Fwd: [SSRI-Research] Doctors Without Borders: Why you can't trust medical journals anymore

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Fri, 16 Apr 2004 02:25:44 -0000

[sSRI-Research] Doctors Without Borders: Why you can't trust medical

journals anymore

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting openness and full disclosure http://www.ahrp.org

 

FYI

 

Doctors Without Borders in the Washington Monthly (excerpt below),

looks at the intricate web of collaborating players in medicine who

are financially tied one and all-like cogs in a wheel--to the

pharmaceutical industry.

 

Shannon Brownlee tells the story of how medicine has been diverted,

in blatant and subtle ways, from its traditional focus of treating

patients and exchanging information freely (from clinical practice

and research) about what works, what doesn't. Within the last twenty

years or so, the culture of medicine has radically shifted. When the

university embraced corporate financial incentives those corporate

sponsors gained inordinate influence over the funding of both private

and public research. Industry sets the research agenda, short

circuiting accepted ethical safeguards, and inserting bias into the

scientific literature. Demonstrably the peer-review system for

ferreting out bias and scientifically questionable reports from

scientific journals has failed utterly because the journals have

grown accustomed to industry's copious advertising dollars.

 

Brownlee writes: " That means that the studies published in scientific

journals like Nature and The New England Journal of Medicine [and The

Journal of the American Medical Association]--those critical

reference points for thousands of clinicians deciding what drugs to

prescribe patients, as well as for individuals trying to educate

themselves about conditions and science reporters from the popular

media who will publicize the findings--are increasingly likely to be

designed, controlled, and sometimes even ghost-written by marketing

departments, rather than academic scientists. "

 

A prime example of industry's insidious influence is the

indiscriminate prescribing of SSRI antidepressants for children--the

result of the collaborative efforts of industry, the media, and the

academic based psychiatric and pediatric establishment that

promulgated a myth about these drug' safety and efficacy. For

example, a recent report in JAMA, accompanied by an editorial by a

prominent Harvard psychiatrist, pronounced the antidepressant drug,

Zoloft, to be " effective and well tolerated for children and

adolescents. " See: Efficacy of sertraline in the treatment of

children and adolescents with major depressive disorder: two

randomized controlled trials by Wagner KD, Ambrosini P, Rynn M,

Wohlberg C, Yang R, Greenbaum MS, Childress A, Donnelly C, Deas D;

Sertraline Pediatric Depression Study Group. JAMA. 2003 Aug 27;290

(8):1033-41

 

However, an examination of the actual data refutes those JAMA backed

claims. Recently, even FDA officials acknowledged that pediatric

SSRI studies that were reported in medical journals as positive, were

in fact negative. See, for example: FDA Background Memorandum on

Suicidality Associated with Antidepressant Drug Treatment, by Thomas

Laughren to Members of PDAC and Peds AC, January 5, 2004.

http://www.fda.gov/ohrms/dockets/ac/04/briefing/4006B1_03_Background%

20Memo%

2001-05-04.htm

 

When previously concealed evidence was publicly disclosed in the UK,

several antidepressant drug manufacturers issued warnings about the

drugs' risks of harm, acknowledging that antidepressants have not

demonstrated a benefit for children but present a two-to-three fold

increased risk of suicidal behavior in children.

See GlaxoSmithKline letter:

http://www.ahrp.org/risks/PaxilRisks0603.html

See Wyeth letter: http://www.ahrp.org/risks/effexorLtr082203.html

See Eli Lilly's revised Prozac UK label (Dec. 2003) stating that

Prozac is NOT RECOMMENDED FOR CHILDREN.

http://www.ahrp.org/infomail/03/12/19.html

 

Unless the entire medical research community claims professional

incompetence, one can only conclude that the psychiatric / medical

research establishment has been complicit in concealing vital safety

information from prescribing doctors and the public. The motive is no

mystery: public disclosure about these drugs' hazards will negatively

impact on sales.

 

*Of particular note*

As a source of information for the Brownlee article, I know that it

was originally written at the request of a major national news

magazine only to be canned. An obvious question arises: did the

editors of that news magazine reject the article because its content

conflicts with the interests of the publication's advertisers?

 

 

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare

 

<http://www.washingtonmonthly.com/features/2004/0404.brownlee.html>

Washington Monthly, April 2004

Doctors Without Borders

Why you can't trust medical journals anymore.

By Shannon Brownlee

 

With financial ties to nearly two dozen drug and biotech companies,

Dr. Charles B. Nemeroff may hold some sort of record among academic

clinicians for the most conflicts of interest. A psychiatrist, a

prominent researcher, and chairman of the department of psychiatry

and behavioral science at Emory University in Atlanta, Nemeroff

receives funding for his academic research from Eli Lilly,

AstraZeneca, Pfizer, Wyeth-Ayerst--indeed from virtually every

pharmaceutical house that manufactures a drug to treat mental

illness. He also serves as a consultant to drug and biotech

companies, owns their stocks, and is a member of several speakers'

bureaus, delivering talks--for a fee--to other physicians on behalf

of the companies' products.

 

But it was just three of Nemeroff's many financial entanglements that

caught the eye of Dr. Bernard J. Carroll last spring while reading a

paper by the Emory doctor in the prominent scientific journal, Nature

Neuroscience. In that article, Nemeroff and a co-author reviewed

roughly two dozen experimental treatments for psychiatric disorders,

opining that some of the new treatments were disappointing, while

others showed great promise in relieving symptoms. What struck

Carroll, a psychiatrist in Carmel, Calif., was that three of the

experimental treatments praised in the article were ones that

Nemeroff stood to profit from--including a transdermal patch for the

drug lithium, for which Nemeroff holds the patent.

 

Carroll and a colleague, Dr. Robert T. Rubin, wrote to the editor of

Nature Neuroscience, which is just one of a family of journals owned

by the British firm, Nature Publishing Group, pointing out the

journal's failure to disclose Nemeroff's interests in the products he

praised. They asked the editor to publish their letter, so that

readers could decide for themselves whether or not the author's

financial relationships might have tainted his opinion. After waiting

five months for their letter to appear, the doctors went to The New

York Times with their story--a move that sparked a furor in academic

circles, and offered the public yet another glimpse into conflict of

interest, one of the most contentious and bitter debates in medicine.

 

In his defense, Nemeroff told the Times he would have been happy to

list his

(many) relationships with private industry--if only the journal had

asked. " If there is a fault here, " he said, " it is with the journal's

policy, " which did not require authors of review articles to disclose

their conflicts of interest.

 

And that is pretty much where the debate over conflict of interest in

medical journals stands: Should research scientists who have

financial stakes in the products they are writing about be forced to

disclose those ties? To which the average person might reasonably

respond, of course they should. But the more pertinent question is

why scientists with financial stakes in the outcome of scientific

studies are allowed anywhere near those studies, much less reviewing

them in elite journals.

 

The answer to that question is at once both predictable and shocking:

For the past two decades, medical research has been quietly corrupted

by cash from private industry. Most doctors and academic researchers

aren't corrupt in the sense of intending to defraud the public or

harm patients, but rather, more insidiously, guilty of allowing the

pharmaceutical and biotech industries to manipulate medical science

through financial relationships, in effect tainting the system that

is supposed to further the understanding of disease and protect

patients from ineffective or dangerous drugs. More than 60 percent of

clinical studies--those involving human subjects--are now funded not

by the federal government, but by the pharmaceutical and biotech

industries.

 

That means that the studies published in scientific journals like

Nature and The New England Journal of Medicine--those critical

reference points for thousands of clinicians deciding what drugs to

prescribe patients, as well as for individuals trying to educate

themselves about conditions and science reporters from the popular

media who will publicize the findings--are increasingly likely to be

designed, controlled, and sometimes even ghost-written by marketing

departments, rather than academic scientists. Companies routinely

delay or prevent the publication of data that show their drugs are

ineffective. The majority of studies that found such popular

antidepressants as Prozac and Zoloft to be no better than placebos,

for instance, never saw print in medical journals, a fact that is

coming to light only now that the Food and Drug Administration has

launched a reexamination of those drugs.

 

Today, private industry has unprecedented leverage to dictate what

doctors and patients know--and don't know--about the $160 billion

worth of pharmaceuticals Americans consume each year. This is an

unsettling charge that many (if not a majority) of doctors and

academic researchers don't want to acknowledge. Once grasped,

however, the full scope and consequences of medical conflict of

interest beget grave doubts about the veracity of wide swaths of

medical science. As Dr. Drummond Rennie, deputy editor of The Journal

of the American Medical Association (JAMA), puts it, " This is all

about bypassing science. Medicine is becoming a sort of Cloud Cuckoo

Land, where doctors don't know what papers they can trust in the

journals, and the public doesn't know what to believe. "

 

Clinical trial and error

 

How did we get to this point? What effect is industry influence

having on the treatment of patients? And why are the medical journals

not more vigilant to weed out papers that have been distorted by

conflict of interest? The answers to these questions begin, oddly

enough, with an amendment to U.S. patent law called the Bayh-Dole

Act. Passed in 1980, Bayh-Dole for the first time permitted

universities to commercialize products and inventions without losing

their federal research funding, the seed money for innovative

research. The brainchild of George Keyworth II, President Reagan's

science advisor, who was watching the United States get beaten in

world markets by the Japanese, Bayh-Dole was intended to stimulate

advanced technological invention and speed its transfer from

university labs into private industry, where it could be put to work

spurring U.S. productivity.

 

It seemed like a win-win proposition. Indeed, Bayh-Dole has helped

launch the biotech industry and has propelled several life-saving

products to market. The basic research behind Gleevec, for instance,

an incredibly effective new anti-cancer drug, was done by a

university scientist. The drug's manufacturer, Novartis, stepped in

and provided additional funding for development. In 1984, private

companies contributed a mere $26 million to university research

budgets. By 2000, they were ponying up $2.3 billion, an increase of

9,000 percent that provided much needed funds to universities at a

time when the cost of doing medical research was skyrocketing.

 

That's the upside. The downside is that Bayh-Dole has also fostered

increasingly cozy relationships between the academics upon whom the

nation depends for unbiased medical information and Big Pharma,

private companies whose main goal, let's face it, is making a profit.

And we're talking serious money here. In addition to the salaries

built into company-sponsored research grants, academic clinicians at

medical schools can pad their already decent incomes with $1,000-a-

day consulting contracts with pharmaceutical companies, patent

royalties, licensing fees, and big-payoff stock options. Nemeroff

stood to reap as much as $1 million in stock from a company that

manufactured one of the products in his Nature Neuroscience paper. At

many of the top research universities and medical schools around the

country, a substantial percentage of the faculty enjoys the perks of

industry relationships. At MIT, 31 percent of the science and

engineering faculty has outside income; at Stanford Medical School,

it's 20 percent.

 

What's in it for the pharmaceutical companies? Simple economics. It's

Marketing 101. By penetrating the wall that once existed around

academic researchers, drug companies have gained access to

the " thought leaders " in medicine, the big names whose good opinion

of an idea or a product carries enormous weight with other

physicians. Companies target academic KOLs, or Key Opinion Leaders,

in the lexicon of marketing, and woo them with invitations to sit on

scientific advisory committees, or to serve as members of speakers'

bureaus, which offer hefty fees for lending their prestige to a

company and touting its products at scientific meetings and

continuing medical education conferences. Of course, KOLs must be

convinced of their own impartiality, says Carl Elliott, a moral

philosopher at the University of Minnesota and author of Better Than

Well: American Medicine Meets the American Dream. " If they understood

that they were being used as industry mouthpieces, they would

probably pull the plug on the whole enterprise. " Drug companies

encourage their KOLs to consult for multiple companies so the

appearance of objectivity can be maintained. But the drug industry's

most powerful means of boosting the bottom line is funding research,

which allows companies to control, or at least influence, a great

deal of what gets published in the medical journals, effectively

turning supposedly objective science into a marketing tool.

 

" These are not benign people who are interested in helping people

with their new wonder drugs, " says Drummond Rennie. " The drug

companies are run by hard-nosed marketers, not by the physicians and

the scientists. They use what works, and money works. " Rennie, who

has a thatch of unkempt white hair and remnants of the accent of his

native Leeds, England, got a clear picture of the extent to which

drug companies will go to control the results of studies they fund in

1993, when a colleague at University of California San Francisco

tried to publish a paper in JAMA in 1993 on the metabolic activity of

four different forms of thyroid hormone. Betty J. Dong, a

pharmacologist, had been contracted in 1987 by Flint Laboratories to

run a clinical trial comparing Synthroid, Flint's synthetic version

of thyroid hormone, to that of three competing formulations. At the

time, Synthroid was the market leader and the most expensive drug in

its class. Dong and Flint signed a lengthy agreement detailing the

design of the study, and both sides fully expected the results would

show that Synthroid was superior.

 

But all four drugs turned out to be essentially equivalent. In 1990,

as Dong prepared a paper for JAMA, the company that was at first so

eager to solicit her help, launched a vigorous campaign to discredit

the study. Flint then rushed its own paper into press at a less

prestigious journal, concluding--surprise!--that Synthroid was

superior. After numerous attempts to address the company's

criticisms, Dong finally submitted her paper to JAMA, only to

withdraw it three months later when the firm threatened to sue for

breach of contract. It took the FDA and U.S. Department of Health and

Human Services to get the company to back down. Dong's paper did not

see print in JAMA until 1997.

 

Xxx cut xxx

 

When industry has penetrated every level of medicine from the lab

bench to the FDA advisory panels, from the pages of the medical

journals to your doctor's prescription pad, how are physicians to

make decisions about treating their patients? How are they to know

whether or not expensive calcium channel blockers are really better

than over-the-counter diuretics for high blood pressure? (They're

not.) Should you take a mildly depressed teenager to a

psychotherapist, or put him on an antidepressant and risk sending him

into a suicidal tailspin? Maybe a cholesterol-lowering statin drug

will prevent this patient from suffering a heart attack, as the

studies claim. Then again, maybe it will simply cause her muscles to

break down and destroy her kidneys, one of the drug's side

effects. .cut..

 

Shannon Brownlee is a fellow at the New America Foundation.

 

 

 

 

 

 

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