The Food and Drug Administration (FDA) is scrambling to recover from an inside source exposing a study that was apparently, according to the whistleblower identified as FDA reviewer David Graham, suppressed by upper FDA officials since May.
The study revealed what many in and out of the scientific community suspected, that GlaxoSmithKline’s diabetes drug Avandia causes serious cardio-events such as heart attack and stroke as compared to a similar drug called Actos. This isn’t the only study to reveal this fact, but there has been heavy pressure put on the FDA to halt their current Avanida/Actos study because of the risk to patients.
The US Senate Finance Committee released a 374 page document showing Avandia had caused up to 83,000 heart attacks since 1999 and recommended that the sale of Avandia be halted immediately. The group Public Citizen has argued that ongoing clinical trials of Avandia should be halted immediately because of the risks of the drug, as has biomedical ethicist Ruth Macklin.
Both of these came much earlier in the year, but the FDA still delays as Glaxo makes millions of dollars weekly off of the sale of the defective drug.
Avandia Heart Attack Risk Study
The reason that there were accusations of foot dragging is that the study by the Office of Surveillance and Epidemiology in Silver Spring, Maryland, was released on May 28th of this year and would still be under wraps if it weren’t for Graham. The end of May is only a short time after the FDA had walked out of a heated appraisal of their conduct regarding Avandia from the House of Representatives Appropriations subcommittee, the people who hold the purse strings for the whole organization.
In that meeting the FDA convinced the subcommittee that they did not have enough evidence to recall the drug.
The May study indicates the authors reviewed records of 227,571 Medicare patients with an average age of 74.4 years who were followed for up to three years after starting either of the two pills.
The results show that Avandia increased the risk of:
- Stroke by 27%
- Heart Failure by 25%
- Death by Heart Failure by 13%
- Death by Acute Myocardial Infarction (AMI) 11%
- AMI, Stroke, or Death by 14%
- AMI, Stroke, Heart Failure or Death by 17%
The research team said that 59 patients treated with Avandia for one year needed to be harmed to produce one excess case “of any of our outcomes.” They added this translates to 48,000 excess events attributable to Avandia among patients 65 years or older between 1999 and June 2009. That’s a huge number, but only 38% of the Avandia users are over the age of 65.
Since 62% of Avandia use has been among people younger than 65, they estimate the national impact is probably 100,000 or more. Both of these numbers combined almost doubles the estimate previous given by the Senate Finance Committee.
“This would place (Avandia) in the same category as (Vioxx) with respect to magnitude and severity of population harm.” The researchers in the study concluded, referring to the 2005 case of the pain drug Vioxx which was pulled from the market after it was revealed that it had caused up to 140,000 heart attacks in the 5 years it was on the market. The ensuing lawsuits, of which there were thousands with some still pending, cost the manufacturer Merck more than $5 billion.
Avandia Lawsuits
Next month, an FDA advisory panel will meet to review Avandia safety and the agency is struggling over the validity of allowing Glaxo to conduct a long-term study. In the interim, the very study that they are conducting, called the SCOUT study, as we have reported earlier on this blog, has had a tremendously hard time finding patients to join. The patients are reluctant for fear of the cardio risk. This has forced Glaxo to branch out to third world countries with less press on the subject and lax standards that allow them to yield some sort of result.
During this whole process an estimated 13,000 lawsuits around the country have been consolidated in to class action suits in their respective states. Glaxo is scrambling to settle them prior to the FDA’s meeting next month because an FDA ban and the full weight of their findings can only be bad for Glaxo and good for those involved in the lawsuits.
But hundreds of lawsuits have already been settled. Just last month, prior to the current study’s release, 700 lawsuits in New Jersey were settled for an estimated $60 million. Experts have called this a paltry sum compared to what they potentially could have gotten if they had merely waited for the FDA’s decision.
Another massive settlement in Philadelphia happened at the beginning of this month where an undisclosed amount was paid to the first lawsuit to actually go to trial hours before it actually was presented in front of a judge. That involved an estimated 5000 participants and there is speculation that litigants also received only partially what they expected to receive from the process.
Avandia Lawyers
As long as the drug stays on the market diabetes patients are at risk of serious personal injury or wrongful death from a cardio-event such as heart attack or stroke. It is important that any patient that is currently taking Avandia speak to their doctor about their risk for such and event and what they can do to prevent it.
Phillips Webster is a skilled and experienced law firm at defective drug litigation. We have a record of success in many other drug lawsuits and have shown that we can represent your best interests in the face of massive global pharmaceutical corporations with seemingly limitless resources.
If you have had a cardio-event or have lost a loved one while they were on Avandia you may be entitled to a settlement. Call Phillips Webster today for a free consultation on how you can get the compensation you deserve.
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