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Truth, falsehood and evidence: investigations of dubious and dishonest science

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The British Pharmacological Society and the MHRA don’t help the cause of honest science. They hinder it.

February 27th, 2013 · 9 Comments

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The bulletin of the British Pharmacological Society, Pharmacology Matters, declined to publish the following article. Sadly the Society seems to be more interested in "reputation management" than in truth. Luckily, it is not easy to suppress criticism these days. A version of the article has appeared in Research Fortnight where it will be seen by far more people than it would have been in Pharmacology Matters. This is the original version that I submitted to them. They would not allow me to quote Lewis’s comment (apropos of the sale of homeopathic meningitis vaccine)

“Children will be harmed by this inaction. Children will die. And the fault must lie with Professor Sir Kent Woods, chairman of the regulator [MHRA].”

If a child were to die of whooping cough or meningitis as a result of buying the fraudulent "vaccines", that would be true. It’s a sad reflection on the state of defamation law that journals are not willing to say so. Blogs are fast becoming the best source of reliable information.

BPS logo
mhra1

Stop press. The BPS has now signed up to Alltrials (too late for the printed version)


Pharmacology society does little to defend its subject

David Colquhoun

Over the past few years a courageous group of writers, researchers and activists has worked to expose the truth about the medicines we are sold, be they conventional or alternative.

Thanks, above all, to Ben Goldacre (1), more people than ever know that the big pharma companies have been concealing evidence of the harm that their products do, or the good they fail to do. Thanks to a small army of bloggers the preposterous claims made by peddlers of homeopathic remedies and other quackery are less likely to go unchallenged.

And yet, the organization charged with safeguarding the good name of pharmacology in this country, the British Pharmacological Society (BPS), has remained silent throughout.

The pharmaceutical industry

The BPS, rather than helping, became actively complicit when, along with much of the medical establishment, it signed an agreement with the ABPI (2). This document, developed under the aegis of the Ethical Standards in Health & Life Sciences Group (ESHLSG), contained two objectionable clauses:

“Industry plays a valid and important role in the provision of medical education”

And

“Medical representatives can be a useful resource for healthcare professionals”

Given that clinical “education” has long been part of Pharma’s marketing strategy, this seems disgraceful.  And most of the doctors I know and respect refuse to see reps altogether.  It is hopelessly optimistic to think that can an industry person can teach clinical pharmacology without bias in favour of his own company’s products. The BPS has many members who teach pharmacology.  Can they really cope so badly that we need to have industry to educate clinicians?   

It’s fine, and sometimes desirable, for academics and industry to work together on drug development.  But only as long as the industry partner has no say in how, or whether, the results are published.  Without that proviso we can expect more corruption of the sort that’s been seen at the University of Sheffield (3).

This is very sad, because I have great reason to like the drug industry.  I’ve benefitted from several of their products myself.  But the industry is in trouble.  Many of its products provide only marginal benefits.  Furthermore, some of the things that seemed to be useful, like SSRI antidepressants, have turned out to be next to useless once hidden trials were revealed (4).  The MHRA’s learning module on SSRIs doesn’t seem to have caught up with this yet.

Sadly, the reaction of industry has been to resort to dishonesty, to hide unfavourable data and to increase yet more what it spends on marketing.  Between 2009 and 2012, fines of at least 10 billion dollars (5) have been imposed on some of the most eminent companies.  They include Lilly, Pfizer, AstraZeneca, Merck, Abbott and GlaxoSmithKline (GSK). The biggest fine of all ($3 bn, in July 2012) went to a British company, GSK.  This succession of large fines seems to be regarded by the companies as mere marketing expenses. 

All these fines were levied in the USA.  Where, one might ask, are the regulators in the UK?  Why have there been no fines here? Why, indeed, are some of the senior managers of these companies not in jail?  Why has the BPS remained silent about the prostitution of its subject?  And why have the MHRA done so little to stop it?

I suggest that you support the petition for release of the results of all trials (6). It’s been supported by many individuals and a lot of organisations, including the BMJ and the Royal Statistical Society.  But, disgracefully, not by the BPS.

Quackery

At least in the case of the pharmaceutical industry some of its products work.  But pharmacologists should also be concerned about the quackery industry, worth about 60 billion dollars per year (as opposed to $600 bn for the pharmaceutical industry).  Virtually none of their products work (7). Why has the BPS said so little about it?  It has, along with most of the medical and university establishment, shrugged its shoulders about the fact that students at Westminster University have been shown dowsing with a pendulum as a method for selection of herbal “remedies”, as part of a Bachelor or “Science” degree.  It is an area in which every regulatory agency has failed to ensure even minimal levels of honesty (8).  And the BPS has just shrugged.

The MHRA has been worse than useless in this area: it has been actively unhelpful (9).  The senior staff of the MHRA are members of the BPS which has, as usual, said next to nothing.  The MHRA’s herbal medicine committee has allowed misleading labels that give indications to be put on herbal potions, and these labels fail to make it clear that no evidence whatsoever of efficacy is required to get the MHRA kitemark.  The wording was suggested (not required) by European law, but that law does not prevent the MHRA from saying, as it should, “there is no reason to think that this product is effective for any of the indications on the label” (10).  Arguably, the MHRA is in breach of Consumer Protection law (11, 12).

At the time, the BPS did make some objection to the labelling (13), but only under great pressure from me (indeed I wrote it) .  That has not been followed up, and I can no longer find it on the BPS web site.  Indeed Philip Routledge, one of the people who is responsible for the misinformation in his capacity as chair of the MHRA Herbal Medicines Advisory Committee, is, at present the president of the BPS.

The MHRA has also been responsible for misleading labelling of the products of the most obviously fraudulent products of the lot: homeopathic pills, the medicines that contain no medicine.  Most of the pills (anything beyond 12x dilution) contain not a single molecule of the substance on the label.  Yet they have been given a get-out clause that enables them to evade prosecution by Trading Standards (an organisation that consistently fails to apply consumer protection laws.  Rose et al (2011) (12) concluded

"EU directive 200s5/29/EC is largely ineffective in preventing misleading health claims for consumer products in the UK".  

It is simply bizarre that the people at the MHRA, many of who are BPS members, have sat round a table and approved the following label. This example is for Arnica 30C pills, which, of course, contain no trace of arnica (14, 8). The outcome of their deliberations is simply surreal (see the actual labels here).

"Used within the homeopathic tradition for the symptomatic relief of sprains, muscular ache; and bruising or swelling after contusions."

This will deceive the naïve into thinking that it will have some effect on sprains etc. It won’t. And the MHRA have declined to test how the label is perceived by the public, though it took some effort to get them to admit it.

"If you are allergic to any of the ingredients in this medicine, consult your doctor before taking this medicine."

The ingredients aren’t stated apart from “contains lactose and sucrose”. That’s all they contain. No arnica.

"If pregnant or breastfeeding consult your doctor before use."

Why should a few mg of lactose and sucrose have the slightest effect on a pregnant or breast-feeding mother. This is pure make-believe

"If you forget to take this product, continue to take your usual dose at the usual time, it does not matter if you have missed a dose. Do not take a double dose to make up for a missed dose."

This statement is even more bizarre. There is nothing in the pills.

"If you take too much of this product (overdose) speak to a doctor or pharmacist and take this label with you."

And this is the ultimate in nonsense. The 1023 campaign regularly swallows whole bottles, and of course nothing happens. You can’t overdose on nothing. The fact that the MHRA can insist on this label, with a straight face, is the ultimate betrayal of science and reason.

"When asked to comment, as part of the consultation on these rules, this was the response from the BPS."

no comment

This is extracted from page 16 of the “selected response” provided by the MHRA under a Freedom of Information Act request [download all]

Things have changed little since A.J. Clark wrote his book on Patent Medicines in 1938 (15).  And the BPS has done next to nothing to help. Neither has the MHRA. In fact both have colluded in the failures of both honesty and reason. 

A BBC South West program recently revealed that a pharmacist was selling “homeopathic vaccines” for whooping cough and meningitis (16).  The MHRA have know about his homicidal practice for years, but have done nothing.  The General Pharmaceutical Council let him off with a rap on the knuckles.  It has been left to bloggers and TV reporters to focus attention on these scoundrels. The well-respected blogger, Andy Lewis, wrote (17)

“Children will be harmed by this inaction. Children will die. And the fault must lie with Professor Sir Kent Woods, chairman of the regulator [MHRA].”

And the full clinical data for Tamiflu are still being concealed by Roche (18).

I think that is rather shameful.

I have been a member of the BPS for all my working life. I was happy when they made me an honorary fellow. But I now find myself asking if I can remain a member of an organisation that has done so little to defend honest scientific behaviour.

References

(1) Ben Goldacre’s Bad Pharma. Buy it now. Then do something. http://www.dcscience.net/?p=5538

(2)  ABPI 2012 Guidance on collaboration between healthcare professionals and the pharmaceutical industry.   http://www.abpi.org.uk/our-work/library/guidelines/Pages/collaboration-guidance.aspx

(3) Colquhoun, D. (2007)  The Corporate Corruption of Higher Education: part 2 http://www.dcscience.net/?p=193

(4) Kirsch,I., B.J.Deacon, T.B.Huedo-Medina, A.Scoboria, T.J.Moore, and B.T.Johnson. 2008. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS. Med. 5:e45.  http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0050045

(5) Groeger, L. (2012) Big Pharma’s Big Fines http://www.propublica.org/special/big-pharmas-big-fines

(6) All trials registered. All results reported, http://www.alltrials.net/supporters/

(7) Singh,S. and E.Ernst. 2009. Trick or Treatment. Corgi. http://en.wikipedia.org/wiki/Trick_or_Treatment

(8) Colquhoun, D. (2012) Regulation of alternative medicine: why it doesn’t work, and never can. http://www.dcscience.net/?p=5562

(9)  Colquhoun, D, (2006) The MHRA breaks its founding principle: it is an intellectual disgrace.  http://www.dcscience.net/?p=32

(10)  Colquhoun, D. (2011). Why does the MHRA refuse to label herbal products honestly? Kent Woods and Richard Woodfield tell me. http://www.dcscience.net/?p=4269

(11) Colquhoun, D. (2009) Most alternative medicine is illegal. http://www.dcscience.net/?p=30

(12) Rose,L.B., P.Posadzki, and E.Ernst. 2012. Spurious claims for health-care products: an experimental approach to evaluating current UK legislation and its implementation. Med. Leg. J. 80:13-18. http://www.dcscience.net/Rose-medico-legal-2012.pdf

(13) Colquhoun, D. (2006) Learned Societies speak out against CAM, and the MHRA. http://www.dcscience.net/?p=30

(14) MHRA Arnicare Arnica 30c pillules NR 01175/0181 http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con049307.pdf

(15)  Colquhoun, D. (2008) Patent medicines in 1938 and now: A.J.Clark’s book. http://www.dcscience.net/?p=257

(16) BBC South West on the evils of homeopathic "vaccines"  http://www.youtube.com/watch?v=TZf9mUzI4RI

(17) Why Does the MHRA Not Close Down these Homeopaths? The regulators have known of serious problems for years, Nothing is done. http://www.quackometer.net/blog/2013/01/why-does-the-mhra-not-close-down-these-homeopaths.html

(18)  Payne, D. (2012). Tamiflu: the battle for secret drug data http://www.bmj.com/content/345/bmj.e7303

Follow-up

25 February 2013 This post has some follow-up even before it appeared on Research Research. I noticed on the BPS web site a press release “BPS announces intention to sign All Trials Petition“. It was dated 20th February, but I didn’t notice it until after the printed edition went to press. It was expressed as a future intention to sign, though in fact they signed almost straight away (though over 100 organisations had already done so). That’s good. I suspect that when my old friend, Humphrey Rang, who is president elect of the BPS, takes charge, the Society may start to take its responsibilities to the public more seriously than it has in the past.

The MHRA, on the other hand, is still evading its self-declared job of ensuring the public that drugs work.

mhra2

13 March 2013. A reply to this piece appeared in red on Research Research, The British Pharmacological Society champions its science. It was written by Humphrey Rang who, as president elect of the BPS naturally felt obliged to defend its record. He defends the BPS membership of ESHLSG, but fails to mention that first the Lancet and then the BMA withdrew their support. Nor does he mention that medical students and doctors launched a campaign, BadGuidelines.org, against the agreement. The Medical Schools Council, which also signed the agreement, said "the scrutiny of the guidance has ‘identified deficiencies in the current statement". Didn’t they read it before signing? Rang says that the BPS is also working to improve the joint statement with the ABPI. That’s good, but one must wonder why the BPS signed up to the original form.

On the points about quackery, Rang sites the BPS statement on homeopathy (now vanished) but fails to mention that that statement was written by me in an attempt to wake the BPS from it’s slumbers on the matter of medicines that don’t work. But he doesn’t mention at all the matter of mislabelling of both homeopathic and herbal preparations.

Of course, the BPS does many good things. But like most organisations, it is too reluctant to speak out when it sees wrongdoing, and too reluctant to say "sorry we made a cock-up that time".

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Tags: Academia · Adrian Eddleston · Big Pharma · British Pharmacological Society · CAM · MHRA

9 responses so far ↓

  • 1 Lindy // Feb 28, 2013 at 09:58

    Always been puzzled by the notion of ‘ within the homeopathic tradition’.  What  precisely is meant by this, other than it’s being a ‘let-us-off-the-hook’ clause for MHRA etc?  If anyone were to stop and think about it, it is totally meaningless.  Maybe this has been done already, but it needs challenging.

  • 2 Wolfgang // Feb 28, 2013 at 12:01

    I do not understand why homeopathic “vaccines” are distributed.

    The Faculty of Homeopathy for the British Homeopathic Association has issued a “fact sheet”

    there you can read ” There are no proven homeopathic substitutes for immunization”….”There is currently no evidence that nososdes are effective in humans”

    and they make a conclusion: “The Faculty of Homeopathy follows the Depatrment of Health guidelines on immunisation and recommends that immunisation be carried out in the normal way unless there are medical contra-indications.”

    Although efficacy was never shown for homeopathic remedies, it is remarkable that homeopaths in UK claim that homeopathic vaccines should not be given. And I am amused that such an organisation can issue a “fact sheet”

  • 3 David Colquhoun // Feb 28, 2013 at 23:49

    @Lindy.  Yes of course, they are weasel words designed to maintain the income of the homeopathic industry.  The government seems to think it more important to protect fraudulent businesses than to protect patients.

    @ Wolfgang.   The Faculty of Homeopathy represents only homeopaths with medical qualifications (yes, there still are some).  Peter Fisher said that  the selling of homeopathic malaria treatments made him “very angry”.  Their medical knowledge makes them rather less dangerous than most homeopaths.  But they are a small minority.  Most homeopaths have little or no knowledge of medicine and many are happy to sell you sugar pills for malaria, meningitis, cholera, AIDS and almost anything else.  That’s wicked and until very recently neither the BPS nor, more seriously, the MHRA has done anything about it.

  • 4 Lindy // Mar 1, 2013 at 21:15

    What does the MHRA have to say about a company that sells the following as ‘remedies’, without specific indications of course, but with many different potencies:

    Griffon vulture, golden eagle, peregrine falcon, Rhino nasal discharge, x-ray, vaginal ultra-sound, fluorescent light, koala (bear I presume),  Hadrian’s Wall, kidney stones, cigarettes ( silk cut amongst others), electricity – high voltage pylon, a gram positive streptococcus and a mynah bird.

    I refer to the Helios website which lists all these and which I visit from time to time.  They used to sell various radioactive items and I reported that to trading standards, and whilst the reply I had was ludicrous and didn’t address anything I’d asked, some of the items have now disappeared.  (Oh, I just thought, maybe they were so effective, that no one needs them anymore)!  The list is long and mind-boggling.

  • 5 David Colquhoun // Mar 1, 2013 at 23:32

    @Lindy

    The Helios catalogue is certainly a bundle of fun.  My favourites where Excrementum Canis 30C (dog poo) and Black Hole (6C-50M). It doesn’t seem to have occurred to the MHRA or Trading Standards to ask where they keep the Black Hole mother tincture. or that for Polonium pills.  It’s simply incomprehensible to me how regulatory agencies put up with such nonsense.

  • 6 Neil Spurr // Mar 2, 2013 at 11:25

    David,

    I’m a big fan of your blog and the work you do. I find this post very depressing. I’ve recently started doing some volunteer work for the Sense About Science ‘Ask for Evidence’ campaign, (http://www.senseaboutscience.org/pages/a4e.html) but where can we go as members of the public if the regulatory bodies such as MHRA are so ineffective? This post has left me feeling rather powerless.

    For example, I have made a complaint to the advertising standards agency over a product I have seen, and I had planned to contact the MHRA for the same reason. However, after reading this post, I have had the wind taken out of my sails somewhat.

    Keep up the good work,

    Neil

  • 7 David Colquhoun // Mar 3, 2013 at 20:59

    @Neil Spurr

    It’s very good to hear that you’re trying to do something.  I certainly didn’t want to depress you, but rather to encourage you to keep working to improve matters.  Thw Advertising Standards Authority has been particularly good at getting misleading claims withdrawn, so it’s certainly worth persisting with them. The ASA can’t prosecute anyone and Trading Standards, who can prosecute, very rarely does. They simply refuse to enforce existing laws,and they need to change. The MHRA may or may not be helpful, but it’s always worth trying. I was certainly very disappointed in the reaction of the MHRA to one of the most cruel scams I’ve ever encountered. I think they did a bit, but they wouldn’t tell me what. There is no excuse for that.

    I  think that by now we know that pressure can work.  It’s sad that the most effective method seems to be public exposure of what’s happening.  Appealing to conscience through the proper channels usually gets you precisely nowhere (that was the case in the Mid-Staffs scandal too).   The people who ignore official complaints don’t like public embarrassment, and can be shamed into doing something about it.

    It does take patience though. I suppose it’s a bit depressing that MHRA have still not acted on things that  we’ve been telling them about for yours.  Remember they’ve been lobbied by Prince Charles and possibly (we’ll never know) by the Queen herself.  The sort of spineless and deferential people in the Department of Health (see my last post) are not going to do anything that might endanger their knighthoods, without a very big push.  It’s up to us, as scientists, to administer that push.  Together we can do it.

    The BPS is a rather different matter. It’s a professional society and hasn’t got any regulatory function.  Nevertheless I feel that it’s neglected to use its influence and expertise to respond to government consultations, and functioned more like a gentlemen’s club.  I’m optimistic that under its new president  that may improve.

     

  • 8 Neil Spurr // Mar 4, 2013 at 23:01

    I will occasionally get asked by friends why faulty science and
    ‘alternative’ medicines bother me so much, with an oft-repeated response
    being that ‘if it doesn’t do any harm, surely it’s worth trying?’ It is posts
    exactly like the one you linked (http://www.dcscience.net/?p=3109) that I send them to in order to illustrate the damage, financially, emotionally and physically, that these products cause
    to vulnerable people.

  • 9 CrewsControl // Mar 7, 2013 at 10:03

    *“The bulletin of the British Pharmacological Society, Pharmacology Matters, declined to publish the following article.”

    “The BPS, rather than helping, became actively complicit..”

    “Why has the BPS remained silent about the prostitution of its subject?”

    It’s rather disconcerting to see a professional body like the BPS take a shotgun, aim carefully, and happily shoot both feet. I note that the new CEO (!) of the BPS, Jonathan Brüün, had this to say in the December 2012 edition of ‘Pharmacology Matters':

    This edition of Pharmacology Matters is very special to me as it examines the role of public engagement in science. ………………………….Helping people to understand the role of pharmacology in public health and wealth is critical, to borrow a phrase, to ‘inspiring a generation’ of drug discoverers, developers, regulators and prescribers. It is something I believe BPS should take seriously. I’m therefore delighted to highlight new developments in this area.

    I would have thought that your submission landed slap-bang in the middle of this ‘mission statement’. Perhaps, the Editor in Chief, Managing Editor and the Editorial Board thought your article wasn’t inspiring enough.

    That you had to call upon a professional and personal relationship to wake the indifferent beast from its slumber in order to merely append a signature does rather cast a dispiriting light on academic integrity.

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