Medical Corruption: Drug profits infect medical studies.

[Guest guest]

Drug profits infect medical studies January 7, 2006

LA Times

By John Abramson

(Distributed by Zeus Information Service)

 

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Merck exaggerating the safety of its blockbuster drug Vioxx, now withdrawn.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 Johnson & Johnson 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 Richard 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 & shy; 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.

 

 

 

 

 

 

JOHN ABRAMSON, a clinical instructor at Harvard Medical School, is author of

" Overdosed America " (HarperCollins, 2004). He is a consultant to attorneys of

patients who took Vioxx and are suing Merck.

 

 

 

" Our ideal is not the spirituality that withdraws from life but the conquest

of life by the power of the spirit. " - Aurobindo.

 

 

 

 

 

 

 

What are the most popular cars? Find out at Autos