
FDA Dangles Golden Ticket to Spur Drugs for Neglected Diseases - septerr
http://www.npr.org/blogs/health/2014/05/16/291972744/fda-dangles-golden-ticket-to-spur-drugs-for-neglected-diseases
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throwaway_yy2Di
Less charitably: the FDA is intentionally slowing drug reviews as a bargaining
tool.

It seems insane that drug approvals _could_ be safely expedited by four
months, at the suggested value to companies of $150-$300 MM, and this isn't
done routinely. That revenue could easily pay for the extra eyeballs at FDA --
which are certainly much cheaper than the clinical trials themselves. I think
if Congress were to question the FDA's workings, this could be prima facie
evidence that the pace of drug reviews isn't set by hard constraints of public
safety: it's slower than it could be, and agency leaders know it.

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htns
This isn't the only fast track program the FDA has. While they might not be
the most flexible organization, at least they are probably thinking in terms
of risk/benefit to the public rather than in terms of safe/unsafe.

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exratione
The FDA has probably caused more deaths in the past half century than all of
the rest of the American state put together, wars and all, by slowing progress
in medicine, making all sorts of avenues for research and development
unprofitable, and making medicine that does exist far more expensive.

Regulators at the FDA are capricious and malign, and there are countless
stories of petty revenge via increased demands for data and enormous imposed
costs in time and money. This is the way things always go in the late stages
of centralized, powerful bureaucracy with a side order of regulatory capture.

The only good thing I can find to say about the bureaucrats at the FDA is that
they respond to regional regulatory arbitrage - to medical tourism - by
loosening their grip and letting things through. Or at least they do when said
treatments are so widely available elsewhere in the world that the risk of
looking bad by continuing to block them in the US is worse than the risk of
looking bad because one of the outcomes of a normal, low error rate in
medicine gets picked up by the press. Look at simple stem cell transplants,
now available in the US these last couple of years, for a good example of this
in practice.

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akiselev
>The FDA has probably caused more deaths in the past half century than all of
the rest of the American state put together, wars and all, by slowing progress
in medicine, making all sorts of avenues for research and development
unprofitable, and making medicine that does exist far more expensive.

As long as we're throwing around bullshit: false hope and pseudoscience has
caused more unnecessary death at the hands of tricksters and con men in the
past two thousand years than all wars humans have fought or ever will fight.

Having worked in biotech I was never a fan of some (or many) of the FDA's
policies but I found this insulting. You have no clue how hard it is to
develop any medicine that doesn't harm the first few patients you give it to,
let alone one that actually reaches the market to help thousands or millions.
You have no clue what it is like to be the _only_ gatekeeper between a $900
billion industry working on some of the hardest scientific problems of our
time and 300 million people. Almost all of whom want their cake, to eat it
_now_ , and for the calories to magically disappear from their
gastrointestinal tract.

The FDA is not a product of pharmaceutical companies, it is a product of a
political system made of voters like you who decide their policies based on
Libertarian pamphlets, Fox News, and Reddit. A political system that allows
pharmaceutical companies to selectively withhold data, that has gutted the
basic scientific research institutions that allows pharma to finance billion
dollar ventures, and that mercilessly punishes any mistake that it itself is
supposed to catch.

You get what you vote for.

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exratione
This was written by people who are much closer to your viewpoints on economic
freedom than mine. They are very mild and conservative in their estimations of
cost in lives. I suggest you read it:

[http://fdareview.org/harm.shtml](http://fdareview.org/harm.shtml)

The delay and large reduction in the total number of new drugs has had
terrible consequences. It is difficult to estimate how many lives the
post-1962 FDA controls have cost, but the number is likely to be substantial;
Gieringer (1985) estimates the loss of life from delay alone to be in the
hundreds of thousands (not to mention millions of patients who endured
unnecessary morbidity). When we look back to the pre-1962 period, do we find
anything like this tragedy? The historical record—decades of a relatively free
market up to 1962—shows that voluntary institutions, the tort system, and the
pre-1962 FDA succeeded in keeping unsafe drugs to a low level. The Elixir
Sulfanilamide tragedy, in which 107 people died, was the worst of those
decades. Every life lost is important, but the grisly comparison is necessary.
The number of victims of Elixir Sulfanilamide tragedy and of all other drug
tragedies prior to 1962 is very small compared to the death toll of the
post-1962 FDA.

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akiselev
I watched someone die of cancer possibly years too soon because it took
Genentech an extra two years to get approval for Avastin for his condition,
volunteered for a patients rights NGO, and worked in several companies heavily
regulated by the FDA. I know all too well about the cost in human lives of not
just the FDA but the companies who gouge customers on the cost of insurance,
medical equipment, and even the basic technology needed to look closely at a
cell in an academic lab.

You can talk about the economics of human lives but the reality is simple:
removing the FDA won't bring on a Golden Age of medicine that will bring back
the dead. Instead, the companies developing the medicine that can actually
save people, companies that are now "delayed" and overburdened by regulation,
will be beaten down by a market of charlatans with big marketing budgets and
limited liability.

Thanks to Facebook, I know of half a dozen former classmates who have close
relatives that lost years of their lives because they chose to listen to some
neo naturalist instead of their oncologist. That is the alternative. It
already exists and destroying the FDA would unleash the flood of crazy that it
has tried, with so little actual support, to hold back for all these years.

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Houshalter
This is not a binary issue. I don't see why we can ban alternative medicine
and have some regulations, but make them more reasonable.

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akiselev
I wasn't arguing against constantly reviewing effectiveness and reassessing
regulation, I was responding to the vilification of a consumer protection
agency by someone who does not have the credentials to be deciding what
"reasonable" is in this context.

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jmckib
We'd probably be better off if every drug got a priority review. The FDA's
incentives are warped: they get blamed for releasing a drug that causes harm,
but receive little blame if a drug that would have prevented harm is delayed
or not released.

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jonlucc
To be fair, those kinds of stories usually play out in the financial news
around drug companies, many of which have lobbyists and a team whose job it is
to make sure they can get their drugs through.

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revelation
Why don't we spend $10M to bolster the review team and clear the queue instead
of creating $150M worth of perverted incentives that the companies will
inevitably recoup from the health care system? Medicaid alone will probably
pay more than it would take in salaries for qualified people to process
applications.

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JumpCrisscross
> _Why don 't we spend $10M to bolster the review team and clear the queue
> instead of creating $150M worth of perverted incentives that the companies
> will inevitably recoup from the health care system?_

Because:

1\. the $10 million would come out of the FDA's budget while the $150 million
doesn't; and

2\. spending $10 million to clear the queue would do nothing to incentivise
drug development for neglected diseases, such as leishmaniasis.

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jonlucc
These are both good points, but it is also important to note that it is not
very easy to hire people to review drugs at the FDA. They have to be pretty
aware of the state-of-the-art in their field in order to be able to
effectively provide guidance to the drug companies.

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barlescabbage
Now this is the type of thing that's fun to see, I feel like this story's
gonna be mentioned in the next freakonomics or Gladwell book. Good for the
FDA, they should be congratulated for doing something good. And this is good.

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olva22
Maybe they can create an incentive to create new antibiotics? I've heard there
are few if any in the pipeline since they are not profitable to pharma
companies and resistance is increasing alarmingly fast!

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refurb
The GAIN Act was passed last year which provides incentives for new anti-
infectives. The DISARM Act is another one being looked at that would make it
easier for hospitals to use the latest and greatest antibiotics.

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olva22
Ah! Good to hear they are legislating towards a bit more progress. Do you know
if any pharma companies have re-entered antibiotic research since GAIN passed?
I believe there's only a small handful of them left.

Not to mention creating new drugs without implementing any rational controls
over their use in humans and livestock is like pouring more gas on the fire.

But I digress about leaving science to legislators....

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refurb
Roche just in-licensed a new compound to restart their antibiotic franchise.

[http://www.roche.com/media/media_releases/med-
cor-2013-11-04...](http://www.roche.com/media/media_releases/med-
cor-2013-11-04.htm)

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powerset
In other words, it's a lever that the FDA can (will they?) use to solve an
important problem: the discrepancy between drugs that bring the greatest
profit and drugs that bring the greatest societal benefit. Potentially a loss
of efficiency in the strictest economic sense, but also potentially a very
good thing in terms of benefit to society.

