Most often it is blamed for putting profits before the interests of patients.
Recently, that same criticism has been levelled at the hallowed ground of the peer-review system, and again the claim is that drugs companies are undermining the integrity of the system to maximise profits.
A series of articles in the national press over the past two years have claimed drug companies are employing 'ghost writers' to place favourable reviews of drugs into some of the most respected peer-review medical journals, including The Lancet and the British Medical Journal (BMJ).
In some cases, doctors and experts in various medical fields have been cited in press coverage as having read articles in journals that named them as the author without their having written or even read the article before it was published.
Together with claims that doctors are regularly offered money to put their names to such reviews. This has called into question the integrity of the healthcare industry and healthcare PROs.
Ensuring transparency
But the investigation into the claims has not stopped at revelatory stories in the media. Evidence presented to a House of Commons select committee earlier this year by The University of Wales professor of psychiatry Dr David Healy suggested that up to half of the articles on therapeutics published in major medical journals are the product of the ghost-writing process.
BMJ deputy editor Jane Smith aims to clarify the journal's position on publishing ghostwritten articles: 'While I concede that covert ghost-writing has been a problem for journals like the BMJ, it's probably not much of one now because we've put measures in place to try to ensure transparency. For example, we require all authors to give a statement of competing financial interests and, for research studies, we also ask the lead author to declare he or she has had full control over the data and its analysis.' The Lancet has expressed similar views (see box).
This month, PROs will be expected to explain their role in 'medical communications', and ghost writing of drug reviews is expected to become a flashpoint.
Ogilvy Healthworld Europe regional president Margot James has already been called to give evidence to the Health Select Committee on 16 December (PRWeek, 26 November).
Despite such dramatic claims, the Association of the British Pharmaceutical Industry (ABPI) is sceptical that fake drug reviews are common.
ABPI head of media relations Richard Ley says: 'Ghost writing is common practice in many organisations, including in the pharmaceutical industry.
In principal, there is nothing wrong as long as the person whose name is on the report has been involved in the research, has read the report, and has had access to the data the report is about.'
He adds: 'I'd be very surprised if anybody senior had put his or her name to such reports if any of those things have not taken place. It's their reputation on the line.'
Such scepticism is not hard to find in the medical communications industry either.
Resolute Communications joint MD Paul Blackburn agrees with the ABPI: 'I really don't think this is a problem. In most cases, it is what they (the named doctor in a drug review) would have written if they had physically had the time to do so.'
Blackburn hopes the committee examining the issue will see that such practices are not damaging to the independence of the review system and are already sufficiently policed.
He defends ghost-written drug reviews by saying: 'We shouldn't see these ghost-written articles from the perspective of someone originating them completely and a doctor just signing them off. One doctor may look at a piece of editorial and say it is appropriate; another might not and will want it to be changed. I don't think any action needs to be taken other than to ensure that our own industry complies with the ABPI code of ethics.'
Nonetheless, the original claims in the press led to the mounting of a campaign by journal editors to stamp out research fraud two years ago.
The media's coverage of the process falls clearly on the side of suspicion, and paints a picture of an industry intent on using any means to convince GPs to prescribe more of their drugs. Nevertheless, the ABPI denies this is a true picture of the industry.
For GCI Healthcare MD Rhonda Smith, the ghost-writing debacle is 'another erosion of trust that is constant' between the pharmaceutical industry and the public.
She believes that such 'scare stories' - about pharmaceutical industry practice as well as individual therapies - will continue unabated until a broad initiative by the healthcare industry to educate consumers is undertaken seriously.
Smith calls for an industry-wide campaign to explain how the industry works, its ethics, and for improved transparency. 'As a nation, we're not equipped to understand scientific concepts or risk assessment, which is why any media puff can cause such damage,' she says.
She argues that the ABPI's efforts to explain that research and development costs of a single new medicine are £550m, and that it can take 12 years to bring to the market, are well placed - but that this is not enough to get the message through.
Nowhere to hide
'The pharma industry cannot hide behind the ABPI. It puts in a layer that allows the pharma industry to relax. Pharmas must do it themselves.
They have a lot of ground to make up and it has got to go much deeper than explaining that profits have to recoup the costs of research and development,' says Smith.
She also points out that ghost-writing is not what it might appear to be to the outside world: 'Often, key opinion leaders are busy doing their own research. Most academic teams provide a wide array of papers on a broad range of topics and there is no way they would have time to produce so much (written research material).
To the public, it looks like a scandal, but it is not.'
Nevertheless, concerns over the way drugs are brought to market have recently led to reform in the regulation of the industry.
In October, Government measures to improve the drug regulation system by making it more independent culminated in a new code of conduct for the Medicines and Healthcare products Regulatory Authority (MHRA), the body responsible for licensing.
Under the new code, members of the Commission for the Safety of Medicines will not be allowed to hold interests in the pharma industry, and patient representatives will enjoy involvement in every expert advisory group.
But it was a debate in Westminster Hall at the time, at which chairman of the Commons Science and Technology Select Committee Dr Ian Gibson criticised the MHRA for its 'culture of secrecy', that has led some healthcare PROs to wonder if the current climate will mean tighter regulation of practices such as the ghost writing of drug reviews.
The ABPI thinks this is unnecessary.
'If a report is published under the name of someone who has not been involved in the report in any way, that is forgery and the matter should be taken up under the ABPI code of practice,' says Ley.
Whether the Commons Select Committee decides that current regulations and industry codes of practice are sufficient protection from malpractice, however, will shortly be seen.
Q&A: Dr ASTRID JAMES, DEPUTY EDITOR, THE LANCET
How big do you think the problem of ghost-written drug reviews actually is?
It is difficult to quantify how big the problem actually is.At The Lancet, where almost all reviews of drugs that we publish are commissioned, ghost-written reviews are extremely rare. However, we are in a fortunate position with choice of content and authors, and editorial independence from our owner, Elsevier. Ghost-written drug reviews are likely to favour the sponsor's product, with potential reprint revenue implications.
How do you go about ensuring such reviews are genuine and sanctioned by the named author?
We will not commission or consider a drug review from anyone who has, or will, receive a fee from any organisation other than The Lancet to write, be named on, or to submit the paper for publication. In addition, all authors of reviews cannot have a contract of employment, or a named position on a company board, stocks, equity, or a patent application or existing patent for any product or company relevant to the review topic.
We ask authors to declare, in writing for print, all potential financial conflicts such as consultancies, travel funding, or expert testimony fees. We also ask authors of drug reviews to include a search strategy so that it is clear what sources they have used to write the review, and what criteria they have used to include or exclude referenced material.
All reviews undergo extensive peer review, usually from three international experts, with one aim being to detect bias in the discussion of findings.
If bias is detected, we will either reject the paper or ask the authors to revise it, and re-review. We also require signed statements from each author declaring their contribution to the writing of drug reviews.
What are your hopes for the outcome of the current Health Select Committee hearings on this issue?
We welcome the committee's gathering of evidence on the influence of the pharma industry, but recognise that responsibility for publication lies with journal editors, who can do more to protect their content and their readers.
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