Industry's Role--NYT_Just how much 'new research' can we trust?

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[sSRI-Research] Industry's Role--NYT_Just how much 'new

research' can we trust? Sunday Times

 

 

 

 

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org/cms/

 

FYI

 

" There is a crisis of credibility in medicine and science, " says Dr

Joseph

Sonnabend who, as a former virologist for the Medical Research

Council and a

retired Aids physician, has watched the basis for public confidence

decline.

" Less and less information seems purely disinterested. You have to

check

everything out. " Indeed!

 

Professional medical associations who accept money from drug

manufacturers

lose their integrity as demonstrated recently in a New York Times

expose

(May 20) that showed the complicity of the American Society for

Hypertension

and drug manufacturers (Merck, Novartis, and Sankyo) to expand th

emarket by

redefining hypertension: http://www.ahrp.org/cms/content/view/172/27/.

Today's Times editorial (below) notes that those who call the society

to

task " complain that the new definition is not grounded on solid

scientific

evidence and inevitably bears the taint of financial ties with the

industry. "

 

The focus of Bian Deer (UK award winning investigative reporter) in

The

Sunday Times shows how a string of published, widely

disseminated, " new

study findings " purporting the benefit of this or that drug treatment

were

found, upon independent critical examination, to be either fraudulent

or

biased.

 

Neither the fact that these reports were accompanied by impressive

trappings

of science (graphs, tables, and string of citations), nor their

authors'

impeccable credentials, nor that they were published in

respected " peer

reviewed " medical journals, ensures the credibility of the data or the

unbiased objectivity of the authors.

 

" Many cases of poor science, or even scientific fraud, are also

failures of

peer review, " says Dr Evan Harris, Liberal Democrat MP for Oxford

West and

Abingdon and a member of the House of Commons science committee. " The

process is critical in distinguishing mere assertion from something

that can

be tested and judged by others. "

 

But, as demonstrated over and over again, the process has been

corrupted by

financial conflicts of interest. Anyone who trusted the reports

about the

benefits of hormone replacement therapy, or COX-2 pain killers, or

SSRI

antidepressants, or atypical antipsychotics, or cholesterol lowering

STATINS, hypertensives, etc, etc because they were published in

respected

medical journals were fooled--and patients prescribed these drugs were

harmed--hundreds of thousands were killed.

 

Even The Lancet, The New England Journal of Medicine, The British

Medical

Journal, not to mention the Journal of the American Medical

Association, and

the numerous journals in psychiatry that lack even a modicum of

scientific

substance or objectivity-all have published fraudulent and biased

conclusions without substantiating data.

 

Medical journals have lost their authority as they became more

concerned

about " bottom line " economics rather than accuracy. " After decades in

which

newspaper journalists were regarded as the medically ignorant,

paradoxically

it is now the medical journals that are under the spotlight over

whether or

not their stories are true. At least that's what new research

suggests. "

 

 

Contact: Vera Hassner Sharav

212-595-8974

veracare <veracare

 

 

http://www.nytimes.com/2006/05/30/opinion/30tue3.html?pagewanted=print

THE NEW YORK TIMES

May 30, 2006

Editorial

Industry's Role in Hypertension

 

If the American Society for Hypertension hoped to devise an expanded

definition of the condition that would be scientifically and ethically

defensible, it sure picked the wrong way to do it. Virtually every

key step

in its efforts to redefine hypertension from mere high blood pressure

to a

broader syndrome has been financed by pharmaceutical companies that

would

gain by selling drugs to more people.

 

As described by Stephanie Saul in The Times on May 20, Merck,

Novartis and

Sankyo gave the small medical society $75,000 in unrestricted grants

that

were used to develop a new definition, and $700,000 more in

unrestricted

grants that financed dinner lectures to promote the new definition.

The drug

companies have too much self-interest to be allowed even a peripheral

role

in defining illness.

 

Hypertension, which is a risk factor for developing cardiovascular

disease,

is currently defined as a blood pressure reading of 140/90 and above.

Some

65 million Americans have high blood pressure by that definition. But

59

million more are considered pre-hypertensive, which means they have

blood

pressure readings of at least 120/80. The new concept being debated

within

the society would move about half of these into the hypertension

category

based on other risk factors.

 

The rationale is that simple blood pressure measurements fail to

identify

all the people who may need to be treated to prevent heart attacks and

strokes. So the expanded definition would throw in various

cardiovascular

risk factors, biochemical markers and signs of organ damage that

could,

collectively, justify a diagnosis of hypertension even if blood

pressure was

too low to meet the current definition. The proposed definition does

not

recommend any specific treatment, but it would seem likely to expand

the use

of medications.

 

While this approach has merit in principle, some prominent members of

the

society complain that the new definition is not grounded on solid

scientific

evidence and inevitably bears the taint of financial ties with the

industry.

No guidelines produced this way will have much credibility.

 

Copyright 2006 The New York Times Company

 

~~~~~~~~~

 

http://www.timesonline.co.uk/printFriendly/0,,1-525-2189540-

525,00.html

The Sunday Times May 21, 2006

Just how much 'new research' can we trust?

Brian Deer says scientific studies are not as reliable as they

pretend to be

 

 

Last month brought welcome news for nicotine junkies everywhere.

According

to press reports from an American conference, " new research "

suggested that

" smokers who've tried but failed to kick their habit may want to pop

a daily

aspirin, ibuprofen or naproxen (Aleve) to help cut their risk of mouth

cancer " .

 

The reports, however, neglected to mention the other side of the

coin: that

these painkillers cause more medical emergencies than any other

pharmaceutical product. " Research " , in fact, suggests that stomach

bleeding

triggered by these so-called " non-steroidal anti-inflammatories " , or

NSAIDs,

leads to about 3,500 hospitalisations and 400 deaths among Britons

over 60

each year.

 

Family doctors are exasperated by patients demanding new drugs or

treatments

based on what they read. " Patients come in all the time under the

influence

of these stories, " says Dr Mike Fitzpatrick, an east London GP. " Like

cholesterol-lowering drugs. One minute new research says they are

better

than we thought. Then more new research links them with serious side

effects. "

 

Maybe somebody should start a league table to rank the credibility of

the

new research's sources. The mouth cancer research, for instance, is

the baby

of Dr Jon Sudbo, a consultant oncologist at Norway's Rikshospitalet

and,

until recently, an adjunct professor at the reputable Oslo

University.

 

Reporting last October in The Lancet, once the flagship of British

medical

publishing, Sudbo and a team of 13 other doctors laid out an

impressive nine

pages of text, tables and statistics pointing to the painkillers'

benefits.

 

That seems to nail it. But on the other hand, the stomach research's

source

is impeccable. The risks of painkillers and bleeding are most notably

the

work of Professor Michael Langman, who is not only the former dean of

medicine at Birmingham University, but also sat for many years on the

government's late committee on safety of medicines. He is an expert's

expert.

 

No assistance yet, then, with Fitzpatrick's dilemma. As a wise aunt

of mine

regularly advised me in my younger and more vulnerable years: " Believe

nothing you hear and hardly anything you see. "

 

If you have the time, however, further inquiry helps. For instance,

Sudbo

has recently joined a growing list of doctors and scientists who have

been

condemned by their colleagues as cheats. Amazingly, two months before

the

press reports announcing his dramatic " new research " for smokers, The

Lancet

had published a worrying 52-word statement buried on a left-hand

page.

 

" We have received confirmation, " Dr Richard Horton, the journal's

beleaguered editor, admitted, " that the paper published by Jon Sudbo

and

colleagues in The Lancet contains fabricated data . . . and we now

retract

this article in full. "

 

This inclines me to think that Langman's research is the weightier of

the

two. If I smoked, I wouldn't also " pop aspirin " . True or false,

Sudbo's

suggestion should therefore perhaps be considered a sort of urban

myth -

like advice to pregnant women to smoke fags for a smaller baby and

that

inhaling blue asbestos clears the lungs.

 

What about this Langman chap? This is a tricky one. Langman is no

faker. Yet

his enthusiasms have sometimes run amok. A Sunday Times investigation

revealed last summer that, while sitting on the government's drug

safety

watchdog, in April 1999 he flew to the United States for the Merck

drug

company and lobbied regulators in support of Vioxx, Merck's

painkiller which

was later withdrawn after an epidemic of heart deaths. Ooops.

 

" There is a crisis of credibility in medicine and science, " says Dr

Joseph

Sonnabend who, as a former virologist for the Medical Research

Council and a

retired Aids physician, has watched the basis for public confidence

decline.

" Less and less information seems purely disinterested. You have to

check

everything out. "

 

If you cannot always trust the doctors, however, what about the

journals in

which they write? About half the top 20,000 medical titles trumpet

their

status as being " peer reviewed " , which means that research is

supposed to be

vetted before publication: not merely with a " spellchecker " but by

relevant

specialists.

 

" A rationale for peer review is that it is rare for an individual

author or

research team to spot every mistake or flaw in a complicated piece of

work, "

is how an anonymous Wikipedia editor (obviously a doctor) explains

it. " In a

new and perhaps eclectic intellectual product, an opportunity for

improvement may stand out only to someone with special expertise or

experience. "

 

It was failings on this front, however, which helped to unleash the

MMR

vaccine debacle. Although place of honour lies with Dr Andrew

Wakefield, the

former gut surgeon whose discredited allegations were published in The

Lancet, it was Horton, and at least one peer reviewer, who failed to

spot

the telltale signs.

 

" Many cases of poor science, or even scientific fraud, are also

failures of

peer review, " says Dr Evan Harris, Liberal Democrat MP for Oxford

West and

Abingdon and a member of the House of Commons science committee. " The

process is critical in distinguishing mere assertion from something

that can

be tested and judged by others. "

 

Failings in this system have particularly stung The Lancet, which in

addition to publishing claims by Sudbo and Wakefield (both

retracted), has

been regularly roasted for printing twaddle. Most famously, in 1999

the

journal set off yet another public scare over genetically modified

food,

which was based on tests (later challenged) with potatoes and rats.

 

The Lancet's troubles, however, are just examples, albeit the most

spectacular. Only last week The Wall Street Journal revealed that an

editor

of The New England Journal of Medicine (the world's No 1 medical

title) had

admitted that " lax editing " had contributed to a research paper in

2000

which gave a misleading impression of Vioxx's safety, and that the

journal

had sold reprints grossing nearly $700,000, most of which had been

bought by

Merck.

 

A few years ago the British Medical Journal published a paper from

researchers at University College London claiming - again with

meticulous

tables - that 53.8% (a majority) of heterosexually active women, aged

44 or

under, suffered from a sexual dysfunction. When I phoned to ask

whether this

could really be true, the paper's chief author hung up.

 

Whether fraud or foolishness, the cause is always the same: the need

to

publish something - anything - in a journal. Researchers gain

promotion

(especially to the magic " professor " circle) on the quantity and

purported

quality of their papers. And the journals, in turn, are ranked by

arcane

" impact factors " which, broadly, measure how often they are quoted.

 

Each year in June these impact factors are recalculated, to be gawked

at

like Strictly Come Dancing. The last release I could find clocked The

New

England Journal of Medicine at a lofty 38.570, Britain's top science

journal

Nature at a credible 32.182, and The Lancet trailing at 21.713.

 

For the journals and their publishers, the bottom line is money. The

Anglo-Dutch Reed Elsevier group, which owns The Lancet and a library

full of

other medical journals, scientific book imprints and technical

databases,

enjoys a healthy profit margin.

 

Any aim to inform sometimes seems incidental to the mission. Accuracy

is

good but not essential. After decades in which newspaper journalists

were

regarded as the medically ignorant, paradoxically it is now the

medical

journals that are under the spotlight over whether or not their

stories are

true. At least that's what new research suggests.

 

Copyright 2006 Times Newspapers Ltd.

 

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