Download Lectures on Biostatistics (1971). Corrected and searchable version of Google books edition
Download review of Lectures on Biostatistics (THES, 1973).
conflict of interest
| “the report is more hypothesis-generating for future research than a rigorous scientific study. Find us some money and we will do a proper job. You can quote me for that.” Professor David Smith (Oxford). Scientific adviser for Food for the Brain. |
For a quick synopsis, look at Holfordmyths.org.
Patrick Holford and Drew Fobbester are joint researchers and authors of the Food for the Brain Child Survey , September 2007 (pdf). Holfordwatch has made a very thorough study of this report, in eight parts (so far). They conclude
“HolfordWatch can not share the optimism for these claimed benefits and finds that there is insufficient data to support them in a robust manner.”
There are many detailed questions, but the basic problem with the report is very simple. The fact that is (a) self-selected and (b) not randomised make it just another naive observational study. The stunningly obvious confounder in this case is, as so often, the socio-economic background of the kids. That was not even assessed, never mind any attempt being made to allow for it.
This isn’t just pedantry because what matters is causality. It is worth very little to know that eating vegetables is correlated with high SAT score if the correlation is a result of having well-off parents. If that were the reason, then forcing kids with poor parents to eat vegetables would make no difference to their SAT score because their parents would still be poor. The only conclusion of the study seems to be that we should eat more fruit and vegetables, something that we are already lectured about in every waking moment.
Many questions about the report have not yet been answered by its authors. But the report has a panel of scientific advisors, some of whom at least seem to be very respectable (though not ‘orthomolecular medicine‘, which is a cult founded on the batty late-life beliefs of the once great Linus Pauling that Vitamin C is a magic bullet).
Furthermore they are thanked thus
As it happens, David Smith is an old friend, so I wrote to him, and also to Philip Cowen, with some detailed questions. I didn’t get detailed answers, but the responses were none the less interesting. Cowen said
“I did see the report and quite agree with your conclusions that it an observational study and therefore not informative about causality.”
“The advice about diet seems reasonable although, as you point out, probably somewhat redundant.”
But still more interesting, David Smith told me (my emphasis)
“the survey was the largest of its kind and was done on minimal funding; hence several matters could not be dealt with and so the report is more hypothesis-generating for future research than a rigorous scientific study. Find us some money and we will do a proper job. You can quote me for that, if you wish.”
I’d grateful to David for his permission to quote this comment, It seems that Holford’s top scientific advisor agrees that it is not a rigorous study, and even agrees that the “proper job” is still to be done.
But it does seem a shame that that was not made clear in the report itself.
Happy new year. not least to the folks at the homeopathy4health site . They are jubilant about a “proof” that homeopathic dilutions could produce effects. albeit only on wheat seedlings. But guess what? After some questioning it was found that they hadn’t actually read the paper. Well I have read it, and this is the result.
The paper is “A Biostatistical Insight into the As2O3 High Dilution Effects on the Rate and Variability of Wheat Seedling Growth”. Brizzi,
Lazzarato, Nani, Borghini, Peruzzi and Betti, Forsch Komplementärmed Klass Naturheilkd 2005;12:277–283
The authors compared these treatments (30 seedlings each).
- C1, C2, C3 (untreated water p.a. Merck, control);
- WP (potentized water p.A. Merck) 5x, 15x, 25x, 35x, 45x;
- AD (diluted arsenic trioxide) 10–5, 10–15, 10–25, 10–35, 10–45;
- AP (potentized arsenic trioxide) 5x, 15x, 25x, 35x, 45x.
The allocation of seedlings to treatments was stated to be blind and randomised. So far, so good.
But just look at the results in Figure 1. They are all over the place, with no obvious trend as ‘potency’ (i.e. dilution) is increased. The
results with homeopathic arsenic at 45 days (the only effect that is claimed to be real) is very little different from the that of shaken water (water that has been though the same process but with no arsenic present initially).
For some (unstated) reason the points have no standard errors on them. Using the values given in Table 3 I reckon that the observation for AP45 is 1.33 ± 0.62 and for the plain water (WP45). it is 1.05 ± 0.69. The authors claim (Table 3) that the former is ‘significant’ (with a profoundly unimpressive P = 0.04) and the latter isn’t. I can’t say that I’m convinced, and in any case, even if the effect were real, it would be tiny.
Later the authors do two things that are a very dubious from the statistical point of view. First they plot cumulative distributions which are notoriously misleading about precision (because the data in adjacent bins are almost the same). They then do some quite improper data snooping by testing only the half of the results that came out lowest. If this were legitimate (it isn’t) the results would be even worse for homeopaths, because the difference between the controls and plain water (WP45) now, they claim, comes out “significant”.
Homeopaths claim that the smaller the dose, the bigger the effect (so better water down your beer as much as possible, making sure to bang the glass on the bar to potentise it). I have yet to see any dose-response curve that has the claimed negative slope. Figure 1 most certainly doesn’t show it.
Of course there is no surprise at all for non-homeopaths in the discovery that arsenic 45x is indistinguishable from water 45x.
That is what we have been saying all along.
We hear a lot about leadership these days. It has become one of the favourite buzzwords of those who do neither research not teaching. The word occurred six times in a recent HR-speak document that was sent to explain the criteria for promotion to a chair. Quite what it means is never clear. Could it just be a talent for telling other people to do things that the leader can’t do himself? (People who describe themselves as leaders are, needless to say, mostly male.) Only too often those who call themselves ‘leaders’ turn out to be suffering from the Siegfried delusion -in the words of Ernest Newman, overgrown boy scouts.
One thing that leadership certainly should include is setting a good example in ethical behaviour. So what’s going wrong?
We’ve seen the case of Howard Newby. We’ve seen vice-chancellors (12 of them) refuse point blank to respond to enquiries about how they justify running degrees in alternative quackery, despite the fact that even the Queen’s Homeopathic physician thinks it is unjustified to run BSc degrees in homeopathy (watch him say so).
We’ve seen the malign influence of corporate money (most strikingly in the UK in the notorious case of the University of Sheffield). We have seen ghost-writing and spin tolerated, and even encouraged, not to mention sham consultations and attempts to impose the Wal-Mart values of PricewaterhouseCooper on research.
Here are two more interesting examples of ‘leadership’.
Professor Sir Roy Anderson
| Next year, the rector of Imperial, Richard Sykes, will be replaced by Roy Anderson, epidemiologist and Chief Scientific Adviser to the UK Ministry of Defence,. Sykes is the chap who (with a little help from my first attempt at a web campaign) failed in his messianic attempt to take over UCL in 2002. |  |
Imperial rector with a past
In June this year, Imperial College London announced that Roy Anderson, a distinguished epidemiologist and former chief scientific adviser to the MoD, would succeed Richard Sykes to become rector next year. An internationally renowned academic and researcher, Anderson is amply qualified for this ambassadorial role in the British scientific establishment. Yet some, including the former director of the Wellcome Trust, Bridget Ogilvie, have remarked to Prospect that parts of the scientific community were “very surprised” at Anderson’s selection in view of the controversies seven years ago that surrounded his professorship at Oxford.
The first scandal arose when Anderson accused a female colleague of having won support for her post via a relationship with her head of department—a claim he was eventually forced to retract as untrue, and which was a major factor in his subsequent resignation from Oxford. At around the same time, Anderson’s resignation from the board of the Wellcome Trust was announced, prompted in part by his failure fully to disclose his relationship with a private biomedical consultancy during his time at Oxford, in breach of the trust’s financial guidelines.
It should, of course, be emphasised that Anderson did nothing illegal; he has always been admired as a dynamic leader, and some feel that the “Oxford scandals” can now be set aside as isolated incidents in an otherwise unblemished career. It will be interesting to see what he makes of his new position.
And this appeared in Nature June 2000. [Download ‘A Question of Trust’] .
But perhaps most damaging was the downfall of Roy Anderson, a leading epidemiologist, and one of the governors who run the trust. Anderson, who also directed the Wellcome Trust Centre for the Epidemiology of Infectious Diseases at Oxford University, was forced to resign from the university, the centre and as a trust governor, following the publication of two damning reports into his management of the Oxford centre. Initially triggered by allegations that Anderson had made sexual slurs against a female colleague chosen for a senior position at Oxford, the investigations went on to examine his failure fully to disclose business interests that had become entangled with the Wellcome centre’s research activities.
There is more comment in Nature 404, 802; 2000 [download pdf] , and “Director of Wellcome centre resigns over damning report” Nature 404, 696; 2000 [download pdf]
A lot of people seem to be quite puzzled by Imperial’s choice of leader.
Sir John Chisholm
| Mild surprise greeted the news that the chairman of the Medical Research Council (MRC), John Chisholm, is also Executive Chairman and former Chief Executive of QinetiQ (the privatised version of the UK Ministry of Defence’s Defence Evaluation and Research Agency). Was this sort of some job creation scheme? The arms merchants providing customers for the health service? |  |
The Parliamentary science and technology committee, certainly had reservations (“New medical research chair unfit for job, say MPs“).
An editorial in the British Medical Journal (March 2007) commented on this unholy mix, thus.
“In a recent editorial in the Journal of the Royal Society of Medicine, Richard Smith drew attention once again to the paradoxical and disturbing association between Reed Elsevier, a huge global publishing company, and the international arms trade.1 While promoting world health through its publications, including the Lancet, Reed Elsevier also organises international trade fairs for the arms industry. By facilitating the sale of armaments, Reed Elsevier is directly implicated in causing untold damage to health.”
In March 2007. Nature commented
“The MRC faces other challenges, too. Last October saw its appointment of a chair, John Chisholm, who has a strong track record in privatizing defence research laboratories. He has recently sent signals that have left MRC researchers dumbfounded. To judge by recent statements, he views biomedical research as being applied research by definition, and sees fundamental research to be all but irrelevant.”
According to a report from the National Audit Office, the Treasury sold off its arms research to the US private equiry group far too cheaply. A handful of directors made staggering personal fortunes from the deal. This interchange occurred in the minutes of evidence to the Committee of Public Accounts (Monday 3 November 2007). The chairman was Edward Leigh (Conservative MP for Gainsborough).
Q18 Chairman: Yes, because you told the Defence Committee on 28 February 2001: “In regard to people who were already in the organisation, certainly when they have proved themselves successful they can expect to earn a reward but they cannot expect to earn it just because we have been privatised”.
What the public think is that it is frankly appalling. It goes totally against any concept of ethical capitalism, Sir John, that you can put £100,000 into a business and emerge with £25 million of taxpayer’s money. Nobody from outside can understand it. Do you have any sense of shame here before us?Sir John Chisholm: I have a considerable sense of having led a team to create £1 billion worth of value for the taxpayer. I think that is a great achievement by the team.
Q19 Chairman: Why should your poor staff get £9 for every pound they put in but you get £200 for every pound that you put in? Do you think that is fair?
Sir John Chisholm: I believe in any deal like this there was a contractual agreement put by the investor to the management team that had considerable risk for the management team at the time and they signed up to it.
. . . .
Q30 Mr Touhig (Lab,Islwyn): You see our concern, because one of the first things that Carlyle did when it became the preferred bidder was to change the planned management incentive scheme following representations from the QinetiQ Board. The outcome of this, as the Chairman has pointed out, was that top management got almost a 20000% increase on the return on their investment. Sir John, that is not so much the unacceptable face of capitalism as the unacceptable face of greed, is it not?
Sir John Chisholm: I do not accept that, no.
So not much concern for “ethical capitalism” there.
Is this what we are meant to learn on the ‘leadership’ courses that are springing up everywhere?
Is this the sort of example to set to young scientists about how to succeed?
Is this how to get good science?
I think not.
Postscript
From Private Eye 26 January 2008.
| NUMBER CRUNCHING £100m. Profits gained by senior executives through QinetiQ privatisation £75m. QinetiQ pension deficit, now being addressed by additional staff contributions. |
The press releases (STOP PRESS)
Uhuh, here we go again.
All over the media we see headlines like “Honey ‘beats cough medicine’ “.
Take for example, the Daily Telegraph, where Ben Farmer writes “Honey is better at treating children’s coughs than an ingredient used in many over-the-counter medicines, according to new research”.
That is NOT what the research found This is what the research paper itself says (DM refers to the standard ‘cough suppressant’ dextromethorphan, which is already known to be ineffective).
| “honey was significantly superior to no treatment for cough frequency’ DM was not better than no treatment for any outcome. Comparison of honey with DM revealed no significant differences.” |
See it? No detectable difference between honey and standard cough medicine.
Everyone in the media misinterpreted what the paper said, but at least one blogger is already on to it, with Today’s “duh” study is a honey”.
At first sight, the results seem contradictory, No difference between honey and DM, No difference between DM and ‘no treatment’. So how can honey be better than ‘no treatment’?
The study was by Ian M. Paul, MD, MSc; Jessica Beiler, MPH; Amyee McMonagle, RN; Michele L. Shaffer, PhD; Laura Duda, MD; Cheston M. Berlin Jr, MD, published in Archives of Pediatrics & Adolescent Medicine 2007, 161, 1140 – 1146.
What was done
The design of this trial was pretty good apart from one thing Three things were compared (a) buckwheat honey, (b) a standard ‘cough suppressant’, dextromethorphan in a honey-flavoured syrup that was designed to be similar to the honey (DM for short), and (c) no treatment whatsoever.
The median age of the children who completed the study was 5.2 years (range, 2.2 – 16.9 years). They all had coughs attributed to upper respiratory tract infection. Thirty-five patients received honey, 33 received DM, and 37 received no treatment.The good thing is that the treatments were allocated randomly to the children, and that the person doing the assessment didn’t know which treatment each child had received. The children didn’t know whether they were getting honey or DM either, but they DID know when they got ‘no treatment’. The trial was carried out over two days. On day one nobody got a treatment, but they filled in a survey that asked, for example, “How frequent was your child’s coughing last night”. The parent had to tick one of seven boxes, from ‘not at all’ (score zero) to ‘extremely’ (score 6). They were then given the treatment allocated to them in a brown paper bag, so the person who gave it didn’t know which it was. The patients then went home and on the next day the same survey was completed by the same parent, over the telephone.
What happened?
First look at the raw data. Here is Figure 2 from the original paper.
The charts show the results for 5 different measures of the severity of cough, and the last chart (F) shows the aggregate score for all the criteria.
The first thing to notice is that there are no error bars on these charts. In my area, at least, no journal would accept a chart like this with no indication of scatter. There is a snag, though. Each patient acts as his/her own control, and that would not be reflected properly if errors bars were calculated for the numbers plotted in Fig. 2. It would therefore have been better to have a chart in which the difference in score between day 1 and day 2 was calculated from each patient, and the size of these differences plotted, with a standard deviation of the mean to indicate the amount of scatter in the observations. I have asked Dr Paul to send me a version that indicates the scatter of the numbers in this way (but I don’t think it will come).
The second thing to notice is that there is there is quite a big difference between the score on the first day (pale columns) and on the second day (dark columns), even in the no treatment group .
Thirdly, the pale columns are all much the same. On the first day the average score was about 4 (“a lot”) though on the second day, even with no treatment, the score fell quite a lot, to something between 2 (“a little”) and 3 (“somewhat”). This is a bit baffling because no treatment was given on either day. Presumably it results from the different settings in which the survey was given, or because the kids were getting better anyway.
Fourthly, insofar as the pale columns (baseline values) are all much the same, the thing you need to concentrate on is the difference, on each chart, between the height of the dark bars, for honey, DM and no treatment. These differences are pretty small, but on all the charts, the honey score is slightly smaller than the DM score, and the DM score is slightly smaller than the ‘no treatment’ score. What are we to make of that?
Here beginneth the statistical lesson.
Because the differences are small, and the scatter is quite big, we have to ask whether the differences are just random fluctuations rather than a result of any real difference between the treatments. That means we need statistics. Here is how the statistical argument works. Put roughly, we ask “how probable is it that the observations could arise by chance”. More precisely, the question is this. If there were no difference between the treatments, what is the probability that we would observe by chance a difference as big as, or bigger than, that seen in the experiment? (You need the subjunctive mood to explain statistics -pity it’s vanishing.)
Above each chart in the Figure we see P < 0.001. This means that there is less than a one in 1000 chance of the results arising by chance. More precisely, if all three treatments (honey, DM and no treatment) were actually identical, it is very unlikely that we’d see these results. The reasonable conclusion is, therefore, that all three treatments are not identical. The problem with this argument is that it tells you nothing about where the differences lie, so it is of no help whatsoever to a patient who is trying to decide what to do about a cough. The other problem is that it includes the ‘no treatment’ group, which was not blind. Both the children and parents were well aware that no treatment was given.
The most helpful comparison is really the properly-blinded comparison between honey and DM. And when this was looked at the result was no significant differences. In other words the small differences between the heights of the dark columns for honey and DM could perfectly well have arisen by chance if honey and DM were identical in their properties.
There isn’t any reason at all to think that honey is better than the standard (but ineffective) cough medicine.
The direct comparison between DM and ‘no treatment’ also shows no significant difference. Yet there are signs of a real difference between ‘no treatment’ and honey, though only for the cough frequency, not the other four measures. The aggregate measure (F in the figure) gave P = 0.04 for the comparison, so the authors are running a risk of 1 in 25 of being wrong in claiming a real effect. Although some people seem to regard a value of P = 0.05 as indicating a real effect, the fact that you’ll make a fool of yourself 1 time in 20 by claiming a real effect when none exists has never seemed to me to be good enough odds to stake one’s reputation on.
The ‘no treatment’ group certainly has some interest, but the fact that it was not blind means that the fact that honey was marginally better than ‘no treatment’ could perfectly well mean that taking honey has a better placebo effect that doing nothing at all. It provides no evidence at all that honey has any genuine therapeutic effect. If it had, one would then have to find out if the therapeutic effect was specific to buckwheat honey, or whether any old honey would do. It could be argued that even if the effect were real rather than placebo, the size of the effect is too small to make all that effort worthwhile.
A couple more things
It is already well known, from several good studies, that DM is useless, no better than placebo. This inconvenient fact has not yet reached many places that it should have (not even mentioned on wikipedia for example), but the American Academy of Pediatrics says
“Numerous prescription and nonprescription medications are currently available for suppression of cough, a common symptom in children. Because adverse effects and overdosage associated with the administration of cough and cold preparations in children have been reported, education of patients and parents about the lack of proven antitussive effects and the potential risks of these products is needed.”
The discussion in the paper by Paul et al, seems surprisingly upbeat about honey, in the light of their own findings. I’m surprised that they use the term ‘demulcent’ which I had thought to have died out, like the word ‘tonic’, on the grounds that it had no defined meaning
It is because meaningless terms and useless medicines die out eventually that medicine makes progress. The problem with alternative medicine is that nothing dies out: on the contrary they keep adding myths.
And finally
Always look at the end of the paper. On this one we see that the study was paid for by the National Honey Board. Dr Paul assures me that the funding source had no say in the design or analysis, which is as it should be.
Financial Disclosure: Dr Paul has been a consultant to the Consumer Healthcare Products Association and McNeil Consumer Healthcare.
Funding/Support: This work was supported by an unrestricted research grant from the National Honey Board, an industry-funded agency of the US Department of Agriculture.
So what is the practical outcome?
My conclusion from all this is simple. If you have got a cough, tough luck. There isn’t really anything available, conventional or alternative, that does much good. You’ll just have to wait for it to get better. But if you want to take something that tastes nice, why not honey? It almost certainly won’t do any good but it tastes good and it’s safer than the standard cough medicine.
The sponsor’s interpretation
It seems that the sponsor of the work is happy with the misinterpretation.
Charlotte Jordan a project manager of research at the National Honey Board, believes the finding confirms what your grandmother told you.
“This is a really exciting finding,” she said. “For a long time it’s been folklore medicine to use honey when you have a cough or a cold, but it’s exciting to have a scientific study to back that up.”
Just one problem, That is NOT what the paper says.
How did all this mis-reporting happen?
One reason is misleading press releases. Universities and Academic journals now engage in shameless PR, spin and hype. They prostitute good science.
Download press releases from Penn State, JAMA and Press Association [pdf file]
Here is the highly misleading bit of hype that came from the Press Office of the Pennsylvania State University. The headline is “Honey a better option for childhood cough than OTCs” (OTC means over-the-counter medicines that contain DM). That contradicts directly the paper which says “Comparison of honey with DM revealed no significant differences”.
Likewise the statement in the Penn State release “Honey did a better job reducing the severity, frequency and bothersome nature of nighttime cough from upper respiratory infection than DM or no treatment” is equally incompatible with “Comparison of honey with DM revealed no significant differences”. Its only possible justification is from the 3 way comparison by analysis of variance and that does not tell us what we need to know.
To make matters worse, the media office is not to blame this time. Ms Manlove told me tonight that the press release had been approved by Dr Paul himself.
| Contact: Megan W. Manlove Penn State Honey a better option for childhood cough than OTCs A new study by a Penn State College of Medicine research team found that honey may offer parents an effective and safe alternative than over the counter children’s cough medicines. The study found that a small dose of buckwheat honey given before bedtime provided better relief of nighttime cough and sleep difficulty in children than no treatment or dextromethorphan (DM), a cough suppressant found in many over-the-counter cold medications. Honey did a better job reducing the severity, frequency and bothersome nature of nighttime cough from upper respiratory infection than DM or no treatment. Honey also showed a positive effect on the sleep quality of both the coughing child and the child’s parents. DM was not significantly better at alleviating symptoms than no treatment. . . . |
All that Candice Yakel, of the Office for Research Protections at Penn State had ro say in the matter was
“Our investigators stand by the conclusions of the study as reported in the Archives of Pediatric and Adolescent Medicine and as characterized in our press release of December 3, 2007.”
And here is the equally misleading bit of hype issued by the Journal of the American Medical Association (Ms Manlove tells me that this was also approved bt Dr Paul).
| JAMA and Archives Journals Study suggests honey may help relieve children’s cough, improve sleep during colds
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The Press Association release was equally bad, and probably the one used by many of the reporters as a basis for stories in the media. The opening statement is totally wrong.
| 1 HEALTH Honey Embargoed to 2100 Monday December 3 HONEY BEST FOR KIDDIES’ COUGHS SAY RESEARCHERS By John von Radowitz, PA Science Correspondent Natural honey is a better remedy for children’s coughs than expensive over-the-counter medicines, researchers said today. A dose of buckwheat honey before bedtime easily outperformed a cough suppressant widely used in commercial treatments, a US study found. . . . |
Follow-up
There is a review of over-the-counter cough medicines in the BMJ (2002) [free full text]. It concludes “Recommendation of over the counter cough medicines to patients is not justified by current evidence”.
Here is an interchange of letters from this week’s BMJ. George Lewith says more money should be spent by the government on research on alternative medicine. Well, only if it is spent properly, and that is not what has happened in the past. (Letters here, if you have a subscription.)
In all probability money spent in this way would be money down the drain, just as it has proved to be in the USA. As pointed out by Wallace I. Sampson, M.D., NCCAM has spent almost a billion dollars on research into alternative medicine, and
“. . it has not proved effectiveness for any “alternative” method. It has added evidence of ineffectiveness of some methods that we knew did not work before NCCAM was formed.”
It is a bottomless pit, and there are more promising ways to spend the money.
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| George T Lewith, Reader in Complementary Medicine, University of Southampton Primary Medical Care, Aldermoor Health Centre, Southampton SO16 5ST Send response to journal: Re: Valuing Research |
I remain unclear about John Garrow and David Colquhoun’s position with respect to “funding CAM”. Are they suggesting that there should be no funding for CAM research or are they suggesting this embargo should apply to the provision of CAM services within the NHS? If the former, how do they justify this position with respect to the many UK taxpayers who use CAM each year and for whom the government has some obligation to provide information? Competing interests: None declared |
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| John S. Garrow, vice-chairman HealthWatch The Dial House, Rickmansworth, WD3 7DQ Send response to journal: Re: Taxpayer funding of CAM research |
Dr Lewith wants clarification of my view about public funding of CAM research. It has changed over the last 7 years. In 2000 the House of Lords Select Committee (HLSC)advised the Department of Health to fund research on acupuncture, chiropractic, herbal medicine, homeopathy and osteopathy to see if these therapies were safe, more effective than placebo and good value for money, At the time I supported this decision. However in 2003 it was disclosed that £1.3m had funded 8 research projects, at the Universities of Leeds, Southampton, Bristol, Brunel, Sheffield and York, but none of these were directly testing the safety, efficacy or value-for- money of the main CAM therapies.[1] I noted that these Universities did not have as good a record of research into the efficacy of CAM as Exeter, which had applied but failed to get funding. It was also noticable that the panel awarding the grants tended to work at the funded Universities. CAM research is not so impoverished as Dr Lewith implies. The onus is now upon the researchers who received £1.3m from the taxpayer, and more from the Foundation for Integrated Health, to tell us what answers they have found to HLSC’s very pertinent questions. Only in the light of these answers can we judge if they deserve further public funding. If initially the Government had an “obligation” to fund CAM research I think the £1.3m discharged it, and now there is an obligation on CAM practitioners to show that they have not misappropriated these funds. [1]Garrow JS et al. UK government funds CAM research. FACT 8:397-402, 2003 Competing interests: None declared |
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| David Colquhoun, Prof of Pharmacology UCL Send response to journal: Re: Funding for alternative medicine research |
I agree entirely with John Garrow’s response. A corollary of his analysis is that, if there is to be any more funding for research in alternative medicine, it is essential that the allocation of the money should not be in the hands of alternative medicine people. The reason for that is that past experience has shown that they will give the money to projects that don’t answer the real questions. If no applications are received that address the proper questions with rigorous experimental design then the money should be clawed back and spent on something that has a better chance of being a real advance. I am perpetually amazed by the reluctance of advocates of alternative medicine to subject their claims to proper tests. The only interpretation that I can see of this failure is that they themselves believe, deep down, that the tests would be failed. I hope that isn’t the explanation though, because if they were convinced that the tests would fail, it would mean that we are dealing with fraud, not just delusion. Competing interests: None declared |
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Thanks to a correspondent for alerting me to a medical emergency in France.
You can read the press release here, from Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS, the French equivalent of the MHRA or FDA).
 Withdrawal of batches of Gingko biloba and Equisetum arvense AFSSAPS has been informed by Laboratoires Boiron of an inversion of the labelling of two homeopathic medicaments, The bottles labelled “mother tincture of Gingko biloba” contain mother tincture of Equisetum arvense and vice versa ;. . . “AFSSAPS has said that this mix-up does not pose any particular risk . . .” . . . “Laboratoires Boiron has asked pharmacists who stock these homeopathic medicaments to report, as far as possible, the inversion of labelling to any doctors in their neighbourhood who may have prescribed these items between May and October 2007.” |
This gem brings to mind the interchange between Lord Broers and Ms Kate Chatfield of the Society of Homeopaths, as recorded in the minutes of evidence to the Select Committee on Science and Technology .
Q538 Lord Broers: I have a simple, technical question about homeopathy and drugs. Is it possible to distinguish between homeopathic drugs after they have been diluted? Is there any means of distinguishing one from the other?
Ms Chatfield: Only by the label.
You can read a lovely analysis of the views of Kate Chatfield here. She works at the University of Central Lancashire, where she is module leader for what the university, disgracefully, calls a “Bachelor of Science Degree” in Homeopathic Medicine. That is the university that refuses to reveal to the public what it is that they are teaching in these courses. I’m still waiting for the result of my appeal to the Information Commisioner: watch this space.
In contrast, Mike Eslea’s pages on pseudoscience are also from the University of Central Lancashire. They are very well worth reading.
Tnanks to the Breath Spa blog for drawing attention to the Broers – Chatfield interchange, in an excellent posting: ” Discouraging News from the Review of Allergy and Intolerance: Homeopathy Means We Need to Rewrite Textbooks”.
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 “
The Involve organisation sent a reporter to one of the public meetings, and commented thus.
“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 ).
They say
“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.
The conversation
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
| 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. |
| 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: 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. |
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.
The Corporate Corruption of Higher Education: part 1
The next post is about examples from the UK.
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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.
Washburn comments
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
its founding
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.
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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.
A Russian translation (draft version) has appeared here . There is also a Russian translation of How to Get Good Science which can be found here.
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
“Note 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€, “formative 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.