Your points about food bring up the main point, which is that both food AND drugs are regulated more strongly than the supplement market. When I buy red wine, I expect that it will contain alcohol and that it won't contain methanol. When I buy broccoli, I don't expect that it will be contaminated with E. coli - and when it does, I expect that it will be tracked down to the farm in Uelzei and anything else so contaminated get recalled.
When I buy pineapple juice, I don't see claims about how it make semen taste good. When I buy food in general, I don't want to see health claims at all being used as advertisement, because I know that any such claims can be cherry picked.
But that last is my own preference. The point of the article is that some 20+% of supplement manufacturers are not in compliance with the existing laws. The problems include horrible hygiene and high variability in the product, such that the consumer cannot make an informed decision about what they are buying.
I read the article again and I see that you are correct - the author does want a change. Orac wants the FDA or some other similar organization to be in charge of deciding what a drug is, and not the manufacturer. For example, is it okay for a manufacturer to decide that an industrial chelator is a supplement, and not a drug? On this, at least, the FDA has said no.
I read the article as saying that the problem is that the muli-billion dollar supplement industry has done a poor job of regulating itself, the FDA took a long time to enforce the law, the supplement industry has strong political influence, and the author is pessimistic and thinks that "any victory will be short-lived." This analysis from the Consumer Reports http://www.consumerreports.org/cro/2012/05/dangerous-supplem... corroborates that pessimistic view.
One of the studies I quoted concluded 'there's little justification for the general and widespread use of dietary supplements' in older women. The more complete quote from their paper seems to be "Based on existing evidence, we see little justification for the general and widespread use of dietary supplements. We recommend that they be used with strong medically based cause, such as symptomatic nutrient deficiency disease."
In an interview with the first author of the paper, the author is asked: Medscape: In your study, the supplement users actually had a healthier lifestyle than the nonusers at baseline. So, they were unlikely to be taking supplements to make up for a deficiency in diet, but for prevention and treatment.
Dr. Mursu: That seems to be the case, and that has been noticed in other studies as well, so usually the supplement users are the ones who do not really need them. Usually, they have healthier lifestyles and they are not taking them to make up for a dietary deficiency.
Dr. Mursu: In our study, among the supplement users, their diet was better, they were exercising more, they were less likely to be smokers, and they were better educated -- so, if you did not adjust for these factors, the findings would be that these supplements are beneficial. Taking these factors into account in the statistical models, then, is a crucial part of the study. I was surprised to see that, after adjustment for these factors, supplements seemed to be harmful. ... We cannot exclude the possibility that in some cases for some diseases, these supplements would be beneficial. The aim of our study was to take a broader look, but the main causes of mortality in this population are still cardiovascular disease and cancer. If supplements were beneficial, then you would have expected to see an effect with the simple approach that we used.
I believe that addresses your point in the negative - most people who take supplements are healthier than average, and it's not because "they possibly some ailment that makes them more interested in improving their health."
If an older woman goes to a supplement store and asks if they should take a supplement like copper, folic acid, B6, or a few of the other supplements in the study, and wants to do so in order to help prevent chronic disease, do you think that most salespeople are going to say "no"? Hardly! I mean, according to Consumer Reports: Undercover investigators from the Government Accountability Office, posing as elderly consumers, caught salespeople on tape dispensing potentially harmful medical advice. In one case, a salesperson told an investigator that a garlic supplement could be taken in lieu of high blood pressure medicine.
But the right, most medically correct answer is "no, there's no observed benefits and it seems there's some risk, so it's probably not worth it unless you have a vitamin or mineral deficiency."
As for your disdain for all but the hardest rules of sciences, how delightfully unbalanced it is that a population study with 30,000 people over a period of decades, published in the Archives of Internal Medicine, etc. is suspect while (according to Consumer Reports): Go Away Gray, a product that is claimed to "help stop your hair from turning gray." ... has not had to provide product information to the FDA. Nor did it conduct any clinical trials of the supplement, which includes a natural enzyme called catalase, before putting it on sale. Beggan pointed us to a study by European researchers published in the July 2009 issue of the Federation of American Societies for Experimental Biology Journal. The study found that gray hair had lower-than-normal levels of catalase but did not prove that taking that enzyme by mouth would stop hair from turning gray. "We are working on getting an actual clinical trial going because the results have been so amazing, and it would just be good to have some concrete data behind it," Beggan said.
Tell me, if the research blatantly violates certain hard rules of science, what are these rules? Should I request that the authors be brought up against an ethics committee? I believe you mean to say that only double-blind trials are acceptable. Why then can a supplement point to http://www.fasebj.org/content/23/7/2065 as justification, while any counter-evidence must be rejected until it has met the most exacting of standards?
The double-blind trial you asked for, which is a follow-up to the Mursu study, starts this year. It will take 5- or 10- years to get enough data. But as the researcher points out, what's been done now should be enough to determine if there's a strong indicator that those supplements are useful. Why do you disagree with that conclusion?
To close out with another quote from that Consumer Report article: we identified a group of ingredients (out of nearly 1,100 in the database) linked to serious adverse events by clinical research or case reports. To come up with our dozen finalists, we also considered factors such as whether the ingredients were effective for their purported uses and how readily available they were to consumers. We then shopped for them online and in stores near our Yonkers, N.Y., headquarters and easily found all of them for sale in June 2010. ... The dozen are aconite, bitter orange, chaparral, colloidal silver, coltsfoot, comfrey, country mallow, germanium, greater celandine, kava, lobelia, and yohimbe. The FDA has warned about at least eight of them, some as long ago as 1993.
> both food AND drugs are regulated more strongly than the supplement market
Incorrect. Although if you DO think that, I can see why you'd think that supplements need more regulation. :)
> When I buy red wine, I expect that it will contain alcohol and that it won't contain methanol. When I buy broccoli, I don't expect that it will be contaminated with E. coli - and when it does, I expect that it will be tracked down to the farm in Uelzei and anything else so contaminated get recalled.
Yep, just like with supplements. Mislabelled or contaminated supplements are illegal, and the FDA is charged with enforcing those regulations.
> When I buy pineapple juice, I don't see claims about how it make semen taste good.
Yep, just like with supplements. False claims are illegal, and again, the FDA is charged with enforcing those regulations.
Also - no, those studies are still crap. Observational studies simply cannot be used in the way you and the people you quote are using them, full stop. :)
(Mind you, I also agree that many supplements on the market do nothing useful, and many of the people taking supplements don't need whatever useful thing the supplement they're using might actually do. I'm just waiting to hear a good reason why we need rules beyond "it has to be whatever it says on the label, it can't actually kill people, and you can't lie about what it does". Keeping in mind, of course, that these are the rules currently in effect...)
By "are regulated" I mean that there are laws and enforcement of those laws. I don't mean only that there needs to be more regulations. (Even if we agree on that, I state it now because I see that it wasn't clear.)
Yes, the FDA is charged with enforcing those laws. I think it's done a piss-poor job in doing so, as several of the links which I and others have provided show. I think there's not enough funding for its mandate, I think there's political pressure both to minimize funding for any government oversight ("let the free market fairy decide"), and I think there's political pressure specifically regarding supplements, as described in the linked-to article.
You are disdainful of existing research but you don't say why. I've asked for clarification, but you only say that they are full of crap, without explanation. Observational studies are done all the time: with people, whales, forests, hurricanes, volcanoes, galaxies, cosmic particles, earthquakes, and more. Are you saying that all of those observational studies are inherently incorrect?
If not, what makes these specific supplement studies full-of-crap while not the ones which don't involve people? What is the methodological error?
I would say that the message of the article is "we need more regulations". My reaction was, basically, "you haven't shown that; at best you've suggested we need better enforcement of existing regulations'. So while I disagree with the original linked article, I'm not sure you and I disagree. :)
As for the studies, this is winding far afield, but there's two main ways you can do a study: Controlled and observational. Controlled is hard, but gives good data. Observational is easy, but gives unreliable data, especially when relating to people.
To a first approximation, a controlled study can prove things about human health, while an observational study can suggest areas where a controlled study would be useful.
It's not that these studies have methodological errors (as far as I know, they don't). It's that they're observational studies, and best case, they can't prove things in the way a controlled study would.
If you want a good primer on "what are observational studies and why are they problematic for human health"...I don't actually have one handy. But there was some very good discussion floating around about the "Red Meat Consumption and Mortality" recently published in the Archives of Internal Medicine.
A lot of headlines said, basically, "science proves meat will give you cancer", but again, it was an observational study, and it simply didn't show what people who didn't understand statistics thought it did. Some links discussing that:
When I buy pineapple juice, I don't see claims about how it make semen taste good. When I buy food in general, I don't want to see health claims at all being used as advertisement, because I know that any such claims can be cherry picked.
But that last is my own preference. The point of the article is that some 20+% of supplement manufacturers are not in compliance with the existing laws. The problems include horrible hygiene and high variability in the product, such that the consumer cannot make an informed decision about what they are buying.
I read the article again and I see that you are correct - the author does want a change. Orac wants the FDA or some other similar organization to be in charge of deciding what a drug is, and not the manufacturer. For example, is it okay for a manufacturer to decide that an industrial chelator is a supplement, and not a drug? On this, at least, the FDA has said no.
I read the article as saying that the problem is that the muli-billion dollar supplement industry has done a poor job of regulating itself, the FDA took a long time to enforce the law, the supplement industry has strong political influence, and the author is pessimistic and thinks that "any victory will be short-lived." This analysis from the Consumer Reports http://www.consumerreports.org/cro/2012/05/dangerous-supplem... corroborates that pessimistic view.
One of the studies I quoted concluded 'there's little justification for the general and widespread use of dietary supplements' in older women. The more complete quote from their paper seems to be "Based on existing evidence, we see little justification for the general and widespread use of dietary supplements. We recommend that they be used with strong medically based cause, such as symptomatic nutrient deficiency disease."
In an interview with the first author of the paper, the author is asked: Medscape: In your study, the supplement users actually had a healthier lifestyle than the nonusers at baseline. So, they were unlikely to be taking supplements to make up for a deficiency in diet, but for prevention and treatment.
Dr. Mursu: That seems to be the case, and that has been noticed in other studies as well, so usually the supplement users are the ones who do not really need them. Usually, they have healthier lifestyles and they are not taking them to make up for a dietary deficiency.
Dr. Mursu: In our study, among the supplement users, their diet was better, they were exercising more, they were less likely to be smokers, and they were better educated -- so, if you did not adjust for these factors, the findings would be that these supplements are beneficial. Taking these factors into account in the statistical models, then, is a crucial part of the study. I was surprised to see that, after adjustment for these factors, supplements seemed to be harmful. ... We cannot exclude the possibility that in some cases for some diseases, these supplements would be beneficial. The aim of our study was to take a broader look, but the main causes of mortality in this population are still cardiovascular disease and cancer. If supplements were beneficial, then you would have expected to see an effect with the simple approach that we used.
I believe that addresses your point in the negative - most people who take supplements are healthier than average, and it's not because "they possibly some ailment that makes them more interested in improving their health."
If an older woman goes to a supplement store and asks if they should take a supplement like copper, folic acid, B6, or a few of the other supplements in the study, and wants to do so in order to help prevent chronic disease, do you think that most salespeople are going to say "no"? Hardly! I mean, according to Consumer Reports: Undercover investigators from the Government Accountability Office, posing as elderly consumers, caught salespeople on tape dispensing potentially harmful medical advice. In one case, a salesperson told an investigator that a garlic supplement could be taken in lieu of high blood pressure medicine.
But the right, most medically correct answer is "no, there's no observed benefits and it seems there's some risk, so it's probably not worth it unless you have a vitamin or mineral deficiency."
As for your disdain for all but the hardest rules of sciences, how delightfully unbalanced it is that a population study with 30,000 people over a period of decades, published in the Archives of Internal Medicine, etc. is suspect while (according to Consumer Reports): Go Away Gray, a product that is claimed to "help stop your hair from turning gray." ... has not had to provide product information to the FDA. Nor did it conduct any clinical trials of the supplement, which includes a natural enzyme called catalase, before putting it on sale. Beggan pointed us to a study by European researchers published in the July 2009 issue of the Federation of American Societies for Experimental Biology Journal. The study found that gray hair had lower-than-normal levels of catalase but did not prove that taking that enzyme by mouth would stop hair from turning gray. "We are working on getting an actual clinical trial going because the results have been so amazing, and it would just be good to have some concrete data behind it," Beggan said.
Tell me, if the research blatantly violates certain hard rules of science, what are these rules? Should I request that the authors be brought up against an ethics committee? I believe you mean to say that only double-blind trials are acceptable. Why then can a supplement point to http://www.fasebj.org/content/23/7/2065 as justification, while any counter-evidence must be rejected until it has met the most exacting of standards?
The double-blind trial you asked for, which is a follow-up to the Mursu study, starts this year. It will take 5- or 10- years to get enough data. But as the researcher points out, what's been done now should be enough to determine if there's a strong indicator that those supplements are useful. Why do you disagree with that conclusion?
To close out with another quote from that Consumer Report article: we identified a group of ingredients (out of nearly 1,100 in the database) linked to serious adverse events by clinical research or case reports. To come up with our dozen finalists, we also considered factors such as whether the ingredients were effective for their purported uses and how readily available they were to consumers. We then shopped for them online and in stores near our Yonkers, N.Y., headquarters and easily found all of them for sale in June 2010. ... The dozen are aconite, bitter orange, chaparral, colloidal silver, coltsfoot, comfrey, country mallow, germanium, greater celandine, kava, lobelia, and yohimbe. The FDA has warned about at least eight of them, some as long ago as 1993.
That doesn't seem right.