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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