Volume 194 - Issue 1
Impact of adverse news media on prescriptions for osteoporosis: effect on fractures and mortality
Authors: Paul J Sambrook, B E Christopher Nordin and Alastair N Goss
Med J Aust 2011; 194 (1): 51-52. || doi: 10.5694/j.1326-5377.2011.tb04153.x
Published online: 3 January 2011
Published online: 3 January 2011
To the Editor: The article by Philip Sambrook et al on the impact of adverse news media on prescriptions for osteoporosis1 contains a number of serious errors and ignores more recent data.
Their article quotes the estimated incidence of osteonecrosis of the jaw (ONJ) after oral bisphosphonate treatment for osteoporosis to be between 1 in 10 000 and 1 in 100 000 patient treatment-years. This is in fact a gross underestimate.2 The results of an independent study funded and conducted by the United States Food and Drug Administration (FDA) found an incidence of between 1 in 537 and 1 in 1537.3 This result is similar to that of an independent Australian study, which found an incidence of 1 in 296 to 1 in 1130.4 Thus, there is evidence that bisphosphonate-associated ONJ is much more common in patients treated with oral bisphosphonates for osteoporosis than the authors claim.
Bisphosphonate-associated ONJ is also much more serious than presented. Patients with ONJ can be affected for years. The condition causes considerable morbidity, with greater interference in a patient’s life than the condition of osteoporosis and vertebral fractures.
It should be noted that the FDA study3 and the Australian study4 were based on documented cases of ONJ, whereas the study by Sambrook et al1 was not based on actual fractures. It is unfortunate that, despite the wording of the Pharmaceutical Benefits Scheme (PBS) regulations, the Pharmaceutical Benefits Advisory Committee has let it be known that osteoporosis diagnosed by bone mineral density is not a requirement for PBS-supported bisphosphonate therapy — all that is required is a minimal trauma fracture, although it is well known that most patients with minimal trauma fracture do not have osteoporosis (however that is defined).5
The issue of adverse effects of bisphosphonate treatment for osteoporosis is currently being tested by a US class action. In the bellwether case of Boles v Merck & Co,6 the issue being tested is whether it was appropriate to prescribe alendronate for a patient with osteopenia but no fractures, and how much this treatment contributed to the patient’s end-stage ONJ. The plaintiff had exposed bone, constant pain, a pathological fracture, and pus dripping from her chin. The New York Supreme Court found in her favour.
Despite the claim by Sambrook and colleagues that unbalanced media coverage “has the potential to do more harm than good”,1 the media do have an important role to play in exposing to the public the risks of pharmaceutical products and the actions of some pharmaceutical companies. It should be noted that Professor Sambrook was not only involved in The 7:30 Report current affairs program, but was also subsequently granted the unusual right of reply on that program. Following these two programs, the public made its decision based on facts about the incidence and morbidity of ONJ that have been confirmed by recent independent studies.3,4,6
Competing interests
Alastair Goss has been a consultant to Merck and Novartis on ONJ, and has provided expert testimony for the plaintiffs in the US class action against Merck with respect to alendronate.
References
- Sambrook PN, Chen JS, Simpson JM, March LM. Impact of adverse news media on prescriptions for osteoporosis: effect on fractures and mortality. Med J Aust 2010; 193: 154-156.
- Khosla S, Burr D, Cauley J, et al. Bisphosphonate-associated osteonecrosis of the jaw: report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res 2007; 22: 1479-1491. 0_i1095865
- Lo JC, O’Ryan FS, Gordon NP, et al. Prevalence of osteonecrosis of the jaw in patients with oral bisphosphonate exposure. J Oral Maxillofac Surg 2010; 68: 243-253. 0_i1095867
- Mavrokkoki T, Cheng A, Stein B, Goss A. Nature and frequency of bisphosphonate-associated osteonecrosis of the jaws in Australia. J Oral Maxillofac Surg 2007; 65: 415-423. 0_i1095869
- Stone KL, Seeley DG, Lui LY, et al. BMD at multiple sites and risk of fracture of multiple types: long-term results from the Study of Osteoporotic Fractures. J Bone Miner Res 2003; 18: 1947-1954. 0_i1095871
- Boles v Merck & Co. Case no. 06-CV-9455. In re Fosamax products liability litigation, MDL 1789, US District Court, Southern District of New York (Manhattan). 0_i1095873