Medical schools urge limits to drug makers' influence on students

From CBC News:
There may soon be no more free lunches — or fridges to store them in — in the student lounges of Canadian medical schools.

No talks given by physicians' experts paid handsomely by pharmaceutical companies. Or unsupervised meetings with drug reps.

The association that represents Canada's medical schools announced Tuesday it is endorsing the principles that lie at the core of rules such as these introduced by its American counterpart earlier this year.

The Association of Faculties of Medicine of Canada said the aim is to limit the influence the pharmaceutical industry has on medical students and residents and assuage the public's concerns about the perceived cosiness between medical schools and drug makers.

"There's no question that the environment within which you're trained will have some sort of impact on the way you perceive these issues," Irving Gold, the association's vice-president of government relations and external affairs, said from Ottawa. ...more

More layoffs, cuts as U.S. drug makers face generics, other woes

From CBC News:
U.S. drugmakers beset by growing generic competition, few new blockbusters, drug safety concerns and pressure from insurers and government health programs to discount prices are cutting tens of thousands of jobs.

Nearly all of the 10 largest pharmaceutical companies in the U.S. are restructuring, with some, such as Schering-Plough Corp., announcing plans to trim 10 per cent or more of the work force.

Since 2007, eight of the world's biggest drugmakers have announced the elimination of more than 42,000 jobs; two other major companies have eliminated another 12,200 jobs in the last few years.

"There are a lot of things going on making this the perfect storm for the industry," said Argus Research health-care analyst Martha Freitag. "My sense is maybe we're halfway through" the cost-cutting.

Today's struggles come after the industry's golden era in the 1990s, when a slew of new drugs quickly became blockbusters, fuelling almost routine double-digit quarterly profit increases and rising stock prices and dividends. ...more

Drug Makers Near Old Goal: A Legal Shield

From the New York Times:
For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted. ...more

Drug recalls linked to U.S. testing deadlines

From the Globe and Mail:
New drugs that are rushed through the approval process to meet government-imposed deadlines in the United States are much more likely to be the subject of recalls and safety problems, reveals a new study that sheds light on how these constraints affect decisions made by health officials.

Working within rigid deadlines may put too much pressure on health regulators, compromising their ability to focus adequate attention on the safety and efficacy of the drug, as well as the quality of clinical data submitted by the pharmaceutical company, according to the study published today in the New England Journal of Medicine.

"Deadlines are a part of life and they do a lot," said Daniel Carpenter, professor of government at Harvard University and lead author of the study. "The question is should we be relying so heavily on deadlines, or could we rely a little bit less on deadlines and a little more on resources?" ...more

Drug-research spending second to marketing: study

From CTV News:
American drug companies spend almost twice as much on promoting their pills than on researching and developing new ones, finds a new Canadian study.

Marc-Andre Gagnon and Joel Lexchin of Toronto's York University found that American drug companies spent US$57.5 billion on promotional activities in 2004 (the latest year for which figures were available).

By contrast, the industry spent only $31.5 billion on industrial pharmaceutical research and development in the same year, the researchers found using a report by the National Science Foundation.

The analysis, called "The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States," is published this week in the journal Public Library of Science Medicine. ...more