May 22 2009

License for Homeopathic Pill in UK

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Regulations for health products are increasingly becoming absurd in the US, UK and other countries. More and more there are double standards – one scientific standard for regular medicine, and then a separate fantasy-land standard for so-called alternative medicines.

Recently the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted an arnica homeopathic product a licence for the relief of sprains or bruising. This means that the product can now state on its label:

“A homeopathic medicinal product used within the homeopathic tradition for symptomatic relief of sprains, muscular aches and bruising or swelling after contusions.”

What does that mean – within the homeopathic tradition? Does this qualifier admit, in a way, that these claims are not legitimate within the scientific tradition? And, by extension, that homeopathy is not scientific? I think it does. But of course the goal is for the consumer to see the specific claims and to feel that they must be legitimate if the MHRA has allowed it.

To anyone who understand anything about science and homeopathy, this is sorry state of affairs. Homeopathy is a pseudoscientific notion that involves remedies that generally are diluted past there point where there is any active ingredient left. The prior-plausibility of homeopathy approaches zero.

In addition, we have copious amounts of clinical evidence to show that homeopathic remedies simply do not work. Edzard Ernst wrote a review of systematic reviews in homeopathy, and concluded:

In particular, there was no condition which responds convincingly better to homeopathic treatment than to placebo or other control interventions. Similarly, there was no homeopathic remedy that was demonstrated to yield clinical effects that are convincingly different from placebo. It is concluded that the best clinical evidence for homeopathy available to date does not warrant positive recommendations for its use in clinical practice.

In short, the science says that homeopathy does not work.  With regard to the specific claim here, homeopathic dilutions of the poison arnica, the evidence is also negative. This review, for example, concluded:

The claim that homeopathic arnica is efficacious beyond a placebo effect is not supported by rigorous clinical trials.

So why would a regulatory body whose job it is to protect the public from false claims for medical products allow a company to claim an effect when the science clearly shows no effect? Here is what an MHRA spokesperson had to say:

The MHRA said that the National Rules scheme was introduced to resolve an inconsistency in European legislation that meant that homeopathic products introduced before 1992 could state indications for their use, whereas remedies approved after that date could not make such claims.

There was another way to resolve the discrepancy – repeal the right to make unscientific and false claims for homeopathic remedies introduced prior to 1992.

We have the same problem in the US in that the homeopathic pharmacopeia was grandfathered in to FDA approval, so that homeopathic remedies did not have to go through testing of safety and efficacy individually to get approval.

There is now an overwhelming body of scientific evidence to show that homeopathic remedies are nothing more than placebos, which is in exact accord with the basic science which says there should be no physiological effect. Why can’t regulatory agencies acknowledge that basic fact which is supported by the vast majority of the scientific community? Until they do, they have no credibility. They are doing a disservice to the public and giving a huge and undeserved boost to quackery.

Now more than ever we need a single, rational, evidence and science-based system of regulation for health products. The public can no longer afford a double standard, where quackery gets a free ride as long as its ideological supporters and profiteers lobby loudly enough.

We are also in the midst of a health care crisis which is resulting in the rationing of care and/or huge debts because of the expense of modern medicine. Addressing this crisis will involve difficult trade-offs. But there is a win-win whenever we can increase the efficiency of health care. There is nothing more inefficient than health care interventions that do not work or are harmful. Therefore it is in everyone’s interest to purge the system of worthless interventions and outdated unscientific notions.

Homeopathy, in its entirety, should be the first to go.

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