Drug Companies Speak
Most of us view diabetes from the view of the patient. We want to know why there are no drugs that will cure diabetes, instead of simply controlling a few symptoms like high blood glucose and blood pressure.
At the recent Cleveland Clinic Medical Innovation Summit, I had a chance to hear about some of the problems from the point of view of the pharmaceutical industry.
Unlike some, I don't think everyone in the pharmaceutical industry is inherently evil. However, I do think they are in business to make money. And unless we nationalize the pharmaceutical industry, this need to make a profit will dominate their outlook.
One theme that came up over and over at the Summit was problems with the changing FDA standards and the new health care laws. In order to get FDA approval of a drug, the drug companies must go through numerous steps. This long process is expensive. And the FDA rules can change.
With any drug, one has to measure risks vs benefits. And they have to convince the FDA that the benefits are worth the risks. That risk/benefit profile might be different for different patients. A drug that might be too risky for a patient with a mild case of some disease might still be worth trying in a patient with a serious, even life-threatening, version of the same disease.
Caution seems to be the word of the day. "The FDA is currently focusing on risk rather than benefits," said Daniel Bradbury, CEO of Amylin Pharmaceuticals. "Maybe the [FDA] pendulum has gone too far in the caution direction," said Kevin Sharer, CEO of Amgen.
Steven Engle, CEO of XOMA, added that the FDA is focusing on cardiovascular effects of new drugs, which he said makes drug development two or three times more costly than it was just two years ago.
The other problem is that with the new Congress, which might try to change President Obama's health care regulations, the companies don't know if the current rules and regulations will be changed again. And because the entire process of getting FDA approval is not only lengthy but expensive, they don't want to invest billions of dollars proving a drug is both effective and safe if the rules will be different when they submit their findings to the FDA, so they'll just have to go back and do the studies all over again.
Another problem is the current economy. Investors don't want to invest in a drug that might never get FDA approval.
Hence most of the industry speakers said that the development of new drugs is currently stalled. And "the days of blockbuster drugs are over."
Philip Schauer, director of the Bariatric and Metabolic Institute at the Cleveland Clinic, said that development of most weight-loss drugs has been stopped because of safety concerns.
Sharer of Amgen said he didn't see "any medications in the next five or ten years that will change the current drug scene." He said one problem is that "we can only modestly treat some of the side effects; we do not understand diabetes." He added, "We need to understand the mechanisms and societal causes" of diabetes.
However, most of the pharmaceutical industry leaders argued that obesity is a disease. "It's important to consider obesity like other diseases. . . One problem is that it's not recognized as a disease," said Alex Gorsky, worldwide chairman of medical devices and diagnostics at Johnson & Johnson.
But there has been a lack of interest among doctors for obesity drugs because many physicians view obesity as a self-control issue, rather than a medical one, said Roger Longman, CEO of Real Endpoints. Steve Nissen, chairman of cardiovascular disease at the Cleveland Clinic, disagreed. He said the problem is that there are no good antiobesity drugs.
Of course the industry would like obesity to be recognized as a disease so insurers would cover their drugs and devices.
No one had a good solution to this problem that drug development has been stalled. Nancy Snyderman, chief medical editor at CBS News, said, "The core problem is that people are looking for perfect drugs, and we don't have any." Even "benign" drugs like aspirin have side effects.
What do you think? Should the FDA approve a drug that might help your diabetes even if it hasn't been proven to be safe? Or should they wait until there are really good data saying the drug won't cause harm, even if this means the drug might not be available for 10 years or more?