
FDA and NIH let clinical trial sponsors keep results secret and break the law - barry-cotter
https://www.sciencemag.org/news/2020/01/fda-and-nih-let-clinical-trial-sponsors-keep-results-secret-and-break-law
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Expez
I just listened to the book Bad Pharma, by Ben Goldacre, which deals with this
problem. The author works as a doctor and so has a bit of an inside view of
how the industry does 'science' and how this affects doctors and patients.

The lack of published negative results isn't a problem unique to pharma but
the drive for profits and the actual life and death outcomes makes it
particular severe in this area of science, I think.

I highly recommend the book, it was both hilarious and terrifying.

~~~
sanxiyn
I must note that according to the linked article, "pharma’s record has been
markedly better than that of academia and the federal government". It's
academia that is not reporting results, not industry.

~~~
hannob
That's an illogical conclusion.

Both don't always report results. Academia is worse. That doesn't make the
industry good in any way.

~~~
Amygaz
I don’t know what problem that would solve. Academia rarely does trials that
end up killing people. Unlike the whole CAR-T cell therapy. Companies like
Juno killed almost 50% of their patient, before the FDA halted their trial,
which was allowed to resume later, and kill more people. Granted they where
going to die anyway. Still the like of Hans Bishop who us held as a hero in
the industry because he sold his company for billions, while the product will
never be approved. Even if were to be, it would sit on a shelf because it’s
too expensive. So much for transparency...

(Edited some typos)

~~~
jcims
I’m standing right now near the window on the 20th floor of a cancer center,
typing this on my phone while my wife sleeps 10 feet from me.

This is high stakes medicine, yet the current environment has the docs on this
floor terrified of doing anything that isn’t in the standard of care runbook.
My wife has had elevated blood glucose levels for six months, which is not
good when you’re fighting cancer, yet i can’t get anyone to treat it because
there’s no clinical evidence that managing glucose levels for her specific
type of cancer has any benefit.

Guess what. Nobody’s doing that trial any time soon. Meanwhile there are
thousands of diabetics managing their blood glucose while fighting cancer and
there is endless material available demonstrating that cancer cells thrive in
hyperglycemic environments.

So, i don’t know anything about Juno, they could be sociopaths. But i have no
issues with high risk attempts as long as the patients are informed and there
are ethical standards for transparency. At least they are trying.

~~~
endothrowho333
I sympathise with your wife's predicament. Good or sub-par treatment, doctors
still get paid.

If you're not opposed to eschewing professional recommendations to not
complicate treatment, there are two things that may be worth looking into:

1). Metformin: Helps control blood glucose by significantly increasing
sensitivity of insulin receptors, i.e more glucose is shuttled out of the
blood stream per insulin molecule. Not scheduled and very cheap. Also trials
are being done on it for cancer prevention -- exactly because of Warburg's
phenomenon (cancer cells and glucose)

2). Ketosis: Hit or miss. By abstaining from carbohydrate consumption, the
result should be drastically reduced blood glucose levels. However, in some
people (e.g type 2 diabetics) it may _elevate_ blood glucose due to metabolic
disfunction. In any case, caloric restriction in general have the effect of
both increasing insulin sensitivity and decreasing blood glucose -- regardless
of macronutrient profile

~~~
sjg007
The doctor though should be able to provide access to a clinical dietician to
help think plan the diet and think through the implications. I imagine some
chemo and targeted drugs could interfere with lipid metabolism and there is
also a risk of acidosis. So I would ask the doctor. It will probably be a case
of "we don't know" but diet is basically the one variable under your control
besides listening to the doctor.

There's one paper on it from a completed clinical trial.
[https://www.ncbi.nlm.nih.gov/pubmed/27525031?dopt=Abstract](https://www.ncbi.nlm.nih.gov/pubmed/27525031?dopt=Abstract)

Also clinical trials using metaformin during cancer treatment. You might
consider enrolling in one of these if it is feasible.

[https://www.cancer.gov/about-cancer/treatment/clinical-
trial...](https://www.cancer.gov/about-cancer/treatment/clinical-
trials/intervention/metformin-hydrochloride)

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andrewla
I don't care about whether they report results or if they miss deadlines for
reporting. That's all this article is talking about.

But _only_ studies that are pre-registered should be considered when approving
a drug, treatment, or device, and any incomplete studies (that is pre-
registered but not reported for any reasons) should be treated as "all the
patients died", and all individual researchers on the preregistration should
be appropriately tainted for future consideration of studies in which they
participate.

The related story in the article, "Gaming the system" does report on this:

> .. a recent study ... examined 19 drugs approved by the FDA in 2015. In only
> 10 cases were all the trials provided to FDA for its decisions registered on
> ClinicalTrials.gov.

This is unacceptable.

~~~
mjevans
All of the punishments you suggested and also any involved patents released to
the public domain since the data wasn't.

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calibas
Hiding research results should be seen as this scandalous, shameful, and
fundamentally anti-scientific practice. A heavy bias towards business profits,
which is exactly what this is, goes against objective science.

What if you kept repeating experiments, and only published when you got the
results you wanted? That goes against my personal ethics _and_ my
understanding of how science is supposed to work.

~~~
Spivak
> What if you kept repeating experiments, and only published when you got the
> results you wanted?

This is pretty much how it's currently done. Science is far less exploratory
than you make it seem. When it comes to publishing you should think of it more
like law. You make the strongest possible case for your conclusion.

~~~
ouid
This is very backwards. In science, the evidence for a claim is precisely how
hard you tried to disprove it. This doesn't mean that you're wrong, of course,
but it's a massive problem.

~~~
Retric
That’s only a subset of experiments, the ideal experiment makes any result
publishable. For example the search for a new particle, don’t find it that’s
fine. Alternatively, any result that’s in doubt like salt’s impact on
cardiovascular heath.

Even better is really cheap experiments like analysis of existing data. That
you can keep trying until you find something, sadly this means publishing
datasets is a bad idea.

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rajman187
Perhaps unbeknownst to some folks, the FDA as a regulatory body is funded in
large part now by Congress but by GDUFA and PDUFA which allows the agency to
collect user fees for both brand and generic drugs from the drug makers
themselves, in essence being funded by the industry it is meant to regulate.
So it is then understandable why a lot of the guidelines become flexible (note
that the FDA cannot enact laws, that is the duty of Congress)

~~~
conistonwater
This is a very common complaint, but the other side of the coin is that FDA
needs resources to do its job and any time the number of submitted drugs
changes the FDA would need less/more funding from congress if it was funded
only by congress. Collecting fees means the size of FDA's funding is
correlated with the amount of work it has to do. The proper way to determine
whether FDA is unduly influenced by this is to look at the actual decisions it
makes, which is something I remember reading medical researchers already tried
to do.

~~~
rajman187
GDUFA guarantees a decision within 10 weeks, which is considerably better than
the running average before and even extreme cases such as 13 years before
addressing applications.

There are unfortunately many cases that have been decided on the basis of
finances rather than clinical justifications. I don’t envy the agency, stuck
between the disdain of the public, pressure from industry, and continually
having to justify their existence to Congressional committees.

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chiefalchemist
> Few trial sponsors have consistently done so, even after a 2007 law made
> posting mandatory for many trials registered in the database.

Then the reality is, it wasn't mandatory.

It's not reasonable to expect citizens to trust these entities when their
conduct is not trustworthy.

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Ididntdothis
If there ever has been a sector where mandatory full transparency is useful
then medicine would be a good candidate. The outcome of trials could be very
useful for other researchers.

Same should apply for pricing. The fact that prices are completely opaque in
the US makes it hard for patients to make good decisions.

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walterkrankheit
I'm kind of shocked that logging these results isn't already common practice.

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jMyles
I think this is the primary purpose of the FDA (though not the NIH). Providing
a shield from transparency, and even against criminal liability, is just
another part of regulatory capture.

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air7
Coincidentally, I've just heard Milton Friedman talk about "Health Care in a
Free Market". Fascinating and eloquent.

He argues that the FDA did more harm than good, and that society would be
better off without a governmental supervision for health care in general.

\--
[https://www.youtube.com/watch?v=-6t-R3pWrRw](https://www.youtube.com/watch?v=-6t-R3pWrRw)

btw, in the end he makes a strong argument _for_ negative income tax. This
surprised me, as my model of his world-view was apparently more simplistic
that it ought to be.

~~~
anthony_doan
I disagree. FDA have set guidelines for clinical trials and moral standards to
it. For an example you cannot experiment on a person without their consent and
you have to state out what your trials is doing. It all lay out. It's because
of Tuskegee syphilis experiment that we have IRB and FDA.

FDA also love stating that they prevented a drug that causes birth defect a
while back unlike Britain.

Another example of government regulation working is cars. Death relating to
car crashes have fallen every year with safety regulations.

It's not perfect but there are many cases that it works and there are laws and
rules set in place.

The free market is not the panacea for everything.

~~~
will4274
Falling car crash rates don't prove regulation is successful. Consumers shop
for safety too. It's difficult to compare the counterfactual, but to make this
claim, you need to at least compare the rate of change of crashes in
unregulated countries or times to regulated countries or times.

~~~
kube-system
For both auto safety and pharmaceutical safety there is a large degree of
consumer information disparity, information unavailability, and disincentive
for the individual to protect the public interest. It takes a lot of resources
to test those products, and consumers don't really have the resources to do it
themselves. In some cases, insurers could possibly foot the bill (eg. IIHS),
but that model still has a couple of big weaknesses: consumers may not be
informed enough to parse the results, consumers might prioritize short-term
needs over public health, and an insurance body may still have some incentives
working against public benefit.

Things like truck under-ride guards likely wouldn't be on commercial trucks if
they weren't regulated. Consumers aren't going to all voluntarily coordinate
to buy vehicles which have crash-compatible bumper heights. Antibiotic misuse
would be even more out of control if it weren't regulated.

Mexico is a good example for road regulations. They do not have the same crash
regulations as the US, and many old model vehicles are still legal for sale
there. Things like the 1950's VW Beetle were still sold there into the 2000s.
They have the highest death rate per distance traveled in the world.

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tracker1
The pharmaceutical industry is full of unscrupulous bastards, news at 11.

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qrbLPHiKpiux
The FDA operates as a corrupt organization and, if wasn’t a government agency,
would be prosecuted under RICO.

