Studies allege Merck manipulated Vioxx data; journal calls for ethics overhaul

From the Canadian Press:
Two new studies suggest drugmaker Merck and Co. manipulated data on its withdrawn drug Vioxx, was slow to disclose adverse events associated with the painkiller and used academic researchers to enhance the credibility of scientific studies largely written by Merck employees.

The articles were based on company documents made public as a result of thousands of lawsuits levelled against Merck and Co. after it withdrew the former blockbluster medication from worldwide markets in September 2004 because studies revealed people who used it were at higher risk of heart attacks and strokes.

They were published Wednesday in the Journal of the American Medical Association, which also ran a damning editorial calling on everyone in the business of clinical research to pull up their socks, starting with doctors.

"The profession of medicine in every aspect - clinical, education and research - has been inundated with profound influence from the pharmaceutical and medical device industries," editor Dr. Catherine DeAngelis and deputy editor Dr. Phil Fontanarosa wrote. ...more

Merck agrees to US$4.85B settlement over Vioxx

From CTV News:
Merck & Co. has offered to pay US$4.85 billion to end litigation with thousands of U.S. plaintiffs over its painkiller Vioxx.

The agreement applies only to U.S. legal residents and those who allege that a heart attack or stroke they experienced while taking Vioxx occurred in the United States.

In Canada, negotiations continue in a number of class-action cases against the makers of Vioxx.

Mike Peerless, of Siskinds LLP, a law firm that represents hundreds of Canadian plaintiffs in Vioxx class actions, tells CTV that the settlement in the U.S. is a good sign and suggests that the company will want to quickly settle its Vioxx cases in Canada. ...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

Vioxx, Avandia, what next?

From the Associated Press:
How does a drug go from blockbuster to bust?

How can big safety issues go undetected in medicines taken by millions of people for many years, as happened this week with the diabetes pill Avandia and a few years ago with the painkiller Vioxx?

Or with devices like drug-coated stents, which came under a cloud last year after six million heart patients had already received them?

All roads - and fingers this week - point to the U.S. Food and Drug Administration. From a company's labs to a consumer's lips, the chronically understaffed federal agency has the power and duty to keep dangerous products from harming the public. ...more