Health Canada Shows Its Strength


A recent study by the Canadian Institute for Clinical Evaluative Sciences (ICES) has not only increased concerns about Avandia and drugs in its class that are used to treat type 2 diabetes, but also raised increased concerns about why the FDA has not pulled the drug. The study compared patients treated with glitazones and those treated with other classes of diabetes drugs. The glitazone patients had a 60 percent higher risk of heart failure requiring hospitalization. They also had a 40 percent higher risk of heart attack, and a 30 percent higher risk of premature death compared to those on the other drugs. The study was conducted by analyzing data for 160,000 diabetics aged 65 and older from the Ontario Drug Benefit (ODB) database.

The data represents a study that is more than an order of magnitude larger than the largest prior study of Avandia. It definitively shows the heart risks attendant on the use of the class of medications and raises questions as to why this dangerous drug is still on the market. The figures show that there were three additional cases of heart failure, four additional heart attacks, and five premature deaths whose cause might be attributed to the drug for every 100 patients taking the drugs for the four years covered by the study, or approximately 8,000 deaths total. Health Canada withdrew approval of the drug for all but patients who could not tolerate other diabetes drugs early in November, but the US Food and Drug Administration (FDA) has been reluctant to do so, although it did put a black-box warning on the drug.

Is this an example of the FDA maintaining too close a relationship with the pharmaceuticals industry? It is impossible to say, but it sure seems likely. The study also points out the disparity between the weak, decentralized regulatory agency in the United States, and the comprehensive, independent, powerful health department in Canada. Although those whose wealth and power would allow them to buy expedited care in the US might complain that socialized medicine makes them wait in line with the hoi polloi, this case shows that the agency seems better equipped to look after the health of the population as a whole. In this country we rely on small studies, usually sponsored by the industry, of barely 14,000 individuals, and the majority of the studies are “inconclusive.” Health Canada, on the other hand, is able to draw conclusions based on its own, wide-ranging data, data that cannot be concealed or cooked by pharmaceutical companies.

It is probably impossible that we would ever be able to reform the US health care system into anything like the socialized care in Canada. Instead, our only recourse to do the job that the FDA is either reluctant or unwilling to do is through the court system. Litigation is our last lever of power against major corporate interests in this country. Remember what Archimedes said, “Give me a lever long enough and a fulcrum on which to place it, and I shall move the world.” If you or someone you love has suffered as a result of a defective pharmaceutical drug, contact today, to get in touch with a local lawyer who can find his own fulcrum.