Perspectives on drug withdrawals

It was with disappointment that I read the CMAJ editorial on the withdrawal of rofecoxib (Vioxx).1 In particular, I am disappointed with the narrow perspective on the safety of our industry's medicines and the supposed conflict caused by a relationship between industry and Health Canada.

The member companies of Rx&D (Canada's Research-Based Pharmaceutical Companies) are committed to patients, to their health and well-being, and to the assurance that new medicines are as safe and efficacious as humanly and scientifically possible. No company wants to launch a medicine on the market to have it withdrawn at some future date. The impact for the company, in terms of both reputation and financial perspective, can be devastating. That is why any negative effect experienced by patients in the development phase of a medicine must be reported. Once a medication is made available to patients, any serious and unexpected adverse effects reported to the manufacturer must, in turn, be reported to Health Canada within 15 days.

When should a medicine be allowed to go to market? Once all possible combinations with other drugs or commonly used products have been studied? For many patients, this is not an option. Who would have thought a few years ago that grapefruit juice could have a dramatic impact on the health of patients taking certain types of medicines? Yet pharmacists now alert their patients to potential interactions between grapefruit juice and medications.2 Patients who take medicines must understand that any pharmaceutical chemical introduced into the body is not natural; hence, they should, with the consultation and supervision of their physician, weigh concerns against benefits and make an informed decision.

Reference to potential conflict caused by an emphasis on Health Canada's “partnerships with industry” is simply not true.

When taken appropriately, medicines can provide positive health outcomes and value to patients, their families, our health care system and society as a whole.