Reputations for Sale ? BMJ-BBC-Panorama-Seroxat/ Paxil

The third in a series of investigative reports by the BBC-Panorama, The
Secrets of Seroxat, will be aired on Monday, January 29. It will tackle The
Secrets of the Drug Trials. 

The first in this series, aired in 2002, was the spark that ignited the
public debate about the hazards of  antidepressants–in particular, the
selective serotonin reuptake inhibitors. BBC-Panorama has focused on the
hazards of Seroxat / Paxil and the corrupt marketing practices by the
British drug manufacturer, GlaxoSmithKline–but the practices uncovered are
no different from the other Big Pharma companies. 

The latest Panorama report focuses on how GSK promoted the drug for the
treatment of children–despite evidence of it offering no benefit, while
increasing the risks of serious harm–including self-harm and homicidal
behavior. According to Joe Collier (BMJ,
<http://www.bmj.com/cgi/doi/10.1136/bmj.39104.771597.59> "the picture
painted is one of a conspiracy orchestrated by the company in which doctors
have been misled, regulators duped, journals exposed, and children harmed."

Panorama sheds light on the integrity of leading child psychiatrists in the
U.S.–the so-called KOLS (key opinion leaders), as well the medical
journals–such as, the Journal of the American Academy of Child and
Adolescent Psychiatry. Among the revelations to emerge is that journal
articles signed by prominent child psychiatrists at prestigious universities
were in fact ghostwritten by science writers hired by drug companies. And
that the prominent academics whose names are appended to the articles, did
not actually even read the reports carefully. The articles were gostwritten
and no more represent science than do the company's marketing copy–yet the
articles passed peer review.

Manufacturers, it seems, have had little difficulty in recruiting academics
willing to sell their reputations. Indeed, one might say that leading
academics have been the major corrupting influence in medicine who have
undermined the integrity of the academic literature about drug treatments.
It is claimed that at least 50% of all publications on treatments in the
BMJ, Lancet, and New England Journal of Medicine have been written by an
unacknowledged ghost writer (BMJ 2004;329:937; 2004;329:1345)

An editorial by Fiona Godlee, editor of the BMJ, hits the bull's eye. She
recognizes that it is not enough to point fingers at drug companies'
conduct–such as the concealment of adverse events, nor is it enough to
inveigh against conflicts of interest in general–as even PhRMA has done.

It is the academic leadership in medicine who need to be put on the witness
stand and need to take responsibility for their professional misconduct. By
penning their names to ghostwritten articles that distorted the data, and by
supporting unsubstantiated company claims in the mass media about the drug's
safety and efficacy, they misled physicians to prescribe drugs whose risks
were not disclosed.

According to Joe Collier, Panorama shows how GSK had: "written up" the
pediatric Paxil trial for publication; "bought and manipulated (apparently
willingly) opinion formers; worked to promote the product for use in
children (although it was not, and never has been, licensed for such use);"
and how the information about the safety and efficacy of Paxil was distorted
in letters to prescribers, in advice to their sales force, and in messages
to the media.

Fiona Godlee poses the question: "So what can we do to change the blind-eye
culture of medicine?"
 
The answer, she concludes: "In the interests of patients and professional
integrity" is to show those who have sold their reputations "intolerance and
exposure."

It is a position that we, at the Alliance for Human Research Protection,
wholeheartedly support for the following reason. 

A scientist's reputation is in fact a scientist's only real asset. Thus, a
blemish on a scientist's reputation–such as public disclosure that a sale
has taken place wherein a scientist has lent his / her name to a
ghostwritten article–would effectively devalue (or at the least raise
doubts about) that scientist's integrity and expertise. Lacking a reputation
for integrity, a scientist is of little value to industry.

Thus, the academic community holds the keys to salvaging its own integrity
and public respect by disavowing the academic hired guns amongst them. Fear
of such a public disavowal would be a powerful deterrent for such
misconduct.

 
Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org
 
 ~~~~~~~~~~~~~~~
http://www.bmj.com/cgi/content/full/334/7586/0
BMJ  2007;334 (27 January)
Editor's Choice
Reputations for sale?
Fiona Godlee, editor, BMJ
fgodlee@bmj.com

This week, BBC's Panorama programme again revisits the controversy
surrounding the SSRI Seroxat. Its 2002 investigation into reports of adverse
events from Seroxat prompted 67 000 people to contact the BBC, forcing a
rethink of the safety data. Now GlaxoSmithKline faces legal action and, if
found culpable, the possibility of huge payouts to thousands of patients.

As Joe Collier explains in his preview of this week's Panorama, to be aired
on Monday 29 January
<http://www.bmj.com/cgi/doi/10.1136/bmj.39104.771597.59> ), the focus this
time is on the interplay between industry and the forces that should counter
what he calls "the adverse effects of drug companies." Panorama's account of
GlaxoSmithKline's successful attempts to market Seroxat for use in children,
despite the fact that its own published trial found evidence of serious
adverse effects and failed to show benefit, is fascinating but depressingly
familiar.

The Vioxx story, told last week (BMJ 20 January, p 120), appears to have all
the same hallmarks, including the paying of opinion leaders and ghost
writers to talk up a drug when the evidence can't speak for itself.

What is even more depressing is that such behaviour is still so widely
tolerated within medicine. There has been no shortage of outcry or official
condemnation -including clear statements from the World Association of
Medical Editors, the International Committee of Medical Journal Editors, and
industry itself through its Good Publication Practice guidelines -that
undeclared conflicts of interest and ghost writing are unacceptable.

But, you might reasonably ask, what use are such huffings and puffings in
the face of the individual rewards on offer from drug companies?

Let's be clear what is and is not acceptable. There is nothing wrong with
getting help from medical writers, provided they and their source of funding
are clearly acknowledged. In fact the BMJ agrees with Keith Dawes
<http://www.bmj.com/cgi/doi/10.1136/bmj.39104.595463.94> ), that medical
writers are generally a good thing (see Resources for authors on bmj.com
http://resources.bmj.com/bmj/authors).

Nor is there anything wrong with academics or clinicians working with
industry, provided they remain personally accountable for everything they
say. What is clearly wrong is writers, academics, or clinicians concealing
under their coat tails an army of company spin doctors intent on distorting
the scientific record.

Legislation is not going to happen soon -the powerful industry lobby will
make sure of that.
Regulation is still inadequate (David Healy, BMJ 2006;333:92-5), although
the US Food and Drug Administration is at last tightening up on
postmarketing surveillance
<http://www.bmj.com/cgi/doi/10.1136/bmj.39104.352616.DB> ).

So what can we do to change the blind-eye culture of medicine?
In the interests of patients and professional integrity I suggest
intolerance and exposure.
 As Joe Collier says, we shouldn't have to rely on investigative journalists
to ask the difficult questions.

So at meetings, why not slow hand clap any speaker who does not begin their
talk with a sentence or slide declaring their conflicts of interest?
And if journals discover authors who are guests on their own papers, they
should report them to their institution, admonish them in the journal, and
probably retract the paper.

Reputations for sale are reputations at risk. We need to make that risk so
high it's not worth taking.

Related Articles

FDA proposes higher fees for drug approvals to cover postmarketing
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 Janice Hopkins Tanne
 BMJ 2007 334: 177. [Extract]
<http://www.bmj.com/cgi/content/extract/334/7586/177-b>  [Full Text]
<http://www.bmj.com/cgi/content/full/334/7586/177-b
 
Ghost writers need to be more visible
 Keith Dawes
 BMJ 2007 334: 208. [Extract]
<http://www.bmj.com/cgi/content/extract/334/7586/208>  [Full Text]
<http://www.bmj.com/cgi/content/full/334/7586/208
 
Inside big pharma's box of tricks
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 BMJ 2007 334: 209. [Extract]
<http://www.bmj.com/cgi/content/extract/334/7586/209>  [Full Text]
<http://www.bmj.com/cgi/content/full/334/7586/209
 
 

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