The New York Times reports, “Medtronic Bone-Growth Product Scrutinized.” Excerpt:
“One of Medtronic’s most profitable divisions — selling bone growth products used in spinal fusion procedures — faces growing pressure amid a widening criminal investigation into the company’s marketing of one product and a rejection by federal regulators of another one.
Recently, the Food and Drug Administration turned down the company’s application to sell a new spinal fusion device that is essentially a high-strength version of an approved one called Infuse. An agency review of clinical studies raised questions about a higher rate of cancers in patients treated with the new product, which is called Amplify, compared with those who did not get it.
Meanwhile, a long-running investigation by the Justice Department into the marketing of Infuse is apparently widening.”
Questions of a different sort – basic questions of efficacy – were raised in a study of memantine (brand name Namenda) for Alzheimer’s disease, published in the Archives of Neurology. The Los Angeles Times reported that the drug “won’t delay the loss of memory and cognitive function that comes in the early stages of the disease, a new study concludes.” It also reports:
“The authors suggested that clinical trials conducted by the manufacturer of the drug drew conclusions about its usefulness that were not warranted by the number of patients with mild Alzheimer’s who participated in the studies. They added that clinicians and researchers began aggressive prescribing of the drug without having turned those studies inside out for stronger evidence of effectiveness.”
Some journalists may complain about how we scrutinize stories about early, exuberant claims made about new products. These are good examples of why we do.