We need this like a hole in the head

We need this like a hole in the head

Yesterday French regulators suspended use of the popular diabetes drug, Actos. Unlike Avandia, which is from the same class of drugs, Actos was not suspended over cardiovascular concerns rather increased bladder cancer risk. Some may recall that last year the FDA issued announced an ongoing safety review of Actos due to this issue but has yet to take any action on the drug.

A study published in the most recent issue of Diabetes Care concluded; “In agreement with preclinical and clinical studies, AERS analysis is consistent with an association between pioglitazone and bladder cancer. This issue needs constant epidemiologic surveillance and urgent definition by more specific studies.”

While Diabetic Investor is not surprised that the FDA has not taken more definitive action on Actos, given their history of paralysis by over analysis, it’s becoming clearer by the day that physicians who treat patients are running out of options. It is also equally clear due to the FDA’s ultra conservative nature patients are being denied access to new, very effective treatment options such as Bydureon.

Given the epidemic growth rate of diabetes and the huge economic burden of treating poorly controlled patients, one just might think the FDA would understand that patients and physicians need more weapons to fight diabetes. One would also think the FDA would have learned from the mistakes they made with Avandia and provide clearer more definitive guidance to physicians.  The fact that the FDA has not acted with Actos shows the agency remains dysfunctional and clueless as to how things work in the real world.

Why would any physician risk prescribing Actos given what’s known about the drug?

For all the talk about reform at the agency their actions, or should we say inaction, speaks louder than the hot air being spewed about reform. Bydureon is a perfect example of just how bad the situation has become. Here you have a drug that has shown to be very effective, has few serious adverse events and is taken just once a week. Yet the FDA in their zeal to cover every possible contingency, even ones that would occur once every million years, wants Amylin (NASDAQ:AMLN) to provide even more data.

It’s obvious that the FDA has yet to learn that no matter how many studies are done there is there is no such thing as perfect diabetes drug. That it is impossible to predict with 100% certainty what events may show up years after a drug has been on the market. They have lost all perspective on balancing the risks of poorly controlled diabetes against the rewards provided by drugs like Bydureon. Is it possible that years from today an issue might develop with Bydureon that was not evident in any of the vast clinical work already done on the drug? Sure it is all one needs to do is look at Avandia and now Actos to see that this is possible. However, the FDA should not delay approving a drug over something that MIGHT happen years from today, especially when all data currently available does not indicate any issues.

Put another way which is worse; stick with status quo where more than two thirds of patients are not properly controlling their diabetes. Stand ideally by as these poorly controlled patients develop costly complications that come from poor control.  Or do they understand there is no such thing as a perfect, adverse event free diabetes drug and approve drugs like Bydureon. Do they wake up and see that diabetes is not going away?  Do they understand what an epidemic is?

While Diabetic Investor can understand why companies like Amylin do not publicly complain about the agency, it’s about time the American Diabetes Association (ADA), the Juvenile Diabetes Research Foundation (JDRF) or the American Medical Association (AMA) spoke up on this issue. How can these respected institutions who are supposed to look out for the interest of patients sit and do nothing.  Someone needs to take on the FDA and make them aware that for an agency that is supposed to protect the public, based on their actions they are doing more harm than good. I

It’s time for balance to be brought back to the drug and device approval process. Diabetic Investor understands the agency has a difficult task, however based on their actions they have taken their mandate to protect the public to an unrealistic extreme. Without change millions of patients will needless suffer and the economic burden of diabetes will continue to spiral out of control.

The time for playing is nice is over and it’s about time someone, anyone took on the FDA.