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Just How Broken is the FDA?

There has been comment of late about the FDA’s refusal — under the guise of protecting trade secrets — to notify practitioners and consumers about defective medical devices. But that controversy pales in comparison with the scandal now swirling around Menaflex, a device intended to fix a torn meniscus. It is manufactured by the company ReGen Biologics, of Hackensack, N.J.
shhIn December 2008, the FDA approved Menaflex over repeated objections from its own scientists and managers. In 2009, after the Wall Street Journal reported that outside pressure had been applied during the approval process, incoming FDA Deputy Commissioner Josh Sharfstein initiated an investigation. Outside orthopedic experts would meet on March 23, 2010. This provoked claims that for the FDA to rescind approval of a device exceeded the limits of the agency’s authority. According to Jeffrey Gibbs, a long-term industry lobbyist: “Congress has laid out reasons the FDA can revoke an approval, and none of them includes ‘We goofed.’ “ However, a September 2009 report critical of the FDA states that the agency bowed to congressional pressure and to lobbying by ReGen.
Another case of lobbyists running amok concerns the patent-extension of the blood thinner Angiomax. In 2009, the manufacturer, The Medicines Company, which missed a deadline to file for a five-year extension, spent $4.4 million in 2009 lobbying activities, including hiring former House majority leaders Richard Gephardt, D-Mo., and Dick Armey, R-Texas. According to the New York Times, this “illustrates the lengths to which drug companies will go to preserve the precious patents that separate name-brand moneymakers from generic also-rans”.

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8 thoughts on “Just How Broken is the FDA?

  • Ruth

    I am not surprised. I have refused lipitor, now a perfect cholesterol read, Viox and Celebrex, no need to comment there, I did take an antibiotic with steroid injection, two days due to side effects stopped immediately. That antibiotic is no longer available by my MD. I receive no vaccines as my niece became completely paralyzed @ 17 yrs,by a flu vaccine. Other children in the hospital came in with GBS at the same time. No mystery there.
    Eat well, not cheap! Nutritious food! Raised as nature intended, sustainably.
    Sleep well, un-drugged!
    Exercise, get off the drugs!
    Expand your education. Choose peace. Choose wisdom.

  • ObserverOnTheHill

    If the health care bill was concerned about health they would have mandated a few different things, such as requiring better info be provided to patients. I am on metformin ( Glucophage ) for type 2 diabetes and it was only through my own research that I discovered how it can greatly decreased my CoQ10 levels. Gee, maybe the guy w/ 8 years of school may have told me that ? When I asked him about this, he looked at me like I had 2 heads and a tinfoil hat ! Which WAS odd because I left my tinfoil hat home that day. I ask you, who are the real quacks ?

  • Joseph C Moore Cpo USN Ret

    I recently had surgery in which a blood thinner is a part of the recovery period. I understand the need to prevent serious or fatal blood clots, but wonder why a rodenticide is the favored means. I went home several days after the operation and privately refused to continue the rodenticide regimen. In stead I took daily doses of fish oil and several other known naturals known for preventing platelet clumping. The FDA with their lobby money from the drug companies does not condone what I did, insisting that “only a drug can treat or cure” obviating the fact that more natural remedies are available to the informed consumer (patient).

  • Andrew Jacobson

    Any agency that cannot put the wellfare of people ahead of the wellfare of the law is missing the fundamental reason for their being. It is clear that the decision makers in the FDA have lost sight of their intended purpose to protect the public.

  • Albert Stawasz

    The FDA is not concerned with people anymore. all they are concerned is with making lots of money for the corporations that they were originally suposed to protect the American People from inflicting unnecessary harm. Well they are now inflicting this harm and the FDA should be totally overhauled or abolished as it is and rebuilt from the ground up with people who have no ties to these large corporations that the FDA is suposed to regulate.

    • Lois Fehr

      I totally agree with all of the above comments. It just seems to me like it’s an impossible job to change the ”status quo” of the FDA regarding Big Pharma.

  • Steve Sollars

    The FDA police does very little monitoring of drug company airwave and print media ads. The only reason they have been given “special interest powers” over food & supplement information is to”protect the Litter” for the “den in control” over what defines health care benefits. Their way or no way! This enforced monopoly antitrust way of protecting their Litter (ie.drug companies) is why health care costs have been in overdrive for a long time. If a major drug company could patent the candy M&M’s, they would market them for $100 plus! This is an example of what has been going on in driving up health care costs; profiteering off controlled health care monopolized by the Den in Control.
    If the FDA had their way about it and if they were in existence back then, they would have banned the “limes” the early explorers consumed on their voyages to the new worlds. We all now know the key nutrient in limes was the cure (Vitamin C) in preventing scurvy. This is the “real” behind natural science. Limes are a fruit that solved a legitimate health care claim of the times. This simple scientific knowledge saved thousands of lives. But, don’t forget, it took many, many years before it was fully accepted by the established medical powers to be. It also took a long time to recognize the simple technique now fully accepted of washing your hands prior to surgery to aid in the prevention of post-operative infections.
    Another scientific truth of today is how beef is transformed from the farm to the table is shocking. Beef that is consumed today is mainly processed in feed lots where cattle are grain fed rather than grass fed. The “real” scientific knowledge is that this beef is deficient in the vital nutrient called conjugated linoleic acid (CLA). A deficiency of CLA increases cancer risks, causes obesity and the lack of the ability to burn off excess fat in the diet over time. No wonder they say fast foods are not good for you. This is the scientific knowledge missing for the public to understand much like the limes and Vitamin C in preventing scurvy. Does the fast food industry want this to be shared? I think not.
    Natural health approaches based on diet, dietary supplements, and lifestyle are too numerous to mention that already enjoy wide publication in trade journals. Special interests will continue to put up their smoke screens for opposition to the potential health benefits of foods and supplements. The scientific community knows what makes the body chemistry work. “You got Milk.” “Let’s get Legal” for food and supplement manufacturers to share this information we all know is true. Let the smoke clear and let’s allow the sharing of this scientific information with society. Big Pharma can say just about anything they want to promote their goods. If a few here and there die, they just pay up and repeat and hide under the guise of the FDA rules and regulations!

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