This blog entry also appeared on LegalNews.TV:
It is essential that the public have confidence in our nation's drug approval system. Yet with the pharmaceutical industry under attack by the plaintiff's bar, consumers might think they have reason to worry about the safety of products approved by Food and Drug Administration (FDA). The Vioxx lawsuits have become shorthand for the need to tighten the drug approval process. It is as if the public demands risk-free pharmacies. If only there were such a thing.
Just last week, the Institute of Medicine (IOM), a non-partisan quasi-governmental agency, seemed to cater to the demand for more caution. However, they came out with some specific guidelines that may do more harm. Unfortunately, if Congress and the FDA adopt the IOM recommendations consumers, may be deprived of an efficient pipeline of life-saving and life-enhancing drugs. Unlike the Vioxx lawsuits, there isn't yet a notorious, illustrative case involving patients who died as a result of an overly cautious drug approval process.
Under the IOM's proposed rules, the Food and Drug Administration (FDA) will take on some of the same hypercautious tendencies that make the Environmental Protection Agency (EPA) a thorn in the side of not only industry but consumers who value innovative, low-cost products such as Teflon pots and fire retardant chemicals.
IOM recommends that newly approved drugs carry a black triangle for their first two years on the market, and that advertising of new drugs be restricted. This is the wrong approach to perceived safety issues.
Most side effects are identified in trials prior to a drug's approval. Those potential adverse reactions, no matter how rare, are then weighed in relation to the potential benefit of the drug (and other factors). But it is impossible to identify every single side effect in relatively small pre-approval trials. Only with careful post-marketing surveillance, where a vastly diverse group of patients are monitored, can the most remote reactions be reported. Such finds are not a sign of a lax approval process, as FDA critics and the plaintiff's bar would have you believe, but rather evidence of a thorough post-marketing surveillance program. This regulatory approach properly balances the benefits of getting drugs to market in a timely fashion with the risks present in putting any drug on the market.
Of course, inherent in this balancing act must be the _risk of not making a drug available_ to sick patients. Putting a black triangle on the label will unnecessarily scare consumers away from taking needed prescription drugs that have already gone through rigorous pre-approval trials. Patients and physicians should always have an open discussion about the potential risks as well as benefits of any drug, taking into account a patient's unique profile, regardless of how long the product has been on the market, but to send the message that every new drug is dangerous is in itself dangerous.
Do we really want the FDA to start acting like the EPA, which treats all new chemicals with great suspicion?
The underlying problem with the EPA is that their incentives are misaligned: EPA officials are blamed any time there is even a potential negative effect of under-regulation, yet are never held responsible for the huge costs of over-regulation. Under this one-sided incentive approach, it is no wonder the EPA behaves as it does. In the absence of absolute proof of a substance's safety, it is "better to be safe than sorry," according to the EPA and other proponents of the so-called "precautionary principle." The EPA applies this rule regardless of the costs of keeping useful products out of the hands of consumers. The EPA isn't called to task for the myriad costs, in both money and quality of life, of regulations meant to protect us from remote risks.
Similarly, FDA is never called to account for the unnecessary deaths of patients who don't get the new drugs they need in a timely way. The IOM's proposed policy changes for the FDA would only further institutionalize the one-sided incentive system that has already been failing the public at the EPA.
Another ill-advised IOM recommendation would further skew the regulatory process -- a call for at least 60% of medical experts serving on FDA advisory panels to be free of "significant" financial involvement with pharmaceutical companies. Yet most truly qualified experts have at one time held significant relationships with pharmaceutical companies. The FDA needs more and better experts, not more restrictions on those most qualified to serve. Instead, the IOM should have simply demanded that 100% of FDA panel members have true expertise in evaluating drug safety and efficacy. Any actual effect of alleged bias -- be it from financial or other causes -- should be weeded out during thorough committee review.
To assume all scientists who have worked with industry are corrupt and ban them from review panels would leave only a strange subset of scientists -- weighted toward those who were ardently anti-industry or lacking the expertise that would inspire companies to hire them as consultants -- to decide when a company could be trusted to put a new drug on the market. This is surely a formula for excessive caution.
It seems that when it comes to our health, zero risk is the only level some people will accept. Yet we know that we engage in risky behavior every day. From crossing the street to exercising, there is always some danger in our everyday activities. But _not taking risks_ opens us up to a whole new set of dangers. For instance, it would be absurd not to exercise out of fear of an injury. We know that such a precautionary approach would do more harm than good. Yet there is now pressure to apply this unwise approach to more complex regulatory matters. The IOM recommendations currently under consideration raise important issues, but on balance, they would not serve to promote public health.
Jeff Stier is an associate director of the American Council on Science and Health (ACSH.org, HealthFactsAndFears.com).
See also: ACSH's brochure and full report on benefits and risks in pharmaceutical use.
