Public Health Imperilled

"If you inject something that is not sterile, that can be life-threatening."
"This is an issue that's not going to go away ... [But] most health professionals are unaware of the issue. I would imagine that most people in Canada are unaware of the issue."
Imti Choonara, clinical pharmacologist, University of Nottingham

"What we now know, more often than not, is that when Health Canada warns about problems, it is because the drug is unstable, contaminated or defective ... which can kill you. This is a threat to every Canadian's life."
"Academics write things that upset governments every day of the week; that's part of our job."
Amir Attaran, health-policy expert, University of Ottawa; Canada research chair in law, population health and global development policy

"Having said that, it is true that the global drug-supply chain has become more complex and stretches far beyond Canadian borders."
Stephane Shank, spokesman, Health Canada

"This is highly irresponsible behaviour, playing one continent against the other [India and Africa] on the basis of a study which doesn't even follow basic protocols of scientific rigour and methodology."
"If India's Mars mission cost one-eleventh of U.S.'s Mars mission, that doesn't make it substandard. Low cost is our advantage and cheap doesn't mean poor quality."
Sudhanshu Pandey, official India Ministry of Commerce 

Just published in the journal BMJ Open is a study that highlights the annual volume of problematical drugs to be found on Health Canada's website as recalls and alerts relating to defective prescription drugs, being used in Canada The British-led study emphasizes how at-risk patients are as a result of the situation. In comparison to Canada's 143 recalls last year (42 in 2005), the United Kingdom had less than half that number of recall/alert cases.

Most commonly, stability relating to drugs that degrade before their expiration date, in all likelihood destroying their effectiveness. Contamination by the presence of foreign objects in medication represents the next most common problem resulting in a recall or warning by Health Canada. Dr. Choonara, lead author in the study, sensibly points out that consumers/patients should be forewarned and have topmost in mind if medicines are not working or appea the result of unexpected side effects, action should be taken.

Dr. Attaran is well versed in the problems. The threat he speaks of to Canadian life is very well demonstrated by the linking in 2008 by U.S. authorities to the deaths of 81 patients to contamination discovered in shipments of the blood thinner Heparin, made in China, as a particular case in point. Health Canada's Stephane Shank points out that Canada has a rigorous drug-safety system, and a newly-enacted law permits government to order a medicine recalled without the consent of its maker.

According to Dr. Attaran, the problem may lie partially in Canada's lack of adequate scrutiny of medicines manufactured in India and in other developing countries of the world. A recent Senate committee report found that 4.6% of prescription drugs used in Canada come from India, thus representing the second highest foreign source of medications after sourcing from American pharmaceutical manufacturers.

A number of Indian manufacturers of drugs such as Ranbaxy Laboratories, which markets 160 medicines in Canada have been noted for their substandard production. Imports were banned by regulators in the United States through its Food and Drug Administration, of Ranbaxy products along with three other drug factories operating in India, with the inclusion of two owned by a Canadian-based generic producer, Apotex Inc.

Dr. Attaran was previously involved in a small study with American colleagues, the results of which they published in an American economics think-tank journal. They had purchased 1,470 samples of Indian-made medications in India, and purchased other pharmaceuticals in several African and medium-income countries, surmising that those bought outside India were likelier substandard than those they bought in India. "Indians were exporting their garbage", said Dr. Attaran.

India took umbrage at this conclusion, for the National Bureau of Economics Research article gained media notice in The Economist and The Wall Street Journal. New Delhi was less than appreciative of the significant implications surrounding their drug manufacturing and distribution. Government officials spoke of a defamation lawsuit targeting the authors of the article, accusing them of a "malicious assault against the country and its drug industry."

In the end, no lawsuit saw the light of day.

But forewarned is certainly favourably forearmed. Apotex was cited as having the largest number of defective drugs among the 20 manufacturers and distributors in the study, followed by Teva Canada Ltd, Pharmascience Inc. and Vita Health Products Inc., makers of both natural-health products and over-the counter drugs. Their ranking paralleled their product-marketing numbers within Canada.

Here's hoping that pharmacists across Canada follow the literature.... And that provincial drug formularies reflect the findings in the literature...in protection of the public weal in health and in sickness.