11 February 2019

Conflicts of interest are muddying the guidelines

Pharmaceuticals Research

Transparency advocates are calling for new laws around the industry funding of medical professionals after an analysis reveals one in four authors of clinical guidelines had hidden conflicts of interest.

An analysis of disease guidelines listed on the NHMRC database revealed that 70% had at least one writer with an undisclosed financial tie to an organisation with an interest in the management of that disease.

“We know from work we’ve done that when guideline panels meet and they decide they are going to change definitions, they often tend to widen them,” researcher and study author Dr Ray Moynihan told The Medical Republic.

One of the most controversial examples of this “diagnosis creep” was in late 2017 when the American Heart Association lowered the threshold for hypertension, effectively labelling half the US population as diseased and driving up treatment rates.

“[Financial ties to industry] raise critical questions about potential bias in processes that may have great impacts on the use of healthcare interventions, disease definitions and patient care,” Dr Moynihan and his team at the Bond University’s Centre for Research in Evidence-Based Practice wrote in the paper.

He and his colleagues are calling for a system like the US’s Sunshine Act, where all payments and benefits to health professionals must legally be made publicly available on a register.

To find out whether there might be any relevant conflicts of interest in Australian guidelines, the team trawled through guideline writers’ research papers from the five years before the guideline was published to see if they had listed any disclosures there.

The guidelines were across 10 disease categories, including cancer, arthritis/musculoskeletal, asthma, kidney/urogenital, neurological and obesity.

In total, 86% of the 402 guideline writers either said they had no ties or disclosed no ties. Yet of those, one in four did have potentially relevant financial ties on further inspection.

The disease areas with the most hidden financial links to industry included cardiovascular disease and diabetes, and the least were found in injury and mental health.

One in three guidelines created by professional bodies had undisclosed conflicts of interest, compared with only 8% of government-funded ones.

Dr Moynihan emphasised that this study wasn’t about shaming individuals, “because we have no idea whether they might have told the guideline development organisation of the tie and that organisation decided not to disclose it”.

“This is a systemic problem.”

At the moment, the repercussions for failing to disclose a financial tie, which may include travel or consulting fees, grants and patents, are about as strong as “being slapped across the face with a wet piece of lettuce”, Dr Moynihan said.

Interest in the role of pharmaceutical money in influencing medical personnel and systems has been growing in recent years, and while there have been known scandals with pharmaceutical money influencing prescribing decisions it’s not been clear what its role has been in guideline creation.

Recent research has found that the conclusions of drug trials were more likely to be favourable to the sponsor in industry-funded trials.

Similarly, when principal researchers had close financial ties to a sponsor, their randomised trials were also more likely to report favourable results.

The Bond University team used the definition of conflict of interest as “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest”.

While the foremost priority of the guideline writer might be to improve health, “a secondary interest could be personal gain derived from a financial relationship with a company active in the relevant therapeutic area.”

“Evidence from other areas, such as clinical trials, has shown such conflicts of interest may introduce bias.”

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daman langguth
1 year 15 days ago

potential relevant ties…a damning indictment

Actual materiel conflict of interest is tied to ongoing financial gain. One can also argue against those in say public hospital settings who are against things as they may increase work for them and thus cost in a non fee for service model.

Saying all that im completely for transparency.