
Canada's Decision To Make Public More Clinical Trial Data Puts Pressure On FDA - pseudolus
https://www.npr.org/sections/health-shots/2019/10/11/769348119/canadas-decision-to-make-public-more-clinical-trial-data-puts-pressure-on-fda
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drawkbox
Anything measured improves. The more data and metrics, the better safety of
drugs can be observed. It is always a good thing to get more insight and
information to help harm reduction and safety.

> _Transparency advocates say clinical study reports need to be made public in
> order to understand how regulators make decisions and to independently
> assess the safety and efficacy of a drug or device. They also say the
> reports provide medical societies with more thorough data to establish
> guidelines for a treatment 's use, and to determine whether articles about
> clinical trials published in medical journals — a key source of information
> for clinicians and medical societies — are accurate._

There really is no reason why this data should not be more public at the FDA.
Transparency improves safety, and that is their stated mission.

> FDA Mission

> The Food and Drug Administration is responsible for protecting the public
> health by ensuring the safety, efficacy, and security of human and
> veterinary drugs, biological products, and medical devices; and by ensuring
> the safety of our nation's food supply, cosmetics, and products that emit
> radiation

~~~
darawk
I suppose one counter-argument might be that if the data is public, drug
companies would have more transparency into the FDAs methods, that might allow
them to tailor their trials in a way to target the FDA's criteria in a way
that would be bad for outcomes? Maybe?

But I come down on the same side, more transparency is probably better, and
the FDA really probably only resists transparency here to avoid their own
accountability to the public.

~~~
crankylinuxuser
'Your account has been banned for violation of policies.

You are not allowed to know why you are banned.

You know what you did.

All your data has been deleted and is no longer accessible to you."

\---Any cloud provider

Is that kind of secrecy useful in any way? No. It, instead serves to cover up
abuses and oversights. Transparency, especially in government is essential.
People should have privacy as their right, but the government should not.

~~~
darawk
Ya, I agree. Just trying to come up with the strongest possible counter-
argument. Which may be that the FDA depends on some level of secrecy in order
to prevent drug companies from overly tailoring their trials to their internal
criteria. To be clear, I don't find that argument convincing, it's just the
best one I could think of.

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dghughes
I just skimmed the article but I think this is partly due to a controversy
over medical device failures. Investigative journalism TV shows discovered a
high rate of failure in medical devices.

A large number of implanted devices like hip joints, pacemakers, insulin
pumps,catheters were failing. That information wasn't public and when it was
made public people freaked out.

[https://www.cbc.ca/news/health/implant-files-
investigation-m...](https://www.cbc.ca/news/health/implant-files-
investigation-medical-devices-1.4924384)

~~~
drawkbox
Keeping this information from the public, even if people freak out, is
dangerous. It would be like car companies not telling you about a recall on
your vehicle. The main reason they don't want it public is
economic/competitive impacts to the companies that lobby to block it.

The medical industry does deal with these cases and let people know when they
have the issue. However, if you keep information from everyone, it doesn't
always get to the people it affects.

Being more transparent could also lead to better product development iteration
on medical devices if feedback is more available.

Hiding information on problems suppresses solutions. Suppression of
information can be catastrophic, ask the FAA.

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Scoundreller
Another environment where Canada is tops is aviation incident reporting.

That’s why you see a lot of reports on avherald.com from Canada.

~~~
Scoundreller
Here's a link to check the Civil Aviation Daily Occurrence Reports:

[https://wwwapps.tc.gc.ca/Saf-Sec-Sur/2/CADORS-
SCREAQ/rs.aspx...](https://wwwapps.tc.gc.ca/Saf-Sec-Sur/2/CADORS-
SCREAQ/rs.aspx?rt=NRL)

Just don't choose the default of today, today's not over yet!

Here's 123 from yesterday: [https://wwwapps.tc.gc.ca/Saf-Sec-Sur/2/cadors-
screaq/rd.aspx...](https://wwwapps.tc.gc.ca/Saf-Sec-Sur/2/cadors-
screaq/rd.aspx?rt=NRL&rd=2019-10-11&fa=&rg=)

It includes a lot because it includes anything that goes in/over Canadian
controlled airspace, including a lot of ocean.

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westurner
We really could get more out of this data through international collaboration
and through linked data (e.g. URIs for columns). See: "Open, and Linked, FDA
data"
[https://github.com/FDA/openfda/issues/5#issuecomment-5392966...](https://github.com/FDA/openfda/issues/5#issuecomment-539296649)
and "ENH: Adverse Event Count / 'Use' Count Heatmap"
[https://github.com/FDA/openfda/issues/49](https://github.com/FDA/openfda/issues/49)

With sales/usage counts, we'd have a denominator with which we could calculate
relative hazard.

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negzero7
This is a terribly worded title by NPR, should be "Canada's Decision To Make
More Clinical Trial Data Public Puts Pressure On FDA."

Having said that I really hope the FDA will follow suit.

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Jgrubb
When I first woke up, the title here matched that of the article. Why change
it?

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pseudolus
I posted the story with the original title. I didn’t edit the post title
afterwards so it was probably changed by staff.

