
The FDA fails to adequately screen or monitor products - js2
https://www.nytimes.com/2019/05/04/opinion/sunday/medical-devices.html
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tomohawk
There's a few things that are problematic about this opinion piece.

First off, many of the items being discussed are related to surgical
treatments. It is very hard to impossible to do a double blind study of a
surgical thing. What are you going to do? Open a bunch of people up and only
do the actual treatment on half of them? I've heard of this being done in very
rare situations, but the ethics of this are pretty edgy.

Secondly, there appears to be a mischaracterization of women being
disproportionately affected by things. This is a pretty complex topic, but
lets balance out the offered information by pointing out that prostate cancer
(men) kills more people than breast cancer (women) and receives a lot less
funding

[https://www.telegraph.co.uk/news/2018/02/02/prostate-
cancer-...](https://www.telegraph.co.uk/news/2018/02/02/prostate-cancer-kills-
people-breast-cancer-first-time-new-figures/)

My personal experience with FDA regulation has been that they are being asked
to do an impossible task, and not doing a great job of it. People close to me
have been hugely (negatively) impacted by FDA decisions because they are going
for a one size fits all solution for everything, and because they somehow
fancy that they know more than doctors involved in a particular situation.

~~~
anon1m0us
Doctors are biased too, that's the problem. Often times, knowing a lot about
something will bias you even more because you fail to acknowledge or accept
what you do NOT know or what conflicts with what you THINK you know.

~~~
tomohawk
Everybody's biased, and I've certainly met my share of biased doctors. If you
have a specific complaint, each doctor brings their toolbag of golden hammers
that they know about and rarely has the ability to look beyond it. It's one of
the challenges of being a patient to wade through that.

The FDA isn't really going to be very helpful with this, and they labor under
the additional burden of being much more subject to politics. Sure, they may
stop the obvious quackery, but remember that general anesthesia used to be
considered quackery, as did prescribing antibiotics for stomach ulcers.

------
gist
What really bothers me about this is a) The editorial board, when writing such
an important piece, is not identified on the actual article other than 'the
editorial board'. Sure you can find out who is on the board but you don't know
what parts they played in the write up. I hate this convention.

b) Chain of information custody issue. They cite this organization with a link
to the page but there is nothing easily apparent on that page that would lead
you to know how legit the actual underlying data (which they are quoting) is.
At least on a quick check.

[https://www.icij.org/investigations/implant-
files/](https://www.icij.org/investigations/implant-files/)

It's almost as if it's a 'well we are the NY Times the paper of record so you
can trust that we have thoroughly vetted all of this as well as how the actual
data was compiled'.

This is not to say there isn't an issue. But it's easy for a writer to sit
back and take pot shots (and find something to support that pot shot) w/o the
scope of the problem other than 'and big number of people are impacted'.

------
aheilbut
The FDA regulates (or fails to regulate) many different classes of products
(drugs, biologics, devices, human cell and tissue products, supplements, food,
tobacco and nicotine products, etc). FDA's authority and its effectiveness is
extremely variable across these classes.

My sense is that the traditional drug and biologic drug parts still work
reasonably well, but the biggest problems lately are coming from devices and
from human cell and tissue products (and with products that are being pushed
into those categories). A lot of this is due to the ways the laws have been
written (due to lobbying and legislative capture), but some of it is
undoubtedly a result of regulatory capture and incompetence.

------
awakeasleep
Another example of a government agency that has been captured and lost the
will to govern

~~~
gumby
Congress has gradually eroded its authority. For example FDA can no longer do
its own science but has to rely on the companies to do so. It has been
stripped of any authority over so-called "natural" supplements so they can
make unproven medical claims (e.g. "our homeopathic remedy will cure your
cold") thanks to Oren Hatch being paid reelection dollars by Herbalife. Etc.

Don't blame the agency, blame congress.

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ralph84
They want a:

> global medical device registry where patient outcomes for all medical
> devices are openly monitored

A global open database of people’s most sensitive medical information, what
could go wrong.

~~~
refurb
Jesus! As someone who works in the Pharma industry that’s dam near impossible.
We’d love to get outcomes data for our product post-approval. Getting that
data is damn near impossible as physicians have zero incentive to provide it,
even when something goes wrong.

~~~
BurningFrog
Yeah, the current binary model of "proven safe" is utterly broken.

First, the product is considered 100% unsafe and criminal to use until going
through some defined set of steps.

Then it is considered 100% safe forever, and no further knowledge needs to be
collected.

Any sane system based on gathering knowledge and saving lives would be _very_
different.

~~~
refurb
No one in the industry calls drugs 100% unsafe or 100% safe. That’s why there
is a long list of side effects on every drug commercial.

A risk/benefit profile is what drugs have.

~~~
BurningFrog
I'm talking about the legal/regulatory framework.

Even there, 100% is an overstatement, there are _some_ minor and slow feedback
mechanisms.

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arkades
Today must be an even-numbered day at the NYTimes.

On odd-numbered days we scold the FDA for demanding too much data and
investigation, and so taking too long to let products onto the market.

~~~
ErikVandeWater
It can be both - The FDA is inefficient when it does test a product causing
the costs to increase, and also doesn't screen every product as well as it
should.

~~~
BurningFrog
It's also has separate legal frameworks for drugs and medical devices.

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danielfoster
It makes sense to rush new medical devices and drugs to market when there's no
better option. For example the Reagan FDA removed the review process for new
AIDs drugs during the 1980s epidemic. But the FDA should have scrutinized
vaginal mesh more closely given that there are already so many effective forms
of birth control.

People also need to remember that you can't pick and choose regulations. I
feel like many readers of this article will be rightfully appalled, but
conversely also want to see increased medical use of psychedelics and
marijuana despite a similar lack of research on long-term effects.

~~~
astura
Transvaginal mesh is for pelvic organ prolapse, not some sort of birth
control.

