

On the 100x Price Rise of a Formerly Generic Drug - nameless_noob
http://pipeline.corante.com/archives/2011/03/11/makenas_price_what_to_do.php

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maxharris
I have a right to choose what I put in my body.^ Companies that make drugs
have a right to sell what they make, as long as they don't lie or defraud me.
Simply by doing what it was created to do, the FDA is violating my rights as a
patient, as well as the rights of all of those whose rights give rise to the
drug companies (i.e., employees and shareholders).

Suppose that a new regulation passed that eliminated off-label prescriptions.
Many will agree that the suffering and death that would result would be
immense. (Just ask anyone who has a friend or relative that's benefited from
an off-label drug.) Yet off-label prescriptions fly in the face of what the
FDA does. What's going on here?

What we choose to do when we're sick ultimately rests on each of us,
individually. We all _need_ to be free to do the research ourselves _or_ to
delegate this responsibility to whomever each of us has trust in (a particular
doctor, for example). _The inevitable consequence of losing this freedom is
that far more of us suffer and die today than would otherwise._

The valid function of the FDA (valid insofar as it is a source of scientific
information) should be performed by a private organization like Consumer
Reports, which has a great deal of authority, but is completely independent of
both companies _and_ the government. Consumer Reports doesn't use violence or
the threat of violence to back itself up: the _one_ thing that keeps it in
business is trust.

Certainly, Consumer Reports doesn't offer its products or services for gratis.
But many people find the service valuable enough to pay, and with our bodies,
the stakes are much higher. Most people will pay for such a drug-vetting
service, either directly or through the professional they delegate health
decisions to.

We all want safe drugs, and the market is capable of producing and selling
safe drugs to us. All we need is to be left free (meaning that the government
does one thing only: prevent force and fraud), and verification organizations
that pride themselves on true independence will arise.

^This right over your own body really is absolute (so long as you're not
hurting someone else). I don't use or advocate for the _use_ of illegal drugs,
but it really is no one's business but your own. Yaron Brook recently summed
it up best when he said, "You know you're in trouble when you declare war on
inanimate objects."

~~~
alnayyir
Stow the politics, this isn't the place for it. Take it to Reddit.

A few points:

1\. Consumer Reports messes up, your dishwasher might break down before the
end of the warranty.

2\. A drug company messes up, hundreds, potentially thousands die or have
their lifespans severely curtailed in terms of quality of life or length.

That's the last I'll say on it, the magnitude of what's at stake should be
otherwise self-evident.

~~~
maxharris
The common case isn't the drug company messing up. It's that the FDA gets in
the way of a new drug (stopping it forever in some cases), and the patient
with the incurable disease dies because there is no legally available
treatment. With the FDA, his right to pursue what remains of his life is
sacrificed to the FDA's illusion of safety.

Human life is so important, and the needs of each individual body are
frequently so diverse from one another, that we can't trust decisions like
these to a one-size-fits-all regulatory body.

This is yet another case where ethics and politics _is_ a life-and-death
matter (and for more people than you'd ever care to think about).

~~~
barrkel
A death owing to a mistake by a drug company is worth at least 100 deaths
owing to lack of drug innovation and experimentation. It's psychology in the
large, and it's very difficult to counteract. It's simply much easier for the
free media to demonize the evil profit-grubbing soulless corporations killing
babies than an abstract notion of opportunity cost.

~~~
maxharris
I voted you up.

But I think that we can make a difference against ignorance, just by speaking
up. In years past, I used to make the mistake of just being quiet when
political or moral topics came up, just because I didn't think it would be of
any use.

I don't think that's true any longer because I realized that if you can state
your case clearly enough, and it's a rational position, at least some people
will listen. You don't have to immediately convince everyone, or even the
majority of people. Just making the correct argument shifts the debate toward
a better direction, and that's a powerful thing.

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reader5000
I dont understand. If the FDA wants to incentivize private companies to update
the research on old drugs, why dont they just pay them to do it (AND not make
the payment contingent on finding the drug marketable as this appears to do)?
Obviously nobody knows the true value of new research on old drugs, but giving
private companies blank checks to insurer's bank accounts doesnt seem like the
best method to go about it.

~~~
barrkel
Actually, some kind of prize system - setting a reward for a drug which has a
certain degree of efficacy on some problem - has been proposed as an
alternative to the government monopolies we currently have, which alleged free
marketers are so in favour of. Dean Baker has written some stuff on it;
<http://prospect.org/cs/articles?article=patent_medicine> has an overview of
and argument for the approach.

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srean
One of the things that Indian law got right was its older patent law on drugs.
The way it used to work was this: you could patent the _process_ of making a
particular drug, not the chemical composition of the drug itself. If you could
build the same or a better product for cheap using a different process, good
for you, and good for everybody else. In most other fields that would be
called innovation and good entrepreneurship. I think the main if not the
principal point of IP laws is to encourage innovation, technological advance
and entrepreneurship.

Unfortunately the older market leveling laws rub a significantly large class
of free-market proponents the wrong way, at least the most vocal and
politically relevant ones.

But back to the laws, a popular counterargument has been that the existing
laws encourage research whereas the older ones did not. I used to be sold on
that line of reasoning till my exposure to the conduct of drug development and
research. In US they are almost always always government funded.

~~~
ericd
The counterargument is that if a company is the first to discover that a given
molecule is useful medically, and is safe in humans, then they should get
exclusive rights to sell that molecule for some time. This makes sense because
it is atrociously expensive to get to that point, and the idea that another
company should be allowed to manufacture and sell that same molecule after all
the hard work has been done by subbing in different chemical reactions to get
there is sort of silly.

EDIT: Didn't see the last line there. Are you sure that the vast majority are
govt. funded all the way to the end of clinical trials? This doesn't jive with
what I've heard.

~~~
srean
Not sure if you are the down-voter. But regardless of that I have to say, I
totally believed in what you just wrote, said so much myself if you note my
last paragraph. But I was naive then. I have come to realize that the
situation you describe is mostly hypothetical and fictional...good argument to
buy favors...but not one that represents reality. The private companies are
not the ones who are spending money or taking the risks in developing new
drugs/molecules (it is mostly the tax payers by way of NIH). If it were the
companies then I wouldn't mind it all. The companies do spend money. But it is
not in the (re)search for more effective or new drugs.

Edit: Re govt funding, I have quite a few friends who are in drug research,
well, in the capacity of current and ex grad students and spread across 3
universities and a research institute. All of them are fed funded, and they
claim that this is generally the rule rather than the exception. In my opinion
the privilege of exclusivity should be doled out in proportion to the
aggregated (monetary)risks entertained.

Edit2: Don't like threads that nest too deep, so adding here. I would readily
concede that I wouldn't have names of drugs at the drop of the hat. My
opinions are largely assimilated from my friends working in the area and what
I get to read. So hardly the person who would be able to quote stats. Recently
an application for extending the period of protection for a anti-retroviral
drug was denied in India on the grounds that the molecular change adds nothing
to the efficacy of the drug and that the molecular changes in itself do not
constitute a non-obvious modification to the chemical to a person of the
trade. However, denials of extension like these are very very rare. It is
common to keep extending a patent on an old molecule in quantums of decades at
a time (Now I wish I had it bookmarked)

However I think your test is stricter than need be. As I said, I am looking
for proportionality between risk taken and period of exclusivity. That can be
broken even if the govt did not carry the full weight from end to end (the
example that you are seeking). Generally it is the research phase that incurs
the most uncertainty and the kind of research that targets greater efficiency
or cheaper production, not what will get the drug or derivative an extended
protection.

In the context of the older Indian scene, it was the govt funded labs that
carried out the research, so it made perfect sense that patents be granted on
the process and not on the compound. It also makes sense for the govt to be in
the business of funding drug research as for many of the diseases the affected
demographics are not most lucrative. (Well unless one is of the opinion that
such a population is better of dead, not an unheard of opinion on the net) The
research scene is still the same but the laws have been changed subject to
international pressure.

There is substantial benefit to be had by driving costs down. In the current
scheme of things there are very little incentives to do so.

~~~
ericd
Nope, didn't downvote.

I know that the US government funds a lot of research via the NIH, and I'm
familiar with the fuzzy lines between government and private research in some
cases (I have relatives who do research for universities but get DARPA
funding), but could you cite some examples of the govt. handing exclusivity to
the drug companies after NIH did all the research and clinical trials for a
drug?

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eekfuh
This reminds me of albuterol for asthema. I used to get it generic for $4. Now
its $45+ with my insurance, since its no longer available as a generic.

I now have to purchase Ventolin, which is no different medication wise, just
the inhaler is different.

~~~
kujawa
Well, it is different in that the propellant doesn't work as good and so the
inhalers tend to fucking clog.

Not that I'm bitter or anything.

Not that I would ever suggest that the EPA and environmentalists prefer their
CFC purity to be 100% at the expense of asthmatics.

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chime
Another example of this was Colchicine as an HN'er mentioned here:
<http://news.ycombinator.com/item?id=2263969>

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Symmetry
"How much is regulatory approval worth, anyway?" To the FDA it apparently
matters a great deal.

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ck2
"the market will balance prices" - oh wait

