The CancerCoverUp.com Monthly Newsletter | JANUARY 2004 | WEAPONS OF MASS DESTRU

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The CancerCoverUp.com Monthly Newsletter | JANUARY 2004 |

Volume 4, Issue 1

Fri, 31 Dec 2004 20:45:01 -0800

 

 

http://www.cancercoverup.com/newsletter/01-2005/

 

WEAPONS OF MASS DESTRUCTION

Part One

By Kathleen Deoul

 

 

n the years ahead, America will spend countless of billions of dollars

to protect the public from the threat of weapons of mass destruction -

devices and technologies that can cause tens or even hundreds of

thousands of fatalities. Few would argue that these expenditures are

unneeded. Yet, even as we spend those billions to protect our people

against a threat that has thankfully not materialized, hundreds of

thousands of Americans are killed needlessly each year by something we

take for granted: the contents of our medicine cabinet.

 

In a very real sense, the lethal medicines Big Pharma has passed off

as safe are the true weapons of mass destruction.

 

* If you think this statement is extreme, consider the following

statistics compiled by no less an authority than the Food and Drug

Administration's Center for Drug Evaluation and Research, or CDER:

* 2,216,000 hospital patients suffer serious adverse drug

reactions (ADRs) each year.

* An additional 350,000 nursing home patients that suffer ADRs are

not included in the above statistic.

* Over 100,000 people die from ADRs annually.

* According to the CDER, this makes adverse drug reactions the

fourth leading cause of death, ranking ahead of pulmonary disease,

diabetes, AIDS, pneumonia, accidents and automobile deaths. Only Heart

Disease, Cancer and Stroke (which, it should be noted can be caused by

adverse drug reactions) rank higher.

 

On one level these statistics should come as no surprise.

 

The combination of traditional medicine's " a pill for every ill "

approach and Big Pharma's relentless advertising has made America the

most over-medicated country on earth. Fully 64% of all doctor visits

result in a prescription being written. In fact, according to the

Department of Health and Human Services, in 2001, there were more than

3.1 billion prescriptions written in the United States. That's more

than ten for every person living in the U.S.

 

The Centers for Disease Control and Prevention report that 44% of all

Americans are taking at least one prescription drug and that 16.5% are

taking at least three. For senior citizens, the numbers are even more

stunning. An astounding 94% of all people over the age of 65 are

taking at least ONE prescription drug and 23% are taking at lease

FIVE! Among women over 65, 12%, or almost one in eight are taking TEN

or more prescription drugs!

 

As well as the obvious human consequences, the " pill for every ill "

attitude of organized medicine also carries an enormous economic cost.

 

The CDER estimates that the economic cost of adverse drug reactions to

the U.S. economy comes to $136 billion annually! That is more than the

total costs of cardiovascular or diabetes care! In fact, according to

the CDER, one in five injuries or deaths experienced by hospital

patients each year are the direct result of adverse drug reactions.

 

The danger is greatest for our most vulnerable population, senior

citizens.

 

As noted, 23% of all persons over 65 are taking five or more

prescription drugs. Yet, according to the CDER, the rate of adverse

drug reactions jumps dramatically among patients taking four or more

prescription drugs.

 

And that's not all.

 

Patients who suffer adverse drug reactions are twice as likely to die

as those who do not.

 

So pill-happy doctors are actually putting their elderly patients'

lives at risk!

 

But, you might ask, don't prescription drugs undergo a careful review?

Aren't the potential adverse effects identified before they are put on

the market? According to the CDER, the answer is NO!

 

In a presentation concerning misconceptions about the drug approval

process, the CDER notes that all serious adverse effects are not

identified by the time a drug is release to the market. The reason is

simple: the rigorous testing we all assume takes place simply doesn't

happen.

 

According to the CDER, the average drug is tested on around 1,500

patients prior to its market approval. Although this is sufficient to

identify the relatively common adverse reactions that occur in a large

proportion of patients - 1% or more - it does not begin to approach

the level required to identify other, less common but potentially

fatal reactions that become evident after the drug is widely marketed.

 

The so-called " blockbuster " drugs that Big Pharma covets so greatly

are commonly prescribed to millions or even tens of millions of

patients. As a result, an adverse drug reaction that might only occur

once in every 5,000 cases, could easily escape detection during

clinical trials. But once the drug is given to millions of people, it

can cause hundreds or even thousands of deaths before anyone realizes

that the cause of the fatalities is an adverse reaction to a

particular drug.

 

This problem is further complicated by the lack of an adequate system

for tracking adverse drug events after a pharmaceutical product is

approved.

 

By the FDA's own admission, only between 1% and 10% of adverse drug

reactions are actually reported. As a result, precious time can lapse

before a serious, previously undetected adverse drug reaction is

discovered. What makes this problem even more difficult is the fact

that Drug companies are under no compulsion to conduct reviews of

their drugs after they reach the market to determine if unsuspected

ADRs might be in evidence. Instead, the FDA relies on the catch as

catch can system of adverse drug reports - a system that by its own

admission is painfully inadequate.

 

But, as bad as it is, the inadequacy of the present system is perhaps

the least insidious aspect of the problem.

 

What is most despicable is Big Pharma's callous and corrupt practice

of allowing drugs they know are deadly to remain on the market.

 

The sad truth is that in far too many instances, pharmaceutical

companies simply ignore, or even conceal damaging data regarding ADRs

that have been identified after a drug goes to market in order to

protect their profits. This callous disregard for the public's safety

and well being is a scandal of unprecedented proportions.

 

A few recent examples demonstrate just how deadly this problem can be.

THE DIET DRUG DISASTER

 

In the early-1990s the fitness craze was beginning to sweep an aging

Baby Boom population, urged along by official pronouncements

concerning the American public's growing girth. The market for

aerobics videos, diet shakes and health club memberships exploded. But

many Baby Boomers lacked the time or patience to get in shape. In

fact, only about 18% were actually attempting to diet - a figure that

had remained constant for four decades. The " Me Generation " simply

wasn't interested in or willing to make the effort needed to slim

down. They wanted a quick fix, and for these veterans of the 60s it

would preferably be in the form of a pill. Needless to say, Big Pharma

was only too happy to comply.

 

Of course, diet drugs are nothing new. As early as 1959, the FDA had

approved a drug called Phentermine for use as an appetite suppressant.

In 1973, the Agency approved Fenfluramine to suppress hunger as well.

But in both cases, the FDA's approval of the drugs was for short-term

use - a few weeks at most. No studies to assess their safety when used

for extended periods of time had ever been conducted.

 

But there was another problem with one of the drugs, Fenfluramine - it

caused drowsiness, depression, memory loss and other neuropsychiatric

side effects in people taking it. As a result, it was never widely

prescribed.

 

But once a drug is approved by the FDA, physicians can prescribe it

for any purpose they deem appropriate. It doesn't matter whether that

purpose is the one the drug was actually approved for. The practice of

prescribing drugs for unapproved purposes is termed " off-label " use

because it involves using a drug to treat some problem not indicated

on the FDA approved label. The reason " off-label " use is frowned upon

is that it is not supported by the kind of rigorous testing that

normally takes place during the drug approval process. Rather, more

often than not it is the product of aggressive pharmaceutical

marketing that employs highly questionable company-sponsored research

to tout a particular use. As a result, unforeseen complications can,

and often do arise. Still, despite its controversial nature, the

practice is common - especially where " trendy " conditions that are

receiving widespread publicity are concerned. And in the early 1990s

there was no health issue more " trendy " than weight loss.

 

All that Big Pharma needed to start the Fen-Phen craze was a handle to

hang its hat on, and the University of Rochester was more than happy

to comply.

 

Michael Weintraub, a pharmacologist at the University believed that if

Fenfluramine was combined with a stimulant, Phentermine, the negative

side effects could be eliminated. With support from the National

Institutes of Health, he embarked on a small study (involving 121

individuals) that was conducted over a period of four years. When the

study was published in the Journal of Clinical Pharmacology in 1992,

it was just what Big Pharma had been looking for.

 

Almost by magic, reprints of Wientraub's article flooded doctors'

offices and were sent to medical writers for major publications.

Demand began for the drugs began to rise. But the publicity campaign

really took off in 1995 when the miracle weight loss combination was

the subject of a major article in the woman's magazine Allure. When

the Allure article was reprinted in the world's most widely read

publication, Reader's Digest, the race was on. Between 1992 and 1997,

as a result of prescriptions of Fen-Phen, sales of Phentermine would

increase by 442% and for Fenfluramine by an astounding 6390%!

 

There was, however, a problem. The patent on Fenfluramine was about to

expire, and that meant anyone could take advantage of the burgeoning

weight loss drug market. Just when things looked darkest for Big

Pharma, the French pharmaceutical giant Servier came up with a

solution to the problem: a new form of the Fenfluramine.

 

One of the long-standing complaints about the Fen-Phen combination was

that it caused drowsiness. Servier had removed one of the drug's

components, Levofenfluramine, that researchers believed caused this

side effect. American Home Products, who held the patent on

Fenfluramine, now had something it could take to the FDA as a " new "

drug, Dexfenfluramine, and get its patent renewed.

 

But, there remained one other small problem with the Fen-Phen combination.

 

The International Primary Pulmonary Hypertension Study was about to be

released. Primary pulmonary hypertension is an irreversible disease

that causes the capillaries in the lungs to thicken making it

difficult to breathe. Members of the FDA panel reviewing the drug were

deeply concerned about the implications the conclusions of this new

study had for the safety of Dexfenfluramine.

 

In September of 1995, an FDA Advisory Panel began its review of

Dexfenfluramine and initially rejected it by a vote of 5 to 3, because

the safety evidence on the drug was " not sufficient to warrant

approval. " This was in part due to concern over reports of the

potential for pulmonary problems. However, after an impassioned plea

from two of the panel's members who believed that the public health

risks from obesity far outweighed any marginal dangers from

Dexfenfluramine's potential adverse reactions, the decision was

reconsidered and a recommendation for approval of the new drug was

passed in November of 1995 by a vote of 6 to 5. In April of 1996, the

FDA issued its approval of Dexfenfluramine under the brand name Redux.

 

The response to the introduction of Redux exceeded American Home

Products wildest imaginings. What the company had not taken into

account was the effect the proliferation of HMOs as the dominant form

of health care delivery had on physician incomes. Many were frustrated

and looking for a way to generate revenues that were not subject to

HMO restrictions. Weight loss clinics were an ideal way to do just that!

 

Not leaving anything to chance, American Home Products began a $52

million marketing campaign. Among other things, the company had its

detail men and women visit some 140,000 doctors' offices to make sure

they knew about Redux! They responded by writing 85,000 prescriptions

a week!

 

By June of 1997, fourteen months after the FDA panel had narrowly

approved its use, almost 2.5 million prescriptions for Redux had been

written. In 1996 alone, there were 18 million prescriptions written

for Redux and the older versions of Fen-Phen! Meanwhile, in its first

year of release, Redux and its predecessor Pondimin earned American

Home Products an estimated $300 million! It was on its way to being

the Billion Dollar Blockbuster the company lusted for.

 

The prospect was made even more certain by one finding of the

Weintraub study: the participants' weight loss only continued as long

as they were on the drug. Whenever they stopped taking it, they

started eating again. That meant that they would have to keep taking

it as long as they wanted to stay thin. It would become a

" maintenance " drug, one that a patient took for their whole lives. For

Big Pharma maintenance drugs are the pot of gold at the end of the

rainbow.

 

But while American Home Products marketing executives were rubbing

their hands in glee, storm clouds were gathering on the horizon.

 

The August issue of the New England Journal of Medicine brought the

backslapping at American Home Products to a screeching halt. An

article by Dr. Heidi Connelly of the Mayo Clinic contained devastating

results. " We report 24 cases of unusual valvular disease in patients

taking fenfluramine-phentermine … " it stated. In addition to the cases

of heart valve disease uncovered by Dr. Connelly, another 75 had been

reported to the FDA.

 

But that wasn't all.

 

Reports were also surfacing regarding cases of primary pulmonary

hypertension associated with Fenfluramine and Dexfenfluramine. Yet,

the drug's label only indicated four cases of the fatal disease had

been associated with its use in the United States.

 

The label was correct in so far as it went. But the drugs had not been

in widespread use at the time the warning label language had been

developed - not in widespread use in the United States, that is. It

had, however, been much more widely used in Europe, and there had been

62 cases of primary pulmonary hypertension associated with

Fenfluramine and related compounds reported to Wyeth-Ayerst, now a

subsidiary of American Home Products and the marketer of Redux. Since

the cases occurred in Europe, however, the company was not required to

report them to the FDA - and so they didn't!

 

In one internal memo, a Wyeth lawyer wrote " Not that a flow (stream?

river?) of international serious reports has begun … we've been

talking about reportability of them. " What made Wyeth even more

nervous about the reports was that along with Interneuron, a firm that

was also marketing the drug in the United States, it was in the

process of negotiating the language to be included on the warning

label for Redux. FDA officials wanted to include a so-called " black

box " warning concerning the potential for Redux to cause primary

pulmonary hypertension. According to a deposition in a lawsuit over

harm caused to a patient, Wyeth officials admitted that the company

wanted to " avoid public panic by implementing a black box warning. " In

other words, to Wyeth, profits were more important than people.

 

Indeed, at one point, the negotiators working for Wyeth were commended

for their tenacity in resisting the warning by an executive who

emailed them " The meeting with the FDA yesterday was a tremendous

success. No black box! "

 

Not everyone at the pharmaceutical giant, however, was as complacent

about the problem as their marketing executives. One lawyer warned not

to assert the drug is safe writing " Don't use the word safe or safety

in an unqualified fashion. "

 

Even as Wyeth and Interneuron executives struggled to keep the black

box warning off of the Redux label, though, events were taking on a

life of their own.

 

On July 9, 1997, a nationwide class action lawsuit was filed alleging

that the manufactures and distributors of Fen-Phen " failed to

adequately and appropriately warn physicians and consumers that the

fen-phen drug combination was not approved by the FDA and had not been

tested by appropriate clinical trials. "

 

On July 21, 1997, less than three weeks after the lawsuit was filed,

another 21 cases of heart valve disease linked to Fen-Phen were

confirmed by the FDA. This brought the total number of reported cases

to 45. Given that only 1% to 10% of all adverse drug reactions are

reported, that meant that anywhere from 450 to 4,500 cases had already

occurred!

 

On September 15, 1997, Wyeth-Ayerst Laboratories and Interneuron

announced withdrawal of Redux and its predecessor Pondimin. At that

point the drugs had been linked to at least 123 deaths in the United

States alone. That figure, however, was just the tip of the iceberg.

 

According to the estimate of one FDA official, as many as 140,000

people may have suffered heart damage or other life-threatening

adverse drug reactions from taking the Fen-Phen diet drug but this

estimate may far understate the reality. Over 336,000 claims have been

filed with the $13 billion fund set up by the drugs' makers to

compensate victims to date, but even this may not represent the full

scope of the damage Fen-Phen caused.

 

The Mayo Clinic study and other research have shown that the incidence

of heart valve damage and other serious complications associated with

Fen-Phen may be as high as 30%. If this figure is correct, with

approximately 6 million individuals who were exposed to the drug, the

potential number of life-threatening injuries could be as high as 1.8

MILLION! To put this in perspective, that figure is more than three

times the total number of American soldiers that have died in ALL of

the wars our nation has fought!

 

What is perhaps most outrageous about the Fen-Phen disaster is that it

was unnecessary. The company knew that it could cause serious health

problems and elected to ignore the evidence in the name of profits.

The sort of callous disregard for human life evidenced in this action

strains belief. Even more disturbing, though, is the fact that what

happened in regard to Fen-Phen is not an isolated example of

out-of-control greed. Rather it is business as usual for Big Pharma.

 

Next month Weapons of Mass Destruction, Part Two, will continue to

expose how Big Pharma is filling your medicine chest with products you

believe are innocuous but in fact are deadly.