by Brian Shilhavy

Editor, Health Impact News

CBC News and the British Medical Journal (BMJ) are reporting that Professor Peter Doshi has won a major legal victory against pharmaceutical companies trying to hide clinical trial data from the public due to “confidential agreements” for 5 pharmaceutical products.

Doshi sued Health Canada to release clinical trial data submitted to Health Canada by the manufacturers of the HPV vaccines Gardasil, Gardasil 9 and Cervarix, and the anti-viral flu medications, Tamiflu and Relenza.

A Canadian Federal Court judge ordered Health Canada to release the pharmaceutical clinical trial data, undercutting the Canadian government’s attempts to keep the information confidential.

As far as I can determine, this landmark court ruling out of Canada has been completely censored in the U.S. corporate-sponsored “mainstream” media.

This appears to be a brilliant legal strategy by Doshi and his attorneys, since they had little to no chance of obtaining this clinical trial data from any court in the U.S., where pharmaceutical companies enjoy legal immunity from most lawsuits.

The importance of receiving this data, particularly on Merck’s Gardasil vaccine, cannot be overstated.

As we have reported many times here at Health Impact News, the entire medical approval process to bring the HPV vaccine into the U.S. market is full of scandals and cover-ups, which has resulted in the injuries and deaths of many young people, particularly young women aged 12 to 26, many of whom can no longer bear children due to the vaccine making them infertile.

“I hope my case sets a precedent and allows researchers, clinicians, and the public easy access to clinical trial data,” Doshi reportedly stated in an email to CBC News. “Regulators shouldn’t have a monopoly on judging the risks and benefits of medicines or hinder others from doing the same via confidentiality agreements.”

The ruling by Canadian Federal Court Justice Sébastien Grammond, who called Health Canada’s stance “unreasonable,” was welcomed by other legal experts in Canada. According to CBC News:

“The court said very clearly the public interest in ensuring access to this information, so that independent researchers can scrutinize it, fundamentally outweighs any sort of interest in terms of protecting commercial interests,” said Matthew Herder, director of the Health Law Institute at Dalhousie University in Halifax. Herder has watched the case closely and said he hopes the ruling will encourage researchers, even those outside Canada, to start requesting data on other current drugs on the market.

Read the decision here.

Dr. Peter Doshi has been a public and vocal critic of pharmaceutical companies and government polices that mislead the public regarding drug safety by concealing clinical trial data under the guise of “trade secrets.”

A 2013 article about him that appeared in the New York Times, when Doshi was completing a postdoctoral fellowship at Johns Hopkins University, profiled his efforts to make clinical drug trial data accessible to the public and independent researchers:

Dr. Doshi’s renown comes not from solving the puzzles of cancer or discovering the next blockbuster drug, but from pushing the world’s biggest pharmaceutical companies to open their records to outsiders in an effort to better understand the benefits and potential harms of the drugs that billions of people take every day. Together, with a band of far-flung researchers and activists, he is trying to unearth data from clinical trials — complex studies that last for years and often involve thousands of patients across many countries — and make it public. The current system, the activists say, is one in which the meager details of clinical trials published in medical journals, often by authors with financial ties to the companies whose drugs they are writing about, is insufficient to the point of being misleading.

This ruling in Canada is a major victory for Doshi, and will hopefully lead to more transparency in clinical drug trials and, potentially, lawsuits against pharmaceutical companies that have acted unethically by bringing dangerous products to market, such as the annual flu vaccine and the HPV vaccines.

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