Friday, October 21, 2011

We Really Need To Make Sure Clinical Guidelines Are Uncontaminated by Conflict of Interest. It May Not Be All That Easy!

The use of clinical decision support to assist in the practice of evidence based care is fundamental to the benefits case for deployment of e-Health at the level of the individual clinician. From both Australia and the US in the last week or so there have been some worrying reports emerge.
First from the US we have:
  • October 12, 2011, 2:24 PM ET

Guideline Experts Have Conflicts of Interest, Study Finds

Ever wonder who’s behind the new recommendations for, say, how to treat high cholesterol or whether to screen men for prostate cancer? More specifically, do you ever wonder whether experts on the panels that develop guidelines have financial ties to pharma or device companies that might be affected?
The Institute of Medicine recommends that ideally, guideline developers shouldn’t have any financial investments in companies that stand to benefit from recommendations, nor should they (or family members) participate in marketing activities or advisory boards of those companies.
Sometimes it’s not possible to convene an entirely conflict-free panel, in which case members with financial ties to industry should be only a minority of the panel, the IOM says. Panel chairs or co-chairs should not have conflicts at all, and industry shouldn’t have a role in developing the guidelines, the group says.
Using that framework, researchers looked at 14 guidelines published by groups in the U.S. and Canada for screening or treatment of high cholesterol and diabetes. Of the 288 total panel members, 52% had conflicts of interest — 138 declared, and 12 undeclared. (Some of those were undeclared because the panels were among the five that didn’t require public disclosure.)
Conflicts were more likely on panels sponsored by non-governmental groups, the study found. The findings appear in BMJ.
More is found here:
And from Australia we have the following editorial in the Medical Journal of Australia this week.

Annette Katelaris: Guidelines conundrum

IT IS hard to imagine that clinical guidelines, in their current incarnation, will survive.
Undoubtedly, doctors need high-quality information to guide clinical decisions, but the development and implementation of clinical guidelines is fraught with difficulty.
We have seen heated debate on this subject in the MJA, and two more articles in the latest issue add fuel to the fire. In one article, Michael Williams and colleagues make a strong demand for the “Comprehensive disclosure of conflicts [of interest] … to safeguard the integrity of clinical guidelines and the medical profession”.
As they observe, and we know, compliance with guidelines is equated to delivery of high-quality care, and can affect doctors’ remuneration. Guidelines themselves, then, must be beyond reproach.
Yet, according to Williams et al, only 15% of the 470-plus guidelines on the NHMRC portal contain a conflict of interest statement — a longstanding requirement for research papers. This is surprising, as guidelines have much more influence on clinical practice than a single research paper.
A 2009 Institute of Medicine report (Conflict of interest in medical research, education and practice) outlined several examples of inappropriate industry influence on clinical guidelines development in the US.
More here:
There is also some additional commentary here:

Guidelines — “valuable and vulnerable”

CLINICAL practice guidelines are vulnerable to bias, with only 15% of NHMRC guidelines from Australia’s most prolific guideline developers including a declaration of conflicts of interest, new research has found.
Although a conflict of interest (COI) statement has long been required from authors of research papers, it is often lacking for developers of clinical practice guidelines, despite the influence of guidelines on clinical care.
The research, in the latest issue of the MJA, looked at more than 200 clinical guidelines that were listed on the NHMRC website. Its authors concluded that the NHMRC needed to “urgently promote a more ethically sound development process for guidelines”. (1)
“Guidelines are valuable and vulnerable”, the authors, led by Michael Williams, a researcher from the Michael Kirby Centre for Public Health and Human Rights at Monash University, wrote.
“Our review of the country’s most prolific guideline developers shows that only 15% of guidelines have COI statements”, they said.
“This raises questions about whether medical bodies are affected by unrecognised, and thus unaddressed, extraneous interests, and may erode the trust the community has in the profession to speak authoritatively about health problems.”
The authors said individuals, institutions and professional bodies could have COIs, with the most common being financial links to industry, such as being paid consultancy fees or honoraria, or holding company shares.
More here:
We also had this article appear where concern is being expressed at a public level.

Drug companies pay doctors to spruik products

DRUG companies are paying specialists up to $1500 to sell the benefits of new products to their peers, a former saleswoman has revealed, raising questions about the independence of the medical profession.
Petra Helesic says many specialists ask drug companies to pay business class airfares for their trips to international medical conferences and cover their bills at five-star hotels.
Sales representatives can earn bonuses of up to $8000 a year if they can increase prescription numbers above certain targets, documents Ms Helesic has provided to The Australian show.
More here:
This is really pretty serious stuff, as there is something about using e-Health to re-enforce clinical practice which is distorted by conflict of interest or other forces.
The recommendation for full disclosure of the funds received by guideline formulators seems more than reasonable, as would the idea that all guidelines be peer reviewed by independent clinicians with no potential conflicts - remembering, of course, that, as drug company funds are the life blood of support for many research projects and the associated academic careers a flat out ban really is not practical.
What is needed is full disclosure, independent peer review and careful use of guidelines that may be over influenced by ‘big pharma’. This will always be a balancing act but we need to be careful!

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