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, [Link] "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.
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 [Link] ), 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 [Link] ), that medical writers are generally a good thing (see Resources for authors on bmj.com [Link]
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 [Link] ).
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.
FDA proposes higher fees for drug approvals to cover postmarketing surveillance Janice Hopkins Tanne BMJ 2007 334: 177. [Extract] [Link] [Link]
Ghost writers need to be more visible Keith Dawes BMJ 2007 334: 208. [Extract] [Link] [Link]
Inside big pharma's box of tricks Joe Collier BMJ 2007 334: 209. [Extract] [Link] [Link]