Pioneering treatment or quackery? How to decide

My mother was only slightly older than I am now when she died of emphysema (chronic obstructive pulmonary disease). It’s a progressive condition for which there is no cure, though it can be managed by use of inhalers and oxygen. I am still angry at the discomfort she endured in her last years, as she turned from one alternative practitioner to another. It started with a zealous nutritionist who was a pupil of hers. He had a complicated list of foods she should avoid: I don’t remember much about the details, except that when she was in hospital I protested at the awful meal she’d been given - unadorned pasta and peas - only to be told that this was at her request. Meat, sauces, fats, cheese were all off the menu. My mother was a great cook who enjoyed good food, but she was seriously underweight and the unappetising meals were not helping. In that last year she also tried acupuncture, which she did not enjoy: she told me how it involved lying freezing on a couch having needles prodded into her stick-like body. Homeopathy was another source of hope, and the various remedies stacked up in the kitchen. Strangely enough, spiritual healing was resisted, even though my Uncle Syd was a practitioner. That seemed too implausible for my atheistic mother, whose view was: “If there is a God, why did he make us intelligent enough to question his existence?”

From time to time, friends and relatives of mine have asked my advice about other treatments that are out there. There is, for instance, the Stem Cell Institute in Panama, offering treatment for multiple sclerosis, spinal cord injury, osteoarthritis, rheumatoid arthritis, other autoimmune diseases, autism, and cerebral palsy.  Or nutritional therapist Lucille Leader,  who has a special interest in supporting patients with Parkinson's Disease, Multiple Sclerosis and Inflammatory Bowel Disease. My mother would surely have been interest in AirEnergy, a “compact machine that creates 'energised air' that feeds every cell in your body with oxygen that it can absorb and use more efficiently”.

Another source of queries are parents of the children with neurodevelopmental disorders who are the focus of my research. If you Google for treatments for dyslexia you are confronted by a plethora of options. There is the Dyslexia Treatment Centre, which offers Neurolinguistic Programming and hypnotherapy to help children with dyslexia, dyspraxia or ADHD. Meanwhile the Dore Programme markets a set of “daily physical exercises that aim to improve balance, co-ordination, concentration and social skills” to help those with dyslexia, dyspraxia, ADHD or Asperger’s syndrome. The Dawson Program offers vibrational kinesiology to correct imbalances in the body’s energy fields.  I could go on, and on, and on….

So how on earth can we decide which treatments to trust and which are useless or even fraudulent? There are published lists of warning signs (e.g. ehow Health, Quackwatch), but I wonder how useful they are to the average consumer. For instance, the cartoon by scienceblogs will make skeptics laugh, but I doubt it will be much help for anyone with no science background who is looking for advice. So here’s my twopennyworth. First, a list of things you need to ignore when evaluating a treatment.

1. The sincerity of the practitioner. It’s a mistake to assume all purveyors of ineffective treatments are evil bastards out to make money of the desperate. Many, probably most,  believe honestly in what they are doing. The nutritionist who advised my mother was a charming man who did not charge her a penny - but still did her harm by ensuring her last months were spent on an inadequate and boring diet. The problem is if practitioners don’t adopt scientific methods of evalulating treatments they will convince themselves they are doing good, because some people get better anyway, and they’ll attribute the improvement to their method.

2. The professionalism of the website. Some dodgy treatments have very slick marketing. The Dore Treatment, which I regard as of dubious efficacy, had huge success when it first appeared. Its founder, Wyford Dore was a businessman who had no background in neurodevelopmental disorders but knew a great deal about marketing. He ensured that if you typed ‘dyslexia treatment’ into Google his impressive website was the first thing you’d hit.

3. Fancy-looking credentials. These can be misleading if you aren’t an expert - and sometimes even if you are. My bugbear is ‘Fellow the Royal Society of Medicine’, which sounds very impressive - similar to Fellow the Royal Society (which really is impressive).  In fact, the threshold for fellowship is pretty low, so much so that fellows are told by the RSM that they should not use FRSM on a curriculum vitae. So when you see this on someone’s list of credentials, it means the opposite of what you think: they are likely to be a charlatan. It’s also worth realising that it’s pretty easy to set up your own organisation and offer your own qualifications. I could set up the Society of Skeptical Quackbusters and offer Fellowship to anyone I choose. The letters FSSQ might look good, but carry no guarantee of anything.

4. Testimonials. There is evidence (reviewed here) that humans trust testimonials far more than facts and figures. It’s a tendency that’s hard to overcome, despite scientific training. I still find myself getting swayed if I hear someone tell me of their positive experience with some new nutritional supplement, and thinking, maybe there’s something in it. Advertisers know this: it’s one thing to say that 9 out of 10 cats prefer KittyMunch, but to make it really effective you need a cute cat going ecstatic over the food bowl. If you are deciding whether to go for a treatment you must force yourself to ignore testimonials. For a start, you don’t even know if they are genuine: anyone who regards sick and desperate people as a business opportunity is quite capable of employing actors to pose as satisfied customers. Second, you are given no information about how typical they are. You might be less impressed by the person telling you their dyslexia was cured if you knew that there were a hundred others who paid for the treatment and got no benefit. And the cancer patients who die after a miracle cure are the ones you won’t hear about.

5. Research articles. Practitioners of alternative treatments are finding that the public is getting better educated, and they may be asked about research evidence. So it’s becoming more common to find a link to ‘research’ on websites advertising treatments. The problem is that all too often this is not what it seems. This was recently illustrated by an analysis of research publications from the Burzynski clinic, which offers the opportunity to participate in expensive trials of cancer treatment. I was interested also to see the research listed on the website of FastForword, a company that markets a computerized intervention for children’s language and literacy problems. Under a long list of Foundational Research articles, they list one of my papers that fails to support their theory that phonological and auditory difficulties have common origins. More generally, the reference list contains articles that are relevant to the theory behind the intervention, but don’t necessarily support it. Few people other than me would know that. And a recent meta-analysis of randomized controlled trials of FastForword is a notable omission from the list of references provided. Overall, this website seems to exemplify a strategy that has previously been adopted in other areas such as climate change, impact of tobacco or sex differences, where you create an impression of a huge mass of scientific evidence, which can only be counteracted if painstakingly unpicked by an expert who knows the literature well enough to evaluate what’s been missed out, as well as what’s in there. It’s similar to what Ben Goldacre has termed ‘referenciness’, or the ‘Gish gallop’ technique of creationists. It’s most dangerous when employed by those who know enough about science to make it look believable. The theory behind FastForword is not unreasonable, but the evidence for it is far less compelling than the website would suggest.

So those are the things that can lull you into a false sense of acceptance. What about the red flags, warning signs that suggest you are dealing with a dodgy enterprise? None of these on its own is foolproof, but where several are present together, beware.

1. Is there any theory behind the intervention, and if so is it deemed plausible by mainstream scientists? Don’t be impressed by sciency-sounding theories - these are often designed to mislead. Neuroscience terms are often incorporated to give superficial plausibility: I parodied this in my latest novel, with the invention of Neuropositive Nutrition, which is based on links between nutrients, the thalamus and the immune system. I suspect if I set up a website promoting it, I’d soon have customers. Unfortunately, it can be hard to sort the wheat from the chaff, but NHSChoices is good for objective, evidence-based  information. Most universities have a communications office that may be able to point you to someone who could indicate whether an intervention has any scientific credibility.  
2. How specific is the treatment? A common feature of dodgy treatments is that they claim to work for a wide variety of conditions. Most effective treatments are rather specific in their mode of action.
3. Does the practitioner reject conventional treatments? That’s usually a bad sign, especially if there are effective mainstream approaches.
4. Does the practitioner embrace more than one kind of alternative treatment? I was intriguted when doing my brief research on Fellows of the Royal Society of Medicine to see how alternative interventions tend to cluster together. The same person who is offering chiropractic is often also recommended hypnotherapy, nutritional supplements and homeopathy.  Since modern medical advances have all depended on adopting a scientific stance, anyone who adopts a range of methods that don’t have scientific support is likely to be a bad bet.
5. Are those developing the intervention cautious, and interested in doing proper trials?  Do they know what a randomised controlled trial is? If they aren’t doing them, why not? See this book for an accessible explanation of why this is important.
6. Does it look as though those promoting the intervention are deliberately exploiting people’s gullibility by relying heavily on testimonials? Use of celebrities to promote a product is a technique used by the advertising industry to manipulate people’s judgement. It’s a red flag.
7. Are costs reasonable?  Does the website give you any idea of how much they are, or do you have to phone up for information? (bad sign!). Are people tied in to long-term treatment/payment plans? Are you being asked to pay to take part in a clinical trial? (Very unusual and ethically dubious). Do you get a refund if it doesn’t work? If yes, read the terms and condition very carefully so you understand exactly the circumstances under which you get your money back. For instance, I’ve seen a document from the Dore organisation that promised a money-back guarantee on condition there was ‘no physiological change’. That was interpreted as change on tests of balance and eye movements. These change with age and practice, and don’t necessarily mean a treatment has worked. Failing to improve in reading did not qualify you for the refund.
8. Can the practitioner answer the question of why mainstream medicine/education has not adopted their methods? If the answer refers to others having competing interests, be very, very suspicious. Remember, mainstream practitioners want to make people better, and anyone who can offer effective treatments is going to be more successful than someone who can’t. 

The weird world of US ethics regulation

There has been a lot of interest over the past week in the Burzynski Clinic, a US organisation that offers unorthodox treatment to those with cancer. To get up to speed on the backstory see this blogpost by Josephine Jones.

As someone who spends more of my time than I’d like grappling with research ethics committees, there was one aspect of this story that surprised me. According to this blogpost, the clinic is not allowed to offer medical treatment, but is allowed to recruit patients to take part in clinical trials. But this is expensive for participants. The Observer piece that started all the uproar this week described how a family needed to raise £200,000 so that their very sick little girl could undergo Burzynski’s treatment.

I had assumed that this trial hadn’t undergone ethical scrutiny, because I could not see how any committee could agree that it was ethical to charge someone enormous sums of money to take part in a research project in which there was no guarantee of benefit. I suspect that many people would pay up if they felt they’d exhausted all other options. But this doesn’t mean it’s right.

I was surprised, then, to discover that the Burzynski trial had undergone review by an Institutional Review Board (IRB - the US term for an ethics committee). A letter describing the FDA’s review of the relevant IRB is available on the web. It concludes that “the IRB did not adhere to the applicable statutory requirements and FDA regulations governing the protection of human subjects.”  There’s a detailed exposition of the failings of the Burzynski Institute IRB, but no mention of fees charged to patients. So I followed a few more links and came to a US government site that described regulatory guidelines for ethics committees, which had a specific section on Charging for Investigational Products. It seems the practice of passing on research costs to research participants is allowed in the US system.

There has been considerable debate in academic circles about the opposite situation, where participants are paid to take part in a study. I know of cases where such payments have been prohibited by an ethics committee on the grounds that they provide ‘inducement’, which is generally regarded as a Bad Thing, though there are convincing counterarguments. But I am having difficulty in tracking down any literature at all on the ethics of requiring participants to pay a fee to take part in research. Presumably this is a much rarer circumstance than cases where participants are paid, because in general people need persuading to take part in research. The only people who are likely to pay large sums to be a research participant are those who are in a vulnerable state, feeling they have nothing to lose. But these are the very people who need protection by ethics committees because it’s all too easy for unscrupulous operators to exploit their desperation. Anyone who doesn’t have approval to charge for a medical treatment could just redescribe their activities as a clinical trial and bypass regulatory controls. Surely this cannot be right.