
This pill used to cost me 10c/pill, now it's $5/pill. I take it 3x day. - zaidf
http://www.slate.com/id/2289616/
======
noonespecial
I think maybe its about time we set up something life the NSF to conduct these
trial for the FDA (in the particular case of orphaned and old drugs) and
generally does a much better job of dealing with the mess that drug trails
have come to be.

At some point, this knowledge becomes a public good and the conflict of
interest presented by those seeking to win approval also being the ones who
stand to win a "get a monopoly free card" becomes too great a moral hazard to
expect to overcome.

There just seems to be something fundamentally wrong with rent seeking
someones pain, no matter what legal process led to that result. It feels like
something we should have grown out of by now.

~~~
CWuestefeld
_I think maybe its about time we set up something life the NSF to conduct
these trial for the FDA_

This would be a disaster. It really is expensive to test drugs, and so pharma
companies must carefully consider which ones are worth pursuing. If they no
longer need to bear the cost, then they'll just throw everything at the
agency. Then the agency will either fall behind, so that good new drugs never
get approved, or it will tremendously balloon the costs of testing (and we're
already complaining about those costs).

~~~
_delirium
I read the comment as proposing only that the NSF (or someone) run the trials
for old drugs that are already widely used, in lieu of the current odd system
of re-monopolizing drugs that had previously been widely available as
generics.

For _new_ drugs hoping to win approval, which are inventions and are already
granted monopolies via patents, things could still work the current way.

------
olalonde
> One can't fault the FDA for the price increases for Makeda and Colcrys; the
> agency is doing what it's supposed to do, clearing out old drugs and
> improving the standards of the national Pharmacopoeia. (Disclosure: I worked
> as a speechwriter for FDA in early 2010 but had no involvement in the
> colchicine or 17OHP issues.)

I think anyone will agree that FDA's intentions are good. But sadly, what
really matters are consequences, not intentions.

> In 2009, after winning FDA approval, URL Pharma won exclusive rights

Exclusive rights granted by who? Why blame pharmaceuticals for following the
incentives they are provided with?

The truth is that FDA and other industry regulations increase costs in
addition to destroying competition and innovation in the pharmaceutical
industry.

Milton Friedman says it better than I can here:
<http://www.youtube.com/watch?v=dZL25NSLhEA>

~~~
jerf
"I think anyone will agree that FDA's intentions are good."

I don't entirely, though I'm not claiming malice either. The purpose of drug
testing is to make drugs safe. The FDA has mistaken goals for means, and now
they are testing drugs for the purposes of testing drugs.

If an untested drug has been used for decades by millions of people to treat a
chronic condition that requires each of them to themselves consume the drug
for decades at a time, that by itself puts such a sharp, strong bound on the
maximum damage the drug may be doing that it is well in excess of what _any_
study could possibly hope to establish. The improved methodology the study may
have is simply swamped by the statistical power of a sample five or six orders
of magnitude larger (measured in man-years) we have in the real world. In fact
you just don't get any statistically more powerful than a "sample" of 100%.

 _Even if_ the study managed to produce some small negative side effect there
is no chance in hell that it will exceed the positive value of a drug for
gout.

I've actually seen this before. Several children's drugs have been
"unrecommended" by the FDA for toddlers, not because they could produce a
shred of evidence that they were dangerous but because the studies-for-the-
sake-of-studies had not been done. Again, decades of use by millions of people
dominates what any study could produce.

(By the way, when I say "dominates what a study would produce" I emphatically
do _not_ mean "is perfectly safe". I mean precisely that a study will not be
able to find the small damage. Drugs have after all gotten all the way through
our stringent approval process and then had to be pulled because it turns out
they were still dangerous. If the process couldn't catch the several diet
drugs that turn out to give you a heart attack, it isn't going to pick up on
something that could escape hundreds of millions of man-years of usage.
Studies do not have infinite resolution.)

It's a continuing degradation in the standards of science, as the disease of
scientific form replacing scientific substance marches on. That's why I don't
claim "malice" in my first paragraph. Malice is not required, merely the
raising of form above substance. I do not call "intention to have good form
even at the cost of substance" good intentions.

------
ck2
Based on previous "investigations", basically nothing will happen to the
company and things will continue as usual.

 _The $5-per-pill price URL Pharma set for Colcrys surprised the FDA_

Find the people that were surprised and terminate them immediately. The "FDA"
wasn't surprised, it was a few idiots left in charge.

What if they just do a compromise of $2.50 a pill, is that really going to
help anyone when it was 10 cents previously? How about $2, or even $1 ? 1000%
markup is okay when it comes to people's health? It's okay for the CEO to buy
their 2nd or 3rd house with the profits while patients suffer? When as a
society are we going to tell corporations they need to be responsible for all
their actions and not just help a few charities to do penance afterwards.

~~~
qwer99
This is just unbelievably incorrect, absurd, and just shows complete ignorance
of the healthcare industry. Profits for healthcare companies are the same as
those in any other industry. A quick check on Yahoo Finance will let you
compare their respective financial statements. The culprit is in the endless
rules and regulations that drive up costs to make the pills, preventing
competitors from coming in to drive down the costs.

~~~
Retric
I don't think you understood what he was saying.

In effect the FDA set a ~1 billion dollar bounty from doing 2 study's on this
drug. What was not said is there are limited resources in the industry so
while this company went after this fairly safe and profitable drug plenty of
other companies went after other drugs and there is no incentive to research
the same drug as another company. This is a land grab plain and simple and
only an idiot would think a company would act any differently.

PS: And when you realize the only thing patents gained from this was higher
prices you need to conciser it poor regulation. (1 study of 200 people says
next to nothing about a drug regularly taken but 10's of thousands of people
for hundreds of years.)

~~~
shpxnvz
It seemed pretty clear that in addition to the FDA he was attacking the
company for behaving like a profit seeking entity (which it, of course, is).
He questioned whether it is "ok" for them to charge the particular price they
wanted and questioned how many homes the CEO should be able to own while there
are still suffering people in the world.

We can argue that this particular bit of regulation is wonderful or evil all
we want, but to think that any for-profit organization is going to act in your
best interest rather than it's own, or that it's even possible to regulate a
company or person into doing so, is just plain naive.

~~~
alexqgb
Relentless profit-seeking tendencies combined with monopolies are
fundamentally toxic. Which is why we (generally) outlaw monopolies. The ones
we do grant have (in theory) provisions that favor the public interest.

In other words, if your business operates a monopoly granted by the state, you
DO have a special set of legal, moral, and ethical obligations that don't
apply to less privileged organizations. If a protected company DOES start to
behave in an anti-social fashion, opting for pure profit-maximization and
short-term shareholder gains, then it's the JOB of the government to attack
them, rescind their monopoly, and generally punish the hell out of them for
violating the basic contract that accompanied the initial grant.

If they don't like that possibility - or realize that they're just not up to
the (admittedly challenging) task of administering an public trust along side
a commercial business - then they can retreat to the less complicated, less
ethically demanding, and more mercenary ranks of those operating in the free
market - which has it's own set of mechanisms from weeding out the truly
dishonest and abusive.

~~~
shpxnvz
_In other words, if your business operates a monopoly granted by the state,
you DO have a special set of legal, moral, and ethical obligations that don't
apply to less privileged organizations._

If there were such obligations, they would be made specific in the regulation.
It's pointless to set the rules for the game and then get upset when they are
followed. I personally find the price gouging distasteful as well, but those
are my ethical beliefs and they in no way compel the behavior of others.

Hence my claim that the regulations should be the subject of the discussion,
not whether some particular company is acting in accordance with our personal
views.

------
jws
The FDA has a somewhat scary recourse here:

Makena (aka 17P), a compound used to control preterm labor got similar
treatment. KV Pharmaceutical announced plans to multiply the price by x100 and
set off a storm.[1]

The FDA has simply decided not to enforce the monopoly that KV legally
acquired.

 _Beth Martino, a spokeswoman for the FDA, called the Makena controversy a
"unique situation." Martino stressed that the drug agency's enforcement
actions are discretionary, and that it has chosen at this time not to take
action against other suppliers in order to "support access to this important
drug."_ [2]

[1] It appears they spent something between $250,000 and $1m acquiring rights
and commissioning studies for the FDA approval or existing practices. They
appear to be set to reap 18 times that in monopoly rent.

[2]
[http://www.stltoday.com/business/local/article_26f67c9a-5ae9...](http://www.stltoday.com/business/local/article_26f67c9a-5ae9-11e0-bd13-0017a4a78c22.html)

~~~
notahacker
"You abuse it, you lose it" actually sounds like a pretty good rule of thumb
for enforcement of patent law...

~~~
yummyfajitas
Where "abuse" is defined by fiat, rather than clear apriori regulations?

What happened to the rule of law?

~~~
notahacker
This is a situation where inconsistent enforcement of law actually works to
the consumer's advantage in reducing the number of edge cases where companies
make speculative bets on exploiting weaknesses in the formal certification
process. Especially with the FDA carefully trying to avoid setting any
precendent.

It would be difficult to draft a definition of "abuse" that didn't encompass
raising cost of a drug a hundredfold above the market rate in order to recoup
costs invested not in research, but in acquiring the company that achieved FDA
certification (mostly using existing NIH funded research) for an already
widely-available treatment.

------
protomyth
Drugs are broken in the US. The FDA testing of a drug costs a huge pile of
money (I was in Clinical Trials for a while). Most protocols don't work out so
your success rate is somewhere around the success of rolling out software. The
ones that do, take a long time and allow for a very limited monopoly period.
So, you spend a lot of money on advertising to maximize. Plus, the FDA does
weird crap and drug producers up the price. It is a very weird cycle.
Including, spending a lot of time on stuff that is more lifestyle than cures.
Never mind the liability laws, since almost every drug made will react badly
with someone.

It is a damn mess, that should have been the first thing addressed in health
care legislation, because it is an input cost to health care. I sometimes
wonder if separating the research from the producer and guaranteeing royalty
for a number of years after approval would have been a good way to go. Much
like not allowing film companies to control the theaters back in the day.

~~~
WalterBright
The way to deal with it is to allow legal consenting adults to take any drugs
they want to - provided they sign a contract saying they understand the drug
is not approved by the FDA.

But if a drug is approved by the FDA, then the drug company is inured against
liability for that drug.

~~~
protomyth
The FDA already has rules to allow patients to take drugs being tested if they
are on death's door (cannot remember the terminology or exact rule).

Drug companies should not have to worry about lawsuits unless they knowing let
a dangerous drug on the market, but people and doctors ignore warnings and
nothing is totally safe for everyone.

~~~
WalterBright
If you've got a chronic/debilitating/painful illness, as long as you're not
about to drop dead, no soup for you? I can't see how that is a compassionate,
just, or rational policy.

~~~
protomyth
With the current court system, it is about as good as it gets. Contracts
absolving other parties of responsibility don't hold up in court. Heck, take a
look at all the problems around Accutane. If you take it, you are told and
sign forms stating it can cause depression. Well, it looks like that won't be
good enough. People's love of punishing the big even companies have doomed
those that suffer more than the revenge has ever been worth.

------
Havoc
The FDA gave them a monopoly on something with inelastic demand and then was
surprised by a price increase? That takes a special kind of stupid...

------
meric
Just had an epiphany. If it is these old drugs (since 6th century) that are
getting monopolized.... It means they don't really need advanced technology to
create! Just grind some herbs, measure carefully, sun dry, etc. If they're
over-charging by 5000% you might actually save money producing the drugs
yourself for self consumption!

Who's up for creating a website to share recipes of these drugs?

~~~
dexen
_> Who's up for creating a website to share recipes of these drugs? _

No, seriously, somebody please figure a pharmaceutics delivery business model
that does not depend on FDA for legality & operations.

~~~
jellicle
Already done. It's called "base your company in India and mail pills to the
U.S.".

------
sentinel
So if I get it right, FDA has enforced a monopoly by not allowing competitors
to penetrate the market with the same drug.

~~~
roel_v
Exactly, and _this_ is the problem, not the drug manufacturers.

~~~
zaidf
The counterpoint to that is if they don't grant the exclusivity, the cos won't
be willing to invest money and resources to do the testing because the returns
wouldn't be as strong.

In these cases though, the counter-argument to that is the price jump is
unjustified relative to the $ invested in doing the testing.

~~~
roel_v
At first I was puzzled by the upvotes because pro-monopoly arguments are
usually unpopular here, but then I realized that I didn't really express
myself clearly and that probably my argument was misunderstood :) So I'm not
against drug monopolies, or patents, (or copyright, for that matter) - in fact
I'm staunchly pro those things; the problem in this case is the strictness of
the FDA, setting an arbitrarily high bar, causing all but one manufacturers to
not be able to produce the drug any more.

The point of the article was that the FDA used to approve other manufacturers,
but then required higher standards which only one manufacturer can meet. So
now there's a de facto monopoly - not because of a patent, but because of the
requirements the FDA set (retro-actively). The FDA needs to restrict itself to
more basic testing (rather, testing requirements) so that the market can take
over in the price setting of the drug through competition.

(I'm not an expert on the chemistry and medical aspects of pharma; actually I
don't know anything about it. I don't know if, in the specific case of the
article, the additional requirements set by the FDA are really required, or
just paranoia. I think the FDA, and similar bodies in general, need to relax
on their 'err on the side of caution' principle. To put it extremely - yes it
sucks to be harmed by a thus far unknown side effect of a drug or food, but
requiring near-100% safety on everything on the market hampers progress, and
we can't know if the positive effect outweigh the negative ones. I hypothesize
they don't, but until we know, let's lay off the state nannying, and replace
it with a clearer mechanism to let consumers know how far something has been
tested, so that they can make their own choices on whether or not they want to
take/eat the drug/food).

~~~
mukyu
You do not seem to understand orphan drugs or this article. Basically every
word of your second paragraph is incorrect.

These are drugs that have _never_ been approved by the FDA. No manufacturers
were previously approved and no standards have been changed.

The FDA wanted clinical trials on the drugs. There are incentives in place to
encourage companies to develop drugs for rare conditions where there are _not
enough patients to warrant investing in for economic rewards_ (and yet you
envision companies in competition over them). These include grants for the
required trials, tax credits for half of the cost of developing the drug, and
a seven year monopoly on the drug.

~~~
roel_v
It was my understanding from the article that originally there were several
versions of the drug, then something changed (the author seemed to blame the
FDA) after which there was only 1 left, and then there was a price hike.

Now it's quite possible that I'm wrong - what was the cheap version that the
author was taking before then? Wasn't it a product of a competitor? And if so,
why isn't it available any more?

~~~
ctdonath
Whatever the prior sources (IIRC, pharmacists could just whip up a batch),
making it was cheap, legal, and unrestricted due to grandfathering. FDA wanted
to regulate it, and granted someone exclusive rights to achieve it.

It's not available now because the FDA wanted certain tests done which hadn't
been. No company did the tests because it wasn't worth their time/money to do
so. The FDA _made_ it worth someone's time and money by offering them
exclusive rights for 3 years if they did the tests. One company ran the tests,
got approved, and was granted exclusivity as a reward. Supply plummeted
(manufacturing went from many sources down to one), demand remained high, and
prices increased 50x as a natural consequence.

The Law of Supply and Demand rules. It always does. Screw with it and you'll
get hurt. The FDA screwed with it, and people got hurt.

~~~
mukyu
It _was not_ legal to make these drugs. However, the FDA did not want to
suddenly get rid of drugs people were already taking so focused their efforts
on drugs that they thought were harmful first.

Drug testing is designed to prevent _actually harm_. With the manufacturer's
plan it seems that the only people that will have to pay significantly more
make over $100k/yr and probably have it covered under their health insurance
anyways.

------
klochner

      The drug maker K-V Pharmaceutical obtained exclusive 
      rights to produce an injection for women at high risk of 
      delivering prematurely. But the FDA is opening up the 
      market to specialty pharmacies after the company raised 
      the dosage price from $20 to $1,500.
    

[http://www.latimes.com/health/la-na-fda-drug-
price-20110331,...](http://www.latimes.com/health/la-na-fda-drug-
price-20110331,0,992096.story)

~~~
zaidf
Hopefully they will do the same for colchicine! So far, no cigar though and
we(colchicine consumers) have a pretty active community that's been trying for
years now to prevent this from happening with little luck.

~~~
ars
It's not the same. The previous "drug" was really just mixing two existing
drugs together. The company hoped they could legally prevent people from
mixing those drugs. But the individual unmixed drugs are widely available. The
FDA said they would not prevent people from mixing (compounding) drugs.

In this case it's drug on it's own. I.e. manufactured. And for this they do
actually have the legal right to be the only ones making it.

------
Ahmes
The problem doesn't end there. Once these drugs' exclusive rights expire and
"generic brand" prescriptions are allowed to compete, most insured patients
will still prefer the "name brand" as they are only charged co-pay. Some
insurance providers may place restrictions on which drugs are eligible for
treatment but this is not the case with traditional U.S. sponsored
Medicare/Medicaid (patients are free to choose between "name brand" and
"generic brand"). Medicare/Medicaid patients may also be eligible for limited
co-pay exemption. ("Why wouldn't I take the 'name brand'? _I'm_ not paying for
it./I'm paying the same price anyways.") This further drives up the price of
"name brand" medication, simply because the "name brand" _can_ get away with
it. "Name brand" suppliers will also cut discounted deals with various
insurance companies...no such luck for the uninsured though.

One particularly frustrating example I heard from my sister was about a mother
on Medicaid who refused to switch her 19-month old infant from formula to
solid food (infants usually make the transition around 7 months), complaining
that the child had digestion problems when she tried. (Digestion problems are
normal and temporary during the transition.) Formula is more calorie rich than
seal milk and nearly as expensive as printer ink, however the patient had to
pay for food but didn't have to pay for formula. As a result the infant became
obese and developed diabetes - the treatment for which, is also covered by
Medicaid.

Meanwhile uninsured/ineligible patients are forced to go for the "generic
brand" pills due to a huge price disparity. This wouldn't be so bad as generic
brands are generally just as effective, except that suppliers of generic
brands can sometimes change who they source their pills from, subtly changing
the dosages with them so users must constantly stay on alert to see if their
pill changes color or shape as this could be an indication of a shift in
supplier and depending on how sensitive the drug is, have mild to severe
repercussions.

The Obama health-care reform was seeking to fix this issue by providing a
third party government insurance plan which would promote a more transparent
market in this arena amongst other things...

~~~
wisty
In Australia, most people have to pay for drugs. There are subsidies
available. If a drug company wants the subsidy, it has to offer a fair price.
If they don't offer a fair price, then they don't get subsidized, and nobody
buys it.

So, patients pay (a bit), so they avoid unnecessary treatment. But they don't
have to pay to much. And if the drug companies try to play funny-buggers, they
get shut out.

Also, the subsidy process is completely hands-off (it's run by an untouchable
board of experts), so while it's a little inefficient (untouchable experts are
always inefficient) it's incorruptible.

~~~
anamax
> Also, the subsidy process is completely hands-off (it's run by an
> untouchable board of experts), so while it's a little inefficient
> (untouchable experts are always inefficient) it's incorruptible.

If they're actually incorruptible, that process can not be used in the US.

Disagree? Then produce a couple of incorruptible groups of experts with
comparable powers in related areas.

Hope is not a plan.

As far as the US is concerned, it doesn't matter what works elsewhere, what
matters is what will work here.

------
lwhi
Surely the problem is the insurance industry? If the insurance industry wasn't
able to foot the bill, no one would buy the product and market forces would be
able to set a reasonable (affordable) price.

As a non-US citizen (I'm from the UK) I can't believe that such an obscene set
of symbiotic relationships have been able to be formed between the medical
establishment, medical insurance industry and pharmaceutics.

There are some things that benefit all - and some issues that every human
holds close to their heart. Medicine and the ability to recover from ill
health is too important to let companies hold individuals to ransom.

I'm shocked the situation was ever allowed to get this bad.

------
elai
Haven't these drugs basically gone through extensive human trial already?

------
jessriedel
There is some large cost of doing this drug research, with benefits that will
accrue to all the people taking colchicine for decades into the future. The
problem here is that congress has decided, through the Orphan Drug Act, to
place that cost _just on the patients who take the drug in the next 3 years_
(the length of URL Pharma's monopoly).

This is stupid. It's not the fault of the FDA (they're following the law) and
it's certainly not the fault of the manufacturer. It's congress.

------
frankydp
I would agree with some of the other comments. The burden of testing this
historical drugs should not be placed in the industries hands. The FDA should
run the testing, either with its own money in the common interest or allow the
collection of manufacturers of a certain drug class to divide the total bill.
The practice of back dated invention seems archaic.

------
monochromatic
Some good discussion from a blogger in the drug discovery industry:

[http://pipeline.corante.com/archives/2011/03/11/makenas_pric...](http://pipeline.corante.com/archives/2011/03/11/makenas_price_what_to_do.php)

[http://pipeline.corante.com/archives/2011/03/24/more_on_kv_a...](http://pipeline.corante.com/archives/2011/03/24/more_on_kv_and_makenas_pricing.php)

[http://pipeline.corante.com/archives/2011/03/30/kv_pharmaceu...](http://pipeline.corante.com/archives/2011/03/30/kv_pharmaceuticals_and_makena_the_fdas_move.php)

------
jpspeno
Gout may be another disease of civilization which might be preventable with
diet. Gary Taubes had a chapter about this that he didn't have room for in his
book, Good Calories, Bad Calories, but you can read it online:
<http://www.fourhourworkweek.com/blog/2009/10/05/gout/>

------
supervillain
I'll just endure the gout pain, with crutches to walk and sleep all day so
that the pain will pass. (with that price for colchicine)

------
Oxryly
Anyone else feel that there's an overwhelming sense of entitlement to the
fruits of the pharmaceutical companies efforts?

------
known
Pills are _regulated_ in America but in Chindia. I believe there is a business
opportunity.

------
hackermom
I get saddened everytime I see this old story of greed and indifference. I've
had a personal run-in with it myself: for years, we Scandinavians with
sleeping disorders could enjoy Melatonin from several different producers to a
very low price. About two years ago a company called Nycomed managed, with
lies and deception, to get a monopoly on selling Melatonin in Scandinavia by
convincing our governmental medical products agencies that Melatonin was
harmful and had severe side-effects - of course, all Melatonin but their own
magic kind, marketed under the name Circadin. Before their "coup", I could
purchase 30 tablets á 2mg Melatonin for €5. Nycomed wants €22 for 21 of their
2mg tablets. We're close to a million people here in Scandinavia who rely on
Melatonin daily to get our sleep. Why did you let this happen to us,
Scandinavian MPAs?

------
TheAmazingIdiot
As a 'budding' herbalist (sorry bad pun), I'd almost be willing to make my own
tincture of this drug. Websites out there are doom and gloom only because you
need to talk with a real herbalist about the proper mixture and technique in
which to extract the chemicals.

This Google Books link seems to give the appropriate amount of drops per hour,
which passes my BS detector. But like I said, you need a real herbalist for
guidelines for making the tincture, or buy it from them.

[http://books.google.com/books?id=gDLIrCv26hkC&pg=PA272&#...</a><p><a
href="http://www.aminaherbs.com/product.php?id_product=91"
rel="nofollow">http://www.aminaherbs.com/product.php?id_product=91</a> Also
sells the seed, as do other sites. I just found this one due to the bulk
nature that they sell in. I have no clue if this company is good, but just
wanted to show that it is easy to buy.<p>Lastly, I thought this was some sort
of sick "April Fools". Come to find out that this is normal FDA business with
corporate profit extraction.

