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Drugs (the legal prescription type) and drug safety seems to continually return to the news, most recently with reports of serious side effects from a new oral contraceptive pill (OCP), featured on NPR’s "Morning Edition”. With regard to OCPs, it is important to note that virtually all the side effects of oral contraceptives, including the serious ones, are the same as the ones women are at greater risk for from being pregnant. The fact that pregnancy is a “natural” event does not make it risk free; complications such as clots in the veins of the legs (deep venous thrombosis, DVT) do occur, associated with the higher levels of estrogen in pregnancy, and occur more frequently than they do for women taking oral contraceptives. Whatever one’s level of risk for OCPs, a risk that increases with increasing age and dramatically if one smokes, that risk is greater from being pregnant.
However, because the probability of getting pregnant (and thus having serious “side effects” from it) decreases with increasing age while the risk of serious side effects from OCPs goes up, it makes sense for older women who are still fertile to use alternative types of contraception – but, unless they are actively trying to get pregnant, to use contraception. The fact that OCPs can have significant benefits (mainly: preventing unwanted pregnancy) does not make them benign, but neither is pregnancy itself.
The choice to use or not use drugs for any condition (or for prevention of a condition), whether they are prescribed by a health care provider or, in the case of many nonprescription drugs, chosen by the person him/herself, is influenced by number of factors. The best one is that a person has a condition that puts them at risk for bad health outcomes (the “patient important outcomes” of premature death or decreased quality of life; see Calcium, Heart Attack and Osteoporosis, August 2, 2010; Rosiglitazone and the "Holy Grail" July 16, 2010; Statins and scientific integrity, July 6, 2010), and the probability that a drug will decrease that risk is significantly greater than the probability that the drug’s effects will cause a problem. There are sometimes other reasons; a person (patient) will hear from a friend that a drug worked for them, or see on it advertised on television or elsewhere, and decide to try it (if non-prescription) or ask their doctor for it (as so often urged on TV commercials). Depending on a number of factors (whether the drug is in fact useful or potentially useful for something the person has, whether it might create increased risk for the patient, how persistent, or even demanding, the person is) the doctor might in fact prescribe it.
In general, it is fine if you ask your doctor about a medication that you have reason to think might benefit you, but probably not such a good idea to persist/insist if s/he suggests it would not be advisable to take it. A few cautions and things to think about, some of which I have previously discussed (“Conservative” Drug Prescribing March 11 2009):
• Not everything is effectively treatable with a drug. Taking a pill may be easier than changing your diet or exercising or doing other hard or proactive things, but without those other activities it may not work or work as well, and may well be worse;
• Not all drugs are “bad”. Some are really helpful for the right people with the conditions that they are effective in treating, and the potential side effects are far less than the benefits.
• Because some drugs do not require a prescription this does not make them “safe”. They should still only be used when the same criteria are fulfilled: scientific evidence demonstrates that the probability of benefit significantly exceeds the probability of harm. The same applies to any “nutritional supplement”. Because it is not called a “drug” doesn’t make it safe. Everything has potential for harm in the wrong people, the wrong circumstances or the wrong dose (Dietary Supplements can be Dangerous for your Health, October 31,2009)
• If a little is good, more is not necessarily better. Nor is less necessarily better. The right amount is: the right amount!
• Despite our culture’s fascination for the “NEW!!”, new is not necessarily better. Frequently it is worse. Drugs are not cars or cell phones. Newer drugs may have side effects that have not become apparent in the necessarily limited testing that is done before they are marketed, but do manifest when many times more people take them. They sometimes have therapeutic benefit for some people that is greater than old drugs, but often they do not. The only reason to even consider a drug that is new on the market is if your old drug, and the other available old (=”well established”) drugs don’t work adequately or have intolerable side effects, and there is reason (=”evidence”) that the new one will (work better), or won’t (have those side effects).
• Advertising drugs, whether to physicians or to patients, is pretty much a bad thing. As in all advertising, the goal is to sell stuff; it is not (despite pharmaceutical company slogans) improving people’s health. This is highly tied to “NEW!!” because it is the new drugs that are the ones that are advertised. This is because they are the ones that cost the most, that have the highest profit margin, and that the companies need to develop a market for. They also have to amortize their research and development costs, as they will often point out. This would be a less offensive claim if most of the drugs that came out and are heavily marketed were not “me too” drugs – modifications (often quite minor) of existing drugs that are no longer under patent and are being sold generically. Drugs that the doctor may have in his/her “sample closet” will always be these same drugs – the newest, highest cost (and highest profit) options. In health care, if something is being advertised, whether a drug or a procedure available at a local hospital, the meaning is “we would like it if you would buy this because we will make money” and not at all necessarily “this will be good for your health”. By the way, in the case of advertised procedures that you may see on billboards for a hospital or clinic, it means also “if you have insurance”.
The issue of advertising to physicians is addressed in an excellent editorial by Matthew Anderson in the current issue of Social Medicine. It examines the historic and current collaboration by medical organizations with big corporations. In addition to the AAFP/Coca-Cola alliance that I have recently written about, it examines the relationship between the American Academy of Pediatrics (AAP) and infant formula manufacturers and the tight involvement of the AMA with pharmaceutical companies. It is eye opening. In addition, the journal contains a powerful piece by Alan Blum introducing two classic articles about physician activism around tobacco written by the same Dr. Blum when he was, 20 years ago, editor of the New York State Journal of Medicine: “Cigarette smoking and its promotion: Editorials are not enough” and When “More doctors smoked Camels”: Cigarette advertising in the Journal” . The introductory quotation to the first article, from Ira Gershwin of all people, cannot be repeated often enough “One man's death is another man's living”.
And, for those who doubt that, given the current shameful practices, sometimes, given enough time pressure and public awareness, progress is possible, it is worth just looking at the Social Medicine’s cover to see how far we have come, in at least the relationships between doctors and tobacco.
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Showing posts with label supplements. Show all posts
Showing posts with label supplements. Show all posts
Tuesday, September 7, 2010
Saturday, October 31, 2009
Dietary Supplements can be Dangerous for your Health
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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!
.
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!
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