As early as 2004, Merck knew its blockbuster osteoporosis
drug Fosamax was causing osteonecrosis of the jaw (ONJ) after in-office dental
procedures and ridiculed afflicted patients. The condition, also called jawbone
death, occurs when traumatized tissue doesn't heal but becomes
"necrotic" and dies. "Ma toot hurts so bad" mimicked Merck
bone scientist Don Kimmel in a 2004 email to Merck health science consultant
Sharon Scurato about the type of patient who was developing ONJ. Such a patient
"could be an oral hog," wrote Kimmel, then a bone scientist in
Merck's department of Molecular Endocrinology/Bone Biology and trained as a
dentist--someone with pre-existing infections and periodontal disease who omits
preventative care.
Newly available emails and internal Merck documents reveal
the company was far from concerned or surprised when ONJ-links to Fosamax
surfaced in the early 2000's and launched elaborate spin campaigns to keep the
$3 billion a year pill afloat. In fact, animal studies revealed ONJ in rats
given bisphosphonates (the class of drugs Fosamax belongs to) as early as 1977
Kimmel admitted under oath in 2008.
Thousands of lawsuits have been filed on behalf of patients
who say they developed ONJ after dental procedures like tooth extraction
because they took Fosamax. Treating ONJ is almost impossible said dentists and
oral surgeons quoted by the Review-Journal in
2005, because "further surgery in an effort to correct the problem only
exacerbates it, leaving the patient with even more exposed bone and even more
disï gured," Jaw removal, bone grafts, and even tracheostomies were
reported by the News-Press in
2006. "Even short-term oral use of alendronate [Fosamax] led to ONJ in a subset
of patients after certain dental procedures were performed," read a study in
the Journal of the American Dental Association in 2009.
Besides attributing ONJ to patients' bad oral hygiene and,
tautologically, their advanced years, Merck withheld crucial safety data from
the American Society for Bone and Mineral Research (ASBMR) when the group
sought to develop a position paper on bisphosphonate-related ONJ. Of 428
suspected ONJ cases related to Fosamax, 378 of which were highly likely to be
ONJ, only 50 cases were shared with ASBMR, according to court documents.
"I see the 50 with regard to the postmarketing," admitted Thomas
Bold, Merck's director of clinical risk management and safety surveillance in
2009, upon viewing the slides Merck provided to ASBMR. "I don't see 378
mentioned and I don't know why that is the case," he conceded.
Though Don Kimmel (of the "ma toot" joke) was prepared for questioning by Merck lawyers, he said, for "approximately 60 hours," he was similarly confused under oath. He did not remember collaborating with researcher Jack Gotcher until he was shown their co-written paper. "Yes. This looks to be an experiment that Jack did," he allowed, but, when asked "Why is your name on it?" replied, "I think [I] assisted in it, and we talked about it."
Kimmel, an animal research expert who served as longtime Director of Animal Experimentation at Merck, also disagreed with colleague Gotcher's conclusions in a PowerPoint presentation that bisphosphonate drugs "caused ONJ" in rats. Despite decades of his own related research in rats, Kimmel said, "It's not proven that a rat is a reliable model of producing ONJ," and "Dr. Gotcher has a viewpoint." Nor was Kimmel certain about the applicability of experiments on dogs and rabbits to bisphosphonate effects in humans. There's no loss of bone in dogs on the drugs, he lamented, "even when you take their ovaries out" and Merck is repeating already completed human experiments on the drugs on rabbits to build lacking "confidence in the rabbit as an animal model."
Kimmel was less doubtful about the noxiousness of the ONJ
condition itself and admitted to writing "Ooooh! Ickkkkk! Yuckkk! It's
ONJ," on an informational slide he prepared about ONJ. But when asked if
"That's a fair way to describe ONJ, it's icky, yucky, it's something you
don't want to have, right?" Kimmel responded, "The outcome of ONJ is
a lot different than the early cases." END
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