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According to the Wall Street Journal, the U.S. Food and Drug Administration is considering halting a study involving the diabetes drug Avandia due to concerns about heart attack risks.

If the agency stops the so-called TIDE study -- which compares the safety of Avandia and its competitor Actos -- it could also lead to the removal of Avandia from the U.S. market.

The FDA has been a defender of the diabetes drug, made by GlaxoSmithKline, despite the publication of studies that link Avandia’s use to 83,000 heart attacks between 1999 and 2007.

In late February, a Senate Finance Committee released a report that was highly critical of GlaxoSmithKline. After a two-year investigation, the committee concluded that the drug maker knew of the heart attack risks associated with Avandia but hid them from the public. The report also questioned the FDA’s close ties with Glaxo.

In March, FDA Commissioner Margaret Hamburg sent a letter to Sen. Chuck Grassley, indicating that the agency was reassessing the TIDE trial.

The FDA now says it has asked the Institute of Medicine to review the ethics of continuing the study comparing Actos and Avandia.

If you or a loved on suffered a heart attack after taking Avandia, contact the attorneys of Carey, Danis & Lowe. We can help. Carey, Danis & Lowe is a national law firm that represents individuals injured by America’s largest corporations.

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When it comes to a “disturbing example of inappropriate conduct surrounding an industry-sponsored clinical trial,” a GlaxoSmithKline study of its diabetes drug Avandia is being held out as Exhibit A in an editorial that appeared in the March 23 issue of the Journal of the American Medical Association.

The rebuke comes on the heels of a U.S. Senate report concluded that Glaxo, worried about independent studies linking its best-selling diabetes drug to heart attacks, rushed its own study into publication in an attempt to undermine the adverse research.

The editorial argues that drug-sponsored studies should be reviewed by independent scientists with no company ties.

Written by the journal’s editor Catherine DeAngelis and executive deputy editor Phil Fontanarosa, the commentary states that researchers should have full access to study data and editors should require an independent statistical analysis before publishing the studies.

The JAMA also published a commentary from Dr. Steven Nissen, the chair of the Cleveland Clinic’s cardiology department who published a 2007 study that linked Avandia use to a 43 percent increase in heart attacks.

“As illustrated by the problems with the RECORD trial, absence of independent access to all of the data in the trial may allow physician-scientists to be manipulated by the sponsor, resulting in a manuscript that does not provide the most accurate assessment of the risks and benefits of the therapy.”

If you or a loved on suffered a heart attack after taking Avandia, contact the attorneys of Carey & Danis. We can help. Carey & Danis is a national law firm that represents individuals injured by America’s largest corporations.

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As the debate over the safety of diabetes drug Avandia continues, confidential reports from within the Food and Drug Administration reveal an effort by some within the agency to have the drug removed from the market, the New York Times reports.

As the article notes, a multi-million dollar advertising campaign by the drug’s maker GlaxoSmithKline helped catapult it into one of the best selling drugs worldwide. In 2006, sales of Avandia reached $3.2 billion.

But in 2007, a study linked Avandia to heart damage and heart attacks. That same year, the FDA issued a warning about the potential dangers. But in an 8-7 vote, the FDA’s oversight board allowed Avandia to stay on the market.

Even though the drug was not pulled from the market, there were those inside the federal agency who were calling for its removal. An internal memorandum written by Dr. David Graham and Dr. Kate Gelperin of the FDA in 2009 claimed that if every patient taking Avandia were switched to Actos, a similar drug, “about 500 heart attacks and 300 cases of heart failure would be averted every month.”

And the same two doctors warned in 2008 that a GlaxoSmithKline study called TIDE was “unethical and exploitive.” That study involved enrolling diabetic patients to study the risks associated with Avandia.

The memorandum warns:

“Although the proposed TIDE trial is motivated by a desire for definitive answers regarding the cardiovascular safety of the drug rosiglitazone, the safety of the study itself cannot be assured and is not acceptable.”

According to the New York Times, Glaxo is currently enrolling patients in the study, which is not expected to be completed until 2020. Glaxo hopes to report some preliminary results in 2014.

If you or a loved on suffered a heart attack after taking Avandia, contact the attorneys of Carey, Danis & Lowe. We can help. Carey, Danis & Lowe is a national law firm that represents individuals injured by America’s largest corporations.

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A team of reviewers from the Mayo Clinic has found that nearly all of the scientific experts who have defended GlaxoSmithKline’s diabetes drug Avandia had ties to the company, Reuters reports.

Despite tens of thousands of deaths and heart attacks linked to Avandia, the drug has received support in scientific studies and commentary. The Mayo Clinic review, which appears in the British Medical Journal, raises a number of concerns.

According to the Mayo Clinic review, approximately 94 percent of the positive Avandia reviews that emerged after a May 2007 study linked Avandia with an increased risk of heart attacks were from scientists with ties to the drug’s maker, Glaxo. And nearly half of the defenders had a conflict of interest because of their financial ties.

In an interview with Reuters, Dr. Victor Montori of the Mayo Clinic noted:

“It was almost three to four times more likely that somebody who had a relationship with a pharmaceutical company had a favorable opinion of the medication.”

The reviewers also looked at whether the scientists disclosed their ties to the drugmaker and found about 25 percent failed to do so.

This latest news comes about a month after a Senate Finance Committee released a highly critical report that claimed Glaxo abused the public’s trust by failing to disclose the serious health risks associated with Avandia.

That investigation, “Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia,” indicated that since coming onto the market, Avandia has been linked to 83,000 deaths.

Earlier this month, Public Citizen, a consumer advocacy group, sent a letter to the Food and Drug Administration urging it to ban Avandia due to the heart attack dangers and the fact that a safer drug, Actos, is already on the market.

If you or a loved on suffered a heart attack after taking Avandia, contact the attorneys of Carey, Danis & Lowe. We can help. Carey, Danis & Lowe is a national law firm that represents individuals injured by America’s largest corporations.

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On March 8, the consumer advocacy group Public Citizen sent a letter to the U.S. Food and Drug Administration urging it to ban the diabetes drug Avandia.

In the letter, Public Citizen Director Sidney Wolfe MD notes the recent FDA recall of products that contain hydrolyzed vegetable protein because of salmonella concerns. Yet, drug safety has not received the same level priority.

Public Citizen highlights the FDA’s failure to ban three harmful prescription medicines, diabetes drug Avandia, the painkiller propoxyphene which includes Darvocet and the diet drug Meridia.

As Wolfe notes, last year a large Canadian study found that heart failure and death was much higher people who used Avandia instead of its safer competitor Actos. For every million people who received Avandia, there were 8,300 more instances of heart failure and 3,500 more deaths than among the patients who were prescribed Actos.

As a result, the American and European Diabetes Associations have unanimously advised against using Avandia.

Wolfe writes:

By deciding not to ban three drugs in particular, the FDA has endangered the lives and health of hundreds of thousands of people. For each of these drugs there is unequivocal evidence that their dangers, resulting collectively in hundreds of deaths each year, clearly outweigh their health benefits.

If you or a loved on suffered a heart attack after taking Avandia, contact the attorneys of Carey, Danis & Lowe. We can help. Carey, Danis & Lowe is a national law firm that represents individuals injured by America’s largest corporations.

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Last Friday, Santa Clara County filed a false-advertising lawsuit against GlaxoSmithKline claiming it hid the heart attack risks associated with the diabetes drug Avandia, the Mercury News reports.

The suit is believed to be the first one filed by a government entity involving the controversial diabetes drug. Avandia has been linked to an estimated 60,000 – 200,000 heart attacks, strokes and cardiovascular deaths nationwide from 1999-2006.

Because Santa Clara runs its own hospital and treats indigent patients, a county lawyer asserts that its local costs associated with the drug’s side effects are higher than in many other areas.

The suit was filed in a San Jose federal court. It alleges the county spent $2 million on Avandia on behalf of indigent patients from 1999 to 2007 and that it covered the costs of treating heart patients whose conditions could have been avoided if they had not taken the drug.

This past September, the county removed Avandia from its list of recommended drugs.

Last month, a Senate committee has issued a report concluding that GlaxoSmithKline knew of the Avandia-heart attack link but hid it from the public.

If you or a loved on suffered a heart attack after taking Avandia, contact the attorneys of Carey, Danis & Lowe. We can help. Carey, Danis & Lowe is a national law firm that represents individuals injured by America’s largest corporations.

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Despite the findings of a new Senate report that underscores the link between the diabetes drug Avandia and heart attacks, the U.S. Food and Drug Administration has not moved to pull the drug off the market.

Instead, the Wall Street Journal reports, the FDA has informed doctors that it is reviewing the information and will discuss the issue at July FDA advisory committee hearing. Until then, it recommends that patients continue taking the drug made by GlaxoSmithKline.

The decision to keep Avandia on the market drew criticism from Rep. Rosa DeLauro (D-Conn). In a statement, the lawmaker who also chairs the House committee that control’s the FDA’s budget, asserted:

“I strongly urge the FDA to remove Avandia from the market until a truly independent, science-based advisory panel can evaluate the effectiveness of the drug. It is reprehensible that many people might have suffered heart attacks or heart failures as a result of taking this drug, especially if safer alternatives exist.”

The Avandia safety issue also highlights the FDA’s conflicting roles as the agency that approves drugs and is responsible for monitoring the safety. In fact, the group that is charged with post-market surveillance of drug safety reports to the division that approves new medications.

If you or a loved on suffered a heart attack after taking Avandia, contact the attorneys of Carey & Danis. We can help. Carey & Danis is a national law firm that represents individuals injured by America’s largest corporations.

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Thousands of heart attacks have been linked to Avandia, a diabetes drug made by GlaxoSmithKline. Now, a Senate committee has issued a report concluding that the drugmaker knew of the risks but hid them from the public.

On Feb. 20 the Senate Finance Committee issued a 334-page report titled “Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia.”

Since Avandia came onto the market, it has been associated with 83,000 heart attacks. In a statement, the committee's chairman, U.S. Senator Max Baucus (D-Montana) asserted:

“Americans have a right to know there are serious health risks associated with Avandia and GlaxoSmithKline had a responsibility to tell them. Patients trust drug companies with their health and their lives and GlaxoSmithKline abused that trust.”

For the report, investigators reviewed more than 250,000 pages of documents and interviewed GlaxoSmithKline, the FDA and whistleblowers who remain anonymous.

According to the report:

• Concerns about the Avandia-heart attack link were raised as far back as 1999. If the cardiovascular risks had been taken more seriously, many heart attacks could have been averted.

• GSK executives tried to intimidate doctors who were concerned about the potential dangers, misrepresented the findings of critical studies and downplayed the benefits of competing drugs.

• In 2008, two FDA safety officials warned that a study comparing Avandia and a competitor was unethical because of the heart attack risks yet the trial is still ongoing.

The bipartisan report also faulted the U.S. Food and Drug Administration, finding it was “too cozy with drug makers.” Senator Chuck Grassley (R-Iowa), the committee's ranking Republican, stated:

“There’s a real problem when FDA’s office that reviews drugs that are on the market is an unequal player in drug safety efforts. It doesn’t make any sense to have these experts, who study drugs after they have been on the market for several years, under the thumb of the officials who approved the drug in the first place and have a natural interest in defending that decision. The Avandia case may be the most alarming example of the problem with this set-up.”

If you or a loved on suffered a heart attack after taking Avandia, contact the attorneys of Carey & Danis. We can help. Carey & Danis is a national law firm that represents individuals injured by America’s largest corporations.

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