The Lost Key

Photo courtesy Bob Wong

Photo courtesy Bob Wong

Nasdrudin, the 600 year-old holy fool, was once seen on his hands and knees at night on the street, looking for something in the full moonlight in front of his neighbor’s house. When questioned by his neighbors, Nasrudin explained that he had lost his key. Everyone got down on their hands and searched with him. After many minutes, the key had still not been found. “Are you sure it’s here, Nasrudin?” someone asked. “Actually, it’s over by my front door somewhere. There’s just more light right here.”

Western medicine is having a Nasrudinesque moment. A few months ago, it was confirmed that along the Thai-Burmese border, malaria has begun to develop resistance to the latest anti-malaria medication a mere 11 years since its promotion by the WHO to the first-line treatment for the tropical parasite. Drug resistance in malaria is not a new concern; every previous medication used against the parasite has decreased in effectiveness because of it. In this case, however, the news is especially troubling. First, because the drug has few side-effects compared to previous anti-malaria medications, and it is relatively cheap to manufacture. More disturbing is that the drug, artemisinin, is derived from a traditional Chinese herbal medicine staple, Artemisia annua (qing hao), which has been documented in the treatment of malaria since the second century AD. In other words, as Artemisia, a whole plant-based medicinal tea, the medicine defeated malaria for nearly two millennia. As artemisinin, a single compound derived from the plant (and its related synthetic analogues), the drug began to fail only 40 years since its first discovery in 1972.

This was not unexpected. As mentioned, previous anti-malaria drugs had suffered the same fate. In fact, in order to head off this resistance, artemisinin was paired with other drugs to form a combination therapy or “cocktail” called ACT. This strategy became mainstream in the 1990’s with antiretroviral (HIV) drugs, and has made HIV a manageable health issue for those infected now that HIV cannot so readily form resistance to the more complex pharmaceutical assault of the drug cocktails. The problem is that, in Asia, artemisinin is so much cheaper than the other components (being plant-derived), it is often sold by traders and given prophylactically as a monotherapy, thereby engendering resistance.

The irony here is that Artemisia annua, as a whole herb, was already being taken as a de facto “drug cocktail” prior to the discovery of artemisinin. Like most herbal medicines, it is a plant with many constituent chemicals, some of which, such as the essential oils, have their own anti-microbial activities. This is most likely the reason the malaria parasite failed to develop resistance to the plant over its extensive period of use prior to the synthesis of artemisinin.

So why didn’t the WHO simply recommend the use of the whole plant extract to begin with? Because of the biomedical drug model, which requires exact dosages and methods of administration not subject to the natural fluctuation of the various “active ingredients” present in a whole plant extract. Herbal medicine is considered folkloric, imprecise, and impossible to test in clinical studies because of the inherent fluctuations in the exact qualities inherent in any natural product, even if, with all these caveats, the herbal version of the same medication is anecdotally more effective or has fewer side effects.

But are these objections to herbs even valid? Is it true that herbal medicine is too imprecise to study effectively and, therefore, to recommend in standard biomedical care? It doesn’t have to be. Even if certain constituent chemicals in an herb are not extracted from the herb to form a drug, they can still be used as a marker to assess the relative strength of a particular batch of an herb. Various batches can then be blended and the end product given a guaranteed of potency within a certain range. In my own practice, for example, I use a whole-herb freeze-dried extract of St. John’s Wort to treat many of my patients with depression. The company that manufactures the capsules gives a certain range for the potency based on the presence of hyperforin, a chemical that is often extracted and either added back to a whole herb base or used alone as a “standardized extract.” Unfortunately, I find that when hyperforin is standardized (i.e. separated and given in an exact dose apart from the other parts of the plant), the number of side-effects (such as headache and stomach upset) go up. In contrast, the whole herb has rarely given my patients side-effects while being, in my experience, just as effective.

Chinese herbal medicine is even more difficult to integrate into the biomedical model, because it uses formulations of two to twenty different herbs. Quite a cocktail! And though the cocktail model is conditionally accepted for anti-retroviral and anti-parasitic treatments, evaluating a product as a combination therapy without first approving each individual ingredient is not how pharmaceuticals are brought to market. But some studies have been done, and the results have been extremely promising. Two studies in the past decade at Mt. Sinai hospital in New York City have tested traditional Chinese herbal formulas for asthma and for peanut allergies. In both cases, the formulas were found to be effective without the side-effects of comparable drug therapies. In the case of the peanut-allergy formula (code-named FAHF-2), it was found to suppress anaphylactic reactions – life-threatening allergic reactions in which the airways can potentially close - for up to 9 months after discontinuation of the herbs, and not only for peanuts, but for tree nuts,

fish, shellfish, tree nuts. The formula has been given investigational new drug approval by the FDA and is in human trials.

In other words, whole-herb ingredients, and complex mixtures thereof, are no impediment to researching and producing effective medicines. They can, in fact, be more effective in some cases, not only because of the immediate benefits (lower incidents of side-effects) on current populations but because of the long-term efficacy over generations that these “combination therapies” are capable of, especially the anti-microbial and anti-viral formulas and herbs. Since they are always mixtures, acting on microbes from multiple avenues, it is virtually impossible for resistance to form.

So why aren’t drug companies manufacturing these herbal drugs and combinations, and why aren’t doctors prescribing them? It is because natural, unrefined ingredients cannot be patented. Simply put, they aren’t as profitable. This is not just the case with herbs, by the way. Minerals and supplements that do not come out of a lab are also less profitable. An example is strontium. Strontium is a benign element found in our bones and proven since the 1950’s to cure osteoporosis. But it has languished at the margins of healthcare while osteoporosis drugs have made drug companies rich even while causing horrifying side-effects such as disintegrated jawbones and deadly hip fractures. Until recently, that is, when a synthetic molecule was developed that could attach to strontium and produce identical results to the mineral, but in patentable form. Studies have shown it to increase bone mass with almost no side-effects. The drug has not yet come to market, so it cannot yet be prescribed. You can, of course, go to the healthfood store and buy strontium, plain-old strontium, and immediately begin rebuilding your bones, but your doctor may not approve, since the FDA has not given the mineral its seal of approval. No drug rep has dropped off samples, no medical school is teaching its benefits. And no one is making much money off it. Even if it is remarkably effective.

I know, I know: sounds too good to be true! And if I hadn’t seen multiple patients increase their bone densities over the past four years, going from osteoporosis to osteopenia and osteopenia to normal,  right there in the boring black-and-white of bone density lab results, I wouldn’t have believed it either. Originally, I had suggested strontium supplements to some of my patients after they had discontinued their prescribed medications in fear of the side-effects then coming to light. Strontium is unbelievably cheap, costing about $15 per month, and I had read the literature on its history and extensive study (thanks, internet!), so it was the obvious choice. And I know now that my patients’ physicians have also seen these results, and that they are aware that these wonderful results are undoubtedly due to the ingestion of a boring mineral. But I am not so certain that strontium is now being prescribed by these physicians, because it is a mineral – because it is not a drug. Its use has little peer support among doctors, its recommendation is not part of standard practice, it is not pushed in expense-paid conferences, it does not have FDA drug approval to treat any illness, and it does not reside in the blessed bins behind the pharmacy counter. The only thing it has going for it is that it is harmless and more effective than the toxic and potentially deadly drugs that compete with it. So I don’t have high hopes.

Because profit, not efficacy, is the great shining streetlamp of drug development. Beneath its glow is where the multinational corporations who produce most medicines look for their new products, not the dimmer, less lucrative areas where cures may more likely be found. And the FDA and our physicians are right there next to them, on hands and knees, going around in circles empty-handed. Even more troubling, as the story of artemisinin illustrates, that which has been found may be lost again, forever. At least 50% of the herbal medicine I prescribe is for viral and bacterial infections, primarily cold, flu, bronchitis and sinusitis. The formulas, if chosen correctly, can be quick-acting and effective, both to prevent the development of viral illnesses, but also to treat them or the bacterial illnesses that can develop (such as sinusitis) subsequent to them. Remarkably, the formulas, and their constituent herbs, have been in use for hundreds of years, just like qing hao, and have retained their efficacy. I rely on this for myself and my patients, this lack of resistance to my herbs. And I lay awake at night wondering which enterprising drug company is systematically studying these same herbs to find marketable chemicals to extract, study, and synthesize from these trusted plants, looking for the money molecule to profit from for five to ten years until it has exhausted its potential, engendered resistance, and is discarded onto the drug heap of history. Because it has already happened, over and over again.

All the antibiotics we have developed since penicillin have become less effective over the years – every single one of them – and almost all of them were derived from natural sources. Each time this happens, millennia of evolution meet their end and we are poorer in health as a result. And someday, inevitably, Chinese herbs will be exploited and accorded the same fate as these other compounds, rendered useless after hundreds of years of good service to humanity. And this will be described in the medical press as inevitable, as the standard saga of any antiviral or antibiotic, doomed to failure, because single molecules – pharmaceuticals – always beget resistance. Unless we change the drug model. Unless we accept a certain amount of imprecision, mess, and lower profit in order to safeguard the health of our species in future generations.

This is the key.

 

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The Lost Key • Written by Benjamin Hawes