Medicine
.
Lots of people take non-prescription “food supplements”, nutritional additives, “vitamins”, “energy tonics”, etc. These are particularly attractive if they are labeled “natural” or “organic”. For some folks, the goal is “general health” – the vitamins, minerals, herbs and other preparations, the herbs that. Many of the users of these substances, whether bought from retail outlets or over the internet are precisely those who disdain prescription medications, who don’t like to “take drugs” but take these “natural” substances. Others are taking them for a specific purpose – weight loss, muscle building, pain relief, energy – often when their doctors have refused to prescribe them, because they are dangerous, or illegal, or both.
Thus, we might conceive of two groups of the 114 million of us who take these medications. “Group 1” are those who believe in “natural” and are trying to “naturally” get healthier. “Group 2” wants magic drugs to help them achieve a goal, would be happy to take them if they could find a doctor to prescribe them, but can’t. Unfortunately, this is much a more hypothetical than real distinction, as there is considerable overlap. Many people in the first group can find their way into the other when they develop symptoms. Especially if the treatments are ostensibly “natural”.
A “Perspective” article in the New England Journal of Medicine, October 15, 2009, by Pieter A. Cohen, MD, titled “American Roulette – Contaminated Dietary Supplements”, discusses these issues. Cohen starts by discussing a police sergeant who lost his job after random drug tests found him positive for amphetamines – an unlabeled ingredient present in the weight-loss supplement he had been taking. It goes on to discuss contaminants found in many such over the counter supplements, both imported and made in USA, sold in retail stores and over the Internet. He notes that the 140 contaminated supplements that the FDA has identified are only a small percentage of those on the market; recently 75 weight-loss drugs were found to be contaminated. And “contamination” is not always the correct word. It implies inadvertent (although perhaps through inadequate quality control) substances present that are not on the label – such as rodent hairs or lead or other heavy metals (beryllium, cadmium, arsenic, etc., which are all poisons that accumulate in the body), bacteria, and plant molds. However, frequently the “off-label” ingredients are there on purpose – they are the drugs that are actually having the desired effect – amphetamines for weight loss or energy, anabolic steroids for muscle building, corticosteroids for arthritis relief, opiates for pain. And these are drugs that are illegal to sell without a prescription (and often heavily restricted even with a prescription!) so they are left off the label. And, in part because the FDA has had its budget gutted and has too few inspectors, are undetected.
There are other reasons that the FDA does not detect such accidental or purposeful adulteration. One is the Dietary Supplement Health and Education Act (DSHEA) of 1994, that limited the ability of the FDA to regulate them. The DSHEA was pushed by the supplement manufacturers, with support of many ordinary people who feared that increased FDA regulation would lead to loss of free access to these substances. Before 1994, Cohen writes, “These supplements, which include botanical products, vitamins and minerals, amino acids, and tissue extracts…were considered food additives, and their manufacturers were required to show proof of safety before marketing them. Since the passage of the DSHEA, dietary supplements are presumed to be safe and can be marketed with very little oversight.” And American consumers, looking for magic potions, pay the price in their health.
There are a few things to remember when considering purchasing and taking dietary supplements, even ones you have long taken. They include:
--“Natural” does not mean “good” or even “safe”. There are plenty of natural poisons, and most substances, taken in excessive amounts can have adverse effects. Similarly, “made in a pharmaceutical laboratory” does not mean “bad”; usually, if it is a reputable and inspected lab (including the pharmaceutical manufacturers I often criticize) it means that there is much more quality control.
--If a substance actually has “good” effects, it can also have “side effects”. Substances only have effects. They don’t know what you want and don’t want. If a substance is actually having biological effects on your body (as opposed to psychological placebo effects), it doesn’t matter if it is “natural” or manufactured, from a plant or a chemical. If, for example, the estrogens in plants “work” just as well as those from animals (mare urine) or chemically produced, they will have the same sort of risks.
--Unregulated or under-regulated substances are often “contaminated”, and this is particularly true for those made in other countries and often bought over the Internet. In this case I mean truly “contaminated”, with the lead, bacteria, molds, and toxins I mention above.
--Plants vary in potency. Thus “1 leaf” or “1 ounce” of a plant may have very different amounts of active ingredient depending upon where and what season it was grown in, and just in terms of random variation. If you buy the actual plants – and if you are a skilled enough botanist to be sure of what you are buying – the variable potency needs to be considered. If, however, you are buying capsules said to contain a specific plant, you are, as described above, shooting craps with your health, because these are subject to much less regulation than “standard” pharmaceuticals.
--If it seems too good to be true, it almost certainly is. If a substance you buy, over the Internet or from a retailer, works amazingly well, it is likely that it contains, probably unlabeled, a very potent drug such as steroids, amphetamines, or opiates. Maybe you knew that and wanted it because your mean doctor would not prescribe them. Maybe that makes you unwise. However, if you bought them under the impression that they were “natural” and “safe”, you may be in for a big surprise. And this is likely to be in terms of the serious adverse effects that led them to be highly regulated in the first place.
Finally, the people manufacturing and selling these “supplements” are profit-making companies. Calling themselves “organic” or “natural” does not make them automatically nice, safe, good guys. As in any other industry, as we have seen so often over the last year, there are opportunists who will lie, cheat, steal, and poison you to make a buck. Strong regulation, well-funded regulation, is the only thing we have on our side to protect us. Limiting regulations of substances that can affect our health is almost always wrong. The DSHEA was a mistake, and well-meaning people who supported it made a mistake in doing so. They now need to demand that their legislators protect them at least as much from over-the-counter dietary supplements as they do from prescription drugs!
.
- Belief Vs. "truth": How People Often Make Medical Decisions
In a fascinating article in the “Medicine and Society” section of the New England Journal of Medicine, “Beyond belief—how people feel about taking medication for heart disease”[1], Lisa Rosenbaum discusses some of the reasons that people do...
- Pharma Industry Free Speech Is Anything But Free
Last month, the American Medical Association (AMA) called for a ban on direct-to-consumer (DTC) advertising of prescription drugs and medical devices, arguing that this type of advertising drives the nation's escalating drug bill by creating demand...
- Concerns About Calcium Supplements
Until recently, the idea that calcium-containing supplements, which more than half of older adults in the U.S. consume regularly, could be harmful would have seemed absurd. Primary care clinicians have long recommended calcium supplements to reduce the...
- Food-borne Illnesses Still A Threat, Despite New Food Safety Law
Ten years ago, while training to be a family doctor, I spent several months admitting sick children to a hospital's pediatric ward. We were almost always treating toddlers for severe dehydration—the result of vomiting and diarrhea. Most of them...
- Money-saving Medication Tips
When you purchase a new item of clothing, television set, or a car, as a general rule you can assume that the higher-quality items are the newest and/or those with the highest price tags, even if you know little about the products themselves. But this...
Medicine
Dietary Supplements can be Dangerous for your Health
.
Lots of people take non-prescription “food supplements”, nutritional additives, “vitamins”, “energy tonics”, etc. These are particularly attractive if they are labeled “natural” or “organic”. For some folks, the goal is “general health” – the vitamins, minerals, herbs and other preparations, the herbs that. Many of the users of these substances, whether bought from retail outlets or over the internet are precisely those who disdain prescription medications, who don’t like to “take drugs” but take these “natural” substances. Others are taking them for a specific purpose – weight loss, muscle building, pain relief, energy – often when their doctors have refused to prescribe them, because they are dangerous, or illegal, or both.
Thus, we might conceive of two groups of the 114 million of us who take these medications. “Group 1” are those who believe in “natural” and are trying to “naturally” get healthier. “Group 2” wants magic drugs to help them achieve a goal, would be happy to take them if they could find a doctor to prescribe them, but can’t. Unfortunately, this is much a more hypothetical than real distinction, as there is considerable overlap. Many people in the first group can find their way into the other when they develop symptoms. Especially if the treatments are ostensibly “natural”.
A “Perspective” article in the New England Journal of Medicine, October 15, 2009, by Pieter A. Cohen, MD, titled “American Roulette – Contaminated Dietary Supplements”, discusses these issues. Cohen starts by discussing a police sergeant who lost his job after random drug tests found him positive for amphetamines – an unlabeled ingredient present in the weight-loss supplement he had been taking. It goes on to discuss contaminants found in many such over the counter supplements, both imported and made in USA, sold in retail stores and over the Internet. He notes that the 140 contaminated supplements that the FDA has identified are only a small percentage of those on the market; recently 75 weight-loss drugs were found to be contaminated. And “contamination” is not always the correct word. It implies inadvertent (although perhaps through inadequate quality control) substances present that are not on the label – such as rodent hairs or lead or other heavy metals (beryllium, cadmium, arsenic, etc., which are all poisons that accumulate in the body), bacteria, and plant molds. However, frequently the “off-label” ingredients are there on purpose – they are the drugs that are actually having the desired effect – amphetamines for weight loss or energy, anabolic steroids for muscle building, corticosteroids for arthritis relief, opiates for pain. And these are drugs that are illegal to sell without a prescription (and often heavily restricted even with a prescription!) so they are left off the label. And, in part because the FDA has had its budget gutted and has too few inspectors, are undetected.
There are other reasons that the FDA does not detect such accidental or purposeful adulteration. One is the Dietary Supplement Health and Education Act (DSHEA) of 1994, that limited the ability of the FDA to regulate them. The DSHEA was pushed by the supplement manufacturers, with support of many ordinary people who feared that increased FDA regulation would lead to loss of free access to these substances. Before 1994, Cohen writes, “These supplements, which include botanical products, vitamins and minerals, amino acids, and tissue extracts…were considered food additives, and their manufacturers were required to show proof of safety before marketing them. Since the passage of the DSHEA, dietary supplements are presumed to be safe and can be marketed with very little oversight.” And American consumers, looking for magic potions, pay the price in their health.
There are a few things to remember when considering purchasing and taking dietary supplements, even ones you have long taken. They include:
--“Natural” does not mean “good” or even “safe”. There are plenty of natural poisons, and most substances, taken in excessive amounts can have adverse effects. Similarly, “made in a pharmaceutical laboratory” does not mean “bad”; usually, if it is a reputable and inspected lab (including the pharmaceutical manufacturers I often criticize) it means that there is much more quality control.
--If a substance actually has “good” effects, it can also have “side effects”. Substances only have effects. They don’t know what you want and don’t want. If a substance is actually having biological effects on your body (as opposed to psychological placebo effects), it doesn’t matter if it is “natural” or manufactured, from a plant or a chemical. If, for example, the estrogens in plants “work” just as well as those from animals (mare urine) or chemically produced, they will have the same sort of risks.
--Unregulated or under-regulated substances are often “contaminated”, and this is particularly true for those made in other countries and often bought over the Internet. In this case I mean truly “contaminated”, with the lead, bacteria, molds, and toxins I mention above.
--Plants vary in potency. Thus “1 leaf” or “1 ounce” of a plant may have very different amounts of active ingredient depending upon where and what season it was grown in, and just in terms of random variation. If you buy the actual plants – and if you are a skilled enough botanist to be sure of what you are buying – the variable potency needs to be considered. If, however, you are buying capsules said to contain a specific plant, you are, as described above, shooting craps with your health, because these are subject to much less regulation than “standard” pharmaceuticals.
--If it seems too good to be true, it almost certainly is. If a substance you buy, over the Internet or from a retailer, works amazingly well, it is likely that it contains, probably unlabeled, a very potent drug such as steroids, amphetamines, or opiates. Maybe you knew that and wanted it because your mean doctor would not prescribe them. Maybe that makes you unwise. However, if you bought them under the impression that they were “natural” and “safe”, you may be in for a big surprise. And this is likely to be in terms of the serious adverse effects that led them to be highly regulated in the first place.
Finally, the people manufacturing and selling these “supplements” are profit-making companies. Calling themselves “organic” or “natural” does not make them automatically nice, safe, good guys. As in any other industry, as we have seen so often over the last year, there are opportunists who will lie, cheat, steal, and poison you to make a buck. Strong regulation, well-funded regulation, is the only thing we have on our side to protect us. Limiting regulations of substances that can affect our health is almost always wrong. The DSHEA was a mistake, and well-meaning people who supported it made a mistake in doing so. They now need to demand that their legislators protect them at least as much from over-the-counter dietary supplements as they do from prescription drugs!
.
- Belief Vs. "truth": How People Often Make Medical Decisions
In a fascinating article in the “Medicine and Society” section of the New England Journal of Medicine, “Beyond belief—how people feel about taking medication for heart disease”[1], Lisa Rosenbaum discusses some of the reasons that people do...
- Pharma Industry Free Speech Is Anything But Free
Last month, the American Medical Association (AMA) called for a ban on direct-to-consumer (DTC) advertising of prescription drugs and medical devices, arguing that this type of advertising drives the nation's escalating drug bill by creating demand...
- Concerns About Calcium Supplements
Until recently, the idea that calcium-containing supplements, which more than half of older adults in the U.S. consume regularly, could be harmful would have seemed absurd. Primary care clinicians have long recommended calcium supplements to reduce the...
- Food-borne Illnesses Still A Threat, Despite New Food Safety Law
Ten years ago, while training to be a family doctor, I spent several months admitting sick children to a hospital's pediatric ward. We were almost always treating toddlers for severe dehydration—the result of vomiting and diarrhea. Most of them...
- Money-saving Medication Tips
When you purchase a new item of clothing, television set, or a car, as a general rule you can assume that the higher-quality items are the newest and/or those with the highest price tags, even if you know little about the products themselves. But this...