Pure Pedantry

More on FDA risk aversion

Ronald Bailey at Reason has an article about the costs of the FDA black box warning on antidepressants:

Excessive caution is risky, too. Back in 1992, Congress, worried about the slow rate of approvals, passed legislation imposing FDA user fees on pharmaceutical companies. Flush with these new funds the agency hired 1000 additional drug reviewers and slashed new drug review time from 30 months to 15 months. Now critics claim that the FDA is in the thrall of drug companies and is endangering the public’s health by rushing dangerous new drugs onto the market. As evidence they cite the dangerous side effects of the painkiller Vioxx, the antipsychotic Zyprexa and more recently the diabetes drug Avandia. Sen. Chuck Grassley (R-Iowa) in a letter to the agency in September, 2006, declared, “Under the current FDA review system, patient safety takes a back seat to the fast approval of products.” Critics like Grassley believe that the FDA should err on the side of caution.

And in fact, recent criticism appears to have made FDA regulators more timid. According to a 2005 JAMA report, “It does seem indisputable that there have been shifts in the acceptable threshold for risk/benefit for many diseases as the depth of scientific understanding increases and as information about the effects of drugs on large patient populations is more readily available.” One disturbing consequence of this shift in the risk/benefit threshold is that for drugs approved in the first half of 2005, the average time from application to approval was 29 months. This is up from an average of 16 months for drugs approved in the first half of 2004. Why the slowdown? Because, as Harvard Business School professor Regina Herzlinger explains in her May 2006 article Why Innovation in Health Care is So Hard (not online): “Officials know they will be punished by the public and politicians more for underregulating — approving a harmful drug, say — than for tightening the approval process, even if so doing delays a useful innovation.”

But if slower regulatory approvals are the price we need to pay for safer drugs, surely that’s a good tradeoff. Not really. A fascinating 2005 study by University of Chicago economists calculated that the speed up in FDA drug approvals that occurred after 1992 may have been responsible for saving the equivalent of 180,000 to 310,000 life-years. On the other hand, the economists estimated that at worst, about 56,000 life-years were lost to drugs that were eventually withdrawn for safety reasons. Unfortunately, it’s much easier to identify people who are harmed by drugs than those who are saved by drugs. In the face of this information asymmetry regulators focus on reducing lives lost to unsafe drugs rather than preventing deaths by speeding effective new therapies to patients. (Emphasis mine.)

Read the whole thing. I talked about the black box warning here.

Here’s a crazy idea. How about we limit FDA approval to just phase 1? (Phase 1 is where drugs are tested for toxicity, but not effectiveness.) Because I was under the impression that its purpose as an agency was to save lives, and it would appear that it is doing the opposite. And just think of how many more new drugs would go on the market when we cut the time and the cost of FDA approval…

Comments

  1. #1 Dan
    May 26, 2008

    The FDA and Its Damaging Lack of Citizen Protection

    The Food and Drug Administration originated in its primitive form several decades ago to ensure the health and safety of the citizens of the United States. However, their focus seems to have changed the past few decades, as they appear to have formed a pathological alliance with the pharmaceutical industry. An example is the large amounts of money the industry gives the FDA for various reasons- amounts so large that this accounts, according to some, for about half of the FDA’s income, upon information and belief. An example of funds received is due to the prescription drug user fee act, which began in 1992. Basically, the drug industry has been authorized and required to pay the FDA for faster approval of their pending medications. Results of this relationship between the drug industry and the FDA, one could posit, could be a contributing factor the progressive and recent approval of unsafe drugs and lack of regulation and monitoring of the pharmaceutical industry that the FDA is obligated to perform. Yet the FDA continues to validate what has been posited through their support from the drug industry, in ways that seem reciprocal, and as a consequence, have possibly neglected the health of the public as best as they should.

    The presumed intimacy between these two organizations does in fact seem to continue to worsen. For example, and recently, a new proposal by the FDA has been introduced that would allow the pharmaceutical industry’s drug sales reps to discuss their products with prescribers off-label, which means that the FDA may allow and accept the industry with their approval to possibly creating harm to patients with this proposal due to uncertainty associated with unapproved uses of a drug promoted in this way. Yet the FDA claims that this proposal would enhance the education and knowledge of the prescriber by the pharmaceutical representative, and this is rather delusional, to say the least.

    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 more pharmaceutical companies are being penalized for this behavior in the past in the form of monetary settlements with the Department of Justice. The drug companies that have allowed such criminal offenses, through vicarious liability at times, perhaps, and rarely admit guilt as part of such settlements.
    This FDA protocol described and proposed is called, “Good Reprint Practices”, would require pharmaceutical sales representatives to use what may not truly exist, which is truthful and authentic clinical trials when and if they do speak off-label to prescribers. This in itself lacks etiology for such discussions by drug reps, as many clinical trials may be flawed due to the trials being possibly manipulated by the pharmaceutical companies of the meds involved in such trials, such as by a third party. Additional trial deception involves ghostwriting and invalid authors of such trials, and this is one of many concerns of this FDA protocol. These facts can be validated and have been discovered by others, so it appears the FDA did not take this into consideration.
    Furthermore, this proposal is flawed in that most pharmaceutical reps lack clinical training and the ability for most drug representatives to analyze the unique statistical data regarding this issue with accuracy and meaning is unlikely, for the most part, I surmise. Remember that most drug reps have no medical or clinical training in any objective way, and, in my experience, have no interest in such training. So this seems to further complicate 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 embellish 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 a possibly harmful association by suggesting such practices as this with deliberate intent and reckless disregard for public health, so it seems. Yet this situation of the FDA proposal mentioned appears to be of most benefit for the drug companies. 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. We as citizens are no longer the concern of the FDA, one could conclude.

    However, there is freedom of speech. Perhaps another alternative would be to have clinically trained people discuss such issues with prescribers, instead of the drug reps, who, unlike those academically enriched, have the objective of increasing the market share of their promoted meds with no regard to the science behind these meds, in large part. Because historically, medications have in fact proven to be beneficial for other disease states other than what a certain med was initially indicated for upon approval. 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 one could argue are in fact somewhat 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, which could be the case now with the FDA. And the health of the public is that interest we as citizens demand, and should be enforced than it appears to be presently.

    “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

New comments have been disabled.