Re: Merck Withdraws Arthritis Drug Vioxx

From: Ilena Rose (ilena_at_san.rr.com)
Date: 09/30/04

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Date: Thu, 30 Sep 2004 10:03:59 -0600

On 30 Sep 2004 08:01:27 -0700, MrPepper11@go.com (MrPepper11) wrote:

>Lesson: The newer the drug - and the more TV commercials - the less
>data they have.

Well said ... take a look at this research:

http://www.cancer-coverup.com/newsletter/print-version/prescription-drug-costs_08-2002.asp

THE RISING TIDE OF PRESCRIPTION DRUG COSTS:
A CORPORATE CON JOB

Over the past half-decade, Americans have reeled under the relentless
assault of ever-higher prescription drug costs. For senior citizens -
who purchase 42% of all prescription drugs - the burden has been
particularly onerous, at times leaving them the untenable choice of
either buying food or medicine. But there is more underlying the
problem than just higher prices. At its core, the problem is
symptomatic of a change in the way medicine is practiced in the United
States - a change that is driven by the greed of multinational
pharmaceutical giants. A change that more and more looks for answers
in the form of a pill. The effects of this change are all too evident
in healthcare cost statistics.

In 2001, retail spending on prescription drugs rose by 17.1%, far
outpacing other categories of healthcare costs. This was the fourth
15%-plus increase in as many years To put this in dollar terms, total
spending on prescription drugs in the United States came to a whopping
$154 billion in 2001, a $22.5 billion increase over the previous year.
This figure is nearly double the $78.9 billion Americans spent on
prescription drugs in 1997, and more than three times the $50.3
billion spent in 1993. Some fear that rising prescription drug costs
may bankrupt the U.S. healthcare system. But solving the problem may
be as complex as the factors that created it.

FACTORS DRIVING SPIRALING PRESCRIPTION DRUG COSTS
There are actually three principle factors underlying the dramatic
increase in prescription drug spending.

The first, and most obvious cause for the increased spending, of
course, are higher prices. The average price of a prescription was
$49.84 in 2001, a 10.1% increase over 2000. By comparison, overall
consumer prices rose just 2.8% for the same period. Between 1999 and
2000, the increase was 9.4%, again far outpacing inflation. But it was
not price alone that caused the huge increase in outlays for
prescription drugs. While the increase in drug prices accounted for
37% of the overall growth of spending on prescription drugs, another
important factor was the kind of drug prescribed.

There has been a marked trend towards prescribing newer, more costly
drugs, driven to no small degree by aggressive pharmaceutical company
marketing. Consumers increasingly are asking their doctors to
prescribe drugs they see advertised, and doctors giving in to pressure
from their patients are complying with their requests. One study found
that roughly 26% of patients visiting their doctors ask about an
advertised drug. The same study found that 81% of the time, the
doctors prescribe the requested medication. The reason this is
important is that newer drugs are more costly than older ones. Indeed,
the average price of a drug approved prior to 1992 was $30.47 in 2000,
whereas the average for drugs approved after 1992 $71.49. This is not
to say that the new formulations are necessarily better - they are
just newer.

In 2001, this "shift" in the nature of drugs prescribed accounted for
24% of the overall increase in outlays. But even these higher prices
were not the most important factor.

Fully 39% of the increase in spending on pharmaceuticals is a result
of more prescriptions being written. In 1985, doctors wrote an average
of 109 prescriptions for every 100 office visits. By 1999, that figure
rose to 146 prescriptions per 100 office visits. The impact of this
trend on the total number of prescriptions written is dramatic.

In 1992, physicians wrote some 1.9 billion prescriptions for various
pharmaceutical products. By 2001 that figure had increased to 3.1
billion a rise of more than 63%. This year the number of prescriptions
written may be double the 1992 level. Indeed, at the current growth
rate, it is expected that total U.S. spending for prescription drugs
will reach $366 billion by the year 2010. That would be more than
double the current level, and more than 4.6 times the amount spent in
1992.

But why are so many more prescriptions being written? Is it a matter
of new medical breakthroughs that permit us to treat previously
incurable diseases? Is some sort of hidden epidemic being treated? Is
the best interest of the patient driving the change?

The answer to all these questions, of course, is a simple no.

What is actually driving increased spending on prescription drugs is
an aggressive, diverse and highly successful campaign by the
multinational pharmaceutical industry to enhance its bottom line. More
important, rather than being in the best interest of patients, it may
actually be causing them harm.

The campaign is taking place across a number of fronts, but the most
insidious may be the manipulation of the so-called "standard of care."

STANDARD OF CARE
In every jurisdiction in America, physicians operate under what are
termed "standards of care." These are guidelines that describe the
appropriate treatment regimens for various medical conditions. The
standards of care are established by specialty medical associations -
the professional organizations certify a doctor's competence to
practice a particular medical specialty and are often based on federal
recommendations. Violations of standards of care are considered
malpractice and open any physician who fails to follow them to both
civil and criminal liability. They therefore are taken very seriously.

The trouble is that most of the panels that establish standards of
care for each specialty are comprised of physicians who have ties to
the pharmaceutical industry. They rely on the industry for research
grants, honoraria, consulting contracts and other substantial
financial benefits. As a result, the influence of "Big Pharma" on
these panels is pervasive. A telling example of how these panels can
manipulate standards of care to benefit their pharmaceutical company
patrons is found in the recent change in standards of care for
managing cholesterol.

CHANGING THE RULES TO BENEFIT THE BOTTOM LINE
In 1993, federal guidelines were established for managing cholesterol.
A key element of these guidelines was the determination that patients
with cholesterol levels above 200 should make dietary and lifestyle
changes to reduce their cholesterol level below that figure. These
included reducing the overall level of fat in their diet to no more
than 30% and reducing the level of saturated fat to no more than 10%.
It also recommended increasing the intake of soluble fats. If a
patient's cholesterol was above 300, the guidelines recommended
placing them on cholesterol-lowering drugs.

Even these guidelines, however, were flawed.

In focusing on the total cholesterol level, the guidelines ignored the
fact that the ratio of LDL, or so-called "bad" cholesterol to HDL, or
"good" cholesterol was the real measure of a healthy cholesterol
level. In fact if the HDL level was too low, even if overall
cholesterol levels were low as well, the patient still faced an
increased risk of heart disease.

Under the 1993 guidelines, 52 million Americans would fall under the
category that required dietary changes and 13 million would require
cholesterol-lowering drugs.

Last year, however, the National Institutes of Health issued
recommendation that the guidelines for management of cholesterol be
revised. The panel recommended changing the dietary guidelines for
patients with elevated cholesterol by reducing the permissible amount
of saturated fat in the diet to 7% while raising the overall
permissible level of fat to 35%. Most important, however, the panel
recommended that cholesterol-lowering drugs be administered to
patients with levels above 200 rather than 300. The impact of this
change was stunning.

Under the new guidelines rather than 13 million Americans being
candidates for cholesterol-lowering drugs, 36 million - three times as
many - would now require drug therapy. The windfall "Big Pharma" will
reap from the change is almost beyond imagining. On average a
prescription for a cholesterol-lowering drug cost $88 in 2001. This
comes to $1,046 per year. That means that if all 23 million candidates
are put on these products, sales will jump by roughly $24.3 billion
annually!

While this may be a blessing for "Big Pharma," it may be a curse for
the patients. Most cholesterol-lowering drugs are from the so-called
"statin" family. Roughly 25% of all individuals taking statin drugs
experience some degree of side effects - many of them serious. Among
the most common are muscle weakness (sometimes quite pronounced) or
cramps and muscle degeneration. But more serious side effects
including liver or kidney failure are also possible. As a result,
individuals on statin drugs are required to take liver function tests
on a regular basis. Moreover, they will have to do so for the rest of
their lives, since as a general rule, once a patient is placed on
cholesterol-lowering drugs, they remain on them forever.
But what if a doctor doesn't want to subject a patient with marginally
high cholesterol levels to the risks statin drugs pose? They really
don't have a choice! The guidelines say drugs are appropriate if the
level is above 200, so at 201 you get medication whether you and your
doctor think you need it or not! If the doctor doesn't write the
prescription, he literally is in danger of losing his license!

It's not just in regard to cholesterol levels that "Big Pharma" and
Big Medicine" have been able to manipulate standards. Think for a
moment about the "obesity epidemic" you hear so much about. According
to the "experts"81% - that's right, 81% of Americans are overweight!
This is up from 58% just a little more than a decade ago. How could
this be? Have we all spent the last ten years pigging out on
McDonald's? Worse, fully one third of us are defined as obese! If you
think something must be wrong - you're right.

The alarms about obesity are based in the notion that four out of five
Americans have a body mass index (BMI) above 25, indicating that they
are overweight. What they don't tell you, however, is that a few years
back, they changed the chart, moving the acceptable body mass to a
lower point. With this one stroke of the pen millions of Americans who
were considered within a healthy weight range were suddenly
overweight! Suddenly they needed special counseling, doctors
supervision and, of course, weight loss drugs like Fen-Phen or now,
Meridian.

The other thing they fail to acknowledge is that BMI is not a reliable
measure of actual body fat. For example, heavily muscled individuals,
such as body builders, have high BMIs because muscle weighs more than
fat. People who are large-boned can also have a higher than average
BMI. Also, genetics play a role. Some people naturally have more body
fat than others, and live perfectly healthy normal lives. This
information of course doesn't sell prescription drugs or other medical
services, so you'll seldom hear it mentioned.

As with cholesterol levels, however, if doctors fail to act to treat
"obese" patients may be violating standards of practice and leaving
themselves open to liability.

But it isn't just licensing boards and regulatory agencies that put
pressure on doctors to write prescriptions. As mentioned earlier, it's
often the patients themselves who pressure doctors in response to the
proliferation of medical advertising.

AN AD BLITZKRIEG
If it seems like every time you turn on the TV you see a new drug ad,
you may be right. Since the FDA first permitted so-called "Direct to
Consumer" or "DTC" advertising by pharmaceutical firms, spending on
ads to push pills has skyrocketed, rising from $1.1 billion in 1997 to
$2.8 billion last year! Of that amount, roughly 60% or almost $1.7
billion was spent on television ads. When you look at some of the most
heavily promoted drugs, the extent of the effort becomes clear.

Take for example, the arthritis painkiller Vioxx.

In 2000, Merck, the manufacturer of Vioxx spent over $161 million to
promote the drug. Compare that figure with some other familiar
products:

Dell Computer spent $160 million to advertise all of its products.
Budweiser spent $146 million to advertise Budweiser beer.
PepsiCo spent $125 million to advertise Pepsi Cola.
Nike spent $78.2 million to advertise its running shoes.
Campbell's Soup spent $58 million to advertise all of its products.
And that's just one drug. Other examples include:

$108 million to advertise Prilosec.
$100 million to advertise Claritin.
$92 million to advertise Paxil.
$91 million to advertise Zocor.
$90 million to advertise Viagra.
$79 million to advertise Celebrex.
$78 million to advertise Flonase.
$67 million to advertise Allegra.
$65 million to advertise Meridia.
In fact, 15 of the 50 most heavily promoted drugs spent more than
Campbell's Soup promoting their product.

What is particularly ironic is that two of the most heavily advertised
drugs, Vioxx and Celebrex are promoted largely on the basis of being
safer than other, older alternatives. A just-released study, however,
suggests that these so-called "Cox-2 Inhibitors" may in fact have more
serious side effects than the drugs they were intended to replace. Yet
DTC ads consumers rely on for their information about Vioxx and
Celebrex continue to tout them as safer.

The failure of Merck and Pharmacia to accurately portray the risks and
benefits of their product in DTC ads should come as no surprise. In
2000 an official of the FDA testified before Congress that between
1997 and 2000, the FDA has issued 45 "notices of violation" and three
warning letters to companies concerning their television ads, and 44
notices of violation and one warning letter concerning print ads. Most
of these letters concerned either overstated claims, or failures to
warn consumers of potential risks. What the FDA official failed to ad
was that nothing was done to punish the offenders - even where they
had repeatedly committed the same offense.

But DTC advertising is only part of the total. Overall, drug companies
spent $15.7 billion on advertising in 2000, twice as much as they
spent on pharmaceutical research. For example:

Merck and Co. allocated 15% of its revenues to advertising and just 6%
to research.
Pfizer allocated 39% to advertising and 15% to research.
Bristol-Myers Squibb allocated 30% to advertising and 11% to research.
Pharmacia Corporation allocated 37% to advertising and 15% to
research.
Abbott Labs allocated 21% to advertising and 10% to research.
American Home products allocated 38% to advertising and 13% to
research.
Eli Lily allocated 30% to advertising and 19% to research.
Schering-Plough allocated 36% to advertising and 14% to research.
Allergan Inc. allocated 42% to advertising and 13% to research.
BEYOND DIRECT TO CONSUMER ADS
But the lion's share of promotional dollars was still focused on
doctors. A survey of 2,068 doctors by the Kaiser family Foundation
found that 61% had received trips, tickets or free meals from
pharmaceutical companies. Fully 92% had received free drug samples.
Another study of physicians in Maryland indicated that 37% had
received some form of compensation from a drug company.

Sometimes, however, there is much more than a free meal involved.

Just-released court documents from a lawsuit allege that sales
representatives of Warner-Lambert participated in a program that paid
physicians to allow them to review patient charts and make
recommendations concerning what medications the patients should
receive. The purpose of the program was to develop so-called "off
label" uses for a drug called Neurotin. Neurotin had been developed
and was approved as a treatment for epilepsy. Warner-Lambert wanted to
increase the market for its product. According to the court documents,
Warner-Lambert sales reps convinced doctors to use Neurotin for
everything from pain to bipolar disorders to attention deficit
disorder in children.

The only trouble was that Neurotin was ineffective as a treatment for
many of these conditions and in some cases could actually make them
worse.

Doctors were paid $350 for each day they allowed the Warner-Lambert
rep into their examination room. They were also hired as consultants,
paid to give speeches or to write journal articles (in some cases just
to put their names on articles that were prepared by ghost writers)
and paid to recruit patients for clinical trials.

Even if the drug wasn't effective for many of the disorders the
physicians were prescribing it to treat, the sales program proved very
effective. In 2000 78% of all prescriptions written for Neurotin were
"off-label." More important, because of the widespread off-label use
sales of the drug were increasing 50% per year. Dr. Jonathan Spom of
NIH told the New York Times " Neurotin is being used like water for
disorders where there is not much evidence that it is effective."

"Big Pharma's" defenders would likely argue that what happened with
Neurotin was an aberration, not likely to be repeated. Unfortunately
this is not the case. For example Takeda Chemical Industries and
Abbott Laboratories joint venture, TAP Pharmaceutical Productions
recently had to pay $875 million to settle civil and criminal charges
stemming from a scheme that defrauded Medicare and Medicaid of
millions of dollars.

The way the scam worked was that TAP sales personnel would give
doctors free samples of its drug, Leuprorelin (known as Lupron in the
U.S.). The TAP personnel would then help the doctors get
reimbursements for the drug's retail cost - even though they had paid
nothing for it. Since each dose costs hundreds of dollars, it proved
highly lucrative for the physicians involved. Of course, once a
patient was started on Lupron with the free sample, they would
generally continue to take the drug generating thousands of dollars in
sales annually for each patient.

Free drugs were not the only inducement TAPS employees offered. They
also provided "educational grants," free trips, free medical equipment
and a host of other gifts. Although in this case, as with Neurotin,
the corruption was eventually discovered, the real question is in how
many instances has it gone undetected?

A FATALLY FLAWED SYSTEM
In the end, the rapid rise in pharmaceutical costs is in actuality a
symptom of a more fundamental problem: the unprecedented control "Big
Pharma" and "Big Medicine" exert over healthcare in the United States.
Their ability to manipulate every aspect of healthcare from research
institutions to regulatory bodies to even the individual doctor's
office is evidence that the system itself is inherently flawed. If
allowed to continue unchecked, what little remaining freedom we have
regarding our health care choices will soon be lost. The time has come
for each of us to stand up and be counted before it is too late.

to top of page

I strongly disagree with your analysis ...

I believe that records will eventually surface that show that Merck
has known or at least ... should have known about these life
threatening risks YEARS AGO ... but that the drug was so profitable
and they had invested so much money already in advertising it as
"safer" ... that they milked the money wagon as long as possible.

Your absurd, Pro Pharma QuackLogic prompted me to look this up quickly
...

Here's an interesting and well researched article on the Industry you
Shill for, Probert.