Posted by JLM on June 12, 2003, at 3:56:27
In reply to Re: Abilify (aripiprazole) cost is PROHIBITIVE!, posted by Rhiannonpa on May 29, 2003, at 10:19:10
> Ok, let me see if I can explain this. I worked for Bristol-Myers Squibb (BMS) prior to this drug being approved. I watched the information going around the company to find out when it would be available. You see amoung other things I am a manic depressive already taking one of BMS's drugs, Serzone, along with Depakote. So I was very interested in this. I left the company before it was approved and went to a differnet Rx company.
>
> Let me see if I can explain some of the cost issues you will not hear Peter Jennings discuss on World News Tonight as to why Rx cost what they do.
>
> In some cases, yes, the NIH "discovers" the compound. HOwever they have little ability to fully develop or research the compound to meet the government standards before approving the drug for human use. Nor does the government have a sales and marketing staff to educate the M.D.'s who will write the Rx.
>
> That is where private industry comes in. Currently I am working in Clinical Oncology for a major Rx company. I am learning a great deal about how the process works.
>
> Did you know that the government regulates what the Rx companys do? Did you know that the gov't has to approve every study on a drug that is done? That the government requires the Rx company to pay all expenses to the Dr.'s and patients including drug during studies? That the gov't REQUIRES Rx companys to hold in person meeting with all dr's and their study teams prior to the study starting? Which means the Rx co. has to pay for transportation, along with hotels, meals etc. for all study investigators involved.
> Did you also know that even if the NIH develops the compound it is up to the Rx compnay to do the work...read: shell out the bucks, to prove the drug actually WORKS and is safe for humans? The Rx company is also the ones that have to write the study platform (a.k.a. Protocol), track and analize the data from the studies, and submit to the FDA (food and drug administration) for approval. Which the FDA and approve, reject for more data, or simply reject.
>
> It is also the Rx companys responsiblity to have highly qualified Drs, and other scientists on staff to monitor the drug through every step from writing the protocol to writing the Final Study Report for the FDA. who as I said, can do anything they want with the data.
>
> Now after spending anywhere between 100 million and 300 million dollars of manpower hours, travel expenses, expert meetings to bring top people in the field from all over the world together to discuss the merits of the drug and how to proceed with studies, etc. And in many cases, taking YEARS to do all of this, the Rx company is LIMITED to how many years they have the right to sell the drug before it goes generic. That's it! If they do not make their money back and make enough to continue to fund other drugs research as well....too bad, the drug is going generic and the gov't gets to decide who will make and market the generic version.
>
> If it patent ends after 7 years the Rx compnay only has 7 years to get its money back. Meanwhile it continues to study the drug to see if it can be used for other disorders, if the current compound can be improved for current disorders, etc.
>
> All of this is federally mandated. MOnitored by the FDA, etc. So while everyone thinks the government is doing so much actually they are the ones, in the name of patient safety, that slows the process down, increases the cost with the safeguards it requires and the mass amount of people that must be involved in each set of the process to get approval.
>
> The world wants the cure for the common cold, cancer and every other thing that plagues mankind, however they seem to think it should be free. Well at least cheap. Not to mention they are looking for someone to blame for what things cost. "oh look at the profits the drug companies make!"
>
> Do you think that EVERY thing you use, wear, drive, or live in someone does not make money on it? Did you know that Rx companies GIVE away large amounts of both money and drug in times of need and to charities? ARe you aware that many of the studies you read about taking place in private colleges and universities are funded by Rx companies.
>
> Why is it in this country it is so very easy to find someone to blame instead of looking at what is really going on? I am sure many of the people on this board see or have seen a therapist. Mine was very determined to break me out of playing the "blame game". You know if something is wrong find someone to blame, they you can feel better cause you can point a finger at someone else. Much easier to do that then to step back and look at what is really going on.
>
> The Government that everyone is waiting for to fix the situation is basicly the one who put all the expensive safeguards in place. They are the ones that require tons of research and study prior to approval and continue to require it for every new indication. Requires more research to keep the patent on the drug.
>
> So the next time you want to rag on the Rx companies for how much something costs or someone close to you is very sick and you want to know why there is no cure, remember ... you don't what to help pay for the research.
>
> Rhiannon
> Wiccan High Priestess, Manic Depressive, & Rx Company Sr. Administrative Assistant, Cancer Drug Studies.
>
>
>
>
>
>
>
> > Hmmmmmm I wonder why Abilify costs so darn much? Its not because the drug companies "invented" Abilify...they didnt invent it. See, all the core medical and pharmaceutical research in the USA usually starts out at a taxpayer funded place called NIH. National Institute of Health does the majority of basic research on new potential drugs and treatments. The pharmaceutical companies then come in, take the good stuff and capitalize on it. They then run clinical trials, perfect it, etc. and then market and sell it. But it shouldnt cost $13 a pill, because the company that makes Abilify didnt actually invent it. Taxpayer funded government research labs invented it.
> >
> > Gee, that makes a lot of sense. You pay all these taxes to our government for basic, core level science research. Then elitist greedy pharmaceutical companies come along and say "hey, that compound looks like it has promise lets pick it up and develop it further." So they do and end up charging YOU, the American taxpayer an arm and a leg for a drug that YOU helped pay for the basic core level research on. How unAmerican.
> >
> > Damn, maybe we need to get rid of our present government and replace it with one that has balls and a backbone for a change.
> >
> > Howdy Dudy.
>
>Why is it then that the breast cancer drug, Tamoxifen, costs 10 TIMES as much in the USA as it does in Canada? Why is that big drug companies are threatening Canadian pharmacies that sells drugs to Americans with pulling their product lines of their shelves? Perhaps to ensure that they continue to have the 'captive audience' that they have here in America?
I don't know about anyone else, but when I read this following article by the TWO former EDITORS IN CHIEF of the New England Journal of Medicine, it really woke me up:
http://www.commercialalert.org/relmanangell.pdf
I'll give you a few choice excerpts. Keep in mind who wrote this GRIN :)
"The rhetoric is stirring, but the
arguments simply do not hold up.
First, research and development
(R&D) constitutes a relatively small part of
the budgets of the large drug companies.
Their marketing and advertising expenditures
are much greater than their investment
in R&D. Furthermore, they make
more in profits than they spend on R&D.
In fact, their profits are consistently much
higher than those of any other American
industry. Prices (which bear little relation
to the costs of developing and manufacturing
a drug) could be lowered substantially
without coming close to threatening the
R&D budgets of drug companies, much
less their economic survival."So much for just 'making their money back' before
the patent expires."Second, the pharmaceutical industry is
not particularly innovative, and it is growing
less so each year. The great majority of
new drugs coming to market these days,
although patented, are not new at all.
They are variations on older drugs already
on the market. These are called ?me-too?
drugs, and they represent attempts to
capitalize on the success of ?blockbuster?
drugs. (Blockbusters are defined here as
drugs with over $500 million in annual
sales.) The few drugs that are truly innovative
have usually been based on taxpayersupported
research done in nonprofit academic
medical centers or at the National
Institutes of Health. In fact, many drugs
now sold by drug companies were licensed
to them by academic medical centers or
small biotechnology companies."Can anyone here say "Nexium" or "Lexapro" ;)
"Far from being a ?research-based industry,?
as it likes to call itself, the pharmaceutical
industry now devotes most of its
resources to functioning as a vast marketing
and advertising enterprise whose
best products were discovered and often
partially developed elsewhere?usually at
public expense. And this industry is hardly
a model of free enterprise. It may be free to
decide which drugs to develop and to set
its own prices, but its lifeblood is government-
granted monopolies?in the form
of patents and FDA-approved exclusive
marketing rights. Drug companies apparently
see no contradiction in manipulating
existing laws and regulations to stave
off competition from generic and foreign
manufacturers and lobbying for even
more governmental protections while at
the same time using free-market rhetoric
to demand less government involvement
in the pricing and the marketing of drugs."Ahhh, can you SMELL the irony? ;) Go ahead, take
a whiff."The suspicion that average R&D costs
per drug are not nearly as high as claimed
is further supported by other data provided
by Public Citizen. If one divides the
industry-supplied estimates of total R&D
expenses by the total number of drugs
entering the market, making appropriate
allowances for the lag time between expenditures
and the date of entrance into
the market, the resulting net out-ofpocket,
after-tax costs would probably be
less than $100 million for each drug that
was approved between 1994 and 2000.
That, admittedly, is only a rough approximation,
but the general conclusion seems
inescapable: that the $802 million estimate
now being promoted by the industry
and its partisans is much too high.""The pharmaceutical industry
justifies its extraordinary profits
largely by the claim that they are
necessary as an incentive to continue its
vital research. The implication is that if
the public wants new cures for diseases, it
should give the industry free rein. It is
important, then, to ask just how innovative
the pharmaceutical industry really
is. We think the answer is not very. Drug
companies greatly exaggerate their role in
the scientific work leading to the discovery
of new drugs. As we have already noted,
the development of important new drugs
is usually the culmination of many discoveries
in basic science laboratories outside
the pharmaceutical industry. This work
increases the understanding of the molecular
basis of disease and thereby identifies
promising targets and models for the design
of new drugs. Most of this groundbreaking
research, done with support
from the National Institutes of Health
(NIH) or other institutions, appears in
scientific journals before the big companies
become involved. The industry is certainly
not the major engine of discovery
and medical progress that it would have
the public believe. Public investment in
research has been primarily responsible
for the great medical advances society is
enjoying, and this is likely to be so in the
future as well.A general idea of the relative contribution
of the pharmaceutical industry to the
underlying medical research that leads
to the development of new drugs can be
gained from a recent study published
in the journal Health Affairs. The study
reported that in 1998 only about 15 percent
of the scientific articles cited in patent
applications for clinical medicine came
from industry research, while 54 percent
came from academic centers, 13 percent
from government, and the rest from various
various
other public and nonprofit institutions.Remember that these are patent
applications for all new drugs and medical
innovations, not simply for those ultimately
judged to be clinically important.
Had the data been limited to only major
breakthrough drugs, the industry?s role
would undoubtedly have looked even
smaller.The relatively small contribution of
industry is also clear from an unpublished
internal document produced by the NIH
in February 2000, which was obtained by
Public Citizen through the Freedom of
Information Act. The NIH had selected
the five top-selling drugs in 1995 (Zantac,
Zovirax, Capoten, Vasotec, and Prozac)
and found that 16 of the 17 key scientific
papers leading to the discovery and development
of these drugs came from outside
the industry. Looking at all the relevant
published research, not just at the key
studies, 85 percent came from American
taxpayer-supported laboratories or foreign
academic laboratories. While it is
true that academic scientists may have
more incentive to publish their research
results than do their colleagues in industry,
these data are persuasive: publicly
funded medical research is by far the
major source of pharmaceutical innovation?
not the industry itself.""That me-too?s have come to dominate
the new drug market is documented very
clearly by the FDA, which classifies drugs
under review by their likely therapeutic
value and by whether they are NMEs or
simply re-formulations and combinations
of old drugs. Over the twelve-year period
beginning in 1990, 1,035 drugs were
approved, and of these only 23 percent
were classified as likely to be a ?significant
improvement? on products already on the
market. (In our own judgment as physicians,
physicians,
even many of these drugs would be
more accurately described as modest, incremental
improvements.) All the others
were classified as appearing to have ?therapeutic
qualities similar to those of one or
more already marketed drugs.? Moreover,
just 15 percent of the approved drugs were
classified as both a significant improvement
and an NME. Last year, the FDA
approved 66 drugs for the entire drug
industry. The agency classified only ten as
a significant improvement, and only seven
of these were NMEs. So the already small
percentage of newly marketed drug products
that are really novel and important
seems to be dropping still further, with
me-too?s becoming the rule. This trend
has continued during the current year."Can anyone here say "Lexapro" or "Nexium" C'mon
say it, I know you want to. Just say it ONE time with me ;) So much for the hype from big pharma about the 'costs of developing life saving new medicines'NME=new molecular entity. IE, something
that is really NEW, ie NOT like Nexium ;)"Industry spokespeople sometimes
justify the growing profusion of
brand-name me-too drugs by arguing
that they increase market competition and
keep prices down. For this reason, they
object to the term ?monopoly? as applied
to the exclusive marketing rights conferred
by patents or FDA approval. But
me-too drugs are not promoted on the
basis of price. Instead, they are marketed
as being especially effective?usually in
total disregard of the facts."Say "Lexapro" yet again. And don't forget to consult Micromedex ;)
"The major difficulty in
launching a me-too blockbuster, however,
is in persuading doctors and patients that
it is better than the others, since the evidence
is at best marginal. Unfortunately,
the FDA will approve a me-too drug on
the basis of clinical trials comparing it not
with an older drug of the same type, but
with a placebo or a drug of another type."So much for the FDA being the 'big meanie' and driving up the costs of drugs. New drugs should
have to go up against older proven drugs, and not just placebo. However, big Pharma almost allways typically avoids comparisons to older products in their published clinical trials. Hrm, I wonder why that is? ;)"Until the past decade, around 80 percent
of clinical trials were conducted on
patients at academic medical centers and
teaching hospitals under the direction of
medical faculty, who usually initiated the
application for support of the trial. Most
of these trials were supported by grants
from a pharmaceutical company to the
academic institution, although some were
funded by the NIH. The design and execution
of the studies and the collection,
interpretation, and reporting of the data
were all the primary responsibility of the
academic team, made up of experts in
the field. They had no financial ties to the
company or to the drug being tested"Can anyone here say 'conflict of interest'? You can? Good, I knew you could.
"If the industry argues that drug prices
necessarily reflect its high costs for R&D,
then what can it say about its much higher
costs for sales promotion? Those who pay
for prescription drugs are paying for marketing,
too. But if the current crop of new
drugs were as valuable as the industry
would like us to believe, and if there were
not so many me-too drugs, surely it would
not be necessary to spend so much money
pushing them. A genuinely important
new drug, such as Gleevec, does not have
to be marketed widely. Cancer doctors
treating patients with CML will know
about this drug and use it. No sales pitch
is needed."That makes total sense. If its something that's really that good, isn't your doctor allready going to know about it? I wonder why it is that the United States is the only major industrialized nation that allows direct to consumer advertising of drugs? Frankly, I'm tired of paying for that Zoloft commerical with the dancing rock ;)
"The largest single piece of the
known drug-marketing budget is
spent on the direct promotion of
drugs to doctors by representatives of drug
firms. (This is called ?detailing.?) There
are some 88,000 sales representatives
throughout the country, who are paid more
than $7 billion per year by the drug companies
to visit doctors in hospitals and offices
to pitch their employers? products. The
number and the ubiquity of these salespeople
have increased greatly over the past few
years. They roam the halls of almost every
sizable hospital in the country seeking
opportunities to talk with the medical staff
and offering gifts (such as books, golf
balls, and tickets to sporting events), drug
samples, and free meals. In many teaching
hospitals, drug representatives regularly
provide lunches for the resident staff in
order to gain their ear. They attend conferences,
they are invited into operating and
procedure rooms, and sometimes they are
even present when physicians examine
patients in clinics or at the bedside."If I ever see a detail man in MY hospital room, he better hope he's wearing a jockstrap that day ;)
"Sales representatives also regularly visit
doctors in their offices, often armed with
information about the doctor?s prescribing
habits obtained from local drugstores.
(There are firms that buy this information
from pharmacies and sell it to drug companies.)"I bet you didn't know that did you? I wonder
how many doctors even know that."Free samples
of drugs for physicians to give to their
patients are a major gift item provided by
representatives of large drug companies.
Industry sources say they spend about $8
billion per year on free samples. These
samples are an effective way to get doctors
and patients committed to the continued
use of the sampled product?usually an
expensive, newly approved drug, with a
long period of exclusivity ahead of it."8 billion eh? I bet they do that out of altruism ;) After all, they couldn't possibly be deriving
any type of financial benefit from it could they? I wonder who pays for that 8 BILLION DOLLARS worth of 'free samples'. Do you think it comes out of any CEO's compensation or stock options? Last year, the CEO for Pfizer got 75 million in compensation and another 75 million in options. Just think of all the new 'me-too drugs' like Nexium that could have been developed with that cash? ;)"About the only organized sector of the
medical profession that seems genuinely
concerned about this issue is the national
organization of medical students, the
American Medical Student Association.
Last spring, this group voted for a total
ban on the acceptance of all drugindustry
gifts and favors to medical students.
It was a brave and laudable gesture,
but its impact on practicing physicians
and their organizations is doubtful.
Recently we attended the annual meeting
of the state medical society of Massachusetts,
where student delegates urged
their elders to pass a similar resolution
that would apply to physicians. It was
decisively defeated in favor of a resolution
that recommended further study of
the issue."At least the youngsters appear to have a pair. There may be hope yet.
"Hatch-waxman has been a
bonanza for the big drug companies.
While it was meant to
stimulate generic competition, it has often
had exactly the opposite effect. Since the
act was passed, brand-name drug companies
routinely file not just one patent on
their drugs, but a series of them spread
throughout the life of the first patent.
These secondary patents are on every
conceivable attribute?never mind usefulness,
novelty, or non-obviousness. The
result is that generic companies are routinely
charged with patent infringement,
which immediately triggers 30 months
of additional exclusivity. When a generic
company challenges a secondary patent,
the brand-name company sometimes
strikes a deal with it that defers entry of the
generic product into the market. Owing to
the six-month exclusivity given to the first
generic company that challenges a patent,
other generic companies are also stopped.
Through such shenanigans, exclusivity can
be prolonged for years.This sort of gaming of the system is not
supposed to be possible. Under the law,
only challenges to certain patents may
trigger the 30-month stay on generic
entry into the market. These are the
patents on approved drugs that companies
list with the FDA in a publication
known as the Orange Book, available on
the FDA website. To be listed in the
Orange Book, patents are supposed to
apply only to the drug itself and the use
for which it was approved. Other patents
related to the drug?such as those for
new dosage forms or uses?are not supposed
to be listed in the Orange Book.But the FDA does not even attempt to
hold drug companies to that restriction.
Instead, drug companies list any patents
they choose, no matter how remote from
the originally approved drug and no
matter how frivolous its use. Sometimes
they list virtually the same patent twice.
And the secondary patents can be listed
at any time, even years after the original
approval. This means that there is
nearly always some patent in effect that
can be used as an excuse for suing
generic companies, thus triggering the
30-month additional exclusivity. By filing
new patents even after the first lawsuit
and then suing for infringement of
them, it is even possible to obtain successive
30-month stays. In the case
of GlaxoSmithKline?s anti-depressant
drug Paxil, five lawsuits against the
same generic company resulted in five
30-month stays, staggered so that, altogether,
GlaxoSmithKline extended its
exclusivity by over five years."So much for the 'evil' FDA. They don't even enforce the Orange Book rules. It makes
me so depressed, that I might need a Paxil CR ;)"In a damning report issued in July
2002, the Federal Trade Commission
(FTC) documented the widespread
anti-competitive activities within the
pharmaceutical industry. And it implicitly
took the FDA to task for failing to
enforce legal restrictions on the listing
of secondary patents in the Orange
Book. The FTC found evidence that
Hatch-Waxman is regularly exploited to
prevent generic competition, and it has
taken antitrust action against several
brand-name and generic drug companies
that colluded to keep generic drugs
off the market."Very capitalist don't you think? ;)
"The companies extend
their exclusivity by using every possible
stratagem simultaneously, so that if one
fails another might work. First, the big
drug companies change their top-selling
drugs in ways that will add three years?
exclusivity, in accord with Hatch-
Waxman. Second, they stagger multiple
secondary patents, which serve as the pretext
for routine lawsuits to trigger a 30-
month extension. Third, nearly every
blockbuster is tested on children to get the
extra six months of patent protection.
That is true whether the drugs are likely to
be used by children or not. Fourth, brandname
companies sometimes collude with
generic companies to delay their entry
into the market. And fifth, when all else
has failed, they can get a new patent on a
trivial variation of their blockbuster and
promote it as an ?improved? version of
the original."Sure, why not test your Alzheimers drugs in children, especially if you get a 6 month extension?
Anyway, I suggest everyone read the article for themselves. It requires the FREE Adobe Acrobat reader from www.adobe.com.
Boy, I sure am GLAD that we have big Pharma out there developing life saving new drugs like Clarinex for us don't you? ;)
poster:JLM
thread:129761
URL: http://www.dr-bob.org/babble/20030609/msgs/233362.html