Standing in the way of innovation – Again

Standing in the way of innovation – Again

This past Thursday an FDA panel voted 17 to 6 in favor of requiring obesity drugs undergoing greater scrutiny for possible cardiovascular events. Members of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee said that drug developers should conduct the tests regardless of whether cardiovascular risks were deemed theoretically likely or had shown up in early testing.  Needless to say this vote and potential impact on companies developing obesity drugs has created opinions on both sides of the aisle.  Here is sampling of what people are saying;

“If the FDA follows through with this vote, we’ve just added another disincentive to the drug companies to come up with obesity drugs,” said committee member Ed Hendricks, medical director of the Center for Weight Management in Roseville and Sacramento, California. “And we desperately need some drugs.”

“I think it is better to be prudent and err on the side of caution,” said Dr. Sanjay Kaul (Cedar Sinai Medical Center, Los Angeles, CA), who voted in favor of the new requirements.

Even though he voted “yes,” Dr. Richard Bergman (North Port, Florida) cautioned: “I think that cardiovascular risk is only one of many other risks that may come to light as new drugs are developed. . . . Focusing on cardiovascular risk at the expense of others is not good.”

Just in case anyone needs to be reminded the fact that the FDA even voted on this shows that lingering impact of the Avandia controversy. Dr. Steven Nissen, that crusading cardiologist, not only has helped slow down approval of new diabetes drugs, his efforts have now spread to obesity drugs and medical devices. It seems as though the good doctor believes that drug and medical device companies are the evil empire and that physicians who are desperate for new and better drugs to treat the diabetes and obesity epidemics must be content with the current crop of ineffective drugs.  The good doctor does not seem to care that patients are needlessly suffering and that new and better medications are desperately needed. Worst of all, the crusading cardiologist and his minions, cannot seem to grasp the simple and very real concept of risk/reward.

Diabetic Investor does not believe it is necessary to once again go through the grim statistics on diabetes or obesity. Unless someone has been hiding in a cave for the past fifty years it’s a well-known and established fact that both diseases have not just become healthcare but economic problems on a huge scale. A problem that is getting worse as millions of baby boomers are becoming Medicare eligible. It’s ironic that this vote by the FDA came just one day after the Supreme Court heard arguments on the nation’s healthcare law. At a time when everyone seems to believe that we need more cost effective methods for treating diabetes and obesity, the FDA instead of helping with this effort is once again standing in the way of innovation.

Given that the diabetes and obesity epidemics are spiraling out of control now is not the time to institute even more layers to the drug approval process. Quite frankly the exact opposite is what is needed as the FDA should be looking for any method that shortens the drug approval process and take away layers of regulation.  Unfortunately this won’t happen as the FDA has become corrupted with the fantasy that there is such a thing as completely safe drug.  To paraphrase Spock, the FDA believes the needs of the one outweigh the needs of the many.

No one is suggesting that the agency throw caution to the wind rather that some balance be brought to the process; that instead of viewing all drug and device companies as the enemy that a dialogue be established so that each side understands the needs of the other.  Finally and most importantly that balance be brought back into the regulatory process. While no one wants to see a person suffer from an adverse event caused by a drug approved by the FDA, neither would they want to see thousands be denied this therapy because of this one person.

Truth is we are at war and the enemies are diabetes and obesity. Rule number one when it comes to fighting a war is that young men and women die. Rule two is there is nothing anyone can do to change rule one. This is the nature of war. However, if we stand any chance at all and are going to defeat our enemies these are sacrifices that must be made.  As Winston Churchill stated; “Never, never, never believe any war will be smooth and easy, or that anyone who embarks on the strange voyage can measure the tides and hurricanes he will encounter. The Statesman who yields to war fever must realize that once the signal is given, he is no longer the master of policy but the slave of unforeseeable and uncontrollable events.”