Put a cork in it Steve

Put a cork in it Steve

Now Diabetic Investor realizes that this is the holiday season and everyone is supposed to be filled with good cheer yet it seems like that crusading cardiologist Dr. Steven Nissen didn’t get the memo. Like the Grinch who stole Christmas or the child who received a lump of coal in their Christmas stocking, the good doctor is not filled with the Christmas spirit. In the most recent issue of the British Medical Journal the good doctor pens a piece entitled; “Rosiglitazone: a case of regulatory hubris”.

Here is a sampling of what the good doctor had to say:

“FDA officials were infuriated with me for challenging the drug’s safety, interpreting my challenge as an attack on their competence and commitment to public health.”  Now we hate to burst your bubble Steve but we don’t exactly think the FDA was infuriated with you personally, rather they we’re likely infuriated that your infamous meta-analysis had more holes in it than there are in Swiss cheese.

“The FDA’s embarrassment and hubris have been the driving force behind its subsequent regulatory approach to the drug.” No Steve, the FDA wasn’t embarrassed as you basically blind-sided the FDA and given the chaos you created they had no choice but to reexamine the drug.  This reexamination initially leads the FDA to condemn the drug even though the data you presented did not provide a clear link between the drug and adverse cardiovascular events. It wasn’t until other respected researchers questioned your initial findings that the FDA did another reexamination and ultimately lifted the restrictions they had put in place.

While this back and forth by the FDA was hardly ideal, the fact is all this data analysis really didn’t matter as the drug went from being a mega-blockbuster to virtually no sales due to the controversy. GlaxoSmithKline (NYSE:GSK) the makers of the drug, not only lost billions in revenue but paid billions more to settle all the lawsuits surrounding the drug. Even with the FDA ultimately vindicating the drug, there is no way GSK can re-launch the drug, recover any of the lost revenue or money paid to settle the lawsuits.  Hubris, if anyone has hubris here it’s you Steve and not the FDA.

“When challenged on issues of drug safety the FDA reacts with hostility, defending its bureaucracy at all costs from any implication of poor decision making.” Honestly Steve for a man who is supposed to well-educated you have a serious case of open mouth and insert foot disease. Onestly

Now we all know that FDA is by no means a perfect agency and that reform is needed. However, look at what happened here. First the agency is blind-sided by the “premature” release of your meta-analysis. The mainstream media picks up on this as at the time the drug was one of the most prescribed diabetes medications. Next, wanting their faces on television Congress holds hearings basically putting the FDA and GSK on the defensive. Hearings that were held well before the data you presented had a chance to be vetted.

Feeling the heat the FDA capitulates to Congressional pressure, places draconian restrictions on the drug which effectively leads the drug to be pulled from the market.  While that was bad enough the FDA wanting to redeem themselves in the public eye decides to go a step further and issues new guidelines for approving diabetes medications. Guidelines which have not just slowed the drug approval process to a virtual standstill but have added to the already expensive cost of drug development. It is not an overstatement to say that these new guidelines have done more harm as patients are being denied new medications that could help them manage their diabetes more effectively.

Thanks to you Steve the makers of DPP4’s and GLP-1’s are now under scrutiny as you have shown that anyone with a forum and fancy degree can wreak havoc by becoming a zealot.  Your dubious meta-analysis has now become the de-facto standard for having regulators questioning every move they make. Frankly it’s understandable that regulators would be loath to approve new drugs as the last thing they want is to be hauled before Congress and ripped a new one.

Seriously for someone who has been around the block you of all people should know that there is no such thing as a drug which is 100% safe and free of any adverse events. You should also know the devastating cost, both economically and emotionally of poorly controlled diabetes. That diabetes is growing at an epidemic rate, that the physicians who treat patients need more not less weapons in their arsenal.

The truth here Steve is that you are a sore loser, your inability to agree to disagree with others who have questioned anything you have done is the ultimate in arrogance.  Think about this for a moment, even though the FDA has ultimately repudiated your findings you got what you wanted all along, Avandia is dead and for all practical purposes off the market never to return.  You have been on television and your notoriety has never been higher. You are now, unfortunately, the go to guy when it comes cardiovascular health.

Still you are not content to take your victory lap, show some humility and be gracious to the many you have vanquished. What you really want is for everyone to kiss your kester and acknowledge that you alone are all knowing.  Frankly Steve it’s time for you to put a cork in it.