Ward - drXeNo

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    • Mannkind Slammed: No Guarantees in Drug Safety [view article]
      Hello Derek,

      The topic of drug safety and the function of the FDA have been two prominent topics with my friends and I over the last few months...yes, this is what we chat about on a Friday night over some glasses of wine!

      We agree that while the FDA is not necessarily to be lauded for all of their past efforts, they are significantly ham stringed in their efforts to monitor drug safety for the general public.

      While I don't have a full solution worked out as of yet, I can provide some critique of the current system. The single biggest issue for the FDA is that they have no incentive for approving a drug.

      Now don't get me wrong, as someone who spends their day life in the biotech industry, it infuriates me when I read about how big Pharma and biotech are only out to stiff sick patients who don't know any better...I sympathize with the FDA's plight despite the perception that all drug companies resent their administration.

      Obviously, the staff at the FDA want to help patients...as do we in the drug industry, in fact it's an obsessive force...that is why we are able to sometimes work for 24+ hours straight to get that piece of data that can change a patient's life months or years down the road. What I'm trying to emphasize in this era started by Vioxx, is that the FDA has no other public incentive to approve a drug that can save lives or significantly improve the quality of life for a patient.

      If a drug is rejected, the drug company gets hammered and all of the press is usually focused on their stock price. If a drug is approved, the lead scientists and PI's are lauded for their acute scientific acumen and the FDA is ignored. If a drug is approved and ends up being a huge public health disaster, the drug company is hammered (the stock price is mentioned) and the FDA is crucified for ever even considering that the drug could be of any use to the public. Thus, the FDA is then pushed to either condemn a drug or be neutral and ask for more data rather than risk an approval, which as you very eloquently point out above, is never a guarantee of safety no matter how long you study the drug or examine its data.

      As I mentioned before, I'm still working on a suggested solution (I resent people who complain, yet do not provide any analysis to back up their complaints or new solutions), but I did want to add to your very perceptive discussion of drug safety.

      Thank you for your article!       Apr 11 02:31 AM
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