bisphosphonate bone drugs like Fosamax and Boniva. Osteoporosis prevention had been the only defensible benefit of HRT.
But doctors warned the drug class, because of suppression of bone turnover, would create fractures— and it did. The drugs were also linked to esophageal cancer, including a charge from an actual FDA employee. Dentists frantically called drugmakers about their patients developing osteonecrosis of the jaw on the drug--some having their jaws removed. It was a side effect that Merck knew from animal studies since the 1970s but hid.
What about Prolia and other injected large molecule monoclonal antibody drugs marketed for bones?( Who hasn’ t noticed that mAbs have taken over the pharmaceutical space because“ small molecule” pills are now low margin?)
“ 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 FDA’ s safety analysis of Prolia in 2009. Test monkeys developed tooth and jaw abscesses, and osteonecrosis of the jaw was a“ recognized risk,” said FDA documents. Fractures plagued the large molecule bone drugs, like it did the small molecule.
Beware Blockbuster Drugs
Millions of US women— estimated at a third— were prescribed HRT, which was marketed as a fountain of youth. Was it the GLPs of its time? Don’ t get old? Don’ t be fat?
But studies subsequent to the WHI found HRT doubled the risk of dementia, shrunk the brains of older women, and increased the risk of hearing loss, gall bladder disease, urinary incontinence, asthma, melanoma, ovarian, endometrial, lung cancers, and non-Hodgkin’ s lymphoma. It increased the risk of lobular breast cancer in just three years and the risk of lung cancer fatalities.
Why were HRT( and bone drug) safety signals ignored and harm lawsuits barely reported? The latter usually include gag orders— yes, hush money— to ensure a new stream of drug takers, but risks were in full view.
And why is HRT back? Were all studies— separate and long-running—“ wrong” as the new devotees claim? Or have the revenue from Ask Your Doctor ads and Alphabet’ s( Big Tech) drug companies Verily Life Sciences and Calico so captured media health reporting that it is just messaging for Pharma drugs?
94 The Trial Lawyer