Recently in Bioethics Category

In a startling reversal of his own ruling, Chief Judge David Hamilton of the Southern District of Indiana issued a 28 page

The Judge rightly concluded that "drug manufacturers
have the authority to strengthen warnings without the advance permission of
the FDA"  and that “failure to warn litigation can serve to reinforce the FDA's
regulations, which already place the obligation to strengthen the warnings
on a drug's label squarely on the shoulders of the drug's manufacturer."
          The Judge relied in part on a recent law review article by former FDA Commissioner, David Kessler, in which he noted the recent change in position by the FDA under the watch of a Chief counsel with significant ties to BigPharma. Mr. Kessler wrote: "The most fundamental problem is that drugs are approved on the basis of
clinical testing that cannot, and is not designed to, uncover risks that are
relatively rare or have long latency periods. Legislation cannot solve this
problem ... Top-down surveillance is no substitute for failure to warn
litigation, which provides the FDA, doctors, and patients with information
about new risks that is otherwise unavailable to the agency."
              The Indiana case involved a 55 year-old Catholic priest with no history of suicidal ideation who took his life 22 days after being put on Paxil.

Alan Milstein

The connection between Mirapex and compulsive gambling first came to light in July 2005 when doctors at the Mayo Clinic reported the results of a study suggesting a link between dopamine agonist drugs like Mirapex and compulsive gambling.

Researchers have long known that certain drugs can cause adverse reactions that can change a person's behavior by initiating destructive thoughts which lead to destructive behavior. It will be interesting to see if a court and jury will accept the theory that a prescription drug is responsible for behavior such as a gambling addiction.

Alan Milstein

Representative  Henry Waxman has introduced  a bill to essentially overrule the recent court rulings such as Riegel v Medtronic holding that civil claims against medical device manufacturers are pre-empted by FDA action.  The Medical Device Safety Act of 2008 would reinstate tort liability in state civil actions alleging negligent design of such devices or the failure to warn of their dangerous propensity. Such a bill would be a welcome relief to consumers seeking just compensation for their injuries.

Alan Milstein

Here is an article I wrote titled “Research Malpractice and the Issue of Incidental Findings,” which just came out in the Summer 2008 issue of “The Journal of Law Medicine and Ethics.”

Alan Milstein

The New York Times

     Senator Chuck Grassley told the Times that, by failing to report this income from the companies who reap hundreds of millions of dollars from their work, the two psychiatrists may have violated university, state and federal rules governing conflicts of interest. Grassley has been conducting hearings on academics who receive grant money from BigPharma and the potential financial conflicts that might arise from such relationships.

         Harvard Spokeswoman Alyssa Kneller told the Times: “The information released by Senator Grassley suggests that, in certain instances, each doctor may have failed to disclose outside income from pharmaceutical companies and other entities that should have been disclosed.” She added that a university conflict committee is reviewing the physicians’ conduct.

        The kinds of studies these psychiatrists and others are conducting on young children is highly questionable. Bloomberg News reported that Dr. Biederman is currently recruiting 4- to6-year-olds with supposed bipolar disorder to test AstraZeneca's antipsychotic, Seroquel, and another group of 6- to 12-year-olds to test Equetro, developed by U.K.-based Shire Ltd.

Alan Milstein 

           

              You might recall this office raised precisely these concerns when arguing that NBA center Eddie Curry could not be compelled by his then employer, the Chicago Bulls, to undergo genetic testing for hypercadiomyopathy. The Bulls ultimately backed down from the demand and traded Curry to the New York Knicks.

              The Senate Bill will be welcome protection to citizens in this brave new world where DNA testing may reveal our propensities, but not our certainties, to contract certain diseases, become addicted to certain behaviors, or engage in certain socially undesirable activities.

Alan Milstein

Here is an article about a lecture I gave recently at the University of Virginia.

Alan Milstein