Monday, January 25, 2016
My eyes are a little tired from all the rolling they did last night while watching a t.v. "documentary" about dietary supplements on Frontline, "Supplements and Safety." This could explain why, in the process of following up on the issue online today, I managed to mis-read an article on Forbes entitled, "Death by Dietary Supplement" which said Lamar Odom was found unresponsive after taking "10 tablets of herbal Viagra," "yet another statistic in the body count racked up by 'herbal supplements.'” I assumed the title of the article referred to Mr. Odom's death, but then realized I had missed three little words, "very nearly became" where it said he had emerged from the coma. He didn't die, whew! So, who did? And what is the current body count? Apparently nobody knows. BTW, I learned from other sources that the author neglected to mention a minor detail: Mr. Odom's near-statistic happened with the overdose of "herbal Viagra" plus cocaine, probably not a safe combination.
The author, Henry I. Miller, who claims to "debunk junk science and flawed public policy" says later in the article, "But because of irresponsible, two-decade-old legislation, [DSHEA] the answer to the critical question, 'How many Americans are killed each year due to ingestion of so-called dietary-nutritional supplements?' cannot be answered." He claims that the "Dietary Supplements Health and Education Act of 1994" exempted supplements from regulation by the FDA when in fact, the opposite is true - it specified how supplements were to be regulated. In any event, Miller says as a result of the DSHEA, in some unclear manner, numerous deaths caused by supplements are being hidden from the public. The article ends by urging more stringent regulation of supplements, otherwise, "the body count will continue to rise." But, I was unable to determine from reading the article how many people, if any, had died.
That's why I went online to look it up today, because the Frontline "documentary" led me to believe that people were dropping like flies from taking supplements, and being a holistic wellness counselor and a consumer myself, this seems like important information that I should know about. Considering that half of all American adults, approximately 150 million people, use supplements, I would expect that there would be some deaths, at least a few. I mean, even excessive intake of water can result in death, and people do die every year from "safe" OTC substances. For example, about 458 people die per year from liver failure due to acetaminophen. I looked it up multiple different ways, but despite extensive googling, I could not find the "supplement body count."
In the process of searching for the elusive supplement death statistics, in addition to Mr. Miller's article, I found several others with alarming titles such as, "Supplements Now More Likely Than Medications to Cause Death," "The Risky Business of Dietary Supplements," "Dietary Supplements Lead to 20,000 ER Visits Yearly," "Vitamins and Supplements May Lead to Earlier Death," and "Death By Supplements," none of which actually contained the information about how many people died.
The American Cancer Society website said that 2 people had died from supplements in 2013, but Clinical Toxicology disputed that. Ephedra was mentioned as a killer in the Frontline program and when I looked it up, I learned that according to the New England Journal of Medicine, it had been used by 12 million people, with a total of 21 deaths between 2001 and 2004, when it was banned by the FDA, and 2 more between 2005 and 2007, after which there were no more ephedra deaths. Interestingly, ephedrine, the drug derived from ephedra, remains available without prescription.
The other death specifically mentioned in the Frontline program was a woman from Maui who died of liver failure in 2013 due to using a diet supplement from a bad batch when the supplier of one of the ingredients in China sent the wrong substance, unbeknownst by the manufacturer of the supplement. A total of 30 people got sick and several required liver transplants; the woman who died was turned down for transplant because she also had breast cancer (a factor not mentioned on the program).
Likewise, my search revealed that a contaminated batch of L-tryptophan killed 28 people in 1989, possibly as a result of faulty genetic engineering of the bacteria used in its production. In this case as in the one above, the poisonings were a result of contamination; the supplements in their original formulation had been safe.
I ran across a 2007 article in the New York Times which stated: "In April 2004 the Food and Drug Administration (FDA) said it had received 260 reports of deaths associated with herbs and other non-vitamin, non-mineral food supplements since 1989." No footnote was provided, however, and despite extensively searching the FDA archives and the CAERS (Center for Food Safety and Applied Nutrition Adverse Event Reporting System) database, I was unable to find any documentation of this statement. The FDA did indicate that incidents reported to CAERS, like VAERS (Vaccine Adverse Event Reporting System) are reports only, not established cases. But to be generous, in the absence of better data, let's assume for the sake of the argument that there actually were 260 supplement-related deaths from 1989 to 2004.
Poison Control Center data from the AAPCC Annual Reports reveals a total of 179 deaths contributed to by vitamins, minerals and botanical supplements from 1999 through 2014, for an average of 11.2 per year. No reports are available prior to 1999. Given the 260 "reported but not verified" deaths from 1989-2004, minus the known 111 deaths from 1999-2004, let's estimate 149 deaths from 1989-1998.
So, as best as I've been able to determine from the data available, since 1989 the "body count" for supplements, including those adulterated, overdosed, or used in unwise combinations with, e.g., cocaine, is approximately 328, or an average of 13.1 per year. This pales in comparison to the 128,000 per year who die from thoroughly regulated and properly prescribed drugs and fewer than the 458 deaths from OTC acetaminophen in 2014. But, it's still 328 deaths too many, of course.
Yes, people are dying from supplements - over 300 people in the last 25 years. Something ought to be done! There ought to be a law! Oh, wait, there is - the DSHEA. In contrast to the claims made by Frontline and Mr. Miller et al, the FDA does regulate supplements to ensure they are not contaminated by dangerous adulterants and that their contents are accurately labeled. The law is in place, it just needs to be enforced. Per the FDA website:
"Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):
Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.
FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.
Under existing law, including the Dietary Supplement Health and Education Act passed by Congress in 1994, the FDA can take action to remove products from the market, but the agency must first establish that such products are adulterated (e.g., that the product is unsafe) or misbranded (e.g., that the labeling is false or misleading)."
This sounds like very good and reasonable regulation: Ensure that supplements are not unsafe or adulterated with drugs or chemicals, and that the label accurately reflects the contents, in the same way that, e.g., if the label on our box of cereal says it is made from oats, it must contain clean, high quality oats and not moldy rye, asbestos or wood pulp. That way the consumers will know what we are getting. We can do our own research on the ingredients to help us decide whether or not we want to purchase the product. And if after purchase and consumption we are not happy with the product, many if not most supplement companies will gladly provide a refund on these relatively inexpensive products. At least, that has been my experience as a consumer for over 20 years and I haven't been disappointed yet.
But, that isn't good enough for the supplement critics, who are not just concerned about potential contamination with dangerous chemicals or incorrect labeling. Rather, they contend that these natural substances themselves are neither safe nor effective until proven otherwise. They want vitamins, herbs and other natural supplements to be subject to the same regulatory process as pharmaceutical drugs, with the manufacturers required to conduct clinical trials proving both "safety and effectiveness." They know that this would essentially put the supplement companies out of business, because the process is too expensive to be conducted on behalf of unpatentable natural substances. It wouldn't make business sense to invest in funding the clinical trials when, if successful, other companies would then be free to sell the product at a competitive price. Pharmaceutical companies are able to pay for the clinical trials only because they own the patent on the drugs they develop and therefore once approved, they can set a high price and make the profit necessary to recoup their investment without competition.
Regarding "safety," to keep things in perspective, let's take another look at the statistics: 60% of adult Americans, or about 180 million people, take prescription drugs which have been "proven safe and effective" according to existing regulations, and 128,000 of them die every year, sometimes prompting recalls of medications already established as "safe." This is in contrast to the 150 million who take the allegedly "unregulated" supplements, of whom approximately 13.1 die per year. Now, it has been argued that adverse events with supplements are under-reported, which may be true, but this is a phenomenon that is well-known in medicine generally and would apply to pharmaceuticals also, and in any case is unlikely to account for the discrepancy of approximately 8142:1 deaths from drugs:supplements.
For that matter, if it is really "safety" or "death" that is prompting the hysteria over supplements, I don't notice anybody lobbying for the regulation or banning of soda pop, which kills 25,000 Americans per year and has no beneficial effects - other than monetary profit for the companies selling it. And dentists and endocrinologists. Oh, and the pharmaceutical companies who sell diabetes drugs. Ok, never mind, I guess soda pop is good for the economy, at least the medical industry or what the New York Times calls "the healthcare economic sector."
I was a bit surprised to learn recently that the skeptics are especially opposed to homeopathy. They expressed disappointment that the Frontline show did not address this, "pure quackery, one of the purest quackeries that exist," based on the principle that "like cures like" and using a very tiny amount of a substance that would provoke the symptoms of an illness to help the body mount a defense against that illness. Ironically, this is the same principle involved in vaccinations, the only "mainstream" treatment to employ homeopathic theory. The difference is that vaccines actually contain a measurable amount of disease material, whereas classical homeopathic remedies are so diluted that they contain only the "vibration" or "memory" of a substance. So if the main ingredient was, say, duck liver, there will in fact be no molecules of duck liver remaining in the final diluted product; about the best we can say is that at one time, the water in that vial was near a duck. Some proponents of homeopathy try to explain its actions in terms of quantum physics, particularly Bell's theorem and non-locality, which seems halfway plausible except that physicists generally don't like it when we try to apply quantum theory to events on a macroscopic level, and the skeptics scoff at such theories.
In any case, from the mainstream perspective, since homeopathic remedies essentially consist of water, their efficacy, if any, can only be placebo. If they have zero physical effects, then clearly they cannot harm anyone. Why, then, does the public need to be "protected" from homeopathy?
When we dig deeper into the objections against supplements, opponents finally admit that biochemical safety per se is not their only concern. They also want to protect the public from financial harm because they believe that even if safe, natural supplements don't work, a belief which I myself once held. They assert that people who use supplements are anti-scientific and need to be saved from our own gullibility. We must not be allowed to spend $12 on a jar of benign herbs, a vial of water or a few granules of sugar. The public needs to be "protected" from spending our own money foolishly.
It's so nice of the critics to be concerned about my finances and saving me from making foolish purchases! My mom and dad allowed me to start spending my own money as I pleased when I was around 16. So thanks, nanny science guys, for going above and beyond the call of duty. While we're on the subject, maybe you could do something about lipstick regulation, which IMO is far too lax. I recently bought some special Star Wars lipstick and while it didn't injure me or make me sick, it also did not transport me to a galaxy far, far away, give me power over the dark side, or even improve my skill at Jedi mind tricks. Of course, these attributes were not actually promised, but they were certainly implied by the commercials, and it turned out to be just regular old lipstick with a "Star Wars" label on it.
But, getting back to medicine. Pardon my skepticism, but I have trouble believing that the skeptics have a science-based concern about how I squander my money. Unless, perhaps, they have a vested interest in my spending it on mainstream pharmaceuticals, and are worried that I might spend it elsewhere. That, after all, is the popular "conspiracy theory" as to why the pharmaceutical lobby is trying to regulate natural supplements out of existence - competition. Dr. Stephen Barrett at Quackwatch refutes this theory, however, saying: "Standard medicine and 'alternative medicine' do not actually compete for patient dollars. Well-designed studies have shown that most 'alternative' methods are used in addition to—rather than instead of—standard methods."
It's true that sometimes the two systems are complementary, e.g. mainstream doctors suggest that their patients take a probiotic supplement to offset the dysbiosis caused by antibiotic use, coenzyme Q10 to correct deficiency caused by statins, or cannabis for side effects of chemotherapy. So they are by no means mutually exclusive.
However, in my own experience and that of many other consumers, sometimes people turn to alternative medicine precisely because mainstream medicine did not work for them and/or had unacceptable side effects. And despite the lack of double-blind controlled studies and clinical trials "proving" efficacy, the reality is, if natural supplements and/or homeopathic remedies didn't "work," people would not buy them. At least, they would not continue to buy them. "Placebo" or not, nobody is holding a gun to anyone's head and forcing the purchase, and unlike pharmaceuticals, most good supplement companies happily provide a money-back guarantee if you're not satisfied. Consumers buy these products because they are obtaining some perceived benefit. Of course, we must be delusional because there is no "proof" and the data we acquire from personal experiments in the laboratory of our own bodies and lives is purely "anecdotal," all 150 million of us and the millions before us who have used natural remedies throughout history.
A legally enforced money-back guarantee on top of the existing safety regulations would protect consumers of supplements on both ends. But, the critics don't want people to be able to experiment and decide for ourselves. It's not enough to enforce the existing law that prevents the sale of substances that are dangerous, adulterated or inaccurately labeled. The consumers need to be "protected" from spending our own money on inexpensive products that are safe, but don't work. We rather ought to be taking expensive pharmaceutical drugs which are "proven safe and effective," despite our own experience and the body count which might suggest otherwise.