[soc.motss] Why AZT is so expensive

drogers@riacs.edu (David Christopher Rogers) (09/15/89)

[Apologies if this is appearing twice.  My mailer barfed trying to post to 
 sci.med.aids]

    Message-ID: <2434@aecom.yu.edu> 
    From: werner@aecom.yu.edu (Craig Werner)

	While we're on the subject of conspiracy theories, here's a bit
    of debunking.  The cost of AZT is usually expressed as an annual cost:
    $8000-10,000.  That seems like a lot of money because it probably is
    a lot of money.

    However, a rough estimate of the cost of producing AZT places
    the actual cost of production at about 20-35% the cost that it is actually
    sold for.  

In other words, a cost of production somewhere between $1600 and $3500
for a years dose.  And a profit somewhere between $5200 and $8000 a year
for each person taking it.

    True, that's a 300% markup, but considering the cost of clinical
    trials, that's actually not way out of line. AZT is a biochemical, and it
    costs roughly $20/gram.  That's about $2  pill.. 

Considering the drug was initially developed at public expense in government
labs, this seems pricey.  (BTW, B-W claims a cost of about $1.50/pill).

The "cost of clinical trials" being used to justify the cost of AZT would
be funny if the clinical trials weren't in such a shambles.

ACT-UP has asked Burroughs-Wellcome to justify their cost by opening their
books, or lower the price.  They have refused to do either.

I've even heard it said how much money B-W has LOST on AZT.  Even THEY 
haven't claimed any loss of money on this product.

    Quite a  commonly used pharmaceutical drugs  cost more than that, but 
    are used for only short periods of time.  AZT is taken 4 times a day, 
    for the rest of one's life, or until  it can no longer be tolerated.  

How many "commonly-used" drugs have a profit-margin of > $5000 per person/yr?
And a customer base that may be >1M in a few years??

The real issue is that Burroughs-Wellcome has only a 7-year monopoly on 
AZT granted by the government, and they want to soak as much as they can
out of it before they lose the monopoly or government finished one of its
longwinded trials and authorizes some other drug.

    That's why it costs so much. It's not the first prescription that 
    gets you, it's all the refills.

Damn right.  The only debunking to do here is the myth of the drug company
acting in the interests of the patients, when it's actually soaking the
patients and the taxpayers on its government-granted monopoly.

David Christopher Rogers
drogers@riacs.edu

werner@aecom.yu.edu (Craig Werner) (09/16/89)

In article <1704@hydra.riacs.edu>, drogers@riacs.edu (David Christopher Rogers) writes:
> The "cost of clinical trials" being used to justify the cost of AZT would
> be funny if the clinical trials weren't in such a shambles.
> 
> I've even heard it said how much money B-W has LOST on AZT.  Even THEY 
> haven't claimed any loss of money on this product.
> 
>     Quite a  commonly used pharmaceutical drugs  cost more than that, but 
>     are used for only short periods of time.  AZT is taken 4 times a day, 
>     for the rest of one's life, or until  it can no longer be tolerated.  
> 
> How many "commonly-used" drugs have a profit-margin of > $5000 per person/yr?
> And a customer base that may be >1M in a few years??
> 
>     That's why it costs so much. It's not the first prescription that 
>     gets you, it's all the refills.
> 
> Damn right.  The only debunking to do here is the myth of the drug company
> acting in the interests of the patients, when it's actually soaking the
> patients and the taxpayers on its government-granted monopoly.
> 
> David Christopher Rogers

	Hey look, it's easy to shout "conspiracy," and it attracts a lot
of attention.  I never implied that any drug company acts solely in the
interest of patients.  Of course, the more patients that are helped, the
more sales they have, and the better the bottom line. So they obviously
care a little bit.
	The cost of clinical trials and the drug they gave away during
the "compassionate use" phase prior to initial approval was worth, by
some estimates $100 million dollars.  Standard practice is to try to
recover that money within three years.  Since initially it was only
approved for those with AIDS, a moving target of roughly 20-40,000
people implies you have to make several thousand dollars per person.
Hey, life isn't fair sometimes. Of course, now that the number of
patients that the drug has been approved for has increased, they should
(and have already announced that they will) lower the price (but probably
not as much as they should.)

	What if AZT were sold at cost.  A rough guess at the chemistry
says it should cost roughly $2/pill.  Boroughs-Welcome quotes $1.50 a 
pill. They're better chemists than I give them credit for.  4 pills a 
day, 365 days/yr.  That's still over $2000/yr.  AZT is just plain
expensive.
	On a yearly basis, consider Ibuprofen by comparison.  I paid 3
bucks for 24 pills. That lasts me a month or so, because I just get
migraines, but imagine I had arthritis and took 6 a day. That's turns
into over $1000/yr, and Ibuprofen is almost a commodity. You can buy it
in the supermarket.  But expressed as a yearly figure, it ends up in the
same neighborhood as the commonly quoted price for AZT.
	For another comparison, remember that on a gram for gram basis
AZT costs roughly 20% of the price of Cocaine.


-- 
	        Craig Werner   (future MD/PhD, 4.5 years down, 2.5 to go)
	     werner@aecom.YU.EDU -- Albert Einstein College of Medicine
              (1935-14E Eastchester Rd., Bronx NY 10461, 212-931-2517)
          "Disinformation is one thing, but misinformation is unforgiveable."

drogers@riacs.edu (David Christopher Rogers) (09/17/89)

    Messge-ID: <2446@aecom.yu.edu> 
    From: werner@aecom.yu.edu (Craig Werner)

    The cost of clinical trials and the drug they gave away during
    the "compassionate use" phase prior to initial approval was worth, by
    some estimates $100 million dollars.  

It is crazy to count the value of the "drug they gave away" as part of 
the `cost' of the trial, as the value is set by whatever inflated price
B-W gives it.

As for B-W spending $100M on these trials, I'd really like to see evidence.
Let's see how much money they spent, and how much they made.  Let them
open their books, rather than let people defend them with completely
unsubstantiated estimates.

    Standard practice is to try to recover that money within three years.  
    Since initially it was only approved for those with AIDS, a moving 
    target of roughly 20-40,000 people implies you have to make several 
    thousand dollars per person.

Pretty amazing underestimation of the numbers of people with HIV infection,
who may need their drug?  To base the price on the most conservative
estimate of sales, you can then be "pleasantly surprised" when you
make lots of money when your estimate are too low.

Awful convenient.

    Hey, life isn't fair sometimes. 

I think we can agree there is a lot of unfairness somewhere in this mess.

    Of course, now that the number of patients that the drug has been 
    approved for has increased, they should (and have already announced 
    that they will) lower the price...

Wrong.  In a meeting with AIDS activists last week, B-W refused to commit 
to lower the price.  Instead, they said they are "studying" the issue.

    ... (but probably not as much as they should.)

I think we agree here.

    What if AZT were sold at cost.  A rough guess at the chemistry
    says it should cost roughly $2/pill.  Boroughs-Welcome quotes $1.50 a 
    pill. They're better chemists than I give them credit for.  4 pills a 
    day, 365 days/yr.  That's still over $2000/yr.  AZT is just plain
    expensive.
	
    On a yearly basis, consider Ibuprofen by comparison.  I paid 3
    bucks for 24 pills. That lasts me a month or so, because I just get
    migraines, but imagine I had arthritis and took 6 a day. That's turns
    into over $1000/yr, and Ibuprofen is almost a commodity. You can buy it
    in the supermarket.  But expressed as a yearly figure, it ends up in the
    same neighborhood as the commonly quoted price for AZT.

Your argument seems to be that AZT isn't that much more expensive than
other drugs.  Perhaps (though calling $1000/yr and $8000/yr "in the same
neighborhood" is stretching it);  but this sidesteps the real issues, which
are:  is the price fair (is B-W "price-gouging"), and: is the price so
high that people who need the treatment for their lives dying because they
can't afford it?

    For another comparison, remember that on a gram for gram basis
    AZT costs roughly 20% of the price of Cocaine.

To compare AZT, needed by people for their LIVES, with the yuppie pleasure
drug cocaine is a callous trivialization of an issue vital to HIV+ people.
AZT is not a "discretionary" purchase for "disposable" income.  People 
will DIE if they cannot afford it.  

David Christopher Rogers
drogers@riacs.edu

dyer@spdcc.COM (Steve Dyer) (09/19/89)

In article <1711@hydra.riacs.edu> drogers@riacs.edu (David Christopher Rogers) writes:
>Wrong.  In a meeting with AIDS activists last week, B-W refused to commit 
>to lower the price.  Instead, they said they are "studying" the issue.

You probably know now that today B-W lowered the price of AZT from
roughly $1.50/capsule to $1.20.

-- 
Steve Dyer
dyer@ursa-major.spdcc.com aka {ima,harvard,rayssd,linus,m2c}!spdcc!dyer
dyer@arktouros.mit.edu, dyer@hstbme.mit.edu

pell@boulder.Colorado.EDU (Anthony Pelletier) (09/20/89)

In article <1711@hydra.riacs.edu> drogers@riacs.edu (David Christopher Rogers) writes:
>
>To compare AZT, needed by people for their LIVES, with the yuppie pleasure
>drug cocaine is a callous trivialization of an issue vital to HIV+ people.
>AZT is not a "discretionary" purchase for "disposable" income.  People 
>will DIE if they cannot afford it.  
>
>David Christopher Rogers

(Cocaine? Yuppie pleasure drug??? Where have you been?)

The sad truth is that they are going to DIE anyway (capitals emulating your
own).  Frankly, I am surprised none of the conspiracy-minded have concluded
that the FDA and B-W are in cahouts because the FDA allows the sale of a drug
that does very little, if anything to help these poor people--we always
come down hard on the con-artists selling "miricle cures" to those dying of
cancer.  Now obviously, FDA was trying to placate the demonstrators insisting
that AZT be cleared for use and was not doing B-W's bidding--but then, I
am not conspiracy minded.
But, I still wonder why others have not accused B-W of preying on people's
fear of dying and selling them a virtually useless product to make a profit.

-tony

rjw@PacBell.COM (Rod Williams) (09/20/89)

>You probably know now that today B-W lowered the price of AZT from
>roughly $1.50/capsule to $1.20.

In today's (9/19) New York Times, the article reporting this also
includes :

    Robert Uhl, a pharmaceutical analyst with Salomon Brothers in
    New York said he believes the company [Burroughs-Wellcome] has
    already recovered its initial investment in the drug, which 
    has been estimated at $80 million to $180 million.  Estimates
    of the company's annual profit from the drug now range from
    $25 million to $100 million per year, depending on how they
    are calculated.

    Estimates of the cost of producing the $1.20 capsule, aside
    from research and development, range from 7 to 15 cents per
    capsule, by Dr. Mathilde Krim of the American Foundation for
    AIDS Research, to 33 to 53 cents, by industry analysts.

The article also says that people with 'advanced cases of AIDS' need
12 capsules per day, while asymptomatic HIV+ people generally take 5
capsules per day.  More than 20,000 people worldwide are currently
taking AZT.  That's expected to rise to 100,000 as a result of the
recent studies showing its effectiveness in delaying the onset of
the disease in asymptomatic HIV+ people, with perhaps 'several
hundred thousand more' eligible to take it.
-- 
Rod Williams                       * * * * * * * * * * * * * * * * * * * * *
Bellcore                           *    Don't hang about in the closet -   *
Piscataway, New Jersey             *    Wear yourself out!                 *

coren@speed (Robert Coren) (09/20/89)

From article <11815@boulder.Colorado.EDU>, by pell@boulder.Colorado.EDU (Anthony Pelletier):
> Frankly, I am surprised none of the conspiracy-minded have concluded
> that the FDA and B-W are in cahouts because the FDA allows the sale of a drug
> that does very little, if anything to help these poor people--we always
> come down hard on the con-artists selling "miricle cures" to those dying of
> cancer.  Now obviously, FDA was trying to placate the demonstrators insisting
> that AZT be cleared for use and was not doing B-W's bidding--but then, I
> am not conspiracy minded.
> But, I still wonder why others have not accused B-W of preying on people's
> fear of dying and selling them a virtually useless product to make a profit.
> 

I was wondering about this, myself. The _New York Native_ has had a
number of articles expressing the view that AZT is useless or worse,
and that the original studies "proving" its effectiveness were flawed,
and that isn't it curious that the data from the latest studies
showing its efficacy to be even greater thatn supposed haven't been
made available. Some of this stuff, particularly the articles by John
Lauritsen, read pretty convincingly. It's all tied up with the
_Native_'s insistence that HIV as the sole cause of AIDS is far from
proven -- an idea that is finally beginning to make its way into other
publications.

On the other hand, it also gets tied up with a certain level of
polemical conspiracy-theorizing that makes it sometimes hard to take
any of it seriously. I have been sufficiently influenced by what I've
read there to cringe inwardly whenever I read or hear of the provision
of AZT to an ever-increasing segment of the population as a high (or
even sometimes the only) priority in AIDS work. On the other hand,
there was the survey in this newsgroup recently (which I'm too lazy to
go look for) which quoted responses from several individuals who
claimed to have been helped by AZT. Of course, anecdotal evidence is
not considered conclusive one way or the other. But I was a little
surprised at the complete lack (until Tony's post) of questioning the
efficacy/safety/advisability of AZT.

I think there's a tendency to forget what the "ID" in "AIDS" stands
for. It isn't "the virus" (if there is indeed such a thing) that kills
you; it's the things that get you because your immune system isn't
functioning. Does AZT do anything directly for the immune system?
	Robert

eesnyder@ncar.UCAR.EDU (Eric E. Snyder) (09/20/89)

In article <929@paperboy.OSF.ORG> coren@osf.org writes:
>
>I think there's a tendency to forget what the "ID" in "AIDS" stands
>for. It isn't "the virus" (if there is indeed such a thing) that kills
>you; it's the things that get you because your immune system isn't
>functioning. Does AZT do anything directly for the immune system?

Think about it.  The reason "your" immune system is not functioning is 
because there are all these little HIVs reproducing in your precious little
CD4+ lymphocytes and killing a great many of them in the process.  AZT
stops viral reproduction by interfering with RNA-dependent DNA polymerase
(AKA reverse transcrpitase) a la di-deoxy sequening. Although the HIV pro-
virus can very well be lurking in stem cells, stop it replicating and
T4 lymphs should start coming back.... unless you are really in a bad way.

---------------------------------------------------------------------------
TTGATTGCTAAACACTGGGCGGCGAATCAGGGTTGGGATCTGAACAAAGACGGTCAGATTCAGTTCGTACTGCTG
Eric E. Snyder                             I love this mansion,
Department of Biochemistry                 'though it's too many windows
University of Colorado, Boulder            to open half-way each morning
Boulder, Colorado 80309                    to close half-way each night.
LeuIleAlaLysHisTrpAlaAlaAsnGlnGlyTrpAspLeuAsnLysAspGlyGlnIleGlnPheValLeuLeu
---------------------------------------------------------------------------

dyer@spdcc.COM (Steve Dyer) (09/20/89)

Pelletier should know better than to make such an irresponsible statement
as he has, but he's just another controversialist who would prefer to drop
a bomb into the middle of a group of people who don't necessarily have the
background to give his comment (along with the _Native's_ ravings) the
isolation it deserves.  He'd sing another tune about AZT's uselessness
were he HIV+ and exhibiting early symptoms of AIDS or ARC.


-- 
Steve Dyer
dyer@ursa-major.spdcc.com aka {ima,harvard,rayssd,linus,m2c}!spdcc!dyer
dyer@arktouros.mit.edu, dyer@hstbme.mit.edu

pell@boulder.Colorado.EDU (Anthony Pelletier) (09/21/89)

In article <4620@ursa-major.SPDCC.COM> dyer@ursa-major.spdcc.COM (Steve Dyer) writes:
>Pelletier should know better than to make such an irresponsible statement
>as he has, but he's just another controversialist who would prefer to drop
>a bomb into the middle of a group of people who don't necessarily have the
>background to give his comment (along with the _Native's_ ravings) the
>isolation it deserves.  He'd sing another tune about AZT's uselessness
>were he HIV+ and exhibiting early symptoms of AIDS or ARC.
>

Sorry to offend you steve. 
Remember i did not say I subscribed to conspiracy theories and there
are alot of polemics, as was pointed out.
I merely wondered why more was not made of it.  I guess I could
be said to be dropping a bomb.  But I think you are underestimating
the audience here if you think they could not tell that I was not
propogating the controversy, just asking about it.  I also did not
bring in the "Native's" ravings.  Someone else did.

I think, at best, the efficacy of AZT is debatable.  It may
prolong life, it may not.  The controlled studies to test it are not
going to be done (who wants to be in the control group?).  Its in vitro
effect on the the replication of the virus certainly is not in doubt (nor
is even this effect 100%) and the biological basis of the effect is
well understood.
What is in doubt is how effective preventing RT-mediated replication will
be in preventing the devastating effects of the disease.  You should
know this.  Its means of spreading once established is not understood,
nor is its means of killing more cells than it appears to infect (perhaps
fusing them, but it is not clear).  It need not use RT to do this.

As for me singing a different tune if I had the disease:  It is interesting
that a couple of people have pointed that out.  Personally, I would not wish
that on anyone in anger like that.  I might want to try AZT or some other
experimental drug.  I am, by profession, an experimentalist.  I might
try it out of professional curiosity.  I don't know how I would react.
     And if I don't know, certainly you don't.
     ---------------------------------------

Whether the virus is the causative agent of the disease or not is debated
by some, but I think the evidence for its role is pretty conclusive.
The arguments I have read for the other side seem poorly founded.  But,
I would be open to hearing some of the ones people think are good.
I don't think the one issue has to be related to the other--whether or
not HIV is the cause, the efficacy of AZT can be debated.

All I meant was that, sociologically, I find it interesting.
We have learned to live with cancer, as a culture.  If someone has
in-operable cancer and several doctors tell him he will die, we feel sorry
about it, but accept it.  We accept that medical science is doing its best.
If he goes to spend his money and little remaining time in Mexico at
a clinic that says they can help, we see the doctors there as quacks
and con-men taking money from a dying man.

AIDS is different.  Many people see medical science and the pharmacutical
industry as an advisary--or at best, an untrustworthy ally with whom one
deals out of desperation.  When science says "there is nothing more we can
do" they are accused of holding back.  People offering the latest "cure" are
saviors rather than quacks.  I'm not sure I know why this is true.
I was curious about it.  Sorry if I offended some.

-tony

dyer@spdcc.COM (Steve Dyer) (09/21/89)

In article <11864@boulder.Colorado.EDU> pell@boulder.Colorado.EDU (Anthony Pelletier) writes:
>I think, at best, the efficacy of AZT is debatable.  It may
>prolong life, it may not.  The controlled studies to test it are not
>going to be done (who wants to be in the control group?)

The original studies of AZT's efficacy in patients with advanced AIDS
used control groups, as did the more recent studies which looked at
the effect of AZT on delaying the onset of ARC and AIDS in HIV+
asymptomatic subjects.  The studies were terminated early because
the trends were unmistakably clear.  I don't understand what feeds
your pessimism, which is certainly not in the medical mainstream
of opinion.

>What is in doubt is how effective preventing RT-mediated replication will
>be in preventing the devastating effects of the disease.  You should
>know this.  Its means of spreading once established is not understood,
>nor is its means of killing more cells than it appears to infect (perhaps
>fusing them, but it is not clear).  It need not use RT to do this.

No one could make a claim that anti-RT-therapy with AZT is the end-all
of AIDS therapy.  To use your cancer analogy, AZT right now is just a
palliative.  That it appears to prolong life is pretty much unarguable.
It does not cure or arrest the disease.  Still, if a drug can add several
years of useful life to someone with an otherwise incurable illness, it
is usually thought to be a good thing.  If we threw out all drugs used
in cancer chemotherapy which did not cure the disease but only served
to keep a person more comfortable, or alive for a few more months or
years, we'd have very little to work with (patients OR drugs.)

>As for me singing a different tune if I had the disease:  It is interesting
>that a couple of people have pointed that out.  Personally, I would not wish
>that on anyone in anger like that.

I would hope that my comment would not be taken as wishing AIDS on anyone.

-- 
Steve Dyer
dyer@ursa-major.spdcc.com aka {ima,harvard,rayssd,linus,m2c}!spdcc!dyer
dyer@arktouros.mit.edu, dyer@hstbme.mit.edu

tidswell@endor.harvard.edu (Ian Tidswell) (09/21/89)

From 0 to 2 postings in 1/2 hour.  Whatever next?

I was meaning to post this a couple of days ago when the issue was
really hot, but it took me until now to give up trying to send stuff 
from the system I use most of the time, and resort to the machine where 
the administrators know what they are doing.  Still, it seems like 
the discussion might benifit from the information.

Heres some info I remember about Burroughs-Wellcome from reading an 
article in The Guardian (a national daily in the UK) a week or so ago.
My already failing mind may have some of the details wrong.

75% of B-W stock is owned by the B-W Foundation, a UK based NON-PROFIT 
organization dedicated to medical research and education.  The remaining
25% of stock is traded on the London Stock Exchange.  The article I read 
was in the business section, and seemed to suggest good times ahead for
B-W and its stockholders (not too surprising) and the B-W might sell 
up to another 15% of stock to cash in on its high share price and improve 
the financial security of the Foundation.  They did not spend any time 
saying what exactly the Foundation does.

This seems to change the equation of the discussion somewhat.  What 
the B-W Foundation is doing with the money raised from AZT sales, I 
don't know, but if it ALL goes toward AIDS research and education, 
then maybe they are not the slimes that has been suggested here.  Anyway, 
they just reduced the price 20%.

---
Ian Tidswell (ian@xray.harvard.edu)

mmm@cup.portal.com (Mark Robert Thorson) (09/23/89)

Could someone present an overview of the production process for AZT?
I seem to recall seeing a description somewhere.  I believe it starts
with some strange raw material, codfish semen or something, and has many
steps.  Is it something that could be done on a bootleg basis?

werner@aecom.yu.edu (Craig Werner) (09/24/89)

> Could someone present an overview of the production process for AZT?
> I seem to recall seeing a description somewhere.  I believe it starts
> with some strange raw material, codfish semen or something, and has many
> steps.  Is it something that could be done on a bootleg basis?

	The starting material for AZT is DNA.  The cheapest way to get
DNA in large quantities of DNA is fish sperm, usually salmon or herring.
You hydrolyze the DNA, separating the 4 nucleotide-5'-monophosphates that
result, then you collect the Thymidine-5'-monophosphate (TMP), substitute
the 3'OH for a 3' N3 (azido) group, and dephosphorylate it.
	From a rough calculation, in this very group, several years ago I
computed that the cost to make it on a small scale, comes very close to
the price that they are selling it for (i.e., it would be very hard to
make it on a small scale for much less than $10/gram, and it would
probably cost closer to $20.  Bouroughs-Welcome now sells it for $12/gram.
My comment is that they are much better organic chemists than I initially
gave them credit for.
	However, what really makes AZT seem so expensive is the fact that
the yearly dosage approaches 3000 pills.  3000 times any per dose cost is
going to add up to a lot of money.

-- 
	        Craig Werner   (future MD/PhD, 4.5 years down, 2.5 to go)
	     werner@aecom.YU.EDU -- Albert Einstein College of Medicine
              (1935-14E Eastchester Rd., Bronx NY 10461, 212-931-2517)
"Comedy, like Medicine, was never meant to be practiced by the general public."

rmadison@euler.Berkeley.EDU (Linc Madison) (09/24/89)

In article <22423@cup.portal.com> mmm@cup.portal.com (Mark Robert Thorson) writes:
>Could someone present an overview of the production process for AZT?
>I seem to recall seeing a description somewhere.  I believe it starts
>with some strange raw material, codfish semen or something, ...

No, no, no.  That's *CODPIECE* semen...    ;->

-- Linc Madison     rmadison@euler.berkeley.edu   {uunet,sun}!euler!rmadison
"Do not adjust your mind; it is reality that is malfunctioning."