Alan Cassels is a drug policy researcher at the University of Victoria and a regular contributor to the blog. He is also the author, most recently, of The Cochrane Collaboration: Medicine’s Best-Kept Secret. He tweets as @AKEcassels.
As the planet’s premier health policy-making body, the WHO influences healthcare and medical practice around the globe. Their expert committees create reports that underpin guidelines, affecting the health care delivered by practitioners on every continent. When the WHO issues a particularly controversial statement, you’d think the world’s news outlets would be all over it.
But just last week, crickets.
An editorial written by top members of the WHO Guidelines Review Committee contained some very candid remarks that generated, as far as I could tell, zero mainstream news coverage. (Please flag any stories that I might have missed, or which get published subsequent to this post, in the comments and I’ll link to them.) In an effort to distance itself from what many have called a flawed and invalid screening tool created by researchers with extensive financial conflicts of interest that leads to overtreatment of women concerned about their bone health, the WHO officials decided it was necessary to “clarify” the organization’s position on the FRAX® tool for fracture prediction.
The WHO officials wrote that they wished “to make clear that the FRAX® tool to evaluate fracture risks of patients is not a ‘WHO tool’ and has not been developed, endorsed, evaluated or validated by WHO, notwithstanding any public statements and claims to that effect.”
One could have thought otherwise given that groups around the world such as Canadian Osteoporosis Society, the American College of Rheumatology and others claim that FRAX was developed by WHO. Its algorithm has been characterized in media reports as a “WHO formula.”
This risk calculator has gone on to influence osteoporosis guideline makers in Belgium, Japan, the Netherlands, Poland, Sweden, Switzerland, the UK, the US and possibly other countries. But WHO officials note that “any treatment recommendations integrated within the FRAX® tool have not been evaluated by WHO’s Guidelines Review Committee and should not be construed as WHO-endorsed recommendations.”
The backstory here is interesting. The FRAX instrument, created by researchers based at the University of Sheffield in the UK, was developed in 2008 and essentially underwritten by the pharmaceutical industry. Its protocols and algorithms are secret and thus impossible to verify independently. The drug industry’s role is controversial because if the threshold for treatment can be set at a lower level, it means bigger markets for osteoporosis drugs. When it was first being developed and launched, FRAX received some coverage back in 2009 with this and this piece in the New York Times that hit on the controversy surrounding the FRAX formula.
The Times captured the essence of the problem around measuring and medicating bone density, particularly the term “osteopenia” which has been described as a risk for having a risk for having a fracture. The Times quotes Dr. Nelson Watts, director of Bone Health and Osteoporosis Center at the University of Cincinnati who said “the diagnosis [of osteopenia] unnecessarily frightened women and should be abolished.”
As for the FRAX tool, one analysis found that if you applied the FRAX guidelines to patients in one of the largest prospective cohort studies in osteoporosis, then nearly three quarters of US white women over 65 would be candidates for drug therapy. That number rises to 93% for those older than 75.
Much about osteoporosis seems to be controversial, even the role of the WHO from the very beginning. The Times noted, “Indeed, it was a W.H.O. panel financed by the pharmaceutical industry that in 1994 defined normal bone mass as that of an average 30-year-old woman. Because bone naturally deteriorates with age, anyone much older than 30 is likely to qualify for a diagnosis of osteopenia; using similar logic, a middle-aged woman might be said to have a skin disorder because she had more wrinkles than her 30-year-old daughter.”
This situation is particularly irksome for Dr. Karl Michaelsson, an orthopedic surgeon and professor of medical epidemiology at Uppsala University in Sweden, who has written extensively about the FRAX tool and the lack of transparency that went into its creation.
“It’s a black box. We don’t know how they performed their analysis,” he told me over Skype about the FRAX tool. “There are lots of missing data and no external researcher has been able to validate the performance of FRAX,” he said. Why this is a problem for him, and why this issue deserves media coverage, is that “many physicians have been deceived by seeing the WHO logo on the FRAX tool.” He added, “It’s used as a tool for prescribing drugs.”
As for what Dr. Michaelsson thinks about the lack of news coverage as WHO distances itself from the FRAX tool, he said: “It’s of importance to journalists and the general audience–to know how the key opinion leaders are framing the message and interacting with industry to have their message presented in the right way.” It is concerning to him that the developer of the FRAX tool, Dr. John Kanis at Sheffield University, has extensive financial ties to companies selling osteoporosis drugs. The FRAX tool is seen by some independent researchers as a way to get more people to take these drugs.
All I can add is that we’ve known for a long time that the drug industry has extensive involvement in shaping the diagnosis and treatment of osteoporosis including the FRAX tool. Why this isn’t a story on the front pages of newspapers around the world is mystifying but it is a story that has many more chapters.
One thing Karl Michaelsson left me is a future “scoop” for journalists interested in reporting on this story. The same researchers behind the FRAX tool have done a randomized trial that assesses FRAX’s role in the prevention bone fractures. That study, called the SCOOP trial, is scheduled to be published soon and is likely to be promoted and publicized to journalists in ways that the WHO editorial clearly was not.
Armed with this back story, we should all be in a better position to scrutinize any claims coming out of this study and explore industry’s extensive involvement with both the researchers and their deceptively promoted fracture screening tool.