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Posts Tagged ‘Programm Evaluation Komplementärmedizin’

PEKing out the bias

Sunday, November 11th, 2007

Lancet Vol 366, Issue 9487, 27 August 2005 

“Research is subordinated (not to a long-term social benefit) but to an immediate commercial profit. Currently, disease (not health) is one of the major sources of profit for the pharmaceutical industry, and the doctors are willing agents of those profits.”
Dr Pierre Bosquet, Nouvelle Critique, France, May 1961

As The Lancet prepares to publish another issue on homeopathy, this seems a suitable moment to republish a blog entry from 18 months ago which described the highly irregular context forming the backdrop to the publication of the seriously flawed study (Shang et al. ‘Are the clinical effects of homeopathy placebo effects? Comparative study of placebo controlled trials of homeopathy and allopathy’ The Lancet 2005;366 (9487):726-733) which claimed to support the conclusion that the effects of homeopathy are no more than placebo.

Further details on the study itself, analyses of it’s principal failings, and the reaction it provoked among serious researchers can be found on the Myths and Misconceptions page.

The Shang et al meta-analysis was an offshoot from a Swiss government study, the Programm Evaluation Komplementärmedizin (PEK), which was designed to allow politicians to assess whether or not five complementary therapies – anthroposophical medicine, homeopathy, neural therapy, phytotherapy and traditional Chinese herbal therapy – should be included in the list of services covered by the Swiss compulsory health insurance scheme (KLV). The cost of complementary therapies were, until 1998, reimbursed under the basic national scheme, but a change in the regulations in 1998 put the decision over which therapies were or were not valid for reimbursement in the hands of the Swiss Department of Internal Affairs (EDI). Public outcry forced the government to back-peddle and the five most popular therapies were reinstated in the KLV scheme from 1999 to 2005, on condition that each therapy was provided by FMH-certified physicians only, and that a simultaneous study in each therapy’s effectiveness was carried out (the PEK study). The decision on whether the therapies were retained within the basic health insurance scheme after 2005 would depend on the demonstration of their efficacy, appropriateness and cost effectiveness.

The study was set up under the Federal Office of Social Insurance (BSV) with a well-defined management structure and review board of internationally-acknowledged experts. It received widespread praise for the quality of its design and the degree of cooperation and transparency amongst its participants. As each area of the study began publishing their findings, the project was cited as an exemplar for future CAM research.

But as the extent of the findings in favour of the five therapies began to become clear, in 2004 PEK’s management structure was abruptly changed and the control of the study was passed to the Federal Office of Health (BAG). From that point onward, many attempts were made to interfere with and derail its emerging conclusions. Transparency was immediately compromised. Economic data showing the cost benefits of CAM were suppressed. The economist preparing to present the results of his work was dismissed without reason and placed under a gagging order. Other departments were prevented from publishing their work.

One member of the PEK steering committee, Dr med Peter Heusser, was so disgusted by what he witnessed that he has written an account of what happened, Medizin und Macht am Beispiel des Programms Evaluation Komplementärmedizin PEK (currently only available in German, but machine-translated here), and this brief summary is drawn largely from his account.

The Swiss authorities – both the government and the Federal Office of Health (BAG) – tried to sweep the PEK study under the carpet. A conference scheduled for April 2005 to present and discuss its results had to be cancelled because the Federal Office of Health prevented the publication of the study data. Some collaborators were even coerced into deleting all PEK-related data from their computers. The final meeting of the PEK international review board (six professors from Switzerland, Germany, Denmark and the UK responsible for the scientific quality of the study), scheduled for June 2005 for a final assessment of the project, was cancelled. (The review board eventually produced a summary report in September, which is highly critical of the political interference in the study.) Many contributors had their contracts terminated before their work could be completed. The recommendation in the final draft that homeopathy, anthroposophical medicine and herbal medicine should stay in the compulsory health insurance scheme was deleted in the final publication.

The Swiss government pre-emptively decided to exclude all CAM therapies from the compulsory health insurance scheme as of 30 June 2005, effectively ignoring not just the weight of scientific findings and economic benefits (which could save SFr millions on the health budget) which were emerging from the still-to-be-completed PEK study, but also the weight of Swiss public opinion.

In this context, the appearance of the Shang et al meta-analysis in The Lancet two months later – notably pre-empting the final report from the PEK international review board – can do little else but appear even more biased and reverse-engineered than it does already in its own right (see Myths and Misconceptions). A letter to The Lancet from the Swiss Association of Homeopathic Physicians raising objections to the study was not even granted publication.

None of this – aside from the initial frenzy surrounding the announcement of the conclusions of the meta-analysis on homeopathy – appears to have raised so much as a whisper from the English-speaking international media. Even in Switzerland it was only reported piecemeal so the full extent of what happened was not readily apparent.

Perhaps it’s worth noting that Switzerland is ranked as 8th most competitive nation in the 2005 World Competitiveness Yearbook. (In comparison, the UK came 22nd.) And it’s also ranked 8th in terms of the major exporting countries of chemical and pharmaceutical products. Around 5% of current global pharmaceutical R&D is attributable to Swiss companies. Just one of these companies, Roche Holding AG, parent company of Roche Pharmaceuticals, the manufacturers of the anti-viral drug Tamiflu, reported 2006 net income which was greater than the entire gross domestic product – that is, the value of all final goods and services produced within a nation in a given year – of the bottom 119 nations of the World Bank’s 183-nation rankings in 2005.

Since many university medical research laboratories would cease to exist without the support of the pharmaceutical industry, it’s perhaps no surprise that “at the end of 2004, professors of the medical faculties had expressed the intention at a meeting of the Swiss Academy of Medical Sciences … to do everything in their power to prevent complementary medicine remaining in the basic insurance. A dean voiced the prevailing opinion: “We must provide hand grenades [literal quotation, personal communication of a participant of that conference] against complementary medicine.”” (Dr med Peter Heusser).

Against the backdrop of more and more high-quality studies demonstrating the clinical effectiveness of homeopathy in practice, it will be interesting to see if The Lancet can recover its scientific credibility this time around, or whether this will turn out to be yet another ill-conceived attempt at a hatchet job jumping on the Colquhoun-Goldacre bandwagon.

“The prerequisite for today’s medical policy is naturally the currently predominant system of medicine. The sick are the source of income, therefore it is necessary for sick people to be there, yes, it proves advantageous if one makes the people artificially sick.”
Dr med Steintl: ‘International Medical Policy’, 1938, Berlin



The studiously unstudied

Thursday, December 7th, 2006

“Nothing exists except atoms and empty space; everything else is opinion.”
Democritus of Abdera

They’re at it again. Yet another medical academic hits the headlines with a denouncement of homeopathy, yet again attempting to scare people away, this time by targeting children. Glasgow’s The Herald put the story on its front page on Monday under the headline “Homeopathic medicines ‘not good for children’” (article now only available by pay per view or subscription to the archives).

The study by Aberdeen University analysed the records of nearly two million patients in 323 practices from 2003-4, and revealed that 60% of GP practices in Scotland make homeopathic and herbal medical prescriptions. Dr James McLay, a clinical pharmacologist and ‘leading child health care expert’ according to The Herald, said “There is a real drive to use rational and proven medication and the whole thing about homeopathy is it is totally unproven and totally irrational as well.” He goes on to say, “It is difficult to know why children are being prescribed homeopathy. If one assumes homeopathy works because of the placebo effect, and I personally do believe that, you can’t do that with children under one year old.”

Yet another beautiful example of mistaking the map for the territory; of extrapolating apparent “sense” from a set of questionable presumptions. At least Dr McLay is to be congratulated for stating this clearly (“if one assumes …”, “I personally do believe …” ) rather than attempting to pass his opinions off as incontrovertible “fact” as so many others have done. I wonder if the fact that people using homeopathy for babies to the extent they do has ever caused him to question his assumptions?

There is enormous irony in so many academics denouncing something they have never taken the time to study in depth. After all, academics are supposed to be people that devote their lives to studying things. Perhaps they have just become altogether too enamoured of their theories and separated from the day-to-day reality of treating people who are sick? Funnily enough, this was the principle complaint of Dr Samuel Hahnemann, the founder of homeopathy, and is what led him to develop his therapy. Meanwhile, 60% of those at the coal face of modern medicine in Scotland are making use of a 250 year-old therapy that only four decades ago was practiced by just a handful of stalwarts and which hardly anybody had ever heard of. Do all these academic scientists imagine that homeopathy would have survived the test of time and risen to its current prominence unless there was a good body of evidence and experience amongst those that have tried it to suggest that it actually does work?

More than a few who practice the therapy, and the vast majority of their patients, don’t actually care that we don’t have a theoretical framework to explain how it works. They’re just glad that it does. It seems that the ones who are squealing the loudest are the ones being brought to confront the possibility that their theoretical frameworks might just require some dismantling and rebuilding.

Or perhaps also those who see their vast and unreasonable profiteering at the expense of suffering humanity under threat by a therapy who’s remedies are absurdly cheap to produce and which can’t be patented? On that subject, the extraordinary course of events surrounding the Swiss PEK study – a spin-off of which was the much-publicised Shang et al meta-analysis published in the Lancet in August 2005 proclaiming ‘the end of homeopathy’ – provide some very interesting reading. Consider the repeated assertions that homeopathy is “unproven” against this background, and a quite different picture emerges.



Evidence? What evidence?

Tuesday, May 23rd, 2006

“I know that most men, including those at ease with problems of greatest complexity, can seldom accept even the simplest and most obvious truth if it would be such as oblige them to admit the falsity of conclusions which they have delighted in explaining to colleagues, which they have proudly taught to others, and which they have woven, thread by thread, into the fabric of their lives.”
Leo Tolstoy

And so it goes on …

It really is extraordinary to what lengths people will go to try to keep the world within their comfort zones. Whatever happened to the concepts of open mindedness and free choice?

Today we have Michael Baum, emeritus professor of surgery at University College London, along with 12 other doctors, writing to 476 primary care trusts urging them to discontinue the funding of complementary therapies. Never mind that an estimated 50% of GPs recommend their patients for complementary treatment, these 13 people clearly believe they have the right to dictate national policy on the matter. Signatories to the letter include Nobel Prize-winner Sir James Black, Sir Keith Peters, president of the Academy of Medical Science, and Edzard Ernst, the UK’s first “professor” of complementary medicine. The letter describes homeopathy as an “implausible treatment for which over a dozen systematic reviews have failed to produce convincing evidence of effectiveness”.

Seems these august gentlemen have got their facts just a little bit wrong here, which ought to royally backfire on them, but probably won’t because so few people bother to read beyond the sensationalist headlines and examine the data on which the conclusions are based. For example, linked from this article on the BBC’s website, is one from November last yearpublicising the Bristol Homeopathic Hospital study in which 70% of 6,500 patients reported positive health changes with homeopathic treatment. The article mentions last year’s Lancet meta-analysis, saying:

“The Swiss-UK review of 110 trials found no convincing evidence the treatment worked any better than a placebo.”

Again, factually incorrect. The review gathered a total of 220 trials for examination, but its conclusions were based solely on a comparison of just 8 homeopathic trials (selected from a total of 110) with 6 conventional medical trials (out of a total of 110). 8 undisclosed trials at that, making it impossible to determine whether what was being measured even falls within an acceptable definition of “homeopathy”. Further, the authors of the study declared their bias from the outset. They believed homeopathy to be placebo and there appeared to be no attempt to do any more than support that opinion. The quality of this study has been so widely condemned by serious academic scientists that it prompted the following comments from Mikel Aickin PhD, Research Professor at the University of Arizona:

“The Lancet article appears to be part of a recent trend, in which medical journals are publishing articles of exceedingly low quality to justify attacks on controversial therapies.”
[…]
“There is unsettling evidence that we are now in the midst of a methodological degeneration in biomedical science. This appears to be occurring in, of all places, our fundamental approach to inference – using observation and evidence to decide how to act or believe. That it might be happening in medical research makes it of more than just academic interest.”
(Aickin, Mikel. The End of Biomedical Journals: There Is Madness in Their Methods. Journal of Alternative and Complementary Medicine Oct 2005, Vol. 11, No. 5: 755-757)

(For a more detailed exposé of the Lancet study and the wider context in which it was produced see my post from March 18 and Myths and Misconceptions about homeopathy, both on this site.)

Edzard Ernst is quoted in the BBC article as saying, “I believe we need one single standard in medicine and that is the standard of evidence based medicine.” Indeed. Couldn’t agree more. Perhaps these 13 devotees of evidence-based medicine should take a closer look at their “evidence” before pontificating so loudly and publicly? If we’re to take their conclusions as representative of the quality and rigour of scientific investigation found in the upper echelons of the medical elite then biomedical science is, as Mikel Aickin suggests, in very deep doodoo.

Several news websites are conducting polls based on this letter. If you would like to take part, try:
BBC
Sky News
Daily Mail



Bias-binding and the PEKing order

Saturday, March 18th, 2006

“Research is subordinated (not to a long-term social benefit) but to an immediate commercial profit. Currently, disease (not health) is one of the major sources of profit for the pharmaceutical industry, and the doctors are willing agents of those profits.”
Dr Pierre Bosquet, Nouvelle Critique, France, May 1961

These days it’s hard not to conclude that the general public throughout the world are being thoroughly stitched up when it comes to the question of reliable information about health matters.

As a minor example, I happened to come across a 2005 study on mobile phone use and the incidence of acoustic neuroma (M J Schoemaker, A J Swerdlow, and others: Mobile phone use and risk of acoustic neuroma: results of the Interphone case-control study in five North European countries. British Journal of Cancer (2005), 1-7) which found a slight but statistically insignificant increase in incidence of acoustic neuroma related to mobile phone use based on 678 cases and 3553 controls in the UK and four Nordic countries over a period of 10 years. The study concludes “… that there is no substantial risk of acoustic neuroma in the first decade after starting mobile phone use. However, an increase in risk after longer term use or after a longer lag period could not be ruled out.” (emphasis added)

The study only looked at one particular type of cancer based on the assumption that acoustic neuroma would be the most likely cancer to develop from an EMF radiation source held close to the ear. Acoustic neuromas are rare, and the assumption that the effects of EMF radiation will only be visible closest to its source (given that EMF radiation is effective over considerable distances, hence its use in mobile phones!) in exactly that way is questionable. And of course a specific study of one type of cancer like this can’t in any way be extrapolated to all cancers.

Yet how did the “responsible” press headline this story?

BBC: Mobile phone cancer link rejected (30 August 2005)
The Guardian: Mobiles’ 10-year all-clear for cancer (31 August 2005)
The Independent: Using a mobile phone regularly does not cause cancer, scientists conclude (31 August 2005)
Reuters: No brain cancer link to mobile phones, study says (30 August 2005)

Never let truth stand in the way of a good story …

But at least we can be thankful that these headlines were only gross exaggeration, as opposed to the outright lies promulgated by The Lancet in claiming an end to homeopathy based on the meta-analysis by Shang et al published last August.

It emerges that the Shang et al meta-analysis was an offshoot from a Swiss government study, the Programm Evaluation Komplementärmedizin (PEK), which was designed to allow politicians to assess whether or not five complementary therapies – anthroposophical medicine, homeopathy, neural therapy, phytotherapy and traditional Chinese herbal therapy – should be included in the list of services covered by the Swiss compulsory health insurance scheme (KLV). The cost of complementary therapies were, until 1998, reimbursed under the basic national scheme, but a change in the regulations in 1998 put the decision over which therapies were or were not valid for reimbursement in the hands of the Swiss Department of Internal Affairs (EDI). Public outcry forced the government to back-peddle and the five most popular therapies were reinstated in the KLV scheme from 1999 to 2005, on condition that each therapy was provided by FMH-certified physicians only, and that a simultaneous study in each therapy’s effectiveness was carried out (the PEK study). The decision on whether the therapies were retained within the basic health insurance scheme after 2005 would depend on the demonstration of their efficacy, appropriateness and cost effectiveness.

The study was set up under the Federal Office of Social Insurance (BSV) with a well-defined management structure and review board of internationally-acknowledged experts. It received widespread praise for the quality of its design and the degree of cooperation and transparency amongst its participants. As each area of the study began publishing their findings, the project was cited as an exemplar for future CAM research.

But as the extent of the findings in favour of the five therapies began to become clear, in 2004 PEK’s management structure was abruptly changed and the control of the study was passed to the Federal Office of Health (BAG). From that point onward, many attempts were made to interfere with and derail its emerging conclusions. Transparency was immediately compromised. Economic data showing the cost benefits of CAM were suppressed. The economist preparing to present the results of his work was dismissed without reason and placed under a gagging order. Other departments were prevented from publishing their work.

One member of the PEK steering committee, Dr med Peter Heusser, was so disgusted by what he witnessed that he has written an account of what happened, Medizin und Macht am Beispiel des Programms Evaluation Komplementärmedizin PEK (currently only available in German, but machine-translated here), and this brief summary is drawn largely from his account.

The Swiss authorities – both the government and the Federal Office of Health (BAG) – tried to sweep the PEK study under the carpet. A conference scheduled for April 2005 to present and discuss its results had to be cancelled because the Federal Office of Health prevented the publication of the study data. Some collaborators were even coerced into deleting all PEK-related data from their computers. The final meeting of the PEK international review board (six professors from Switzerland, Germany, Denmark and the UK responsible for the scientific quality of the study), scheduled for June 2005 for a final assessment of the project, was cancelled. (The review board eventually produced a summary report in September, which is highly critical of the political interference in the study.) Many contributors had their contracts terminated before their work could be completed. The recommendation in the final draft that homeopathy, anthroposophical medicine and herbal medicine should stay in the compulsory health insurance scheme was deleted in the final publication.

Review board member Harald Walach PhD protested:

“I protested on behalf of the international review board whose membership was against this highly unusual procedure. I had an interesting exchange of e-mails and letters with the vice-president of the Swiss federal health agency, which told me a lot about the irrelevance of scientific data in the face of political decisions. What I basically learned was that the data gathered by the researchers were absolutely irrelevant to the decision. The vice-president, in an e-mail to me, literally called the data “waste products which do not bear any relevance to the political decisions.” It is important to highlight this situation in the face of editorials and information in the public press, which seem to imply that the Swiss decision was based on evidence about the higher costs and ineffectiveness of complementary medicine. Very likely, the opposite was true: The data probably suggested some cost effectiveness and they certainly did not imply zero effectiveness. But this information was held back from the public in order to veil the political nature of the decision, I assume.”

Walach concludes his editorial,

“This is a very interesting, informative, and, in fact, very sobering piece of recent history in the evaluation of complementary medicine. Public authorities, health systems researchers, and, in fact, all CAM researchers should at least take some note of this process in order to understand the complexities of the issues at stake and of the power-plays of different stakeholders in the game.”
(Walach, H. The Swiss Program for the Evaluation of Complementary Medicine (PEK). Journal of Alternative and Complementary Medicine, April 2006; Vol 12, No 3, pp 231-232)

The Swiss government pre-emptively decided to exclude all CAM therapies from the compulsory health insurance scheme as of 30 June 2005, effectively ignoring not just the weight of scientific findings and economic benefits (which could save SFr millions on the health budget) which were emerging from the still-to-be-completed PEK study, but also the weight of Swiss public opinion.

In this context, the appearance of the Shang et al meta-analysis in The Lancet two months later – notably pre-empting the final report from the PEK international review board – can do little else but appear even more biased and reverse-engineered than it does already in its own right (see Myths and Misconceptions). A letter to The Lancet from the Swiss Association of Homeopathic Physicians raising objections to the study was not even granted publication.

None of this – aside from the initial frenzy surrounding the announcement of the conclusions of the meta-analysis on homeopathy – appears to have raised so much as a whisper from the English-speaking international media.

Perhaps it’s worth noting that Switzerland is ranked as 8th most competitive nation in the 2005 World Competitiveness Yearbook. (In comparison, the UK came 22nd.) And it’s also ranked 8th in terms of the major exporting countries of chemical and pharmaceutical products. Around 5% of current global pharmaceutical R&D is attributable to Swiss companies. Since many university medical research laboratories would cease to exist without the support of the pharmaceutical industry, it’s perhaps no surprise that “at the end of 2004, professors of the medical faculties had expressed the intention at a meeting of the Swiss Academy of Medical Sciences … to do everything in their power to prevent complementary medicine remaining in the basic insurance. A dean voiced the prevailing opinion: “We must provide hand grenades [literal quotation, personal communication of a participant of that conference] against complementary medicine.”” (Dr med Peter Heusser).

On a more metaphysical note, it’s interesting too how the number 8 appears twice in the Swiss rankings (not to mention being the final ridiculously small number of homeopathic trials selected to represent the therapy in the Shang et al meta-analysis) given its numerological associations with executive character, political skills, handling of power and authority, working for a cause, command, ambition, lacking humanitarian instincts, repression and materialism … and itself a figure, in the form of the lemniscate, often connected with the maxim “as above, so below”.

More comment on this topic:
Dr Manish Bhatia

“The prerequisite for today’s medical policy is naturally the currently predominant system of medicine. The sick are the source of income, therefore it is necessary for sick people to be there, yes, it proves advantageous if one makes the people artificially sick.”
Dr med Steintl: ‘International Medical Policy’, 1938, Berlin



DISCLAIMER
Thanks to the current insanity revolving around homeopathy in this country, in both media and blogosphere, it's become necessary to insult your intelligence by explicitly drawing your attention to the obvious fact that any views or advice in this weblog/website are, unless stated otherwise, the opinions of the author alone and should not be taken as a substitute for medical advice or treatment. If you choose to take anything from here that might be construed as advice, you do so entirely under your own recognisance and responsibility.

smeddum.net - Blog: Confessions of a Serial Prover. Weblog on homeopathy, health and related subjects by homeopathic practitioner Wendy Howard