Risk of depression dims hopes for new anti-addiction pills

From the Canadian Press:
Two years ago, Scientists had high hopes for new pills that would help people quit smoking, lose weight and maybe kick other tough addictions like alcohol and cocaine.

The pills worked in a novel way, by blocking pleasure centres in the brain that provide the feel-good response from smoking or eating. Now it seems the drugs may block pleasure too well, possibly raising the risk of depression and suicide.

Margaret Bastian of suburban Rochester, N.Y., was among patients who reported problems with Chantix, a highly touted quit-smoking pill from Pfizer Inc. that has been linked to dozens of reports of suicides and hundreds of suicidal behaviours. The product is sold as Champix in Canada and other countries.

"I started to get severely depressed and just going down into that hole ... the one you can't crawl out of," said Bastian, whose doctor took her off Chantix after she swallowed too many sleeping pills and other medicines one night. ...more

Anti-obesity drugs provide only modest weight loss

From CTV News:
Anti-obesity medications can only help obese patients lose a "modest" amount of weight, report Canadian researchers in a review of a group of studies on the long-term effectiveness of the drugs.

The researchers from the University of Alberta and the University of Calgary reviewed 30 placebo-controlled studies in which adults took anti-obesity drugs for a year or longer. ...more

Federal drug approvals plunge

The American and Canadian drug approval systems often share information and make similar decisions. I suspect the decrease in approvals of new products in the States has likely resulted in some of these products not being approved in Canada. Quite often, these drugs have received approval in other Western countries. Examples would include rimonabant and Arcoxia.

The pendulum has swung regarding North American drug approvals. In the wake of the Vioxx scandal, I suppose it was inevitable. But I wonder how many benficial new medications won't be approved because of the now exceedingly cautious regulatory bodies?

From CNN Money:
Federal drug approvals have plummeted by nearly a third in 2007, according to a report issued Thursday that is likely to fuel complaints that regulators are stymieing efforts to get new treatments on the market.

The Food and Drug Administration approved 59 new drugs through October, down 29 percent from the same period last year, according to a report from James Kumpel, an industry analyst at Friedman, Billings, Ramsey Group.

Significantly, the report says that the problem is not in the industry pipeline.

Kumpel said that the ratio of applications to approvals in 2007 is shaping up to hit a 13-year low. The FDA is on track to approve 60 percent of applications for new drugs this year, compared to 76 percent in 2006.

"While some pundits have argued that the pipeline [of applications] submitted to the FDA by the pharmaceutical industry has been weak in recent years, the facts dispute such claims," said Kumpel, in his report, released on Thursday.

Kumpel found an 18 percent decline in approvals of a key category of drugs - those that are in a brand-new molecular class. The FDA approved only 14 of these new drugs, which represent the most significant medical advances because they do not piggyback onto existing treatments. ...more

FDA Panel Rejects Sanofi Weight Loss Drug Acomplia

I'm the first to admit I expected big sales once Acomplia was approved. However, it seems somewhat unlikely it will ever make an appearance in the United States. I've not heard any news about it's approval status in Canada, but I suspect this won't help.

From CNN:
A U.S. Food and Drug Administration panel Wednesday unanimously rejected Acomplia, a weight-loss drug from Sanofi-Aventis SA (SNY), on concerns the drug increases the number of psychiatric events like depression and suicidal thinking among users.

The panel's decision is a blow to the Paris-based drug maker, which was hoping it could sell Acomplia on the U.S. market. The FDA typically follows its panels' advice but isn't required to do so. The FDA is set to make a final decision on whether to approve Acomplia, known generically as rimonabant, by the end of July.

"It was quite obvious there was serious concerns about the safety profile of rimonabant," said Eric Colman, the FDA's metabolic and endocrine drug product deputy director, noting that the 14 voting members said additional safety information should be required before the FDA should consider approving the drug.

If rimonabant were to be approved in the U.S., the drug would likely be called Zimulti because the FDA rejected the brand name of Acomplia. But approval is unlikely anytime soon. The FDA has been under fire from Congress about its handling of various drug-safety issues, including recent concerns that GlaxoSmithKline PLC's (GSK) diabetes drug Avandia raises heart-attack risks. ..more