Jane McCredie: Basic flaws

WE’VE heard much in recent years on the potential for clinical researchers’ relationships with industry to skew published research findings, with flow-on effects on prescribing and other aspects of clinical practice.

This Cochrane review, for example, last year found industry-sponsored trials of drugs and devices were more likely to report favourable results for both efficacy and harms and to reach overall positive conclusions about the treatment being studied.

But what about industry involvement in basic scientific research?

On the face of it, you might think basic research would have little impact on clinical practice, but Dr Adriane Fugh-Berman, who researches industry-physician relationships at Georgetown University in the US, argues it is widely used to support pharmaceutical marketing.

Animal and even cellular studies are used by manufacturers to promote off-label prescribing, to reduce concern about side-effects and to create a buzz about forthcoming drugs, she writes in PLOS Biology.

A former pharmaceutical executive, communicating on condition of anonymity, told Dr Fugh-Berman about some of the ways preclinical work is used by the industry to support clinical messages.

“The work of basic scientists is used for indirect and sometimes direct marketing to highlight a therapy’s mechanism of action, to suggest surrogate markers of safety and efficacy, and to differentiate a product from competitors’ [products]”, he writes.

Dr Fugh-Berman describes her own experience as a doctor in the early 2000s, facing the marketing push to prescribe hormone replacement therapy (HRT) to postmenopausal women off-label for possible prevention of cardiovascular disease and dementia.

“No randomized controlled trials with disease endpoints supported this use”, she writes, “so [physicians paid by the company] invoked observational studies, studies with surrogate endpoints (ie, cholesterol-lowering), experimental animal studies, and even cell-culture studies.”

One industry slide shown at medical meetings compared brain cells grown in media with and without oestrogen, she writes.

“Brain cells grown in estrogen-free media were shriveled and dying, a pathetic counterpoint to the vigorous confluence of cells grown in estrogen-containing media.”

Whatever your take on the whole HRT debacle, it would seem unwise to assume the results of that kind of study would be automatically replicated in living human brains.

There has been little focus so far on whether industry funding of basic research has the potential to skew results in a similar way to clinical research, but Dr Fugh-Berman believes there certainly should be.

She cites evidence suggesting industry sponsorship may indeed encourage positive findings in basic research as well as discouraging publication of less favourable results.

The anonymous pharma executive told her: “It is to industry’s advantage to selectively support particular researchers whose point of view supports marketing goals, and to encourage selective publication of articles.”

Unsurprising perhaps, but the bottom line is any research used to market drugs or other treatments needs to be subjected to rigorous scrutiny, whether it’s a full-blown clinical trial or a few cells in a Petri dish.

Jane McCredie is a Sydney-based science and medicine writer.