The Trickle Down Effect
Yesterday an FDA advisory panel voted 10-6 against recommending Qnexa, a weight loss drug from Vivus (NASDAQ:VVUS), for full approval. While the full FDA does not have to follow the panel’s recommendation they usually do so. Qnexa is just the first of three new weight loss drugs to be examined by the FDA, also in the running is Lorcaserin from Arena Pharmaceuticals Inc (NASDAQ:ARNA) and Contrave from Orexigen Therapeutics (NASDAQ:OREX).
While this vote surprised some it does fall into line with the new more conservative stance at the FDA, a stance that appears to have trickled down from the full agency to their “independent” panel members. As we experienced with the just completed two-day Avandia circus, the agency is becoming increasingly conservative in their approach appearing to actively seek reasons not to approve new drugs. Some would even state the agency has become obsessed with adverse events and lost all perspective on examining a drugs complete risk/reward profile.
Reading through the various comments made by the members of the panel one gets the sense these members understood clearly what the FDA wants. Prior to the meeting many experts believed Qnexa stood the best chance of being approved as the drug offered solid weight loss with only a handful of adverse events. It was widely assumed that the panel would approve the drug while recommending that additional follow up studies would be conducted to monitor adverse events once the drug was on the market. While this thinking may have been appropriate in past years, the drug really didn’t stand a chance in today’s regulatory environment.
Like diabetes, obesity is not just a healthcare crisis but an economic crisis as well. Depending on which set of statistics you want to use, 50% to 70% of all Americans are obese. The fight against fat is not just a vanity issue either as obesity is a leading cause of diabetes. It’s no accident that all three companies had conducted studies using patients with Type 2 diabetes, as the correctly understood combined with other treatment options their drugs would help patients fight both obesity and diabetes.
It really should come as no surprise that shares of Vivus and Orexigen are getting hammered today, while shares of Arena are rising. The main reason Arena is moving up instead of down is directly related to the belief that Lorcaserin while not as powerful for weight loss produces fewer adverse events.
Looking ahead it’s clear that drug companies are in for some tough times. While Diabetic Investor understands the FDA’s concern over adverse events we believe the agency has lost perspective on the use of risk/reward analysis. We have had noted far too many times that no drug is completely free of adverse events. However the FDA is taking this concern with adverse events to unprecedented levels. Just as it is problematic to approve new drugs without paying attention to adverse events, it’s equally problematic to pay too much attention to adverse events.
Simply put balance must be brought back to the agency so that patients are not denied new drugs that have the potential to help them. The fact is patients and the physicians that treat need the full set of facts when choosing their medications. They must understand not just the potential benefits of a new drug but the possible risks as well. With all the facts patients and physicians can make informed decisions on how to proceed. Sadly the way things are going at the FDA patients and physicians aren’t being given the opportunity to make an informed decision, they are just being denied new and possibly better drugs.
The bottom line here is the FDA has become a broken agency that has lost balance and perspective. They seem to have forgotten that diabetes and obesity are growing at epidemic rates and both disease states have serious healthcare and economic consequences. They fail to acknowledge that the current set of drugs options just aren’t getting the job done and patients need more and better weapons to fight these serious disease states. Instead of trusting the public by providing them with all relevant facts so they can make an informed choice, understanding all possible rewards as well as risk, the agency has taken the freedom of choice away from the American people.
As James Madison noted in his speech to the Virginia Convention back in 1788; “There are more instances of the abridgement of the freedom of the people by gradual and silent encroachments of those in power than by violent and sudden usurpations.”