Alicia Ault

At a meeting convened by the Food and Drug Administration, pharmaceutical and medical device manufacturers, advertisers, medical Web site owners, search engine companies, and consumer advocates all argued for greater regulation of health-specific content on the Internet, including social media sites.

The agency was seeking opinions on how it could guide health-related communications and promotions for YouTube, Twitter, blogging, and social networking sites. Notably, there were no speakers from any medical society or health care provider organization.

The FDA has not said when it might issue guidance, but it will continue to accept comments until Feb. 28, 2010, said Thomas W. Abrams, director of the FDA Center for Drug Evaluation and Research's division of drug marketing, advertising, and communications.

All speakers agreed that consumers and health care providers increasingly rely on the Internet for information about drugs, devices, and specific conditions, and also to forge communities to share everything from caregiving recommendations to tips on how to perform a knee replacement.

All also agreed that there is a huge amount of inaccurate and misleading information and that it has a great potential for harm—to patients and their families, to health care providers, and to industries seeking credibility. Even as they seek to be the go-to place for accurate, scientific information, drug and device makers said they are wary—of social media in particular—because of the lack of FDA guidance.

Consumer groups raised the specter of pharmaceutical or device companies putting out purely promotional information that glosses over FDA rules requiring a fair balance of a product's risks and benefits.

Michele Sharp, senior director of United States Regulatory Affairs at Eli Lilly, said the company “had avoided significant interactions with providers and patients online” because of FDA's lack of clarity.

“We're looking to the FDA to provide leadership,” Ms. Sharp said.

Jeffrey K. Francer, assistant general counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA), said that “the FDA should facilitate manufacturers' communication of important medical information about their products in a responsible way, taking advantage of the same technologies that the FDA and the White House use, including blogs, video, search, and social networking sites such as Twitter.”

PhRMA has proposed that posts on Twitter or blogs or other social media sites be accompanied by an official logo that would signify that the information was officially sanctioned by the FDA. Tweets, which are limited to 140 characters, could provide a hyperlink to the full risk and benefit information, Mr. Francer said.

He and other industry representatives said they wanted FDA to review information and promotional materials before they were posted on the Web. This would be a departure from current policy where only a small fraction of print or broadcast materials are reviewed in advance.

Some groups are trying to establish rules before FDA does. The Interactive Advertising Bureau said it was developing standards to provide “safe harbors” for the drug and device industry. IAB members provide 85% of online ads in the United States, said IAB representative David Wright. The Social Media Working Group has also been discussing what drug companies can do to self-police, said Mark Gaydos, chairman of the group and a regulatory affairs director at sanofi-aventis U.S. The group is made up of representatives from five pharmaceutical manufacturers who meet on a voluntary basis.

Google also proposed its own standards for “sponsored” searches. The search result would include a link to the official drug site and a link at the end, “more info,” which would take users directly to the risk information, said Amy Cowan, head of industry for Google's health division. All results would also include a short warning statement.

At a meeting convened by the Food and Drug Administration, pharmaceutical and medical device manufacturers, advertisers, medical Web site owners, search engine companies, and consumer advocates all argued for greater regulation of health-specific content on the Internet, including social media sites.

The agency was seeking opinions on how it could guide health-related communications and promotions for YouTube, Twitter, blogging, and social networking sites. Notably, there were no speakers from any medical society or health care provider organization.

The FDA has not said when it might issue guidance, but it will continue to accept comments until Feb. 28, 2010, said Thomas W. Abrams, director of the FDA Center for Drug Evaluation and Research's division of drug marketing, advertising, and communications.

All speakers agreed that consumers and health care providers increasingly rely on the Internet for information about drugs, devices, and specific conditions, and also to forge communities to share everything from caregiving recommendations to tips on how to perform a knee replacement.

All also agreed that there is a huge amount of inaccurate and misleading information and that it has a great potential for harm—to patients and their families, to health care providers, and to industries seeking credibility. Even as they seek to be the go-to place for accurate, scientific information, drug and device makers said they are wary—of social media in particular—because of the lack of FDA guidance.

Consumer groups raised the specter of pharmaceutical or device companies putting out purely promotional information that glosses over FDA rules requiring a fair balance of a product's risks and benefits.

Michele Sharp, senior director of United States Regulatory Affairs at Eli Lilly, said the company “had avoided significant interactions with providers and patients online” because of FDA's lack of clarity.

“We're looking to the FDA to provide leadership,” Ms. Sharp said.

Jeffrey K. Francer, assistant general counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA), said that “the FDA should facilitate manufacturers' communication of important medical information about their products in a responsible way, taking advantage of the same technologies that the FDA and the White House use, including blogs, video, search, and social networking sites such as Twitter.”

PhRMA has proposed that posts on Twitter or blogs or other social media sites be accompanied by an official logo that would signify that the information was officially sanctioned by the FDA. Tweets, which are limited to 140 characters, could provide a hyperlink to the full risk and benefit information, Mr. Francer said.

He and other industry representatives said they wanted FDA to review information and promotional materials before they were posted on the Web. This would be a departure from current policy where only a small fraction of print or broadcast materials are reviewed in advance.

Some groups are trying to establish rules before FDA does. The Interactive Advertising Bureau said it was developing standards to provide “safe harbors” for the drug and device industry. IAB members provide 85% of online ads in the United States, said IAB representative David Wright. The Social Media Working Group has also been discussing what drug companies can do to self-police, said Mark Gaydos, chairman of the group and a regulatory affairs director at sanofi-aventis U.S. The group is made up of representatives from five pharmaceutical manufacturers who meet on a voluntary basis.

Google also proposed its own standards for “sponsored” searches. The search result would include a link to the official drug site and a link at the end, “more info,” which would take users directly to the risk information, said Amy Cowan, head of industry for Google's health division. All results would also include a short warning statement.

At a meeting convened by the Food and Drug Administration, pharmaceutical and medical device manufacturers, advertisers, medical Web site owners, search engine companies, and consumer advocates all argued for greater regulation of health-specific content on the Internet, including social media sites.

The agency was seeking opinions on how it could guide health-related communications and promotions for YouTube, Twitter, blogging, and social networking sites. Notably, there were no speakers from any medical society or health care provider organization.

The FDA has not said when it might issue guidance, but it will continue to accept comments until Feb. 28, 2010, said Thomas W. Abrams, director of the FDA Center for Drug Evaluation and Research's division of drug marketing, advertising, and communications.

All speakers agreed that consumers and health care providers increasingly rely on the Internet for information about drugs, devices, and specific conditions, and also to forge communities to share everything from caregiving recommendations to tips on how to perform a knee replacement.

All also agreed that there is a huge amount of inaccurate and misleading information and that it has a great potential for harm—to patients and their families, to health care providers, and to industries seeking credibility. Even as they seek to be the go-to place for accurate, scientific information, drug and device makers said they are wary—of social media in particular—because of the lack of FDA guidance.

Consumer groups raised the specter of pharmaceutical or device companies putting out purely promotional information that glosses over FDA rules requiring a fair balance of a product's risks and benefits.

Michele Sharp, senior director of United States Regulatory Affairs at Eli Lilly, said the company “had avoided significant interactions with providers and patients online” because of FDA's lack of clarity.

“We're looking to the FDA to provide leadership,” Ms. Sharp said.

Jeffrey K. Francer, assistant general counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA), said that “the FDA should facilitate manufacturers' communication of important medical information about their products in a responsible way, taking advantage of the same technologies that the FDA and the White House use, including blogs, video, search, and social networking sites such as Twitter.”

PhRMA has proposed that posts on Twitter or blogs or other social media sites be accompanied by an official logo that would signify that the information was officially sanctioned by the FDA. Tweets, which are limited to 140 characters, could provide a hyperlink to the full risk and benefit information, Mr. Francer said.

He and other industry representatives said they wanted FDA to review information and promotional materials before they were posted on the Web. This would be a departure from current policy where only a small fraction of print or broadcast materials are reviewed in advance.

Some groups are trying to establish rules before FDA does. The Interactive Advertising Bureau said it was developing standards to provide “safe harbors” for the drug and device industry. IAB members provide 85% of online ads in the United States, said IAB representative David Wright. The Social Media Working Group has also been discussing what drug companies can do to self-police, said Mark Gaydos, chairman of the group and a regulatory affairs director at sanofi-aventis U.S. The group is made up of representatives from five pharmaceutical manufacturers who meet on a voluntary basis.

Google also proposed its own standards for “sponsored” searches. The search result would include a link to the official drug site and a link at the end, “more info,” which would take users directly to the risk information, said Amy Cowan, head of industry for Google's health division. All results would also include a short warning statement.

WASHINGTON — A report commissioned by the Blue Cross Blue Shield Association says that individuals buying insurance on the open market will pay 54% more in premiums than they do today if the Senate health reform bill is enacted.

The analysis had been in the works for awhile, but comes on the heels of a Congressional Budget Office that estimated premium costs for individuals and the group market if all the Senate reform proposals were adopted and put into place by the scheduled 2016 implementation date. The CBO report estimated that individuals would pay $5,800 a year for premiums, a slight increase from the $5,500 they could expect to pay under current law.

The individual premium, without federal subsidies, would also be about 10%-13% higher than premiums paid by group members under the reform proposal, said the CBO. But the agency estimated that slightly more than half of those individuals would be eligible for federal subsidies. Those individuals would actually pay 56%-59% less than someone in a group would pay, the CBO estimated.

The BlueCross analysis, which was conducted by the actuarial company Oliver Wyman Inc., estimated that individuals would pay $4,561 in annual premiums, or 54% more than they would pay without reform. Small group premiums (for employers with 2-50 workers) will be about 20% higher, according to the analysis. Both figures exclude medical inflation, so the increases could be even greater, said Jason Grau, an associate partner at Oliver Wyman and a co-author of the analysis.

The Wyman analysis calculated premiums for the year 2019, a few years after the market had settled into the new law, he said.

The CBO underestimated the effects of adverse selection, which he said was more likely given that the Senate bill had minimal penalties for those who choose not to purchase insurance. The lack of stiff fines and the elimination of age rating—in which younger, healthier people pay less—means that insurers will have to raise premiums to cover costs for the older, sicker population likely to sign up for policies, said Mr. Grau.

WASHINGTON — A report commissioned by the Blue Cross Blue Shield Association says that individuals buying insurance on the open market will pay 54% more in premiums than they do today if the Senate health reform bill is enacted.

The analysis had been in the works for awhile, but comes on the heels of a Congressional Budget Office that estimated premium costs for individuals and the group market if all the Senate reform proposals were adopted and put into place by the scheduled 2016 implementation date. The CBO report estimated that individuals would pay $5,800 a year for premiums, a slight increase from the $5,500 they could expect to pay under current law.

The individual premium, without federal subsidies, would also be about 10%-13% higher than premiums paid by group members under the reform proposal, said the CBO. But the agency estimated that slightly more than half of those individuals would be eligible for federal subsidies. Those individuals would actually pay 56%-59% less than someone in a group would pay, the CBO estimated.

The BlueCross analysis, which was conducted by the actuarial company Oliver Wyman Inc., estimated that individuals would pay $4,561 in annual premiums, or 54% more than they would pay without reform. Small group premiums (for employers with 2-50 workers) will be about 20% higher, according to the analysis. Both figures exclude medical inflation, so the increases could be even greater, said Jason Grau, an associate partner at Oliver Wyman and a co-author of the analysis.

The Wyman analysis calculated premiums for the year 2019, a few years after the market had settled into the new law, he said.

The CBO underestimated the effects of adverse selection, which he said was more likely given that the Senate bill had minimal penalties for those who choose not to purchase insurance. The lack of stiff fines and the elimination of age rating—in which younger, healthier people pay less—means that insurers will have to raise premiums to cover costs for the older, sicker population likely to sign up for policies, said Mr. Grau.

WASHINGTON — A report commissioned by the Blue Cross Blue Shield Association says that individuals buying insurance on the open market will pay 54% more in premiums than they do today if the Senate health reform bill is enacted.

The analysis had been in the works for awhile, but comes on the heels of a Congressional Budget Office that estimated premium costs for individuals and the group market if all the Senate reform proposals were adopted and put into place by the scheduled 2016 implementation date. The CBO report estimated that individuals would pay $5,800 a year for premiums, a slight increase from the $5,500 they could expect to pay under current law.

The individual premium, without federal subsidies, would also be about 10%-13% higher than premiums paid by group members under the reform proposal, said the CBO. But the agency estimated that slightly more than half of those individuals would be eligible for federal subsidies. Those individuals would actually pay 56%-59% less than someone in a group would pay, the CBO estimated.

The BlueCross analysis, which was conducted by the actuarial company Oliver Wyman Inc., estimated that individuals would pay $4,561 in annual premiums, or 54% more than they would pay without reform. Small group premiums (for employers with 2-50 workers) will be about 20% higher, according to the analysis. Both figures exclude medical inflation, so the increases could be even greater, said Jason Grau, an associate partner at Oliver Wyman and a co-author of the analysis.

The Wyman analysis calculated premiums for the year 2019, a few years after the market had settled into the new law, he said.

The CBO underestimated the effects of adverse selection, which he said was more likely given that the Senate bill had minimal penalties for those who choose not to purchase insurance. The lack of stiff fines and the elimination of age rating—in which younger, healthier people pay less—means that insurers will have to raise premiums to cover costs for the older, sicker population likely to sign up for policies, said Mr. Grau.

A continued wide disparity in access to and quality of care across the United States argues strongly for a national health reform plan, according to executives at the Commonwealth Fund, who released a state-by-state survey of 38 health indicators.

According to the survey, there is a fivefold difference in performance on the indicators between the highest-ranked states and the lowest.

“The differences we see among the states translate to real lives and real dollars,” Karen Davis, president of the Commonwealth Fund, said at a press conference. “In the richest country in the world, there is no justification for any state to be far below the best state for quality and access to health care.”

Health reform legislation under consideration in Congress would go a long way toward improving access and coverage, and that would increase quality overall, Ms. Davis said.

Since 2007, the number of uninsured adults has risen–and this survey was done on the eve of the recession, so the “worst is yet to come,” according to Cathy Schoen, senior vice president of the Commonwealth Fund.

The top quartile comprises Connecticut, Hawaii, Iowa, Maine, Massachusetts, Minnesota, Nebraska, New Hampshire, North Dakota, Rhode Island, South Dakota, Vermont, and Wisconsin.

Ten of the 13 states in the lowest quartile–Alabama, Arkansas, Florida, Kentucky, Louisiana, Mississippi, Nevada, Oklahoma, Tennessee, and Texas–also ranked at the bottom on the previous 2007 report. Illinois, New Mexico, and North Carolina dropped into the lowest quartile since the last survey, while California, Georgia, and West Virginia moved up out of the last quartile in this most recent report. The lower-performing states had rates of uninsured adults and children that were double those in the top quartile.

The report also reflected some bright spots: The quality of hospital care for heart attack, heart failure, pneumonia, and the prevention of surgical complications improved dramatically for all states, as did the quality of nursing home care.

A continued wide disparity in access to and quality of care across the United States argues strongly for a national health reform plan, according to executives at the Commonwealth Fund, who released a state-by-state survey of 38 health indicators.

According to the survey, there is a fivefold difference in performance on the indicators between the highest-ranked states and the lowest.

“The differences we see among the states translate to real lives and real dollars,” Karen Davis, president of the Commonwealth Fund, said at a press conference. “In the richest country in the world, there is no justification for any state to be far below the best state for quality and access to health care.”

Health reform legislation under consideration in Congress would go a long way toward improving access and coverage, and that would increase quality overall, Ms. Davis said.

Since 2007, the number of uninsured adults has risen–and this survey was done on the eve of the recession, so the “worst is yet to come,” according to Cathy Schoen, senior vice president of the Commonwealth Fund.

The top quartile comprises Connecticut, Hawaii, Iowa, Maine, Massachusetts, Minnesota, Nebraska, New Hampshire, North Dakota, Rhode Island, South Dakota, Vermont, and Wisconsin.

Ten of the 13 states in the lowest quartile–Alabama, Arkansas, Florida, Kentucky, Louisiana, Mississippi, Nevada, Oklahoma, Tennessee, and Texas–also ranked at the bottom on the previous 2007 report. Illinois, New Mexico, and North Carolina dropped into the lowest quartile since the last survey, while California, Georgia, and West Virginia moved up out of the last quartile in this most recent report. The lower-performing states had rates of uninsured adults and children that were double those in the top quartile.

The report also reflected some bright spots: The quality of hospital care for heart attack, heart failure, pneumonia, and the prevention of surgical complications improved dramatically for all states, as did the quality of nursing home care.

A continued wide disparity in access to and quality of care across the United States argues strongly for a national health reform plan, according to executives at the Commonwealth Fund, who released a state-by-state survey of 38 health indicators.

According to the survey, there is a fivefold difference in performance on the indicators between the highest-ranked states and the lowest.

“The differences we see among the states translate to real lives and real dollars,” Karen Davis, president of the Commonwealth Fund, said at a press conference. “In the richest country in the world, there is no justification for any state to be far below the best state for quality and access to health care.”

Health reform legislation under consideration in Congress would go a long way toward improving access and coverage, and that would increase quality overall, Ms. Davis said.

Since 2007, the number of uninsured adults has risen–and this survey was done on the eve of the recession, so the “worst is yet to come,” according to Cathy Schoen, senior vice president of the Commonwealth Fund.

The top quartile comprises Connecticut, Hawaii, Iowa, Maine, Massachusetts, Minnesota, Nebraska, New Hampshire, North Dakota, Rhode Island, South Dakota, Vermont, and Wisconsin.

Ten of the 13 states in the lowest quartile–Alabama, Arkansas, Florida, Kentucky, Louisiana, Mississippi, Nevada, Oklahoma, Tennessee, and Texas–also ranked at the bottom on the previous 2007 report. Illinois, New Mexico, and North Carolina dropped into the lowest quartile since the last survey, while California, Georgia, and West Virginia moved up out of the last quartile in this most recent report. The lower-performing states had rates of uninsured adults and children that were double those in the top quartile.

The report also reflected some bright spots: The quality of hospital care for heart attack, heart failure, pneumonia, and the prevention of surgical complications improved dramatically for all states, as did the quality of nursing home care.

CMS Adds Geriatric Code

The Centers for Medicare and Medicaid Services has established a new physician specialty code for geriatric psychiatry. The code, 27, will go into effect April 1, 2010, the agency announced in late October. CMS directed all its contractors to recognize the new physician specialty code on all claims.

Dr. Nemeroff Lands in Miami

Dr. Charles B. Nemeroff, who was hounded by charges of conflicts of interest in his biological studies of neuropsychiatric disorders, has left Emory University, Atlanta, for the University of Miami. He will be professor and chairman of the department of psychiatry and behavioral sciences. While at Emory, Dr. Nemeroff was accused of failing to disclose $800,000 in payments from GlaxoSmithKline while he was directing National Institutes of Health studies that used some of that company's products. Emory subsequently stripped him of his psychiatry chairmanship and blocked him from seeking NIH grants for 2 years. It also prompted Emory to revise its conflict rules. According to a statement from Miami's Miller School of Medicine, Dr. Nemeroff plans to work on mental health and aging, HIV, drug abuse, and links between depression and cancer and heart disease.

Shire Receives OIG Subpoena

The British-based pharmaceutical company Shire plc has received a subpoena from the Office of the Inspector General of the U.S. Department of Health and Human Services seeking documents related to the sales and marketing of Adderall XR (amphetamine/dextroamphetamine), Daytrana (methylphenidate), and Vyvanse (lisdexamfetamine). Shire disclosed the subpoena in a statement with its third-quarter 2009 earnings announcement, which said sales of Adderall XR dropped 74% in the quarter. But Vyvanse sales continued to grow, partly because of the Food and Drug Administration's rejection of a generic competitor earlier this year and partly because of a 10% growth in the market for attention-deficit/hyperactivity disorder treatments, Shire said. The company also said it is about to launch its latest drug for ADHD, Intuniv (guanfacine).

Huge Seroquel Settlement

AstraZeneca will pay $520 million to settle several legal proceedings relating to its atypical antipsychotic Seroquel (quetiapine). The settlement was for two federal investigations and two whistleblower (qui tam) suits. In its third quarter–2009 earnings filing, the company said that the qui tam suits were related to two investigations by the U.S. Attorney's Office in Philadelphia. One concerns off-label sales and marketing, and the second is about “selected physicians who participated in clinical trials involving Seroquel,” the company said. AstraZeneca reached an agreement in principle to resolve the investigations in September, which included the payout. Meanwhile, Seroquel sales continue to rise. Compared with those last year, sales increased 16% in the United States for the 9 months ending Sept. 30, 2009, totaling $2.5 billion. Sales in the rest of the world increased 9%, to $1 billion, despite a 73% decline in Canada because of the introduction of a generic.

Risperdal Litigation Grows

There are now 425 cases pending against Johnson & Johnson's Ortho-McNeil-Janssen Pharmaceuticals Inc. alleging various damages from the atypical antipsychotic Risperdal (risperidone). The figure was disclosed in the company's third-quarter earnings statement. The company also said attorneys general in eight states and the Office of General Counsel of Pennsylvania are seeking reimbursement for public funds spent on off-label prescriptions and to treat adverse reactions. The Texas attorney general has joined a whistleblower suit seeking similar relief. More may be coming: Attorneys general in 40 other states have taken an interest in such litigation and have secured a ruling that stays the statute of limitations while they investigate. Six union health plans also have sued to recover alleged overpayments and have sought certification for a class action. Meanwhile, Risperdal sales dropped 60% in the first 9 months of 2009, partly because of generic competitors. But those sales are being replaced by the company's Risperdal Consta, which had revenues of $1 billion from January to October.

More Autism Grants From AARA

The NIH has awarded 50 grants for autism research totaling $65 million. The funds were provided by the American Recovery and Reinvestment Act (ARRA), known popularly as the economic stimulus package. A statement from the National Institute of Mental Health said all the grants were awarded based on how well they met short-term research objectives outlined in a plan devised by Interagency Autism Coordinating Committee. Much of the data from the studies will be available to other researchers through the National Database for Autism Research. NIMH's director, Dr. Thomas R. Insel, said the studies “hold the best promise of revealing what causes autism, how it might be prevented, what treatments are effective, and how service needs change across the lifespan.”

CMS Adds Geriatric Code

The Centers for Medicare and Medicaid Services has established a new physician specialty code for geriatric psychiatry. The code, 27, will go into effect April 1, 2010, the agency announced in late October. CMS directed all its contractors to recognize the new physician specialty code on all claims.

Dr. Nemeroff Lands in Miami

Dr. Charles B. Nemeroff, who was hounded by charges of conflicts of interest in his biological studies of neuropsychiatric disorders, has left Emory University, Atlanta, for the University of Miami. He will be professor and chairman of the department of psychiatry and behavioral sciences. While at Emory, Dr. Nemeroff was accused of failing to disclose $800,000 in payments from GlaxoSmithKline while he was directing National Institutes of Health studies that used some of that company's products. Emory subsequently stripped him of his psychiatry chairmanship and blocked him from seeking NIH grants for 2 years. It also prompted Emory to revise its conflict rules. According to a statement from Miami's Miller School of Medicine, Dr. Nemeroff plans to work on mental health and aging, HIV, drug abuse, and links between depression and cancer and heart disease.

Shire Receives OIG Subpoena

The British-based pharmaceutical company Shire plc has received a subpoena from the Office of the Inspector General of the U.S. Department of Health and Human Services seeking documents related to the sales and marketing of Adderall XR (amphetamine/dextroamphetamine), Daytrana (methylphenidate), and Vyvanse (lisdexamfetamine). Shire disclosed the subpoena in a statement with its third-quarter 2009 earnings announcement, which said sales of Adderall XR dropped 74% in the quarter. But Vyvanse sales continued to grow, partly because of the Food and Drug Administration's rejection of a generic competitor earlier this year and partly because of a 10% growth in the market for attention-deficit/hyperactivity disorder treatments, Shire said. The company also said it is about to launch its latest drug for ADHD, Intuniv (guanfacine).

Huge Seroquel Settlement

AstraZeneca will pay $520 million to settle several legal proceedings relating to its atypical antipsychotic Seroquel (quetiapine). The settlement was for two federal investigations and two whistleblower (qui tam) suits. In its third quarter–2009 earnings filing, the company said that the qui tam suits were related to two investigations by the U.S. Attorney's Office in Philadelphia. One concerns off-label sales and marketing, and the second is about “selected physicians who participated in clinical trials involving Seroquel,” the company said. AstraZeneca reached an agreement in principle to resolve the investigations in September, which included the payout. Meanwhile, Seroquel sales continue to rise. Compared with those last year, sales increased 16% in the United States for the 9 months ending Sept. 30, 2009, totaling $2.5 billion. Sales in the rest of the world increased 9%, to $1 billion, despite a 73% decline in Canada because of the introduction of a generic.

Risperdal Litigation Grows

There are now 425 cases pending against Johnson & Johnson's Ortho-McNeil-Janssen Pharmaceuticals Inc. alleging various damages from the atypical antipsychotic Risperdal (risperidone). The figure was disclosed in the company's third-quarter earnings statement. The company also said attorneys general in eight states and the Office of General Counsel of Pennsylvania are seeking reimbursement for public funds spent on off-label prescriptions and to treat adverse reactions. The Texas attorney general has joined a whistleblower suit seeking similar relief. More may be coming: Attorneys general in 40 other states have taken an interest in such litigation and have secured a ruling that stays the statute of limitations while they investigate. Six union health plans also have sued to recover alleged overpayments and have sought certification for a class action. Meanwhile, Risperdal sales dropped 60% in the first 9 months of 2009, partly because of generic competitors. But those sales are being replaced by the company's Risperdal Consta, which had revenues of $1 billion from January to October.

More Autism Grants From AARA

The NIH has awarded 50 grants for autism research totaling $65 million. The funds were provided by the American Recovery and Reinvestment Act (ARRA), known popularly as the economic stimulus package. A statement from the National Institute of Mental Health said all the grants were awarded based on how well they met short-term research objectives outlined in a plan devised by Interagency Autism Coordinating Committee. Much of the data from the studies will be available to other researchers through the National Database for Autism Research. NIMH's director, Dr. Thomas R. Insel, said the studies “hold the best promise of revealing what causes autism, how it might be prevented, what treatments are effective, and how service needs change across the lifespan.”

CMS Adds Geriatric Code

The Centers for Medicare and Medicaid Services has established a new physician specialty code for geriatric psychiatry. The code, 27, will go into effect April 1, 2010, the agency announced in late October. CMS directed all its contractors to recognize the new physician specialty code on all claims.

Dr. Nemeroff Lands in Miami

Dr. Charles B. Nemeroff, who was hounded by charges of conflicts of interest in his biological studies of neuropsychiatric disorders, has left Emory University, Atlanta, for the University of Miami. He will be professor and chairman of the department of psychiatry and behavioral sciences. While at Emory, Dr. Nemeroff was accused of failing to disclose $800,000 in payments from GlaxoSmithKline while he was directing National Institutes of Health studies that used some of that company's products. Emory subsequently stripped him of his psychiatry chairmanship and blocked him from seeking NIH grants for 2 years. It also prompted Emory to revise its conflict rules. According to a statement from Miami's Miller School of Medicine, Dr. Nemeroff plans to work on mental health and aging, HIV, drug abuse, and links between depression and cancer and heart disease.

Shire Receives OIG Subpoena

The British-based pharmaceutical company Shire plc has received a subpoena from the Office of the Inspector General of the U.S. Department of Health and Human Services seeking documents related to the sales and marketing of Adderall XR (amphetamine/dextroamphetamine), Daytrana (methylphenidate), and Vyvanse (lisdexamfetamine). Shire disclosed the subpoena in a statement with its third-quarter 2009 earnings announcement, which said sales of Adderall XR dropped 74% in the quarter. But Vyvanse sales continued to grow, partly because of the Food and Drug Administration's rejection of a generic competitor earlier this year and partly because of a 10% growth in the market for attention-deficit/hyperactivity disorder treatments, Shire said. The company also said it is about to launch its latest drug for ADHD, Intuniv (guanfacine).

Huge Seroquel Settlement

AstraZeneca will pay $520 million to settle several legal proceedings relating to its atypical antipsychotic Seroquel (quetiapine). The settlement was for two federal investigations and two whistleblower (qui tam) suits. In its third quarter–2009 earnings filing, the company said that the qui tam suits were related to two investigations by the U.S. Attorney's Office in Philadelphia. One concerns off-label sales and marketing, and the second is about “selected physicians who participated in clinical trials involving Seroquel,” the company said. AstraZeneca reached an agreement in principle to resolve the investigations in September, which included the payout. Meanwhile, Seroquel sales continue to rise. Compared with those last year, sales increased 16% in the United States for the 9 months ending Sept. 30, 2009, totaling $2.5 billion. Sales in the rest of the world increased 9%, to $1 billion, despite a 73% decline in Canada because of the introduction of a generic.

Risperdal Litigation Grows

There are now 425 cases pending against Johnson & Johnson's Ortho-McNeil-Janssen Pharmaceuticals Inc. alleging various damages from the atypical antipsychotic Risperdal (risperidone). The figure was disclosed in the company's third-quarter earnings statement. The company also said attorneys general in eight states and the Office of General Counsel of Pennsylvania are seeking reimbursement for public funds spent on off-label prescriptions and to treat adverse reactions. The Texas attorney general has joined a whistleblower suit seeking similar relief. More may be coming: Attorneys general in 40 other states have taken an interest in such litigation and have secured a ruling that stays the statute of limitations while they investigate. Six union health plans also have sued to recover alleged overpayments and have sought certification for a class action. Meanwhile, Risperdal sales dropped 60% in the first 9 months of 2009, partly because of generic competitors. But those sales are being replaced by the company's Risperdal Consta, which had revenues of $1 billion from January to October.

More Autism Grants From AARA

The NIH has awarded 50 grants for autism research totaling $65 million. The funds were provided by the American Recovery and Reinvestment Act (ARRA), known popularly as the economic stimulus package. A statement from the National Institute of Mental Health said all the grants were awarded based on how well they met short-term research objectives outlined in a plan devised by Interagency Autism Coordinating Committee. Much of the data from the studies will be available to other researchers through the National Database for Autism Research. NIMH's director, Dr. Thomas R. Insel, said the studies “hold the best promise of revealing what causes autism, how it might be prevented, what treatments are effective, and how service needs change across the lifespan.”

As a result of the public health emergency declared Oct. 23 by President Obama, hospitals and health providers may ask the Health and Human Services department to waive certain provisions required under federal health programs, including Medicare, Medicaid, the Children's Health Insurance Program, the Health Insurance Portability and Accountability Act (HIPAA), and the Emergency Medical Treatment and Labor Act (EMTALA).

The declaration—issued in response to the novel influenza A(H1N1) pandemic—allowed HHS Secretary Kathleen Sebelius to authorize what are called section 1135 waivers. Normally, the waivers allow a limited-time suspension of certain federal health program requirements. These waivers usually are granted in a specific geographic area, often during a time of natural disaster such as a hurricane. Under the 2009 H1N1 emergency, the waivers are being granted nationwide and will be in effect for the duration of the pandemic.

To better care for patients during the pandemic, hospitals and health providers may ask HHS to waive requirements in five areas:

▸ Conditions and requirements of participation, certification requirements, and preapproval requirements.

▸ Sanctions against relocations and transfers under EMTALA.

▸ Sanctions related to self-referrals.

▸ Deadlines for performance of required activities, including billing and administrative activities.

▸ Sanctions arising from noncompliance with certain HIPAA rules.

Demand for waivers has been relatively low, according to Jean Sheil, pandemic coordinator at the Centers for Medicare and Medicaid Services. As of early November, 73 waivers had been submitted. Of those, 5 were approved and 64 withdrawn, said David Wright, an HHS official coordinating the waiver process.

Most of the withdrawals came after discussions with the CMS confirmed that the facilities or physicians did not need the waiver, he said.

Providers may be wary of applying out of concern that it may take too long to get an answer. Waiver requests are expedited, however; the five approved waivers were all completed in about 24 hours, according to Mr. Wright.

More information can be found at www.cms.hhs.gov/H1N1

As a result of the public health emergency declared Oct. 23 by President Obama, hospitals and health providers may ask the Health and Human Services department to waive certain provisions required under federal health programs, including Medicare, Medicaid, the Children's Health Insurance Program, the Health Insurance Portability and Accountability Act (HIPAA), and the Emergency Medical Treatment and Labor Act (EMTALA).

The declaration—issued in response to the novel influenza A(H1N1) pandemic—allowed HHS Secretary Kathleen Sebelius to authorize what are called section 1135 waivers. Normally, the waivers allow a limited-time suspension of certain federal health program requirements. These waivers usually are granted in a specific geographic area, often during a time of natural disaster such as a hurricane. Under the 2009 H1N1 emergency, the waivers are being granted nationwide and will be in effect for the duration of the pandemic.

To better care for patients during the pandemic, hospitals and health providers may ask HHS to waive requirements in five areas:

▸ Conditions and requirements of participation, certification requirements, and preapproval requirements.

▸ Sanctions against relocations and transfers under EMTALA.

▸ Sanctions related to self-referrals.

▸ Deadlines for performance of required activities, including billing and administrative activities.

▸ Sanctions arising from noncompliance with certain HIPAA rules.

Demand for waivers has been relatively low, according to Jean Sheil, pandemic coordinator at the Centers for Medicare and Medicaid Services. As of early November, 73 waivers had been submitted. Of those, 5 were approved and 64 withdrawn, said David Wright, an HHS official coordinating the waiver process.

Most of the withdrawals came after discussions with the CMS confirmed that the facilities or physicians did not need the waiver, he said.

Providers may be wary of applying out of concern that it may take too long to get an answer. Waiver requests are expedited, however; the five approved waivers were all completed in about 24 hours, according to Mr. Wright.

More information can be found at www.cms.hhs.gov/H1N1

As a result of the public health emergency declared Oct. 23 by President Obama, hospitals and health providers may ask the Health and Human Services department to waive certain provisions required under federal health programs, including Medicare, Medicaid, the Children's Health Insurance Program, the Health Insurance Portability and Accountability Act (HIPAA), and the Emergency Medical Treatment and Labor Act (EMTALA).

The declaration—issued in response to the novel influenza A(H1N1) pandemic—allowed HHS Secretary Kathleen Sebelius to authorize what are called section 1135 waivers. Normally, the waivers allow a limited-time suspension of certain federal health program requirements. These waivers usually are granted in a specific geographic area, often during a time of natural disaster such as a hurricane. Under the 2009 H1N1 emergency, the waivers are being granted nationwide and will be in effect for the duration of the pandemic.

To better care for patients during the pandemic, hospitals and health providers may ask HHS to waive requirements in five areas:

▸ Conditions and requirements of participation, certification requirements, and preapproval requirements.

▸ Sanctions against relocations and transfers under EMTALA.

▸ Sanctions related to self-referrals.

▸ Deadlines for performance of required activities, including billing and administrative activities.

▸ Sanctions arising from noncompliance with certain HIPAA rules.

Demand for waivers has been relatively low, according to Jean Sheil, pandemic coordinator at the Centers for Medicare and Medicaid Services. As of early November, 73 waivers had been submitted. Of those, 5 were approved and 64 withdrawn, said David Wright, an HHS official coordinating the waiver process.

Most of the withdrawals came after discussions with the CMS confirmed that the facilities or physicians did not need the waiver, he said.

Providers may be wary of applying out of concern that it may take too long to get an answer. Waiver requests are expedited, however; the five approved waivers were all completed in about 24 hours, according to Mr. Wright.

More information can be found at www.cms.hhs.gov/H1N1

At a meeting convened by the Food and Drug Administration, pharmaceutical and medical device manufacturers, advertisers, medical Web site owners, search engine companies, and consumer advocates all argued for greater regulation of health-specific content on the Internet, including social media sites.

The agency was seeking opinions on how it could guide health-related communications and promotions for YouTube, Twitter, blogging, and social networking sites.

Notably, there were no speakers from any medical society or health care provider organization.

The FDA has not said when it might issue guidance, but it will continue to accept comments until Feb. 28, 2010, said Thomas W. Abrams, director of the FDA Center for Drug Evaluation and Research's division of drug marketing, advertising, and communications.

All speakers agreed that consumers and health care providers increasingly rely on the Internet for information about drugs, devices, and specific conditions, and also to forge communities to share everything from caregiving recommendations to tips on how to perform a knee replacement.

All of the participants also agreed that there is a huge amount of inaccurate and misleading information and that it has a great potential for harm—to patients and their families, to health care providers, and to industries seeking credibility. Even as they seek to be the go-to place for accurate, scientific information, drug and device makers said they are wary—of social media in particular—because of the lack of FDA guidance.

Consumer groups raised the specter of pharmaceutical or device companies putting out purely promotional information that glosses over FDA rules requiring a fair balance of a product's risks and benefits.

Michele Sharp, senior director of United States Regulatory Affairs at Eli Lilly, said the company “had avoided significant interactions with providers and patients online” because of the FDA's lack of clarity.

“We're looking to the FDA to provide leadership,” Ms. Sharp said.

Jeffrey K. Francer, assistant general counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA), said that “the FDA should facilitate manufacturers' communication of important medical information about their products in a responsible way, taking advantage of the same technologies that the FDA and the White House use, including blogs, video, search, and social networking sites such as Twitter.”

PhRMA has proposed that posts on Twitter or blogs or other social media sites be accompanied by an official logo that would signify that the information was officially sanctioned by the FDA. Tweets, which are limited to 140 characters, could provide a hyperlink to the full risk and benefit information, Mr. Francer said.

He and other industry representatives said they wanted the FDA to review information and promotional materials before they were posted on the Web. This would be a departure from current policy where only a small fraction of print or broadcast materials are reviewed in advance.

Some groups are trying to establish rules before the FDA does. The Interactive Advertising Bureau said it was developing standards to provide “safe harbors” for the drug and device industry. IAB members provide 85% of online ads in the United States, said IAB representative David Wright.

The Social Media Working Group has also been discussing what drug companies can do to self-police, said Mark Gaydos, chairman of the group and a regulatory affairs director at Sanofi-Aventis U.S.

The working group is made up of representatives from five pharmaceutical manufacturers who meet on a voluntary basis.

Google also proposed its own standards for “sponsored” searches. The search result would include a link to the official drug site and a link at the end, “more info,” which would take users directly to the risk information, said Amy Cowan, who is head of industry for Google's health division. All results would also include a short warning statement.

Consumer advocate Diana Zuckerman, Ph.D., said she believed that the FDA has historically done a poor job of monitoring direct-to-consumer promotions and going after violators.

The agency will be even more challenged in an environment where information can be changed hourly, said Dr. Zuckerman, president of the Washington-based National Research Center for Women and Families.

But, she said, the FDA must monitor the Internet and social media.

“Realistically the FDA would need a lot more resources to do that,” Dr. Zuckerman acknowledged.

The center, along with Consumers Union, will push for higher users fees to fund policing of the Web, Ms. Zuckerman said.

At a meeting convened by the Food and Drug Administration, pharmaceutical and medical device manufacturers, advertisers, medical Web site owners, search engine companies, and consumer advocates all argued for greater regulation of health-specific content on the Internet, including social media sites.

The agency was seeking opinions on how it could guide health-related communications and promotions for YouTube, Twitter, blogging, and social networking sites.

Notably, there were no speakers from any medical society or health care provider organization.

The FDA has not said when it might issue guidance, but it will continue to accept comments until Feb. 28, 2010, said Thomas W. Abrams, director of the FDA Center for Drug Evaluation and Research's division of drug marketing, advertising, and communications.

All speakers agreed that consumers and health care providers increasingly rely on the Internet for information about drugs, devices, and specific conditions, and also to forge communities to share everything from caregiving recommendations to tips on how to perform a knee replacement.

All of the participants also agreed that there is a huge amount of inaccurate and misleading information and that it has a great potential for harm—to patients and their families, to health care providers, and to industries seeking credibility. Even as they seek to be the go-to place for accurate, scientific information, drug and device makers said they are wary—of social media in particular—because of the lack of FDA guidance.

Consumer groups raised the specter of pharmaceutical or device companies putting out purely promotional information that glosses over FDA rules requiring a fair balance of a product's risks and benefits.

Michele Sharp, senior director of United States Regulatory Affairs at Eli Lilly, said the company “had avoided significant interactions with providers and patients online” because of the FDA's lack of clarity.

“We're looking to the FDA to provide leadership,” Ms. Sharp said.

Jeffrey K. Francer, assistant general counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA), said that “the FDA should facilitate manufacturers' communication of important medical information about their products in a responsible way, taking advantage of the same technologies that the FDA and the White House use, including blogs, video, search, and social networking sites such as Twitter.”

PhRMA has proposed that posts on Twitter or blogs or other social media sites be accompanied by an official logo that would signify that the information was officially sanctioned by the FDA. Tweets, which are limited to 140 characters, could provide a hyperlink to the full risk and benefit information, Mr. Francer said.

He and other industry representatives said they wanted the FDA to review information and promotional materials before they were posted on the Web. This would be a departure from current policy where only a small fraction of print or broadcast materials are reviewed in advance.

Some groups are trying to establish rules before the FDA does. The Interactive Advertising Bureau said it was developing standards to provide “safe harbors” for the drug and device industry. IAB members provide 85% of online ads in the United States, said IAB representative David Wright.

The Social Media Working Group has also been discussing what drug companies can do to self-police, said Mark Gaydos, chairman of the group and a regulatory affairs director at Sanofi-Aventis U.S.

The working group is made up of representatives from five pharmaceutical manufacturers who meet on a voluntary basis.

Google also proposed its own standards for “sponsored” searches. The search result would include a link to the official drug site and a link at the end, “more info,” which would take users directly to the risk information, said Amy Cowan, who is head of industry for Google's health division. All results would also include a short warning statement.

Consumer advocate Diana Zuckerman, Ph.D., said she believed that the FDA has historically done a poor job of monitoring direct-to-consumer promotions and going after violators.

The agency will be even more challenged in an environment where information can be changed hourly, said Dr. Zuckerman, president of the Washington-based National Research Center for Women and Families.

But, she said, the FDA must monitor the Internet and social media.

“Realistically the FDA would need a lot more resources to do that,” Dr. Zuckerman acknowledged.

The center, along with Consumers Union, will push for higher users fees to fund policing of the Web, Ms. Zuckerman said.

At a meeting convened by the Food and Drug Administration, pharmaceutical and medical device manufacturers, advertisers, medical Web site owners, search engine companies, and consumer advocates all argued for greater regulation of health-specific content on the Internet, including social media sites.

The agency was seeking opinions on how it could guide health-related communications and promotions for YouTube, Twitter, blogging, and social networking sites.

Notably, there were no speakers from any medical society or health care provider organization.

The FDA has not said when it might issue guidance, but it will continue to accept comments until Feb. 28, 2010, said Thomas W. Abrams, director of the FDA Center for Drug Evaluation and Research's division of drug marketing, advertising, and communications.

All speakers agreed that consumers and health care providers increasingly rely on the Internet for information about drugs, devices, and specific conditions, and also to forge communities to share everything from caregiving recommendations to tips on how to perform a knee replacement.

All of the participants also agreed that there is a huge amount of inaccurate and misleading information and that it has a great potential for harm—to patients and their families, to health care providers, and to industries seeking credibility. Even as they seek to be the go-to place for accurate, scientific information, drug and device makers said they are wary—of social media in particular—because of the lack of FDA guidance.

Consumer groups raised the specter of pharmaceutical or device companies putting out purely promotional information that glosses over FDA rules requiring a fair balance of a product's risks and benefits.

Michele Sharp, senior director of United States Regulatory Affairs at Eli Lilly, said the company “had avoided significant interactions with providers and patients online” because of the FDA's lack of clarity.

“We're looking to the FDA to provide leadership,” Ms. Sharp said.

Jeffrey K. Francer, assistant general counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA), said that “the FDA should facilitate manufacturers' communication of important medical information about their products in a responsible way, taking advantage of the same technologies that the FDA and the White House use, including blogs, video, search, and social networking sites such as Twitter.”

PhRMA has proposed that posts on Twitter or blogs or other social media sites be accompanied by an official logo that would signify that the information was officially sanctioned by the FDA. Tweets, which are limited to 140 characters, could provide a hyperlink to the full risk and benefit information, Mr. Francer said.

He and other industry representatives said they wanted the FDA to review information and promotional materials before they were posted on the Web. This would be a departure from current policy where only a small fraction of print or broadcast materials are reviewed in advance.

Some groups are trying to establish rules before the FDA does. The Interactive Advertising Bureau said it was developing standards to provide “safe harbors” for the drug and device industry. IAB members provide 85% of online ads in the United States, said IAB representative David Wright.

The Social Media Working Group has also been discussing what drug companies can do to self-police, said Mark Gaydos, chairman of the group and a regulatory affairs director at Sanofi-Aventis U.S.

The working group is made up of representatives from five pharmaceutical manufacturers who meet on a voluntary basis.

Google also proposed its own standards for “sponsored” searches. The search result would include a link to the official drug site and a link at the end, “more info,” which would take users directly to the risk information, said Amy Cowan, who is head of industry for Google's health division. All results would also include a short warning statement.

Consumer advocate Diana Zuckerman, Ph.D., said she believed that the FDA has historically done a poor job of monitoring direct-to-consumer promotions and going after violators.

The agency will be even more challenged in an environment where information can be changed hourly, said Dr. Zuckerman, president of the Washington-based National Research Center for Women and Families.

But, she said, the FDA must monitor the Internet and social media.

“Realistically the FDA would need a lot more resources to do that,” Dr. Zuckerman acknowledged.

The center, along with Consumers Union, will push for higher users fees to fund policing of the Web, Ms. Zuckerman said.

Legislation that would have provided a 10-year replacement of Medicare's sustainable growth rate formula was blocked when senators voted 53–47 against bringing the bill to the floor.

The sustainable growth rate (SGR) has dictated how Medicare pays physicians. For the last 7 years, the formula has required a reduction in physician fees, but each of those years, Congress has voted to reverse the cuts.

Eleven Democrats voted against cloture, a procedural motion that precedes a legislative vote: Evan Bayh (Ind.), Robert Byrd (W.Va.), Kent Conrad (N.D.), Byron Dorgan (N.D.), Russ Feingold (Wisc.), Herbert Kohl (Wisc.), Bill Nelson (Fla.), Jon Tester (Mont.), Mark Warner (Va.), James Webb (Va.), and Ron Wyden (Ore.). Independent Joseph Lieberman (Conn.) also voted no. No Republicans voted yes.

In a statement, American Medical Association President James Rohack said, “The AMA is deeply disappointed that the Senate today blocked consideration of S. 1776, legislation to preserve access to health care for America's seniors, baby boomers and military families.”

Sen. Debbie Stabenow (D-Mich.), the legislation's sponsor, and her Democratic colleagues did not offer any way to pay for the fix, which would have cost an estimated $250 billion over the 10 years.

Republicans—and some Democrats—leapt on the bill's lack of funding, especially since President Obama has said he would not sign a health bill that added to the deficit. The SGR fix was presented by Sen. Stabenow and her supporters—including the AMA—as something entirely separate from health reform, thus possibly exempt from that promise.

“Although many will claim that their vote against cloture was a vote for fiscal responsibility, there is nothing fiscally responsible about pretending that Medicare will save money from cuts that Congress has no intention to let go into effect,” said Dr. Joseph W. Stubbs, president of the American College of Physicians.

The House is not expected to act on any physician fee fix until after it considers health reform.

To respond to this column, e-mail Dr. Eastern at sknews@elsevier.com

Legislation that would have provided a 10-year replacement of Medicare's sustainable growth rate formula was blocked when senators voted 53–47 against bringing the bill to the floor.

The sustainable growth rate (SGR) has dictated how Medicare pays physicians. For the last 7 years, the formula has required a reduction in physician fees, but each of those years, Congress has voted to reverse the cuts.

Eleven Democrats voted against cloture, a procedural motion that precedes a legislative vote: Evan Bayh (Ind.), Robert Byrd (W.Va.), Kent Conrad (N.D.), Byron Dorgan (N.D.), Russ Feingold (Wisc.), Herbert Kohl (Wisc.), Bill Nelson (Fla.), Jon Tester (Mont.), Mark Warner (Va.), James Webb (Va.), and Ron Wyden (Ore.). Independent Joseph Lieberman (Conn.) also voted no. No Republicans voted yes.

In a statement, American Medical Association President James Rohack said, “The AMA is deeply disappointed that the Senate today blocked consideration of S. 1776, legislation to preserve access to health care for America's seniors, baby boomers and military families.”

Sen. Debbie Stabenow (D-Mich.), the legislation's sponsor, and her Democratic colleagues did not offer any way to pay for the fix, which would have cost an estimated $250 billion over the 10 years.

Republicans—and some Democrats—leapt on the bill's lack of funding, especially since President Obama has said he would not sign a health bill that added to the deficit. The SGR fix was presented by Sen. Stabenow and her supporters—including the AMA—as something entirely separate from health reform, thus possibly exempt from that promise.

“Although many will claim that their vote against cloture was a vote for fiscal responsibility, there is nothing fiscally responsible about pretending that Medicare will save money from cuts that Congress has no intention to let go into effect,” said Dr. Joseph W. Stubbs, president of the American College of Physicians.

The House is not expected to act on any physician fee fix until after it considers health reform.

To respond to this column, e-mail Dr. Eastern at sknews@elsevier.com

Legislation that would have provided a 10-year replacement of Medicare's sustainable growth rate formula was blocked when senators voted 53–47 against bringing the bill to the floor.

The sustainable growth rate (SGR) has dictated how Medicare pays physicians. For the last 7 years, the formula has required a reduction in physician fees, but each of those years, Congress has voted to reverse the cuts.

Eleven Democrats voted against cloture, a procedural motion that precedes a legislative vote: Evan Bayh (Ind.), Robert Byrd (W.Va.), Kent Conrad (N.D.), Byron Dorgan (N.D.), Russ Feingold (Wisc.), Herbert Kohl (Wisc.), Bill Nelson (Fla.), Jon Tester (Mont.), Mark Warner (Va.), James Webb (Va.), and Ron Wyden (Ore.). Independent Joseph Lieberman (Conn.) also voted no. No Republicans voted yes.

In a statement, American Medical Association President James Rohack said, “The AMA is deeply disappointed that the Senate today blocked consideration of S. 1776, legislation to preserve access to health care for America's seniors, baby boomers and military families.”

Sen. Debbie Stabenow (D-Mich.), the legislation's sponsor, and her Democratic colleagues did not offer any way to pay for the fix, which would have cost an estimated $250 billion over the 10 years.

Republicans—and some Democrats—leapt on the bill's lack of funding, especially since President Obama has said he would not sign a health bill that added to the deficit. The SGR fix was presented by Sen. Stabenow and her supporters—including the AMA—as something entirely separate from health reform, thus possibly exempt from that promise.

“Although many will claim that their vote against cloture was a vote for fiscal responsibility, there is nothing fiscally responsible about pretending that Medicare will save money from cuts that Congress has no intention to let go into effect,” said Dr. Joseph W. Stubbs, president of the American College of Physicians.

The House is not expected to act on any physician fee fix until after it considers health reform.

To respond to this column, e-mail Dr. Eastern at sknews@elsevier.com

Botox Still Big Profit Driver

Allergan just reported its third-quarter earnings, and although Botox (onabotulinumtoxinA) sales increased a scant 3%, the company said that the injectable contributed to a net profit rise of 8.3%. The company predicted that its total Botox sales for the year would be almost $1.3 billion. Also in the third quarter, Allergan filed for Food and Drug Administration approval to promote the use of Botox for migraine headaches and submitted additional data to the agency on the drug's use for upper limb spasticity. Allergan also stated that it expects sales of the eyelash lengthener Latisse (bimatoprost) to hit $70 million for the year.

J&J Pulling Evolence

Johnson & Johnson's Ortho Dermatologics division is ceasing manufacture and sales of the collagen-based wrinkle filler Evolence. The discontinuation of the product is part of J&J's “effort to refine strategic priorities and focus investment on other growth opportunities,” said the company in a statement accompanying its third-quarter financial report. Evolence was approved by the FDA in June 2008 for correction of moderate to deep facial wrinkles and folds. The product had been on the market for several years before that in Canada, Europe, Israel, South Korea, and Russia. Evolence faced stiff competition from hyaluronic acid–based fillers. Ortho said in its statement that physicians and patients should be assured that Evolence “remains effective for correction of moderate to deep wrinkles and folds with a favorable safety profile.”

Plan to Boost Melanoma Research

The Melanoma Research Foundation has assembled a group of academic medical centers and pharmaceutical companies to speed development of melanoma therapies. “We are fed up with melanoma patients having so few treatment options to battle their disease,” Randy Lomax, the foundation's chairman, said in a statement. Most melanoma research has focused on single-agent therapies, according to the foundation. The consortium intends to break down barriers between researchers so they can study combinations of new drugs. A consortium goal is to see such clinical trials begin as soon as 2010.

Call for Better Lupus Treatments

Federal agencies need to work closely with researchers, industry, and patient advocates to overcome barriers that have stymied new lupus treatments for decades, according to a new report commissioned by the Lupus Foundation of America. After a 9-month study, the Lewin Group advised researchers to work with the National Institutes of Health to create an agenda for drug development in lupus. Scientists also need to improve clinical trials' selection of participants, end points, and use of background medications and placebos, the report said.

Arthritis Challenges Widespread

In a recent worldwide survey, more than half of people with rheumatic diseases said that having a supportive boss and coworkers is the key to performing well in the workplace, with flexible working hours also ranking high. The online survey was commissioned by the European League Against Rheumatism (EULAR). The survey included responses from 2,500 people with rheumatic disease, as well as health care providers and employers, in 79 countries. Nearly 70% of employers said that understanding the needs of patients with rheumatic diseases is a challenge, and only about a third of patients said that changes had been made to accommodate them at their workplaces.

Boomer Health Spending Rises

Total health care expenses for Americans aged 45–64 doubled between 1996 and 2006, from an inflation-adjusted $187 billion to $370 billion, according to the Agency for Healthcare Research and Quality. The AHRQ found that while the proportion of middle-aged people who incurred medical expenses remained constant at 89%, average health care expenses for those who had them increased from an inflation-adjusted $3,849 to $5,455. Prescriptions constituted a much higher portion of total expenses in 2006 than in 1996, AHRQ said, while the share spent for hospital inpatient care decreased. The average expense per service rendered also increased significantly.

Botox Still Big Profit Driver

Allergan just reported its third-quarter earnings, and although Botox (onabotulinumtoxinA) sales increased a scant 3%, the company said that the injectable contributed to a net profit rise of 8.3%. The company predicted that its total Botox sales for the year would be almost $1.3 billion. Also in the third quarter, Allergan filed for Food and Drug Administration approval to promote the use of Botox for migraine headaches and submitted additional data to the agency on the drug's use for upper limb spasticity. Allergan also stated that it expects sales of the eyelash lengthener Latisse (bimatoprost) to hit $70 million for the year.

J&J Pulling Evolence

Johnson & Johnson's Ortho Dermatologics division is ceasing manufacture and sales of the collagen-based wrinkle filler Evolence. The discontinuation of the product is part of J&J's “effort to refine strategic priorities and focus investment on other growth opportunities,” said the company in a statement accompanying its third-quarter financial report. Evolence was approved by the FDA in June 2008 for correction of moderate to deep facial wrinkles and folds. The product had been on the market for several years before that in Canada, Europe, Israel, South Korea, and Russia. Evolence faced stiff competition from hyaluronic acid–based fillers. Ortho said in its statement that physicians and patients should be assured that Evolence “remains effective for correction of moderate to deep wrinkles and folds with a favorable safety profile.”

Plan to Boost Melanoma Research

The Melanoma Research Foundation has assembled a group of academic medical centers and pharmaceutical companies to speed development of melanoma therapies. “We are fed up with melanoma patients having so few treatment options to battle their disease,” Randy Lomax, the foundation's chairman, said in a statement. Most melanoma research has focused on single-agent therapies, according to the foundation. The consortium intends to break down barriers between researchers so they can study combinations of new drugs. A consortium goal is to see such clinical trials begin as soon as 2010.

Call for Better Lupus Treatments

Federal agencies need to work closely with researchers, industry, and patient advocates to overcome barriers that have stymied new lupus treatments for decades, according to a new report commissioned by the Lupus Foundation of America. After a 9-month study, the Lewin Group advised researchers to work with the National Institutes of Health to create an agenda for drug development in lupus. Scientists also need to improve clinical trials' selection of participants, end points, and use of background medications and placebos, the report said.

Arthritis Challenges Widespread

In a recent worldwide survey, more than half of people with rheumatic diseases said that having a supportive boss and coworkers is the key to performing well in the workplace, with flexible working hours also ranking high. The online survey was commissioned by the European League Against Rheumatism (EULAR). The survey included responses from 2,500 people with rheumatic disease, as well as health care providers and employers, in 79 countries. Nearly 70% of employers said that understanding the needs of patients with rheumatic diseases is a challenge, and only about a third of patients said that changes had been made to accommodate them at their workplaces.

Boomer Health Spending Rises

Total health care expenses for Americans aged 45–64 doubled between 1996 and 2006, from an inflation-adjusted $187 billion to $370 billion, according to the Agency for Healthcare Research and Quality. The AHRQ found that while the proportion of middle-aged people who incurred medical expenses remained constant at 89%, average health care expenses for those who had them increased from an inflation-adjusted $3,849 to $5,455. Prescriptions constituted a much higher portion of total expenses in 2006 than in 1996, AHRQ said, while the share spent for hospital inpatient care decreased. The average expense per service rendered also increased significantly.

Botox Still Big Profit Driver

Allergan just reported its third-quarter earnings, and although Botox (onabotulinumtoxinA) sales increased a scant 3%, the company said that the injectable contributed to a net profit rise of 8.3%. The company predicted that its total Botox sales for the year would be almost $1.3 billion. Also in the third quarter, Allergan filed for Food and Drug Administration approval to promote the use of Botox for migraine headaches and submitted additional data to the agency on the drug's use for upper limb spasticity. Allergan also stated that it expects sales of the eyelash lengthener Latisse (bimatoprost) to hit $70 million for the year.

J&J Pulling Evolence

Johnson & Johnson's Ortho Dermatologics division is ceasing manufacture and sales of the collagen-based wrinkle filler Evolence. The discontinuation of the product is part of J&J's “effort to refine strategic priorities and focus investment on other growth opportunities,” said the company in a statement accompanying its third-quarter financial report. Evolence was approved by the FDA in June 2008 for correction of moderate to deep facial wrinkles and folds. The product had been on the market for several years before that in Canada, Europe, Israel, South Korea, and Russia. Evolence faced stiff competition from hyaluronic acid–based fillers. Ortho said in its statement that physicians and patients should be assured that Evolence “remains effective for correction of moderate to deep wrinkles and folds with a favorable safety profile.”

Plan to Boost Melanoma Research

The Melanoma Research Foundation has assembled a group of academic medical centers and pharmaceutical companies to speed development of melanoma therapies. “We are fed up with melanoma patients having so few treatment options to battle their disease,” Randy Lomax, the foundation's chairman, said in a statement. Most melanoma research has focused on single-agent therapies, according to the foundation. The consortium intends to break down barriers between researchers so they can study combinations of new drugs. A consortium goal is to see such clinical trials begin as soon as 2010.

Call for Better Lupus Treatments

Federal agencies need to work closely with researchers, industry, and patient advocates to overcome barriers that have stymied new lupus treatments for decades, according to a new report commissioned by the Lupus Foundation of America. After a 9-month study, the Lewin Group advised researchers to work with the National Institutes of Health to create an agenda for drug development in lupus. Scientists also need to improve clinical trials' selection of participants, end points, and use of background medications and placebos, the report said.

Arthritis Challenges Widespread

In a recent worldwide survey, more than half of people with rheumatic diseases said that having a supportive boss and coworkers is the key to performing well in the workplace, with flexible working hours also ranking high. The online survey was commissioned by the European League Against Rheumatism (EULAR). The survey included responses from 2,500 people with rheumatic disease, as well as health care providers and employers, in 79 countries. Nearly 70% of employers said that understanding the needs of patients with rheumatic diseases is a challenge, and only about a third of patients said that changes had been made to accommodate them at their workplaces.

Boomer Health Spending Rises

Total health care expenses for Americans aged 45–64 doubled between 1996 and 2006, from an inflation-adjusted $187 billion to $370 billion, according to the Agency for Healthcare Research and Quality. The AHRQ found that while the proportion of middle-aged people who incurred medical expenses remained constant at 89%, average health care expenses for those who had them increased from an inflation-adjusted $3,849 to $5,455. Prescriptions constituted a much higher portion of total expenses in 2006 than in 1996, AHRQ said, while the share spent for hospital inpatient care decreased. The average expense per service rendered also increased significantly.

At a meeting convened by the Food and Drug Administration, pharmaceutical and medical device manufacturers, advertisers, medical Web site owners, search engine companies, and consumer advocates all argued for greater regulation of health-specific content on the Internet, including social media sites.

The agency was seeking opinions on how it could guide health-related communications and promotions for YouTube, Twitter, blogging, and social networking sites. Notably, there were no speakers from any medical society or health care provider organization.

The FDA has not said when it might issue guidance, but it will continue to accept comments until Feb. 28, 2010, said Thomas W. Abrams, director of the FDA Center for Drug Evaluation and Research's division of drug marketing, advertising, and communications.

All speakers agreed that consumers and health care providers increasingly rely on the Internet for information about drugs, devices, and specific conditions, and also to forge communities to share everything from caregiving recommendations to tips on how to perform a knee replacement.

All also agreed that there is a huge amount of inaccurate and misleading information and that it has a great potential for harm—to patients and their families, to health care providers, and to industries seeking credibility. Even as they seek to be the go-to place for accurate, scientific information, drug and device makers said they are wary—of social media in particular—because of the lack of FDA guidance.

Consumer groups raised the specter of pharmaceutical or device companies putting out purely promotional information that glosses over FDA rules requiring a fair balance of risks and benefits.

Michele Sharp, senior director of United States Regulatory Affairs at Eli Lilly, said the company “had avoided significant interactions with providers and patients online” because of FDA's lack of clarity.

“We're looking to the FDA to provide leadership,” Ms. Sharp said.

Jeffrey K. Francer, assistant general counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA), said that “the FDA should facilitate manufacturers' communication of important medical information about their products in a responsible way, taking advantage of the same technologies that the FDA and the White House use, including blogs, video, search, and social networking sites such as Twitter.”

PhRMA has proposed that posts on Twitter or blogs or other social media sites be accompanied by an official logo that would signify that the information was officially sanctioned by the FDA. Tweets, which are limited to 140 characters, could provide a hyperlink to the full risk and benefit information, Mr. Francer said.

He and other industry representatives said they wanted FDA to review information and promotional materials before they were posted on the Web. This would be a departure from current policy where only a small fraction of print or broadcast materials are reviewed in advance.

Consumer advocate Diana Zuckerman, Ph.D., said she believed that the FDA has historically done a poor job of monitoring direct-to-consumer promotions and going after violators. The agency will be even more challenged in an environment where information can be changed hourly, said Dr. Zuckerman, president of the Washington-based National Research Center for Women and FamiliesOK TK. But, she said, the FDA must monitor the Internet and social media. “Realistically the FDA would need a lot more resources to do that,” she acknowledged.

At a meeting convened by the Food and Drug Administration, pharmaceutical and medical device manufacturers, advertisers, medical Web site owners, search engine companies, and consumer advocates all argued for greater regulation of health-specific content on the Internet, including social media sites.

The agency was seeking opinions on how it could guide health-related communications and promotions for YouTube, Twitter, blogging, and social networking sites. Notably, there were no speakers from any medical society or health care provider organization.

The FDA has not said when it might issue guidance, but it will continue to accept comments until Feb. 28, 2010, said Thomas W. Abrams, director of the FDA Center for Drug Evaluation and Research's division of drug marketing, advertising, and communications.

All speakers agreed that consumers and health care providers increasingly rely on the Internet for information about drugs, devices, and specific conditions, and also to forge communities to share everything from caregiving recommendations to tips on how to perform a knee replacement.

All also agreed that there is a huge amount of inaccurate and misleading information and that it has a great potential for harm—to patients and their families, to health care providers, and to industries seeking credibility. Even as they seek to be the go-to place for accurate, scientific information, drug and device makers said they are wary—of social media in particular—because of the lack of FDA guidance.

Consumer groups raised the specter of pharmaceutical or device companies putting out purely promotional information that glosses over FDA rules requiring a fair balance of risks and benefits.

Michele Sharp, senior director of United States Regulatory Affairs at Eli Lilly, said the company “had avoided significant interactions with providers and patients online” because of FDA's lack of clarity.

“We're looking to the FDA to provide leadership,” Ms. Sharp said.

Jeffrey K. Francer, assistant general counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA), said that “the FDA should facilitate manufacturers' communication of important medical information about their products in a responsible way, taking advantage of the same technologies that the FDA and the White House use, including blogs, video, search, and social networking sites such as Twitter.”

PhRMA has proposed that posts on Twitter or blogs or other social media sites be accompanied by an official logo that would signify that the information was officially sanctioned by the FDA. Tweets, which are limited to 140 characters, could provide a hyperlink to the full risk and benefit information, Mr. Francer said.

He and other industry representatives said they wanted FDA to review information and promotional materials before they were posted on the Web. This would be a departure from current policy where only a small fraction of print or broadcast materials are reviewed in advance.

Consumer advocate Diana Zuckerman, Ph.D., said she believed that the FDA has historically done a poor job of monitoring direct-to-consumer promotions and going after violators. The agency will be even more challenged in an environment where information can be changed hourly, said Dr. Zuckerman, president of the Washington-based National Research Center for Women and FamiliesOK TK. But, she said, the FDA must monitor the Internet and social media. “Realistically the FDA would need a lot more resources to do that,” she acknowledged.

At a meeting convened by the Food and Drug Administration, pharmaceutical and medical device manufacturers, advertisers, medical Web site owners, search engine companies, and consumer advocates all argued for greater regulation of health-specific content on the Internet, including social media sites.

The agency was seeking opinions on how it could guide health-related communications and promotions for YouTube, Twitter, blogging, and social networking sites. Notably, there were no speakers from any medical society or health care provider organization.

The FDA has not said when it might issue guidance, but it will continue to accept comments until Feb. 28, 2010, said Thomas W. Abrams, director of the FDA Center for Drug Evaluation and Research's division of drug marketing, advertising, and communications.

All speakers agreed that consumers and health care providers increasingly rely on the Internet for information about drugs, devices, and specific conditions, and also to forge communities to share everything from caregiving recommendations to tips on how to perform a knee replacement.

All also agreed that there is a huge amount of inaccurate and misleading information and that it has a great potential for harm—to patients and their families, to health care providers, and to industries seeking credibility. Even as they seek to be the go-to place for accurate, scientific information, drug and device makers said they are wary—of social media in particular—because of the lack of FDA guidance.

Consumer groups raised the specter of pharmaceutical or device companies putting out purely promotional information that glosses over FDA rules requiring a fair balance of risks and benefits.

Michele Sharp, senior director of United States Regulatory Affairs at Eli Lilly, said the company “had avoided significant interactions with providers and patients online” because of FDA's lack of clarity.

“We're looking to the FDA to provide leadership,” Ms. Sharp said.

Jeffrey K. Francer, assistant general counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA), said that “the FDA should facilitate manufacturers' communication of important medical information about their products in a responsible way, taking advantage of the same technologies that the FDA and the White House use, including blogs, video, search, and social networking sites such as Twitter.”

PhRMA has proposed that posts on Twitter or blogs or other social media sites be accompanied by an official logo that would signify that the information was officially sanctioned by the FDA. Tweets, which are limited to 140 characters, could provide a hyperlink to the full risk and benefit information, Mr. Francer said.

He and other industry representatives said they wanted FDA to review information and promotional materials before they were posted on the Web. This would be a departure from current policy where only a small fraction of print or broadcast materials are reviewed in advance.

Consumer advocate Diana Zuckerman, Ph.D., said she believed that the FDA has historically done a poor job of monitoring direct-to-consumer promotions and going after violators. The agency will be even more challenged in an environment where information can be changed hourly, said Dr. Zuckerman, president of the Washington-based National Research Center for Women and FamiliesOK TK. But, she said, the FDA must monitor the Internet and social media. “Realistically the FDA would need a lot more resources to do that,” she acknowledged.

BETHESDA — It may be time for a retrenching in basic science when it comes to the use of stem cells to treat heart disease, prominent researchers said at a National Heart, Lung, and Blood Institute–sponsored symposium.

Dr. Stephen G. Ellis, section head of invasive/interventional cardiology at the Cleveland Clinic Lerner College of Medicine, reviewed a series of human trials in acute myocardial infarction and congestive heart failure. “The initial results are somewhat mixed, but they are promising,” Dr. Ellis said. The stem cells—technically, bone marrow–derived mononuclear cells—that were used in the studies have shown some utility in acute MI, but not as much in heart failure, Dr. Ellis said at the Symposium on Cardiovascular Regenerative Medicine.

In the acute MI trials, patients who improved most had left ventricular ejection fractions below the median at baseline, he said. And the improvement may even be sustainable over 5 years, Dr. Ellis said. There was a consistent reduction in the clinical end points of death, reinfarction, and heart failure in patients who had the bone marrow–derived cells injected into the myocardium. A meta-analysis of the published data showed an aggregate ejection fraction benefit of about 3.5%, compared with placebo.

The method of cell isolation and the timing of injections may influence results. Ongoing studies are comparing delivery times: several days post infarction versus several weeks, he said.

The unknowns are even greater when it comes to using the cells to treat heart failure, he said. First, the homing signal is weak at best, leaving little likelihood that the stem cells will reach the target cells. Even with acute MI, homing signals are present only for a week or two. Results of studies so far show that improvement in perfusion may be possible, but little is known about the best possible target population, the best cells to use, the optimum delivery method, possible side effects, and whether concomitant improvement in left ventricular function is possible, Dr. Ellis said.

Even so, “rather than calling a halt to clinical trials, we need to learn from one another.” Researchers should use animal models and basic models to come up with initial therapeutic impressions, and then move on to human phase I and II studies. But there should be careful reflection on those results and refinement of that knowledge before there is a move toward large-scale trials, he said.

Dr. Joshua M. Hare, director of the Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine, said that there are a lot of data yet to emerge from a slew of ongoing studies in various delivery methods and different cell types. “It is essential to continue with the clinical testing in parallel with the basic science testing. That's where we'll get the greatest bang for the buck,” he said.

Some researchers complained that trials are continuing with little basic knowledge about the various cells and with little characterization of what cells are actually being used. In many studies, the injections are a heterogeneous mix, not a homogeneous, pure therapy.

Dr. Martin Friedlander, a professor in the department of cell biology at the Scripps Research Institute in San Diego, was “flabbergasted” that thousands of patients had been enrolled in studies with “no clear rationale” and a lack of clarity on what cell types were being used. He suggested that scientists take a step back and determine more about the cells and their microenvironments, as well as further define the therapeutic goals.

Dr. Valentin Fuster, director of Mount Sinai Heart, New York, urged his colleagues to do more thinking. He said he would put more resources first into basic understanding, then into large animal studies, and finally into human trials.

But for Dr. Ellis, human trials are a public health imperative. “Whether it's a stem cell therapy or not, I think our patients deserve a trial to define whether or not there's benefit,” he said

Dr. Ellis disclosed that he had consulting arrangements with multiple companies, including Abbott Laboratories. No other researcher reported conflicts.

BETHESDA — It may be time for a retrenching in basic science when it comes to the use of stem cells to treat heart disease, prominent researchers said at a National Heart, Lung, and Blood Institute–sponsored symposium.

Dr. Stephen G. Ellis, section head of invasive/interventional cardiology at the Cleveland Clinic Lerner College of Medicine, reviewed a series of human trials in acute myocardial infarction and congestive heart failure. “The initial results are somewhat mixed, but they are promising,” Dr. Ellis said. The stem cells—technically, bone marrow–derived mononuclear cells—that were used in the studies have shown some utility in acute MI, but not as much in heart failure, Dr. Ellis said at the Symposium on Cardiovascular Regenerative Medicine.

In the acute MI trials, patients who improved most had left ventricular ejection fractions below the median at baseline, he said. And the improvement may even be sustainable over 5 years, Dr. Ellis said. There was a consistent reduction in the clinical end points of death, reinfarction, and heart failure in patients who had the bone marrow–derived cells injected into the myocardium. A meta-analysis of the published data showed an aggregate ejection fraction benefit of about 3.5%, compared with placebo.

The method of cell isolation and the timing of injections may influence results. Ongoing studies are comparing delivery times: several days post infarction versus several weeks, he said.

The unknowns are even greater when it comes to using the cells to treat heart failure, he said. First, the homing signal is weak at best, leaving little likelihood that the stem cells will reach the target cells. Even with acute MI, homing signals are present only for a week or two. Results of studies so far show that improvement in perfusion may be possible, but little is known about the best possible target population, the best cells to use, the optimum delivery method, possible side effects, and whether concomitant improvement in left ventricular function is possible, Dr. Ellis said.

Even so, “rather than calling a halt to clinical trials, we need to learn from one another.” Researchers should use animal models and basic models to come up with initial therapeutic impressions, and then move on to human phase I and II studies. But there should be careful reflection on those results and refinement of that knowledge before there is a move toward large-scale trials, he said.

Dr. Joshua M. Hare, director of the Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine, said that there are a lot of data yet to emerge from a slew of ongoing studies in various delivery methods and different cell types. “It is essential to continue with the clinical testing in parallel with the basic science testing. That's where we'll get the greatest bang for the buck,” he said.

Some researchers complained that trials are continuing with little basic knowledge about the various cells and with little characterization of what cells are actually being used. In many studies, the injections are a heterogeneous mix, not a homogeneous, pure therapy.

Dr. Martin Friedlander, a professor in the department of cell biology at the Scripps Research Institute in San Diego, was “flabbergasted” that thousands of patients had been enrolled in studies with “no clear rationale” and a lack of clarity on what cell types were being used. He suggested that scientists take a step back and determine more about the cells and their microenvironments, as well as further define the therapeutic goals.

Dr. Valentin Fuster, director of Mount Sinai Heart, New York, urged his colleagues to do more thinking. He said he would put more resources first into basic understanding, then into large animal studies, and finally into human trials.

But for Dr. Ellis, human trials are a public health imperative. “Whether it's a stem cell therapy or not, I think our patients deserve a trial to define whether or not there's benefit,” he said

Dr. Ellis disclosed that he had consulting arrangements with multiple companies, including Abbott Laboratories. No other researcher reported conflicts.

BETHESDA — It may be time for a retrenching in basic science when it comes to the use of stem cells to treat heart disease, prominent researchers said at a National Heart, Lung, and Blood Institute–sponsored symposium.

Dr. Stephen G. Ellis, section head of invasive/interventional cardiology at the Cleveland Clinic Lerner College of Medicine, reviewed a series of human trials in acute myocardial infarction and congestive heart failure. “The initial results are somewhat mixed, but they are promising,” Dr. Ellis said. The stem cells—technically, bone marrow–derived mononuclear cells—that were used in the studies have shown some utility in acute MI, but not as much in heart failure, Dr. Ellis said at the Symposium on Cardiovascular Regenerative Medicine.

In the acute MI trials, patients who improved most had left ventricular ejection fractions below the median at baseline, he said. And the improvement may even be sustainable over 5 years, Dr. Ellis said. There was a consistent reduction in the clinical end points of death, reinfarction, and heart failure in patients who had the bone marrow–derived cells injected into the myocardium. A meta-analysis of the published data showed an aggregate ejection fraction benefit of about 3.5%, compared with placebo.

The method of cell isolation and the timing of injections may influence results. Ongoing studies are comparing delivery times: several days post infarction versus several weeks, he said.

The unknowns are even greater when it comes to using the cells to treat heart failure, he said. First, the homing signal is weak at best, leaving little likelihood that the stem cells will reach the target cells. Even with acute MI, homing signals are present only for a week or two. Results of studies so far show that improvement in perfusion may be possible, but little is known about the best possible target population, the best cells to use, the optimum delivery method, possible side effects, and whether concomitant improvement in left ventricular function is possible, Dr. Ellis said.

Even so, “rather than calling a halt to clinical trials, we need to learn from one another.” Researchers should use animal models and basic models to come up with initial therapeutic impressions, and then move on to human phase I and II studies. But there should be careful reflection on those results and refinement of that knowledge before there is a move toward large-scale trials, he said.

Dr. Joshua M. Hare, director of the Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine, said that there are a lot of data yet to emerge from a slew of ongoing studies in various delivery methods and different cell types. “It is essential to continue with the clinical testing in parallel with the basic science testing. That's where we'll get the greatest bang for the buck,” he said.

Some researchers complained that trials are continuing with little basic knowledge about the various cells and with little characterization of what cells are actually being used. In many studies, the injections are a heterogeneous mix, not a homogeneous, pure therapy.

Dr. Martin Friedlander, a professor in the department of cell biology at the Scripps Research Institute in San Diego, was “flabbergasted” that thousands of patients had been enrolled in studies with “no clear rationale” and a lack of clarity on what cell types were being used. He suggested that scientists take a step back and determine more about the cells and their microenvironments, as well as further define the therapeutic goals.

Dr. Valentin Fuster, director of Mount Sinai Heart, New York, urged his colleagues to do more thinking. He said he would put more resources first into basic understanding, then into large animal studies, and finally into human trials.

But for Dr. Ellis, human trials are a public health imperative. “Whether it's a stem cell therapy or not, I think our patients deserve a trial to define whether or not there's benefit,” he said

Dr. Ellis disclosed that he had consulting arrangements with multiple companies, including Abbott Laboratories. No other researcher reported conflicts.