Osteoporosis is said to afflict 1 in 3 women over 50 , but some medical sources disagree . The British Medical Journal ( BMJ ) observes that osteoporosis advocacy groups are funded by drugmakers , which leads to broadened diagnostic criteria .
An article in the British Journal of Nursing notes that “ the marketing of osteoporosis has created the impression that all women ( and many men ) are at risk of suffering fragile bones , hip fracture , and death . Large sums of money have been spent on raising awareness , diagnosing , and treating osteoporosis .” PLOS research also states that osteoporosis “ has the potential to be overdiagnosed since , according to its definition , many otherwise healthy people are labeled with a ‘ disease .’”
Nonetheless , bone drugs such as bisphosphonates have vaulted in popularity — Fosamax alone netted $ 3.05 billion in 2007 . But even as the drug class boomed , serious safety signals surfaced . By 2009 , FDA reports revealed 23 cases of esophageal cancer , and Fosamax was “ the suspect drug ( in 21 patients ) or the concomitant drug ( in 2 patients ), according to a letter published in The New England Journal of Medicine . Bisphosphonate patients also experienced inflamed / ulcerated esophagi , atrial fibrillation , intractable pain , osteonecrosis of the jaw ( ONJ ), and the very fractures the drugs were supposed to prevent .
As early as the 1970s , Merck knew about ONJ effects in rats , according to internal emails . As risk emerged , the drugs seemed to be a triumph of marketing over medicine .
A New Bone Drug Debuts
When the biotech drugmaker Amgen launched Prolia ( denosumab ) in 2009 , a novel monoclonal antibody biologic to be injected every six months , many hoped it would be safer . But background documents for FDA hearings didn ’ t bode well . “ Three subjects , two of which were healthy subjects under the age of 35 , required hospitalization for pneumonia after a single dose of denosumab ,” noted the Denosumab Safety FDA Analysis . Test monkeys developed tooth and jaw abscesses on the drug , and osteonecrosis of the jaw was a “ recognized risk ” with denosumab , documents stated .
Sadly , by the time it was approved , Prolia posed the same significant risks — ONJ , atypical femoral fractures , pain — as bisphosphonates , according to the drug ’ s warnings and precautions . It also had a higher price tag at $ 2,557 a year and patients were cautioned that “ multiple vertebral fractures could occur upon discontinuation of Prolia treatment ” — a side effect not seen with bisphosphonates .
Why do both bisphosphonates and Prolia encourage osteonecrosis of the jaw — exposure of jaw bone through lesions that don ’ t heal and often linked to invasive dental procedures ? Both drugs suppress “ bone remodeling ” ( renewal ) to prevent bone resorption / thinning , and the jaw bone “ has a higher remodeling rate than other bones ,” write ONJ researchers in StatPearls . Yes , the drugs may increase bone density , wrote researchers in Nature , but they “ also increase … bone brittleness ,” and the paradoxical actions may “ provoke local fractures .”
According to the European Journal of Cancer , ONJ is a serious condition and may result “ in a chronic disease with negative impact on the quality of patients ’ lives .”
Aggressive Marketing
Two weeks after Prolia ’ s FDA approval , Amgen deployed up to 1,000 drug reps to call on doctors and sell them on Prolia by focusing on the high discontinue rate of bisphosphonates . Today , instructions in Amgen ’ s “ Patient Identification Series ” tell doctors how to recognize patients who “ may look perfectly fine on the outside ” but are “ failing ” or “ intolerant ” on bisphosphonates , the competitor bone drugs . Prolia doctor marketing also includes a “ Coding and Billing Information Guide ” showing exactly how to fill out Medicare forms for the drug .
Switching patients from bisphosphonates to Prolia may be a lucrative marketing strategy , but research in both the journal Odontology and in Case Reports in Dentistry notes the switch furthers fracture risks and ONJ risks , respectively .
Harmed Patients
Many patients have spoken out about the side effects of taking bone drugs . On the Webby-winning website Askapatient . com , of 263 women in their 50s and older who had been prescribed Prolia , approximately 250 gave the drug the lowest possible rating . Most women cited incapacitating pain and weakness in their bones and joints along with dental pain , tooth degradation , and tooth loss .
A 64-year-old woman says she sustained an atypical femur fracture and left femur damage after a year on Prolia and a 78-year-old woman wrote that after one year on Prolia , she broke a toe . More women expressed fear of fractures if they stopped Prolia as prescribing materials warn . Being effectively “ stuck ” on Prolia , several women say their lives are “ over .” Many said Prolia should be removed from the market .
Some women wrote that they became debilitated and bedridden from Prolia after leading active , energetic lives . Some said they now require a cane to walk , and two wrote that they
The Trial Lawyer x 31