Lancet withdraws its support of document on collaboration between doctors and drug industry
(Published 05 February 2013)
Cite this as: BMJ 2013;346:f770
The Lancet has withdrawn its support from a document outlining how healthcare professionals could collaborate with the drug industry.
In an editorial titled “Falling out with pharma,”1 the journal’s editor, Richard Horton, said that the statements the document made did not match the latest evidence on the behaviour of drug companies today and that this evidence undermined the principles to which he originally signed up in an attempt “to forge a new and more constructive partnership between medicine and the pharmaceutical industry.”
The four page document was published in 2012 by the Ethical Standards in Health and Life Sciences Group,2 which is co-chaired by the president of the Royal College of Physicians, Richard Thompson, and the president of the Association of the British Pharmaceutical Industry, Deepak Khanna. The group’s members include several royal colleges, the BMA, the Department of Health for England, and the Lancet. The document is available on the websites of the RCP and the ABPI.3
Horton said that his action was triggered by Tom Yates, a doctor who is a PhD student at University College London and who is active in Conflict Free, a campaign for medical education to be freed of any industry involvement.
Yates told Horton that the document contained claims that were demonstrably false: that the industry “plays a valid and important role in the provision of medical education” and that “medical representatives can be a useful resource for healthcare professionals.”
The second claim, said Yates, conflicted with the finding of a systematic review by Geoffrey Spurling and colleagues that exposure to information from drug companies led to a higher frequency of prescribing, higher costs, and lower prescribing quality.4
Horton concurs with Yates and adds that the drug industry has a long way to go to meet acceptable standards of transparency over clinical trial results. “It’s time for us to withdraw our name from the guidance as it currently stands,” he wrote.
The ABPI said that, contrary to Horton’s assertion, the guidance was not an ABPI document, nor was it led by the ABPI, but that a range of healthcare organisations agreed and signed it. It was reviewed regularly to ensure that it continued to represent best practice across all the organisations involved with the Ethical Standards in Health and Life Sciences Group, the association added. All the group’s members, including the Lancet, see and approve all documents that the group produces before their publication.
On the issue of clinical trials, the ABPI spokesman added that since 2012 the association’s code of practice had required companies to disclose details of the results of all clinical trials in accordance with guidance of the International Federation of Pharmaceutical Manufacturers and Association. This includes a requirement that all results must be published within one year of marketing authorisation. Companies must also publicly register clinical trials within 21 days of initiation of patient enrolment.
As far as past trials were concerned, the ABPI said that there was more common ground than the Lancet suggested. “We believe that greater transparency of clinical trial data is in the best interests of patients, medicine and science,” the association said in a statement. “Our differences lie in how this should be achieved. We are part of the EMA [European Medicines Agency] working groups which are looking into the mechanics of exactly how to do this, and we await their findings which will be reported later this year.”
The Spurling review cited by Yates concluded that although the study did not find evidence of net improvements in prescribing among doctors exposed to drug company literature, the available information did not exclude that possibility. The team acknowledged that, in theory, increased prescribing might in some cases provide better health outcomes. The limitations of the literature were such that this theory could not be disproved, though little evidence had been found to support it.
Richard Thompson said, “I was surprised to read the Lancet editorial, as not one group has previously approached the Ethical Standards in Health Life Sciences Group to share their concerns on this issue.
“However, since we are all working towards the same aims—the highest standards in clinical research, providing the best medicines and devices for patients—the group will, of course, address the issue in its coming meetings, and I hope that those campaigning on this issue can work with us to help to find a solution.”
Horton told the BMJ, “There can be very positive interactions with the industry, but only if based on reliable evidence and with the patient’s interests centre stage. What is now much clearer is that several of the statements in the document do not stand up to scrutiny. Since there is no process to raise these matters in a joint working group (I have never been invited to the meetings), the only action we could take was to withdraw.”
Cite this as: BMJ 2013;346:f770