Retraction Watch

Tracking retractions as a window into the scientific process

WHO asks dozens of journals to correct papers on diagnostic tool developed by former collaborators

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In one of the largest such requests we’ve ever heard of, the World Health Organization has asked 46 journals to correct articles that refer to a bone fracture risk diagnostic tool as developed or endorsed by the WHO.

By WHO’s count, the tool — known as Fracture Risk Assessment Tool (FRAX), which has come under scrutiny as experts have questioned its effectiveness — has been linked to the WHO in over 500 scientific articles. The organization wants to change that. The health agency says it has no ties to the tool and claims its developers have spread “misinformation” asserting a link to the WHO. But the tool’s lead developer disputes this, claiming the agency collaborated on the tool from its inception.

Last December, in an editorial published in the Bulletin of the World Health Organization titled “Clarifying WHO’s position on the FRAX tool for fracture prediction,” the organization disavowed a connection to the tool:

By this statement, the World Health Organization wishes 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…Furthermore, according to our records, WHO has not authorized the use of the WHO name, acronym or emblem in connection with the FRAX® tool, including for the tool’s branding, promotion or sale.

WHO’s correction campaign has a long road ahead. By its count, 377 articles referred to FRAX in association with WHO, and 198 articles listed the FRAX developers as being affiliated with a WHO Collaborating Centre after 2010, when the agreement ceased. In all, the articles appeared in 180 different journals.

In February, WHO requested corrections from the 46 journals that published two or more of these papers. According to a WHO statement to us in July, two journals had agreed to issue a corrigendum, and two had declined; nine others expressed interest in publishing a statement from WHO or were deliberating on the matter.

Bone of contention

FRAX was produced by researchers in the Department of Genomic Medicine at the University of Sheffield. The department was designated a WHO Collaborating Centre for Metabolic Bone Diseases from 1991 to 2010. During this time, the group’s leader, John Kanis, chaired the WHO panel that established diagnostic criteria for osteoporosis in 1994.

He also led the development of FRAX, a questionnaire that asks a set of simple questions—like age, sex, previous fracture history, smoking and alcohol consumption—and then calculates a ten-year probability of hip fractures and other major osteoporotic events. Launched in 2008, it has gone on to become widely used, approved by the US Food and Drug Administration and the UK National Institute for Health and Care Excellence, and sold in desktop and mobile app versions.

Researchers have questioned the tool’s effectiveness and methodology. And its developers have been criticized for a lack of transparency regarding the tool’s algorithms, industry ties with pharmaceutical companies that sell drugs that fight bone loss, and inconsistent disclosures of conflicts of interest. (Kanis says he has no competing interests with regard to FRAX, as all financial interests in the tool are owned by the International Osteoporosis Foundation. Kanis was the president of the IOF from 2008 until March 2017, and remains a member of its board and executive committee.)

The field of osteoporosis has been dogged by accusations of overdiagnosis and what a 2015 British Medical Journal piece called a “web of industry, advocacy, and academia.”

Since its launch, FRAX has often been referred to as “a WHO tool” in the scientific literature as well as in mainstream media. A 2009 New York Times article addressing the then-nascent controversy over FRAX wrote of the tool:

Now the World Health Organization has developed an online tool meant to help doctors and patients determine when treatment for deteriorating bones is appropriate.

“Storm in a teacup”

The WHO editorial also referenced the controversy surrounding the tool:

The subsequent scientific literature and one judicial proceeding reflect controversy over the use of this tool to identify individuals at risk of fracture who may benefit from pharmaceutical treatment to improve bone density.

(The “judicial proceeding” reference was a case in a London court to which Kanis was not a party, but a witness. A drug company selling a bone supplement had sought approval from a UK regulatory panel, which asked Kanis to share the underlying data behind the FRAX model to inform its decision. The judge found that Kanis had made a good faith offer to do so on a confidential basis, although the panel had not taken him up on the offer.)

WHO Bulletin editor Laragh Gollogly sent us a statement that blamed the FRAX developers for misrepresenting the WHO’s connection to the tool:

Although the department was a WHO Collaborating Centre from 1991-2010, development of FRAX was not under the terms of this collaboration. Despite this, FRAX developers called their work the “WHO FRAX tool” and stated that it was developed by WHO on the FRAX website, in promotional material, and in dozens of articles on its clinical use.

Kanis told us that he continued to refer to his group as a WHO-affiliated center after the term of the agreement had ended—an error that warranted errata. But he calls WHO’s characterization of its relationship to FRAX “disingenuous:”

This episode is really a storm in a teacup engineered by misinformation somehow fed to the WHO…The development of FRAX was very much under the terms of this collaboration…

He provided us with a copy of his 2000 proposal to renew the WHO Collaborating Centre designation, which appears to outline a plan to develop what would become FRAX:

The objective of this development programme is to provide international and validated practice guidelines for the identification of patients at high or low risk of osteoporotic fracture. […] This programme of work is currently within the terms of reference of the WHO Collaborating Centre at Sheffield.

Kanis said he submitted an editorial to the WHO Bulletin, which was reviewed but not published. In his draft, which he shared with us, he writes that a WHO technical report on FRAX had been planned:

The report was subsequently reviewed by WHO and (at the expense of the Collaborating Centre) edited by a WHO recommended editor. The passage to publication was derailed when WHO asked the Collaborating Centre for an additional $100,000 to publish the report, leading to its subsequent publication via the University of Sheffield. Notwithstanding, the report reviewed and edited by WHO approved the use of the term ‘WHO fracture assessment tool (FRAX)’. Thus, the editorial statement that ‘WHO has not authorized the use of the WHO name, acronym or emblem in connection with the FRAX® tool’, airbrushes history.

In his editorial, Kanis writes:

The question that then arises is what or who inappropriately motivated the WHO to undermine the FRAX tool, the author of this editorial and the field of osteoporosis?

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Written by Mark Zastrow

November 16th, 2017 at 11:10 am

Posted in Geriatric medicine

Comments
  • Robert Marcus November 16, 2017 at 1:02 pm

    I have followed the development of the FRAX tool throughout its entire history. There is no doubt that this occurred under WHO aegis and I view attempts to undermine Dr. Kanis and the other scientists who have presented their work in this area at international bone meetings on a regular basis to be scurrilous. I have never heard any promotional or commercial statements referring to any specific pharmacologic therapy from any of the FRAX investigators, although certainly promotional activities on behalf of pharma may give treatment guideline suggestions based on FRAX data. This is entirely proper. I suspect this controversy is nothing more than a turf war between WHO and the Sheffield group and the outcome of undermining a useful clinical tool will just end up being detrimental to patient care worldwide.

  • Looking Closer November 16, 2017 at 2:16 pm

    Is this the same department as Professor Richard Eastell?

  • Looking Closer November 16, 2017 at 2:28 pm

    We have seen many forms of early stage disease testing, be it colon cancer, breast cancer, bone diseases. Inherently, of course, this may be seen as a good thing. But, and its a big BUT, what about PREVENTION of disease? Instead of cow herding patients into the ever declining pharmaceutical roller coaster where cures are nay to be found, side effects are plenty, should our physicians be advising against such a profit driven strategy, and for example in this case, research into how to prevent the aged from falling over – the leading cause of fracture? Drugs should be the last step used in medical care, not the first.

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