TCS Daily

The Battle Over Drug Safety and Preemption

By James V. DeLong - January 31, 2009 12:00 AM

Two recent pronouncements represent contrasting views on pharmaceutical safety.

John Calfee of the American Enterprise Institute writes about the continuing problem that the FDA is pressured toward over-caution and suppression of useful drugs, often on the basis of anecdotes and press hype. "This one-sided criticism, which in recent years has risen to the level of vitriol, is bound to push the FDA staff toward over-caution, i.e., toward a disproportionate emphasis on safety rather than, say, getting new drugs to market."

The results can be tragic not only in terms of long-term suppression of useful drugs but immediately. "[T]here is strong evidence that when the FDA responded to critics by imposing stark warnings on antidepressants, the net effect was more suicides rather than fewer because the warnings deterred usage among seriously depressed younger patients."

On the other side stands the American Trial Lawyers Association (which now calls itself the American Association for Justice). ATLA is upset because a number of regulations that are being pushed by the Bush Administration contain language might prevent state courts from imposing standards even more restrictive than those imposed by federal agencies. Included on the ATA list are 20 from the FDA.

ATLA takes the view that state courts and juries should be allowed to second guess the FDA, using 20-20 hindsight of course, and impose hefty liability on drug companies if they decide that the risk/benefit balance struck by the agency was in error.

The major problems with the ATLA position is the one inherent in Calfee's point, that the FDA is plenty risk averse already, and adding more layers of caution is not just unnecessary but harmful. But there are three other problems, too:

  • First, drugs are powerful. That is why they work. That is also why they can do harm. Determining the potential effects, intended and otherwise, and then balancing the possibilities of good and harm is difficult, and taxes the capabilities of the medical and scientific communities. To think that the enterprise should then be repeated in every state in the form of a trial in front of lay judges and jurors is insane. This is not meant to insult juries -- Merck did win most of the Vioxx cases - but simple industrial efficiency dictates that the task should be done once, as well as we can do it. And Merck also paid almost $5 billion in settlement, money that could have been spent on drug research, or even to compensate the very limited number of people who were actually harmed by the drug.

  • Second, we don't like to think of it this way, but releasing a drug for general use is in itself a clinical trial. While large-scale effects can be found in the small-scale trials required before FDA approval, it is inevitable that mass use will sometimes find results that are less common, more subtle, or prevalent in particular sub-populations.

    The medical community knows this, and devotes considerable resources to tracking post-release experience with drugs to get feedback on any problems. Patients need to accept that using a new drug has risks and that is an unavoidable part of the price that must be paid if there are to be any drugs at all.

    Perhaps there should be a fund for people harmed by such effects, paid for as part of the system, but drug makers should not be accused of negligence for a problem that is not a failure of evaluation procedures but a law of nature and statistics. The litigation approach introduces confusion that is moral as well as economic.

  • Third, no one can possibly believe that mass litigation in state courts is a good way to settle anything. Professor Lester Brickman and Judge Janis Jack have documented the astounding shenanigans and fraud in the asbestos and silicosis cases, and to think a higher standard prevails in drug litigation would be na├»ve.

    In the New Jersey Vioxx case, the judge opened a major trial by throwing out the entire testimony of the company's lead-off expert on a procedural technicality. The judge, who was in charge of overseeing almost 3,500 Vioxx cases, was a former partner in a plaintiff's law firm that specializes in medical cases. No wonder Merck paid $4.85 billion, even after a lot of success.

The pre-emptive effect of Federal laws and regulations is a hot legal issue now. Last year, in Medtronics, the Supreme Court decided that the Medical Device Amendments Act of 1976 blocks state common law claims. The Court is now considering Wyeth v. Levine, which deals with preemption imposed via FDA labeling requirements.

Both these cases address the question whether Congress meant the language of particular laws to preempt state suits. Neither questions the fundamental doctrine that a federal agency has the power to pre-empt if it so chooses.

The political fight in 2009 will be the ATLA effort to persuade Congress to prevent agencies, and particularly the FDA, from exercising this power of pre-emption. Most people regard the stories of asbestos or Vioxx as horrible examples of a system gone awry. ATLA regards them as ideals to be replicated infinitely. The question is where Congress will come down. The trial lawyers spent a bundle on the last election, and preemption is at the top of their agenda. Let us hope the representatives pause long enough to read Calfee's work.

James V. DeLong is the Vice President and a Senior Analyst at the Convergence Law Institute

1 Comment

Depression drugs.
Does any one have a good link to the study showing Depression drugs increase the rate of suicide? I have problems with this.

How can you study a population that is already prone to suicide? How accurate can a control group really be? What kind of sample size would you need to get a good statistical measure.

I suffer from Bi_polar my self, and would be a lot worse with these kinds of medications. I have never met ANY one personally who has been damaged.

I have met people who went OFF these drugs, stopped seeing a Psych and then killed them selves...

These commercials are dumb dumb dumb.

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