Did NZ drug regulator do some laundering for GlaxoSmithKline?

I wrote previously about the hidden bioavailability analysis of GSK's new formulation of Eltroxin (thyroxine). These concerns followed multiple complaints from patients about side effects on the new formulation. Medsafe (the New Zealand drug regulator) had issued an alert, stating that:

"In response to these reports, Medsafe has reassessed the change in Eltroxin formulation and can confirm that the new formulation satisfies all quality, safety, and bioequivalence criteria. In addition, all excipients and excipient quantities present in the new formulation are commonly used in medicines."

GSK stated that

"extensive testing and retesting by GSK has shown that the tablets should be safe and effective when used as prescribed"

However in response to my communications Medsafe refused to discuss what GSK's supposedly "extensive testing" was, the study design or the actual results - citing that the science "is commercial in confidence". Nor it seems were any of the data published in the scientific literature.

Now we have some information about these so called "extensive" tests, courtesy, not of usual science, but through response to a New Zealand parliamentary written question. Still no data, but it now seems that:

1. Only 36 "test subjects" were studied.
2. Studies lasted only 48 hours (perhaps long enough to determine bioavailability using measurements of T3 and T4 in blood - but in the absence of any details of study design or the actual results one cannot tell).
3. It seems that "Almost 25% of the subjects experienced an adverse event when taking the new formulation of Eltroxin, compared to just 8% taking the standard formulation".

Parliamentarians are asking questions.

Member of Parliament Jackie Blue says "the authorities need to explain why this information did not ring alarm bells for them".

My questions would be more fundamental, regardless of the data. Why are we in this position in the first place, and what is the role of a scientific regulator?

See also the excellent Pharmalot on some aspects of this story

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Betty Dong Redux (from Boots to GlaxoSmithKline)

Recent problems with Eltroxin in New Zealand raise memories of a landmark scandal involving the researcher Betty Dong. Eltroxin is the brand name for levothyroxine (also known as thyroxine) as produced by GlaxoSmithKline.

Some history

In 1990, Betty Dong, a researcher at UCSF was funded by Boots Pharmaceuticals to carry out research to compare Boots thyroxine (Synthroid) and generic alternatives of the same drug. She discovered that the Boots drug was no more effective than three cheaper competitor products available at that time. When she tried to publish, Boots threatened to sue. Dong withdrew the manuscript from the JAMA publication process following legal threats. UCSF failed to uphold academic integrity. Company executives then published an inaccurate version of the findings while excluding Dong and threatening legal action. Even then, UCSF remained silent.

Nine years later the sordid details were exposed in the press and Dong’s paper was published. In November 1997 the manufacturer (then Knoll Pharmaceuticals) paid around $100 million to settle dozens of lawsuits charging that the company had cheated consumers. However, the company made a profit of $3billion in inflated costs during the nine year delay. No company executives were prosecuted. The American Thyroid Association failed to take any stance on scientific integrity, leaving, according to Drummond Rennie "the sad impression that the ability of the association to influence these events was weakened by its heavy dependence" on the drug maker’s financial support.

The 2008 Eltroxin problem in New Zealand

Eltroxin is the trade name of thyroxine as sold by GlaxoSmithKline. Over the past few months at least 500 patients in New Zealand complained of a variety of side effects and lack of drug efficacy following reformulation of Eltroxin. Manufacture of the New Zealand supply of Eltroxin had moved from Canada to Germany.

It is not the purpose of this discussion to examine the patient complaints. The resulting news reports can be accessed here, here and here.

The structural aspect of this problem are however interesting.

Generics have to be shown to be chemically identical to the original (usually easy), and to have identical bioavailability under clinically relevant conditions of dosing (often tricky). Generics might differ from each other, but might also vary over time. In normal scientific medicine one would expect such information would be published in the scientific literature (or at the very least would be available for open and full scrutiny).

Medsafe (the New Zealand drug regulator) immediately hit back with an alert which suggested that the GSK product was absolutely fine. They asserted in their alert that:

"In response to these reports, Medsafe has reassessed the change in Eltroxin formulation and can confirm that the new formulation satisfies all quality, safety, and bioequivalence criteria. In addition, all excipients and excipient quantities present in the new formulation are commonly used in medicines."

So I wrote to Medsafe with regard to the evidence underlying their assertions:

Can you please tell me whether
a) the studies to prove bioequivalence of this formulation are published in the scientific literature, or otherwise available?
b) I can have a copy of the study report and findings?

The reply I received was as follows:

To: Aubrey Blumsohn
Subject: Eltroxin Bioequivalence
From: Chris_James@moh.govt.nz
Date: Mon, 8 Sep 2008 12:39:34 +1200

Dear Dr Blumsohn,

Thank you for your email.

In answer to your questions and request for information, I can provide the following:

1. Medsafe is not aware of the bioequivalence study, conducted for the changed formulation of Eltroxin, being available in the scientific literature. I suggest you contact the manufacturer (GSK) for further information.

2. Medsafe evaluated the bioequivalence study and concluded that the change in Eltroxin formulation met all internationally accepted criteria for bioequivalence. Unfortunately, Medsafe cannot currently provide you with the actual study report as this contains data that is "commercial in confidence". For additional information on bioequivalence requirements Medsafe applies, please see our regulatory guidelines at:http://www.medsafe.govt.nz/regulatory/Guideline/medicines.asp

In assessing bioequivalence studies Medsafe also utilises international regulatory guidance, including:
CPMP/EWP/QWP/1401/98. Note for Guidance on the Investigation of Bioavailability and Bioequivalence. Link: http://www.emea.europa.eu/pdfs/human/qwp/140198enfin.pdf. FDA Guidance for Industry, Bioavailability and Bioequivalence, Studies for Orally Administered Drug Products - General Considerations. Link: http://www.fda.gov/cder/guidance/5356fnl.pdf

Medsafe is intending to make more information publicly available on our website shortly, in response to the questions we are being asked.

Yours sincerely,

Chris James
Advisor Pharmacy
Clinical Risk Management, Medsafe
Sector Accountability & Funding Directorate
Ministry of Health

I wrote to GSK asking for the data, but received no response. However in a press statement today GSK states that in their view "extensive testing and retesting by GSK has shown that the tablets should be safe and effective when used as prescribed"

The upshot of all this

1. A generic drug (or a batch of that generic) may have a problem.
2. A drug regulator has seen some data which may or may not be relevant to the situation.
3. Patients, doctors and the public are not allowed to see that information (or to know what studies were carried out). This is because the regulator regards that science as "commercial in confidence". Doctors have to prescribe based on GSK's own evaluation of their supposedly "extensive testing" as well as a guess as to the capability of regulators to evaluate that hidden information.
4. It is not clear how the studies supposedly seen by the regulator relate to the questions being asked by patients or by doctors. What batches were tested? What tests were carried out? Were there clinical bioavailability studies? What were the study endpoints? Which patients were studied? How many patients were studied? What was the study design? What were the results?
5. Is the behaviour of GSK and Medsafe really different from the behaviour of Boots and UCSF?
6. Can we really regard Eltroxin as a science-based product when the science is hidden, and should science-based doctors prescribe it?

Also of interest: The Dilantin story

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Whose mouse is it anyway?

The LA Times has a fascinating article about Disney's copyright claim to Mickey Mouse. The article is relevant to this blog because it is about bullying and legal overkill in an attempt to suppress discussion (including, in one instance, academic discussion).

After the painful experience of losing Oswald the Rabbit, the Disneys "held on to everything they did with a ferociously strong grip".

The discussion about Mickey resulted in a 2003 paper in a University of Virginia legal journal that argued "there are no grounds in copyright law for protecting" the Mickey of those early films. A Disney lawyer "threatened the author with legal action for "slander of title" under California law".

Earlier, Gregory S. Brown, a Disney researcher challenged the arguments of Disney lawyers who wrote that "Mickey Mouse had been created by Walt Disney Co. in 1928". The former archivist knew that the company didn't exist then. Without ruling on the merits of Brown's arguments, the judge tossed it aside as untimely. "He was clobbered with a $500,000 judgment". "His appeal was dismissed when he missed a filing deadline. Disney then seized $20,000 from his accounts" and he was left bankrupt.

They "threatened to sue three Florida day-care centers for painting Disney figures on their walls." They sued a a home-based business for $1 million "after a couple put on children's parties with ersatz Eeyore and Tigger costumes."

In fact "many of Disney's most famous figures were the creations of others, including Cinderella, Pinocchio, Pooh and Snow White, though it has vigorously protected its depictions of them." (A legal dispute with Disney bankrupted the publisher holding the Bambi copyright).

[In my view there is a fundamental difference between Mickey and Avandia (or Zetia, Actonel, Zyprexa, Vioxx, Paxil) as a "product" anyway. A scientific medical product is not simply the molecule (the depiction of the Mouse). A drug product is a scientific package comprising both the molecule and open scientific discussion. Without the honest and transparent science, there is no product at all.]

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Placebo Journal and AccuPringles

The Placebo Journal continues to produce great material. Watch the latest Placebo TV broadcast on product-free pharmaceutical advertising.

I was particularly struck by their promotion of Accupringles from our friends at P&J Pharmaceuticals



Available in

• Original
• Sour Cream and Hydrochlorthiazide
• Ranch and a Channel Blocker
• Jalapeno and an ARB

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Pharmaceutical Mergers - Update

I updated the previously discussed historical database of pharmaceutical mergers to include Searle and the Roche Holding acquisitions of Syntex (1994, renamed Roche Bioscience in '95), and recently Genentech.

Please send along any corrections or additions to me at Email.

Here, of interest, is a listing of the eighteen largest pharmaceutical companies as ranked 21 years ago (in 1987). The source is an extremely odd, but interesting book : "Murder By Injection" by Eustace Mullins.

1. Merck (U.S.) $4.2 billion in sales.
2. Glaxo Holdings (United Kingdom) $3.4 billion.
3. Hoffman LaRoche (Switzerland) $3.1 billion.
4. Smith Kline Beckman (U.S.) $2.8 billion.
5. Ciba-Geigy (Switzerland) $2.7 billion.
6. Pfizer (U.S.) $2.5 billion (Standard & Poor's gives its sales as $4 billion.)
7. Hoechst A. G. (Germany) $2.5 billion (Standard & Poor's lists its sales as $38 Billion Deutschmarks).
8. American Home Products ( U.S.) $2.4 billion ($4.93 billion according to Standard & Poor's).
9. Lilly (U.S.) $2.3 billion ($3.72 billion Standard & Poor's).
10. Upjohn ( U.S.) $2 billion.
11. Squibb (U.S.) $2 billion.
12. Johnson & Johnson ( U.S.) $1.9 billion.
13. Sandoz (Switzerland) $1.8 billion.
14. Bristol Myers (U.S.) $1.6 billion.
15. Beecham Group (United Kingdom) $1.4 billion (Standard & Poor's gives $1.4 billion in sales of the U.S. subsidiary $2.6 billion pounds sterling as overall income).
16. Bayer A. G. (Germany) $1.4 bilIion (Standard & Poor's gives the figure as $45.9 billion Deutschmarks).
17. Syntex (U.S.) $1.1 billion.
18. Warner Lambert (U.S.) $1.1 billion (Standard & Poor's gives the figure as $3.1 billion).

I received a huge number of helpful responses including this one:

From: "World Changer" anakahamon@ritternet.com
To: ablumsohn-3@yahoo.co.uk
CC: John Kaminski skylax@comcast.net, JB Campbell jb_campbell@yahoo.com, Christopher Bollyn bollyn.books@yahoo.com, Prothink@yahoo.com, Counter Bias counterbias@yahoo.com.au
Subject: Pharmaceutical Mergers - Scientific Misconduct Wiki
Date: Tue, 2 Sep 2008 14:19:18 -0500

The main thing you need to do with your list is to list all the Jews who own and run the companies.

Given the recent revelations that George Bush is Jewish and attended Sheffield University, can anyone help with the vital task of collating ethnic affiliations of current pharmaceutical CEO's?

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Mail Order Academics

A new hot website.
Order your academic online here. Also available - kits to make your own academic.

http://www.thejabberwock.org/shop/

(Product of a serious few hours working-up a new web authoring package).

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Listing of historical Pharmaceutical Corporate mergers

Some may find this useful. I have been trying to collate a large historical database of scientific deception, indexed against University, corporation, person and journal.

To do this, I needed to decide what to call various corporate entities. This is hard to do, as mergers and names vary with geographic location. For example the US division of Bayer went a completely different route from the parent Bayer (which re-emerged from the death camps of IG Farben). I have (for the moment) taken some poetic license.

Anyway, here is my work-in-progress - a historical listing of pharmaceutical mergers and major subsidiaries that can be sorted by date and company. Please send along any corrections or additions.

http://www.thejabberwock.org/wiki/index.php?title=Pharmaceutical_Mergers

If you want to help maintain it (or if you know of anything better along these lines) then Email me. Feel free to criticize my artwork.

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Conflicts of Interest - and silence

I'm a fan of Scott Adams and Dilbert. I like this 1996 strip. First, it features Procter and Gamble. Second it has something to say about conflicts of interest.

Phil the Prince of Insufficient Light is the ruler of Lower Heck (and the brother of the pointy-haired boss). It pokes fun at P&G's logo controversy. In brief, P&G received undesired media publicity in the 1980s when an urban legend declared that their corporate logo was a Satanic symbol. This forced P&G to adopt a new logo. In 2007 a court ruled that P&G is not in league with his Satanic Majesty. P&G won a $19m lawsuit against rival Amway over the rumours. I'll have more to say of this controversy later.



"This is about protecting our reputation," said Jim Johnson, P&G's chief legal officer.

The strip also has something interesting to say about conflicts of interest (and declaring of such conflicts). Some imagine that declaring conflicts is the be-all-and-end-all solution to the problems of pharmaceutical science. One counter-argument is that conflicts influence not only that which is done, but also that which is not done. Sitting in silence while a colleague is bullied for example.

I propose that more consideration should be given to the concept of corporate sponsorship "to stay away". Click Here to fund the Scientific Misconduct Blog.

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Awakenings

I have taken a break over the past months while doing some more formal writing and (partially) recovering from illness. I ended up missing a whole lot of deadlines. The picture of Sisyphus sleeping is reproduced with kind permission of artist Michael Bergt.

I also spent some time thinking about the way we discuss malfunctioning systems in medicine.

During my break, I received some interesting documents about various cases I have been exploring. I received two amazing documents about UK medical regulators. These tell a story of corrupt organizations that are more interested in a surreal brand of public relations and self-protection than in any form of honesty. I received a few documents about myself.

Some of these documents made me angry. I have been wondering whether there is a type of discussion that is not legitimate. The internet is a scary place. Is it reasonable to embarrass individuals in positions of authority when those individuals have not (by any reasonable standards) behaved appropriately? I have generally tried to avoid embarrassing individuals, even though I have had ample reason and opportunity to do so.

Some of the documents I have are about other scandals that have already been ignored for many years. In many of these cases, both perpetrators and accusers have already suffered greatly. These are not individuals who are now in positions of any great authority.

The Bruce Hall affair

One such case is that involving Professor Bruce Hall in Australia. The scandal involving Hall resulted in the destruction of several careers. It has never been properly and openly addressed or discussed. The lessons have not been learned. Almost two years ago, I attempted to find out what happened. I began communicating with three very angry complainants, a journalist, several onlookers and Professor Hall himself. My questioning precipitated a trail of events which conveyed more about what might have happened than was conveyed by any of the conflicting reports. I was left with an immense feeling of sadness, not only for the students and staff who had raised problems, but also for Professor Hall himself.

Those students and staff wanted accountability, honesty and transparency. There was nothing that suggested to me that this was the intent of any of those in charge. Professor Hall was tired and apparently ill. He wanted to get on with doing good science. The real villains, it seemed to me, were not Hall or his wife, but rather the University of New South Wales and two medical journals who had behaved abominably. I ended up not discussing it at the time.

A document about myself

I also received a document about myself. This was an item of correspondence between two rather powerful individuals. It seems that my own refusal to go along quietly with attempts to manipulate the scientific method and the scientific record might imply that I am mentally ill. This kind of assertion is unfortunately a regular feature in many similar scandals. The person who wrote that letter should have known better. He failed to ask any of the obvious questions. He failed to stand up for what was right. He was someone I respected as a scientist. Indeed, he was someone who respected me (until I started asking the wrong type of question about the activities of his friends). I found this letter far more depressing than any of the futile and damning attempts by various authorities to cover-up what happened.

Is it worth discussing these things?

I think it probably is.

But it is hard to find a voice that conveys an attempt to learn (and teach) about malfunctioning systems - without also appearing to have a vindictive wish to inflict damage.

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Nottingham University goes 'kerplunk'!

I have posted previously about the embarrassment that has emanated from Nottingham University over recent weeks. The Nottingham saga related to a student who had in his possession a printout of terrorist material. The student was studying terrorism. The material was printed (and freely accessible) from a US government website.

Why discuss this on a scientific integrity blog?

It reflects the same system malfunction which leads lawyers and Vice Chancellors to make unprincipled anti-academic comments about the most basic safeguards of academia in science. Do I, as an academic, have the right to see, discuss, and properly assess data (mis)represented in my name by a commercial company? Are doctors prescribing drugs allowed to see and discuss the most fundamental aspects of science underlying that prescribing decision? Does an academic studying terrorism have the right to assess and to see (and even to possess) the information he is studying? What exactly are the roles and obligations of a University and of academic leadership?

Now we have this from the Times Higher Education Supplement (17 July 2008):

Researchers have no 'right' to study terrorist materials, By Melanie Newman

"Academics have no "right" to research terrorist materials and they risk being prosecuted for doing so, the vice-chancellor of the University of Nottingham has told his staff."...

Mr Sabir's personal tutor Bettina Renz, a lecturer in international security, and his MA supervisor, Rod Thornton, a terrorism specialist and former soldier, have both said they told police that Mr Sabir's possession of the document was legitimate given his research interests....

[Despite this, the University in a new letter] "warned Mr Sabir that he risked re-arrest if found with the manual again" and added: "The university authorities have now made clear that possession of this material is not required for the purpose of your course of study nor do they consider it legitimate for you to possess it for research purposes."...

"Since his release without charge, Mr Sabir has been accepted to study for a PhD in radical Islam at Nottingham under Dr Thornton's supervision. His doctorate application proposes an analysis of Islamic terrorists' military and political strategy "based on primary documents, including reports published by think-tanks and research centres and documentation published or released by Islamist groups (strategic and political statements, military manuals, group manifestos and charters)"....

"Mr Sabir insisted to Times Higher Education that he had downloaded his version of the al-Qaeda manual from a US government website and that it was still freely available on the internet"....

"He said he was now unclear what he could and could not legitimately research for his PhD, given the police and the university's warning"....

"Vanessa Pupavac, lecturer in international relations at Nottingham, said: "The university suggests it is illegitimate to study the operational or the tactical as opposed to the political or strategic dimension of al-Qaeda." Scholars were interested in both dimensions, she argued."...

Oliver Blunt QC, of the Anti-Terrorism team at Furnival Chambers in London, said that academics do have a "right" to "access" terrorist materials, whether for research or otherwise, as long as they do not "possess" them. (!) He said: "Once the researcher knowingly downloads or saves the materials that he is accessing, then he is in 'possession' of terrorist materials.

On the internet, what exactly is the difference between "reading", "downloading" and "possessing"?

The Vice Chancellor at Nottingham is quoted as follows

"There is no 'right' to access and research terrorist materials. Those who do so run the risk of being investigated and prosecuted on terrorism charges. Equally, there is no 'prohibition' on accessing terrorist materials for the purpose of research. Those who do so are likely to be able to offer a defence to charges (although they may be held in custody for some time while the matter is investigated). This is the law and applies to all universities." --- Colin Campbell, Vice-Chancellor of Nottingham University (THE, 17 July 2008)

The following from Professor Scott Lucas (University of Birmigham), an open letter to the Vice Chancellor at Nottingham

The problem was never the type-set pages of Mein Kampf; rather, it was in the use of those pages to justify bigotry, racism, war, genocide. The problem was never Marx’s Das Kapital or Mao’s Little Red Book or Adam Smith’s The Wealth of Nations or the Koran or the Bible. It was, still is, and always will be the manipulation of those texts to justify the taking of lives.

Vice-Chancellor, do you think that --- through your denial of texts to us --- that you make us safer? Do you think that, by denying us our ability to think, consider, criticise that you shelter us from harm? Do you think that you protect us from ourselves, prevent us from becoming extremists? If you do, you are reducing your staff, your students, your administrators, your trustees to no more than children incapable of judgement? You go in one step from being a proud university to a fortress of ignorance.

“There is no 'prohibition' on accessing terrorist materials for the purpose of research. Those who do so are likely to be able to offer a defence to charges.” Thus we are allowed freedom of thought under the caution that we are guilty before being proven innocent. Perhaps you know, Vice Chancellor, of other societies in other times who have also maintained their standard. Perhaps you know where scholars, students, citizens have been advised that they may read their books and then, as those books are burned, explain why they have not committed a crime. Read on

What has become of us, and why do the leadership of other universities remain silent?



There are cogent comments from Edward Reid-Smith on the THES article

The situation seems to be that a small elite group is able to access and possess certain materials without being themselves "corrupted" or to be charged as terrorists .... Their decision is that others accessing and possessing the same materials will be "corrupted" or liable to be charged as "terrorists" whether or not they actually are terrorists. The 99.9% of the population not privileged will not be allowed to possess the material, and legislation will ensure that they are terrorised into not seeking knowledge about what "terrorists" actually think and do.....

The passing of legislation which leaves any community uncertain of exactly what is allowed and what is banned, presents an excellent tool for oligarchic dictatorship at whim. One may question whether non-specific legislation is the result of ineptitude, or because there is some strange pleasure to be gained from putting the populace in fear (i.e. terrorising?) seeking information.

Upper echelons of the university (businessmen) have decided that they know what constitutes "legitimate research material".

Certainly there are real and serious dangers in this world of ours. People who feel they have the right to blow other random individuals apart (or to act as apologists for others who do) are a part of that problem. Dealing with those dangers involves proper discussion as to what they are. That is what Universities are for.

A few other links about this story here, here, here. U-Tube video of Rizwaan Sabir here.

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Why it's bad to cheat

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The art of malfunction

Great fun. This new online tool enables you to take a chunk of text and generate a nice bit of artwork. Here for example is the 6 September 2005 letter suspending me from my post at the University of Sheffield.



Below is the joint mission statement of GlaxoSmithKline, the UK drugs "regulator" (the MHRA) and the General Medical Council (UK professional regulator)

• GSK: "We have a challenging and inspiring mission: to improve the quality of human life by enabling people to do more, feel better and live longer."
• MHRA: We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks."
• GMC: "Regulating doctors - Ensuring good medical practice."

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Crooked academics and the Universities that shield them - more on Brown and Keller

It's all very well blaming pharmaceutical companies for the decrepit state of integrity in medicine.

The chief villians remain our academic institutions and medical leadership. They have colluded with and have acted as apologists for commercial scientific fraud. They have tolerated the telling of lies by senior academics. They have encouraged the prostitution of medicine. They have allowed abuse of the most fundamental safeguards of science. Most importantly, they have set terrible examples for our students.

Last week I posted a copy of my letter to the new Dean of Medicine at Brown University, Professor Ed Wing. The letter was about scientific integrity at Brown, the problem of Professor Martin Keller, and the silence over Brown's treatment of Professor David Kern.

I have not had a response.

A source now informs me that Brown has conducted a formal "investigation" into the activities of Professor Martin Keller. The prior probability that such an investigation would be anything other than a sham is pretty low (P<0.001), but the report is nevertheless "confidential". The trail of oddities involving Keller extends into the distant past. Now the US Senate Finance Committee is probing Keller's financial kickbacks.

It is hard to say this nicely. Based on the publicly available evidence, Professor Martin Keller is guilty of gross and obvious scientific deception and abuse of the scientific process. He has betrayed the trust of our patients. More about Keller here, here, here, here, here, here, here and here

Brown University have continued to provide Keller with a shield of University respectibility. Since he remains in post, we can only guess the level of scientific deception that Brown administration deem to be acceptable.

Should you remain silent Professor Wing?

This is the guidance Brown University provides to it's students:

Principles of the Brown University Community

We, as members of the Brown University community – faculty, undergraduates, graduate and medical students, and staff – are dedicated to supporting and maintaining a scholarly community in which all share together in the common enterprise of learning. As a central aim, Brown University promotes intellectual inquiry through vigorous discourse, both oral and written. The fundamental principles that must necessarily undergird this aim include respect for the integrity of the academic process; individual integrity and self-respect; respect for the freedoms and privileges of others; and respect for University resources. In becoming a part of Brown University, we accept the rights and responsibilities of membership in the University’s academic and social community, and assume the responsibility to uphold the University’s principles.

Respect for the Integrity of the Academic Process

The rights and responsibilities that accompany academic freedom are at the heart of the intellectual purposes of the University. Our conduct as community members should protect and promote the University’s pursuit of its academic mission. We are all, therefore, expected to conduct ourselves with integrity in our learning, teaching, and research, and in the ways in which we support those endeavors.

Individual Integrity

In order to ensure that the University can dedicate itself fully to its academic and educational vision, it is expected that an individual’s personal integrity will be reflected not only in honest and responsible actions but also in a willingness to offer direction to others whose actions may be harmful to themselves or the community. The University expects that members of the Brown community will be truthful and forthright. The University also expects that community members will not engage in behavior that endangers their own sustained effectiveness or that has serious ramifications for their own or others’ safety, welfare, academic well-being, or professional obligations.

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A crooked scientist

There was a crooked man,
And he walked a crooked mile.
To confer with his crooked neighbor,
Who wore a crooked smile.
The crooked man's neighbor,
Lived in a crooked nook.
Both being crooked people,
They read a crooked book.
Inside were crooked tales,
Of other crooked men.
'Twas a crooked man's dream,
Shared with a crooked friend.

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The Osler Corner - On probability

"The problems of disease are more complicated and difficult than any others with which the trained mind has to grapple... Variability is the law of life. As no two faces are the same, so no two bodies are alike, and no two individuals react alike and behave alike under the abnormal conditions which we know as disease. This is the fundamental difficulty in the education of the physician, and one which he or she may never grasp... probability is the guide of life".
Sir William Osler 1, 1921

Here lies the basis for clinical decision making and evidence based medicine. What is the probability that "Liver extract" will improve fatigue or that Astaxanthin (a carotenoid pigment) will solve male infertility? (more of these later)

For that matter, what is the probability that any given clinical trial sponsored and controlled by GlaxoSmithKline, Merck, or Procter and Gamble will be honest?

This quote appears on a few websites promoting magical medicine. However they routinely omit the last sentence of the quotation, reversing the essence of Osler's wisdom. Osler would not have liked magical medicine - of the "GlaxoSmithKline" variety or the "liver extract" variety.

Click here for collated posts from the Osler Corner

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Blogs versus power - Paul Blackburn of GSK resigns from Ofsted

Paul Blackburn, GSK Vice president has resigned from the Ofsted board in the last few hours over "the activities of his employer" (see background here)



See here

From: enquiries@ofsted.gov.uk
To: fiddaman64
Sent: Wednesday, July 09, 2008 1:22 PM
Subject: Fw: Appointment of GSK Vice President to Ofsted

Dear Mr Fiddaman

Further to my email to you this morning, please be advised as follows:

Paul Blackburn resigned as a non executive member of the Ofsted Board on 5th July. His resignation follows public concerns about the activities of his employer GSK. Paul did not want any negative press interest to detract from the excellent work of Ofsted and therefore resigned. As far as Ofsted is concerned the matter is now concluded.

Should you require any further assistance please do not hesitate to contact us.

Regards,

Alan O'Neal
Customer Service Advisor
Ofsted - National Business Unit

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"We promise to be honest" at the University of Toronto - is it enough?

Biomedical researchers at the University of Toronto are starting to sign a new honesty oath - See report in the Globe, also published in the Journal Science last week.

Now why should I have a problem with this?

Those behind this initiative (Karen Davis and Ori Rotstein) presumably have good intentions.

Unlike doctors, scientists don't have an ancient moral code like the Hippocratic oath.

But graduate students beginning their careers in medical research at the University of Toronto now have their own solemn ceremony in which they pledge to conduct themselves in an ethical fashion.

Karen Davis, graduate co-ordinator at the Institute of Medical Science, says the new vow stems, in part, from the growing recognition of the potential for academic misconduct, which includes fraud, plagiarism and the shaping of experiments and research papers in ways that help pharmaceutical companies sell more drugs.

Spot on.

Now let's read the oath itself:

"I promise never to allow financial gain, competitiveness or ambition cloud my judgment in the conduct of ethical research and scholarship," reads the oath, which was recited for the first time last September by graduate students at the Institute of Medical Science. "I will pursue knowledge and create knowledge for the greater good, but never to the detriment of colleagues, supervisors, research subjects or the international community of scholars of which I am now a member."

There are a multitude of problems here. Starting with the minor and ending with the dismally depressing:

a) The Hippocratic oath is clearly working extremely well for the medical profession right now.

b) Given the critical ethical scientific scandals which have occurred at the University of Toronto, the phrase "but never to the detriment of colleagues" is perverse. Ethical behaviour is often to the detriment of unscrupulous colleagues. Are we suggesting that Nancy Olivieri should have hidden scientific findings and accepted sham investigations (at UoT) to avoid causing detriment to colleagues?

c) The phrase "I will pursue knowledge and create knowledge for the greater good" is woefully off target. The obligation of a scientist is to the scientific method. It is to describe that method honestly, including conflicts of interest, access to data, authorship, protocol and statistics. It is an obligation to share raw data. It is an obligation to avoid lying about data. Any "greater good" may or may not flow from honest method.

d) The clear lesson from recent scandals is that it's not junior scientists who have the most pressing need for an oath. The pressing need is for Universities and medical leaders to take an oath themselves.

One could imagine an oath for the University of Toronto:

"We promise never to allow financial gain or the natural desire to hide unethical behaviour cloud our judgment in the conduct of ethical research and scholarship. We will allow scientists to pursue knowledge and create knowledge for the greater good. We will continue to do so even if it is to the detriment of other more important colleagues or large corporations. We promise never to bully or to fire scientists who behave with integrity. We promise never to conduct sham investigations or to tell lies for purposes of bullying, hiding the truth or protecting our friends."

e) The biggest problem in scientific ethics is the failure to speak. It is the disconnect between perfectly good codes and the application of those codes to actual troubling incidents. It is the fact that codes are toothless. UoT already has perfectly good codes, procedures and rules of conduct.

That is not to say that Karen Davis and Ori Rotstein are not well intentioned. However, given the problems at Toronto one has to ask where they were when they should have spoken? When they cite examples, why do they not cite incidents rather closer to home?

A Google search for "Karen Davis" and "Gideon Koren", "Karen Davis" and "Nancy Olivieri", "Karen Davis" and "David Healy"
"Ori Rotstein" and "Gideon Koren", "Ori Rotstein" and "Nancy Olivieri", "Ori Rotstein" and "David Healy" yields nothing of any relevance to their involvement in practical ethics.

f) Perhaps all of these codes serve as pretext for virtuous mumbling by groups whose very success is based on ethical failure. Morality they say is sometimes taught by the immoral. It is no surprise that Dr David Goldbloom at the University of Toronto (yes the one who fired Professor David Healy) lectures on ethical physician interaction with the pharmaceutical industry, "harmonized research ethics", advises about conflicts of interest, and wrote the 2003 University of Toronto "Task force report" on Interactions with the pharmaceutical industry. He is paradoxically recipient of the Henry Durost Award for "Excellence in Creative Professional Activity" having destroyed a source of real creative scientific thinking within his own institution.

We have an unrehabilitated institution with a less-than-moral reputation producing smokescreen codes without addressing actual failures.

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Slip Slidin' Away - Scientific integrity and the rot in the UK Government

"A good day ain't got no rain. A bad day's when I lie in bed and think of things that might have been."
-Paul Simon, Slip Slidin' Away

This week sees a new furore over the appointment of a GlaxoSmithKline Senior Vice President (Paul Blackburn) to the board of the education watchdog Ofsted. Any last shred of credibility of the UK Labour government is gone. The implications of this despicable appointment are obvious to anyone who has followed the various ins and outs of misrepresented pharmaceutical science and government collusion with GSK. Much of this bad science involved children. It certainly involved deaths and much human suffering.

Perhaps Gordon Brown dreamed up this truly marvellous public relations plan for his friends while floating in the bath. What are they thinking.....? See discussion here, here, here, here, here.

I am not a leftist or a rightist. I would prefer to see small government, honest government and transparent government. Protecting the vested interests of any favored group or corporation (except to uphold democratically decided law) is not a legitimate role of government. I suppose that makes me a libertarian.

I have no time for those who try to create false ideological opponents by declaring themselves on the side of "the free market" and against "intrusive regulation" while failing to define the meaning of the words they use. This is a debate about corrupted markets and falsified science versus honesty, integrity, and transparency. It is I suppose about the children who died, and whether we care.

Is it "lefty" to suggest that corporations selling products under the banner of science should actually obey the most fundamental rules of science?

Is it "lefty" to propose that drug regulators should actually look at raw data before licensing drugs? Is it "lefty" to suggest that scientists, doctors who prescribe, (and patients who consume) should be allowed to see the honest science underlying prescribing decisions? Is it "lefty" to suggest that regulators are committing criminal acts when they collude with industry to hide the most fundamental facts about drugs under a cloud of corporate secrecy? Is it the role of government in a free market to shield corporate criminals from prosecution and scrutiny?

Unless the debate can rise above the false left/right dichotomy we are doomed. The victims of the current widespread fraud in this industry are not only patients. The victims are the credibility of UK science, medicine, and the honest and most innovative parts of the pharmaceutical industry itself.

The days of the UK Labour Government are numbered. They are likely to go down in history as a cynically corrupt government that has betrayed every aspect of their own supposed mission. I'll leave a detailed discussion of the entanglement between the labour government and pharmaceutical scientific fraud for another day.

So to Gordon Brown -- you are a dismal thoughtless pathetic failure. Sadly, the corruption of politics is such that your successor may not be any better.

Just don't let the door hit you on the way out.

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Dean Edward J Wing and integrity at Brown Medical School

One thing will be obvious to anyone who has spent time looking at scientific misconduct and academic bullying. Publicly known instances tend to aggregate within particular institutions.

It may be a denominator effect. "Bad apples" might arise in productive institutions with a large number of apples. Ineffective (or corrupt) leadership might also permit fraud and bullying. Unprincipled leadership is also associated with sham investigation and attempted cover-up, which in turn precipitates public discussion.

True "bad apple" aberrations never leave an institutional stain. The fraud of Jan Hendrik Schön did not alter the reputation of Bell Laboratories. Other so called "bad apple" cases are nothing of the sort. The fraud of John Darsee at Harvard, or Vijay Soman at Yale involved collusion of leadership, ignoring of principles, bullying and cover-up.

Several institutions spring to mind, not only for the frequency of serious problems but also dismal cover-up, ignoring of principles, and bullying of those who have discussed integrity.

• The University of Toronto (cases of Nancy Olivieri, David Healy, Godeon Koren, Brenda Gallie and others)
• Berkeley (Ignacio Chapela, Tyrone Hayes)
• Brown University Medical School (David Kern, Martin Keller)
• Harvard (too many cases to mention)
• Kingston University in the UK

Another characteristic of leadership failure is the refusal of institutions to apologize when they must know that they have done wrong. There is failure to discuss the principles honestly and publicly. There is failure to demonstrate proper academic behavior to students. When apology does take place it is often end-stage "damage limitation" of the sort illustrated here by John Cleese.



Why discuss Brown University now? Brown has a new Dean of Medicine as of 5 days ago. Professor of Edward J. Wing, M.D. took up his position on July 1 2008. There was considerable controversy about the manner of his appointment. In particular there were concerns that the process was designed to limit the field to particular insiders (see here, and here). Perhaps choosing an insider was not the best idea for an institution with a growing integrity stain.

Wing was certainly present at Brown during the terminal phase of the bullying of David Kern. It is not known that he did anything to help Kern. He must also have had interactions with Professor Martin Keller.

It is however possible that Wing will do the right thing. I wrote to Wing to find out. My communication was also sent to Associate Provost Pamela O'Neil, Provost David Kertzer and President Ruth Simmons. Given the absence of any acknowledgement, I thought I would make my communication public.

Professor Ed Wing
Chairman of Medicine
Brown Medical School

29 June 2008

Dear Professor Wing

I note that you will take up your Deanship at Brown two days from now. I congratulate you on your appointment.

I am sure you are aware of increasing concern about the integrity and honesty of leadership in medicine. Further, I am sure that you realize that the outsider's view of Brown is tainted by two unfortunate scandals. One a decade ago, has never been resolved in any principled manner. The other is ongoing.

I am referring to the cases of Dr David Kern, Professor of Occupational Medicine, and the many problems involving Professor Martin Keller.

David Kern was bullied and effectively fired at around the time you joined the faculty at Brown. Brown has never to my knowledge undertaken any soul searching with regard to this dismal affair.

I am sure that you are aware of the obvious obscenity of tainted research and research misrepresentation involving Professor Martin Keller. This research has done a grave disservice to the image of our profession. Brown has so far taken no apparent action.

I am therefore writing to ask whether you have made (or intend to make) any comment about these two incidents.

Have you anything to say of the future integrity of research at Brown, Professor Wing?

Kind Regards

Dr Aubrey Blumsohn
Sheffield, England

There is a Chinese saying, "a fish begins to smell from the head down...". You may not be a culpable head as yet Professor Wing. You are however in a position to make some statement about the institutional infection that has characterized Brown.

As Peter Drucker said, "Management is doing things right; leadership is doing the right things". Some statement about manipulated drug studies, an honorary degree for David Kern and an honest statement of regret might be a good idea.

Perhaps consider doing the right thing Professor Wing.

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A page from The life and times of Sally Hunt

Sally Hunt is currently General Secretary of the University and College Union (UCU), and the last General Secretary of the Association of University Teachers (UK) prior to its merger with NATFHE to form the UCU. For background see letter here.



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A letter to Sally Hunt (Moran, Blumsohn)

Sally Hunt is currently General Secretary of the University and College Union (UCU), and the last General Secretary of the Association of University Teachers (UK) prior to its merger with NATFHE to form the UCU. The below letter from Rhetta Moran and myself is self explanatory. See also this and this for some background.




For pdf version of letter and attachments see here. For many other UK cases involving AUT/UCU/NAFTHE inaction see the extensive Bullied Academics blog

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Rhetta Moran, David Healy - and the language of academic bullying

My friend Rhetta Moran was fired from Salford University (a "greater" Manchester University) in 2005 under very unusual circumstances.

There are fascinating linguistic aspects of sham university procedures and integrity scandals. Rhetta's research was said to be "no longer compatible with the school".

A key problem facing academia in the UK is the lack of any plausible institution that speaks up for integrity and the values of a university. As Rhetta states, "One would have thought that the idea of "compatible" or "incompatible" research would be something that should interest an academic union".

This brief summary of Rhetta's story serves as a prelude to my next post about a joint letter we wrote to Sally Hunt about the dismal integrity failures of the Association of University Teachers (AUT). Hunt is currently General Secretary of the University and College Union (UCU), and the last General Secretary of the AUT the merger with NATFHE to form the UCU.

The idea of "incompatible" research formed a key part of the scandalous firing of Professor David Healy at the University of Toronto. Following a lecture during which Healy expressed concerns about the integrity of pharmaceutical research, Dr. David Goldbloom fired him, stating that : "We believe that it is not a good fit between you and the role as leader of an academic program in mood and anxiety disorders at the Centre and in relation to the University. This view was solidified by your recent appearance at the Centre in the context of an academic lecture. While you are held in high regard as a scholar of the history of modem psychiatry, we do not feel your approach is compatible with the goals for development of the academic and clinical resource that we have."

In contrast to supine academic unions in the UK, some other academic unions (most notably the Canadian Association of University Teachers) have acted vigorously to defend many academics confronted by important assaults on integrity.

I will let Rhetta introduce herself:

Dr Rhetta Moran, 1 July 2008

I was dismissed by the University of Salford under unusual circumstances in 2005 following a previously successful academic career. During the previous year, I had been the lead investigator in a publicly funded project (Salford RAPAR SRB5) which was designed to collate accurate information about housing, health, employment, economic, personal safety and education problems involving people seeking asylum. The project was funded through the Office of the Deputy Prime Minister. Clearly this was a contentious project.

No factually plausible reasons for my dismissal as an academic under such circumstances have ever been provided. Employers appear to exercise the right to dismiss staff on the most thinly constructed grounds, or even no grounds at all, such as unspecified research "incompatibility". The university returned all grant funds including a newly obtained one (£192,316) from the European Social Fund.

I have learned that legal structures designed to deal with employment disputes have almost no relevance to academic integrity. Neither, unfortunately, did the Association of University Teachers (AUT).

We now know that the PCT Chief Executive, Mike Burrows, wrote to my "boss" Professor Michael Harloe and told him I was being removed from leadership of the research in April 2004. This was very shortly after a newspaper article appeared in the Observer. In this article (March 28, 2004) the Observer described how young asylum-seeking women were having to go underground in Salford. Drawing on work and contacts provided by myself, it cited me as follows:

People have been dumped in Salford, but without resources,' says Dr Rhetta Moran, a senior research fellow at the Revans Institute with overall responsibility for the Salford RAPAR project. 'There was no additional support for local practitioners. There is not one immigration solicitor in the whole city. And it leads to bitterness because this is a place where locals have been making their own demands on the council for years.

Other staff employed on the project were threatened with immediate suspension for gross misconduct if they had anything to do with me. It appears that there was an attempt to induce staff to accuse me of bullying, but they declined to do so. The following month I received a letter of dismissal signed by John Dobson, who advised that my research was no longer "compatible" with the school. Dobson as it happens is also the current President of Salford University UCU.

This lack of "compatibility" was never explained.

One would have thought that the idea of "compatible" or "incompatible" research would be something that should interest an academic union. The AUT attempted to induce to me to go along with a sham process as well as a gag agreement while ignoring every principle involved. Their silence has been deafening.

The university then stated that the reason for my dismissal was because I was "redundant" - a truly marvellous tautology.

I was finally sacked in January 2005, the day before the Deputy Prime Minister announced the opening of the Central Salford Urban Regeneration Company, in which my former boss Vice Chancellor, Michael Harloe has major involvement.

It is not clear whether any "incompatibility" might be down to fear of research or academic discussion that a City Council or conflicted academic leadership would find uncomfortable. It would be good to know.

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Officer and Thug

I thought I would repeat the story of the thug and the policeman from the end of my previous post.

Think 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 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 "regulators" of course). Usual understanding turned inside out.

Buy the book here

OFFICER AND THUG
by Ambrose Bierce (from a Subtreasury of American Humor)

A CHIEF OF POLICE who had seen an Officer beating a Thug was very indignant, and said he must not do so any more on pain of dismissal.

"Don't be too hard on me," said the Officer, smiling; "I was beating him with a stuffed club."

"Nevertheless," persisted the Chief of Police, "it was a liberty that must have been very disagreeable, though it may not have hurt. Please do not repeat it."

"But," said the Officer, still smiling, "it was a stuffed Thug."

In attempting to express his gratification the Chief of Police thrust out his right hand with such violence that his skin was ruptured at the armpit and a stream of sawdust poured from the wound.

He was a stuffed Chief of Police.

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ORI Research misconduct survey reports the obvious - again

The Office for research integrity has just published a survey in Nature.

Sandra L. Titus, James A. Wells Lawrence J. Rhoades (2008-06-19). Repairing research integrity. Nature. 453, 980-982.

The survey suggests that most research misconduct in the United States is unreported to the ORI. Furthermore, fraud is not rare.

The US National Academy of Sciences has asserted that scientists share an 'obligation to act' when suspected research misconduct is observed. However the reported number of investigations submitted to ORI has remained low: on average 24 institutional investigation reports per year.

"The 2,212 researchers we surveyed observed 201 instances of likely misconduct over a three-year period. That's 3 incidents per 100 researchers per year. A conservative extrapolation from our findings to all DHHS-funded researchers predicts that more than 2,300 observations of potential misconduct are made every year. Not all are being reported to universities and few of these are being reported to the ORI."

"These numbers indicate a sizeable disconnect between what universities are seeing and the 24 investigations evaluated by the ORI annually."

There is a leadership problem, whitewashing, bullying, and sham investigation.

The leaders of institutions may also have concerns about handling research misconduct. Because public image is important to institutions, some may try to minimize reporting and keep unfavourable information from reaching the ORI and the press. An institution may choose to ignore conducting an investigation and instead they may simply dismiss an accused person or even a whistleblower in the hope that the problem will go away without needing further examination. Additionally, institutional leaders may wish to ignore or minimize allegations of possible research misconduct to protect the revenue that the researcher generates; some may avoid investigations because they are costly in terms of time and money.

The paper makes six recommendations

1. Adopt zero tolerance. Social responsibility to the academic community and to the public who fund the research will be strengthened when it is apparent that an institution has a real commitment to integrity.
2. Protect whistleblowers: 43% reported that institutions encouraged them to drop the allegation.
3. Clarify how to report
4. Train the mentors
5. Use alternative mechanisms
6. Model ethical behaviour: People imitate the behaviour of powerful role models. Institutions successfully stop cheating, for example, when they have leaders who communicate what is acceptable behaviour, encourage faculty members and staff to follow the policies, develop fair and appropriate procedures for handling misconduct cases, focus on ways to develop and promote ethical behaviour, and provide clear deterrents that are communicated(McCabe, D. L., Trevino, L. K. & Butterfield, K. D. 2001 Ethics Behav. 11, 219–232).

The conclusion is:

"Our study calls into question the effectiveness of self-regulation. We hope it will lead individuals and institutions to evaluate their commitment to research integrity."

There are some problems here. Much serious fraud takes place at the commercial-academic interface with the acquiescence of government. The ORI has no role here. Furthermore, carefully evolved re-definitions of fraud have made it difficult to deal with the most serious instances of fraud. The ORI fails to comment on most cases of fraud which arise.

So much for leadership, role models and the rest.

Despite the appropriate conclusions, the study adds nothing beyond the long trail of other ignored studies which have reported the same. This is a never-ending loop of many roads leading from nowhere to nothing. It's all a heady mix of righteous indignation, hand sitting and some occasional wrist slapping.

So let's say it again:

1. Research fraud is not rare.
2. Investigation of fraud is a sham
3. Fraudsters are usually shielded from criticism except for the occasional random punishment that maintains the illusion.
4. Those who state the obvious are abused.
5. Official integrity bodies and regulators are entirely useless and are often complicit.
6. It is not necessary to conduct research to demonstrate the obvious. In the pharmaceutical arena the list is endless (Vioxx, Avandia, Zetia, Actonel).
7. In each and every instance there are attempts at cover-up, serious damage to the public and damage to science.
8. Most importantly, there is failure of the very organizations who claim to act as guardians of integrity to open their mouths.

It reminds me of the very old story of the Officer and the Thug

OFFICER AND THUG

A CHIEF OF POLICE who had seen an Officer beating a Thug was very indignant, and said he must not do so any more on pain of dismissal.
"Don't be too hard on me," said the Officer, smiling; "I was beating him with a stuffed club."
"Nevertheless," persisted the Chief of Police, "it was a liberty that must have been very disagreeable, though it may not have hurt. Please do not repeat it."
"But," said the Officer, still smiling, "it was a stuffed Thug."
In attempting to express his gratification the Chief of Police thrust out his right hand with such violence that his skin was ruptured at the armpit and a stream of sawdust poured from the wound.

He was a stuffed Chief of Police.

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The fall of the General Medical Council - Part I: Confidence or con

Last week I received a tentative invitation (via the group Justice in Health) to "attend" an "event" at Westminster on 24 July 2008. The event "The Future of Health Professional Regulation" is hosted by the Council for Healthcare Regulatory Excellence (CHRE) and the Department of Health. It is supposedly about sorting out professional medical regulators in the interests of patients.

I will not be attending.

Sham public consultation has become a dismal hallmark of this Labour government. They have not learned to listen.

One of those regulators is the General Medical Council (GMC). The GMC is the body that registers and is supposed to "regulate" the integrity and "fitness to practice" of UK medical doctors. This is an important job. The GMC have a huge credibility problem.

If the DoH and the General Medical Council really wanted to find out how to reform themselves in the "patient interest" then they would invite their fiercest and most thoughtful critics to explain the problems that have arisen. There are many such critics. Those critics would detail lamentable and inappropriate behaviour. They would explain how "regulators" have acted to hide fraud, misconduct, and other activities which have damaged patients and science. They would explain how the GMC has bullied some individual doctors, while ignoring parallel but far more serious integrity failings involving the "old boy's network".

There are many people they could invite to present aspects of the regulatory problem in detail. I am relatively sensible. Others provide a range of insights - Peter Wilmshurst, Rita Pal, Charles Medawar, John Abraham to name a few. Many patients tell compelling stories of obvious regulatory obstruction.

But inviting thoughtful hard-hitting criticism is not the intent.

Instead we have a profusion of "reports" which have no meaningful intersection with the real world.

Here is one from a week back:

"Implementing the White Paper - Trust, Assurance and Safety: enhancing confidence in healthcare professional regulators - final report and DH response to recommendations" (2 June 2008). Read it here.

The woefulness is implicit in the title. The report is not about the actual integrity, plausibility, honesty and consistency of medical regulators. It is about "enhancing public confidence in the regulators of healthcare professionals". It is about inducing confidence in the unacceptable. It is not about real confidence. It is a con.

I talk regularly to doctors and patients about the systems that regulate integrity in the UK. I discuss the malfunction of professional and pharmaceutical regulators, sham investigations, and the bizarrely inconsistent approach of the General Medical Council to the telling of lies by doctors. My thoughts are marginally less boring, irrelevant and nausea-inducing than "Implementing the White Paper". Here is the feedback form from my recent teaching session with postgraduate general medicine trainees in Sheffield. No nausea is reported.

So, Department of Health (and the General Medical Council), why not invite your critics to explain how you need to restore decency and relevance to regulation? Invite them to explain in detail - not under conditions of a carefully controlled "consultation". The ghosts of the Bristol babies, the many patients who have died as a result of corrupted pharmaceutical research and the victims of Harold Shipman might applaud. I doubt they would applaud throwing time and public money at an irrelevant confidence scam.

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How a new paradigm is created

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One million evil men

I am doing a bit of serious writing for a book chapter about the General Medical Council, the UK Medicines and Healthcare Products Regulatory Authority, Procter and Gamble and regulatory failings. During this hiatus I'll be posting a few offbeat things here from my amusement file, and I'll be taking a few constructive wacks at the General Medical Council (GMC). Given the current shambolic pontifications of the GMC about science in three Fitness to Practice cases (Southall, Wakefield, Eastell) I'll revisit the ethics of two of my own published studies involving injection of radioactive isotopes and some sperm.

Thank you to all those who have E-mailed to ask if I'm OK. Stay tuned.

From Chapter 17 of the book Shantaram by Gregory David Roberts




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The problems at Nottingham University

This post is not about science. It is in support of a postgraduate student (Rizwaan Sabir) and an administrator (Hisham Yezza) at Nottingham University, a short drive from my home.

Following my series of posts about MK-ULTRA research 50 years ago, Daniel Goldberg at the Medical Humanities Blog elaborated on the idea of state involvement as a necessary element in the most serious kinds of unethical human research.

This can happen in several ways: a) some of the worst examples of unethical research have been carried out by the state itself, b) precedents set by the state create cynicism over professional ethical guidance which is administered by the state, and c) state functionaries (professional regulators, product regulators) play an important role in the suppression of concerns over unethical conduct and assist in the bullying and marginalization of individuals raising legitimate concerns.

Systems function well, and gravitate towards some sort of integrity and truth when there is variability within those systems. Properly functioning systems require dissent. They require the diverse commentary of many individuals with differing perspectives on ethical standards. They require transparency. They require crooks, cooks and discussion over the definition of crookery and acceptable behaviour.

Clearly, the involvement of the state as a necessary element in systematic University malfunction goes beyond science. The problems of the past week at Nottingham University have been discussed elsewhere in some detail. Briefly, a postgraduate student (Rizwaan Sabir) was conducting research (into terrorism). He was arrested after downloading material (related to terrorism) from a US government website. I believe that the material is here - take a look. His Nottingham University supervisors insisted the materials were directly relevant to his research (which is on terrorism). A university administrator and previous student at Nottingham University (Hisham Yezza) printed some of the (publicly available) material for him. Both men were arrested, their homes were searched by police, and Yezza (the printer) faces immediate deportation. Upper echelons of the university (businessmen) decided that they knew what constitutes "legitimate research material". Certainly there are real and serious dangers in this world of ours. People who feel they have the right to blow other random individuals apart (or to act as apologists for others who do) are a part of that problem. Dealing with those dangers involves proper discussion as to what they are. That is what Universities are for.

Some news reports are here, and here. A campaign site is here. Yezza is Editor of the magazine Ceasefire - (download the latest issue here).
In the words of Thomas Jefferson 200 years ago:

It is error alone which needs the support of government. Truth can stand by itself.
(Thomas Jefferson 1743-1846, U.S. President, Notes on the State of Virginia, 1782)

We understood this 60 years ago.





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The bystander effect: would you stop for Britney Begonia?

Local 6, a Florida TV station has been conducting a series of experiments on the bystander effect.

In the latest "missing child experiment" they placed numerous posters in a mall with photographs of a missing 8 year old "Britney Begonia". Britney herself sat next to some of the signs. Hundreds of people walked past and saw the posters, but only two stopped to ask Britney anything. Many bystanders questioned later said they noticed the strange resemblance between Britney and the poster but were "fearful of getting involved."

An earlier Local 6 experiment involved a fake burglar breaking into a home. See also this publication on the bystander response to a mock casualty involving arterial bleeding.

The bystander effect has been extensively studied. The more people who observe an event, the less likely it is that anyone will intervene to help. Observers assume that someone else will do something and they feel less responsible. The obviousness of the problem makes little difference.

This is something that will be familiar most people who have tried to raise problems in science and in medicine. It is the underlying message of at least a dozen E-mails I get each week. Local academic colleagues very rarely engage with problems that go right to the heart of what it is to be an academic (or a doctor). They are happy to allow principles to be ignored, patients to be abused and for those raising concerns to be bullied into unemployment or even suicide. The silence and collusion with misconduct and fraud extends to professional regulatory bodies, drug regulators and government. It is hardly surprising concerns are never raised until it is too late.

Here is a selection of quotes about collaborators, bystanders and the shame of all those who fail to speak, and who fail to ask questions.

Science may have found a cure for most evils; but it has found no remedy for the worst of them all - the apathy of human beings.
Helen Keller

Truth is not only violated by falsehood; it may be equally outraged by silence.
Henri Frederic Amiel

To assist Enron all they had to do is to do nothing, and they did nothing very well

He who passively accepts evil is as much involved in it as he who helps to perpetuate it.
Martin Luther King, Jr

Our lives begin to end the day we become silent about things that matter.
Martin Luther King, Jr.

What luck for the rulers that men do not think.
Adolph Hitler

And the multitude was silent, not a voice, not a sound was heard upon the hillsides, across the valleys where they stood.
Richard Bach, Illusions

To sin by silence when they should protest makes cowards of men.
Abraham Lincoln

There is no shame in not knowing; the shame lies in not finding out.
Russian proverb

A society of sheep must in time beget a government of wolves.
Juvenal

The average age of the world's greatest civilizations has been two hundred years. These nations have progressed through this sequence: From bondage to spiritual faith; from spiritual faith to great courage; from courage to liberty; from liberty to abundance; from abundance to selfishness; from selfishness to complacency; from complacency to apathy; from apathy to dependence and back into bondage.
Fraser Tyler

You may never know what results come from your action. But if you do nothing, there will be no results.
Gandhi

The world is a dangerous place to live; not because of the people who are evil, but because of the people who don't do anything about it.
Albert Einstein

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