Regulations
introduced two years ago were expected to give consumers better protection from
unfair trading. But, as John Garrow has discovered, the way they’ve been
implemented has had the opposite effect—new barriers distancing the public
from enforcement officers seem to have made it open season for vendors making
unjustifiable product claims.In my final year as HealthWatch’s first chairman I made an expensive (but interesting) mistake. In Issue 13 of the HealthWatch Newsletter I wrote: “It has become increasingly clear to me that local authority Trading Standards Officers are one of the most effective organisations for controlling health fraud.”
My error was to use the word “fraud” when referring to the conviction of the vendors of a nutritional supplement, under the Trade Descriptions Act (TDA). That conviction did not in fact imply fraud, but was merely for applying a misleading description to their product. The error cost HealthWatch about £3000, and it taught me a lesson.
Re-reading that 1993 issue of the newsletter reminded me that for twenty years
HealthWatch and Trading Standards Officers (TSOs) have worked together to control
misleading descriptions for health products. The “scandal” in the
title of this article is that recent changes in the consumer protection legislation
have virtually severed this co-operation.
The most important change in consumer protection regulations arises from EU
Directive 2005/29/EC. The effect in UK law was that from 28th May 2008 the Consumer
Protection from Unfair Trading Regulations (CPUTR) became effective. This seemed
a welcome advance. Under the old TDA the onus was on the TSO to show that a
claim was false, which meant that the local authority had to pay for the prosecution
and needed to employ an expert witness who could convince the court that the
claim was untrue. If the prosecution was successful the court usually gave costs
to the TSO, but if it failed it was a significant cost to the local authority.
But under the new CPUTR the onus of proof is reversed: the vendor must prove
that the claim was justified.
However the other change in the management of consumer protection was the installation in 2005 of a cluster of eight call centres called Consumer Direct (CD). The intention was to make basic advice available to everyone who was dissatisfied with the service they had received from a vendor of goods or services. But the public would no longer have direct access to TSOs: all complaints had to be filtered through the call centres.
Consumer Direct's web site [1] says in large type: “Our regionally based advisors are specially trained to give practical advice on all kinds of consumer issues—from problems with cars to faulty household appliances.” This may be fine for the consumers who are dissatisfied with their car or household appliance, and want a refund, but that is a matter for civil law, and under civil law the onus is on the consumer to prove that the product is defective.
In June 2008 Les Rose (a member of HealthWatch Committee) noticed a product called ‘Skinny water’ on sale in Tesco Express in Southampton. On the bottle, and on the related web site, there were improbable claims about the beneficial effects of the additives in the water (chromium and L-carnitine). To see how the new CPUTR performed he sent off his complaint, together with a report from me that the claims were almost certainly untrue. The result was unsatisfactory—the details are reported elsewhere [2].
I am very concerned about misleading claims for products that offer to help overweight consumers to lose weight or fat. For 25 years I ran an NHS outpatient clinic from Northwick Park Hospital, and later from St Bartholomew’s Hospital. During that period I saw about 3,500 obese outpatients, and was able to admit more than 500 of them to a metabolic research ward. Almost all of these severely obese patients (BMI 30 to 55) had tried “magic” remedies that had done them no good—they wasted money and caused depression and disappointment. The situation concerning obesity is getting worse year by year: the Department of Health now rates obesity as the greatest threat to public health, having overtaken cigarette smoking as a health hazard. I hoped that the new CPUTR rules would stem the flow of misleading claims for obesity cures, but it did not.
Despite our previous failure to get any TSO to take action on Skinny Water, I decided to try again. To see if other complainants were having more success I asked, in December 2009, under the Freedom of Information Act 2000, how many prosecutions there had been since 28th May 2008 under CPUTR for misleading claims for any health product, especially those promising weight or fat loss.
On 19th January 2010 I received the answer to my question. A list of prosecutions under CPUTR regulations is kept by the Office of Fair Trading. Prosecutions for misleading claims for health products since May 2008, showed a total of zero.
I had learned that the only way a consumer can get access to the Office of Fair Trading or TSO is through Consumer Direct. I therefore made another attempt to get the OFT to enforce the CPUTR concerning false claims that the product would make the consumer lose fat. I chose Skinny Water again, because there was no ambiguity about the claim. It was written on the side of the bottle:
“Skinny Water’s ingredients have been shown to suppress appetite, block carbohydrates from converting into fat, and increase fat burning…”.
My modest objective was to get a TSO to require the vendor of Skinny Water (Bio-Synergy Ltd) to show this claim was true, because its veracity had been challenged by a well-informed consumer. I assumed that the CD staff would be aware that this was what the CPUTR rules required, but that assumption proved to be misguided.
I called my local TSO, but was immediately transferred to the East England CD, where my call was taken by Laura. The whole conversation was recorded, and the CD have kindly sent me a copy of the recording. It lasted 17.24 minutes: if you want to hear every word it can be accessed by clicking here. (It is a large file and may be slow to download, so be patient). The interesting bit starts at 1.45 minutes, where Laura asks me to briefly describe my complaint.
I explained that I believed the claim that Skinny Water increased fat burning etc. was not true. She took notes, and then (at 2.56) asked me if I had been using the product for long? Otherwise how could I show that the claims were not true? I said I understood that the CPUTR rules put the onus on the vendor to validate claims, not for the consumer to disprove them.
At this stage the rapport between us deteriorated. She asked me what I paid for the water (3.27), and said she would pass on the information to the TSO, but there was no commitment that they would communicate with me unless they wanted further information (5.58).
Despite continuing the conversation for another 10 minutes it was obvious that my ambition to get a TSO to test the claims about fat burning, etc. were far too optimistic. Laura assumed that my ambition must be to get a refund on my money (£1.60) that I paid for the water. Whatever information she passed on could not have made any sense to the TSO, since when we parted Laura had not grasped that fact that I was not seeking a refund of £1.60, but a prosecution of Bio-Synergy.
I think that the present situation is a scandal. Far from the new CPUTR making it easier to control false claims for slimming products by putting the onus of proof of claims about efficacy onto the vendor, the insertion of the CD in the information chain has made it virtually impossible for a legal challenge to those claims to get to the people whose job it is to enforce the law.
John Garrow
Emeritus Professor of Human Nutrition
University of London
Click here to play the phone conversation (It is a large file and may be slow to download, so be patient).
The following week the GP’s magazine Pulse reported that of nearly 800 GPs responding to their survey, 80% said the NHS should not continue funding for homeopathy [2].
In a report published on 22nd February, the House of Commons Science & Technology Committee concluded that the NHS should cease funding homeopathy and that the Medicines and Healthcare products Regulatory Agency (MHRA) should not allow homeopathic product labels to make medical claims without evidence of efficacy [3].
The backlash came fast. The British Medical Journal’s report of the MPs' conclusions appeared on 23 February [4], and attracted 19 online rapid responses, most of which were from homeopaths (excepting a tongue-in-cheek letter from Caroline Richmond) while MP David Tredinnick’s Early Day Motion5 opposing the Science and Technology Committee report has, at the time of writing, been signed by 70 out of the House’s 646 MPs.
Mandy Payne
SCIENCE WRITER Simon Singh has won the right to rely on the defence of fair comment in the case of the libel action being brought against him by the British Chiropractic Association. The decision to allow his appeal, handed down at the Royal Courts of Justice on 1st April, followed the hearing in February in which the Law Lords examined the meaning of Singh’s 2008 Guardian article questioning the evidence behind claims that certain childhood conditions could be treated with chiropractic. Links to press reports are on http://www.senseaboutscience.org.uk/index.php/site/project/473/
JOHN GARROW brought the issue of the rise in uncontrolled health claims in ads (see his article in this issue) to the attention of British Medical Journal readers in his rapid response to an article by Professor Gareth Williams reacting to the withdrawal of the anti-obesity drug Sibutramine in Europe. See http://www.bmj.com/cgi/eletters/340/feb09_3/c824#231638
EDZARD ERNST’S unit at the Peninsula Medical School in Exeter
may close in June 2011 unless additional funds of £1.5m can be
found. The university blames the financial climate but Ernst, the UK’s
only professor of complementary medicine, suspects his public disagreements
with the Prince of Wales’ Foundation for Integrated Health have made him
unpopular with managers. See http://www.guardian.co.uk/lifeandstyle/2010/
mar/03/edzard-ernst-complementary-medicine
“THE MAN Who Stopped Smoking” is a 10-minute documentary
charting the remarkable life of the late Professor Sir Richard Doll (1996 HealthWatch
Awardwinner), whose case control study, published in 1950, first identified
smoking as an important cause of cancer and other diseases. The film, made by
TV producer Martin Freeth, was made to promote the BMJ archive’s now being
fully searchable back to 1840, and can be viewed online athttp://www.bmj.com/video/doll.dtl
ANDREW HERXHEIMER, for many years a member of the HealthWatch committee
and now a member of the UK Cochrane Collaboration, joined European
experts recently to speak out on the European Commission’s legislative
proposals on pharmacovigilance—the process of evaluating and improving
the safety of medicines. At the meeting, organised by the Association Internationale
de la Mutualité and held at the European Parliament in Brussels on 27th
January, concern was expressed that Member States’ own drug evaluating
authorities could be increasingly bypassed in favour of pharmaceutical companies.
However, legal provisions to allow direct reporting of adverse drug reactions
by patients to health authorities were welcomed and Dr Herxheimer presented
new evidence on the value of patient reports. The European Parliament votes
on the pharmacovigilance proposal in May.
See http://www.aim-mutual.org/?page=17&id=201
CELEBRITIES such as Roger Moore and Heather Mills were named
and shamed for offering daft health advice in Sense About Science’s “Celebrities
and Science 2009” round-up, and the press had a field day. Read the report
and the news coverage onhttp://www.senseaboutscience.org.uk/index.php/site/about/444/
ALAIN BRAILLON (contributor to HealthWatch Newsletter
issue 73, April 2009) was fired from the public health dept of the university
hospital of Amiens, France in January. He has been outspoken in his claims that
the alcohol industry and other vested interests have undue influence over French
health policy. His recent letter in the British Medical Journal protested against
French urologists’ continued promotion of prostate cancer screening despite
unproven benefits.
Braillon A. French exceptionalism BMJ 2009; 339: b4285.
MICHAEL BAUM (HealthWatch Awardwinner 2002, and writing in this issue) has just published “Breast beating: a personal odyssey in the quest for an understanding of breast cancer, the meaning of life and other easy questions”. The book has a foreword by Nick Ross. Available in paperback at £35.00, published by Anshan Ltd.
IN RESPONSE to concerns that UK libel laws could be restricting freedom
of expression, the government has set up a working group to examine
the issues.
See http://www.wired-gov.net/wg/
wg-wlabel-dti.nsf/wfArticle?ReadForm&unid= 2DFBDE3F60EBD2BA802576B8005CEF22
Supporters of the campaign to reform UK libel laws in favour of more open public
discussion of science can visithttp://www.libelreform.org/sign.
More than 40,000 have signed the petition so far.
Recently
there has been a spate of articles in various journals criticising evidence
based medicine, and in particular what has become known as the ‘hierarchy
of evidence’. These articles—all by alternative practitioners, or
those sympathetic to CAM—quote the following passage from the 2008 Harveian
Oration [1] by Sir Michael Rawlins, chairman of NICE.
“The notion that evidence can be reliably placed in hierarchies is illusory. Hierarchies place RCTs [randomised controlled trials] on an undeserved pedestal for, as I discuss later, although the technique has advantages it also has significant disadvantages ... judgements are an essential ingredient of most aspects of the decision-making process.”
An editorial from last year’s British Medical Journal [2] is representative of the types of argument being used, and produced a flurry of online responses from HealthWatch members and CAM practitioners alike...
James May, HealthWatch chairman and general practitioner
Two
recent high-profile peer reviewed papers [1,2] and three meetings I attended
recently show that the subject of mammographic screening for breast cancer is
once again under public scrutiny. The polarity of opinions on the subject is
illustrated by the fact that two of the meetings, an International Conference
on Women’s Health held on November 11th at the Royal College of Obstetricians
and Gynaecologists, and a debate on breast cancer screening at the AGM of Europa
Donna on the 13th of January, ended up as ill mannered shouting matches.
There is a biological model of the natural history of breast cancer that is rarely explicitly stated in debates on this topic. One of these rare occasions was at the EUROPA DONNA meeting. Professor Lazlo Tabar, the principal investigator of Sweden’s “Two County trial” [3], is one of the leading proponents of screening in the world. He described a growth pattern with predictable transitions from in situ to early invasive disease, from early invasive to localized advanced disease and from that stage to distant metastases. It’s more or less the same belief system that inspired the development of the radical mastectomy [4]…
Michael Baum
Professor Emeritus of Surgery, Visiting Professor of Medical Humanities
University College London
The
number of hours worked by junior doctors has been progressively reduced and
in 2009 the European Working Time Directive (EWTD) was implemented with a maximum
working week of 48 hours despite opposition by the medical profession. The Royal
College of Surgeons was particularly concerned by the impact this would have
on the training of our future consultant surgeons [1].
In a traditional on-call arrangement, a team of junior staff led by their consultant was responsible for a group of emergency patients. They would all be on call, with the house surgeon or registrar being resident. Clinical problems were dealt with according to the experience of the individual who could seek advice from the next more experienced person. The consultant took the ultimate responsibility.
From my own experience living in the hospital for a week at a time, and residing in a doctors’ mess, enabled rapid exchange of clinical information with other junior staff…
Keith Isaacson
Senior consultant orthodontist
North Hampshire Hospital, Basingstoke
This article is based on a paper, Worrall M. Do reduced hours create better safety for patients? Bulletin of The Royal College of Surgeons of England 2009; 91(7): 224-225. With acknowledgements to Matthew Worrall, Media Communications Manager to the Royal College of Surgeons of England.
1. Black J. We enter the second decade. Ann R Coll Surg Engl (Suppl) 2010; 92: 42–43.
In
January the New York Times published an obituary [1] of Dr James L Goddard,
a “brash, crusading” commissioner of the Food and Drug Administration
in the 1960s who helped revolutionize the US government’s methods of evaluating
drugs. From 1966 to 1968 Dr Goddard strove to put the FDA onto a sounder scientific
footing to better serve the consumer. He cracked down on exaggerated drug advertising
and delayed approval of new drug applications until manufacturers had backed
them up with more laboratory and clinical testing. And he campaigned to take
ineffective drugs off the market…
Caroline Richmond, medical journalist
1. New York Times 1 January 2010. View on http://www.nytimes.com/ 2010/01/02/health/02goddard.html