A perfect storm for broken bones or for disease-mongering of osteoporosis?

Last week in The New York Times, Jane Brody predicted “A Perfect Storm for Broken Bones.”  But the column has elements of a perfect storm of disease-mongering.

She writes that “fewer adults at risk of advanced bone loss and fractures are undergoing tests for bone density, resulting in a decline in the diagnosis and treatment of osteoporosis” which “threatens to derail the progress that has been made in protecting the bone health of Americans.”

Brody’s column promotes the idea that more drug treatment is required, when, in fact, almost everything about osteoporosis is the subject of intense debate: the link between bone density and fracture risk, the usefulness of the tests for low bone density, the role of the pharmaceutical industry in reconceptualizing risks as disease, the notorious expanding disease definitions which contribute to overdiagnosis, as well as the marketing of drugs often of minimal benefit and evidence of substantial harm.

The study which forms the main basis of this article, describes hip fracture rates between 2002 and 2015 declining over most of that period but leveling off since 2012.  The single biggest factor blamed on this leveling of rates is fear of the adverse effects of osteoporosis drugs. Those fears have certainly been stoked by FDA warnings indicating that longer term use of bisphosphonates increases one’s risk of developing an “atypical” fracture of the femur or thighbone.  Taking a drug because of concern about fracture risk from osteoporosis, only to find it could cause the spontaneous snapping of the largest bone in one’s body is enough to make many people think twice.   Surely there have been other factors that might affect hip fracture rates, but the story doesn’t discuss any. For every research group claiming that osteoporosis is underdiagnosed and undertreated, there are those on the other side–including patients, researchers and clinicians– pointing to evidence that it is overdiagnosed and overtreated.

Osteoporosis: The emperor has no clothes

One of those researchers who has delved deep into – and written widely about – these controversies is Teppo Järvinen, MD, PhD, an orthopedic surgeon and researcher from the University of Helsinki in Finland.

“In my opinion, overstating the need to treat osteoporosis and downplaying the dangers of osteoporosis drugs together amount to a perfect storm of disease mongering,” wrote Järvinen in an email.  “It is easy to exaggerate the effects of osteoporosis drugs, and maintain the fiction that vertebral fractures, which are rarely associated with any pain or other symptoms, are deadly and serious.  Both of these are among the many tactics used to sell more drugs in the name of fracture prevention.”

In a journal article, “Osteoporosis: the emperor has no clothes,” Järvinen and colleagues wrote that the evidence supporting the use of bone-targeting drugs to prevent hip fractures is limited to women between 65 and 80 with established osteoporosis (whereas there’s meager proof the drugs help women over 80 or men at all ages).  He noted specifically that the “anti-hip fracture efficacy shown in clinical trials is absent in real-life studies [while] many drugs for the treatment of osteoporosis have also been associated with increased risks of serious adverse events.”

You can learn more about Järvinen’s research in a 2015 podcast we produced with him.

So when the New York Times sounded the alarm bells and decried the alleged treatment gap in osteoporosis without delving into these many controversies, the newspaper delivered a serious disservice to their readers.

Interviewing sources with conflicts of interest

Perhaps one of the reasons why the Times presented a one-sided argument promoting more osteoporosis drug treatment is that most of the authors of the journal article upon which the column is based have deep financial connections to a wide range of osteoporosis drug makers.  In particular, the lead researcher discloses that he received “institutional grant/research support from Amgen, Merck, and Lilly; he has served on scientific advisory boards for Amgen, Merck, Lilly, and Radius.”  Other authors’ admitted conflicts include:

• One is a paid data analyst for the International Society for Clinical Densitometry.
• One is a consultant for Amgen and Radius.
• One has received institutional grant/research support from Amgen and is a consultant for Pfizer.
• One has received research grants from Amgen, Lilly, and Merck and has served on scientific advisory boards for Amgen, Merck, and Radius.
• One has served on scientific advisory boards for Amgen, Lilly, and Radius; is a consultant for Amgen, Lilly, Merck, Radius, Medtronic, and Hologic; and is on the speakers’ bureau for Amgen and Lilly.

In this case, an independent expert could have reminded readers that this was an observational study, and may have been affected by uncontrolled or uncontrollable biases. There are other possible hypotheses which could explain the leveling off of hip fracture rates that have absolutely nothing to do with osteoporosis testing and treatment. For example, the overuse of certain types of drugs such as sedatives, benzodiazepines and opioids can affect the rate of falls and fractures and yet it is clear that those effects were not accounted for in this study.  One might even assert a strong counter-hypothesis: that it is the increased use of opioids in the years from 2012 to 2015 which could help explain the increase in hip fractures.

Disconnect with readers

There was a perceptible disconnect between the Times column and what may be going on with so many women.  The article quotes one bone specialist: “many patients, even those who unequivocally need treatment, are either not being prescribed osteoporosis medication at all, or when prescribed, refuse to take them.” Osteoporosis treatment decisions should be a matter for fully-informed shared decision-making encounters between patients and doctors.  “Unequivocal need” for treatment might be questioned by some women in such settings.

There was an even more clear disconnect between the Times column and some of its readers, who left online comments such as:

• “It’s really not worth reading Jane Brody’s columns since one can find the same point of view in the barrage of Big Pharma marketing to which we are subjected. I’ve nothing against bone density scans (I’ve had two so far), but if the rationale for them is to get more women on Fosamax etc., much of the research seems to indicate that the outcome would be not only harmful, but difficult to reverse.”
• “I was disturbed by Jane Brody’s article- and felt she was simply writing for the drug companies, not sharing a true overall picture.”
• “I have been asking every clinician I see and have searched Pub Med for years, in search of the clinical proof of bone density increases (or in the least, a halting of the process that results in bone loss). My search comes up empty. And not one clinician has been able to find me a journal publication demonstrating density improvement….The medical profession wonders why we are skeptical? Give me answers to my questions.”
• “An excellent critical overview of the osteoporosis drugs is “Osteoporosis: The Emperor Has No Clothes,” published by Jarvinen et al. in 2015. The language used by Brody throughout her piece, e.g., ‘should be treated,’ and the multitude of quotes by physicians pushing the drugs, with not a single viewpoint from either a dissenting physician or a patient who has suffered one of the allegedly “very rare” side effects, reflects badly on The NY Times, which ought not be proselytizing for drug treatment under the guise of objective journalism.”

As we wrap this up, more than 250 reader comments have been left online following the Times column demonstrating the intensity of the public dialogue and debate, and further demonstrating how the Times column could have been improved.

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Disclosure: Alan Cassels is a pharmaceutical policy researcher at the University of Victoria and has collaborated on projects with Teppo Järvinen, MD, PhD, quoted in this story, and other researchers at the University of Helsinki.