Looking at the Legal Costs in Avandia v. Vioxx

Image via WikipediaInteresting read which should lead as a discussion point for some lawyers. In a recent Forbes.com post, the author commented on the legal bills related to each drug. GSK has spent $6 Billion to defend cases involving Avandia while Merck spent $4 Billion to settle all of Vioxx.

Read it here: Link.http://blogs.forbes.com/matthewherper/2011/01/18/which-is-worse-vioxx-or-avandia/ 

Glaxo's Legal Bills for Avandia: $3.5 Billion and counting

Image by neofedex via FlickrThere is news that Glaxo  will have fourth-quarter legal costs of $3.5 billion because of investigations into sales practices for certain products and product-liability cases related to Avandia, a diabetes drug.

The company will be putting aside additional monies for other investigations, including one by the U.S. attorney in Colorado into the company’s sales and promotional practices of certain products.

The troubles mount for Glaxo, and this report simply shows the costs related to a drug that the FDA has put under the microscope. As recently as 9/23/10, the FDA placed restrictions on the drug.


From the FDA release:

The U.S. Food and Drug Administration announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.

 

“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” said FDA Commissioner Margaret A. Hamburg, M.D. “We are seeking to strike the right balance to support clinical care.” Link.

 

More news here.

Feds/States Launch Avandia Investigations

The maker of Avandia -- GSK --- has received from the Department of Justice more than one subpoena. Several U.S. states are also considering action against the company, and new claims from patients hit the courts regularly.

Avandia, the once-top-selling diabetes drug, has been plagued by safety concerns since 2007. After several years of weighing data and more data, regulators in Europe chose to pull the drug off the market completely, while FDA put severe restrictions on its use. The company won't market the drug anymore, either. GSK wrote off supplies of the drug--$233 million worth--because they'll never see the light of day.
Justice's subpoena involves GSK's development and marketing of Avandia, the company says; as the Wall Street Journal notes, it's unclear whether the probe is criminal or civil. No doubt the feds will be looking into allegations the company kept safety concerns about the drug under wraps. GSK maintains that it handled Avandia worries appropriately.

The company said it has also received "civil investigative demands" from states attorneys general about Avandia's development and marketing. Then there are the patient suits; GSK says it doesn't yet know whether it needs to set aside more money to cover eventual liabilities from the drug. This legal battle has only just begun.


Read more: GSK: Feds, states launch Avandia probes - FiercePharma http://www.fiercepharma.com/story/gsk-feds-states-launch-avandia-probes/2010-10-22#ixzz13UhiHEY8
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October Avandia Legal News for Georgia

A good report from American Counsel on Science and Health:

As drugs continue to be taken for longer periods of time, unexpected complications may arise that were absent from short-term clinical trials. New York Times science journalist Gina Kolata reported on what happens when drugs cause problems they were originally developed to prevent, focusing on the risks associated with the now highly restricted diabetes drug Avandia, and bisphosphonates, a class of medicine used to treat osteoporosis. 

After post-market analysis revealed that Avandia is alleged to be associated with an increased risk of heart failure, the drug was temporarily removed from the market in Europe and then restricted by the FDA last month. 

“Diabetic treatment is supposed to reduce the rate of diabetic complications including vascular disease, kidney disease and neuropathy — not merely control blood sugar. Studies that show Avandia may increase the risk of heart failure illustrate a case of when a drug does the opposite of what it’s supposed to.” 

Here is the link: http://www.acsh.org/factsfears/newsID.1961/news_detail.asp

In the Middle East, this news:

The UAE Ministry of Health has ordered all doctors and hospitals to suspend prescribing the diabetes drug Avandia.

According to a circular issued Sunday, health officials have decided to suspend all products containing Rosiglitazone over fears in the United States and Europe over its safety. Bahraini health officials have also banned drugs containing Rosiglitazone, like Avandaryl, Avandamet and Avandia, the Gulf Daily News reports.

Dr Ameen Al Amiri, CEO for medical practice and licensing at the ministry, was reported by the official news agency WAM as saying the drug control directorate had held extensive talks with Avandia’s manufacturers and local distributors.

http://www.arabianbusiness.com/avandia-diabetes-drug-be-banned-over-health-fears-351519.html

http://www.markzamora.com/AvandiaGA/index.html

Why the EU banned Avandia but the FDA Didn't

From Fortune and CNN/Money:


Avandia has taken some beatings over the years, but it pretty much took a fatal blow yesterday. That's when the Food and Drug Administration ruled to keep the drug on the market in the United States with some serious restrictions.
Those being: GlaxoSmithKline (GSK), the drug's manufacturer, can't promote it. Patients currently on the drug will be advised to switch to another similar treatment, if possible. Doctors can't prescribe Avandia to new patients without explaining in detail why it might be more likely to cause a heart attack than other options. The FDA basically mandated everything short of putting a skull and crossbones on the label. But here's the rub: The European Union's European Medicines Agency dispensed with the subtleties and outright banned Avandia from being sold. Why didn't the FDA?

For more go here.  http://money.cnn.com/2010/09/24/news/companies/FDA_Avandia_GSK_ban.fortune/index.htm?section=money_latest&utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%253A+rss%252Fmoney_latest+%2528Latest+News%2529

Georgia Avandia: News of Problems in Forums/Chat Rooms as early as 04?

Image by neofedex via Flickr
A new report says patients began discussing the risks of GlaxoSmithKline diabetes drug Avandia in online forums and blogs well before a meta-analysis linked it to higher heart-attack risk. Neither physicians nor company officials acknowledged their worries, contributing to an alarming drop in patient sentiment and, according to authors, a lost opportunity to reach out and restore trust.

Patients first started questioning whether it was safe to take Avandia given their situation, especially those with congestive heart failure (CHF), in 2003 and 2004, but the drug was still seen as a good alternative for many with type 2 diabetes, notes the report. Negative comments began referencing Avandia risks in 2005 but were more likely to grow out of frustration with weight gain and edema—potential side effects of drugs in the thiazolidinedione (TZD) class.

The tone changed in 2006. Discussions went beyond swelling and weight gain to comparisons with other products shown to lower blood sugar without these risks, such as Eli Lilly/Amylin's Byetta and Merck's Januvia. Chatter about other side effects lit up message boards, as well. Analysis of comments shows patients connected edema to an increased risk of CHF, and some reported increased blood pressure. Anger and frustration grew, as physicians seemed disconnected from the concerns.


More here

Georgia Avandia Lawyer and Avandia Clinical Trial News for July 22, 2010

Image via CrunchBase

The FDA has ordered drug maker GlaxoSmithKline to stop enrolling new patients in a  clinical trial of its d diabetes drug, Avandia.



The clinical trial, called TIDE, was mandated by the FDA to assess safety risks of the drug, which is prescribed to treat type-2 diabetes.


The FDA said the action does not mean the drug will be removed from the market. But the agency is demanding that GlaxoSmithKline update physicians and ethics oversight boards involved in the trial regarding all new safety information about the drug.

We are investigating claims regarding Avandia. 

Georgia: Avandia Case Settles in PA

Image by neofedex via Flickr

GlaxoSmithKline Plc (GSK.L) has settled more lawsuits alleging its Avandia diabetes drug caused heart attacks, heading off the first trial in the United States concerning the medicine.

The company said on Tuesday that terms of the settlement remained confidential. It declined to specify how many claimants were involved.

"We can confirm that the case that was scheduled for the first trial in state court in Philadelphia, for June 1, 2010, has been settled," company spokeswoman Claire Brough said in an emailed statement.

"The next case scheduled for trial is in that court and is scheduled for October 2010. GSK has not settled the multi-district litigation pending in federal court."

The latest move follows reports by plaintiff lawyers last month that about 700 cases had been settled for around $60 million.

Source

Georgia Avandia: Lawsuits settled

Image by neofedex via Flickr

GlaxoSmithKline Plc agreed to pay about $60 million in the first settlements of lawsuits alleging the company’s Avandia diabetes drug causes heart attacks and strokes in some users.

Avandia has been in the spotlight recently, following reports from various studies linking the drug to cardiovascular complications. The FDA estimates that Avandia treatment caused at least 83,000 heart attacks from 1999 to 2007, and clinical studies have shown that Avandia increases the risk of heart attack by 43 percent and can double the risk of heart failure after only one year of treatment.

At least 13,000 Avandia lawsuits have been filed nationwide, with plaintiffs accusing GlaxoSmithKline of failing to adequately warn patients about the serious risks of heart attack, stroke, heart failure, bone fractures, vision loss, and death associated with the medication.


Source here.

GA Avandia: TIDE Trial

From: http://www.theheart.org/article/1069095.do

Looks like folks will have to wait until July of 2010 to see if the Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) trial, commissioned by the FDA and pitting rosiglitazone against pioglitazone (Actos, Takeda Pharmaceuticals), will be allowed to continue.

There are concerns about whether or not the informed consent forms are up to snuff:

"If people were to reexamine the informed-consent forms, particularly in light of the data as of 2010, they may have second thoughts about whether they want to continue the trial at their own institution."

More at the link, above.

Georgia: Report - FDA May Halt Avandia Safety Study

According to the Wall Street Journal report, FDA commissioner Margaret Hamburg wrote a letter to Grassley in late March saying that the agency is reassessing a trial that compares the drug to a drug made by Takeda Pharmaceutical Co called Actos. That trial is also called the TIDE trial, according to the Journal.

FDA Principal Deputy Commissioner Joshua Sharfstein told the Journal that the decision on the trial "cannot be de-linked from the agency's view of Avandia."

Sharfstein said no decision had been made on the trial -- the FDA has asked a government scientific panel to review the ethics of head-to-head trials, the Journal said.

Link here: http://online.wsj.com/article/SB10001424052748704508904575191944217066832.html?mod=WSJ_hpp_MIDDLENexttoWhatsNewsSecond

Georgia and USA: JAMA and Avandia (Heart Attack Claims by Some)

A few years ago, the “New England Journal of Medicine", published a study that identified a potential heart risk with Glaxo’s then-blockbuster diabetes pill, Avandia.


In an editorial in the latest issue of "The Journal of the American Medical Association" or JAMA, Drs. Catherine DeAngelis and Phil Fontanarosa call what happened “a disturbing example of inappropriate conduct surrounding an industry-sponsored clinical trial. The circumstances represent another example of corporate motives apparently outweighing scientific standards and perhaps ethical principles, thereby exposing patients to potential harm.”

Find it here: http://jama.ama-assn.org/cgi/content/full/303/12/1196

From the conclusion:

Given the circumstances surrounding rosiglitazone1-2 and the RECORD trial,10-11 and perhaps other industry-sponsored trials, it is now time for all editors to require that academic researchers have full access to all trial data and that all industry-sponsored trials include independent statistical analysis and assurance. This approach would add powerful support to the fundamental principle that physicians must first do no harm.

Georgia Avandia: Heart Attack and Stroke Risks?

Image by neofedex via Flickr

From the Institute for Safe Medicine Practices:

Rosiglitazone (AVANDIA). More than 1000 reports of patient deaths were received for
rosiglitazone in the first three quarters of 2009, more than any other drug we monitor. Rosiglitazone is an oral medication for treating Type 2 or adult onset diabetes. Most deaths were attributed to cardiovascular causes, a problem for which the FDA has required warnings. While these cases do not appear to signal previously undetected risks of rosiglitazone, the large number of reports alleging serious and fatal injuries associated with rosiglitazone further reinforces concerns about its cardiovascular safety. The company, GlaxoSmithKline, told us it believed most reports were generated by lawsuits.

In February 2010 the FDA announced it was conducting an overall safety review of
rosiglitazone and would present its findings to a special advisory committee meeting in July.


"Rosiglitazone should be removed from the market," concluded Dr. David Graham and Dr. Kate Gelperin, both epidemiologists with the FDA. Linkavandia

Avandia - Diabetes Drug- Heart Attack Link?

Avandia is manufactured by GlaxoSmithKline for type 2 diabetes. It was first approved for use in 1999. Since then more than 6 million people worldwide have taken this drug. Avandia helps sensitize the body to insulin and helps control blood sugar. According to a recent study by the New England Journal of Medicine, patients taking Avandia have a 43% higher rate of heart attacks.

Several published and unpublished data from long-term clinical trials of Avandia, including an interim analysis of data from the RECORD trial (a large, ongoing, randomized open label trial) and unpublished reanalyses of data from DREAM (a previously conducted placebo-controlled, randomized trial) provide contradictory evidence about the risks in patients treated with Avandia.

The most recent labeling change for Avandia also included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia. This new warning was based on the result of a controlled clinical trial in patients with existing congestive heart failure.

If you believe you were injured because of your use of Avandia, talk with me.