May 23, 2008
FDA to Expand Post-Approval Review of Drugs
Gardiner Harris of the New York Times reports today in an article entitled "FDA to Expand Scrutiny of Risks From Drugs After They're Approved for Sale" that the FDA has a new program called the "Sentinel Initiative" that will monitor how approved drugs affect consumer health. They will use information from Medicare beneficiaries.
Researchers praised the government initiative, but many said its fruits would take years to realize. And several said the Bush administration’s policy of delivering the Medicare drug benefit through myriad private plans made the effort that much more difficult.
“This is going to take a lot of work,” said Dr. Bruce Psaty, a professor of medicine and epidemiology at the University of Washington.
Mr. Leavitt said “the power of this is in the capacity to take disparate databases and use it in a productive way.” Dr. Janet Woodcock, director of the F.D.A.’s drug center, agreed that much work remains to be done.
The article points out that this is better than what the FDA does now (the article explains that the FDA currently has "an unsystematic system in which doctors, patients and manufacturers report problems with drugs and medical devices when they deem them important.") There are several problems with using Medicare data, including the fact that it is claims data not patient records and the fact that Medicare recipients use many more drugs than the general population, and are sicker than the general population.
May 22, 2008
Institute for Safe Medicine Practices Releases New Chantix Report
The Institute for Safe Medicine Practices, a non-profit group organized to improve drug safety and review the FDA's adverse-event reports, recently released a study on Chantix. The report indicated a greater spectrum of side effects, including heart trouble, seizures, and diabetes in addition to the effects already identified such as suicide and depression. Here's an excerpt from the Wall Street Journal:
Thomas Moore, the study's lead author and the institute's senior scientist for drug safety, called on Pfizer and the FDA to "immediately" strengthen Chantix's label warnings and rigorously examine emerging safety issues. "Based on the data available now, the existing warnings are completely inadequate," he said. "You'd expect a stop-smoking drug to have a relatively low number of reports," because it isn't used in high-risk patients.
. . .
Mr. Moore's study links the drug to a greater spectrum of maladies. The report identified 173 injuries, including falls and traffic accidents, involving people taking Chantix that were possibly the result of such factors as muscle spasms, dizziness and confusion. The FDA data also contain 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes.
After just months on the market, Chantix broke into the small group of medicines with more than 100 reports of serious injury. In the 2007 fourth quarter, with nearly 1,000 reports, it topped the group's list of 769 drugs examined in the U.S. for serious side effects. By contrast, the median number of serious-injury reports for other drugs is five. Most medications that came close to Chantix carry the FDA's most-serious "black box" warning, the study says.
The institute's findings have limitations. Using adverse-event reports doesn't establish a causal relationship between a drug and a side effect. Such reports are turned in by doctors, patients and sometimes plaintiffs' lawyers positing a connection but not proving one. Mr. Moore, who has consulted for plaintiffs' attorneys on drug issues, said the study isn't being published in a medical journal because he wanted to publicize the findings more promptly. A spokeswoman for the ISMP says that the group doesn't receive funding from plaintiffs' attorneys or other parties with a commercial interest in this report, and is primarily financed through subscriptions to its newsletter and grants.
Fen-Phen Kentucky Lawyers on Trial
There have been several reports lately about the mishandling of Fen-Phen settlement funds in Kentucky. Here are two excerpts. The first is from the Wall Street Journal Law Blog:
There are many bizarre aspects of the story behind the three Fen Phen lawyers on criminal trial for alleging bilking their clients out of $65 million of settlement money. The most well-reported oddity is that two of the lawyers used settlement funds to invest in the race horse, Curlin. But how about their decision to donate $20 million of the $200 million settlement to a charitable fund — called the Kentucky Fund For Healthy Living — that they created and controlled, and for which they allegedly paid themselves about $150,000 each to manage?
That part of the case came to light yesterday, as Joyce Brown, a plaintiff in the Fen-Phen case, testified in federal court that she specifically opposed the charity idea. According to this report in the Herald-Leader, Brown testified that she phoned the law office of William Gallion (pictured, right), one of three lawyers now on trial, to express her opposition, but a woman told her that the charity plan was going through, and that she had no choice in the matter. Another plaintiff, Connie Centers, testified that no one discussed a charitable contribution with her.
The second is from the Lexington Herald-Leader:
A Lexington woman who was a plaintiff in a $200 million fen-phen class action settlement testified in federal court Tuesday that she specifically opposed plans by three lawyers in the case to donate leftover settlement money to charity.
Joyce A. Brown said that when she telephoned the Lexington law office of William Gallion to express her opposition, a woman on the phone told her that the charity plan was going through, and that she had no choice in the matter.
Another plaintiff, Connie Centers of Lawrenceburg, said no one ever discussed a charitable contribution with her.
Gallion and fellow attorneys Melbourne Mills Jr. and Shirley Allen Cunningham Jr. ultimately placed about $20 million of settlement money in a charitable foundation they created and controlled. They also paid themselves about $150,000 each to manage the fund, called the Kentucky Fund For Healthy Living.
Mills, Cunningham and Gallion are on trial in federal court for conspiracy to commit wire fraud in their handling of the settlement, which grew out of a class-action lawsuit they filed in Boone Circuit Court in 1998 against American Home Products, the company that marketed fen-phen.
Prosecutors allege that the defendants unlawfully pocketed millions from the settlement, defrauding their clients out of about $65 million.
May 21, 2008
FAA Bans Chantix Use By Pilots and Air Traffic Controllers
Article on cnnmoney.com -- FAA bans Pfizer anti-smoking drug. Our initial Chantix blog post in November 2006 has so far lead to 178 comments, most of them describing physical and mental problems occurring in people using Chantix. Here's an excerpt from today's article:
Pfizer Inc.'s once-promising anti-smoking drug Chantix received another blow Wednesday after a nonprofit group's report about serious physical side effects prompted the Federal Aviation Administration to ban the drug's use by pilots and air traffic controllers.
The report, from the Institute for Safe Medication Practices, points out hundreds of serious problems reported since the popular drug was approved in May 2006, including dizziness, loss of consciousness, seizures, and abnormal spasms and movements.
Merck to Settle Vioxx Advertising Claims by AGs for $58 Million & Ban on Medical Ghostwriting
Article in the Wall Street Journal -- Merck Will Pay $58 Million To Settle Vioxx Ad Claims, by Kevin Kingsbury. Here's an excerpt:
Merck & Co. agreed to pay $58 million to settle claims by 28 states and the District of Columbia that the drug maker used deceptive advertising for its Vioxx painkiller.
The drug maker also agreed to a ban on medical ghostwriting, under which an author's true identity is concealed. Last month, two medical-journal studies suggested Merck violated scientific-publishing ethics by ghostwriting dozens of academic articles, and minimized the impact of patient deaths in its analyses of some human trials involving Vioxx.
Pennsylvania Attorney General Tom Corbett said Tuesday that in 1999, Merck launched "an aggressive and deceptive advertising campaign which misrepresented the safety and improperly concealed the increased risks associated with Vioxx." The drug was pulled from the market in 2004, after safety concerns were raised.
10 Best Law Review Articles on Mass Torts
Since law professors love lists and hierarchies, I thought it might be fun to consider the best articles on the subject of this blog: mass tort litigation. I have excluded from the list below (1) any participants in this blog and (2) empirical studies. Of course, books are excluded as well. A list of the best empirical studies on complex litigation is a project for another day. I suggest 7 below, thanks to at least one wise suggestion, and look forward to more nominations. Those of you starting out in the field, these might be a good place to begin your research.
So, without further ado, my suggestion for the best law review articles on mass torts, in chronological order.
David Rosenberg, The Causal Connection in Mass Exposure Cases: A "Public Law" Vision of the Tort System, 97 Harv. L. Rev. 851 (1984).
Francis McGovern, Resolving Mature Mass Tort Litigation, 69 B.U. L. Rev. 659 (1989)
Robert G. Bone, Statistical Adjudication: Rights, Justice and Utility in a World of Process Scarcity, 46 Vand. L. Rev. 561 (1993)
Jack B. Weinstein, Ethical Dilemmas in Mass Tort Litigation, 88 Nw. U. L. Rev. 469 (1994)
Richard A. Nagareda, Turning From Tort to Administration, 94 Mich. L. Rev. 899 (1996)
William B. Rubenstein, A Transactional Model of
Adjudication, 89 Geo. L.J. 371 (2001)
Samuel Issacharoff & John Fabian Witt, The Inevitability of Aggregate Settlement: An Institutional Account of Tort Law, 57 Vand. L. Rev. 1571 (2004)
May 20, 2008
Video of Widener Law School Symposium on Crimtorts