Book Reviews | Gordon Campbell | News Flashes | Scoop Features | Scoop Video | Strange & Bizarre | Search

 


"Ma Toot Hurts So Bad" Mock Newly Released Merck Emails

"Ma Toot Hurts So Bad" Mock Newly Released Merck Emails

by Martha Rosenberg
December 7, 2012


Click for big version.

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 disgured," 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."

*************

The complete story of bisphosphonate-linked ONJ is found in Martha Rosenberg's acclaimed expose, Born With a Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Prometheus Books, 2012).

© Scoop Media

 
 
 
 
 
Top Scoops Headlines

 

New HiveMind Project: What Should We Do About Sugar?

While most people agree that increased sugar consumption is a major cause of too many New Zealanders being overweight and obese, what we should do about this remains a matter of debate and argument. More>>

ALSO:


Gordon Campbell: On Vladimir Putin’s Wonderful, Fabulous, Very Good Year

Safe to say that no-one, but no-one has had a better 2016 than Vladimir Putin. What an annus mirabilis it has been for him. Somehow, Russia got away with directly interfering in the US election process, such that a friendly oligarch is about to take up residence in the White House, rather than a genuine rival. More>>

ALSO:


Gordon Campbell: On The Media Normalisation Of Trump

We all supposedly agree that the media is going to hell in a tabloid handbasket, but the trends to the contrary can be a bit harder to spot. In his 1970s book The Right Stuff, Tom Wolfe had mocked the way the media instinctively acts as what he called The Victorian Gentleman. More>>

ALSO:

Binoy Kampmark: The Reality Of Fake News

Fake news as reality; the inability to navigate the waters in which it swims; a weakness in succumbing to material best treated with a huge pinch of salt. That, we are told, is the new condition of the global information environment. More>>

Alastair Thompson: Helen Kelly And The Compassionless People
I wasn't a close friend of Helen Kelly's. But her passing has moved me to tears more than once in the past two weeks. I feel honoured to be one of the many who worked with her and was helped by her. More>>

Postnatal Depression: 'The Thief That Steals Motherhood' - Alison McCulloch

Post-natal depression is a sly and cruel illness, described by one expert as ‘the thief that steals motherhood’, it creeps up on its victims, hiding behind the stress and exhaustion of being a new parent, catching many women unaware and unprepared. More>>

ALSO:

Gordon Campbell: On News From The US Election Eve

Here’s a somewhat scary headline from October 30 on Nate Silver’s 538 site, which summed up the statistical factors in play at that point: “The Cubs Have A Smaller Chance Of Winning Than Trump Does” More>>

ALSO:

Get More From Scoop

 
 
 
 
 
 
 
Top Scoops
Search Scoop  
 
 
Powered by Vodafone
NZ independent news