The story is covered in the Harvard Crimson and on the Wall Street Journal Health Blog (Hip-Protector Maker Sues Harvard Doc Over JAMA Study)
The JAMA study, published last year, involved more than 1,000 people at 37 different nursing homes. Participants wore a hip protector on one side of the body. Over 20 months of follow-up, the study found that there was no difference in fracture rate between the protected and unprotected sides. The upshot of the JAMA paper was that:
"In summary, this large multicenter clinical trial failed to demonstrate a protective effect of a hip protector on hip fracture incidence in nursing home residents despite high adherence, confirming the growing body of evidence that hip protectors are not effective in nursing home populations."So why is the author being sued? Well, the makers of the Hipsaver device state that
"These results add to the increasing body of evidence that hip protectors, as currently designed, are not effective for preventing hip fracture among nursing home residents"
"The researcher’s JAMA-published conclusions have wrongfully damaged the entire field of hip protection, including the HipSaver brand".According to the Harvard Crimson: "Representatives for HipSaver accuse Kiel of deliberately using one particular type of hip protector that is inferior to many of the protectors on the market and concluding that all hip protectors were not effective."
"It would have been more appropriate and scientifically accurate for Dr. Kiel to limit his conclusions to the specific hip protector that he studied"
"It is totally irresponsible for public health opinion leaders with tax-funded grants to study and publish the results of a dud hip protector and then trash the entire field of hip protection."
There is indeed increasing evidence from other sources that hip protectors are not as useful as initially hoped (See Cochrane Review : BMJ 2006;332:571-574 - "Pooling of data from three individually randomized trials of 5135 community dwelling participants showed no reduction in hip fracture incidence with provision of hip protectors.")
Robert L. Hernandez, who is representing HipSaver, described Kiel’s article as "disparaging" and "grandiose".
The bottom line however is that there is no good evidence that the Hipsaver device works any better to prevent fractures. Hipsaver imply (without any evidence) that their device would prevent more fractures than the chosen device. So what do Hipsavers cite as their "evidence". On their website, they cite their best evidence for efficacy - a 13 month long uncontrolled study of 38 individuals who wore a hip protector.
And guess what: "Number of hip fractures in HipSaver wearer group was: 0"
Now that is some evidence. Firstly, the expected hip fracture rate in elderly individuals at risk is (ballpark) 2% per annum. So the expected number of fractures in these 38 individuals would have been around ......... 1 fracture...... maybe.
Furthermore, we can calculate the upper confidence limit of a reported zero fracture rate at N=38 (See here for calculation). All we can say on the basis of Hipsaver's experiment is that the 95% upper confidence limit of the event rate in these "Hipsaver protected" individuals is around 7.5% per year. In other words the information content of HipSaver's experiment is almost zilch.
To make matters even more depressing, the JAMA paper received publicity last year when it was reported that three of the authors received money from makers of bone-strengthening drugs and failed to disclose that potential conflict to JAMA.
The field of osteoporosis - my field - is sadly a minefield of bad science. It is dominated by a powerful clique of characters who live in a parallel universe in which the normal rules of science are ignored. By their silence, these individuals have lent tacit support to all sorts of inappropriate things, including legal bullying. Dr Kiel is not part of that clique, but I didn't notice any enquires from the Harvard bone fraternity when I tried to stand up for honest science. Well you know guys, every time you remain silent, you are casting a vote for the kind of science you want.
Or, as Helen Keller said:
Science may have found a cure for most evils; but it has found no remedy for the worst of them all - the apathy of human beings.Earlier|Later|Main Page
(Helen Keller, My Religion)