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Jack Sisson's Life Ethics Blog

We must find new ways through many ethical issues, especially regarding bioethics, medical ethics, and criminal justice. Jack Sisson's 'Life Ethics' blog focuses on numerous areas of concern, including the philosophical and ethical dilemmas surrounding stem-cell research, abortion, medical research, and health care.


From The Vancouver Sun:

Many family doctors are not being warned about the dangerous side effects of new drugs before they start prescribing them to patients, according to new research from the University of B.C.

More than half (59 per cent) of pharmaceutical sales representatives failed to tell the doctors about common or serious side effects. The numbers were highest in Vancouver, where 66 per cent failed to disclose harmful side effects.

The international UBC-led study, published today in the Journal of Internal Medicine, involved Canadian, U.S. and French physicians in Vancouver, Montreal, Sacramento and Toulouse. More than 250 doctors who were asked to fill out a questionnaire following each sales visit provided information on nearly 1,700 drug promotions between May 2009 and June 2010.

The threat of serious harm or death was disclosed in only five per cent of pitches for drugs that carried such a warning in Vancouver and Montreal, slightly less often than in Toulouse and Sacramento.

Significant contraindications — warnings about potential drug interactions and patient exclusions based on age or other factors — were disclosed only 14 per cent of the time in Vancouver and Montreal, compared with 17 per cent of the time in Sacramento and 40 per cent of the time in Toulouse.

"Our results suggest a serious lack of information on harmful effects of promoted medicines," the researchers wrote. "Such omissions may threaten patient health."

Dr. Tom Perry, an internal medicine and clinical pharmacology specialist at the UBC Hospital in Vancouver, who was not part of the study, expressed concern about the findings.

"Doctors learn relatively little about drugs in medical school, and much of their exposure to pharmacology after graduation may be in the form of advertising. If they are unaware of the potential harms from drugs they prescribe, patients inevitably suffer the consequences."

Perry also called for much stricter control of drug advertising in Canada.

Drug marketing in Canada is regulated by the industry, based on Health Canada guidelines, said lead author and UBC researcher Barbara Mintzes. "But no one is monitoring these visits and there are next to no sanctions for misleading or inaccurate promotion."

Marketing in France and the United States is scrutinized by government agencies and their physicians were more likely to hear of common side effects, she said.

"In Canada, we delegate (oversight) to the code of ethics committee of the pharmaceutical industry association Rx&D and they are very vague about what kinds of information should be provided," Mintzes told The Sun.

Physicians should always consult outside sources for information about any new drug before prescribing it, according to physician Shelley Ross, president of the B.C. Medical Association.

"You need to know the benefits, whether it's the best drug for your patient, is it going to interact with other meds," said Ross. "You need to know the downside and any side effects that you should warn the patient about. You have to know these things before you talk to a patient about a medicine."

Ross was surprised side effects were discussed by so few sales representatives.

"I've seen hundreds of reps in my time and you often have a relationship for years and years," said Ross. "They know not to try something like that, because if you can't trust them they never get another visit."

"There is a very old maxim that says physicians should strive to be neither the first nor the last to implement a new therapy," said physician Galt Wilson, deputy registrar of the College of Physicians and Surgeons of B.C. "Due diligence includes carefully considering the product monograph and consulting unbiased references."

Serious risks were mentioned in only six per cent of the promotions, the study says, even though 57 per cent of the medications involved came with U.S. Food and Drug Administration "black box" or Health Canada boxed warnings — the strongest drug warning that can be issued by both countries.

"The majority of time, the doctors weren't getting any information about a single harmful effect," said Mintzes, who studies drug advertising at UBC's School of Population and Public Health.

Doctors in Toulouse were more likely to be told of a harmful effect in a promotional visit, compared to doctors in Canada and the U.S., according to the study.

Researchers suggested that this may reflect stricter regulatory standards for promotion of medicines in France.

The Canadian Medical Association has published voluntary guidelines for physician interactions with industry, which includes a provision that any mention of a product or service must be balanced "based on the prevailing body of scientific information" and a ban on accepting gifts. Canadian physicians are permitted to accept free product samples, a practise that is banned in France.

In the UBC-led study, all physicians were asked to report the sales reps' key messages for each visit. For the diabetic drug rosiglitazone, or Avandia — withdrawn in Europe and restricted in the U.S. and Canada because of an increased risk of heart attack and stroke — "nearly all were claims of safety," the researchers wrote.

Among the messages the doctors took away: "Avandia is safe even in patients with heart disease, as long as they don't have heart failure," "Avandia is not as dangerous as the public makes it out to be," and "new studies indicate safety."

Overall, even though doctors said they were rarely informed about serious side effects, most judged the quality of the information provided by the reps as "good" or "excellent." Nearly two-thirds said they were "somewhat" or "very likely" to start or increase prescribing of the drug after the visit.

Link to The Vancouver Sun.

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