August 21, 2006
North American women are at risk for certain major nutrition-related diseases and conditions, including diabetes mellitus, cardiovascular disease and osteoporosis, that might benefit from specifically targeted functional foods.
While there is a slight preponderance in the number of women within reproductive age over the number of men, this disparity is increasing. Information from the 2000 U.S. Census shows the childbearing group of women is declining, and the elderly are becoming a growing population base, currently with over 58 percent of the adults over the age of 65 being female. By 2010, a third of all Americans will be aged 50 years or over. However, despite female ownership of this large segment of the population, the medical community only recently has focused on the differences between the sexes, other than simple reproductive capacity. The assumption used to be that men and women reacted comparably to medical conditions and, therefore, drug treatment, except during pregnancy.
Until the 1990s, scientists frequently excluded women from medical research, including drug studies. The reason for this exclusion was two-fold: first, concern over adverse effects drugs might have on reproduction and offspring; and, secondly and ironically, a long-standing assumption that men and women were biologically the same except for their reproductive organs. In addition to justified precautions about women during pregnancy, there was also a general assumption in the medical community that the periodic hormonal cycles in women would not be a factor in men, who were seen as more constant in terms of physiology and, thus, would produce more easily understandable results when tested with new drugs. Also, there was likely a certain Victorian modesty factor from the earliest days of quantitative medical observation in the 1800s, when men were more likely the subjects of study than women.However, the emergence in the 1990s of gender-specific medicine—studying the biological and physiological differences between the human sexes and how that affects differences in disease—shifted the thought processes of the medical establishment. The National Institutes of Health’s (NIH) Office of Research on Women’s Health was established in 1990. And the inclusion of women (and minorities) in clinical trials in sufficient number to allow analysis of differences in intervention effect became public law when Congress made this provision part of the NIH Revitalization Act of 1993 (Pub L No. 103-43).
Today, clinical experience and research show the diagnosis and treatment of certain medical conditions is indeed different between genders. This realization comes after many women have been misdiagnosed and under treated because they did not present to their doctors with the “classical, textbook” symptoms—symptoms that, after all, were recorded from observations in men. More recent evidence, however, demonstrates there are some significant differences, many of them of having mortal consequences.
Women—who are 11 times more likely to die from a heart attack than from breast cancer—frequently don’t have chest pain during a heart attack and complain of more vague, flu-like symptoms.
Aspirin does not protect women against heart attacks in the same way it does men.
Non-smoking women appear to be more susceptible to lung cancer than non-smoking men. Women also tend to get lung cancer at younger ages than men.
Women metabolize nicotine faster than men do—especially women who are taking oral contraceptives. Researchers indicate that this could affect women’s smoking behavior, as well as their response to nicotine-based quitting aids.
Women are less likely than men to get oral cancer.
Women are twice as likely than men to develop gall bladder problems.
Women are more prone to autoimmune diseases, including lupus, rheumatoid arthritis and multiple sclerosis, in which diseasefighting mechanisms mistakenly attack the body’s own tissues.
Research is being conducted in the fields of digestive disorders, general medicine, autoimmune diseases, bariatrics and heart disease, all of which are recognized as either presenting differently or more frequently, or having different outcomes in women.
The Impact on Functional Foods
Development of gender-based medicine and women’s growing concerns with health issues have led to increased demand for functional foods, reflected by heightened sales from over $50 billion in 2004 to an anticipated $70 billion by 2009. The marketing of products with a gender in mind is not a novel approach, whereas the ‘for women only’ and ‘formulated for women’s health’ segments have reached more than $4 billion in retail sales in 2004, up approximately 11 percent from the year before.
In addition to recognition of gender-based medicine, other elements are coming together to create this huge new market. One significant element is the empowerment of women in making decisions and the context in which these decisions are made.
Baby boomer women have more purchasing power than any preceding generation and, as with the preceding generations, are the decision makers for food purchases.
Baby boomers, men and women alike, are concerned about the high cost of drugs and have a greater faith in natural remedies than preceding generations. Further, this generation is more likely to believe conspiracy theories about “big pharma” keeping natural products off the market because of the inability to patent natural remedies.
Women tend to have a greater faith and required patience in employing nutritional benefits for disease prevention, as opposed to men, who are more prone to quick fixes with drug treatment only after a disease is manifested.
There is also an increased fear of the tragic consequences of even approved drugs (à la Celebrex® and Vioxx®) that may not have even been marginally more efficacious than much cheaper acetaminophen or ibuprofen.
Another key element in shaping this market for functional foods for women is the position taken by the Food and Drug Administration (FDA). Traditionally, the FDA had strong feelings about keeping any food with a health claim off the market, because of its previous experience with spurious claims that bilked consumer of tens of millions of dollars in the early 1900s. In the book The Medical Messiahs, A Social History of Health Quackery in Twentieth-Century America (Princeton University Press, N.J.), author James Harvey Young discusses how claims from the first wave of “Medical Messiahs” about “brain food” or special “blood replenishers” were no more than hucksterism and quackery.
FDA fought hard to take those products off the market, but with no laws in place with any real teeth, the agency was largely powerless, until, not ironically, a very effective women’s movement took action, informing the public and arousing the interest of a sensationalistic press in need of awe-striking headlines. In the end, Congress, previously mollified by personal claims of product safety by owners of “snake oil” factories, was forced to act, giving FDA the power to challenge outlandish claims and force violative products off the market.
Once empowered in 1938 by an amendment to the original 1906 Food and Drug Law, FDA zealously drew a bright line between what was considered a food and a drug, with even nutritional claims for food extremely limited. Further contributing to this dilemma was the academic community, which, although it agreed in principle on many issues, could not arrive at a consensus on certain nutritive factors or the doses required to affect a difference physiologically. This indecision further justified actions by FDA to keep anything off the market that merely alluded to nutritional benefit, until the assertion by Kellogg’s in the 1970s that fiber in cereal had beneficial effects. Several years later, FDA made the bold step to allow this non-nutritive claim, and this was to serve as the pathway to subsequent claims for other non-nutritive (i.e., functional) food claims.
Since approval of fiber as a legitimate claim, several additions and changes to the law have been made to allow FDA more options for claim approval; and, when FDA was too conservative, Congress and the courts prodded for change, tending to favor a more liberalized pathway for health-type claims (including maintenance, enhanced function and performance).
Functional foods represent an area that will likely remain of interest to consumers contemplating life-long, beneficial effects from day-to-day nutrition. Specialty foods for women are here and more in the pipeline, but this is only a start.
The selection process for consumers making choices concerning diet and supplements is complex, which should alert industry and regulators to focus on two key areas—the importance of using sound science when substantiating claims for functional foods, and educating the public to facilitate in the decision making. For now and the immediate future, functional food for women is on a roll: the consumer base is in place, the science is maturing, and the regulatory atmosphere is favorable for quantitative gains in women’s health through the use of functional foods.
Ioana Carabin, M.D., is the president and medical director of the Vero Beach, Fla.-based Women’s Health Sciences Institute (www.womensci.org). She has over 11 years of clinical experience, as well as extensive consulting competence in toxicology and risk assessment. Her expertise also extends to the safety evaluation and regulatory issues of foods, food ingredients and dietary supplements. Dr. Carabin is also a medical consultant for Burdock Group (www.burdockgroup.com).
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