
The FDA buries evidence of fraud in medical trials. My students and I dug it up - tokenadult
http://www.slate.com/articles/health_and_science/science/2015/02/fda_inspections_fraud_fabrication_and_scientific_misconduct_are_hidden_from.single.html
======
MichaelGG
A related and very interesting story is this article[1] on Ranbaxy. Basically
this company was corrupt and fraudulent from the top down. Falsifying data,
copying competitor information as their own, etc. Or encouraging
internationally traveling employees to privately import medicines to India for
them. Or asking doctors on staff to write prescriptions for everyone in the
office to boost sales figures.

The FDA applied light bans, only on individual manufacturing sites, allowing
the company to continue to push out product from other sites. Including making
a bunch of pills with glass fragments in it.

The FDA eventually fined them $500M, and the company has since been bought by
Sun Pharma, the largest in India. Zero indication that the systemic
corruption, fraud, poor quality, etc. have had real change.

1: [http://fortune.com/2013/05/15/dirty-
medicine/](http://fortune.com/2013/05/15/dirty-medicine/)

~~~
hga
A bit more happened, last year the FDA started making unannounced visits to
their production plants in India. When I checked on this about a month ago, it
appeared that _every_ Ranbaxy plant in India had been shut down. This Google
search will provide a lot of info,
[https://www.google.com/search?q=Ranbaxy+flies](https://www.google.com/search?q=Ranbaxy+flies)
that's "flies" as in those disease spreading insects. One of the articles had
a picture of a man unloading dung from a cart with a Ranbaxy plant in the not
too distant background....

I pay attention to this because I take a lifesaving maintenance medicine that
my medical plan currently sources from Sun :-(. Since that and another
important drug I take went generic over the last few years, my doctor has been
_very_ happy with my reporting that to me, they seem to be bioequivalent. He's
in a field when generics of one class of drugs, the anti-convulsants, are
notorious for not being easily substituteble with brand name.

Ah, a bit more on that fabulous Fortune article: their First World drug mules
were being asked to deliver First World brand name manufactured drugs so that
Ranbaxy could falsify equivalence tests. One US executive left the company
after the 2nd "wow, these guys are so good their data matches the brand
names's point to point" "coincidence".

~~~
refurb
_When I checked on this about a month ago, it appeared that every Ranbaxy
plant in India had been shut down._

I'm not sure if they are shutdown, but the FDA has _banned_ imports into the
US from everyone of the Ranbaxy plants. Sun Pharma is in a bad situation with
this since they can't sell into the US market from their new acquisition.

~~~
hga
Initially they of course didn't shut down, that's not in Ranbaxy's DNA, but
other parts of the world were none too pleased with the horrendous details of
the FDA inspections, and that forced the shutdown of every one of their Indian
plants at their 4 major locations.

As for Sun, who knows? In 2008 Ranbaxy managed to pawn off 64% of the company
to Japan's Daiichi-Sankyo for $7 billion. Sun bought that stake in 2014 for $4
billion ... in Sun shares, i.e. a firesale price, at least compared to the
original. And Ranbaxy has lots of plants outside India which to my knowledge
and recent research can still ship to the US.

Although I'm not sure how many of those actually synthesize the raw stuff as
these Indian plants did, then again Sun is probably best off with them shut
down; that they didn't proactively deal with the Ranbaxy's cancer ... well,
you can see why I'm nervous about that drug I'm taking.

------
guylhem
In healthcare, there are many skeletons in the closet - and many closets.

This FDA story is sad, but not surprising. The article seems to suggest the
European equivalent (the EMA) is way better. Maybe it did behave better on
this case, but as a rule of thumb, I strongly doubt it is much better.

The only advantage Europe has is how it works: if you want to bring a drug to
the market, you either have it to get it accepted in one member state (then
you can sell it everywhere) or go to the EMA. That's moderate competition. It
may works slightly better, but it's still limited by the number of countries
and regulatory agencies.

The only conclusion we should make from such stories is that there should be
no public bodies susceptible to regulatory capture, but various independent
organizations doing that.

See that as adding redundancy - if one was found to cheat and lie, it wouldn't
be too big to fail, and a competitor would be glad to update its rating on say
the 40 generics whose bioequivalence ratings are based on cooked data. That's
a bit like how I trust Michelin guides more than any government evaluation of
restaurants.

EDIT: I noticed a comment about financial ratings agencies. You realize there
are only 3 big ones (Moody's, S&P, Finch) and that they have very strong ties
to some governments, right? I predict they give you more quality that the FDA
(because it's a legal monopoly), but less than what more competition could
bring.

~~~
voronoff
Because the financial ratings agencies have proved to be such a huge success?

~~~
Retric
US raiting agency's are setup to be corrupt as the seller pays the raiting
agency so there going to look for the loosest respectable option. And the
agency has little incentive to dig deep.

~~~
woodman
Setup by the SEC. The incentives are structured, by the government, in the
most ridiculous way possible. Pointing at the failure of government mandated
and monitored rating agencies as a failure in private enterprise is just
stupid.

~~~
Retric
I think it's more nuanced than that. Private companies optimize for money,
with the right incentives they work well, with poor incentives they become a
pointless money sink.

All too often you see the equivalent of “though the magic of the invisibly
hand we will solve X.” But, without the proper incentives simply privatizing
or reducing regulations are going to do little but line someone’s pockets.

~~~
woodman
> But, without the proper incentives simply privatizing or reducing
> regulations are going to do little but line someone’s pockets.

Well, that is true every system - including functions of government. It has
nothing to do with privatization vs nationalization. The government mandates
that certain financial instruments must be rated by a short list of companies
that have been blessed to do so. So the government has limited competition
among rating agencies, a laughable mistake in judgement. Then these companies
only get paid by the folks trying to sell the instrument under review...
another stupid move.

Many government programs, presumably setup with the best intentions, have
serious negative consequences because the moron behind it didn't think more
than one step ahead. This happens in private industry as well, the difference
being that there the market corrects for mistakes by mercilessly crushing
fools. In government the fools live on, and their plans are slow to change
because it is now law.

~~~
Retric
'the moron behind it didn't think more than one step ahead'

I think many and possibly most of these are based on regulatory capture where
elected officials / regulators are ‘given incentives’ to look the other way.

Lots of seemingly stupid decisions are completely reasonable from the person
who made them. All it takes is for someone to be judged just on their little
piece of what happens (how much do we spend on paper) and not judged based on
how much their changes hurt the corporation/overall economy etc. And before
you know it, we saved 1million in ink last year at the cost of 50 million in
manpower.

~~~
woodman
> Lots of seemingly stupid decisions are completely reasonable from the person
> who made them.

Lol, good intentions are worth absolutely nothing. Your misallocation of
resources story isn't really helpful either, if you think the SEC made a great
move in structuring financial instrument ratings - explain it.

~~~
Retric
That's not what I meant. It's not 'good intentions' vs 'reality' it's 'selfish
intentions' +'bad measurement' = 'WTF rules'.

~~~
woodman
Ah, well that is a consequence of poor planning by the well-intentioned. Here,
I'll show you:

People are bad, therefor we need a government made of people are bad, therefor
we need a government made of people are bad...

------
graeme
How much of this could be solved by replication? Some sort of rule where we
say, formally, not to take any study seriously unless it's been replicated?

On the one hand, it's very bad that the FDA has covered this up. But on the
other hand, there was science before the FDA. I may be interpreting the
article wrong, but it seems as though the FDA is merely failing to prevent bad
science.

Presumably, journals that cited these experiments didn't replicate that and
knew they weren't replicated. Is science too complex and expensive to
replicate these days? If so, is it even still science?

(Those are actual questions, not rhetorical ones. I don't know the answers
here).

Edit: For some reason, at present my comment seems to be the top comment. I
don't want to detract from the story itself. The actual issues at the FDA
raised by the article deserve discussion.

~~~
Scaevolus
Clinical trials are very expensive to run. The only people financially
interested in running them are the pharmaceutical companies trying to make new
products available.

Replication is hard enough to achieve in hard sciences where replicating a
study might cost tens of thousands of dollars. Finding the money to replicate
or refute a clinical trial for millions of dollars is _very_ difficult.

~~~
graeme
So can we still call it science, or not? And if not, what do we call it?

~~~
chris_va
Well, technically they are replicating the study over 50+ different hospitals
until they reach some confidence interval on the safety data. If you get fraud
in a small fraction of them, it should not (and if you read the actual
testimony, does not) impact the net result.

~~~
static_noise
If you need 50 experiments to actually show that the effect exists, then even
a small fraction of fraudulent experiments can heavily skew the result when
looking at confidence intervals.

Think of selfhealing as a coin toss with 50/50 chance and a medication
increasing this chance:

a) Medication increases healing chances to 80% -> Only few experiments needed.

b) Medication increases healing chances to 55% -> Many experiments needed to
prove that the effect exists.

c) Medication is not effective but 5% fraud is introduced so that data shows
55% healing chances -> The same as in b) but with only "a little" fraud
involoved.

~~~
logfromblammo
Don't forget the placebo effect.

A major flaw I see in most medications studies is that the market prices for
the experimental drug or placebo are not included in the study.

My hypothesis is that a placebo described as costing $1000 per dose will
produce a greater effect than a placebo described as costing $10 per dose,
even if the patients are not asked to pay that cost.

Could it be that those drugs that barely outperform a gratis placebo are only
producing that effect because the act of charging more for them makes them
better placebos?

If that's the case, the fraud would only be needed to eliminate evidence of
harm to get approval for a bogus remedy. All the effectiveness would come from
magnified placebo effect.

~~~
static_noise
Current stdies should account and compensate for the placebo effect (double
blind study).

I think there was a study which compared different placebos and the more
expensive ones showed better effects. So your hypothesis may be right.

------
CodyBZ
Statins are the most widely prescribed drug on earth. The drug company's
report that myopathy occurs in 1% of the population. Field reports show that
number is around 20%. One in five people statin intolerant due to muscle
disorders. Its common knowledge these drugs can cause serious muscle problems,
yet most doctors are unaware.

[http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3463373/](http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3463373/)
"It is impossible to discern the true incidence of mild muscle complaints
because these problems typically are not examined in pharmaceutical sponsored
trials and because of study design. In HPS, for example, subjects were not
randomized to simvastatin or placebo until they had successfully tolerated
simvastatin 40 mg for a 5 week introductory period (17), and most trials
report muscle symptoms only when CK values exceeded 10 times upper limits of
normal."

------
SixSigma
The juxtaposition of adverts for "earn money participating in medical trials"
at the top of the page made me smile.

[http://imgur.com/nZTnzb5](http://imgur.com/nZTnzb5)

------
Alex3917
Tokenadult,

Out of curiosity, given that you've said in your previous comments that you
believe medical questions are best answered with 'science-based medicine',
which is a philosophy that explicitly rejects evidence-based medicine: do you
believe that the FDA covering up scientific fraud is bad, or do you agree with
the FDA's argument that it's justified?

Also, do you still believe that "It's an exaggeration (contradicted by
thoughtful comments by drug industry researchers who have already posted
replies in this thread) to say that the enterprises that develop new drugs for
prescribed medical treatment are corrupt in general [...]."?

~~~
austinz
Question (not being sarcastic): what's the difference between 'science-based
medicine' and 'evidence-based medicine'? I did a quick Wikipedia search, but
the former just redirects to the latter.

~~~
teddyh
I think the _real_ question most people want to know the answer to is: Is one
of them a front for homeopathy, anti-vaccinations and/or Scientology, or are
they both mostly imperceptibly different degrees of serious research?

Downvoters: Please explain. I have no idea about what any of SBM or EBM is,
and I hadn’t even heard about any of them before now. This is _genuinely_ what
I what to know when I encounter the terms.

~~~
wanion
EBM is meant to be serious science, but there's been a real effort to co-opt
it for quackery. SBM is an attempt to inject science back into it. The
difference comes down to how they treat evidence.

For example, homeopathy states that a remedy becomes stronger the more dilute
it becomes - i.e. the lower the dose, the stronger the effect. This defies the
dose-response relationship between an active ingredient and its effect.
Further, it states that even when no more of the active ingredient remains, it
can still have an effect.

SBM would say homeopathy isn't worth studying because it has no plausibility
based on what we know of medicine and physics.

EBM would say let's test it and see what we get.

The problem is that if you test the same thing enough times, or measure enough
variables, and then discard the ones that don't meet your desired outcome, you
can gather "evidence" for basically anything.

SBM would say weak evidence for a claim like homeopathy is meaningless, as the
claim is extraordinary (it overturns physics), so you need stronger evidence
than you might accept for a less exceptional claim. EBM doesn't make that
judgment, it treats all evidence as equally valid.

~~~
heliumcraft
for the record: homeopathy does not do well with EBM either.. (as in quality
double blind studies)

~~~
spydum
sure, but if researchers can cherry pick the data and studies, they just have
to avoid those quality double blind studies. all of a sudden, their meta
analysis of # studies shows significance!

------
pasbesoin
To clarify: I'm not calling for less regulation from the FDA. Far from it.
Rather, I'm pointing out that in the follow instance where more regulation is
being called for, a major influence is again Big Pharma and the motivation is,
to my eyes and reading, _not_ primarily consumer protection.

\----

There is also the other "half" of this FDA saga. "Supplements" and herbal
treatments are a mixed bag, and there are fraudulent manufacturers and
suppliers in this market as well. However, there are repeated pushes to get
the FDA to more or less outlaw all of them and/or to regulate this marketplace
out of existence.

I'm someone who, along with more than a bit of grief from pharmaceutical
industry products, has actually found some significant results in the
"natural" marketplace. I've had to be careful, and I've had to find
manufacturers who actually deliver what they say. But the idea of one of these
knee jerk, "ban 'em all" reactions taking these items away from me, scares me
in no small measure.

The FDA appears no longer to be an effective regulator; it has become ever
more an economic and political tool of the most moneyed private interests.
(Where a focused Big Pharma far outweighs the broader field of smaller
supplement providers, for example.)

To be somewhat repetitive, I don't want to discount the significant problems
with the "supplements" marketplace. But I have been able to achieve results
with it that I have _not_ found in the pharmaceutical marketplace. I am
unwilling to cede this territory to the pharmaceutical companies, as they seek
to have it shut down -- for their own economic self-interest, rather than the
public interest.

~~~
fapjacks
I am in a similar situation, using a product which the FDA has declared unfit
for human consumption based on anecdote. The FDA has stolen my mail a few
times, despite the substance not being controlled or otherwise illegal. The
FDA has a really bizarre set of priorities, and "protecting consumers" is
somewhere either at the bottom or just not even on the list at all.

------
powera
I think we have to face that the FDA is incompetent and corrupt. Getting a
drug approved is more dependent on how much money you want to spend than on
whether it works. Some drugs that may be effective are delayed for years and
years ( [http://well.blogs.nytimes.com/2015/02/05/for-a-l-s-
patients-...](http://well.blogs.nytimes.com/2015/02/05/for-a-l-s-patients-a-
hopeful-drug-thats-out-of-reach/?_r=0) ) while other drugs that don't work are
approved as being effective.

~~~
Alex3917
And this article doesn't even cover 95% of the problems with the FDA, many of
which are as bad or worse. But on this topic, here is a good example that the
article missed:

[http://www.washingtonpost.com/wp-
dyn/articles/A9802-2004Sep9...](http://www.washingtonpost.com/wp-
dyn/articles/A9802-2004Sep9.html)

Basically the FDA ordered pharma companies bury the research showing that
antidepressants were ineffective in children and could lead to suicide,
because they were worried that parents would stop spending money on them.

~~~
refurb
The FDA's actions in this case are understandable. Proving that CNS drugs work
is a huge pain in the ass and the FDA knows this. There is a huge placebo
effect (that is interestingly increasing over time) and the our tools to
measure depression frankly suck (too subjective). Yes, a number of
antidepressant trials failed to show efficacy. However, a few of the trials
did show improvement. The FDA decided that allowing patients access to a
_potentially_ helpful therapy (antidepressants do help some patients) is
better than just pulling the product off the market.

As for the suicide risk, again, there is data to suggest that antidepressants
can increase the risk of suicide. However, that data isn't cut and dry. Over
the last few years the FDA has actually loosened it's warning since the data
is in question. Note that the FDA required all of these drugs to have a black
box warning stating the risk of suicide (the most strict warning any drug can
have).

Producing and testing drugs does not result in a binary outcome (drug
good/drug bad). What the FDA does is look at the risk/benefit and makes a
decision on that. Frankly I think they do a pretty good job at it.

~~~
Alex3917
> The FDA decided that allowing patients access to a potentially helpful
> therapy (antidepressants do help some patients) is better than just pulling
> the product off the market.

I'm all for allowing patents to access unproven medicines, but why should the
companies be allowed to run billion dollar marketing campaigns saying that
they work?

------
DigitalSea
Both honestly and sadly, I think nobody is actually legitimately surprised by
this. The pharmaceutical industry is a profit machine that will do anything to
ensure that it remains profitable.

If anyone hasn't seen John Oliver's latest video, it's on the whole marketing
to doctors thing and touches upon the pharmaceutical industry and I highly
recommend watching it:
[https://www.youtube.com/watch?v=YQZ2UeOTO3I](https://www.youtube.com/watch?v=YQZ2UeOTO3I)
\- he sums it up perfectly.

~~~
refurb
_The pharmaceutical industry is a profit machine that will do anything to
ensure that it remains profitable._

But this isn't about the pharmaceutical industry, it's about the FDA. The FDA
is clearly catching these companies doing wrong, so why are they covering it
up?

And if you think the FDA and the pharmaceutical industry are in bed with each
other, I would have to disagree (coming from the industry). The company I used
to work for would never mess with the FDA since you could be shutdown in an
instant.

To be honest, I think a lot of the FDA failings come from a lack of resources.
Most of the drugs people take in the US and EU are made in places like India
and China. The FDA is _just starting_ to think about inspecting those plants.
They just don't have enough inspectors to make sure each and every
manufacturer is doing things by the book.

~~~
hurin
> (as someone coming from the industry)

What do these _particular failings_ referred to in the article have to do with
the FDA's lack of resources?

From what I can see all you are doing is trying to change the subject of
discussion away from the industry.

~~~
Intermernet
I personally think @refurb asked exactly the right question (whether he's from
the industry or not).

>The FDA is clearly catching these companies doing wrong, so why are they
covering it up?

This deserves more research. Don't get distracted by "big pharma", ask why the
FDA aren't doing anything about the wrong-doing they're uncovering.

Occam's razor cuts towards lack of funding.

Next question: Who is in charge of FDA funding? How can this be changed?

~~~
pbhjpbhj
I'd expect uncovering the evidence to be the hard part - but then I remember
how messed up the USA legal system is ...

------
parallelist
Talk about this kind of journalism out of context (why you don’t trust a
particular study, for instance) and you’ll be called a quack or conspiracy
theorist.

------
edkennedy
Time to split into a Food Dept. and Drug Dept. and reform them from the ground
up to be health based rather than corporately based.

------
hurin
Pharmaceuticals is a ridiculous industry, public health and scientific merit
are on the lowest rungs of their list of priorities.

~~~
ekianjo
To be honest I can't think of many industries which place public health
scientific merit at their top priorities either. You could say the same thing
about the food and beverages industries, and Soylent too if you care about
mentioning stuff that makes HN tick often.

~~~
hurin
Of course - but the food and beverage industry can't serve you amphetamine-
salts in your coke (well not anymore) just because it's profitable.

I don't know what soylent is (beyond just searching it in google). Wikipedia
says:

 _Soylent is a nutritional drink, intended to cover all human nutritional
requirements for an adult so that it may serve as main or sole food_

There should be a very obvious test for this right? I think a large-scale
controlled study would likely show negative effects compared to a randomly
sampled population consuming the nutritional equivalent in natural products.
This is actually part of the problem - you'll never read about such a study.
Why? Because there is no profit incentive for anyone to finance a large-scale
study that proves soylent or hypothetical product X to be useless or harmful.

If soylent (or company X) finances a study of their product and the results
are contrary to their expectations (assuming the researches are honest and do
not engage in fraud) - they can simply shelve that material - and if
eventually study i++ is successful they can publish that (without ever
referencing any number of past unpublished studies).

The FDA is wasting my money and yours (if you are a US citizen), in a way that
normally should address this imbalance of selective interest in research. That
it does not - hardly surprises me.

~~~
zaroth
Soylent is not intended to diagnose, treat, cure, or prevent any disease. FDA
be damned, people are actually allowed, with great level of discretion, to
choose what they eat. There are controls on what they can put it in, it must
have an accurate ingredient list, a nutritional label, etc., but medicine it
is not.

~~~
kirsebaer
Soylent is intended to prevent malnutrition. It is advertized as fullfilling
_all_ of your nutritional needs. (Why would they call it Soylent? The name
comes from a sci-fi movie where Soylent is a food made from human corpses.
Using that name is an indication that there is a lack of judgement in the
Soylent team.)

~~~
logfromblammo
Prevention of malnutrition is not the same as treatment of nutritive
deficiency diseases. Prevention of malnutrition is more simply termed "eating
food".

Products like Soylent or Plumpynut are foods, not drugs. Replacing one's
entire diet with Soylent is logically equivalent to choosing to eat a banana
rather than an apple with your lunch today.

If you have kwashiorkor or beriberi or scurvy or pellagra, it is unlikely that
you could be effectively treated with Soylent, because it is formulated to
satisfy daily needs, rather than to correct a deficiency that may have taken
many months to manifest symptoms. It is designed to be a complete food, using
a recipe.

And if you watched the movie (it doesn't hurt all that much), you would know
that only Soylent _Green_ was made from people, rather than algae, as was
claimed. The Soylent company sold other types of food products, and everyone
ate mostly Soylent-brand foods, because they could not afford anything better.
In the film, all the extras got most of their nutrition from Soylent Orange or
Soylent Blue, or whatever those grubby-looking flakes were in the bins.
Soylent _Green_ always sold out early, and was in short supply.

Still... not the best naming decision. Most people haven't seen any more of
the movie than the scene where Heston cries "You've gotta tell 'em. Soylent
Green is people!"

------
CodeWriter23
The misconduct itself is not surprising, given that all drug studies required
for drug approval are performed by the company seeking the approval. The
cover-ups are also not surprising, given that industry insiders go back and
forth between jobs in Industry, and running the FDA.

~~~
marincounty
Maybe as a condition of hire, the appicliant, if hired by the FDA, couldn't
seek future employment in any aspect of the Pharmacutical industry?

I belonged to a union that flat out told apprentices that they were forbidden
from going through the program and opening up a non-union shop. I've always
wondered about the legality of putting conditions on a job? I know the
formentioned union still has the clause in it's bylaws, and it's a union in a
huge city.

~~~
sanderjd
It all comes down to the incentives. I doubt the FDA is beating away
applicants as it is. If the FDA enacts your proposed policy, what do we do if
they can't find qualified applicants?

~~~
littletimmy
Raise the salary.

~~~
mirimir
The US pharmaceutical industry is too wealthy for that to be workable. The
game is to make friends while working at the FDA, and then to cash in. In
order to serve the public interest, drug discovery and testing ought to occur
in academia. The pharmaceutical industry should play no role in that, and
should merely manufacture approved drugs.

Edit: Please see _The Truth About Drug Companies_ , by Marcia Angell, M.D.,
formerly an editor of the New England Journal of Medicine.

~~~
refurb
_In order to serve the public interest, drug discovery and testing ought to
occur in academia._

Where do the funds for R&D come from? Getting academia to discover drugs is
not a workable solution.

~~~
ska
Academia already does much of the fundamental research.

It's mostly the "D" part of the "R&D" that is expensive, and shapes the pharma
industry. Some of this could be addressed by making clinical trials cheaper to
operate and initialize, but it's always going to be quite expensive.

~~~
refurb
I agree that most fundamental (chemistry, biology) research is done in
academia. But fundamental research doesn't deliver new drugs, it only supports
discovery.

About 24% of new drugs are discovered in academia.[1] The remainder come from
industry. I think offloading all discovery to academia, plus the "D" part of
R&D would be something academia would struggle with.

[1][http://pipeline.corante.com/archives/2010/11/04/where_drugs_...](http://pipeline.corante.com/archives/2010/11/04/where_drugs_come_from_the_numbers.php)

~~~
ska
Sure, a lot of discovery is done in industry too (and, as you note, is
supported by academic outputs). But that's not the expensive part which is
what I was trying to say -- obviously not clearly enough.

~~~
mirimir
Reforming the current system would be difficult, no doubt. And perhaps it's
unworkable. Big pharma also owns academia. Much of the peer-reviewed
literature for many drugs has been ghostwritten by industry-funded
consultants. Sometimes the authors don't even read their manuscripts, and in
some cases haven't been informed of them. Some journals have been addressing
this, but it's pervasive.

In any case, the current system isn't working. Incentives for fraud far
outweigh those for improving public health. And there is virtually no
accountability.

------
molyss
I'm just wondering something probably very stupid. Shouldn't an FOIA request
turn back all information that the article claims the FDA is refusing to give
away ? Looking at the FDA FOIA exemption list
([http://www.fda.gov/RegulatoryInformation/FOI/ucm390370.htm](http://www.fda.gov/RegulatoryInformation/FOI/ucm390370.htm)
or
[http://www.foia.gov/faq.html#exemptions](http://www.foia.gov/faq.html#exemptions)),
there's none that seems to match a drug name, a lab's name, a detail on a
mistake or even communication between ab and FDA. The only things that I would
think apply would be internal FDA comm, and patient names. None of the things
I cited sound like : \- national security threats \- internal rules \-
breaking federal law \- trade secrets, commercial or financial info \-
inter/intra agency comm \- personal privacy (if we exclude patient names) \-
law enforcement info \- supervision of financial institutions (that's an
interesting exception to see BTW) \- geological info on wells (totally off
topic, but I'm kind of curious about this one).

It looks like the author si as baffled by the assumption that misconduct fall
into the "commercial info" exception...

Really scary also is the whole orange book thing. I thought generics were
actually the exact same molecule, as in "we've done a mass spectrometry of the
stuff, and it's the same shit, only cheaper". It looks it's not at all the
case... Reading the wikipedia talks on generic drugs, it looks like there was
confusion there as well
([http://en.wikipedia.org/wiki/Talk%3AGeneric_drug#Orange_book](http://en.wikipedia.org/wiki/Talk%3AGeneric_drug#Orange_book)).
As of today, there's only one reference to the word molecule in the wikipedia
article ("[...] most small molecule drugs are accepted as bioequivalent
if[...]), which doesn't seem to address the confusion.

Assuming (and it's a pretty big assumption) that insurances really want you to
get better, it would then look like the should tell you _not_ to use generics,
rather than pushing you to. Argument could be made that you only depend on
them for a limited time. I guess the same argument could be made for public
healthcare systems (like France), in the sense that you're less expensive dead
on generics than alive on the real stuff, but I sound a bit cynical, even to
myself.

~~~
zerocrates
Generally, generics are required to have the same _active_ ingredient as the
brand-name, in addition to showing bioequivalence.

~~~
mirimir
Biological availability is a key issue. Having the right molecule is pointless
if it's not absorbed as efficiently. Conversely, more-efficient absorption
could be dangerous. It's an especially critical issue for extended-release
forms.

------
thisIsNotMikey
The problem with the FDA is it usurps liability from the manufacturer and
responsibility from the consumer. Most Americans will grant more time to a
free app review, than to a nutrition label. We have a false sense of security
that food and drugs are FDA "approved." This same problem exists in banking
because of the FDIC. How many people know what's on their bank's balance
sheets?

~~~
acdha
How many consumers are capable of evaluating drug safety and have time to do
so? This is a real problem requiring time from a limited number of highly
skilled professionals and easy proposed solutions are naive.

~~~
thisIsNotMikey
The consumers directly don't. But as a consumer I don't know how to evaluate
an automobile, a smart-phone, or other products. But there is a market that
provides the relevant data to consumers. Before I buy a car, I check out
USNews, or Edmunds; before I buy any product I check out the relevant
resources. Because of the way the FDA is structured, not much non-FDA research
and reviews are being done. Lol. I didn't propose a solution.

~~~
acdha
… and those markets have a long history of being gamed despite enjoying much
larger numbers of people who can check the work. The drug market is huge and
extremely lucrative which ensures that any successfully started review service
would be under attack from multiple fronts – lawsuits, attempts to hire people
away or buy influence, setting up “competing” groups which try to sound
legitimate but exist only to attack the other group’s claims, etc.

Read the history of what happened with say the financial ratings companies
during the 2000s for one side (regulatory capture) and the tobacco or fossil
fuel industry for the dirty tricks version. There's no reason to think that
wouldn't keep happening, all of which dramatically increases the cost and
likelihood of failure.

------
tangerine_beet
This article really brings home the truth of how helpless we are in the face
of corrupt government bodies like the FDA. You can just picture von Eschenbach
and his group reading the piece, and then calculating whether a response is
going to be needed: Maybe it will all blow over if we just stay quiet? What
can one do as a citizen to fight this kind of corruption?

------
tracker1
Simple, take away patent protections from the drug companies for derivative
works... Then make all unredacted documents regarding FDA trials once a
medication is approved for use available publicly...

The first will lead to correcting bad faith efforts and marketing in the drug
companies... the second will lead to fixing the FDA.

------
zipfle
I find it really interesting to juxtapose this situation with the current
furor over Brian Williams' not actually having been in a helicopter he said he
was in.

It's odd, but not too surprising, that the only job you can actually get fired
from for lying is "propaganda mouthpiece."

~~~
bgun
_the only job you can actually get_ _publicly shamed and publicly_ _fired from
for lying is "propaganda mouthpiece."_

Someone being fired for lying, and someone you _heard about_ getting fired for
lying, are very different things.

------
nodefortytwo
Could this type of investigation be done automatically. pulling data from FDA
and cross referencing against medical journals and FDA redacted docs.

I would love to try however I don't feel i know enough about the available
data to work out what would be required

------
known
I normally cross-check with
[https://en.wikipedia.org/wiki/Agency_for_Healthcare_Research...](https://en.wikipedia.org/wiki/Agency_for_Healthcare_Research_and_Quality)

------
known
Can't you cross check with
[https://en.wikipedia.org/wiki/European_Medicines_Agency](https://en.wikipedia.org/wiki/European_Medicines_Agency)
?

------
vaadu
The authors better be careful or the next contact they have with government
documents is notice of an IRS audit.

------
tokenadult
I post a fair number of stories about regulation of medical treatments here on
Hacker News. I see this one has attracted a lot of reader interest. The
comments already posted as I post this comment point out that once someone
sets up a regulatory program, the incentives become powerful to figure out
ways to cheat the regulators. And, as usual, scientific research is hard
(another topic I post a lot about here), and researchers all operate under
incentives to publish interesting and hopeful results rather than acknowledge
that their research program didn't show what the researchers hoped to show.

The submitted article identifies a specific problem in how the FDA doesn't
publish identifying details of studies that its own inspectors discovered to
have problems. Biomedical researchers, then, don't know which previous study
findings are flawed, even though the FDA detected flaws, and much time and
effort is wasted trying to pursue research results that don't reflect reality.
That has to change.

Meanwhile, there is a different pattern of regulation for some products that
consumers in the United States take regularly as they seek better health,
namely "natural supplements." For natural supplements, the regulatory problem
is far worse, because those products can go on the market with no research
done on safety or effectiveness at all, and without even any guarantee that
the product contains the labeled active ingredient,[1] a plain violation of
the warranty of merchantability in the Uniform Commercial Code.

So the better trade-off for the consumer here is to amend existing law so that
as drugs go through clinical trials, disclosure and peer review of FDA
inspection findings during the trials is a condition for marketing approval.
If manufacturers can't deal with that kind of regulation, tough. But it's only
fair that natural supplement products, a multi-billion-dollar industry, should
be regulated the same way.

(To answer a question asked in another comment, already well answered
overnight in my time zone, yes, "science-based medicine" includes "evidence-
based medicine," that is clinical trials, as a subset of practices that
include also consideration of fundamental principles of science and
statistical understanding of prior plausibility before interpreting clinical
trial results. If a sample size is small enough, many implausible treatments
can look like successes in a clinical trial, especially for subjective,
patient-self-reported symptoms, but we shouldn't call such treatments
effective until they have been replicated in larger samples and verified with
independently gathered "hard endpoint" data about clinical signs.)

[1] "Searching for the supplement in your supplement"

[http://www.sciencebasedmedicine.org/searching-for-the-
supple...](http://www.sciencebasedmedicine.org/searching-for-the-supplement-
in-your-supplement/)

~~~
Alex3917
> For natural supplements, the regulatory problem is far worse [...] So the
> better trade-off for the consumer here is to amend existing law so that as
> drugs go through clinical trials, disclosure and peer review of FDA
> inspection findings during the trials is a condition for marketing approval.

\- The FDA already has the power to regulate supplements, for the most part
they just choose not to. So the idea that supplements just need FDA regulation
like 'regular drugs' is largely fallacious.

\- Why should supplements need clinical trials for marketing approval when
that isn't the standard for other any other comparable drugs on the market?
I.e. almost all drugs that were in use before the 50s are allowed to be
marketed without any testing for safety or efficacy, and since almost all
supplements have a much longer history of human use, why should they be
treated differently?

~~~
tokenadult
_The FDA already has the power to regulate supplements, for the most part they
just choose not to._

No, the "natural supplements" industry has carved out for itself a huge
exemption from most of the regulation that applies to drugs, on the one hand,
or foodstuffs, on the other hand. See a group blog post on "Big Supp"[1] for
more information about this. For years, that industry had a champion in
Congress[2] who resisted more effective and rational regulation.

[1] [http://www.sciencebasedmedicine.org/big-supp-resists-
giving-...](http://www.sciencebasedmedicine.org/big-supp-resists-giving-
consumers-safety-and-effectiveness-information/)

[2] [http://www.sciencebasedmedicine.org/fda-versus-big-supp-
rep-...](http://www.sciencebasedmedicine.org/fda-versus-big-supp-rep-burton-
to-the-rescue-again/)

~~~
Alex3917
> No, the "natural supplements" industry has carved out for itself a huge
> exemption from most of the regulation that applies to drugs, on the one hand

The FDA's own website contradicts you here:

[http://www.fda.gov/Food/DietarySupplements/](http://www.fda.gov/Food/DietarySupplements/)

The FDA, on their own website, says it's their job to make sure that
supplements are unadulterated and not mislabeled. If 80% of supplements are in
fact completely fake, then I don't see how you're using the problems of the
supplement industry to show how well the drug industry is regulated in
comparison.

------
harkyns_castle
I feel like we're so deep in the mire now, of this kind of corruption and
control by wealthy people/interests/entities, it'll be tough, if not
impossible, to dig out of.

Being a fairly selfish person, that's not for my own self interest. Its a
recipe for disaster. We need a massive overhaul.

Edit: Lobbying and the ability for a fiat currency to control decisions, and
revolving door setups, seems like the obvious first step to me. But the people
that can make that happen are the people that benefit from it currently. Bring
on a new planet, without those types of people.

~~~
colechristensen
It is only with a false view of the past that today can be seen as more
corrupt than any point in history.

Of course there is an ebb and flow of where the corruption lies, and to what
extent it takes hold. People tend to forget that we're living in the safest,
most transparent, most free point in the whole of human history. We've been
digging ourselves out of a pit of corruption for ten thousand years, don't let
yourself be fooled into thinking things are terrible by focusing on a few
things that have gotten worse over a decade or two. Big picture: things are
and have been getting massively better continuously.

You should be celebrating that such corruption can so easily come to light
instead of decrying doom that it has been discovered.

~~~
meric
I was trying to think of an argument to disagree with you with but you're
right. From the times of Woodrow Wilson's reign to John Edgar Hoover and Nixon
to the NSA, there's never really been a time in the past hundred years some
part of the government wasn't corrupt and power hungry. And probably even
before 1900 too with slavery and subduing of the Indian tribes. The freest
least corrupt point in USA government's history is probably July 2, 1776.

