OLESTRA

Henry Blackburn, M.D., 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.

With this kind of help, who needs enemies? 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... [t]he 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 (a member of the Junk Science 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?

Material presented on this page constitutes opinion of the author.

Copyright © 1996 Westlake Solutions, Inc.