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GSK reportedly settles thousands of Avandia suits for $460M

Posted July 14, 2010

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— Drug giant GlaxoSmithKline (NYSE: GSK) is paying $460 million to settle thousands of lawsuits that allege health problems related to use of its diabetes drug Avandia, according to Bloomberg news.

Citing people familiar with the the situation, Bloomberg said some 10,000 suits have been settled at an average cost of $46,000.

The news broke as GSK and the U.S. Food and Drug Administration prepared for the second day of a hearing about Avandia. An FDA committee could recommend that Avandia be removed from the market.

Bloomberg noted that GSK, which maintains its U.S. headquarters in RTP and employs some 5,000 people in the area, faces some 13,000 suits. A federal trial is scheduled to open in October.

UBS AG analyst Gbola Amusa told Bloomberg that the settlement costs were “exceptionally good news, given the market has discounted $6 billion in liability” for Avandia suits.

In Washington on Tuesday as the FDA hearing opened, meanwhile, the focus was on the question: Does Avandia cause heart attacks?

It's the type of crucial safety question that the agency was established to answer. But the task of evaluating rare side effects of the drug that emerged after the agency approved it has dragged on for years without clear answers.

It became clear that the agency's own scientists are deeply divided.

On Wednesday the FDA will ask a panel of outside advisers to untangle the mess of data that has stumped its own scientists for more than three years.

The group will vote on a range of recommendations, including possible withdrawal of the drug. The FDA will make a final decision in coming months.

The FDA has been down this road before. In 2007 a similar group of experts voted to keep Avandia on the market despite an analysis of dozens of studies suggesting it increased the risk of heart attack.

The agency is not required to follow the group's advice, though it often does.

New data on Avandia's risks, and pressure from public safety advocates, have prompted the agency to re-examine the drug's safety.

FDA Commissioner Margaret Hamburg opened the meeting by advising panelists to "follow the science wherever it leads and the rest will fall into place."

But it quickly became clear that the FDA's own staff have reached vastly different conclusions from the same science.

The FDA's first two presenters delivered conflicting opinions of a key study of Avandia which GlaxoSmithKline has touted as proof of the drug's safety.

The so-called RECORD study is crucial to the debate because it is the only study designed specifically to look at heart safety of Avandia versus other diabetes treatments.

FDA drug reviewer Thomas Marciniak gave a stinging review of the study, which was sponsored by GlaxoSmithKline. Marciniak complained that an unusually high number of patients dropped out of the study and that several heart attack reports were excluded from the final results.

Part of the problem with the study was that doctors tracking patients — who were paid by GlaxoSmithKline — were aware of which patients were receiving Avandia versus other diabetes drugs. Often such trials are designed so doctors don't know who receives which pill.

Without the "blinded" structure, Marciniak said there may have been an incentive for doctors to underreport problems with the Glaxo's drug.

"I would have rejected this study design as completely biased," Marciniak told panelists.

Another FDA drug reviewer described the trial in even harsher terms.
"Everything we've seen up to this point shows you can't trust it," said David Graham. "And if you do trust it, you're engaging in the willful suspension of disbelief."

But following the criticism of RECORD, a senior level FDA official attempted to bolster support for the trial.

Ellis Unger, FDA's deputy director for drug evaluation, said that he found the RECORD results "largely free of bias, and very reassuring."

While some heart attacks were left out of the study, he pointed out that overall survival statistics were accurately reported and showed no disadvantage for Avandia.

Still, Unger acknowledged the difficult questions facing the FDA's advisers.

"There is no clear picture here, otherwise you'd be back at home," Unger told the panel. "That's why you guys are here: to read 1,000 pages and sort out what it all means."

Despite the reams of data presented at the meeting, the FDA's problem remains one of too little data.

While the original studies of Avandia showed the drug helped control blood sugar levels — the key measure for diabetes drugs — they were not large enough to detect all the potential side effects, such as heart attacks.

Since diabetics are already predisposed to heart risks it is extremely difficult to tell which heart attacks are drug-related and which are simply a result of the underlying disease.

Some scientists have tried to get an accurate picture of those risks by pooling hundreds of thousands of data points from various sources.

The most recent analysis — presented Tuesday by FDA's Graham, who wants the pill banned — estimated that as many as 100,000 heart-related problems may have been caused by Avandia.

Avandia was Glaxo's third best-selling drug in 2006 with U.S. revenue of $2.2 billion, according to health care statistics firm IMS Health. Safety concerns swirling around the drug have pummeled sales, which have fallen 75 percent to $520 million last year.
While there are more than a dozen diabetes medications on the market, only Actos from Japan-based Takeda Pharmaceuticals works the same way as Avandia.

Critics of Avandia say there is no reason to leave the drug on the market when Actos provides the same benefits without the potential heart risks.

Both drugs work by increasing diabetics' sensitivity to insulin, a key protein needed for digestion.

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  • chfdcpt Jul 14, 11:51 a.m.

    "Let me guess, $10 million to each law firm and $1.67 to each plaintiff. Gotta love class action settlements"...citizen

    Does anyone remember that toll free number for the lawyer that runs late night commercials for all types of lawsuits? The Law Offices of James Sokolov...

    Or will the case be handled by the offices of Dowe, Cheathem and Howe?

  • froggytroat Jul 14, 10:20 a.m.

    >>we are the ones who will pay for the lawsuit....drug prices will go up, yet again.

    Well, you should buy some stock in the drug companies and law firms that file the suits, then. 460M to settle and almost 8B in revenue. They're still making plenty of money. They just consider the lawsuits the cost of doing business.

  • See Chart Jul 14, 10:02 a.m.

    This is what you get when a respected drug company messes up.
    More to come on this from the media and yes the lawyers .

  • fishon Jul 14, 9:43 a.m.

    My doctor told me it was a result of my lifestyle. So I bought a Bowflex home gym and use it 3-4 times a week, walk in the morning and/or lunchtime, never eat hi glycemic foods without eating some kind of protein, lost some weight and now years later still under control.

    Early on met with a dietician who discussed having protein of some kind with every meal/snack. She also thought if you are taking meds for other problems for many years, say asthma, the weakest part of your system could be affected (pancreas?). And that your liver secretes more sugar if you are under stress.

    Unfortunately meds and stress are also part of my non- lavish "lifestyle".

  • ghimmy51 Jul 14, 9:43 a.m.

    If it's not double blind it's not science. It's opinion. As Golo shows opinion has nothing to do with facts.

  • djofraleigh Jul 14, 9:30 a.m.

    Waht do thin people do when their blood sugar is high? I know a woman who, if she misses a meal, has her sugar go up, and it goes up every night, because her liver starts making the sugars. She has to eat six or so small meals spread over the day without Missing one. Consistency seems to be the key for her body. Unlike most americans with appetite, she has to make herself eat.

  • GT Nupe Jul 14, 9:27 a.m.

    $2.8B in sales in 2006, $1.8B in 2007, $1.5 in 2008, and $1.2B in 2009. $7.3B in total sales since 2006. $460M is a drop in the bucket and drug companies would and will gladly take a 6% fee for their drug to sell as well as Avandia did. And so the cycle continues...on to the next one for GSK.

  • WRALblows Jul 14, 9:11 a.m.

    The Mayo Clinic and the American Medical Associations publicly printed position is "Type 2 Diabetes is most often a weight related condition". So one could safely say it is "often" a lifestyle disease.

    "There's no cure for type 2 diabetes, but you can manage — or even prevent — the condition. Start by eating healthy foods, exercising and maintaining a healthy weight." - mayoclinic.com

  • Conservative Jul 14, 9:10 a.m.

    "ARTHUR IN THE PARK... you DO NOT KNOW what you are talking about! i know PLENTY of people who have type 2 and are thin as rails....never were overweight in their lives! dont be so mean!!"

    What Arthur pointed out is nothing different from what doctors also say. Just because 1 percent of the diabetic population does not meet the otherwise well known characteristics of a diabetes patient, the allegation that a statement like that is mean can at best be described as "ridiculous". Generalization is often based on characteristics observed in the majority of a population and not based ont he exception.

  • WRALblows Jul 14, 9:05 a.m.

    Let me guess, $10 million to each law firm and $1.67 to each plaintiff. Gotta love class action settlements.

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