.

In widely disseminated online posts, Dr. Mercola has called the COVID-19 pandemic a “scam” and said “forced vaccination” is part of a plan to re-set the global economic system. He called COVID-19 vaccines “a medical fraud,” claiming they “alter your genetic coding.” In February, the U.S. Food and Drug Administration ordered Dr. Mercola to stop saying on his website that various vitamins and dietary supplements he sells through his website are effective in preventing or treating COVID-19.

 

 

The New York Times reported in July that Dr. Mercola’s English-language Facebook page has more than 1.7 million followers, that his Spanish-language page has one million, and that he has 300,000 followers on Twitter and 400,000 on YouTube.

In August, Dr. Mercola announced that he was deleting the large archive of articles he’s written on his website but would continue to post articles every day that would be available on the site for only 48 hours. He explained his decision by saying he’s facing “blatant censorship” as part of a “McCarthyism-like attack” from “the sitting President of the United States.” He encouraged people to read his book, “The Truth about COVID-19.”

The lack of action against Dr. Mercola for his lengthy list of scientifically unfounded statements and marketing claims about COVID-19 and other medical conditions infuriates Quackwatch’s Dr. Barrett. He’s amazed that the Illinois board did not discipline Dr. Mercola despite a number of enforcement actions against him by the FTC and the FDA.

“If a doctor were to say to a patient, ‘Don’t wear a mask and don’t get vaccinated,’ the doctor would be held responsible for a bad outcome,” he said. “But if you say it to millions and as a direct result a dozen people die, shouldn’t the doctor also be held responsible for that misinformation? I think he should lose his license.”

Another of the four physicians cited in the “Disinformation Dozen” report is Sherri Tenpenny, DO, an osteopath licensed in Ohio, who has published posts on social media advocating against masking, testing, and vaccines to prevent COVID-19 infections. A spokesperson for the State Medical Board of Ohio said Dr. Tenpenny’s license expires on Oct. 1, 2021, and that any investigation would be confidential. She added that grounds for disciplinary action include “making a false, fraudulent, deceptive, or misleading statement in relation to the practice of medicine and surgery.” Dr. Tenpenny could not be reached for comment.

A third physician named in the report is Christiane Northrup, MD, an ob.gyn. formerly licensed in Maine, who has published posts advocating unproven cures for COVID-19 and claiming that vaccines increase chronic illness. Dennis Smith, executive director of the Maine Board of Licensure in Medicine, said the board received complaints about Dr. Northrup’s posts but can’t act because she withdrew her Maine license in 2015. He added that the Maine board can issue sanctions against physicians who engage in fraud, deceit, or misrepresentation or who post scientifically unfounded statements online.

The fourth physician identified in the “Disinformation Dozen” report is Rashid Buttar, DO, an osteopath practicing in Mooresville, N.C., who has claimed in social media posts that COVID-19 vaccines cause infertility and that COVID-19 tests contain living microorganisms. A spokeswoman for the North Carolina Medical Board said she could not confirm or deny the existence of any investigation of Dr. Buttar, who signed a consent order with the medical board in 2010 following charges of exorbitant fees, worthless tests and treatment, and false diagnoses. Undisclosed conditions were placed on his medical license in 2013. The spokesperson added that the board would investigate any information alleging that a physician spread false information about COVID-19.

Another physician who has caused widespread consternation over scientifically unfounded statements about COVID-19 is Simone Gold, MD, formerly an emergency department physician in Los Angeles. She founded a group called America’s Frontline Doctors, which filed a federal lawsuit in Alabama this spring to block the FDA from issuing an emergency use authorization allowing teenagers to receive COVID-19 vaccinations. She called the vaccines “an experimental biological agent whose harms are well-documented.”

Last summer, Dr. Gold and other physicians in her group held a news conference on the steps of the U.S. Supreme Court Building promoting hydroxychloroquine as a COVID-19 treatment. They declared that masks don’t work and that the virus isn’t deadly, and made other false claims. The news conference was livestreamed by conservative media outlets, was promoted on Twitter by then-President Trump and his family, and was viewed online more than 14 million times.

One of the participating physicians, Stella Immanuel, MD, of Houston, claimed in a video that went viral that she had successfully used hydroxychloroquine for more than 400 patients to cure the disease. In response, the Texas Medical Board, without naming Dr. Immanuel, warned that if it received a complaint about any physician who made a false claim about having a cure for COVID-19, it would investigate and potentially take disciplinary action.

Although no publicly known disciplinary action has been taken against Dr. Gold, she told The Washington Post last January that after participating in that July 2020 news conference, she was fired from her emergency department job at two hospitals and that she hasn’t worked as a physician since. Dr. Gold did not respond to a request for comment.

The outcome in her situation is consistent with the view of NYU’s Dr. Caplan that methods other than medical board discipline – such as action by employers, social media pressure, and reprimands from professional societies –will have to be used to hold physicians accountable for spreading COVID-19 misinformation.

“I’m disappointed to have to say it, but I don’t think medical boards are going to be effective,” he said. “We don’t know how to manage misinformation despite being in a plague. We just don’t.

A version of this article first appeared on Medscape.com.

 

A tall, distinguished-looking physician in shirtsleeves and suspenders walked to the microphone at the Mt. Vernon, Ind., school board meeting on a Friday evening in early August. He launched into an impassioned, 7-minute attack on the public health establishment’s medical guidelines for COVID-19.

“The Center for Disease Control and the Indiana State [Department] of Health are giving you very bad scientific guidance,” said Daniel Stock, MD, a primary care physician with a concierge practice in Noblesville, Ind., He described himself as a “functional family medicine physician,” though he is not board certified in family medicine.

Dr. Stock told the school board members that COVID-19 vaccines are counterproductive because they make coronavirus infections worse. He claimed his treatment of “over 15” COVID-19 patients with vitamin D, ivermectin, and zinc has kept them out of the hospital, and that those treatments reduce mortality risk from the disease by 75%. (A study released in mid-August found that ivermectin is ineffective in treating COVID-19).

In response to Dr. Stock’s remarks, the state health department quickly issued a statement reaffirming that COVID-19 vaccines “are highly effective at preventing hospitalizations and deaths.” But by then, the YouTube video of Dr. Stock’s comments had garnered nearly 600,000 views as of Aug. 12 and had been shared over 10,000 times on Facebook. Opponents of COVID-19 vaccines and masking policies across the country have been citing his comments.

Across the country, state medical licensing boards and state and national medical associations are struggling with how to respond to scientifically baseless public statements about COVID-19 by some physicians such as Dr. Stock. They fear such statements are increasing public confusion and are heightening political conflict. Physicians accused of spreading false information include public officials such as Scott Atlas, MD, who served as President Donald Trump’s COVID-19 advisor, and Kentucky Sen. Rand Paul, an ophthalmologist, whose YouTube account was temporarily suspended in August after he posted a video disputing the effectiveness of masking in stopping the spread of COVID-19.

“That’s the problem – those types of viral videos of someone somewhere who thinks they know something the rest of us don’t,” lamented Jennifer Bryan, MD, board chair of the Mississippi State Medical Association. “I don’t know any good reason why a physician should be advising against vaccination. It’s appropriate for medical boards to look into those situations.”

The Federation of State Medical Boards agrees. In July, it warned that physicians who willfully spread false information about COVID-19 risk suspension or revocation of their medical license. The federation cited a “dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians.” That’s particularly dangerous, it said, because physicians enjoy a high degree of public credibility.

Medical boards will particularly examine cases in which there is a pattern of misinformation or disinformation showing that a physician poses a continuing threat to public health, said Hank Chaudhry, DO, the federation’s CEO. In some cases, he said, boards have contacted physicians and have persuaded them to voluntarily refrain from making false public statements, without taking disciplinary action.

“Words matter,” he said. “Physicians have a really big platform, whether they realize it or not. Misinformation or disinformation in the context of COVID can not only cause harm but also death. We felt it was appropriate to remind physicians to be careful.”

Although medical leaders stress that most physicians are promoting solid science on COVID-19, the London-based Center for Countering Digital Hate, in a May report titled “The Disinformation Dozen,” named four U.S. physicians among 12 people who it said produce 65% of the misleading claims and lies about COVID-19 vaccines that abound on Facebook, Instagram, and Twitter. The leading spreader of false claims, the group said, is Joseph Mercola, MD, an Illinois-licensed osteopath living in Cape Coral, Fla. He did not respond to requests for comment.

But so far, state licensing boards and federal and state medical associations generally have been reluctant to discipline or publicly call out physicians who have spread misinformation about the causes, treatments, vaccines, and prevention strategies for COVID-19. Some of these physicians, such as Dr. Mercola, have a long history predating the COVID-19 pandemic of disseminating scientifically baseless information, often in connection with their marketing of products and services.

For instance, the Medical Licensing Board of Indiana and the state attorney general’s office, which brings medical disciplinary actions, declined to comment on Dr. Stock’s public statements at the August school board meeting. When asked about Dr. Stock, the Indiana State Medical Association, without mentioning his name, said: “We urge Hoosier physicians to share the proven facts [about public health measures recommended by the CDC and the Indiana Department of Health] with their patients and their communities.” Dr. Stock did not respond to a request for comment.

Experts say state medical boards are ill equipped and are often unwilling to address the challenge of disciplining physicians who disseminate dangerously false medical information. That enforcement gap is particularly troubling in the middle of a deadly pandemic such as this one.

“Unless you can show a harm to an individual patient, it’s pretty tough to get the boards to do much,” said Art Caplan, PhD, a professor of bioethics at New York University. “I wish they would, but they just don’t.”

That’s partly because state laws require the boards to engage in lengthy, confidential investigations and adversarial legal processes before imposing disciplinary actions. The laws generally require patients or members of the public to file a complaint before an investigation can start. Some states, however, do allow their medical boards to take rapid emergency action if a physician poses an immediate threat to patients or the public.

Another hurdle is that medical boards that seek to sanction physicians for making dangerously misleading public statements could face lawsuits alleging that such actions violate the physicians’ constitutional free speech rights or their professional autonomy.

“We have free speech, and you can get away with a lot of stuff,” said Stephen Barrett, MD, who for many years has critically documented examples of medical fraud on his website, Quackwatch. “Some doctors would sue if they were challenged by medical boards, and I’m not sure the boards would win that court fight. People have written books with advice that killed people, and I’m not aware of a single case where the author was disciplined.”

In addition, it’s not clear that U.S. physicians who are not government officials have any legal obligation – as opposed to a moral obligation – to the government or the public to promote public health, said Jonathan Moreno, PhD, a professor of medical ethics at University of Pennsylvania, Philadelphia. “Is transmitting misinformation about COVID-19 public health malpractice?” he asked. “Do we as a society see physicians having a special role as guides in an emergency? I’d like to think we do, but we don’t have a strong tradition like that in the U.S.”

But California State Sen. Richard Pan, MD, a pediatrician who represents the Sacramento area, doesn’t buy the arguments about why medical boards can’t discipline physicians for spreading misinformation. He successfully sponsored a 2019 bill that strengthens the medical board’s ability to discipline physicians who dole out medically unjustified vaccine exemptions to children.

“A medical license is a privilege. It’s an imprimatur from the state that the person is someone who upholds professional standards,” Dr. Pan said. “If someone is intentionally spreading disinformation for personal gain and that’s putting the public at risk, the medical board has a duty to act.”

There have been only a few publicly announced disciplinary actions related to COVID-19 misinformation so far.

Last December, the Oregon Medical Board, on an emergency basis, suspended the license of Steven LaTulippe, MD, of Dallas, Ore. He had publicly announced that he and his staff were not wearing masks in his clinic. In addition, he compared COVID-19 to the common cold and denied the governor’s legal authority to adopt public health protection measures. A recorded message on his office phone said he’s challenging the licensure action in court.

Last January, the Medical Board of California made Thomas Cowan, MD, of San Francisco surrender his license after Dr. Cowan posted a YouTube video, which went viral last year, that claimed that 5G Internet networks cause COVID-19. He did not respond to a request for comment.

In May, the College of Physicians and Surgeons of British Columbia reprimanded Stephen Malthouse, MD, and forbade him from speaking on issues related to COVID-19. He had written a widely circulated open letter to the province’s chief health office claiming that the pandemic was “over” and that measures to control the spread of COVID-19 were worse than the virus. He has challenged the disciplinary action in court, alleging it violates his right to free speech.

Attacking the problem from a different angle, the U.S. Federal Trade Commission has issued enforcement actions in cases in which physicians and other health care professionals engaged in deceptive business practices related to COVID-19. That approach may be applicable to a number of physicians accused of spreading COVID-19 misinformation, who allegedly have done so at least partly to sell unproven products and services to prevent or treat the disease.

In June, the FTC settled a case against Stephen Meis, MD, of Porterville, Calif. The settlement required that he stop making unsupported claims that his company’s dietary supplements effectively treat COVID-19 symptoms and that he pay $103,420 in refunds to defrauded customers.

State medical boards in the United States generally are not allowed to disclose investigations or disciplinary processes until they finalize a disciplinary action, so other investigations that have not been publicly disclosed may be pending.

A spokesperson for the Medical Board of California said the board is aware of questionable statements about COVID-19 made by several physicians and “will be looking into it.” That comment was in response to a question about statements made at a news conference last year by two Bakersfield emergency physicians, Artin Massihi, MD, and Dan Erickson, DO. They claimed that their COVID-19 testing data showed that the virus is not that dangerous. Dr. Erickson is an osteopath and is regulated by the Osteopathic Medical Board of California.

The two physicians’ news conference prompted an unusual joint statement from the American College of Emergency Medicine and the American Academy of Emergency Medicine in April 2020 declaring that they “emphatically condemn” Dr. Massihi’s and Dr. Erickson’s “reckless and untested musings.” The groups added that it appeared that the physicians issued the comments “to advance their personal financial interests without regard for the public’s health.”

Neither Dr. Massihi nor Dr. Erickson responded to a request for comment.

As for the physician dubbed by the Center for Countering Digital Hate as the world’s most influential spreader of COVID-19 misinformation on social media: No recent public complaints have been filed, and no disciplinary action has been taken against Dr. Mercola, according to a spokesman for the Illinois Department of Financial and Professional Regulation.

According to court records, Dr. Mercola faced disciplinary complaints from the Illinois board in the early 2000s for allegedly providing false and potentially harmful medical advice on his website. There is no record of any final disciplinary action taken against him.

In widely disseminated online posts, Dr. Mercola has called the COVID-19 pandemic a “scam” and said “forced vaccination” is part of a plan to re-set the global economic system. He called COVID-19 vaccines “a medical fraud,” claiming they “alter your genetic coding.” In February, the U.S. Food and Drug Administration ordered Dr. Mercola to stop saying on his website that various vitamins and dietary supplements he sells through his website are effective in preventing or treating COVID-19.

 

 

The New York Times reported in July that Dr. Mercola’s English-language Facebook page has more than 1.7 million followers, that his Spanish-language page has one million, and that he has 300,000 followers on Twitter and 400,000 on YouTube.

In August, Dr. Mercola announced that he was deleting the large archive of articles he’s written on his website but would continue to post articles every day that would be available on the site for only 48 hours. He explained his decision by saying he’s facing “blatant censorship” as part of a “McCarthyism-like attack” from “the sitting President of the United States.” He encouraged people to read his book, “The Truth about COVID-19.”

The lack of action against Dr. Mercola for his lengthy list of scientifically unfounded statements and marketing claims about COVID-19 and other medical conditions infuriates Quackwatch’s Dr. Barrett. He’s amazed that the Illinois board did not discipline Dr. Mercola despite a number of enforcement actions against him by the FTC and the FDA.

“If a doctor were to say to a patient, ‘Don’t wear a mask and don’t get vaccinated,’ the doctor would be held responsible for a bad outcome,” he said. “But if you say it to millions and as a direct result a dozen people die, shouldn’t the doctor also be held responsible for that misinformation? I think he should lose his license.”

Another of the four physicians cited in the “Disinformation Dozen” report is Sherri Tenpenny, DO, an osteopath licensed in Ohio, who has published posts on social media advocating against masking, testing, and vaccines to prevent COVID-19 infections. A spokesperson for the State Medical Board of Ohio said Dr. Tenpenny’s license expires on Oct. 1, 2021, and that any investigation would be confidential. She added that grounds for disciplinary action include “making a false, fraudulent, deceptive, or misleading statement in relation to the practice of medicine and surgery.” Dr. Tenpenny could not be reached for comment.

A third physician named in the report is Christiane Northrup, MD, an ob.gyn. formerly licensed in Maine, who has published posts advocating unproven cures for COVID-19 and claiming that vaccines increase chronic illness. Dennis Smith, executive director of the Maine Board of Licensure in Medicine, said the board received complaints about Dr. Northrup’s posts but can’t act because she withdrew her Maine license in 2015. He added that the Maine board can issue sanctions against physicians who engage in fraud, deceit, or misrepresentation or who post scientifically unfounded statements online.

The fourth physician identified in the “Disinformation Dozen” report is Rashid Buttar, DO, an osteopath practicing in Mooresville, N.C., who has claimed in social media posts that COVID-19 vaccines cause infertility and that COVID-19 tests contain living microorganisms. A spokeswoman for the North Carolina Medical Board said she could not confirm or deny the existence of any investigation of Dr. Buttar, who signed a consent order with the medical board in 2010 following charges of exorbitant fees, worthless tests and treatment, and false diagnoses. Undisclosed conditions were placed on his medical license in 2013. The spokesperson added that the board would investigate any information alleging that a physician spread false information about COVID-19.

Another physician who has caused widespread consternation over scientifically unfounded statements about COVID-19 is Simone Gold, MD, formerly an emergency department physician in Los Angeles. She founded a group called America’s Frontline Doctors, which filed a federal lawsuit in Alabama this spring to block the FDA from issuing an emergency use authorization allowing teenagers to receive COVID-19 vaccinations. She called the vaccines “an experimental biological agent whose harms are well-documented.”

Last summer, Dr. Gold and other physicians in her group held a news conference on the steps of the U.S. Supreme Court Building promoting hydroxychloroquine as a COVID-19 treatment. They declared that masks don’t work and that the virus isn’t deadly, and made other false claims. The news conference was livestreamed by conservative media outlets, was promoted on Twitter by then-President Trump and his family, and was viewed online more than 14 million times.

One of the participating physicians, Stella Immanuel, MD, of Houston, claimed in a video that went viral that she had successfully used hydroxychloroquine for more than 400 patients to cure the disease. In response, the Texas Medical Board, without naming Dr. Immanuel, warned that if it received a complaint about any physician who made a false claim about having a cure for COVID-19, it would investigate and potentially take disciplinary action.

Although no publicly known disciplinary action has been taken against Dr. Gold, she told The Washington Post last January that after participating in that July 2020 news conference, she was fired from her emergency department job at two hospitals and that she hasn’t worked as a physician since. Dr. Gold did not respond to a request for comment.

The outcome in her situation is consistent with the view of NYU’s Dr. Caplan that methods other than medical board discipline – such as action by employers, social media pressure, and reprimands from professional societies –will have to be used to hold physicians accountable for spreading COVID-19 misinformation.

“I’m disappointed to have to say it, but I don’t think medical boards are going to be effective,” he said. “We don’t know how to manage misinformation despite being in a plague. We just don’t.

A version of this article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Delta whiplash: How the new surge is affecting mental health

Article Type
Changed

Thanks to the rollout of the COVID-19 vaccines, more than just flowers were blooming this past spring. People came out of lockdown like bears emerging from hibernation, making plans to reunite with friends and loved ones they hadn’t seen in months. But with the tremendous surge in cases brought by the Delta variant, this summer has been anything but sunny and carefree. Case counts have once more reached prevaccination levels. In a repeat of last summer, people are canceling travel plans, and the lead-up to the new school year has become fraught and stressful.

“This whiplash is causing people to feel a variety of emotions: disappointment, uncertainty, anxiety, possibly anger and frustration,” says Vaile Wright, Ph.D., senior director of health care innovation at the American Psychological Association. “When it seemed like there was a light at the end of the tunnel, and we have the tools to overcome [the virus], and we’re not really using them, it can be hard for people to understand.”
 

The importance of hope

For decades, researchers have been digging into the crucial role hopefulness plays in mental health. The vaccine rollout, earlier than anticipated, provided a much needed burst of hope after months of bad news.

“It was a feeling of almost euphoria in June: ‘We’re going to see everybody!’” says Rachel Goldenberg, a rabbi in Jackson Heights, NY. “We have a theme for our High Holidays, and this year’s is very hopeful: Sow in tears, reap in joy. It felt like the sowing in tears part was behind us, and we were looking forward to reaping in joy. Slowly but surely, with Delta, everything has turned upside down.”

For Roxanne Hawn, a writer in Golden, Colo., vaccination offered a glimpse of something like normal life.

“I wore cute clothes. I stopped and got takeout for lunch. I bought myself flowers. I even had a little uplifting soundtrack for that time of hope and relief,” she says. “With the Delta variant, it feels like that window of normalcy closed quickly.”

Having that little bit of hope dashed can wear down even the sturdiest spirits, says Marissa King, PhD, author of “Social Chemistry: Decoding the Elements of Human Connection”.

“There was a moment when we were able to reconnect, to experience joy and the hope of being able to revitalize relationships,” she says. “The loss of that hope and the fear of being isolated again is causing so much distress.”
 

A new kind of loneliness

When the pandemic started, mom of three Julie Schwietert Collazo formed a WhatsApp group with several friends who were taking lockdown seriously. They got each other through months of isolation and celebrated the idea of reopening. Then Ms. Collazo’s oldest got COVID, just 5 weeks before her 12th birthday, and their family went back into quarantine. Her moms’ group is no longer on the same page about precautions.

“Last year we were doing it together, and it made it feel a bit easier,” she says. “As things started to normalize, everybody started thinking and moving in different directions. It feels like we’re not working through the same issues collectively like before.”

Dr. King says the feeling Ms. Collazo describes is quite common these days.

“A profound sense of loneliness comes from feeling like you’re the only one,” she says. “There’s such disagreement about the best path forward, it can feel lonely just because you think differently.”
 

 

 

An epidemic of anxiety

As the Delta variant drives case numbers back up again, worries increase as well.

“Is this ever going to end?” asks Ms. Collazo. “Is this our new reality, constantly having to order our lives around COVID?”

This uneasiness affects our well-being.

The National Center for Health Statistics and the Census Bureau have monitored the nation’s mental health via the ongoing Household Pulse Survey during the pandemic. It asks participants about their symptoms of either anxiety or depression. Throughout, more people have reported feeling anxious than depressed.

Anxiety peaked around Thanksgiving and Christmas, with nearly 38% of people reporting symptoms. The first vaccines began to roll out around that time, and anxiety levels steadily went down through the spring and early summer, dipping below 25% in late June. But those numbers have begun to creep back up – the most recent data, which goes through Aug. 2, found 27% of Americans reporting symptoms of anxiety.

“Nervous is the new normal,” says Vivian Pender, MD, president of the American Psychiatric Association. “Uncertainty makes people feel anxious.”
 

Empathy vs. anger

The way politics play into basic measures like mask-wearing and vaccination adds its own layer of stress. Physical altercations have resulted: In Los Angeles, a participant was stabbed at an antivaccination protest. At an Austin, Tex., elementary school, angry parents physically and verbally assaulted teachers who wore masks. Things have gotten so heated, the Department of Homeland Security issued a National Terrorism Advisory System bulletin last week. It warns that extremists could use new COVID-driven public health restrictions as an excuse to commit domestic terrorism.

Anger goes in the opposite direction, too, with people who’ve been following recommended procedures becoming increasingly fed up with those who flout them. Those intense emotions may not lead to violence, but they do make it harder for us to feel secure.

“It’s a public health crisis, and it’s turned into something different. When we get into us/them situations, we start to lose empathy. Empathy is important to identify solutions and work together as a community,” says Dr. Wright. “That’s what sparks the anger: the sense of ‘You aren’t doing what you’re supposed to be doing.’”
 

How to cope

Loneliness, anxiety, and anger may be swirling all around you right now. But that doesn’t make you powerless to boost your mental health. These suggestions may help:

  • Trust your gut. If your community is reopening faster than feels comfortable to you, do whatever makes your family feel safe. “Ask yourself how you’re feeling, and use your feelings to guide your decisions,” says Dr. Pender. “Get more information, then follow the science.”
  • Stop judging yourself. If you’re feeling lonely or mourning the losses COVID has brought, don’t fight it, says Wright. “Let it be an emotion that comes and goes, and try to find ways to feel connected to other people.”
  • Practice self-care. It may sound simplistic, but eating healthy foods, exercising, and getting a good night’s sleep can all contribute to a more positive 
  • Try to ease anxiety. Meditation, calming self-talk, and soothing music can all lift your spirits. Or try diaphragmatic breathing: Breathe in for 5 seconds, hold for 2, and breathe out for 5. Even squeezing a stress ball can give you a tangible sense of 
  • Take action. Both Rabbi Goldenberg and Ms. Collazo, who runs a nonprofit that works to reunite immigrant families, say helping their community helps them feel better. “To sing and lead Shabbat services, even on Zoom, to see the faces of my people, it’s very healing,” says Rabbi Goldenberg. One small thing you can do: If you have family or friends who are hesitant about vaccination, Dr. Wright suggests having gentle conversations to convince them. “You can be way more influential than a celebrity,” she says.
  • Remember you’re not alone. Whether you’re physically isolated from others or just feel like nobody else is following the same protocols as you, there are ways to feel connected. “Reach out to people you’ve been close with in the past, but you may have lost touch,” says Dr. King. “It gives you an opportunity to rekindle joy. Particularly in this moment, when a lot of people are so afraid, it’s easier to reach out to those you already know than try to meet new people.” Dr. King’s research has found it takes as few as two close connections to make people feel supported.
  • Stay in the present. Instead of stressing over what’s already happened or worrying about what might still come, just think about today. “We’ve learned a lot about the coronavirus, and we’re still learning more,” says Dr. Wright. “We don’t know what the future looks like, but it won’t be like this forever.”

A version of this article first appeared on WebMD.com.

Publications
Topics
Sections

Thanks to the rollout of the COVID-19 vaccines, more than just flowers were blooming this past spring. People came out of lockdown like bears emerging from hibernation, making plans to reunite with friends and loved ones they hadn’t seen in months. But with the tremendous surge in cases brought by the Delta variant, this summer has been anything but sunny and carefree. Case counts have once more reached prevaccination levels. In a repeat of last summer, people are canceling travel plans, and the lead-up to the new school year has become fraught and stressful.

“This whiplash is causing people to feel a variety of emotions: disappointment, uncertainty, anxiety, possibly anger and frustration,” says Vaile Wright, Ph.D., senior director of health care innovation at the American Psychological Association. “When it seemed like there was a light at the end of the tunnel, and we have the tools to overcome [the virus], and we’re not really using them, it can be hard for people to understand.”
 

The importance of hope

For decades, researchers have been digging into the crucial role hopefulness plays in mental health. The vaccine rollout, earlier than anticipated, provided a much needed burst of hope after months of bad news.

“It was a feeling of almost euphoria in June: ‘We’re going to see everybody!’” says Rachel Goldenberg, a rabbi in Jackson Heights, NY. “We have a theme for our High Holidays, and this year’s is very hopeful: Sow in tears, reap in joy. It felt like the sowing in tears part was behind us, and we were looking forward to reaping in joy. Slowly but surely, with Delta, everything has turned upside down.”

For Roxanne Hawn, a writer in Golden, Colo., vaccination offered a glimpse of something like normal life.

“I wore cute clothes. I stopped and got takeout for lunch. I bought myself flowers. I even had a little uplifting soundtrack for that time of hope and relief,” she says. “With the Delta variant, it feels like that window of normalcy closed quickly.”

Having that little bit of hope dashed can wear down even the sturdiest spirits, says Marissa King, PhD, author of “Social Chemistry: Decoding the Elements of Human Connection”.

“There was a moment when we were able to reconnect, to experience joy and the hope of being able to revitalize relationships,” she says. “The loss of that hope and the fear of being isolated again is causing so much distress.”
 

A new kind of loneliness

When the pandemic started, mom of three Julie Schwietert Collazo formed a WhatsApp group with several friends who were taking lockdown seriously. They got each other through months of isolation and celebrated the idea of reopening. Then Ms. Collazo’s oldest got COVID, just 5 weeks before her 12th birthday, and their family went back into quarantine. Her moms’ group is no longer on the same page about precautions.

“Last year we were doing it together, and it made it feel a bit easier,” she says. “As things started to normalize, everybody started thinking and moving in different directions. It feels like we’re not working through the same issues collectively like before.”

Dr. King says the feeling Ms. Collazo describes is quite common these days.

“A profound sense of loneliness comes from feeling like you’re the only one,” she says. “There’s such disagreement about the best path forward, it can feel lonely just because you think differently.”
 

 

 

An epidemic of anxiety

As the Delta variant drives case numbers back up again, worries increase as well.

“Is this ever going to end?” asks Ms. Collazo. “Is this our new reality, constantly having to order our lives around COVID?”

This uneasiness affects our well-being.

The National Center for Health Statistics and the Census Bureau have monitored the nation’s mental health via the ongoing Household Pulse Survey during the pandemic. It asks participants about their symptoms of either anxiety or depression. Throughout, more people have reported feeling anxious than depressed.

Anxiety peaked around Thanksgiving and Christmas, with nearly 38% of people reporting symptoms. The first vaccines began to roll out around that time, and anxiety levels steadily went down through the spring and early summer, dipping below 25% in late June. But those numbers have begun to creep back up – the most recent data, which goes through Aug. 2, found 27% of Americans reporting symptoms of anxiety.

“Nervous is the new normal,” says Vivian Pender, MD, president of the American Psychiatric Association. “Uncertainty makes people feel anxious.”
 

Empathy vs. anger

The way politics play into basic measures like mask-wearing and vaccination adds its own layer of stress. Physical altercations have resulted: In Los Angeles, a participant was stabbed at an antivaccination protest. At an Austin, Tex., elementary school, angry parents physically and verbally assaulted teachers who wore masks. Things have gotten so heated, the Department of Homeland Security issued a National Terrorism Advisory System bulletin last week. It warns that extremists could use new COVID-driven public health restrictions as an excuse to commit domestic terrorism.

Anger goes in the opposite direction, too, with people who’ve been following recommended procedures becoming increasingly fed up with those who flout them. Those intense emotions may not lead to violence, but they do make it harder for us to feel secure.

“It’s a public health crisis, and it’s turned into something different. When we get into us/them situations, we start to lose empathy. Empathy is important to identify solutions and work together as a community,” says Dr. Wright. “That’s what sparks the anger: the sense of ‘You aren’t doing what you’re supposed to be doing.’”
 

How to cope

Loneliness, anxiety, and anger may be swirling all around you right now. But that doesn’t make you powerless to boost your mental health. These suggestions may help:

  • Trust your gut. If your community is reopening faster than feels comfortable to you, do whatever makes your family feel safe. “Ask yourself how you’re feeling, and use your feelings to guide your decisions,” says Dr. Pender. “Get more information, then follow the science.”
  • Stop judging yourself. If you’re feeling lonely or mourning the losses COVID has brought, don’t fight it, says Wright. “Let it be an emotion that comes and goes, and try to find ways to feel connected to other people.”
  • Practice self-care. It may sound simplistic, but eating healthy foods, exercising, and getting a good night’s sleep can all contribute to a more positive 
  • Try to ease anxiety. Meditation, calming self-talk, and soothing music can all lift your spirits. Or try diaphragmatic breathing: Breathe in for 5 seconds, hold for 2, and breathe out for 5. Even squeezing a stress ball can give you a tangible sense of 
  • Take action. Both Rabbi Goldenberg and Ms. Collazo, who runs a nonprofit that works to reunite immigrant families, say helping their community helps them feel better. “To sing and lead Shabbat services, even on Zoom, to see the faces of my people, it’s very healing,” says Rabbi Goldenberg. One small thing you can do: If you have family or friends who are hesitant about vaccination, Dr. Wright suggests having gentle conversations to convince them. “You can be way more influential than a celebrity,” she says.
  • Remember you’re not alone. Whether you’re physically isolated from others or just feel like nobody else is following the same protocols as you, there are ways to feel connected. “Reach out to people you’ve been close with in the past, but you may have lost touch,” says Dr. King. “It gives you an opportunity to rekindle joy. Particularly in this moment, when a lot of people are so afraid, it’s easier to reach out to those you already know than try to meet new people.” Dr. King’s research has found it takes as few as two close connections to make people feel supported.
  • Stay in the present. Instead of stressing over what’s already happened or worrying about what might still come, just think about today. “We’ve learned a lot about the coronavirus, and we’re still learning more,” says Dr. Wright. “We don’t know what the future looks like, but it won’t be like this forever.”

A version of this article first appeared on WebMD.com.

Thanks to the rollout of the COVID-19 vaccines, more than just flowers were blooming this past spring. People came out of lockdown like bears emerging from hibernation, making plans to reunite with friends and loved ones they hadn’t seen in months. But with the tremendous surge in cases brought by the Delta variant, this summer has been anything but sunny and carefree. Case counts have once more reached prevaccination levels. In a repeat of last summer, people are canceling travel plans, and the lead-up to the new school year has become fraught and stressful.

“This whiplash is causing people to feel a variety of emotions: disappointment, uncertainty, anxiety, possibly anger and frustration,” says Vaile Wright, Ph.D., senior director of health care innovation at the American Psychological Association. “When it seemed like there was a light at the end of the tunnel, and we have the tools to overcome [the virus], and we’re not really using them, it can be hard for people to understand.”
 

The importance of hope

For decades, researchers have been digging into the crucial role hopefulness plays in mental health. The vaccine rollout, earlier than anticipated, provided a much needed burst of hope after months of bad news.

“It was a feeling of almost euphoria in June: ‘We’re going to see everybody!’” says Rachel Goldenberg, a rabbi in Jackson Heights, NY. “We have a theme for our High Holidays, and this year’s is very hopeful: Sow in tears, reap in joy. It felt like the sowing in tears part was behind us, and we were looking forward to reaping in joy. Slowly but surely, with Delta, everything has turned upside down.”

For Roxanne Hawn, a writer in Golden, Colo., vaccination offered a glimpse of something like normal life.

“I wore cute clothes. I stopped and got takeout for lunch. I bought myself flowers. I even had a little uplifting soundtrack for that time of hope and relief,” she says. “With the Delta variant, it feels like that window of normalcy closed quickly.”

Having that little bit of hope dashed can wear down even the sturdiest spirits, says Marissa King, PhD, author of “Social Chemistry: Decoding the Elements of Human Connection”.

“There was a moment when we were able to reconnect, to experience joy and the hope of being able to revitalize relationships,” she says. “The loss of that hope and the fear of being isolated again is causing so much distress.”
 

A new kind of loneliness

When the pandemic started, mom of three Julie Schwietert Collazo formed a WhatsApp group with several friends who were taking lockdown seriously. They got each other through months of isolation and celebrated the idea of reopening. Then Ms. Collazo’s oldest got COVID, just 5 weeks before her 12th birthday, and their family went back into quarantine. Her moms’ group is no longer on the same page about precautions.

“Last year we were doing it together, and it made it feel a bit easier,” she says. “As things started to normalize, everybody started thinking and moving in different directions. It feels like we’re not working through the same issues collectively like before.”

Dr. King says the feeling Ms. Collazo describes is quite common these days.

“A profound sense of loneliness comes from feeling like you’re the only one,” she says. “There’s such disagreement about the best path forward, it can feel lonely just because you think differently.”
 

 

 

An epidemic of anxiety

As the Delta variant drives case numbers back up again, worries increase as well.

“Is this ever going to end?” asks Ms. Collazo. “Is this our new reality, constantly having to order our lives around COVID?”

This uneasiness affects our well-being.

The National Center for Health Statistics and the Census Bureau have monitored the nation’s mental health via the ongoing Household Pulse Survey during the pandemic. It asks participants about their symptoms of either anxiety or depression. Throughout, more people have reported feeling anxious than depressed.

Anxiety peaked around Thanksgiving and Christmas, with nearly 38% of people reporting symptoms. The first vaccines began to roll out around that time, and anxiety levels steadily went down through the spring and early summer, dipping below 25% in late June. But those numbers have begun to creep back up – the most recent data, which goes through Aug. 2, found 27% of Americans reporting symptoms of anxiety.

“Nervous is the new normal,” says Vivian Pender, MD, president of the American Psychiatric Association. “Uncertainty makes people feel anxious.”
 

Empathy vs. anger

The way politics play into basic measures like mask-wearing and vaccination adds its own layer of stress. Physical altercations have resulted: In Los Angeles, a participant was stabbed at an antivaccination protest. At an Austin, Tex., elementary school, angry parents physically and verbally assaulted teachers who wore masks. Things have gotten so heated, the Department of Homeland Security issued a National Terrorism Advisory System bulletin last week. It warns that extremists could use new COVID-driven public health restrictions as an excuse to commit domestic terrorism.

Anger goes in the opposite direction, too, with people who’ve been following recommended procedures becoming increasingly fed up with those who flout them. Those intense emotions may not lead to violence, but they do make it harder for us to feel secure.

“It’s a public health crisis, and it’s turned into something different. When we get into us/them situations, we start to lose empathy. Empathy is important to identify solutions and work together as a community,” says Dr. Wright. “That’s what sparks the anger: the sense of ‘You aren’t doing what you’re supposed to be doing.’”
 

How to cope

Loneliness, anxiety, and anger may be swirling all around you right now. But that doesn’t make you powerless to boost your mental health. These suggestions may help:

  • Trust your gut. If your community is reopening faster than feels comfortable to you, do whatever makes your family feel safe. “Ask yourself how you’re feeling, and use your feelings to guide your decisions,” says Dr. Pender. “Get more information, then follow the science.”
  • Stop judging yourself. If you’re feeling lonely or mourning the losses COVID has brought, don’t fight it, says Wright. “Let it be an emotion that comes and goes, and try to find ways to feel connected to other people.”
  • Practice self-care. It may sound simplistic, but eating healthy foods, exercising, and getting a good night’s sleep can all contribute to a more positive 
  • Try to ease anxiety. Meditation, calming self-talk, and soothing music can all lift your spirits. Or try diaphragmatic breathing: Breathe in for 5 seconds, hold for 2, and breathe out for 5. Even squeezing a stress ball can give you a tangible sense of 
  • Take action. Both Rabbi Goldenberg and Ms. Collazo, who runs a nonprofit that works to reunite immigrant families, say helping their community helps them feel better. “To sing and lead Shabbat services, even on Zoom, to see the faces of my people, it’s very healing,” says Rabbi Goldenberg. One small thing you can do: If you have family or friends who are hesitant about vaccination, Dr. Wright suggests having gentle conversations to convince them. “You can be way more influential than a celebrity,” she says.
  • Remember you’re not alone. Whether you’re physically isolated from others or just feel like nobody else is following the same protocols as you, there are ways to feel connected. “Reach out to people you’ve been close with in the past, but you may have lost touch,” says Dr. King. “It gives you an opportunity to rekindle joy. Particularly in this moment, when a lot of people are so afraid, it’s easier to reach out to those you already know than try to meet new people.” Dr. King’s research has found it takes as few as two close connections to make people feel supported.
  • Stay in the present. Instead of stressing over what’s already happened or worrying about what might still come, just think about today. “We’ve learned a lot about the coronavirus, and we’re still learning more,” says Dr. Wright. “We don’t know what the future looks like, but it won’t be like this forever.”

A version of this article first appeared on WebMD.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

CDC launches new center to watch for future outbreaks

Article Type
Changed

 

The Centers for Disease Control and Prevention is setting up a new hub to watch for early warning signs of future infectious outbreaks, the agency announced on Aug. 18.

Epidemiologists learn about emerging outbreaks by tracking information, and the quality of their analysis depends on their access to high-quality data. Gaps in existing systems became obvious during the COVID-19 pandemic as experts were challenged by the crisis.

The new Center for Forecasting and Outbreak Analytics will, in part, work like a meteorological office that tracks weather-related changes, only the center will track possible flareups in infectious disease.

The day after he took office, President Joe Biden pledged to modernize the country’s system for public health data. First funding for the initiative will come from the American Rescue Plan.

“We are excited to have the expertise and ability to model and forecast public health concerns and share information in real-time to activate governmental, private sector, and public actions in anticipation of threats both domestically and abroad,” CDC Director Rochelle Walensky, MD, said in a statement.
 

Devastating toll of COVID-19

Many world leaders are now responding to the destruction of the health crisis and are investing in new infrastructure. A July report from a G-20 panel calls for $75 billion in international financing for pandemic prevention and preparedness –twice as much as current spending levels.

Testifying in a congressional hearing, epidemiologist Caitlin Rivers, PhD, from the Johns Hopkins Center for Health Security, Baltimore, voiced the importance of never being caught unprepared again.

“We were unprepared to manage the emergence and swift global spread of the novel coronavirus, and we were late to recognize when it reached our shores. Those delays set us on a worse trajectory than we might have otherwise faced,” she said.

Dr. Rivers will join the new center’s leadership team as associate director working alongside Marc Lipsitch, PhD, director for science.

“The new center will meet a longstanding need for a national focal point to analyze data and forecast the trajectory of pandemics with the express goal of informing and improving decisions with the best available evidence,” Dr. Lipsitch said in the CDC’s news release announcing the new center.

Experts will map what data sources are needed to assist disease modelers and public health emergency responders tracking emerging problems that they can share with decision-makers. They will expand tracking capability and data sharing using open-source software and application programming with existing and new data streams from the public health ecosystem and elsewhere.

Dylan George, PhD, who will be the center’s director for operations, said in the CDC news release that the center will provide critical information to communities so they can respond.

“Pandemics threaten our families and communities at speed and scale – our response needs to move at speed and scale, too,” he said.

A version of this article first appeared on WebMD.com.

Publications
Topics
Sections

 

The Centers for Disease Control and Prevention is setting up a new hub to watch for early warning signs of future infectious outbreaks, the agency announced on Aug. 18.

Epidemiologists learn about emerging outbreaks by tracking information, and the quality of their analysis depends on their access to high-quality data. Gaps in existing systems became obvious during the COVID-19 pandemic as experts were challenged by the crisis.

The new Center for Forecasting and Outbreak Analytics will, in part, work like a meteorological office that tracks weather-related changes, only the center will track possible flareups in infectious disease.

The day after he took office, President Joe Biden pledged to modernize the country’s system for public health data. First funding for the initiative will come from the American Rescue Plan.

“We are excited to have the expertise and ability to model and forecast public health concerns and share information in real-time to activate governmental, private sector, and public actions in anticipation of threats both domestically and abroad,” CDC Director Rochelle Walensky, MD, said in a statement.
 

Devastating toll of COVID-19

Many world leaders are now responding to the destruction of the health crisis and are investing in new infrastructure. A July report from a G-20 panel calls for $75 billion in international financing for pandemic prevention and preparedness –twice as much as current spending levels.

Testifying in a congressional hearing, epidemiologist Caitlin Rivers, PhD, from the Johns Hopkins Center for Health Security, Baltimore, voiced the importance of never being caught unprepared again.

“We were unprepared to manage the emergence and swift global spread of the novel coronavirus, and we were late to recognize when it reached our shores. Those delays set us on a worse trajectory than we might have otherwise faced,” she said.

Dr. Rivers will join the new center’s leadership team as associate director working alongside Marc Lipsitch, PhD, director for science.

“The new center will meet a longstanding need for a national focal point to analyze data and forecast the trajectory of pandemics with the express goal of informing and improving decisions with the best available evidence,” Dr. Lipsitch said in the CDC’s news release announcing the new center.

Experts will map what data sources are needed to assist disease modelers and public health emergency responders tracking emerging problems that they can share with decision-makers. They will expand tracking capability and data sharing using open-source software and application programming with existing and new data streams from the public health ecosystem and elsewhere.

Dylan George, PhD, who will be the center’s director for operations, said in the CDC news release that the center will provide critical information to communities so they can respond.

“Pandemics threaten our families and communities at speed and scale – our response needs to move at speed and scale, too,” he said.

A version of this article first appeared on WebMD.com.

 

The Centers for Disease Control and Prevention is setting up a new hub to watch for early warning signs of future infectious outbreaks, the agency announced on Aug. 18.

Epidemiologists learn about emerging outbreaks by tracking information, and the quality of their analysis depends on their access to high-quality data. Gaps in existing systems became obvious during the COVID-19 pandemic as experts were challenged by the crisis.

The new Center for Forecasting and Outbreak Analytics will, in part, work like a meteorological office that tracks weather-related changes, only the center will track possible flareups in infectious disease.

The day after he took office, President Joe Biden pledged to modernize the country’s system for public health data. First funding for the initiative will come from the American Rescue Plan.

“We are excited to have the expertise and ability to model and forecast public health concerns and share information in real-time to activate governmental, private sector, and public actions in anticipation of threats both domestically and abroad,” CDC Director Rochelle Walensky, MD, said in a statement.
 

Devastating toll of COVID-19

Many world leaders are now responding to the destruction of the health crisis and are investing in new infrastructure. A July report from a G-20 panel calls for $75 billion in international financing for pandemic prevention and preparedness –twice as much as current spending levels.

Testifying in a congressional hearing, epidemiologist Caitlin Rivers, PhD, from the Johns Hopkins Center for Health Security, Baltimore, voiced the importance of never being caught unprepared again.

“We were unprepared to manage the emergence and swift global spread of the novel coronavirus, and we were late to recognize when it reached our shores. Those delays set us on a worse trajectory than we might have otherwise faced,” she said.

Dr. Rivers will join the new center’s leadership team as associate director working alongside Marc Lipsitch, PhD, director for science.

“The new center will meet a longstanding need for a national focal point to analyze data and forecast the trajectory of pandemics with the express goal of informing and improving decisions with the best available evidence,” Dr. Lipsitch said in the CDC’s news release announcing the new center.

Experts will map what data sources are needed to assist disease modelers and public health emergency responders tracking emerging problems that they can share with decision-makers. They will expand tracking capability and data sharing using open-source software and application programming with existing and new data streams from the public health ecosystem and elsewhere.

Dylan George, PhD, who will be the center’s director for operations, said in the CDC news release that the center will provide critical information to communities so they can respond.

“Pandemics threaten our families and communities at speed and scale – our response needs to move at speed and scale, too,” he said.

A version of this article first appeared on WebMD.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

How to pick the best face masks for children, according to the experts

Article Type
Changed

 

One essential back-to-school item for children this fall is a face mask – the Centers for Disease Control and Prevention and the American Academy of Pediatrics both recommend them – but finding one that’s actually protective for a child is not a straightforward task, as many parents can attest. 

There’s little in the way of official guidance or research to inform evidence-based recommendations on what type of face masks works best for children. 

Search for children’s face masks on Amazon and you’ll run into a smorgasbord of options: masks with three, four, or five layers, different designs, and different materials. There’s one company selling a mask it calls an m95 model, a term the company devised. 

It’s almost impossible to verify many of the claims being made by the manufacturers, or to know if they will fit your child’s face until you order some, which can get expensive.

But it’s worth looking for a good mask.  A large study of more than 1 million people being conducted online by Facebook and Carnegie Mellon University found that students who wore face masks in school had a reduced risk for testing positive for the virus and getting sick with COVID-19 symptoms. The study was published in June in the journal Science.
 

Delta more contagious

The Delta variant of the new coronavirus is much more contagious than previous versions of the virus. Studies have shown that infected people carry 1,000 times more virus in their noses and throats than with the viruses that circulated last winter and spring. They shed more viral particles into the air when they talk or yell or sing, making this COVID-19–causing virus much more transmissible than in the past.

What that means, says Kimberly Prather, PhD, an aerosol scientist and distinguished professor at the Scripps Institution of Oceanography in La Jolla, California, is that if it once took about 15 minutes of proximity to an infected person to catch the infection, that window of risk is now much shorter.

“If you believe the 15-minute magical number, now if you take 1,000 times the viral load, basically in 1 second you could inhale that same amount of virus. So it’s gone from 15 minutes to 1 second,” Dr. Prather said in an online seminar on school safety she helped to organize. 
 

A better mask

What that means is that we need to upgrade our face masks, switching away from ill-fitting fabric masks, which can offer varying degrees of protection depending on the number of layers and type of fabric that’s used, to more highly protective surgical masks or better yet, N95 respirators, which provide the highest level of filtration.

That’s harder to do for children, who have much smaller faces.

Any masks that gapes around the edges isn’t going to work well, no matter how well it filters.

“N95s are not made to fit kids. They do not come in kid sizes, so I do not recommend N95s for kids,” said Linsey Marr, an environmental engineer at Virginia Tech, who tests face masks in her lab.

Ms. Marr says parents need to consider the attributes masks in this order of priority: 

Comfort: “If your kid won’t wear it, it’s not helping at all,” she said.

Fit: “Leaks around the sides are like having a hole in your mask and aerosols carrying the virus can get right through,” Ms. Marr said.

Filtration: How well the mask blocks small particles.

One option to improve fit is to layer a fabric mask over a surgical mask. The fabric mask helps to hold the edges of the surgical mask more tightly to a person’s face.  The surgical mask creates better filtration.

Ms. Marr said KN94 or KN95 masks, which are being manufactured in China and Korea, are good choices. They offer nearly the same degree of filtration as an N95, and they fit closely to the face, to minimize leaks.
 

 

 

Check for counterfeits

The KN94 and KN95 masks for children are widely available, but Ms. Marr said parents do need to watch out for counterfeits, which don’t perform as well.

The National Institute for Occupational Safety and Health gives examples of counterfeit products here.

There’s also a type of cloth mask that has a built-in, edge-to-edge filter layer that is made for children.

“Some of these filter out more than 99% of particles and those can be very effective, if they fit well,” Ms. Marr said.

She has compiled and publicly posted a list of her recommendations for masks for children.

There’s also a new standard for face masks. It’s called ASTM F3502-21, and it’s published by an international organization that sets voluntary standards for thousands of products. To claim that a mask meets this standard, a manufacturer has to have its mask tested and demonstrate that it provides a certain level of filtration and breathability.

A version of this article first appeared on Medscape.com.

Publications
Topics
Sections

 

One essential back-to-school item for children this fall is a face mask – the Centers for Disease Control and Prevention and the American Academy of Pediatrics both recommend them – but finding one that’s actually protective for a child is not a straightforward task, as many parents can attest. 

There’s little in the way of official guidance or research to inform evidence-based recommendations on what type of face masks works best for children. 

Search for children’s face masks on Amazon and you’ll run into a smorgasbord of options: masks with three, four, or five layers, different designs, and different materials. There’s one company selling a mask it calls an m95 model, a term the company devised. 

It’s almost impossible to verify many of the claims being made by the manufacturers, or to know if they will fit your child’s face until you order some, which can get expensive.

But it’s worth looking for a good mask.  A large study of more than 1 million people being conducted online by Facebook and Carnegie Mellon University found that students who wore face masks in school had a reduced risk for testing positive for the virus and getting sick with COVID-19 symptoms. The study was published in June in the journal Science.
 

Delta more contagious

The Delta variant of the new coronavirus is much more contagious than previous versions of the virus. Studies have shown that infected people carry 1,000 times more virus in their noses and throats than with the viruses that circulated last winter and spring. They shed more viral particles into the air when they talk or yell or sing, making this COVID-19–causing virus much more transmissible than in the past.

What that means, says Kimberly Prather, PhD, an aerosol scientist and distinguished professor at the Scripps Institution of Oceanography in La Jolla, California, is that if it once took about 15 minutes of proximity to an infected person to catch the infection, that window of risk is now much shorter.

“If you believe the 15-minute magical number, now if you take 1,000 times the viral load, basically in 1 second you could inhale that same amount of virus. So it’s gone from 15 minutes to 1 second,” Dr. Prather said in an online seminar on school safety she helped to organize. 
 

A better mask

What that means is that we need to upgrade our face masks, switching away from ill-fitting fabric masks, which can offer varying degrees of protection depending on the number of layers and type of fabric that’s used, to more highly protective surgical masks or better yet, N95 respirators, which provide the highest level of filtration.

That’s harder to do for children, who have much smaller faces.

Any masks that gapes around the edges isn’t going to work well, no matter how well it filters.

“N95s are not made to fit kids. They do not come in kid sizes, so I do not recommend N95s for kids,” said Linsey Marr, an environmental engineer at Virginia Tech, who tests face masks in her lab.

Ms. Marr says parents need to consider the attributes masks in this order of priority: 

Comfort: “If your kid won’t wear it, it’s not helping at all,” she said.

Fit: “Leaks around the sides are like having a hole in your mask and aerosols carrying the virus can get right through,” Ms. Marr said.

Filtration: How well the mask blocks small particles.

One option to improve fit is to layer a fabric mask over a surgical mask. The fabric mask helps to hold the edges of the surgical mask more tightly to a person’s face.  The surgical mask creates better filtration.

Ms. Marr said KN94 or KN95 masks, which are being manufactured in China and Korea, are good choices. They offer nearly the same degree of filtration as an N95, and they fit closely to the face, to minimize leaks.
 

 

 

Check for counterfeits

The KN94 and KN95 masks for children are widely available, but Ms. Marr said parents do need to watch out for counterfeits, which don’t perform as well.

The National Institute for Occupational Safety and Health gives examples of counterfeit products here.

There’s also a type of cloth mask that has a built-in, edge-to-edge filter layer that is made for children.

“Some of these filter out more than 99% of particles and those can be very effective, if they fit well,” Ms. Marr said.

She has compiled and publicly posted a list of her recommendations for masks for children.

There’s also a new standard for face masks. It’s called ASTM F3502-21, and it’s published by an international organization that sets voluntary standards for thousands of products. To claim that a mask meets this standard, a manufacturer has to have its mask tested and demonstrate that it provides a certain level of filtration and breathability.

A version of this article first appeared on Medscape.com.

 

One essential back-to-school item for children this fall is a face mask – the Centers for Disease Control and Prevention and the American Academy of Pediatrics both recommend them – but finding one that’s actually protective for a child is not a straightforward task, as many parents can attest. 

There’s little in the way of official guidance or research to inform evidence-based recommendations on what type of face masks works best for children. 

Search for children’s face masks on Amazon and you’ll run into a smorgasbord of options: masks with three, four, or five layers, different designs, and different materials. There’s one company selling a mask it calls an m95 model, a term the company devised. 

It’s almost impossible to verify many of the claims being made by the manufacturers, or to know if they will fit your child’s face until you order some, which can get expensive.

But it’s worth looking for a good mask.  A large study of more than 1 million people being conducted online by Facebook and Carnegie Mellon University found that students who wore face masks in school had a reduced risk for testing positive for the virus and getting sick with COVID-19 symptoms. The study was published in June in the journal Science.
 

Delta more contagious

The Delta variant of the new coronavirus is much more contagious than previous versions of the virus. Studies have shown that infected people carry 1,000 times more virus in their noses and throats than with the viruses that circulated last winter and spring. They shed more viral particles into the air when they talk or yell or sing, making this COVID-19–causing virus much more transmissible than in the past.

What that means, says Kimberly Prather, PhD, an aerosol scientist and distinguished professor at the Scripps Institution of Oceanography in La Jolla, California, is that if it once took about 15 minutes of proximity to an infected person to catch the infection, that window of risk is now much shorter.

“If you believe the 15-minute magical number, now if you take 1,000 times the viral load, basically in 1 second you could inhale that same amount of virus. So it’s gone from 15 minutes to 1 second,” Dr. Prather said in an online seminar on school safety she helped to organize. 
 

A better mask

What that means is that we need to upgrade our face masks, switching away from ill-fitting fabric masks, which can offer varying degrees of protection depending on the number of layers and type of fabric that’s used, to more highly protective surgical masks or better yet, N95 respirators, which provide the highest level of filtration.

That’s harder to do for children, who have much smaller faces.

Any masks that gapes around the edges isn’t going to work well, no matter how well it filters.

“N95s are not made to fit kids. They do not come in kid sizes, so I do not recommend N95s for kids,” said Linsey Marr, an environmental engineer at Virginia Tech, who tests face masks in her lab.

Ms. Marr says parents need to consider the attributes masks in this order of priority: 

Comfort: “If your kid won’t wear it, it’s not helping at all,” she said.

Fit: “Leaks around the sides are like having a hole in your mask and aerosols carrying the virus can get right through,” Ms. Marr said.

Filtration: How well the mask blocks small particles.

One option to improve fit is to layer a fabric mask over a surgical mask. The fabric mask helps to hold the edges of the surgical mask more tightly to a person’s face.  The surgical mask creates better filtration.

Ms. Marr said KN94 or KN95 masks, which are being manufactured in China and Korea, are good choices. They offer nearly the same degree of filtration as an N95, and they fit closely to the face, to minimize leaks.
 

 

 

Check for counterfeits

The KN94 and KN95 masks for children are widely available, but Ms. Marr said parents do need to watch out for counterfeits, which don’t perform as well.

The National Institute for Occupational Safety and Health gives examples of counterfeit products here.

There’s also a type of cloth mask that has a built-in, edge-to-edge filter layer that is made for children.

“Some of these filter out more than 99% of particles and those can be very effective, if they fit well,” Ms. Marr said.

She has compiled and publicly posted a list of her recommendations for masks for children.

There’s also a new standard for face masks. It’s called ASTM F3502-21, and it’s published by an international organization that sets voluntary standards for thousands of products. To claim that a mask meets this standard, a manufacturer has to have its mask tested and demonstrate that it provides a certain level of filtration and breathability.

A version of this article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Tocilizumab shortage continues as pandemic wears on

Article Type
Changed

With worldwide supplies of tocilizumab dwindling as the COVID-19 pandemic rages on, a shortage of the agent will persist “for at least the next several weeks,” according to Genentech, the Roche unit that manufactures tocilizumab under the trade name Actemra IV.

The World Health Organization and Unitaid have called on Genentech to guarantee equitable distribution of the biologic agent globally and to ease up on technology transfer restrictions to make the treatment more accessible.

At this point, supplies of tocilizumab for subcutaneous use to treat rheumatoid arthritis and its other approved indications for inflammatory conditions aren’t as dire, but Genentech is watching them as well, the company says.

In June, the Food and Drug Administration issued an emergency use authorization for intravenous tocilizumab for hospitalized COVID-19 patients. Since then, it has been included in the WHO Therapeutics and COVID-19: living guideline. And on the same day Genentech and Roche reported the tocilizumab shortage, the European Medicines Agency posted a statement that it had started evaluating RoActemra, the European brand name for tocilizumab, for hospitalized COVID-19 patients.

The FDA authorization has caused an unprecedented run on supplies for the biologic agent, which is FDA approved to treat RA, giant cell arteritis, systemic sclerosis–associated interstitial lung disease, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome. 
 

Depleted stocks

In the United States, stocks of the 200- and 400-mg units were unavailable, according to an FDA update in mid-August on its website, and the 80-mg/4-mL unit is available by drop ship only. Supplies of 80-mg units were expected to be depleted by the end of the third week in August, Genentech said in a press release.

The company expects to resupply stocks by the end of August. “However,” the Genentech statement added, “if the pandemic continues to spread at its current pace, we anticipate additional periods of stockout in the weeks and months ahead.”

For patients with RA or other approved indications taking the subcutaneous formulation – pens and prefilled syringes – supplies continue to be available, but, the company added, “the supply situation continues to evolve.” The subcutaneous formulations aren’t authorized for use in COVID-19 patients. However, the American Society of Health-System Pharmacists’ website lists the 162-mg/0.9-mL prefilled syringe as one of the products affected by the shortage.

In a separate statement, Roche said that demand for tocilizumab increased 300% in developing countries over prepandemic orders, and that U.S. demand spiked more than 400% in the first 2 weeks of August.

Roche laid out four reasons for the shortage: global manufacturing capacity limits; raw material shortages; the overall complex process of manufacturing biologic agents; and “the dynamically evolving nature of the pandemic.”

The Roche statement noted the company ramped up manufacturing of tocilizumab more than 100% over prepandemic capacity.

With regard to issues WHO and Unitaid raised in their statement, Roche stated that about 60% of its COVID-19 supplies have gone to developing countries, and that Roche and partner Chugai – both of whom hold tocilizumab-related patents – won’t assert any patents over its use for COVID-19 in low- and middle-income countries (LMICs) during the pandemic.

“Roche is in the midst of discussions with WHO and we are committed to support access in LMICs as much as we can,” a Roche spokesperson said in an interview.

Blair Solow, MD, chair of the American College of Rheumatology’s government affairs committee, said the organization supports the equitable distribution of tocilizumab. “We will work to ensure that our patients continue to have access to the medications they need,” she said. “We will continue to engage with the FDA and others to address shortages and ensure patient access to critical therapies.”

The ACR said that any health care professionals having difficulty getting tocilizumab IV or any other COVID-19-related issues can contact the organization at COVID@rheumatology.org.

A version of this article first appeared on Medscape.com.

Publications
Topics
Sections

With worldwide supplies of tocilizumab dwindling as the COVID-19 pandemic rages on, a shortage of the agent will persist “for at least the next several weeks,” according to Genentech, the Roche unit that manufactures tocilizumab under the trade name Actemra IV.

The World Health Organization and Unitaid have called on Genentech to guarantee equitable distribution of the biologic agent globally and to ease up on technology transfer restrictions to make the treatment more accessible.

At this point, supplies of tocilizumab for subcutaneous use to treat rheumatoid arthritis and its other approved indications for inflammatory conditions aren’t as dire, but Genentech is watching them as well, the company says.

In June, the Food and Drug Administration issued an emergency use authorization for intravenous tocilizumab for hospitalized COVID-19 patients. Since then, it has been included in the WHO Therapeutics and COVID-19: living guideline. And on the same day Genentech and Roche reported the tocilizumab shortage, the European Medicines Agency posted a statement that it had started evaluating RoActemra, the European brand name for tocilizumab, for hospitalized COVID-19 patients.

The FDA authorization has caused an unprecedented run on supplies for the biologic agent, which is FDA approved to treat RA, giant cell arteritis, systemic sclerosis–associated interstitial lung disease, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome. 
 

Depleted stocks

In the United States, stocks of the 200- and 400-mg units were unavailable, according to an FDA update in mid-August on its website, and the 80-mg/4-mL unit is available by drop ship only. Supplies of 80-mg units were expected to be depleted by the end of the third week in August, Genentech said in a press release.

The company expects to resupply stocks by the end of August. “However,” the Genentech statement added, “if the pandemic continues to spread at its current pace, we anticipate additional periods of stockout in the weeks and months ahead.”

For patients with RA or other approved indications taking the subcutaneous formulation – pens and prefilled syringes – supplies continue to be available, but, the company added, “the supply situation continues to evolve.” The subcutaneous formulations aren’t authorized for use in COVID-19 patients. However, the American Society of Health-System Pharmacists’ website lists the 162-mg/0.9-mL prefilled syringe as one of the products affected by the shortage.

In a separate statement, Roche said that demand for tocilizumab increased 300% in developing countries over prepandemic orders, and that U.S. demand spiked more than 400% in the first 2 weeks of August.

Roche laid out four reasons for the shortage: global manufacturing capacity limits; raw material shortages; the overall complex process of manufacturing biologic agents; and “the dynamically evolving nature of the pandemic.”

The Roche statement noted the company ramped up manufacturing of tocilizumab more than 100% over prepandemic capacity.

With regard to issues WHO and Unitaid raised in their statement, Roche stated that about 60% of its COVID-19 supplies have gone to developing countries, and that Roche and partner Chugai – both of whom hold tocilizumab-related patents – won’t assert any patents over its use for COVID-19 in low- and middle-income countries (LMICs) during the pandemic.

“Roche is in the midst of discussions with WHO and we are committed to support access in LMICs as much as we can,” a Roche spokesperson said in an interview.

Blair Solow, MD, chair of the American College of Rheumatology’s government affairs committee, said the organization supports the equitable distribution of tocilizumab. “We will work to ensure that our patients continue to have access to the medications they need,” she said. “We will continue to engage with the FDA and others to address shortages and ensure patient access to critical therapies.”

The ACR said that any health care professionals having difficulty getting tocilizumab IV or any other COVID-19-related issues can contact the organization at COVID@rheumatology.org.

A version of this article first appeared on Medscape.com.

With worldwide supplies of tocilizumab dwindling as the COVID-19 pandemic rages on, a shortage of the agent will persist “for at least the next several weeks,” according to Genentech, the Roche unit that manufactures tocilizumab under the trade name Actemra IV.

The World Health Organization and Unitaid have called on Genentech to guarantee equitable distribution of the biologic agent globally and to ease up on technology transfer restrictions to make the treatment more accessible.

At this point, supplies of tocilizumab for subcutaneous use to treat rheumatoid arthritis and its other approved indications for inflammatory conditions aren’t as dire, but Genentech is watching them as well, the company says.

In June, the Food and Drug Administration issued an emergency use authorization for intravenous tocilizumab for hospitalized COVID-19 patients. Since then, it has been included in the WHO Therapeutics and COVID-19: living guideline. And on the same day Genentech and Roche reported the tocilizumab shortage, the European Medicines Agency posted a statement that it had started evaluating RoActemra, the European brand name for tocilizumab, for hospitalized COVID-19 patients.

The FDA authorization has caused an unprecedented run on supplies for the biologic agent, which is FDA approved to treat RA, giant cell arteritis, systemic sclerosis–associated interstitial lung disease, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome. 
 

Depleted stocks

In the United States, stocks of the 200- and 400-mg units were unavailable, according to an FDA update in mid-August on its website, and the 80-mg/4-mL unit is available by drop ship only. Supplies of 80-mg units were expected to be depleted by the end of the third week in August, Genentech said in a press release.

The company expects to resupply stocks by the end of August. “However,” the Genentech statement added, “if the pandemic continues to spread at its current pace, we anticipate additional periods of stockout in the weeks and months ahead.”

For patients with RA or other approved indications taking the subcutaneous formulation – pens and prefilled syringes – supplies continue to be available, but, the company added, “the supply situation continues to evolve.” The subcutaneous formulations aren’t authorized for use in COVID-19 patients. However, the American Society of Health-System Pharmacists’ website lists the 162-mg/0.9-mL prefilled syringe as one of the products affected by the shortage.

In a separate statement, Roche said that demand for tocilizumab increased 300% in developing countries over prepandemic orders, and that U.S. demand spiked more than 400% in the first 2 weeks of August.

Roche laid out four reasons for the shortage: global manufacturing capacity limits; raw material shortages; the overall complex process of manufacturing biologic agents; and “the dynamically evolving nature of the pandemic.”

The Roche statement noted the company ramped up manufacturing of tocilizumab more than 100% over prepandemic capacity.

With regard to issues WHO and Unitaid raised in their statement, Roche stated that about 60% of its COVID-19 supplies have gone to developing countries, and that Roche and partner Chugai – both of whom hold tocilizumab-related patents – won’t assert any patents over its use for COVID-19 in low- and middle-income countries (LMICs) during the pandemic.

“Roche is in the midst of discussions with WHO and we are committed to support access in LMICs as much as we can,” a Roche spokesperson said in an interview.

Blair Solow, MD, chair of the American College of Rheumatology’s government affairs committee, said the organization supports the equitable distribution of tocilizumab. “We will work to ensure that our patients continue to have access to the medications they need,” she said. “We will continue to engage with the FDA and others to address shortages and ensure patient access to critical therapies.”

The ACR said that any health care professionals having difficulty getting tocilizumab IV or any other COVID-19-related issues can contact the organization at COVID@rheumatology.org.

A version of this article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Vax campaign averted nearly 140,000 U.S. deaths through early May: Study

Article Type
Changed

From mid-December 2020 through early May 2021, there were 139,393 fewer deaths from COVID-19 and about 3.1 million fewer confirmed cases in the United States than would have been expected without the COVID-19 vaccination campaign, finds a new report published online in Health Affairs.

New York had 11.7 fewer COVID-19 deaths per 10,000 adults, and Hawaii had 1.1 fewer deaths per 10,000 than would have occurred without vaccinations, the study shows. The rest of the states fell somewhere in between, with the average state experiencing five fewer COVID-19 deaths per 10,000 adults.

At a national level, this means that instead of the 550,000 COVID-19 deaths that occurred by early May, there would have been 709,000 deaths in the absence of a vaccination campaign, according to the study.

Researchers from RAND and Indiana University created models to estimate the number of COVID-19 deaths that would have happened without vaccinations. The difference between the actual number of deaths and those estimates provides a measure of the number of COVID-19 deaths averted by the vaccination campaign.

Information about vaccine doses administered in each state came from the Bloomberg COVID-19 Vaccine Tracker, and data on COVID-19 deaths for each state came from The New York Times’ Coronavirus (COVID-19) Data in the United States database.

The study spanned the period from Dec. 21, 2020 to May 9, 2021. The U.S. Food and Drug Administration issued its first emergency use authorization (EUA) for a COVID-19 vaccine to Pfizer/BioNTech on December 11, followed by an EUA for the Moderna vaccine on December 18 and one for Johnson & Johnson’s vaccine on Feb. 27, 2021.
 

Varied by state

There were wide variations in the speed and extent of the vaccination campaigns in various states, the researchers found. For example, West Virginia was the first state to reach 10 doses per 100 adults, reaching that goal on Jan. 16, 2021, and Idaho was the last state to hit that mark, on Feb. 4, 2021. Alaska was the first to reach 20 doses per 100 adults, on January 29, and Alabama was the last to do it, on February 21.

On May 6, California was the first state to administer 120 doses per 100 adults, but many states have still not reached that milestone.

The median number of days between the milestones of 10 and 20 doses per 100 adults was 19 days, and the median number of days between 20 and 40 doses per 100 adults was 24 days.
 

Hard to establish causality

The researchers emphasized that “establishment of causality is challenging” in comparing individual states’ vaccination levels with their COVID-19 mortality rates.

Aside from the study being observational, they pointed out, the analysis “relied on variation in the administration of COVID-19 vaccines across states … Vaccine administration patterns may be associated with declining mortality because of vaccine prevention of deaths and severe complications as state-level vaccine campaigns allocated initial doses to the highest-risk populations with the aim of immediately reducing COVID-19 deaths.”

Nevertheless, the authors note, “clinical trial evidence has shown that COVID-19 vaccines have high efficacy. Our study provides support for policies that further expand vaccine administration, which will enable larger populations to benefit.”
 

 

 

Study confirms vaccine benefit

Aaron Glatt, MD, chair of medicine at Mount Sinai South Nassau in Oceanside, New York, and a spokesman for the Infectious Disease Society of America, said in an interview that the study is important because it confirms the benefit of COVID-19 vaccination.

Regardless of whether the study’s results are statistically valid, he said, “I don’t think anyone can argue the benefit isn’t there. It’s a question of how important the benefit is.”

Dr. Glatt is not surprised that there are variations across states in the number of COVID-19 deaths averted through vaccination. “Clearly, in states where there was a lot of disease, a significant amount of vaccination is going to impact that tremendously.”

The authors note that their paper has some limitations. For one thing, they couldn’t determine what share of the estimated reduction in COVID-19 deaths was a result of the proportion of the population that was vaccinated or had antibodies and what share was a result of lower population-level risk for COVID-19 transmission.
 

Vaccination versus natural immunity

In addition, the researchers weren’t able to identify the roles of vaccination, natural immunity, and changes in mobility in the numbers of COVID-19 deaths.

Dr. Glatt says that’s understandable, since this was a retrospective study, and the researchers didn’t know how many people had been infected with COVID-19 at some point. Moreover, he adds, scientists don’t know how strong natural immunity from prior infection is, how long it endures, or how robust it is against new variants.

“It’s clear to me that there’s a benefit in preventing the second episode of COVID in people who had a first episode of COVID,” he said. “What we don’t know is how much that benefit is and how long it will last.”

The researchers also didn’t know how many people had gotten both doses of the Pfizer or the Moderna vaccine and how many of them had received only one. This is an important piece of information, Dr. Glatt said, but the lack of it doesn’t impair the study’s overall finding.

“Every vaccine potentially prevents death,” he stressed. “The more we vaccinate, the more deaths we’ll prevent. We’re starting to see increased vaccinations again. There were a million of them yesterday. So people are recognizing that COVID hasn’t gone away, and we need to vaccinate more people. The benefit from the vaccination hasn’t decreased. The more we vaccinate, the more the benefit will be.”

A version of this article first appeared on Medscape.com.

Publications
Topics
Sections

From mid-December 2020 through early May 2021, there were 139,393 fewer deaths from COVID-19 and about 3.1 million fewer confirmed cases in the United States than would have been expected without the COVID-19 vaccination campaign, finds a new report published online in Health Affairs.

New York had 11.7 fewer COVID-19 deaths per 10,000 adults, and Hawaii had 1.1 fewer deaths per 10,000 than would have occurred without vaccinations, the study shows. The rest of the states fell somewhere in between, with the average state experiencing five fewer COVID-19 deaths per 10,000 adults.

At a national level, this means that instead of the 550,000 COVID-19 deaths that occurred by early May, there would have been 709,000 deaths in the absence of a vaccination campaign, according to the study.

Researchers from RAND and Indiana University created models to estimate the number of COVID-19 deaths that would have happened without vaccinations. The difference between the actual number of deaths and those estimates provides a measure of the number of COVID-19 deaths averted by the vaccination campaign.

Information about vaccine doses administered in each state came from the Bloomberg COVID-19 Vaccine Tracker, and data on COVID-19 deaths for each state came from The New York Times’ Coronavirus (COVID-19) Data in the United States database.

The study spanned the period from Dec. 21, 2020 to May 9, 2021. The U.S. Food and Drug Administration issued its first emergency use authorization (EUA) for a COVID-19 vaccine to Pfizer/BioNTech on December 11, followed by an EUA for the Moderna vaccine on December 18 and one for Johnson & Johnson’s vaccine on Feb. 27, 2021.
 

Varied by state

There were wide variations in the speed and extent of the vaccination campaigns in various states, the researchers found. For example, West Virginia was the first state to reach 10 doses per 100 adults, reaching that goal on Jan. 16, 2021, and Idaho was the last state to hit that mark, on Feb. 4, 2021. Alaska was the first to reach 20 doses per 100 adults, on January 29, and Alabama was the last to do it, on February 21.

On May 6, California was the first state to administer 120 doses per 100 adults, but many states have still not reached that milestone.

The median number of days between the milestones of 10 and 20 doses per 100 adults was 19 days, and the median number of days between 20 and 40 doses per 100 adults was 24 days.
 

Hard to establish causality

The researchers emphasized that “establishment of causality is challenging” in comparing individual states’ vaccination levels with their COVID-19 mortality rates.

Aside from the study being observational, they pointed out, the analysis “relied on variation in the administration of COVID-19 vaccines across states … Vaccine administration patterns may be associated with declining mortality because of vaccine prevention of deaths and severe complications as state-level vaccine campaigns allocated initial doses to the highest-risk populations with the aim of immediately reducing COVID-19 deaths.”

Nevertheless, the authors note, “clinical trial evidence has shown that COVID-19 vaccines have high efficacy. Our study provides support for policies that further expand vaccine administration, which will enable larger populations to benefit.”
 

 

 

Study confirms vaccine benefit

Aaron Glatt, MD, chair of medicine at Mount Sinai South Nassau in Oceanside, New York, and a spokesman for the Infectious Disease Society of America, said in an interview that the study is important because it confirms the benefit of COVID-19 vaccination.

Regardless of whether the study’s results are statistically valid, he said, “I don’t think anyone can argue the benefit isn’t there. It’s a question of how important the benefit is.”

Dr. Glatt is not surprised that there are variations across states in the number of COVID-19 deaths averted through vaccination. “Clearly, in states where there was a lot of disease, a significant amount of vaccination is going to impact that tremendously.”

The authors note that their paper has some limitations. For one thing, they couldn’t determine what share of the estimated reduction in COVID-19 deaths was a result of the proportion of the population that was vaccinated or had antibodies and what share was a result of lower population-level risk for COVID-19 transmission.
 

Vaccination versus natural immunity

In addition, the researchers weren’t able to identify the roles of vaccination, natural immunity, and changes in mobility in the numbers of COVID-19 deaths.

Dr. Glatt says that’s understandable, since this was a retrospective study, and the researchers didn’t know how many people had been infected with COVID-19 at some point. Moreover, he adds, scientists don’t know how strong natural immunity from prior infection is, how long it endures, or how robust it is against new variants.

“It’s clear to me that there’s a benefit in preventing the second episode of COVID in people who had a first episode of COVID,” he said. “What we don’t know is how much that benefit is and how long it will last.”

The researchers also didn’t know how many people had gotten both doses of the Pfizer or the Moderna vaccine and how many of them had received only one. This is an important piece of information, Dr. Glatt said, but the lack of it doesn’t impair the study’s overall finding.

“Every vaccine potentially prevents death,” he stressed. “The more we vaccinate, the more deaths we’ll prevent. We’re starting to see increased vaccinations again. There were a million of them yesterday. So people are recognizing that COVID hasn’t gone away, and we need to vaccinate more people. The benefit from the vaccination hasn’t decreased. The more we vaccinate, the more the benefit will be.”

A version of this article first appeared on Medscape.com.

From mid-December 2020 through early May 2021, there were 139,393 fewer deaths from COVID-19 and about 3.1 million fewer confirmed cases in the United States than would have been expected without the COVID-19 vaccination campaign, finds a new report published online in Health Affairs.

New York had 11.7 fewer COVID-19 deaths per 10,000 adults, and Hawaii had 1.1 fewer deaths per 10,000 than would have occurred without vaccinations, the study shows. The rest of the states fell somewhere in between, with the average state experiencing five fewer COVID-19 deaths per 10,000 adults.

At a national level, this means that instead of the 550,000 COVID-19 deaths that occurred by early May, there would have been 709,000 deaths in the absence of a vaccination campaign, according to the study.

Researchers from RAND and Indiana University created models to estimate the number of COVID-19 deaths that would have happened without vaccinations. The difference between the actual number of deaths and those estimates provides a measure of the number of COVID-19 deaths averted by the vaccination campaign.

Information about vaccine doses administered in each state came from the Bloomberg COVID-19 Vaccine Tracker, and data on COVID-19 deaths for each state came from The New York Times’ Coronavirus (COVID-19) Data in the United States database.

The study spanned the period from Dec. 21, 2020 to May 9, 2021. The U.S. Food and Drug Administration issued its first emergency use authorization (EUA) for a COVID-19 vaccine to Pfizer/BioNTech on December 11, followed by an EUA for the Moderna vaccine on December 18 and one for Johnson & Johnson’s vaccine on Feb. 27, 2021.
 

Varied by state

There were wide variations in the speed and extent of the vaccination campaigns in various states, the researchers found. For example, West Virginia was the first state to reach 10 doses per 100 adults, reaching that goal on Jan. 16, 2021, and Idaho was the last state to hit that mark, on Feb. 4, 2021. Alaska was the first to reach 20 doses per 100 adults, on January 29, and Alabama was the last to do it, on February 21.

On May 6, California was the first state to administer 120 doses per 100 adults, but many states have still not reached that milestone.

The median number of days between the milestones of 10 and 20 doses per 100 adults was 19 days, and the median number of days between 20 and 40 doses per 100 adults was 24 days.
 

Hard to establish causality

The researchers emphasized that “establishment of causality is challenging” in comparing individual states’ vaccination levels with their COVID-19 mortality rates.

Aside from the study being observational, they pointed out, the analysis “relied on variation in the administration of COVID-19 vaccines across states … Vaccine administration patterns may be associated with declining mortality because of vaccine prevention of deaths and severe complications as state-level vaccine campaigns allocated initial doses to the highest-risk populations with the aim of immediately reducing COVID-19 deaths.”

Nevertheless, the authors note, “clinical trial evidence has shown that COVID-19 vaccines have high efficacy. Our study provides support for policies that further expand vaccine administration, which will enable larger populations to benefit.”
 

 

 

Study confirms vaccine benefit

Aaron Glatt, MD, chair of medicine at Mount Sinai South Nassau in Oceanside, New York, and a spokesman for the Infectious Disease Society of America, said in an interview that the study is important because it confirms the benefit of COVID-19 vaccination.

Regardless of whether the study’s results are statistically valid, he said, “I don’t think anyone can argue the benefit isn’t there. It’s a question of how important the benefit is.”

Dr. Glatt is not surprised that there are variations across states in the number of COVID-19 deaths averted through vaccination. “Clearly, in states where there was a lot of disease, a significant amount of vaccination is going to impact that tremendously.”

The authors note that their paper has some limitations. For one thing, they couldn’t determine what share of the estimated reduction in COVID-19 deaths was a result of the proportion of the population that was vaccinated or had antibodies and what share was a result of lower population-level risk for COVID-19 transmission.
 

Vaccination versus natural immunity

In addition, the researchers weren’t able to identify the roles of vaccination, natural immunity, and changes in mobility in the numbers of COVID-19 deaths.

Dr. Glatt says that’s understandable, since this was a retrospective study, and the researchers didn’t know how many people had been infected with COVID-19 at some point. Moreover, he adds, scientists don’t know how strong natural immunity from prior infection is, how long it endures, or how robust it is against new variants.

“It’s clear to me that there’s a benefit in preventing the second episode of COVID in people who had a first episode of COVID,” he said. “What we don’t know is how much that benefit is and how long it will last.”

The researchers also didn’t know how many people had gotten both doses of the Pfizer or the Moderna vaccine and how many of them had received only one. This is an important piece of information, Dr. Glatt said, but the lack of it doesn’t impair the study’s overall finding.

“Every vaccine potentially prevents death,” he stressed. “The more we vaccinate, the more deaths we’ll prevent. We’re starting to see increased vaccinations again. There were a million of them yesterday. So people are recognizing that COVID hasn’t gone away, and we need to vaccinate more people. The benefit from the vaccination hasn’t decreased. The more we vaccinate, the more the benefit will be.”

A version of this article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Why are boosters being given after 8 months? Experts weigh in

Article Type
Changed

Following the White House administration’s announcement to start booster COVID-19 vaccinations for American adults in September, experts weighed in on the evidence for choosing an 8-month cutoff, how breakthrough infections figure in, and why calling one mRNA vaccine better than the other could be misleading.

Timing came up more than once at the Aug. 18 White House briefing announcing the booster plans. Reporters asked about the start time of Sept. 20 and people waiting at least 8 months after their second mRNA vaccine dose to get a booster.

Anthony Fauci, MD, chief medical adviser to the president and director of the National Institute of Allergy and Infectious Diseases, explained that late September gives the United States time to set up the logistics.

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, added that 8 months is in part based on data from Israel and other countries on the waning of vaccine effectiveness over time.

“It is possible that 8 [months] is associated with the amount of time that we’ve been able to follow large groups of people, especially those who are 65 and older,” Julie Swann, PhD, said during a subsequent media briefing sponsored by Newswise on Aug. 18. “I know that Pfizer has said that they think a booster sometime between 6 and 12 months would be reasonable.”

Dr. Swann supported the administration’s booster shots plan. She said it is important “that we continue to get people the full amount of protection if it’s recommended by CDC and ACIP [Advisory Committee on Immunization Practices] that would come from a booster shot.” Dr. Swann is department head and A. Doug Allison Distinguished Professor at North Carolina State University and an adjunct professor in the joint department of biomedical engineering at the University of North Carolina at Chapel Hill. 
 

Rising importance of breakthrough cases

Also on Aug. 18, news emerged that breakthrough cases are on the rise in seven U.S. states, likely because of the Delta variant.

These SARS-CoV-2 infections among the fully vaccinated account for 20% of cases in six of the seven states cited in a New York Times report, for example. Researchers also suggested that hospitalization and deaths associated with breakthrough cases could be higher than previously appreciated.

“It is expected that over time we will see more cases of Delta variant infections among vaccinated people. This points toward the need for booster vaccines and/or eventual modifications to the vaccine to capture new variants in the future,” Juan Wisnivesky, MD, DrPH, chief of the division of general internal medicine at Mount Sinai Health System in New York City, said during the briefing.
 

Vaccine comparisons unfair?

Following the release of a Mayo Clinic study reporting lower effectiveness of the Pfizer mRNA vaccine at 42% versus 76% for the Moderna product, some people started asking if one vaccine was better than the other.

“To begin with, the vaccines are not being compared side-by-side,” Dr. Wisnivesky said. “So we only know the effectiveness of each vaccine versus placebo, but we don’t know one versus the other.”

He added that different study designs, different populations, and other factors make direct comparisons difficult.

More evidence will be needed, Dr. Wisnivesky said, before public health officials can recommend that someone who received one mRNA vaccine switch to another for their booster shot.
 

 

 

Layering protections

Continuing to recommend masks is essential, Dr. Swann added. “With this Delta variant, it does appear that the possibility of reinfection or of a disease case breaking through vaccination can occur. So that makes it even more important to consider using nonpharmaceutical interventions while we continue to vaccinate people.”

Wearing or not wearing a mask is one of the behaviors that drive the transmission of disease, Dr. Swann said.

“What we saw across the board is that many people really wanted to go back to normal as much as they could. And we went back to normal a little bit too soon, especially given this new version of the virus that was circulating,” she said.
 

In poll, most favor boosters

A recent poll conducted by Medscape indicates that a majority of vaccinated physicians and nurses are ready and willing to take a COVID-19 booster vaccine. For example, 93% of 943 doctors and 87% of 1,680 nurses who responded want booster shots, either immediately or when they are authorized and recommended.

Among 510 WebMD readers responding to a similar poll, 82% indicated they wanted a booster shot.
 

A challenging task lies ahead

According to CDC data, as of Aug. 18, 2021, almost 169 million Americans are fully vaccinated, including the one-shot Johnson & Johnson adenovirus vaccine.

“I think it will be a challenge to get everyone who is fully vaccinated to come in for that booster,” Dr. Swann said.

Logistically speaking, Dr. Swann explained that many sites that were open for initial vaccinations, including drive-up locations and 24/7 vaccination sites, are no longer operating.

“We might see that rollout look a little bit differently. You might be able to go to your pharmacy or go to your primary care physician,” she said.

“But we may not see as many weekend events so it is going to be easier to get some people a booster than others.

“One interesting thing will also be whether a booster is effective in actually preventing you from giving a disease to someone else,” Dr. Swann said. “That could make a difference as well, because that might play into whether companies, hospitals, universities, or others require a booster.”

A version of this article first appeared on Medscape.com.

Publications
Topics
Sections

Following the White House administration’s announcement to start booster COVID-19 vaccinations for American adults in September, experts weighed in on the evidence for choosing an 8-month cutoff, how breakthrough infections figure in, and why calling one mRNA vaccine better than the other could be misleading.

Timing came up more than once at the Aug. 18 White House briefing announcing the booster plans. Reporters asked about the start time of Sept. 20 and people waiting at least 8 months after their second mRNA vaccine dose to get a booster.

Anthony Fauci, MD, chief medical adviser to the president and director of the National Institute of Allergy and Infectious Diseases, explained that late September gives the United States time to set up the logistics.

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, added that 8 months is in part based on data from Israel and other countries on the waning of vaccine effectiveness over time.

“It is possible that 8 [months] is associated with the amount of time that we’ve been able to follow large groups of people, especially those who are 65 and older,” Julie Swann, PhD, said during a subsequent media briefing sponsored by Newswise on Aug. 18. “I know that Pfizer has said that they think a booster sometime between 6 and 12 months would be reasonable.”

Dr. Swann supported the administration’s booster shots plan. She said it is important “that we continue to get people the full amount of protection if it’s recommended by CDC and ACIP [Advisory Committee on Immunization Practices] that would come from a booster shot.” Dr. Swann is department head and A. Doug Allison Distinguished Professor at North Carolina State University and an adjunct professor in the joint department of biomedical engineering at the University of North Carolina at Chapel Hill. 
 

Rising importance of breakthrough cases

Also on Aug. 18, news emerged that breakthrough cases are on the rise in seven U.S. states, likely because of the Delta variant.

These SARS-CoV-2 infections among the fully vaccinated account for 20% of cases in six of the seven states cited in a New York Times report, for example. Researchers also suggested that hospitalization and deaths associated with breakthrough cases could be higher than previously appreciated.

“It is expected that over time we will see more cases of Delta variant infections among vaccinated people. This points toward the need for booster vaccines and/or eventual modifications to the vaccine to capture new variants in the future,” Juan Wisnivesky, MD, DrPH, chief of the division of general internal medicine at Mount Sinai Health System in New York City, said during the briefing.
 

Vaccine comparisons unfair?

Following the release of a Mayo Clinic study reporting lower effectiveness of the Pfizer mRNA vaccine at 42% versus 76% for the Moderna product, some people started asking if one vaccine was better than the other.

“To begin with, the vaccines are not being compared side-by-side,” Dr. Wisnivesky said. “So we only know the effectiveness of each vaccine versus placebo, but we don’t know one versus the other.”

He added that different study designs, different populations, and other factors make direct comparisons difficult.

More evidence will be needed, Dr. Wisnivesky said, before public health officials can recommend that someone who received one mRNA vaccine switch to another for their booster shot.
 

 

 

Layering protections

Continuing to recommend masks is essential, Dr. Swann added. “With this Delta variant, it does appear that the possibility of reinfection or of a disease case breaking through vaccination can occur. So that makes it even more important to consider using nonpharmaceutical interventions while we continue to vaccinate people.”

Wearing or not wearing a mask is one of the behaviors that drive the transmission of disease, Dr. Swann said.

“What we saw across the board is that many people really wanted to go back to normal as much as they could. And we went back to normal a little bit too soon, especially given this new version of the virus that was circulating,” she said.
 

In poll, most favor boosters

A recent poll conducted by Medscape indicates that a majority of vaccinated physicians and nurses are ready and willing to take a COVID-19 booster vaccine. For example, 93% of 943 doctors and 87% of 1,680 nurses who responded want booster shots, either immediately or when they are authorized and recommended.

Among 510 WebMD readers responding to a similar poll, 82% indicated they wanted a booster shot.
 

A challenging task lies ahead

According to CDC data, as of Aug. 18, 2021, almost 169 million Americans are fully vaccinated, including the one-shot Johnson & Johnson adenovirus vaccine.

“I think it will be a challenge to get everyone who is fully vaccinated to come in for that booster,” Dr. Swann said.

Logistically speaking, Dr. Swann explained that many sites that were open for initial vaccinations, including drive-up locations and 24/7 vaccination sites, are no longer operating.

“We might see that rollout look a little bit differently. You might be able to go to your pharmacy or go to your primary care physician,” she said.

“But we may not see as many weekend events so it is going to be easier to get some people a booster than others.

“One interesting thing will also be whether a booster is effective in actually preventing you from giving a disease to someone else,” Dr. Swann said. “That could make a difference as well, because that might play into whether companies, hospitals, universities, or others require a booster.”

A version of this article first appeared on Medscape.com.

Following the White House administration’s announcement to start booster COVID-19 vaccinations for American adults in September, experts weighed in on the evidence for choosing an 8-month cutoff, how breakthrough infections figure in, and why calling one mRNA vaccine better than the other could be misleading.

Timing came up more than once at the Aug. 18 White House briefing announcing the booster plans. Reporters asked about the start time of Sept. 20 and people waiting at least 8 months after their second mRNA vaccine dose to get a booster.

Anthony Fauci, MD, chief medical adviser to the president and director of the National Institute of Allergy and Infectious Diseases, explained that late September gives the United States time to set up the logistics.

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, added that 8 months is in part based on data from Israel and other countries on the waning of vaccine effectiveness over time.

“It is possible that 8 [months] is associated with the amount of time that we’ve been able to follow large groups of people, especially those who are 65 and older,” Julie Swann, PhD, said during a subsequent media briefing sponsored by Newswise on Aug. 18. “I know that Pfizer has said that they think a booster sometime between 6 and 12 months would be reasonable.”

Dr. Swann supported the administration’s booster shots plan. She said it is important “that we continue to get people the full amount of protection if it’s recommended by CDC and ACIP [Advisory Committee on Immunization Practices] that would come from a booster shot.” Dr. Swann is department head and A. Doug Allison Distinguished Professor at North Carolina State University and an adjunct professor in the joint department of biomedical engineering at the University of North Carolina at Chapel Hill. 
 

Rising importance of breakthrough cases

Also on Aug. 18, news emerged that breakthrough cases are on the rise in seven U.S. states, likely because of the Delta variant.

These SARS-CoV-2 infections among the fully vaccinated account for 20% of cases in six of the seven states cited in a New York Times report, for example. Researchers also suggested that hospitalization and deaths associated with breakthrough cases could be higher than previously appreciated.

“It is expected that over time we will see more cases of Delta variant infections among vaccinated people. This points toward the need for booster vaccines and/or eventual modifications to the vaccine to capture new variants in the future,” Juan Wisnivesky, MD, DrPH, chief of the division of general internal medicine at Mount Sinai Health System in New York City, said during the briefing.
 

Vaccine comparisons unfair?

Following the release of a Mayo Clinic study reporting lower effectiveness of the Pfizer mRNA vaccine at 42% versus 76% for the Moderna product, some people started asking if one vaccine was better than the other.

“To begin with, the vaccines are not being compared side-by-side,” Dr. Wisnivesky said. “So we only know the effectiveness of each vaccine versus placebo, but we don’t know one versus the other.”

He added that different study designs, different populations, and other factors make direct comparisons difficult.

More evidence will be needed, Dr. Wisnivesky said, before public health officials can recommend that someone who received one mRNA vaccine switch to another for their booster shot.
 

 

 

Layering protections

Continuing to recommend masks is essential, Dr. Swann added. “With this Delta variant, it does appear that the possibility of reinfection or of a disease case breaking through vaccination can occur. So that makes it even more important to consider using nonpharmaceutical interventions while we continue to vaccinate people.”

Wearing or not wearing a mask is one of the behaviors that drive the transmission of disease, Dr. Swann said.

“What we saw across the board is that many people really wanted to go back to normal as much as they could. And we went back to normal a little bit too soon, especially given this new version of the virus that was circulating,” she said.
 

In poll, most favor boosters

A recent poll conducted by Medscape indicates that a majority of vaccinated physicians and nurses are ready and willing to take a COVID-19 booster vaccine. For example, 93% of 943 doctors and 87% of 1,680 nurses who responded want booster shots, either immediately or when they are authorized and recommended.

Among 510 WebMD readers responding to a similar poll, 82% indicated they wanted a booster shot.
 

A challenging task lies ahead

According to CDC data, as of Aug. 18, 2021, almost 169 million Americans are fully vaccinated, including the one-shot Johnson & Johnson adenovirus vaccine.

“I think it will be a challenge to get everyone who is fully vaccinated to come in for that booster,” Dr. Swann said.

Logistically speaking, Dr. Swann explained that many sites that were open for initial vaccinations, including drive-up locations and 24/7 vaccination sites, are no longer operating.

“We might see that rollout look a little bit differently. You might be able to go to your pharmacy or go to your primary care physician,” she said.

“But we may not see as many weekend events so it is going to be easier to get some people a booster than others.

“One interesting thing will also be whether a booster is effective in actually preventing you from giving a disease to someone else,” Dr. Swann said. “That could make a difference as well, because that might play into whether companies, hospitals, universities, or others require a booster.”

A version of this article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Medicinal liquor and edited mosquitoes

Article Type
Changed

 

Drink to your health?

Whether you drink or not, most of us can agree that liquor is not the first thing that comes to mind when looking to make health improvements. But researchers have found a small exception in something traditional.

Xvision/Moment

We’ve added buckwheat to pancakes, bread, and other baked goodies we made during the height of quarantine, but it’s also used to create a traditional liquor in some East Asian countries, where it is used medicinally.

Investigators have found that extracts in the Tartary buckwheat used to make the liquor induce autophagy, a process cells go through to remove proteins that are damaged or not needed anymore – sort of like a cellular spring cleaning.

To test this, the researchers treated liver and skin cells with Tartary buckwheat extract and looked to see how the cells responded with fluorescent markers. The results were clear.

“Treating cells with the extract stimulated the formation of autophagosomes, specialized cellular structures that carry out autophagy, and altered the location of proteins involved in regulating autophagy,” said senior author Takeshi Noda of Osaka (Japan) University.

Looking deeper, the researchers found that quercetin, a component of the buckwheat extract, had the same autophagic effect. And both the buckwheat and the quercetin gave the green light for liver cells to induce aggrephagy, the process of cleaning up protein aggregates.

Those protein aggregates in liver cells are closely linked to alcoholic liver disease, suggesting that quercetin could be a game changer in its treatment. In other words, liquor could help fix the problem that liquor started. Go figure.
 

From hospital bills to X-rated

Ralph Puglisi was an accounting manager for the University Medical Service Association (UMSA), a nonprofit that supports the massive University of South Florida health system. The association took in over $300 million in revenue in the 2019-2020 fiscal year, which is a rather large sum of money, but we’ll glide over the ethics of a “nonprofit” making a few hundred million for now.

wakila/Getty Images

Mr. Puglisi was in very close proximity to the money, generated from patient care, and he pled guilty to stealing it using UMSA credit cards. Now, that wouldn’t be LOTME worthy on its own, but what elevates this above garden-variety embezzlement is how the intrepid Mr. Puglisi chose to spend the millions he stole from the university health system: Adult entertainment.

And before you ask, he didn’t spend $11.5 million on something most people so inclined can find for free with judicious Google searches. What Mr. Puglisi actually did was invest in a website providing adult content through individual user profiles, one of which is believed to belong to his stepson’s fiancée, which brings a whole new level of sleaze to this enterprise. Over the course of 2 years, he visited her profile 2,800 times, an amount some might view as excessive.

While the vast majority of the embezzled money went to the adult website, Mr. Puglisi also used thousands of UMSA dollars to pay for travel, household improvements, rent, the works. Almost $44,000 was spent at a resort sometimes known as the happiest place on earth.

Then there’s Mr. Puglisi’s wife. Oh yes, this guy is married. He poured over $600,000 into a company he and his wife owned, which is a lot, but how much do you think went to the woman he married? Probably quite a bit. Go ahead, try to think of a number. It’s not like it was his money.

Did you guess $100 went into his wife’s PayPal account? No? Clearly you don’t understand the criminal mind. His stepson’s fiancée got millions, and his wife got a hundred. Now there are some priorities.
 

 

 

Step 1: Sit at desk. Step 2: Get in shape

Being a physician is not really a desk job, but doctors must spend a fair share of their time sitting, yes? Dealing with recalcitrant EHRs or talking on the phone to insurers or PBMs? If you are one of these physicians, or if you have patients who spend a lot of time sitting at their desks and might need to get a bit of exercise, then we’ve got a multitasking tip for you.

Mohamed Hassan/pxhere

It came to us via one of our favorite websites, Sad and Useless. It’s the site that declares itself “the most depressive humor site on the Internet” and they’re offering up the “12 Best Exercises To Do At Your Desk.” It may not sound like much, but we think that the gang at Dunder-Mifflin would approve. And besides, who couldn’t stand to burn a few calories without having to leave the chair?

We won’t spoil your fun by going through all 12 – each one comes with step-by-step instructions and a helpful illustration or GIF – but here are just a few:

  • Bending over backwards: “Agree to do something you don’t want to do. Spend twice as long as expected doing that thing. Hate yourself.”
  • Fake laughter: “Hear a joke that isn’t even remotely funny. Open your mouth and make laughing sounds.”
  • Bang your head: Feel the “pointlessness of your job overwhelm you” and then “bring your head forcefully down to your desk.”

Now, we here at LOTME are, of course [Bang!], highly skilled, professional wordsmithing humorists [Bang!], so when we tell you that this is a great workout [Bang!] … that this is a great workout [Bang!] … it’s great … uggh.

Wooooo. Feel the burn.
 

One order of mosquitoes, extra Crispr

What would it be like to have a barbecue in your backyard on a humid summer night and not get eaten alive by mosquitoes? If you’re like us, you probably thought you’d never see that day.

©TacioPhilip/Thinkstock

Mosquitoes cause itchy bites, but, more importantly, they can carry dengue, malaria, yellow fever, and Zika virus. New research shows that protection from these diseases may be possible with use of the Crispr-Cas9 gene-editing tool, which could make humans invisible to mosquitoes by taking away their light-sensing abilities and, thus, their ability to find us.

“The better we understand how they sense the human, the better we can control the mosquito in an eco-friendly manner,” Yinpeng Zhan, a postdoctoral researcher at the University of California, Santa Barbara, and the study’s lead author, told the New York Times.

After studying the mosquitoes and figuring out their hunting patterns, the researchers found that mosquitoes are attracted to dark spots more than white spots and used this to their advantage. After knocking out two of the proteins that mosquitoes need for vision – via Crispr – the little suckers could not distinguish the difference between the white and dark spots.

We’re sure mosquitoes don’t mean any harm – they’re just trying to survive and reproduce like any other species – but thanks to this new tool, gone might be the days of having to douse yourself in bug spray that smells like a mix of chemicals and melon.

Publications
Topics
Sections

 

Drink to your health?

Whether you drink or not, most of us can agree that liquor is not the first thing that comes to mind when looking to make health improvements. But researchers have found a small exception in something traditional.

Xvision/Moment

We’ve added buckwheat to pancakes, bread, and other baked goodies we made during the height of quarantine, but it’s also used to create a traditional liquor in some East Asian countries, where it is used medicinally.

Investigators have found that extracts in the Tartary buckwheat used to make the liquor induce autophagy, a process cells go through to remove proteins that are damaged or not needed anymore – sort of like a cellular spring cleaning.

To test this, the researchers treated liver and skin cells with Tartary buckwheat extract and looked to see how the cells responded with fluorescent markers. The results were clear.

“Treating cells with the extract stimulated the formation of autophagosomes, specialized cellular structures that carry out autophagy, and altered the location of proteins involved in regulating autophagy,” said senior author Takeshi Noda of Osaka (Japan) University.

Looking deeper, the researchers found that quercetin, a component of the buckwheat extract, had the same autophagic effect. And both the buckwheat and the quercetin gave the green light for liver cells to induce aggrephagy, the process of cleaning up protein aggregates.

Those protein aggregates in liver cells are closely linked to alcoholic liver disease, suggesting that quercetin could be a game changer in its treatment. In other words, liquor could help fix the problem that liquor started. Go figure.
 

From hospital bills to X-rated

Ralph Puglisi was an accounting manager for the University Medical Service Association (UMSA), a nonprofit that supports the massive University of South Florida health system. The association took in over $300 million in revenue in the 2019-2020 fiscal year, which is a rather large sum of money, but we’ll glide over the ethics of a “nonprofit” making a few hundred million for now.

wakila/Getty Images

Mr. Puglisi was in very close proximity to the money, generated from patient care, and he pled guilty to stealing it using UMSA credit cards. Now, that wouldn’t be LOTME worthy on its own, but what elevates this above garden-variety embezzlement is how the intrepid Mr. Puglisi chose to spend the millions he stole from the university health system: Adult entertainment.

And before you ask, he didn’t spend $11.5 million on something most people so inclined can find for free with judicious Google searches. What Mr. Puglisi actually did was invest in a website providing adult content through individual user profiles, one of which is believed to belong to his stepson’s fiancée, which brings a whole new level of sleaze to this enterprise. Over the course of 2 years, he visited her profile 2,800 times, an amount some might view as excessive.

While the vast majority of the embezzled money went to the adult website, Mr. Puglisi also used thousands of UMSA dollars to pay for travel, household improvements, rent, the works. Almost $44,000 was spent at a resort sometimes known as the happiest place on earth.

Then there’s Mr. Puglisi’s wife. Oh yes, this guy is married. He poured over $600,000 into a company he and his wife owned, which is a lot, but how much do you think went to the woman he married? Probably quite a bit. Go ahead, try to think of a number. It’s not like it was his money.

Did you guess $100 went into his wife’s PayPal account? No? Clearly you don’t understand the criminal mind. His stepson’s fiancée got millions, and his wife got a hundred. Now there are some priorities.
 

 

 

Step 1: Sit at desk. Step 2: Get in shape

Being a physician is not really a desk job, but doctors must spend a fair share of their time sitting, yes? Dealing with recalcitrant EHRs or talking on the phone to insurers or PBMs? If you are one of these physicians, or if you have patients who spend a lot of time sitting at their desks and might need to get a bit of exercise, then we’ve got a multitasking tip for you.

Mohamed Hassan/pxhere

It came to us via one of our favorite websites, Sad and Useless. It’s the site that declares itself “the most depressive humor site on the Internet” and they’re offering up the “12 Best Exercises To Do At Your Desk.” It may not sound like much, but we think that the gang at Dunder-Mifflin would approve. And besides, who couldn’t stand to burn a few calories without having to leave the chair?

We won’t spoil your fun by going through all 12 – each one comes with step-by-step instructions and a helpful illustration or GIF – but here are just a few:

  • Bending over backwards: “Agree to do something you don’t want to do. Spend twice as long as expected doing that thing. Hate yourself.”
  • Fake laughter: “Hear a joke that isn’t even remotely funny. Open your mouth and make laughing sounds.”
  • Bang your head: Feel the “pointlessness of your job overwhelm you” and then “bring your head forcefully down to your desk.”

Now, we here at LOTME are, of course [Bang!], highly skilled, professional wordsmithing humorists [Bang!], so when we tell you that this is a great workout [Bang!] … that this is a great workout [Bang!] … it’s great … uggh.

Wooooo. Feel the burn.
 

One order of mosquitoes, extra Crispr

What would it be like to have a barbecue in your backyard on a humid summer night and not get eaten alive by mosquitoes? If you’re like us, you probably thought you’d never see that day.

©TacioPhilip/Thinkstock

Mosquitoes cause itchy bites, but, more importantly, they can carry dengue, malaria, yellow fever, and Zika virus. New research shows that protection from these diseases may be possible with use of the Crispr-Cas9 gene-editing tool, which could make humans invisible to mosquitoes by taking away their light-sensing abilities and, thus, their ability to find us.

“The better we understand how they sense the human, the better we can control the mosquito in an eco-friendly manner,” Yinpeng Zhan, a postdoctoral researcher at the University of California, Santa Barbara, and the study’s lead author, told the New York Times.

After studying the mosquitoes and figuring out their hunting patterns, the researchers found that mosquitoes are attracted to dark spots more than white spots and used this to their advantage. After knocking out two of the proteins that mosquitoes need for vision – via Crispr – the little suckers could not distinguish the difference between the white and dark spots.

We’re sure mosquitoes don’t mean any harm – they’re just trying to survive and reproduce like any other species – but thanks to this new tool, gone might be the days of having to douse yourself in bug spray that smells like a mix of chemicals and melon.

 

Drink to your health?

Whether you drink or not, most of us can agree that liquor is not the first thing that comes to mind when looking to make health improvements. But researchers have found a small exception in something traditional.

Xvision/Moment

We’ve added buckwheat to pancakes, bread, and other baked goodies we made during the height of quarantine, but it’s also used to create a traditional liquor in some East Asian countries, where it is used medicinally.

Investigators have found that extracts in the Tartary buckwheat used to make the liquor induce autophagy, a process cells go through to remove proteins that are damaged or not needed anymore – sort of like a cellular spring cleaning.

To test this, the researchers treated liver and skin cells with Tartary buckwheat extract and looked to see how the cells responded with fluorescent markers. The results were clear.

“Treating cells with the extract stimulated the formation of autophagosomes, specialized cellular structures that carry out autophagy, and altered the location of proteins involved in regulating autophagy,” said senior author Takeshi Noda of Osaka (Japan) University.

Looking deeper, the researchers found that quercetin, a component of the buckwheat extract, had the same autophagic effect. And both the buckwheat and the quercetin gave the green light for liver cells to induce aggrephagy, the process of cleaning up protein aggregates.

Those protein aggregates in liver cells are closely linked to alcoholic liver disease, suggesting that quercetin could be a game changer in its treatment. In other words, liquor could help fix the problem that liquor started. Go figure.
 

From hospital bills to X-rated

Ralph Puglisi was an accounting manager for the University Medical Service Association (UMSA), a nonprofit that supports the massive University of South Florida health system. The association took in over $300 million in revenue in the 2019-2020 fiscal year, which is a rather large sum of money, but we’ll glide over the ethics of a “nonprofit” making a few hundred million for now.

wakila/Getty Images

Mr. Puglisi was in very close proximity to the money, generated from patient care, and he pled guilty to stealing it using UMSA credit cards. Now, that wouldn’t be LOTME worthy on its own, but what elevates this above garden-variety embezzlement is how the intrepid Mr. Puglisi chose to spend the millions he stole from the university health system: Adult entertainment.

And before you ask, he didn’t spend $11.5 million on something most people so inclined can find for free with judicious Google searches. What Mr. Puglisi actually did was invest in a website providing adult content through individual user profiles, one of which is believed to belong to his stepson’s fiancée, which brings a whole new level of sleaze to this enterprise. Over the course of 2 years, he visited her profile 2,800 times, an amount some might view as excessive.

While the vast majority of the embezzled money went to the adult website, Mr. Puglisi also used thousands of UMSA dollars to pay for travel, household improvements, rent, the works. Almost $44,000 was spent at a resort sometimes known as the happiest place on earth.

Then there’s Mr. Puglisi’s wife. Oh yes, this guy is married. He poured over $600,000 into a company he and his wife owned, which is a lot, but how much do you think went to the woman he married? Probably quite a bit. Go ahead, try to think of a number. It’s not like it was his money.

Did you guess $100 went into his wife’s PayPal account? No? Clearly you don’t understand the criminal mind. His stepson’s fiancée got millions, and his wife got a hundred. Now there are some priorities.
 

 

 

Step 1: Sit at desk. Step 2: Get in shape

Being a physician is not really a desk job, but doctors must spend a fair share of their time sitting, yes? Dealing with recalcitrant EHRs or talking on the phone to insurers or PBMs? If you are one of these physicians, or if you have patients who spend a lot of time sitting at their desks and might need to get a bit of exercise, then we’ve got a multitasking tip for you.

Mohamed Hassan/pxhere

It came to us via one of our favorite websites, Sad and Useless. It’s the site that declares itself “the most depressive humor site on the Internet” and they’re offering up the “12 Best Exercises To Do At Your Desk.” It may not sound like much, but we think that the gang at Dunder-Mifflin would approve. And besides, who couldn’t stand to burn a few calories without having to leave the chair?

We won’t spoil your fun by going through all 12 – each one comes with step-by-step instructions and a helpful illustration or GIF – but here are just a few:

  • Bending over backwards: “Agree to do something you don’t want to do. Spend twice as long as expected doing that thing. Hate yourself.”
  • Fake laughter: “Hear a joke that isn’t even remotely funny. Open your mouth and make laughing sounds.”
  • Bang your head: Feel the “pointlessness of your job overwhelm you” and then “bring your head forcefully down to your desk.”

Now, we here at LOTME are, of course [Bang!], highly skilled, professional wordsmithing humorists [Bang!], so when we tell you that this is a great workout [Bang!] … that this is a great workout [Bang!] … it’s great … uggh.

Wooooo. Feel the burn.
 

One order of mosquitoes, extra Crispr

What would it be like to have a barbecue in your backyard on a humid summer night and not get eaten alive by mosquitoes? If you’re like us, you probably thought you’d never see that day.

©TacioPhilip/Thinkstock

Mosquitoes cause itchy bites, but, more importantly, they can carry dengue, malaria, yellow fever, and Zika virus. New research shows that protection from these diseases may be possible with use of the Crispr-Cas9 gene-editing tool, which could make humans invisible to mosquitoes by taking away their light-sensing abilities and, thus, their ability to find us.

“The better we understand how they sense the human, the better we can control the mosquito in an eco-friendly manner,” Yinpeng Zhan, a postdoctoral researcher at the University of California, Santa Barbara, and the study’s lead author, told the New York Times.

After studying the mosquitoes and figuring out their hunting patterns, the researchers found that mosquitoes are attracted to dark spots more than white spots and used this to their advantage. After knocking out two of the proteins that mosquitoes need for vision – via Crispr – the little suckers could not distinguish the difference between the white and dark spots.

We’re sure mosquitoes don’t mean any harm – they’re just trying to survive and reproduce like any other species – but thanks to this new tool, gone might be the days of having to douse yourself in bug spray that smells like a mix of chemicals and melon.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

The hateful patient

Article Type
Changed

A 64-year-old White woman with very few medical problems complains of bug bites. She had seen no bugs and had no visible bites. There is no rash. “So what bit me?” she asked, pulling her mask down for emphasis. How should I know? I thought, but didn’t say. She and I have been through this many times.

Dr. Jeffrey Benabio

Before I could respond, she filled the pause with her usual complaints including how hard it is to get an appointment with me and how every appointment with me is a waste of her time. Ignoring the contradistinction of her charges, I took some satisfaction realizing she has just given me a topic to write about: The hateful patient.

Hateful patients are not diagnostic dilemmas, they are the patients whose name on your schedule evokes fury. They are frustrating, troublesome, rude, sometimes racist, misogynistic, depressing, hopeless, and disheartening. They call you, email you, and come to see you just to annoy you (so it seems). And they’re everywhere. According to one study, nearly one in six are “difficult patients.” It feels like more lately because the vaccine has brought haters back into clinic, just to get us.

But hateful patients aren’t new. In 1978, James E. Groves, MD, a Harvard psychiatrist, wrote a now-classic New England Journal of Medicine article about them called: Taking Care of the Hateful Patient. Even Osler, back in 1889, covered these patients in his lecture to University of Pennsylvania students, advising us to “deal gently with this deliciously credulous old human nature in which we work ... restrain your indignation.” But like much of Osler’s advice, it is easier said than done.

Dr. Groves is more helpful, and presents a model to understand them. Difficult patients, as we’d now call them, fall into four stereotypes: dependent clingers, entitled demanders, manipulative help-rejectors, and self-destructive deniers. It’s Dr. Groves’s bottom line I found insightful. He says that, when patients create negative feelings in us, we’re more likely to make errors. He then gives sound advice: Set firm boundaries and learn to counter the countertransference these patients provoke. Don’t disavow or discharge, Dr. Groves advises, redirect these emotions to motivate you to dig deeper. There you’ll find clinical data that will facilitate understanding and enable better patient management. Yes, easier said.



In addition to Dr. Groves’s analysis of how we harm these patients, I’d add that these disagreeable, malingering patients also harm us doctors. The hangover from a difficult patient encounter can linger for several appointments later or, worse, carryover to home. And now with patient emails proliferating, demanding patients behave as if we have an inexhaustible ability to engage them. We don’t. Many physicians are struggling to care at all; their low empathy battery warnings are blinking red, less than 1% remaining.

What is toxic to us doctors is the maelstrom of cognitive dissonance these patients create in us. Have you ever felt relief to learn a difficult patient has “finally” died? How could we think such a thing?! Didn’t we choose medicine instead of Wall Street because we care about people? But manipulative patients can make us care less. We even use secret language with each other to protect ourselves from them, those GOMERs (get out of my emergency room), bouncebacks, patients with status dramaticus, and those ornery FTDs (failure to die). Save yourself, we say to each other, this patient will kill you.

Caring for my somatizing 64-year-old patient has been difficult, but writing this has helped me reframe our interaction. Unsurprisingly, at the end of her failed visit she asked when she could see me again. “I need to schedule now because I have to find a neighbor to watch my dogs. It takes two buses to come here and I can’t take them with me.” Ah, there’s the clinical data Dr. Groves said I’d find – she’s not here to hurt me, she’s here because I’m all she’s got. At least for this difficult patient, I have a plan. At the bottom of my note I type “RTC 3 mo.”

Dr. Benabio is director of healthcare transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

Publications
Topics
Sections

A 64-year-old White woman with very few medical problems complains of bug bites. She had seen no bugs and had no visible bites. There is no rash. “So what bit me?” she asked, pulling her mask down for emphasis. How should I know? I thought, but didn’t say. She and I have been through this many times.

Dr. Jeffrey Benabio

Before I could respond, she filled the pause with her usual complaints including how hard it is to get an appointment with me and how every appointment with me is a waste of her time. Ignoring the contradistinction of her charges, I took some satisfaction realizing she has just given me a topic to write about: The hateful patient.

Hateful patients are not diagnostic dilemmas, they are the patients whose name on your schedule evokes fury. They are frustrating, troublesome, rude, sometimes racist, misogynistic, depressing, hopeless, and disheartening. They call you, email you, and come to see you just to annoy you (so it seems). And they’re everywhere. According to one study, nearly one in six are “difficult patients.” It feels like more lately because the vaccine has brought haters back into clinic, just to get us.

But hateful patients aren’t new. In 1978, James E. Groves, MD, a Harvard psychiatrist, wrote a now-classic New England Journal of Medicine article about them called: Taking Care of the Hateful Patient. Even Osler, back in 1889, covered these patients in his lecture to University of Pennsylvania students, advising us to “deal gently with this deliciously credulous old human nature in which we work ... restrain your indignation.” But like much of Osler’s advice, it is easier said than done.

Dr. Groves is more helpful, and presents a model to understand them. Difficult patients, as we’d now call them, fall into four stereotypes: dependent clingers, entitled demanders, manipulative help-rejectors, and self-destructive deniers. It’s Dr. Groves’s bottom line I found insightful. He says that, when patients create negative feelings in us, we’re more likely to make errors. He then gives sound advice: Set firm boundaries and learn to counter the countertransference these patients provoke. Don’t disavow or discharge, Dr. Groves advises, redirect these emotions to motivate you to dig deeper. There you’ll find clinical data that will facilitate understanding and enable better patient management. Yes, easier said.



In addition to Dr. Groves’s analysis of how we harm these patients, I’d add that these disagreeable, malingering patients also harm us doctors. The hangover from a difficult patient encounter can linger for several appointments later or, worse, carryover to home. And now with patient emails proliferating, demanding patients behave as if we have an inexhaustible ability to engage them. We don’t. Many physicians are struggling to care at all; their low empathy battery warnings are blinking red, less than 1% remaining.

What is toxic to us doctors is the maelstrom of cognitive dissonance these patients create in us. Have you ever felt relief to learn a difficult patient has “finally” died? How could we think such a thing?! Didn’t we choose medicine instead of Wall Street because we care about people? But manipulative patients can make us care less. We even use secret language with each other to protect ourselves from them, those GOMERs (get out of my emergency room), bouncebacks, patients with status dramaticus, and those ornery FTDs (failure to die). Save yourself, we say to each other, this patient will kill you.

Caring for my somatizing 64-year-old patient has been difficult, but writing this has helped me reframe our interaction. Unsurprisingly, at the end of her failed visit she asked when she could see me again. “I need to schedule now because I have to find a neighbor to watch my dogs. It takes two buses to come here and I can’t take them with me.” Ah, there’s the clinical data Dr. Groves said I’d find – she’s not here to hurt me, she’s here because I’m all she’s got. At least for this difficult patient, I have a plan. At the bottom of my note I type “RTC 3 mo.”

Dr. Benabio is director of healthcare transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

A 64-year-old White woman with very few medical problems complains of bug bites. She had seen no bugs and had no visible bites. There is no rash. “So what bit me?” she asked, pulling her mask down for emphasis. How should I know? I thought, but didn’t say. She and I have been through this many times.

Dr. Jeffrey Benabio

Before I could respond, she filled the pause with her usual complaints including how hard it is to get an appointment with me and how every appointment with me is a waste of her time. Ignoring the contradistinction of her charges, I took some satisfaction realizing she has just given me a topic to write about: The hateful patient.

Hateful patients are not diagnostic dilemmas, they are the patients whose name on your schedule evokes fury. They are frustrating, troublesome, rude, sometimes racist, misogynistic, depressing, hopeless, and disheartening. They call you, email you, and come to see you just to annoy you (so it seems). And they’re everywhere. According to one study, nearly one in six are “difficult patients.” It feels like more lately because the vaccine has brought haters back into clinic, just to get us.

But hateful patients aren’t new. In 1978, James E. Groves, MD, a Harvard psychiatrist, wrote a now-classic New England Journal of Medicine article about them called: Taking Care of the Hateful Patient. Even Osler, back in 1889, covered these patients in his lecture to University of Pennsylvania students, advising us to “deal gently with this deliciously credulous old human nature in which we work ... restrain your indignation.” But like much of Osler’s advice, it is easier said than done.

Dr. Groves is more helpful, and presents a model to understand them. Difficult patients, as we’d now call them, fall into four stereotypes: dependent clingers, entitled demanders, manipulative help-rejectors, and self-destructive deniers. It’s Dr. Groves’s bottom line I found insightful. He says that, when patients create negative feelings in us, we’re more likely to make errors. He then gives sound advice: Set firm boundaries and learn to counter the countertransference these patients provoke. Don’t disavow or discharge, Dr. Groves advises, redirect these emotions to motivate you to dig deeper. There you’ll find clinical data that will facilitate understanding and enable better patient management. Yes, easier said.



In addition to Dr. Groves’s analysis of how we harm these patients, I’d add that these disagreeable, malingering patients also harm us doctors. The hangover from a difficult patient encounter can linger for several appointments later or, worse, carryover to home. And now with patient emails proliferating, demanding patients behave as if we have an inexhaustible ability to engage them. We don’t. Many physicians are struggling to care at all; their low empathy battery warnings are blinking red, less than 1% remaining.

What is toxic to us doctors is the maelstrom of cognitive dissonance these patients create in us. Have you ever felt relief to learn a difficult patient has “finally” died? How could we think such a thing?! Didn’t we choose medicine instead of Wall Street because we care about people? But manipulative patients can make us care less. We even use secret language with each other to protect ourselves from them, those GOMERs (get out of my emergency room), bouncebacks, patients with status dramaticus, and those ornery FTDs (failure to die). Save yourself, we say to each other, this patient will kill you.

Caring for my somatizing 64-year-old patient has been difficult, but writing this has helped me reframe our interaction. Unsurprisingly, at the end of her failed visit she asked when she could see me again. “I need to schedule now because I have to find a neighbor to watch my dogs. It takes two buses to come here and I can’t take them with me.” Ah, there’s the clinical data Dr. Groves said I’d find – she’s not here to hurt me, she’s here because I’m all she’s got. At least for this difficult patient, I have a plan. At the bottom of my note I type “RTC 3 mo.”

Dr. Benabio is director of healthcare transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article