Over Dose: The Case Against the Drug Companies

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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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