Monday, January 26, 2015

APPROVED BY FDA



    Announcement of FDA approval of a new drug by a pharmaceutical firm, invites, as a minimum, a revealing of the conditions under which approval was gained. Presumably, there was full disclosure of all development  and testing results, the benefits of the drugs for treating specific ailments, and the side effects of the drugs resulting from  the testing phase on the public. Approval is assumed to be accompanied with caveats, otherwise, why would the advertising that ensues, first describe benefits, and then follow with a litany of possible negative or side effects, including such calamatous events  as onset of blindness, loss of hearing, kidney failure, heart failure, dizziness and  could even be fatal?
    The mindset that leads  to approval must be centered  on concluding that the benefits of the drug far outweigh its shortcomings, so the latter can be considered acceptable noise level nuisance. For the unfortunate individual who is afflicted by the side effect, however, it is certainly not noise level.
         The machinations at play are more likely based on potential for profit as opposed to doing what is best for the patient. There are many cases, but one that is recent and is pertinent to personal experience is the Bristol Myers Corp. activity in producing blood thinners. The first was warfarin, which costs only a few cents a day. It requires periodic monitoring at the doctors office for efficacy. This was followed by Plavix, which costs a lot more, and has numerous side effects, and in my case caused a permanent numbness down the left side of the body, which Bristol Myers chooses to ignore, but does warn as a possible side effect. The company then  went after its own product, warfarin, bad-mouthing it while promoting a new pill, Equilis, which does the same thing as Plavix, has similar side effects, and costs up to eighteen dollars a day. It is hard to see all this as anything but manipulation in order to gain more profit.
    All of which begs the question: How could thiings be improved? One way would be to follow up FDA approval with another level of approval within the medical community. A panel of physicians with no ties to the pharmaceutical industry would review the product and recommend whether it should be used in light of their previous experience in the profession. However, it might be futile, if, as commonly suspected, physicians enjoy a little income from the pharmaceutical industry in exchange for their promotion of a drug.

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