Chelation, biomed belittled - Drug profits infect medical studies

[Guest guest]

Why are chelation and other biomedical treatments continually lambasted

by most medical big-wigs and many (perhaps most) mainstream physicians

and pediatricians? The underlying motive may derive from the fact that

most biomedical treatments do not use a patented pharmaceutical

medication. For instance, GF, CF, and SF can be done without a

prescription. GSE and melatonin can be given w/o a prescription. Sure, a

few treatments require a prescription, but (in biomed autism) most of

those treatments are not too chronic unless absolutely necessary.

" ...over the last 25 years, clinical research has been largely

privatized. Three-quarters of the clinical studies published in the

three most respected medical journals (the New England Journal of

Medicine, the Journal of the American Medical Assn. and the Lancet) are

now commercially funded. As a result, our medical knowledge grows not in

the direction that best improves our health but toward corporate

profits, the way that plants grow toward sunlight. This wasn't always

so. Before 1980, most medical studies were publicly funded, and most

academic researchers scorned industry support. Now, however, the vast

majority of clinical trials are commercially funded, and with the

financial stakes so high, there is mounting evidence of individual

scientists and corporations manipulating their findings. "

This relationship seems to extend to many university diagnostic clinics

wherein ABA will be advocated and biomed belittled (if even mentioned).

Drug profits infect medical studies

By Abramson, a clinical instructor at Harvard Medical School, is

author of " Overdosed America " (Harper, 2004).

He is a consultant to attorneys of patients who took Vioxx and are suing

Merck.

January 7, 2006

http://www.latimes.com/news/opinion/commentary/la-oe-abramson7jan07,0,1957242.st\

ory

SEVERAL OF OUR most venerated scientific journals have recently been

besmirched by allegations of scientific misconduct. Shocking? We should

be just as shocked as Inspector Renault when he discovered gambling at

Rick's Cafe in Casablanca.

First, the New England Journal of Medicine made public its concerns

about crucial data having been withheld from its 2000 report on a study

sponsored by Merck exaggerating the safety of its blockbuster drug

Vioxx, now withdrawn. Then the lead author of a seminal article

published in the journal Science reporting the creation of viable stem

cells from cloned human embryos admitted he falsified results and

resigned his academic post in disgrace.

This week brings the news that a & subsidiary failed to

include the deaths of two patients in a clinical trial of its new drug

for heart failure, Natrecor, in an article published in the Journal of

Emergency Medicine.

Why shouldn't we be surprised? Because over the last 25 years, clinical

research has been largely privatized. Three-quarters of the clinical

studies published in the three most respected medical journals (the New

England Journal of Medicine, the Journal of the American Medical Assn.

and the Lancet) are now commercially funded. As a result, our medical

knowledge grows not in the direction that best improves our health but

toward corporate profits, the way that plants grow toward sunlight.

This wasn't always so. Before 1980, most medical studies were publicly

funded, and most academic researchers scorned industry support. Now,

however, the vast majority of clinical trials are commercially funded,

and with the financial stakes so high, there is mounting evidence of

individual scientists and corporations manipulating their findings.

Even our most trusted journals are dependent on drug-company money. Drug

makers don't just buy advertising in their pages. According to

Horton, editor of the Lancet, they also pay up to $1.75 million for

reprints of articles favorable to their drugs, which sales reps then

hand out to doctors.

And many journal articles are biased in favor of their sponsors'

products. A 2003 report in the Journal of the American Medical Assn.

found that clinical studies funded by drug companies are three times

more likely to conclude that the sponsor's drug is the treatment of

choice, compared to studies of the same drug that were not commercially

funded. (This study of the effects of commercial bias, by the way, was

funded by Danish research institutions.) The disturbing conclusion is

that most of the evidence in what doctors believe to be " evidence-based

medicine " is more infomercial than dispassionate science.

It's vital to protect the integrity of our medical knowledge. But the

current peer review system alone can't do the job. The journals, and the

peer reviewers they rely on, are in the untenable position of having to

trust that corporate sponsors have accurately and completely reported

their findings. At present, journal editors and peer reviewers typically

are not allowed unrestricted access to the data from commercially

sponsored research. Amazingly, many drug company-funded researchers who

write the articles are also not allowed access to all of the data the

company has collected.

There is no better cautionary tale than the unwarranted success of

Vioxx. Greater safety was the only reason for doctors to have prescribed

Vioxx, given that it provided no better relief of arthritis symptoms or

pain and cost up to 10 times more than the older anti-inflammatory drug,

naproxen (sold without a prescription as Aleve). But Merck's own study

clearly showed that Vioxx was more dangerous than naproxen overall and

caused significantly more heart attacks, blood clots and strokes --

whether or not the patient had a previous history of cardiovascular disease.

SO WHY DID American doctors prescribe $7 billion worth of Vioxx after

Merck and the Food and Drug Administration knew all this?

Because the New England Journal article that ostensibly reported the

results of Merck's study didn't even mention either the cardiovascular

or the overall dangers of Vioxx. Instead, it reported only selective

data on heart attacks and strokes, allowing Merck to claim that Vioxx

wasn't a risk to people without a history of these problems.

The Journal's editors are now accusing Merck of withholding critical

data. Shame on Merck. But shame on the Journal too for not insisting

that the article include a discussion of the most important

complications. Doctors were left with the impression that Vioxx was

safer than naproxen when exactly the opposite was true.

The Journal again misled its readers in 2001, when one of its

influential review articles dismissed the dangers of Vioxx as perhaps

reflecting " the play of chance. " This article was published seven months

after FDA reviewers' concerns and Merck's own research data, which

documented the dangers, had been posted on the FDA's website. Worse, the

Journal violated its own policy prohibiting scientists with conflicts of

interest from writing review articles. (Both authors had financial ties

to Merck.) That the Journal disclosed those ties mitigates neither its

ethical breach nor the consequences of its repeated understatement of

the risks of Vioxx.

This is hardly an academic argument. According to an article in the

Lancet, based on Merck's own data Vioxx probably caused between 88,000

and 144,000 cases of serious heart disease.

The stem cell and Natrecor debacles offer further evidence that the

problem is not just individual bad actors or occasional lapses of

scientific integrity by drug makers. It's that even the most prestigious

journals are unable to perform the quality control that doctors take for

granted.

Sadly, the evidence shows that it's time for the journals to change

their policies from trust to " trust, but verify. " They should introduce

a new standard requiring an independent audit of the accuracy and

completeness of research reports before they are sent out for peer

review. These scientific auditors should be statisticians and medical

experts who are completely free of conflicts of interest and are given

unfettered access to the data.

The journals will rightfully claim they cannot afford to pay for such

scientific oversight. But the lack of oversight is even more costly.

Americans waste billions each year on drugs of dubious value. Until we

find a way to fund quality controls on published research, the cost of

our medical care will continue to soar and our health will suffer.

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