What is Dr. Gottlieb Smoking?
In today’s Wall Street Journal Dr. Scott Gottlieb penned an opinion piece entitled “Uncle Sam, M.D”. While the piece contained some valid points on the role our government should and should not play in the drug approval process. Diabetic Investor found one paragraph particularly disturbing.
“Now we’re focused on unearthing cases where prolonged use of some drugs may prompt small elevations in the risk and even common events, like heart attacks. This was the issue that caused the withdrawal of the painkiller Vioxx and the premature flap around the diabetes drug Avandia.”
While Diabetic Investor cannot speak for everyone we don’t think anyone who’s had a heart attack would call it a common event. And how many patients taking Avandia need to experience a heart attack before the flap around the drug is not premature. Is not the first rule of medicine do no harm?
There is no question that the drug approval process is in desperate need of reform. However, Dr. Gottlieb assertion that the flap over Avandia is premature is ludicrous. The viewpoint expressed by Dr. Gottlieb is typical of a physician who believes he knows it all and has never had diabetes or a family member with diabetes. Treating patients with diabetes is great but it does not provide the realities of living with a disease 24 hours a day 365 days a year. There are no days off when you have diabetes and none of us with the disease would consider a heart attack a common event.
Dr. Gottlieb’s flippant attitude is all too common and unfortunately shared by others. What Dr. Gottlieb fails to mention is there are alternatives to Avandia which work as well or better in treating patients with Type 2 diabetes. Is not the prudent approach to examine all the available evidence on Avandia? Is not the FDA’s role here to put the interests of millions of patients with diabetes ahead of what’s best for GlaxoSmithKline (NYSE:GSK)?
Given that Avandia has been on the market for nearly 8 years and there have been numerous clinical studies conducted using Avandia, there should be an adequate amount of data to answer a simple question; Is Avandia safe? If the FDA cannot answer that question, it seems reasonable that the agency could ask the company to conduct a trial that will provide the data so the question can be answered. The goal here is not to extend the life of a drug that has generated millions in profits for Glaxo. The goal here is to protect the millions of patients with diabetes who want to know whether the medication they take each and every day is safe. Patients who do not see a heart attack as a common event.
Come to think of it I wonder if Dr. Gottlieb’s mother or father had type 2 diabetes would he feel comfortable prescribing Avandia. I wonder if he would see a heart attack in his family as an unfortunate but common event.
Based on Dr. Gottlieb’s comments it seems his motto is “Let it fly no matter what might happen” – that might be fine when your writing op-ed pieces for the Wall Street Journal but doesn’t cut it in the real world of diabetes where peoples lives are actually at stake.