Old cheap drugs more effective than new expensive
drugs
Bitter medicine - there is little evidence that the huge increase in
pharmaceutical spending is
dramatically improving the health of Americans
Is US Health Really the Best in the World?
Barbara Starfield, MD, MPH
12,000 deaths/year from unnecessary surgery, 7000 deaths/year from medication
errors in hospitals, 20,000 deaths/year from other errors in hospitals, 80,000
deaths/year from nosocomial infections in hospitals, 106,000 deaths/year from
nonerror, adverse effects of medications. These total to 225,000 deaths per year
from iatrogenic causes. Three caveats should be noted. First, most of the data
are derived from studies in hospitalized patients. Second, these estimates are
for deaths only and do not include adverse effects that are associated with
disability or discomfort. Third, the estimates of death due to error are lower
than those in the IOM report. If the higher estimates are used, the deaths due
to iatrogenic causes would range from 230,000 to 284,000. In any case, 225,000
deaths per year constitutes the third leading cause of death in the United
States, after deaths from heart disease and cancer. http://jama.ama-assn.org/issues/v284n4/full/jco00061.html
"It used to be that drug companies simply gave grants to academic
medical centres for the use of their clinical researchers to do a study and that
was it. It was at arm's length. The researcher did a study and he or she
published the results, whatever those results would be. Now, it's very, very
different. The drug companies increasingly design the studies. They keep the
data. They don't even let the researchers see the data. They analyse the data.
They decide whether they're going to even publish the data at the end of it.
They sign contracts with researchers and with academic medical centres saying
that they don't get to publish their work unless they get permission from the
drug company.ÀÀ So, you can see that the distortion starts even before
publication. ItÀ starts in determining what's going to be published and what
isn't going toÀ be published. This is no longer arm's length. It's treating the
researchers and the academic medical centres as though they were hired guns or
technicians or something. They just do the work. And the drug company will
decide what the data show, what the conclusions are and whether it will even be
published."------Dr Marcia Angell, former editor of the New England Journal
of Medicine http://www.abc.net.au/lateline/s160431.htm
"By the time it was pulled from the market, the FDA had received reports
of 24 deaths of children under age 6 who were given Propulsid. By then the drug
had generated U.S. sales of $2.5 billion for Johnson & Johnson
Co." - LA Times Read
about the "new" FDA."
Did God "bless us" with doctor's as some religious people believe?
And how should we pray for sick loved one's who are hospitalized or under a
doctor's care?
Pray that they will find the truth and seek help outside the mainstream
treatments if you really want these people to recover and live. If we are going
to pray for "the doctors to have wisdom" we need to pray they will be
willing to put their license on the line and treat the patient with something
that really works!! Contrary to some beliefs, God did not give us doctors to
heal and cure us anymore than He gave us auto mechanics to fix our cars!! They
are both technicians trained to do their work, while subject to the same
limitations of educational bias, profit-motive, and obsolete knowledge. The
difference is that a bad mechanic may ruin your car, but an uninformed doctor
can kill you - they are the 3rd leading cause
of death In the US!!
What's the answer to the FDA/AMA Pharma-Cartel's tight grip around the throat
of the medical industry? Give Almighty God complete control of our individual
lives - then, we will begin to know the truth; the truth will set us free; and
we will have His wisdom about our health, etc. It is NOT His will that our lives
be cut short by disease, nor that greedy evil men be allowed to triumph.
STUDY: Old cheap
drugs more effective than new expensive drugs
"It is unlikely, in my opinion, that the pharmaceutical industry is
going to do these kinds of studies of head-to-head comparisons on their
own." - Dr Paul Whelton
Treating hypertension
'Newshour' interview, with Ray Suarez
December 18, 2002
http://www.pbs.org/newshour/bb/health/july-dec02/hypertension.html
A Journal of the American Medical Association study on the treatment of
hypertension revealed that the traditional diuretics are more effective than the
expensive alternatives.
Ray Suarez discusses the study with a professor of epidemiology and medicine at Tulane University.
RAY SUAREZ: Hypertension, or high blood pressure, affects about 50 million
Americans-- one in four of the population-- and can cause stroke, heart failure,
and other serious health problems. For many years, water pills, or diuretics,
were the most common treatment.
But recently, several highly marketed new drugs have increased in popularity.
A study in today's Journal of the American Medical Association compared the
benefits of different drugs with some surprising results.
Dr. Paul Whelton was one of the leaders of the study. He's a professor of
epidemiology and medicine at Tulane University.
Hypertension, or high blood pressure, affects about 50 million Americans --
one in four of the population -- and can cause stroke, heart failure, and other
serious health problems.
Dr. Whelton, what is hypertension?
DR. PAUL WHELTON, Tulane University: Hypertension is high blood pressure.
And as you said, as it goes up, it increases the risk of complications--
stroke, heart failure, kidney failure, and a number of others.
RAY SUAREZ: So there is just excess fluid, pressure on your circulatory
system?
DR. PAUL WHELTON: There is excess pressure on the blood vessels and
eventually that leads to damage of the vessels with clotting or some sometimes
with destruction of the vessels and bleeding as you will see with hemorrhagic
stroke.
RAY SUAREZ: Well, if last week or last month a person in consultation with
their doctor decided to start using drugs as part of their management course for
hypertension, what would they have commonly done?
DR. PAUL WHELTON: Very likely in the very recent past, they would have
received advice on lifestyle change, probably -- getting a good weight, being
physically active; being careful with diet, and so on, but if they were to be
start on a medication, many would be... they probably would have been advised
to start on one of the newer agents. Calcium channel blocker agent or an ace
inhibitor, two of the drugs we tested.
RAY SUAREZ: So what do you find out when looking across the range of commonly
offered medications?
DR. PAUL WHELTON: "Well, we found a very interesting result.
"All of the drugs that we tested - - and as you said, we tested the
diuretic or the fluid pill against the calcium channel blocker and we also
tested it against the ace inhibitor. And what we found out is that the
diuretic seemed to be the best.
"All three of these drugs are known to lower blood pressure, all three
are known to reduce the risk of complications.
"But none... no study had really compared all three head to head
before. And we found that the diuretic certainly was as good with respect to
important outcomes like heart attacks, and better with respect to preventing
stroke and heart failure, very impressive results."
RAY SUAREZ: The other drugs did work, though? I mean, they weren't found to
be ineffective?
DR. PAUL WHELTON: Right. The other drugs are very effective. And, in fact,
although we are recommending diuretics as the first step for drug treatment,
and that is a very appropriate recommendation based on our results many people
will require a second drug. And these two other drugs that we tested are very
appropriate as second drugs.
RAY SUAREZ: Well, as you look at this as a specialist in this field, and you
look back over your shoulder, how do you think it happened that a drug that is
now found to be very effective and very cheap compared to the others ended up
being a treatment in a minority of cases over the years?
DR. PAUL WHELTON: Well, the diuretics have always been known to be very
effective. And we've done lots of trials, but naturally you are looking for
new agents, and thank goodness we have many other agents. As those new ones
came out, for many doctors, and for many researchers, there was the opinion
and the feeling that they would be better than diuretics. In fact, of course,
that is why we did the study. We wanted to know were these newer, drugs which
cost a lot more, seriously better than the diuretic? I would say, you know, in
the 30 years that I've been a doctor and a researcher, this question comes up
every time a doctor treats a patient, and probably every time a patient asks a
doctor for advice. So it's has been a question that has been around for a long
time. Now we've resolved the question.
RAY SUAREZ: But we're not talking about a close call in this case, are we? I
mean, these drugs cost 10 to 20 times as much as a diuretic.
DR. PAUL WHELTON: Yes, the newer drugs clearly are a lot more expensive.
And it seems that for the average person, they can do as well and better with
the cheaper, old friend than with the newer agent. Now, not to say there isn't
a place for these newer drugs, and sometimes you are treating not only high
blood pressure and worrying about its complications, but you are treating
something else as well. For instance, a patient might have angina pectoris or
heart pain. And in that instance, another drug, such as a calcium channel
blocker, would be very appropriate because it not only lowers blood pressure
and the complications of blood pressure, but also is an effective treatment of
angina. So these new drugs do have a place, but I think what we are saying is
for most patients the starting drug ought to be a diuretic, and if they need a
second drug, that is when you add one of those other agents on top.
RAY SUAREZ: Might this be particularly good news to certain high-risk
populations for hypertension, like African Americans, who also have an access
and cost problem when gaining medical care at the same time?
DR. PAUL WHELTON: Yeah, I think this is good news for everyone. It's great
news for African Americans. It's great news for anyone really to get the
answer to the question, "Which is the best drug to start with?" It's
particularly good news for the person who has to pay for their own
medications. It could be the difference between getting treatment for what is
a serious risk factor for cardiovascular complications or having untreated
hypertension with all of the adverse consequences.
RAY SUAREZ: Now if you are one of the millions of Americans currently on a
drug regimen to help manage your hypertension, should you be on the phone in the
morning running down to your doctor or clinic and saying get me on diuretics or
stop taking what you been taking? How do you proceed?
DR. PAUL WHELTON: Well, I think you proceed to see your doctor. And
hypertension is a lifelong problem. It isn't that the consequences occur
overnight, and there may be reasons that the doctor put the patient on that
particular medicine other than to lower their blood pressure. So I think it's
very important that people have the conversation with their health care
provider. And I think in many instances, the health care provider will likely
switch that person to a diuretic, or if they are starting treatment, start
them on a diuretic. But it's not a good idea to change one's own medications.
RAY SUAREZ: And can this help control health care cost inflation, news like
this?
DR. PAUL WHELTON: Well, I think this is important news and this is an
important model for how we can test these questions. It is unlikely, in my
opinion, that the pharmaceutical industry is going to do these kinds of
studies of head-to-head comparisons on their own. Here is an instance where
the National Heart, Lung and Blood Institute, with a lot of help from the
Veterans Administration, from over 600 practitioners around the country and
indeed help from the pharmaceutical industry as well, stepped up to the plate,
did an important study that needed to be done, got an answer and got it at a
relatively low price given the importance of the marketplace, both in terms of
health and indeed the fact that we spend probably about $20 billion a year on
anti-hypertensive drugs. So I think there is a message for other common
treatments where we need to do these kinds of studies.
RAY SUAREZ: Dr. Whelton, thanks a lot.
DR. PAUL WHELTON: My pleasure.
Bitter
Medicine
Pills, Profit and the
Public Health
http://abcnews.go.com/onair/ABCNEWSSpecials/pharmaceuticals_020529_pjr_feature.html
May 29 [2002] — 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 non-profit 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.
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?
New drugs 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.
http://abcnews.go.com/sections/community/DailyNews/chat_pharmaceuticals020530.html
Moderator
Dr. Levine, welcome and thanks for joining us. We'll begin with a question
from Robert E. McLeod:
"Who is looking out for the consumer? Many, if not most physicians
depend on the drug companies for education on new pharmaceuticals. Isn't that
the same as asking the fox to watch the hen house? The drug representatives are
looking for sales. They are trying to make more money — but who is looking out
for the consumer's interest?"
Dr. Sharon Levine
That's absolutely right. Physicians have a need for an independent source of
credible information free from the influence of the drug industry. Drug reps'
jobs are to sell and the federal government needs to sponsor the kind of
research to provide physicians with that independent information.
Moderator
Edio Zampaglione, MD, writes: "The pharmaceutical industry is doing what
just about every business in this country does — trying to make money for
itself and shareholders. If the incentive to make profits is taken away, then it
will be the public who will suffer in the long run when there are no new
breakthrough medications and treatments being developed."
Any comment?
Dr. Sharon Levine
The issue is balance. The need for innovative pharmaceuticals is genuine. But
the incentive needs to be structured so that profit results from true
innovation, not clever marketing or clever lawyers exploiting loopholes in
patent laws.
Consumers today are being asked to pay an exorbitant price for the promise of
innovation in the future. I think the program last night demonstrated very well
that a lot of what is being sold as innovation is really just repackaging of
existing drugs.
Steve Berna asks:
I was interested to know about what you think of the PPI drug class. Do you
find similar evidence that the new class of PPI drugs (Nexium/Prilosec) is not
significantly better than the older drugs (Tagamet)?
Dr. Sharon Levine
The PPI (Proton Pump Inhibitor) represented an innovative drug when it was
introduced to the market. The issue with the PPIs is that they are being vastly
over-prescribed and vastly over-utilized.
This is a drug which has genuine benefits for very specific conditions such
as Peptic Ulcer Disease and GERD. What we see in the marketing and advertising
is that people with heartburn are being encouraged to use the drug, when the
older H2 blokers (Tagamet) would take care of the symptoms and the conditions.
So it's an issue of over-prescribing and over-utilizing an expensive PPI for
many people for whom an established, effective and less expensive H2 blocker
would do.
Moderator
A number of people in our audience say last night's broadcast was off the
mark regarding the benefits of Celebrex and Vioxx compared to the older,
over-the-counter anti-inflammatory drugs.
Amanda Herman writes: "After watching the program, I found it
interesting that about 15 minutes was taken up by bashing Celebrex and not Vioxx.
Why was it not expressed that these new drugs are significantly safer,
especially in the GI tract? Seventeen thousand people die every year from a GI
bleed. Drug companies are producing SAFER drugs for the public to use."
And from Peggy: "I disagree with the doctor who spoke about Ibuprofen
and Aleve giving the same relief effects for osteo arthritis. Having suffered
for over two years with tremendous hip pain, hand pain, and using up to 2400 mg
of ibuprofen and then four Aleve a day, I bless the day my doctor suggested
Vioxx. I feel like a new person."
Can you comment?
Dr. Sharon Levine
Celebrex and Vioxx have a demonstrated modest benefit for patients who are at
high risk for a GI bleed. At most, that represents 4-5 percent of the
population, and it's only a modest benefit. Neither drug eliminates the risk of
a GI bleed completely.
What we see is that 55 percent of all the prescriptions for NSAIDS in this
country today are for Celebrex and Vioxx. So a huge number of people are paying
a very expensive premium for protection against a risk they don't have.
For Peggy: the research does not look at individual results — it looks at
large numbers of people in order to demonstrate that on a statistical basis,
these drugs have a high likelihood of being more effective for pain reduction
and inflammation reduction. Both of these drugs, Celebrex and Vioxx, failed that
test time and again.But that doesn't mean that in an individual situation, it
may not be the best medication for a specific patient. And for Peggy, it may
make sense if it's the only anti-inflammatory that gives her relief.
My point in the broadcast was that for most people, it doesn't do a better
job, and there's tons of research that supports that.
Gerry Grasso says:
What disturbed me most in the broadcast last night was the fact that no one,
not even the medical community, seems to have the objective data needed to
evaluate the value of prescription drugs. Where does a wary buyer go for
information?
Dr. Sharon Levine
There are a number of people who are beginning to take seriously the need for
good, independent pharmaco-economic research that answers the value question.
It's difficult work to do because many times the true value of a drug takes a
decade or so to emerge.
But it's absolutely essential that it be done, and that consumers begin to
ask the value question of their doctors and of their pharmacists, and that is:
Am I getting a dollar's worth of health value for every dollar I spend on these
very expensive drugs. Is there an equally effective generic drug that will treat
my condition?
There really isn't a particularly good source of consumer information
comparing the cost and benefits of similar drugs that do the same thing.
The best thing most patients can do today is ask their doctors to help them
determine what the most cost-effective drug is for their situation and encourage
their physicians to begin to ask the same questions of the pharmaceutical
industry, representatives in the federal government and the FDA. This is an
issue that requires national action.
One good source of information for physicians is the Medical Letter. JAMA and
the British Medical Journal, particularly in the last several years, have
published good articles looking at the relative efficacy and value of
prescription drugs.
J. Coghlan asks:
Is it possible and probable to enact legislation that would effectively close
the loop holes that allow drug companies to re-patent 20-year-old drugs with
only minor alterations and would this press the big drug companies to come up
with more radically beneficial drugs at a faster rate than at present?
Dr. Sharon Levine
I think so. I think the case has been made many times that the way you
structure incentives determines what you get.
It's much cheaper to pay lawyers to preserve patents and much faster than it
is to develop innovative new drugs.
Some of these issues around the patent extension are addressed in a bill that
is pending in Congress — the McCain-Schumer bill. That would be a good
start.f67wes says:
No one mentioned the culpability of the insurance companies in the cost
inflation. Since insurance companies won't pay for over-the-counter drugs, the
doctor feels compelled to prescribe 'something' so that the patient doesn't have
to pay for his/her medications. Often the patient liability is as much or more
than the cost of the over-the-counter drug, but he/she doesn't know it.
Dr. Sharon Levine
Consumers are led to believe that if a prescription is covered by their
insurance company, it is less costly to them than an over-the-counter drug.
The reality is that oftentimes the cost of the over-the-counter drug is less
than the drug co-pay the consumer is paying.
When a physician prescribes and a consumer uses a very expensive drug, when
an inexpensive or generic over-the-counter drug would work, the consumer is
paying for the drug. They're just paying for it in the form of a
rapidly-increasing monthly premium for their health insurance.
Moderator
Finally, from Judith Passmore: "So how do we convince the general
public, especially those who pay for their own prescriptions, that newer (and
more expensive) is not necessarily markedly better?"
Dr. Sharon Levine
Judith has raised the million-dollar question. I think the first step is for
people to ask the question: How do I distinguish "new" from
"improved?"
Clarinex is Claritin in a new package. In fact, when you swallow Claritin,
your body makes Clarinex. When Claritin loses its patent protection later this
year, why would you pay a premium for Clarinex?
When you dissolve Prilosec, you get Nexium in another metabolite. When
Prilosec loses its patent protection, why would you pay a premium for Nexium?
In both cases, the manufacturer is trying to convince consumers that "Nex"
drugs are improved just because they're new.
As consumers and as physicians, our biggest challenge to the pharmaceutical
industry must be: Convince me that this is not just new, but really better.
Your viewers have raised all the right questions and all the right issues.
When physicians and consumers together begin to ask the hard questions,
hopefully we'll get some better answers from industry.
Moderator
Our thanks to Dr. Sharon Levine and all those who joined the live chat.
Moderated by ABCNEWS.com's Saira Stewart
_______________________________________________
XI - Big Pharmaceuticals, Big Money
By Wanda Hamilton - Publication date: August 24, 2001
"The top 10 drug companies are reported to have profits averaging about 30
percent of revenues-a stunning margin. Over the past few years, the
pharmaceutical industry as a whole has been by far the most profitable
industry in the United States." Angell M, "The Pharmaceutical
Industry-To Whom Is It Accountable?" New England Journal of Medicine,
June 22, 2000.
"In every year since 1982, the drug industry has been the most profitable
in the United States, according to Fortune magazine's rankings. During
this time, the drug industry's returns on revenue (profit as a percent of
sales) have averaged about three times the average for all other industries
represented in the Fortune 500." Public Citizen Report, "Rx
R&D Myths: The Case Against the Drug Industry's R&D 'Scare Card,"
July 23, 2001.
"Put together, the market capitalization of the four largest
[pharmaceutical] companies is more than the economy of India." David
Earnshaw, formerly director of European government affairs for SmithKline
Beecham, now leader of Oxfam's campaign on access to medicines. Quoted in
Roger Dobson, "Drug Company lobbyist joins Oxfam's cheap drugs
campaign," BMJ, 322, April 28, 2001, p. 1011.
The international illegal drug cartel no doubt makes a lot of money, but the
risks are very high and include death by multiple gunshot wounds. The big
pharmaceutical companies, on the other hand, make even more money, and the
worst risks they face are such things as lawsuits. Furthermore, instead of
trying to put them out of business, the U.S. government uses tax dollars
to help them develop highly profitable new products.
Just how much money is involved in legal drug sales? According to IMS Health's
Drug Monitor Report, pharmaceutical sales in major world markets were $179
billion for the fiscal year ending March 1998. Of that, U.S. sales
accounted for $68.7 billion. By March 2000, IMS America reported that in the
U.S. alone prescription drug sales had climbed to an astonishing $145
billion, and those monitoring U.S. prescription drug sales expect this
trend to continue
at least for the next nine years. Since 1993, nationwide spending for
prescription drugs has increased at an average annual rate of 12%, while all
other types of health spending increased at an average annual rate of only
5%. The cost of drugs is now outpacing the cost of physician care in the
U.S. and Canada.
"Historically, hospitals have constituted the greatest of Canada's total
health expenditures, followed by the combined cost of all physicians'
services, with drug expenditures in third place. In 1997 drug spending
vaulted into second place, at 14.5% of the total $79 billion spent on
public and private health costs. (Spending on physicians' services represented
14.2% of expenditures; hospitals 32.5%). By 2000, drugs were 15.5% of
total expenditure." Candis McLean, "The Real Drug Pushers,"
Report Newsmagazine.
The enormous growth in drug sales isn't due to a growth in revolutionary new
drugs. According to a new report by Public Citizen, only about 22 percent
of new drugs brought to market in the last 20 years were truly innovative
drugs representing important therapeutic improvements over existing drugs
(Public Citizen report, "Rx R&D Myths: The Case Against The Drug
Industry's R&D 'Scare Card,'" July 23, 2001). According to many
experts, the single biggest factor in
the increase in drug sales can be summed up in one word: Marketing.
Breakthroughs Down, Marketing Up
"Last year, the Food and Drug Administration approved just 27 wholly new
drugs, down from 53 in 1996." Gardiner Harris, "Pitch to
Switch," Wall St. Journal, May 21, 2001, p.1A.
"Overall, the industry's marketing and administration expenses are
generally more than twice those of research and development. At Pfizer,
for instance, marketing and administration make up 39% of expenses,
compared with 17% for R&D.. A Pfizer spokesman says the company 'is
very optimistic about the future' and relies not only on launching new medicines
but increasing the sales of old ones. While that can be done by testing
new uses to old drugs and combining them with other drugs, the best means
is boosting marketing budgets." Gardiner Harris, "Drug Firms,
Stymied in the Lab, Become Marketing Machines," Wall St. Journal,
July 6, 2000, p. A1.
"If one company epitomizes the modern drugs industry it is Pfizer. Just
a decade ago, it was regarded as an industry also-ran. But the US company
has powered its way up the global ranking list to its unassailable
position thanks mainly to its marketing prowess.. While some of Pfizer's
research has been excellent, its success stems largely from its ability to
turn drugs-often ones licensed in from its competitors-into multi-billion
dollar products." David Pilling,
"Pharmaceuticals 2001/Sales & Marketing: Relentless rise in role
of reps and big launches," Financial Times, April 26, 2001.
While they have not run completely dry, the pharmaceutical industry's labs
simply aren't producing many important new medicines. As one industry
spokesman put it, all the low-hanging fruit has already been picked.
Because the big companies' own labs aren't coming through,
they are increasingly relying on licensing new drugs from universities,
government or smaller companies that hold the patents
for them.
Sometimes these licensing agreements are very complex. For example,
Advanced Therapeutic Products (ATP) patented the technology forming
the basis of both the Nicorette and Nicotrol nicotine inhalers.
Pharmacia acquired the production rights for the inhaler from ATP for
a percentage of product payments. Pharmacia, in turn, manufactured
the Nicorette inhaler for SmithKline Beecham and the Nicotrol inhaler
for Johnson & Johnson subsidiary McNeil, and these two companies market the inhalers under their own trademarks.
Many, if not most, of the biggest-selling drugs are actually developed
through government grants to universities or individual researchers.
"According to NIH [National Institutes of Health], taxpayer-funded
scientists conducted
55 percent of the research projects that led to the discovery and
development of the top five selling drugs in 1995." "Rx R&D
Myths:
The Case Against the Drug Industry's R&D 'Scare Card,'" Public
Citizen report, July 23, 2001.
Though it has not yet been clinically tested for FDA approval, the new
orally ingestible nicotine for smoking cessation drugs was developed
by two Duke University researchers with funding by the U.S.
Department of Veterans Affairs. The researchers have already sold
production rights to a small pharmaceutical company. This company in
turn will no doubt sell ingestible nicotine formulations to one or
more of the big pharmaceutical companies, which will fund the clinical trials, get FDA approval, and then market the new cessation
drugs under their own trademarks.
Thus, the taxpayers, not the big pharmaceutical companies, actually
pay for much of the basic research for new drugs entering the market.
"In 1999, the National Institutes of Health (NIH) provided $17.8
billion for research, and the major proportion was expended for basic
research; the top 10 pharmaceutical companies spent $22.7 billion,
primarily on clinical research." DeAngelis CD, "Conflict of
Interest
and the Public Trust," JAMA 284(17), Nov 1, 2000.
"45 of the 50 top-selling drugs from 1992-1997 received government
funding for some phase of development, according to an investigation
by The Boston Globe. In all, taxpayers spent at least $175 million
helping to develop these 50 drugs." "Rx R&D Myths,"
Public Citizen
report, July 23, 2001.
In addition to licensing new drugs to market, the big drug companies
are also focusing on developing "me too" drugs (products almost
identical to drugs already on the market), finding new medical
applications for existing drugs, and marketing "new" formulations of
older drugs. But all of these require little investment in basic
research. In fact, they are more akin to new marketing tools than
anything else, despite the clinical testing that must be conducted
for FDA approval.
"Consider the welter of very similar drugs to lower cholesterol
levels. Developing genuinely innovative drugs is difficult and
chancy. It is easier to make 'me-too' drugs or minor variants of
established products. To be profitable, the variation need only be
sufficient to secure a new patent, and the rest is marketing." Angell
M, "The Pharmaceutical Industry-To Whom Is It Accountable?" New
England Journal of Medicine, June 22, 2000.
Johnson & Johnson's Nicotrol patch is essentially the same as
SmithKline's Nicoderm patch and neither was developed by the
companies marketing them. Glaxo Wellcome's Zyban for smoking
cessation is exactly the same thing as Glaxo Wellcome's older drug
Wellbutrin for depression. GlaxoSmithKline's see-through patch is the
same old wine in a new bottle as is the company's "new"
orange-flavored Nicorette gum.
Direct-to-Consumer Marketing
Since 1997, when the FDA relaxed television and radio advertising
restrictions for prescription drugs, the big pharmaceutical companies
have increasingly turned to direct-to-consumer (DTC) marketing to
increase their profits.
"Last year pharmaceutical companies spent $1.8 bn on 'direct to
consumer' advertising, mostly on television. Advertising expenditure
in 1999 rose by 38.5% from the 1.3 bn spent in 1998, and was 33 times
the amount spent on media advertisements in 1991." Fred Charatan,
"Prescription drug sales boosted by advertising," BMJ, 321, Sept. 30,
2000, p. 783.
And it appears to be working. As the big drug companies have poured
more and more money into DTC television ads, drug spending has risen
enormously, and the bulk of the rise was accounted for by increased
sales of the most heavily advertised prescription drugs.
"Doctors wrote 34.2% more prescriptions in 1999 than in 1998 for the
25 drugs promoted direct to consumers that contributed most to
overall drug spending. Doctors wrote only 5.1% more prescriptions for
all other prescription drugs." Charatan, BMJ, Sept. 30, 2000, p. 783.
However, some physicians and industry watchdog organizations are
becoming increasingly alarmed by the influence of the drug companies'
direct-to-consumer advertising tactics. They point out that not only
do all drugs-especially prescription drugs-have negative side
effects, but that such continual bombardment by drug ads
"normalizes"
taking drugs.
"It's insidious; companies want you to think there's something wrong
with you. It's saying in effect, 'If you've got a problem, the way to
deal with it is through pills.' It's also 'medicalizing' a problem
which may not be a problem you need to deal with, like male pattern
baldness or shyness. Once you have a drug, it becomes a medical
problem." Dr. Joel Lexchin, a Toronto physician and member of Medical
Reform Group. Quoted in Candis McLean, "The real drug pushers,"
Report Newsmagazine, Mar 19, 2001.
In addition to increasing numbers of these highly profitable
"lifestyle" drugs, the pharmaceutical industry has capitalized
on the
current medical focus on prevention by turning out more and more
medications designed to prevent disease, such as drugs to lower
cholesterol and blood pressure levels and a host of new vaccines.
While some of these drugs undoubtedly do help prevent disease for
some people, they are sometimes prescribed when there is not a clear
and compelling need for them (or when industry-friendly
quasi-government panels lower the bar for what is deemed high blood
pressure or high cholesterol).
Even such toxic and costly pharmaceuticals as chemotherapy drugs are
sometimes used without sufficient justification, despite their
serious side-effects.
"Many patients with cancer receive chemotherapy at the end of life,
even if their kind of cancer is known to be unresponsive to the
drugs, according to a study reported at the recent annual meeting of
the American Society of Clinical Oncologists held in San Francisco."
Gottlieb S, "Chemotherapy may be overused at the end of life," BMJ,
322, May 26, 2001, p. 1267. Dr. Ezekiel Emanuel, lead author of the
study, also noted that chemotherapy is very expensive, $38,308 for
treatment of a patient in the final year of life as compared to
$27,567 for a patient not in the final year of life.
While treating cancers known to be unresponsive to chemotherapy with
these drugs may do nothing to help suffering patients, it certainly
benefits the pharmaceutical companies providing the drugs.
The fact is that all drugs, not just chemotherapy drugs, have
potentially serious side effects, and no drug should be prescribed
unless it is truly necessary to the health and well-being of a
patient. Not even if the patient insists on having it because he or
she has seen an upbeat television ad and is convinced that the
advertised wonder drug will cure all of life's pains and anxieties.
Side-effects and Medication Errors
"[P]rescription drugs.account for more deaths each year than all
murders, auto accidents and airplane crashes combined. It is
estimated that 100,000 people die every year from the adverse effects
of prescription drugs, and 1 million are injured so severely they
require hospitalization." Thomas Moore, "Prescription drug risks are
too high," The Miami Herald, April 12, 1998, p. 6L.
"It has been estimated that fatalities directly attributable to
adverse drug reactions are the fourth to sixth leading cause of death
in US hospitals, exceeding deaths caused by pneumonia and diabetes.
The economic burden resulting from drug-related morbidity and
mortality is equally significant and has been conservatively estimated
at $US30 billion dollars annually, and could exceed $US130 billion in
a worst-case scenario." White TJ, Araakelian A, Rho JP,
"Counting the
costs of drug-related adverse events," Pharmacoeconomics, 15(5):
445-58, May 1999.
"David Lawrence, CEO of Kaiser Permanente, the nation's oldest HMO,
calls medication errors 'the number one public health risk in the
United States, ahead of tobacco, alcohol, [illegal] drugs, or guns."
Ted Sandoval, "Cutting Medication Errors Requires Proactive
Steps,"
Web MD, Medcast, June 20, 2000.
All drugs have negative side effects, even aspirin. However,
prescription drugs have far more potentially dangerous side effects
than do over-the-counter medications. Most people who take these
drugs according to their physicians' directions do not experience
serious side effects, but some do. Some people have severe allergic
reactions, some suffer heart attacks or seizures, and some experience
organ damage because of the prescription drugs they take. One of the
most common serious drug problems is liver damage because most
medicines taken by mouth are ultimately processed through the liver.
In addition to the negative side effects induced by individual drugs,
some drugs interact negatively with certain foods or with other
drugs.
Another factor involved in the large number of people killed or made
ill by prescription drugs are medication errors, and the primary
reason for medication errors can be traced to the sheer number of
prescription drugs on the market.
"There are currently more than 17,000 trade and generic names for
drugs in the United States, according to the Institute for Safe
Medication Practices in Huntingdon Valley, Pa. The organization also
estimates that the number of drugs on the U.S. market has grown
500% in the last decade." Braus P, "Want to avoid drug errors? New
software can help," American College of Physicians-American Society
of Internal Medicine Observer, April
2001.
The vast majority of these drugs are not important, breakthrough
medications, but "me-too" drugs, generic versions of name-brand
drugs, new variations of older drugs, and old drugs with new names
for new medical applications. But with so many medications and so
many names for the same medications, it is not surprising that there
are medication errors, including negative drug interactions.
"With so many people on so many pills, small wonder that part of the
increase in healthcare costs is illness caused by drug interactions.
A Queen's University study of seniors' medication released in
January, for example, found that in 96% of cases studied, doctors'
knowledge of their patients' medication use was inaccurate. On
average, the patients had a daily dose of seven medications." Candis
McLean, "The real drug pushers," Report Newsmagazine, March 19,
2001.
Given so many potential hazards-from prescription errors to
life-threatening side effects-it is clear that pharmaceutical
products can kill as well as cure. Nevertheless, most people naïvely
continue to believe that FDA approval means a drug has been thoroughly
tested and is safe for them to use.
Clinical Tests
"Baycol is the 12th prescription drug to have been taken off the U.S.
market because of dangerous side effects since 1997. Some critics
said many of those bans happened because the FDA, under political
pressure, had sped up drug approvals during the 1990s. Baycol was not
a 'fast-track' drug: The agency spent 11 months reviewing it before
approving it in 1997." "Bayer Pharmaceutical's Cholesterol-Lowering
Drug Baycol Linked to Deaths, Pulled Off Market," AP, Aug. 8, 2001.
One of the statin drugs, Baycol destroyed muscle tissue and was
linked to 31 deaths in the U.S. and 9 abroad.
"Rezulin [a diabetes drug] was taken out of pharmacies and off the
market. But by then it was linked to 63 deaths from liver failure."
"FDA: Guardian Or Rubber Stamp?" CBS Evening News, July 12,
2001.
Critics of the FDA point out the agency's close ties to the big drug
companies as one of the problems in the drug approval process. A USA
Today report found that more than half the advisors to the FDA have
"financial relationships" with drug companies that have an
interest
in FDA decisions (De Angelis C, "Conflict of Interest and the Public
Trust," JAMA, Nov 1, 2000). But even if panel members involved in
approving a drug are scrupulously honest, they still depend on data
from that company's clinical trials to approve the drug as safe and
efficacious, and the data can be misleading.
Pharmaceutical companies are well aware of how to manipulate clinical
trials and the resulting data to show their products in the most
favorable light.
"Efforts by drug companies to suppress, spin, and obfuscate findings
that do not suit their commercial purposes were first revealed to
their full, lethal extent during the thalidomide tragedy. Although
government drug regulation schemes around the world are now in place,
the insidious tactics of big pharma have changed little." "The
Tightening Grip of Big Pharmaceutical Companies," Editorial, The
Lancet, April 14, 2001.
For example, a clinical trial might over-select young, healthy
subjects when the drug being tested is intended for use primarily on
older patients.
"Rochon et al. found that only 2.1 percent of subjects in trials of
nonsteroidal anti-inflammatory drugs were 65 years of age or older,
even though these drugs are more commonly used and have a higher incidence of side effects in the elderly." Bodenheimer T,
"Uneasy
Alliance-Clinical Investigators and the Pharmaceutical Industry," New
England Journal of Medicine, 342(20), May 18, 2000.
After FDA approval, it was discovered that Glaxo Wellcome's flu
medication Zanamivir could be dangerous for patients with underlying
respiratory diseases such as asthma or other chronic pulmonary
illness. After some deaths were reported, the FDA issued a warning
and required labeling changes for the drug.
Or in comparison trials, the drug being tested might show that it is
more efficacious than the drug it is being compared with simply
because higher dosages of the new drug were administered. And, since
the data from the trials are generally housed and often analyzed by
the drug companies themselves, unfavorable results can be suppressed
or long-term data showing negative effects might not be presented.
The highly advertised (and expensive) anti-inflammatory drug Celebrex
was hailed by an article in the Journal of the American Medical
Association as vastly superior to existing
(and far less expensive) anti-inflammatory drugs such as aspirin and
Ibuprofen (Motrin and Advil) because it eliminated the problem of
gastric bleeding associated with these drugs. However, researchers at
the Therapeutics Initiative in Canada discovered that the study's
authors had cut the trial data off at six months. The longer-term
results showed that Celebrex was also associated with gastric
bleeding, but that it just took longer for these side effects to
manifest themselves. The FDA had concluded that there were no major
differences between Celebrex and the existing medications, but the
published study in JAMA left out the longer-term data.
"Perhaps even more importantly, the [Therapeutics Initiative] report suggests significant safety concerns. 'Any benefit in serious
gastrointestinal side effects appear to be cancelled by increased
cardiovascular events, including heart attacks, clotting, hypertension
and heart failure,' Dr. Wright [director of TI] declares. Celebrex
may be 'trading off a decreased chance of stomach ache and ulcer for
potentially serious cardiovascular problems.'" Candis McLean,
"The
real drug pushers," Report Newsmagazine, March 19,
2001.
Celebrex is now being clinically tested for lung cancer prevention and
has already been approved by the FDA for use in preventing colon
cancer in patients who are at particularly high risk for the disease
("Celebrex Under Study for Lung Cancer Prevention," ScienceDaily
Magazine, Aug. 8, 2001).
As bad as some of the manipulations of clinical trials and study data
and published clinical reports are, none approach the sheer
immorality of some of the drug companies' clinical trials conducted
in developing countries. Test subjects in developed countries today
are legally protected against abuse, but protective laws in some
poorer countries are more lax and are not as rigidly enforced.
"An investigation into corporate drug experiments in Africa, Asia,
Eastern Europe and Latin America reveals a booming, poorly regulated
system in which experiments involving risky drugs proceed with little
independent oversight, and impoverished, poorly educated patients are
sometimes tested without understanding that they are guinea pigs.
These foreign trials speed new drugs to the marketplace-where they
are often sold mainly to patients in wealthy countries." Joe
Stephens, "Testing drugs: Overseas trials lack oversight: Companies
target patients in poor nations," The Miami Herald, Jan 7, 2001, p.
1L.
"'We're colonizing a region for clinical trials' declared Juan Pablo
Guzman, who has worked on clinical trials in Latin America for Searle
and Pharmacia, at June's annual meeting of the Drug Information
Association in San Diego. 'We have to believe there is gold at the
end of the journey.'" "Latin America is fertile ground for
experiments," The Miami Herald, Jan 7, 2001, p. 3L.
In one such instance, researchers for Pfizer clinically tested what
the company believed to be a promising new antibiotic on Nigerian
children who had fallen victim to the country's meningitis epidemic.
Among the 200 test subjects, 11 died and others suffered
meningitis-related symptoms such as seizures, blindness, deafness, and
lameness. The drug being tested, orally-administered Trovan, had
never been approved or tested for use with children, and chemically
similar drugs had caused joint damage in animal experiments.
According to an article in the Miami Herald, Pfizer's own internal
report showed children did die shortly after taking oral Trovan.
"The experiment's final report concluded that Trovan and the
comparison drug were equally safe and effective." Joe Stephens,
"Testing drugs: Overseas trials lack oversight," The Miami
Herald,
Jan. 7, 2001.
But of course many of the sick and dying in these countries will never
be able to afford treatment with the successful drugs once they are
approved as safe and efficacious by the FDA.
Maintaining the High Cost of Medicines
Increasingly the big multinational drug companies are coming under
fire for doing everything in their power to maintain the high costs
of their products, even when those costs mean that essential drugs
will not be available to the poor (or even to some of our own elderly
who have limited incomes).
"Using big money, creative court challenges and a regulatory system
prone to delays, the nation's leading manufacturers of brand-name
drugs are fighting harder than ever to keep cheaper generic
imitations off the market.. Generic drug makers have at times enriched
themselves by keeping their products off the market, deliberately, in
exchange for payments from patented drug companies." Greg Fields,
"Brand-name drug makers' tactics slow generics," The Miami
Herald,
Aug. 17, 2000, p. A1.
By far, the greatest public outcry over the high cost of drugs came as
a result of the AIDS epidemic in Africa. AIDS drugs, such as those
manufactured by GlaxoSmithKline, are extremely expensive, far too
expensive for them to be used in developing countries where the
disease is truly at epidemic proportions.
"These drugs aren't expensive because of the cost to develop and
manufacture them
(many were actually invented at public universities using grants from
taxpayers). Rather they're expensive because some of the
pharmaceutical giants that market them demand huge profits, estimated
by Brazil's health minister, Jose Sera, at up to 10 times cost, or
1,000 percent." Tom Fiedler, "AIDS fight boils down to dollars vs
lives," Miami Herald editorial, June 24, 2001, p. 5L.
Smaller drug companies in such countries as India and others in
sub-Saharan Africa sought to manufacture affordable versions of the
AIDS drugs for use in their own and other poor countries, but the big
multinationals sued the smaller companies, alleging they were
pirating patented drugs.
GlaxoSmithKline ultimately bowed somewhat to public pressure and
lowered the cost of its antimalarial and newer HIV and AIDS drugs to
developing countries. However, as critics pointed out, even with the
lowered prices of the AIDS drugs, they will still be too expensive
for the huge majority of Africans.
At the same time, the burden of medication expense for many of our own
elderly citizens, who often take multiple medications, means that
they are either doing without essential drugs or are lowering their
use of the medications by deliberately skipping doses (which in some
cases could be more dangerous than not taking the drugs at all).
Medicare does not cover prescription drugs except those administered
in hospital. According to Public Citizen, the big drug companies are
charging these seniors twice as much on average as the companies
charge their most favored customers such as HMOs and the Departments
of Veterans Affairs and Defense. Public Citizen claims that the mark-up for Medicare outpatients for Merck's high cholesterol drug
Zocor is 144%. The organization says that the mark-up for Pharmacia's
diabetes medication Micronase is a whopping 363%, and that Abbot
Laboratories' hormone treatment Synthroid is even worse at an
incredible
1,446%.
The current political solution to this problem of medication cost to
seniors is to have the taxpayers assume the burden for it, but since
the taxpayers have already paid for the basic research to develop
many of these drugs and have even paid for some of the clinical
trials, that seems asking a bit much of the taxpayers. Perhaps a
better solution would be to put pressure on Big Drugs to come up with
a reasonable plan to lower the cost of necessary medications for
seniors-or at least give them the same price breaks they give their
"favored" customers.
There is no question the pharmaceutical industry provides important
and necessary products to improve the health of Americans and save
the lives of those who have infectious and parasitic diseases.
However, the big drug companies' marketing and testing abuses and
their almost unbridled influence on public policy (and government
agencies) are major problems in this country and in the world. It
could be that their control of the practice of medicine and of public
health policy is even more dangerous to the health of society in the
long run than some of their drugs are to the health of individual
consumers.
Suggested Supplemental Reading Online
"The real drug pushers," by Candis McLean, Report Newsmagazine, March
19, 2001. http://193.78.190.200/10a/the%20real%20drug%20pushers.htm
"Rx R&D Myths: The Case Against The Drug Industry's R&D 'Scare
Card,'"
Public Citizen report, July 23, 2001.
http://www.citizen.org/congress/drugs/R&Dscarecard.htm
"The Drug-Induced Lung Diseases," Pneumotox Online.
http://www.pneumotox.com
http://www.forces.org/evidence/pharma/bigpharma.htm
http://www.forces.org/evidence/pharma/bigpharma.htm
