Wednesday, May 8, 2013
The Food and Drug Administration, the oldest comprehensive consumer protection agency in the U.S. federal government, is charged with protecting the public health. Under this mandate, it regulates drugs and medical devices for their safety and effectiveness. But is it a failing mandate? It’s long been argued that the FDA’s long and costly approval processes stifle innovation and keep life-changing treatments from the market. But the question remains: when it comes to public health, is it ever okay to sacrifice safety for speed?
For
Dr. Scott Gottlieb
Resident Fellow, American Enterprise Institute
For
Peter Huber
Senior Fellow, Manhattan Institute and Author
Against
Dr, Jerry Avorn
Professor of Medicine, Harvard Medical School
Against
Dr. David Challoner
VP for Health Affairs Emeritus, University of Florida
MODERATOR
John Donvan
Author & Correspondent for ABC News
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Subscribe to the PodcastFor The Motion
Dr. Scott Gottlieb
Resident Fellow, American Enterprise Institute
Scott Gottlieb, M.D., is currently a practicing physician and resident fellow at the American Enterprise Institute. From 2005-2007, Dr. Gottlieb served as FDA Deputy Commissioner and before that, from 2003-2004, as a senior advisor to FDA Commissioner Mark McClellan and as the FDA’s Director of Medical Policy Development. He left the FDA in the spring of 2004 to work on implementation of the new Medicare Drug Benefit as a senior adviser to the administrator of Medicare and Medicaid Services, where he supported the agency's policy work on quality improvement and coverage and payment decision-making, particularly related to new medical technologies. Dr. Gottlieb has held editorial positions on the British Medical Journal and the Journal of the American Medical Association and appears regularly as a guest commentator on the cable financial news channel CNBC.
For The Motion
Peter Huber
Senior Fellow, Manhattan Institute and Author
Peter Huber is a senior fellow at the Manhattan Institute writing on the issues of drug development, energy, technology, and the law. Before joining the Manhattan Institute, Huber served as an assistant and later associate professor at MIT for six years. He clerked on the D.C. Circuit Court of Appeals for Ruth Bader Ginsburg, and then on the U.S. Supreme Court for Sandra Day O'Connor. Huber also is a partner at the Washington, D.C., law firm of Kellogg, Huber, Hansen and Todd. He is the author of The Bottomless Well (2005), co-authored with Mark P. Mills, and the forthcoming book, The Cure in the Code: How 20th Century Law is Undermining 21st Century Medicine. Huber earned his law degree from Harvard University and a doctorate in mechanical engineering from MIT.
Against The Motion
Dr. Jerry Avorn
Professor of Medicine, Harvard Medical School
Jerry Avorn, M.D., is a professor of medicine at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women's Hospital. An internist, geriatrician, and drug epidemiologist, he studies the intended and adverse effects of prescription drugs, physician prescribing practices, and medication policy. Dr. Avorn pioneered the “academic detailing” approach to continuing medical education, in which non-commercial, evidence-based information about drugs is provided to doctors through educational outreach programs run by public-sector sponsors. Such programs are now in use in the U.S., Canada, Australia, and Europe. He has served as a member of the Institute of Medicine Committee on Standards for Developing Trustworthy Clinical Practice Guidelines and is the author or co-author of over 400 papers in the medical literature on medication use and its outcomes, and of the book, Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs (2004), now in its 11th printing.
Against The Motion
Dr. David Challoner
VP for Health Affairs Emeritus, University of Florida
David R. Challoner, M.D., is Vice President Emeritus for Health Affairs of the University of Florida. Dr. Challoner has held leadership and health policy positions in many national organizations, including the Association of American Medical Colleges where he holds Distinguished Service Membership, the American Medical Association where he served as Chairman of the Section on Medical Schools, and the American Federation for Clinical Research which he served as President. From 1988-1990, he was appointed by President Reagan to Chair the President's Committee on the National Medal of Science. He also served as the chairman of the membership committee, as a member of the governing council of the Institute of Medicine, and as a member of the governing board of the National Research Council. He received the 2010 Walsh McDermott Medal of the IOM for Distinguished Service. He Chaired the IOM’s Committee on the Public Health Effectiveness of the FDA 510K Clearance Process (2011).
Declared Winner: For The Motion
Online Voting
Voting Breakdown:
43% voted the same way in BOTH pre- and post-debate votes (19% voted FOR twice, 18% voted AGAINST twice, 6% voted UNDECIDED twice). 57% changed their minds (2% voted FOR then changed to AGAINST, 2% voted FOR then changed to UNDECIDED, 12% voted AGAINST then changed to FOR, 2% voted AGAINST then changed to UNDECIDED, 22% voted UNDECIDED then changed to FOR, 17% voted UNDECIDED then changed to AGAINST) | Breakdown Graphic
Research
Research For The Motion:
- Articles & Publications: Dr. Scott Gottlieb
- Articles & Publications: Peter Huber
Research Against The Motion:
- Articles & Publications: Dr. David Challoner
- Articles & Publications: Dr. Jerry Avorn
About This Event
Event Photos
http://intelligencesquaredus.org/debates/upcoming-debates/item/802-the-fdas-caution-is-hazardous-to-our-health#sigProGalleriafc79700880
16 comments
- Comment Link
Tuesday, 28 May 2013 11:20 posted by Janaki Kuruppu This debate was fascinating, and hit home for me personally, as I am a physician, and I specifically care for people living with HIV/AIDS. I lived through the period of the evolution of the FDA adopting the accelerated approval process, and, in addition, my husband works for the FDA.
The point that was not brought up adequately, IMO, was the fact that our "intuition" about what should happen is not always correct. One of the debaters on the PRO side mentioned using a surrogate marker of reduction of number of cysts in polycystic kidney disease rather than the mortality benefit - there are numerous examples where the surrogate marker that we assume should indicate efficacy is merely a correlate, and not causative of morbidity or mortality. - Comment Link
Sunday, 26 May 2013 22:47 posted by Lauren As a mother of a boy battling a sarcoma - which the treatment hasn't changed since the 1980s - AND a daughter of a very healthy man who took Celebrex and now only has 20% lung function AND the daughter-in-law of a very healthy woman who had mesh and two months ago had a stroke and is now bedridden:
1) I know that if I want a drug for my son that has not passed FDA testing, I can go to Thailand or other countries to get it. However, I know that I have an extra level of confidence in drugs offered in the US because they are tested more thoroughly than they are in other countries.
2) I know that Celebrex and the mesh were "rushed" through, and now we have lost our home paying for all the medical costs of my father, mother-in-law, and son. One is bad enough, but three has taken everything from us, and we are going to lose all three of them, our home, our retirement, and our lives.
No, I want the FDA to be even more diligent than they are now! If I want my son in a clinical trial, I have that choice. I also want the choice to choose a drug that has been TESTED and found to be SAFE! - Comment Link
Thursday, 23 May 2013 15:38 posted by Adam I was hoping the the topic of regulating supplements and alternative medicines would come up in this debate. In that respect, the FDA (under direction from Congress) has no power to regulate these products. Companies are able to market such products without the oversight that drugs require, especially when many have active ingredients with really physiological effects. In that way, the FDA is woefully under-cautious.
- Comment Link
Thursday, 23 May 2013 10:06 posted by Cheryl It is never good to sacrifice safety over speed, especially when it comes to our health.
- Comment Link
Thursday, 16 May 2013 00:55 posted by Nhersh The arguments are too arcane for most. The victors, at least one of whom (Gottlieb), as a financial advisor, have definite conflict of interest, have proven that when it comes to complex scientific issues anecdotal arguments will on average win the day.
- Comment Link
Tuesday, 14 May 2013 17:50 posted by Patrick About time we had a good debater laying out something more in line with my generally libertarian leaning beliefs.
How many pharmaceutical companies are left? Like 2 or 3? Just think about that for a second, and then tell me about how awesome of a job the FDA is doing. Why do you think medicine is so expensive here? To the point where we have to OUTLAW bringing it in from Canada, even though it is drastically cheaper there! - Comment Link
Monday, 13 May 2013 18:23 posted by GVRange Even if the FDA Agency was perfectly balanced, managed and staffed to ensure human hazard prevention, we would still be at risk.
"To label or not to label"
The truth is not scientific criteria could be defined and confirmed without "Statistics, Math or Scientific knowledge". We need subject study, research & clinical trials, efficacy and adverse events.
FDA is too large a domain to actually understand potential risks factors.
DRUGS - Manufacturing, use, interaction, prescript, rejection
MEDICAL DEVICES - Action, delivery, failure modes, selection procedure, etc
NON-REGULTED - Products
ENVIRONMENTAL - EPA
GENETIC - In VITRO or Mom & Dad.............
Then their classification and level of "Regulatory Enforcement"
We are not devices or robots all built equally.
We are not Adam & Eve are we?
Each of us is a complex system affected by internal and external factors and interactivity.
Would the FDA be responsible for all that also? - Comment Link
Saturday, 11 May 2013 12:51 posted by Fernando This is one of those examples in which an idea which looks like a terrific idea on the surface has gone terribly wrong when big business learned how to use the tools that big government put at its disposal.
It reminds, although the analogy is not 100% accurate, what happened with the USPTO.
Just as the USPTO has basically become a source of material for big companies to intimidate each other (or for said companies to intimidate smaller companies), the FDA is now so infiltrated by Big Pharma that it has become, in effect, the representative of Big Pharma in the federal government.
The most outrageous example of this collusion is probably Dan Troy, now Senior Vice President & General Counsel at GSK, the company that made the headlines last year when it agreed to pay billions of dollars in order to settle numerous civil and criminal charges for illegal marketing of drugs. Prior to taking that position, Dan Troy was Chief Counsel for the FDA. So it cannot get more explicit than this. - Comment Link
Saturday, 11 May 2013 07:25 posted by GEDouglas Great debate. A debate on the effectiveness and/or necessity of many federal agencies would be welcomed. Needless to say our federal government has become a behemoth. It is a bureaucracy that has become faceless, often heartless, politicized, unaccountable and at times used as a tool against the citizenry by unethical politicians.
- Comment Link
Thursday, 09 May 2013 22:13 posted by Wanda Why does the FDA exist? Think about it. I found my mother's immunization record for something from 1926. In doing research I discovered that the AMA actually fought immunizations because doctors were afraid of losing patients (no pun intended). Some government entity has to be charged with looking out for patients.
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