
Many medical devices on the market have undergone no clinical testing - howsilly
https://www.nytimes.com/2018/01/13/opinion/sunday/can-your-hip-replacement-kill-you.html
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dwyerm
Yes, but resolving this might be a case where the cure is worse than the
disease. Take Colchicine for example, which is one of the first medicines
_ever_. It was cheap and plentiful, and thousands of people used it daily to
help control gout.

However, nobody ever actually did modern science on it. We all just assumed it
was safe and effective, because it had been so for thousands of years.

So, in 2006 the US FDA started the Unapproved Drugs Initiative. The US
government said they would give an exclusive right to the drug to anyone who
did the science. So, URL Pharma did a tiny bit of research to prove what
generations of physicians already knew, and the US Government let them have
the exclusive right to sell Colchicine. The price immediately went from
pennies a pill to $3 and up.

While I applaud the goal, it is far too easy to turn these well-meaning
initiatives into cynical IP land-grabs that are distinctly anti-consumer.

[https://www.jwatch.org/jw201006100000001/2010/06/10/spotligh...](https://www.jwatch.org/jw201006100000001/2010/06/10/spotlight-
colchicine-colcrys-controversy)

~~~
c3534l
The problem is that in medicine, it's rarely the engineering that's valuable,
it's knowing if it's safe and effective. I can see why that would rub people
the wrong way, but it's also worrying that people were prescribing medicine
based on tradition rather than science. Pennies to dollars for a period of
time is better than pulling the drug off the market entirely until it was
proven safe (which no one would have done).

~~~
MrLeap
Rather than issue an artificial monopoly, what if a "reward" to the company
that "did the science" was capped at 2x their costs or X years, whichever
comes first. Then it's public domain.

Wouldn't that get SOMEBODY to take the nigh guaranteed investment? I think
what rubs people the wrong way is the limitless profits that are guaranteed by
government sanctioned monopoly for things that save people's lives. It's a
strange perversion of the free market that benefits the wrong people
disproportionately.

~~~
rgbrenner
Between failure, placebo effect, and the possibility of being less effective
than other treatments... that isn't guaranteed. Studying these drugs may just
prove they aren't worth using.

If it's so straight forward to prove, the government should just fund the
studies itself. There's no reason to grant any private company anything in
that case.

~~~
aaavl2821
The NIH currently spends $33B a year on research. Not all of that is drug
related

The top ~15 pharma companies spend over $70B a year on r&d, and VC funds $15B
in the US alone

Even assuming government operates as efficiently as private industry, we are
talking almost triple the NIH budget to accomplish that

~~~
CogitoCogito
> Even assuming government operates as efficiently as private industry, we are
> talking almost triple the NIH budget to accomplish that

So increase the budget? If we assume the government would operate as
efficiently as private industry, then it would be cheaper overall. The other
option is for private industry to recoup the costs plus profits from society
at large.

Obviously increasing the budget is politically difficult, but let's not
pretend the current method makes any real economic sense.

~~~
aaavl2821
The NIH budget has declined 20% in the last 15 years. Not only is there a
strong downward trend, but the movements in funding levels are gradual. I'd
say that tripling the NIH budget is not just politically difficult, but
politically impossible

~~~
CogitoCogito
Then just leave the drugs grandfathered. If we view something as a problem
(i.e. the lack of formal drug approval processes on old drugs), but we are not
willing to solve the problem right (i.e. providing funding to government
agencies to do the research), then we shouldn't do anything at all. Continuing
the status quo is also a reasonable action.

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Thriptic
This is a silly piece and it misrepresents the space.

For starters, the 510(k) pathway only applies to moderate risk class 2
devices. It's not like every device on the market prior to 1976 was
automatically granted 510(k) status which is what this piece implies.

Second, holding medical devices to the same safety standards as drugs is
unnecessary. The reason drugs are held to a higher standard is because they
present a high risk of acute injury and they are more novel. Most medical
devices won't kill you suddenly if they are faulty, and the ones that can are
class 3 devices which require a clinical trial component.

Third, the 510(k) pathway exists because the safety risks for device classes
are relatively similar whereas for drugs there can be high variability
depending on structures. If you design a dental implant that is made of the
same material, has a similar design, and has a similar purpose as a pre-
existing device which has been shown to be safe, it will generally be safe to
assume the new device will also be safe. Most new devices that cannot be shown
to be similar to something already on the market are automatically deemed to
be high risk and require a trial.

Finally, you can't have your cake and eat it too. Want devices to be as safe
as drugs? Apply the same safety standards and watch device costs skyrocket.
Then nyt will be back to incorrectly blaming product manufacturers for sky
high healthcare costs. The FDA is already in a position where they do not have
the funding or manpower to even review all the 510(k)s they get every year. If
you make every device submission a premarket approval (highest level of
scrutiny + a clinical trial) then devices will never get approved in a timely
fashion.

~~~
ProAm
What happened in-regards to the device in the article? What class is it?

~~~
Thriptic
It was one of 19 devices that were class 3 (high risk) but granted 510(k)
exemptions due to precedent. Ultimately all of these devices were intended to
be transitioned to the higher standard pma approval process normally
associated with class 3 devices, but were allowed to leverage moderate risk
510(k) pathways typically granted to class 2 devices until pma processes were
developed for them. FDA was slow in orchestrating the change, and so this was
allowed to continue until these safety concerns manifested, forcing FDA's
hand.

I was actually not aware that this had happened as by the time I entered this
space almost all of the class 3 devices in question had transitioned to pma.
To my knowledge there are very few devices left where this is still the case.

------
refurb
This isn't really news for people familiar with medical device regulation.
Depending on exactly what the new technology is, you can get approval based on
a predicate device.

Otherwise, your most basic medical devices (bladder catheters) would be crazy
expensive as the manufacturer would need to run a clinic trial to test a piece
of tubing.

~~~
maxerickson
It seems pretty crazy that new alloys and materials for long term implants
wouldn't have to do any bio-compatibility testing.

I also wonder what the culture is like for orthopedic surgeons. What risks and
benefits did the doctor-patient in the article perceive came with the
particular implant?

~~~
seehafer
They would have to do biocomp testing. Every 510(k) requires an analysis of
device compliance to ISO 10993, regardless of whether or not its predicate is
preamendment. The premise of the article is alarmist and acts as if FDA
requires _no_ testing whatsoever, when the list of standards is as long as my
arm:
[https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/cla...](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=4508)

Now one could argue that biocomp testing, which is done on animal models for
the most part, is insufficient for any implanted device. That's a fair
argument and one worth having. But the linked op-ed is a polemic.

~~~
danvoell
Agreed. This article is pretty alarmist. I would ask the author to actually go
through the process and report back. It's not for the weak of pocketbook or
compliance.

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mortenjorck
There was an episode of Reveal awhile back about Essure, a permanent,
implantable female contraceptive that, due to unforeseen nickel leakage,
caused severe long-term reactions (and in some cases, even pregnancy) in a
significant subset of its patients. Essure underwent clinical trials prior to
FDA approval, but there was no control group, and its ~400 women studied for
one year were compared against a long-term study of 10,000 tubal ligation
patients.

Reveal episode: [https://soundcloud.com/thisisreveal/her-own-devices-is-a-
con...](https://soundcloud.com/thisisreveal/her-own-devices-is-a-
contraceptive-implant-making-us-sick)

There's also a good Washington Post long-form on the subject:
[http://www.washingtonpost.com/sf/style/2017/07/26/essure/](http://www.washingtonpost.com/sf/style/2017/07/26/essure/)

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Tade0
My father's last position before retirement was as a civil servant responsible
for approving equipment for medical use.

One of his last cases concerned a businessman who insisted, that a vacuum
cleaner produced by his company should be certified as a medical device -
ostensibly its use was to deliver drugs(via reverse action and inhalation).

My father rejected this notion on the grounds that, among other things, it was
impossible to control the dosage. Unfortunately once my father retired that
man eventually found somebody who would give in to pressure.

What I'm trying to say is that there's a decent amount of "medical" devices on
the market that serve no such purpose so, a non-conformant artificial hip
joint is only the tip of the iceberg.

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godzillabrennus
It costs $5 Billion Dollars now to bring a new drug to market. Can anyone
blame companies for trying to find loopholes to that staggering fee?

[https://www.forbes.com/sites/matthewherper/2013/08/11/how-
th...](https://www.forbes.com/sites/matthewherper/2013/08/11/how-the-
staggering-cost-of-inventing-new-drugs-is-shaping-the-future-of-medicine/)

We should be finding better ways to do clinical trials to help companies lower
the cost.

I'm glad there was a blockchain event in Miami recently about this. It's one
of the most under discussed issues in tech/healthcare today.

~~~
jopsen
Maybe we should just give up on privacy for medical records and require that
all prescriptions, tests, symptoms, etc. are thrown into a large database
where they can be analyzed.

Then approval is given for X number of patients, when hypothesis is defined.
And further approval follows automatically as long as on-the-fly analysis of
all health records supports the hypothesis.

Okay, I'm naive, and we integrating all health records is certainly non-
trivial. My point is every prescription is an experiment that could be used as
further evidence.

~~~
dhbradshaw
Any time you care about the results of a set of actions, you should measure
those results. If we care about the results of medical care, we should measure
those results.

It's irresponsible not to. I would venture to guess that millions of people
are dying early because we don't have this as a mandatory, built in part of
the process.

But let's put this in terms of not just science but economics. A working
market depends on having information about the normalized value of a
particular proposition. To understand that value, you need to know the
proposition's cost and its benefit. Insurance and other systems remove us from
information about cost. Throwing away results data obscures the benefit. Is it
any shock then that prices spiral out of control?

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neonate
[http://archive.is/O6M10](http://archive.is/O6M10)

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fzeroracer
Personally I would consider being even more strict on medical device testing.
My mother who had a stroke about a decade ago was using a device designed to
test the PT/INR levels of her blood. The stroke had made her body less capable
of properly balancing her blood, so she has to constantly test her levels to
ensure she doesn't suffer from either fatal bleeding or internal clotting.

The device she was using had to be recalled after years of use because it
could report a low value, causing her to over-balance her medication into
dangerous levels. Not only that, but they chose not to inform my mother after
the recall and made no efforts to fix the issue.

Needless to say I was not pleased.

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pdkl95
It's even worse if software is involved. Radio controlled heart implants that
rely on security through obscurity is tragedy waiting to happen. I recommend
Karen Sandler's talk about her own experiences with that kind of device.

[https://www.youtube.com/watch?v=qW1h1s_ojpM](https://www.youtube.com/watch?v=qW1h1s_ojpM)

"Freedom in My Heart - Lessons from a Cyborg Lawyer"

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bjd2385
This sounds like individuals or groups of individuals covering their own rears
instead of facing the problem for themselves.

It's very difficult to see product defects from behind a desk. And it's
impossible to recognize the personal complications and difficulties that arise
for people on the receiving end while looking at statistics and financial
reports.

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wunderlust
A recent episode[1] of Fresh Air (NPR) discussed medical implants. Pretty eye
opening.

[1] [https://www.npr.org/2018/01/17/578562873/are-implanted-
medic...](https://www.npr.org/2018/01/17/578562873/are-implanted-medical-
devices-creating-a-danger-within-us)

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gersh
What is a medical device? Are we talking about things like thermometers,
wheelchairs, and surgical knives. Is this saying you need a double-blind study
for every new design of wheelchair?

~~~
HeyLaughingBoy
Sometimes. No. Yes. No.

[https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidan...](https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm)

Sometimes the medical device is software. In fact, there are many software
products on the markets whose makers don't even realize are unapproved medical
devices. However, the FDA just doesn't have the manpower to investigate that
on a wide scale.

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billfruit
I hear that that's true of other things in medical practice as well. For eg:
are surgical procedures validated by any kind of controlled clinical trails?

