Trick or Treatment—The Undeniable Facts about Alternative Medicine (Electronic book text)

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.

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.

These inordinate costs were cited in the journal Scientific American in 2000, so they have probably increased significantly in the last few years. Moreover, only a third of those drugs that enter Phase I trials reach the stage of New Drug Application, which allows a drug to be marketed to the public.

In short, conventional medicines have to leap over extraordinarily high hurdles, which requires a vast amount of money and time, but this level of testing is essential if the public is to be protected from harmful and ineffective drugs. Such rigorous testing should bring reassurance to patients, and it would not be unreasonable to demand similar levels of testing and regulation for alternative medicine.

There is, however, an argument that suggests that the sequence of testing for alternative medicines should be reversed. This is for the simple reason that these treatments are already widely available, whereas the pharmacological approach outlined above was developed for entirely new drugs. If millions of people are already using treatments such as herbal remedies and acupuncture, then it seems most sensible to assess the safety of these treatments based on the experiences of patients. For instance, practitioners could be asked to note the details of any adverse reactions and post them to a central database. The next priority would be to submit alternative therapies to clinical trials in order to find out for what (if any) conditions they are effective. Finally, if these tests were positive for a particular alternative therapy, scientists might investigate the mechanism behind the therapy and conduct the preclinical research.

This reversed approach puts patient safety first, because the consumer is already being exposed to alternative medicine, but it ultimately demands the same level of scientific rigour. Conducting such rigorous testing would be expensive, but remember that alternative medicine is a billion-dollar global industry, so it would not be unfair for it to devote part of its vast profits towards properly testing the products that it sells to the public. Moreover, governments already have funds for medical research, and they could act in a coordinated manner to devote a fraction of this money towards high quality clinical trials focused on the biggest selling products and the most popular therapies.

The reversed testing procedure, like the normal procedure, would take several years to complete. In the meantime, while awaiting the results, governments could require alternative remedies to carry labels and compel therapists to make disclosures that accurately reflect the existing evidence. Dylan Evans suggested exactly this idea in his book Placebo. For homeopathic remedies, he suggested the following label:

Homeopathy

Warning: this product is a placebo. It will work only if you believe in homeopathy, and only for certain conditions such as pain and depression. Even then, it is not likely to be as powerful as orthodox drugs. You may get fewer side-effects from this treatment than from a drug, but you will probably also get less benefit.

We believe that Evans’s idea has some merit, because such open, honest and accurate summaries would certainly help patients. For alternative treatments supported by evidence, the summaries would contain the sort of helpful advice that we see on conventional pharmaceuticals. For other alternative treatments, the summaries would read more like a statutory health warning, akin to those found on cigarette packets.

As we approach the final few pages of the final chapter, it is interesting to see what happens if we apply Evans’s idea to a selection of alternative therapies discussed elsewhere in this book. In some cases, the Evans-style summaries would appear on boxes of tablets, while in other cases they might appear on websites or in leaflets distributed in a clinic. And in every case, the summaries would help patients to be more aware of the evidence relating to any particular therapy.

Acupuncture