Food and Drug Regulation Under The Microscope
Shiv Chopra's story is for anyone who wants to understand the intersection between politics and corporate influence.
By David Hutton and Michael McBane
Hill Times: November 24th, 2008
OTTAWA—Just as outbreaks of food poisoning are causing public anxiety about the effectiveness of government regulators, a newly-published book sheds fresh light on this very subject.
Corrupt to the Core: Memoirs of a Health Canada Whistleblower, paints a disturbing picture of the internal machinations of a regulator bent on pleasing its drug company “clients,” often with scant concern for the public health implications.
The author, Dr. Shiv Chopra, is one of three Health Canada scientists whose testimony before a Senate Committee in 1998 triggered headlines around the world. The scientists testified that Health Canada managers had pressured them to release suspect veterinary drugs into the food chain without the evidence of safety required by the Food and Drugs Act.
One result of these revelations was the widespread rejection of bovine growth hormone (rBGH, a drug which boosts the milk production of dairy cattle) in Europe, Canada, and most developed countries—even though it had been already approved in the U.S.A.
In telling the story of his career, Chopra provides a detailed account of intrigue, manipulation, and deception as Health Canada managers scramble to please drug companies—at the behest of their own political masters—by approving inadequately-tested drugs. He accuses management of practices such as:
- Ignoring a central requirement of the Food and Drugs Act—Health Canada’s raison d’ être—that manufacturers must provide evidence of safety before approval can be given.
- Ignoring, sidelining, and attacking scientists who would not bow to management pressure to approve drugs without the legally-required evidence of safety.
- Arbitrarily approving by fiat veterinary drugs containing known carcinogens and hormones with known serious health impacts.
- Promoting people who showed themselves willing to comply with these deceptive practices, while sidelining scientists who adhered to the law.
- Muzzling scientists whose findings were inconvenient to the department, by forbidding them to speak to anyone about their work.
Chopra and his two colleagues are now unemployed. Although the Senate promised them protection, all three were fired simultaneously in 2004. Health Canada denies they were fired because they spoke out and they have spent the past four years in hearings before the Public Service Labour Relations Board (PSLRB), as their union battles to have them reinstated. Meanwhile they remain isolated, out of Health Canada’s way, and unable to exert any influence over the department’s ongoing approval of drugs.
Some readers may find it difficult to believe that a government department could routinely engage in the kind of tactics described in this book. However, this is not a big stretch for anyone familiar with Health Canada’s involvement in the Tainted Blood Scandal, or its track record since then.
For example, according to the Canadian Association of Journalists, Health Canada is the most secretive government department in Canada. In 2004 CAJ awarded the department its fourth annual “code of silence” award for showing “remarkable zeal in suppressing information” and “concealing vital data about dangerous drugs.”
CAJ asserts that, over a period of more than five years Health Canada denied journalists or members of the public any meaningful access to a database of prescription drugs that were harmful or potentially fatal, and refused to release information on adverse drug reactions in a format that would allow researchers to study the records electronically.
Another recent example is the case of Dr. John O’Connor, an Alberta doctor who was startled to encounter several cases of a very rare cancer in Fort Chipewyan, in the Athabasca oil patch. He concluded from further investigations that there were unusually high rates of cancers among the residents, reinforcing concerns that extraction operations upstream might be contaminating the environment with carcinogens. He called for a thorough health review of the community.
Such reporting of concerns by alert doctors in the field is vital to public health and has in the past led to the early detection of new diseases such as AIDS. Yet, in what was perceived as an attempt to muzzle him, Health Canada employees lodged four complaints against O’Connor with his professional body. He was accused of engendering mistrust, blocking access to files, billing irregularities, and raising undue alarm in the community — serious charges which could have resulted in the loss of his licence. Doctors were so alarmed by this incident that in 2007 the Canadian Medical Association passed a resolution calling for whistleblower protection for doctors— apparently to protect them from Health Canada.
Chopra’s story is valuable to anyone who wants to understand the intersection between politics and corporate influence, science, and the law, within one of Canada’s most controversial government departments.
Whatever the outcome of the PSLRB hearings on his case, experiences like these serve as reminders of the urgent need for real whistleblower protection in Canada—not the ineffective regime created by the Accountability Act—so that wrongdoing by governments and corporations can be exposed and eliminated without honest employees having to suffer career-ending reprisals.
David Hutton is the executive director of Federal Accountability Initiative for Reform (FAIR) and Michael McBane is the national coordinator of the Canadian Health Coalition.
Copyright Hill Times 2008
Click here for a review of the book Corrupt To The Core
Click here for more about Shiv Chopra and the 'Health Canada Three'
