Is this the start of something bigger?

Is this the start of something bigger?

According to a tweet by Congressional Quarterly’s Healthbeat last evening FDA deputy Commissioner Josh Sharfstein is leaving the agency to become the secretary of health and mental hygiene in Maryland. Some Diabetic Investor readers may remember Mr. Sharfstein as he was instrumental in the FDA’s decision to allow Avandia to remain on the market albeit with additional restrictions.

For some time rumors have flying out of the agency that there would be some major departures from the agency that could be directly linked to the Avandia decision. Although the agency did their best to put forth a united front on Avandia, internally there was heated debate and a great deal of disagreement with the final decision. According to sources inside the FDA, the agency was divided on how to handle Avandia with each side adamant that their stance was the correct course of action. This internal friction was so bad there was a private meeting where department heads insisted that the agency make the “right” decision on Avandia. The only problem was no one clearly stated exactly what that meant.

Based on various accounts it seems as if the FDA’s feelings on Avandia were as divided as the rest of us. One group insisting that Avandia be pulled from the market and the other insisting there just wasn’t enough scientific or “hard evidence” to pull the drug from the market. It didn’t help matters any when an FDA panel formed to provide guidance for the agency, failed to deliver a clear course of action for the agency to follow. Simply put the panel put the Avandia problem back into the laps of the FDA and told them to make this difficult decision. Not wanting to risk an all-out revolt at the agency, the FDA tried to make both sides happy (an impossible task given their respective beliefs) and allowed Avandia to remain on the market with additional restrictions. A decision they thought would finally put an end to the Avandia controversy. Needless to say instead of ending the debate on Avandia, the FDA’s decision just added fuel to an already raging fire as no one was happy and everyone wanted to make their feelings known.  

Although Diabetic Investor had been hearing rumors of people leaving the agency before the Avandia decision was rendered, these rumors accelerated once the decision became public. The general consensus was both sides felt slighted by decision, each believing the agency did not follow the correct course of action and worse, each believed their arguments feel on deaf ears.  At this point Diabetic Investor felt it was just a matter of time before members of the agency said enough is enough and took their talents to the private sector or elsewhere. Simply put, the damage inflicted by the Avandia controversy was irreparable.

Diabetic Investor suspects that Mr. Sharfstein decision to leave is only the beginning and more departures are looming. The question now becomes who will leave and who will remain. Whatever the eventual outcome it’s clear the Avandia controversy has forever changed the FDA and could well be a watershed event in the agency’s history. While Diabetic Investor strongly believes change is needed at the agency we’re not entirely sure the Avandia controversy and its corresponding fallout will foster change for the better.

To this day Diabetic Investor believes the FDA should have pulled Avandia from the market. Not because we necessarily believed the scientific evidence supported this course of action, it didn’t. Rather because we believed this endless debate would create more questions and no clear answers, which is exactly what happened. As we have noted from the beginning, when it comes to drugs there is no such thing as a completely “safe” drug and even when a drug looks to be “safe” there is no way to know for sure what issues may pop up after long term use. This is why it is critical the FDA follow the best available scientific evidence and not voodoo methodology more commonly known as a meta-analysis. The FDA should encourage an open debate of this hard scientific evidence and use this input to make their final decision.

Finally some balance and perspective needs to be brought into the process. The FDA must come to grips with two facts; there is no such things as a completely safe drug and there is nothing they can to do to change this. Additionally they must weigh the cost of their decision against the harm inflicted by the disease drugs are used to treat. As regrettable as serious adverse events are, should we pull a drug or not approve one because one patient experiences a serious adverse event? To paraphrase Mr. Spook do they needs of the one outweigh the needs of the many?  

The fact is the world is at war against diabetes and right now the world is losing. Diabetes continues to grow at epidemic rates and sadly nearly two thirds of patients are not properly controlling their diabetes. Diabetes is not just a healthcare crisis but an economic tsunami that will bankrupt our already debt heavy government. Instead of helping fight this war with the most advanced weaponry, the FDA is telling patients to fight a nuclear war with a musket rifle. And unfortunately like so many of the wars fought so bravely by the men and women of our armed services, needless deaths will occur because our elected officials failed to act.