MPT WWW
Selected news articles which highlight important policy issues.

News: Weekly Archives

News for the week of 05-23-2007

Lawyers forecast a flood of Avandia litigation
Reuters News, 5-23-07

Editor's Notes:

There is one certainty in the ongoing debate surrounding a potential increase in heart disease risk for patients taking GlaxoSmithKline's diabetes medicine Avandia: No matter what the science says, lawsuits will pile up against the company in short order—and perhaps siphon billions of dollars away from drug research into years of costly litigation.

GlaxoSmithKline is expected to be hit with a wave of lawsuits from users of the diabetes drug Avandia, plaintiff's lawyers said on Wednesday.

Lawyers who bring product liability cases say they are fielding calls from Avandia users who are contemplating suing Glaxo, following a pooled analysis of trials in the New England Journal of Medicine this week that concluded the drug raised the risks of cardiac-related deaths and heart attacks.

Glaxo could face potential liability in "the tens of billions of dollars," said Barry Knopf, a plaintiff's lawyer and partner in the New Jersey law firm of Cohn Lifland Pearlman Herrmann & Knopf. "If the increased risk of cardiac death is as high as (the study) suggests, it should be possible to draw the connection to cardiac events" among people taking Avandia, "especially patients who had not had previous heart disease or heart attacks," he said.

Another plaintiff's lawyer, Perry Weitz of Weitz & Luxenberg in New York, said his firm has been in touch with Avandia users and is doing due diligence on the situation as it weighs whether to bring any suits.

[permanent link]

For drug makers, a downside to full disclosure
The New York Times, 5-23-07

Editor's Notes:

File this story under "damned if you do, damned if you don't." Even as companies comply with demands from Congress and the media to put ever more clinical trial data into public repositories on the Web, they expose themselves to lawsuits and accusations of hiding safety data. The problem is that safety signals that come from the meta–analyses of many different clinical trials—many of them small and of uncertain clinical value—are very much open to interpretation and debate.

In the meantime, as the scientific evaluation around the data proceeds slowly, patients are frightened and lawsuits proliferate. Until the FDA, industry, and academics agree on the basic parameters for analyzing data under these circumstances, at least as much confusion will be generated by transparency as information of real value.

When GlaxoSmithKline settled a lawsuit three years ago with the State of New York over the antidepressant medication Paxil, the company agreed to take an unusual step: publicly disclosing the results of its clinical trials for Paxil and other drugs.

The company, which was criticized at the time for failing to publicize all pediatric trials of Paxil, not just the positive ones, made good on its promise. The first posting on a new Web site was about 65 studies involving its popular diabetes drug, Avandia.

This week, GlaxoSmithKline learned what that greater disclosure could mean.

A cardiologist at the Cleveland Clinic, Dr. Steven Nissen, stumbled onto the Glaxo Web site while researching Avandia last April. He and a colleague quickly analyzed the data, and on Monday, The New England Journal of Medicine released its finding that Avandia posed a heightened cardiac risk.

"It was a treasure trove," Dr. Nissen said about the Web site.

GlaxoSmithKline has disputed the journal's interpretation. Officials with the Food and Drug Administration said they were reviewing whether to take any action on Avandia.

Whatever the drug's fate, the episode is likely to fuel efforts by some medical experts, including Dr. Nissen, to persuade lawmakers to require makers of drugs and medical devices to disclose study results publicly. Currently, producers are not required to do so, but Congress is considering legislating a requirement.

Many companies besides GlaxoSmithKline already post results from some studies or trials on their Web sites, or one operated by the Pharmaceutical Research and Manufacturers Association, a trade group in Washington.

Dr. Bruce M. Psaty, a cardiologist at the University of Washington, said that having such information can play a critical role, as the case of Avandia suggests, in spotting signals of a drug's possible dangers.

Other experts have argued that the relative efficacy or cost of competing drugs can be compared only when all study results, rather simply those that a company chooses to publicize, are available.

Studies have found that the vast majority of drug and medical device studies are never published in medical journals.

"The more information, the better," Dr. Psaty said.

Dr. Ronald L. Krall, chief medical officer for Glaxo, said his company sharply disputed the methodology of Dr. Nissen's study, and a top F.D.A. official said that the agency had previously informed doctors about Avandia’s heart risks.

Dr. Krall said his company was aware when it created its database of study results a few years ago that it might lead to controversy. Other scientists might look at its data or choose to analyze it differently than company officials did, he said.

"We are committed to the principle of transparency," Dr. Krall added. "But we knew that when starting this, by putting the data in the public, many things could happen, some of which could be trouble."

Some experts also believe that releasing the results of hundreds of studies involving drugs or medical devices might create confusion and anxiety for patients who are typically not well prepared to understand the studies or to put them in context.

"I would be very concerned about wholesale posting of thousands of clinical trials leading to mass confusion," said Dr. Steven Galson, the director for the Center for Drug Evaluation and Research at the F.D.A.

[permanent link]

Avandia concerns reopen a wider debate
Wall Street Journal, 5-23-07

Editor's Notes:

This article, from the Wall Street Journal, reports that Avandia's class of drugs, called peroxisome proliferated–activated receptors or PPARS, have a long track record of both extraordinary promise and safety problems. Companies are working hard to maximize the benefit of PPAR drugs while minimizing the risks; hopefully, the backlash against Avandia will not shelve promising research in this area.

"It is a challenging class of drugs," said Robert Meyer, who heads the Food and Drug Administration office that oversees diabetes medications. "These are drugs with many effects and many targets" in the body.

On Monday, the New England Journal of Medicine released an analysis by Cleveland Clinic cardiologist Steven Nissen linking Avandia to a potential risk of heart attacks. Glaxo has said it disagrees with the finding, which it says is contradicted by data from sources the company considers stronger. But analysts warned yesterday that concerns about safety could cut Avandia's sales in half.

The PPAR drugs can target three different receptors in the cell nucleus. Avandia and Actos, which affect the PPAR-gamma receptor, can bring down blood sugar and are used to treat diabetes. A sister class called PPAR-alpha medicines, which includes older drugs such as gemfibrozil and fenofibrate, tends to boost HDL, or "good," cholesterol, and reduce triglycerides, or fats in the blood. A third type, PPAR–delta drugs, are seen as a prospective treatment for obesity. The jackpot would be medications that combine more than one of these mechanisms.

The drugs also may hold potential in other areas. Glaxo is studying Avandia for Alzheimer's disease. Bruce Spiegelman, a professor of cell biology at Harvard Medical School, plans to examine a PPAR-gamma medication for cancer, after "extremely good" data in animals. "You have the potential to affect a lot of things, and that can be good and that can be bad," he says of the PPAR drugs.

...

A Glaxo spokeswoman said the British company is studying new PPAR drugs in early-stage development. She said it was difficult to say whether such drugs are especially cursed with side effects. "Are there side effects in the PPAR class? Yes. Compared to the conditions that diabetes can lead to—blindness, kidney failure and amputation—we think the risk–benefit profile [of Avandia] is a very positive one."

[permanent link]



Project FDA.

2007-06-11
2007-06-07
2007-05-28
2007-05-23
2007-04-26
2007-04-18
2007-04-13
2007-04-05
2007-03-30
2007-03-12
2007-03-08
2007-03-01
2007-02-21
2007-02-14
2007-01-31
2007-01-28
2007-01-18
2007-01-11
2007-01-02
2006-12-29
2006-12-20
2006-12-12
2006-12-04
2006-11-27
2006-11-26
2006-11-13
2006-11-06
2006-11-01
2006-10-24
2006-10-19
2006-10-10
2006-10-06
2006-09-25
2006-09-23
2006-09-13
2006-08-30
2006-08-23
2006-08-14
2006-08-10
2006-08-03
2006-07-26
2006-07-18
2006-07-10
2006-07-06
2006-06-30
2006-06-22
2006-06-15
2006-06-08
2006-06-02
2006-05-23
2006-05-19
2006-05-08
2006-05-01
2006-04-19
2006-04-12
2006-02-14
2006-02-09
2006-02-01
2006-01-24
2006-01-19
2006-01-10
2006-01-04
2005-12-29
2005-12-21
2005-12-13
2005-12-06
2005-11-30
2005-11-22
2005-11-17
2005-11-09
2005-11-02
2005-10-26
2005-10-19
2005-10-12
2005-10-05
2005-09-28
2005-09-21
2005-09-14
2005-09-05
2005-08-29
2005-08-23
2005-08-16
2005-08-09
2005-08-04
2005-07-27
2005-07-20
2005-07-11
2005-07-06
2005-07-01
2005-06-13
2005-06-09
2005-06-05
2005-05-25
2005-05-18
2005-05-10
2005-05-02
2005-04-27
2005-04-20
2005-04-11
2005-04-05
2005-03-30
2005-03-21
2005-03-18
2005-03-08
2005-03-01
2005-02-23
2005-02-14
2005-02-07
2005-01-31
2005-01-24
2005-01-17
2005-01-10
2005-01-04
2004-12-31
2004-12-21
2004-12-13
2004-12-06
2004-11-29
2004-11-22
2004-11-15
2004-11-10
2004-11-01
2004-10-28
2004-10-19
2004-10-11
2004-10-05
2004-09-29
2004-09-21
2004-09-15
2004-09-08
2004-08-30
2004-08-25
2004-08-16
2004-08-09
2004-08-03
2004-07-26
2004-07-19
2004-07-12
2004-07-05
2004-06-29
2004-06-21
2004-06-14
2004-06-08
2004-06-01
2004-05-24
2004-05-17
2004-05-10
2004-05-02
0206-12-04
0000-00-00

  
home   spotlight   commentary   research   events   news   about   contact   links   archives
Copyright Manhattan Institute for Policy Research
52 Vanderbilt Avenue
New York, NY 10017
(212) 599-7000
mpt@manhattan-institute.org