The Corporate Corruption of Higher Education: part 2.

Scientists are no longer perceived exclusively as guardians of objective truth, but also as smart promoters of their own interests in a media-driven marketplace. Haerlin & Parr, Nature, 1999, 400, 499.

This is a continuation of the previous post on Universities Inc, but with two examples from the UK. The two cases are quite different, but they have one thing in common and that is the cover-up of bad behaviour by the university itself, at the highest level.

University of Sheffield and Proctor & Gamble

Dr Aubrey Blumsohn MBBCh, PhD, MSc, BSc(hons), FRCPath was, until 2006, a senior lecturer and honorary consultant in metabolic bone diseases at Sheffield University. He, and his boss, Richard Eastell, were doing a clinical study of a Procter & Gamble Pharmaceuticals (P&G) drug, Actonel (risedronate), The work was funded by Procter & Gamble.

Richard Eastell is Professor of Bone Metabolism, and was Research Dean.

Proctor & Gamble refused, from 2002 onwards, to release the randomisation codes for the trial to the authors whose names appear on the paper. After trying to see the data for years, and getting little support from his employer, Blumsohn subsequently got hold of it in 2005, and then discovered flaws in the analysis provided by P&G’s statistician. P&G wrote papers on which the names of university academics as authors. Blumsohn did the only thing that any honest scientist could do: he went public with his complaint.

The result? Blumsohn has had to leave Sheffield Richard Eastell remains.

Attempts to find out what has been done by the University of Sheffield meet with silence.

Compare and contrast these two extracts (the emphasis is mine).

The first one is from Eastell, Barton, Hannon, Chines, Garnero and Delmas, 2003. (Barton and Chines were employees of Proctor & Gamble, who paid for the study). Read the full paper here

ACKNOWLEDGMENTS We would like to acknowledge the help of Dr Simon Pack and Lisa Bosch of Procter & Gamble Pharmaceuticals, as well as the help of Oldham Hospital Clinical Chemistry Department for measuring urinary CTX and creatinine. This study was supported by grants from Procter & Gamble Pharmaceuticals, Inc. (Cincinnati, OH) and Aventis Pharma, Bridgewater, NJ. Employees of Procter & Gamble Pharmaceuticals and Aventis Pharma participated in the design and execution of the study, the analysis of the data, and the preparation of the manuscript. All authors had full access to the data and analyses.

The second quotation is from Eastell, Hannon, Garnero, Campbell and Pierre D Delmas, 2007. Read the full paper here.

In the original paper,(1) one of the authors, a statistician working for P&G (IB), had full access to all data. P&G (like most pharmaceutical companies we contacted over this issue) used the PhRMA guidelines in relation to publication of clinical trial data, and these restrict the release of original data to investigators (http://www.phrma.org/).At the time of writing (2002/03), not all the original authors were given access to the raw data. In 2006, the American Association of Medical Colleges published recommendations regarding access to raw data. These proposed that the sponsor may conduct all the analyses but that the investigators should be able to conduct their own analysis if they deem it to be necessary, and we endorse these recommendations.

So the statement that “All authors had full access to the data and analyses” was untrue for five of the six authors of the first paper. This was know to the authors at the time it was written. It is not usual to put it so bluntly, but it was clearly a deliberate lie. The second paper does not even apologise for the lie, but merely seems to be saying that lying was normal practice at the time.In September 2003 Blumsohn told Eastell that he thought the plotted graphs were misleading. But Eastell, whose work for the university has attracted research grants from P&G of £1.6m in recent years, told him that they ‘really had to watch it’ with P&G. In a conversation which Blumsohn taped, Eastell said:

“The only thing that we have to watch all the time is our relationship with P&G. Because we are… we have the big Sheffield Centre Grant which is a good source of income, we have got to really watch it. So, the reason why I worry is the network within P&G is like lightning. So if Ian [Barton] is unhappy it goes to Arkadi [Chines, global medical director of P&G Pharmaceuticals] and before we know it, there is an issue, there is a problem.”

Just listen to the audio recording, and weep for academic integrity

More detailed accounts of this story

This is a particularly interesting case because so much information about it is now available. A particularly good edition of the BBC Radio 4 programme, You and Yours, gave a lot of the evidence. Martin Bland. Professor of Medical Statistics at York University, explains that there is actually no evidence for the plateau effect claimed by P&G and by Eastell, an effect which, if real, would allow P&G to claim that Actonel was as good as its Merk rival, Fosomax. Your can read Martin Bland’s report here.
The presenter, Vivienne Parry, concludes

“But, what it very much looks like here is that we have a company buying independent scientific expertise to give its research that veneer of credibility, only for it to withold the data generated from independent scrutiny when the results don’t suit its marketing objectives”.

Blumsohn commented thus.

“Following a protracted period of trying to contact a number of university officials to discuss this problem, I realised that raising of the problem within the university was going to prove impossible. I then engaged a lawyer and very shortly after the university suspended me from my position on the principal grounds of disobeying a supposedly reasonable mangemant instruction by communicating with the media.”

Here are some links..

• BBC Radio 4: You and Yours (2 February, 2006). ” [download realplayer file]
• Investigative Journalist, by Jennifer Washburn gave an excellent account of this whole sorry affair ” Rent-a-Researcher. Did a British university sell out to Procter & Gamble?”. It has links to many of the emails that were sent.
• Observer (4 December 2005) How the drugs giant and a lone academic went to war.
• The Alliance for Human Reserach Protection. An account from this New York-based organisation, “Scientific fraud and corruption” , and an earlier (Nov 2005) report.
• Aubrey Blumsohn’s own account, with original data and links to many sources, Proctor Research Shenanigans
• Freedom to care, “Drug Company’s Pretence“
• The Times Higher Education Supplement published a series of reports on the case. They are available only with a subscription, but click here for the latest,”Expert admits he did not have full access to data“
• A collection of media reports can be seen here.

Many of the emails make you shudder. For example, the following are extracts from an invitation to have a paper ghost-written by the Company that was sent to Eastell and Blumsohn by the company’s statistician (see the whole mail here). The emphasis is mine.

To: r.eastell@sheffield.ac.uk, ablumsohn@sheffield.ac.uk CC: mroyer@twcny.rr.com, chines.aa@pg.com, pack.s@pg.com, david.cahall@aventis.com From: barton.ip@pg.com Date: Thu, 24 Apr 2003 14:36:41 +0100 Dear Richard and Aubrey I wanted to introduce you to one of The Alliance’s external medical writers, Mary Royer.Mary is based in New York and is very familiar with both the risedronate data and our key messages, in addition to being well clued up on competitor and general osteoporosis publications.. . .. . are you thinking of drafting the publications first and then let Mary take over or would you like Mary to write from the beginning? I’m very flexible. Mary and I have just finished writing a publication with Steven Boonen (Richard you will be contacted as you’re a co-author!) and Mary was involved at the very beginning and wrote from scratch. If you could let both Mary and I [sic] know how you envisage us all working together that would be extremely helpful.

Why has the University of Sheffield done nothing about it?

It is one thing to find that some individuals are less than honest about reporting research. It is far more serious when the University does nothing about it. On the contrary, Sheffield effectively fired the wrong person, the person who was too honest to go along with the lies. Blumsohn eventually managed to get complete evidence, and indeed Eastell himslef, in the 2007 paper, admits that he’d lied about having complete access to the data. Yet nothing happened when Blumsohn wrote to Eastell, his Dean, his vice-chancellor or his personnel manager (the links show you the letters he sent). Because the university seemed intent on covering-up the wrongdoing, Blumsohn, very properly, did the only think that was left to him, and went to the media (e.g. THES).
This was then used by the university as an excuse to fire him.

Sheffield University has behaved abominably in this matter. And they refuse to say anything about it. After I wrote to the (new) vice-chancellor. Keith Burnett, this is what I got.

I would like to reassure you that the University of Sheffield takes very seriously its responsibilities in the area of research integrity and always strives to act in a manner that upholds this, in accordance with its reputation.

Well, perhaps. But there is no detectable sign of anything at all having been done, during the four years that have elapsed so far.

What can be done about corruption in universities?

Nature this week (1 Nov 2007) published an editorial, “Who is accountable“. Here are some quotations.

We suggest that journals should require that every manuscript has at least one author per collaborating research group who will go on record in a way that collectively vouches for the paper’s standards. Each would sign a statement with reference to Nature ‘s publication policies
as follows:

“I have ensured that every author in my research group has seen and approved this manuscript. The data that are presented in the figures and tables were reviewed in raw form, the analysis and statistics applied are appropriate and the figures are accurate representations of the data. Any manipulations of images conform to Nature ‘s guidelines. All journal policies on materials and data sharing, ethical treatment of research subjects, conflicts of interest, biosecurity etc. have been adhered to. I have confidence that all of the conclusions presented are based on accurate
extrapolations from the data collected for this study and that my colleagues listed as co-authors have contributed and deserve the designation ‘author’.”

Misconduct investigators go out of their way to spare anyone apart from the direct perpetrators, but they have indicated concerns over the degree of oversight within collaborations. If the damage to reputations were more widespread in the event of fraud, researchers would be even more fastidious about the data emanating from their labs and the due diligence they would impose. The chances of major frauds, with their disproportionate impact on the reputation of science as a whole, would be diminished.”

Wakefield, MMR and the Royal Free Hospital

This has been written about endlessly. Wakefield’s bad science has resulted in deaths from measles, and the safety of MMR has been investigated very thoroughly.

Again, the odd bad scientist is inevitable. What I would like to have seen investigated more openly is the complicity of the medical school (all this happened, thank heavens, shortly before the Royal Free Hospital Medical School became part of UCL). According to the very thorough investigation by Brian Deer:

“This “finding”, and massive publicity that the Royal Free hospital and medical school encouraged for it [through a press release , video news release and a televised press conference] launched a worldwide scare over the vaccine’s safety, triggering falls in immunisation rates, outbreaks of potentially fatal or disabling diseases, and an epidemic of unwarranted self-recrimination among parents of autistic children. ”

“Although Wakefield had performed no research upon which to credibly base such a recommendation, this attack on MMR had been orchestrated through a 20-minute video news release , prepared weeks in advance and issued to journalists by the Royal Free hospital’s press office. In this video, which doctors knew was likely to cause public alarm, and damage to immunisation rates, Wakefield four times claimed that single shots were likely to be safer than MMR, which he said should be withdrawn by the government. ”

“Unknown to the public prior to the Dispatches investigation, nearly nine months before the press conference, Wakefield and the Royal Free medical school had filed the first in a string of patent applications for extraordinary products which could only have stood any chance of success if MMR’s reputation was damaged. These included, firstly, a single vaccine against measles – a potential competitor to MMR – and, secondly, purported remedies, perhaps even what they bizarrely called a ” complete cure “, for both inflammatory bowel disease and autism. “

Follow-up

May 2005. Eastell was suspended from his NHS post after allegations that he had wrongly charged the health service for lab tests carried out for his university work outside the NHS. He resigned before a verdict could be delivered and thus escaped judgement.

November 2009 Eastell faced a General Medical Council “fitness to practice” hearing. The GMC evidently does not consider that lying in a scientific paper is misconduct (no, really). The hearing said that Eastell’s actions had not been “deliberately misleading or dishonest”, although he may have been negligent in making “untrue” and “misleading” declarations; the council did not make a finding of misconduct.. There is no "may have been", It is in print, in black and white. The GMC were utterly pusillanimous in this case. Another example of a useless regulator.

18 February 2010. A young radiologist in Sheffield, Guirong Jiang, found results which suggested that the field of osteoporosis might be distorted by the over-diagnosis of vertebral fractures (a finding that might reduce the sales of osteoporosis drugs). She was told by Eastell not to publish it. She had to go through disciplinary proceedings. Like Blumsohn, she got no support from the university: quite on the contrary. The university said her actions breached the terms of a 2007 contract with Sanofi-Aventis, an agreement that she had neither seen nor signed.

When universities behave like this it becomes hard to believe anything published by the University of Sheffield.