Dr. Paul Offit, the Chief, Division of Infectious Diseases at Children’s Hospital of Philadelphia has authored a new book, Do You Believe in Magic? The Sense and Nonsense of Alternative Medicine (Harper, 2013) Now on the stump, he encourages thinking more critically about health care treatments. Too bad his is a one-sided view. And that his intended audience is unlikely to be convinced because health information has been increasingly available over the last twenty-five years. Nor do many physicians and prominent medical organizations subscribe to his views (although a few legislators do.)
“People are systematically choosing to manage their own health in a way that is unprecedented,” points out James S. Turner, Chairman of Citizens for Health, a health advocacy group with over one hundred thousand members. “The conventional treatments that Offit champions are often very helpful. The problem is that the industry has oversold them, and more and more people see that now.”
If Offit’s book had aimed to explore all health options even-handedly for their upsides and their downsides, it might have truly advanced the conversation about how to better health and lower health care costs. (And ranking below sixteen developed nations across the life span and for all income levels, http://www.theatlantic.com/health/archive/2013/01/new-health-rankings-of-17-nations-us-is-dead-last/267045/ while stuck in the midst of a polarized debate over costs and coverage, the U.S. sorely needs that conversation.) But instead in his book and media tour, Dr. Offit plays the predictable role of debunker, single-mindedly championing his own medical brand. Unfurling an arch skepticism towards the use of herbs and other nutritional supplements, for example, Offit presents himself as the stalwart for science. But it’s instructive to see what happens when he encounters someone conversant with the health literature.
In a radio exchange with NPR reporter Ira Flatow and Victoria Maizes, MD on Science Friday http://sciencefriday.com/segment/07/05/2013/is-alternative-medicine-really-medicine.html, Offit targeted St John’s Wort. Based on a single study, he dismissed its efficacy. Victoria Maizes, MD, the Executive Director of the Arizona Center for Integrative Medicine and a Professor of Medicine and Public Health at the University of Arizona countered with a 2008 review of 29 trials—including seventeen that compared SWJ to standard anti-depressants, and found it just as effective for moderate depression— with fewer side effects.
Upon hearing this key finding, Offit never paused for breath before he redirected to attack some other hapless herb. There is an extensive scientific literature on St. John’s Wort (and other nutrients available in supplements) but Offit cherry picks the few studies that validate his concerns that supplements are dangerous.
Say your body needs lycopene and the lycopene content typically found in tomatoes has been depleted by conventional agriculture practices. If you get lycopene from eating a tomato, or even five tomatoes, you’re not trespassing onto the sacred ground of medicine.
But if you take a lycopene capsule, you have stepped over a line, Offit and company claim. If conventional medicine were producing such terrific results, perhaps more people would be eager to see what pharmaceutical research would do with that lycopene, beyond spending millions on a special extraction of the active ingredient to make it available only by prescription at sky high prices.
The 1994 battle for the Dietary Supplement Health and Education Act (DSHEA) was fought to protect the public right to access low harm supplements. It’s is one of the most successful citizen-driven movements of the late 20th century, which activated nearly two million people to contact their legislators. The popular will has thus far opposed and defeated Big Pharma in its ongoing campaign to regulate supplements as drugs.
The Rationale for Supplement Use
With an obesity epidemic and millions of people eating sweets, soda, and fast foods, there’s little reason to pretend that all Americans consume a healthy diet. Moreover, USDA data reveals that the nutrient quality in even healthy foods has declined due to depleted soils. A comparison of nutrient values in food grown in the years 1950 and 1999 reveals declines of key nutrients and protein in forty-three foods. http://www.jacn.org/content/23/6/669.short
This is due in part to conventional agricultural practices. “In hundreds of studies, scientists have shown that incrementally higher levels of fertilizer negatively impact the density of certain nutrients in harvested foodstuffs, hence the name, the ’dilution [of nutrients] effect,’” said Dr. Preston Andrews, PhD, of Washington State University in a 2009 presentation on the impact of conventional agricultural practices on food quality.
Alan Gaby, MD, an expert on supplementation and the author of The Natural Pharmacy: Complete A-Z Reference to Natural Treatments for Common Health Conditions, says that “people who consume foods grown on deficient soils may not obtain sufficient amounts of trace minerals like selenium, iodine, chromium, or manganese in their diet.”
Gaby further points out that many common foods contribute to nutritional depletion. (So do drugs.) According to several studies, caffeine consumption can contribute to calcium loss. which can be mitigated by calcium supplementation other research found.
High sugar consumption prompts urinary excretion of chromium, one study found, while a USDA study found that chromium intake helped to improve glucose tolerance in people with diabetes.
These are just a few examples of the extensive literature that reveals both the reasons many may have nutritional deficiencies, and the benefits of using micronutrients from foods to correct them.
Who Takes Supplements?
In 2008, the CDC and the National Center for Complementary and Alternative Medicine (NCCAM) found that that natural nutritional products are the most commonly used “integrative” health approach. A 2007 Council for Responsible Nutrition (CRN) survey found that 68 percent of adults (over 150 million Americans) report taking nutritional or dietary supplements.
Medical opinion has converged on some supplementation as essential. “For women of childbearing age, every single national medical organization agrees,” says Maizes. “The US Preventive Task Force, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American College of Obstetrics and Gynecology all advise that women of child bearing age should be taking a multivitamin with folic acid to prevent neural tube defects, heart defects, skeletal defects, and cleft palate.”
According to Maizes, who is also the author of author of Be Fruitful: The Essential Guide to Maximizing Fertility and Giving Birth to a Healthy Child (Scribner, 2013), “The Nurses’ Health Study found that among those taking a multi-vitamin six times per week, there was 41% less infertility, fewer miscarriages, and less cancer in their children.” She points out that, “The CDC says that 75% of Americans don’t get enough folate. Dr. Offit is out there countering a science based public health message.”
What causes Offit’s disquiet? He quotes Yale neurologist Steven Novella on herbal remedies, “Herbs are drugs and can be studied be studied as drugs.” He would like to see supplements studied and regulated as drugs.
Even though the FDA does regulate supplements as food products, and they are currently the most highly regulated food products. The FDA cannot regulate either BPA or mercury because they are “grandfathered” into use. The FDA chooses not to regulate personal care products, or cosmetics. The FDA does not bother to study the safety of GMOs, or the chemicals used in fracking, but according to Offit’s book, certain FDA officials are miffed that they can’t regulate vitamin C, a component of food found in many fruits and vegetables, as a drug.
Before conferring the special status of drug-hood on a lowly herb, (or other food ingredient) it’s fair to ask whether drugs and nutrients are equivalently dangerous and therefore require the same extensive and costly drug trials to assure their safety for use.
Take too much vitamin C and you might get a loose bowel movement. Take too much of a statin drug and you might get liver damage or kidney failure. That’s just one example of the difference in risk between high harm and low harm ingredients. Drugs are heavily studied and regulated because they are high harm— highly toxic single novel chemicals devised in a lab for a high potency targeted use with mechanisms of action and side effects new to the human organism. Basic nutrients from foods and plants are low harm because they are natural complexes of ingredients with long histories of biological compatibility with humans.
It’s therefore not surprising that the number of adverse events reported to the FDA due to the use of pharmaceuticals number a total of 2,739,254 for the years 2008 through 2011, while those for supplements number 6,307 for the same years, according to a March 2013 report by the General Accounting Office. (This data cannot tell us what any given report was about, or its validity.)
Nevertheless, in an apparent quest to reassert the conventional monopoly on health authority, Offit wants every nutrient to be vetted like a drug by an RCT—the randomized controlled double-blind trial considered the gold standard of evidence-based medicine. In his view, just like drugs, vitamins, minerals, and herbs are dangerous until proven innocent.
There are three key problems with Offit’s caring caution. What he’d like to see is:
1. Impossible. Conducting an RCT of every edible component in nature will never happen because going through the FDA study and review process typically costs $100 million per component. No one with the money to spend has the incentive to study natural substances that cannot by law be patented.
2. Unnecessary. RCTs came into use to assess the benefits/risk ratio of novel highly toxic chemicals, namely drugs. An existing and growing body of literature studies nutritional supplements for their utility and efficacy in less costly ways.
3. It’s colonial. Unless every edible natural substance in existence, many safely consumed or used by humans for millennia, can be colonized and vetted by a recently devised process designed to test drugs, they are assumed to be harmful? That’s empire building, not empirical science.
According to Jim Turner, “Dr. Offit’s form of science is like taking a flashlight into the attic and shining it on an old photo album. That’s good. But Dr. Offit goes off track when he contends that there’s nothing else up there in the attic. It’s a specific belief system: He believes that all that exists is that which falls into the range of his flashlight.”
According to Maizes, many kinds of health levers will never be visible within the range of that flashlight. “We can’t do a double blind study on the effects of yoga. People know if they are doing yoga or not. We can’t expose one group to toxic chemicals in order to study the effects on them. Nor can we put people into a nutrition lab for decades to see if eating a specific diet makes a difference. Therefore, we need observational trials and that means we have to be open to other kinds of scientific data.” Maizes maintains that it makes sense to use a hierarchy of evidence—the more harmful the ingredient the stricter the assessment of safety for use.
Offit claims that he accepts all health treatments that work and even deigns to dub those that do as “medicine.” Nevertheless, he devotes an entire book chapter to deploring the inclusion of integrative medicine into medical centers nation wide. He chides the public for influencing their doctors to consider integrative approaches, and is piqued by doctors listening to patients.
Some of the most prominent medical institutions don’t share his view.
When the Consortium of Academic Health Centers for Integrative Medicine first formed in 2000, there were eight centers with active programs. Over a dozen years later, there are fifty-six, nearly half of the nearly one-hundred-twenty five medical schools in North America, which belong to the Consortium and have integrative programs. Harvard, UCLA, Duke, Michigan, Albert Einstein, and more, all have programs with the strong support of their medical college deans. Hardly a rejection of integrative health approaches. Moreover, many doctors use these approaches themselves.
A 2007 study conducted by the Council for Responsible Nutrition (CRN) found that 72 percent of physicians and 89 percent of nurses personally use vitamin, mineral, herbal, and other supplements. Eighty-five percent of these providers recommend supplements to their clients. Among the 28 percent of physicians who don’t personally use supplements, 62 percent recommend them to their patients nevertheless.
With our without RCTs, both the scientific and clinical evidence— and their own health experiences— appear to be persuasive. Are the parameters for evidence-based medicine expanding, even though some holdouts (like Dr. Offit) haven’t gotten the memo?
“There are no guarantees in medicine. You can do every aggressive treatment for cancer and still die. No one would tell anyone that they have a 100% chance of survival with any treatment,” Maizes says. “There’s a multi-billion dollar industry implanting stents in people when studies show it does not enhance survival.”
Despite the recurrent rallying call to evidence based medicine, less conventional practice is based upon it than people realize. A 2009 study published in JAMA http://www.ncbi.nlm.nih.gov/pubmed/19244190 found that only nineteen percent of the most basic cardiovascular treatments (or devices) are based on RCTs.
“There’s a double standard when it comes to integrative approaches, bolstered by the myth that everything in conventional medicine is proven and nothing in integrative medicine is. But the reality is subtler,” says Maizes. “In health care, we always need more study. If a study only goes up to people aged sixty-five—is it relevant for an eighty year old? We can’t say for sure. For years we only had studies on men and told women to do the same thing even though women respond differently. We will never have all the evidence.”
In this context, with plenty of standard medicine used in practice failing to meet this exalted RCT standard, Offit’s demand for it sounds much more like a call to brand loyalty. And if he’s truly interested in seeing more science on nutrients, he can always look into the existing literature.