Why did we know this was coming?
According to a study published in Circulation: Cardiovascular Quality and Outcomes, the heart risk from Actos is just as great as the risk posed by Avandia. According to a story published today by the Los Angeles Times:
“In the new study reported Monday, a team led by Debra Wertz, an outcomes research manager at HealthCore Inc., the research subsidiary of the health insurance company WellPoint Inc., studied the records of 28,938 clients who took either of the two drugs from 2001 to 2005. They obtained information about health outcomes from the company’s own records and about deaths from the National Death Index, a database administered by the government’s National Center for Health Statistics.
They reported in the journal Circulation: Cardiovascular Quality and Outcomes that, when they accounted for potential confounding effects, including age, gender and prior heart disease, about 4% of each group had a heart attack, heart failure or died. Specifically:
— 96 patients on Avandia suffered a heart attack, compared with 121 on Actos;
— 265 on Avandia suffered heart failure, compared with 243 on Actos;
— 24 on Avandia suffered both heart attack and heart failure, compared with 18 on Actos;
— and 217 on Avandia and 217 on Actos died.
“What distinguishes this latest study from other claims-based analyses is its analysis of death records, which include out-of-hospital deaths,” Wertz said in a statement. The study also followed patients for a longer period of time than earlier studies and the patients were younger, she added. Unlike the earlier studies, however, it did not include strokes in the data, which may account for part of the difference in outcomes.”
Diabetic Investor isn’t surprised by this finding given all that has been discovered regarding Avandia, which like Actos is a TZD. It’s interesting to note that up until this recent study other studies seemed to indicate that Actos did not have the same heart risks as Avandia. This would not be the first, nor will it be the last time, different studies on the same subject come to very different conclusions.
The real question is where do physicians and patients go from here. When the Avandia controversy first came to light many physicians switched their patients from Avandia to Actos, believing that Actos did not carry the same cardiovascular risk as Avandia. Given the attention this study is likely to generate and the fact that Actos had nearly $5 billion in sales, which drug will replace Actos. The most likely candidate has to be Januvia from Merck (NYSE:MRK) and extends Januvia’s streak of good fortune. Never in the history of diabetes drugs, has such a lackluster drug benefited from every possible brake.
Here we are at a time when diabetes is growing at epidemic rates and the options used to treat diabetes are shrinking instead of expanding. At a time when action is needed the FDA continues to make approving new diabetes drugs tougher than ever. Bydureon from Amylin (NASDAQ:AMLN), Lilly (NYSE:LLY) and Alkermes (NASDAQ:ALKS), a drug that could dramatically alter the landscape for treating type 2 diabetes awaits approval delayed not because of anything wrong with the drug, delayed because the FDA has been preoccupied with the Avandia controversy.
One has to wonder with this new study on Actos and all the fuss surrounding Avandia, will the FDA pull both drugs from the market even though a panel voted to keep Avandia on the market. Normally the FDA follows the recommendation of the panel but these are not normal times and the FDA is taking an increasingly conservative stance. The last thing the FDA needs at the moment is more egg on their collective faces.
Whatever the outcome from this most recent piece of news and the controversy it will surly generate, once again everyone will ignore one central over-riding fact; nearly two-thirds of all patients are not properly controlling their diabetes. Diabetes is no longer just a healthcare crisis and has become a major economic crisis and at time when we need more tools to fight diabetes, the exact opposite is happening. How the FDA can sit around and watch this happen is unbelievable.
The bottom line here is thousands will suffer needlessly because the agency failed to act decisively. They allowed the Avandia controversy to consume the agency and now have another problem on their hands. How many diabetics must suffer before the FDA wakes up and sees what’s going on in the real world?