In 2011, Americans spent some $30 billion on dietary supplements. Yet, except for the industry itself and a few politicians and “health freedom” advocates, you’d be hard pressed to find anyone (who’s given it some thought) of the opinion that dietary supplement regulation is adequate. Three recent reports, two from the government and one from a newspaper, demonstrate why this near-universal conclusion is warranted.
Another government report on lax supplement regulation
Here’s how an October, 2012, Department of Health and Human Services Office of Inspector General’s (OIG) report described the FDA’s regulatory authority:
DSHEA [Dietary Supplement Health and Education Act] does not require manufacturers to submit dietary supplements to FDA for safety or approval prior to sale. As a result, FDA has no comprehensive list of dietary supplements on the market. Dietary supplement manufacturers must ensure that their products are safe, they have evidence to substantiate structure/function claims, and that product labels are truthful and not misleading.
In other words, the fox guards the henhouse.
Why take a drug, herb or any other supplement? It’s usually because we believe the substance will do something desirable, and that we’re doing more good than harm. To be truly rational we’d carefully evaluate the expected risks and benefits, estimate the overall odds of a good outcome, and then make a decision that would weigh these factors against any costs (if relevant) to make a conclusion about value for money. But having the best available information at the time we make a decision can still mean decisions turn out to be bad ones: It can be that all relevant data isn’t made available, or it can be that new, unexpected information emerges later to change our evaluation. (Donald Rumsfeld might call them “known unknowns.”)
As unknowns become knowns, risk and benefit perspectives change. Clinical trials give a hint, but don’t tell the full safety and efficacy story. Over time, and with wider use, the true risk-benefit perspective becomes more clear, especially when large databases can be used to study effects in large populations. Epidemiology can be a powerful tool for finding unexpected consequences of treatments. But epidemiologic studies can also frustrate because they rarely determine causal relationships. That’s why I’ve been following the evolving evidence about calcium supplements with interest. Calcium supplements are taken by almost 1 in 5 women, second only to multivitamins as the most popular supplement. When you look at all supplements that contain calcium, a remarkable 43% of the (U.S.) population consumes a supplement with calcium as an ingredient. As a single-ingredient supplement, calcium is almost always taken for bone health, based on continued public health messages that our dietary intake is likely insufficient, putting women (rarely men) at risk of osteoporosis and subsequent fractures. This messaging is backed by a number of studies that have concluded that calcium supplements can reduce bone loss and the risk of fractures. Calcium has an impressive health halo, and supplement marketers and pharmaceutical companies have responded. There are pills, liquids, and even tasty chewy caramel squares embedded with calcium. It’s also fortified in foods like orange juice. Supplements are often taken as “insurance” against perceived or real dietary shortfalls, and it’s easy and convenient to take a calcium supplement daily, often driven by the perception that more is better. Few may think that there is any risk to calcium supplements. But there are now multiple safety signals that these products do have risks. And that’s cause for concern. (more…)
Via the magic of legislative alchemy, chiropractors are already licensed health care providers in all 50 states. Thus their legislative efforts tend to focus on expanding their scope of practice and forcing public and private insurers to cover their services, in some cases at the same rate as medical doctors. Those efforts continue in 2013 with 65 bills impacting chiropractors introduced so far. Of those including substantive provisions (as opposed to, say, simply raising fees), only one is not to their advantage.
New Mexico chiropractors are once again attempting expansion of their scope of practice. In 2008 and 2009, the New Mexico legislature created a new iteration of chiropractor, called “the certified advanced practice chiropractic physician.” A certain faction of the chiropractic industry is attempting to rebrand chiropractors nationwide as primary care physicians and this was a signature event in those efforts. With 90 hours of additional education, these advanced practice chiropractors can administer a bevy of dubious remedies, such as bioidentical hormones.
The new law also permitted prescription of dangerous drugs and controlled substances and administration of drugs by injection, but only if on a formulary approved by the state pharmacy and medical boards. The chiropractic board didn’t like having to get approval from pharmacists and medical doctors, so they went ahead and added what they wanted to the formulary, ignoring the other boards despite their own attorney’s advice that they couldn’t do this. This got them into a couple of court battles with the pharmacy and medical boards. The International Association of Chiropractors (ICA), the traditional, subluxation-only chiropractic faction, jumped into the fray to oppose this power grab. The ICA believes chiropractic should remain drug and surgery free.
If you’re a regular reader of this blog, I’ll bet you’re not a regular consumer of vitamins or supplements. I’m in that group. Aside from sporadic vitamin D in winter, I don’t take any vitamins or supplements routinely, nor do I give any to my children. Your reasons may be close to mine: There is little to no evidence suggesting that dietary deficiencies are widespread, nor is there good evidence to suggest that vitamin supplements are beneficial in the absence of deficiency. I don’t have any need for an other supplements, nor am I confident in the scientific evidence for many of them.This position of “no supplements” is a cautious and conservative one, but is based on a consideration of the scientific evidence. I view decisions about healthcare as evaluations of risk and benefit, and then cost if necessary. Given supplementation (with some exceptions) has no demonstrable benefits and, in some cases, a little risk, the odds favour not supplementing in most cases. Add in costs, and it’s even less attractive as a routine health strategy.
Yet a decision not to take vitamins or supplements regularly is becoming a minority position. Supplement use has grown over the past 40 years among Americans, with the National Health and Nutrition Examination Survey (NHANES) showing steadily increasing utilization among younger and older adults:
My son has been coughing for several weeks, and the cough will probably persist for another 2 or 3 weeks. Coughs last a long time. Patients think a cough will go away in less than a week but in reality they are likely to last several weeks.
Coughs are a pain for the patient and an annoyance for the people around them. You never really know if the cougher in the row behind you has asthma, a post infectious cough or is actively spewing TB or influenza all over the airplane. I learned from Clinton the importance of not inhaling, especially on airplanes.
I tend to leave most symptoms alone if the they are not life threatening or otherwise unbearable for the patient. Codeine is the only really good cough suppressant and none of the over the counter cough medications are effective. I assume that coughing with infection, like diarrhea, is beneficial. Key to treating all infections is to physically remove it. Undrained pus doesn’t heal, and a good cough is the most efficient way I know to remove potential pathogens from the lungs.
If there are benefits to suppressing the cough associated with acute respiratory infections I can’t find any and we have all seen people who, because of inability to cough secondary to rib fractures, develop severe pneumonia. As a resident I had an elderly male die of just such a series of unfortunate events.
I suffer from a mild form the the naturalistic fallacy. I tend to let normal physiologic processes run their course unimpeded as long as they pose no harm to the patient. So I do not treat infectious coughs, in part because medications are not effective, in part there is no benefit and in part because the medications that are effective, and those that are not, have side effects. (more…)
A fresh season of state legislative sessions is upon us and with it comes the ubiquitous attempts by purveyors of so called “complementary and alternative medicine” (or “CAM”) to join the health care provider fraternity. Via the magic of legislative alchemy, state legislatures transform pseudoscientific diagnoses (e.g., “chronic yeast overgrowth”) and treatments (e.g., homeopathy) into faux, but legal, health care. Once the imprimatur of legitimacy is bestowed by the state in the form of a health care practice act tailored to their special brand of quackery, these newly licensed health care providers are free to foist their practices onto an unsuspecting public and charge them for the privilege. All of this is done under the false assumption that such legislation is necessary to protect the public health, safety and welfare.
We might well want to consider how far this whole thing is going. Will practitioners of CAM split into an ever-expanding number of CAM provider guilds, all with their own practice acts? First, chiropractors were the only CAM practitioners who managed to get themselves licensed in all 50 states. Then along came acupuncturists, who are now licensed to practice in over 40 states. A few states license homeopaths. Some states licensed naturopaths early on. Now the naturopaths, licensed in 16 states, are in a full court press to catch up and legitimize themselves with licenses to practice “naturopathic medicine.”
Why? Because, according to Lorilee Schoenback, ND, a Vermont practitioner and American Association of Naturopathic Physicians (AANP) Board member:
If the law [the Affordable Care Act, or ACA] is implemented as intended NDs in 16 states will immediately be covered by insurance.
Chiropractors are trying to rebrand themselves as primary care physicians, a topic both Harriet Hall and I have addressed (here and here) on SBM. Toward this end, they are seeking the expansion of their scope of practice, via the magic of legislative alchemy, to include the prescription and administration of drugs. Not drugs that any self-respecting M.D. would use, but drugs nonetheless. That effort succeeded to an extent in New Mexico. Recently Colorado got into the act. Other states have followed suit.
Chiropractors have claimed from the very beginning they are primary care physicians. Chiropractic was born in 1895 with the notion that virtually all diseases could be resolved with chiropractic treatment. This was Daniel David Palmer’s original contention, that the interruption of “nerve flow” by “subluxations” caused disease which could be remedied by spinal adjustment to restore the flow, thereby allowing the body to heal itself.
State chiropractic practice acts have always given chiropractors a broad scope of practice which allows them to diagnose and treat virtually any condition as long as they can squeeze the treatment into the “chiropractic paradigm.” If they can pretend the condition is amenable to chiropractic treatment via the detection and correction of subluxations, they can diagnose and treat it legally. This is how they are able to claim, falsely, that asthma, allergies, colic, and many other health problems can be resolved by chiropractic care. This is how “straight” chiropractors still practice.
A stay-at-home mom recently e-mailed me. She is a former CAM user who once treated her infant’s colic with homeopathy but has since seen the light and is now thinking skeptically. She asked that I look into the dōTERRA company, seller of essential oils: concentrated extracts distilled from plants, containing the “essence” or distinctive odor of the plant. She said:
…moms, well educated and seemingly rational moms, will believe anything. This isn’t a big deal if we are talking about sugar pills trying to cure crying that has no cause. However, I recently attended a dōTERRA “talk” (aka pressure to buy) about how essential oils can cure everything and anything, including one woman’s mother’s skin cancer. I didn’t want to offend this mom by calling her a quack, so I walked away spending 60 bucks on oils to be polite (this was the least amount I could spend and I used these oils to make my home smell nice, even though they were intended to solve all sorts of skin and digestive problems. I didn’t want to use them without knowing if they actually worked).
Instead of stressing the aromas, the focus was on the need to spend hundreds of dollars on these products to keep your family healthy. A handout showed how you could replace everything in your medicine cabinet with an essential oil alternative. She said:
The reps talked about how conventional medicine failed them and how they never go to the doctor anymore because the oils are a better cure.
“One of the most important discoveries I believe we’ve made that will help you burn fat – green coffee bean extract” – Dr. Oz, September 10, 2012, Episode “The Fat Burner that Works”
Dr. Mehmet Oz may be biggest purveyor of health pseudoscience on television today. How he came to earn this title is a bit baffling, if you look at his history. Oz is a bona fide heart surgeon, (still operating 100 times per year), an academic, and a research scientist, with 300+ or 400+ (depending on the source) publications to his name. It’s an impressive CV, even before the television fame. He gained widespread recognition as the resident “health expert” on Oprah, and went on to launch his own show in 2009. Today “The Dr. Oz Show” is a worldwide hit, with distribution in 118 countries, a massive pulpit from which he offers daily health advice to over 3 million viewers in the USA alone. For proof of his power to motivate, just look at the “Transformation Nation Million Dollar You” program he launched in 2011, enrolling an amazing 1.25 million participants. Regrettably, what Oz chooses to do with this platform is often disappointing. While he can offer some sensible, pragmatic health advice, his show’s content seems more focused on TV ratings than medical accuracy, and it’s a regular venue for questionable health advice (his own, or provided by guests) and poorly substantiated “quick fixes” for health issues. (And I won’t even touch Oz’s guests like psychic mediums.) One need only look at the number of times the term “miracle” is used on the show as a marker of the undeserved hyperbole. Just this week, Julia Belluz and Stephen J Hoffman, writing in Slate, itemized some of the dubious advice that Oz has offered on his show, with a reality check against what the scientific evidence says. It’s not pretty. (more…)
Vaccines, and flu shots in particular, have been covered ad nauseum on this blog; but the anti-vaccine propaganda never stops, so forgive me for bringing it up again. A correspondent inquired about a podcast by Steve Wright on Revolution Health Radio entitled “The Truth About Flu Shots (and What to do Instead).” You can either listen or read the transcript. It’s just too funny to pass up. That is, it would be funny if it weren’t endangering our public health by spreading misinformation. (more…)