Tuesday, October 08, 2013

How a marriage with big pharma ended in divorce

By Sophie Arie, freelance journalist


The abrupt termination last week of an umbrella group of leading drug companies, royal medical colleges, and leading health organisations comes as no surprise to critics of the body’s pro-pharma statements. Sophie Arie investigates

In March 2012 a group of 19 of Britain’s leading pharmaceutical and healthcare bodies1 published two documents that were meant to provide definitive guidance on the interaction between doctors and drug companies and transparency in clinical trials.

The short, pamphlet style documents—Guidance on Collaboration between Healthcare Professionals and the Pharmaceutical Industry and Clinical Trial Transparency: Principles and Facts—were the first publications from the Ethical Standards in Health and Life Sciences Group (ESHLSG), formed in 2011 to advance collaboration between healthcare professionals and industry for the benefit of patients. Health ministries and other interested parties outside the group also gave their stamp of approval.

“There are many real benefits to be gained by working together in an open and transparent manner, and this new set of guidelines are an excellent start,” said Richard Thompson, co-chair of the ESHLSG at the time and president of the Royal College of Physicians. “I urge all health professionals to embrace them.”

There was only one problem. The guidelines contained statements that critics said were clearly pro-pharma and highly controversial.

A news report in the BMJ triggered a flurry of criticism,2 and in February 2013 several concerned activist groups launched the Bad Guidelines campaign (http://badguidelines.org), calling for the documents to be withdrawn. The campaigners highlighted statements in the collaboration guidelines that they thought were “demonstrably wrong” such as “Industry plays a valid and important role in the provision of medical education” and that drug company representatives “can be a useful resource for healthcare professionals.” Many people believe that contact with drug representatives and industry sponsored education are forms of marketing, and studies have shown that they lead doctors to prescribe drugs that may not be in patients’ best interests.3

The Bad Guidelines campaign also pointed out that the trial transparency document made several statements that implied all was well with the way in which drug companies publish trial results when there is huge public debate about the need for greater access to clinical trial data.

Second thoughts
Within days, the Lancet, which was not a group member but had added its logo to the guidelines on collaboration, withdrew its support. The BMA, which had approved both documents, followed in March and decided to leave the group. The BMJ, which supports the clinical trials document, has never endorsed the guidance on collaboration between healthcare professionals and the drug industry.

The remaining 18 members of the group—including the Royal Colleges of Physicians, General Practitioners, and Psychiatrists and the British Pharmacological Society and the NHS Confederation—agreed to review the guidelines.

For months there was no further news, and the guidance documents remained on the ESHLSG website, labelled in red as “under review.” In September, the BMJ was told that the group was close to agreeing on “radically rewritten” versions in its imminent quarterly meeting. But instead, the 25 September meeting was cancelled after an informal meeting of the health members, and last week the co-chairs told the BMJ that the ESHLSG was disbanding.

“The group has reached a time when it needs to change and evolve into something different,” co-chair Tim Evans, from the Royal College of Physicians, told the BMJ. “The group ESHLSG will be disbanded, “ he said. “The documents and the guidelines are not going to be reviewed. They are not going to be replaced.”

Although Evans admits the guidance documents were a “failure,” he says the more important issue is the realisation that a wider group of organisations—including devices companies, pharmaceutical companies not so far represented, and other organisations—need to be involved.

Evans acknowledged that the group had thought “naively” that it could produce agreements between a diverse range of organisations on the big issues of the day such as the role of industry in medical education, disclosure of payments, and transparency of clinical trials. He emphasised, however, that he considered it essential that the royal colleges continue to engage in what is a vitally important dialogue between industry and healthcare professionals and to build upon what the group did achieve.

“The real recognition, with Tim and myself, is that ESHLSG is a great forum to have a debate and create recommendations but it’s not really a policy setting organisation,” said Deepak Khanna, president of the Association of the British Pharmaceutical Industry (ABPI) and co-chair of the ESHLSG with Evans. “We can influence the debate, move the agenda forward in the right way but ultimately Tim or I couldn’t mandate a single member to say ‘you must do A, B, or C.’”

Consequently, in 2014 a new, wider forum will be established, to organise discussions and circulate feedback in the hope of influencing the policy decisions of individual organisations.

“It’s for the best,” said David Carroll, a member of the Bad Guidelines campaign. “Hopefully there will be no more silly documents pretending that problems don’t exist any more.” He welcomed the prospect of a broader discussion group being created that does not attempt to make policy.

Evans and Khanna describe the disbanding of the group and its planned replacement with a wider forum as part of an “evolution” that will “enable further progress” and say there was no single sticking point that led to the break-up of the group.

Unrealistic expectations?
But its abrupt termination highlights the limits of any attempt at constructive partnership between the great and the good of healthcare and industry. Peter Gotzsche, head of the Nordic Cochrane Centre and author of Deadly Medicines and Organised Crime: How Big Pharma has Corrupted Healthcare, believes there is no point in attempting to reach agreements between those in the health sector who are involved with providing care and those who make commercial profits.

“There is overwhelming evidence that we cannot by voluntary agreement get to the bottom of these problems,” he says. “It has to be done by legislation.”

One of the greatest concerns for campaigners was lack of transparency surrounding the guideline documents. Inquiries by Ben Goldacre, a leader of the Bad Guidelines campaign and author of Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients into how the documents were drawn up and approved were answered unclearly by the group, and most of the members would not comment individually.

The BMA, which left the group in March 2012, said in a statement that the “process for developing guidance did not always allow sufficient time for the BMA to consult internally and to go through its usual review procedures, before documents were finalised.

“The BMA had concerns regarding specific sections of the guidance on collaboration between health professionals and the pharmaceutical industry and some other decisions made by the group but it had not always been possible for these to be taken into account.”

Remaining members were unwilling to comment during the review process, and the BMJ has been told that there will be no published minutes of the meeting in which healthcare members decided the group should disband. The ESHLSG’s administrative costs were funded by subscriptions from members but its research was all paid for by the ABPI. The new, wider forum will be led by the healthcare members and it is not yet clear what the role of the ABPI will be.

Why did so many organisations sign up?
The experience of the Ethical Standards in Health and Life Sciences Group has left one big question still unanswered. That is how so many revered and long established organisations managed to sign up to the ESHLSG documents, each only four pages long, without noticing the errors within. None of the members have been able to explain.

Richard Horton, wrote in a Lancet editorial in February 2013 that the creation of the document on collaboration had been “led” by the ABPI.4 But the ABPI refuted this, saying that the documents had been agreed and signed by all the group’s members.

Goldacre’s researchers, medical students David Carroll and Beth Evans, were able to gain some insight only by using freedom of information requests to the English Department of Health and the Scottish and Welsh governments, which added their logos to the guidelines on collaboration even though they were not members of the group. These requests showed that the Department of Health had concerns but eventually signed up after being contacted by ABPI staff.

Simon Reeve, head of clinical and cost effectiveness in the Department of Health’s medicines, pharmacy, and industry group wrote an internal email to Naima Khondkar, deputy section head in the department’s industry sponsorship branch: “At risk of being boring, I think that to add a DH logo onto this, we may need to get an agreement from the gateway team and convince them that all the relevant policy interests had been consulted (possibly including workforce?). I may be wrong but it would be worth checking so we don’t get into bother later.” In a subsequent internal message, Reeve asks, “Do we know if all the organisations listed on the front have now explicitly signed up to this? If they have, that might tip me in favour as it could look odd to be left out unless we had a specific concern.” Ultimately, a signature was granted by telephone and the Department of Health has not been able to say by whom.

Professor Bill Scott, chief pharmaceutical officer for Scotland, stated in an internal email on 1 November that his “initial thought is that the NHS and the SGHD [Scottish Government Health Directorates] would not be interested in joining the collaborative effort and co-badging this as we were not involved at any stage.” When Goldacre’s researchers asked why the Scottish government logo had eventually appeared on the document, Scott explained “following a late approach by the ABPI we agreed in principle to endorse the guidance.” The freedom of information requests showed that ABPI staff pursued government staff by phone and email for their approval of the guidance documents.

“It seems industry pushed hard to produce a document that said, ‘Everything’s fine,’” said Goldacre. “By giving their endorsement, the great and good of the medical world gave false reassurance to patients and professionals on some of the most important problems facing medicine today. Their failure to give a clear account of how they came to endorse these documents is very worrying.”

Cite this as: BMJ 2013;347:f6062


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