Landmark Court Ruling to Release Vaccine Data for Gardasil, Cervarix and Tamiflu Clinical Trials

A major legal victory has been granted to an American professor who went after Health Canada in order to obtain clinical trial data on vaccines that was being hidden from the public.

The Canadian federal government has tried to keep a lid on the data saying it was "confidential business information". But the July 9 ruling by the Federal Court overruled the government's refusal to provide the data.

_{pixabay, wikimedia}

Peter Doshi, an assistant professor at the University of Maryland School of Pharmacy and an associate editor at the BMJ, sued Health Canada to get them to release the clinical trial data that was submitted to them by manufacturers of vaccines. In total there were 5 vaccines with data released: Gardasil, Gardasil 9 and Cervarix user as an HPV vaccine, and Tamiflu and Releneza used as a flu vaccine.

Most of the mainstream media, certainly in the US, has been silent on this landmark court ruling over big pharma and their secrecy over vaccine trials. But the CBC and BMJ (British Medical Journal) have covered the release.

The ruling in Canada is the best strategy that Doshi could engage in, as his legal team had little to no chance of winning such a ruling in the US courts. The pharmaceutical companies that manufacture vaccines are far too insulated in the US legal system, as they were granted immunity from being sued in 1986. Canada allowed a more honest ruling that didn't favor the interests of the vaccine manufacturers.

This ruling is important because the approval process for the HPV vaccine is mired in flawed trials, scandals and cover-ups. The vaccine has resulted int he death and injuries of many young people, especially women between 12 and 26 years old, many of whom can no longer have children due to being made infertile by the HPV vaccine.

Speaking to CBC News in an email, Doshi said:

"I hope my case sets a precedent and allows researchers, clinicians, and the public easy access to clinical trial data. Regulators shouldn’t have a monopoly on judging the risks and benefits of medicines or hinder others from doing the same via confidentiality agreements"

Federal Court Justice Sébastien Grammond said Health Canada's position was "unreasonable", which another health expert -- Matthew Herder, director of the Health Law Institute at Dalhousie University in Halifax -- agrees with. Herder hopes this ruling will encourage other researchers to start requesting data on other drugs in the market, saying to CBC:

"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. The court didn't say a confidentiality agreement is never appropriate, it didn't go that far, but it certainly enshrined the importance of being able to disseminate findings."

Doshi has publicly called for more open access to clinical trial data since 2013. He's described in an article from the New York Times called Breaking the Seal on Drug Research:

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.

Dr. Peter Doshi's win in court could help to rebut the critics and nay-sayers who call him "anti-vaccine" in order to discredit his honest concerns. He's been an open critic of big pharma and governmental politics that have been concealing clinical trial data and misleading the public about the safety of drugs under the claim that it would reveal "trade secrets".

Hopefully this ruling will lead to more transparency brought onto big pharma, with researchers being able to verify the clinical data and make big pharma more honest. This will beenfit public health and potentially "uncover biased testing, selective publishing and regulatory failures, or overturn previous conclusions on the reliability of drugs". Maybe this can finally prove that the women women and girls have been made infertile by the HPV vaccine and the truth can finally be known.

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References:

• Health Canada ordered to release confidential drug company data on HPV vaccines
• Canadian government ordered to release unpublished Tamiflu data in landmark ruling
• Gardasil Vaccine Legal Victory: Canada Federal Court Rules to Release Clinical Trial Data to American Researcher
• PETER DOSHI v. ATTORNEY GENERAL OF CANADA
• Breaking the Seal on Drug Research

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