Healthy Skepticism Library item: 295

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Morgan S.
Opening more than the medicine cabinet
Winnipeg Free Press 2004 Apr 11

Full text:

Last week, a Commons committee revealed a long-running scandal that makes the federal sponsorship mess seem innocuous.

Citing problems of endemic secrecy, questionable ethics and a lack of enforcement of existing rules, the standing committee on health found that prescription drugs likely kill more than 10,000 Canadians a year. Some of these deaths are inevitable, but many are not.

The report, endorsed by all political parties, puts Health Canada and the pharmaceutical industry squarely in the crosshairs. Academics should also be feeling the heat.

The committee outlined major failings in the regulation and monitoring of pharmaceutical products. Many of the problems have been raised before, some dating back to inquiries conducted in the 1960s. These include secrecy in the drug-approval process, a lack of transparency and accountability in clinical trials, and inadequate monitoring of serious adverse reactions to drugs used by Canadians. Fixes for these problems have long been known but seldom acted upon.

The committee also acknowledged a new threat to safe and appropriate drug use: increased direct-to-consumer advertising of prescription-only drugs.

The fix for this problem — laws prohibiting such marketing practices — is already in place, but enforcement is lax and largely ceded to industry self-regulation. The committee’s solution? Close regulatory loopholes and strictly enforce the ban on consumer-targeted advertising of prescription-only drugs.

The overarching message was that Health Canada should focus regulatory efforts solely on the protection of public health and safety, not development of the pharmaceutical industry. Most Canadians would consider this to be intuitive. But in acting on such recommendations, the government is caught in a serious conflict of interest.

While concerned with protecting the public against health risk and fraud, the government is also interested in promoting industry and attracting investment. Analysts often refer to this as the Health Canada versus Industry Canada conflict. It is a serious tension. Now, with increased emphasis on Canada’s “innovation agenda,” the distinction between Health Canada and Industry Canada is blurred.

To be fair, if Health Canada believes that industry, not the public, is its key client, it is not alone. Universities are increasingly complicit in the promotion of industrial interests in health care as they strive to commercialize academic activity. In both science and policy, researchers are now strongly encouraged to forge partnerships with industry. This is often said to be a survival strategy in an era of decreased public funding of higher education. Such arguments should not placate a concerned public.

The problem is that when policy-makers (and the researchers who inform them) attempt to promote commercial activity at the expense of sound health policy, the cost can literally be measured in body bags. Never mind the billions of dollars spent every year on drugs that do not perform as advertised.

One must be clear in recognizing that pharmaceutical companies are not charities. They are not branches of a public body or any organization with a mandate to promote public health. The sole responsibility of the for-profit manufacturer is to maximize return on investment. Shareholders — and this includes those of us who invest in pension or mutual funds — would have it no other way.

The profit motive can inspire great creativity and progress in the pharmaceutical sector, but it can also conflict with the pursuit of unbiased evidence and public safety. If this were not true, there would be no such thing as commercial confidentiality clauses that prohibit patients and prescribers from accessing valuable information about product risks and benefits.

It may come as a surprise to many Canadians, but neither you nor your doctor are entitled to see the safety and effectiveness data that firms disclose only to Health Canada. This information, although clearly critical to public health and safety, is kept confidential solely because its disclosure might reduce profitability.

All information gathered by, or on behalf of, a corporation during a clinical trial remains confidential. Manufacturers generally only publish information deemed to be in their commercial interest. If one trial shows a drug to be better than a placebo or ‘sugar pill’ and another does not, guess which trial is published? The end result, multiplied many times over, is asystematic bias in the available scientific evidence on both the benefits and harmful effects of drug treatments. In an industry portrayed as being driven by scientific research and knowledge, this situation is scandalous.

Academics take part in such secrecy when they sign confidentiality agreements in exchange for industry funding. Canadian researchers who have broken confidentiality agreements in the name of patient safety have faced legal, personal and professional attacks. Dr. Nancy Olivieri, a researcher who spoke out about safety risks in a company-sponsored trial, was attacked not only by the corporate sponsor but also by her own university. The University of Toronto, it turned out, was courting the corporation for a major donation.

Reacting to this problem, the Commons committee is calling for the reduced use of confidentiality agreements and other contractual arrangements that shroud the scientific community in profit-motivated secrecy.

Strict and transparent regulation of pharmaceutical products is necessary to balance conflicting interests. This is far more important with pharmaceuticals than other high-tech sectors because drugs are not like other commodities. Computers do not lead to measurable risks to the life and health of their users. A privacy agreement with a DVD manufacturer is unlikely to place researchers in ethical conflicts that could be a matter of life and death. The same is not true of pharmaceuticals, which have inherently complex and unpredictable effects on the human body.

The Commons committee’s regulatory reforms are laudable, practical and, in the main, could be implemented without any changes to existing law. The only missing ingredient in setting up a safer, publicly accountable system of drug regulation is the political will to separate the goal of developing commercial activity from that of protecting public health and safety.

Ironically, Ottawa is currently holding consultations on proposed changes to federal health-protection law that would actually weaken existing drug regulation and introduce full U.S.-style direct-to-consumer advertising.

The committee did not explicitly address this proposal, but its report is a clear message to Health Canada to abandon any such industry-driven initiatives.