Yesterday, a large assembly of drug experts met in an FDA advisory panel to decide whether to recommend that the type 2 diabetes drug Avandia should be pulled because of concerns of increased cardiovascular risk. Some have said that this vote would make a big impact on pending lawsuits from patients who experienced negative cardiovascular outcomes or lost loved ones while using the drug. The thought was that if the FDA voted to pull the drug, it would lend strength to the lawsuits while a vote to keep the drug on the market would weaken them. Even though the FDA voted to keep Avandia on the market, the outcome of the hearing seems to give strength to those lawsuits pending and many more yet to be filed.
No one but the most stalwart defenders would argue now that Avandia does not lead to an increased risk of adverse cardiovascular events, especially heart attacks, but also stroke and cardiovascular death, often lumped together under the label MACE (Major Adverse Cardiovascular Events). Even the data used by GlaxoSmithKline (GSK) to defend Avandia, five out of 16 studies showed a clearly increased risk of myocardial infarction (MI, heart attack). Three more showed marginally increased risk. The other eight showed about equal risk–none showed a decreased risk. This means that, in the aggregate, the evidence points to some level of increased risk. You can view the data here on slide A-20.
However, what matters in pharmaceutical injury litigation is not only the presence of risk–or even the level of risk–but also whether a drug company knew about risk and failed to inform the public that the risk existed, either through a simple omission or through active suppression of data. Last year’s landmark decision by the Supreme Court in Wyeth v. Levine reaffirms that a manufacturer is required “to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug.” And as a result of the FDA hearings, it is clear that the manufacturer had “reasonable evidence of an association” between heart risk and Avandia as early as 1999, but actively sought to conceal this information, successfully hiding the risk until 2007 when it was revealed by independent research. There is also evidence that GSK may have manipulated a major study to further conceal these risks.
The data on GSK’s manipulation of study data comes from an in-depth review of patient information in the RECORD (Rosiglitazone Evaluated for Cardiovascular outcomes in ORal agent combination therapy for type 2 Diabetes) study. This in-depth analysis was conducted by a senior FDA official who initially set out to show the strength of the study in refuting claims that Avandia was associated with heart risk.
However, in looking at the paper records of the original data–something the FDA rarely does–, he quickly discovered that there were many problems with the study data. For example, one patient taking Avandia in the study had a heart attack, was given heart surgery, and died of heart failure three weeks later, but the event was deleted from the records without explanation fifteen months after the heart attack. In another case, a patient admitted to the hospital for pulmonary edema, an accumulation of fluid in the lungs, caused when the heart is unable to remove enough blood from the lungs. It is, in other words, a heart problem, but no cardiovascular event was reported even thought the patient died of pneumonia (inflammation of the lungs, sometimes caused by bacteria, but and sometimes caused by irritating liquids) in the hospital.
Overall, the official’s cursory review of about 1/8th of cases in the study showed that nearly 13% of the cases had problems, and that, by a ratio of greater than 4:1, these problems favored Avandia. As a result, the official concluded that the results of the RECORD study should be considered not an estimate of the actual risk, but a lower bound of the cardiovascular risk of the drug. In other words, he considers the evidence to show that the risk MUST BE HIGHER than shown in the RECORD study.
In the light of this information, many have moved beyond wondering whether the study was deliberately underpowered to give vague answers about possible risk to whether the risk was so great that even a statistically underpowered study showed them too clearly and study data was criminally manipulated to conceal it.
You can read the FDA reviewer’s detailed report here (warning–it’s a 765-page-pdf), and look at the chilling slides from his presentation to the panel here.
If you or a loved one has been hurt by a drug with serious risks, like Avandia, you may be able to file a pharmaceutical injury lawsuit on the basis of a failure to warn on the part of the manufacturer. The product liability lawyers of Robert W. Kerpsack, CO. LPA can help you get compensation for your injuries. Please call or email us today for a free initial consultation.