Thanks, Congress, for making bull testicles available as a dietary supplement!
On October 21, 1993, there was a hearing before the U.S. Senate Committee for Labor and Human Resources, with the long-winded title:
Examining How the Federal Government Should Regulate the Marketing and Use of Dietary Supplements and Related Measures, Including S. 784, To Strengthen Federal Standards with Respect To Dietary Supplements.
S. 784, sponsored by Sen. Orrin Hatch, would eventually be enacted as the Dietary Supplement Health and Education Act of 1994 (DSHEA).
I discovered this bit of Congressional theater when doing research for my recent talk at NECSS. Scott Gavura and I joined forces to present “Natural Disaster: Dietary Supplements.” Scott focused on pharmacology, while I talked about FDA regulation of dietary supplements (or lack thereof). Thanks to him, I now have a rudimentary knowledge of pharmacokinetics, the science behind how a drug or supplement works (or doesn’t) in the body. If you haven’t read his post from last week explaining this, and more, you should.
Reading the lengthy hearing transcript (well, ok, a lot of it) confirmed my suspicions that the fix was in even before the gavel went down to begin the hearing. What I had not realized was, at least according to some proponents of DSHEA, part of the deal was that consumers would have access to accurate information backing efficacy claims made for supplements and their safety. Nor had I realized that the weaknesses of DSHEA, which have become painfully obvious in the 20-plus years since the law was passed, were anticipated from the get-go and that Congress was well-informed of what they were. Finally, I was not previously aware of the provenance (shall we say) of the “experts” asked to testify at the behest of Sen. Hatch.
First, let’s set the stage on which this drama plays out, according to two excellent books on dietary supplements, Natural Causes and Vitamania. In 1991, Congress passed the Nutrition Education and Labeling Act (NELA). Most famously, NELA, for the first time, required that all foods bear the now-familiar nutrition label. It also required that any health claims made for foods be backed by “significant scientific agreement.” Rep. Henry Waxman and others wanted the same standard applied to dietary supplement health claims. After all, if food companies had to meet a certain standard to make health claims for, say, calcium in their products, why shouldn’t claims for the health benefits of calcium in dietary supplement form be held to the same standard? But the supplement industry knew it couldn’t survive under such stringent rules and Sen. Hatch made sure it didn’t happen. All parties agreed to let the FDA decide what standard should be required of supplement health claims and left it at that.
Lo and behold, the FDA turned right around proposed a regulation that dietary supplement health claims would be held to the same “significant scientific agreement” standard. This could be met in one of two ways. The supplement company could submit the evidence to the FDA for review or show that the claim was backed by a statement from a recognized scientific authority, like the National Academy of Sciences. (Actually, this is still the standard for health claims, but DSHEA did away with the necessity of making health claims. The nebulous “structure/function” claim and the “substantiation” standard for evidence obviated the need go to all the trouble.)
Sen. Hatch and the industry were not amused. The industry started an absolutely false rumor that the FDA was out to “ban” or “take away” consumers’ supplements. Thus riled up, hundreds of thousands of people wrote and called Congress demanding that something be done. With that, let’s turn to the hearing itself.
Where’s the evidence?
Rep. Bill Richardson (D-NM), who sponsored the House version of S. 784, led off the testimony. Rep. Richardson framed the issue as one of “freedom of choice.” If consumers could “choose dietary supplements that will help them prevent illness and disease,” the “safe use of supplements could save this country billions of dollars in health care costs each year.” How? By giving consumers “adequate information” using labels and “pamphlets.” (This is before the age of Google U and widespread use of internet sales.) And,
I also believe that health claims must be truthful, nonmisleading, and based upon the totality of scientific evidence . . . [M]anufacturers of supplements must be allowed to make truthful and nonmisleading claims when there is scientific evidence to back those claims. Let’s allow science to be the determining factor for the validity of health claims for supplements and any questions involving safety. This should be our goal as we move forward. [Emphasis added.]
The importance of consumer access to the evidence was emphasized by the Commission on Dietary Supplement Labels, which was created by DSHEA. The largely forgotten Commission, which included industry representatives, was charged with making recommendations for
the regulation of label claims and statements for dietary supplements . . . [T]he Commission shall evaluate how best to provide truthful, scientifically valid, and not misleading information to consumers so that [they] may make informed and appropriate health care choices.
The Commission’s 1997 Report said that the supplement industry has a responsibility to provide a synopsis of the scientific evidence regarding statements of nutritional support and product safety to potential buyers and health professionals. These synopses should indicate how health professionals can obtain access to the studies and evidence that support these statements, which would facilitate the ability of health professionals and consumers to evaluate them.
Later in the hearing, Sen. Tom Harkin, of NCCAM/NCCIH fame, steps up to the bat, teeing off (badly scrambled sports metaphor noted) with his infamous story about how bee pollen cured his allergies. To that he added an anecdote about how someone gave him a traditional Native American substance (never identified) to chew on and it cured his sore throat, practically instantaneously. He then wanted to know why supplement companies shouldn’t be able to tell consumers that some people have been “cured of allergies,” for example, by a dietary supplement. However, to his credit, Sen. Harkin ends up agreeing with David Kessler, then head of the FDA and a witness at the hearing, that “significant scientific agreement” would be an appropriate standard.
Science and the Senator
As might be expected, the supplement industry’s protector-in-chief, Sen. Orrin Hatch, who dominated the mic, spent most of his time lambasting the FDA, including a downright abusive confrontation with Dr. Kessler. (Fortunately, Sen. Katzenbaum, for the record, stepped in and established that the rumors about the FDA “banning” supplements were encouraged by the industry and absolutely false.)
For their part, Dr. Kessler and other FDA officials present at the hearing tried to warn the committee about the dangers of supplements and the lack of evidence of their efficacy. Their points:
- Many products sold as dietary supplements – amino acids, herbs and botanicals, and other non-vitamin and non-mineral products, have no established role in nutrition, have been associated with serious adverse reactions and frequently bear unsubstantiated claims to prevent or treat disease.
- If no scientific standard is imposed, the market will be filled with unsubstantiated claims, putting the public’s health at risk, including diverting people from proven medical treatments.
- The lack of reported adverse events doesn’t mean they don’t happen because there is no system for reporting them.
- Although some botanicals are derived from well-known culinary herbs, most are not and have no known nutritional value or history of use as foods. Dietary supplements containing herbs and botanicals are not standardized, making testing them for efficacy or safety problematic. The FDA’s testimony specifically discussed the risks of germander, comfrey, chapparal, yohimbe, lobelia, Jin Bu Huan, Stephania/Magnolia, Ma Huang (ephedra) and willow bark.
And, finally, in Dr. Kessler’s own words,
The proposed legislation would permit companies to make the initial judgment. A claim could be made as long as it accurately described the state of the scientific evidence, which under the bill as written could include a complete lack of evidence. Thus, a claim could be based on mere belief or on one small preliminary study that in no way established the nutrient-disease relationship, as long as the label statements accurately portray the state of the evidence.
[I am not sure what he is referring to by “accurately portray the state of the evidence” as there is no such requirement in DSHEA.]
In yet another session of lambasting Dr. Kessler and the FDA, Sen. Hatch makes two statements confirming my initial impression that either Sen. Hatch does not, or does not want to, understand science-based, or even evidence-based, medicine. First, he asks, in essence, “what’s the harm?” If a supplement doesn’t hurt someone, why not let it remain on the market, even without evidence of efficacy:
The fact of the matter is that many people get well because they take placebos because in a large sense they believe they are doing something that helps them, and psychosomatically it does.
And,
[what] you have been advocating for . . . is basically that they [the supplement companies] have got to prove every claim that they make before they can put the claims out there’re. And, if they do not, they cannot do it. Therefore, a lot of products that basically are helping people like Senator Harkin . . .
Sen. Hatch then trails off into the “bee pollen anecdote” but his message is clear: anecdotal evidence is sufficient and supplement companies should not have to have any valid evidence before making claims.
He also said, in questioning a representative of the Center for Science in the Public Interest,
I have seen estimates where just if people would take Vitamin E that we would save about $25 billion a year in health care costs on the reduction of cardiovascular disease. You could just extrapolate that out with Vitamin C, beta carotene, Vitamin A. You could just go right through it. The American people would be much better off.
He does not explain exactly how one can “extrapolate” the alleged evidence for the efficacy of one vitamin to prove the efficacy of other vitamins, but such is the scientific prowess of our elected representatives in Congress.
Sen. Hatch’s “experts”
Sen. Hatch’s remarks were not without humor, although that certainly wasn’t his intent. The good Senator thanked a number of luminaries from the alternative medicine industry “who have worked closely with us during our consideration of this issue.” These included “Citizens for Health,” now run by James Turner, “neutraceutical” litigator and lobbyist, and supported by the Weston A. Price Foundation and the National Health Freedom Coalition, on whose board the late homeopathy enthusiast Rustum Roy sat.
Also recognized were a number of “helpers” with obvious ties to the supplement industry. And:
Another individual who has been a great help to me is Dr. Julian Whitaker, a noted physician, author of the monthly newsletter, “Health and Healing,” President of the American Preventive Medical Association.
I laughed out loud when I came to this point in the transcript. We’ll all have to agree that Dr. Whitaker is “noted,” just not in the way Sen. Hatch had in mind. He is an anti-vaccinationist who debated our very own Steve Novella. And, if that weren’t enough, he is a supporter of cancer quack Stanislaw Burzynski, claims he can cure diabetes “naturally,” thinks antibiotics don’t work, and prescribes chelation therapy for this patients. The American Preventive Medical Association, now the American Association for Health Freedom, was described by SBM’s Kimball Atwood as part of “what is probably the largest and most insidious family of organizations hyping implausible practices and the ‘freedom’ to peddle them.”
Dr. Whitaker did not personally appear, but submitted written testimony touting the benefits of saw palmetto, calling it more effective than Proscar. Apparently, Dr. Whitaker was the source of Sen. Hatch’s claim that we could save “billions” by taking Vitamin E. He extrapolated from two observational studies that by taking Vitamin E there would be a 23% reduction in the U.S. heart disease rate.
Another of Sen. Hatch’s experts at the hearing was Michael Janson, MD, who, according to his website, is past president of both the American Preventive Medicine Association and the American College for Advancement in Medicine, another pseudomedical pseudoprofessional organization. Quackwatch, which lists the ACAM among “Questionable Organizations,” complained to a website about it’s referring readers to ACAM for advice on “alternative medicine” that
referring readers to ACAM members is like referring people who want to borrow money to Mafia loan sharks.
Dr. Janson also described himself in his testimony as a charter member of yet another pseudomedical professional organization, the American Holistic Medical Association, whose members include such luminaries as Christine Northrup, MD.
Dr. Janson seemed to enjoy his position as medical advisor to Sen. Hatch, a position of authority one doubts comes his way all that often. He refers to the “vast medical literature” substantiating the use of dietary supplements for health. He describes supplements as “safer than water.” His claimed that saw palmetto reduces enlarged prostates, heart attacks are preventable by taking vitamin C, and that antioxidant supplements are beneficial. He also sets up a giant straw man by displaying, in a chart, adverse reactions to drugs. He used the opportunity to promote one of his books by handing out free copies.
Although he didn’t personally testify, a letter from Linus Pauling to President Bill Clinton was included in the record. He opined that “vitamin C can help prevent the common cold” and that “a whole range of vitamins, known as antioxidants, can also prevent chronic illnesses including the nation’s two largest killers, heart disease and cancer.”
Of course, if you’re pushing for a law like DSHEA, these are just the sort of “experts” one would want as advisors.
On the other hand, Bruce Silverglade, from the Center for Science in the Public Interest, presented the views of that organization and the American Cancer Society, American Heart Association, American Association of Retired Persons, American College of Physicians, American Institute for Cancer Research, American Nurses Association, Association of State and Territorial Public Health and Nutrition Directors, Citizens for Public Action on Cholesterol, Consumer Federation of America, Public Voice for Food and Health Policy and the Society for Nutrition Education. With all due respect to Mr. Silverglade and his excellent testimony, having one person present the opinion of so many different organizations was a tactical error. Given the influence of the supplement industry and its powerful protector, I doubt it would have made any difference in the outcome, but it would have at least made the outcome look worse.
Mr. Silverglade said, in a statement overly generous in its interpretation of S. 784, that the bill would allow health claims “so long as manufacturer disclosed the state of the evidence supporting the claim, even if it was minimal.” This concerned him because
Manufacturers could hype products on the basis of preliminary, shaky, and inconclusive scientific evidence that would preclude consumers from making an informed choice, and a [sic] uninformed choice is tantamount to no choice at all.
He also warned against making health policy based on the “sole assumption that because a product has been used for many years that it is safe.” As well, he thought the level of proof required for removing products from the market – “substantial and unreasonable risk of injury or illness” – was too stringent and that the “amount and type of evidence needed by a supplement manufacturer to substantiate safety is insufficient.”
So, who was right?
How has DSHEA worked out? Splendidly, for the dietary supplement industry. Sales of dietary supplements were at $4 billion annually in 1994. In 2014, they were just under $37 billion.
For the rest of us, not so much. Over 20 years later,we know that some of the testimony at the hearing was prescient. Some of it proved dead wrong.
- Consumers and health care professionals have never received the promised evidence for safety and efficacy. In fact, the industry fought legislation which would make them tell us what evidence they have backing their claims, even though they are required to have substantiation. And when the Department of Health and Human Services Office of Inspector General looked into whether a sample of the industry was complying with the “substantiation” requirement, they were not. The prediction that supplements would be put on the market with flimsy evidence behind them came true.
- Placebos have yet to make anyone “get well.” But, as we know, there are dangers of thinking you are better because you feel better. For example, choosing alternative medicine over effective asthma treatment because placebo responses lead to feeling better without altering the underlying illness, could very well lead to preventable asthma deaths.
- The supplements touted by Julian Whitaker and others at the hearing have not held up to further scrutiny, for Vitamin E and cardiovascular disease, for saw palmetto and prostate problems, for Vitamin C and colds or heart disease, or for antioxidant supplements. In fact, a 2012 systematic review of randomized, placebo-controlled clinical trials led the authors to conclude
With the possible exceptions of Vitamin D and omega-3 fatty acids there is no data to support the widespread use of dietary supplements in Westernized populations; indeed, many of these supplements may be harmful.
- The evidence that the health care system has saved “billions” of dollars annually due to the public’s taking dietary supplements never materialized.
- The standard for getting supplements off the market has proven problematic. Only one ingredient, ephedrine alkaloids, has been banned by the FDA, and that took a decade to accomplish. The other supplements Dr. Kessler and the FDA warned the committee about are still available and still have serious adverse effects: germander, chapparal, comfrey, Jin Bu Huan, yohimbe, lobelia, stephania, magnolia, and willow bark. Yet, because DSHEA does not require warning labels, consumers may not know of the risks.
- Anecdotes weren’t evidence then, and they still aren’t.
- Not knowing about adverse events doesn’t mean they aren’t happening. Investigation of one manufacturer, we learned that the company withheld over 13,000 adverse events from the government. It was not until 2008 that a reporting system was imposed, although it is only for serious adverse events.
- Recently, as Dr. Kessler predicted, the disturbing possibility that use of dietary supplements might actually result in rejecting an effective medical intervention was raised when researchers discovered a correlation between CAM use, including supplements, and chemotherapy refusal among breast cancer patients.
The real experts, those who hew to the standards of evidence-based medicine, are vocal in their condemnation of DSHEA and the profligate use of dietary supplements. (For example, here, here, here, here, here, here and here.) But as long as Orrin Hatch remains in the Senate and the dietary supplement industry continues to rake in billions, regulatory reform is unlikely.
