No longer are we just told what to do from the top. Important decisions are preceded by a long period of consultation. That is a wonderful contribution to democracy. Sometimes. But in truth, these consultations are only too often totally sham public relations exercises. Here are a couple of examples. The first is a government consultation, followed by consultations within universities.
Consultations on nuclear power stations
I am not using this example to propose a particular view on muclear power stations, but rather as an example of sham consultation.
The background is this.
The government was obliged to run the “fullest public consultation” ( pdf ) before changing its policy on nuclear power. In 2006 they tried to run one but it was descibed by a high court judge described it as “unfair”, “misleading”, “very seriously flawed” and ” procedurally unfair ” and he ordered them to do the whole thing again. In May 2007 the government announced a new nuclear consultation that would remedy all the
judge’s concerns. It has recently finished.
The government (again) paid a large amount of public money to an organisation called Opinion Leader Research (OLR) to run the consultation. One does not need to go further than their own web site to discover that, as its name suggests, this organisation exists not to discover public opinion but to influence it in whatever direction it is paid (in this case by the government) to do. Here are some of OLR’s own words.
|“Opinion Leader believe that research is an active part of the communications process enhancing the client’s reputation by positioning them as open, engaging, listening and responding.”
“We develop bespoke approaches to help our clients develop clear actionable insights.”
“Opinion Leader draws on the widest range of approaches to design research based solutions to address client challenges. Our work is tailor-made to suit the specific needs of our clients. We continually innovate and develop new approaches and thinking to help our clients achieve their ambitions.”
According to reports of what happened, that is exactly what OLR did. Here is what Channel 4 News said.
“In nine day-long meetings across Britain two weekends ago, nearly a thousand people were shown a series of videos, presentations and handouts – and their opinion on building new nuclear power stations canvassed.
The government got the result it wanted – 44 per cent said power companies should have option of building nuclear, 36 per cent said no. But day before, the environmental group, Greenpeace, along with other green groups, had pulled out, alleging the questions were loaded and the information biased, partial and factually inaccurate.
Greenpeace would say that, you could argue. But, independently, 20 senior academics too have come forward and will be writing to government with similar reservations.
They say the consultations were deliberately skewed by linking nuclear to fears about climate change – because the government knew past research had shown it’s the only way to get people to accept nuclear, albeit reluctantly.”
“In the videos – alternative viewpoints had doom-ridden music in the background. The government’s view was then given against calm, relaxing music. I feel I have been mugged.”
“Not at all a consultation, merely a sleek marketing ploy.”
“I went in with an open mind… myself and others felt we were being misled and manipulated.”
Channel 4 News also spoken to someone involved in the events. They want to remain anonymous but told us “…repeating the government view, on page after page, on videos and in handouts, acted to almost bludgeon it into their heads.”
You can see some of the slides that were used here. One of them reads thus.
“In the context of tackling climate change and ensuring energy security, do you agree or disagree that it would be in the public interest to give energy companies the option of investing in new nuclear power stations?”
One very apt comment on this was
“Guess what, a majority of people agreed, and when you count the “neither agree or disagree” (which will be tacitly taken to mean “go for it now, build build build!”) the figure goes well into an overall majority. You can’t beat a good loaded question to elicit the desired response.
It’s a bit like asking someone allergic to cats: Do you like fluffy kittens, or are you a Nazi?”
Opinion Leader Research. A family affair?
There’s some very interesting background about OLR here.
“According to this morning’s Independent the energy giant EDF has gone on a public relations offensive to promote it’s new reactors in conjunction with another supplier, Areva . They have launched a website with a generic design assessment called EPR Reactor , which is of course perfectly timed with the consultation upon which the Government appears to have already made up it’s mind.
What’s odd (given what you’d exepct the Indy line to be on things like nuclear) is that they don’t mention that Gordon Brown’s brother, Andrew, is the Head of Media Relations at EDF. Unbelievably good timing for a web site though, don’t you think? The Government makes an announcement of a nuclear consultation on Friday and in the space of two days the big boys have designed and completed
a new website to tell everyone all about the wonders of nuclear? They must have been whipping those Indian developers in Bangalore good this weekend.
It’s worth noting as well that they also don’t mention that Brown’s protege, the Secretary of State for Children, Schools and Families, Ed Balls, has a father-in-law, who just happens to be the former Chairman of the Nuclear Industry Association, and is now a non-executive director of the Government quango known as the Nuclear Decommissiong Authority .
If you’re thinking right now “father-in-law?” and “Cooper?” the answer is yes. He is the father of the Minister of State for Housing (attending Cabinet) at the Department for Communities and Local Government, Yvette Cooper. Purely as an aside, you have to love the doublespeak style in the name of the NDA don’t you? It makes it sound like its interests are somehow opposite to the interests of the nuclear industry. “
There is more on this at the Guido Fawkes blog
“Gordon’s pollster Deborah Mattinson sits on the board of Gordon’s think-tank, the Smith Institute. Her relationship with Gordon has been very profitable for her firm, OLR. According to today’s Sunday Telegraph , government contracts totalling some £3 milllion have
come her way. ”
“the taxpayer is paying OLR £153,484.38 for one-day seminars “
“On Saturday 8 events were run across the UK to consult 1,100 people on the future of nuclear power. This was the second time the government had run the consultation. The previous being judged to be “seriously flawed” and “manifestly inadequate and unfair” by the high court. The inadequacies stemmed partly from poor management and a lack of time for people to state their views, but also because leading politicians had publicly made up their mind to support nuclear which critically undermined the consultation.
The same problem rose its head again on Friday when Britain’s leading environmental groups formally withdrew from the second nuclear consultation, citing serious concerns with our new Prime Minister, Gordon Brown telling parliament that a decision to continue with nuclear power had been taken “and that is why the security of our energy supply is best safeguarded by building a new generation of nuclear power stations”. The prime minister qualified his remarks a week later after a warning letter from Greenpeace’s lawyers.
The green groups were also concerned that the “ [consultation] document was full of pro-nuclear opinion masquerading as fact …
This document is fundamentally flawed and cannot form the basis for a full public consultation.” “
Sham consultations in universities
In universities one might hope things would be done better. But sadly, it is not so. We too have become accustomed to sham consultations. In many places, for example Edinburgh, staff have been consulted, but what they say has had little effect. The same has happened at UCL. As a matter of historical record, it is worth giving a very abbreviated account of our own sham consultation.
For two years meetings were held. It was made pretty clear at the outset, what the plans were. Few people had the courage to oppose them in a public meeting. Those who did were largely ignored. Most people didn’t even come to the meetings anyway. Most people cynically, or perhaps just realistically, presumed it would be a waste of time and effort. As a result, the voices of our top scientists were rarely heard, and had little influence.
The next stage was external review. Surely that should provide an independent voice? Four possible plans were put to the external review committee. It was made clear to the external review committee that plan 1 (the least disastrous one) was what “we” preferred, though in fact none of the plans had been agreed or even properly discussed by most of the people who do the research and the teaching. Plan 1 involved removal of all existing departments, with consequent destruction of brand names that, over a long period, have reflected well on the reputation of UCL. The external review obligingly said that plan 1 was OK, though they made one (very important) criticism. They said that the size of the research groups was too big. That criticism was rejected by UCL’s senior management team (SMT). We therefore ended up with precisely what the SMT had put to the external reviewers in the first place. With a fine bit of spin. this is represented as following the advice of the external reviewers.
So far, the whole procedure has born an eerie resemblance to the Blairite idea of what constitutes consultation. But the changes had, according to UCL’s statutes, to be recommended to Council by the Academic Board (which consists of all professors and many non-professorial representatives). That safeguard proved ineffective. At the Academic Board meeting of May 24 2007, the consultation stopped, with jaw-dropping speed. In an item that was not even marked for discussion, Academic Board was persuaded to relinquish its statutory powers, and to leave all future decisions about organisation of the Faculty of Life Sciences to the SMT. After three years of talking, it suddenly became apparent that no opposition would be tolerated. No wonder so few people turned up at the Academic Board meeting on November 7th. What point would there be in going, when all power had already been removed from them?
A report on the meeting of the Academic Board on May 24 was sent to a member of UCL Council (at his request). In the interests of completing the historical record I have now made it available to download (with names removed).
This may seem very odd to people outside the biosciences area, but in recent years a business has grown up that will write a paper for you, on the basis of data supplied by a pharmaceutical company. The person who actually did the writing will usually not appear as an author at all This practice is known as ghost writing.
It is obvious from the last two posts ( here and here ) that ghost writing of papers has became a major menace to science in the clinical world. The authors may have not even seen all of the data, and some “authors” may even not have seen the paper at all. Awareness of the size of the problem has increased, especially since the paper by Healy & Catell (2003) [ download the pdf ] (see also here ).
“a process of changing scientific authorship that could conceivably culminate in a situation in which the dominant figures in therapeutics actually have comparatively little first-hand research experience and few raw data that they can share with others.”
See also “Declaration of Medical Writing Assistance in International Peer-Reviewed Publications”, Wooley et al ., 2006, JAMA, 296, 932 – 3 [get pdf ], and a Professional Ethics Report published by the American Association for the Advancement of Science.
I recently had a conversation with a “medical writer” (don’t bother asking me who, I’m not saying). I’m very grateful that he spoke to me, because this is the sort of information that is usually concealed carefully from public view. He was clearly a person with integrity, but nonetheless what he had to say was quite disturbing. Here are some of the things that I learned.
- So called ‘Medical education agencies’ are also marketing agencies. They give expert advice to industry on how to select information from large clinical studies and how to cut and slice it to generate numerous papers. They advise on ‘publication planning’ and on which journals are best to reinforce particular messages that the companies want to convey.
- Medical writers who are acting as ‘ghost writers’ often interact with clients in the industry and don’t necessarily interact with the proposed academic authors. Opportunities to talk to the authors directly can be very limited and discussions are often mediated by a third party.
- Medical writers often do not see evidence that all authors have approved the submitted manuscript. It is perceived that only the primary author has actually approved the manuscript.
- Even if medical writers are aware of their responsibilities concerning ‘good publication practice’ and publication ethics it can be difficult to persuade clients to adopt all of these practices.
- Often medical writers do not see all of the raw data for a study or publication, they can get pre-selected data or just tables and figures for inclusion in the paper. Medical writers who are relatively inexperienced do not realise that this is not ‘best practice and will prepare a paper without requesting further background data.
- Medical writers can be pressurised by clients to include ambiguous data or marketing terms in manuscripts. When medical writers have problems with clients, support from their employers can be limited as clients are paying the bills. In this context, the ‘client’ is the company who produce the drug, not the people who eventually appear as authors.
- Ghost written papers have a number of authors. Often the most important is the primary author; this can be a selected ‘key opinion leader’ whose reputation is relied on by the company for promotion of the product.
In defence he did say that 99% of those working in the pharmaceutical industry are a pretty decent bunch. They understand that the consequences of manipulating data or employing unethical publication practices, if discovered, can be disastrous for the company and their product.
He also said that unethical publication practices occur regularly in purely academic environments. And in that he is, unfortunately, absolutely right. After all, the business of “medical writing” would not exist at all if senior academics were not willing to attach their names to papers that they have not written, and may well not even have seen all of the data.
Still worse, having been caught out doing that, they may be defended by their vice chancellors rather than condemned. Indeed anyone who dares to mention that it is going on is taking the risk of being fired. There is a shocking example here.
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.
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
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.
|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.
“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: email@example.com, firstname.lastname@example.org
CC: email@example.com, firstname.lastname@example.org, email@example.com, firstname.lastname@example.org
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.|
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
“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. “
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.
The Corporate Corruption of Higher Education: part 1
The next post is about examples from the UK.
The problem in the USA came to the fore with the passage of the Bayh-Dole Act (1980). This act allowed universities to patent ‘inventions’ that came from research funded by the taxpayer, and, far worse, allowed them to grant exclusive licences to a single commercial company. Although as originally formulated the act contained safeguards, these were mostly stripped out by the time it was passed. The nominal reason for the Act was “to bring ideas out of the ivory tower and into the market place more quickly”.
Nothing wrong with that of course. But Washburn chronicles how, not only did it fail to fulfil that aim, but corrupted universities as well. In fact with only a handful of exceptions, it did not even generate any large income for the universities. Nevertheless, the Act is still in place.Here are some examples from the USA. Examples from the UK are in a separate post.
Stanford University, Garry Nolan and Rigel Pharmaceuticals
David Zapol went from MIT to be a graduate student in Stanford, in June 1996. At the time he arrived his supervisor, Garry Nolan, set up a company, Rigel Pharmaceuticals Inc. to exploit genomic screening Stanford licensed to technology exclusively to Nolan’s company.
Although the lab was meant to be separate from the Company, that was obviously impossible. Zapol, and fellow student Michael Rothenberg,. were asked by Nolan to work on “proof of concept” for Rigel’s technology. The students found that “I can;t get time with my adviser and he’s completely preoccupied” [with the company]. A year later, Rothenberg came to the lab distraught, and told Zapol he’d been at Rigel’s offices hand had seen their “proof of concept” work shown in a company presentation for investors, with no acknowldegment of their authorship. Only they and Nolan knew about the work.
When I asked Nolan to to respond to Zapol’s allegations concerning Rigel’s misuse of his students’ data, he replied in writing
“I do not have a memory of this event”
The research on which the spin-off company was based was (as so often) still unproven, and the two graduate students found themselves competing with scientists in the (better-finded) company owned by their supervisor. If the latter won, the university graduate students would end up with nothing to publish.
When, in 1997, Rothenberg emailed his supervisor, Nolan, the reply he got was openly threatening
“Please, do not be referring to this situation as ‘Rigel’s inappropriate use of my data without referencing me’ “. “Be careful what you say”
In April 1997, Rothenberg (who worked in the university remember) was warned by an executive of the company, Donald Payan, not to communicate with a colleague in another university who was working in the same area.
“You should know that he is one of the founders of Selectide, a major competitor of ours . . . ” “. The guys here will be less than pleased if the ideas they give you re structures etc . . . end up in the hands of Selectide. Get my drift?”.
Stanford seems to have made few attempts to investigate the matter properly. Both graduate students left (with no peer-reviewed publications). Nolan is still there. Why is this? Stanford University (as well as Nolan) had substantial equity in Rigel (sold in 2000-01 for over $0.9m) and Stanford owned six of Nolan’s patents. What do the careers of two graduate studenst matter when there are big bucks at stake? Not much it seems.
Rigel, incidentally, has yet to produce a useful drug, eleven years after
Washburn’s book has many such examples. What is particularly upsetting about them is, in many cases, not so much the behaviour of greedy or dishonest scientists, but the behaviour of their employers. In any case where much money is at stake, the university fails to defend the honest scientists, but is more interested in its income than in truth. One has come to expect companies to behave in this way. It is a shock to see universities do the same.
GSK, Seroxat and Brown University: academics for hire, a shocking story
BBC TV’s Panorama programme showed the latest investigation of GlaxoSmithKline’s suppression of evidence of side effects of Paroxetine (Seroxat, Paxil). It seems that television journalists and lawyers have been a great deal more effective in unearthing the evidence than the regulatory authorities or the police. The MHRA has been working on the case for three years and has still not produced its report. Read the transcript here .
Lawyers in the USA managed to extract many secret emails from GSK, and they tell a sad story. Since the deregulation of industry that started around 1979 with Ronald Reagan and Margaret Thatcher, one has become accustomed to dishonesty by big business. But academics are involved too GSK organised three large scale clinical trials of Seroxat on children with depression, in the hope of getting Seroxat licensed for this use. The biggest of these is known as ‘Study 329’. It is these trials that have given rise to the charge that GSK tried to suppress evidence that Seroxat caused an increase risk of suicide in young people.
|Martin Keller is chair of psychiatry at Brown University. The evidence found by Panorama also shows that his reputation seems to be for hire. His university home page shows that he holds many influential politicians. It does not mention that in one year he got half a million dollars from drug companies including GSK.In one email Keller thanks a ghost writer who worked for a PR company hired by GSK.
In another mail from the ghost writer to Dr Keller says that all the necessary materials are enclosed so that he can submit study 329 for publication, even down to the covering letter which says: “please re-type on your letterhead. Revise if you wish.”. Perhaps Keller at least checked the results carefully? But it seems not. Keller said
“I’ve reviewed data analytic tables, I don’t recall how raw it was. The huge printouts that list items by item number.. you know, item umbers, invariable numbers and don’t even have words on ’em. I tend not to look at those. I do better with words than I do with symbols.”
The BBC reporter , Shelley Jofre, comments “Inside GSK, though, the discussion was all about what a failure study 329 had been. This is what another of its PR people wrote when asked if the journal article would be publicised.” “Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results. Essentially the study did not really show it was effective in treating adolescent depression which is not something we want to publicise.” [Email dated: 5th March 2001]
This is bad as any quackery, and the collusion of academics is very sad.
Brown University does not appear to have learned the lesson. The news section on their web site boasts of this ghost written work
“The largest clinical trial studying the use of antidepressants for treating major depression in adolescents suggests that paroxetine, sold under the brand name Paxil, may be successful.
“This is the first substantial evidence of a safe and effective treatment with an antidepressant for adolescents,” said Martin B. Keller, M.D., who led the study, which appears in the July issue of the Journal of the Academy of Child and Adolescent Psychiatry .”
Fiona Godlee , editor of the British Medical Journal, spoke on the programme. She had spotted the problems with the paper and declined to publish it. She comments “Another journal had peer reviewers who also spotted a number of the problems but the paper was published nonetheless relatively unchanged, and I think the journal must take some responsibility for that.”The editor of the ‘other journal’ ( Journal of the Academy of Child and Adolescent Psychiatry ) expressed no regrets.
See also “Ghost Authorship in Industry-Initiated Randomised Trials” by Gotzsche et al. ( PLOS Medicine 2007 ), and the commentary by Wagner , “Authors, Ghosts, Damned Lies, and Statisticians”. The latter concludes
“perhaps we should now admit that there are four types of lie: lies, damned lies, statistics, and the authorship lists of scientific papers, and that statisticians may be able to help prevent both the third and fourth types.”.
How irrational thinking in government and universities has led to the rise of new-age nonsense in the name of science.
This article appeared on 15th August 2007, on the Guardian Science web site.
The Guardian made very few cuts to the original version, but removed a lot of the links. If you want to have references to some of the claims that are made, try the original, which I reproduce here. [Download this as pdf]
The Guardian Science site also has a piece on this topic by Alok Jha: Reigniting the enlightenment How do we win back our civilisation from the jaws of darkness?
Comments can be left there too.
A German translation of this piece has been posted at the Mental health blog.
Etymological note. The word endarkenment has been used by several people as an antonym for the enlightenment, but the first time it caught my eye was in an article in 2005 by Gerald Weissman, The facts of evolution: fighting the Endarkenment. The article opens thus.
“Those of us who practice experimental science are living in the best of times and the worst of times, and I’m not talking about A Tale of Two Cities, but a tale of two cultures.”
Science in an Age of Endarkenment
“Education: Elitist activity. Cost ineffective. Unpopular with Grey Suits. Now largely replaced by Training.” Michael O’Donnell, in A Sceptic’s Medical Dictionary (BMJ publishing, 1997).
The enlightenment was a beautiful thing. People cast aside dogma and authority. They started to think for themselves. Natural science flourished. Understanding of the real world increased. The hegemony of religion slowly declined. Real universities were created and eventually democracy took hold. The modern world was born. Until recently we were making good progress. So what went wrong?
The past 30 years or so have been an age of endarkenment. It has been a period in which truth ceased to matter very much, and dogma and irrationality became once more respectable.
This matters when people delude themselves into believing that we could be endangered at 45 minute’s notice by non-existent weapons of mass destruction.It matters when reputable accountants delude themselves into thinking that Enron-style accounting is acceptable.
It matters when people are deluded into thinking that they will be rewarded in paradise for killing themselves and others.
It matters when bishops attribute floods to a deity whose evident vengefulness and malevolence leave one reeling. And it matters when science teachers start to believe that the earth was created 6000 years ago.
These are serious examples of the endarkenment mentality, but I’ll stick with my day job and consider what this mentality is doing to science.
One minor aspect of the endarkenment has been a resurgence in magical and superstitious ideas about medicine. The existence of homeopaths on the High Street won’t usually do too much harm. Their sugar pills contain nothing. They won’t poison your body; the greater danger is that they poison your mind.
It is true that consulting a homeopath could endanger your health if it delays proper diagnosis, or if they recommend sugar pills to prevent malaria, but the real objection is cultural. Homeopaths are a manifestation of a society in which wishful thinking matters more than truth; a society where what I say three times is true and never mind the facts.
If this attitude were restricted to half-educated herbalists and crackpot crystal gazers, perhaps one could shrug it off. But it isn’t restricted to them. The endarkenment extends to the highest reaches of the media, government and universities. And it corrupts science itself.
Even respectable newspapers still run nonsensical astrology columns. Respected members of parliament seem quite unaware of what constitutes evidence. Peter Hain (Lab., Neath) set back medicine in Northern Ireland. David Tredinnick (Cons., Bosworth) advocated homeopathic treatment of foot and mouth disease. Caroline Flint condoned homeopathy, and Lord Hunt referred to ‘psychic surgery’ as a “profession” in a letter written in response to question by a clinical scientist
Under the influence of the Department of Health, normally sane pharmacologists on the Medicines and Health Regulatory Authority, which is meant to “ensure the medicines work”, changed the rules to allow homeopathic and herbal products to be labelled, misleadingly, with “traditional” uses, while requiring no evidence to be produced that they work.
Tony Blair himself created religiously-divided schools at a time when that has never been more obviously foolish, and he defended in the House of Commons, schools run by ‘young-earth creationists‘, the lunatic fringe of religious zealots. The ex-Head Science teacher at Emmanuel College said
â€œNote every occasion when an evolutionary/old-earth paradigm . . . is explicitly mentioned . . . we must give the alternative (always better) Biblical explanation of the same dataâ€:
That is not from the fundamentalists of the southern USA, but from Gateshead, UK.
The Blairs’ fascination with pendulum wavers, crystals and other new age nonsense is well known. When their elders set examples like that, is it any surprise that over 30% of students in the UK now say they believe in creationism and “intelligent design”? As Steve Jones has pointed out so trenchantly, this makes it hard to teach them science at all. Welcome back, Cardinal Bellarmine.
Homeopaths and herbalists may be anti-science but they are not nearly as worrying as the university vice-chancellors who try to justify the giving of bachelor of science degrees in subjects that are anti-science to their core. How, one may well ask, have universities got into the embarrassing position of having to answer questions like that?
Here are a couple of examples of how. The University of Bedfordshire (in its previous incarnation as the University of Luton) accredited a Foundation Degree course in ‘nutritional therapy’, at`the Institute of Optimum Nutrition (IoN). The give-away is the term Nutritional Therapy . They are the folks who claim, with next to no evidence, that changing your diet, and buying from them a lot of expensive ‘supplements’, will cure almost any disease (even AIDS and cancer).
The IoN is run by Patrick Holford, whose only qualification in nutrition is a diploma awarded to himself by his own Institute. His advocacy of vitamin C as better than conventional drugs to treat AIDS is truly scary. His pretensions have been analysed effectively by Ben Goldacre, and by Holfordwatch.. See the toe-curling details on badscience.net .
The documents that relate to this accreditation are mind-boggling. One of the recommended books for the course, on “Energy Medicine” (a subject that is pure fantasy) has been reviewed thus.
“This book masquerades as science, but it amounts to little more than speculation and polemic in support of a preconceived belief.”.
The report of Luton’s Teaching Quality and Enhancement Committee (May 24th 2004) looks terribly official, with at least three “quality assurance” people in attendance. But the minutes show that they discussed almost everything about the course apart from the one thing that really matters, the truth of what was being taught. The accreditation was granted. It’s true that the QAA criticised Luton for this, but only because they failed to tick a box, not because of the content of the course.
The University of Central Lancashire ‘s justification for its BSc in Homeopathic Medicine consists of 49 pages of what the late, great Ted Wragg might have called “world-class meaningless bollocks”. All the buzzwords are there “multi-disciplinary deliveryâ€, â€œformative and summative assessmentâ€, log books and schedules. But not a single word about the fact that the course is devoted to a totally discredited early 19th century view of medicine. Not a single word about truth and falsehood. Has it become politically incorrect to ask questions like that? The box-ticking mentality is just another manifestation of the endarkenment thought. If you tick a box to say that you are fully-qualifed at laying-on-of-hands, that is good enough. You have done the course, and it is irrelevant whether the course teaches rubbish.
These examples, and many like them, result, I believe from the bureaucratisation and corporatisation of science and education. Power has gradually ebbed away from the people who do the research and teaching, and become centralised in the hands of people who do neither.
The sad thing is that the intentions are good. Taxpayers have every right to expect that their money is well spent, and students have every right to expect that a university will teach them well. How, then, have we ended up with attempts to deliver these things that do more harm than good?
One reason is that the bureaucrats who impose these schemes have no interest in data. They don’t do randomised tests, or even run pilot schemes, on their educational or management theories because, like and old-fashioned clinician, they just know they are right. Enormous harm has been done to science by valuing quantity over quality, short-termism over originality and, at the extremes, fraud over honesty. Spoofs about the pretentiousness and dishonesty of some science, like that published in The New York Times last year, are too close to the truth to be very funny now.
Science, left to itself, and run by scientists, has created much of the world we live in. It has self-correcting mechanisms built in, so that mistakes, and the occasional bit of fraud, are soon eliminated. Corporatisation has meant that, increasingly, you are not responsible to your conscience, just to your line manager. The result of this, I fear, is a decrease in honesty, and in the long run inevitably a decrease in quality and originality too.
If all we had to worry about was a few potty homeopaths and astrologers, it might be better to shrug, and get on with trying to find some truths about the world. But now the endarkenment extends to parliament, universities and schools, it is far too dangerous to ignore.
The two chiropodists who run the Marigold Homeopathic Podiatry clinic (no, honestly, it’s real) at the Royal London Homeopathic Hospital seem to be spending much of their budget with a company that they themselves own. The UCLH Trust did not receive any notification of this until I told them about it.
This has been re-posted from the story on the old IMPROBABLE SCIENCE page.
It’s about time I dealt with the health fraud on my own doorstep. University College London Hospitals (UCLH) is not part of UCL, but is a National Health Service Foundation Trust. The trust is responsible for eight hospitals: University College Hospital, The Middlesex Hospital, Hospital for Tropical Diseases, National Hospital for Neurology & Neurosurgery, Elizabeth Garrett Anderson & Obstetric Hospital, Eastman Dental Hospital, The Royal London Homoeopathic Hospital and The Heart Hospital.These are all (but one) absolutely first class teaching hospitals, with responsibility for clinical teaching for UCL medical students. The one blot on the landscape is the Royal London Homeopathic Hospital. This hospital was acquired by UCLH in April 2002. Why on earth is a respectable NHS trust promoting quackery? The UCLH web site says
“The merger enables closer collaboration between complementary therapies and conventional medicine to provide better care for NHS patients. The merger co-incides with the government’s commitment to integrate complementary and conventional care within the NHS, where there is evidence of the effectiveness of complementary therapies.” Notice that the crucial proviso in this statement.
“. . . where there is evidence of the effectiveness of complementary therapies.”
That would be fine If there were evidence of effectiveness, but there is next to no such evidence. Why does UCLH brush this inconvenient fact under the carpet?
The Trust actually has an absolutely first class way of assessing the effectiveness of treatments that are used within UCLH. It is called the Use of Medicines Committee. All NHS Trusts are required to have such a committee, and UCLH’s committee was singled out for praise after a visit by the Parliamentary Select Committee on Health, in their 4th report. These committees are required to obtain good evidence that a proposed treatment works, and their evaluations may be more stringent than those of NICE.
“ During the inquiry, we visited University College London hospital to hear about its Use of Medicines Committee. We were incredibly impressed with its drug formulary, which is used not only by the hospital trust but by the nearby primary care trusts. Because members of those trusts are on the committee, it is also well accepted by the GPs in the area.”
So does the UCLH formulary contain homeopathic and herbal products? If so they will have bypassed entirely the high standards of evidence that are required by the Use of Medicines Committee for any other sort of medicine. If these standards were applied to homeopathic and herbal treatments, the Royal London Homeopathic Hospital would have to close down, because few of these alternatives to medicine would pass an evidence-based assessment. Presumably UCLH Management has foreseen this, and would rather adopt a double-standard than deal with the political fall-out that would result from applying rules of evidence to alternative medicine.
A fine example of the abuse of language: Homeopathic podiatry
The UCLH web site says (somewhat ungrammatically): “The Royal London Homoeopathic Hospital is celebrating the first decade of its Marigold Clinic which provides complementary treatment of homeopathic podiatry. ”
“ Dr Peter Fisher, RLHH Clinical Director, said: “It is an honour for the hospital to host the Marigold Clinic which has been tremendously successful. The Royal London Homoeopathic Hospital has a history of acting as a test bed for NHS innovation. The complementary cancer service and acupuncture are just two examples of therapies the RLHH has been the first to introduce on the NHS. I foresee the same thing happening with homoeopathic podiatry. It’s time has come, current reforms and patient choice are working in our favour.” ”
|It is embarrassing to a real university like UCL to see a conference, sponsored by RLHH, on ‘Improving the success of homeopathy’ branded with a logo that looks very like UCL’s own (old version) logo. The title carries the assumption that there is something to be ‘improved’. The conference dealt not only with marigold for bunions, but also HIV/AIDS|
What does the Royal London Homeopathic Hospital cost you, the taxpayer?
Guess what? Nobody knows. But with the help of the Freedom of Information Act 2000, I have been able to make some good guesses.
For a start, at least £18 million has been spent on refurbishing the RLHH. The recurrent costs are not so easy to discover. By use of the Freedom of Information Act 200, this is what I discovered.
The direct cost of running the RLHH is £3.379 million per year of which £3.175 million per year are paid by the NHS. Approximately 75% of the direct costs are for salaries.These are the salary cost of staff working at the RLHH. The staff are medical, nursing, pharmacy, administrative and managerial, and ancillary. The balance of cost is for purchase of drugs, laboratory tests, use of patient beds in other Trust hospitals, building and office running costs.
As well as this, the NHS pays also for indirect services, but nobody seems to know the cost of these (and still less, their value). Indirect services are those not charged directly to the RLHH and will include the following. Payroll, payment and income services, accountancy, recruitment , training, personnel, governance and clinical audit, R and D management and governance, medical and nursing education, training and professional support, communications, I.M. and T., estates maintenance management and planning, catering, cleaning, security, insurance, depreciation, payment of public dividend. These sevices are supplied by the Finance Directorate, Workforce Directorate, Chief Nurse Directorate, Capital Investment Directorate, IM and T Directorate, R and D Directorate, Governance Directorate, Directorate of Corporate Sevices, Communications Directorate.
For the UCLH Trust as a whole, indirect costs amount to 39.2 percent of direct costs. If that proportion applies to RLHH, then the total annual cost of RLHH would be £4.7 million.
That sounds to me like a lot of money for a placebo effect.
The RLHH is 97.7 percent homeopathic
Their web site lists eight consultants, all described as “homeopathic consultants” and a ninth has been added recently, Dr H. Roniger. Thus it seems that Lord Winston made an error of fact when he defended the RLHH in the House of Lords by saying “My Lords, perhaps I may be allowed to break with tradition and come to the assistance of my noble friend. Is it not the case that the national homeopathic hospital conducts perfectly normative medicine and is it not justified in doing that, irrespective of the efficacy or otherwise of homeopathy, which I believe is only a small part of its practice?”
This is the breakdown of prescribing at the RLHH (audit taken August 2004, provided under the Freedom of Information Act). It refers to the number of items dispensed, not their value (which I am still trying to discover).
|Herbal tinctures and potencies <6x||5.7|
|Supplements/homeopathic (New Era Products)||7.8|
NB: Creams are herbal or homeopathic.
And the cost of CAM in Glasgow
A freedom if Information Act request elicited the following costs. Much of
the information I asked for is not even recorded.
The cost of the Glasgow Homoeopathic Hospital.
The running costs for the Homoeopathic Hospital were:
The cost of all CAM services at Baillieston Health Centre
There is no record of any specific costs associated with CAM incurred at Baillieston Health Centre.There was many years ago a Baillieston Childrens’ Homoeopathic Clinic but this service was subsumed into the new Glasgow Homoepathic Hospital. That hospital opened in 1999 at a total capital and building cost of £2,780,189.The total cost came from the New Homoeopathic Hospital Endowment Fund.
3) The cost of CAM provided by GPs or any other part of the Trust.
There is no record of specific costs associated with GPs or others employed by the NHS Board providing complementary and alternative medicine. If homoeopathy, hypnosis, acupuncture or any other form of complementary medicine is provided it is not as a costed, discrete service.
A conflict of interest at RLHH
The table shown above shows the precribing habits at the Royal London Homeopathic Hospital, The 4.2 percent of precriptions labelled ‘Marigold products’ in the Table were for the products of a company called Marifold Footcare Ltd.
The UCLH Trust web site says
“Dr M Taufiq Khan founded the Marigold Clinic in 1981 at St Pancras Hospital, London, and then established it in 1992 at the RLHH. Dr Khan is the Director of Homeopathic Podiatory Sevices at the RLHH and specialises in the treatment. His son Dr Tariq Khan, is the Deputy Director.”
|The list above shows that 4.2% of all precriptions at RLHH were for “Marigold Products”. This company is Marigold Footcare Ltd., 134 Montrose Avenue, Edgeware, Middlesex, HA8 0DR.||
From left to right: Dr Taufiq Khan, Dr Peter Fisher, Lord Paul of Marylebone and Dr Taufiq Khan open the Sick Feet – Healing Flowers exhibition.
- Dr Mohammed Taufiq Khan, PhD of 134 Montrose Avenue, Edgeware, Middlesex
- Mr Mohammed Taufiq Khan of Bedford House, 17 New North Street, London
- Mrs Shamim Fatima Khan of 134 Montrose Avenue, Edgeware, Middlesex
It appears that the director and deputy director of the Marigold Clinic are paying substantial amounts of NHS money to their own company.
Research-based? Which research?
The web site of the Marigold Clinic makes the following claim.
Marigold therapy is an integral part of homoeopathic podiatry. It comprises specially formulated medication applied topically in conjunction with podiatry. It is research based medicine which has been clinically evaluated in double blind placebo controlled trials at British Universities and NHS Trusts.
And Marigold Footcare Ltd claims
“The safety and efficacy of Marigold Therapy have been demonstrated through extensive clinical use in podiatry clinics and numerous studies and in randomised, double blind, placebo controlled trials: (1) at the University of Brighton (Faculty of Health); (2) University of East London (Institute of Health and Rehabilitation, Faculty of Health and Science); (3) University of London (Faculty of Medicine, School of Pharmacy and the Royal London Homeopathic Hospital).”
This sounds impressive, but what exactly is this research? All I can find in Pubmed about marigold treatment in podiatry is two papers. One is in the Journal of Pharmacy and Pharmacology (1996, 48, 768-770) and one is in Phytotherapy Research (1996, 0, 211-214).
And who is the first author on both of these papers? You guessed: M.T. Khan.
The first paper (Khan, 1996) is from the School of Pharmacy, the second (Khan, Potter and Birch, 1996) is from School of Pharmacy and the podiatry department, Leaf Hospital, Brighton. I can find no trace of publications from the University of East London or from RLHH. Repeated requests for references elicited no reply at all for a long time.
Eventually, I had a reply from M. Tariq Khan in response to my request for references to back the claim on their company’s web site. He sent a list of 54 assorted conference communications and student projects, and 28 “papers” published in Journals. Every one of these 82 items bore the names of one or both M. T. Khans. There were no more ‘serious’ papers than Pubmed had revealed. There appears to be no independent verification whatsoever of their claims.
Reaction of the UCLH Trust
The UCLH Trust, when notified about what was going on, referred the matter to Dr Peter Fisher, the homeopath and clinical director at rhe RLHH. Tonia Ramsden, Director of Corporate Services for UCLH told me on July 27 2006
“I can confirm that I have received and registered the declaration of Interest.”
Quite true, It was only later that I was told that the declaration of interest was received by the Trust only after I had told them about what was going on!
Peter Fisher, assured me that he was aware of the Khan’s behaviour. Rather surprisingly, he seemed to think that no conflict of interest was involved. He said
“Thank you for drawing to my attention the potential conflict of interest in relation to podiatry. The management of the RLHH has always been aware of the situation”
That was it. No comment at all was made on the propriety of the Khans’ behaviour. Dr Fisher also assured me that the evidence for the efficacy of marigold products was good, without actually citing what this evidence was. I replied thus.
“I find it quite disturbing that you say below that “the RLHH is committed to evidence-based practice”, but that you seem to regard as evidence two small papers, both from the same people with a financial interest in the outcome, and not replicated elsewhere. Incidentally neither of these papers declared the authors’ financial interest. It is equally disturbing that your letter to me does not seem to give a realistic idea of the strength of the evidence. I had to find that for myself. ”
Declarations of interest shoud be public, but are not,
A declaration of conflict of interest is, I suppose, better than nothing. But these pieces of paper sit in a drawer in the Trust. They are kept secret from both the public and the patients. The patient should know when the prescriber has a financial interest in what he prescribes, but they are kept in the dark. When I wrote to the UCLH clinical governance committee to suggest a bit more openness would be desirable, they did not even bother to reply. That is when I decided to make this information public.