Tuesday, September 14, 2010

Arena Loses, Fat People Lose Too

Wow. The FDA Advisory Panel's notes caused panic for Arena Pharmaceuticals today. The share price dropped 40% in early trading to close at at $4.01 in after hours trading. The loss for the day is $2.84 a share. Is this stock dead? Is Lorqess a junk drug?

The notes brutalized Lorqess in several ways. First, efficacy. While the notes acknowledged that Lorqess is an effective weight loss product, it described the product as BARELY EFFECTIVE. B-A-R-E-L-Y, indeed. The viewpoint should be more simple. Either the drug is effective or it isn't! In the case of Lorqess, it is effective. That's it. Pregnant or not pregnant? Why the pejorative language?

Second, the Panel has safety CONCERNS. Of course there are concerns. Every drug, every adventure, every trip to the diner raises safety concerns. The Panel's concerns fall into three general areas: cardiac, depression and malignancy. While drugs similar to Lorqess, i.e., fenfluramine, have been associated with heart valve damage, there is NO evidence Lorqess has any like effect. And Arena has studied this carefully in all of the test subjects. There have been NO cardiac issues, NO valvular issues. For the Panel to raise the cardiac issue is disingenuous at this point.

The neuropsychiatric side effects of Lorqess have been reported. Indeed. But these can be accepted as risks and dealt with. Avoid the drug in patients with depression. Use antidepressants if needed. Hepatitis C treatment, interferon, causes depression, too, in some patients. The side effect of depression does not make Lorqess inherently unsafe. Don't all drugs have risks that need to be factored into their use? Just look at the swine flu vaccine...or aspirin...or penicillin...or ibuprofen... or simvastatin....

Lastly, there were reports of increases in mammary tumors in rats getting pharmacologic doses or Lorqess. These are much higher dosages based on weight and they were rats. Rats are not people. Enough said.

Safety concerns always are a part of all decision making. In the case of Lorqess the three areas of concern need to addressed but none alone nor the three in any combination should trigger a real safety impediment for the drug to be given a positive nod by the Panel. The Panel must avoid being overly cautious.

The REAL ISSUE is that the fat drugs are given short shrift because obesity is considered by many as a self induced cosmetic problem. The old safety hob knobs of diet and exercise are hard to match up against in terms of safety and efficacy. Too bad d+e don't work well. If d+e were effective on the whole, Americans would be be a lot slimmer. Obesity is a MEDICAL problem with severe sequelae. Cardiac disease, hypertension, stroke, diabetes, loss of vision, amputations, arthritis, joint replacement, dermatitis, esophageal reflux and more are associated with obesity. Obesity is an epidemic of ill health. Inasmuch as there is a dearth of reasonable pharmaceuticals available to treat obesity, Lorqess needs to be viewed in a positive light. As did Qnexa, the fat drug rejected by this same Panel in July 2010.

Tomorrow the Panel drops the boom on Meridia, an older diet drug with some known and real cardiac issues. Yes, put it to pasture. Then the Panel needs to rest up and wake up and give Lorqess a thumbs up on Thursday.

Fat people need help, not pious pap about it's their own fault. Treat obesity as a real disease. So it goes.

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