The Olestra Story
“Olean,” Procter and Gamble’s trade name for “Olestra,” was poised for mass marketing in savory snacks, mainly potato chips, in the mid-1990s. Originally developed by lipid chemist Fred Mattson, in his search for non-caloric substitutes for infant formulas. Procter and Gamble had unsuccessfully applied to FDA many years ago for its use as a cholesterol-lowering drug. It was turned down for lack of effectiveness. They continued to test its animal and human toxicity, however, over the years and felt that based on the several groups of short-term studies extending up to 16 weeks, they had demonstrated its safety and it was ready for reapplication under the new DHEA regulations involving food substitutes/ These required no evidence of benefit, only adequate evidence of human safety.
I had been appointed to the committee in part due to the absence of any direct experience on my part with the development over the years. Whereas many people in the nutrition, diet-heart community had in one way or another been involved with the issue or in consultation to Procter and Gamble. Delayed by an acute back sprain, I arrived on the second morning of the special committee meeting on Olestra and found Joan Gussow ill with the flu and in a feverish and irate state after a sleepless night. It soon became clear to me why she was upset. As I listened to the last of the FDA staff presentations, which amounted to apologias, on the safety of olestra I too became exercised. Right there in the meeting, P&G mounted a lobbying effort among committee members using its high-placed consultants, including Gil Ommen, then Dean of Public Health, University of Washington, later at the University of Michigan, in an attempt to influence members. This distinguished public health scientist sidled up to me in a most cordial fashion and asked me right off during the morning coffee break 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 Procter & Gamble’s White Paper on Olestra, had been misquoted or at least taken out of context. He replied that on the contrary, he thought Olestra had been extensively tested and was a good idea to help deal with a mounting health problem of obesity in the American population. I had long admired Gil Ommen’s broad scholarship and genteel style. Now I sensed something else.
Indeed, the toxicology and first-round human studies reported by Procter and Gamble were well done. They showed that in experiments as long as 16 weeks that the material could be tolerated by most people. They failed to demonstrate longer term safety and they clearly established that this man-made fat substitute adsorbed soluble vitamins to take them quickly out of the system. They addressed this issue by supplementing Olestra with those vitamins. They also referred to its side effects in the euphemism: “occasional soiling” and “intestinal rumblings.” In other words, cramps and diarrhea.
The arguments of a few of us on the committee fell on deaf ears, that Olestra was slated for mass experimental applications in high doses among millions of subjects as a new product with active, absorptive and potential metabolic effects, to no proven end of efficacy. Olestra was, nevertheless, approved by our committee by a vote of 20 to 4 and given a 20-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.
FDA Commissioner, David Kessler, made some sage and cautious comments at the meeting’s conclusion. It seemed to us he was not going to draw a line in the sand and do battle with the giant Procter and 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, according to Harvard’s Walter Willett to “a mass uncontrolled experiment on the American people.” My concern about the product’s benefit and safety and the process of FDA approval was voiced in a NEJM editorial invited by its editor, Marcia Angell. (N Engl J Med.1996;334:984–986.)
Meanwhile, the nonprofit Center for Science in the Public Interest opened an all-out war, as a biblical David against the food industry Goliath, launching the more dramatic of their innovative campaigns. This included an airplane trailing a banner over the Ohio State football stadium during a big game. The banner questioned whether people had tried Olean snacks. Then it asked “feel sick?” And gave an 800 number to call.
I shared the views of CSPI but was unable to endorse or join their sensational antics. In the end, CSPI deserves major credit for discrediting nationally this unfortunate technical innovation. The olean-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 sold the easy way, “the quick fix, having our cake and eating it too, the magic bullet,” and all such classics of American hedonism.and Madison Avenue inducements. (A current proposal in this vein comes from the UK from two respected epidemiologist types, Wald and Law. They have patented and promoted the Polypill for use by all, purported to replace painful lifestyle change and “to reduce to heart attack and cancer risk by 80%!”
The Olestra story is also one in which money and power are insinuated into academia and government and involves unhappy trade-offs and compromise. It is a story of clever science, careful calculation, deliberate deception, shrewd marketing, and strange bedfellows. It was a movement attempting to substitute for healthful realities and serve the status quo of well-conditioned food dependencies. This economic force avoids real change, goes hell-bent on a foolish mass experiment; it ignores the safe and time-tested alternatives such as the palatable satisfying, healthy eating patterns of the Mediterranean, Caribbean or Asian regions. In the end, neither genetic biology nor a pill Panacea makes for a healthy society.
Sequel
I was viciously attacked in an editorial by the “junk man” a food and chemistry industry lackey with a website (www.junkscience.com) and also placed in his Junk Science Hall of Fame. His blog whined: “The FDA has spent 25 years considering Olestra. Olestra has been studied and restudied, tested and retested, 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 predilection against olestra a facade covering an anti-technology sentiment? Could it be that he has take a page from the unibomber’s manifesto and applied it to public health? I’ll take Blackburn’s concerns more seriously when he pushes the FDA to regulate caffeinated, chocolate flavored, and other stimulant-containing foods as drug delivery devices.”
I replied that, of course, I read the Unibomber’s Manifesto daily, either alone or before my local chapter of the Luddite Society!
Sequel
As for Olean, apparently the American way has prevailed. People have voted with their tummies and their pocketbooks. The new factory that Procter and Gamble had built to produce Olestra in great volume has been decommissioned and the Olestra staff shifted to other issues. Chips made with Olean did not sell well and P&G’s stock has tumbled in the new millennium. The sales of its mainline products have failed to expand, while its innovative projects, such as Olean, flop.
“Olestra is, or was, a peculiarly American attempt to a solution for what are major cultural concerns: overweight, eating pattern of super-sized servings, rich in saturated fat, concentrated sugars and simple carbohydrates, and 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 the population-wide solution for these burdens. The prevalence of Olestra was an unacceptably risky and uncontrolled mass experiment. We can be grateful that the experiment was short-lived.”
References
Blackburn H. Olestra and the FDA. Editorial in the NEJM, 1996, vol 334, pages 984-986.
Blackburn, H. “It isn’t always fun. A Memoir from a Different Sort of Medical Life,” Vol 2. privately published.