The Harper Index

Pharmaceutical lobby calls shots on food and drug amendments

Natural supplements users protest C-51, but bigger danger may be that drug companies will be able to regulate themselves and sell untested drugs.

The drug industry has lobbied to let potentially harmful drugs get to market with less testing.OTTAWA, June 10, 2008: Rallies are being held across Canada to protest what the federal government's proposed Food and Drug Act amendments (Bill C-31) will do to health supplements and vitamin sales. More alarming may be what the legislation proposes regarding prescription drugs. From both sides, critics say the government has given in to the pharmaceutical industry and put the health of Canadians at risk. The bill is currently up for Second Reading.

Most of the protest is organized by the natural food industry and its consumers. Protestors say the new rules will make natural supplements and vitamins impossible for consumers to find or too expensive for small companies to process. Although the government denies that the natural supplements industry is the target of the legislation, critics say big drug companies have pushed for the changes so they can get complete control of this sector.

While this aspect of the legislation has received most media attention, other critics say the way the bill will affect the licensing of prescription drugs is far more dangerous. They say the government has caved in to drug industry pressure for less stringent testing before new drugs are put on the market. The new system is called "progressive licensing."

"The only reason [the bill] was introduced was to serve the industry," says Mike McBane of the Canadian Health Coalition. "It was written by and for Big Pharma" - a term frequently used for the multinational pharmaceutical industry.

The current system of drug approval, which all sides agree needed overhaul, requires prior evidence of a minimum of safety and efficacy. The new legislation reverses the existing process by bringing "promising" new drugs onto the market after fairly minimal testing, and then monitoring their effectiveness. "This practice will expose Canadians to new drugs before their potential dangers are known," says James Clancy, President of the National Union of Public and General Employees.

"C-51 would permit the speedy marketing of expensive new drugs, many of which have no therapeutic advantage over safer, cheaper drugs, before research on effectiveness and safety is completed." He warns that even the post-marketing surveillance to be done after new drugs are marketed will be carried out by the drug manufacturer involved, and thus will be biased.

"The Canadian public would be poorly protected if our drug approval policy is shifted to one with an increased reliance on research conducted by the drug manufacturers," Clancy told federal health minister Tony Clement in a letter last month.

He says big drug companies cannot be relied upon to produce unbiased research on drugs, as shown by the lengths that Merck and Co., went to minimize the death risk to patients taking the arthritis drug Vioxx, which may have caused thousands of patient deaths. Not only did Merck under-report risks associated with Vioxx, it paid doctors to sign ghost written reports of clinical trials. Last year Merck agreed to pay $4.85 billion to settle thousands of lawsuits alleging Vioxx caused heart attacks and strokes in some users.

The drug industry, according to McBane has enormous power and influence. "They're now teaching our doctors. They've basically taken over the medical schools. They have purchased the universities, and they're controlling medical research."

The prescription drug industry may have the biggest lobby of all industries. Their industry association called "Rx and D," is all about lobbying, each drug company has its own lobbyists working for it, and most of the nation's lobbying and government relations firms work under contract for drug companies.

"This lobby is ubiquitous," says Jeff Connell of the Canadian Generic Pharmaceutical Association (CGPA). "It's the best-funded, most well- resourced lobby in the world. CGPA is currently feeling the influence of Big Pharma as it deals with new proposed patent rules that would delay generic versions of popular drugs such as Lipitor and Viagra by as much as two years, at a cost to consumers and taxpayers of tens of millions of dollars annually.

Many drug lobbyists have are deeply connected with the governing Conservatives. A May 6, 2008 article in the National Post reported that two prominent Conservatives have been involved with the drug companies' lobby effort to restrict the availability of generic drugs. They are Goldy Hyder, a former chief of staff to Joe Clark in 2001-2002, and Geoff Norquay, former communications director for Stephen Harper. And the federal budget of 2007, including $300 million for cervical cancer vaccination, was announced a month after Harper's close ally Ken Boessenkool registered as a lobbyist for the vaccine's supplier, Merck Frosst.

"Basically every public relations, ever lobby in the phonebook working for Big Pharma," says McBane. "They're prepared to spend over $50,000 per doctor in bribes," including free samples, meals, trips, honoraria, and paying doctors for the use of their names for ghost-written medical journal articles.

"There is nobody more powerful in terms of the ability to purchase a politician or a regulator" than the drug industry, McBane says. "They pay for the regulator, and they get what they pay for." The industry finances Health Canada's approvals process, he says, through a fee for service system brought in by the Chrétien government.

"That's when we lost our culture of safety," says McBane. With drug reviewers working for the companies, "the public lost."

Since then, he says, Health Canada has worked with the drug industry "in terms of speeding up the drug approvals process and rushing them to market, with no concern for efficacy and safety." For example, the cost to Merck & Co. of the Vioxx settlement was far outweighed by profits the company made from the drug.

"What makes it worse is that the federal government doesn't pay for these drugs, foisting dangerous useless drugs onto the provinces and the public," says McBane. Employers' and provincial drug plans bear most of the cost burden.

He says the bill relieves the government of liability for negligence should drugs prove dangerous. "It washes the government's hands," whereas under current legislation, "the regulator has huge liabilities responsibilities, called the duty of care."

Harper Conservative vs. Public Values Frame
  Lobbying, Marketing untested drugs / Public accountability, public values
  Big Pharma / Patients, families
  Corporate profits / Provincial and employer health plans

Links and sources
  Harper's Bill C-51 will weaken drug safety requirements, NUPGE, May 19, 2008
  New drug licencing bill gambles with lives of Canadians, NUPGE, April 25, 2008
  Will draconian Bill C-51 ban natural therapeutic products?, May 8, 2008,
  Under The Influence, 60 Minutes' Steve Kroft Reports On Drug Lobbyists' Role in Passing Bill That Keeps Drug Prices High, July 29, 2007
  Stop C-51 website

Posted: June 11, 2008

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