Bioethics: December 2007 Archives

Said the Rev. Charles Williams, president of the National Council for Community Empowerment, a civil rights group: "We are an African-American community that has been treated like guinea pigs." 

       Zoloft is the most widely prescribed antidepressant in the United States, with 32.7 million prescriptions written in 2003. Though the drug was never approved for children nor ever shown to be effective for childhood depression, as much as 10% of the sales of the drug are for adolescents. In 2004, the Food and Drug Administration ordered Zoloft and other antidepressants to carry “black box” warnings — the government’s strongest warning short of a ban — about an increased risk of suicidal and violent behavior in children.

Now we wait. Currently pending before the Supreme Court and the Third Circuit are two critical cases involving the issue of federal preemption of state law claims against manufacturers of medical devices and pharmaceuticals.

The Supreme Court case is  Riegel v. Medtronic, Inc. In that case, the widow of Charles Riegel filed suit against Medtronic after the catheter inserted inside Mr. Reigel burst during a coronary angioplasty because it had been inflated beyond the recommended pressure. Medtronic moved for summary judgment on the ground that the state common law claims were preempted by the Medical Device Amendments to the Food, Drug and Cosmetics Act ("FDCA"), 21 U.S.C. § 360k(a).

The Second Circuit affirmed dismissal of the case holding that because the design of the device was approved by the FDA, any state claim alleging faulty design was preempted; only claims alleging negligent manufacturing could survive.

The Third Circuit case argued just a few days ago is Colacicco v. Apotex, in which the widow of a suicide filed suit against the manufacturer of the antidepressant her husband was taking alleging a failure to warn. Like in the device case, the company argued that state law claims should be preempted because they conflict with FDA's approval of the warnings accompanying the drugs.

The wrong decisions in these cases will be a setback to the rights of individuals to seek justice against large manufacturers who have injured them. The history of tort law reflects the fact that government regulators have not always been correct about the safety of the products they have approved. Perhaps the best example is the Thalidomide scandal of the late fifties. Here was a drug approved by the FDA as safe and yet it wasn't and thousands of children suffered severe deformities as a result.

If a product or device is proved defective or unreasonably dangerous, the issue alleged by the plaintiffs in these two cases, it should not matter that the FDA had once thought otherwise, particularly when the basis of such a decision is information supplied by the manufacturer. We will keep you posted.

 

This first appeared at Blog-Bioethics.Net.

The media coverage of the recent termination of the Pfizer torcetrapib clinical trial has been nothing short of startling in this age of aggressive investigative journalism. In short, the stories have been about Money, Money, Money. In announcing the halt of this experiment after a finding that human subjects had died because of their participation, the New York Times announced, “End of Drug Trial is a Big Loss for Pfizer.” Bloomberg broke the story by observing: “Pfizer Shares Drop After Company Abandons Cholesterol Drug.” The Toronto Star had a different take: ‘Drug Failure Cost Pfizer 23 Billion.”

In its front page story, the New York Times further added this remarkable conclusion: “Pfizer will not face the product liability lawsuits that have dogged Merck over its painkiller, Vioxx . . . Patients in clinical trials must sign waivers confirming that they understand the risks they face when they take unapproved medicines in clinical trials.” Do they?.

Why am I skeptical? Money. Money. Money. Pfizer had long touted this drug in meetings with shareholders, actual and potential, as the Mother of all Blockbusters. Could this potential have delayed the end of this experiment, even though some researchers had long warned that such drugs might actually pose more risks than benefits.

Two aspects of this trial, what surprisingly little we know about it, trouble me. First, the experiment took place largely in the offices of thousands of cardiologists across the country. What this means is that the subjects may have been induced to participate by their long trusted physician and signed on not to better mankind (or “Pfizer”) but because they believed their physician thought it was in their best therapeutic interest to do so. This might make the informed consent document neither voluntary nor informed.

Second, Pfizer says the delay in halting the trial was because this was a double blinded experiment with one arm taking Lipitor only and the other adding torcetrpib. Only when the data managing subcontractor removed the blinds were the devastating results revealed.

Call me naïve (I’ve been called worse), but why double blind a study where the data is comprised of good and bad cholesterol numbers? Does anyone believe there could be a placebo response that would raise good cholesterol? I have long advocated that the industry’s reliance on this “gold standard” is not always to eliminate researcher bias or that dreaded placebo response. Sometimes it is to keep subjects and physicians in the game. And if this had not been a double blinded study, could the ongoing results have been known to the physicians and disclosed to their patients earlier?
Alan Milstein

This first appeared at Blog-Bioethics.Net.