I will probably go buy this issue to have a better, more readable copy of this article. The author has done outstanding research and puts the entire industry into both historical and current perspective. I hope this link lasts (not sure about the New Yorker’s links) – MIRACLE IN A BOTTLE
I will quote a few key paragraphs to make some points and highlight the issue:
The diet-pill business may be the most visible segment of the vitamin-, mineral-, and herbal-supplement industry, but it is by no means the largest. Thousands of different tablets, elixirs, potions, and pills are sold in the United States, and remarkably little is known about most of them. That doesn’t deter consumers. Since 1994, when Congress passed a law that deregulated the supplement industry and opened it to a flood of new products, the use of largely unproved herbal remedies – from blueberry extract for impaired vision to saw palmetto for the treatment of enlarged prostates and echinacea to prevent colds – has increased as rapidly as the use of any commonly prescribed drug.
Since that legislation, the Dietary Supplement Health and Education Act, became law, companies have been able to say nearly anything they want about the potential health benefits of what they sell. As long as they don’t blatantly lie or claim to have a cure for a specific disease, such as cancer, diabetes, or aids, they can assert, without providing evidence, that a product is designed to support a healthy heart (CardiAll, for example), protect cells from damage (Liverite), or improve the function of a compromised immune system (Resist). There are almost no standards that regulate how the pills are made, and they receive almost no scrutiny once they are, so consumers never truly know what they are getting. Companies are not required to prove that products are effective, or even safe, before they are put on the market.
Those two paragraphs nicely summarize the effects of the DSHEA.
Since then, the English language has been stretched to its limits in the attempt to link products to health benefits. Even claims that are true may be irrelevant. Vitamin A, for example, is important for good vision – as supplements for sale in any health-food store will tell you. Insufficient consumption of Vitamin A causes hundreds of thousands of cases of blindness around the world each year, but not in the United States; here people don’t have vision problems arising from a lack of Vitamin A. Although statements advertising Vitamin A for good vision may, like many others, be legally permissible, they are meaningless. “The laws allow manufacturers to make fine legalistic claims,” Paul M. Coates, the director of the Office of Dietary Supplements at the National Institutes of Health, told me. “What we now have is an entire cottage industry of creative linguistics dedicated solely to selling these products.” Instead of mentioning a disease (which in most cases would be illegal without F.D.A. approval), companies make claims that a food can affect the structure or function of the body. Such claims can appear on any food, no matter how unhealthy it is. You cannot assert that a product “reduces” cholesterol, but you can certainly say that it “maintains healthy cholesterol levels.” You cannot state that the herb echinacea cures anything, since it has never been shown to do that. But there is no prohibition on stating that it “has natural antibiotic actions” and is considered “an excellent herb for infections of all kinds.” Gingko biloba has been recommended to Alzheimer’s patients because it “supports memory function.” Does it? Since research is not required before a supplement is released, there are not nearly enough data to know.
Obviously the key here is the advertising. You can obviously sell almost anything to some people with good enough advertising. Data are irrelevant.
One recent Harris poll found that most people believe that if a supplement is on the market it must have been approved by some government agency (not true); that manufacturers are prohibited from making claims for their products unless they have provided data to back those claims up (no such laws exist); and that companies are required to include warnings about potential risks and side effects (they aren?t). “When something goes wrong, though, most people expect government health officials to find a solution,” David A. Kessler told me. Kessler, who is the dean of the School of Medicine at the University of California at San Francisco, was the F.D.A. commissioner when Congress passed the Dietary Supplement Act, which he adamantly opposed. “This is really the classic American ambivalence, and it has always been part of our nature,” he said. “The view of most people is simple: I want access to everything and I want it now.” The Federal Trade Commission – not the F.D.A. – regulates supplement advertising. But the F.T.C. is principally concerned with commerce, not science: it focusses on the content of the labels, not the content of the pills. Although since 1994 the agency has sued more than a hundred diet-pill companies, in 2002 it found that at least half of all weight-loss ads contained false or misleading statements. Despite its vigilance, the agency has an impossible job; for each success, ten new companies seem to appear.
When people get sick, Dr. Kessler pointed out, the refrain is always “‘Where the hell is the F.D.A. to protect me’? The supplement industry doesn’t have to report adverse events, so the F.D.A. doesn’t have the data it needs to protect people. You cannot prove something is unsafe if you don’t have the data. It’s the ultimate Catch-22. It is also a colossal failure to protect the public health of this country.”
I hope that these excerpts have whet your appetite to read the best single overview of the dietary and supplement industry that I have yet read. DSHEA respresents the worst of our political process. The government has put the citizenry at both health and financial disadvantage. I hope that common sense and good science can prevail. Unfortunately, I am skeptical.
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{ 7 comments }
I read this article this week, too.
I wonder if the problem isn’t with our almost total disregard of science? Cross validation, double blind studies and peer review are ideas most people just don’t grasp. Americans hate thinking hard. It reminds me of some of my relatives who still refuse to fly (either because of 9-11 or typical anxiety) but will get in their roll-over prone SUV and drive 16 hours. Don’t bother them with statistics!
This article and the lessons it tells us remind me of Phineas T. Barnum, who with his empty showmanship in the 19th century
demonstrated once and for all that we should never underestimate the ability of the people to believe in anything, even bunk when presented as pseduo-scientific.
The explanation is simple: the billions of money made from this enterprise. The obsession to buy these products mirrors another disturbing trend: the number of visits made by Americans to so-called alternative practitioners, who profit from selling these products. It is estimated that more Americans visit these practitioners than they do their primary care physicians.
The average citizen obviously needs to be more educated about these products. In tandem with this, Congress needs to revisit the issue, amend the DSHEA to require more stringent, and scientific, standards before these products are peddled to an unsuspecting public.
We all complain about the rising costs of medical care, but look where a lot of people are spending their money. We need to put an end to all this bunkum.
Couldn’t agree more with that last paragraph R.G.
Maybe a few lawsuits against supplement makers would help level the playing field?
I see where the above comments are going. Have you set back in our seat and taken a good look at the article? There is a strong resemblence in supplement manufacturing to the evidence-based industry of pharmaceuticals.
I’m a chiropractor and love reading the information on this site, because it is very informative. I also find myself agreeing with most of what is discussed here. I did see a reason to respond to this post,and the disturbing comment by R.G. Lacsamana:
‘The obsession to buy these products mirrors another disturbing trend: the number of visits made by Americans to so-called alternative practitioners, who profit from selling these products.’
As a chiropractor, I’m a part of the alternative trend. I realize some reigns need to be put on herbs and other so-called alternative therapies, but I don’t think we need to dismiss the right of the patient to make their own educated decision. After all, a patient is not going to keep up with something that is harmful to them, unless their doctor tells them to. If millions, thousands, heck hundreds within a year were suffering problems from these herbal supplements, the word of mouth of their failure would kill the sales.
Back to the article. I worked for Monsanto for three years running pilot research for pharmaceuticals, before continuing my education. A lot of how herbs are made are the same way pharmaceuticals are made. Where do you think they got the refinement processes to get product to powder form.
Big pharma is very similar to the supplemnetal industry, except big pharma spends thousands of dollars in “research on efficacy” of medicine. Yes, they spend millions in “research”, but most of the research is directed to profit. My job (research) was to get more of the pure product by the most cost effective means. We did a lot of expensive process changes to get our results. You see, the drug had already been approved from lab, we spent the most money and time, developing the process to production size.
I’m sure we all know how statistics can be used to get results we need, or at least point our direction. Everybody knows that if you flip a “roll-over” prone SUV that it was probably your fault. If the plane craches, well that was out of your hands. Personally I like to have control of the reigns, like most Americans.
I think CoryT is using sophistry to argue that herbal products are similar to drugs made by ethical pharmaceutical companies. The resemblance is superficial; beyond the same manufacturing process, herbals do not go through the same rigorous process of scientific testing as drugs do that have been approved by the FDA. That is a world of difference.
To state further that herbal products are being bought on the basis of “educated decisions” is ludicrous. People buy them mainly because of massive advertising, often with claims that cannot be documented because they have not been tested.
At a time when so many scientific advances have been made and when people demand that
there should be truth in advertising, why would “alternative practitioners” like CoryT insist on validating what they sell to the public by exploiting people’s gullibility? More than the money that can be made, CoryT needs to care about truth and to depend less on claims that cannot be documented.
When we serve millions of people, we need to instill in ourselves and in our professions standards of ethics and scientific validity. Like Caesar’s wife, we need to be above suspicion.
Let me clarify a few things. First, I don’t sell herbal supplements in my practice. Also, not every alternative practitioner is trying to exploit people’s gullibility. There are some viable supplement companies out there, that do good research, Standard Process is the one I would use.
Second, I worked for a pharmaceutical company. I know how to slant numbers through statistics, when you are doing a project. This blog had a link about the pharmaceuticals industry on Jan 14. to ‘Forgone conclusions.’ I thought it was funny along with the reference in the ‘Forgone conclusions’ to the BMJ article by Sackett and Oxman. It was funny, because this is how industry does what it does. Pahrmaceuticals lobby, to keep in control while “pimping” to the gullibility of medical doctors (not all)to get products to the patient (the public). Plus, now they have a new weapon, which I’m sure medical doctors just love, the TV ad which targets the gullibilty of the people. To me it doesn’t sound much different than the pimping that goes on in the herbal supplement industry. They just don’t have the FDA to stand behind…yet.
I think a lot of people in this day and age have a lot of resources to pull there decisions from. The internet has viable resources like this website, and others like it that are valid. Not to mention there is a lot of access to peer review publications, for the general public, at the library and on the web. It doesn’t take a genius to understand an abstract, and most of us don’t understand what they are talking about in the rest of the article anyway (unless of course you are doing that same type of research). The public is educating themselves more now than any other time.
I’m not trying to step on anybody toes, or start any problems. I’m sorry I came across as using sophistry, I was trying to make a point in a creative way. I still do not appreciate R.G. Lacsamana’s earlier comment. Healthcare itself, is big business, with billions being made from it. Why target just alternative practitioners? I have plenty of pateints who come in and talk about the herbal crap that there medical practitioner is telling them they need to take. I usually try to point them to something a little more effective or better then what is sold at Walmart. Even with the billions being made from healthcare, pharma, and supplements, I sure don’t think most of the physicians running practices are seeing that money profit. Money isn’t why most physicians (chiropactic, medical, osteopathic) stay in healthcare, it’s for the patient. I care about my patients, and I try to stay sharp, as I’m sure other practitioners do, on current topics.
CoryT still doesn’t get it.
Let me point out a few thing to him.
(l) He keeps invoking his previous work with a pharmaceutical company, claiming he can slant numbers and statistics to arrive at “foregone conclusions.” That is dishonest and unethical. Companies and their workers engaged in that type of work are not going to last long and most likely will be banned forever from scientific research.
(2) It is nice to know CoryT does not sell supplements but anybody can get them from any variety of outlets without medical prescriptions. Furthermore, the vast majority of physicians do not tell their patients to take them, knowing that most of these herbals have dubious efficacy and can interact with a number of drugs that may harm patients.
(3) It is true that most patients are now better equipped than ever to know about medical care in general, but where are the
sources of information on herbals that they can access for them to make “educated decisions?” NADA, ZILCH, NOTHING! I think CoryT is daydreaming in suggesting that the FDA, in the future, may give approval to some of these herbal products. Fantasies ought not to be confused with hard science.
(4) Nobody is trying to target “alternative practitioners” in the sale of these herbals. It’s just the truth.
Like a lot of physicians, I also believe that we ought not to classify medical practitioners by creating categories like “alternative.” If medical care is good and grounded in hard science, why creat an “alternative?”
I realize CoryT has his own points of view, but I’m afrad they are out of stream.
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