Bisphosphonates? Who needs them

These days even a diagnosis of mild bone loss (osteopenia) is likely to have you walking out your physician’s door with a prescription for a bisphosphonate drug – most likely Fosamax, Actonel or Boniva. As new clinical guidelines around who should be screened for osteoporosis are set to net most of the female US population over the age of 50, bisphosphonate prescriptions are soaring, as vast numbers of healthy individuals are exposed to their effects for better or worse.
When it was revealed in 2002 that the harms of hormone replacement therapy (HRT) outweighed the benefits, its demise was the moment bisphosphonate manufacturers had been waiting for. By 2006 Fosamax prescriptions totaled 22 million and annual sales of these drugs reached a staggering US$8.3 billion by 2009. Persuasive advertising, and exaggerated scenarios linking osteoporosis hip fractures to an untimely death easily convinced women to move from one questionable drug therapy to another.
But it now seems to be a case of history repeating itself. As the balance of benefit to harm weighs heavily towards serious damage from these drugs, bisphosphonates are well on the way to being shrugged off as another medical mistake of gargantuan proportions.
After decades of indiscriminate prescribing to mostly well individuals, the attitude of the experts who vehemently promoted the drugs is noticeably toned down. The accumulating evidence that bisphosphonates can cause severe adverse effects including spontaneous fractures of the femur (thigh bone), has the experts quietly recommending patients who have taken the drugs for five or more years take a ‘drug holiday’. In a November 2010 LA Times article Dr. Felicia Cosman, clinical director of the National Osteoporosis Foundation is quoted as saying: “it’s ironic that many of these cases of femur factures were in women with mild bone loss who probably should not have been on these drugs…We probably used too many bisphosphonates in too many women for too many years. “
And what about the benefits? Close scrutiny of the evidence indicates that these are drugs that probably don’t prevent fracture at all. Apart from a possible short-term reduction of vertebral height “fractures” determined by x-ray in a very small percentage of high-risk patients, hip fractures are NOT reduced, and may in fact be increased in bisphosphonate users. A large cohort study from Denmark of 16,000 women over 8 years found the incidence of hip fractures was higher in the women taking Fosamax. And a large US trial also found that wrist fractures were higher in the group taking Fosamax. In the long term there is an increased risk of ‘atypical’ (i.e. sudden and spontaneous and slow healing) fractures of the hip and thigh.
Given that the potential harms now include jaw osteonecrosis (bone death), pain affecting the bone, joints or muscles, atrial fibrillation, esophageal cancer and spontaneous fracture, some clinicians and researchers are calling for immediate suspension of the use of these drugs.
New drugs waiting in the wings like the FDA-approved drug Prolia look set to take over from the bisphosphonates. Prolia has huge potential for harm. And huge potential for profit – predicted to bring in US$2.1 billion by 2012. Sound familiar?
For more on this and all aspects of the osteoporosis industry and on maintaining bone health read my newly revised book The Myth of Osteoporosis.

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