Alicia Ault

WASHINGTON — The historic midterm election victory by Republicans does not signal the end of the Affordable Care Act, but now the law will very likely undergo the scrutiny that many in the GOP say it did not get as it made its way through Congress.

The GOP now holds a majority in the new House, with 239 seats, compared with 187 for the Democrats. Republican members of the Senate are still in the minority, but the current 52-46 Democratic margin is much slimmer than before the election.

Before the midterm elections, House Republican leaders and Senate Minority Leader Mitch McConnell (R-Ky.) vowed to “repeal and replace” the ACA if they regained the majority. A Republican-led House cannot make that happen alone; the Democratic-led Senate is unlikely to pass repeal legislation, and President Obama would likely veto any bill sent to him.

After the midterm elections, At esident Obama said he welcomed GOP input. “If the Republicans have ideas for how to improve our health care system, if they want to suggest modifications that would deliver faster and more effective reform to a health care system that has been widely expensive for too many families, businesses, and certainly our federal government, I'm happy to consider some of those ideas,” he said.

But he said that the White House would not entertain a repeal debate.

Speaking at a postelection forum, Jim Slattery, a former six-term Democratic congressman from Kansas, said that he expected to see a repeal proposal. “The new Tea Party congresspeople and the leadership in the House will probably have to introduce some kind of resolution that would call for the repeal of ACA, and I think they know it's going nowhere and it's not going to happen,” said Mr. Slattery, now a lobbyist with Wiley Rein.

Mr. Slattery said that President Obama mainly has himself to blame for the Democrats' poor showing in the election and for polling data indicating that half of Americans want to repeal the ACA. The president “failed to connect the dots” with Americans on how the law would benefit them, he added.

At the same forum, Nancy Johnson, a former Republican House member from Connecticut, said that she expected to see a number of oversight and investigative hearings on the ACA.

“The one thing that has to be done [in the next Congress] is, people have to regain their confidence in government and that's not about policy, that's about process,” said Ms. Johnson, a senior public policy adviser at Baker Donelson. “Half the bill is terrific. But the other half wasn't seen, and that created suspicion.”

Congressional Republicans have said they will keep some of the insurance market reforms – such as the prohibition on denying coverage for preexisting conditions – but will seek to throw out the mandate that individuals have health insurance coverage. That is a formula for disaster for the law – and for insurance companies, wrote Henry Aaron, a senior fellow at the Brookings Institution, in a perspective article published in the New England Journal of Medicine (2010;18: 1685-7). Unless most Americans are covered, insurers might be bankrupted by the reforms, he said.

“In brief, the pledge to keep insurance-market reforms without both mandated coverage and subsidies is untenable,” Mr. Aaron wrote.

Mr. Slattery agreed. “If you're going to really reform the insurance industry with the preexisting-condition reforms, we have to have a mandate of some kind,” he said.

The requirement that individuals carry insurance or pay a penalty, however, is the central issue being challenged by 20 states. and governors and attorneys general elected in five statesalampaigned on the promise that they, tuld support overturning the mandate.

With money tight and millions of potential new Medicaid enrollees, governors from all parties may revolt against the mandate, said Ms. Johnson. States are challenging the mandate, in partthecause it imposes burdens they can't fulfill, she noted.

Back on Capitol Hill, the GOP-led House will also likely take a close look at the ACA-created Independent Payment Advisory Board, said Ms. Johnson. The IPAB, charged with looking at how the federal government pays physicians, hospitals, pharmaceutical companies, and other health providers, would have broad powers that make many Republicans uncomfortable, she said.

WASHINGTON — The historic midterm election victory by Republicans does not signal the end of the Affordable Care Act, but now the law will very likely undergo the scrutiny that many in the GOP say it did not get as it made its way through Congress.

The GOP now holds a majority in the new House, with 239 seats, compared with 187 for the Democrats. Republican members of the Senate are still in the minority, but the current 52-46 Democratic margin is much slimmer than before the election.

Before the midterm elections, House Republican leaders and Senate Minority Leader Mitch McConnell (R-Ky.) vowed to “repeal and replace” the ACA if they regained the majority. A Republican-led House cannot make that happen alone; the Democratic-led Senate is unlikely to pass repeal legislation, and President Obama would likely veto any bill sent to him.

After the midterm elections, At esident Obama said he welcomed GOP input. “If the Republicans have ideas for how to improve our health care system, if they want to suggest modifications that would deliver faster and more effective reform to a health care system that has been widely expensive for too many families, businesses, and certainly our federal government, I'm happy to consider some of those ideas,” he said.

But he said that the White House would not entertain a repeal debate.

Speaking at a postelection forum, Jim Slattery, a former six-term Democratic congressman from Kansas, said that he expected to see a repeal proposal. “The new Tea Party congresspeople and the leadership in the House will probably have to introduce some kind of resolution that would call for the repeal of ACA, and I think they know it's going nowhere and it's not going to happen,” said Mr. Slattery, now a lobbyist with Wiley Rein.

Mr. Slattery said that President Obama mainly has himself to blame for the Democrats' poor showing in the election and for polling data indicating that half of Americans want to repeal the ACA. The president “failed to connect the dots” with Americans on how the law would benefit them, he added.

At the same forum, Nancy Johnson, a former Republican House member from Connecticut, said that she expected to see a number of oversight and investigative hearings on the ACA.

“The one thing that has to be done [in the next Congress] is, people have to regain their confidence in government and that's not about policy, that's about process,” said Ms. Johnson, a senior public policy adviser at Baker Donelson. “Half the bill is terrific. But the other half wasn't seen, and that created suspicion.”

Congressional Republicans have said they will keep some of the insurance market reforms – such as the prohibition on denying coverage for preexisting conditions – but will seek to throw out the mandate that individuals have health insurance coverage. That is a formula for disaster for the law – and for insurance companies, wrote Henry Aaron, a senior fellow at the Brookings Institution, in a perspective article published in the New England Journal of Medicine (2010;18: 1685-7). Unless most Americans are covered, insurers might be bankrupted by the reforms, he said.

“In brief, the pledge to keep insurance-market reforms without both mandated coverage and subsidies is untenable,” Mr. Aaron wrote.

Mr. Slattery agreed. “If you're going to really reform the insurance industry with the preexisting-condition reforms, we have to have a mandate of some kind,” he said.

The requirement that individuals carry insurance or pay a penalty, however, is the central issue being challenged by 20 states. and governors and attorneys general elected in five statesalampaigned on the promise that they, tuld support overturning the mandate.

With money tight and millions of potential new Medicaid enrollees, governors from all parties may revolt against the mandate, said Ms. Johnson. States are challenging the mandate, in partthecause it imposes burdens they can't fulfill, she noted.

Back on Capitol Hill, the GOP-led House will also likely take a close look at the ACA-created Independent Payment Advisory Board, said Ms. Johnson. The IPAB, charged with looking at how the federal government pays physicians, hospitals, pharmaceutical companies, and other health providers, would have broad powers that make many Republicans uncomfortable, she said.

WASHINGTON — The historic midterm election victory by Republicans does not signal the end of the Affordable Care Act, but now the law will very likely undergo the scrutiny that many in the GOP say it did not get as it made its way through Congress.

The GOP now holds a majority in the new House, with 239 seats, compared with 187 for the Democrats. Republican members of the Senate are still in the minority, but the current 52-46 Democratic margin is much slimmer than before the election.

Before the midterm elections, House Republican leaders and Senate Minority Leader Mitch McConnell (R-Ky.) vowed to “repeal and replace” the ACA if they regained the majority. A Republican-led House cannot make that happen alone; the Democratic-led Senate is unlikely to pass repeal legislation, and President Obama would likely veto any bill sent to him.

After the midterm elections, At esident Obama said he welcomed GOP input. “If the Republicans have ideas for how to improve our health care system, if they want to suggest modifications that would deliver faster and more effective reform to a health care system that has been widely expensive for too many families, businesses, and certainly our federal government, I'm happy to consider some of those ideas,” he said.

But he said that the White House would not entertain a repeal debate.

Speaking at a postelection forum, Jim Slattery, a former six-term Democratic congressman from Kansas, said that he expected to see a repeal proposal. “The new Tea Party congresspeople and the leadership in the House will probably have to introduce some kind of resolution that would call for the repeal of ACA, and I think they know it's going nowhere and it's not going to happen,” said Mr. Slattery, now a lobbyist with Wiley Rein.

Mr. Slattery said that President Obama mainly has himself to blame for the Democrats' poor showing in the election and for polling data indicating that half of Americans want to repeal the ACA. The president “failed to connect the dots” with Americans on how the law would benefit them, he added.

At the same forum, Nancy Johnson, a former Republican House member from Connecticut, said that she expected to see a number of oversight and investigative hearings on the ACA.

“The one thing that has to be done [in the next Congress] is, people have to regain their confidence in government and that's not about policy, that's about process,” said Ms. Johnson, a senior public policy adviser at Baker Donelson. “Half the bill is terrific. But the other half wasn't seen, and that created suspicion.”

Congressional Republicans have said they will keep some of the insurance market reforms – such as the prohibition on denying coverage for preexisting conditions – but will seek to throw out the mandate that individuals have health insurance coverage. That is a formula for disaster for the law – and for insurance companies, wrote Henry Aaron, a senior fellow at the Brookings Institution, in a perspective article published in the New England Journal of Medicine (2010;18: 1685-7). Unless most Americans are covered, insurers might be bankrupted by the reforms, he said.

“In brief, the pledge to keep insurance-market reforms without both mandated coverage and subsidies is untenable,” Mr. Aaron wrote.

Mr. Slattery agreed. “If you're going to really reform the insurance industry with the preexisting-condition reforms, we have to have a mandate of some kind,” he said.

The requirement that individuals carry insurance or pay a penalty, however, is the central issue being challenged by 20 states. and governors and attorneys general elected in five statesalampaigned on the promise that they, tuld support overturning the mandate.

With money tight and millions of potential new Medicaid enrollees, governors from all parties may revolt against the mandate, said Ms. Johnson. States are challenging the mandate, in partthecause it imposes burdens they can't fulfill, she noted.

Back on Capitol Hill, the GOP-led House will also likely take a close look at the ACA-created Independent Payment Advisory Board, said Ms. Johnson. The IPAB, charged with looking at how the federal government pays physicians, hospitals, pharmaceutical companies, and other health providers, would have broad powers that make many Republicans uncomfortable, she said.

The four biggest primary care physician organizations issued a joint document last month that contained what they believe are important principles to guide the development of accountable care organizations.

The 21 principles were developed and issued by the American Academy of Family Physicians, American Academy of Pediatrics, the American College of Physicians, and the American Osteopathic Association. According to the groups, the principles were submitted to the Centers for Medicare and Medicaid Services for consideration as guiding principles for ACO demonstration projects.

The organizations also are hoping to see the guidelines adopted more widely. “The AAP urges adoption of these principles by governments, payers, providers and all others who are involved in the health, well-being and success of America's children and their families,” Dr. O. Marion Burton, president of the AAP, said in a statement.

ACOs are being considered as the underpinning of health reform, changing how health care is delivered and financed. The Affordable Care Act calls for Medicare beneficiaries to be assigned to ACOs, which has spurred some debate.

The CMS is charged with developing regulations on how ACOs will be structured and how Medicare and Medicaid will pay providers that participate. The agency, along with the Federal Trade Commission and the Office of Inspector General of the Department of Health and Human Services, held a public meeting on ACOs on Oct. 5 to gather input.

And in mid-November, the CMS issued a request for information on ACOs. All comments were due by Dec. 3. The agency is expected to issue regulations later, perhaps by early 2011.

The agency has been looking at a risk-sharing payment methodology that would reward providers for improved quality and lower costs.

The Joint Principles for Accountable Care Organizations issued by the primary care groups outlines a number of principles that should guide that payment system. Incentives should “adequately reflect the relative contributions of participating physicians,” and practices that participate in ACOs and achieve recognition as medical homes “should receive additional financial incentives,” according to the Joint Principles.

The Medicare Payment Advisory Commission has backed the ACO concept and the notion of shared savings as a means for eliminating inefficiencies.

In comments submitted to the CMS on Nov. 22, MedPAC Chairman Glenn Hackbarth wrote, “If structured carefully, a shared savings program for ACOs could present an opportunity to correct some of the undesirable incentives inherent in fee-for-service payment and reward providers who are doing their part to control costs and improve quality.”

Shared savings also could “help beneficiaries receive more coordinated care and become more engaged with their care management, particularly if beneficiaries are informed when they are assigned to ACOs,” Mr. Hackbarth wrote.

Dr. Roland Goertz, president of the AAFP, agreed that ACOs will be crucial to shifting the delivery and payment system.

“If implemented correctly, ACOs may help improve quality and efficiency of care and reduce costs while strengthening the patient-physician relationship in the context of a patient-centered medical home,” he said.

The American Medical Association (AMA) also has established guiding principles for ACOs. Members approved the 13 principles at its interim House of Delegates meeting in November.

The AMA is concerned that existing antitrust and fraud rules can make it difficult for physicians to participate in ACOs. The organization called for increased flexibility in those laws, and for the FTC to provide explicit exceptions to antitrust laws for ACO participants.

ACO savings should be retained for patient care services and distributed to ACO participants, and the organizations should also be allowed to use a variety of payment models, according to the AMA principles.

The four biggest primary care physician organizations issued a joint document last month that contained what they believe are important principles to guide the development of accountable care organizations.

The 21 principles were developed and issued by the American Academy of Family Physicians, American Academy of Pediatrics, the American College of Physicians, and the American Osteopathic Association. According to the groups, the principles were submitted to the Centers for Medicare and Medicaid Services for consideration as guiding principles for ACO demonstration projects.

The organizations also are hoping to see the guidelines adopted more widely. “The AAP urges adoption of these principles by governments, payers, providers and all others who are involved in the health, well-being and success of America's children and their families,” Dr. O. Marion Burton, president of the AAP, said in a statement.

ACOs are being considered as the underpinning of health reform, changing how health care is delivered and financed. The Affordable Care Act calls for Medicare beneficiaries to be assigned to ACOs, which has spurred some debate.

The CMS is charged with developing regulations on how ACOs will be structured and how Medicare and Medicaid will pay providers that participate. The agency, along with the Federal Trade Commission and the Office of Inspector General of the Department of Health and Human Services, held a public meeting on ACOs on Oct. 5 to gather input.

And in mid-November, the CMS issued a request for information on ACOs. All comments were due by Dec. 3. The agency is expected to issue regulations later, perhaps by early 2011.

The agency has been looking at a risk-sharing payment methodology that would reward providers for improved quality and lower costs.

The Joint Principles for Accountable Care Organizations issued by the primary care groups outlines a number of principles that should guide that payment system. Incentives should “adequately reflect the relative contributions of participating physicians,” and practices that participate in ACOs and achieve recognition as medical homes “should receive additional financial incentives,” according to the Joint Principles.

The Medicare Payment Advisory Commission has backed the ACO concept and the notion of shared savings as a means for eliminating inefficiencies.

In comments submitted to the CMS on Nov. 22, MedPAC Chairman Glenn Hackbarth wrote, “If structured carefully, a shared savings program for ACOs could present an opportunity to correct some of the undesirable incentives inherent in fee-for-service payment and reward providers who are doing their part to control costs and improve quality.”

Shared savings also could “help beneficiaries receive more coordinated care and become more engaged with their care management, particularly if beneficiaries are informed when they are assigned to ACOs,” Mr. Hackbarth wrote.

Dr. Roland Goertz, president of the AAFP, agreed that ACOs will be crucial to shifting the delivery and payment system.

“If implemented correctly, ACOs may help improve quality and efficiency of care and reduce costs while strengthening the patient-physician relationship in the context of a patient-centered medical home,” he said.

The American Medical Association (AMA) also has established guiding principles for ACOs. Members approved the 13 principles at its interim House of Delegates meeting in November.

The AMA is concerned that existing antitrust and fraud rules can make it difficult for physicians to participate in ACOs. The organization called for increased flexibility in those laws, and for the FTC to provide explicit exceptions to antitrust laws for ACO participants.

ACO savings should be retained for patient care services and distributed to ACO participants, and the organizations should also be allowed to use a variety of payment models, according to the AMA principles.

The four biggest primary care physician organizations issued a joint document last month that contained what they believe are important principles to guide the development of accountable care organizations.

The 21 principles were developed and issued by the American Academy of Family Physicians, American Academy of Pediatrics, the American College of Physicians, and the American Osteopathic Association. According to the groups, the principles were submitted to the Centers for Medicare and Medicaid Services for consideration as guiding principles for ACO demonstration projects.

The organizations also are hoping to see the guidelines adopted more widely. “The AAP urges adoption of these principles by governments, payers, providers and all others who are involved in the health, well-being and success of America's children and their families,” Dr. O. Marion Burton, president of the AAP, said in a statement.

ACOs are being considered as the underpinning of health reform, changing how health care is delivered and financed. The Affordable Care Act calls for Medicare beneficiaries to be assigned to ACOs, which has spurred some debate.

The CMS is charged with developing regulations on how ACOs will be structured and how Medicare and Medicaid will pay providers that participate. The agency, along with the Federal Trade Commission and the Office of Inspector General of the Department of Health and Human Services, held a public meeting on ACOs on Oct. 5 to gather input.

And in mid-November, the CMS issued a request for information on ACOs. All comments were due by Dec. 3. The agency is expected to issue regulations later, perhaps by early 2011.

The agency has been looking at a risk-sharing payment methodology that would reward providers for improved quality and lower costs.

The Joint Principles for Accountable Care Organizations issued by the primary care groups outlines a number of principles that should guide that payment system. Incentives should “adequately reflect the relative contributions of participating physicians,” and practices that participate in ACOs and achieve recognition as medical homes “should receive additional financial incentives,” according to the Joint Principles.

The Medicare Payment Advisory Commission has backed the ACO concept and the notion of shared savings as a means for eliminating inefficiencies.

In comments submitted to the CMS on Nov. 22, MedPAC Chairman Glenn Hackbarth wrote, “If structured carefully, a shared savings program for ACOs could present an opportunity to correct some of the undesirable incentives inherent in fee-for-service payment and reward providers who are doing their part to control costs and improve quality.”

Shared savings also could “help beneficiaries receive more coordinated care and become more engaged with their care management, particularly if beneficiaries are informed when they are assigned to ACOs,” Mr. Hackbarth wrote.

Dr. Roland Goertz, president of the AAFP, agreed that ACOs will be crucial to shifting the delivery and payment system.

“If implemented correctly, ACOs may help improve quality and efficiency of care and reduce costs while strengthening the patient-physician relationship in the context of a patient-centered medical home,” he said.

The American Medical Association (AMA) also has established guiding principles for ACOs. Members approved the 13 principles at its interim House of Delegates meeting in November.

The AMA is concerned that existing antitrust and fraud rules can make it difficult for physicians to participate in ACOs. The organization called for increased flexibility in those laws, and for the FTC to provide explicit exceptions to antitrust laws for ACO participants.

ACO savings should be retained for patient care services and distributed to ACO participants, and the organizations should also be allowed to use a variety of payment models, according to the AMA principles.

Beginning next year, health insurance companies will be required to prove that they spend at least 80% of premium dollars collected on direct medical care and quality improvement efforts under new federal regulations.

The interim final rule took effect Jan. 1 and was required by the Affordable Care Act. The so-called medical loss ratio rule was developed by the National Association of Insurance Commissioners, which submitted its recommendations to the Health and Human Services department in late October.

According to the rule, HHS reviews insurers' medical loss data at the end of 2010. Companies that spend less than 80%-85% of their premium dollar on direct medical care will be required to issue rebates to consumers, said HHS Secretary Kathleen Sebelius at a press briefing. The rebate checks will begin arriving in 2012.

In some markets, insurers spend as little as 60% of the premium dollar on direct care, said Ms. Sebelius, who added that under the rule, those companies might have “to return nearly $3,500 to every family they insure.” Her calculation was based on an average annual premium of $13,250 paid by a family of four.

Timothy Jost, a professor of law at Washington and Lee University, Lexington, Va., who advised the NAIC task force, said he estimated that insurers currently spend 12% of the premium dollar on pharmaceuticals and 31% for physician services, and 31% on administrative costs.

Beginning next year, health insurance companies will be required to prove that they spend at least 80% of premium dollars collected on direct medical care and quality improvement efforts under new federal regulations.

The interim final rule took effect Jan. 1 and was required by the Affordable Care Act. The so-called medical loss ratio rule was developed by the National Association of Insurance Commissioners, which submitted its recommendations to the Health and Human Services department in late October.

According to the rule, HHS reviews insurers' medical loss data at the end of 2010. Companies that spend less than 80%-85% of their premium dollar on direct medical care will be required to issue rebates to consumers, said HHS Secretary Kathleen Sebelius at a press briefing. The rebate checks will begin arriving in 2012.

In some markets, insurers spend as little as 60% of the premium dollar on direct care, said Ms. Sebelius, who added that under the rule, those companies might have “to return nearly $3,500 to every family they insure.” Her calculation was based on an average annual premium of $13,250 paid by a family of four.

Timothy Jost, a professor of law at Washington and Lee University, Lexington, Va., who advised the NAIC task force, said he estimated that insurers currently spend 12% of the premium dollar on pharmaceuticals and 31% for physician services, and 31% on administrative costs.

Beginning next year, health insurance companies will be required to prove that they spend at least 80% of premium dollars collected on direct medical care and quality improvement efforts under new federal regulations.

The interim final rule took effect Jan. 1 and was required by the Affordable Care Act. The so-called medical loss ratio rule was developed by the National Association of Insurance Commissioners, which submitted its recommendations to the Health and Human Services department in late October.

According to the rule, HHS reviews insurers' medical loss data at the end of 2010. Companies that spend less than 80%-85% of their premium dollar on direct medical care will be required to issue rebates to consumers, said HHS Secretary Kathleen Sebelius at a press briefing. The rebate checks will begin arriving in 2012.

In some markets, insurers spend as little as 60% of the premium dollar on direct care, said Ms. Sebelius, who added that under the rule, those companies might have “to return nearly $3,500 to every family they insure.” Her calculation was based on an average annual premium of $13,250 paid by a family of four.

Timothy Jost, a professor of law at Washington and Lee University, Lexington, Va., who advised the NAIC task force, said he estimated that insurers currently spend 12% of the premium dollar on pharmaceuticals and 31% for physician services, and 31% on administrative costs.

Groups Pipe Up on Stent Case

The American College of Cardiology and the Society for Cardiovascular Angiography and Interventions say they're trying to address the issue of questionable stent implants and high costs to Medicare. In a joint e-mail, the they responded to a Senate Finance Committee report alleging that Maryland cardiologist Dr. Mark Midei had inappropriately implanted 600 stents from 2007 to 2009 at a cost to Medicare of $3.8 million. The report said that Abbott Laboratories feted Dr. Midei as one of its “Project Victory” cardiologists for top stent volume and paid him to promote the company's stents. Acknowledging that inappropriate implantations would be a violation of the Hippocratic Oath and a black mark on cardiology, the two groups said that they and their Maryland chapters have “been proactively addressing the issues raised by these allegations” by, for instance, helping states draft laws requiring accreditation of hospitals performing percutaneous coronary interventions.

State Smokes Heart Disease

The Massachusetts Medicaid program has curbed smoking prevalence and hospital admissions for some smoking-related diseases, according to a study reported in Public Library of Science Medicine. In 2006, the program began comprehensive coverage of tobacco cessation therapies and counseling. About 75,000 Medicaid recipients used that benefit from 2006 to early 2009 and smoking dropped from 38% to 29% among the Medicaid population, reported researchers from the state's Tobacco Cessation and Prevention Program and Harvard Medical School, Boston. Moreover, the percentage of smokers who said they quit during the previous year increased from 7% in the prebenefit period to 19% 2.5 years later. The rate of Medicaid hospital admissions for coronary atherosclerosis declined 49% and that for acute myocardial infarction dropped 46%. However, there was no change in admissions for lung diseases or some other tobacco-related conditions. In a statement American Heart Association Chief Executive Officer Nancy Brown said the study “provides ample evidence that comprehensive smoking cessation benefits must be a core component of antitobacco initiatives.”

Another Industry-Pay List

Massachusetts has published an online database listing 6 months of payments from pharmaceutical companies and medical device makers to health care providers. The data show that the top-spending company in the state was Boston Scientific, which paid $2.5 million to 129 recipients including physicians and hospitals. From July to December 2009, 283 companies paid $35.7 million to all recipients, including $16.4 million to 5,048 physicians, according to the Boston Globe.

Guilty of Inflated Prices

Three drug makers – Abbott Laboratories, B. Braun Medical, and Roxane Laboratories – have agreed to pay $421 million to settle the government's claim that they inflated wholesale prices of their drugs to get higher reimbursement from Medicare and Medicaid. The Department of Justice said the government had paid “millions of claims of far greater amounts than it would have if Abbott, B. Braun, and Roxane had reported truthful prices.” Roxane was charged with reporting false prices for azathioprine, diclofenac sodium, furosemide, hydromorphone, ipratropium bromide, Oramorph SR, Roxanol, and Roxicodone. The Abbott drugs were dextrose solutions, sodium chloride solutions, sterile water, vancomycin, and erythromycin. B. Braun was alleged to have inflated prices for 49 products. The case was brought to light by a whistle-blower in Florida, who is to receive nearly $90 million, according to the government statement.

Hospital Adverse Events Common

More than 13% of Medicare beneficiaries hospitalized in late 2008 experienced at least one adverse event causing lasting harm during their stays. Among them, 1.5% had an event that contributed to their deaths, according to a report from the Health and Human Services Office of the Inspector General. Another 13% of hospitalized beneficiaries had temporary harm, such as hypoglycemia, the report found. The combination of events cost Medicare an estimated $324 million in October 2008, the month the report covered, which means that such events could cost $4.4 billion a year. Physicians reviewing the data said that 44% of the adverse events, such as hospital-acquired infections, and temporary-harm events were clearly or probably preventable.

AMA Issues Social Media Policy

Physicians using social media sites such as Facebook and Twitter should carefully guard patient privacy while monitoring their own Internet presence in order to make sure it is accurate and appropriate, the American Medical Association said in a new policy statement. During its semiannual policy meeting in San Diego, the association called for physicians to “recognize that actions online and content posted can negatively affect their reputations among patients and colleagues, and may even have consequences for their medical careers.” The AMA urges physicians to set privacy settings on Web sites at their highest levels, maintain appropriate boundaries when interacting with patients online, and consider separating personal and professional content online.

Groups Pipe Up on Stent Case

The American College of Cardiology and the Society for Cardiovascular Angiography and Interventions say they're trying to address the issue of questionable stent implants and high costs to Medicare. In a joint e-mail, the they responded to a Senate Finance Committee report alleging that Maryland cardiologist Dr. Mark Midei had inappropriately implanted 600 stents from 2007 to 2009 at a cost to Medicare of $3.8 million. The report said that Abbott Laboratories feted Dr. Midei as one of its “Project Victory” cardiologists for top stent volume and paid him to promote the company's stents. Acknowledging that inappropriate implantations would be a violation of the Hippocratic Oath and a black mark on cardiology, the two groups said that they and their Maryland chapters have “been proactively addressing the issues raised by these allegations” by, for instance, helping states draft laws requiring accreditation of hospitals performing percutaneous coronary interventions.

State Smokes Heart Disease

The Massachusetts Medicaid program has curbed smoking prevalence and hospital admissions for some smoking-related diseases, according to a study reported in Public Library of Science Medicine. In 2006, the program began comprehensive coverage of tobacco cessation therapies and counseling. About 75,000 Medicaid recipients used that benefit from 2006 to early 2009 and smoking dropped from 38% to 29% among the Medicaid population, reported researchers from the state's Tobacco Cessation and Prevention Program and Harvard Medical School, Boston. Moreover, the percentage of smokers who said they quit during the previous year increased from 7% in the prebenefit period to 19% 2.5 years later. The rate of Medicaid hospital admissions for coronary atherosclerosis declined 49% and that for acute myocardial infarction dropped 46%. However, there was no change in admissions for lung diseases or some other tobacco-related conditions. In a statement American Heart Association Chief Executive Officer Nancy Brown said the study “provides ample evidence that comprehensive smoking cessation benefits must be a core component of antitobacco initiatives.”

Another Industry-Pay List

Massachusetts has published an online database listing 6 months of payments from pharmaceutical companies and medical device makers to health care providers. The data show that the top-spending company in the state was Boston Scientific, which paid $2.5 million to 129 recipients including physicians and hospitals. From July to December 2009, 283 companies paid $35.7 million to all recipients, including $16.4 million to 5,048 physicians, according to the Boston Globe.

Guilty of Inflated Prices

Three drug makers – Abbott Laboratories, B. Braun Medical, and Roxane Laboratories – have agreed to pay $421 million to settle the government's claim that they inflated wholesale prices of their drugs to get higher reimbursement from Medicare and Medicaid. The Department of Justice said the government had paid “millions of claims of far greater amounts than it would have if Abbott, B. Braun, and Roxane had reported truthful prices.” Roxane was charged with reporting false prices for azathioprine, diclofenac sodium, furosemide, hydromorphone, ipratropium bromide, Oramorph SR, Roxanol, and Roxicodone. The Abbott drugs were dextrose solutions, sodium chloride solutions, sterile water, vancomycin, and erythromycin. B. Braun was alleged to have inflated prices for 49 products. The case was brought to light by a whistle-blower in Florida, who is to receive nearly $90 million, according to the government statement.

Hospital Adverse Events Common

More than 13% of Medicare beneficiaries hospitalized in late 2008 experienced at least one adverse event causing lasting harm during their stays. Among them, 1.5% had an event that contributed to their deaths, according to a report from the Health and Human Services Office of the Inspector General. Another 13% of hospitalized beneficiaries had temporary harm, such as hypoglycemia, the report found. The combination of events cost Medicare an estimated $324 million in October 2008, the month the report covered, which means that such events could cost $4.4 billion a year. Physicians reviewing the data said that 44% of the adverse events, such as hospital-acquired infections, and temporary-harm events were clearly or probably preventable.

AMA Issues Social Media Policy

Physicians using social media sites such as Facebook and Twitter should carefully guard patient privacy while monitoring their own Internet presence in order to make sure it is accurate and appropriate, the American Medical Association said in a new policy statement. During its semiannual policy meeting in San Diego, the association called for physicians to “recognize that actions online and content posted can negatively affect their reputations among patients and colleagues, and may even have consequences for their medical careers.” The AMA urges physicians to set privacy settings on Web sites at their highest levels, maintain appropriate boundaries when interacting with patients online, and consider separating personal and professional content online.

Groups Pipe Up on Stent Case

The American College of Cardiology and the Society for Cardiovascular Angiography and Interventions say they're trying to address the issue of questionable stent implants and high costs to Medicare. In a joint e-mail, the they responded to a Senate Finance Committee report alleging that Maryland cardiologist Dr. Mark Midei had inappropriately implanted 600 stents from 2007 to 2009 at a cost to Medicare of $3.8 million. The report said that Abbott Laboratories feted Dr. Midei as one of its “Project Victory” cardiologists for top stent volume and paid him to promote the company's stents. Acknowledging that inappropriate implantations would be a violation of the Hippocratic Oath and a black mark on cardiology, the two groups said that they and their Maryland chapters have “been proactively addressing the issues raised by these allegations” by, for instance, helping states draft laws requiring accreditation of hospitals performing percutaneous coronary interventions.

State Smokes Heart Disease

The Massachusetts Medicaid program has curbed smoking prevalence and hospital admissions for some smoking-related diseases, according to a study reported in Public Library of Science Medicine. In 2006, the program began comprehensive coverage of tobacco cessation therapies and counseling. About 75,000 Medicaid recipients used that benefit from 2006 to early 2009 and smoking dropped from 38% to 29% among the Medicaid population, reported researchers from the state's Tobacco Cessation and Prevention Program and Harvard Medical School, Boston. Moreover, the percentage of smokers who said they quit during the previous year increased from 7% in the prebenefit period to 19% 2.5 years later. The rate of Medicaid hospital admissions for coronary atherosclerosis declined 49% and that for acute myocardial infarction dropped 46%. However, there was no change in admissions for lung diseases or some other tobacco-related conditions. In a statement American Heart Association Chief Executive Officer Nancy Brown said the study “provides ample evidence that comprehensive smoking cessation benefits must be a core component of antitobacco initiatives.”

Another Industry-Pay List

Massachusetts has published an online database listing 6 months of payments from pharmaceutical companies and medical device makers to health care providers. The data show that the top-spending company in the state was Boston Scientific, which paid $2.5 million to 129 recipients including physicians and hospitals. From July to December 2009, 283 companies paid $35.7 million to all recipients, including $16.4 million to 5,048 physicians, according to the Boston Globe.

Guilty of Inflated Prices

Three drug makers – Abbott Laboratories, B. Braun Medical, and Roxane Laboratories – have agreed to pay $421 million to settle the government's claim that they inflated wholesale prices of their drugs to get higher reimbursement from Medicare and Medicaid. The Department of Justice said the government had paid “millions of claims of far greater amounts than it would have if Abbott, B. Braun, and Roxane had reported truthful prices.” Roxane was charged with reporting false prices for azathioprine, diclofenac sodium, furosemide, hydromorphone, ipratropium bromide, Oramorph SR, Roxanol, and Roxicodone. The Abbott drugs were dextrose solutions, sodium chloride solutions, sterile water, vancomycin, and erythromycin. B. Braun was alleged to have inflated prices for 49 products. The case was brought to light by a whistle-blower in Florida, who is to receive nearly $90 million, according to the government statement.

Hospital Adverse Events Common

More than 13% of Medicare beneficiaries hospitalized in late 2008 experienced at least one adverse event causing lasting harm during their stays. Among them, 1.5% had an event that contributed to their deaths, according to a report from the Health and Human Services Office of the Inspector General. Another 13% of hospitalized beneficiaries had temporary harm, such as hypoglycemia, the report found. The combination of events cost Medicare an estimated $324 million in October 2008, the month the report covered, which means that such events could cost $4.4 billion a year. Physicians reviewing the data said that 44% of the adverse events, such as hospital-acquired infections, and temporary-harm events were clearly or probably preventable.

AMA Issues Social Media Policy

Physicians using social media sites such as Facebook and Twitter should carefully guard patient privacy while monitoring their own Internet presence in order to make sure it is accurate and appropriate, the American Medical Association said in a new policy statement. During its semiannual policy meeting in San Diego, the association called for physicians to “recognize that actions online and content posted can negatively affect their reputations among patients and colleagues, and may even have consequences for their medical careers.” The AMA urges physicians to set privacy settings on Web sites at their highest levels, maintain appropriate boundaries when interacting with patients online, and consider separating personal and professional content online.

WASHINGTON — For the first time, there is evidence of immediate and direct harm done by smoking even one cigarette, according to the 30th annual United States Surgeon General's Office report on smoking, issued Dec. 9.

Surgeon General Regina M. Benjamin said at a press briefing that previous reports from her office honed in on the various diseases that smoking could cause. “This report focuses on how tobacco smoke causes damage to every organ in your body,” she said.

When asked why this report could make a difference when so many previous warnings have not convinced all Americans to quit smoking, Dr. Benjamin said that she thinks that the direct evidence of harm will personalize the message.

“I believe it's very important that every American knows what's happening in their bodies, particularly those who are trying to quit.” She said it might be helpful for people to know the various biological reasons why quitting is so hard.

Dr. Benjamin said she knew that even President Obama was trying very hard to quit and that she'd told him about the new findings.

The 700-page “Report of the Surgeon General: How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease” determined that tobacco smoke contains 7,000 chemicals, hundreds of which are known to be toxic and 70 of which are carcinogenic, she noted.

The report describes multiple insults to the body from those chemicals, including changes in DNA that can lead to cancer; damage to the lining of the lungs; obstructive pulmonary disease and bronchitis; stress on the vasculature and cardiovascular disease; and an increased risk of heart attack, stroke, and aortic aneurysm.

Smoking also interferes with the effectiveness of chemotherapy and the control of blood sugar and leads to fertility problems, including difficulty conceiving, miscarriage, and preterm birth. Just one cigarette can trigger a heart attack or stroke, she said.

In addition, the report examined the effects of secondhand smoke, finding that even brief exposure can cause cardiovascular disease and can also trigger acute cardiac events, such as heart attack. Babies exposed to secondhand smoke are more likely to die of sudden infant death syndrome.

The report highlights the increasingly addictive properties of today's cigarettes, many of which are designed to enhance nicotine absorption and its crossing of the blood-brain barrier, Dr. Benjamin said. Some cigarettes also allow smokers to inhale more deeply into the lungs, increasing the disease risk.

Department of Health and Human Services Secretary Kathleen Sebelius said at the briefing that the report shows that “there is no safe level of exposure to tobacco smoke,” and, she added, “If you're a smoker, the best time to quit is right now.”

John R. Seffrin, Ph.D., CEO of the American Cancer Society Cancer Action Network, agreed. “Today's report makes it clear, once again, that there is no such thing as a safe cigarette and no such thing as a safe level of exposure to secondhand smoke for nonsmokers,” he said in a statement.

Ms. Sebelius noted that, every day, 4,000 Americans under the age of 18 years try their first cigarette, and that 1,000 of them become daily smokers. Some 1,200 Americans die every day as a result of tobacco-related causes, she said, and the report is part of the Obama administration's ongoing strategy to completely eliminate tobacco use.

Smoking rates declined until 2003, but since that time the rate has plateaued, with 20% of adults admitting they currently smoke. The administration has launched a multipronged attack, including giving the Food and Drug Administration the power to regulate tobacco and increasing funding to state and local programs for intervention and outreach programs. Medicare and the Federal Employees Health Benefits Program both now offer coverage of tobacco-cessation strategies, Ms. Sebelius said.

Tobacco-related disease is a big reason why America is less healthy than other countries, and that has consequences. “If we're a less healthy nation, we're not competitive in a global economy,” she added.

The Surgeon General's report is available at www.surgeongeneral.gov.

The report focuses on smoking's effects only on adults. The office is working on another report on adolescents and teenagers, Dr. Benjamin said.

WASHINGTON — For the first time, there is evidence of immediate and direct harm done by smoking even one cigarette, according to the 30th annual United States Surgeon General's Office report on smoking, issued Dec. 9.

Surgeon General Regina M. Benjamin said at a press briefing that previous reports from her office honed in on the various diseases that smoking could cause. “This report focuses on how tobacco smoke causes damage to every organ in your body,” she said.

When asked why this report could make a difference when so many previous warnings have not convinced all Americans to quit smoking, Dr. Benjamin said that she thinks that the direct evidence of harm will personalize the message.

“I believe it's very important that every American knows what's happening in their bodies, particularly those who are trying to quit.” She said it might be helpful for people to know the various biological reasons why quitting is so hard.

Dr. Benjamin said she knew that even President Obama was trying very hard to quit and that she'd told him about the new findings.

The 700-page “Report of the Surgeon General: How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease” determined that tobacco smoke contains 7,000 chemicals, hundreds of which are known to be toxic and 70 of which are carcinogenic, she noted.

The report describes multiple insults to the body from those chemicals, including changes in DNA that can lead to cancer; damage to the lining of the lungs; obstructive pulmonary disease and bronchitis; stress on the vasculature and cardiovascular disease; and an increased risk of heart attack, stroke, and aortic aneurysm.

Smoking also interferes with the effectiveness of chemotherapy and the control of blood sugar and leads to fertility problems, including difficulty conceiving, miscarriage, and preterm birth. Just one cigarette can trigger a heart attack or stroke, she said.

In addition, the report examined the effects of secondhand smoke, finding that even brief exposure can cause cardiovascular disease and can also trigger acute cardiac events, such as heart attack. Babies exposed to secondhand smoke are more likely to die of sudden infant death syndrome.

The report highlights the increasingly addictive properties of today's cigarettes, many of which are designed to enhance nicotine absorption and its crossing of the blood-brain barrier, Dr. Benjamin said. Some cigarettes also allow smokers to inhale more deeply into the lungs, increasing the disease risk.

Department of Health and Human Services Secretary Kathleen Sebelius said at the briefing that the report shows that “there is no safe level of exposure to tobacco smoke,” and, she added, “If you're a smoker, the best time to quit is right now.”

John R. Seffrin, Ph.D., CEO of the American Cancer Society Cancer Action Network, agreed. “Today's report makes it clear, once again, that there is no such thing as a safe cigarette and no such thing as a safe level of exposure to secondhand smoke for nonsmokers,” he said in a statement.

Ms. Sebelius noted that, every day, 4,000 Americans under the age of 18 years try their first cigarette, and that 1,000 of them become daily smokers. Some 1,200 Americans die every day as a result of tobacco-related causes, she said, and the report is part of the Obama administration's ongoing strategy to completely eliminate tobacco use.

Smoking rates declined until 2003, but since that time the rate has plateaued, with 20% of adults admitting they currently smoke. The administration has launched a multipronged attack, including giving the Food and Drug Administration the power to regulate tobacco and increasing funding to state and local programs for intervention and outreach programs. Medicare and the Federal Employees Health Benefits Program both now offer coverage of tobacco-cessation strategies, Ms. Sebelius said.

Tobacco-related disease is a big reason why America is less healthy than other countries, and that has consequences. “If we're a less healthy nation, we're not competitive in a global economy,” she added.

The Surgeon General's report is available at www.surgeongeneral.gov.

The report focuses on smoking's effects only on adults. The office is working on another report on adolescents and teenagers, Dr. Benjamin said.

WASHINGTON — For the first time, there is evidence of immediate and direct harm done by smoking even one cigarette, according to the 30th annual United States Surgeon General's Office report on smoking, issued Dec. 9.

Surgeon General Regina M. Benjamin said at a press briefing that previous reports from her office honed in on the various diseases that smoking could cause. “This report focuses on how tobacco smoke causes damage to every organ in your body,” she said.

When asked why this report could make a difference when so many previous warnings have not convinced all Americans to quit smoking, Dr. Benjamin said that she thinks that the direct evidence of harm will personalize the message.

“I believe it's very important that every American knows what's happening in their bodies, particularly those who are trying to quit.” She said it might be helpful for people to know the various biological reasons why quitting is so hard.

Dr. Benjamin said she knew that even President Obama was trying very hard to quit and that she'd told him about the new findings.

The 700-page “Report of the Surgeon General: How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease” determined that tobacco smoke contains 7,000 chemicals, hundreds of which are known to be toxic and 70 of which are carcinogenic, she noted.

The report describes multiple insults to the body from those chemicals, including changes in DNA that can lead to cancer; damage to the lining of the lungs; obstructive pulmonary disease and bronchitis; stress on the vasculature and cardiovascular disease; and an increased risk of heart attack, stroke, and aortic aneurysm.

Smoking also interferes with the effectiveness of chemotherapy and the control of blood sugar and leads to fertility problems, including difficulty conceiving, miscarriage, and preterm birth. Just one cigarette can trigger a heart attack or stroke, she said.

In addition, the report examined the effects of secondhand smoke, finding that even brief exposure can cause cardiovascular disease and can also trigger acute cardiac events, such as heart attack. Babies exposed to secondhand smoke are more likely to die of sudden infant death syndrome.

The report highlights the increasingly addictive properties of today's cigarettes, many of which are designed to enhance nicotine absorption and its crossing of the blood-brain barrier, Dr. Benjamin said. Some cigarettes also allow smokers to inhale more deeply into the lungs, increasing the disease risk.

Department of Health and Human Services Secretary Kathleen Sebelius said at the briefing that the report shows that “there is no safe level of exposure to tobacco smoke,” and, she added, “If you're a smoker, the best time to quit is right now.”

John R. Seffrin, Ph.D., CEO of the American Cancer Society Cancer Action Network, agreed. “Today's report makes it clear, once again, that there is no such thing as a safe cigarette and no such thing as a safe level of exposure to secondhand smoke for nonsmokers,” he said in a statement.

Ms. Sebelius noted that, every day, 4,000 Americans under the age of 18 years try their first cigarette, and that 1,000 of them become daily smokers. Some 1,200 Americans die every day as a result of tobacco-related causes, she said, and the report is part of the Obama administration's ongoing strategy to completely eliminate tobacco use.

Smoking rates declined until 2003, but since that time the rate has plateaued, with 20% of adults admitting they currently smoke. The administration has launched a multipronged attack, including giving the Food and Drug Administration the power to regulate tobacco and increasing funding to state and local programs for intervention and outreach programs. Medicare and the Federal Employees Health Benefits Program both now offer coverage of tobacco-cessation strategies, Ms. Sebelius said.

Tobacco-related disease is a big reason why America is less healthy than other countries, and that has consequences. “If we're a less healthy nation, we're not competitive in a global economy,” she added.

The Surgeon General's report is available at www.surgeongeneral.gov.

The report focuses on smoking's effects only on adults. The office is working on another report on adolescents and teenagers, Dr. Benjamin said.

Fake Pot Gets Busted

The United States Drug Enforcement Administration took emergency action to put five chemicals used to make "fake pot" on the controlled substances list. They will now be designated as Schedule I, the most restrictive category. Possessing or selling the chemicals or the products that contain them – such as "Spice," "K2," "Blaze," and "Red X Dawn" – will be illegal for the next year. The products are labeled as "incense," but they are plant material coated with chemicals that mimic tetrahydrocannabinol, the active ingredient in marijuana, the DEA said in its announcement. While the agents are strictly controlled, the DEA and the Department of Health and Human Services will study them and consider whether to permanently add them to the controlled substances schedule.

Salvia’s Effects Described

A small placebo-controlled study of the effects of Salvia divinorum shows that it has similarities to classic hallucinogens "including mystical-type effects," according to researchers at the psychiatry and neuroscience departments of Johns Hopkins University, Baltimore, and at the University of Kansas, Lawrence. The researchers conducted a double-blind trial in four psychologically and physically healthy hallucinogen-using adults, giving them 16 ascending doses of salvinorin A and 4 intermixed placebo doses over 20 sessions and several weeks. Salvinorin A is the known psychoactive constituent of S. divinorum. Acute effects peaked at 2 minutes after inhalation and generally were gone in 20 minutes. There were no adverse events, and no significant changes in heart rate or blood pressure. Two participants reported that the effect was "as strong as imaginable for this drug." But there was a relative lack of dysphoric effects, said the researchers. Commonly reported were changes in spatial orientation, feelings of energy, and recurring themes such as revisiting childhood memories and cartoonlike imagery. The study is in press at Drug and Alcohol Dependence.

Single Abuse Institute Urged

A body that oversees the National Institutes of Health has recommended that a single institute be created to address substance use, abuse, and addiction research. The NIH Scientific Management Review Board made the recommendation in a report on how HHS might better-organize the NIH. The report recommends integration of the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, and related research portfolios from other NIH centers. The formation of a single institute "makes scientific sense and would enhance NIH’s efforts to address the substance abuse and addiction problems that take such a terrible toll on our society," said NIH Director Francis Collins in a statement. He estimated that a detailed reorganization plan would be presented to him by mid-2011 but said that nothing will change until then.

Neurostimulation Device Inquiry

Medtronic Inc. said that on Oct. 14, it was subpoenaed by the United States Attorney’s Office for the Western District of New York "relating to the Company’s sales, marketing, and reimbursement support practices regarding certain neurostimulation devices." The disclosure was made in December in the company’s required third-quarter report to the Securities and Exchange Commission. In the filing, Medtronic said that it "is fully cooperating with this investigation."

Counseling Cuts Smoking, Some Ills

The Massachusetts Medicaid program has curbed smoking prevalence and hospital admissions for some smoking-related diseases, according to a study published online in Public Library of Science Medicine. In 2006, the program began comprehensive coverage of tobacco cessation therapies and counseling. About 75,000 Medicaid recipients used that benefit from 2006 to early 2009, and smoking dropped 10% among the Medicaid population, reported researchers from the state’s Tobacco Cessation and Prevention Program and Harvard Medical School, Boston. The rate of Medicaid hospital admissions for coronary atherosclerosis declined 49%, and that for acute myocardial infarction dropped 46%. But there was no change in admissions for lung diseases or some other tobacco-related conditions.

AMA Issues Social Media Policy

Physicians using social media sites such as Facebook and Twitter should carefully guard patient privacy while monitoring their own Internet presence to make sure it is accurate and appropriate, the American Medical Association said in a new policy statement. During its semiannual policy meeting in San Diego, the AMA called for physicians to "recognize that actions online and content posted can negatively affect their reputations among patients and colleagues, and may even have consequences for their medical careers." The AMA urges physicians to set privacy settings on Web sites at their highest levels, maintain appropriate boundaries when interacting with patients online, and consider separating personal and professional content online.

–Alicia Ault

Fake Pot Gets Busted

The United States Drug Enforcement Administration took emergency action to put five chemicals used to make "fake pot" on the controlled substances list. They will now be designated as Schedule I, the most restrictive category. Possessing or selling the chemicals or the products that contain them – such as "Spice," "K2," "Blaze," and "Red X Dawn" – will be illegal for the next year. The products are labeled as "incense," but they are plant material coated with chemicals that mimic tetrahydrocannabinol, the active ingredient in marijuana, the DEA said in its announcement. While the agents are strictly controlled, the DEA and the Department of Health and Human Services will study them and consider whether to permanently add them to the controlled substances schedule.

Salvia’s Effects Described

A small placebo-controlled study of the effects of Salvia divinorum shows that it has similarities to classic hallucinogens "including mystical-type effects," according to researchers at the psychiatry and neuroscience departments of Johns Hopkins University, Baltimore, and at the University of Kansas, Lawrence. The researchers conducted a double-blind trial in four psychologically and physically healthy hallucinogen-using adults, giving them 16 ascending doses of salvinorin A and 4 intermixed placebo doses over 20 sessions and several weeks. Salvinorin A is the known psychoactive constituent of S. divinorum. Acute effects peaked at 2 minutes after inhalation and generally were gone in 20 minutes. There were no adverse events, and no significant changes in heart rate or blood pressure. Two participants reported that the effect was "as strong as imaginable for this drug." But there was a relative lack of dysphoric effects, said the researchers. Commonly reported were changes in spatial orientation, feelings of energy, and recurring themes such as revisiting childhood memories and cartoonlike imagery. The study is in press at Drug and Alcohol Dependence.

Single Abuse Institute Urged

A body that oversees the National Institutes of Health has recommended that a single institute be created to address substance use, abuse, and addiction research. The NIH Scientific Management Review Board made the recommendation in a report on how HHS might better-organize the NIH. The report recommends integration of the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, and related research portfolios from other NIH centers. The formation of a single institute "makes scientific sense and would enhance NIH’s efforts to address the substance abuse and addiction problems that take such a terrible toll on our society," said NIH Director Francis Collins in a statement. He estimated that a detailed reorganization plan would be presented to him by mid-2011 but said that nothing will change until then.

Neurostimulation Device Inquiry

Medtronic Inc. said that on Oct. 14, it was subpoenaed by the United States Attorney’s Office for the Western District of New York "relating to the Company’s sales, marketing, and reimbursement support practices regarding certain neurostimulation devices." The disclosure was made in December in the company’s required third-quarter report to the Securities and Exchange Commission. In the filing, Medtronic said that it "is fully cooperating with this investigation."

Counseling Cuts Smoking, Some Ills

The Massachusetts Medicaid program has curbed smoking prevalence and hospital admissions for some smoking-related diseases, according to a study published online in Public Library of Science Medicine. In 2006, the program began comprehensive coverage of tobacco cessation therapies and counseling. About 75,000 Medicaid recipients used that benefit from 2006 to early 2009, and smoking dropped 10% among the Medicaid population, reported researchers from the state’s Tobacco Cessation and Prevention Program and Harvard Medical School, Boston. The rate of Medicaid hospital admissions for coronary atherosclerosis declined 49%, and that for acute myocardial infarction dropped 46%. But there was no change in admissions for lung diseases or some other tobacco-related conditions.

AMA Issues Social Media Policy

Physicians using social media sites such as Facebook and Twitter should carefully guard patient privacy while monitoring their own Internet presence to make sure it is accurate and appropriate, the American Medical Association said in a new policy statement. During its semiannual policy meeting in San Diego, the AMA called for physicians to "recognize that actions online and content posted can negatively affect their reputations among patients and colleagues, and may even have consequences for their medical careers." The AMA urges physicians to set privacy settings on Web sites at their highest levels, maintain appropriate boundaries when interacting with patients online, and consider separating personal and professional content online.

–Alicia Ault

Fake Pot Gets Busted

The United States Drug Enforcement Administration took emergency action to put five chemicals used to make "fake pot" on the controlled substances list. They will now be designated as Schedule I, the most restrictive category. Possessing or selling the chemicals or the products that contain them – such as "Spice," "K2," "Blaze," and "Red X Dawn" – will be illegal for the next year. The products are labeled as "incense," but they are plant material coated with chemicals that mimic tetrahydrocannabinol, the active ingredient in marijuana, the DEA said in its announcement. While the agents are strictly controlled, the DEA and the Department of Health and Human Services will study them and consider whether to permanently add them to the controlled substances schedule.

Salvia’s Effects Described

A small placebo-controlled study of the effects of Salvia divinorum shows that it has similarities to classic hallucinogens "including mystical-type effects," according to researchers at the psychiatry and neuroscience departments of Johns Hopkins University, Baltimore, and at the University of Kansas, Lawrence. The researchers conducted a double-blind trial in four psychologically and physically healthy hallucinogen-using adults, giving them 16 ascending doses of salvinorin A and 4 intermixed placebo doses over 20 sessions and several weeks. Salvinorin A is the known psychoactive constituent of S. divinorum. Acute effects peaked at 2 minutes after inhalation and generally were gone in 20 minutes. There were no adverse events, and no significant changes in heart rate or blood pressure. Two participants reported that the effect was "as strong as imaginable for this drug." But there was a relative lack of dysphoric effects, said the researchers. Commonly reported were changes in spatial orientation, feelings of energy, and recurring themes such as revisiting childhood memories and cartoonlike imagery. The study is in press at Drug and Alcohol Dependence.

Single Abuse Institute Urged

A body that oversees the National Institutes of Health has recommended that a single institute be created to address substance use, abuse, and addiction research. The NIH Scientific Management Review Board made the recommendation in a report on how HHS might better-organize the NIH. The report recommends integration of the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, and related research portfolios from other NIH centers. The formation of a single institute "makes scientific sense and would enhance NIH’s efforts to address the substance abuse and addiction problems that take such a terrible toll on our society," said NIH Director Francis Collins in a statement. He estimated that a detailed reorganization plan would be presented to him by mid-2011 but said that nothing will change until then.

Neurostimulation Device Inquiry

Medtronic Inc. said that on Oct. 14, it was subpoenaed by the United States Attorney’s Office for the Western District of New York "relating to the Company’s sales, marketing, and reimbursement support practices regarding certain neurostimulation devices." The disclosure was made in December in the company’s required third-quarter report to the Securities and Exchange Commission. In the filing, Medtronic said that it "is fully cooperating with this investigation."

Counseling Cuts Smoking, Some Ills

The Massachusetts Medicaid program has curbed smoking prevalence and hospital admissions for some smoking-related diseases, according to a study published online in Public Library of Science Medicine. In 2006, the program began comprehensive coverage of tobacco cessation therapies and counseling. About 75,000 Medicaid recipients used that benefit from 2006 to early 2009, and smoking dropped 10% among the Medicaid population, reported researchers from the state’s Tobacco Cessation and Prevention Program and Harvard Medical School, Boston. The rate of Medicaid hospital admissions for coronary atherosclerosis declined 49%, and that for acute myocardial infarction dropped 46%. But there was no change in admissions for lung diseases or some other tobacco-related conditions.

AMA Issues Social Media Policy

Physicians using social media sites such as Facebook and Twitter should carefully guard patient privacy while monitoring their own Internet presence to make sure it is accurate and appropriate, the American Medical Association said in a new policy statement. During its semiannual policy meeting in San Diego, the AMA called for physicians to "recognize that actions online and content posted can negatively affect their reputations among patients and colleagues, and may even have consequences for their medical careers." The AMA urges physicians to set privacy settings on Web sites at their highest levels, maintain appropriate boundaries when interacting with patients online, and consider separating personal and professional content online.

–Alicia Ault

The Food and Drug Administration on Dec. 22 approved the Gardasil vaccine to prevent anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people aged 9-26 years.

The approval was expected, as in November, an FDA advisory committee agreed that the data submitted by Merck & Co. supported approval. Merck had filed for the additional approval in early 2010.

[FDA Committee Considers Gardasil for Anal Cancer Prevention]

"Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

Anal cancer is not common, affecting 5,300 people annually in the United States, according to estimates from the American Cancer Society. But HPV is associated with approximately 90% of anal cancer, according to the FDA.

The vaccine was approved based on data from a randomized, controlled trial of 602 men who have sex with men (MSM), a group known to be at the greatest risk for anal cancer. Those data were part of a larger study that led to Gardasil’s approval in 2009 for preventing genital warts in boys and men. The participants received three doses of vaccine or a placebo. Compared with placebo, the vaccine showed 78% effectiveness in preventing anal intraepithelial neoplasms – precursors to anal cancer – related to HPV types 6, 11, 16, and 18.

According to the FDA, because anal cancer is the same in both men and women, the effectiveness data could support approval in both sexes. The agency stressed that for all indications, the vaccine is most effective when given prior to infection.

The new approval could be cause for the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices to revisit a previous recommendation against routine HPV vaccination for boys and men for genital wart prevention. The ACIP meets in February.

Gardasil is approved in 121 countries and, according to Merck, since its first approval in 2006 through May 31, 2010, more than 65 million doses have been distributed worldwide. It is approved in the U.S. for use in girls and young women aged 9-26 years for the prevention of cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts (condylomata acuminata) caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.

The Food and Drug Administration on Dec. 22 approved the Gardasil vaccine to prevent anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people aged 9-26 years.

The approval was expected, as in November, an FDA advisory committee agreed that the data submitted by Merck & Co. supported approval. Merck had filed for the additional approval in early 2010.

[FDA Committee Considers Gardasil for Anal Cancer Prevention]

"Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

Anal cancer is not common, affecting 5,300 people annually in the United States, according to estimates from the American Cancer Society. But HPV is associated with approximately 90% of anal cancer, according to the FDA.

The vaccine was approved based on data from a randomized, controlled trial of 602 men who have sex with men (MSM), a group known to be at the greatest risk for anal cancer. Those data were part of a larger study that led to Gardasil’s approval in 2009 for preventing genital warts in boys and men. The participants received three doses of vaccine or a placebo. Compared with placebo, the vaccine showed 78% effectiveness in preventing anal intraepithelial neoplasms – precursors to anal cancer – related to HPV types 6, 11, 16, and 18.

According to the FDA, because anal cancer is the same in both men and women, the effectiveness data could support approval in both sexes. The agency stressed that for all indications, the vaccine is most effective when given prior to infection.

The new approval could be cause for the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices to revisit a previous recommendation against routine HPV vaccination for boys and men for genital wart prevention. The ACIP meets in February.

Gardasil is approved in 121 countries and, according to Merck, since its first approval in 2006 through May 31, 2010, more than 65 million doses have been distributed worldwide. It is approved in the U.S. for use in girls and young women aged 9-26 years for the prevention of cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts (condylomata acuminata) caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.

The Food and Drug Administration on Dec. 22 approved the Gardasil vaccine to prevent anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people aged 9-26 years.

The approval was expected, as in November, an FDA advisory committee agreed that the data submitted by Merck & Co. supported approval. Merck had filed for the additional approval in early 2010.

[FDA Committee Considers Gardasil for Anal Cancer Prevention]

"Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

Anal cancer is not common, affecting 5,300 people annually in the United States, according to estimates from the American Cancer Society. But HPV is associated with approximately 90% of anal cancer, according to the FDA.

The vaccine was approved based on data from a randomized, controlled trial of 602 men who have sex with men (MSM), a group known to be at the greatest risk for anal cancer. Those data were part of a larger study that led to Gardasil’s approval in 2009 for preventing genital warts in boys and men. The participants received three doses of vaccine or a placebo. Compared with placebo, the vaccine showed 78% effectiveness in preventing anal intraepithelial neoplasms – precursors to anal cancer – related to HPV types 6, 11, 16, and 18.

According to the FDA, because anal cancer is the same in both men and women, the effectiveness data could support approval in both sexes. The agency stressed that for all indications, the vaccine is most effective when given prior to infection.

The new approval could be cause for the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices to revisit a previous recommendation against routine HPV vaccination for boys and men for genital wart prevention. The ACIP meets in February.

Gardasil is approved in 121 countries and, according to Merck, since its first approval in 2006 through May 31, 2010, more than 65 million doses have been distributed worldwide. It is approved in the U.S. for use in girls and young women aged 9-26 years for the prevention of cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts (condylomata acuminata) caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.

A new study by the Association of Community Cancer Centers finds that very few hospitals are monitoring readmissions or following up with discharged patients.

The study of cancer patients’ transitions from inpatient to outpatient settings also found that while 85% of responding hospitals had a process to manage patients between-care settings, only 55% had a written transition policy, while only 3% had a specific transition policy that applied specifically to oncology patients.

In conducting the study, the ACCC "examined components of the care transition, including the adequacy and completeness of the medical record, medication reconciliation, and communication among providers – both within their own programs and between the two care settings," said ACCC President Al B. Benson III in a statement. Dr. Benson added, "Our goal was to understand the challenges involved in transitioning patients between settings and to identify best practices ensuring a smooth transition."

The study was conducted through two online surveys: one of oncology physician practices and the other for hospital-based oncology programs. About 100 participants completed surveys overall, according to the ACCC. Five hospital and four physician practices were selected as "exemplary" sites, based on a series of quality metrics.

Among the findings for hospitals: 93% had a process for contacting the patient’s oncologist when he or she was admitted for oncology-related treatment, but only 66% had procedures in place for making the contact when the patient was admitted with cancer as a secondary diagnosis.

Only 18% of hospitals contact oncology patients post discharge to confirm that follow-up appointments have been scheduled or met; 33% of hospital-based clinicians check, usually through a phone call to see how patients are doing more generally.

ACCC found that most hospitals and oncology practices "have fairly effective medication reconciliation procedures in place." But most hospitals also rely "almost entirely" on the patient or the family to tell them which drugs the patient is taking, the dose, and prescribed use – and do not confirm with the outpatient physician, the ACCC found.

Electronic health record (EHR) systems are making inroads but are generally accessible only by the admitting oncologist, not the community oncologist. Only 35% of hospitals with EHRs said they can transmit data to independent oncology groups, and only 32% automatically forward a discharge summary to independent groups.

On the outpatient side, the ACCC found that while oncologists infrequently are notified that their patients have been admitted, up to 60% of the responding oncology groups said they took proactive steps to determine admissions, by checking the EHR or hospital lists.

Fifty percent of the groups have designated staff to manage the transition, and more than 60% followed-up or made the post-discharge office appointment. But the ACCC found few groups have specific policies or checklists to help manage the transition.

Most groups (80%) said they conducted medication reconciliation and 75% had computerized order entry systems. Half use the systems to electronically transmit prescriptions to the pharmacist, but few can use computerized prescriber order entry to access external prescription databases, said the ACCC.

They also found that most oncology groups obtained the hospital medical records and discharge summaries, which they added to patient’s office chart. But the information was flagged for review in only about 25% of practices.

To a large extent, it seems that management of the patient transition is dependent on hospital-based EHR systems, said the ACCC.

The group highlighted other challenges such as hospitals and physicians competing for patients; the competition can sometimes impede communications during the transition. Also, the cost of managing a transition is not usually reimbursed.

A new study by the Association of Community Cancer Centers finds that very few hospitals are monitoring readmissions or following up with discharged patients.

The study of cancer patients’ transitions from inpatient to outpatient settings also found that while 85% of responding hospitals had a process to manage patients between-care settings, only 55% had a written transition policy, while only 3% had a specific transition policy that applied specifically to oncology patients.

In conducting the study, the ACCC "examined components of the care transition, including the adequacy and completeness of the medical record, medication reconciliation, and communication among providers – both within their own programs and between the two care settings," said ACCC President Al B. Benson III in a statement. Dr. Benson added, "Our goal was to understand the challenges involved in transitioning patients between settings and to identify best practices ensuring a smooth transition."

The study was conducted through two online surveys: one of oncology physician practices and the other for hospital-based oncology programs. About 100 participants completed surveys overall, according to the ACCC. Five hospital and four physician practices were selected as "exemplary" sites, based on a series of quality metrics.

Among the findings for hospitals: 93% had a process for contacting the patient’s oncologist when he or she was admitted for oncology-related treatment, but only 66% had procedures in place for making the contact when the patient was admitted with cancer as a secondary diagnosis.

Only 18% of hospitals contact oncology patients post discharge to confirm that follow-up appointments have been scheduled or met; 33% of hospital-based clinicians check, usually through a phone call to see how patients are doing more generally.

ACCC found that most hospitals and oncology practices "have fairly effective medication reconciliation procedures in place." But most hospitals also rely "almost entirely" on the patient or the family to tell them which drugs the patient is taking, the dose, and prescribed use – and do not confirm with the outpatient physician, the ACCC found.

Electronic health record (EHR) systems are making inroads but are generally accessible only by the admitting oncologist, not the community oncologist. Only 35% of hospitals with EHRs said they can transmit data to independent oncology groups, and only 32% automatically forward a discharge summary to independent groups.

On the outpatient side, the ACCC found that while oncologists infrequently are notified that their patients have been admitted, up to 60% of the responding oncology groups said they took proactive steps to determine admissions, by checking the EHR or hospital lists.

Fifty percent of the groups have designated staff to manage the transition, and more than 60% followed-up or made the post-discharge office appointment. But the ACCC found few groups have specific policies or checklists to help manage the transition.

Most groups (80%) said they conducted medication reconciliation and 75% had computerized order entry systems. Half use the systems to electronically transmit prescriptions to the pharmacist, but few can use computerized prescriber order entry to access external prescription databases, said the ACCC.

They also found that most oncology groups obtained the hospital medical records and discharge summaries, which they added to patient’s office chart. But the information was flagged for review in only about 25% of practices.

To a large extent, it seems that management of the patient transition is dependent on hospital-based EHR systems, said the ACCC.

The group highlighted other challenges such as hospitals and physicians competing for patients; the competition can sometimes impede communications during the transition. Also, the cost of managing a transition is not usually reimbursed.

A new study by the Association of Community Cancer Centers finds that very few hospitals are monitoring readmissions or following up with discharged patients.

The study of cancer patients’ transitions from inpatient to outpatient settings also found that while 85% of responding hospitals had a process to manage patients between-care settings, only 55% had a written transition policy, while only 3% had a specific transition policy that applied specifically to oncology patients.

In conducting the study, the ACCC "examined components of the care transition, including the adequacy and completeness of the medical record, medication reconciliation, and communication among providers – both within their own programs and between the two care settings," said ACCC President Al B. Benson III in a statement. Dr. Benson added, "Our goal was to understand the challenges involved in transitioning patients between settings and to identify best practices ensuring a smooth transition."

The study was conducted through two online surveys: one of oncology physician practices and the other for hospital-based oncology programs. About 100 participants completed surveys overall, according to the ACCC. Five hospital and four physician practices were selected as "exemplary" sites, based on a series of quality metrics.

Among the findings for hospitals: 93% had a process for contacting the patient’s oncologist when he or she was admitted for oncology-related treatment, but only 66% had procedures in place for making the contact when the patient was admitted with cancer as a secondary diagnosis.

Only 18% of hospitals contact oncology patients post discharge to confirm that follow-up appointments have been scheduled or met; 33% of hospital-based clinicians check, usually through a phone call to see how patients are doing more generally.

ACCC found that most hospitals and oncology practices "have fairly effective medication reconciliation procedures in place." But most hospitals also rely "almost entirely" on the patient or the family to tell them which drugs the patient is taking, the dose, and prescribed use – and do not confirm with the outpatient physician, the ACCC found.

Electronic health record (EHR) systems are making inroads but are generally accessible only by the admitting oncologist, not the community oncologist. Only 35% of hospitals with EHRs said they can transmit data to independent oncology groups, and only 32% automatically forward a discharge summary to independent groups.

On the outpatient side, the ACCC found that while oncologists infrequently are notified that their patients have been admitted, up to 60% of the responding oncology groups said they took proactive steps to determine admissions, by checking the EHR or hospital lists.

Fifty percent of the groups have designated staff to manage the transition, and more than 60% followed-up or made the post-discharge office appointment. But the ACCC found few groups have specific policies or checklists to help manage the transition.

Most groups (80%) said they conducted medication reconciliation and 75% had computerized order entry systems. Half use the systems to electronically transmit prescriptions to the pharmacist, but few can use computerized prescriber order entry to access external prescription databases, said the ACCC.

They also found that most oncology groups obtained the hospital medical records and discharge summaries, which they added to patient’s office chart. But the information was flagged for review in only about 25% of practices.

To a large extent, it seems that management of the patient transition is dependent on hospital-based EHR systems, said the ACCC.

The group highlighted other challenges such as hospitals and physicians competing for patients; the competition can sometimes impede communications during the transition. Also, the cost of managing a transition is not usually reimbursed.

The Food and Drug Administration on Dec. 16 recommended removing bevacizumab’s indication as a breast cancer therapy.

The actual removal of the indication—if it ultimately happens—could take months, as the manufacturer of bevacizumab (Avastin), is being given the opportunity to appeal the decision.

The FDA’s action does not impact bevacizumab’s other approvals. And, while the appeals process continues, bevacizumab will remained approved for breast cancer, agency officials said.

Oncologists who want to continue treating breast cancer patients with bevacizumab “should use their medical judgment,” Dr. Richard Pazdur, director of the FDA’s Office of Oncology Drug Products, said in a briefing announcing the agency’s decision.

The decision has been awaited by oncologists and the breast cancer community since at least mid-July, when in a near-unanimous vote, the FDA’s Oncologic Drugs Advisory Committee recommended that the approval of bevacizumab as a first-line treatment for patients with metastatic breast cancer be withdrawn. That recommendation was based on results of follow-up studies that failed to confirm progression-free survival benefits in this population.

“I understand that today’s recommendation is disappointing for patients with breast cancer,” Dr. Pazdur said. “Please note these results are also disappointing for the FDA as well,” he said, adding that he had been hopeful that survival improvements seen in the E2100 study that supported the drug’s accelerated approval in 2008 would bear out in later studies.

But because bevacizumab entered the U.S. market through the accelerated approval process, the agency has the power to remove the drug if subsequent trials do not bear out initial results.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, agreed with Dr. Pazdur that agency officials did not take the withdrawal lightly. She said that FDA staff who reviewed the bevacizumab data “have close, personal experience with this disease” and that they were oncologists “who have treated patients with cancer and have been personally touched by this disease.”

The FDA is hopeful that bevacizumab still has promise, said Dr. Woodcock. “We don’t doubt based on the data that this is an active drug,” she said, but added that despite a tumor response, there had been no survival benefit demonstrated.

In the briefing, agency officials painstakingly laid out how the FDA came to its decision. The agency took into account the E2100 study, which evaluated bevacizumab use in patients who had not previously received chemotherapy for their metastatic HER2-negative breast cancer; these patients showed a five-month improvement in survival. They also evaluated three more studies that FDA reviewers said did not replicate that benefit: AVADO, RIBBON1, and AVF2119g.

In addition, patients taking bevacizumab had a higher risk of serious side effects, including stroke, wound healing complications, organ damage or failure, and the development of a neurological condition called reversible posterior leukoencephalopathy syndrome (RPLS). Given these side effects, the risk of using bevacizumab outweighed its benefits, officials said.

Genentech was given 15 days to appeal the agency’s decision, which the company said it would do, even as the briefing was being conducted.

The company now has 30 days to submit a package to the agency with data and evidence that “there are material facts in dispute” to be granted the hearing, Denise Esposito, deputy director of the FDA’s Office of Regulatory Policy, said in the briefing.

If the agency grants a hearing, it will be announced in the Federal Register. It would be a public hearing, with outside experts invited to participate but not vote, said Ms. Esposito. It’s possible those experts could be some or all members of the advisory committee that previously voted on bevacizumab. Genentech also would be allowed to make its case.

The agency would then take time to make a decision, said Ms. Esposito. She said the whole process could take at least several months.

The FDA’s decision follows the recommendation made earlier in December by the National Institute for Health and Clinical Excellence. That body, the clinical effectiveness agency for England and Wales, recommended against use of bevacizumab in combination with taxane chemotherapy for metastatic breast cancer, citing high costs and an unclear survival benefit.

The European Medicines Agency ruled on Dec. 16, however, that the benefits of bevacizumab in combination with paclitaxel outweigh its risks and said, “This combination remains a valuable treatment option for patients suffering from metastatic breast cancer.” The agency added that bevacizumab should not be used in combination with docetaxel for breast cancer.

Dr. Pazdur said he could not speculate why the EMA had reached a slightly different conclusion on the same data reviewed by the FDA. But, he said, the FDA was acting within the rules laid out by the accelerated approval process, whereas the EMA had fully approved bevacizumab based on the E2100 trial results.

The drug also recently failed to improve pathological complete response in a large, European trial among women with primary HER2-negative breast cancer who were given a neoadjuvant regimen that combined bevacizumab with epirubicin, cyclophosphamide, and docetaxel.  The results were reported at the San Antonio Breast Cancer Symposium.

The Food and Drug Administration on Dec. 16 recommended removing bevacizumab’s indication as a breast cancer therapy.

The actual removal of the indication—if it ultimately happens—could take months, as the manufacturer of bevacizumab (Avastin), is being given the opportunity to appeal the decision.

The FDA’s action does not impact bevacizumab’s other approvals. And, while the appeals process continues, bevacizumab will remained approved for breast cancer, agency officials said.

Oncologists who want to continue treating breast cancer patients with bevacizumab “should use their medical judgment,” Dr. Richard Pazdur, director of the FDA’s Office of Oncology Drug Products, said in a briefing announcing the agency’s decision.

The decision has been awaited by oncologists and the breast cancer community since at least mid-July, when in a near-unanimous vote, the FDA’s Oncologic Drugs Advisory Committee recommended that the approval of bevacizumab as a first-line treatment for patients with metastatic breast cancer be withdrawn. That recommendation was based on results of follow-up studies that failed to confirm progression-free survival benefits in this population.

“I understand that today’s recommendation is disappointing for patients with breast cancer,” Dr. Pazdur said. “Please note these results are also disappointing for the FDA as well,” he said, adding that he had been hopeful that survival improvements seen in the E2100 study that supported the drug’s accelerated approval in 2008 would bear out in later studies.

But because bevacizumab entered the U.S. market through the accelerated approval process, the agency has the power to remove the drug if subsequent trials do not bear out initial results.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, agreed with Dr. Pazdur that agency officials did not take the withdrawal lightly. She said that FDA staff who reviewed the bevacizumab data “have close, personal experience with this disease” and that they were oncologists “who have treated patients with cancer and have been personally touched by this disease.”

The FDA is hopeful that bevacizumab still has promise, said Dr. Woodcock. “We don’t doubt based on the data that this is an active drug,” she said, but added that despite a tumor response, there had been no survival benefit demonstrated.

In the briefing, agency officials painstakingly laid out how the FDA came to its decision. The agency took into account the E2100 study, which evaluated bevacizumab use in patients who had not previously received chemotherapy for their metastatic HER2-negative breast cancer; these patients showed a five-month improvement in survival. They also evaluated three more studies that FDA reviewers said did not replicate that benefit: AVADO, RIBBON1, and AVF2119g.

In addition, patients taking bevacizumab had a higher risk of serious side effects, including stroke, wound healing complications, organ damage or failure, and the development of a neurological condition called reversible posterior leukoencephalopathy syndrome (RPLS). Given these side effects, the risk of using bevacizumab outweighed its benefits, officials said.

Genentech was given 15 days to appeal the agency’s decision, which the company said it would do, even as the briefing was being conducted.

The company now has 30 days to submit a package to the agency with data and evidence that “there are material facts in dispute” to be granted the hearing, Denise Esposito, deputy director of the FDA’s Office of Regulatory Policy, said in the briefing.

If the agency grants a hearing, it will be announced in the Federal Register. It would be a public hearing, with outside experts invited to participate but not vote, said Ms. Esposito. It’s possible those experts could be some or all members of the advisory committee that previously voted on bevacizumab. Genentech also would be allowed to make its case.

The agency would then take time to make a decision, said Ms. Esposito. She said the whole process could take at least several months.

The FDA’s decision follows the recommendation made earlier in December by the National Institute for Health and Clinical Excellence. That body, the clinical effectiveness agency for England and Wales, recommended against use of bevacizumab in combination with taxane chemotherapy for metastatic breast cancer, citing high costs and an unclear survival benefit.

The European Medicines Agency ruled on Dec. 16, however, that the benefits of bevacizumab in combination with paclitaxel outweigh its risks and said, “This combination remains a valuable treatment option for patients suffering from metastatic breast cancer.” The agency added that bevacizumab should not be used in combination with docetaxel for breast cancer.

Dr. Pazdur said he could not speculate why the EMA had reached a slightly different conclusion on the same data reviewed by the FDA. But, he said, the FDA was acting within the rules laid out by the accelerated approval process, whereas the EMA had fully approved bevacizumab based on the E2100 trial results.

The drug also recently failed to improve pathological complete response in a large, European trial among women with primary HER2-negative breast cancer who were given a neoadjuvant regimen that combined bevacizumab with epirubicin, cyclophosphamide, and docetaxel.  The results were reported at the San Antonio Breast Cancer Symposium.

The Food and Drug Administration on Dec. 16 recommended removing bevacizumab’s indication as a breast cancer therapy.

The actual removal of the indication—if it ultimately happens—could take months, as the manufacturer of bevacizumab (Avastin), is being given the opportunity to appeal the decision.

The FDA’s action does not impact bevacizumab’s other approvals. And, while the appeals process continues, bevacizumab will remained approved for breast cancer, agency officials said.

Oncologists who want to continue treating breast cancer patients with bevacizumab “should use their medical judgment,” Dr. Richard Pazdur, director of the FDA’s Office of Oncology Drug Products, said in a briefing announcing the agency’s decision.

The decision has been awaited by oncologists and the breast cancer community since at least mid-July, when in a near-unanimous vote, the FDA’s Oncologic Drugs Advisory Committee recommended that the approval of bevacizumab as a first-line treatment for patients with metastatic breast cancer be withdrawn. That recommendation was based on results of follow-up studies that failed to confirm progression-free survival benefits in this population.

“I understand that today’s recommendation is disappointing for patients with breast cancer,” Dr. Pazdur said. “Please note these results are also disappointing for the FDA as well,” he said, adding that he had been hopeful that survival improvements seen in the E2100 study that supported the drug’s accelerated approval in 2008 would bear out in later studies.

But because bevacizumab entered the U.S. market through the accelerated approval process, the agency has the power to remove the drug if subsequent trials do not bear out initial results.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, agreed with Dr. Pazdur that agency officials did not take the withdrawal lightly. She said that FDA staff who reviewed the bevacizumab data “have close, personal experience with this disease” and that they were oncologists “who have treated patients with cancer and have been personally touched by this disease.”

The FDA is hopeful that bevacizumab still has promise, said Dr. Woodcock. “We don’t doubt based on the data that this is an active drug,” she said, but added that despite a tumor response, there had been no survival benefit demonstrated.

In the briefing, agency officials painstakingly laid out how the FDA came to its decision. The agency took into account the E2100 study, which evaluated bevacizumab use in patients who had not previously received chemotherapy for their metastatic HER2-negative breast cancer; these patients showed a five-month improvement in survival. They also evaluated three more studies that FDA reviewers said did not replicate that benefit: AVADO, RIBBON1, and AVF2119g.

In addition, patients taking bevacizumab had a higher risk of serious side effects, including stroke, wound healing complications, organ damage or failure, and the development of a neurological condition called reversible posterior leukoencephalopathy syndrome (RPLS). Given these side effects, the risk of using bevacizumab outweighed its benefits, officials said.

Genentech was given 15 days to appeal the agency’s decision, which the company said it would do, even as the briefing was being conducted.

The company now has 30 days to submit a package to the agency with data and evidence that “there are material facts in dispute” to be granted the hearing, Denise Esposito, deputy director of the FDA’s Office of Regulatory Policy, said in the briefing.

If the agency grants a hearing, it will be announced in the Federal Register. It would be a public hearing, with outside experts invited to participate but not vote, said Ms. Esposito. It’s possible those experts could be some or all members of the advisory committee that previously voted on bevacizumab. Genentech also would be allowed to make its case.

The agency would then take time to make a decision, said Ms. Esposito. She said the whole process could take at least several months.

The FDA’s decision follows the recommendation made earlier in December by the National Institute for Health and Clinical Excellence. That body, the clinical effectiveness agency for England and Wales, recommended against use of bevacizumab in combination with taxane chemotherapy for metastatic breast cancer, citing high costs and an unclear survival benefit.

The European Medicines Agency ruled on Dec. 16, however, that the benefits of bevacizumab in combination with paclitaxel outweigh its risks and said, “This combination remains a valuable treatment option for patients suffering from metastatic breast cancer.” The agency added that bevacizumab should not be used in combination with docetaxel for breast cancer.

Dr. Pazdur said he could not speculate why the EMA had reached a slightly different conclusion on the same data reviewed by the FDA. But, he said, the FDA was acting within the rules laid out by the accelerated approval process, whereas the EMA had fully approved bevacizumab based on the E2100 trial results.

The drug also recently failed to improve pathological complete response in a large, European trial among women with primary HER2-negative breast cancer who were given a neoadjuvant regimen that combined bevacizumab with epirubicin, cyclophosphamide, and docetaxel.  The results were reported at the San Antonio Breast Cancer Symposium.

An ongoing shortage of some crucial chemotherapy drugs is driving up the cost of the products and forcing oncologists to scramble for supplies or to find therapeutically equivalent alternatives, if there are any.

In some cases, oncologists are creating a triage system whereby the patient who is most likely to be cured will receive the therapy that’s in short supply.

Periodic shortages of pharmaceuticals are not unusual, but a number of factors have converged to create a unique squeeze in oncology – one that clinicians see as a mounting public health threat.

Dr. Michael Neuss said that the shortage will become a crisis only "when the first high-profile patient dies." Despite active concern and action by the American Society of Clinical Oncology, the shortage hasn’t reached the crisis point yet, at least in the public’s eye, said Dr. Neuss, immediate past chair of ASCO’s Clinical Practice Committee and a physician in private practice with Oncology Hematology Care in Cincinnati.

"There is no smoking gun that makes this obvious to people," he said.

Dr. Neuss sees the invisible hand of the free market as a not-beneficial guiding force in the shortage. Once a shortage occurs, distributors buy up the supplies and essentially corner the market, he said, citing conversations with his purchasing agent. That results in inflated prices for purchasers who have no alternative.

And cancer patients who need the therapies ultimately suffer, said Dr. Neuss.

Many Drugs Affected

At press time, both the Food and Drug Administration and the American Society of Health-System Pharmacists were reporting shortages of many drugs, including cisplatin, doxorubicin (both lyophilized powder and solution for injection), etoposide solution for injection, leucovorin calcium lyophilized powder for injection, levoleucovorin (Fusilev) 50-mg single-use vials, and some sizes of vincristine.

Cytarabine injection (powder for reconstitution) was added to the list in mid-December, and there’s also an ongoing shortage of certain vial sizes of Procrit (epoetin alfa) because of a manufacturing-related recall that took place in September.

Recently, there have been shortages of cyclophosphamide, daunorubicin, epirubicin, fluorouracil, mitomycin, paclitaxel, and vinblastine, among other chemotherapeutics.

The FDA – which, according to its Web site, has a policy "to help prevent or alleviate shortages, primarily of medically necessary drug products, since these can have significant public health consequences" – is monitoring the shortages. The agency does "see an end to these shortages based on the plans reported by the manufacturers," said Capt. Valerie Jensen, associate director of the FDA’s Center for Drug Evaluation and Research Drug Shortage Program, in an e-mail.

But, she added, "many of these shortages involve older sterile injectable drugs, and we’ve continued to see a trend of increasing shortages developing over the past several years for this group of drugs."

Fewer companies are interested in making the low-profit injectables, and those firms that do go into the market have limited manufacturing capability, said Capt. Jensen. Many of the companies in the market have had issues with accessing raw materials, or problems meeting the FDA’s quality guidelines.

Then there’s the manufacturing itself. "Sterile injectables have a long manufacturing lead time and a complex process, and when one of the few firms making these products experiences a problem, a shortage almost always occurs, since it is extremely difficult for the remaining firms to keep up with demand," she said.

Leucovorin: Canary in the Coal Mine

One of the biggest players in injectables – and generics – is Teva Pharmaceuticals. In April, the company began a voluntary manufacturing hold at its Irvine, Calif., plant to update systems and processes. The plant was the primary manufacturing site for all its injectables. The stoppage has had a domino effect, shifting demand to other manufacturers. Some have managed, but the shortage continues – especially for leucovorin and etoposide.

Teva spokeswoman Denise Bradley said, "We continue to work towards resuming manufacturing at that facility," but gave no indication as to when that might occur.

Capt. Jensen said that Teva should be back online by April 2011. In the meantime, the FDA has looked for additional manufacturers for leucovorin, including those overseas, as it also had to do to manage a shortage of propofol, an anesthetic agent. The agency has not found a suitable overseas candidate, but is working with another generic manufacturer to "have their product ready for the U.S. market as soon as possible."

For now, though, clinicians are struggling to figure out how to make do. Dr. George Kovach, medical director at Iowa Cancer Specialists in Davenport, said that his practice has not been affected by other shortages, but that getting leucovorin has been a challenge. Financially managing the shortage has also been an issue, said Dr. Kovach in an interview.

The alternative, Fusilev, costs about ten times as much as leucovorin. And Medicare reimburses only $750 of the $1,200 cost for Fusilev, said Dr. Kovach, a member of the Association of Community Cancer Care Centers (ACCC) board of trustees. For many patients, the practice would "eat the loss." Other patients were sent to the hospital outpatient department for treatment. The shortage seems to have lessened for the time being, but reimbursement continues to be an issue, said Dr. Kovach.

The leucovorin shortage has "impacted many colorectal cancer regimens," at the Maine Center for Cancer Medicine in Scarborough, said Steven L. D’Amato, a clinical pharmacy specialist, in an interview. "Clinics like ours lose money with every dose administered, but we’ve done this to maintain patients’ treatment schedules," said Mr. D’Amato.

"With leucovorin, we literally decide how much we have every day," said Dr. Neuss. Patients are prioritized to receive the drug based on whether administration would be curative. His practice has managed to procure adequate supplies of Fusilev, but it is, as noted, much more expensive.

And oncologists "really don’t know" whether Fusilev is equivalent, Dr. Neuss said. The FDA also warns on its shortage page that "there is potential for dosing errors when interchanging leucovorin and levoleucovorin (Fusilev)."

Forced to Alternatives

Similarly, there is an alternative to IV etoposide – an oral version. But with oral administration, "myelosuppression can be more erratic," said Dr. Lawrence Einhorn, a past president of ASCO and a distinguished professor and Lance Armstrong Foundation Chair in Oncology at Indiana University, Indianapolis, in an interview on the ASCO Web site. "Oral etoposide is a substitute, but a poor substitute for IV etoposide," he said.

Dr. Neuss said that his practice had been doubling the dose of the oral version as a substitute. "Is that the exact right conversion? I’m not sure," he said.

There are four manufacturers of the injection form: Teva, Bedford, APP, and Bristol-Myers Squibb. Because Teva has halted production, the FDA has worked with the others to increase production, said Capt. Jensen.

Mr. D’Amato said that the Maine Center is no longer experiencing etoposide shortages, but that getting doxorubicin has been a challenge. The shortage is starting to alleviate, but the lack of the therapy has affected investigational protocols and "all of our anthracycline-containing regimens," he said.

The situation has been more dire in Cincinnati, said Dr. Neuss. His practice has been unable to find an adequate supply. "We hold it back for patients that are getting curative therapy," he said.

Mr. D’Amato also notes recent shortages of bleomycin, desmopressin, and heparin. "Heparin flush solutions are still not available to us, so we prepare our own from higher concentrations of heparin. This is time consuming and also costly," he said.

And, the Maine Center just began experiencing problems getting melphalan tablets (Alkeran), which were produced by GlaxoSmithKline but will now be manufactured by ApoPharma. "They have no release date for the product, which is very problematic for existing patients being treated for multiple myeloma," said Mr. D’Amato.

Pediatric oncology seems to be hit particularly hard, as the intent for most children is to cure them of their cancer. Thus, a shortage could mean the difference between life and death. "I think those children need to be protected," said Dr. Neuss.

In an interview with ASCO’s Web site, pediatric oncologist and ASCO President-Elect Michael Link said that there are few acceptable alternatives for many of the therapies used in children. "Almost all children are treated on clinical trial protocols, and have been for many years, so we have a very large evidence base for many of the common drugs that we use – but are lacking evidence for substitutions, particularly in complex multi-drug regimens," Dr. Link said.

Where Next?

In early November, ASCO, ASHP, the American Society of Anesthesiologists, and the Institute for Safe Medication Practices convened a summit to talk about causes of the shortages and to discuss potential solutions. The FDA and many drug manufacturers – including APP, Bedford, Hospira, and Teva, which had the most shortages in 2010 – attended the meeting.

According to a statement, the FDA told attendees that it had managed to prevent 24 shortages in the past year by working with the industry.

The ASHP said that work groups had been formed and would continue to develop action plans to "carry out the summit’s recommendations."

In early December, Sen. Amy Klobuchar, a Minnesota Democrat whose district includes the Mayo Clinic, wrote to FDA Commissioner Margaret Hamburg, urging an "immediate solution to the shortage of chemotherapy drugs."

ASCO is encouraging members to report shortages to the FDA and the ASHP. Dr. Link said in the ASCO interview that he realized that reporting "does nothing to alleviate that burden for the patient who needs the drug today – but the FDA can act more effectively when it’s armed with current information."

Dr. Neuss, for his part, thinks that the free market is not the answer. He thinks there should be a government-run exchange of some type to manage the supply, so that patients aren’t faced with potentially-life-threatening shortages.

Dr. Neuss, Dr. Kovach, and Mr. D’Amato reported no conflicts.

An ongoing shortage of some crucial chemotherapy drugs is driving up the cost of the products and forcing oncologists to scramble for supplies or to find therapeutically equivalent alternatives, if there are any.

In some cases, oncologists are creating a triage system whereby the patient who is most likely to be cured will receive the therapy that’s in short supply.

Periodic shortages of pharmaceuticals are not unusual, but a number of factors have converged to create a unique squeeze in oncology – one that clinicians see as a mounting public health threat.

Dr. Michael Neuss said that the shortage will become a crisis only "when the first high-profile patient dies." Despite active concern and action by the American Society of Clinical Oncology, the shortage hasn’t reached the crisis point yet, at least in the public’s eye, said Dr. Neuss, immediate past chair of ASCO’s Clinical Practice Committee and a physician in private practice with Oncology Hematology Care in Cincinnati.

"There is no smoking gun that makes this obvious to people," he said.

Dr. Neuss sees the invisible hand of the free market as a not-beneficial guiding force in the shortage. Once a shortage occurs, distributors buy up the supplies and essentially corner the market, he said, citing conversations with his purchasing agent. That results in inflated prices for purchasers who have no alternative.

And cancer patients who need the therapies ultimately suffer, said Dr. Neuss.

Many Drugs Affected

At press time, both the Food and Drug Administration and the American Society of Health-System Pharmacists were reporting shortages of many drugs, including cisplatin, doxorubicin (both lyophilized powder and solution for injection), etoposide solution for injection, leucovorin calcium lyophilized powder for injection, levoleucovorin (Fusilev) 50-mg single-use vials, and some sizes of vincristine.

Cytarabine injection (powder for reconstitution) was added to the list in mid-December, and there’s also an ongoing shortage of certain vial sizes of Procrit (epoetin alfa) because of a manufacturing-related recall that took place in September.

Recently, there have been shortages of cyclophosphamide, daunorubicin, epirubicin, fluorouracil, mitomycin, paclitaxel, and vinblastine, among other chemotherapeutics.

The FDA – which, according to its Web site, has a policy "to help prevent or alleviate shortages, primarily of medically necessary drug products, since these can have significant public health consequences" – is monitoring the shortages. The agency does "see an end to these shortages based on the plans reported by the manufacturers," said Capt. Valerie Jensen, associate director of the FDA’s Center for Drug Evaluation and Research Drug Shortage Program, in an e-mail.

But, she added, "many of these shortages involve older sterile injectable drugs, and we’ve continued to see a trend of increasing shortages developing over the past several years for this group of drugs."

Fewer companies are interested in making the low-profit injectables, and those firms that do go into the market have limited manufacturing capability, said Capt. Jensen. Many of the companies in the market have had issues with accessing raw materials, or problems meeting the FDA’s quality guidelines.

Then there’s the manufacturing itself. "Sterile injectables have a long manufacturing lead time and a complex process, and when one of the few firms making these products experiences a problem, a shortage almost always occurs, since it is extremely difficult for the remaining firms to keep up with demand," she said.

Leucovorin: Canary in the Coal Mine

One of the biggest players in injectables – and generics – is Teva Pharmaceuticals. In April, the company began a voluntary manufacturing hold at its Irvine, Calif., plant to update systems and processes. The plant was the primary manufacturing site for all its injectables. The stoppage has had a domino effect, shifting demand to other manufacturers. Some have managed, but the shortage continues – especially for leucovorin and etoposide.

Teva spokeswoman Denise Bradley said, "We continue to work towards resuming manufacturing at that facility," but gave no indication as to when that might occur.

Capt. Jensen said that Teva should be back online by April 2011. In the meantime, the FDA has looked for additional manufacturers for leucovorin, including those overseas, as it also had to do to manage a shortage of propofol, an anesthetic agent. The agency has not found a suitable overseas candidate, but is working with another generic manufacturer to "have their product ready for the U.S. market as soon as possible."

For now, though, clinicians are struggling to figure out how to make do. Dr. George Kovach, medical director at Iowa Cancer Specialists in Davenport, said that his practice has not been affected by other shortages, but that getting leucovorin has been a challenge. Financially managing the shortage has also been an issue, said Dr. Kovach in an interview.

The alternative, Fusilev, costs about ten times as much as leucovorin. And Medicare reimburses only $750 of the $1,200 cost for Fusilev, said Dr. Kovach, a member of the Association of Community Cancer Care Centers (ACCC) board of trustees. For many patients, the practice would "eat the loss." Other patients were sent to the hospital outpatient department for treatment. The shortage seems to have lessened for the time being, but reimbursement continues to be an issue, said Dr. Kovach.

The leucovorin shortage has "impacted many colorectal cancer regimens," at the Maine Center for Cancer Medicine in Scarborough, said Steven L. D’Amato, a clinical pharmacy specialist, in an interview. "Clinics like ours lose money with every dose administered, but we’ve done this to maintain patients’ treatment schedules," said Mr. D’Amato.

"With leucovorin, we literally decide how much we have every day," said Dr. Neuss. Patients are prioritized to receive the drug based on whether administration would be curative. His practice has managed to procure adequate supplies of Fusilev, but it is, as noted, much more expensive.

And oncologists "really don’t know" whether Fusilev is equivalent, Dr. Neuss said. The FDA also warns on its shortage page that "there is potential for dosing errors when interchanging leucovorin and levoleucovorin (Fusilev)."

Forced to Alternatives

Similarly, there is an alternative to IV etoposide – an oral version. But with oral administration, "myelosuppression can be more erratic," said Dr. Lawrence Einhorn, a past president of ASCO and a distinguished professor and Lance Armstrong Foundation Chair in Oncology at Indiana University, Indianapolis, in an interview on the ASCO Web site. "Oral etoposide is a substitute, but a poor substitute for IV etoposide," he said.

Dr. Neuss said that his practice had been doubling the dose of the oral version as a substitute. "Is that the exact right conversion? I’m not sure," he said.

There are four manufacturers of the injection form: Teva, Bedford, APP, and Bristol-Myers Squibb. Because Teva has halted production, the FDA has worked with the others to increase production, said Capt. Jensen.

Mr. D’Amato said that the Maine Center is no longer experiencing etoposide shortages, but that getting doxorubicin has been a challenge. The shortage is starting to alleviate, but the lack of the therapy has affected investigational protocols and "all of our anthracycline-containing regimens," he said.

The situation has been more dire in Cincinnati, said Dr. Neuss. His practice has been unable to find an adequate supply. "We hold it back for patients that are getting curative therapy," he said.

Mr. D’Amato also notes recent shortages of bleomycin, desmopressin, and heparin. "Heparin flush solutions are still not available to us, so we prepare our own from higher concentrations of heparin. This is time consuming and also costly," he said.

And, the Maine Center just began experiencing problems getting melphalan tablets (Alkeran), which were produced by GlaxoSmithKline but will now be manufactured by ApoPharma. "They have no release date for the product, which is very problematic for existing patients being treated for multiple myeloma," said Mr. D’Amato.

Pediatric oncology seems to be hit particularly hard, as the intent for most children is to cure them of their cancer. Thus, a shortage could mean the difference between life and death. "I think those children need to be protected," said Dr. Neuss.

In an interview with ASCO’s Web site, pediatric oncologist and ASCO President-Elect Michael Link said that there are few acceptable alternatives for many of the therapies used in children. "Almost all children are treated on clinical trial protocols, and have been for many years, so we have a very large evidence base for many of the common drugs that we use – but are lacking evidence for substitutions, particularly in complex multi-drug regimens," Dr. Link said.

Where Next?

In early November, ASCO, ASHP, the American Society of Anesthesiologists, and the Institute for Safe Medication Practices convened a summit to talk about causes of the shortages and to discuss potential solutions. The FDA and many drug manufacturers – including APP, Bedford, Hospira, and Teva, which had the most shortages in 2010 – attended the meeting.

According to a statement, the FDA told attendees that it had managed to prevent 24 shortages in the past year by working with the industry.

The ASHP said that work groups had been formed and would continue to develop action plans to "carry out the summit’s recommendations."

In early December, Sen. Amy Klobuchar, a Minnesota Democrat whose district includes the Mayo Clinic, wrote to FDA Commissioner Margaret Hamburg, urging an "immediate solution to the shortage of chemotherapy drugs."

ASCO is encouraging members to report shortages to the FDA and the ASHP. Dr. Link said in the ASCO interview that he realized that reporting "does nothing to alleviate that burden for the patient who needs the drug today – but the FDA can act more effectively when it’s armed with current information."

Dr. Neuss, for his part, thinks that the free market is not the answer. He thinks there should be a government-run exchange of some type to manage the supply, so that patients aren’t faced with potentially-life-threatening shortages.

Dr. Neuss, Dr. Kovach, and Mr. D’Amato reported no conflicts.

An ongoing shortage of some crucial chemotherapy drugs is driving up the cost of the products and forcing oncologists to scramble for supplies or to find therapeutically equivalent alternatives, if there are any.

In some cases, oncologists are creating a triage system whereby the patient who is most likely to be cured will receive the therapy that’s in short supply.

Periodic shortages of pharmaceuticals are not unusual, but a number of factors have converged to create a unique squeeze in oncology – one that clinicians see as a mounting public health threat.

Dr. Michael Neuss said that the shortage will become a crisis only "when the first high-profile patient dies." Despite active concern and action by the American Society of Clinical Oncology, the shortage hasn’t reached the crisis point yet, at least in the public’s eye, said Dr. Neuss, immediate past chair of ASCO’s Clinical Practice Committee and a physician in private practice with Oncology Hematology Care in Cincinnati.

"There is no smoking gun that makes this obvious to people," he said.

Dr. Neuss sees the invisible hand of the free market as a not-beneficial guiding force in the shortage. Once a shortage occurs, distributors buy up the supplies and essentially corner the market, he said, citing conversations with his purchasing agent. That results in inflated prices for purchasers who have no alternative.

And cancer patients who need the therapies ultimately suffer, said Dr. Neuss.

Many Drugs Affected

At press time, both the Food and Drug Administration and the American Society of Health-System Pharmacists were reporting shortages of many drugs, including cisplatin, doxorubicin (both lyophilized powder and solution for injection), etoposide solution for injection, leucovorin calcium lyophilized powder for injection, levoleucovorin (Fusilev) 50-mg single-use vials, and some sizes of vincristine.

Cytarabine injection (powder for reconstitution) was added to the list in mid-December, and there’s also an ongoing shortage of certain vial sizes of Procrit (epoetin alfa) because of a manufacturing-related recall that took place in September.

Recently, there have been shortages of cyclophosphamide, daunorubicin, epirubicin, fluorouracil, mitomycin, paclitaxel, and vinblastine, among other chemotherapeutics.

The FDA – which, according to its Web site, has a policy "to help prevent or alleviate shortages, primarily of medically necessary drug products, since these can have significant public health consequences" – is monitoring the shortages. The agency does "see an end to these shortages based on the plans reported by the manufacturers," said Capt. Valerie Jensen, associate director of the FDA’s Center for Drug Evaluation and Research Drug Shortage Program, in an e-mail.

But, she added, "many of these shortages involve older sterile injectable drugs, and we’ve continued to see a trend of increasing shortages developing over the past several years for this group of drugs."

Fewer companies are interested in making the low-profit injectables, and those firms that do go into the market have limited manufacturing capability, said Capt. Jensen. Many of the companies in the market have had issues with accessing raw materials, or problems meeting the FDA’s quality guidelines.

Then there’s the manufacturing itself. "Sterile injectables have a long manufacturing lead time and a complex process, and when one of the few firms making these products experiences a problem, a shortage almost always occurs, since it is extremely difficult for the remaining firms to keep up with demand," she said.

Leucovorin: Canary in the Coal Mine

One of the biggest players in injectables – and generics – is Teva Pharmaceuticals. In April, the company began a voluntary manufacturing hold at its Irvine, Calif., plant to update systems and processes. The plant was the primary manufacturing site for all its injectables. The stoppage has had a domino effect, shifting demand to other manufacturers. Some have managed, but the shortage continues – especially for leucovorin and etoposide.

Teva spokeswoman Denise Bradley said, "We continue to work towards resuming manufacturing at that facility," but gave no indication as to when that might occur.

Capt. Jensen said that Teva should be back online by April 2011. In the meantime, the FDA has looked for additional manufacturers for leucovorin, including those overseas, as it also had to do to manage a shortage of propofol, an anesthetic agent. The agency has not found a suitable overseas candidate, but is working with another generic manufacturer to "have their product ready for the U.S. market as soon as possible."

For now, though, clinicians are struggling to figure out how to make do. Dr. George Kovach, medical director at Iowa Cancer Specialists in Davenport, said that his practice has not been affected by other shortages, but that getting leucovorin has been a challenge. Financially managing the shortage has also been an issue, said Dr. Kovach in an interview.

The alternative, Fusilev, costs about ten times as much as leucovorin. And Medicare reimburses only $750 of the $1,200 cost for Fusilev, said Dr. Kovach, a member of the Association of Community Cancer Care Centers (ACCC) board of trustees. For many patients, the practice would "eat the loss." Other patients were sent to the hospital outpatient department for treatment. The shortage seems to have lessened for the time being, but reimbursement continues to be an issue, said Dr. Kovach.

The leucovorin shortage has "impacted many colorectal cancer regimens," at the Maine Center for Cancer Medicine in Scarborough, said Steven L. D’Amato, a clinical pharmacy specialist, in an interview. "Clinics like ours lose money with every dose administered, but we’ve done this to maintain patients’ treatment schedules," said Mr. D’Amato.

"With leucovorin, we literally decide how much we have every day," said Dr. Neuss. Patients are prioritized to receive the drug based on whether administration would be curative. His practice has managed to procure adequate supplies of Fusilev, but it is, as noted, much more expensive.

And oncologists "really don’t know" whether Fusilev is equivalent, Dr. Neuss said. The FDA also warns on its shortage page that "there is potential for dosing errors when interchanging leucovorin and levoleucovorin (Fusilev)."

Forced to Alternatives

Similarly, there is an alternative to IV etoposide – an oral version. But with oral administration, "myelosuppression can be more erratic," said Dr. Lawrence Einhorn, a past president of ASCO and a distinguished professor and Lance Armstrong Foundation Chair in Oncology at Indiana University, Indianapolis, in an interview on the ASCO Web site. "Oral etoposide is a substitute, but a poor substitute for IV etoposide," he said.

Dr. Neuss said that his practice had been doubling the dose of the oral version as a substitute. "Is that the exact right conversion? I’m not sure," he said.

There are four manufacturers of the injection form: Teva, Bedford, APP, and Bristol-Myers Squibb. Because Teva has halted production, the FDA has worked with the others to increase production, said Capt. Jensen.

Mr. D’Amato said that the Maine Center is no longer experiencing etoposide shortages, but that getting doxorubicin has been a challenge. The shortage is starting to alleviate, but the lack of the therapy has affected investigational protocols and "all of our anthracycline-containing regimens," he said.

The situation has been more dire in Cincinnati, said Dr. Neuss. His practice has been unable to find an adequate supply. "We hold it back for patients that are getting curative therapy," he said.

Mr. D’Amato also notes recent shortages of bleomycin, desmopressin, and heparin. "Heparin flush solutions are still not available to us, so we prepare our own from higher concentrations of heparin. This is time consuming and also costly," he said.

And, the Maine Center just began experiencing problems getting melphalan tablets (Alkeran), which were produced by GlaxoSmithKline but will now be manufactured by ApoPharma. "They have no release date for the product, which is very problematic for existing patients being treated for multiple myeloma," said Mr. D’Amato.

Pediatric oncology seems to be hit particularly hard, as the intent for most children is to cure them of their cancer. Thus, a shortage could mean the difference between life and death. "I think those children need to be protected," said Dr. Neuss.

In an interview with ASCO’s Web site, pediatric oncologist and ASCO President-Elect Michael Link said that there are few acceptable alternatives for many of the therapies used in children. "Almost all children are treated on clinical trial protocols, and have been for many years, so we have a very large evidence base for many of the common drugs that we use – but are lacking evidence for substitutions, particularly in complex multi-drug regimens," Dr. Link said.

Where Next?

In early November, ASCO, ASHP, the American Society of Anesthesiologists, and the Institute for Safe Medication Practices convened a summit to talk about causes of the shortages and to discuss potential solutions. The FDA and many drug manufacturers – including APP, Bedford, Hospira, and Teva, which had the most shortages in 2010 – attended the meeting.

According to a statement, the FDA told attendees that it had managed to prevent 24 shortages in the past year by working with the industry.

The ASHP said that work groups had been formed and would continue to develop action plans to "carry out the summit’s recommendations."

In early December, Sen. Amy Klobuchar, a Minnesota Democrat whose district includes the Mayo Clinic, wrote to FDA Commissioner Margaret Hamburg, urging an "immediate solution to the shortage of chemotherapy drugs."

ASCO is encouraging members to report shortages to the FDA and the ASHP. Dr. Link said in the ASCO interview that he realized that reporting "does nothing to alleviate that burden for the patient who needs the drug today – but the FDA can act more effectively when it’s armed with current information."

Dr. Neuss, for his part, thinks that the free market is not the answer. He thinks there should be a government-run exchange of some type to manage the supply, so that patients aren’t faced with potentially-life-threatening shortages.

Dr. Neuss, Dr. Kovach, and Mr. D’Amato reported no conflicts.