Alaska Injury Law Blog

Another reason to question what your doctor and the FDA tell you about the safety and efficacy of any drug has now come to light. The Annals of Internal Medicine has just reported that Merck used the unsavory tactic of a “seeding trial” in its development of Vioxx. (This has come to light as a result of Vioxx litigation, and is not data the public would know if only the FDA, rather that the courts, were looking over Merck’s shoulder.) A seeding trial is carried out by a drug manufacturer just prior to or shortly after FDA approval of a new drug. Ostensibly, such a clinical trial is completed for the obvious medical research benefits, for example post-approval surveillance for safety and efficacy. In reality, there is an unspoken agenda: to get the drug in as many physicians’ hands as possible, enlisting them as investigators while picking up the support for monitoring and paperwork. The physicians receive the prestige of participating in a drug trial as clinical investigators and are financially reimbursed, and the drug manufacturer is familiarizing physicians with the drugs, thereby shortening the path to profitability, or “accelerating uptake” in the parlance. Such trials should be initiated for a legitimate research purpose, not as a pretext for profit.

The guidelines imposed by science, the FDA and institutional review boards are there for a purpose–to be sure that evidence-based science guides critical decisionmaking. When medical journals, the FDA, and the public are deceived with these kinds of tactics, the credibility of the system is corroded. Such deception cannot be permitted to stand without penalty by the FDA, and Merck should be subjected to professional and public scorn.

It is a difficult enough proposition for science to drive decisionmaking in America today. Too often, politics and the mythical thinking justifying the herbal phenomenon win the day. When money corrupts the scientific process, its credibility is undermined and the public increases its distrust of conventional medicine. Simply put: seeding trials are a pernicious practice that should never be permitted.

At the Alaska Personal Injury Law Group, we commonly face the unpleasant task of explaining to prospective clients the way in which “tort reform” has dramatically taken away the legal rights they thought they possessed. One of the recent unsung accomplishments of the Bush Administration is the silent destruction of the legal rights of those hurt by the malfeasance of corporations–stealth tort reform at the FDA.

Utterly unnoticed by the American public was an unheralded aboutface at the FDA. Although it had been silent on the issue before, the FDA began taking an active role in pending private litigation espousing the proposition that, if the FDA had approved a drug or medical device, then that approval should shield the manufacturer from any liability if the product were to injure or kill. In legal terms, that shield is called “preemption, ” the argument being that the federal government, by regulating the industry, has preempted state regulation and state tort claims. Manufacturers have long sought this shield, but the courts recognized the argument for the folly that it is, and commonly rejected it. Not surprisingly, this policy reversal by the White House was implemented by Dan Troy, one of 100’s of industry lobbyists President Bush put to work in positions responsible for public advocacy. Before his appointment, Troy’s practice was based on representing drug and tobacco companies in challenging FDA regulations. It was under Troy’s guidance that the FDA flip-flopped its position on preemption, much to the delight of the industry the FDA was supposed to be regulating.

The United States Surpeme Court, its makeup another Bush Legacy, has recently breathed life into the preemption defense, with its ruling in Riegel v. Medtronic. The ruling effectively wipes out all pending medical device litigation, from faulty pacemakers to defective insulin pumps. The natural extension of the legal argument will be to apply this ruling to preemption arguments in drug claims. And from there the erosion of legal rights will spread to every area of American society touched by the FDA (and by logical extension, any federal agency), whether the injury comes from a toxic chemical exposure or tainted hamburger.

The Alaska Personal Injury Law Group has long been involved in the analysis of defective products sold by the diet supplement industry. Talbert v. E’ola Products, Inc. We have watched this industry repeatedly use unqualified personnel to design and sell products that are, in a word, dangerous. The industry has run amuck with virturally no regulatory oversight, and the consumer is repeatedly defrauded or hurt by exposure to the rapacious and dangerous practices of this industry.

It is thus with some appreciation of the legal and karmic forces at work in the universe to read today’s news that Michael Ellis, former CEO of Metabolife, was sentenced to prison for 6 months based on pleading guilty to a single count of lying to the FDA about the effects of Metabolife 356 and its notorious ingredient, ephedra. Despite the millions the company relieved consumers of, he was fined just $20,000. In 2005, William Bradley, who was Ellis’ partner in Metabolife, pleaded guilty to seven felonies, including tax evasion, and sentenced the following year to six months in custody.

Metabolife and Ellis had sent letters to the FDA stating that they had “never received a notice from a consumer that any serious adverse health event has occurred because of the ingestion of Metabolife 356.” Metabolife’s own documents, however, showed that it had received many reports from consumers of strokes, heart attacks, seizures, and other serious illnesses. The company ultimately turned over the reports of 14,000 ephedra-related adverse events that the company had previously not disclosed to the FDA, which ultimately was a key factor in the FDA’s ban on ephedra imposed on the industry in 2004.