Lawmakers Warn Drug Makers To Knock It O..

Lawmakers Warn Drug Makers To Knock It Off After Avandia Debacle - Part I

November 20, 2007. By Evelyn Pringle

Washington, DC: On November 15, 2007, the ranking Republican member of the Senate Finance Committee, Senator Charles Grassley, sent a not-so-subtle warning to the pharmaceutical industry when he invited scientists to contact his office if a company threatens their career or attacks their reputation when they raise alarm about a possibly dangerous drug.

"What I am here to say today, is that attacks on medical researchers by the pharmaceutical industry must stop," he stated. "And stop now."

"Until this practice ends," he said, "I want to let America's scientists know that I am very interested in their concerns."

His statement on the Senate floor accompanied the release of a November 2007 report on an investigation that showed executives at GlaxoSmithKline intimidated Dr John Buse, a medical researcher at the University of North Carolina, when he tried to sound the alarm about the increased cardiovascular risks associated with the diabetes drug Avandia.

In early 1999, the same year that Avandia was FDA approved for use in the US, Dr Buse gave speeches at meetings of the Endocrine Society and the American Diabetes Association and suggested that Avandia (rosiglitazone), a thiazolidinedione used to control blood sugar in patients with type 2 diabetes, may increase cardiovascular risks.

The Finance Committee, which oversees Medicaid and Medicare, initiated an investigation into the Avandia debacle last spring after the New England Journal of Medicine published a study on May 21, 2007, by Cleveland Clinic Cardiologist Dr Steven Nissen and Kathy Wolski, which found that Avandia was associated with a 43% increased risk of heart attacks and potentially a 64% increase in the risk of cardiovascular death.

Experts found the study disturbing because heart disease is highly prevalent in diabetics and accounts for between 65% and 80% of all deaths. Therefore, a drug that might increase the risk of heart disease represented a potentially important public health concern.

In a May 21, 2007, letter to Christopher Viehbacher, President of GSK's US Pharmaceuticals, Committee Chairman Max Baucus (D-MO) and Senator Grassley wrote, "It is troubling to say the least that by taking Avandia, diabetics may be increasing their risk of the very adverse event that they hope to prevent by controlling their blood sugar."

"To make matters worse," the letter advised, "American taxpayers have spent hundreds of millions of dollars on this drug through the Medicare and Medicaid programs."

"One of the most immediate concerns to us," the letter stated, "are reports that GSK employees silenced one or more medical professionals who attempted to speak out about the potential for cardiovascular problems with Avandia."

The May 21, 2007, USA Today reported that doctors in the US wrote 13 million prescriptions for Avandia in 2006, generating more than $2 billion in sales for GSK, citing figures from the data tracking firm IMS Health.

In a June 5, 2007, editorial in the New England Journal of Medicine, entitled, "The Record on Rosiglitazone and the Risk of Myocardial Infarction," Dr Bruce Psaty of the University of Washington and Dr Curt Furberg of Wake Forest University placed some of the blame for the Avandia debacle on the FDA itself.

"The primary measure of regulatory success is the timeliness of information, warnings, and withdrawals," they wrote. "With rosiglitazone, the FDA failed to warn or inform in a timely fashion."

They point out that in August 2006, GSK provided the FDA and the European Medicines Agency with the results of several studies, including a meta-analysis on Avandia, with results similar to Dr Nissen's and that the product labels in Europe included the information by October 2006.

They also report studies that show Avandia is associated with "significant weight gain, an adverse effect on low-density lipoprotein cholesterol, an increased risk of heart failure, an increased risk of fractures in women, and an apparent increase in the risk of myocardial infarction."

In February 2003, the World Health Organization issued a warning of the potential cardiac risks associated with drugs like Avandia.

The Subcommittee of the House Committee on Oversight and Government Reform, which oversees the FDA, also held hearings on Avandia. In an opening statement at a June 6, 2007, hearing, Committee Chairman Henry Waxman (D-CA) stated: "Although Avandia has been on the market for eight years and has been used by millions of Americans, the post-market studies have not been done to say conclusively whether Avandia increases or decreases the risk of heart attacks."

"That's a major failure of our system," he stated.

"As a member of Congress," he said, "I'm not qualified to judge whether the risks of Avandia outweigh its benefits."

"But I do know," he added, "that the millions of diabetics who have taken Avandia have not been well served by our regulatory system."

"The FDA is on notice that we have reached the end of our rope on their stonewalling of investigations into their failures to keep Americans safe from dangerous drugs," Rep Bart Stupak (D-MI) said in a May 21, 2007 written statement.

Lawmakers on both side of the isle also called on FDA Commissioner Andrew von Eschenbach to explain the agency's conflict-of-interest policies regarding employees hired from companies which are regulated by the FDA, after it became known that on May 24, 2007, FDA spokesman Doug Arbesfeld, who worked for numerous drug companies prior to being hired, sent an email to journalists with derogatory comments about Dr Nissen, implying that he published bogus research on Avandia because GSK does not conduct research at the Cleveland Clinic.

On May 30, 2007, Dr Nissen told ABC News, "I'm a pretty tough guy, but I'll tell you, having this kind of an e-mail that questions my motives, broadcast to the major journalists with whom I work and have established a reputation, is -- it's an outrage."

A letter was sent to the FDA Commissioner on June 7, 2007, requesting more information about Mr Arbesfeld's e-mail to journalists, which was signed by Senators Grassley, Baucus and Sherrod Brown, as well as Representatives John Dingell and Bart Stupak.

The letter noted that Mr Arbesfeld sent the message using his Government e-mail, which carried his FDA signature line and work-related contact information and that in several news articles on other matters, Mr Arbesfeld was listed as spokesman for the FDA.

The letter stated, in part, "this e-mail may have given journalists the impression that the United States Government actively encourages smear campaigns against independent scientists."

"If so," it said, "this is a completely unacceptable use of Government time and equipment."

In a press release announcing the letter, Senator Grassley stated, "it's discouraging and alarming to see another situation where you can't tell the difference between the actions of the FDA and those that might come from a drug maker it's regulating."

"The opinions of independent scientists must be valued by the FDA," Senator Baucus stated.

"I have some serious questions about Mr. Arbesfeld's use of government resources, but I am even more concerned about whether his drug company connections led him, in any way, to seek to unjustly discredit Dr. Nissen," he said.

"The FDA's ultimate duty" he pointed out, "is to ensure the safety of the products it regulates, which includes sharing credible, potentially life-saving information from any trustworthy source."

"The FDA should thank doctors who identify potential health risks, not demonize them. Congress is working on legislation to clean up FDA's act, and none too soon," Senator Brown said in the press release.

Staffers of the Finance Committee also came across a February 22, 2006, internal FDA memorandum, which showed that safety official Dr David Ross recommended that GSK add a black box warning about congestive heart failure to the Avandia label a year earlier.

In addition, the memo recommended that macular edema, a condition that causes swelling of the retina and can lead to blindness, be listed as a serious adverse event and shows that, although the recommendations were approved by Dr Rosemary Johann-Liang, the Deputy Director of the FDA's Division of Drug Risk Evaluation, they were never added to label.

Instead of forcing GSK to post warnings, the Committee reports, top FDA officials basically demoted Dr Johann-Liang for approving the warnings to begin with.

In a July 26, 2007 speech on the Senate floor, Senator Grassley said, "Not only did the FDA disregard the concerns and recommendations from the office responsible for post-marketing surveillance, but I have found that it also attempted to suppress scientific dissent."

In the past two months, he said, "I've had to write to the FDA regarding the suppression of dissent from not one but two FDA officials involved in the review of Avandia."

In a July 25, 2007 press release announcing the company's 2007 second quarter earnings, GSK reported that sales of Avandia fell 22% worldwide and 31% in the US, following the publication of the May 2007 analysis in the NEJM.

The press release also reported the filing of Avandia related lawsuits. "Following publication of the NEJM article," it stated, "the Group has been named in product liability lawsuits on behalf of individuals and purported class action cases asserting consumer fraud and/or personal injury claims on behalf of purchasers and users of Avandia."

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