Tuesday, March 04, 2008

Threats and Hipsavers in osteoporosis - rescuing science from lawyers

A Harvard researcher who published a study in JAMA that showed that a particular hip protector doesn't reduce the risk of fractures in the elderly is being sued by a company (Hipsaver). Hipsaver makes a different hip protector.

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."

"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"
So why is the author being sued? Well, the makers of the Hipsaver device state that
"The researcher’s JAMA-published conclusions have wrongfully damaged the entire field of hip protection, including the HipSaver brand".
"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."
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."

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.
(Helen Keller, My Religion)
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soulful sepulcher said...

"Well you know guys, every time you remain silent, you are casting a vote for the kind of science you want."

This is SO true. As an advocate in the mental health system, I can safely say that having only one voice is a difficult platform to win a battle. There were times, several times, when someone else could have spoken up, and did not, and my answer was this, what you wrote. Silence offers up an agreement and an apparent side to the bully party.

This is one time, yours and what I did, where silence is NOT golden.

On the hip device: maybe there were no fractures because who could move with that thing on?!
Just remember though in the end, it is the one person who spoke up and did the right thing; who is the right one.

Standing up for the right thing comes with a lonely road, and the ones who walk it should be held in high regard.[that means you Aubrey].

Anonymous said...

Excellent post.

Here is the blog of a law professor who is an expert in this area of law.


Radagast said...

This is bollox! The Law of Defamation does not cover opinion fairly held on a matter of public interest. Unless, that is, the US take on this area has changed things around!

Moreover, one cannot libel a class, and one cannot libel an inanimate object (unless, possibly, that implicates the manufacturer of said object). Only companies and people can be libeled. I could say that all scientists were charlatans, and give generic examples of the sort of things that they did, but no single scientist would be able to sue me.

The test is this: would the plaintiff's reputation have been unfairly damaged by the comments, in the eyes of the public? Unless detail was included (by the researchers) that specifically draws attention to the product mentioned, in this case, then the plaintiff is bargaining in the shadow of the Law, and has actually drawn attention to its own product as being one of the ineffective (as alleged by the study) hip protectors.

Jesus, any first year (freshman) Law student could shoot holes in Hipsaver's argument. To reiterate: unless opinion has been expressed that specifically identifies Hipsaver's product, and the comments are made maliciously (ie, not just being fair comment on a matter of public interest), then Hipsaver is wasting its time.


Anonymous said...

Here's another blog post on this:



Radagast said...

As an afterthought, I think that this is an important case. Not on the basis of the subject matter under discussion, but for the fact that it might set a precedent, such that if Hippo win, academics become (even more) afraid to say "controversial" stuff about dubious drugs and devices.

I'm not sure whether I want Kiel to file for dismissal, or go to court and trounce Hipsway.


Anonymous said...

Professor Tushnet now has a discussion of the case on her blog, with a link to your post.



Anonymous said...

Dear dear.

Take all the lawyers and drown them in the blood of all the people they have screwed up.