Health
US FDA plans overhaul of decades-old medical device system
WASHINGTON — US health officials say they plan to overhaul the country’s decades-old system for approving most medical devices, which experts have long criticized for failing to catch problems with risky implants and medical instruments.
The Food and Drug Administration announced plans Monday aimed at making sure new medical devices reflect up-to-date safety and effectiveness features. The system targeted by the actions generally allows manufacturers to launch new products based on similarities to decades-old products, not new clinical testing.
The FDA’s pledge came one day after the publication of a global investigation into medical device safety by more than 50 media organizations, including The Associated Press. The probe, led by the International Consortium of Investigative Journalists, analyzed more than 8 million device-related health records, including death and injury reports and recalls.
Matthew Perrone, The Associated Press
Business
The Health Research Funding Scandal Costing Canadians Billions is Parading in Plain View
Why Can’t We See the Canadian Institutes for Health Research-Funded Research We Pay For?
Right off the top I should acknowledge that a lot of the research funded by the Canadian Institutes for Health Research (CIHR) is creative, rigorous, and valuable. No matter which academic category I looked at during my explorations, at least a few study titles sparked a strong “well it’s about time” reaction.
But two things dampen my enthusiasm:
- Precious few of the more than 39,000 studies funded by CIHR since 2011 are available to the public. We’re generally permitted to see no more than brief and incomplete descriptions – and sometimes not even that.
- There’s often no visible evidence that the research ever actually took place. Considering how more than $16 billion in taxpayer funds has been spent on those studies over the past 13 years, that’s not a good thing.
If you’ve been reading The Audit for a while, you know that I’ll often identify systems that appear vulnerable to abuse. As a rule though, I’m reluctant to invoke the “s” word. But here’s one place where I can think of no better description: the vacuum where CIHR compliance and enforcement should be is a national scandal.
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I’ve touched on these things before. And even in that earlier post I acknowledged how:
…as a country, we have an interest in investing in industry sectors where there’s a potential for high growth and where releasing proprietary secrets can be counter productive.
So we shouldn’t expect access to the full results of every single study. But that’s surely not true for the majority of research. And there’s absolutely no reason that CIHR shouldn’t provide evidence that something (anything!) productive was actually done with our money.
Because a well-chosen example can sometimes tell the story better than huge numbers, I’ll focus on one particular study in just a moment. But for context, here are some huge numbers. What follows is an AI-powered breakdown by topic of all 39,751 research grants awarded by CIHR since 2011:
Those numbers shouldn’t be taken as anything close to authoritative. The federal government data doesn’t provide even minimal program descriptions for many of the grants it covers. And many descriptions that are there contain meaningless boilerplate text. That’s why the “Other – Uncategorized” category represents 72 percent of all award dollars.
Ok. Let’s get to our in-the-weeds-level example. In March 2016, Greta R. Bauer and Margaret L. Lawson (principal investigators) won a $1,280,540 grant to study “Transgender youth in clinical care: A pan-Canadian cohort study of medical, social and family outcomes”.
Now that looks like vital and important research. This is especially true in light of recent bans on clinical transgender care for minors in many European countries following the release of the U.K.’s Cass report. Dr. Cass found that such treatment involved unacceptable health risks when weighed against poorly defined benefits.
A website associated with the Bauer-Lawson study (transyouthcan.ca) provides a brief update:
As of December of 2021, we have completed all of our planned 2-year follow up data collection. We want to say thanks so much to all our participants who have continued to share their information with us over these past years! We have been hard at work turning data into research results.
And then things get weird. That page leads to a link to another page containing study results, but that one doesn’t load due to an internal server error.
Before we move on, I should note that I come across a LOT of research-related web pages on potentially controversial topics that suddenly go off-line or unexpectedly retire behind pay walls. Those could, of course, just be a series of unfortunate coincidences. But I’ve seen so many such coincidences that it’s beginning to look more like a pattern.
The good news is that earlier versions of those lost pages are nearly always available through the Internet Archive’s WayBackMachine. And frankly, the stuff I find in those earlier versions is often much more – educational – than whatever intentional updates would show me.
In the case of transyouthcan.ca, archived versions included a valid link to a brief PDF document addressing external stressors (which were NOT the primary focus of the original grant application). That PDF includes an interesting acknowledgment:
This project is being paid for by a grant from the Canadian Institutes of Health Research (CIHR). This study is being done by a team of gender-affirming doctors and researchers who have many years of experience doing community-based trans research. Our team includes people who are also parents of trans children, trans adults, and allied researchers with a long history of working to support trans communities.
As most of the participants appear to have financial and professional interests in the research outcome, I can’t avoid wondering whether there might be at least the appearance of bias.
In any case, that’s where the evidence trail stopped. I couldn’t find any references to study results or even to the publication of a related academic paper. And it’s not like the lead investigators lack access to journals. Greta Bauer, for example, has 79 papers listed on PubMed – but none of them related directly to this study topic.
What happened here? Did the authors just walk off with $1.2 million of taxpayer funding? Did they do the research but then change their minds about publishing when the results came in because they don’t fit a preferred narrative?
But the darker question is why no one at CIHR appears to be even mildly curious about this story – and about many thousands of others that might be out there. Who’s in charge?
Keep these posts coming: subscribe to The Audit.
Alberta
Alberta mother accuses health agency of trying to vaccinate son against her wishes
From LifeSiteNews
Alberta Health Services has been accused of attempting to vaccinate a child in school against his parent’s wishes.
On November 6, Alberta Health Services staffers visited Edmonton Hardisty School where they reportedly attempted to vaccinate a grade 6 student despite his parents signing a form stating that they did not wish for him to receive the vaccines.
“It is clear they do not prioritize parental rights, and in not doing so, they traumatize students,” the boy’s mother Kerri Findling told the Counter Signal.
During the school visit, AHS planned to vaccinate sixth graders with the HPV and hepatitis B vaccines. Notably, both HPV and hepatitis B are vaccines given to prevent diseases normally transmitted sexually.
Among the chief concerns about the HPV vaccine has been the high number of adverse reactions reported after taking it, including a case where a 16 year-old Australian girl was made infertile due to the vaccine.
Additionally, in 2008, the U.S. Food and Drug Administration received reports of 28 deaths associated with the HPV vaccine. Among the 6,723 adverse reactions reported that year, 142 were deemed life-threatening and 1,061 were considered serious.
Children whose parents had written “refused” on their forms were supposed to return to the classroom when the rest of the class was called into the vaccination area.
However, in this case, Findling alleged that AHS staffers told her son to proceed to the vaccination area, despite seeing that she had written “refused” on his form.
When the boy asked if he could return to the classroom, as he was certain his parents did not intend for him to receive the shots, the staff reportedly said “no.” However, he chose to return to the classroom anyway.
Shortly after, he was called into the office and taken back to the vaccination area. Findling said that her son then left the school building and braved the sub-zero temperatures to call his parents.
Following his parents’ arrival at the school, AHS claimed the incident was a misunderstanding due to a “new hire,” attesting that the mistake would have been caught before their son was vaccinated.
“If a student leaves the vaccination center without receiving the vaccine, it should be up to the parents to get the vaccine at a different time, if they so desire, not the school to enforce vaccination on behalf of AHS,” Findling declared.
Findling’s story comes just a few months after Alberta Premier Danielle Smith promised a new Bill of Rights affirming “God-given” parental authority over children.
A draft version of a forthcoming Alberta Bill of Rights provided to LifeSiteNews includes a provision beefing up parental rights, declaring the “freedom of parents to make informed decisions concerning the health, education, welfare and upbringing of their children.”
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