Misconduct roundup 17 May 09

UK Universities Preventing openness over research misconduct

The Times Higher Education Supplement reports on the ongoing attempt in the UK to prevent proper, open, independent and transparent investigation of research misconduct. It turns out that Research Councils UK (RCUK) attempted to induce Universities UK to allow the formation of a "national body for research integrity with powers to investigate allegations of misconduct". They "consulted" with the Universities who refused to go along with this citing "concerns that such a body would be trespassing upon employer responsibilities".

So following this "consultation" RCUK simply shied away from the idea. The body will now be "advisory".

My own very thoughtful response was cited in the article:

Aubrey Blumsohn, a campaigner for greater openness in research conduct, dismissed the plans. "Experience from a multitude of cases has rudely shattered the idea that it will ever be possible for institutions to investigate themselves ... It is a bit like using a condom with hundreds of holes and calling it safe sex."

So what is this all about? It seems obvious that "investigations" of scientific misconduct should themselves align with the usual principles of scientific discourse (open discussion, honesty, transparency of method, public disclosure of evidence, open public analysis, and public discussion of reasoning underlying any conclusion). This is not what UK Universities are trying to achieve. When you see universities reluctant to investigate things properly, it provides reasonable evidence that they really don't want to investigate things properly.

And this is precisely why Universities UK (or it's Monty Pythonesque "Panel for Research Integrity") have not commented on the role of UK Universities in scientific misconduct or its coverup here, here, or here (three random examples).

More concern over osteoporosis drugs

Here back in my own area of voyeuristic interest (skeletal medicine and calcium physiology) we have a very slowly expanding issue which raises questions as to how we should define scientific fraud.

This paper just out in electronic version in the Journal of Bone and Mineral Research adds to the chatter of concerns about bisphosphonates.

Bilateral Fractures of the Femur Diaphysis in a Patient with Rheumatoid Arthritis on Long-term Treatment with Alendronate : Clues to the Mechanism of Increased Bone Fragility. J Bone Miner Res. 2009 May 6. Somford MP, et al.

Unusual fractures of the femur diaphysis have been reported in patients treated with alendronate and although no causal relationship has been established, excessive suppression of bone turnover and length of treatment with alendronate have been implicated in their pathogenesis. We report here clinical, biochemical and radiological findings of a patient with rheumatoid arthritis and multiple risk factors for fractures who was treated with alendronate for 8 years and developed spontaneous bilateral subtrochanteric/diaphyseal fractures. Bone biopsies obtained form the iliac crest and the femur revealed decreased bone formation with histomorphometric evidence of markedly increased bone resorption at the femur. These results show for the first time that an imbalance between bone resorption and bone formation at the affected bone is associated with the occurrence of these atypical femur fractures. The cause of this imbalance is currently unknown and further studies of the epidemiology and pathogenesis of diaphyseal femur fractures are warranted.

In my view, these are very useful drugs. However, I suspect we are going to see a lot more of this and other problems with time. Perhaps there will be the usual faux regret that we didn't get the thresholds at which undoubted benefit exceeds risk quite right.

Is this fraud? There is a type of "groupthink" and incremental data manipulation by bribed clinicians that has led a whole field of science astray.

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The fake editorial board of Merck's fake bone journal

My previous post was about a fake scientific bone journal produced by Elsevier and paid for by Merck.

I thought it interesting to look at the editorial board - and at the names of my previous esteemed academic colleagues within the bone field who would lend their names to such fakery. The fake editorial board (see here) of this fake journal includes some well known luminaries (Reid, Seeman, Ebeling).

As an aside, Professor Peter Brooks was Executive Dean of Health Sciences at the University of Queensland at the time the University came down hard on Dr Andrew Gunn for asking scientific questions in public about a Merck drug which earns the University a mint (Brooks was not one of the bullies).

Also of interest is the regular appearance of clinicians who held postdoctoral positions at the Mayo Clinic (Rochester, Minnesota) from 1975 to 1985 in the list of clinicians involved in dubious practices in the field of osteoporosis. In this instance, even though this is an Australasian list, there are two such appearances (Peter Ebeling and Ego Seeman both trained at the Mayo under Professor Larry Riggs).

Editorial board of "The Australasian Journal of Bone and Joint Medicine"

Dr Jim Bertouch
Consultant Rheumatologist, NSW

Professor Peter Brooks
Executive Dean (Health Sciences)
University of Queensland

Professor Richard Day
St Vincent's Hospital, NSW

Professor Peter Ebeling
Royal Melbourne Hospital

Professor John Hart
Monash University

Professor Michael Hooper
Concord Repatriation General Hospital
Sydney

Dr Julien de Jager

Professor Geoff Littlejohn
Monash Medical Centre

Dr Peter Nash

Professor Nicholas Pocock
St Vincent's Hospital, NSW

Professor Ian Reid
University of Auckland
New Zealand

Professor Philip Sambrook
Sydney University

Professor I Ego Seeman
Austin and Repatriation Medical Centre

Professor David Sonnabend
Royal North Shore Hospital

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Fake bone journals

From The Scientist comes news of a fake bone journal produced by Elsevier for Merck. "The Australasian Journal of Bone and Joint Medicine" was a bit of fakery which gave the appearance of a proper scientific journal (like the "proper" bone journal, the Journal of Bone and Mineral Research which is reputedly entirely uninfluenced by industry manipulation). Merck apparently paid an undisclosed sum in exchange for the fakery. Sample scans of complete issues are here and here.

The Scientist (free registration required).

Merck published fake journal, Bob Grant, 30th April 2009

[Abstracted summary]

Merck paid an undisclosed sum to Elsevier to produce several volumes of a publication that had the look of a peer-reviewed medical journal, but contained only reprinted or summarized articles--most of which presented data favorable to Merck products--that appeared to act solely as marketing tools with no disclosure of company sponsorship.
[snip]
The Australasian Journal of Bone and Joint Medicine, which was published by Exerpta Medica, a division of scientific publishing juggernaut Elsevier. The issues contained little in the way of advertisements apart from ads for Fosamax, a Merck drug for osteoporosis, and Vioxx.
[snip]
It came to light in the context of a civil suit filed by Graeme Peterson, who suffered a heart attack in 2003 while on Vioxx, against Merck and its Australian subsidiary, Merck, Sharp & Dohme Australia (MSDA).

In testimony provided at the trial last week, which was obtained by The Scientist, George Jelinek, an Australian physician and long-time member of the World Association of Medical Editors, reviewed four issues of the journal that were published from 2003-2004. An "average reader" (presumably a doctor) could easily mistake the publication for a "genuine" peer reviewed medical journal, he said in his testimony. "Only close inspection of the journals, along with knowledge of medical journals and publishing conventions, enabled me to determine that the Journal was not, in fact, a peer reviewed medical journal, but instead a marketing publication for MSD[A]."
[snip]
A spokesperson for Elsevier, however, told The Scientist, "I wish there was greater disclosure that it was a sponsored journal." Disclosure of Merck's funding of the journal was not mentioned anywhere in the copies of issues obtained by The Scientist.

Elsevier acknowledged that Merck had sponsored the publication, but did not disclose the amount the drug company paid.
[snip]
The spokesperson added that Elsevier had no plans to look further into the matter.

One of the members of Australasian Journal of Bone and Joint Medicine's "Honorary Editorial Board," Peter Brooks, a rheumatologist in Australia, said he didn't recall who asked him to serve on the board, but noted that he was on Merck's Asian Pacific and international advisory boards from the mid 1990s until about 2004, as well as the advisory boards of other pharmaceutical companies, including Pfizer and Amgen. "You get involved in a whole bunch of things at this level," Brooks said, adding that he had put his name on "a few advertorials" for pharmaceutical companies about 10 years ago.
[truncated]

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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".

Disparaging?
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.

38

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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