I am Dr. Jennifer Yttri and I am speaking today on behalf of the National Research Center for Women & Families. Our organization does not accept funding from pharmaceutical companies and therefore I have no conflict of interest.
Our nonprofit research center includes scientists and medical and public health experts who analyze and review research on important health issues. We conduct research, publish our findings in medical journals, and provide unbiased and understandable information to patients, health professionals, and policy makers through CMEs, briefings, testimony, and reports. We have a major focus on FDA policies, and our president is on the Board of Directors of two nonprofit organizations dedicated to helping the FDA obtain the resources it needs: the Reagan-Udall Foundation and the Alliance for a Stronger FDA.
The adjudication of RECORD by DCRI has the same findings as the original FDA review of the RECORD trial. The same safety signals arise. Concerns about the quality of the original trial design and the data are beyond the scope of adjudication.
We can debate all day long about biases and questionable reporting, but that will bring us no closer to conclusions about the validity of the RECORD trial. The study was poorly designed and conducted, so the data are flawed and that undermines ALL analyses, whether it’s the first round by FDA, a second round by another FDA reviewer, or a third round by an outside entity funded by GlaxoSmithKlein.
The bottom line is still that taking Avandia increases the risk of heart failure. This safety signal is consistent. This finding supports the REMS and Elements to Assure Safe Use restrictions that are currently in place.
I think many of us agree that other diabetes drugs have their own risks. The FDA should do more to evaluate those risks, so that patients, physicians, and Advisory Committees can understand the safety of comparator drugs like metformin and pioglitazone.
In the meantime, we need the safeguards that are currently in place for Avandia in order to provide patients and their physicians with the information they need regarding this drug.
With the halt of the TIDE trial in 2010, no new data have been provided. The committee must therefore consider other sources of information, such as adverse reports and published scientific literature since rosiglitazone was originally approved in 2007.
When we consider independently performed studies (those not sponsored by a drug company), most of those studies have found that patients taking RSG have an increase in myocardial infarction compared to patients taking other drugs, including pioglitazone. More importantly, any study that measured heart failure found increased risks with RSG over any other treatment.
Is Avandia needed in the battle against type 2 diabetes? Sales have steadily decreased. There is no clear profile for patients who are currently using Avandia, and reason to think that they are primarily patients who were on it before 2010’s restrictions and with their doctor’s consent have chosen to continue to take it.
We believe that the documented safety risks would justify the FDA removing this failed drug from the market entirely. That would eliminate the concerns that some patients and physicians do not fully understand the risks of using this hazardous drug.
We are disappointed that the FDA continues to waste their limited resources reopening what should be a closed case. If you are not ready to make that recommendation, then please keep the current safeguards in place.