On 29 May 2002, ABC News aired 'Bitter Medicine - Pills,
Profit and the Public Health, 'a special expose' narrated by Peter
Jennings. [Appended further below is a summary of the expose' from ABC
News' web site with several points underscored.]
The expose' focused on the following three points:
1) The enormous profits amassed by public-sector
pharmaceutical industries;
2) The way in which NIH [National Institutes of Health]
- which is funded by tax dollars -contributes materially to
pharmaceutical industry R&D [research and development], and
3) The prevalence of the profit-inducing ruse when
existing drugs are changed in minute ways by pharmaceutical companies
(even by a single molecule in some instances) and introduced to the
public as "revolutionary," "improved" and "new" in order for the
pharmaceutical companies to retain a monopoly on patents (thus,
preventing the drug from being released as a less expensive "generic.")
'Bitter Medicine' did not mention the gruesome, painful
and (often) fatal animal testing which is inherent in pharmaceutical
R&D. However, the Food and Drug Administration [FDA] requires animal
testing for toxicity of all new drugs... even ones changed by a single
molecule.
The innocent and unconsenting animals who are used as
disposable pawns in
pharmaceutical industry profiteering are seemingly unmentionables.
Pitting anti-vivisection activists against NIH has
always seemed comparable to a match between David and Goliath --
likewise for anti-vivisectionists up against the pharmaceutical
industry. To learn that NIH and the pharmaceutical industry work
hand-in-hand is akin to Goliath doubling in size and strength.
GRAB A SLINGSHOT
No doubt, the airing of 'Bitter Medicine' will have
raised public awareness about long-standing flaws in "the system." Many
people are likely asking why it is the case that tax-funded drug
"research" at NIH is directly channeled to pharmaceutical companies. In
essence, the public pays for drugs in advance via obligatory imposed
taxes and then again pays marked-up retail prices to pharmaceutical
companies.
The few attempts to legislate "fairness" in
drug-manufacturing have been smashed by the pharmaceutical industry.
According to the Washington Post, in year 2001 alone, the pharmaceutical
industry spent $75 million on lobbying -- more than any other sector.
According to the Pharmaceutical Law and Policy Report, "Because of the
pharmaceutical industry's lobbying efforts, too many members of Congress
are afraid to directly challenge the industry."
Enough is enough. It is time that Congress take control
of this demon. Please write to your Congressperson and urge her/him to
sponsor legislation to reform the drug industry.
Suggested talking points:
* Congress has an obligation to look out for the
interests of constituents ("the public"), despite the temptation to
succumb to pay-offs by powerful special interest groups such as the
pharmaceutical industry.
* Explain that it is in the best interest for consumers
and animals for Congress to enact legislation which restricts the
ability of drug-manufacturers from introducing variants of existing
drugs merely to bolster their own enormous profits. The public loses by
having to consistently pay high prices for pharmaceutical products and
the animals lose by being subjected to what is the equivalent of
duplicitous "testing." Once the money-making incentive of inundating the
market with secondary drugs (ones in which there is no notable
difference from an existing drug) is reduced, there will be a decrease
in production, thus a decrease in the animal testing which is currently
required for these drugs to be introduced to the market.
Go to
http://www.house.gov/writerep/ to find the contact information for
your U.S. Congressperson.
Summary of 'Bitter Medicine - Pills, Profit and the
Public Health' from
http://abcnews.go.com/onair/ABCNEWSSpecials/pharmaceuticals_020529_pjr_feature.html
Bitter Medicine
Pills, Profit and the Public Health
May 29 � First there was aspirin to treat pain and
inflammation, then came Advil, Aleve, and 40 other similar drugs. By
1999, Celebrex and Vioxx were on the scene, and they now outsell every
other prescription pain reliever on the market. Every year, $4 billion
is spent on Celebrex and Vioxx alone.
"There's never been a study showing that they are more
effective at relieving symptoms of joint pain and inflammation than all
these other medicines that have been available for many, many years and
are much more affordable," said Dr. Matt Handley, a physician with Group
Health Cooperative, a nonprofit managed-care organization in Seattle. On
top of the $532 million spent every year on over-the-counter drugs,
consumers spent $90 billion more on prescription drugs last year than
the $64 billion that was spent just six years ago. And yet, there is
little evidence that the huge increase in spending is dramatically
improving the health of Americans. Are consumers getting their money's
worth?
$802 Million for One New Medicine
Why do prescription drugs cost so much money? According
to a Tufts University study, on average it costs $802 million to bring
one new medicine to market. The high cost of drug development is the
industry's justification for the high price of drugs.
"The $802 million figure is used by pharmaceutical
firms, I believe, to help explain the enormous challenge involved in
bringing a new product to market," said Ken Kaitin, who runs the Tufts
Center for the Study of Drug Development. "These are extraordinary costs
to bring individual products to market."
While it is not possible to look at a breakdown of
research costs � companies aren't required to make this information
public � their profits are public, and the drug industry is the most
profitable industry in the country.
"Their R&D [research and development] costs could be $15
billion, $15 trillion, $15 gazillion, and it wouldn't matter if their
profits are double that," said Dr. Marcia Angell, a former editor of the
New England Journal of Medicine.
The drug industry claims its high profits are necessary
in order to conduct expensive research and development. It spends more
on research than any other industry. [Note: Animal testing is inherent
in this "research."]
The federally funded National Institutes of Health may
be the drug industry's biggest benefactor. This government agency alone
will spend more than $23 billion on research this year. And much of the
research benefits the drug industry.
"There's no other industry in which you have so much
public investment in the fundamental knowledge that enables � the
development of the commercial industry itself," said Dr. Bernadine
Healy, who used to run the NIH.
And how important is this publicly funded research to
the industry? The NIH looked at the five top-selling drugs of 1995 in a
report. It found that "NIH-funded research played a critical role" in
discovering each one of those drugs.
But however much it may actually cost to develop a drug,
which drugs are
consumers getting for their money?
Similar to Existing Drugs
A closer look reveals that much of the profits from
prescription sales are not derived from breakthrough drugs, but rather
from drugs that are similar to already popular medications.
When a drug company submits a drug to the Food and Drug
Administration for
approval, the agency tries to determine how important the drug may be.
And the FDA divides all drugs into two categories: "priority" drugs �
which are believed to be a "significant improvement" over what already
exists, and "standard" drugs � which are similar to what exists.
But, adding up all the drugs approved over the past six
years, 80 percent of all those drugs were deemed by the FDA to be
similar to what already exists. In other words, not a significant
improvement.
"I think the level of innovation that we're seeing from
the pharmaceutical industry is really mixed," said Nancy Chockley, who
runs an institute funded by managed-care organizations. In a new report,
NICHM found the percentage of new, innovative drugs coming from the
pharmaceutical industry is actually decreasing.
"What we found is that over the last 12 years that
there's really been a shift in the type of new drugs being approved by
the FDA," said Chockley. "And we found that most of the growth was
really in drugs that did not show any significant clinical improvement."
Extending the Patent Life
The patent system gives companies an exclusive monopoly
for the length of the patent � meaning they can make huge profits. That
is the incentive drug companies have to continually invent new drugs.
Then, when the patents on those drugs expire, other companies can copy
the drug, make a generic version, and the new competition in the
marketplace lowers the price. The FDA says the generic drugs are just as
good as the original drugs.
That's the way the patent system is supposed to work,
but that is not the way it always works. The drug industry's lawyers and
lobbyists have created or found so many loopholes in the laws that some
generic drugs are often delayed or never get to market.
BuSpar is an anti-anxiety drug manufactured by
Bristol-Myers Squibb. After the company had had a monopoly on the drug
for years, the patent on BuSpar was set to expire on Nov. 21, 2000,
which meant a cheaper generic version was supposed to be approved by the
FDA and available to consumers the next day.
And then, just hours before its patent on BuSpar
expired, Bristol-Myers Squibb got a new patent on what the drug becomes
after you swallow it. And the law is written in such a way that
Bristol-Myers was able to then keep the generic drug off the market,
claiming that it would violate its new patent. There was no innovation
involved � only an innovative legal strategy.
Dr. Carol Ben-Maimon, who has worked in the drug
industry for 15 years and is chairwoman of the Generic Pharmaceutical
Association, believes that Bristol-Myers was in this for profit and not
public health. "I don't think there's any question," she said. "They
didn't do anything to the product to improve it. "
Bristol-Myers was sued by the generic companies, which
claimed that the last-minute patent filed with the FDA should not keep
the generic drug off the market. It took four months for a court to rule
in the generic companies' favor.
"During those four months, Bristol-Myers continued to
have the exclusive right to sell this product on the market, no generic
competition, and I believe this product is about, over a $700
million-a-year revenue product for Bristol-Myers," said Rob Funston, an
attorney for a company that produced the generic version, Watson Labs.
"So during those four months, they made approximately $200 million."
When asked several times to discuss its strategy to extend the patents
on BuSpar and on other drugs, Bristol-Myers refused.
Less Innovation
Many experts believe the industry, in general, is
producing fewer innovative drugs.
"If I'm a manufacturer and I can change one molecule and
get another 20 years of patent rights, and convince physicians to
prescribe and consumers to demand the next form of Prilosec, or weekly
Prozac, instead of daily Prozac, just as my patent expires, then why
would I be spending money on a lot less-certain endeavor, which is
looking for brand-new drugs," said Dr. Sharon Levine, the associate
executive director and a pediatrician for the Kaiser Permanente Medical
Group. She is responsible for assessing the best resources for the
medical group, including helping decide which drugs are used.
But with so many drugs for each of these conditions, how
are consumers supposed to know which drugs are the best? Surprisingly
enough, the FDA says a new drug does not have to be any better than what
already exists. "All you have to be able to prove is that the drug is
better than nothing," said Levine.
The rules by which this hugely profitable industry
operates do not always serve customers adequately. The Federal Trade
Commission is investigating whether drug makers illegally delay generic
competition. Some members of Congress are trying to close the loopholes
in the law to make it easier for generic drugs to become available.
However, the drug industry has enormous influence in
Washington. The pharmaceutical industry has more registered lobbyists
than the number of senators and congressmen combined.
Go on to Through
Opened Eyes (The Activist)
Return to 16 June 2002 Issue
Return to Newsletters
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