“It Isn’t Always Fun.” – The FDA Food Advisory Committee, 1995-2000
The Food and Drug Administration (FDA) appoints Advisory Council members, according to Lynn Larsen, its hard-working executive, from nominees solicited at major universities. It considers criteria of geographic distribution, expertise, and lack of strong identification with the particular issues coming up on the FDA agenda. The two major issues of my tenure on the FAC were the safety of Chinese Ma Huang and ephedra-containing over-the-counter preparations, and Olestra, the non-digestible, sucrose polyester fat substitute. Originally developed by Fred Mattson at Procter & Gamble, Olean, the trade name for Olestra, was poised for mass marketing in “savory snacks,” mainly chips. Both materials qualify under the legislated food supplements responsibility of the FDA. And I had no track record on either issue to sully my objectivity.
The invitation to serve came during the years of my phased retirement and promised exposure to matters in which I had an ongoing general interest, nutrition and public policy. Thus, I accepted the appointment. “Little did I realize . . .” as they say.
Ephedra
At my first Food Advisory Committee (FAC) meeting, in the spring of 1995, I was warmly welcomed by the bright and lovely people who represented the “progressive wing” of the committee, including Marion Nestle and Katherine Clancy, and was invited out to lunch for a neophyte’s earful. The DHEA Legislation of the early ’90s deregulated dietary supplements and thereby loosed a huge fringe industry. Harbored through Congress by Senator Orin Hatch, the bill has allowed a whole new supplements industry to run rough-shod over reasonable policy on quality, benefit, and safety. The FDA Food Advisory Committee is left to deal slowly and painfully with the results of massive uncontrolled national experiments: broadcast sales of diet supplements not required to demonstrate benefit and under the most flaccid constraints regarding their composition and safety.
In this meeting we were exposed to an exhibit of ephedra-containing preparations of great variety, labeled with outlandish health claims and with no evidence of quality control in their preparation. One group of products pandered to fitness seekers, emphasizing “Power,” another to thrill-seeking kids. Can you think of a worse combination for persons who “pump iron?” Against a background of anabolic steroid-taking is the imposition of intense isometric work with superimposed repetitive “hits” of a brisk ephedra (adrenaline)-caffeine cocktail!
Analysis Subcommittee of the FDA Food Advisory Committee: Stephen Benedict, Katherine Clancy, Susan Harlander, Mary Wang, Henry Blackburn
The more shocking exhibit among many dozens of ephedra products was a pyramidal container labeled “Ecstasy,” containing pseudoephedrine and caffeine, clearly playing on the appeal of the illicit hallucinatory drug, “Ecstasy,” then and still the rage among the kid druggy set at their “raves.”
Representatives of the burgeoning supplement industries were present in force to defend ephedra, citing the centuries-long experience in Asian cultures of Ma Huang used as a mild stimulant in tea brewed of the grass itself. Their arguments were condoned by the committee majority, with the only admonition that producers sharpen their quality control so that the actual contents were known, verifiable, and listed on the package. Meanwhile, the state health officers nationally, represented at our meeting by the chief epidemiologist of the State of Texas, were screaming bloody murder. They reported kids killed or stroked out by ephedra-containing alkaloids and were demanding a complete ban. The FDA simply blew them off.
In 2002, the FDA was forced, by unhappy experience nationally, to review and rescind its earlier permissive ruling on ephedra and pseudoephedrine-containing compounds. I suspect this was due less to the fatality reports among healthy young people than to the fact that readily available pseudoephedrine became the prime ingredient for amateur methamphetamine production. At any rate, the ephedra experience is finally raising concerns about the initial legislation that freed up the burgeoning and largely irresponsible supplement industry, which takes little care in quality control, not much more for safety, and has no concern at all for demonstrated health benefit.
Olestra
The November 1995 FAC meeting dealt with Olestra, 25 years in the making and in the approval process between Procter & Gamble and the FDA. With Olestra, stuff really hit the fan. I was stricken with an acute back strain and unable to travel for the opening of the three-day meeting in which I had been assigned to an expert working group to consider Olestra and make recommendations to the full committee. When I arrived on the second morning, fellow member Joan Gussow, ill with the flu, had spent a feverish and sleepless night. But on that morning she was vigorous and irate. At first it wasn’t clear to me why.
Then, I listened to the last of the FDA staff presentations, rather apologias, on the safety of Olestra and I, too, became exercised. Meanwhile, P and G had mounted a massive Madison Avenue campaign among us committee members, using its high-placed consultants, including Gil Ommen, then Public Health dean at the University of Washington and now dean of the University of Michigan School of Public Health. He sidled up to me in a most friendly fashion and asked right off where I stood on approving Olestra. I replied that I hoped his glowing advocacy of Olestra as a public health strategy against obesity, as printed in P and G’s white paper, had been misquoted or taken out of context. He replied that on the contrary, he thought Olestra had been extensively tested and he found it a good idea to help in weight reduction. I had long admired Gil’s broad scholarship and genteel style. Now, I sensed something else.
CSPI, the non-profit Center for Science in the Public Interest, then went into all-out-war mode. Its campaign as a biblical David was as ferocious as any ever made against the food industry Goliath. But one of the CSPI staff embarrassed me no end by coming to my chair at the Advisory Council table during short breaks and hissing to me in gutter language about fellow members of the committee and their motives, implying their active practice of the world’s most ancient profession. I may have agreed with her assessment, if not her language, but finally had to tell her that I could speak to her only outside and after the meeting! [CSPI went ahead with the more dramatic of its often innovative attack campaigns, including flying a plane with trailing banner over the Ohio State football stadium during a big game. The banner questioned whether people had tried Olestra snacks, then asked: “Feel Sick?” and gave out an 800 number to call. Though again I shared the views of CSPI, I was unable to endorse or join in their sensational antics, But to them, in the end, must go major credit for the discrediting nationally of this unfortunate technical innovation.]
The arguments of a few of us on the committee fell on deaf ears, that Olestra was slated for mass experimental application in high doses among millions of subjects, as a new and man-made product with active adsorptive and potential metabolic effects. It was nevertheless approved by our committee by a vote of 20 to 4 and was given a 30-month period during which observations were to be made by the company and any others wishing to do so, at which time the Advisory Council would again review its safety. Commissioner David Kessler made some sage and cautious comments at the meeting’s conclusion. He was clearly not going to draw a line in the sand or do battle with the giant Procter & Gamble. We speculated at the time that he had bigger fish to fry — the tobacco industry, for example.
Olestra was thus approved and on its way, “a mass uncontrolled experiment on the American people,” said Harvard’s Walt Willett. My concern about the product’s benefit/safety, and the process of FDA approval, was voiced in a New England Journal of Medicine editorial invited by Marcia Angell.1
The Olestra Story is a classic of American enterprise, technical brilliance, gimmickry, and huckstering. But instead of contributing to a genuine restoration of caloric balance in the population or encouraging a healthy eating pattern, it panders to the easy way, the quick fix, to having our cake and eating it, too, to the magic bullet and all such classics of American hedonism. [The UK is now in the act. In 2003, otherwise respectable epidemiological types have patented and promoted the “Poly-Pill” for all, purported to replace painful lifestyle change and to “reduce heart attack and cancer risk by 80%!”]
The Olestra Story is also one in which money and power are insinuated into academia and government, involving trade-offs and compromise. It is a story of clever science, careful calculation, deliberate deception, shrewd marketing, and, it turns out, strange bedfellows.
Procter & Gamble and its Olestra locomotive, in the late 90s, barreled through the night toward a new and uncertain destination, an imaginary utopian community, where safe, sexy, high-tech innovation, like Aldous Huxley’s Soma, tries to substitute for healthful realities and serves the status quo of well-conditioned food dependencies. All the while, this economic force avoids real change and goes hell-bent on a foolish mass experiment. And it ignores safe and time-tested alternatives such as the palatable, satisfying, healthy eating patterns of Mediterranean, Caribbean, or Asian regions. In the end, neither genetic biology nor a pill panacea makes for a healthy society.
CFSAN Doesn’t Get It
Following the FDA vote of limited approval for use of Olestra in “savory snacks,” in subsequent communications with FDA staff and the Commissioner I sang the same old song about the possible long-term risks of Olestra. This serenade never became a hit. I pleaded also that CFSAN, the Center for Food Science and Nutrition of the FDA, needed epidemiological disciplines built-in to its administrative structure, fully on a par with its sections on nutrition and toxicology. The director responsible for developing and commissioning the new CFSAN unit pooh-poohed that idea, saying that when his unit needed epidemiological skills he could borrow them from other branches or from NIH.
Clearly he doesn’t get it. Modern issues of food safety and nutrition and health are not just toxicological and nutritional problems. They are social and public health phenomena and they require a broader understanding, a population-wide viewpoint, and epidemiologic savvy. It seems to me that public health science should be on an administrative par with the other scientific divisions of regulatory agencies, just as it is found in the better research institutions of the country. I mentioned NHLBI to the CFSAN chief as a model that attempted to balance bench, clinical, and epidemiological programs and administration.
I suspect that as long as this narrow clinical viewpoint persists, mistakes will prevail in the interpretation of evidence in the non-drug functions of the FDA. Policy errors will continue to be made about benefits and costs of diet, nutrients, and food supplements, as were made with Olestra and with Ephedra. In addition to this built-in deficiency of public health views and skills is the fact that almost all scientific advisers to the FDA’s CFSAN are bench and clinical investigators, many of whom have clear but ill-recognized conflicts of interest, either from past or present professional and consulting roles. Because of this specialization, Food Advisory Committee opinions in particular lack a population-public health view. I suspect that CFSAN is both weaker and less credible to the Congress and to the public than it would be if it were organizationally representative and competent in epidemiology. CFSAN might do well to model itself after the FDA’s own drug division, where epidemiological and clinical-trials savvy, along with full administrative clout, have, I believe, traditionally given depth and credibility to FDA opinion in that area.
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We are Blessed by the Enemies We Keep
I suppose that I am blessed by having the “Junkman” on the world-wide web choose me. I am doubly blessed to be a member of his “Hall of Shame.” The atrocious editorials of this chemical, oil, and food industries lackey can be found at www.junkscience.com. The Junkman’s style is exemplified by his brief editorial quoted here, attacking my views on Olestra:
Olestra and the FDA
Henry Blackburn, M.D.,
Editorial, N Engl J Med 1996;334:984-986
In this essay, Blackburn, a member of the FDA Working Group on Olestra and the FDA Food Advisory Committee, rails against FDA approval of Olestra, the fat substitute that will soon be used in a number of snack foods such as potato chips. The essence of Blackburn’s argument is the FDA did not compel Olestra’s manufacturer, Procter & Gamble, to prove that the use of Olestra as a food additive poses zero risk to the American public.
Blackburn states that by being ‘supportive and collaborative with industry rather than adversarial,’ the FDA has colluded with industry. Supportive and collaborative?! Petitioning the FDA to approve Olestra took 25 years and $200 million! I’d hate to see what the time and cost would be if the FDA decided to be adversarial!
Take your vitamins! Well, on second thought, maybe not. Apparently, one of Blackburn’s public health concerns is that Olestra may leach certain vitamins from the body, including vitamins A, D, E, and K. At least some of the concern with this leaching is that these antioxidant vitamins are thought to play a role in preventing cancer.
News flash to Blackburn: Beta Carotene and Vitamin A Cause Lung Cancer in Major Study! [J Natl Cancer Inst 1996;88:145- 6]. I think it’s fairly safe to conclude that no one really knows the true association (one way or the other) between vitamin intake and cancer.
Potato Chips as a Drug Delivery System! As a fat substitute, Blackburn wonders why Olestra, purveyed for the preventative purpose of weight control, was not viewed in the same way [as a drug], but instead was evaluated under the more relaxed regulations governing [food] additives.
Remember TV commercials touting the addictive power of Lay’s Potato Chips? (“I’ll bet you can’t eat just one!”) Potato chips have had drug-like characteristics long before Olestra was even thought of! I’ll take Blackburn’s concerns more seriously when he pushes the FDA to regulate caffeinated, chocolate-flavored and other stimulant-containing foods and beverages as drug delivery devices.
Certainty of zero risk: The new standard? Blackburn believes that ‘a perspective based on epidemiologic concepts of attributable risk’ is needed for Olestra . . . (‘the FDA and industry are clearly years behind in [clinical] studies of safety and the epidemiologic thinking that underlies evidence about risk and benefits in populations.’) There’s also the quote from Walter Willet [another member of the JunkScience Hall of Shame] that ‘the American public is about to become involved in a major uncontrolled experiment.’
The FDA has spent 25 years considering Olestra. Olestra has been studied and restudied, tested and re-tested, both clinically and toxicologically. How much, and what kind of, safety needs to be demonstrated for Blackburn? It appears that Blackburn’s standard of proof is so high that it could never be met. Blackburn would prevent virtually any new product from ever coming on the market.
Is Blackburn really concerned about public health? Or, is his protestation against Olestra a facade covering anti-technology sentiment? Could it be that he has taken a page from the Unabomber’s Manifesto and applied it to public health?”
[Of course, I read the Unabomber’s Manifesto daily, either alone or before my local chapter of the Luddite Society!]
Sequel
As for Olestra, apparently the American Way has prevailed. People have voted with their tummies and their pocketbooks. I understand that the new factory Procter & Gamble built to produce Olestra in great volume was decommissioned and the Olestra staff shifted to other issues. I hear, too, that Wow! Chips, made with Olean, didn’t sell well and that P & G’s stock has tumbled in the new millennium. It appears that sales of its mainline products fail to expand while its “innovative” products, such as Olestra, flop.
One still encounters planted op-ed articles, such as one in 2000 by a physician at the Hoover Institute, bemoaning the fact that the FDA does not actively promote the ‘health-giving properties’ of Olestra. Legitimate differences of opinion aside, I did not realize the Hoover Foundation kept product panderers in its crusty stables.
Olestra is, or was, a peculiarly American attempted solution for what are major cultural concerns: overweight, an eating pattern of super-sized servings rich in saturated fat, concentrated sugars, and simple carbohydrates, an eating pattern and a food economy that determine the population burden of obesity, diabetes, and heart and vascular disease among Western countries. Even if Olestra or another fat substitute were effective, safe, palatable, convenient, and cheap, it would contribute little to a population-wide solution for these burdens. The purveyance of Olestra was an unacceptably risky and uncontrolled mass experiment. We can be grateful that the experiment was short-lived.
1. Blackburn, H., Olestra and the FDA. Editorial, N Engl J Med 1996;334:984-986