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Diet Supplements and Safety
While reading this keep in mind that supplement producers are not
required to report adverse effects of their products, as even aspirin produceres are required. This looks at adverse effects from another source and likely represents a fraction of actual adverse events. Diet Supplements and Safety: Some Disquieting Data By DAN HURLEY In October 1993, during a Senate hearing on a bill to regulate herbs, vitamins and other dietary supplements on the presumption that they were safe, Senator Orrin G. Hatch, Republican of Utah, spoke up in their defense. Herbal remedies have been on the market for centuries, he said, adding: In fact, most of these have been on the market for 4,000 years, and the real issue is risk. And there is not much risk in any of these products. That benign view was written into the bill when it was passed by both houses the following year. While the law, the Dietary Supplement Health and Education Act of 1994, forbade manufacturers to claim that their products treat, cure or prevent any disease, it allowed them to make vaguer claims based on a standard that did not require them to do any testing. And it stated that dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare. But hiding in plain sight, then as now, a national database was steadily accumulating strong evidence that some supplements carry risks of injury and death, and that children may be particularly vulnerable. Since 1983, the American Association of Poison Control Centers has kept statistics on reports of poisonings for every type of substance, including dietary supplements. That first year, there were 14,006 reports related to the use of vitamins, minerals, essential oils which are not classified as a dietary supplement but are widely sold in supplement stores for a variety of uses and homeopathic remedies. Herbs were not categorized that year, because they were rarely used then. By 2005, the number had grown ninefold: 125,595 incidents were reported related to vitamins, minerals, essential oils, herbs and other supplements. In all, over the 23-year span, the association a national organization of state and local poison centers has received more than 1.6 million reports of adverse reactions to such products, including 251,799 that were serious enough to require hospitalization. From 1983 to 2004 there were 230 reported deaths from supplements, with the yearly numbers rising from 4 in 1994, the year the supplement bill passed, to a record 27 in 2005. The number of deaths may be far higher. In April 2004, the Food and Drug Administration said it had received 260 reports of deaths associated with herbs and other nonvitamin, nonmineral supplements since 1989. But an unpublished study prepared in 2000 for the agency by Dr. Alexander M. Walker, then the chairman of epidemiology at the Harvard School of Public Health, concluded: A best estimate is that less than 1 percent of serious adverse events caused by dietary supplements is reported to the F.D.A. The true proportion may well be smaller by an order of magnitude or more. The supplements linked to the most reactions in 2005, according to the poison control centers, were ordinary vitamins, accounting for nearly half of all the reports received that year, 62,446, including 1 death. Minerals were linked to about half as many total reports, 32,098, but that number included 13 deaths. Herbs and other specialty products accounted for still fewer total reports, 23,769, but 13 deaths. Essential oils were linked to 7,282 reports and no deaths. Among herbs and other specialty products, melatonin and homeopathic products prepared from minuscule amounts of substances as diverse as salt and snake venom had the most reports of reactions in 2005. The poison centers received 2,001 reports of reactions to melatonin, marketed as a sleep aid, including 535 hospitalizations and 4 deaths. Homeopathic products, often marketed as being safe because the doses are very low, were linked to 7,049 reactions, including 564 hospitalizations and 2 deaths. But most other types of herbs and specialty supplements also appear in the annual report. In 2005, the poison centers received 203 reports of adverse reactions to St. Johns wort, including 79 hospitalizations and 1 death. Glucosamine, with or without chondroitin, was linked to 813 adverse reactions, including 108 hospitalizations and 1 death. Echinacea was linked to 483 adverse reactions, including 55 hospitalizations, 1 of them considered life-threatening. Saw palmetto was not listed on the report. Injuries to children under 6 account for nearly three-quarters of all the reports of adverse reactions to dietary supplements, according to the poison centers. In 2005, the most recent year for which figures are available, 48,604 children suffered reactions to vitamins alone, the ninth-largest category of substances associated with reactions in that age group. Major medical groups and government agencies do not generally recommend vitamin or mineral supplements for children who are otherwise healthy. But an analysis of the National Maternal and Infant Health Survey, published in the journal Pediatrics in 1997, found that 54 percent of parents of preschool children gave them a vitamin or mineral supplement at least three days a week. Advocates of the products correctly point out that the poison centers figures do not prove a causal link between a product and a reaction and that, in any case, far more people are injured and killed by drugs. Painkillers alone were associated with 283,253 adverse reactions in 2005, according to the poison centers, more than twice as many as with supplements. But only 3.5 percent of those reactions occurred when people took the prescribed amount of painkiller; most were from overdoses, either accidental or intentional. The same was true of asthma drugs (3.6 percent of reactions were associated with the prescribed dose) and cough and cold drugs (3.1 percent). While reactions to vitamins, minerals and essential oils occurred at similarly low levels when people took the recommended amounts, adverse reactions linked to the recommended levels of herbs, homeopathic products and other dietary supplements accounted for 10.3 percent of all reactions to those products reported to the poison centers about three times the level seen for most drugs. Drugs marketed in the United States go through a rigorous F.D.A. approval process to prove that they are effective for a particular indication, with the potential risks balanced against the benefits. While the approval process has come under attack in recent years as unduly favorable to drug companies, it remains among the toughest in the world. There is no comparable requirement for supplements. Even so, hundreds of millions of tax dollars have been spent since the early 1990s on hundreds of studies to test the possible benefits of supplements. The National Center for Complementary and Alternative Medicine, established by Congress in 1991 to investigate and validate unconventional medical practices, has a 2007 budget of more than $120 million. Since April 2002, five large randomized trials financed by the center have found no significant benefit for St. Johns wort against major depression, echinacea against the common cold, saw palmetto for enlarged prostate, the combination of glucosamine and chondroitin for arthritis, or black cohosh and other herbs for the hot flashes associated with menopause. A new source of data on adverse reactions to dietary supplements will soon become available: in December, Congress passed a measure requiring the manufacturers of dietary supplements and over-the-counter drugs to inform the F.D.A. whenever consumers call them with reports of serious adverse events. The bill was signed by President Bush the day after Christmas. It is a welcome acknowledgment that natural does not always mean safe. Dan Hurley is the author of the new book Natural Causes: Death, Lies and Politics in Americas Vitamin and Herbal Supplement Industry (Broadway Books), from which this essay is adapted. |
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Diet Supplements and Safety
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Diet Supplements and Safety
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Diet Supplements, and Safety
wrote:
While reading this keep in mind that supplement producers are not required to report adverse effects of their products, as even aspirin produceres are required. This looks at adverse effects from another source and likely represents a fraction of actual adverse events. While I haven't had a chance to read Dan Hurley's book, your comments contain several distortions and omissions. I would like to address all of these later. Meanwhile, readers should know that Poison Control reports are seldom based on medical evaluation, and that most common poison exposures in children under the age of six result from poisoning by: 1) cosmetics and personal care products (13.3%), 2) cleaning substances (10.3%), 3) analgesic (painkilling) drugs (7.4%), and 4) foreign bodies (7.1%). These figures are directly from the American Association of Poison Control Centers [http://www.1-800-222-1222.info/stats/home.asp.] While drugs make the heavy-hitter list for children (whose "major medical" impact in year 1998 was 395 times greater than it was for vitamin products [ref. http://www.aapcc.org/tessbro/emsc98ph.PDF]), dietary supplements do not. Obviously, adult poisonings related to prescription and OTC drugs are many times greater than those in children, since more adults than children take drugs. More than 60% of all poisoning fatalities occur in adults between the ages of 20 to 49, and a substantial percentage of those are related to prescribed and OTC medications. These data can be expressed in myriad ways, however placing full emphasis on absolute numbers for one category of event rather than looking at the relative differences between two or more categories is misleading. This is what the drug makers and their PR grunts in the newsgroups are attempting to cover up. A few years ago, I posted the following after interviewing the Washington DC Poison Control Center for a better understanding of how such reports are filed and what they mean. I believe reposting those comments in response to the other poster's "analysis" may be helpful. TESS (Toxic Exposure Surveillance System) refers to the database of poisoning reports collected by Poison Control centers. I contacted Poison Control and interviewed a specialist to be sure I understood the process. Here is what I learned. When a person contacts Poison Control, the caller is surveyed with a few simple questions and a report documenting the call is created. Naturally, anything ingested within 24 hours prior to the adverse medical event is recorded. If more than one item is indicated, for instance aspirin and ginseng, both are catalogued. At this point, things get tricky. Only one of these products will be identified as representing a "probable" cause of illness in the report. What is the criteria for "probable" cause? In most cases, since a caller does not seek medical care, a medical examination never occurs. That means in the great majority of cases, about 70%, individuals are never subject to any type of toxicology at all. In the absence of such forensics, "probable cause" is just the call taker's best guess. It is here, in my view, that Poison Control introduces an unfortunate bias into the reporting process. When an OTC or prescription drug is taken in addition to an herbal by a poison victim, though it cannot be known whether the adverse event results from a chemical reaction between them, if that is suspected, the tally stroke is applied to the herbal if the drug is doctor prescribed. Please read this again. It means that a prescription drug under such conditions is *assumed* to be unrelated to the reported medical event, even if the drug has been associated with such medical events in the medical literature. I find that quite remarkable. And because of such bias, the following statistics are all the more alarming. According to Poison Control, only 2.4% of all human poisoning in the US is associated with the entire spectrum of dietary supplements. By contrast, 11.4% of all poisonings are associated with just **ONE** class of pharmaceutical drug -- the analgesics, or painkillers, such as aspirin and tylenol. A similar breakout for the majority of prescription drugs, including depressants, anti-depressants, antibiotics, beta blockers, blood thinners, statins, cytotoxics, anorectics, and other drug classes, are available for viewing in the TESS reporting system online, which you can see for yourself. A crucial point here is that any disparity between the two produce classes (pharmaceutical drugs and dietary supplements) in terms of product safety, are probably even wider than the data already shows. What are specific categories of medical impact related to either drug or dietary supplement poisoning? The largest subgroup are those individuals experiencing a complication despite having taken the proper dosage. This group includes those who experience a potentially serious allergic reaction that may be fatal or cause organ damage. Another subgroup are children who become victims by accidental exposure, whereas children represent at least 50% of all reported poisonings. Very few accidental poisonings in children are related to a dietary supplement, and fewer still (in that category) are fatal. The last group is a set of mortalities resulting from suicide. Autopsy will usually settle the question in such cases, whereas it should come as no suprise that prescription and OTC drugs are frequently the method of choice. By contrast, the great majority of dietary supplements are so safe that taking an entire bottle still wouldn't be enough to kill you. The data shows clearly that pharmaceutical drugs are several orders of magnitude more dangerous than dietary supplements, and that regulatory oversight by FDA is largely ineffective, due to inadequate testing and regulation of these products. Any call for greater regulation of dietary supplements by FDA, when the same mechanisms for oversight of drugs so clearly fails to protect public health, is a product of industry media efforts asimed at protecting existing market share. In summary, the fact that many millions of dietary supplements are consumed each and every day with only a handful of mortalities *potentially associated with them* is quite astonishing. Unless you ignore the medical literature, death by bee sting (estimated to be about 100 deaths per year -- a little piece of data quite difficult to nail down, by the way) is a more serious threat to public health than products purchased at a health food store. If the drug industry had a record like this, FDA would have closed its doors long ago, saving the taxpayer many billions of dollars, not to mention saving millions of lives. PeterB |
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Diet Supplements, and Safety
On 18 Jan 2007 13:08:09 -0800, "PeterB" wrote:
Unless you ignore the medical literature, death by bee sting (estimated to be about 100 deaths per year -- a little piece of data quite difficult to nail down, by the way) is a more serious threat to public health than products purchased at a health food store. If the drug industry had a record like this, FDA would have closed its doors long ago, saving the taxpayer many billions of dollars, not to mention saving millions of lives. But what about a cost benefit analysis. The health food store does virtually no good to anyone who eats a healthy diet and has reasonable activity. So even one belly ache is too much to pay, IMHO. Whereas the huge benefit from the modern pharmacopoea saving countless thousands of lives is well worth the occasional adverse reaction or even death. jack |
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Diet Supplements and Safety
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Diet Supplements and Safety
GMCarter wrote: On 18 Jan 2007 16:59:56 GMT, wrote: While reading this keep in mind that DAN HURLEY...has about the same credibility as other luminaries of the media like Celia Farber and morons infesting the quackwatch world. I pulled up Hurley's book cover online yesterday and it reads exactly like the script our pharmboys use here in the newsgroups. Amazon's website also peddles a fluff piece in its "editorial review." It refers to Hurley's criticism of the supplement industry for "strong-arming the 1994 Dietary Supplement Health and Education Act through Congress-a law that rendered the FDA virtually powerless to regulate these remedies-and observes the FDA's "coziness" with the industry it regulates. From snake oil and shark cartilage to ephedra, Hurley consistently animates patches of dry legal and medical material with harrowing case studies." What's bizarre here is the phrase "FDA's coziness with the industry it regulates." Since FDA only actively regulates the drug industry (if you want to call that regulation), this reference would logically refer to FDAs cozy ties to its primary funding source, the drug makers, who cover most of FDA's operating budget. I don't know whether this was a zombie-like confession or if someone aware of the truth managed to slip it in. The statement that the supplements industry "strong-armed" the Congress to pass DSHEA, however, is just ridiculous. More Americans sent letters and made calls to Congress on this one issue than they did during the Vietnam war, and it was the most widely supported legislation at a grass roots level than any other law in history. As far as any review of "harrowing case studies" involving dietary supplements, that would be like spotting meteors in the night sky before going to bed. For every such case you might find linked to a dietary supplement, you would find literally thousands linked to a pharmaceutical drug. So yes, I smell a rat. |
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Diet Supplements and Safety
Flip the coin and substitute "alterblogger" pr terms in the rightplaces
for the below, it works the same. All of this done without benefit of reading the book and the evidence presented of course. I pulled up Hurley's book cover online yesterday and it reads exactly like the script our pharmboys use here in the newsgroups. Amazon's website also peddles a fluff piece in its "editorial review." It refers to Hurley's criticism of the supplement industry for "strong-arming the 1994 Dietary Supplement Health and Education Act through Congress-a law that rendered the FDA virtually powerless to regulate these remedies-and observes the FDA's "coziness" with the industry it regulates. From snake oil and shark cartilage to ephedra, Hurley consistently animates patches of dry legal and medical material with harrowing case studies." What's bizarre here is the phrase "FDA's coziness with the industry it regulates." Since FDA only actively regulates the drug industry (if you want to call that regulation), this reference would logically refer to FDAs cozy ties to its primary funding source, the drug makers, who cover most of FDA's operating budget. I don't know whether this was a zombie-like confession or if someone aware of the truth managed to slip it in. The statement that the supplements industry "strong-armed" the Congress to pass DSHEA, however, is just ridiculous. More Americans sent letters and made calls to Congress on this one issue than they did during the Vietnam war, and it was the most widely supported legislation at a grass roots level than any other law in history. As far as any review of "harrowing case studies" involving dietary supplements, that would be like spotting meteors in the night sky before going to bed. For every such case you might find linked to a dietary supplement, you would find literally thousands linked to a pharmaceutical drug. So yes, I smell a rat. |
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Diet Supplements and Safety
PeterB wrote:
The statement that the supplements industry "strong-armed" the Congress to pass DSHEA, however, is just ridiculous. Wrong. First, there is Orrin Hatch of Utah, home of some of the largest supplement manufacturers. Second, I read the FDA and FTC websites and have read many letters that have very similar, if not the same, verbiage opposing FDA/FTC actions regarding supplement makers. They are complaining that the requirement that medical claims be backed up is an unfair limitation on the free speech of the supplement sales people. After reading these letters, it is clear to me that there is an organized effort. Strong armed tactics. |
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