Repost Message #10875: Over Dose: The Case Against the Drug Companies

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Gettingwell , Frank <califpacific> wrote:

 

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Over Dose: The Case Against the Drug Companies

By Jay Cohen, M.D.

 

 

Part 1 of 2. Chapter 1: The Race To the Bottom.

 

Over Dose: The Case Against the Drug Companies: Prescription Drugs,

Side Effects, and Your Health.

 

I was in my recliner, headset on, writing this book when the

telephone rang.

 

" Dr. Cohen, my name is Alex. I'm sorry to bother you, but I need to

speak to you about problems I'm having with my medication. "

 

I don't get many calls. After twenty years in practice, I've been

disabled for ten. I have no office or funding for my research, so I

work at home. My telephone number is unlisted. Alex, a young man from

the other end of the country, had obviously gone to considerable

trouble to find me.

 

" I'm taking Prozac for panic attacks and depression, " Alex told

me. " I was nearly housebound by agoraphobia once. I was okay for

three years, but things got stressful at work and the problems

returned. "

 

" Prozac is a reasonable choice for your disorder, " I said. " What's

the problem? "

 

" I've gotten much worse since starting the drug. I get terribly

agitated now, and my heart pounds and I can't sleep. I get so shaky

sometimes, I'm afraid to go out. I'm withdrawing And depressed again.

I think the Prozac is making me worse. "

 

" What do your doctors say? "

 

" They say that the side effects from the Prozac -- the insomnia and

palpitations -- show that it is working, and that I should wait it

out. "

 

I sighed quietly. This was awful advice, but not unusual. Although I

already knew the answer, I asked, " What dose of Prozac are you

taking? "

 

" Twenty milligrams a day. "

 

Twenty mg - that's what Lilly and Company, Prozac's manufacturer,

recommends initially for otherwise healthy people ages eighteen to

sixty-five, and that's what physicians prescribe. Unfortunately,

neither Alex nor his physicians knew that early research had already

shown that doses one half or even one quarter Lilly's recommended

amount are all that some patients need.

 

Anything greater commonly causes side effects including agitation,

insomnia, rapid heart rate, and consequent depression and social

withdrawal. These are signs that Alex was being over-dosed.

 

Alex isn't alone. In 1998 an extensive study published in the Journal

of the American Medical Association (JAMA) showed that 106,000 people

die annually in American hospitals from medication side effects.

 

Medication reactions are the fourth leading cause of death in the

United States, dwarfing the number of deaths caused by automobile

accidents, AIDS, alcohol and illicit drug abuse, infectious diseases,

diabetes, and murder. In addition to the medication-related deaths,

the JAMA study also tallied 2,216,000 severe medication reactions in

U.S. hospitals annually.

 

Because of the especially rigorous methods the researchers applied,

even these numbers may not present the full picture. The authors

defined serious side effects narrowly, including only clear cut

reactions causing permanent disability, hospitalisation, or death.

Thus, they excluded side effects that disable people for weeks or

months, side effects such as dizziness or sedation that cause

automobile accidents or falls and broken limbs, side effects that

require emergency interventions, and side effects that prolong

hospitalisations or force people to miss work.

 

And the authors didn't even try to count the largest category of all -

side effects occurring in outpatients. Overall, the authors excluded

side effects that occur far more often than the ones they included.

 

Despite omitting so many side effects, the JAMA study still recorded

numbers reaching epidemic proportions. And, as the authors noted,

this side-effect epidemic wasn't new: " The incidence has remained

stable over the last 30 years. "

 

Because it is sometimes difficult to place such statistics in

everyday terms, consider this: 106,000 deaths a year averages out to

nearly 300 deaths a day, every day. In comparison, about 85 people

died from accidents linked to faulty Firestone tires. The Firestone

deaths occurred over a period of several years - medication reactions

kill 300 people every day. Yet, it was the Firestone deaths that

dominated the news for several weeks and drew Congressional hearings.

 

Deaths from all major airline crashes in the United States average

less than 300 annually, but one airplane crash gets more media

attention and governmental scrutiny than the 300 medication-related

deaths that occurred not only the same day as the airline crash, but

also every day before and after for decades.

 

Why has this epidemic of side effects gone unrecognised? Deaths from

medication reactions rarely look any different than natural deaths.

There's no visible wreckage to videotape, no crash sites to horrify

and fascinate viewers. As media people say, " No film, no story. "

 

Medication deaths often occur quietly in hospitals, emergency rooms,

and homes. When medication-related deaths occur, it is often unclear

at first whether the cause was the medication, the illness, or other

factors. In other words, to much of the media, there's nothing sexy

about side effects.

 

Moreover, the public likes to believe that our hospitals and

medications are safe and that our doctors are taking every reasonable

precaution.

 

Facing the failure of a major industry is never comfortable. How many

decades did it take recognize the drunk driving problem? To bring the

dangers of cigarettes to public awareness? To mandate seatbelts in

cars? Maybe with medication side effects it's the same: We'd rather

not know.

 

It might be different if the public received an accurate account of

the scope of the side-effect epidemic. Alex' experience, for example,

may have been severe enough to drive him to contact an unfamiliar

doctor 2,500 miles away, but his case will never be counted in the

side-effect statistics.

 

His doctors didn't recognize Alex' side effects, and even if they

had, they probably wouldn't have reported them to the FDA. " Most

physicians feel that detecting adverse reactions is a professional

obligation, but relatively few actually report such reactions [to the

FDA], " states Goodman and Gilman's The Pharmacological Basis of

Therapeutics, one of medicine's most respected drug references.

 

Dr. Brian Strom, former chairman of the Department of Biostatistics

and Epidemiology at the University of Pennsylvania, told the New York

Times in 1997: " Most doctors don't know the system [for reporting

medication reactions to the FDA] exist. " When speaking to medical

groups, Dr. Strom showed a slide of an FDA Medwatch form and

asked: " How many of you have ever seen that? " Usually, less than a

third raise their hands.

 

Yet, it is from voluntary reports from physicians that side-effect

statistics are derived. Physicians, however, often feel that so-

called minor side effects - the ones that make millions of people

like Alex feel merely miserable or unable to function normally -

aren't worth reporting.

 

Reporting more serious reactions may raise questions about treatment

or lead to lawsuits. Another highly regarded drug reference, Melmon

and Morrelli's Clinical Pharmacology: Basic Principles in

Therapeutics, commented: " Drug-induced complications can mimic and

therefore be attributed to disease-induced problems. When therapy

fails, we [physicians) frequently can attribute the failure to the

disease and escape blame. Probably nowhere else in professional life

are mistakes so easily hidden, even from ourselves. " The result is

that only one in twenty side effects is reported to authorities.

 

Drug companies and medical institutions have their own reasons for

underestimating the full scope of the side-effect epidemic. Dr. David

Bates, an associate professor of medicine at the Harvard Medical

School, wrote in JAMA: " Hospitals have had strong incentives not to

identify too many of these adverse drug events. Reporting large

numbers of adverse events and any serious preventable event brings

intense scrutiny from regulators and the public. Thus, most hospitals

have relied on spontaneous reporting, which only identifies about 1

in 20 adverse reactions and leads to the perception that injuries

from ADRs are less common than they really are. "

 

Even the Food and Drug Administration acknowledges that adverse drug

reactions are grossly underreported. In March, 2000, Dickinson's FDA

Review reported on its interview with Jerry Phillips, associate

director of the Office Of Post-Marketing Drug Risk Assessment at the

FDA: " These reports, however, are generally believed by experts to

grossly understate the actual situation, " Phillips said. " In the

broader area of adverse drug reaction data, the 250,000 reports

received annually probably represent only 5% of the actual reactions

that occur. "

 

A simple extrapolation from these numbers reveals a total of five

million medication reactions each year in the US - and this is still

probably an underestimate.

 

However, one by one, the public is learning about the perniciousness

of the side-effect epidemic. Knowledgeable people have told me that

their elderly parents died not from their illnesses, but from being

prescribed too many too powerful medications. Dozens of websites now

exist where patients can discuss medication reactions that have

caused major reactions or disabilities that their physicians have

ignored.

 

Many physicians dismiss anecdotal reports or cases posted on the

Internet, but scientific discovery often begins with individual

reports of an unrecognised or poorly understood problem. These

reports, especially when hundreds of in-depth, medically credible

descriptions are listed, should be taken seriously, because they

represent another unrecognised aspect of the side-effect epidemic.

 

It might be different if the side-effect epidemic was caused by a few

bad drugs. Every industry produces some lemons. Thus, the FDA has had

to remove ten prescription drugs (plus a vaccine and an anesthetic)

within the last four years. But, as this book will document, the

problem extends well beyond these few. Instead, it involves hundreds

of drugs including top-sellers like Viagra, Premarin, Prozac,

Lipitor, Celebrex, and Motrin.

 

Because the problem is so large and so many drugs are involved, blame

is difficult to assess. In addition, these same drugs help millions

of people, which further obscures the many problems they cause, why

they cause them, and how easily many of these side effects, like

Alex', could be avoided.

 

Consider, for example, one class of medications: women's hormones.

When I was a medical intern in 1971, I treated a young woman with a

blood clot in her lower leg (thrombophlebitis). She required

hospitalisation and bed rest for nearly two weeks. She was lucky:

Hundreds of women like her died each year when such clots broke free

and coursed to their lungs.

 

These clots were caused by birth control pills - pills that in the

1960s and 1970s contained three to eight times more estrogen and

progesterone than actually needed. That's 300 to 800 percent more of

these powerful hormones than today's pills - doses that exposed

millions of women to greatly increased risks of blood clots, strokes,

and death.

 

The death rate from thromboembolism alone was 600 percent higher with

the original high-dose pills. I don't know where my patient is today,

but she probably is now worrying about the increased risks of breast

cancer that have been reported with these high-dose pills. How many

women have been harmed by these excessive doses that were prescribed

in the United States for twenty-eight years? Some data exist, but the

full extent of the damage has never been defined.

 

Perhaps my patient, after entering menopause, received hormone

therapy for hot flashes. If she was prescribed Premarin for hot

flashes at the dosage recommended by its manufacturer, Wyeth-Ayerst,

she might have received double or even quadruple the amount she

actually needed. Wyeth-Ayerst recommended 1.25 mg of Premarin as its

initial dose for hot flashes from 1964 through 1999, long after

medical experts had shown that 0.625 mg and even as little as 0.3 mg

were sufficient for many women.

 

Premarin is perhaps the most prescribed drug ever; in 1999 alone,

women purchased more than 47 million prescriptions in the United

States. Yet even in 2000, after Wyeth-Ayerst finally reduced its

recommended starting dose for hot flashes to 0.625 mg, this amount

remains excessive for some women (20-22). Similarly, the recommended

doses of Premarin for preventing osteoporosis have been unnecessarily

high for many women.

 

Meanwhile, estrogens like Premarin have been linked to increased

rates of breast cancer - and it is likely that the higher the dose of

oestrogen, the greater the risk. Has my patient been affected? How

many thousands of women have been harmed over the years? We'll never

know, and the side-effect statistics will never reflect them.

 

Why weren't lower, safer, effective doses of these hormones, as used

today, developed decades earlier? The technology existed in the 1960s

to determine the lowest, safest doses of these potent drugs. But the

intense, fast-paced competition of the medication marketplace

frequently spurs drug companies to conduct small, brief,

insufficiently extensive studies on the dosages of new drugs -

dosages that will be taken by millions of people.

 

The result is that only belatedly, years or even decades later, do we

discover that lower doses are not only effective, but avoid many side

effects. Of course, by this time, tremendous damage has been done to

people and their families.

 

The story is the same with many drugs - not just obscure drugs, but

many top-selling drugs. The problem encompasses the entire field of

medication therapy, as recognized experts have attested: Carl Peck,

M.D., former director of the FDA's Center for Drug Evaluation and

Research: " There are noteworthy examples in drug development of

failing to get the dose right when a drug is first marketed. "

 

Dr. Raymond Woosley, the chairman of the department of pharmacology

at Georgetown: " The US society has invested in developing wondrous

new pharmacologic therapies but has failed to invest adequately in

their safe use. "

 

Dr. Norman Sussman, editor of Primary Psychiatry: " There are lots of

problems with the current system of drug testing. Often it fails to

detect efficacy and, more often than would be desired, misses

significant side effects. "

 

Dr. Marcia Angell, former editor-in-chief of the New England Journal

of Medicine: " To rely on the drug companies for unbiased evaluations

of their products makes about as much sense as relying on beer

companies to teach us about alcoholism. "

 

The result of these shortcomings? Dr. Thomas J. Moore of Georgetown

University, Dr. Bruce Psaty of the University of Washington, and Dr.

Curt Furberg of Wake Forest University determined that " 51% of

approved drugs have serious adverse effects not detected prior to

approval. "

 

Think about this - more than half of our drugs, after being

deemed " safe " by the FDA and then prescribed to millions of people,

are subsequently detected to have previously unrecognised, medically

serious side-effects. No wonder we have a side-effect epidemic.

 

When the majority of our drugs are approved with serious risks, the

threat isn't small. Forty-six percent of Americans take at least one

prescription drug daily. That's more than 128 million people. Most of

these people are taking medications long-term, so their exposures

aren't brief. Twenty-five percent of Americans take multiple

prescription drugs every day.

 

In 1999, Americans purchased 2,587,575,000 prescriptions - that's

nine prescription drugs (as well as several over-the-counter drugs)

for every person in America.

 

Americans paid $125 billion for these prescriptions - $50 per

prescription on average. One would think that with so much cost and

utilization, medications would be our most carefully manufactured and

safest products. Yet, as Dr. Bates wrote: " Only after drugs leave the

trial setting and are used in sicker patients do their true risks

become apparent. "

 

It doesn't have to be this way. As Dr. Bates also wrote, " Although

some risks are inevitable, they can be significantly reduced " I

agree - side effects can be significantly reduced, but they aren't.

The inadequate methods by which drugs are developed and prescribed

are why.

 

Weary of seeing avoidable side effects affect patient after patient,

I began investigating the origins of this problem. With a background

in general medicine, pain research, general pharmacology and

psychopharmacology, and experience as a staff member at UCLA, UCSD

(the University of California, San Diego), and at the world's largest

naval medical centre at Balboa Hospital in San Diego, I began voicing

my concerns publicly in 1988.

 

First I wrote letters to medical journals and authored health columns

in a local newspaper. Beginning in 1996, I began publishing lengthy

articles describing my findings in respected medical journals such as

the Archives of Internal Medicine, Postgraduate Medicine, Geriatrics,

The Annals of Pharmacotherapy, and Drug Safety.

 

After more than a decade of research conducted without any

influences, I found that the drug companies dominate the entire

process of medication therapy - from early research to ultimate

usage - as few other industries control their products today. Drug

company research and development often serves marketing strategies

more than sound science or patients' safety.

 

The many ways that drug companies accomplish this is discussed in

depth in Chapter 9, but here is a glimpse - derived from numerous

medical journal articles including JAMA, the New England Journal of

Medicine, and Lancet - of the methods that drug companies use in

accomplishing their goals: Drug companies can choose research study

designs that are more likely to produce favourable results rather

than designs that might provide more accurate results.

 

Drug companies can conduct multiple studies on new drugs, and then

select and publish the most favourable ones while suppressing the

rest. Drug company studies can measure a drug's effectiveness in

multiple ways, then select and publish only the best results.

Sometimes these favourable results have little to do with whether the

drugs will help patients.

 

Drug companies hire professional writers to prepare articles

according to company guidelines, using favourable phrases and terms

selected by the companies. Drug companies hire high-profile experts

to place their names on drug company-generated articles, although the

experts have not participated in the studies and their financial

connections with the drug companies are not disclosed.

 

These excesses might be unimportant if drug company research

represented a small portion of all medication research. However, the

drug companies underwrite 70 percent of all medication research

today. This gives the pharmaceutical industry tremendous power over

the entire medication research effort, including the threat of

lawsuits or loss of future funding for physicians wanting to publish

unfavourable findings.

 

More and more, drug companies are requiring researchers to sign

confidential agreements before receiving any funding, giving the

companies the power to suppress findings they don't like.

 

The pharmaceutical industry's ability to amass wealth while hospitals

and medical centres struggle financially has allowed the drug

companies to intrude into the arena of independent academic medicine.

This intrusion is so great that in 2000, Dr. Angell issued an

astonishing article - " Is Academic Medicine for Sale? " - in the New

England Journal of Medicine: Academic medical institutions are

themselves growing increasingly beholden to industry.... Some

academic institutions have entered into partnerships with drug

companies to set up research centres and teaching programs in which

students and faculty members essentially carry out industry

research....

 

When the boundaries between industry and academic medicine become as

blurred as they now are, the business goals of industry influence the

mission of the medical schools in multiple ways… The influences of

the marketplace should not become woven into the fabric of academic

medicine. We need to remember that for-profit businesses are pledged

to increase the value of their investors' stock. That is a very

different goal from the mission of medical schools.

 

Despite the concerns of Dr. Angell and other experts, drastic

reductions in insurance and Medicare payments have placed great

pressure on medical institutions and research physicians to accept

the money - and terms - of the drug companies.

 

At the same time, the drug companies spend billions targeting office

physicians, as well as new interns and residents, with gifts, free

meals, travel subsidies, and subsidized symposia presenting the drug

companies' spin on their medications.

 

Beyond these direct influences, drug companies exert broad influence

over the drug information received by doctors and consumers. The vast

majority of everything physicians and consumers read and know about

medications comes from the drug companies. Medication package

inserts, drug advertising toward physicians and consumers, and the

information in the ubiquitous Physicians' Desk Reference (PDR) come

directly from the drug companies.

 

Where do most doctors turn for medication and dosage information? To

the PDR, to drug company representatives who make the rounds of

doctors' offices, and to advertising in medical journals. Yet, the

medication information offered by these drug company-supported

sources is often biased, incomplete, and sometimes inaccurate.

 

CTM Comment: Dr Cohen's new release is a tremendous document,

itemising the abuses going on in the pharmaceutical industry, which

remain largely unreported. It is a shame that, in his writings, Dr

Cohen falls short of recommending the alternative safety of

bolstering the patient's health with good, no-nonsense nutrition and

similar, non-toxic approaches. Dr Joseph Mercola, in his review of

the above article at www.mercola.com, agrees, and advises the patient

becomes educated on their illness, and tries alternative, proven, non-

drug based approaches before resorting to the chemical option.

 

For more information on this subject, see Health Wars by Phillip Day.

Available at www.credence.org

 

 

 

 

 

 

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