Monday, April 21, 2008

Whistleblowing 101

I hate that word "whistleblowing". However here is a rapid pictorial guide to asking questions while preserving your sanity.

Lesson 1: Ignore those many institutions whose sole apparent remit is to hide problems on behalf of powerful friends. It is not the best of times for institutions that have claimed the right to uphold standards of integrity in medicine. In the UK, the General Medical Council (GMC), the Medicines and Healthcare Products Regulatory Authority (MHRA), the UK Panel for Research Integrity and Public Concern at Work are examples of organizations that are having trouble working out what they are for. Just state the obvious and let the obfuscators obfuscate.

As Groucho Marx said of the MHRA and research fraud:
"Either it is dead or my watch has stopped".
Or as George Orwell said of the General Medical Council:
"We have now sunk to a depth where the restatement of the obvious is the first duty of intelligent men".
How about this as a statement of the obvious: "Research fraud is not generally a good thing in medicine".

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The Contract (Procter and Gamble)

In 2002 I signed a research agreement with Procter and Gamble Pharmaceuticals [1]. Research was to be carried out at the University of Sheffield by two named investigators (Dr Aubrey Blumsohn, Professor Richard Eastell).

It is accepted that a University would be guilty of negligence in permitting investigators to sign a contract prohibiting or hindering release of information involving a drug [2,3]. Industry cannot buy the right to desired findings or the right to suppress undesired findings. The agreement signed[1] was however in accordance with good practice, and should have protected integrity:
  • The agreement did not seek to impose restrictive limitations on the rights and obligation of investigators with regard to data [1 section 4.3]. It specified that the university clinical investigators would interpret and report upon the data.
  • The agreement did not seek to impose restrictive conditions on honest unfettered publication [1 section 4.3]. The contract stated that sponsor should be given courtesy of sight of any proposed publication, but specified that investigators were under no obligation to incorporate any comment from the sponsor.
  • The agreement imported the obligations placed on academics by the University itself, the policies of the University, and obligations imposed by professional rules of conduct [1 section 1.2]. It stated - "The institution through its policies and practices" should cause the investigators to observe "all responsibilities" as "employees of the University of Sheffield". The University of Sheffield in turn has clear guidance pertaining to research integrity and professional obligations (See Sheffield University Research Integrity Guidelines).
  1. Research Agreement between P&G Pharmaceuticals, Dr A Blumsohn and Professor R Eastell. The University of Sheffield (2002-06-02).
  2. Steinbrook, Robert (2005-05-26). "Gag clauses in clinical-trial agreements". The New England journal of medicine 352 (21): 2160-2. PMID 15917381.
  3. Mello, Michelle M; Brian R Clarridge, David M Studdert (2005-05-26). "Academic medical centers' standards for clinical-trial agreements with industry". The New England journal of medicine 352 (21): 2202-10. PMID 15917385.

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Saturday, April 19, 2008

Telling it like it is (Procter and Gamble)

Not sure how I missed this one. From the Center for Media and Democracy ( 25 March 2008.
The director of external relations for Procter & Gamble, Mark Chakravarty, recently told a UK healthcare PR conference that the drug industry is less than popular with the public. "There is a high suspicion of the pharma industry. Greed, dishonesty and fraud are some of its associations. The clinical trial press this week and an increased number of drug scandals add to this image," he said.
Quite, Procter and Gamble.

I'm less worried about the "greed". Commercial companies don't need to apologise for generating money from honest science and real innovation. Let's concentrate on the lies and the fraud, and more importantly on the collusion with government and "regulators" to hide evidence, to excuse bad science and to escape responsibility. Why not give me a call Mr Chakravarty? Effective public relations requires working with critics, admitting faults and correcting them.

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Tuesday, April 15, 2008

Those with unbitten hands

Dont bite ..... the hand that feeds you

And the corollary is .... if the hand is unbitten, look at who it feeds.

Lick the hand.

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Monday, April 14, 2008

Money and accountability (Procter and Gamble)

My ex colleagues at Sheffield University are in receipt of a great deal of new grant money. That is good. I am pleased. However, with greatness comes the need for accountability and answering. One of those colleagues has a great number of questions to answer about research involving Procter and Gamble. Honest answering is particularly important for a scientist, a very senior doctor and a previous Research Dean of a Medical School. Such individuals are held to a higher standard.

I am glad that Professor Eastell has had the good grace to admit to the false "findings" previously reported, the lie told to the Journal, and a little of the hidden data. The answering could however have been a little more straightforward, with less in the way of linguistic acrobatics. The scientific community has already demonstrated that it is not quite so easily diverted. The false publication should simply have been retracted (statistics and further publication to follow). And that was just the first of the three intended false publications.

With time I have become a dispassionate but interested observer of these events. There is a great deal to learn from them. The sad, almost desperate, attempts at obfuscation by others should be examined. Those attempts convey a great deal about the integrity and motives of regulators and leadership in medicine. It conveys how little respect we have for our patients who place themselves at risk to contribute to our "science". The events also convey a lot about way in which we deal with scientific misconduct when it involves considerable power. The system is kaput, bankrupt.

Character, they say, is like a fence. It can never be strengthened by whitewash, and it is a mistake to try. An apology might have been appropriate, and would certainly have helped a little.

"And sorry seems to be the hardest word
It's sad, so sad,
It's a sad, sad situation
And it's getting more and more absurd"
(Elton John)

09 April 2008
New Biomedical Units to put Sheffield at forefront of clinical research

The University of Sheffield, in partnership with Sheffield Teaching Hospital´s NHS Foundation Trust Sheffield, has been successful in its bid to develop two National Institute for Health Research (NIHR) Biomedical Research Units in musculoskeletal and cardiovascular disease.

The Biomedical Research Units will drive innovation in the prevention, diagnosis and treatment of ill-health and translate advances in medical research into benefits for patients.

They will be established in priority areas of disease, ill health and clinical need. Each unit will receive funding for four years with the first year drawing in £750k and £1m per year for the remaining three years (around $7.5 million)

The awards were made following bids by Professor Richard Eastell and Professor David Crossman from the University´s School of Medicine and Biomedical Sciences.

Professor Richard Eastell, Head of the Academic Unit of Bone Metabolism at the University of Sheffield and Honorary Consultant in the Metabolic Bone Centre at Sheffield Teaching Hospital´s NHS Trust, said: "We are delighted to have been successful in our application for this funding. This is a great boost to the Trust and the University.

"Having these two biomedical research units based in Sheffield is a major coup for the city and will firmly place us at the forefront of research.

"So many people will benefit from these units as they will enable us to be even stronger in these areas. This announcement is just the beginning, this is a wonderful opportunity for the city to shine.

Professor David Crossman, Head of Cardiovascular Science at the University and Honorary Consultant Cardiologist at Sheffield Teaching Hospital´s NHS Foundation Trust, said: "I am delighted with the investment in cardiovascular research in Sheffield. This will allow us the opportunity to launch new programmes of work designed at bringing our basic research to our patients with coronary artery disease."

Professor Tony Weetman, Dean of the School of Medicine and Biomedical Sciences at the University of Sheffield, said: "This is welcome news, which allows the University´s School of Medicine and Biomedical Sciences and the Trust to build on our successful partnership in translating research into medical practice for the benefit of patients.

"Our success in bidding for these prestigious NIHR Biomedical Research Units has been underpinned by our joint clinical research facilities, and I look forward to even closer working with the Trust as we develop the profile of academic medicine in Sheffield."

Andrew Cash, Chief Executive of Sheffield Teaching Hospitals NHS Foundation Trust, said: "This is a fantastic coup for Sheffield Teaching Hospitals and the University of Sheffield which will put the city firmly on the research map. We have an excellent ongoing relationship with the University and this is a further opportunity to extend that work for the benefit of patients in Sheffield and beyond."

For further information please contact: Jenny Wilson, Media Relations Officer on 0114 2225339 or email

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Sunday, April 13, 2008

More great statistics from Procter and Gamble (Micro Statistics Tutorial 08)

Advertising Standards Authority (UK): 26 March 2008, Adjudication over Cat Food Advertisement (Iams Cat Food). More worthwhile statistics from Procter and Gamble:

The advertisements stated:
  1. "Vets know catering to all your cats' different needs isn't easy ... 8 out of 10 vets recommend Iams
  2. Voted No.1 recommended dry cat food brand available in supermarkets
  3. Small print at the bottom of the ad stated "*Based on an independent survey of vets at the Congress of the British Small Animal Veterinary Association on complete dry cat foods available in supermarkets (April 2007)".
The Advertising Standards Authority noted that:
  1. The survey asked vets if they would recommend any dry dog food, dry cat food or wet cat food brands. Only 31% of the participating vets (31% of 334) in fact recommended Iams.
  2. Furthermore, the survey questions allowed participants to select a number of brands; they did not select only one brand.
  3. Two other brands had more recommendations but these brands were available in pet food shops.
  4. 80% of vets who recommended a brand of dry cat food available in supermarkets included Iams amongst the selection of products recommended, but not necessarily over those other products
Action: ASA told P&G to remove the claims "8 out of 10 vets" and "Voted No. 1 by vets" from future advertisements. The ASA did not comment on the irrelevancy of the survey (it should have surveyed cats), the nature of the sample, the post-hoc hypothesis, lack of any P value or who commissioned the "survey". For contaminated P&G catfood, see here.

Tutorial: Try to reconstruct the statistics from the ASA report.

See here for Collated Micro-Statistics Tutorials

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Wednesday, April 09, 2008

Princess Zetia and the pea

Is it a nugget for Zetia?

Or a pebble?

Or a pea?

Here is a bit of junk sounding research.

Or at least junk inferences drawn.

85 patients perhaps taking Zetia who improved compared to a "control" group
with different blood pressure control,
on (perhaps) a surrogate endpoint
in an underpowered study.

The study enrolled 499 Native American diabetics, half of whom were assigned to achieve LDL or bad cholesterol levels of 70 or lower while the others aimed for 100 or below.
The aggressive treatment group also aimed for systolic blood pressure readings of 115 compared to 130 for those assigned to standard of care.
About a third (perhaps) of the aggressively treated patients took Zetia (maybe 85 or so), but no one knows which.

Some got thick carotid artery walls and flabby ventricles. No clinical endpoints studied.

The dissection is continuing.

See Wall Street Journal Blog 9 April 2008: From ENHANCE to SANDS: A Nugget for Zetia?

See also

Pharmalot: Vytorin Prescriptions Will Plummet. Surprised?
Pharma Giles: Mr. Ten Percent... Redundancies at Scherigh Plough
Dr. Peter Rost: How does it feel to fire 5,000 employees, Mr. Hassan?

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Tuesday, April 08, 2008

The Scientific Misconduct Wiki (Procter and Gamble)

Unlike static websites, the blogging paradigm allows a great deal of collaboration and interchange between people (witness the rallying of support for Bob Fiddaman over the legal threats he received from GSK). Investigative journalism through Blogs has becoming increasingly important. It is fair to say that the majority of concerns raised about the ENHANCE trial of Vytorin have been brought to light by investigative bloggers, Forbes magazine and the Wall Street Journal. The immediacy of blogs (and news reports) makes it hard to develop a body of systematic evidence, or to get keep historical perspecive. A Wiki provides a different model which allows both collaboration and systematic collection of information.

I have therefore started the Scientific Misconduct Wiki to run in parallel with this blog. Hopefully this will form the seed of a peer reviewed online journal devoted to Scientific Integrity. For the moment, it will serve as a non-collaborative repository for reports and academic analysis of the integrity scandal involving Procter and Gamble and the drug Actonel (including the serious implications of the failed but rather sad attempts at coverup and delay by "regulators"). I will add to the collection in parallel with the blog postings. Currently, the Wiki contains all of the Collated News Reports about the Actonel story to set a framework and timescale for discussion of the science and principles.

Most recent in the news listings is this paper by Professor Martin Bland on the statistical re-analysis and attempted reconstruction of the first of the three implicated P&G publications. (Bland, M. 2007. "Risedronate, the BBC and me". Significance - Royal Statistical Society:@ 4:4:175-178). The reanalysis of the second of the three publications is here.

Here is the raw data eventually provided by Procter and Gamble in April 2006 [Link] that formed the supposed basis of three P&G publications (two only in draft) as well as many scientific meeting abstracts. Under the circumstances, P&G should have allowed an open statistical analysis, but they have refused to allow such open scrutiny. The data is therefore encrypted (see "Procter & Gamble - Let's take the high road"). Nevertheless, please join the people who downloaded it previously.

This refusal of openness is unexpected, because P&G no longer have much to hide. P&G and "authors" (of publication 1) have of course admitted to all of the key "errors" in the first publication. The problems in the second and third publications were similar, but even more overt. Authors have also admitted to having been less than truthful over access to data - the central problem. Of ongoing concern is the refusal by P&G to provide confounding variables to authors, and more perversely the refusal to provide the wording of consent forms that patients would have signed.

If anyone would like to assist as editor of a peer-reviewed Wiki-based Scientific Integrity Journal, please let me know.

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Monday, April 07, 2008

Avandia is - - - - dead

The Scotsman, 7 April 2008
Doctors demand freeze on use of diabetes drug for heart patients

SCOTTISH doctors have said there is "no defence" for the use of a widely prescribed diabetes drug after warnings that it should not be used in patients with heart problems, The Scotsman can reveal.

The consultants, who work in the NHS Greater Glasgow and Clyde area, recommend no new patients are given Avandia – also known as rosiglitazone.

They said GPs should look carefully at those already taking the drug, used to treat type 2 diabetes, and stop the treatment if any risk factors are found.

One senior source said consultants "felt very uncomfortable with its ongoing usage" and it was likely that GPs would be prevented from prescribing the drug....

There are signs of other health boards introducing measures. Research published in the New England Journal of Medicine in May suggested Avandia may raise the risk of heart attacks by 43 per cent, and the risk of cardiovascular deaths by 64 per cent.

In January, the European Medicines Agency (EMEA) said the drug should carry extra warnings, including the fact that it must not be used in patients with acute coronary syndromes such as angina. However, a review of the whole class of drugs – glitazones – by the agency has concluded that the benefits of Avandia still outweighed the risks. [Medicine 101: The primary goal of treatment in diabetes is to reduce cardiovascular disease] ...

Despite this, the Glasgow doctors are making recommendations to the area drug and therapeutics committee (ADTC) that could lead to many patients being taken off the medicine...

"The consensus was that there was no defence for its use unless the goalposts changed in times to come," the minutes read.

A senior source present at the meeting told The Scotsman that while some consultants thought Avandia should be withdrawn completely, the majority view was that doctors needed to look very closely at patients on the drug and decide whether they should continue with it.

"It is a case of looking carefully at the patients who are on rosiglitazone, making sure that it's safe to use it. And if it is not safe at all, then stop it completely."

The expert thought it was likely the drug would be placed on a restricted formulary, meaning only specialist consultants could prescribe it. GPs would no longer be able to issue Avandia.

A spokeswoman for the health board said: "We are aware of the safety issues surrounding the drug including the recent correspondence from the EMEA, and prescribers have been kept fully up to date with the safety information."...

Paul Beardon, head of prescribing management at NHS Dumfries and Galloway, said it was likely that Avandia would be withdrawn from its formulary in the next month.

A spokeswoman for GlaxoSmithKline said: "After an extensive review of the data [presumably hidden and unhidden], the European medicines regulatory agency concluded in October last year that the benefits of rosiglitazone in type 2 diabetes continue to outweigh its risks – in other words, that rosiglitazone is still of value in the treatment of patients with type 2 diabetes. [See above] ....

The company added: "GlaxoSmithKline believes that rosiglitazone remains a valuable medicine for many patients with type 2 diabetes and an important treatment option for doctors, when used appropriately [this seems to be begging a tiny question] and that the decision about a patient's treatment should be made by the doctor, in consultation with the patient" [Template Consultation: "Mrs Jones, the main concern in treating diabetes is to give you as normal a lifespan as possible and to reduce cardiovascular disease. The best evidence we have about this drug is that it increases the risk of heart attacks by 43 per cent and cardiovascular death by 64 per cent. Would you like to take it?"]

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Sunday, April 06, 2008

Hazards of preemption - Did Johnson and Johnson fudge data for Evra patch?

From Bloomberg news
"Johnson & Johnson hid or altered data on the health risks of its Ortho Evra birth-control patch and flaws in the manufacturing of the device, lawyers for women suing the company claim in court papers."

"Manufacturing defects made the patch unstable and the dosage unpredictable, according to the filing. Tests showed in 2003 that the patch produced 60 percent more estrogen than oral contraceptives, it said. A company pharmacologist, Dr. Larry Abrams, applied a "correction factor" to lower estrogen results given to the FDA by 60 percent, according to the filing."

"Through a sleight of hand, and altering of numbers,'' Abrams ``presented a truly misleading picture of the amount of estrogen delivered by the patch," the filing said.

"The FDA warned in November 2005 that the patch may cause clots and expose women to 60 percent more estrogen than oral contraceptives. In February 2006, another study found a twofold increase in the risk of clots compared with use of the pill."

"The actual results showed the patch released 30.4 micrograms when applied to the abdomen and 38.1 micrograms when applied to the buttocks, according to the filing. Abrams, who is now retired, applied his ``correction factor'' to lower the results, and the company obscured his method in reports to the FDA."

"The company also couldn't replicate in its commercial patch the results obtained in clinical trials, it said. The levels of estrogen also varied from batch to batch, it said. The company hid those problems from the FDA, it said."
Also of interest in the article is the reference to "preemption" rules. This is part of the attempt in the US to create a legal landscape in which it would be impossible for a consumer to sue if a drug is FDA approved. For companies that claim to be "science-based" and to believe in the "free market", this is a complete inversion of both. Such protection for commercial entities would seemingly still apply in the usual scenario where the FDA approves on the basis of misleading, fraudulent or missing data. It would also apparently apply if the scientific literature is distorted through company interference, and if that leads to mis-prescribing. Preemption subverts the free market, throws science out of the window, and places all the responsibility for prescribing in the hands of an unaccountable big-brother government agency. How convenient. No one is then responsible for the consequences of scientific misconduct or hidden science. The company would claim that they couldn't possibly be held responsible because the FDA dictated what they had to tell doctors. The prescribing doctor could not be held responsible (so long as they do what the FDA tells them to do) because they are not permitted to do or see anything else, and the data is not available to the scientific community.

Preemption is also based on a deliberate misunderstanding of medicine. Prescribers don't prescribe a random drug as a reflex simply because a patient has a "disease" and because a drug is "approved" for that "disease". If only the algorithm were so simple. There is a complex decision making process involved in any act of prescribing, and that process depends on the availability of honest information. If that information is not honest and not complete, then the process cannot work. The FDA cannot pre-empt that decision process, unless they provide guidance for every possible complex clinical scenario, and indeed dictate which drug to prescribe.

This is the law dictating to our profession that science, logic and honesty should not be permitted to operate in medicine.
Plaintiffs responded to a company motion to dismiss the cases that argued that FDA approval of the device and its label supersedes, or preempts, the ability of patients to seek damages under state laws.

Hat tip Pharmagossip
See also Drug Makers Near an Old Goal: A Legal Shield (NYT April 6, 2008)
and a series of great posts on the legal problem of Preemption at Drug Injury Watch

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Saturday, April 05, 2008

My fortune cookie

I just returned from a great sociology/philosophy meeting near Paris. My fortune cookie at dinner had this rather nice message:

and in French

See previous posts on decorum in science here:
  1. On decorum in medicine
  2. On swearing versus thuggery
"What I lack in decorum, I make up for with an absence of tact."
- Don Williams, Jr. (American Novelist and Poet, b.1968)

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Gardasil scandal: University of Queensland exits the civilized scientific community

Just after my last post on the role of a University I read this piece in today's British Medical Journal about an appalling episode at the University of Queensland that goes right to the heart of what a University is. The University of Queensland has broken its contract with the scientific community. This is an absolute disgrace.

I am reminded of the letters to me stating that I needed University "authorisation" to discuss issues of scientific procedure. I recall the warning of "public dissociation" and that "public interest disclosure legislation" somehow applied to discussion of scientific methodology involving Procter and Gamble.

From the University secretary and registrar at Queensland (Douglas Porter) this most absurd of comments:

Douglas Porter, wrote to Dr Gunn, asking him to provide a written apology to CSL stating that the "comments were made by you in your personal capacity and were not endorsed or authorised by the university." - "The University of Queensland’s vice chancellor declined to comment and referred the BMJ to Mr Porter, who said that Dr Gunn "had no authority to speak on behalf of the university" and should not have mentioned his university position. "It’s an absolute storm in a teacup."

What are you Mr Porter - The University of Kentucky Fried Chicken, or a real University? Shame, shame and more shame.

BMJ 2008;336:741 (5 April) [Link]
Academic freedom is at risk in dispute over Gardasil, lecturers say
Melissa Sweet, Sydney

Senior academics are outraged that the University of Queensland has asked an academic to apologise to a drug company for his public comments on a vaccine against human papillomavirus that was developed jointly by the university and the company.

Academics at the university and elsewhere say that the request is a threat to academic freedom and warn that it raises worrying concerns about universities’ independence and ability to negotiate conflicts of interest.

The request came after the company, CSL, wrote to the university’s vice chancellor complaining about comments on the radio made by Andrew Gunn, a senior lecturer in general practice.

The programme dealt with the general issue of pharmaceutical marketing and briefly mentioned Gardasil, whose development has reaped millions of dollars for the university as well as public and political kudos.

CSL’s director of public affairs, Rachel David, wrote: "I feel Dr Gunn’s comments are inappropriate and inconsistent with the long-standing relationship CSL has with the University of Queensland and given the involvement of the university in the development of Gardasil."

On 14 March the university’s secretary and registrar, Douglas Porter, wrote to Dr Gunn, asking him to provide a written apology to CSL stating that the "comments were made by you in your personal capacity and were not endorsed or authorised by the university." Mr Porter also asked to be sent a copy of Dr Gunn’s letter to CSL.

Dr Gunn said he was disappointed by the university’s response and that the company’s complaint seemed to be aimed at stopping him from speaking out again. "Even if you’re fairly resistant to pressure, it’s got to make you think twice about saying potentially critical things about their products," he said.

Wayne Hall, of the university’s School of Population Health, described CSL’s response as "heavy handed" and said that the university’s response was "disrespectful of the rights of academics to speak out on matters of public interest."

The university’s executive dean of health sciences, Peter Brooks, also expressed concerns about the handling of the complaint and said that universities generally needed to do a better job of resolving conflicts of interest.

"If you’ve got very large amounts of money changing hands, then it’s very difficult, I think, not to let that influence you to some extent," he said. "It’s a dilemma that universities have.

"Quite frankly, I have said that I think that if anybody at UQ [University of Queensland] makes a statement about Gardasil, including the inventors, if it’s going to be a public statement then probably under conflict of interest [guidelines] they should acknowledge that the university receives significant funding from CSL each year."

Paul Glasziou, director of the Centre for Evidence-Based Medicine at the University of Oxford and a former University of Queensland academic, said that the freedom of academics to speak without interference from their employers or government was crucial in an open society and that it was reasonable for Dr Gunn to have used his academic title.

Chris Del Mar, dean of health sciences and medicine at Bond University, Robina, Queensland, and an honorary professor at the University of Queensland, said that universities should support academics in saying what they think. "Discourse and argument are the stock in trade of academics," he said. "To gag [argument] is anti-academic."

Simon Chapman, of the University of Sydney’s School of Public Health, said that the registrar’s letter should appal all researchers and academics.

"The registrar and vice chancellor would do well to read their own website on how academics should present themselves in public. The University of Queensland’s policy states: ‘It is accepted practice that where a member of staff is writing on something which is clearly within the range of professional expertise, it is appropriate for the member of staff’s university position to be given.’"

Professor Chapman said that the registrar’s suggestion that a university would have official views on drug company promotions or a specific vaccine is "both preposterous and inimical to academic freedom."

David Henry, adjunct professor at the School of Medicine and Public Health at the University of Newcastle, New South Wales, said that the university’s response was even more inappropriate than CSL’s.

He said, "It is fairly predictable that a company will react to what they see as a commercial threat, but it is very worrying that a university would require an academic to get clearance before giving an interview."

"It shows that poor funding of Australian universities has led to desperation in their attempts to raise funds from other sources, including commercial companies. In doing this they are abandoning part of their mission, which is to generate and communicate new knowledge in a fearless and impartial way."

Carolyn Allport, president of the National Tertiary Education Union, added: "If freedom of inquiry is to be respected as a core responsibility of universities, then it is important that both universities and academics and researchers retain their rights to engage in critical commentary, in the public interest."

The University of Queensland’s vice chancellor declined to comment and referred the BMJ to Mr Porter, who said that Dr Gunn "had no authority to speak on behalf of the university" and should not have mentioned his university position.

"You’re just beating this up," he told the BMJ. "It’s an absolute storm in a teacup."

Dr David of CSL said that she had asked the university to clarify whether Dr Gunn was speaking on behalf of the university, because "if the university does not have access to correct information about our products, it is clearly a more important issue than if the interview simply reflected the opinions of an individual."

She said, "Neither I nor anyone else at CSL has the power or the inclination to ‘gag academic freedom’ or any form of freedom of speech, and I am not aware of any arrangement with the university or any other academic institution in Australia that would even allow for this possibility."

A spokesman for UniQuest, the university’s commercial arm, said that the exact value of Gardasil’s returns to the university was confidential but that it amounted to some millions of dollars annually.

A transcript of Dr Gunn’s comments is available at

Although not relevant here - remind me - what is the evidence that Gardasil actually works?

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What is a scientist?

Any discussion of academic or university malfunction has to begin with at least some mention of the nature of being an academic, and the raison d'être of a University. Universities exist for only one reason: to add to human knowledge and to disseminate that knowledge through publication and teaching. A scientist is an academic who uses the scientific method.

Extreme cases are always useful. Assume we have a university employee who accepts money, in exchange for fronting scientific findings "produced" by others. Assume further that the employee is disabled from verifying those findings (which might have been falsified). Assume too that this person attempts to persuade others to do the same. Most sensible individuals would agree that such a person would not fulfil the minimal trade description standards for being an academic or a scientist. At what point does an scientist cease to be a scientist? At what point does a University cease to be a University?

To quote Carlo Suarès (French writer, painter and Kabbalah author):
This table has four legs.
A table with a broken leg remains a table.
But a table from which the four legs have been removed becomes only a flat piece of wood.
At what moment did it cease to be a table?

Is Professor Martin Keller of Brown University a scientist? At what moment did he cease to be one?

And are some fields more "scientific" than others? This might depend to some extent on the nature of the field itself. It is very difficult to be a successful unscientific physicist. By contrast, branches of "alternative" medicine may reject the need to evaluate hypotheses, and are unscientific by definition. However, in most fields, integrity is determined by the leadership of the field, and the extent to which those leaders care about honest science. The health of a discipline or an institution is most clearly revealed when things go badly wrong. The leadership of the field I know best (osteoporosis) consists of a mixture of excellent scientists and some scientifically discreditable individuals. To paraphrase Dr. Stephen Leader it is at least in part a field
"whose goal it is to turn bullshit into airline tickets".

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It's Time

I haven't devoted much public effort over the past few months to Procter and Gamble, Actonel, the hidden data, and the three misleading publications. I felt it best to allow time for the excuses and regulatory hand-sitting to be finalized.

To collude with dishonest science, and to protect powerful colleagues, all the regulators had to do was to do nothing of any relevance. There has been ample opportunity to do nothing very well. This is despite partial admissions that scientific conclusions were false, that statistical analyses were false, that lies had been told to a medical journal, and that every code of good scientific and medical conduct had been breached.

There is nothing unusual about inaction or the protection of vested interests and friends. There is nothing unusual about the observation that honest science seems not to matter to medical leadership, even when there is demonstrable harm to patients. There is nothing unusual about the observation that regulators fail to uphold their own codes of conduct when it suits them, but use those same codes to bully individuals asking difficult questions. There are almost no instances where medical "regulators" have acted to uphold scientific integrity in the UK. There is also nothing unusual about the silent complicity of colleagues. What happened to me happens to many others. I want to ask some fairly simple questions.

Over the next weeks I will devote considerable effort to the facts, regulatory failures, and the principles of good conduct in academic medicine. I will discuss the types of behaviours regulators regard as acceptable. I will try to relate these failings to their stated codes of conduct, and ask what purpose these organizations serve. I will discuss the nonsensical concept of "whistleblowing" in research, and the shameful way in which research misconduct is dealt with in the UK. Hopefully the discussion will be of wider interest. Let the science begin.

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Thursday, April 03, 2008

Has GlaxoSmithKline bitten off more than it can chew? - bloggers weigh in over intimidation

Bob Fiddaman has now posted the intimidatory letter he received from GlaxoSmithKline over a video in which he discussed aspects of GSK's science. The comparisons Fiddaman drew elsewhere (not in the video) between a GSK employee and a) Hitler b) faeces are inappropriate. Fiddaman agrees and has apologized over that aspect. One is left wondering who has caused the greater offence, who owes the apology, and to whom that apology is owed. The scientific questions are overwhelming, and the intimidation of a questioning patient cannot be allowed to divert attention from the lack of any real answering.

Dr Alastair Benbow of GSK does have some serious answering to do. He has to explain in detail why public comments he made were truthful (or otherwise). If not truthful, he has to explain whether he lied, was duped by his employer, or whether he failed to examine the facts before making public statements. He has to respond in detail both as a scientist and as a medical doctor. And he has to respond in public. It is inappropriate for a public scientific figure to claim harassment when asked to justify crucial (and potentially lethal) public scientific statements that he made.

More and more decent people out there are linking in to this story. That’s a great show of solidarity against completely inappropriate action by a corporate bully that hasn't even begun to address the scientific questions it has been asked. Here is a primer to some of those questions. There are many others.

Bloggers discussing the intimidation of a patient, Bob Fiddaman, by GlaxoSmithKline
Please let me know if anybody has any more links and we’ll add them in.

I encourage you to spread the links to those blogs discussing this threat to Fiddaman. To make life a little easier, here’s some cut and paste code which I’ll also keep updated. Stick it in your blog post and the list will appear (just drag through and select all the text in the box from the start to the end of the scrollbox, right click and copy to the clipboard, and then post into your blog post after your own comments).

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Tuesday, April 01, 2008

It's Groundhog Day for bullying by GlaxoSmithKline over Seroxat

It seems that attorneys representing GlaxoSmithKline (GSK) in the UK have sent a letter threatening a patient (Bob Fiddaman). Fiddaman writes the "Seroxat (Paxil) Sufferers blog". As a result of the letter, Fiddaman felt intimidated to remove a video he created and posted to his website in February.

Here is a link to the Fiddaman Video which is now hosted on U-Tube.

As doctors we sell our services and the products of industry under the banner of science. The leadership of our profession has long colluded with industry to silence those who draw attention to dishonest science. Although much criticism of medicine is ill-founded, many critics strike at the core of what we do. Their questions are about science. Many of those critics are our patients. They question the quality, transparency and honesty of our science, and they do so with good reason. We ignore these patients and these questions at our peril. That such patients should be threatened is a disgrace.

GSK stand accused of conducting some fairly disreputable science. The particular questions Fiddaman has been asking in his blog relate to a particular medical employee of GSK, Dr Alastair Benbow. The attorneys apparently complained to Fiddaman that Benbow was feeling harassed as a result of the video. They also took umbrage that Fiddaman has implied that Benbow was a liar.

It seems to me that Dr Benbow does indeed have some serious answering to do. He has to explain whether public comments he made were truthful (or otherwise) at the time he made them. If not truthful, he has to explain whether he lied, was duped by his employer, or whether he failed to examine the facts before making crucial public statements. He has to respond both as a scientist and as a medical doctor. And he has to respond in public.

It is not sufficient for a public scientific figure to claim harassment when asked to justify crucial public scientific statements that he made. There is a bit of age-old advice called the Second Rule of Holes: "When you find yourself in a hole, the first thing to do is to stop digging." In other words, don't let your ghostwriters draft your obituary.

Some of the questions Benbow has to answer are in the Glenmullen report. There are many other questions. Read Fiddamans blog, or other excellent blogs about the failure of science involving SSRI's written by questioning patients or patient representatives (Seroxat Secrets, Furious Seasons, AHRP, Matt Holford). Those very same questions are being asked by psychiatrists and psychologists (Clin Psych, Carlat).

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