Download Lectures on Biostatistics (1971). Corrected and searchable version of Google books edition
Download review of Lectures on Biostatistics (THES, 1973).
Universities
This is the third post based on a recent trip to North America (here are the first and second)
One aspect of the endarkenment, the Wal-Mart model of a university, is very much the same in the US as in the UK. At one US university, an excellent scientist offered the theory that an alien spacecraft had scattered spores across the land which developed into HR staff who appeared at first sight to be human, and who colonised academia.
The penetration of quackademics into US universities is a bit different from in the UK.
In the UK, the plague is restricted to sixteen or so ex-polytechnic universities which, to their great shame, actually offer Bachelor of Science degress in subjects like homeopathy. There are bits of quackery in good teaching hospitals (such as laying-on-of-hands at UCLH), but not very much.
In the USA and Canada, this sort of “vocational” training does not occur much in universities, but in separate colleges. The situation is worse there though, insofar as these colleges have been allowed to award titles like ‘doctor of naturopathic medicine (ND)’, for work that in no respect compares with what the rest of the world has to do to earn a doctorate. This prostitution of academic titles has not happened to anything like the same extent in the UK. How our own quacks would love it if they were allowed to call themselves ‘doctor’ and sport the initials ND (so easily mistaken for MD at first sight).
It is on the clinical side where the situation is far worse than in the UK. Almost every university hospital, including Harvard, Yale and Stanford, has departments devoted to fairy-tale medicine.
Quacks use a number of euphemisms to make themselves sound more respectable. First they became ‘alternative medicine’, then ‘complementary medicine’. Now the most-used euphemism is ‘integrative medicine’, which is favoured by most US universities (as well as by the Prince of Wales). Raymond Tallis pointed out that this seems to mean integration of treatments that don’t work with treatments that do work.
An official roll of shame for North American universities can be seen here (35 in USA and 4 in Canada). 
A bigger collection of 44 universities has been posted by the incomparable Orac at the The Academic Woo Aggregator. He’s had good support in the USA from DrRW (R.W. Donnell), see particularly his articles on How did pseudoscience get admitted to medical school? and What is happening to our medical schools? Abraham Flexner is turning over in his grave.
All these outfits have two things in common. They all claim to be scientific and evidence-based, and none has produced any real evidence that any of their treatments work.
Here are a few examples of what’s going on.
Yale University School of Medicine
The usual theme is expressed thus.
“Through open-minded exploration and rigorous scientific inquiry, we aim to improve awareness and access to the best in evidence-based, comprehensive medical care available worldwide, with the goal of optimizing health and healing for patients”
The driving force behind the woo seems to be a fourth year medical student, Rachel Friedman, so I wrote to her to ask what useful alternative treatments had been established by research at Yale. But she could not identify any. All I got was this.
“My best advice would be to do some medline searching of metaanalyses” there’s been enough research into some of these modalities to provide for a metaanalysis.”
So she was unable to produce nothing (and anyway. metanalyses, useful though they may be, are not research).. A glance at the Yale publications page shows why.
The Scripps Institute
Scripps Center for Integrative Medicine says
“In use at Scripps since 1993, Healing Touch is an energy-based, non-invasive treatment that restores and balances energy to help decrease pain and relieve associated anxiety.
Healing Touch is performed by registered nurses who recognize, manipulate and balance the electromagnetic fields surrounding the human body, thereby promoting healing and the well-being of body, mind and spirit.”
“Balances energy”?
“manipulate and balance the electromagnetic fields surrounding the human body”?
This is just meaningless baloney. And it come from the Scripps Institute.
The Oregon Health & Science University
OHSU is an excellent and well-respected research university where I have many friends. It was a pleasure to meet them recently.
But it also has a big department of “Complementary and alternative medicine” and an “Integrated medicine service”. There are some good bits of advice mixed up with a whole range of crazy stuff. Take their page on homeopathy.
“This therapy treats ailments with very small amounts of the same substance that causes the patient’s symptoms.”
WRONG. In most cases it is zero amount. To brush this fact under the carpet is simply dishonest (and perhaps a sign of guilt). Then comes this (my emphasis)..
Explanations for why homeopathy works range from the idea that homeopathic medicine stimulates the body’s own natural defenses to the idea that homeopathic medicine retains a “memory” of the original substance.
However, there is no factual explanation for why homeopathy works and more research is needed.”
WRONG. This statement carries (twice) the expicit message that homeopathy does work, quite contrary to a mountain of good evidence that it is merely a placebo. The statement is deceptive and dishonest. And it comes with the OHSU logo.
The University of Arizona
” Heal medicine”, “Transform the world?” Modest uh?
The University of Arizona Program in Integrative Medicine is certainly not modest in its claims, but its publications page shows that it doesn’t even attempt to find out if its “therapies” actually work.
Here is an example. They are advertising their Nutrition and Health conference
heavily.
There’s nothing wrong with good nutrition of course, but the ‘alternative’ approach is instantly revealed by the heavy reliance on the great antioxidant myth.
And look at the sponsors. The logo at the top is for Pistachio Health, a company that promotes pistachio nuts: “Delicious and good-for-you, pistachios are nature’s super heart-healthy snack. Nutrient dense, full of fiber and antioxidants, pistachios give you more bang per calories than any other nut.”.
The other advertisement is ‘POM Wonderful’, a company that sells and promotes pomegranate juice, “POM is the only pomegranate juice you can trust for real pomegranate health benefits”
No doubt pistachio nuts and pomegranate juice are perfectly good foods. But the health claims made for them are just marketing and have very little basis in fact.
Now let’s look at the speakers. Take, for example, Dr David Heber, MD., PhD. He is director of the UCLA Center for Human Nutrition at the University of California, Los Angeles, a professor of Medicine and Public Health, and the founding Chief of the Division of Clinical Nutrition in the Department of Medicine. He is the author of several books including “What Color is Your Diet” and the “L.A. Shape Diet.” With the possible exception of the books, you can’t sound like a more respectable and impartial source of advice than that.
But hang on. Dr Heber is to be seen in a video on the Pistachio Health web site doing what amounts to a commercial for pistachio nuts.
OK let’s take a look at one of Dr Heber’s papers. Here’s one about, guess what, pomegranate juice. “Pomegranate Juice Ellagitannin Metabolites Are Present in Human Plasma and Some Persist in Urine for Up to 48 Hours”. The work was “Supported by the Stewart and Lynda Resnick Revocable Trust and from the NIH/NCI grant P50AT00151”. So no problems there. Well not until you check POM Wonderful in Wikipedia, where you find out that Stewart and Lynda Resnick just happen to be founders of POM.
Of course none of these interesting facts proves that there is anything wrong with the work. But they certainly do show that the alternative nutrition business is at least as much hand-in-glove with big business as any other form of medicine. And we know the problems that that has caused.
So, if you want impartial advice on nutrition, sign up for the 6th Annual Nutrition and Health meeting. For “MD, DO, ND & other doctors”, it will cost you only $845 to register .
The meeting is being run by The University of Arizona College of Medicine and Columbia University’s College of Physicians and Surgeons.
The University of Arizona is, incidentally, also the home of the famous (or perhaps infamous) Gary Schwartz (see also, here). He “photographs” non-existent “energy fields” and claims to be able to communicate with the dead, and he is director of its Human Energy Systems Laboratory at the University of Arizona. He is also head of the inappropriately-named Veritas Research Program and “Centre for Frontier Medicine in Biofield Science”. All of these activities make homeopathy look sane, but he is nevertheless part of an otherwise respectable university. In fact he is He is Gary E. Schwartz, Ph.D. is professor of psychology, medicine, neurology, psychiatry and surgery at the University of Arizona. Even more incredibly, this gets NIH funding.
Columbia University, along with Cornell, also has its own “Complementary, alternative, and integrative medicine“, defined as “the use of treatments, such as homeopathic medicine, ayurveda, botanical dietary supplements”. And their “Integrative Therapies Program for Children” is intimately tied up with a company called Origins, which is more a cosmetics company, Origins” (with all the mendacity that implies). They say
“Origins understands the importance of addressing wellness through an integrative approach,” says Daria Myers, President of Origins Natural Resources. “With our recent Dr. Andrew Weil collaboration, Origins demonstrated its support for the integrative wellness concept. Now, with the introduction of the new Nourishing oil for body and massage, we hope to bring not only a moment of comfort but also a healthy future to children enduring the fight of their life.”
Andrew Weil is, of course, the promoter of the Arizona meeting.
The corruption of Universities by this sort of activity is truly amazing.
Thursday 24 Jan.
One of the original reasons for going to North America was an invitation from the Toronto Secular Alliance and Center for Inquiry. The talk for them was given a lot of publicity, for example here and here and from the totally admirable Orac.
Toronto seems to be no worse than anywhere else when it comes to delusional thinking about medicine. It is, of course, the home of Ryerson University, the place that produced one of the most outrageous pieces of postmodernist nonsense on record. But when this sort of thing gets into really good universities, it is more worrying.
As a result of the publicity there was some media coverage (and a record 7109 hits on this site on Sunday).
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Friday 25th January, Reception and talk: Center for Inquiry. Science in an Age of Endarkenment: Some Examples from Scientific Fraud, Quackery, Religion and University Politics |
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The interview was broadcast on Sunday morning (28 Jan) and elicited a lot of correspondence. CBC made it available as a podcast which can be downloaded from CBC here. The endarkenment interview was the last 22 minutes (out of 64 minutes) [play the interview here (mp3, 20 Mb)]. |
Sunday Edition: the follow-upThe week following this CBC show, the backlash started. The Sunday Edition wrote
“A stirred-up hornet’s nest is a mild disturbance compared to the firestorm we unleashed last week over my conversation with Dr. David Colquhoun. Dr. Colquhuon [sic] is a gangly, pipe-puffing British pharmacologist who thinks all alternative medicine, all of it, is a fraud perpetrated by quacks. But he went further, somehow suggesting that those who believe in it probably supported Margaret Thatcher, Ronald Reagan and the Ayatollah Khomeini. He pooh-poohed acupuncture, chiropractic, homeopathy, even vitamins.
Well, his remarks opened the floodgates of listener mail, screaming for Dr. Colquhoun’s head on a pike. In a few moments, alternative or complimentary [sic] medicine strikes back. With the help of two experts, we will try to give the other side of contentious Colquhounism.”
The programme for 3 Feb 2008 started with a few emails from listeners, mainly of the “homeopathy cured my granny” type. Nothing of much significance there. But then Enright interviewed Dugald Seely of the Canadian College of Naturopathic Medicine and Dr. Kien Trinh of the DeGroote School of medicine at McMaster University in Hamilton. You can download the podcast here.
The flat earth problem.
Michael Enright was a good interviewer, but Sunday Edition suffers, like the BBC, from a problem. It is admirable that CBC, like the BBC, should strive to be ‘fair and balanced’, but it is not always easy to see what that means in practice. Is it fair and balanced to give equal time to people who think that the earth is flat and those who think it is spherical (OK, an oblate ellipsoid)? Perhaps, but it also
quite misleading because it can easily convey a very distorted idea of the balance of informed opinion. In this case the flat-earthers are the homeopaths and other alternative medicine advocates. That would not matter so much if the interviewers had enough knowledge of the subject to pin down the falt-earth advocates with the sort of penetrating questions that people like John Humphrys (of the BBC’s Today programme) are so very good at. When it comes to science, though, the flat-earthers tend to get away with murder, and the public can easily be left with a very distorted view. Which “expert” should they believe? If I had been given the option, I would have loved to debate the problems of alternative medicine directly with Trinh and Seely I could have asked then a few questions that Enright missed.
Let’s take a look at what happened at the follow-up.
Quackery at McMaster University
McMaster is one of many universities in North America that has chosen to betray the intellectual tradition of the enlightenment by buying into superstition (see the roll of shame here). The ‘contemporary medical acupuncture program appears to run under the aegis of the anaesthesia
department, though the fact that is doen’t appear on the department’s front page suggests there may be some embarrassment about it. The medical acupuncture program itself, has separate web pages which don’t seem to be on the McMaster server at all (they are on a private server, ThePlanet.com Internet Services, Inc.
As so often, these pages pay lip service to an ‘evidence based’ or ‘scientific’ approach, while doing nothing of the sort. In his CBC interview Kien Trinh agreed (twice) with my contention that trials had shown that it doesn’t matter where you put the needles. But then he failed totally to draw the obvious conclusion that ‘meridians’ are mumbo jumbo. He went right on taking the conventional mystical view of meridians and “energy” flow. Like most proponents of alternative medicine, Trinh seems to live in some sort of parallel universe in which the normal rules of logic don’t apply.
On wouldn’t expect regular anaesthetists to accept this sort of mystical nonsense, but it seems one would be wrong. When I wrote to the Chair of the Department of Anesthesia, at McMaster to ask about their relationship with acupuncturists there was no hint of embarrassement. Dr Norman Buckley, BA (Psych), MD, FRCPC, wrote
“It operates under the principles of evidence based medicine, and relates the concepts raised by the Acupuncture/traditional Chinese medicine to physiology anatomy et as it is more usually taught in Western schools.”
That would be all very well if it were true, but it simply isn’t true. The evidence just isn’t there, and the departments involved make no serious attempts to get evidence. In a later letter, Dr Buckley seems to acknowledge that it may be all placebo, but seems reluctant to offend anyone by saying so. That, I suspect, is how quackery has gained such a foothold.
It is good to keep an open mind, but if it is too open your brains fall out. Or, in another variant, if it is too open, someone will fill it with trash.
One looks in vain on Trinh’s web site for any good evidence. They quote approvingly the conclusion of a 1997 NIH Consensus statement that says “There is sufficient evidence of acupuncture’s value to expand its use into conventional medicine and to encourage further studies of its physiology and clinical value.”, but forget to mention that this document is headed “This statement is more than five years old and is provided solely for historical purposes.”. The department doesn’t seem to do much original research, just to write endless reviews of other peoples’ work. The reviews aren’t too bad, and mostly they come to the right conclusion, that there is not enough evidence to come to firm conclusions. The difference from science is that this doesn’t dent their confidence for a moment. A typical sort of conclusion seems to be
Elbow pain. A review by Green et al. concluded “needle acupuncture [is] of short-term benefit with respect to pain, but this finding [is] based on the results of two small trials, the results of which [are] not able to be combined in metaanalysis.”
The results of thousands of years experience with acupuncture seem to be pretty pathetic so far..
Quackery at the Canadian College of Naturopathic Medicine (CCNM)
Unlike McMaster, CCNM isn’t a proper university, though nonetheless is hands out ‘doctorates’. Dugald Seely’s contribution was interesting insofar as he admitted that there was a lot of fraud and unjustified claims in the alternative medicine industry (never forget there are megabucks involved). What he didn’t explain was how he himself could be distinguished from the frauds. The problem, as always is the second-rate research that goes on in this area.
Take one of Seely’s papers, Adaptogenic Potential of a Polyherbal Natural Health Product: Report
on a Longitudinal Clinical Trial. Is only too typical: a small non-randomised, open-label (not blind) “trial” of a complex herbal mixture on 17 patients. The conclusion was, as it almost always is,
“Further research using a randomized controlled design is necessary to confirm the findings from this pilot study.”
In other words, no conclusion at all. Why is it that the proper trial never seems to appear? Could it be that naturopaths, and the wealthy industry behind them, are afraid to do proper trials? That is certainly the impression they give.
One way in which the alternative medicine industry operates is to invent new words with ill-defined meanings (and Big Pharma does it too). In case you were wondering about the word “adaptogen” it is defined as “Essentially the adaptogen supports the body’s ability to ‘adapt’ ideally to its environment. Essentially the adaptogen supports the body’s ability to ‘adapt’ ideally to its environment. ”
Whatever that means.
The Canadian College of Naturopathic Medicine offers the following “therapies”.
- acupuncture/Asian medicine
- botanical medicine
- physical medicine (massage, hydrotherapy, etc.)
- clinical nutrition
- homeopathic medicine
- lifestyle counseling
Well, nothing wrong with nutrition and lifestyle counseling as long as the claims aren’t exaggerated. But, as always, the claims that are made are vastly exaggerated. For example they claim
Homeopathic remedies are particularly effective for:
- depression
- anxiety
- allergies
- infections
- gynecological concerns
- skin conditions
- digestive problems
- chronic and acute conditions including colds and flu
These claims are simply not true, in my view. If you don’t believe me, check NELCAM (the NHS Complementary and Alternative Medicine Specialist Library). This is written by advocates of alternative medicine, yet it finds no convincing evidence for effectiveness of homeopathy in any of the conditions listed above.
Or, even more remarkably, from a report in Newsweek.
“Dr. Jack Killen, acting deputy director of the National Center for Complementary and Alternative Medicine, says homeopathy “goes beyond current understanding of chemistry and physics.” He adds: “There is, to my knowledge, no condition for which homeopathy has been proven to be an effective treatment.”
The National Center for Complementary and Alternative Medicine (NCCAM) has, incidentally, spent almost one billion US$ billion of US taxpayers’ money and has come up with next-to-nothing useful.
So the claims made by the Canadian College of Naturopathic Medicine are not backed up even by people who are directly involved in alternative medicine You don’t have to be a rocket scientist to understand that the medicine contains no medicine.
| “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.
As I have often said, you don’t need to be a scientist to see that most alternative medicine is bunk, though it is bunk that is supported and propagated by an enormously wealthy industry..
There were two good examples this week, John Sutherland, who was until recently professor of English literature at UCL, understands it very well. And so does political columnist, Polly Toynbee.
“Complementary and Natural Healthcare Council”
Polly Toynbee’s column, “Quackery and superstition – available soon on the NHS“, was prompted by the announcement in The Times that the government was to set up a “Natural Healthcare Council”. It was soon renamed the “Complementary and Natural Healthcare Council” (CNHC) It was instantly dubbed ‘OfQuack’ in an admirable analysis by quackometer.a>
The very name is tendentious and offensive to any thinking person. What is “natural” about sticking needles in yourself, or taking homeopathic polonium?
Toynbee comments
“Put not your trust in princes, especially not princes who talk to plants. But that’s what the government has decided to do. The Department of Health has funded the Prince of Wales Foundation for Integrated Healthcare to set up the Natural Healthcare Council to regulate 12 alternative therapies, such as aromatherapy, reflexology and homeopathy. Modelled on the General Medical Council, it has the power to strike therapists off for malpractice.”
There was only one thing wrong in this article. Toynbee says
“The alternative lobby replies that conventional medicine can also do more harm than good. They chortle with glee at an article in the Lancet suggesting there is no scientific evidence for the efficacy of 46% of conventional NHS treatments. But that’s no reason to encourage more of it.”
Professor John Garrow has pointed out (see, also Healthwatch )
“It is true they chortle, but they have got their facts wrong. The 46% of treatments which are not proven to be effective is 46% of all treatments for 240 common conditions – and very few are used in the NHS. The great majority are treatments used by alternative practitioners. “
The unconstitutional interference by the Prince of Wales in public affairs has been noted often before, and it seems that it’s happening again.
For example, there is the TV programme, “Charles, the Meddling Prince”, or, for a US view, see “Homeopathy: Holmes, Hogwarts, and the Prince of Wales“. And then there’s Michael Baum’s superb “An open letter to the Prince of Wales: with respect, your highness, you’ve got it wrong“.
It isn’t that regulation isn’t needed, but that the sort of regulation being proposed won’t do the trick. The framework for the “Natural Healthcare Council” has been set up by Professor Dame Joan Higgins, and it seems to be very much along the lines proposed by the Prince of Wales. Here’s what’s wrong.
| Professor Dame Joan Higgins (Jan 10th) says “Complementary therapists have been in practice for many years” and “If complementary therapy is not to be banned, is it not, therefore, wise to regulate it and offer the public some measure of protection”. That’s fine, but I think the sort of regulation that she, and the Prince of Wales, are proposing won’t do the trick. We don’t need new laws, or new quangos, just the even-handed application of existing laws. Homeopathic arnica 30C contains no arnica, and one would expect that the Office of Fair Trading would have banned it. It is no different from selling strawberry jam that contains no strawberries. But absurd legal loopholes make homeopaths immune to prosecution for this obvious mislabeling, whereas jam fraudsters would be in deep trouble. The Advertising Standards Authority, likewise, is prevented from doing its job by legal loopholes, and by the fact that it has no jurisdiction over web advertising, which is now the main source of untrue claims. If alternative medicine advocates had to obey the same laws as the rest of us, the public would be better protected from fraud and delusion. What won’t work is to insist that homeopaths are “properly trained”. If one takes the view that medicines that contain no medicine can’t work, then years of being trained to say that they do work, and years spent memorizing the early 19th century mumbo-jumbo of homeopathy, does not protect the public, it imperils them. |
The “Natural Healthcare Council” isn’t the only example either. Try Skills for Health.
Skills for Health
This appears to be a vast bureaucratic enterprise devoted to HR-style box-ticking. Just in case you don’t know about this latest bit of HR jargon, there is a flash movie that explains all.
“Competences are descriptors of the performance criteria, knowledge and understanding that are required to undertake work activities. They describe what individuals need to do, and to know, to carry out the activity -regardless of who performs it.”
That sounds OK until you realise that no attention whatsoever is paid to the little problem of whether the “knowledge and understanding” are pure gobbledygook or not. It’s rather like the HR form that ensures UCLH that you are a fully-qualified spiritual healer “Laying on of hands: just tick the box“.
It is an invidious insult to human intelligence to suppose that exercises like this are an appropriate way to select people for jobs. They have precisely the opposite effect to that intended.
An indication of the level of their critical thinking is provided what is written about the 62 items listed under “Complementary Medicine” These include “CHH5 Provide Healing”.
“This workforce competence is applicable to:
- healing in the presence of the client
- distant healing in contact with the client
- distant healing not in contact with the client
Both healing in the presence of the client and distant healing use exactly the same mental and spiritual processes. Clearly, however, distant healing does not involve many of the physical aspects of healing in the presence of the client. The performance criteria have been written so as to be able to be interpreted for use in any healing situation.
The workforce competence links to CHH6 which is about evaluating the effectiveness of the healing.”
It also includes homeopathy, for example “HM_2: Plan, prescribe and review homeopathic treatment“.
I sent an email to Skills for Health to ask who wrote this stuff. A reply from their Technical Development Director failed to elicit any names.
| We develop competences to fit sector needs and demands. When that need is moved into a competence project we establish a number of groups from the specific area to work with us to develop the competences. One of these groups is a “reference” group which is made up of experts from the field. In effect these experts give us the content of the competences, we write them in our format. So I guess the answer as to who is the author is Skills For Health, but with more complexity behind statement.Please do not hesitate to get in touch with me for further clarity. |
A conversation with Skills for Health
I did want more clarity, so I phoned Skills for Health. Here are some extracts from what I was told.
“It’s not quite as simple as that”
“the competencies on our data base are written by “experts in the field”
DC. Yes and it is their names that I was asking for
“I’m not sure I can give you the names . . . We’re starting to review them in the New Year. Those competencies are around six years old. ”
“We are working with the Prince’s Foundation for Integrated Health [FIH] via Ian Cambray-Smith to review these competencies, all the complementary therapy competences on our web site”
“They are written as a consensus decision across a wide number of stakeholders across that area of …”
DC. Written by whom though?
“written by a member of Skills for Health staff or a contractor that we employ simply to write them, and the writing is a collation of information rather than their original thoughts, if you like”
DC yes, I still think the sources can and should be given.
“FIH didn’t spend any money with us on this project. This project was funded by the Education act regulatory bodies, QCA, the Qualifications and Curriculum Authority . . . ”
“They [FIH] may well have put in and supported members of their professions or groups to do part of this . . they were there as experts on that particular area of complementary therapy ”
DC it’s their names that I was after
“There may well have been members [of FIH] on the reference groups that I’ve referreed to who are members of the FiH . . .they were there as experts from that area of complementary therapies.”
DC Oh, and are the names of [the people on] these reference groups published?
“No they are not published”
DC ah, why not?
“We do not consider it necessary”
DC Well, I consider it very necessary myself
“Tell me why”
DC It’s a question of public accountability
“I guess the accountability lies with us as the owners of those competencies”
DC Uh I’m afraid your bureaucratic jargon is a bit much for me there. “The owners of those competencies”? I’m not sure what that means
“Why do you want the information?”
DC haha, well if you want me to be entirely blunt, it’s because I’m appalled that this black magic is appearing on a government web site
“. . . can I say that as an organisation funded by a number of sources, one being Department of Health England, none of our work condones the practice you’ve just suggested. Our work supports best practice in areas that are evidence- and research-based”
DC Ah would you mind pointing me to the evidence for homeopathy and distant healing?
“Uh [pause] there is [pause]”
DC Yes, go on
“Well homeopathy is a contentious issue, because every newspaper article I read seems to suggest that homeopathy, in itself, is not an appropriate, uh, not an, uhm, appropriate, uh, therapy.”
DC Yes so why are you laying down standards in it?. You know I’m curious. I’m genuinely curious about this
“The areas involved in them have asked us to, including the Prince’s Trust hence the reason we are doing . . .”
DC But the Prince’s Trust is not part of government. Ha, it behaves as though it was , I agree, sometimes but it is surely for the Department of Health to ask you to do these things, not the Prince of Wales.
“We cover the whole health sector.. We don’t purely work for, or are an organisation of, the Department of Health.”
DC. I’m very baffled by the fact that you say, you very accurately the research on homeopathy, namely that it doesn’t work, but you are still setting standards for it. It’s quite baffling to me.
“Working with the Foundation for Integrated Health, as we are doing, homeopathy is one of the 10 areas that is listed for regulation by FIH ”
DC. Well yes the Prince of Wales would like that. His views on medicine are well known, and they are nothing if not bizarre. Haha are you going to have competencies in talking to trees perhaps?
“You’d have to talk to LANTRA, the land-based organisation for that.”
DC. I’m sorry, I have to talk to whom?
“LANTRA which is the sector council for the land-based industries uh, sector, not with us sorry . . . areas such as horticulture etc.”
DC. We are talking about medicine aren’t we? Not horticulture.
“You just gave me an example of talking to trees, that’s outside our remit ”
After explaining that talking to trees was a joke, the conversation continued
DC So can I clarify then? Who is it that said you must include these fairly bizarre things like distance healing and homeopathy? Who decides whether it goes in?
“We did”
“We are going to do a major review. We are doing that review in partnership with the FiH and the awarding bodies that award the qualifications that are developed from these competencies”
“When that need is moved into a competence project we establish a number of groups from the specific area to work with us to develop the competences. One of these groups is a “reference” group which is made up of experts from the field. In effect these experts give us the content of the competences, we write them in our format.”
Conclusions from this dialogue
We still don’t know the names of the people who wrote the stuff, but a Freedom of Information Act request has been submitted to find out
The Skills for Health spokesperson seems to a a bit short of a sense of humour when it comes to talking to trees.
The statement that “Our work supports best practice in areas that are evidence- and research-based” is not true, and when pressed the spokesperson more or less admitted as much.
Most importantly, though, we do now know that the revision of this gobbledygook will be carried out entirely by the Prince’s Foundation for Integrated Health and the people who set exams in the relevant form of gobbledygook. No critical voice will have an input, so don’t expect much improvement. “We are working with the Prince’s Foundation for Integrated Health [FIH] via Ian Cambray-Smith to review these competencies”. And in case you don’t know about the medical expertise of Ian Cambray-Smith, it is described on the FIH web site. He is the FIH’s Health Professionals Manager.
 |
Ian Cambray-Smith acts as the focus for FIH’s involvement with healthcare professionals. He works collaboratively to develop a range of work programmes, policies and initiatives to support healthcare professionals and help them to deliver a truly integrated approach to health. Ian’s background is in plastics research, project management and business development; he has an MSc in polymer technology. He joined the Foundation in 2006. |
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 Times Higher Education Supplement (THES) last week had a headline “Staff loyalty key to Hefce report”.
Staff loyalty is something I’m interested in, so I read on eagerly.
The article was about report from the Higher Education Funding Council for England (HEFCE). It came from their Leadership, Governance and Management Strategic Advisory Committee (dated 2-3 July 2007). [Download the report: Word format]
Well there is the first cringe already. Whenever you see the word ‘leadership’ you can bet that it means that you are going to be lectured on how to do your job by somebody who has never done it themselves. (probably somebody suffering from Siegfried delusions -in the words of Ernest Newman. an overgrown boy scout).
| No disappointment on that score. This particular sermon is being delivered not by a successful researcher. Not even by an unsuccessful researcher who has been moved up to manage the successful ones. It is being given by Ed Smith, Global Chief Operating Officer and Strategy Leader for Assurance, PricewaterhouseCoopers. |  |
Their web site says of Ed Smith:
“He is a leading advocate of, and external speaker on People management in organisations, in particular diversity and work/life having led PwC’s own enlightenment in this area “
“PwC’s own enlightenment” ? Cringe!. Who writes this stuff, one wonders,
Here are the main points.
“3. There are high level activities to be undertaken of reconceptualising the university and rethinking the business model.”
Reconceptualise? Is it a condition of essential condition of working for PricewaterhouseCoopers to be unable to write plain English?
More to the point, one would be interested to know what concept of a university he has in mind? The statement as it stands has roughly zero content.
“4. To implement the outcome of this rethinking, there will need to be significant culture change. HEIs’ staff will need to be more aware of and aligned to the strategic needs of the HEI.
Academics’ goals are often related to their discipline rather than their institution and they will need to develop institutional loyalties in addition to discipline loyalties. Corporate planning processes will need to be communicated more effectively for those processes to be more successful. “
This statement fails to make the important distinction between the Institution itself, and the people who, for the time being, are running it (see Letters). The first thought that comes to mind after reading this is that it is a statement that is likely to have exactly the opposite effect from that intended by the writer. The more statements like this that come from on high, the less inclined people are to feel allegiance to the institution that issues them, or, to be more precise, the people who are running the institution for the time being.
Respect has to be earned.
“5. HE staff can find themselves uncertain about their role, typically
because it has never been fully made clear. Research has often become too prominent as an indicator of performance, because it has been measured in the RAE, and other activity has not been equally recognised and rewarded. “
Aha, now does that mean that our role is not to do research and teaching after all? Perhaps it has now been redefined somehow? Perhaps our role now is to waste time on sham consultations, read reams of world-class policy bollocks, and do what one is told by some official in HR? I don’t think so. The second sentence has some justice, but I guess Mr Smith has not had to suffer floods of contradictory instructions from the endlessly-multiplying ‘managers’.
One day a ‘manager’ says we must all publish three papers a year, and they must all be in the same handful of journals (though there has not, as far as I know, been
the sort of crude bullying about this at UCL that I have heard about in, say Imperial and a few other places). Furthermore we mustn’t collaborate with anyone in the same place because the same paper must not appear to the RAE to come from two groups.
The next day we will be told that the entire place must be turned upside down because of the absolute necessity for collaborations. Of course the measures that are proposed never have the slightest effect on collaboration, because they come from people who talk about it, not from people who do it.
And the next day we are told by a third person that all of the above is secondary and that teaching matters more than anything else.
Of course all these contradictory instructions do nothing but prevent us doing the research and teaching that we had supposed to be our job.
“7. HEIs will need to develop their business process and become more efficient, so that they can re-invest. The Committee advises that HEIs should not be afraid of the language and culture of business. “
The language of business, at least of the sort that now permeates universities, is usually both vacuous and pretentious. The culture of business is what produces BSc degrees in anti-science (not to mention accounting scandals).
The use of the word “afraid” in this context is sheer overweening arrogance. I have spent a lifetime trying to express complicated ideas in simple language. That seems to me to be as desirable in real science as it is in my attempts to improve public understanding of science. The aim of managers seems often to be to express
simple ideas in complicated language. I’m never quite sure whether the reason for this is illiteracy. or a conscious effort to disguise the emptiness of the ideas. A bit of both, I expect.
What do we conclude from this?
The interesting thing about this document is that it is written by a businessman but appears to me to ignore two basic business principles that can be put in perfectly simple language.
(1) Supply and demand. There will always be an endless supply of managers and pensioned-off researchers who are willing to accept professorial salaries for producing reams of policy bollocks. There isn’t even much shortage of people who can do a tolerable job of teaching at least at first or second year level. The really scarce people are the top flight original researchers, the ones who will make a difference to the future. It follows that these people have enormous power (though often they are too busy to use it). If the place that they works adopts the culture of managerialism, they will just leave Highly original minds have a low tolerance for policy bollocks. Of course this is a slow process. It might take a decade or more to destroy a good research outfit in this way, and by the time managers notice the consequences of their actions it would already be too late. It is much easier to destroy than to build.
(2) The value of brand names . This is where it gets personal, though I imagine many other people have had similar experiences in recent years. The Pharmacology Department at UCL has had a distinguished history for 100 years. I can’t count the number of times that I’ve been at meetings and heard people say “gosh you are from Pharmacology at UCL -that’s impressive”. People in the department got a glow from comments like that. That is what generated loyalty to the department and to the College that houses it. Now we are told that we are to be part of an over sized monstrosity called the “Research department of Neuroscience, Physiology and Pharmacology”. That really trips off the tongue, right? One can’t imagine something with an utterly unmemorable name like that ever getting an international reputation. In any case, I expect that another policy wonk will come along and change the name again in 5 year’s time,
How does this sort of vandalism happen? I guess one reason is that the sort of people who get to be managers just aren’t sufficiently in contact with science to be aware of the reputation that we used to have. They seem to be unaware that the reputation of an institution is no more than the sum of the reputations of the researchers and teachers who work in it (not the administrators). And if a department has a few good people in it over a long period, the department as a whole contributes too. The College reputation barely exists in isolation, just the sume of individuals. Take an example. At UCL we have an excellent department of German, a department that contributes to the reputation of UCL. But of course not one pharmacologist in a million has heard of it, just as I imagine not one German historian in a million has heard of our (late) pharmacology department.
Let’s get a few things clear.
- The job of universities is to do teaching and research.
- The teaching is enormously important but the external reputation of the establishment will inevitably depend almost entirely on its research.
- The success of the place therefore depends entirely on the people who do the research and teaching. Everybody else, from junior technician to vice chancellor is there only to support them.
- The people who do the research and teaching are the only ones who know how to make a success of those jobs The HR department, for example, know nothing about either either teaching or research. How could they? They have never done either. Their job is to make sure people get paid, not to bully and harass the people doing the real work of the university.
- The aims of business are, in some ways, precisely the opposite of those of universities. Business aims to sell things. Spin and mendacious advertising are an accepted part of the game. The tendency for them to become part of the game in universities too can do nothing but harm. Are universities mean to admire the mentality that gave rise to Enron and Worldcom?
- Remember the words of Robert May (President of the Royal Society, 2000 – 2005).
“A rather different issue that has emerged during the Blair decade is the tendency to invite people from the world of business to advise on the management of universities, or to head them. Given that UK universities still stand significantly higher on international league tables than does most of the UK business sector, this seems odd.”
On ‘leadership’ and ‘vision’.
The two most overworked words in management-speak remind me inexorably of the rhetoric used by those who advocated the merger of UCL and Imperial. And of two comments that appeared in the financial (not the academic) press after the attempt crumbled.
Lessons of a failed merger (Matthew Lynn, Bloomberg News. 20-Nov-02). “: [get the pdf].
“Unfortunately for Sykes, the professors of Imperial and University College London were smarter than the last recipients of his strategic wisdom, the shareholders in the formerly independent drug companies Glaxo Wellcome and SmithKline Beecham.
The biggest universities in the world are clearly not the best. So why do some British universities think that mergers will make them world class? (John Kay, 21-Nov-02 Financial Times).
” The same empty phrases that were used in the 1990s to justify corporate mergers are today used to justify university mergers – the aspiration to be a “global player”, the need to achieve “critical mass”. But greater size is always the aspiration of those with no better strategic vision.”
Two letters
These two responses appeared in THES the following week (Dec 7th), from opposite ends of the age spectrum. Notice that the younger one does not dare to give a name. I don’t blame him or her. That is the rule rather than the exception, when people feel intimidated. Exactly the same thing happened when the crazy “vision” of merging Imperial and UCL was on the cards. Anyone with half a brain could see it was nuts (with the exception of the senior management team at the time), but not everyone dared to say so.
| Loyalty, but not blind allegiance 1 Research associate, Russell Group university Published: 07 December 2007 Loyalty cuts both ways (“Staff loyalty key to Hefce report”, November 30). Look at contract research staff such as myself who are forced to seek employment in other institutions and environments. I cannot say that I have had an experience in my institution that inspires anything like loyalty. People there want it to go only one way. When are we going to get loyalty from our employing institutions rather than being treated as disposable drones? Research associate, Russell Group university. |
| Loyalty, but not blind allegiance 3 Geoffrey Alderman Published: 07 December 2007 Many years ago, it fell to me to chair Higher Education Funding Council for England teaching-quality inspections of academic departments. At one such event, the head of department confided to me and my team that he and his team completely disagreed with the strategic direction in which their vice-chancellor was taking them and were doing all they could to undermine it, in the interests of the discipline they taught. We agreed, and gave the department top marks. Geoffrey Alderman, Michael Gross professor of politics and contemporary history Buckingham University. |
Postscript
How very nice to get an endorsement from a Nobel prizewinner. Why, I wonder, was he not asked for his opinion about how to get good science. Perhaps PricewaterhouseCooper know better
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
|
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”.
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.
 |
|
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.”.
| A paper published in the Postgraduate Medical Journal, October 2007, has been reported widely. In the same issue there was a commentary by Edzard Ernst. They show the astonishingly poor evidence than herbal treatments work, despite the fact that they have been around for thousands of years. They looked at 1330 published trials on herbal medicines and found 3 (yes three) that stood up to scrutiny, Of those three, two were negative and one indecisive |  Red clover, Derwentwater. |
A systematic review of randomised clinical trials of individualised herbal medicine in any indication, R. Guo, P. H. Canter, and E. Ernst, Postgrad Med J 83: 633-637 [Get the reprint]
Herbal medicine: buy one get two free, E. Ernst, Postgrad Med J 83: 615-617 [get the reprint]
Grab the reprints before I am told to remove them.
The paper says
“Systematic searches of electronic databases and contacting
experts and professional bodies in the field resulted in the
location of only three randomised clinical trials of individualised
herbal medicine. It should be stressed that professional
bodies representing the interests of different practitioner
factions from around the world were unable to contribute any
more studies than this. In view of the long history and
widespread use of medical herbalism, Chinese herbal medicine
and Ayurvedic herbal medicine in many and diverse indications,
this should be a cause for concern. It indicates that
individualised herbal medicine has an extremely sparse
evidence base and that there is no convincing evidence
supporting its use in any indication.”
The National Institute of Medical Herbalists says
“More and more people are turning to herbal medicine as a kinder alternative to mainstream medicine, with its over reliance on pharmaceutical products.”
Wrong. Herbal medicines are pharmaceutical products. They are just unstandardised, and often impure and contaminated, pharmaceutical products.
In the Guardian we find Ann Walker quoted thus.
“Ann Walker, director of the British Herbal Medicines Association, insisted that most herbalists were well-trained and knew when to refer patients. She said herbalists took a three or four-year degree course before accreditation.
She acknowledged the lack of proof of efficacy for individualised herbal medicine. “The evidence is scanty because the studies have only recently been started,” she said. This did not mean there was no efficacy.”
Just a thought: shouldn’t you have some evidence that they work before you start selling them? These things have been around for thousands of years but the “studies have only recently been started”. You couldn’t make it up. You can’t have a high level of training if there is no evidence. The paucity of trials makes it very hard to know how you can fill up a three or four year course with anything but idle speculations. Universities should not being giving degrees in idle speculation.
Quote of the day. . Of all the pathetic defences offered by herbalists, this one, quoted in the Daily Mail, is my favourite.
“Jane Gray, of the National Institute of Medical Herbalists, said: “We would challenge the conclusions reached by this study based on such little data.”
“We want more research, but we’re all in private practice and cannot afford to stop earning to run a trial over several months.”
The fact that there is “so little data” is the conclusion. And perish the thought that a herbalist should “stop earning” just in order to find out whether what they are selling does any good.
The regulation scam
Alison Denham, speaking for the National Institute of Medical Herbalists, is quoted as saying
“But there are certainly issues around the expertise of practitioners which need to be addressed, and we look forward to government regulation which imposes a high standard of training on anyone who wants to register.”
Like all forms of alternative medicine, herbalists are desperate for government “regulation” because they know it gives the appearance of official approval without requiring them to show that they can do the slightest good.
Reports on this paper
The BBC web site: “Tailored herbal medicine ‘futile'”.
The Guardian report, by Sarah Boseley, is pretty good. “Herbalists’ cocktails may do more harm than good, say researchers.”
- Call for individualised remedies to be banned
- Little evidence to support claims of efficacy
The Times has another excellent report by Nigel Hawkes. “High street herbalists can offer no evidence that their remedies work”
The Independent. “Natural medicine on trial: The trouble with herbs. Traditional herbal remedies have never been more fashionable: sales have almost doubled in eight years. There’s just one problem: science suggests that they don’t work.”. This time Jeremy Laurance got the headline right (unlike the acupuncture piece). But where did that list of “Herbal remedies that work” at the end come from? Had he checked the Cochrane Reviews? I think not.
The Daily Mail. “Herb cures that ‘do you more harm than good’ “. Pretty good report. specially for the Daily Mail.
The Scotsman. “A natural cure?” Lyndsay Moss. Sadly, and unusually, this is the only really poor report. Just look at the end of it.
Postscript
On Saturday morning (6 October) I did an interview on the Dublin radio station, Newstalk. The host, Brendan O’Brien spoke also to Mary Plunkett, from the Professional Register of Traditional Chinese Medicine. She assured us that that, although there may be no evidence that it works published in the West, there were lots written in Chinese. What a pity that I had not yet read Ben Goldacre’s column, on this week’s bad news for herbalists. He cited a reference that was new to me.
You can read the abstract here. [download pdf]. The paper, by Vickers, Niraj, Goyal, Harland and Rees (1998, Controlled Clinical Trials, 19, 159-166) has the title “Do Certain Countries Produce Only Positive Results? A Systematic Review of Controlled Trials”. The conclusion is riveting.
“In the study of acupuncture trials, 252 of 1085 abstracts met the inclusion criteria. Research conducted in certain countries was uniformly favorable to acupuncture; all trials originating in China, Japan, Hong Kong, and Taiwan were positive, as were 10 out of 11 of those published in Russia/USSR. In studies that examined interventions other than acupuncture, 405 of 1100 abstracts met the inclusion criteria. Of trials published in England, 75% gave the test treatment as superior to control. The results for China, Japan, Russia/USSR, and Taiwan were 99%, 89%, 97%, and 95%, respectively. No trial published in China or Russia/USSR found a test treatment to be ineffective.”
The British Medical Journal ran an article on “doctor bloggers” last week.
Photo ©Mark Thomas
The BMJ put the article behind a paywall, but you can download a reprint here.
Oops, no you can’t. The BMJ have dictated that their piece on bloggers should not be available to bloggers. If you want a copy, email me. The question of availability is more interesting than the article itself anyway. It is by a journalist, Rebecca Coombes. Contrary to what you might think from reading it, I have never met her. She asked for opinions by email, so I spent a while writing something out, which she cut and pasted into an article (and I spent another hour with their photographer, Mark Thomas, who took a lot of pictures). But I can’t use either the article or the photos freely. I don’t even get paid. The commercial journals, as always, do pretty well out of exploiting academics.
| The picture at the top should have been Ben Goldacre, whose badscience.net is now number two in the world. That picture prompted the child of a friend to ask if I was doing an impression of a velocirapter, I guess that is one better that gimpyblog’s perception of me as being a dead ringer for some computer game thug. So here is another one (possibly no less scary). |
Photo ©Mark Thomas |
By way of compensation, here is a picture of Goldacre.
 Goldacre |
 Science writer award 2005 |
Goldacre said
“. . . blogs are popular because they are more honest than other media. It is hard to get away with misrepresenting stuff when the original source is but a click away. I see it as a way of making conversation public. What is good about it is you get unmediated expertise.”
“In the press it’s hard to know what is true. But with blogs people can link directly to the original source: this never happens in a newspaper.”
DC said
“I think they [blogs] have really had some success in spreading public understanding of science and even in influencing public affairs (firstly with the merger [of Imperial and UCL] and more recently with withdrawal of NHS funding for homoeopathy). My own research is on the stochastic properties of single ion channels. I love it, but it is specialist and of zero interest to the public. So it’s fun to talk about things that do interest the public. It’s also fun to be able to influence politicians and vice chancellors, though that is rather harder.”
21 September 2007
Channel 4 News reported on the pressure to save money by stopping NHS funding for “unproven and disproved treatments”.
Watch the video.
The report started badly when the journalist, Victoria Macdonald, said that the bottles of homeopathic pills contained “only natural ingredients”.
Wrong
They contain NO ingredients. That is just as well perhaps, when you recall that natural ingredients in homeopathic pills include things like polonium. In the Nature newsblog that followed my piece about BSc degrees in anti-science, I responded
“Well CAM is a bit like university management. Don’t try to satirise it, because the next thing you know the satire has come true.
There is even a whole book about homeopathic polonium, and you can by not only polonium, but also holmium, dysprosium, europium, gadolinium, Terbium, Thulium (this is beginning to sound like Tom Lehrer), And don’t forget Excrementum caninum (yes, you got it, dog shit). With the 3C “potency” of the latter you might even get a few molecules of it. All this at http://www.archibel.com/homeopathy/synthesis/newremedies/
And don’t forget your homeopathic bioterrorism protection kit.”
The thrust of the report was to suggest that our attempts to improve NHS treatment were some sort of Big Pharma funded conspiracy to suppress those nice homeopaths and so kill old ladies whose lives depended on taking medicines that contain no medicine.
Peter Fisher sounded a bit desperate in his attempts to associate me and my colleagues with the defence of GM foods, a topic on which, as far as I know, none of us uttered a word in public.
Sorry, Dr Fisher, but there is no conspiracy, and no involvement of Big Pharma. Just a disparate bunch of doctors and scientists who decided it was time to do something about the spending of scarce NHS money being spent on new age nonsense. It really is that simple.
I’m always a bit amused when people who make a lot of money from alternative medicine accuse me of representing some vested interest. The media ‘nutritional therapist’, Patrick Holford, said, in the British Medical Journal
“I notice that Professor David Colquhoun has so far not felt it relevant to mention his own competing interests and financial involvements with the pharmaceutical industry “
To which my reply was
” Oh dear, Patrick Holford really should check before saying things like “I notice that Professor David Colquhoun has so far not felt it relevant to mention his own competing interests and financial involvements with the pharmaceutical industry”. Unlike Holford, when I said “no competing interests”, I meant it. My research has never been funded by the drug industry, but always by the Medical Research Council or by the Wellcome Trust. Neither have I accepted hospitality or travel to conferences from them. That is because I would never want to run the risk of judgements being clouded by money. The only time I have ever taken money from industry is in the form of modest fees that I got for giving a series of lectures on the basic mathematical principles of drug-receptor interaction, a few years ago.”
I spend a lot of my spare time, and a bit of my own money, in an attempt to bring some sense into the arguments. The alternative medicine gurus make their livings (in some cases large fortunes) out of their wares.
So who has the vested interest?
Sorry Dr Fisher, but there is no conspiracy. Tim Crayford (Association of Directors of Public Health), put the matter very simply in the interview.
It is more to do with a point of principle. There are very many really effective treatments that the NHS can’t currently afford to provide. And we should we not be ensuring that the limited resources we’ve got in the NHS go to the things that really work well, and are going to save lives”
That is all there is to it.