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Fosamax July 20
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Did Reports Of Side Effects Contribute To Drop In Bone Drug Use?
Jul 17, 2015 | Reuters
By Lisa Rapaport
...Fosamax (alendronate sodium) won U.S. marketing approval in 1995. Widespread use of the drug and others like it over the next two decades coincided with a dramatic drop in hip fractures, the researchers note in the Journal of Bone and Mineral Research... -
Takeda Ruling On Expert Standards To Ripple Beyond Actos
Jul 17, 2015 | Law360
By Sindhu Sundar
...At the heart of the appeal was the trial court's ruling striking the testimony of the plaintiffs' expert Norm Smith, an oncologist who specializes in urinary tract cancers. Plaintiffs attorneys say that defendants have cited that opinion in other cases — including litigation with Merck & Co. Inc. over osteoporosis drug Fosamax's alleged femur fracture...
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Did Reports Of Side Effects Contribute To Drop In Bone Drug Use?
Jul 17, 2015 | Reuters
By Lisa Rapaport
Media reports raising safety concerns about osteoporosis drugs known as bisphosphonates may have contributed to a sharp drop in their use - even though U.S. doctors and drug regulators haven’t recommended against taking them, a study suggests.
Fosamax (alendronate sodium) won U.S. marketing approval in 1995. Widespread use of the drug and others like it over the next two decades coincided with a dramatic drop in hip fractures, the researchers note in the Journal of Bone and Mineral Research.
Starting in 2006, a series of media reports highlighted research linking the drugs to rare but serious side effects, including unusual fractures of the thigh bone, death of bone tissue in the jaw and esophageal cancer.
...For older women, the risk of fall-related injuries is compounded by osteoporosis, or thinning bones, which occurs when production of the hormone estrogen declines after menopause.
Fosamax, as well as similar drugs such as Actonel (risedronate sodium) and Boniva (ibandronate sodium), work by slowing down the process by which the body removes old bone, which allows time to rebuild normal bone. The drugs can help prevent bone loss and also regrow bone to make fractures less likely.
Using data from Google, Battacharyya and colleagues looked at patterns in online searches for Fosamax and other bisphosphonates, and found a series of spikes from 2006 to 2010 that lined up with heavy media coverage of side effects associated with the drugs.
The first prominent spike in the Google data lined up with media reports about the first lawsuit filed against Fosamax maker Merck & Co. over the death of jaw tissue.
Another surge in Google searches occurred in 2008 after a study in the Archives of Internal Medicine linked the drug to an increased risk of an arrhythmia called atrial fibrillation.
There was also a sharp increase in 2010, when ABC World News aired a segment highlighting studies being presented at the American Academy of Orthopedic Surgeons linking Fosamax to atypical fractures of the femur, or thigh bone.
Oral bisphosphonate use peaked at 15.8 percent of women older than 55 in 2008, and topped out at 1.9 percent of men in 2010.
White women, rural residents and women with less than a high school degree were more likely to shift away from the drugs, the study found...
For full story:
http://www.reuters.com/article/2015/07/17/us-health-bones-bisphosphonates-idUSKCN0PR1XL20150717
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Takeda Ruling On Expert Standards To Ripple Beyond Actos
Jul 17, 2015 | Law360
By Sindhu Sundar
A California appellate court's finding that a plaintiffs expert didn't have to rule out all other possible causes of a man's bladder cancer beside's Takeda Pharmaceutical Co. Ltd. drug Actos will help plaintiffs combat companies' growing insistence on stricter standards for expert testimony, attorneys say.
...At the heart of the appeal was the trial court's ruling striking the testimony of the plaintiffs' expert Norm Smith, an oncologist who specializes in urinary tract cancers. Plaintiffs attorneys say that defendants have cited that opinion in other cases — including litigation with Merck & Co. Inc. over osteoporosis drug Fosamax's alleged femur fracture risks — to support their arguments for a higher bar for plaintiffs expert testimony. The appeals court's ruling now gives attorneys a way to undermine the influence of that opinion in other cases, they say.
"This opinion was being paraded around as a new standard for the proper conduct for differential diagnosis," said Tim O'Brien of Levin Papantonio Thomas Mitchell Rafferty & Proctor PA. "Our hope is that this extreme view of differential diagnosis methodology now stands corrected."...For full story:
http://www.law360.com/articles/680521/takeda-ruling-on-expert-standards-to-ripple-beyond-actos
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