If there is one aspect of “alternative” medicine that both critics and fans should agree on, it’s that products should be manufactured to high standards. What’s on the label should accurately describe what’s in the bottle. Product quality standards are essential, whether you’re using herbs or drugs. And when it comes to ensuring the products we buy are of high quality, we’re all effectively reliant on regulation to protect us. As a pharmacist, I can’t personally verify that each tablet in your prescription contains the active ingredient on the label. I am dependent on a supply chain that may stretch around the world. While the product manufacturer may be reputable, it’s only a regulator that can realistically verify and enforce production to strict quality standards. The same cannot be said for products like supplements and herbs which are regulated differently than drugs, and held to different, and in some cases, weaker standards. A weak regulatory framework, which doesn’t hold manufacturers to account, would be expected to result in a product of lower quality. And that’s exactly what you see when you look at supplements on the market today.
Posts Tagged supplements
When you pick up a bottle of supplements, should you trust what the label says? While there is the perception that supplements are effective and inherently safe, there are good reasons to be skeptical. Few supplements are backed by good evidence that show they work as claimed. The risks of supplements are often not well understood. And importantly, the entire process of manufacturing, distributing, and marketing supplements is subject to a completely different set of rules than for drugs. These products may sit on pharmacy shelves, side-by-side with bottles of Tylenol, but they are held to significantly lower safety and efficacy standards. So while the number of products for sale has grown dramatically, so has the challenge to identify supplements that are truly safe and effective. (more…)
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:
I don’t much like Senator Tom Harkin (D-IA), and, I daresay, neither do any of my fellow bloggers here.
The reason should be painfully obvious. Arguably, no single elected official currently serving today (or ever) has done more over a longer period of time to promote quackery in the United States. I make this harsh assessment because Senator Harkin was the legislator who created the National Center for Complementary and Alternative Medicine (NCCAM) and has been its most powerful patron, promoter, and protector. It’s a center in the National Institutes of Health (NIH) of which we at this blog have regularly been quite critical, right from the very beginning, when I pointed out how our taxpayer dollars were being wasted on pseudoscience and quackery, while Wally Sampson provided some perspective on how this situation came to be and I gave a bit of history of NCCAM. Since then, we’ve been hammering away at NCCAM as a blight on the the science of the NIH, whether intramural or extramural.
Three years ago, we even managed to attract the notice of Josephine Briggs, the current director of NCCAM, who invited us to Bethesda for a meeting. It was a very cordial meeting, as described by Steve Novella and myself. Unfortunately, in the name of “balance,” Dr. Briggs turned right around and met with a bunch of homeopaths and then drew a false equivalency between us “skeptics” and proponents of quackery as represented by the homeopaths. Clearly, she didn’t get it, or, if she did get it, her position was such that she couldn’t bite the hand that feeds NCCAM. A year after that, NCCAM published a five year strategic plan, which I characterized as “let’s do some rigorous science for a change,” given that that’s about all it said. It’s a nice sentiment. We’ll see if it actually happens, although I doubt that it will. Although studying herbs is nothing but a form of pharmacognosy (natural products pharmacology) and studying lifestyle interventions is science-based medicine, neither of them are actually “CAM” per se, because there is nothing “alternative” about them other than their having been co-opted as a “foot in the door” grafted onto the more serious woo. Like a stray limb grafted onto Frankenstein’s monster, they don’t belong and don’t fit.
But I digress. NCCAM has that effect on me.
A Congressional champion of quackery decides to quack no more (after 2014, anyway)
I was asked to write an article for Slate, the on-line magazine, about Andrew Weil’s selection as the keynote speaker for the 2012 AAFP annual scientific assembly. The science and health editor, Laura Helmuth, was initially enthusiastic about what I wrote, but eventually decided not to publish it. Here is the initial draft of my article. My comments follow.
Original Draft of Article for Slate
The American Academy of Family Physicians picked Andrew Weil to be the keynote speaker at its annual scientific assembly October 16-20 in Philadelphia. What were they thinking? That’s like having an astrologer give the keynote speech at an astronomy meeting.
The AAFP stands for the best in conventional medicine, for the standard of care as determined by physicians and scientists. Weil doesn’t. The AAFP stands for evidence-based medicine. Weil doesn’t. (more…)
One of the points I’ve tried to emphasize through my contributions to Science-Based Medicine is that every treatment decision requires an evaluation of risks and benefits. No treatment is without some sort of risk. And a decision to decline treatment has its own risks. One of the challenges that I confront regularly as a pharmacist is helping patients understand a medication’s expected long-term benefits against the risks and side effects of treatment. This dialogue is most challenging with symptomless conditions like high blood pressure, where patients face the prospect of immediate side effects against the potential for long-term benefit. One’s willingness to accept side effects is influenced, in part, by and understanding of, and belief in, the overall goals of therapy. Side effects from blood-pressure medications can be unpleasant. But weighed against the reduced risk of catastrophic events like strokes, drug therapy may be more acceptable. Willingness to accept these tradeoffs varies dramatically by disease, and are strongly influenced by patient-specific factors. In general, the more serious the illness, the greater the willingness to accept the risks of treatment.
As I’ve described before, consumers may have completely different risk perspectives when it comes to drug therapies and (so-called) complementary and alternative medicine (CAM). For some, there is a clear delineation between the two: drugs are artificial, harsh, and dangerous. Supplements, herbs and anything deemed “alternative”, however, are natural, safe, and effective. When we talk about drugs, we use scientific terms – discussing the probability of effectiveness or harm, and describing both. With CAM, no tentativeness or balance may be used. Specific treatment claims may not be backed up by any supporting evidence at all. On several occasions patients with serious medical conditions have told me that they are refusing all drug treatments, describing them as ineffective or too toxic. Many are attracted to the the simple promises of CAM, instead. Now I’m not arguing that drug treatment is always necessary for ever illness. For some conditions where lifestyle changes can obviate the need for drug treatments, declining treatment this may be a reasonable approach – it’s a kick in the pants to improve one’s lifestyle. Saying “no” may also be reasonable where the benefits from treatment are expected to be modest, yet the adverse effects from treatments are substantial. These scenarios are not uncommon in the palliative care setting. But in some circumstances, there’s a clear medical requirement for drug treatment – yet treatment is declined. This approach is particularly frustrating in situations where patients face very serious illnesses that are potentially curable. This week is the World Cancer Congress in Montreal and on Monday there were calls for patients to beware of fake cancer cures, ranging from laetrile, to coffee enemas, to juicing, and mistletoe. What are the consequences of using alternative treatments, instead of science-based care, for cancer? There are several studies and a recent publication that can help answer that question. (more…)
Among the myriad of supplements being offered to the public are various bee products, including bee pollen. The claims made for bee pollen supplements are typically over-hyped and evidence-free, as is typical of this poorly regulated industry. The claims from bee-pollen-supplements.com are representative:
The benefits are enormous and the substance has been proven by many health experts. This particular substance is known as an effective immune booster and one of the best ways to achieve a sound nutritional regime.
The pollen from the bee has been proven to increase sexual functions in both men and women. It stimulates our organs, as well as our glands and is known to improve the natural increase on a person’s lifespan.
What you never find on such websites are references to published peer-reviewed studies that substantiate the specific claims being made. There are also concerns about safety which have not been adequately studied.
A recent case report highlights one safety concern regarding bee pollen products – allergic and even anaphylactic reactions. The Canadian Medical Association Journal reports:
A 30-year-old woman with seasonal allergies but no history of allergies to food, drugs, insects or latex had an anaphylactic reaction after taking bee pollen. She had swelling of the eyelids, lips and throat, difficulty swallowing, hives and other life-threatening symptoms. After emergency treatment and discontinuation of the bee pollen supplements, there were no further reactions.
Two weeks ago I promised that I would discuss the Marino Center for Integrative Health, identified in the recent Bravewell report as having a “hospital affiliation” with the Newton-Wellesley Hospital (NWH) in Newton, Massachusetts, which is where I work. I also promised in that post that I’d provide examples of ‘integrative medicine’ practitioners offering false information about the methods that they endorse. I’d previously made that assertion here, and Jann Bellamy subsequently discussed its legal and ethical implications here. The Marino Center is a wellspring of such examples.
A Misleading ‘Affiliation’
Let’s quickly dispel the “hospital affiliation” claim. According to the Marino Center website:
Hospital AffiliationsIn support of our services and to ensure that our patients have access to exceptional tertiary care, the Marino Center maintains deeply established relationships and affiliations for referrals and admitting privileges with major medical facilities in the Boston area.
The Marino Center:
- Is a proud member of the Partners Healthcare family
- Is affiliated with Newton Wellesley Hospital
- Makes referrals to Mass General Hospital, Dana Farber, Children’s Hospital and more
Well, it wouldn’t surprise me if the Marino Center is a ‘member’ of the Partners Healthcare family, which includes not only the Newton-Wellesley Hospital, but lesser known entities such as the Massachusetts General Hospital and the Brigham and Women’s Hospital. After all, there are already unfortunate pseudomedical schemes involving Partners entities, such as the Osher Center for Complementary and Integrative Medical Therapies and, even under my own roof (I shudder as I write this), a Reiki Workshop. Nevertheless, it’s telling, I hope, that not only does the Marino Center fail to appear under any list of Partners affiliates, Community Health Partnerships, Wellness, Prevention, or any other conceivable category, but it fails to yield a single ‘hit’ when entered as a search term on the Partners website (the term ‘integrative’ yields seven hits, but none appears to be about ‘CAM,’ except possibly for an RSS feed that I’ve no patience to peruse. Is it possible that Partners is embarrassed by the Osher Center? I hope that, too).
I’ve previously asserted that the NWH is not affiliated with the Marino Center, other than that some Marino Center physicians have been—against my judgment, not that I was consulted—granted hospital staff privileges. I made this assertion in my original Bravewell post a couple of weeks ago, after having questioned the NWH Chief Medical Officer, Dr. Les Selbovitz, who verified it; nothing on the NWH website suggests otherwise.
I’ve no reason to doubt the Marino Center’s third bullet above, “makes referrals to Mass General Hospital,” etc., but this is something that any physician can do, regardless of affiliation. I suspect that if there were an ‘integrative hospital‘ in Boston, reason forbid, the Marino Center would make referrals to it.
False and Misleading Information about ‘Services’
Let’s get to the meat of the problem.
I suppose it was bound to happen, but it still rankles. Here is the back cover of last week’s issue of the decreasingly prestigious New England Journal of Medicine:
It’s the 200th Anniversary issue, no less. Some might protest that ‘probiotics’—live bacteria of ‘good’ varieties, as far as the gut is concerned—aren’t all that implausible, and that there is some trial evidence that they help for some conditions. That’s true, but as is typically the case even for the somewhat plausible end of the “CAM” spectrum, the hype greatly surpasses the evidence. The abstract of the most recent systematic review that I could find for probiotic treatment of irritable bowel syndrome (IBS: symptoms and signs that best match the claims in the advertisement above) concluded:
Here on SBM we have frequently had cause to criticize the media for poor science reporting and for spreading misinformation. Among many other individual offenders, we have criticized Dr. Oz for promoting alternative medicine on his TV show and gullibly promoting guests who pretend to talk to the dead and pretend to heal people with carnival sideshow tricks. We tend to be negative and critical because somebody has to do it, but it’s not pleasant. For once, I have some good things to say.
The September 12 issue of TIME magazine was a Special Nutrition Issue. The cover featured pictures of food and the title “What to Eat Now: Uncovering the Myths about Food by Dr. Oz.” It devotes 7 pages to an article by him entitled “The Oz Diet: No more myths. No more fads. What you should eat — and why.” This is followed by a 5 page article by John Cloud “Nutrition in a Pill? I took 3000 supplements over five months. Here’s what happened.” Both articles have a rational, science-based perspective without any intrusions of woo-woo. (more…)