The FDA'S Caution Is Hazardous To Our Health

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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?

  • Gotlieb90


    Dr. Scott Gottlieb

    Resident Fellow, American Enterprise Institute

  • huber90x90


    Peter Huber

    Senior Fellow, Manhattan Institute and Author

  • Avorn Jerry90x90


    Dr, Jerry Avorn

    Professor of Medicine, Harvard Medical School

  • david-challoner90x90


    Dr. David Challoner

    VP for Health Affairs Emeritus, University of Florida

    • Moderator Image


      John Donvan

      Author & Correspondent for ABC News

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For 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.

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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.

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Avorn Jerry90x90

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.  

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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).

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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

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    • Comment Link Sudip Tuesday, 19 November 2013 09:09 posted by Sudip

      The food safety is an exemtrely important to all of us. The food manufacturers in US are regulated and inspected by FDA USDA Agencies. However, 23 percent of our food we consume is originally imported from China and only 3 percent of these foods were inspected by FDA. The question is- Are all of the imported food products safe?- Are they produced under food safety guidelines?Recently, there were a lot of scandal about safety of chinese food products such as melamin in milk, lead, pesticides, and illegal antibiotic in seafoods, etc. All of us need to do something about this.

    • Comment Link Keith K. Tuesday, 29 October 2013 11:01 posted by Keith K.

      So for all the commenting done, I am very surprised that the entire crux of the debate seems to be an all or nothing proposition. Either the FDA as it currently exists is good or it needs to be removed in its entirety.

      Could we not simply repeal the worst aspects of the FDA and allow replace them with better aspects? For example, why does the FDA have to approve the drugs themselves? Why can they not, for example, certify private laboratories to do this work? Or, we could return to the pre-1960s requirements of safety AND efficacy testing and simply make the FDA a certifier of safety. For that matter, why is FDA approval required before a product can be sold? Instead of a mandatory product approval, why not move it to a voluntary certification standard?

      The whole premise of how the FDA currently works is that people are too stupid choose, and healthcare providers are too untrustworthy to sell, treatment methods which are safe and effective. If the FDA really wanted to provide a useful service to the public, it would be to do nothing except conduct experiments on treatments and find what works and what doesn't and do so independently of drug companies/device manufacturers. FDA approval doesn't really mean anything now because every product has to get it. I mean how can it be a genuinely good guarantee of safety if every single company will do everything in its power to acquire approval? All it means is that companies will do everything in their power to just barely measure up to FDA requirements, instead of figuring out what the best requirements really are for their product.

      I mean from a scientific perspective there is no question the FDA as it currently exists does more harm than good. Almost every econometric study on the effects of FDA regulation has found that more people die/are harmed from the withholding (and indeed the non-starting) of drugs and treatments than are saved from the removal of shoddy products from the marketplace. The data is clear here: the FDA is a hazard to people's health.

    • Comment Link Mark Monday, 30 September 2013 01:17 posted by Mark

      I think the moderator does the entire forum a disservice by imposing his own internal dialogue onto everyone else. A debate can take on a life of its own with unexpected insights and twists and turns - but this dynamic aspect of idea sharing/amalgamation can be hindered - if not destroyed altogether - by an "alpha" type moderator.

    • Comment Link steve fredman Saturday, 07 September 2013 10:28 posted by steve fredman

      The problem not discussed is how money and politics make it difficult to get a dangerous drug or device off the market. Prior to approval of two glitazones in 1999, the FDA knew that one of them, Avandia, raised the level of cholesterol in the blood and the other didn’t. (People with diabetes have an increased risk of heart attacks.) When subsequent studies showed that Avandia was as bad as feared, the drug was grossing $500 million a year and the panels of doctors the FDA voted to keep the drug on the market and add a black box warning.
      In July 2010 the manufacturer of Avandia settled a lawsuit for the harm the medication did for $460 million. Compared to revenue of $1.1 billion dollars the prior year and much more in the years before the 2007 hearings, the monies paid out did relatively little harm to the company’s bottom line.
      In 2005 Johnson and Johnson argued their metal on metal hip should be approved without clinical testing because the new product was “substantially equivalent” to the earlier hip, which was all that was needed under the 510 rule. It turned out that when the ball and cup are both made of metal, ions can enter the blood stream and tiny fragments can break off. That’s why a DuPuy metal-on-metal joint was recalled in Australia in 08. The FDA took a while to examine the data, the company stalled, and by the time the agency took action (August 2010) 93,000 Americans already had the dangerous joints in their bodies.

    • Comment Link PABoley Saturday, 07 September 2013 10:10 posted by PABoley

      I don't know the backgrounds of your audience members but I find it SCARY that they are wiling to sacrifice safety to get their hands on drugs faster. I also think it is a conflict that FDA salaries are coming from the drug companies and that the leaders in the FDA don't feel a greater responsibility to the public but rather a duty to make things easier for drug companies. Isn't it bad enough that they are price gouging this country for thir drugs!

    • Comment Link BrettG Saturday, 27 July 2013 14:22 posted by BrettG

      As someone who worked in a hospital & prepared M&M/QA notes - as support staff, I find the FDA not cautious enough. Since they only approve data submitted by Big Pharma & the study stats are often cherry-picked or hidden I tell my friends & fellow sufferers of shingles/PHN to be cautious of all meds as only when they are widely prescribed are they being "tested" in a real-world patient population.

      Since growing numbers of our patient population are on chronic meds, the side effects of the drug combinations only become evident in the open patient population.

      Since the FDA isn't funded to run effectiveness trials of new drugs vs. old drugs (e.g., combo cholesterol/hypertension drugs vs. HCTZ, aspirin & blockers) as the UK & Australia do & as the Commonwealth of PA has done, the approval of the FDA of any drug, device, etc. should be taken with a salt mine of caution.


    • Comment Link Janaki Kuruppu 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 Lauren 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 Adam 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 Cheryl 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 Nhersh 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 Patrick 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 GVRange 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
      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 Fernando 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 GEDouglas 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 Wanda 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.

    • Comment Link Kevin Wednesday, 08 May 2013 20:47 posted by Kevin

      Government regulations are one of the best ways to create jobs. Recall, we don't have an economic crisis; corporate profits and productivity are at record highs; the DOW hit 15000.


      All the wealth is concentrated at the top. Anything that forces corporate owners to hire is a good thing. Regulations create middle class jobs. In government and in industry.

      Remember, a perfectly efficient corporation would have zero employees and one owner. A social and economic disaster.

    • Comment Link hilary Wednesday, 08 May 2013 20:31 posted by hilary

      Haste makes waste. FDA doing good job. H.

      At end of debate I have changed my mind and am undecided as I feel the FDA has to become more relevant to be current in its form of testing.

    • Comment Link hilary Wednesday, 08 May 2013 19:59 posted by hilary

      Haste makes waste FDA doing good job. H.

    • Comment Link Brian Wednesday, 24 April 2013 12:52 posted by Brian

      Caution, outside regulations, and multiple levels of oversight is the key to protecting public health and safety. This how the FDA is effective. Rushing new products to market will end up with a return to hokum medicine of the 19th century and before. Include that with the power of modern marketing techniques and you will end up will an out of control medical system, as can be seen in the anti-vaccine/homeopathic groups.

      Is the system perfect? No. Is it better than a private regulatory agency? Yes, we can look at the effectiveness of other private ratings agencies and with the exception of the Underwriters Laboratories, they have been failures.

      The next question should be whether people can choose to not abide by FDA regulations and use experimental drugs? This requires a much more complicated answer due to the fact that we are irrational beings without free will. Outside influences are more powerful than we acknowledge and can muddle our decisions.

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