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20+ years investing in the stock market across many market sectors. Multiple advanced degrees.
  • FDA kills patients & drives up health care costs 2 comments
    Jul 16, 2010 2:30 PM | about stocks: VVUS
    The FDA kills patients. How many people will die because the FDA won't approve critical drugs for patients in need? How many times will the FDA vote "no" just to protect their own self interests at patients expense? If a drug saves 99 patients from dying, but kills 1, the FDA will not approve the drug because there was a problem and the drug wasn't completely safe.

    Take for instance the most recent FDA panel vote about VVUS's Qnexa drug. The FDA helped design the SPA parameters, and approved the 1-year trials, but the panel then turned right around and declared that a 1-year study wasn't long enough (considering many patients may be on the drug for much longer). So, despite the fact that the 2 components of Qnexa have been on the market for a long time and have been well studied, the FDA panel voted no. One panel member was so inept he accidentally voted yes and then changed his vote to no. I guess they really are that stupid on these FDA panels.

    Additional side effects of Qnexa include reduced blood pressure, reduced need for diabetes medication, and other beneficial residual results. The FDA had already stated that Qnexa would have to have a warning label for pregnant women, but the panel didn't think the FDA's warning would be enough (so the FDA panel didn't agree with the FDA's specified warning).

    So how many obese patients will now be deprived of critical (life saving?) weight loss because the panel is concerned about the possibility (not the actuality, just the possibility) of birth defects. So instead of just recommending that pregnant women go off the drug (as an ultra-safe precaution) the FDA will block access for ALL PATIENTS to the most effective weight-loss drug in more than a decade.

    The laundry list of disapproved drugs is far too long. Just as bad, the FDA sometimes comes out with the dreaded "approvable" letter stating that the company could get their drug approved if they just do more (fill in the blank here; more clinical trials; more safety data; more whatever).

    The FDA drives up health care costs. The FDA forces up medication costs by not approving drugs and forcing the recapture of these costs through fewer and fewer approved drugs. The pharmaceutical companies are forced to amortize their investments over fewer approved drugs, forcing the cost up substantially for each treatment.

    The politicians always point to the insurance companies, hospitals, even sometimes doctors - for the cost of health care - but never the government itself. Just another case of the government blaming everybody else for the problem that they are creating.

    It should be a simple solution to allow another category of medication, below "Proven safe and effective to the FDA" highest standard, to still allow patients to gain access to drugs that are safe for their situation (as seen by their own physician who knows their personal case history better than any FDA panel member - who can't even vote yes/no correctly). Clearly the FDA is broken and despite a new administration, nothing changes. Drugs continue to get denied, health care costs continue to rise, and patients continue to die.

    Disclosure: long VVUS
    Stocks: VVUS
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Comments (2)
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  • Tony101
    , contributor
    Comments (12) | Send Message
    Sorry you lost money on VVUS.
    17 Jul 2010, 07:06 PM Reply Like
  • Tony101
    , contributor
    Comments (12) | Send Message
    Sorry to know you lost money on VVUS
    17 Jul 2010, 07:06 PM Reply Like
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