Beware Big Pharma

"It's a good first step. The literature shows that when doctors get information from drug companies, it either has no effect on their prescribing, or makes their prescribing worse. There is no evidence it makes them better."
Dr. Joel Lexchin, emergency physician, health-policy professor, York University, Toronto

"We don't want practising physicians to be sales persons for either the pharmaceutical industry or medical device manufacturers. It just doesn't make sense. [It is especially vital that doctors not indulge in "peer selling" -- company-sponsored talks to colleagues promoting products.
Dr. Louis Hugo Francescutti, president, Canadian Medical Association

These comments in the wake of GlaxoSmithKline Inc. (GSK)'s announcement it plans to halt its practise of paying fees to physicians, nor will it any longer tie bonuses for its drug representatives to the prescribing habits of specific doctors. Specialists known as "key opinion leaders" encouraged to give talks on products of a disease area using those products to be phased out.

"Patients' interests ... always come first", said Andrew Witty, Glaxo's chief executive. GSK, according to a spokeswoman, currently pays Canadian doctors to act as sales reps in a sense, and to pay them in participating in scientific meetings and other such activities useful to the company's sales of their products. It is a generalized pharmaceutical sales-persuasive tactic of long standing.

Embarking suddenly on a new track, to demonstrate unequivocally that it's first interest will always be the well-being of the patient, secondarily their hugely remunerative products. It hardly seems likely that a few reputation-deleterious occurrences had a chastening effect, but who knows? The company is under investigation in China, of all places, for allegedly bribing doctors and officials.

China, calling it like it is, while in Canada, it has become accepted practise, never spoken of as 'bribes', heavens no. Glaxo was fined $3-billion in the U.S. by the government for illegally marketing its anti-depressants for unapproved uses and also just incidentally but still in the best interests of patients, withholding safety data on its diabetes drug Avandia.

Changes are needed in Canada. Dr. Lexchin, who recently led  an enquiry into questionable marketing tactics on the part of pharmaceutical companies and the general lax attitude of most physicians in routinely accepting freebies, concluded that the system is ailing. Health Canada, suggested Dr. Lexchin, should adopt a "sunshine" law similar to the one soon to be implemented in the U.S. requiring drug-industry payments to doctors to be publicly released.

A recent report published in the American Journal of Perinatology found that research leading to the conclusion that the drug Diclectin, originally produced by Merrell Dow Pharmaceuticals, which temporarily removed it due to a thalidomide scare, and is now prescribed widely in Canada to reduce the effects of pregnancy-induced nausea and vomiting, does not, as claimed, reduce the chance of abnormal birth defects, but rather marginally increases their occurrence.

"Why are so many prescriptions written for Diclectin? I think you come back to this inaccurate information about the safety of it. It could lead to pregnant women taking the medication when they might not have taken any medication", queried Dr. Nav Persaud, family physician and researcher at Toronto's St. Michael's Hospital, author of a new study raising questions about the commonly prescribed drug.

In response, Dr. Gideon Koren, who had co-authored a 1997 paper that incorrectly concluded the safety and efficacy of the drug, including its usefulness in preventing birth defects, and who is head of the Motherisk program at Toronto's Sick Kids Hospital stressed all evidence to date reinforces that the time-release pill combining Vitamin B-6 and antihistamine doxylamine is safe and effective.

"Looking at new studies published since then, they continue to show the safety. It's very important not to put a lot of women at unease because of re-analysis and so forth", he said, denying that the money Duchesnay, Quebec-based producer of Diclectin, provides in financial support of Motherisk in any way influences his approach to the drug's use.

Although the company funded a 1998 conference on pregnancy nausea, along with a number of other projects, Dr. Koren insists his group maintains a strict arm's length relationship with industry donors.The Society for Obstetricians & Gynecologists also receives funding from Duchesnay, and they in turn see nothing amiss in recommending Diclectin as "the standard of care" for morning sickness.

According to health statistics, one in two Canadian women uses Diclectin during pregnancy. Britain's National Institute for Health  Care Excellence makes note of the fact that most cases of pregnancy nausea gradually vanish throughout pregnancy, recommending ginger, acupuncture and antihistamines if women urge their doctors to prescribe treatment. A common-sense approach to ameliorate the side-effects of a natural event.

The American College of Obstetricians & Gynecologists list a few "first-line" treatments, including multivitamins at the time of conception; notably vitamin B-6 or B-6 with the addition of doxylamine.
Based on current evidence, Britain's Cochrane Collaboration concluded in a review of previous research that it is not possibly to identify with confidence any "safe and effective interventions" for morning sickness.

Dr. Persaud recommends women with morning sickness try vitamin B-6 alone giving similar benefits to Diclectin, for which they would have no need of a prescription, and as a useful alternative is much less expensive.

The pharmaceutical industry serves the best interests of the patient in persuading the patient that there is a drug-cure for anything perceived as an irritating affliction, and natural events that impose a burden on people they are unwilling to manage sensibly, constitute just such an affliction to be managed with the use of prescription drugs.