April 12, 2020

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The FDA vs Health Canada

If you think Health Canada does a better job than the American HHS or FDA, at being more thorough, transparent or unbiased when monitoring drugs and vaccines, or regulating those products, think again. In Canada, we have repeatedly followed in the footsteps of the FDA, and in addition to that, we have also implemented legislation that creates a veil of secrecy to protect industry from the public. You read that correct. Though it is assumed that Health Canada is supposed to protect the public from industry, legislation is actually written in reverse, so that industry is protected from the public.

Canadian research from 2004 states:

In Canada, the information used to approve new drugs is deemed commercially sensitive and hence confidential under the Access to Information Act, and the Therapeutic Products Directorate (TPD) will not release such information without the manufacturer's approval. As a consequence, safety and efficacy information contained in unpublished trials submitted to the TPD is generally unavailable to researchers, physicians and patients, a situation that can potentially lead to the inappropriate prescribing and use of medications.

 

The standard argument for the legal protection of these data is that their disclosure would compromise the economic interests of drug manufacturers. This rationale is difficult to credit in view of experience in other jurisdictions. The US Food and Drug Administration (FDA) discloses research information from preclinical and clinical trials that is considered proprietary in Canada, without apparent negative effects on companies' profitability or willingness to operate in the US market. 

 

On the other hand, nondisclosure has serious disadvantages for the TPD, health professionals and the Canadian public. If scientific data submitted to regulatory agencies are never disclosed or allowed to enter normal peer-review channels, neither these data nor TPD reviewers' evaluations can become subject to scrutiny by independent scientists...

 

...A model for the minimum level of reporting already exists in FDA approval packages. Once a drug has been approved in the United States, the FDA posts on its Website a detailed summary of the information that the company has submitted, including the clinical trial data. Compared with what is already available in the US, this initiative for greater transparency in Canada is grossly inadequate. 

 

And in a more recent paper from 2016, which evaluated the evolution of Canadian drug regulation during the 20th century, the article explained that Canada relied heavily upon input from the pharmaceutical industry, and followed in the footsteps of the US. The paper stated:

...indus­try’s influence over regulatory decision­ making increased throughout the 20th century. Once the Department of Health was formed, industry became directly involved in drafting regulations and developing guidelines and other materi­als. The regulator assumed a cooperative approach with industry on the theory that this was the more effective means of reg­ulation, reinforced through a revolving door of employees between industry and the regulator...[A]s early as the 1940s, Canadian regulatory officials began interacting with their American counterparts, embracing the norms of confidentiality that dictated American regulatory practice.

 

That paper also had the following to say:

How do you change the way an institution has worked for nearly a century? This is the challenge that the biomedical community must help Health Canada confront if the regulation of pharmaceutical drugs is to sub­stantially improve. Transparency was once characteristic of Canadian pharma­ceutical regulation. Recent changes in law may mark a return to openness, but if history is instructive, physicians and bio­medical researchers will need to push the regulator for change.

 

The regulation of pharmaceutical drugs was once a remarkably public exercise. Starting in 1887, the Canadian regulator (originally the Department of Inland Revenue) began publishing bul­letins. Often hundreds of pages, the bul­letins named names, identifying “drug houses” and “shop­keeps” that produced adulterated goods...

 

When the new federal Department of Health took over and Canada’s inaugu­ral Food and Drugs Act was passed in 1920, regulation went dark....When the department began collecting evidence about drug safety in the 1940s and ’50s (including drug effectiveness in the later decade), it treated that information as company property, not to be shared. Fast­forward to the present and it’s clear that this institutionalized practice of secrecy has not served the public well: physicians have been misinformed and patients have been unnecessarily harmed. For example, tens of thousands of people are estimated to have died from cardiac arrest after being pre­scribed the arthritis medication rofe­coxib (Vioxx) — a risk that regulatory officials had previous knowledge of but nevertheless kept confidential.

 

What Canadian's need to realize is that Canadian regulation practices are very similar to American practices, which is obvious recognizing that both countries have approved the same dangerous drugs, like Vioxx, that later needed to be recalled. Another similarity between the two countries, is that Canada uses many of the same vaccine brands that are used in the US, and Canada follows a very similar vaccine schedule despite several other 1st world nations following a significantly lesser vaccination schedule. A key difference between Canada and the US, is that unlike in the US, Canada doesn't have a compensation program to provide financial assistance following a vaccine injury, and we also don't have a Federal Agency that is officially tasked with conducting biennial vaccine safety audits on all childhood vaccines, to identify ways vaccines are unsafe.

 

For vaccine safety in Canada, we rely solely on the pre-licensing testing completed by the vaccine manufacturers themselves, testing which only monitors vaccine recipients for a few hours or days following receipt of a vaccine. Furthermore, Health Canada maintains that that pre-licensing data must be kept confidential to protect the manufacturer. Once a vaccine is being used widely on Canadians, we then rely upon doctors to identify and report adverse reactions. Unfortunately, it is common knowledge that the vast majority of medical professionals throughout the world, fail to file the appropriate adverse event reports which they are required to file, reports that would help track and monitor vaccine safety.

 

One Canadian father is trying to combat this. In 2000, a young girl by the name of Vanessa Young died suddenly from an adverse effect of a medication that she had been prescribed, an adverse affect that Health Canada was aware about but did little to inform doctors about. Since then, her father, Canadian MP Terence Young, has worked tirelessly to bring about reform within Canadian drug regulation, and his relentless effort finally paid off in 2014. As a result of his effort, Health Canada passed a new Bill, called Vanessa's Law. Vanessa's Law is a step in the right direction. It gives Health Canada powers it didn't have before. Health Canada now has the authority to withdraw a dangerous drug from the market. What's incredible about that is Health Canada didn't have this power before. And now Health Canada can release confidential information about the pre-licensing testing. Vanessa's Law also gives Health Canada the ability to impose heavy penalties, daily, against parties that contravene the legislation, and the legislation has the potential to improve the reporting of adverse drug and vaccine reactions. Though this legislation is a step in the right direction, it is likely that for the time being, many measures within Vanessa's Law will not be implemented fully or change the current secretive culture within Health Canada. 

 

For Vanessa's Law to have a real impact, doctors need to first be educated and supported, so that they are able to follow through rigorously on the policy's mandates. Currently, a doctor's understanding of what constitutes an adverse drug or vaccine reaction is inadequate. And the current adverse event reporting processes are inefficient, time consuming, and misaligned with how work-flow operates within medical care. As a consequence, doctors and nurses continue to fail to file these reports.

 

As for the current culture of secrecy within Health Canada, the way Vanessa's Law is written, the law states that Health Canada has the discretion to release confidential information. That means that the data held by Health Canada will remain confidential. At present, information that is currently made public for Americans by their FDA, that same information will remain hidden from Canadians, and the information will only be shared with Canadians if the health minister "believes" the therapeutic product "may" cause harm to the public. A July 2018 article shows that Health Canada is still trying to prevent public access to such data. In spite of Vanessa's Law, Health Canada refused to release the information and the inquiring researcher had to file a lawsuit in Canadian Federal Court against Health Canada. The Federal Court judge deemed Health Canada's actions unreasonable, and the final ruling required Health Canada to release the documents to the researcher. Health Canada's backwards approach, its motivation to protect pharmaceutical interests over public interests matches David Graham's accusation of the FDA, that the FDA views industry as their client not the public or public health. As a result, Canadian drug regulation is as bad, or worse, compared to HHS and FDA practices.

 

 

CONTINUE to the next article in this series: Ch9: Part 6

 

 

Article Sources

  • HHS Instruction: well-founded vaccine safety concerns cannot be allowed to exist Here

  • HHS: Instruction to media to censor vaccine critical discussions Here

  • ICAN letter addressed to the Secretary of HHS Here

  • Investigation into FDA VRBPAC committee conflicts of interest Here

  • Investigative Report (Science Magazine) - pay-later conflicts of interest Here

  • Science Magazine article about pay-later conflicts of interest Here

  • Health Canada protects industry from the public Here

  • Health Canada has had a culture of secrecy for 100 years Here

  • Worldwide it is recognized that only a fraction of adverse events are reported Here

  • Media coverage of Vanessa's Law - current adverse event reporting is for only a fraction of the events that occur  Here

  • Federal Court Judge orders Health Canada to release documents Here

  • Vanessa's Law - an amendment to Health Canada's Food and Drugs Act Here

  • You can re-fresh your memory on all the things David Graham said about the flawed FDA regulations from his 2005 interview Here

 

 

 

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