Book review: Scientific Misconduct And Its Cover-up

I found this book interesting.

Scientific Misconduct And Its Cover-up: Diary Of A Whistleblower. Rivlin, Solomon. Boca Raton: Brown Walker Press (Fl), 2004.

The linguistics of scientific integrity would merit considerable academic study. This book provides (through a single case-example) a veritable style manual for Universities and journals trying to impede attempts to hold scientists responsible for their conduct. It includes the original (anonymized) correspondence of one particular case - a treasure trove of linguistic hocus pocus and academic bullying.

The Kafakarian behavior of the involved scientific journals is only too familiar. The essence of scientific misconduct is intentional behavior that disrupts the integrity of the scientific record. Unacceptable and obfuscatory handling of allegations of misconduct would seem to constitute scientific misconduct in and of itself.

Previous book reviews on this blog:
  • Shuchman, Miriam. the Drug Trial: Review| Rating 0/10
  • Shuchman, Miriam. the Drug Trial: Review| Rating 0/10
  • Washburn, Jennifer. University, Inc.: The Corporate Corruption of American Higher Education: Review| Rating 10/10
  • Rivlin, Solomon. Scientific Misconduct And Its Cover-up: | Rating 7/10

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Procter and Gamble goes dumpster diving

procter and gamble goes dumpster divingI tape recorded Procter and Gamble and other "researchers" involved in some problematical sponsored clinical research. That was an important thing to do. I have been waiting a while for an honest response. I have been waiting for permission to make available the hidden (and now revealed) raw data upon which P&G relied in their three scheduled Actonel ghostwritten publications. I have been waiting for a few other refused things (like the text of consent forms from patients upon whom I performed measurements).

Here is the correct analysis for one of the publications. Here is the correct analysis for another of the publications (Eastell et al., 2003). Here are the Data underlying all three publications (encrypted).

So far all involved have been a little evasive, giving artful answers to "questions" that had not in fact been asked. That seems to be to be a bad idea John Eisman.

While being politely patient, I found some most interesting old news reports about P&G's own spying tactics.
New York Times Page C7, September 7, 2001
P.& G. Said to Agree to Pay Unilever $10 Million in Spying Case
By JULIAN E. BARNES (NYT); Business/Financial Desk
DISPLAYING ABSTRACT - Procter & Gamble will pay Unilever about $10 million and agree to unusual third-party audit to settle dispute that arose after P&G acknowledged that it had taken documents from trash cans outside Chicago office of Unilever; Unilever had made demand to ensure that Procter & Gamble did not change its marketing or product development plans for its hair care business after reviewing about 80 pages of confidential Unilever plans
Procter & Gamble Admits to Spying on Unilever

In a disclosure that shines a light on the shady world of corporate espionage, FORTUNE magazine recently reported that Procter & Gamble, one of the nation's largest and most admired corporations, has "recently engaged in a corporate espionage program against competitors in its hair care business that even the company itself admits spun out of control."

P&G claims it did not break any laws, but a spokeswoman conceded that spying activities undertaken by a "corporate intelligence" company that was hired by P&G "violated our strict guidelines regarding our business policies."

DEFINITION: Corporate or industrial espionage is the practice of spying on business competitors to steal proprietary information, including product designs and marketing plans. While corporate espionage sometimes includes computer hacking, it is just as likely to involve non-technology-related practices, such as rummaging through a competitor's trash ("dumpster diving") or simply interviewing disgruntled employees.

P&G has confirmed that at least one competitive intelligence company it hired engaged in dumpster diving to find information on rival Unilever's hair-care business. The competitive intelligence operatives are also said to have lied to Unilever employees - claiming they were market analysts in a further effort to gather information.
Procter & Gamble vs. Unilever
In 2001, P&G undertook a corporate-espionage program by hiring a "consulting firm" to rummage through Unilever's trash and steal the secret formula for a new hair-care product. The two companies eventually reached a settlement; P&G agreed to pay Unilever $10 million. The firm hired to do the dirty work is headed by a former Green Beret and U.S. government intelligence operative who served in the Phoenix Program, a covert operation during the Vietnam War.

Remarkably this isn't the first time P&G has gotten caught in corporate espionage against Unilever. In 1943, a Procter & Gamble executive bribed an employee of Lever Brothers (as Unilever was then called) to steal prototype bars of a new soap Lever was developing. P&G used the stolen formula to rework its own Ivory Soap, which soon became one of the most familiar brand names in America. P&G ended up having to pay Lever $5 million for patent infringement.
One year later, P&G Pharmaceuticals signed a research agreement.

See also
The Ethics of Competitive Intelligence

The moral:
Before you criticize people, you should walk a mile in their shoes.
That way, when you criticize them, you've got a mile-long head start.
And you have their shoes.

The Lion (in The Wizard of Oz)

(Thank you John - a medical publication professional - for the tip)

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Scientific Misconduct Word-of-the-Week: Neutralize

Word of the weekI introduce two new weekly features on this blog.
  • Word of the week (or concept of the week):
    The interesting language of integrity and accountability in science
  • Retro roundup:
    What happened this past week in the history of academic integrity, and what we haven't learned.
The language of debate about pharmaceutical and scientific integrity is very different from colloquial English. Instead of a few thousand commonly used words, we have a restricted lexicon of a few hundred words, many of which bear a superficial resemblance to common English. For example words or concepts such as "transparency", "independent", "public interest", "criminal investigation", "research misconduct" and "the free market" have quite different meanings from those normally encountered.

Today's word of the week is "NEUTRALIZE"

In the dictionary we read

neu·tral·ize
  1. To make neutral.
  2. To counterbalance or counteract the effect of; render ineffective.
  3. To declare neutral and therefore inviolable during a war.
  4. Chemistry : To cause (an acid or base) to undergo neutralization.
  5. Medicine: To counteract the effect of (a drug or toxin).
  6. Slang: To remove as a threat, especially by killing.
However, a brief reading of text in this area shows that this is in error.

Neutralize in fact means "to educate".

To trace the changes of form of these words is no easy task. I believe the word "neutralize" in it's current sense was first applied in 1962, but it's meaning was consolidated by Merck & Co. pharmaceuticals in 2005. Merck's marketing team targeted doctors viewed as unfriendly toward Vioxx to bring them into the fold (or to neutralize them).

In one written example Nancy Santanello, head of Merck's epidemiology department was questioned about an internal list of 36 doctors identified as:

"physicians to neutralize"

"Attached is the complete list of 36 physicians to neutralize with background information and recommended tactics. You will notice that some have already been neutralized".

In court, Santanello said the term "neutralize" was a marketing strategy to educate doctors about Vioxx
(first Vioxx trial 07/19/2005, Associated Press)

In other instances it could involve payment of money or threats of legal action - both good scientific methodologies.

The correspondence given to jurors was to or from Susan L. Baumgartner, who worked for Merck as a consultant. In videotaped testimony, she repeatedly said neither she nor anyone she knew at Merck intimidated anyone, and that the terms had nothing to do with intimidation, and were marketing jargon rather than dictionary terms

That, said Baumgartner, meant to provide correct information so those doctors would "come to a neutral or fair position". In a memo with "discredit" under a name, she said her recollection was that the doctor "discredited himself based on his own actions."

See also
http://www.dentonrc.com/sharedcontent/APStories/stories/D8BEMPE00.html
http://hcrenewal.blogspot.com/2005/07/neutralizing-doctors.html
http://hcrenewal.blogspot.com/2005/12/more-allegations-that-merck-executives.html

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Pharmaceutical Dilbert of the day (4) - Numbers in Medicine



Medicine is about numbers, or at least an evidence-based gut-feel for numbers.

The art of good medicine is based on understanding what is likely to happen to a patient if we do something - or if we do nothing.

Sometimes we gain that understanding from experience. Sometimes understanding is based on statistical findings which go beyond the experience of an individual clinician.

It is infuriating when those who purport to regulate the safety of medicines collude to give the impression that no-information is information. For example, the MHRA (the increasingly beleaguered UK drug regulator) proudly proclaim that

"The MHRA have highlighted that the product information for rosiglitazone (Avandia) has carried warnings about heart failure since 2000 and myocardial infarction since 2006"
and
"Avandia's warning label already warned of the risk of cardiovascular adverse events".

Well that's alright then.

Actually it isn't.

Pharmaceutical companies and doctors must warn ultimate purchasers (patients) of dangers inherent in drugs sold and prescribed. Legitimate lawsuits should be about whether a company took reasonable and timely action to make a drug’s risks known. That means far more than telling consumers that a bad event may occur. Manufacturers do not fulfill their duty to warn by providing meaningless information.

The legal system and regulators regularly misunderstand (or pretend to misunderstand) the numeric basis of medicine. If information is provided without attempting to assign honest estimates of probability (with confidence intervals), that information is essentially without meaning.

Let us suppose for a moment that I am the manufacturer of a motor vehicle. I sell that vehicle with a disclaimer that : "the tires on this vehicle may explode resulting in the death of passengers and bystanders". In a scientific or medical context such information is equivalent to no-information. It is meaningless (without content). It does not inform decision-making in any way.

When the numbers are knowingly obscured, ignored, denied, delayed, disguised or falsified, then medicine stops.

Knowing now what GSK must have known, an appropriate warning for Avandia might have looked something like:

"Reducing blood sugar is not the primary goal of treatment in diabetes. The main goal of treatment in diabetes is to prevent the chance of cardiovascular death. If a drug increases that risk, it can have profound health consequences. There is as yet no evidence to suggest that Avandia reduces the rate of death in diabetes. There is some evidence to suggest that the risk of adverse cardiovascular events death might be increased. The confidence limits for such an increase are from X1 to X2."

The MHRA also helpfully advise that

“patients should not stop treatment with rosiglitazone but should discuss their medication with their doctor at their next routine appointment“.

What exactly should doctors discuss with patients? Given that the MHRA (and FDA) have a history of helping companies hide the information that doctors should be discussing, they might wish to tell us what we should discuss - instead of passing the buck. Alternatively we could turn the whole art and enterprise of medicine over to GSK, the Department of Health, Ian Oulsnam, and an MHRA computer. Why do we as doctors allow ourselves to be placed in the position of having to lie to patients?

See also Pharmagossip.

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Science Idol 2007 Cartoon Contest - Vote Now

Only a few hours left to vote. Please vote here.

Science Idol: The Scientific Integrity Editorial Cartoon Contest.

My second favorite cartoon from the 2006 competition is below. My favorite (and winner) was here.

Editorial Cartoons Can Be Funny.
Interference in Science Is Not.

Please support the Union of Concerned Scientists

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Intimidation by patient advocacy groups: More on the Gillberg Affair

Much has been written about the problem of "astroturf" patient advocacy groups (1,2,3,4,5,6). These are patient "support" groups with a facade of grassroots advocacy - but with real interests that lie elsewhere (7).

It isn't hard to discern fake advocacy. The cracks show when concerns are raised about scientific dishonesty, hiding of evidence, and regulatory malfunction. Patients rely on honest independent science. Legitimate advocacy groups (such as MIND ) show concern and outrage when there is evidence of threat to the integrity of science upon which their patient "clients" depend. Mute behavior of an "advocacy" group provides evidence of illegitimacy.

Less widely discussed is the inclination of some "advocacy" groups to intimidate individual scientists, clinicians or patients who wish to discuss concerns about scientific integrity.

Dr Leif ElinderFor a good example of this, I return to my ongoing investigation of the Gillberg Affair. Dr Leif Elinder (left) is one of the two individuals who raised serious concerns about the veracity of the study findings and patient consent in studies reported by the Gillberg team in Sweden. Elinder is an Uppsala pediatrician specialising in the care of children with complex educational needs. He also expressed concerns about poor science and industry influence underlying the diagnosis of ADHD (as have many others). During these events the Gillberg team destroyed all their raw data, preventing any exploration of alleged research misconduct (for details see here and here). This followed a court order to allow proper and confidential scrutiny of the records by investigators. The Gillberg team provided a laughable rationale for their destruction of those data and their prevention of scrutiny. A key aspect of the science involving the diagnosis of ADHD was thereby placed into considerable doubt. Any legitimate advocacy group would have been outraged (likewise all honest psychiatrists).

The Attention Society (Riksförbundets Attention) is the Swedish society supposedly advocating for children with ADHD (UK equivalent of ADDISS, or the US CHADD).

What did these advocacy groups do?

Well the facts stand for themselves:

1) Riksförbundets Attention did not criticize the actions of the Gillberg team. Neither to my knowledge did ADDISS or CHADD.

2) Riksförbundets Attention instead started a financial collection on their website in support of legal expenses for Christopher Gillberg [Insamling till stöd för Christopher Gillberg]

3) Riksförbundets Attention on their website resorted to the dismal technique of implying that Elinder is a Scientologist, which (even if relevant) he is not. They state: "När det gäller medicinering som är det stora svarta skynket för dessa personer, vars åsikter ligger nära scientologerna" [which is the real bad thing for these people, whose views are close to the Scientology movement].

4) They then placed a formal complaint with the National Board for Education and the body that licenses doctors in Sweden about Elinder (not Gillberg).

Swedish Radio 17 Aug 2006 reported that:
Ann-Kristin Sandberg, Chairman for the Riksförbundet Attention had approached both The National Board of Social Welfare (Socialstyrelsen, the body that registers doctors in Sweden) to "investigate whether the Uppsala physician Leif Elinder, known for his controversial views on ADHD should be allowed to keep his doctors certificate". "The organisation has the view that the National Board of Social welfare (Socialstyrelsen) should investigate Elinders suitability as a physician" "This spring he wrote an article for the newspaper in Uppsala where he called ADHD concept a horoscope. This was the final straw and it was taken as an insult towards our members who are suffering from the symptoms."

5) Similarly the Swedish newspapers (Publicerad: 2006-06-08) reported that:

"The view of the Attention society who strongly attacks Leif Elinder who calls ADHD a horosope concept. For this reason the Attention society, an interest organisation for people with neuropsychiatric disabilities such as ADHD have sent a petition to Skolverket to attempt to consider whether Elinder can pursue his work in his field"

6) Riksförbundets Attention wrote to Socialstyrelsen in an attempt to get Elinder struck off. That letter is here (click on images for larger versions):

Click to expand

Socialstyrelsen replied quite appropriately telling Riksförbundets Attention to get lost:

Click to expand

7) Gillberg as well as his wife (Carina) wrote intimidating letters to about a dozen member's of Elinder's family, but Riksförbundets Attention didn't comment on the appropriateness of this either.

Click to expand

8) In the meantime the website of Riksförbundets Attention states that they get extensive funding from a variety of pharmaceutical companies. Dr Björn Kadesjö is one of three members of their medical advisory board. This same Kadesjö has co-signed commercial pharmaceutical confidentiality agreements with Gillberg (link). Kadesjö has published 14 papers with Gillberg about ADHD (link) constituting Kadesjö's entire research output.

Woe be to all of us.

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More on the David Kern affair at Brown University

Dr David KernI have written previously about the depressingly familiar treatment of Professor David Kern at Brown University. The reputation of Brown was brought into disrepute through those events and through other parallel scandals such as that involving Professor Martin Keller. As Kern states "while our medical school and university administrators continue to proclaim a dedication to truth, to the search for knowledge, and to the advancement of civilization, it is all pretense as wordsmithing triumphs over truth and as knowledge is buried."

The best description of the Kern affair is hidden within the (non electronic) archives of the International Journal of Occupational and Environmental Health. It is the now the 10th anniversary of those events. Brown University have yet to make any public apology, conduct any public exploration of their actions, or explain their actions. The main point of this posting is to make available the full text of the 1998 Kern manuscript detailing those events of 1997. I do so with the kind permission of the IJOEH editors. It is mandatory reading for anyone who cares about research integrity and the functioning of universities.

The manuscript is here (IJOEH 1998, 4(1) 19-40):
Manuscript (1.1 Mb)
Appendices (0.2 Mb)

An important quote in the paper comes from The American Thoracic Society who stated:

"Barriers to the open communication of scientific information must be resisted. In particular, the threat of litigation and/or elimination of financial support to prevent the open communication of scientific information is abhorrent."

Kern emphasizes the points actually at issue: the need to protect the freedom of scientists to communicate findings important to the health of the public, and the physician's overarching professional responsibility to his or her patients.

Some extracts from the paper follow:

We are left confronting arrogance, dishonesty, and a callous disregard for the health of workers. While our medical school and university administrators continue to proclaim a dedication to truth, to the search for knowledge, and to the advancement of civilization, it is all pretense as wordsmithing triumphs over truth and as knowledge is buried. What makes such pretense infuriating goes beyond hypocrisy to the failure of these administrators to realize that people's lives hang in the balance. They either fail to appreciate or are unwilling to acknowledge that their words and actions have jeopardized the health of individual workers, have contributed to the potentially irrevocable loss of an opportunity to advance both scientific understanding and the public health, and have undermined the collective sense of trust and mission in this academic community.

At the close of the meeting, I provided the company with a draft of a scientific abstract, describing the clinical dimensions of the ILD outbreak, which I was planning to submit to the American Thoracic Society for presentation at its annual international conference in May 1997. Two days later, Mr. Fulks called to say that I could not submit the abstract and, that if I did, the company would take legal action against both the hospital and me.

THE MEDICAL SCHOOL ADMINISTRATION'S FIRST STRIKE

During the following week, I contacted the University Grants Office and was referred to Peter Shank, Associate Dean of Medicine and Biological Sciences. Dr. Shank wrote to me, stating: "I see no way in which you can publish results of your studies at the company with-out their written approval . . . you should immediately withdraw your abstract to the national meeting." He copied his letter to both Rick Dietz and H. Denman Scott, MD, Physician-in-Chief at Memorial Hospital. [Professor Shank's letter is here]

THE HOSPITAL'S SHIFTING SANDS

The following day, Dietz told me that he would arrange for me to speak with the hospital's legal counsel. He then went on to say that given the absence of any public health concern it seemed to him that I should withdraw the abstract. When I asked him why the disease outbreak did not pose a public health concern, his response was that no other company in the world makes what this company manufactures and that NIOSH personnel were already conducting an investigation at the company. I explained that this is not the only company in the world manufacturing these products, to which he replied, "Yes it is." I noted the existence of two other companies in Rhode Island, a considerable number of business competitors throughout New England, and an international trade organization having at least 50 member companies. With that, he became somewhat agitated, stating that I was going to destroy the company.

CONFLICTS OF INTEREST

Perhaps worthy of note is that Microfibres is one of eight benefactors responsible for construction of the hospital's histology laboratory. Three members of the company owner's family serve as members of the Memorial Hospital Corporation. More troubling, however, is that the company was asked to contribute to the hospital's Primary Care Center Capital Campaign at approximately the same time as Frank Dietz and Dr. Scott were attempting to allay the company owner's anger about our having submitted a scientific abstract on the disease outbreak. Moreover, the solicitation was made jointly by Rick Dietz and the Chairman of the Capital Campaign. The Chairman of the Capital Campaign also serves both as Vice Chairman of the hospital's Board of Trustees and as hospital attorney. In the latter role, he has provided guidance to Frank Dietz on how to deal with the confidentiality agreement, the submitted scientific abstract, and me.

THE MEDICAL SCHOOL ADMINISTRATION'S SECOND STRIKE

On December 20, I asked Dr. Scott for clarification of two points. When I asked what would happen if I re-fused to withdraw the abstract, I was informed that if the company sued the hospital, the hospital would in turn countersue me. When I explained that what I had really been asking was what would happen to my job, he answered that he did not know. When I asked what Frank Dietz had meant in stating that our occupational health program no longer existed, Dr. Scott answered that I could not have any contracts with industry.

THE MEDICAL SCHOOL ADMINISTRATION'S THIRD STRIKE

Over the following month, the actions and statements of both Dean Marsh and the Committee of Inquiry made it clear that a search for truth was not in progress.

A Committee of Inquiry released its report. While the committee concluded that my academic freedom had been violated, it reached this conclusion on the basis of tortured legalistic reasoning and all but ignored the truly compelling facts and issues. It is difficult to imagine how anyone can take the report seriously given such conclusions as: "The company's attempt to have the abstract withdrawn is not considered by the Committee to be an attempt to compromise the health of its employees but rather an effort to avoid bad publicity and to protect its economic position."

COMMENT

Representatives of the company, the hospital, and the university have gone to great lengths to distort the truth. Yet, even were their claims true, their points of contention are irrelevant to the critical issues in this matter. That is [not], whether ... the confidentiality agreement in question has any legal standing [but]
  • attempts to suppress the dissemination of scientific findings critically important to the public health
  • interference with my professional responsibilities to care for patients, and
  • immediate termination of our occupational health program.
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Usual understanding turned inside out

MangledThink of your favorite teddy bear. Now imagine it’s been torn apart, disemboweled, and turned inside-out. That’s what artist Kent Rogowski’s has done in his excellent Bear series. He mangles our memories of the world.

Perhaps a metaphor for the effect of the pharmaceutical industry on the conduct of science (in collusion with our medical leadership and the "regulators" of course). Usual understanding turned inside out.

More bears here
Buy the book here
Read one of a million inside out stories here or here.


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The Gillberg affair and the fall of a scientific journal (JAACAP)

Journal of the American Academy of Child and Adolescent PsychiatryProfessor Christopher Gillberg was Professor of child psychiatry at Gothenburg University, in Sweden. He is visiting Professor of psychiatry at the University of Strathclyde in Glasgow. He is involved in patient care at the National Centre for Young People with Epilepsy and is registered as a Child Psychiatrist in the UK as of 21 April 2004 (Medical Qualification Lakarexamen 1973 Goteborg, Specialist Register Child and Adolescent Psychiatry from 21 APR 2004, GMC number 6095760). Notably, this registration with the General Medical Council occurred after the events referred to below.

I have much to say about this affair, but I will concentrate only on the role of a medical journal, and my discussions with that journal.

For detailed discussion, original documents and references relating to this incident see here. Briefly, in 2002 Gillberg was accused of research misconduct in critical research involving a psychiatric concept known as "DAMP". This is part of the ADHD spectrum of diagnoses, and an area of medicine which is under intense scrutiny. Evidence to support the allegations of research misbehavior seem to be substantial (here). The authors refused to allow anyone to inspect their data properly. A court ordered that the data be made available to investigators. Before that could be enforced, though, the data was deliberately destroyed --100,000 pages, covering 16 years of research on children. The approach of Gothenburg University was subject to extensive criticism (as detailed here). Despite the destruction of data under such circumstances, the relevant publications purporting to represent those data have not yet been retracted. Such a situation is untenable.

The intention of this post is not to discuss Christopher Gillberg or the precise alleged misconduct. The mechanics of the affair are of considerable interest but are not directly pertinent here. However, the Gillberg affair raises a number of issues that are pertinent to this blog
  • the failure of structures designed to maintain integrity in medical science
  • the collusion of institutions, medical journals and commercial entities with scientific misbehavior
  • convenient manipulation of language and definition to obscure distortion of the scientific literature
Perhaps the most critical implicated publication is the following:

Rasmussen P, Gillberg C. (2000) Natural outcome of ADHD with developmental coordination disorder at age 22 years: a controlled, longitudinal, community-based study. J Am Acad Child Adolesc Psychiatry. 2000 Nov;39(11):1424-31 Pubmed Link.

Now this prestigious journal, the Journal of the American Academy of Child and Adolescent Psychiatry is already under considerable international fire over another paper which has not yet been retracted. In particular, in a widely discussed recent television broadcast the editor of JAACAP displayed no concern when presented with evidence that an important paper about GSK's antidepressant drug Paxil and the infamous study 329 published in JAACAP - a) might have reported "findings" that misrepresented the underlying data, b) that this should have been known to the writers, and c) that reviewers had been ignored. It is possible that this publication might have contributed to the death or injury of some children. For discussion of this JAACAP affair see here, here, here, here, here and here.

In that instance, Editor Dr Mina Duncan simply stated on a Panorama Television Broadcast [Link, Link] that:

"I don’t have any regrets about publishing [the study] at all – it generated all sorts of useful discussion which is the purpose of a scholarly journal."

As previously discussed according to this logic, we should publish studies with as many flaws as possible so that we can “usefully discuss” them.

With that in mind, I reproduce my trail of correspondence with the Editors of JAACAP about this other Gillberg publication (Child Adolesc Psychiatry. 2000 Nov;39(11):1424-31) and the shocking dismissive response.

It is not clear to me that JAACAP should any longer be considered as a legitimate scientific journal.

Date: Wed, 23 May 2007 15:17:50 +0100
From: Aubrey Blumsohn
To: Sherri Willoughby, Editor JAACAP

Subject: Gillberg Publication in JAACAP

Dear Dr. Willoughby,

I write further to some information that has been circulating about a 2000 publication in JAACAP about a putative psychiatric disorder in children (Rasmussen & Gillberg, 39: 1424-1431).

It is apparent that the raw data underlying this (and perhaps other) publications has been destroyed by the authoring scientists and their team. Refusal of a scientist to reveal raw data would normally provide prime facie evidence of scientific misconduct. Destruction of such data while questions were being asked about the veracity of the research would constitute a very serious breach of scientific norms.

I am therefore writing with two simple questions:

  1. Is the journal aware that the raw data underlying this manuscript was destroyed by the authoring scientific team?
  2. This manuscript and it's conclusions are clearly unsafe. I am concerned that this manuscript has not yet been retracted. Please let me know what steps have been undertaken to do this or explain why this has not yet been done.
Kind Regards

Dr Aubrey Blumsohn
MBBCh, PhD, MSc, BSc(hons), MRCPath

Subject: RE: Gillberg Publication in JAACAP
Date: Thu, 24 May 2007 13:29:56 -0500
From: "Sherri Willoughby" JAACAP
To: "Aubrey Blumsohn"


Dear Dr. Blumsohn,

Policies regarding the retention of raw data are not under the purview of the Journal. These are typically set by the academic institution where the investigators work and/or by the funding agency (or regulatory body, in the case of medications, although that does not apply to this study).

Sincerely,

Sherri Willoughby, Managing Editor
Journal of the American Academy of Child and Adolescent Psychiatry

At the same time Doug Keenan, a mathematician, received a similar "reply"

From: "Sherri Willoughby" JAACAP
To: "D.J. Keenan"

Subject: RE: JAACAP data request policy

Dear Dr. Keenan,

Thank you for your interest in the Journal and its policies.

JAACAP has a longstanding policy that unpublished instruments and manuals be made available by the author to interested readers (but we do not require that this be free of charge).

We do not have a policy on access to data, but if we should receive a request (e.g. for purposes of a meta-analysis), we would refer the requester to the corresponding author of the paper. We do not obligate the author to provide the data. If the Journal did, in the future, develop such a policy, it would apply only to papers published after the policy was established and to authors who were informed of the policy before submitting to JAACAP (by having it in the Instructions for Authors).

Sincerely,

Sherri Willoughby, Managing Editor
Journal of the American Academy of Child and Adolescent Psychiatry
I replied as follows:
Date: Thu, 24 May 2007 20:23:09 +0100
From: Aubrey Blumsohn
To: "Sherri Willoughby" Editor JAACAP

Subject: Re:Gillberg Publication in JAACAP

Dear Dr Willoughby

I am sorry but your reply appears to me to be wholly inadequate. This paper involves a putative psychiatric disorder in children.

You seem to be suggesting that the destruction of data, under conditions where that data is being questioned isn't (nor should be) of any concern to you as an editor of a Journal.

I wish to publish your response, but I thought I would give you the chance to further clarify your position on this.

Kind Regards

Dr Aubrey Blumsohn
MBBCh, PhD, MSc, BSc(hons), MRCPath
Having received no further reply, I wrote again....
Date: Tue, 5 Jun 2007 15:36:51 +0100
From: Aubrey Blumsohn
To: "Sherri Willoughby" Editor JAACAP
Subject: Re:Gillberg Publication in JAACAP

Dear Dr Willoughby,

Thank you again for your illuminating response.

I have been reading your instructions for authors that would have pertained at the time this manuscript was submitted. http://edmgr.ovid.com/jaacap/accounts/ifauth-before-April1.htm

1) Firstly I note that you subscribe to ICMJE guidelines in terms of data. You therefore import into your guidelines for authors clear guidelines with regard to data.

2) I further note that the web address to ICMJE within your guidelines has an error (a space) which suggests perhaps it is has not been referred to recently.

3) Perhaps some aspects of editorial practice and good science are so obvious that they do not require explicit mention in guidelines.

4) I also note that you hold copyright on the publication. This must surely imply that you vouch for its contents.

Might I ask whether you have enquired of the institution concerned whether they have completed their analysis of these data to check the veracity of the reported findings. If not, this may be appropriate at this juncture.

Your response would be appreciated.

Best wishes

Dr Aubrey Blumsohn
MBBCh, PhD, MSc, BSc(hons), MRCPath
and again ......
Date: Sun, 10 Jun 2007 10:46:25 +0100
From: Aubrey Blumsohn
To: "Sherri Willoughby" Editor JAACAP
Subject: Re:Gillberg Publication in Journal of the American Academy of Child and Adolescent Psychiatry

Dear Dr Willoughby

I have not received an acknowledgment of my last communication below.

Please therefore accept this communication as a formal letter of concern to you as Editor with regard to the veracity of the paper:

Rasmussen & Gillberg (2000) JAACAP 39: 1424-1431

I must admit that I also have serious concerns about potential Editorial misconduct in this instance.

I believe JAACAP was also somehow involved in publishing disputed research involving Seoxat/Paxil, and I would have serious concerns about the plausibility of JAACAP given such repeated instances of apparent disconcern about scientific integrity.

Best wishes

Dr Aubrey Blumsohn

The problem extends beyond questions of ADHD, child psychiatry, Gillberg or the JAACAP. By ignoring such problems, the integrity of all research involving human subjects is put into jeopardy. When journal editors behave in this manner, it raises questions about the entire research enterprise in medicine.

Such behavior on the part of a journal editor is also unfair to the many authors who have published respectable and legitimate science within their pages. It means that all manuscripts published in JAACAP should be viewed with suspicion. It is also unfair to the many psychiatrists and psychologists who are involved in honest clinical practice, and whose profession has been brought into disrepute.

What exactly is the function of a scientific journal beyond serving as a laundering operation?

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P&G's nonexistent plateau - part I

Here is the abstract I presented at the International Bone and Mineral Society Congress in Montreal last week (in between a lost passport, vomiting and cancelled trains). It involves the smallest of the three implicated Procter and Gamble publications (backstory here). Two more to follow.

Relationship of fracture risk to change in bone resorption with risedronate in the HIP study - is there a plateau response?

Authors: A. Blumsohn (1), J. L. Hutton (2)
(1) Sheffield Teaching Hospitals, Sheffield, UNITED KINGDOM,
(2) Department of Statistics, University of Warwick, Coventry, UNITED KINGDOM.

Understanding the determinants of bisphosphonate induced change in fracture risk is a prerequisite to rational prescribing and therapeutic monitoring. A previous abstract (Blumsohn, Barton, Chines, Eastell. JBMR 2003;18 S2:S89), and draft publications failed to shed light on the true relationship between change in bone resorption (uNTX/Cr) and fracture risk in the HIP study. The study included 938 women (FN T score <-3, age 74 SD 3) who received Ca and either 5mg risedronate/day, 2.5mg or placebo for 3 years. Randomization and event codes were supplied to authors in 2006. Data did not provide evidence to support previous conclusions.

Previous reports on these data suggested risk of incident vertebral fracture (V#) was non-decreasing when NTX decreases beyond -30% (%?NTX < -30%), and the relationship was "non linear" with "little further improvement in fracture benefit below a decrease of 30 to 35%". It further suggested that another marker (%?PINP) was significantly predictive of V#.

We used several statistical models as well as visual inspection to evaluate a potential "plateau" effect at a putative threshold -30% or -40%. Cox and logistic regression models were used, with thresholds of -30% and -40%, and two transformations of NTX: %?NTX and ?log(NTX). The response was allowed to take different values above and below the threshold, for both linear and quadratic functions. Conclusions were essentially the same for all models, with or without inclusion of data on the unlicensed (2.5mg) dose.

Visual inspection showed no evidence of a plateau near the putative threshold. With 5mg risedronate most (9/11) incident V# occurred with change in NTX beyond the proposed -30% threshold (median %?NTX with V# was -49%). No patients with %?NTX < -61% sustained V# (-61% was also the approximate lower limit of data plots presented to authors by the sponsor). However 44% of patients on 5mg had %?NTX < -61%. Regression models showed no evidence for a plateau at either threshold, and significant evidence of no plateau (Cox P < p="0.010," p="0.013,">0.22).

In conclusion, this study provides no evidence to support a plateau relationship between NTX change and fracture risk with threshold near -30% in patients taking risedronate.

Author Disclosure: Study funded by Procter & Gamble Pharmaceuticals.
Reference: A. Blumsohn,A., Hutton,J.L. (2007) Relationship of fracture risk to change in bone resorption with risedronate in the HIP study - is there a plateau response? Bone 40(6 S2) S303-4.

Here are the poster and poster handout in pdf format. Both explain the relevant background to this abstract. This was also the presentation subjected to the Dr Purple treatment.

Much more to follow (including some serious science).

"The time has come," the Walrus said,
"To talk of many things:
Of shoes-and ships-and sealing wax-
Of cabbages-and kings-
And why the sea is boiling hot-
And whether pigs have wings."


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How the light gets in

This one is for Juchuan, and serves as a prelude to the next postings.

Ring the bells that still can ring.
Forget your perfect offering.
There is a crack in everything.
That's how the light gets in.

Leonard Cohen [Anthem]

Light

We can easily forgive a child who is afraid of the dark;
the real tragedy of life is when men are afraid of the light.
Plato (427 AD - 347 AD)


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