“If you’re a patient with a terrible disease, a serious cancer or something like that, I think you ought to take heart from what we are seeing.” These words come from Janet Woodcock, director of the FDA’s drug division and appeared in a Wall Street Journal article entitled “Drug Makers Refill Parched Pipelines”. According to the article; “The pharmaceutical industry, after years of research flops that led some to write its obituary, shows signs it is coming back to life.
Credit a revamped research approach by the industry, which, after years of focusing on me-too drugs for ills that were already well treated, is pouring firepower into diseases that aren’t.”
While this may be great news for some, these words unfortunately ring hallow for the millions of patients with diabetes who are being denied new drugs and devices that could help them manage their diabetes more effectively and possibly lead to better overall outcomes. It seems as if Ms. Woodcock, who is overseeing many of these stalled drugs and devices, is a guilty of revisionist history. It is not an understatement to say that under her watch the FDA has done more damage to the hopes of millions of patients with diabetes than any other time at the FDA. At a time when these patients need more weapons to help them fight their diabetes, from all outward appearances it seems as if the FDA is actively looking for reasons not to approve new diabetes drugs or devices.
At the same time the FDA seems to have missed the memo on approving me-too drugs.
A perfect example of this situation can be seen with Bydureon and Tradjenta. Here you have two new drugs, one innovative and potentially game changing and the other, nothing but a copycat of two already approved drugs that do exactly the same thing. Although Diabetic Investor has no quarrel with the FDA approving innovative drugs for other disease states, we wonder given Ms. Woodcock’s statement if the FDA somehow believes that diabetes is not “a terrible disease.” Is it not true that diabetes is growing at epidemic rates? Is it also not true that nearly two-thirds of patients are not properly controlling their diabetes? Is it not a fact that besides being a healthcare crisis, diabetes is also an economic crisis costing this nation billions?
Now we’re not sure how the FDA defines a “terrible disease” but given this set of facts Diabetic Investor believes that most reasonable people would believe that diabetes qualifies. We would also state that most reasonable believe that while we have made great strides over the past few years the central fact remains that diabetes is an out of control epidemic and that the current crop of drugs and devices, while good, are not good enough.
Yet, for reasons only the FDA seems to understand, they continue to impose ever harsher standards for approval of new diabetes drugs and devices. Standards that came about largely from the Avandia controversy and were imposed before they were properly vetted, truth be told industry didn’t stand a chance after Dr. Steven Nissen, that crusading cardiologist and his merry band of followers grabbed the spotlight. The “good doctor” and his friends in Congress used the Avandia controversy, a controversy based on debatable science that is if you can call a flawed meta-analysis science, not to inform and protect the public but instead to get their faces on television and look like they were doing something when in reality they did nothing but make matters worse.
While Ms. Woodcock may believe that “you ought to take heart from what we are seeing”, she would do well to open her own eyes to just how ludicrous the situation has become. Take for example what used to be the rather simple process of approving a blood glucose monitor. Again for reasons the FDA only understands they punishing two companies, Sanofi-Aventis (NYSE:SNY) and Intuity Medical, who are awaiting approval for two new monitors. The iBGStar from Sanofi and the Pogo all-in-one device are awaiting approval while the agency struggles to understand that patients with diabetes are not heroin addicts. Just as they have done with many of the new drugs awaiting approval, the agency is trying to kill a common house fly with a tactical nuclear weapon.
The simple fact is the FDA is an agency that is seriously out of touch with reality. They continue to ignore what is going on in the real world and continue to live with the foolish belief that there is such a thing as drug that does not have any adverse events or that devices work 100% of the time. They continue to ignore that millions of patients are needlessly suffering as they move with glacial speed to approve therapies and devices that would have an immediate and positive impact. They continue to listen to people like Dr. Nissen and his group of zealots. A group that seems to believe we should go back to the 18th century and that every drug and device should be tested six ways from Sunday and then some before it can get into the hands of the people who need them most.
What is truly disturbing here is that the FDA actually believes they are doing the right thing and there is no need to change. Yes, like everyone else Diabetic Investor has heard the calls for reform and yes like everyone we hope reform comes. However, it’s well to keep in mind that the FDA is a government agency where reform comes slowly, if at all. Reforming the FDA is like turning around a battleship, it’s not something that can be done quickly or without some resistance.
Add it all up and what you really have is a dysfunctional agency that has lost touch with the real world. An agency that continues to ignore the impact their actions have on the very people they are supposed to protect. Worst of all, the agency is allowed to wreak havoc and is not held accountable for the devastation they leave behind. Like a tornado the agency comes in with little warning, destroying whatever lies in its path and then goes away and leaves the mess to be cleaned up by someone else. And just like a tornado or other natural disaster the agency does not seem to care when they hit or who they hurt.
The fact is that diabetes is a terrible disease and will only get worse if the FDA does not come down from their Ivory Tower and begin to take a realistic look at what everyone else can see so clearly.