GMC Hearings of Professor Richard Eastell - Day 1

I have just attended the first day of the General Medical Council "hearings" involving Professor Richard Eastell.

These have been truly fascinating, and will surely provide fodder for much discussion about publication ethics and scientific accountibility.

A quick note ...... rushing off to watch the rest of the evolving farce.

These are the key background documents and issue the GMC should be discussing
here. None of these are apparently to be seen in the case. They are all documents Professor Eastell will have.

There have been some real howlers. Unfortunately the GMC have (deliberately?) constructed a case that has ensured that the panel members are disabled from knowing or seeing the most relevant and damning evidence. The panel have been disabled from knowing that at the very time Professor Eastell knowingly allowed false declarations to appear in publication submissions (this is acknowledged both to be knowing and to be false), he was being actively denied access to the data (randomisation codes and fracture codes) underlying these studies by the sponsor.

Unfortunately Eastell's defense team appear to understand nothing of science, scientific thinking or scientific ethics. As a result they have fed nonsense to their client thinking it would help him, but have instead dropped him into a huge scientific hole.

For example they managed to get Eastell to state that fundamental misrepresentations of science, fundamentally faked graphs, a key result that was completely wrong (in three manuscripts) are mere "quibbles". Really?

They then got Eastell to try to say that being shown graphs of data or "working very closely" with those producing those "outputs" somehow constitutes access to raw data. They then managed to get Eastell and Rosemary Hannon to say that he, as a scientist and Research Dean, and her as a scientist really wouldn't know what to do with data anyway if he they had it (so perhaps they should retract all of those many noncommercial publications then?).

There is some more background here.

Much more later..

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More news of NMT Medical MIST Trial - false declarations

More news on the scientific jiggery pokery that took place in the MIST trial paid for by NMT Medical, and some emerging news on the usual attempts at cover-up in this case. Authors denied data, colluding journals, and collusion of the UK regulator (the MHRA) with scientific misconduct. More of the same old story and Déjà vu all over again.

The only chink of light - that there are still great journalists (like Shelley Wood) doing the job that the mainstream medical journals, regulators and leadership of medicine are manifestly failing to do. Well done Shelley.

The Heartwire article of yesterday is reproduced intact below. For my collated postings on this scandal click here

MIST correction published; no new information on disputed echo review for PFO/migraine trial
Sep 9, 2009
Shelley Wood
Heartwire

Dallas, TX - Authors of the controversial Migraine Intervention with STARflex Technology (MIST) trial paper [1] in Circulation have now published a lengthy correction [2] to the manuscript that originally appeared online in March 2008. As previously reported by heartwire, journal editors requested a correction from the authors after questions were raised—most notably by one of the original investigators for MIST—about details purportedly missing from the publication.

The correction by Dr Andrew Dowson (Kings College Hospital, London, UK) and colleagues appeared online Monday August 31, 2009, and the online version of the article has been updated to reflect the changes.

MIST was the first randomized, sham-controlled trial to investigate patent foramen ovale (PFO) closure as a treatment for migraine; the study failed to show a benefit of PFO closure. Garnering even more attention than the study results, however, have been questions from physicians both within and outside of the study about the design and conduct of the study and the airing of its results. The study sponsor, NMT Medical, is currently suing one of the original co-PIs for MIST, Dr Peter Wilmshurst (Royal Shrewsbury Hospital, UK), for concerns he raised to heartwire about how MIST data were being managed.

The disputed echo reviews

Wilmshurst, along with his Shrewsbury Hospital colleague Dr Simon Nightingale, refused to sign off on the manuscript before it was submitted for publication and are not included as authors. Following the publication of MIST in Circulation, Wilmshurst contacted the journal about his concerns.

Conspicuously absent from the correction is information about an "off-protocol" review of the echocardiographic information that suggested a higher residual shunting rate following PFO closure than that reported by Dowson at the TCT 2007 meeting. Dowson reported a 94% closure rate—derived, as per trial protocol, from the follow-up conducted by the implanting cardiologist. Wilmshurst, however, says he conducted an after-the-fact review of echocardiograms, at NMT's behest, which suggested residual shunting in approximately one-third of patients. A residual shunt can point to either incomplete device closure of the PFO or to the presence of pulmonary shunts not properly identified at baseline.

Both Dowson and NMT originally denied to heartwire that this echo review had ever taken place (repeatedly insisting that it was not part of the trial protocol) and rejected Wilmshurst's suggestion that NMT had asked investigators to send their echos to him to review. Another trial investigator, however, Dr Michael Mullen (Royal Brompton Hospital, London, UK), subsequently confirmed to heartwire that a review had indeed been undertaken but insisted the information did not belong in the MIST paper.

Asked by heartwire why information about the disputed echo review is not mentioned in the correction, Circulation issued a statement saying, "The Circulation editors were unaware of this controversy during the review of the paper; however, they investigated the matter at the same time that they investigated Dr Wilmshurst's other claims, and they decided that this information did not belong in the paper."

Also contacted by heartwire, Wilmshurst responded with a written statement:

"The correction of the MIST paper states that I did not sign the Copyright Transfer Agreement because of an internal disagreement about the conduct of study. In an email to Dr Dowson in October 2007, I gave two reasons for refusing to sign the Copyright Transfer Agreement. First, that the paper contained errors, which are confirmed by this correction. Second, that I could not in conscience sign the declaration, [which reads] 'The authors had full access to the data and take responsibility for its integrity.' To sign a declaration knowing it to be false would make me guilty of a criminal offence in the United Kingdom. In November 2007, NMT's lawyer wrote to me: 'No investigator is given a full detailed set of all the data.' For 18 months I pressed Circulation for a correction. I sent the editor hundreds of pages of documents, including a copy of my email to Dr Dowson. All of the errors and omissions in the correction are ones that I reported to Circulation, but not all errors and omissions that I reported have been corrected. In addition, the contributions of some who did little in the study, including an 'author' who died in May 2004, before the trial started, are credited, but the contributions of Dr Nightingale and I, who helped design the trial, were members of the steering committee, wrote the early draft of the paper, and did over 600 of the 2000 patient visits in the trial, are not acknowledged."

NMT chief financial officer Richard Davis, also commenting on the correction for heartwire, emphasized that the "clarifications were made on request of the editors of the journal.

"The correction that appears in the journal Circulation includes a single error in the reference to a histogram contained in the original manuscript. No changes to the results, analysis, or conclusions of the study are made. The remainder of the published correction contains clarifications, many of which were not included in the original manuscript due to the word-count limitations.

"To comply with these word-count requirements, the manuscript focused specifically on the critical elements of the trial design and results. All serious adverse events were listed; other information was excluded that was deemed irrelevant to the findings regarding the effect of PFO closure on migraine. One procedural embolization in a cohort of 74 patients is not uncommon for these types of devices, and retrieval of a device due to poor positioning followed by replacement with a second device, as happened in two cases, is also not unusual. It is important to note that these procedural difficulties were not considered serious by the investigator or the safety committee of the study."

Clearing the MIST

The correction runs over 700 words long, with a four-page data supplement, and addresses what Dowson and colleagues term "a number of errors and omissions," including:

• An explanation of why Wilmshurst and Nightingale were not listed as authors.
• An expanded description of how intracardiac shunts were assessed.
• Clarification on specific adverse events related to failure to find or cross a PFO, two cases of device embolization, and one nondeployment.
• New information on patients who withdrew from the study and why.
• A correction to the units used for number of migraine days per month for Figure 3.
• Reiteration of the reasons for excluding two patients from an analysis looking at median total migraine days and the calculations used.
• Clarification that the authors' conflicts of interest information provided in the article was accurate.

To this last point, the correction states: "The authors confirm that they disclosed all relevant relationships and potential conflicts of interest that were present during the two years leading up to manuscript submission, as required by the American Heart Association." The Circulation manuscript itself notes that two study authors—Mullen and Dr David Hildick-Smith (Brighton and Sussex University Hospitals NHS Trust, UK) have ownership interests in NMT Medical and that Mullen has received teaching honoraria and has acted as a consultant to NMT, but that the remaining authors report no disclosures.

Of note, at the time of Dowson's October 2007 TCT presentation, he disclosed that he had received grant/research support from NMT, and Davis estimated in an interview with heartwire shortly after Dowson's presentation that up to 10 study investigators and/or steering committee members had received consulting fees from the company. Wilmshurst once told heartwire that he and Nightingale had turned down offers for "large" consultancy payments from NMT.

1. Dowson A, Mullen MJ, Peatfield R, et al. Migraine Intervention with STARFlex Technology (MIST) trial. A prospective, multicenter, double-blind, sham-controlled trial to evaluate the effectiveness of patent foramen ovale closure with STARFlex septal repair implant to resolve refractory migraine headache. Circulation 2008; 117:1397-1404.
2. Correction for Dowson et al. Circulation 2009; DOI: DOI: 10.1161/CIRCULATIONAHA.109.192626. Available at: http://circ.ahajournals.org.

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NMT Medical - the MIST trial starts to unwind

I have posted previously (here and here) about this ethical and scientific scandal. The saga involves a medical device, and the conduct and conclusions of the Migraine Intervention with STARflex Technology (MIST) I trial. Peter Wilmshurst and another "author" of this study alleged scientific misconduct, hiding of data from authors and legal bullying by the sponsor, NMT Medical. They refused to sign the manuscript, made their views public, and were sued.

Now the remaining authors have been forced to submit an extensive manuscript "correction" which addresses a few of the many problems raised. Amongst other things there is an admission that "side effects" of the device were misrepresented. Devices embolized inside the heart and to the left pulmonary artery. A device that embolised into the pulmonary artery was reported to be in "an unsatisfactory position" and was not mentioned at all in the paper (or apparently to the Ethics Committee). The stated "authors" declare that they "regret" the "errors".

The Journal (Circulation) did not question the changing authorship on the four versions of the paper that they received. The Editor in Chief of Circulation (Dr Loscalzo) earlier wrote to say that "We now consider the matter closed". The UK regulator, the Medicines and Healthcare Regulatory Authority (MHRA) previously stated that it had "reviewed the "available evidence" and has found nothing to suggest that there is a problem". Since the ejected authors and presumably the regulators had no relevant evidence at all, the MHRA response and their definition of "a problem" appears predictably odd to say the least.

The text of the statement of "correction" is here.

I don't think that this is going to be last word on this sorry matter.

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Weetman chair of the Medical Schools Council

Tony Weetman, Sheffield University Pro Vice Chancellor for medicine has been elected chair of the Medical Schools Council. It is said that Weetman plans to "optimise the UK's health, wealth and knowledge and the profession of medicine through biomedical research".


(BMA News 15 Aug 2009)

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Sitting leaders ask you to stand up for safety

Here is an excellent letter in the British Medical Journal (18 July 2009; 339:124).



The same letter in text format (minus references) is below:

Sitting leaders ask you to stand up for safety

If junior doctors follow the recommendation of medical leaders and stand up for the safety of patients will they receive support from those leaders? (1)

“Staff concerns about safety at Mid Staffordshire trust were ‘lost in a black hole.’” (2) The evidence suggests that whistleblowers who report concerns are treated no better in the NHS now than at the time of the scandal at Bristol Royal Infirmary. (3) Medical leaders are responsible for the culture of silence. To become a medical leader one needs to compromise principles for expediency to meet the demands of politicians (in an organisation or government) with the power to advance or destroy a career. Medical leaders lack moral authority because few of them have taken the risk of speaking out on their way to the top. They are too often complicit in concealment of problems to protect their organisations or political masters.(4)

Fiona Godlee spoke at the conference and represented the BMJ.(1) The BMJ has removed from its website articles that have appeared in the paper journal purely to avoid the risk of the journal being sued for libel. The articles have not been retracted because there are no grounds for retraction of truthful reports. Does the BMJ want junior doctors to take the risk of losing their careers by speaking out when it is afraid of the financial cost of speaking?

Liam Donaldson also spoke at the conference.(1) I have had correspondence and meetings with the chief medical officer to discuss misconduct by doctors, but I am left with the impression that he is unwilling or unable to act when the allegations involve senior medical leaders. Yet Sir Liam wants junior doctors to be brave enough to speak about problems.

The motivational speeches of medical leaders to junior doctors seem to be like the pep talks of generals to soldiers at the Somme before the troops went over the top and the leaders returned to their chateau for lunch. Medical leaders must now lead from the front and share the risks.

Peter T Wilmshurst
Consultant cardiologist
Royal Shrewsbury Hospital
Shrewsbury SY3 8XQ

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Consultation

A hallmark of the UK NuLabour government is the sham public "consultation". Over recent months, Universities have been "consulted" on new procedures for self investigation (and effective cover-up) of research fraud (see consultation). The General Medical Council is "consulting" about their (already reasonable) guidance for doctors who fake research - while they fail to deal with actual doctors who have brought shame on the clinical research enterprise. The GMC is also "consulting" on how it could "improve its procedures for handling Fitness to Practice cases".

Much of what passes for "consultation" is theater designed to create an illusion that serious problems with these organisations are being addressed. I have yet to see actual examples of regulatory integrity lapses, cover-up and cock-up included within any consultation document.

Funniest of all is the current consultation on government regulation of "Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and Other Traditional Medicine Systems Practised in the UK". David Colquhoun is lucid on the problem of what we are regulating. He discusses in some detail examination papers and teaching material from degree courses on acupuncture and Chinese medicine at the University of Salford and the University of Westminster.

I am hardly a defender of the current state of medicine. Scientific medicine, medical leadership, and genuine evidence-based medicine are in a shambles right now. This is in part because of government interference, and because regulators have assisted in the "normalisation" of scientific fraud. It seems to me that there are a few things to address before "consulting" on the mechanics of regulation for these practitioners. Yet again, the clear message from government is that honest science and evidence are not on their agenda. Regulation and yet more guidance are not the solution to our problems - they are the problem.

I differ slightly from David in that I don't care that ill folk choose to get all sorts of advice. Nor do I care that such wares are sold, so long as they describe exactly what they do (see this company), and I don't foot the bill.

In any event, why regulate only these specific practitioners and techniques? Given my African origins I responded to the consultation with the helpful suggestion that we consider the regulatory normalisation of other therapeutic techniques such as scarification or FGM, drugs such as muti (human or otherwise), and diagnostic technologies such as bone throwing.

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Can we bank on trust?

In a feature today "Can We Bank on Objectivity" Patti Tereskerz looks at the rules proposed by the National Institutes of Health for dealing with financial conflicts of interest in biomedical research.

While agreeing with the article in large part, it starts from a somewhat misguided position. Take a read and see what you think.

It begins:
"Trust is the crown jewel of the research enterprise. Financial arrangements related to research that call into question the integrity of investigators or research institutions are damaging, not only because they may potentially harm research participants, but because they are associated with the appearance of impropriety. Either way, trust is compromised."

This misunderstands the nature of science. Science is, at its core, based not trust, but on it's very opposite - scepticism. Obviously, some researchers are trustworthy, whilst others are liars. But trust is about predictability - even criminals trust one another to some extent. Companies trust Key Opinion Leaders. Our perception of "what science is" limits the range of solutions we see. It also determines which problems we choose to ignore.

Mertonian ideals

Robert Merton (1973) described four norms that are prerequisites to scientific activity:

1. Organised skepticism: (Nothing is ever taken on trust)
2. Universalism: (acceptance of the integrity of research relies on its merits, and not the black/white/Jewish/Hindu status of the resercher, or whether that researcher is a funded opinion leader like Martin Keller or Richard Eastell)
3. Communalism: Sharing of information, absence of secrecy (inappropriate refusal to release data or methodological information makes work unscientific by definition)
4. Disinterestedness: (Not committed to any ideology - able to criticize and accept research based on its merits, not on a prior view that "vaccines are bad", or "doctors are corrupt")

Trust is important. Trust doesn't always work out that well.

The Gordon Brown reference

1. Macleod, Catherine (2007-05-18). Take me on trust 'Humbled' Brown pledges open and honest government. The Herald (Scotland).

Hat tip: Professor David Healy

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Misconduct roundup 26 May 09

A New issue of the Journal Science and Engineering Ethics

is now available. Most is sadly the type of scientific debate Springer thinks needs to be hidden behind its paywall. However one useful article is open access, and worth a read. I'll discuss it over the next few days. Here it is:

Implementing the Netherlands Code of Conduct for Scientific Practice—A Case Study: Daan Schuurbiers, Patricia Osseweijer and Julian Kinderlerer. Science and Engineering Ethics15(2)/ June, 2009 213-231 (PDF here)

Chinese Earthquakes - ?cheating in scientific reports on building construction

It is just over a year since the Sichuan earthquake in southwestern China. In an article in The Guardian (UK) Ai Weiwei writes of alleged state scientific misconduct and cover-up involving the Chinese Government. It involves the stated reasons for the collapse of various buildings (Our duty is to remember Sichuan, 25 May 2009). It is said that the so called "scientific investigation carried out is nothing more than a trick in the game of bureaucracy". Commenters discuss what happened to John Sweeney of the BBC when he tried to interview Sichuan earthquake parents, and how Financial Times journalist Jamil Anderlini was beaten.

World Tarot Day

Yesterday, 25 March, was World Tarot Day. To celebrate randomized analysis of hidden data to achieve a marketing objective, World Tarot Day is proud to support the efforts of Procter and Gamble

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How bad science transmutes into an anti-vaccine meme

The pharmaceutical industry is hardly my friend. A whole lot of badly corrupted science results from collusion between large parts of this industry, prostituted academics and "regulators".

However, I frequently marvel at the way in which some supposed campaigners against industry corruption seem to have incorporated the worst excesses of the very same corruption into their approach -- bullying, anonymity, rejection of science, and discussion based on a prior view rather than on evidence and logic.

There are many honorable and effective campaigners for integrity. However, there are a good many "campaigners" who muddle the possibility of scientific debate so successfully, that (to paraphrase David Healy on scientology) - if some of these "campaigners" did not exist, industry would have to invent them.

Let us take a look at a recent Mayo Clinic study reported in preliminary form this week at the International Conference of the American Thoracic Society in San Diego.

This was an oddly designed retrospective study, ostensibly aimed at investigating the effect of Flu Vaccination on Flu-Related Hospitalizations in Asthmatics. The meeting abstract by Joshi et al., was entitled:

"Flu Vaccination in Asthmatics: Does It Work?"
Presentation time: May 19: 3:20 p.m.
Location: San Diego Convention Center, Room 3

The study examined a cohort of "all pediatric subjects who were evaluated at Mayo Clinic, Rochester, MN, USA who had laboratory confirmed influenza during each flu season from 1999-2006". The authors conducted a case control study looking at those individuals who had been hospitalized with flu (cases) and those who had flu without hospitalization (controls). They further determined who had received vaccination, and who had not. They found (unsurprisingly for a study of this design) that having received prior vaccination was associated with a three times greater chance of hospitalization.

In other words, individuals with Flu were divided into four groups:



Now, there is some legitimate concern that Flu vaccination might cause exacerbation of asthma under some circumstances (The Lancet, 1998, 351: 326-31). Whatever the merits of Flu vaccination, anyone with the vaguest understanding of science and logic will understand that the Mayo study has nothing much to do with answering the question of "should asthmatics be give the flu vaccine". It may be the case that the vaccine is entirely useless, or even harmful, but this study is not particularly informative.

Concluding that vaccination causes the increased hospitalisation rate in this study would be like doing a study looking at chest X-rays (CXR) and death from lung cancer. No doubt one would find that those who had a CXR die at least 1000 times more often from lung cancer. Ergo, CXR is a massive cause of lung cancer.

If you really wanted to answer the question you would allocate a very similar group of individuals to receive the vaccine (or not to receive it), and you would end up dividing near-identical groups of patients as follows.



Despite wanting their photographs in the press, these Mayo authors state that their study is worth as much as the CXR example. The lead author stated: "This may not be a reflection of the vaccine but that these patients are the sickest, and their doctors insist they get a vaccination" (paraphrase - "this study is completely uninformative and misleading nonsense").

Despite this (and the fact that any scientific novice should have had no problem understanding the concept of causation), false scientific statements promptly propagated through the internet:

Age of Autism (May 21 2009) correctly reported the meaningless finding that "researchers from the Mayo Clinic in Minnesota found that children who had received the flu vaccine had three times the risk of hospitalization, as compared to children who had not received the vaccine."

However their ranting post about turning children into horned beasts was titled

"Flu Vaccine Triples Child Hospitalizations".

Actually No, that is not what the study shows.

KCEN-TV (May 20th, 2009) title their news report:

"Flu Shot Little Help for Kids with Asthma"

That may be correct, but it is not what this particular study found.

What Doctors Don't Tell You (20 May 2009) titled their post

"Children who have flu jab 'three times more likely to need hospital care"

They start by saying:

"Children who have the standard flu jab are three times more likely to end up in hospital".

That is stricly speaking correct, but has nothing to do the effect of vaccine adminstration (or non administration) on the chance of patient X ending up in hospital. If WDDTY don't understand that, they should not be writing about science.

However they then go on to say:

"The vaccine is also useless at preventing the disease, new research has discovered."

They don't understand.

Science daily title their report:

Children Who Get Flu Vaccine Have Three Times Risk Of Hospitalization For Flu, Study Suggests

They then go on to say:

The inactivated flu vaccine does not appear to be effective in preventing influenza-related hospitalizations in children, especially the ones with asthma.

Actually, No.

The Alliance for Human Research Protection suggests that:

So, will these disturbing findings--namely, ineffectiveness of the TIV vaccine coupled with evidence of harm--lead the the Center for Disease Control and the American Academy of Pediatrics (AAP) to rescind their recommendation for annual influenza vaccination for all children aged six months to 18 years?.....When evidence suggests that current vaccine recommendations are harming children it is unethical to delay issuing a cautionary advisory by invoking "more studies are needed" to delay action. Public health policy should be guided by the precautionary principle--"Above all, do no harm"--not by business interests.

Now, I personally think that the advice of the CDC’s Advisory Committee on Immunization Practices (ACIP) and AAP to recommend annual influenza vaccination for all children aged six months to 18 years is not particularly logical or evidence based. In fact I think the advice is flat out bizarre. A lot of guidance is not based on logic. However, quite how misrepresenting science can be helpful to address misrepresented science is beyond my comprehension.

Healthcare Republic (22-May-09) writes:

News
Flu jab 'triples admission rate'

Flu vaccination can triple the risk of children being admitted to hospital with flu, US research suggests.

The study does has nothing to do with that.

openUReyes demonstrates a similar parroting of scientific incomprehension.

Even Heathfinder.gov propagated a title

"Hospitalization Rates Higher in Kids Who Get Flu Shots"

but they at least had the sense to include a subtitle:

Link likely due to other health problems in children most recommended for vaccination, experts say.

To summarise, if you want to discuss science (or to challenge bad science) it helps if you understand what you are talking about.

See also Psychescientia for a logical discussion of the Mayo study (he also addresses how an oddly titled press release by media staff at the American Thoracic Society contributed to the problem).

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Is Medicine in the same boat as the Catholic Church?

This post has nothing directly to do with scientific fraud, science or medicine.

It is about recent reports of corruption and terrible evils that have taken place within the confines of the leadership of the Catholic Church.

A few days ago a long-delayed investigation into Ireland’s Roman Catholic-run institutions was released. It chronicled how priests and nuns molested, abused and tortured thousands of boys and girls for decades. More importantly it documented how those in authority, government officials, and government inspectors failed to stop the beatings, rapes and abuse. The report concludes that church officials shielded their orders' pedophiles from arrest, amid a culture of self-serving secrecy. They turned a blind eye.

In the United Kingdom, we have medical "regulatory" bodies (such as the MHRA and the General Medical Council). We have individuals promoted to positions of professional leadership. These bodies and individuals are supposed to act as guardians of scientific and clinical integrity in medicine. They are supposed to protect the public against quackery, and to uphold the scientific ideals of our profession. Like the corrupt bodies within the Church, these institutions don't always fulfill their stated mission. Too often they act act as protectors of those who are guilty of scientific fraud, of abusing patients and of corruption. Particular individuals within those bodies act to conceal crimes and deception. Rules of conduct are meticulously created and revised, but disobeyed with impunity. The supposed mission of these organisations and the reputation of our profession is brought into disrepute through these actions.

These organisations hide their sins behind a barrrier of secrecy. Names and transparency are important however. The Christian Brothers successfully sued the commission in 2004 to keep the identities of all of its members unnamed in the report resulting in massive backfire and complete loss of any residual reputation. In medicine, bodies such as the General Medical Council demonstrate the same staggering incompetence when they try to get involved in tricky little exercises to protect their friends. Those, like the hilarious exercise to try to hide the scientific adventures of their friend Professor Richard Eastell and his "collaborations" with Procter and Gamble Pharmaceuticals tend to result in a similar outcome for the profession of medicine.

Read the full report of the Commission to Inquire Into Child Abuse report here, or a summary (Associated Press).

The corruption was articulated even more strongly in Milwaukee this week. It is said that retired Archbishop Rembert G. Weakland states that he "did not comprehend" the potential harm to victims in Milwaukee, nor did he understand that what the priests had done constituted a crime (see here and here)

Said Weakland:

"We all considered sexual abuse of minors as a moral evil, but had no understanding of its criminal nature."

I "accepted naively the common view that it was not necessary to worry about the effects on the youngsters: either they would not remember or they would ‘grow out of it’."

Weakland stands accused of assisting in cover-up of the abuse. A 2003 report on the sexual abuse of minors by clergy in the Roman Catholic Archdiocese of Milwaukee revealed that allegations of sexual assaults on minors had been made against 58 ordained men, who were under the direct supervision of the Archbishop of Milwaukee. By early 2009, the Archdiocese of Milwaukee had spent approximately $26.5 million in attorney fees and settlements to victims. Weakland retired in 2002 after it became known that he paid $450,000 to a man who had accused him of date rape.

Why are these men and women not in prison?

See also:

1. Cargo Cult Science : Large Groups of Humans
2. Video Documentary : Deliver us from Evil
3. The Freethinker: ‘We did not know that child abuse was a crime,’ says retired Catholic archbishop
4. Report of the Commission to Inquire Into Child Abuse in Ireland

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Peer review by accountants

The hillarious Pharma Giles is fortunately alive and well and in communication with the great Pharmagossip. This relating of the nature of peer review was so important as to merit repeating in full. Listen up Journal of Bone and Mineral Research.

Pharma Giles writes......



A furore has erupted following The Scientist magazine’s revelations that Phoni Pharmaceuticals paid an undisclosed sum to scientific vanity publisher Elsleazier to produce several volumes of a publication that had the look of a peer-reviewed medical journal but which contained only reprinted or summarized articles, most of which presented data favourable to Phoni products. The journal appeared to act solely as a marketing tool with no disclosure of company sponsorship.

The Australian Journal of Boneheads and Joint Medicine, which was published by Extracta Moneya, a division of Dutch scientific publishing juggernaut Greed-Elsleazier, also contained little in the way of advertisements apart from ads for Formonimax, a Phoni drug for osteoporosis, and Viletoxx, Phoni’s controversial pain-killer.

In a statement provided last week to The Scientist, an eminent 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, such as a doctor, could easily mistake the publication for a genuine peer reviewed medical journal”, he said. "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 Phoni."

“They’ve done a heck of good job, and it was only when I noticed that some of the names of the so-called “honorary editorial board” appeared to be made up that I became suspicious,” the reviewer admitted.

“Professor Phil. I. Daftwhoofing appears to be an anagram of “Ripping Off Fools Who Read This,” for example. Similarly, Dr. Leon Theophuleet is an anagram of “Pulled The Other One”. And “Gill Ripcheap” seems to be an anagram of Rich Pillager, who I believe is Phoni’s Head of Global Marketing…”

A spokesperson for Elsleazier, however, told The Scientist, "All of our journals are thoroughly peer-reviewed prior to publication, by our accountants. Our company would never publish a journal unless it was guaranteed to make us lots of money. After all, our publications are well-known for the standards they deliver – standards of living for our publishing executives, that is…"

Disclosure of Phoni's funding of the journal was not mentioned anywhere in the copies of issues obtained by The Scientist. Elsleazier acknowledged that Phoni had sponsored the publication, but did not disclose the amount the drug company paid.

The spokesperson added that Elsleazier had no plans to look further into the matter. “The high prices of subscriptions to our journals are a guarantee of their quality,” he said. “After all, everyone recognises the quality of Australian scientific publications, in the same way that American diplomacy journals or Nigerian accountancy and banking magazines are regarded…”

One of the genuine members of the Australian Journal of Boneheads and Joint Medicine's "Honorary Editorial Board," Dr. Táké Bakhandar, a rheumatologist in Australia, said he was delighted to serve on the board, however. Dr. Bakhandar has been on Phoni's Asian Pacific and international advisory boards since the mid 1990s, 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," he said, adding that he had put his name on "quite a few advertorials" for pharmaceutical companies in the past 10 years. “I’m delighted to be able to promote the life-enhancing products of the pharmaceutical industry,” Dr. Bakhandar said.

His colleague and fellow member of the Australian Journal of Boneheads and Joint Medicine's Honorary Editorial Board, Dr. Pádme Baksheesh, agreed. “My own observations conclusively show that there is a direct relationship between the number of products I plug for pharmaceutical companies, and the degree to which my life is enhanced,” he said.

Rich Pillager, Head of Global Marketing for Phoni Pharm. Inc. was also unrepentant.

“The Australian Journal of Boneheads and Joint Medicine” is an important tool in Phoni’s CME (Continuing Medical Education) programme,” he said.

“After all, we’ve been putting out advertorials for years. Everyone remembers our series of children’s books that were designed to promote the use of Phoni’s SSRI Saloadatat in children, for example,” Pillager notes, referring to the controversial “Mr. Bipolar” book based on the UK “Mr. Men” franchise.

“Our competitors have been doing exactly the same thing, only we’re aiming our latest fairy tales at the adult market. I can’t see what the problem is,” he frothed rabidly.

A related tale from the real world is recounted here. And it would also seem that a so-called scientific publisher in the parallel universe of reality has some “previous” when it comes to controversy...

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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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Misconduct roundup 13 May 09

Here is a roundup of a few misconduct issues of the day

Kuklo fraud, Medtronic Inc., and Washington University

The New York Times today reports on some dubious behavior involving a former surgeon at Walter Reed Army Medical Center. Dr. Timothy R. Kuklo, falsified data involving a bone-growth product (Infuse produced by Medtronic Inc.). Amongst other things he forged the signatures of four Walter Reed doctors on the article before submitting it last year to a British medical journal, falsely claiming them as co-authors. The journal has retracted the article.

Medtronic is under fire on several other grounds (including, apparently, paying doctors to use Infuse). However they so far deny funding "this particular study" (they don't deny funding Kuklo).

But, Kuklo is now an associate professor at the Washington University Medical school in St. Louis. Per the usual scenario, Washington University School of Medicine have done nothing at all, and have declined to comment.

Something going on at Sequenom

Two anonymous correspondents alerted me to "something going on at a company called Sequenom". They write in obscure terms that "this company claims almost 99 percent specificity and sensitivity for a year and now says it was all mishandled by four employees".

A quick search on Google reveals that Sequenom's product is a potentially better test for Down's syndrome based on maternal blood sampling. After a massive rise, their stock has taken a dive over the past few days as investors take legal action against them for making "materially false and misleading statements regarding the clinical performance of the Company's developmental Down syndrome screening test". The company issued this press release on 29 April where they talk of "employee mishandling of R&D test data and results".

If anyone has any secret inside information about scientific deception here, let me know.

This is interesting for two reasons. First, investors very rarely care about scientific deception except when the link between deception and profits is very short-term. I think that is because they often don't understand what they are losing. Second, deception involving diagnostic products gets far less attention than it deserves given its importance. With the entanglement of the pharmaceutical industry in so called personalized medicine (and in therapeutic monitoring) this is an area to watch closely.

The rise and fall of a physics fraudster

In her new book Plastic Fantastic (2009, Palgrave Macmillan), Eugenie Samuel Reich chronicles how Jan Hendrik Schön shook the scientific world. A summary of the book is here (hat-tip Sarah Askew).

[Comment: This is a classic case of scientific misconduct. Unfortunately some commentators on scientific fraud try hard to create the misimpression that fraud in science is a rare anomaly. These commentators invariably cite this case and several other classic cases, while ignoring many far more troubling cases that don't fit the stereotype of the rare rogue male scientist acting alone.]

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Misconduct roundup 12 May 09

I am going to try to make this a regular feature.

Here are a few items of note:

Professor Chris Gillberg, scientific misconduct and a problematical academic appointment

Professor Christopher Gillberg is now in possession of an honorary Professorship and joins the staff list at University College London (UCL) and at Great Ormond Street Hospital for Children (see here). Gillberg, you will recall, is the scientist who headed the Swedish team that destroyed hundreds of thousands of pages of raw clinical research data after being asked to explain anomalies in their findings. The destruction took place in the face of a pending research misconduct examination. To make matters worse, Gillberg's supporters blamed scientologists for somehow causing the problem and supporters may have attempted to intimidate those who accused them. The journal involved refused to retract the publication. Quite how any scientology demons managed to induce such an act of data destruction was never explained.

This appointment does set an interesting precedent for trainees at UCL and for the plausibility of other misconduct investigations that might take place at that esteemed institution. Perhaps the next UCL student accused of research fraud should claim demonic possession by scientology.

The "demonic possession" defense could be employed for a whole range of deeds committed by other very important people. The Labour peer Lord Ahmed is another important man. Ahmed seems to be able to kill people and get away with it because of his "valuable community work".

One could imagine the scene:

Lord Ahmed: Yes officer, I did plough my motor vehicle over that man and I was texting on my mobile phone, but I was posessed by a scientology demon at the time.

Police Officer: That's OK then. Have a good evening. Move on.

Elsevier apologizes for promoting scientific fakery - but what about the scientists involved

This is a follow up on the story that Elsevier and Merck colluded with several prominent academics to create a fake scientific journal. Elsevier has now issued a press release about the matter, saying "This was an unacceptable practice, and we regret that it took place". However, it now turns out that Elsevier published a whole collection of fake journals for industry. Elsevier CEO Michael Hansen now admits that at least six fake journals "were published for pharmaceutical companies."

Is participation in this fakery scientific misconduct? What will happen to the perpetrators?

The academics who agreed to front this fakery have some answering to do. As one of the commenters on this blog pointed out, one of those on the editorial board of the fake bone journal is none other than Professor Richard Day, Chair of the Australian Government's Pharmaceutical Health and Rational Use of Medicines (PHARM) Committee from 1999 to 2008 – in other words, arguably the most influential pharmacologist in Australia.

Simon Singh sued for discussing science

This is an important story. Singh, a science reporter is being sued for libel by the British Chiropractic Association after writing a column in The Guardian where he raised concerns about chiropractic medicine. Suing people who make scientific assertions is really a form of scientific fraud (attempting to drive scientific debate through bullying). It would be far better if the BCA were to discuss the actual scientific issues, discuss the nature of evidence, and promote some actual science. In this respect the British Chiropractic Association is no different from the worst parts of the pharmaceutical industry. The precedents set by this UK court are astonishing, bizarre and exceeding worrying. This is going to run and run. For a good introduction see Petra Boynton's blog, Bad Science, and this depressing legal summary.

This is the statement that got Simon Singh sued.

"This organization is the respectable face of the chiropractic profession and yet it happily promotes bogus treatments".

The case (which Singh will lose) turns on a novel definition of the word "bogus" (see here) which is clearly different from the very similar English word "bogus".

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Calcium and weight loss - barking up a dubious tree?

Here is a some more dismal behavior by scientists back in my own area of voyeuristic interest (skeletal medicine and calcium physiology). This bit of jiggery pokery involves a study looking at calcium supplementation as an aid to losing weight.

The study was published (1) with much media fanfare (3,4,5,6,7) a few weeks ago. It suggests, based on a supposedly randomized and blinded placebo-controlled trial, that calcium supplements help some obese individuals lose weight. Study funding was from Wyeth.

Big time stuff, and also very controversial. It is certainly possible - but needs some proper science with reasonable numbers.

The worry comes from the same pot of dubiousness described in my previous post (the Wang case). Scientific authors, having published some findings and having enjoyed a media blitz, refuse to convey what they actually did ("method"), how they analyzed data (more "method"), the study protocol ("method") or even a rudimentary plot of the data to allow basic plausibility evaluation.

The particular refusal in this case is the most bizarre I have personally encountered from supposedly "scientific" authors. These authors refuse to reveal what the calcium supplement and placebo contain!

They state that this is "confidential".

As I will discuss, this is hardly a trivial matter. It also makes me wonder whether peer-reviewers should sometimes be named and shamed for failing to ask the most obvious questions (as well as for raw data when necessary).

Before discussing the authors' refusal, it is necessary to know a little about calcium supplements. As anyone who has ever conducted a calcium RCT will know, it is a headache trying to create a placebo. The placebo has to look and taste the same as the calcium. The problem is particularly acute when supplements are supplied in a solid form, because calcium supplements are BIG......

The participants in this study were given 1200mg of elemental calcium per day (about 3 grams of calcium carbonate plus flavorings and some vitamin D). Here is what a slightly lower dose of calcium (2 x 500mg) looks like (in the form of Cacit - P&G's supplement).



Those are mighty big chewy or effervescent tablets. Now the placebo has to consist of something, and that something cannot be pure air. It may be sorbitol, some other sugar, or something else altogether.

So, what do we know about this study. Well, in the two so far published papers about this small RCT (1,2), both in prestigious nutrition journals, the authors write



Now that's none too helpful. Even small timed doses of a variety of nutrients can have some big effects on gastrointestinal function, bone turnover, gut hormone release and satiety. Given the very modest weight "effect" in this study (calcium versus "placebo") the question of placebo composition is hardly arcane.

I also worried about the statistical analysis. The authors conducted a critical retrospective subgroup analysis on a small subgroup of participants. I don't plan to discuss statistical issues in this post, but the relevant questions should be obvious to any modestly critical reader or honest peer-reviewer. So I wrote to the authors asking about the composition of the placebo, and for the weight/calcium data (or at least a scatter plot of their key "finding").

This was the first letter I wrote:

Date: Mon, 23 Mar 2009 09:21:56 +0000
To: angelo.tremblay@kin.msp.ulaval.ca
Subject: Re:Calcium and weight study

...

a) Can you tell me the nature of the placebo since
this is not clear from the manuscript.

b) Can I please have a copy of the raw data giving
only the weight before, weight after, calcium
intake and placebo/treatment assignments of each
patient?

Yours Sincerely

Dr Aubrey Blumsohn

This was met with a straightforward refusal to supply any raw data, and no response at all on the question of the placebo.

So I wrote again

Date: Tue, 24 Mar 2009 15:12:57 +0000
To: angelo.tremblay@kin.msp.ulaval.ca
Subject: Re:Calcium and weight study

...

Can you:

a) At least tell me what the placebo was

b) Send me a scatter plot showing all data points
for weight change versus baseline calcium intake for
placebo and treated arms separately. That is
directly related to what you published and not
different information.

Kind Regards

Dr Aubrey Blumsohn

And this is what I received

Date: Tue, 24 Mar 2009 15:12:57 +0000
To: Aubrey Blumsohn
From: angelo.tremblay@kin.msp.ulaval.ca
Subject: Re:Calcium and weight study

Bonjour Dr. Blumsohn,

I take once again several additional minutes to give you an
additional reply in an environment which is more and more demanding,
mainly because of electronic communication. My specific answers to
your specific questions can be summarized as follows:

1. The placebo: The placebo was prepared by the company (Wyeth
Consumer Healthcare) who provided the financial support to this
study. We know what is the composition of the placebo but this
information is confidential.

2. Scatter plot of data points: As I told you, we might consider that
and publish this information in the future.

...

Kind regards,

Angelo T

A subsequent request for the study protocol was also met with refusal.

Is this science and can these authors be held to be in any way "scientific" authors? Watch this space.

Incidentally, "Tremblay A" appears to have published 8 papers in the past six weeks.

References

1. Major GC, Alarie FP, Doré J, Tremblay A. Calcium plus vitamin D supplementation and fat mass loss in female very low-calcium consumers: potential link with a calcium-specific appetite control. Br J Nutr. 2009 Mar;101(5):659-63.
2. Major GC, Alarie F, Doré J, Phouttama S, Tremblay A. Supplementation with calcium + vitamin D enhances the beneficial effect of weight loss on plasma lipid and lipoprotein concentrations. Am J Clin Nutr. 2007 Jan;85(1):54-9.
3. http://www.foxnews.com/story/0,2933,511005,00.html
4. http://www.medicalnewstoday.com/articles/142198.php
5. http://www.sciencedaily.com/releases/2009/03/090312115053.htm
6. http://www.nutraingredients.com/Research/Calcium-may-boost-weight-loss-but-only-if-you-re-deficient
7. http://esciencenews.com/sources/science.blog/2009/03/12/a.diet.rich.calcium.aids.weight.loss

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Allegations of fraud at Albany - the Wang case

Professor Wei-Chyung Wang is a star scientist in the Atmospheric Sciences Research Center at the University at Albany, New York. He is a key player in the climate change debate (see his self-description here). Wang has been accused of scientific fraud.

I have no inclination to "weigh in" on the topic of climate change. However the case involves issues of integrity that are at the very core of proper science. These issues are the same whether they are raised in a pharmaceutical clinical trial, in a basic science laboratory, by a climate change "denialist" or a "warmist". The case involves the hiding of data, access to data, and the proper description of "method" in science.

The case is also of interest because it provides yet another example of how *not* to create trust in a scientific misconduct investigation. It adds to the litany of cases suggesting that Universities cannot be allowed to investigate misconduct of their own star academics. The University response has so far been incoherent on its face.

Doug Keenan, the mathematician who raised the case of Wang is on the "sceptic" side of the climate change debate. He maintains that "almost by itself, the withholding of their raw data by [climate] scientists tells us that they are not scientists".

Below is my own summary of the straightforward substance of this case. I wrote to Wei-Chyung Wang, to Lynn Videka (VP at Albany, responsible for the investigation), and to John H. Reilly (a lawyer at Albany) asking for any correction or comments on the details presented below. My request was acknowledged prior to publication, but no factual correction was suggested.

Case Summary

1. The allegations concern two publications. These are:
   • Jones P.D., Groisman P.Y., Coughlan M., Plummer N., Wang W.-C., Karl T.R. (1990), “Assessment of urbanization effects in time series of surface air temperature over land”, Nature, 347: 169–172. (PDF here)
   • Wang W.-C., Zeng Z., Karl T.R. (1990), “Urban heat islands in China”, Geophysical Research Letters, 17: 2377–2380. (PDF here)
2. The publications concern temperature at a variety of measuring stations over three decades (1954-1983). Stations are denoted by name or number. A potential confounder in such research is that measuring stations may be moved to different locations at different points in time. It is clearly important that readers of publications understand the methodology, and important confounders.
3. The publications make the following statements:
   • (Statement A) "The stations were selected on the basis of station history: we chose those with few, if any, changes in instrumentation, location or observation times." [Jones et al.]
   • (Statement B) "They were chosen based on station histories: selected stations have relatively few, if any, changes in instrumentation, location, or observation times…." [Wang et al.]
4. The publications refer to a report produced jointly by the U.S. Department of Energy (DOE) and the Chinese Academy of Sciences (CAS) which details station moves, and the publications further suggest that stations with few if any moves or changes were selected on the basis of that report. However:
   • Of 84 stations that were selected, Keenan found that information about only 35 are available in the DOE/CAS report
   • Of those 35 stations at least half did have substantial moves (e.g 25 km). One station had five different locations during 1954–1983 as far as 41 km apart.
5. If true, it appears that Statements A and B would be false, or at best grossly misleading. If false, readers would have been misled both in terms of the status of the stations and the manner in which they had been selected (or not selected).
6. Keenan then communicated with the author of one of the publications (Jones) to ask about the source of location information pertaining to the other 49 stations that had not been selected using the described methodology. Jones informed Keenan that his co-author Wang had selected those stations in urban and rural China based on his "extensive knowledge of those networks".
7. On 11 April 2007 Keenan E-mailed Wang, asking "How did you ensure the quality of the data?”. Wang did not answer for several weeks, but on 30 April 2007 he replied as follows:

   "The discussion with Ms. Zeng last week in Beijing have re-affirmed that she used the hard copies of station histories to make sure that the selected stations for the study of urban warming in China have relatively few, if any, changes in instrumentation, location, or observation times over the study period (1954-1983)"

8. Keenan points out that the “hard copies” to which Wang refers were not found by the authors of the DOE/CAS report, who had endeavored to be "comprehensive" (and that the DOE/CAS report was authored in part by Zeng, one of the co-authors on Wang). Keenan further notes that any form of comprehensive data covering these stations during the Cultural Revolution would be implausible.
9. In August 2007 Keenan submitted a report to the University at Albany, alleging fraud. Wang could at that stage have made the "hard copy" details of the stations selected available to the scientific community. However, he failed to do so.
10. In May 2008, the University at Albany wrote to Keenan that they had conducted an investigation and asked him to comment on it (see the rather odd letter). However they refused to show him the report of the investigation or any of the evidence to allow any comment (further odd letter).
11. In August 2008 the University sent Keenan an astonishing letter of "determination" stating that they did not find that Wang had fabricated data, but that they refused to provide any investigation report or any other information at all because "the Office of Research Integrity regulations preclude discussion of any information pertaining to this case with others who were not directly involved in the investigation".
12. Wang has still not made the station records available to the scientific community. If he provided such records to the University as part of a misconduct investigation, then the University has apparently concealed them.

Comments

1. In the absence of any explanation to the contrary, it seems that the methodology for station selection as described in these two publications was false or at best grossly misleading.
2. Wang maintains that hard copy records do exist detailing the location of stations selected by himself outwith the published methodology. However the refusal to clarify "method" is inappropriate and a form of misconduct in and of itself. It does not lend credence to Wang's assertion that fraud did not take place. It would also be necessary to see records of stations that were not selected, in order to confirm that selection was indeed random, and only "on the basis of station history".
3. The University at Albany is in a difficult position.
   • If the University received such records as part of the supposed misconduct investigation, then they could easily resolve the problem by making them available to the scientific community and to readers.
   • If the University does not have such records then they have been complicit in misconduct and in coverup of misconduct.
   • If the University at Albany does have such records, but such records are not in accordance with the stated methodology of the publications, then the University has more serious difficulties.
4. "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 and reasoning underlying any conclusion). This was not the case at the University at Albany. When you see universities reluctant to investigate things properly, it provides reasonable evidence that they really don't want to investigate things properly.

For further information on this case see here and here.

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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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