In keeping with the previous post on the woes of the underfunded FDA, the New England Journal (which no doubt takes their cues from this blog) ran two commentaries on the FDA's ability to guarantee the safety of the U.S. prescription drug supply in its April 24 issue. Mostly this was going over well-known ground, but I was struck by the suggestion made by Dr. Alastair J.J. Wood of Cornell. (It's my understanding that Dr. Wood was widely thought, in the past, to be the most logical person with the greatest relevant expertise to become the Commissioner of the FDA, and was not given that job because he was insufficiently pro-business. If true, that's a deficiency that Dr. Wood appears now to be eager to remedy, as NEJM states that he's "managing director of Symphony Capital" and also has received lecture fees from PhRMA.)
However, in comments that I doubt were paid for by the drug industry, Dr. Wood offers a counterpoint to the general clamor for FDA accountability for allowing poisonous chemicals to enter the U.S. drug supply via China. He offers the refreshing proposal that the drug companies should instead be held responsible for this and the FDA should basically admit that it has no control over these matters. After all, Dr. Wood reminds us, why are these shady Chinese companies in the loop at all? It was the American or global drug companies' own business plans that led them to decide that they could make a fast buck by outsourcing their chemical supply sources. Since they presumably made extra profits by buying cheaper ingredients for their drugs, they can reinvest some of those earnings in taking whatever steps are needed to assure quality and safety of the drugs that they peddle--or else be held fully accountable for foisting poisons on the American public.
As explained in HOOKED, this shows the ambivalent relationship that is set up by the phenomenon of "regulatory capture" of a Federal agency by the industry it is supposed to regulate. The drug companies are walking a very fine line. They want the FDA to be rendered sufficiently toothless as to be unable to take any actions that cause any inconvenience or lowered profits for them. But at the same time they want the FDA to appear powerful and threatening enough so that they can turn around and blame the FDA oversight process whenever a scandal arises like tainted Chinese-made heparin. Ditto for the present efforts of the industry to support FDA rules changes that would allow companies to market drugs off-label by circulating reprints from medical journals (based on the assumption that the FDA stringently regulates this process so that no false information could ever get through), and to convince the U.S. Supreme Court that they should be shielded from any legal liability in relation to any drug that has been FDA approved (again assuming that the FDA approval process is so stringent that the public needs no additional safeguards).
Wood AJJ. Playing "kick the FDA"--risk-free to players but hazardous to public health. N Engl J Med 358:1774-75, April 24, 2008.
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The Food and Drug Administration originated in its primitive form at the time several decades ago to ensure the health and safety of the citizens of the United States. However, their focus seems to have changed, as they appear to have formed a pathological alliance with the pharmaceutical industry through the money the industry gives the FDA for various reasons, yet so large amounts of funds are issued to the FDA by the industry that it has resulted in possibly half of the FDA’s annual income. Results of this relationship, one could posit, have been the approval of unsafe drugs and lack of regulation and monitoring of the pharmaceutical industry that the FDA is obligated to perform, and have failed to do so as much as they should for our benefit.
And the intimacy between the two organizations seems to continue to progress, as illustrated with the new proposal by the FDA to allow the pharmaceutical industry reps to discuss their products with prescribers off-label, which means that the FDA may allow and accept the industry possibly creating harm to patients with this proposal due to uncertainty associated with unapproved uses of a drug promoted in this way.
A prescriber, upon their own discretion, can in fact prescribe a drug off-label, but historically, however, representatives from the pharmaceutical industry have been prohibited from suggesting this type of activity. In fact, it is a federal offense for such reps to speak off-label about the drugs they promote, and some have been penalized for this behavior in the past in the form of monetary settlements with the Department of Justice.
This FDA protocol that is being considered, called, “Good Reprint Practices”, would require reps to use what does not truly exist, which is truthful and authentic clinical trials when they do speak off-label to prescribers. This in itself lacks etiology for such discussions by reps, as most clinical trials are flawed due to the trials being possibly manufactured by the pharmaceutical companies of the meds involved in such trials. Additional trial deception involves ghostwriting and invalid authors of such trials. These facts can be validated and have been discovered by others.
Furthermore, this proposal is flawed in that most pharmaceutical reps lack clinical training and the ability to analyze data regarding this issue accurately is unlikely, for the most part, I surmise. This complicates the idea of this off-label concept due to the ignorance of the reps of the complexities of these once reliable and dependable methods of proof. In addition, the relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for reps to manipulate statements to prescribers for their own benefit in regards to their promoted meds. So, our previous safety association, the FDA, appears to be evolving into our harmful association by suggesting such practices with deliberate intent and reckless disregard for public health, so it seems. It’s unbelievable this proposal ever came into existence, with the delusional fallacy that it would be of benefit to patient health, most likely. Furthermore, this may complicate existing patient medication errors, such as in the elderly or dosing for children, complicated by the fact that many are unable to understand label instructions on their med. So there are enough problems with prescribing, and adding this FDA proposal would just make the situation worse.
However, there is freedom of speech. Perhaps another alternative would be to have clinically trained people discuss such issues with prescribers, instead of the reps, who, unlike those academically enriched, have the objective of increasing the market share of their promoted meds. Regardless, awareness needs to happen by the citizens involving tactics that are possibly deceptive such as this and many more activities by the pharmaceutical industry that are overall covert and tacit. As citizens, we have the right to insist of the pharmaceutical company to maintain focus on the interest of others besides themselves.
“As far as we can discern, the sole purpose of existence is to kindle a light in the darkness of being.”
---- Carl Jung
Dan Abshear
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