Trick or Treatment (40 page)

The Department of Health tried to defend the booklet’s lack of rigour by declaring that it was never intended to include any scientific evidence about effectiveness, but this was less than honest. Professor Ernst had originally been asked to contribute to a whole section about scientific evidence, but this part was discarded before publication as such information presumably would have undermined the booklet’s ambitions. Also, correspondence between the Department of Health and the Foundation for Integrated Health (obtained by Les Rose under the Freedom of Information Act) clearly shows that the guide was originally meant to include reliable information on effectiveness. In any case, if a patient guide does not contain such information, what on Earth is it for?

In a second example of British disinformation, the Medicines and Healthcare Products Regulatory Agency (MHRA) in 2006 took the shocking decision to allow homeopathic products to make claims on their labels based on homeopathy’s own theory of testing known as ‘provings’. As discussed in Chapter 3, these tests cannot demonstrate clinical effectiveness, and yet customers will now encounter labels based on provings and endorsed by the MHRA. This will mislead consumers into believing that homeopathic products are effective. The MHRA, which is an executive agency of the Department of Health, makes the proud claim: ‘We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe.’ Yet, for the first time since the creation of the Medicines Act, they have sacrificed their integrity.

The reason for the MHRA’s shameful irresponsibility is hard to fathom, but Professor David Colquhoun feels strongly that the Prince of Wales has been an influential figure in this regrettable endorsement:

The MHRA argue that it is better to regulate and allow homeopathic remedies for safety reasons, but even if this were a good idea (and we do not think it necessarily is), then there still would be no need to give misleading indications of efficacy. Professor Michael Baum commented, ‘This is like licensing a witches’ brew as a medicine so long as the bat wings are sterile.’ Journalist and broadcaster Nick Ross was equally scathing: ‘Sometimes politics must take priority over science. After all, Galileo capitulated to the Inquisition. But what instruments of torture threatened members of the MHRA – or were they simply intellectual cowards?’

10 World Health Organization

This list of people, organizations and entities responsible for the unwarranted growth of ineffective and sometimes dangerous alternative medicine has been in no particular order, except that the World Health Organization (WHO) has been deliberately chosen to complete the list as it holds a special position.

No organization has done more to improve health around the world, such as the eradication of smallpox, and yet the WHO has acted shamefully in its attitude and actions towards alternative medicine. We would have expected it to provide clear and accurate guidance about the value of each popular alternative therapy, yet (as we saw in Chapter 2) in 2003 the WHO muddied the waters by publishing a highly misleading document on the value of acupuncture. Entitled
Acupuncture: Review and analysis of reports on controlled clinical trials
, the report based its conclusions on several unreliable clinical trials and thus endorsed acupuncture as a treatment for over 100 conditions. Of course, the evidence from high-quality reliable clinical trials paints a very different picture. In reality, acupuncture might possibly (though it looks less possible as each year passes) be effective in treating some types of pain and nausea, but it offers no proven benefit for any other conditions.

Naturally, ever since its publication, acupuncturists have cited the WHO report as the most authoritative evaluation of their mode of healing. And, not surprisingly, prospective patients have been persuaded that acupuncture must be effective for a whole range of conditions, because, after all, it has the blessing of the WHO. However, the WHO report was a shoddy piece of work that was never rigorously scrutinized and which should never have seen the light of day.

The WHO could repair its reputation if it were prepared to re evaluate acupuncture fairly and publish a new report that reflected the evidence from the latest and most reliable trials. In this way, it could make a huge contribution to the public’s understanding of what acupuncture can and, more often, cannot treat. Unfortunately, there is no sign that this is likely to happen.

Worse still, it seems that history is about to repeat itself and that the WHO is destined to fail us and embarrass itself again. According to a report in the
Lancet
, the WHO is planning to publish a report on homeopathy, which will have much in common with its irresponsible report on acupuncture. In other words, it will be rose-tinted and lacking in rigour.

Once again, practitioners will use the report to help validate invalid treatments. And, once again, patients will be persuaded that it is worth spending their money and risking their health on bogus treatments. For example, those who have seen a preliminary version of the report state that the WHO views homeopathy as a valid form of treatment for diarrhoea. Globally, over a million children die each year of diarrhoeal diseases, and an increased use of homeopathy would only make the situation worse. India’s National Rural Health Mission is already showing signs of advocating homeopathy to treat diarrhoea, and the WHO report would only give credibility to this foolhardy policy.

The future of alternative medicine

The Scottish distiller Thomas Dewar once said: ‘Minds are like parachutes. They only function when open.’ On the other hand, the
New York Times
publisher Arthur Hays Sulzberger stated: ‘I believe in an open mind, but not so open that your brains fall out.’

Of course, Dewar and Sulzberger both had a point, and their views were combined in a lecture in Pasadena in 1987, when the great American physicist Carl Sagan explained how science should treat new ideas:

Throughout this book we have tried to strike a balance by being open to all forms of alternative medicine and all their respective claims, while submitting each one to the ordeal of testing. In general, the key test has been the clinical trial. Pioneered 250 years ago by James Lind and then refined over the course of the next century by Alexander Hamilton, Pierre Louis and many others, the clinical trial remains a beautifully simple, yet powerful, mechanism for getting to the truth. Indeed, Pierre Louis’ description of a clinical trial still holds true today:

Having sought to be both open-minded and sceptical, and having relied on all the best available evidence, our broad conclusion is fairly straightforward. Most forms of alternative medicine for most conditions remain either unproven or are demonstrably ineffective, and several alternative therapies put patients at risk of harm.

There will always be new research that will add to our knowledge, and it is possible that alternative treatments that currently appear in effective might turn out to offer a significant benefit. However, while writing this book during the course of 2007, there have been major new studies that have only further undermined the credibility of alternative medicine. One of the most important was published in the
British Medical Journal
under the title ‘Acupuncture as an adjunct to exercise based physiotherapy for osteoarthritis of the knee: randomised controlled trial’. The researchers gave advice and exercise to 352 patients, and then one-third received nothing else, one-third received real acupuncture, and one-third received sham acupuncture via the stage-dagger needles described in Chapter 2. The researchers concluded: ‘Our trial failed to show that acupuncture is a useful adjunct to a course of individualised, exercise based physiotherapy for older adults with knee osteoarthritis.’ This conclusion was reinforced by Eric Mannheimer’s analysis of all the latest data, also published in 2007. These results were a serious blow for acupuncturists, who have argued that acupuncture for knee osteoarthritis was their most effective intervention. This particular treatment was even singled out for a special mention when the Prince of Wales addressed the WHO in 2006. It now seems that the jewel in the acupuncturists’ crown is fake.

We wrote this book because we wanted to provide people with the most important research about alternative medicine, in the hope that readers would be in a better position to make informed decisions about their own healthcare. But what about those people who have not read this book? What about the millions of patients who have only been exposed to the media hype in the newspapers, exaggerated claims on the internet and misleading adverts in shop windows? Is it fair that they may waste their money and risk their health by using alternative medicine?

One of the greatest problems is that patients have virtually no protection when they enter the world of alternative medicine. Homeopathic remedies, for instance, are available on the internet, in high-street pharmacies and from anyone who claims to be a homeopath – in each case the vendors are selling treatments under false pretences, as homeopathic remedies are disproven and illogical. Similarly, couples seeking fertility treatment can waste large amounts of money on herbal treatments when there is no proper evidence or reason why they should be effective. Meanwhile, chiropractors expose their patients to large doses of X-ray radiation, manipulate the fragile bones of infants and apply heavy forces to adult necks, even though these treatments, in many cases, are totally in effective. And so the story continues, with acupuncturists, reiki healers, psychic healers, shiatsu therapists and many other alternative practitioners making totally unfounded, yet hugely enticing, claims.

Notably, if any conventional doctor made such ludicrous promises and offered similarly unproven and even risky remedies, then he or she would be struck off or would perhaps end up in the dock.

Conventional medicine and alternative medicine both have the same ambition, namely to cure the sick, and yet one is tightly regulated and the other operates in the medical equivalent of the Wild West. This means that patients who venture towards alternative medicine are at risk of being exploited, losing their money and damaging their health.

The solution, surely, would be to create a level playing field, whereby alternative medicine has to maintain the same high standards required of conventional medicine. Regulation across the board would provide protection to all patients seeking any form of medical treatment.

In particular, this would mean that each alternative treatment would have to be tested, and only if it were proved that it generated more good than harm would it be permitted. Most patients are unaware of the immense amount of testing undergone by conventional treatments, so it is worth quickly summarizing how pharmaceuticals are assessed and investigated in order to see the sort of scrutiny that we are also proposing for alternative treatments.

Regulation and associated testing procedures vary across the world, but America is home to the biggest pharmaceutical industry, and its regulations are fairly typical of those found in many developed countries. The road from early-stage research to drugs available to patients can be broken down into six stages:

1. Preclinical Research.
   Scientists test different chemicals to see if they might have a role in medicine. This is likely to involve preliminary testing on animals to see if the chemical is likely to be sufficiently safe and effective. It will also take into consideration how the chemical might be mass produced if it turns out to be useful. This takes at least five years.
   
2. Clinical Studies, Phase I.
   The potential drug is given to between 10 and 100 volunteers to investigate safety in humans. The main goal of Phase I clinical studies is to identify a safe range of dosage. This takes between one and two years and costs roughly $10 million.
   
 

3. Clinical Studies, Phase II.
   The drug is given to between 50 and 500 patients with a relevant disease. The main goal is to gauge the effectiveness of the drug in humans. At the same time it is important to establish the optimum dosage and duration of treatment for the next stage of testing. Phase II takes two years and may cost a further $20 million.
   
 

4. Clinical Studies, Phase III.
   The drug is given to hundreds or thousands of patients to determine its effectiveness and any side-effects. This usually involves randomized clinical trials and the drug is tested against a control group receiving a placebo or the best existing drug. For thoroughness, Phase III may involve two independent studies. It might generate a further stage of research if the drug seems to be effective only for a subset of patients, such as those in the early stages of the disease. Phase III takes three to four years and may cost $45 million.
   
 

5. Review by Food and Drug Administration (FDA).
   If Phase III has been successful, then it is possible that news of a breakthrough will reach the public. Before the drug is made available, however, the evidence has to be reviewed by the FDA in America, and its counterparts elsewhere, such as the European Agency for the Evaluation of Medicinal Products. This takes a further one or two years.
   
 

6. Post-marketing Surveillance.
   Even when the drug has passed all the tests and is being prescribed or sold over the counter, doctors will still be alert to any adverse reactions and report them to the FDA. This ongoing monitoring is important just in case there is a small risk that was not identified at Phase III.