No end to FDA disclosure debate
New waiver law fails to quiet criticism over experts' financial ties to drug companies
The financial ties were disclosed under a law passed last November meant to limit industry influence on the FDA's actions. The law doesn't bar doctors, researchers, statisticians, and other experts from participating if they have received drug company money. Instead, the FDA can grant them waivers but makes the experts disclose those financial ties.
Managing conflicts of interest that accompany top scientists is a juggling act the FDA has been doing for years. The new law was supposed to make it better without grinding FDA approvals to a halt. Since the law was passed, the FDA has issued nearly 100 waivers -- and the controversy hasn't faded.
Critics say the new transparency has changed little and scientists who have conflicts of interest can still guide FDA decision making. The FDA counters that public health would suffer if the agency bypassed the nation's best scientists because of funding sources.
''All behavior is guided by both conscious and unconscious motives," said Dr. Karl Kieburtz, the Tysabri advisory committee chairman who is also a consultant to Biogen. ''Consciously, I'm not aware of any swaying of my decision-making based on the fact I did consulting for Biogen Idec within the last year."
A neurology professor at the University of Rochester, Kieburtz voted to return Tysabri to the market. The FDA doesn't have to follow the advice of its panels but usually does. Biogen, based in Cambridge, marketed Tysabri with an Irish partner, Elan Corp. The companies voluntarily pulled Tysabri off the market after the drug was linked to a potentially fatal brain infection.
The panel unanimously agreed in early March to bring Tysabri back and said in a 7 to 5 vote that patients could use it first, rather than after trying older therapies. The FDA is expected to disclose its final decision as early as this spring.
The FDA reports panelists' financial ties in broad categories, such as less than $10,001 per year, and from $10,001 to $50,000 per year. The disclosure on the FDA's website says Kieburtz received $10,001 to $50,000 in the prior 12 months from the drug's sponsor and less than $30,000 per year as a consultant for three Biogen competitors.
In an interview, Kieburtz offered more specific information, saying he received no more than $12,000 from Biogen, and that his consulting does not have to do with MS or Tysabri.
Kieburtz said he gave the payments to the University of Rochester or to charities. Another FDA adviser on Tysabri, Dr. Steven DeKosky, the chairman of the University of Pittsburgh Medical School's department of neurology, agrees with the FDA that federal advisers with no experience running clinical trials -- which by their nature are often funded by drug companies -- could do the public a disservice.
DeKosky said he didn't know he had a conflict until he filled out the FDA's disclosure forms in which he had to list all work he'd done recently for the industry. The FDA advisers report past and present financial ties to drug companies, and future financial interests they are negotiating. On it, DeKosky disclosed he'd received less than $10,001 as an industry sponsored speaker and was paid less than $10,001 by Pfizer Inc. as a visiting professor. Until the FDA issued his waiver, DeKosky said he did not know a rival MS drug is made by a company that has a financial agreement with Pfizer.
''It certainly didn't enter into any of my thinking. I am supposed to have a reputation as a honest, straight-shooting guy," he said.
The Center for Science in the Public Interest, Washington-based consumer advocates, argues advisers should be independent and the FDA shouldn't grant any waivers.
''Period. End of story. Get rid of scientists with conflicts from serving on the FDA advisory panels," said Merrill Goozner, director of the center's Integrity in Science project.
Dozens of times each year, the FDA empanels advisers plucked from academic institutions, government agencies, and industry. The advisers read stacks of documents before meetings and sit through hours of complex scientific presentations and often emotional testimony from patients. The experts cast votes on such questions as whether to strengthen warning labels for antidepressants and attention deficit remedies taken by millions or whether to lift sales restrictions on silicon gel breast implants. Industry representatives on the panels cast nonbinding votes.
The new law was spurred by high-profile hearings last year on a troubled class of painkillers that included Bextra, Celebrex, and Vioxx. The FDA came under congressional fire for permitting federal advisers who had accepted money from makers of those drugs to vote on whether the painkillers should be sold. In response to the new law, the FDA now posts conflict notices for its advisers on its website in advance of meetings.
Andrew von Eschenbach, the FDA's acting commissioner, said during a recent congressional hearing that the FDA's push to attract the best experts leads to senior scientists who receive drug industry sponsorship. Barring those researchers would result in smaller panels with less expertise.
''I do not believe that it is a process where we simply can exclude or ignore anyone who has remotely been associated with any organization or any program that's relevant to the subject matter," von Eschenbach testified. Barring those scientists would ''undermine the ability to have the best minds make the best decisions."
MS, a disease of young adults, disrupts communication between the brain and other parts of the body, resulting in symptoms that can intensify with little warning. Some have difficulty concentrating, remembering or making decisions. Others are rendered unable to speak, write or walk.
Current drugs and experimental therapies aim to reduce the number of exacerbations in hopes of slowing the progression of physical disability. Because Tysabri worked well in curbing flare-ups, some patients clamored for its return.
Other Tysabri advisers reached by The Boston Globe who received FDA waivers said drug industry funding did not influence their votes.
Dr. Lily Jung, the medical director of the neurology clinic at Swedish Neuroscience Institute in Seattle, received $10,001 to $50,000 in the previous 12 months from Biogen and less than $20,000 from two rivals with competing MS drugs as a speakers' bureau member. Jung, the consumer representative on the panel, said she advocates for MS patients, not the companies selling MS drugs that sponsor her talks. ''I don't think it conflicts at all."
Dr. Ralph L. Sacco, a Columbia University neurologist, did not return several calls seeking comment. According to the FDA, Sacco received less than $10,001 in consulting fees in the previous 12 months from a Biogen competitor.
Dr. Larry B. Goldstein, a Duke University neurologist, received $10,001 to $50,000 in the previous 12 months from one Biogen competitor and less than $10,001 per year from another rival for consulting work unrelated to MS. He said drug company funding did not impact his vote ''one way or the other."
http://www.boston.com/business/healthcare/articles/2006/04/21/no_end_to_fda_disclosure_debate/?page=full
WASHINGTON -- When a Food and Drug Administration panel of a dozen experts voted to bring back to market the multiple sclerosis drug Tysabri, five had financial ties to the drug's maker, Biogen Idec Inc., or one of its competitors.
The financial ties were disclosed under a law passed last November meant to limit industry influence on the FDA's actions. The law doesn't bar doctors, researchers, statisticians, and other experts from participating if they have received drug company money. Instead, the FDA can grant them waivers but makes the experts disclose those financial ties.
Managing conflicts of interest that accompany top scientists is a juggling act the FDA has been doing for years. The new law was supposed to make it better without grinding FDA approvals to a halt. Since the law was passed, the FDA has issued nearly 100 waivers -- and the controversy hasn't faded.
Critics say the new transparency has changed little and scientists who have conflicts of interest can still guide FDA decision making. The FDA counters that public health would suffer if the agency bypassed the nation's best scientists because of funding sources.
''All behavior is guided by both conscious and unconscious motives," said Dr. Karl Kieburtz, the Tysabri advisory committee chairman who is also a consultant to Biogen. ''Consciously, I'm not aware of any swaying of my decision-making based on the fact I did consulting for Biogen Idec within the last year."
A neurology professor at the University of Rochester, Kieburtz voted to return Tysabri to the market. The FDA doesn't have to follow the advice of its panels but usually does. Biogen, based in Cambridge, marketed Tysabri with an Irish partner, Elan Corp. The companies voluntarily pulled Tysabri off the market after the drug was linked to a potentially fatal brain infection.
The panel unanimously agreed in early March to bring Tysabri back and said in a 7 to 5 vote that patients could use it first, rather than after trying older therapies. The FDA is expected to disclose its final decision as early as this spring.
The FDA reports panelists' financial ties in broad categories, such as less than $10,001 per year, and from $10,001 to $50,000 per year. The disclosure on the FDA's website says Kieburtz received $10,001 to $50,000 in the prior 12 months from the drug's sponsor and less than $30,000 per year as a consultant for three Biogen competitors.
In an interview, Kieburtz offered more specific information, saying he received no more than $12,000 from Biogen, and that his consulting does not have to do with MS or Tysabri.
Kieburtz said he gave the payments to the University of Rochester or to charities. Another FDA adviser on Tysabri, Dr. Steven DeKosky, the chairman of the University of Pittsburgh Medical School's department of neurology, agrees with the FDA that federal advisers with no experience running clinical trials -- which by their nature are often funded by drug companies -- could do the public a disservice.
DeKosky said he didn't know he had a conflict until he filled out the FDA's disclosure forms in which he had to list all work he'd done recently for the industry. The FDA advisers report past and present financial ties to drug companies, and future financial interests they are negotiating. On it, DeKosky disclosed he'd received less than $10,001 as an industry sponsored speaker and was paid less than $10,001 by Pfizer Inc. as a visiting professor. Until the FDA issued his waiver, DeKosky said he did not know a rival MS drug is made by a company that has a financial agreement with Pfizer.
''It certainly didn't enter into any of my thinking. I am supposed to have a reputation as a honest, straight-shooting guy," he said.
The Center for Science in the Public Interest, Washington-based consumer advocates, argues advisers should be independent and the FDA shouldn't grant any waivers.
''Period. End of story. Get rid of scientists with conflicts from serving on the FDA advisory panels," said Merrill Goozner, director of the center's Integrity in Science project.
Dozens of times each year, the FDA empanels advisers plucked from academic institutions, government agencies, and industry. The advisers read stacks of documents before meetings and sit through hours of complex scientific presentations and often emotional testimony from patients. The experts cast votes on such questions as whether to strengthen warning labels for antidepressants and attention deficit remedies taken by millions or whether to lift sales restrictions on silicon gel breast implants. Industry representatives on the panels cast nonbinding votes.
The new law was spurred by high-profile hearings last year on a troubled class of painkillers that included Bextra, Celebrex, and Vioxx. The FDA came under congressional fire for permitting federal advisers who had accepted money from makers of those drugs to vote on whether the painkillers should be sold. In response to the new law, the FDA now posts conflict notices for its advisers on its website in advance of meetings.
Andrew von Eschenbach, the FDA's acting commissioner, said during a recent congressional hearing that the FDA's push to attract the best experts leads to senior scientists who receive drug industry sponsorship. Barring those researchers would result in smaller panels with less expertise.
''I do not believe that it is a process where we simply can exclude or ignore anyone who has remotely been associated with any organization or any program that's relevant to the subject matter," von Eschenbach testified. Barring those scientists would ''undermine the ability to have the best minds make the best decisions."
MS, a disease of young adults, disrupts communication between the brain and other parts of the body, resulting in symptoms that can intensify with little warning. Some have difficulty concentrating, remembering or making decisions. Others are rendered unable to speak, write or walk.
Current drugs and experimental therapies aim to reduce the number of exacerbations in hopes of slowing the progression of physical disability. Because Tysabri worked well in curbing flare-ups, some patients clamored for its return.
Other Tysabri advisers reached by The Boston Globe who received FDA waivers said drug industry funding did not influence their votes.
Dr. Lily Jung, the medical director of the neurology clinic at Swedish Neuroscience Institute in Seattle, received $10,001 to $50,000 in the previous 12 months from Biogen and less than $20,000 from two rivals with competing MS drugs as a speakers' bureau member. Jung, the consumer representative on the panel, said she advocates for MS patients, not the companies selling MS drugs that sponsor her talks. ''I don't think it conflicts at all."
Dr. Ralph L. Sacco, a Columbia University neurologist, did not return several calls seeking comment. According to the FDA, Sacco received less than $10,001 in consulting fees in the previous 12 months from a Biogen competitor.
Dr. Larry B. Goldstein, a Duke University neurologist, received $10,001 to $50,000 in the previous 12 months from one Biogen competitor and less than $10,001 per year from another rival for consulting work unrelated to MS. He said drug company funding did not impact his vote ''one way or the other."
Diedtra Henderson can be reached at dhenderson@globe.com. 
http://www.boston.com/business/healthcare/articles/2006/04/21/no_end_to_fda_disclosure_debate/?page=full
posted by Bill at 1:04 AM
1 Comments:
Appreciate your blog,mental health consumers are the least capable of self advocacy,my doctors made me take zyprexa for 4 years which was ineffective for my symptoms.I now have a victims support page against Eli Lilly for it's Zyprexa product causing my diabetes.--Daniel Haszard www.zyprexa-victims.com
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