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News Articles >> Lawsuits Against Glaxo Rise as Avandia S..
Lawsuits Against Glaxo Rise as Avandia Sales Plummet
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| August 1, 2007. By Evelyn Pringle |  RSS  Del.icio.us  Seed Newsvine  Facebook |
Washington, DC: A study released in July 2007, by the Federal Agency for Health Care Research and Quality, reported that the older diabetes drugs, available for as little as $10 a month, are as safe and effective as the newer drugs like Avandia (rosiglitazone), which costs between $131 and $262 a month.
On July 20, 2007, Science Daily reported that little evidence supports using Avandia to improve the quality or lengthen of life among adults with diabetes, citing a systematic review of data by German researchers.
"Furthermore," Science wrote, "data suggest that the drug might worsen complications of the disease such as weight gain, swelling, bone fractures and heart disease."
"The benefit-risk ratio of rosiglitazone therapy for type 2 diabetes mellitus needs urgent clarification," Science quoted the authors of the review, led by Bernd Richter, MD, of Heinrich-Heine University, as saying, "New safety data ... should lead to a very cautious approach to rosiglitazone use. If possible, other antidiabetic medications should be employed."
Avandia (rosiglitazone), also marketed as Avandamet and Avandaryl, is sold by GlaxoSmithKline.
In treating diabetics, a doctor currently can prescribe insulin injections and four classes of oral medications; one increases insulin production, one reduces sugar production in the liver, one slows the breakdown of carbohydrates and Avandia's class enhances insulin action so that patients can reduce insulin intake, which means fewer shots.
In 2006, Avandia was the top-selling oral diabetes drug in the US with $2.2 billion in sales, according to IMS Health, a medical information tracking firm, and it was Glaxo's 2nd best-selling drug world-wide, with sales of $3.3 billion.
However, sales have taken a nose-dive since May 21, 2007, when the FDA issued a safety alert for Avandia based on the pooled analysis of previously completed controlled clinical trials demonstrating a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.
Also, on May 21, 2007, an analysis of Avandia studies, conducted by Cleveland Clinic cardiologist Dr Steve Nissen, was published online by the New England Journal of Medicine. Dr Nissen's analysis was based on data from 42 controlled clinical trials, and his conclusions were that Avandia increased the risk of heart attacks by 43% and the risk of death from cardiovascular causes by 64%, which was similar to the findings of the FDA.
In a May 21, 2007, letter to FDA, Senate Finance Committee Chairman Max Baucus (D-Mont.) and the ranking Republican Senator Charles Grassley (R-Iowa), informed Commissioner Andrew von Eschenbach that the Committee had received reports that executives with Glaxo met with FDA officials in October 2005 and later in August 2006 after further exploring the same cardiovascular problems.
"We understand that during the same time period," they also said, "other concerns were raised by FDA employees."
In a May 23, 2007, interview with the Wall Street Journal, Dr Nissen explained that, "Cardiovascular disease is far and away the leading cause of death in diabetes."
"If you find a diabetes drug increases the risk of heart attacks," he warned, "the consequences are so grave that it warrants urgent action."
On the ABC television program "Nightline," Dr Nissen warned that the deaths caused by Avandia could "dwarf" the carnage of 9/11.
On May 23, 2007, the FDA sent letters to Glaxo and the manufacturer of Actos (piaglitazone), another diabetes drug in the same class, requesting that the labeling for the drugs include a black box warning about the risks of congestive heart failure associated with the use of the drugs.
The next day, on May 24, 2007, the New York Times reported that a leading diabetes doctor had sent the FDA a letter in 2000 that warned about the heart risks of Avandia.
In a June 4, 2007, letter to the FDA Commissioner, Senators Baucus and Grassley demanded answers about why macular edema, a condition that involves swelling of the retina and can cause blindness, was not listed on the Avandia label as a serious adverse event and why congestive heart failure was not highlighted in a boxed warning, as recommended in an internal FDA memorandum dated February 22, 2006, prepared by "a very seasoned safety evaluator", who said that Glaxo should list warnings.
It is now known that the "seasoned safety evaluator" was FDA scientist Dr David Ross.
By July 25, 2007, Glaxo earnings reports showed US sales of Avandia had fallen 31% to $226 million in the quarter following the posting of Dr Nissen's study online.
Shareholders were alarmed over the immediate drop in stock value when the news broke on May 21, 2007, and have since accused Glaxo of concealing the risks associated with the drug. On June 11, 2007, the New York law firm of Kaplan Fox & Kilsheimer announced in a press release the filing of a shareholders lawsuit against Glaxo, alleging the company misled investors about the safety of its diabetes drug Avandia.
The lawsuit alleges that Glaxo failed to disclose an analysis of clinical trials that found Avandia patients were at an increased risk of heart attacks, "engaged in a scheme to deceive the market" with conduct that "artificially inflated GSK's stock price," and "as a result, plaintiff and other members of the class suffered economic loss."
A little over a month later, on July 13, 2007, Charles H Johnson & Associates announced that another class-action lawsuit had been filed on behalf of purchasers of Glaxo publicly-traded securities during the class period of October 27, 2005 through May 21, 2007, which also alleges that Glaxo failed to adequately disclose the fact that it had performed a meta-analysis of Avandia which showed an increased risk of heart attacks.
Glaxo presented the preliminary results of the analysis to the FDA in September 2005, and updated results were disclosed to the FDA in August 2006, but the results "were never adequately disclosed to the investing public," the firm's press release states.
The complaint alleges that on May 21, 2007, before the close of trading, the results of another analysis of Avandia by a doctor from the Cleveland Clinic was published in the NEJM similar to Glaxo's analysis conducted in 2005 and 2006, and revealed that Avandia increased the risk of heart attacks and possibly heart-related deaths.
As a result of the reports, the press release states, "the price of GSK securities declined $4.53 per share, or 7.8%, to close at $53.18 per share."
On June 20, 2007, the Drinnon Law Firm in Dallas announced that the widow and son of a Texas man had filed a private lawsuit against Glaxo alleging that the diabetes drug contributed to the man's fatal heart attack. Ironically, the 60-year-old man died from a heart attack the same day that the report was published in the NEJM, according to the firm.
On July 30, 2007, a panel of FDA advisors, which the Senate Finance Committee claims had too many members with ties to the pharmaceutical industry, voted 22-1 to allow Avandia to remain on the market.
Two FDA scientists, Dr David Graham and his superior, Dr Gerald Dal Pan, advised the panel that the drug should be removed from the market. The FDA itself will make the final decision on whether the drug will be sold in the US and, although the agency usually follows the recommendations of the advisory panels, it is not required to do so.
However, in the meantime, two more class-action lawsuits were filed against Glaxo in Ontario and Saskatchewan Canada on the same day as the advisory panel hearing on behalf of numerous patients who have experienced health complications after taking Avandia, according to the July 31, 2007, Mississauga News.
Attorney Tony Merchant told the Canadian Press that the lawsuits are on behalf of patients who have died or suffered heart attacks and loss of vision, the News reported.
Law firms all over the US report that the number of calls from persons requesting information about Avandia-related injuries is rising every day.
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