Bioethics: February 2008 Archives
The Supreme Court in an 8 to 1 decision held that The Medical Device Amendments of 1976 (
Donna Riegel had brought suit against Medtronic after a Medtronic catheter ruptured in her husband’s coronary artery during heart surgery. The catheter is a Class
Writing for the majority, Justice Scalia reasoned that the FDA spends substantial time reviewing each device application and grants premarket approval only if it finds there is a “reasonable assurance” of its “safety and effectiveness. . . It may thus approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives.” Attacking the jury system which has done as much to protect consumers from dangerous drugs and devices as the agency viewed by many as too friendly to BigPharma, Scalia wrote that jurors would probably not be in a position to weigh the benefits and dangers of medical devices as well as agency experts because a jury “sees only the cost of a more dangerous design, and is not concerned with its benefits; the patient who reaped those benefits are not represented in court.” Apparently Scalia is unfamiliar with the way product liabilty cases are tried. Manufacturers in such cases always present evidence of the benefits their product provides.
Such a decision does real harm to consumers and ignores the history of unreasonably dangerous drugs and medical devices which slipped through the many hours of FDA scrutiny. While plaintiff’s lawyers are an easy target for critics, they have repeatedly uncovered the dangerous propensities of medical devices and drugs which had received the safe and effective stamp of approval by the federal agency charged with protecting consumers but has all too often answered to industry.
In its opinion, the Court leaves for another day the question of whether suits against drug manufacturers should similarly be preempted. While we are not optimistic with respect to how the Court will answer that question, drug manufacturers cannot rely on a federal statute such as the MDA to support their argument that they should be immune from suit even if they release drugs whose benefit does not outweigh the potential for harm.
Alan Milstein
We no longer have to put up with those ads for Vytorin and Zetia after cinical trial results questioned the efficacy of those drugs in controlling plaque. Soon we may be free of those Lipitor ads featuring Robert Jarvik. This time it is not because the cholesterol lowering drug has been shown less effective than advertised. It is the use of Jarvik that has caused critics to accuse the drug maker Pfizer of overselling its product.
Jarvik was the inventor of the first artificial heart. Few remember that after the clinical trial testing that device proved so ethically troubling, there was a fifteen year moratorium on artificial heart human experiments. In any event, the implication of using Dr. Jarvik as the pitchman is that the inventor of the artificial heart must know more about the health of real hearts than just about anyone. So we should listen to what he says about heart disease. The problem is that while Jarvic has a medical degree, he is not a cardiologist or even licensed to practice medicine. And while he looks fit rowing in his scull, presumably in part from the drug, the truth is the good doctor is not a rower and Pfizer used a double to do the actual rowing in the ad. “He’s about as much an outdoorsman as Woody Allen,” said a longtime collaborator, Dr. O. H. Frazier of the Texas Heart Institute. “He can’t row.”
The controversy has renewed the debate over direct advertising of prescription drugs to consumers. Some Congressmen have suggested Dr. Jarvik come in to testify and explain whether the ads misrepresent material information to potential users of the drug. As soon as they finish with the steroid issue in baseball, I am sure they will get to it.
Alan Milstein
The FDA has issued a draft proposal which would permit BigPharma to market their drugs for off label use by physicians. The proposal would permit drug manufacturers to distribute peer reviewed scientific articles touting their products for uses for which the companies had never sought FDA approval or even been denied such approval.
Not that the companies don’t market off label anyway. Pfizer, for instance, paid enormous fines for marketing its drug Neurontin for a panoply of off label uses that proved to be ineffective if not outright dangerous. And BigPharma has long promoted the use of antidepressants by children even though no study has demonstrated that such drugs are either effective or safe for use by anyone but adults. In fact, the estimates are that more than 20% of all prescriptions are for uses not approved by the FDA and not indicated in the labeling the companies supply with their products.
Such a proposal can only lead to harm to consumers. As the New England
Alan Milstein
This appeared today at blog-bioethics.net.
A comment from Paul Gelsinger on gene therapy and informed consent
In a guest post earlier this week Alan Milstein, the attorney who represented Jesse Gelsinger's family, wrote about his reaction to a recent editorial by James Wilson about gene therapy and informed consent in the journal Human Gene Therapy. The guest post prompted a number of comments, including one from Paul Gelsinger -- Jesse's father. Here's Mr. Gelsinger's comment in full:
To clear the air about what really happened, let me take you back nearly 9 years to the meeting we had with the principal investigator 3 months before Jesse's actual participation in the "gene therapy" clinical trial. Understanding the information regarding the gene therapy that Jesse was to receive wasn't all that difficult for me, since I had extensive experience in science. The risks were fairly well spelled out. There was the possibility that he would have an immune response, that his liver could be seriously damaged, that a liver biopsy to be done a week after the vector infusion had the risk of serious side effects. When I questioned this investigator as to whether they had seen any ill effects, he stated that they had only had to deal with flu like symptoms. In further conversation, he remarked that the liver was a remarkable organ, the only organ in the body capable of regenerating itself. The risks were downplayed. There was no mention by the investigator or the consent form of any animals having died in the research.
A month later, a call from the expert on Jesse's disorder, another of the principal investigators, led us to believe that the most recent patient had benefited from the vector infusion. He stated that she showed a 50% improvement in her ability to excrete ammonia following the gene therapy. When I said, "Wow, this really works", he stated yes and that it would be for those for whom this therapy was designed, not kids like Jesse with mild otc, but newborns with the almost always fatal form. We totally dropped our guard and Jesse made arrangements to participate.
Three months after his death we discovered that there was never any efficacy, that the 50% improvement that the patient showed was not related, that the researchers had multiple toxicites at 1/10 the dose that Jesse received that were each a stop sign for the protocol (and the FDA knew of these), and that animals had died in the research. I had been very supportive of these men and their institution after his death, but with this new knowledge I was no longer able to support them. Jesse had been doing very well (he was virtually normal except he had to take medication) on the standard drug therapy, and he only wanted to help those less fortunate than himself. You can not imagine how disillusioning it was to discover the lapses by the researchers and the government.
The financial conflicts of interest for both the sponsor (James Wilson) and the University were basically ignored by the University's Conflict of Interest Committee. This led to a blindness on the part of all parties to the dangers they were seeing. These were not bad men doing evil. They were men blinded by ambition and greed. They have told me that they could not have foreseen Jesse's death, yet their data was screaming at them to stop. We trusted a system that was untrustworthy, one that didn't even pay attention to its own stops. So we sued and settled within 6 weeks. The quickness of that should tell how badly the other side wanted this to go away.
The government in the form of the FDA criminal division and the Department of Justice did a 5 year investigation at the end of which they fined the institutions involved a combined total of a little over a million dollars. They decided not to press any criminal charges and slapped the docs on the wrist with retraining and supervision.
So, my son, doing the right thing, was killed by a sytem and people rife with conflicts of interest, and real justice has been found to be very lax. It's essentially business as usual. You may think that I am bitter, but I am not. My son gave me the best possible example on how to be. The system showed me what everything is really all about. Hopefully, given enough time they'll fix this, but I'm not holding my breath. Anyone considering joining a clinical trial needs to be aware that they are dealing with a system that is seriously flawed.
