Too close for comfort?
pharmafile | January 19, 2004 | Feature | Medical Communications, Sales and Marketing |Â Â doctors, industry reputationÂ
The pharmaceutical industry's increasing scale and influence means that no part of its conduct is above scrutiny, and criticism of its marketing practices is now an inevitable part of the business, and reflective of its unique role in public life.
In particular, 2003 saw the pharmaceutical companies once again accused of trying to buy doctors and influence their prescribing decisions by developing inappropriately close relationships with them.
These are ethical questions which simply won't go away, and indeed seem to be under increasingly greater scrutiny. While the industry has plenty of dogged and irrational critics, two of the most credible are the editors of the UK'sBMJ, Richard Smith and The Lancet's Richard Horton. Both men continue to keep the issue of conflicts of interest high on their agenda.
The journals, two of the most respected in medical science, occupy the very nexus of the debate, attempting to publish only the very best new clinical studies but also partly dependent on the industry's advertising money.
Mr Smith recently gave a talk to an industry audience entitled Is the relationship between the industry and prescribers in trouble? Unsurprisingly, his conclusion was that it indeed was, and called for a large-scale disentanglement of industry and medicine.
Evidence of that relationship being in trouble comes no clearer than the very public spat between Mr Horton and AstraZeneca chief executive Tom McKillop over the marketing of the company's new blockbuster Crestor.
Using an editorial to attack what he called an "unprincipled campaign" he said: "AstraZeneca's promotional tactics raised disturbing questions about how drugs enter clinical practice and what measures exist to protect patients from inadequately investigated medicines."
This is of particular significance to The Lancet, of course, because publication of biased or flawed research damages a journal's reputation, one of its key assets.
Mr Horton said Crestor's Galaxy series of clinical trials included "weak data", "adventurous statistics" and "marketing dressed up as research".
Mr McKillop retaliated in the letters page of The Lancet, saying regulators, doctors, patients and his company had been poorly served by "your flawed and incorrect editorial." He added: "I deplore the fact that a respected scientific journal such as The Lancet should make such an outrageous critique of a serious, well studied, and important medicine."
Earlier last year, the BMJ had caused offence to a much wider audience in a May issue dedicated to the issue of conflicts of interest. Inside the journal, 'entanglement' was scrutinised in a number of articles, including an analysis of clinical trials which concluded companies continue to influence the outcome of studies. Despite the seriousness of this evidence, the UK industry body was denied a chance to state its position in the journal, to the regret of its medical director Richard Tiner.
The conduct of parts of the medical profession was also called into question in the issue, while the front cover depicted doctors as pigs and the industry as lizards feasting at a table.
Mr Tiner says: "I attended a couple of BMA meetings not long after that issue was published and a number of doctors said how insulted they were by how they were portrayed. They felt he [ Richard Smith, the editor ] had gone too far."
He says a lot of the criticism in the issue was wide of the mark, failing to acknowledge the ABPI Code of Practice's positive influence on relations, and said the excesses depicted -lavish spending, golfing holidays – were a thing of the past in the UK.
"When I first qualified as a doctor the code of practice wasn't as strong as it is now and there was a lot of cash swishing around but things have changed. Things are so much tighter now and those things just don't happen anymore.
"One of the problems with the BMJ editorial was that it looked at the question from a global basis – in the UK we have things pretty good; we have a strong code of practice which companies don't like being found in breach of," he adds. "The 22 clauses of the code are generally speaking well adhered to."
Meanwhile, a voluntary web-based register of clinical trials was launched by the ABPI last year, in part to improve transparency and counter accusations of selective publication. The response has been disappointing, with just six companies participating, but Mr Tiner says he expects that number to increase significantly this year. The code of practice does not however cover the industry interaction with key opinion leaders, and a wide array of potential conflicts of interest.
Mr Tiner says: "In my view that is done in a pretty ethical way. Clearly when we are developing a new product you want to have among your senior investigators people experienced in treating that disease.A number of other organisations such as the ethical committees and drug safety monitoring boards who are independent of the investigators and the company are now increasingly used to safeguard the probity of trials and their safe running.
But on two burning issues – ghostwriting and declarations of interest – Mr Tiner says there is considerable room for improvement, where some leading doctors put their name to research papers which they may not have even read.
On ghostwriting – the use of medical writers to put together research papers for publication on behalf of researchers – he says: "I think there is a problem, but it's not just a problem in industry but in academia as well. If you agree to your name going on the paper then you must be absolutely sure you agree with what's in it.
"But to suggest that ghostwriting is wrong goes to far getting it written by an expert in writing is OK, but the person whose name is on it should have done the research.
ABPI launches own publication guidelines
Unprompted by these developments, the ABPI is currently developing its own Good Clinical Publication guidelines to clarify these and other issues which mirror frameworks already produced in other countries, and is due to be published sometime in 2004. The ABPI is equally in favour of full declaration of interests.
"The BMJ has been declaring conflicts of interest for a number of years and we support that completely," says Mr Tiner. "If people have declared their interest, then the reader can make a decision for themselves on whether what they've read is in any way biased. Otherwise it is very difficult to make that decision.
But is full 'disentanglement' of the industry from doctors possible? After all, the industry will keep launching new products, and doctors will always have to learn about them in as helpful a context as possible.
The new GMS (nGMS) contract and the evolution of primary care is an excellent example – a genuine 'opportunity' for industry doctors who genuinely need assistance in changing their working lives, in IT, professional appraisal and business management, areas where the industry is perfectly placed to assist.
Increasingly, the industry is being asked to contribute to pooled resources for postgraduate courses where there is no guarantee they will fund education in any of their therapy areas.
"The industry sponsors about 50% of GP education currently. That is not going to be taken over by the Department of Health and GPs are not going to pay for all of that either. Within the Code there are very strong rules governing this, so it's an opportunity for doctors to get an education that is broader than it would have been otherwise.
Developing guidelines together
Professional bodies such as the Royal Colleges are well aware that the onus lies with their members to maintain an ethical position as much as with the industry. While it might seem appropriate not to consult the industry when drafting codes for doctors, Mr Tiner points out it is sometimes in everyone's interest to agree on standards in advance and develop a mutual system.
He says the Royal College of Physicians recently drew up a code of practice for its members when dealing with the commercial sector, and stated that publications or meetings should not carry any promotions of their sponsor.
"That is completely against our code: it states companies sponsoring a meeting must be named on the programme," says Mr Tiner. "People should know that -otherwise who knows what you are going to hear."
The ABPI has raised the issue, and hopes the College will re-draft the rule to bring agreement on the issue. "It would be silly for them to have a code which doesn't agree with ours, because it puts our people in a difficult position."
Another example of a progressive industry-medical accord on working together is the recently published A Common Understanding guidance on joint working between NHS Scotland and the pharmaceutical industry. The document was put together by ABPI Scotland the Scottish Executive and sets out a number of core principles which should help foster greater mutual respect and understanding between the two sides.
In England and Wales, the ABPI was again involved in co-ordinating involvement of a number of companies in developing and implementing national service frameworks in diabetes and mental health, eliminating unnecessary duplication of contacts and ensuring pharma contribution was concentrated on key targets and where the NHS needed most help.
Meanwhile, stuck in the middle are the medical journals who will continue to push for greater transparency in the service of their own interests. In January The Lancet published new stricter rules to govern the submission and editing of clinical trial papers in its pages.
Astrid James and Mr Horton set out the new guidelines commenting: "We guard our editorial independence fiercely, and recognise that the integrity of the journal depends on it. This independence is increasingly important as medicine becomes more commercially minded and influenced.
"Some journal editors experience covert as well as explicit pressure to be more pro-pharma in their work. For example, editors might be encouraged to avoid criticising industry in their pages, to publish more drug-company trials, or to avoid public comment about aspects of medicine that might adversely affect the publisher. These limitations of independence are to be deplored."
The journals will continue to defend their position, and demand improvements, such as more publicly funded research to counterbalance the industry.
Meanwhile, pharma and doctors will remain mutually dependent and will continue to work together together in most cases to the benefit of all sides. Equally, both must accept their relationships do have limits and keep in mind their primary purpose is to serve the needs of patients.The pharmaceutical industry's increasing scale and influence means that no part of its conduct is above scrutiny, and criticism of its marketing practices is now an inevitable part of the business, and reflective of its unique role in public life.
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