Erik Goldman03.01.08
Monkey See, Monkey…….Don’t!
Rather than mirror big pharma, and capitalize on their losses, we must come up with remedies that truly do what drugs cannot do.
ByErik Goldman
Findings from the ENHANCE (Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression) study showing that the cholesterol-lowering combo-drug Vytorin (Zetia plus Zocor) did not reverse coronary artery atherosclerosis, despite the expected lowering of LDL cholesterol, have sent shockwaves through the medical community.
Cardiologists, shaking their heads in disbelief, are struggling to explain the results, while primary care doctors struggle with what to tell their suddenly suspicious patients. The public relations wings of Merck and Schering-Plough, the joint owners of Vytorin, are no doubt burning the midnight oil trying to find a salvaging spin to convince the public that this med still has merits. The fact that the drug makers sat on the ENHANCE data for two years before finally releasing it—a delay that prompted a Congressional investigation—certainly doesn’t help their case.
Meanwhile plaintiff’s attorneys sharpen their swords, investors watch those Merck and Schering stocks plummet, and executives at other pharmaceutical giants watch nervously for collateral damage to their own cholesterol-lowering properties.
Like the broadly publicized Women’s Health Initiative study six years ago, showing that hormone replacement with estrogen and progesterone actually increased rather than decreased post-menopausal womens’ risk of breast cancer and cardiovascular disease, the ENHANCE findings run directly counter to a sacred axiom of modern allopathic medicine: that elevated LDL cholesterol is a primary driver of atherosclerosis, and that lowering LDL—by any means necessary—will inevitably reduce atherosclerosis and decrease heart attack risk.
Such studies inevitably provoke a crisis of faith among patients and doctors alike: An expected benefit, one that was all but guaranteed, somehow proves elusive. In the case of Vytorin, the impact is huge given that literally millions of people were, and are still, taking this drug. According to pharma industry score-keeper, ImpactRx, a company that tracks drug prescription rates, primary care doctors were putting 15% of all first-time cholesterol drug users on Vytorin in the months prior to the ENHANCE release. The figure dropped to 5% in the week following the release.
But the ENHANCE data challenge more than just Vytorin; they challenge the entire cholesterol-lowering enterprise. The Merck/Schering official statements following the ENHANCE release very rightly point out that the study shows that the drug does exactly what its makers claim it will do: maximally lower LDL cholesterol. But people don’t pay big money for these drugs because they want to lower some blood lipid or other, they take them because they want to avoid dying prematurely of a heart attack. If maximally lowering LDL does not reduce atherosclerotic plaque thickness, can we still safely assume that it will reduce heart attack incidence?
Maybe yes, maybe no. We’ll have to wait for data from the IMPROVE-IT study—another Merck-Schering sponsored trial looking at whether the combination of Zetia (ezetimibe) and Zocor (the two components of Vytorin) will actually reduce heart attacks, strokes, and untimely deaths better than Zocor (simvastatin) alone—to find out. Data from that trial won’t be available for a few more years. For the moment, the cholesterol-equals-heart attack hypothesis is not quite as ironclad as it once seemed.
Even within mainstream cardiology, there’s a growing awareness that lipid chemistry is only part of the heart disease story. There’s ample epidemiologic evidence that only about half of all individuals having acute myocardial infarctions and sudden cardiac deaths had high-risk lipid profiles prior to the actual events. Most conventionally trained physicians acknowledge that chronic inflammation, emotional stress, and abnormal glucose metabolism are also key factors in the emergence of heart disease.
But by and large the thrust of conventional treatment for at-risk individuals has been focused almost exclusively on lipids.
Big Pharma’s Loss is the Natural Products Industry’s Gain?
Many of us in the natural products and holistic medicine communities enjoy a secret (or perhaps not so secret) thrill when Big Pharma takes a fall. From a self-consecrated moral high-ground, we propound that we represent a kinder, gentler form of medicine unquestionably benevolent, free from potential for harm, and inherently more in tune with whatever we conceive of as “Nature.” We cherish our under-dog status, and we like it when those profit-hungry, mega-corporate big dogs on the Pharma side of the fence feel the lash.
But before we gloat, before we relish that ever-so-sweet sense of “Told You So,” it would be very good for us to reality-check our own practices and principles. In truth, the natural products industry is all too often engaged in an elaborate game of “Monkey See, Monkey Do” with Big Pharma.
The drug giants push their latest products for lowering cholesterol and blood pressure, and our industry is right there, with “natural” versions, derived from some plant or making use of some nutrient, and promoted as doing the same thing as the drugs but without the side effects. Big Pharma launches drugs that inhibit some enzyme or other involved in the biochemistry of pain and inflammation, and sure enough, there’s a natural version claiming to do the same thing only more safely. Need we even mention the massive number of “natural alternatives” to pharma-based hormone replacement?
We’ve got natural products for cholesterol-lowering, blood-pressure reduction, inflammation-quelling, fat burning, hormone control, mood-regulation, erection-inducement, pain management, smoking cessation, you name it. If there’s a drug for it, there’s very likely an allegedly natural product that is promoted as doing the same thing, only more safely, and at a lower cost. If pharma’s got one, we’ve got one too ... and ours is friendlier.
The inclination to parrot Big Pharma is easy to understand: The drug companies are, after all, very good at developing and marketing new, innovative and profitable products the public is highly conditioned to think in simplistic “ill-needs-pill” terms, and well-habituated to taking drugs, which doctors are very comfortable in recommending or prescribing.
The problem is that all-too-often we fail to ask ourselves whether the pharma solutions we’re imitating are truly healthy. Our industry rushes to market with herbal or nutraceutical alternatives to cholesterol-lowering statins, without questioning whether lowering LDL will really reduce heart attacks. Big Pharma says it does, the FDA says it does, the mainstream doctors say it does. It must be so.
Is a “natural” COX-2 inhibitor fundamentally different from the pharmaceutical COX-2 inhibitors like Vioxx? Is a natural product that lowers blood pressure really getting at the underlying causes of a person’s condition, or merely masking a symptom, just like the anti-hypertensives produced by Big Pharma? Have the makers of the myriad “natural” HRT alternatives really reckoned with the question of whether it is truly natural for a 65-year-old woman to have the hormone profile of a 30-year-old?
Mirroring what the pharmaceutical companies do is not inherently bad. The pharma giants do produce many helpful products, and it’s nice to have naturally-occurring alternatives, especially if the makers can really prove that these are as effective and truly safer.
The problem is that this mirroring all too often weds the development of natural/holistic medicine to the reductionistic way of thinking that drives allopathic medicine and pharmaceutical development. And all too often, this leads to trouble at worst, and sub optimal health at least.
Holistic and naturopathic medicine is based on fundamentally different core principles from allopathic medicine: rather than looking for solutions at ever smaller “micro” levels, they seek to restore health by addressing the relationship of the parts to the whole.
Nearly all forms of holistic medicine, from ancient systems like Ayurveda and traditional Chinese medicine through more modern approaches like biofeedback and guided imagery, acknowledge the idea of a vital force, an idea that is categorically excluded from Western allopathic thinking. Holistic approaches are founded on the notion that people have an innate capacity to heal, and that living systems will inevitably move toward health and balance given the right conditions. The specific modalities, be they nutritional, directly physical or psycho-spiritual are primarily about stimulating, nurturing and facilitating that movement toward health.
The Broader, More Holistic View
Rather than squelching symptoms and opposing the alleged causes of disease, holistic modalities are about re-balancing the various organ systems, stimulating the vital force, and strengthening an individual’s resilience. I believe the best, most innovative natural products are those that are grounded in these principles. And they deliver benefits that pharmaceuticals cannot.
Omega-3 fatty acids are a great example. Not only are they good for cardiovascular function, they’re also good for brain development. And they reduce inflammation. And they promote emotional balance and psychological well-being. Why? Because they provide all the various organ systems with substances they need for healthy function.
Probiotics are another good example. They are not “anti” anything, they simply seed the digestive system with organisms that are supposed to be there, and that produce essential substances for proper digestion, sleep regulation and immune system strength. The many whole-herb products currently available are likewise systemic in their effects, providing multiple constituent ingredients with diverse health effects.
Rather than seeking to mimic the Big Pharma blockbusters, we as an industry ought to work to define and clarify the principles that make natural medicine a true alternative, not by opposing allopathic medicine but by doing what allopathy and its pharmaceutical allies cannot do.
I once had the privilege of hearing Bill Mitchell, ND, one of the founding fathers of modern naturopathic medicine—who sadly and much too soon passed on last year—give a lecture on botanical medicine. He said that there were multiple levels of plant medicine, ranging from what he called “Green Allopathy”—which uses specific plant-derived “constituent” substances to counter symptoms—to the use of whole plant extracts to modulate multiple physiological functions and activate a person’s innate capacity for self-healing, all the way up to direct communication with the “spirits” or essences of plants, a fundamental aspect of Shamanic healing practices around the world.
Dr. Mitchell emphasized that there’s nothing morally wrong with the Green Allopathy approach; it’s just that it is based in a very limited view of both human physiology and medicinal plants, and it will run into many of the same reductionistic limitations and clinical conundrums as conventional allopathic medicine and its synthetic drug tool kit.
Plants, he said, are ancient and very complex beings. They figured out how to thrive on Planet Earth and how to transform sunlight into fuel, long before we came on the scene. They can nourish us, stimulate healing processes, and help us re-find internal and external balance. It is from this broader, more holistic view that the greater value of botanical medicine becomes apparent. The mad search for “active” magic-bullet compounds that will eliminate specific symptoms or modulate specific risk factors just like synthetic drugs, will inevitably limit that value.
As the natural products industry and holistic medical professions continue to grow and gain greater mainstream acceptance, we would do well to keep Dr. Mitchell’s teachings close to our hearts and minds.NW
Holistic Primary Care is holding its first conference, called “Heal Thy Practice: Transforming Primary Care,” October 31-November 2, 2008, at the Westin La Paloma Resort in Tucson, AZ. For more information about Holistic Primary Care or the conference, E-mail: Erik@holisticprimarycare.net.