Canada's Decision To Make Public More Clinical Trial Data Puts Pressure On FDA

https://www.npr.org/sections/health-shots/2019/10/11/769348119/canadas-decision-to-make-public-more-clinical-trial-data-puts-pressure-on-fda

 

Canada's Decision To Make Public More Clinical Trial Data Puts Pressure On FDA

 

"Last March, Canada's department of health changed the way it handles the huge amount of data that companies submit when seeking approval for a new drug, biological treatment, or medical device — or a new use for an existing one. For the first time, Health Canada is making large chunks of this information publicly available after it approves or rejects applications.

 

Within 120 days of a decision, Health Canada will post clinical study reports on a new government online portal, starting with drugs that contain novel active ingredients and adding devices and other drugs over a four-year phase-in period. These company-generated documents, often running more than 1,000 pages, summarize the methods, goals, and results of clinical trials, which test the safety and efficacy of promising medical interventions. The reports play an important role in helping regulators make their decisions, along with other information, such as raw data about individual patients in clinical trials.

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The British-based pharmaceutical company GlaxoSmithKline (GSK) has gone further than most in providing public access to its data. In 2013, the company began posting clinical study reports through its own online portal, Clinical Study Register, which is open to the public. "We have published over 2,500 clinical study reports and nearly 6,000 summaries of results — both positive and negative — from our trials on Clinical Study Register," Andrew Freeman, director and head of medical policy, said in an emailed statement. "GSK is leading the industry in transparency."

 

Even so, GSK controls the level of redaction, says Jefferson of Cochrane, who tried to use clinical study reports posted on the company's portal for a systematic review of HPV vaccines. "Important aspects, for instance the narratives of serious adverse events — those are all blocked out. Big black boxes," he says. "So they are of moderate use."

 

Meanwhile, many researchers do not realize that Health Canada and the EMA are making clinical study reports available. An online survey of 160 researchers around the world who conduct systematic reviews found that 133 "had never considered accessing regulatory data" and 117 of those 133 "were not aware (or were unsure) of where to access such material." They continue to rely on the limited data in journal articles and other published literature, says Herder of Dalhousie University.

 

"Transparency is wonderful in theory but unless people actually do the work of getting data and independently analyzing it, transparency is window dressing," he says."

 

My thought: How about reopening the approval process of Valium and subsequently approved benzos, and accessing the raw data including the adverse effects disclosed from the raw data? eg. Similar to the botched attempt in the U.K. for filing a class action lawsuit.

 

 

I'm a little disappointed that others have not followed up on this post.

 

Health Canada's portal to raw data, even if only for new benzos that have been accepted or rejected, should be of interest to some of the more inquisitive and/or proactive among us, shouldn't it?

 

Personally, I would like to read some non-redacted human studies being conducted on novel benzos to, among other reasons, better understand the symptoms many of us experience for the older benzos like Valium, Xanax, Ativan, Klonopin, etc. Others may be interested in reading non-redacted human studies of other medications before they consent to using them.

 

Has anyone tried to use Health Canada's new portal discussed in the above referenced NPR link?

Just as an FYI, Fi, here in Canada, we're in the midst of a federal election campaign, and it's also Thanksgiving weekend. So, the Canadians among us might be focused on other things this weekend. Personally, I was overwhelmed a number of things and didn't get to read the article. I did plan to come back to it, though.

This is one example of novel benzodiazepines being tested on mice that will likely make its way to human clinical studies sooner than later:

 

https://www.karger.com/Article/FullText/496086

 

"Novel Benzodiazepine-Like Ligands with Various Anxiolytic, Antidepressant, or Pro-Cognitive Profiles"

 

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Reversal of Age-Induced Working Memory Deficit

 

The efficacies of GL-II-73 and GL-II-75 in reversing working memory deficits were next assessed in old male mice. ANOVAs revealed significant differences between young, old, and old treated mice (F > 12.3; p < 0.0015). The 22-month old mice displayed alternation rates in the YM at chance level, suggesting cognitive impairment (p < 0.002 compared to young mice). At 5 mg/kg, GL-II-73 or GL-II-75 significantly reversed spatial working memory deficits of old mice to levels indistinguishable from young controls (p < 0.03 compared to old vehicle; Fig. 4e–f and online suppl. Table S10).

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Lapis, I just visited the Canadian portal and found the list of drugs currently available for review. I did not find any benzos or anti-depressants among their data base but there is a list of other drugs there that may be of interest to others. Best Wishes!

 

Edit:

 

Here is Health Canada's public portal link:

 

https://clinical-information.canada.ca/search/ci-rc

Thanks, Fi. I'm hoping to read the first article later on. Just a bit too much on my plate right now. But thanks for sharing this info.

Last time I checked this database they only had 4 drugs there, so at least someone is doing something. I don't see any psychotropics there yet though, mostly cancer drugs. Health Canada is even more lax about patient safety than the FDA though, so I would expect them to allow heavy redaction.

Wow, the number of adverse reactions to the MMRV vacccine is way higher than I was expecting:

 

"The most commonly reported (≥10% incidence rate) systemic clinical adverse

experiences following receipt of a single dose of ProQuadô alone (varicella virus

potency ≥3.97 log10 PFU/dose) were fever (37.2%), upper respiratory infection (23.5%),

otitis media (12.0%), and irritability (11.3%). The most commonly reported systemic

clinical adverse experiences following receipt of M-M-RôII and VARIVAXô were the

same (fever: 31.5%; upper respiratory infection: 20.7%; otitis media: 11.2%; and

irritability: 10.2%). "

 

"After receiving a dose of ProQuadô with varicella virus potency ≥3.97 log10 PFU/dose,

76.1% (3366/4424) of subjects reported one or more systemic clinical adverse

experiences during Days 0 to 42 postvaccination. Among recipients of M-M-RôII and

VARIVAXô, 72.3% (1444/1997) reported one or more systemic clinical adverse

experiences during the same time period. This difference was significantly different

based on the estimated risk difference."

Last time I checked this database they only had 4 drugs there, so at least someone is doing something. I don't see any psychotropics there yet though, mostly cancer drugs. Health Canada is even more lax about patient safety than the FDA though, so I would expect them to allow heavy redaction.

 

Thanks Data, I was going to google search each drug reported there to see what categories of drugs are included but, it appears you've already done that.

 

I hope the FDA will provide at least as much transparency as Canada. Since almost everything is now digitized, it would be nice if all FDA approved drugs are included on a public portal for patients, prescribers & others to consider while making medical decisions.

Is there some historical, legal, or political reason why would Canada doing this would change the way the FDA operates?

Is there some historical, legal, or political reason why would Canada doing this would change the way the FDA operates?

 

That's a good question. Some suggest that the unexpected resignation of Scott Gottieb as the Commissioner of the FDA may have been due to pressure from political interests and corporate profits but, Gottieb cited that he wanted to spend more time with his family.

 

"On March 5, 2019, Gottlieb announced his resignation as FDA Commissioner, effective in about a month. He said that he wanted to spend more time with his family. At the time of his resignation, Politico observed, "FDA leaders have typically focused much of their attention on a handful of medical topics, but Gottlieb has been active and aggressive on many issues as commissioner without hewing to a strictly conservative or liberal ideology. It’s an approach that’s won him praise from many in the health sector, while garnering criticism from several of the targeted businesses like tobacco companies and the fast-growing e-cigarette industries."

 

https://en.wikipedia.org/wiki/Scott_Gottlieb

Interesting, but of course, it takes no bravery to go after cigarettes or vaping, and he also joined the board of Pfizer. I wonder if the being "active and aggressive on many issues," included any areas that were in conflict with the interest of Pharma?

 

Asking the FDA to act quickly on matters of human health that aren't in conflict with powerful interest groups would seem to be just an expectation of them doing the minimum job requirement. But of course we can't expect that at all, and we are proof that the relationship between the FDA and Pharma is one of grotesque symbiosis and mutual benefit. Imagine what an FDA that actually, aggressively, looked after citizen welfare would look like. For me, that is actual impossible to conceive of, because we'd be living in a completely different landscape.