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The Supreme Court of Canada recently ruled that medical marijuana users have the right not to have to smoke their medicine. Bring on the pot-infused cookies, lozenges, oils and teas. For some conditions alternative cannabis treatment is more effective and less risky than inhaling. Until the SCC ruling it was a criminal offence for medical users to ingest pot in any other form than dry leaf.
Wellness custodian of the land, Health Minister Rona Ambrose was "outraged" by the ruling.
"Marijuana has never gone through the regulatory approval process at Health Canada, which requires rigorous safety reviews and clinical trials with scientific evidence," said Ambrose. "So frankly, I'm outraged by the Supreme Court."
For some, outrage would have been justified had the ruling favored the status quo whereby a mother of a seven-year-old would have to insist Johnny take his medicine by sparking up a joint to get his seizures under control.
Others are outraged at Ambrose's claim that Health Canada "requires rigorous safety reviews and clinical trials with scientific evidence."
According to former Health Canada drug evaluator Shiv Chopra the real outrage is that "Health Canada is violating its own Food and Drugs Act by playing fast and loose with drug approvals, allowing drug manufacturers to regulate themselves," and not insisting on 'rigorous safety reviews' as Ambrose claimed.
For Chopra the outrage is that 15 years after he and two fellow scientists, Margaret Haydon and Gérard Lambert blew the whistle on their Health Canada bosses for licensing drugs of questionable safety, nothing has changed.
In 1998 the scientists had gone public with allegations that they and other drug evaluators in the Bureau of Veterinary Drugs were pressured by senior managers and industry lobbyists to approve genetically engineered products such as hormones and antibiotics given to food producing animals without seeing the human safety data of these drugs. Chopra and his colleagues claim that refusing to approve these drugs without seeing the data and going public about it is what eventually got them fired in 2004.
It's all in the book. Shiv Chopra's 2009 tell-all, Corrupt to the Core: Memoirs of a Health Canada Whistleblower, is an unflinching account of regulatory recklessness in the public health sector.
Here's the backstory: Drug regulators first heard the drums of deregulation beating during the 1985 Shamrock Summit in Quebec City. While Brian Mulroney and Ronald Regan were harmonizing in their famous duet of "When Irish eyes are smiling," Canadian and American officials were harmonizing NAFTA, the North American Free Trade Agreement. Everything was on the table. Chopra recalls the media glitz surrounding the event. "The underlying message of those sound bites," he writes, "was that they were effectively constructing a policy of deregulation of drugs, foods, medical devices, pesticides, all kinds of products of questionable safety."
After Shamrock, pharmaceutical lobbyists pushed bureaucrats hard for new product approvals, including new drugs to be administered to food producing animals in order to artificially glean extra yields of meat and milk.
Monsanto claimed, for example, that if you inject a cow with Posilac, a genetically engineered bovine growth hormone (rBGH), she will produce 10 to 20 per cent more milk. According to Chopra, Monsanto insisted on approval by reminding Health Canada that its U.S. counterpart the Food and Drug Administration had found rBGH to be safe. The message to regulators was clear: Get in line or get out of the way. However, Chopra and other drug evaluators refused to approve rBGH pointing to huge gaps in Monsanto's human safety data submissions.
Chopra led an internal investigation which revealed that Monsanto had indeed submitted a 90-day rat-feeding study on rBGH showing serious adverse side effects, but a special file manager at Health Canada had kept the negative results under lock and key away from human safety evaluators.
In his report Chopra included the history of how senior managers harassed and pressured evaluators to pass drugs of questionable safety for humans. Also in the report was Dr. Haydon's allegation that she was in the room during a meeting with Health Canada officials when a Monsanto operative offered $1-to-$2-million to Health Canada to have Posilac approved without having to submit data from further studies or trials. Monsanto claimed it offered the money to fund new research. According to Chopra, senior managers ordered these and other items stricken from the report and kicked the revised document upstairs. Health minister Alan Rock and Prime Minister Jean Chretien were copied. Chopra refused to sign the altered document.
Instead, he led a joint harassment grievance of five scientists to complain that management's tactics for fast-tracking the drug regulatory process were in contravention of the Food and Drugs Act. Chopra claims that scientists who had objected were moved off the file and replaced by more obedient colleagues. When the grievance was dismissed by an assistant deputy minister as "interpersonal problems," the group took it up with their union, the Professional Institute of the Public Service of Canada which brought the issue into the public eye.
The late Senator Eugene Whelan who had been Trudeau's agriculture minister, got hold of the rBGH file and mobilized the Senate Standing Committee on Agriculture to launch a public investigation. Whelan the colourful former Windsor-Essex MP held fellow Liberal Alan Rock's feet to the fire by asking some tough questions of Health Canada officials and Monsanto lobbyists. One of Rock's former policy advisers joined Monsanto Canada's government affairs team after leaving office.
The senate hearings were beamed across the country by CPAC. Thousands of citizens wrote to senators and public interest groups flocked to Parliament Hill to voice concerns about rBGH going into the nation's food supply.
Monsanto witnesses who appeared before the committee testified there were plenty of "exhaustive scientific studies" that concluded "overwhelmingly" that bovine growth hormone was safe for humans. Nevertheless, the senators on the committee concluded that final rBGH approvals should be based on what Health Canada scientists determined to be safe.
Green Party leader Elizabeth May who was Sierra Club CEO at the time had got wind of the impending threat of rBGH approval from a government insider. "Provincial bureaucrats across the country had been notified that bovine growth hormone was going to be registered," says May. "Nobody knew publicly that Alan Rock had already decided to register it. And then the hearings took place."
In dramatic testimony in front of Parliamentary cameras Chopra and Haydon hung out Health Canada's dirty laundry for appalled Canadians to see.
In January, 1999 Alan Rock decided not to register rBGH for licensing. Although Chopra and his fellowship of Health Canada regulators did not approve it, bovine growth hormone was never banned outright, and thanks to NAFTA rBGH-treated dairy products from the U.S. continue to make their way into Canadian grocery stores.
Sixteen years after the hearings the Senate committee's list of recommendations made in a 1999 interim report on how Health Canada should fix its broken regulatory process and troubling coziness with industry, remains an interim report with none of its recommendations enacted to this day. There's an outrage.
In fact, in the interests of "making it easier for Canadians and businesses to deal with their government" as it was expressed in the 2012 federal budget, there is today even less of government and more of industry in food safety. The Harper government carved $56 million from the Canadian Food Inspection Agency's operating funds. The CFIA which shares food safety oversight with Health Canada would lose 650 jobs many of them veterinarians and chemists who inspect meat products and certify their safety.
In the 2012 budget announcement the late finance minister Jim Flaherty had trumpeted a new directive: "The CFIA will introduce a web-based label verification tool that encourages consumers to bring validated concerns directly to companies and associations for resolution." That's code for, industry will now be inspecting itself, if you have an issue with food safety, take it up with the food producer.
NDP foreign affairs critic Paul Dewar, who calls Chopra and Haydon's drug safety battles with Health Canada heroic says, "There is not one person in charge at the Public Health Branch who has a background in research. Those people have been shuffled out." In keeping with muzzling of scientists in other sectors Dewar says this has resulted in lack of oversight of drug and food safety: "Health Canada is entirely negligent when it comes to allowing people to understand what's in their food."
Dewar introduced a private members bill back in 2008 that would have required mandatory labeling of food product ingredients including genetically engineered hormones such as rBGH, pesticides, non-therapeutic antibiotics, GMOs and slaughterhouse waste.
Chopra calls them the five pillars of food safety. Suspected to be of questionable safety and kept off shelves in EU countries, none of the products containing these ingredients have undergone clinical trials by Health Canada that produced scientific evidence of their human safety.
"You won't find the safety data for these five things in our food supply anywhere," says Chopra.
In a 2014 TV program entitled "Drugstore Remedies -- Licence to Deceive," CBC Marketplace producers exposed what a dangerous joke Health Canada's "rigorous safety reviews" have become.
The program's producers filled out a licence application for a children's remedy that claimed to reduce fever, inflammation and pain. They called it Nighton, an anagram of "nothing" because the drug didn't actually exist. The only scientific evidence Marketplace host Erica Johnson submitted to back up the drug's claims was five photocopied pages from a 1902 homeopathic reference book. She mailed out the application in May and in October a brown envelope came back with her Health Canada licence.
Now there's an outrage.
This piece originally appeared n the July 20, 2015 The Hill Times and is reprinted with permission.
Peter Biesterfeld is a freelance writer, independent documentary maker and educator based in Toronto. He writes and makes films about social justice and media watch issues. He has written for NOW magazine, Common Ground, The Dominion and Videomaker.
Photo: flickr/ Health Gauge
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