No Evidence But The Money Keeps Rolling In

Last Sunday's Background Briefing covered Alternative Money Spinners:

They are called herbal medicines, or complementary, or alternative - but many of them are not useful and may be harmful. At the very least you are likely to be wasting money. There are legal ways in which open debate is discouraged.

A couple of EoR's favourites got coverage, including Oxygen 4 Life (which EoR has previously covered in warnings to pharmacists about it and its ludicrous claims.

Background Briefing has Latrobe University's Dr Ken Harvey rightly calling Oxygen 4 Life's claims "spurious".

It's been proven not to work in the sense that firstly that we absorb oxygen from the lungs, not from the gut; secondly, complaints about those claims have been submitted to proper authorities and the claims have been held to be spurious. So it doesn't work, yet the guys keep on claiming it, and they keep on making money and in fact they even produce more products, more recently, to make more claims.

The director of the Australian distributor claims tests proving its efficacy, but it's "tests" in the minimally qualifying sense of that word: there are only two, one of which is statistically insignificant, and the other used only 2 people, both of whom are athletes.

The other product looked at in length is Gingko biloba in cases of tinnitus and, specifically, Tebonin (EoR has previously covered Schwabe Pharma's Big Altie use of the legal system to crush any outside investigations of Tebonin's efficacy).

As you heard, and will hear more about in today's Background Briefing, there are a wide range of views on the use and effectiveness of alternative medicines. Scientists, doctors and 'quack-busters' often deride them. Alternative practitioners say their treatments are effective where Western medicine is not. But public access to information and debate about some alternative therapies can be difficult. Things may be 'commercial in confidence', or injunctions can be taken out to stop publication of certain material. The infamous SLAPP writs (that stands for Strategic Legal Action Against Public Participation) are still around. Often just a threatening letter from a lawyer will intimidate people enough to stop further questioning.

University of Otago, New Zealand, Associate Professor Cynthia Darlington points out that tinnitus is a major disease:

There's a high incidence of anxiety and depression, and suicidal ideations in people who suffer from chronic tinnitus that is perceived as being very loud.

Since Gingko biloba has been used in cases of neural damage, she looked at its effectiveness in cases of tinnitus.

After rigorous analysis of the literature, Cynthia Darlington found no evidence that Ginkgo Biloba can help people with tinnitus.

Blitzing pharmacists, Schwabe pushed its Gingko biloba product, Tebonin. When the studies of Gingko biloba and its effectiveness were questioned by Auspharm Consumer Health Watch, Schwabe didn't address their concerns, nor did they instigate more rigourous trials. They took Auspharm Consumer Health Watch to court and won their case (but not on scientific grounds):

Astonishingly, it wasn't the content of the report that was deemed at fault, it was the fact that they had sent a draft to the Therapeutic Goods Administration. The judge found that this might mean that the TGA, as regulators, would not be able to make an independent judgment. Part of the Judge's injunction closes off any future publication of any similar report by Auspharm.

Cynthia Darlington explains the way alternative therapies are promoted:

Well I'm afraid the evidence isn't so good. Part of the problem I think with studies of many of the natural remedies that have been around for a long, long time, I mean Ginkgo Biloba has been in use for 5,000 years in China, and I think one of the problems is they come in to pharmacology through the back door. You don't have the stringent testing that you have for drugs that have been deliberately developed. So they get on the market and there's a folklore around them. And that is certainly unfortunately what I have found in my review of the Ginkgo Biloba literature, is that there are a lot of studies, but when you actually read the studies carefully they're not particularly good and there are only a very few studies that have been performed properly, that is, using good scientific method, good experimental design and from those studies the results have been less than really exciting.

The reporter states

Cynthia Darlington and her colleagues at the University of Otago applied the principles of evidence-based medicine and found there is no proven benefit in taking Tebonin or other Ginkgo Biloba extracts.

EoR must take exception to this finding: there is a vast proven benefit in taking Tebonin, and it relates entirely to the income stream it generates for the alternative pharmaceutical company.

Pharmacists are on thin ice in promoting the plethora of alternative products they stock, but meaningful sanctions don't exist for offenders against what regulations do exist.

By and large, complementary or alternative medicines are regarded as low risk. All the TGA does is check they're safe, and not breaking any advertising rules. It doesn't check to see if they work.

The regulator refuses to take previous offences into account when a complaint is made, every complaint being a one off with some companies becoming repeat offenders since the sanctions provided are ineffectual.

So if the regulator isn't checking herbal products to see if they work, who is? Well, no-one. The Federal Health Department says it does random and targeted audits of the evidence held by drug companies for the effectiveness of their products.

Dr Ken Harvey again:

I have no problem that there is much more to medicine than swallowing chemicals, that the more holistic approach, the interaction of the physician or the health worker and a patient, spiritual aspects etc., these are obviously all important, harder to measure together. But we're not really talking about that in the promotion of these complementary medicines. These are sponsors that are taking herbs that are quite often simply isolating the particular herb, sometimes combining two or three, and they are promoting it as a Western medicine according to Western scientific traditions, and therefore I would argue that they need to be evaluated by those traditions.

Clearly, Schwabe Pharma is unswayed by criticisms, and published a newspaper article in Australia this week, in the format of a news article, claiming

scientifically and clinically proven in numerous published studies [...] Many scientific studies on EGb 761^*, including numerous human clinical trials have led to the acceptance and success of the Gingko biloba extract.