Healthy Skepticism Library item: 7165

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Publication type: news

Goldstein A.
FDA Stent Experts Have Financial Ties to J&J, Rivals
Bloomberg.com 2006 Dec 4
http://www.bloomberg.com/apps/news?pid=20601202&sid=aC0N5sNeh6G4&refer=healthcare

Abstract:

Six physicians with financial ties to Johnson & Johnson and other heart-device makers will be advising U.S. regulators whether to restrict the use of some products because of potentially lethal side effects.

The doctors will serve this week on a Food and Drug Administration panel of experts in Washington reviewing blood clots linked to stents, tiny devices that prop open arteries. The panel members, listed on an FDA Web site Nov. 22, will include Robert Harrington, who runs a Duke University research institute funded by stent makers J&J and Boston Scientific Corp.

To allow the doctors to participate in the review, the FDA is waiving rules that bar panelists from serving in matters affecting companies in which the experts have stock ownership or consulting contracts. Regulators say expert researchers often consult for makers of products under review. Agency critics, including Republican Senator Charles Grassley of Iowa, say only advisers without financial conflicts should be chosen.

``I could think of 100 people who could qualify,’‘ said Herman Gold, a cardiologist at Massachusetts General Hospital in Boston and a Harvard Medical School associate professor. ``The FDA has been asleep at the switch with regard to the safety’‘ of stents, Gold said in a Nov. 28 interview.

Gold, 65, said he plans to present research to the FDA panel explaining how coatings on some stents raise blood-clot risk. Last year, stents coated with drugs designed to keep arteries from reclogging accounted for 43 percent of sales for Natick, Massachusetts-based Boston Scientific and 5.2 percent for New Brunswick, New Jersey-based J&J.

Fivefold Danger

The risk of blood-clot formation is raised as much as fivefold in heart patients who receive drug-coated stents compared with those getting bare-metal ones, according to a Cleveland Clinic Foundation analysis released Nov. 29. The study is the latest to raise concerns that drug-eluting stents are more likely to cause clots leading to heart attacks and strokes.

Shares of J&J rose 31 cents to $66.28 at 4:01 p.m. in New York Stock Exchange composite trading and have climbed 10 percent this year. Boston Scientific rose 18 cents, or 1.1 percent, to $15.94. It has declined 35 percent this year.

Some members of Congress, including Grassley, and consumer groups such as Public Citizen in Washington have criticized the FDA in past cases for selecting panelists with financial ties to companies whose drugs or devices are under review.

FDA Criticism

Ten of 32 members of the FDA advisory group on painkillers such as Vioxx, the drug withdrawn by Merck & Co. of Whitehouse Station, New Jersey, in September 2004 because of cardiac risk, had financial ties to makers of the medicines, according to a study last year by the Center for Science in the Public Interest, a Washington-based advocacy group.

The panel voted 17-15 to allow Vioxx back on the market. Nine of the 10 panelists with financial ties to the makers of this class of drugs voted with the majority, according to the advocacy group. The FDA later rejected the advice.

Blood clots in drug-coated stents may be causing an extra 2,160 deaths in the U.S. each year, according to Sanjay Kaul, director of the cardiology fellowship training program at Cedars- Sinai Medical Center in Los Angeles, and a colleague, who wrote an editorial posted on the Internet on Oct. 11 by the American College of Cardiology. Boston Scientific, J&J and some researchers say the risks are minuscule, no worse than for uncoated stents.

$6 Billion Market

Recommendations by the panel, which will meet Dec. 7 and 8 in Gaithersburg, Maryland, may influence FDA guidelines involving the $6 billion-a-year global stent market. The panelists will consider whether cardiologists implant too many coated stents, how long companies should test new models to get U.S. approval, and whether patients should take the anti-clotting drug Plavix for a year or more.

Plavix, from Bristol-Myers Squibb Co. and Sanofi-Aventis, was the world’s second-best-selling medicine last year, after the cholesterol drug Lipitor, made by New York-based Pfizer Inc.

FDA documents on the Web site disclosed the appointments of the six doctors with financial connections to the industry. The agency deleted company names, consulting fees and stock ownership.

The six doctors’ expertise on heart disease outweighs the fact that they hold shares in, or receive fees from, stent companies, Randall Lutter, the FDA’s associate commissioner for policy and planning, said in the postings.

The Duke Clinical Research Institute in Durham, North Carolina, has grants or contracts from 182 drug and device companies, including J&J, Boston Scientific, Conor MedSystems Inc. in Menlo Park, California, Medtronic Inc. in Minneapolis, and Abbott Laboratories in Abbott Park, Illinois, according to documents released by Duke.

`Deep Understanding’

Harrington, the institute’s director, said he performs research and lectures on a new anti-clotting drug for New York- based Bristol-Myers and reviews clinical-trial data for an experimental medicine from Paris-based Sanofi-Aventis.

``If you would like people working in the field with a deep understanding of the issues to be involved, then by default you are going to approach people who likely have conflicts, real or perceived,’‘ he said in a telephone interview on Nov. 29. ``The FDA believes, and I concur, that my particular conflicts for this are not going to have any impact on my impartiality.’‘

Another panelist will be George Vetrovec, a cardiologist at Virginia Commonwealth University in Richmond. The FDA said Vetrovec owns shares of four medical companies, including a stent maker, and receives fees from one for consulting on drug-eluting stents. Vetrovec wasn’t available to comment, said Joe Kuttenkuler, a university spokesman.

Consulting Fees

Four other panelists have ties to stent makers, the FDA said. The panel will have additional members whose names will be released on Dec. 6, said Heidi Valetkevitch, a spokeswoman for the agency.

Mitchell Krucoff, a researcher in the institute run by Harrington at Duke, said the FDA hasn’t granted him a waiver, even though he has served on the advisory group for three years.

``We don’t get a formal explanation on why they recused me,’‘ Krucoff said in a telephone interview on Nov. 1.

Besides Harrington and Vetrovec, the panelists with potential conflicts are Judah Weinberger, a cardiologist and clinical-trials specialist at Columbia University in New York; JoAnn Lindenfeld, director of the University of Colorado heart- transplant program in Denver; Richard Page, a heart-rhythm expert at the University of Washington in Seattle; and Clyde Yancy, a heart doctor at the University of Texas Southwestern Medical Center in Dallas.

Disclosure at Meeting

Weinberger’s ties to industry will be disclosed in detail at the meeting, he said in an e-mail sent by Craig LeMoult, a spokesman for Columbia’s medical center. Lindenfeld declined to comment on her potential conflicts of interest, said Tonya Ewers, a spokeswoman for the University of Colorado.

Page wouldn’t name the companies to which he has financial ties, said Clare Hagerty, a spokeswoman for the University of Washington. Yancy also declined to comment, referring questions to the FDA, said Maria Carpenter, a University of Texas spokeswoman.