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HAIR DYE STUDY WRONG AND NEEDLESSLY ALARMIST, LEADING SCIENTISTS SAY

HAIR DYE STUDY WRONG AND NEEDLESSLY ALARMIST, LEADING SCIENTISTS SAY
 WASHINGTON, July 1 /PRNewswire/ -- The Cosmetic, Toiletry, and Fragrance Association issued the following:
 The Sheila Zahm study on hair dye safety is incorrect and needlessly alarmist, say a number of the nation's leading epidemiologists and public health academicians, responding to an article in the July issue of the American Journal of Public Health. They conclude that the research reported in the Journal is questionable in its interpretations and erroneous in its conclusions.
 According to the U.S. Food and Drug Administration, in a statement released Tuesday, "the study's design does not allow the establishment of a causal link between hair dye and increased cancer." FDA and the National Cancer Institute both agree that "no recommendation to change patterns of hair dye use can be made at this time, based on these research results."
 After a methodological evaluation of the study, Alvan Feinstein, M.D., Sterling professor of medicine and epidemiology at Yale University School of Medicine, concluded "the work has so many scientific defects that it cannot be regarded as credible."
 Concurring with this conclusion, Dr. Burton Singer, professor of epidemiology and public health at Yale, commented, "The very provocative and suggestive conclusions in the paper ... are simply not warranted by the data presented in the tables."
 The safety and effectiveness of hair coloring products have been tested thoroughly over the many years of their use. Independent research by numerous scientific institutions, including Harvard, Yale and Oxford, has shown no significant differences in cancer rates between users and non-users of hair dyes.
 Over the last decade, the cancer-causing potential of hair dyes was evaluated also by the U.S. Food and Drug Administration, the International Commission for Protection Against Environmental Mutagens and Carcinogens and the International Agency for Research on Cancer. None of these reviews found any evidence to support the hypothesis that hair dye poses a cancer risk. Their conclusions support the results of a previous Harvard study which also failed to find a cause-and-effect relationship between hair dye use and cancer.
 The Journal reports on a study that was originally designed to assess correlation between pesticide exposure and cancer, particularly non-Hodgkin's lymphoma, in farmers in eastern Nebraska. This is important, as the incidence of this type of lymphoma is higher among flour processing and agricultural workers. Further, in many cases, the research involved next-of-king interview, asking survivors of non-Hodgkin's lymphoma victims to recall the personal care habits of their long-deceased relatives. Additionally, several of the tables provide data that run counter to the conclusions in the paper. These include subjects who experienced higher exposure to hair dyes, yet had a lower incidence of lymphomas.
 "In summary, the inconsistencies in these data raised a question mark about the authors' interpretations of them as being positive," said Dr. Roy Shore, professor of epidemiology and biostatistics at New York University. "Their failure to do the most appropriate analyses (of exposure) is an egregious omission."
 The Cosmetic, Toiletry, and Fragrance Association is confident in the safety of hair dyes, understands the concerns that can be raised by this type of questionable data and encourages hair dye users not to be alarmed. These products have been used for many years and have a strong safety record supported by the existing body of extensive scientific and medical research.
 To answer consumer questions on this matter, CTFA has established a toll-free telephone line -- 800-824-1312.
 Citations:
 Harvard
 Hennekens CH et al., Use of permanent hair dyes and cancer among
 registered nurses. The Lancet, June 30, 1979, P. 1390.
 Yale
 Teta J., Walrath J., Meigs W., and Flannery J., Cancer incidence
 among cosmetologists. J. Natl. Cancer Inst. 72, 1051, 1984.
 Oxford
 Kinlen, L.J. et al., "Hair Dyes - Epidemiological evidence.
 Symposium on the interpretation of negative epidemiological
 evidence for carcinogenicity." 1983 Symposium at Oxford, IARC
 Publ. 65, 1985, pp. 57-68.
 Other Reviews
 ICPEMC Mutation Research 87, 1981, 63-79.
 IARC, Monograph Volume 27, pp. 307-318 (by Clemmesen).
 FDA Federal Register, Vol. 44, Oct. 16, 1979, P. 59522
 Top Scientists Say Hair Dye Study Wrong
 Following are their comments on "Use of Hair Coloring Products and the Risk of Lymphoma, Multiple Myeloma, and Chronic Lymphocytic Leukemia," by Sheila Hoar Zahm et al., American Public Health Journal, July 1992:
 "Why was the current study conducted in the 66 counties of eastern Nebraska and can those regional results be extrapolated to the world beyond eastern Nebraska? Unfortunately, Zahm et al. provide no answers to these straightforward, obvious scientific questions. ... My main reaction to this paper is surprise that it was accepted for publication. The many violations of elemental scientific principles are so overt and striking that I feel sure the paper would have been rejected at most epidemiological journals that apply critical standards. ... In conclusion, although this paper may receive considerable media publicity, the work has so many scientific defects that it cannot be regarded as credible and given serious attention."
 -- Alvan R. Feinstein, professor of medicine and epidemiology, Yale School of Medicine (203-765-4145).
 "The very provocative and suggestive conclusions in the paper ... are simply not warranted by the data presented in the tables."
 -- Burton H. Singer, Ph.D., chairman and associate dean for public health, Yale School of Medicine (203-785-2867).
 "The investigators' strategy appeared to be to analyze the data every which way and to emphasize a selection of these results in accordance with their overall interpretation of the study. ... Slicing the data so many ways creates a multiple comparisons problem, i.e., when there are many comparisons it is almost assured that some of them will show significant associations just by chance. ... However, in spite of slicing the data many ways, Zahm et al. did not analyze the data using an index of integral exposure (i.e., total exposure), which is the single most important measure of exposure. ... Zahm et al. did not create any measure that captured integral hair dye use, and hence did not perform the most appropriate and direct test of whether there is an association between total exposure and the diseases under study.
 "In summary, the inconsistencies in these data raise a question mark about the authors' interpretation of them as being positive. Their failure to do the most appropriate analyses, namely, analyses of integral hair-dye use, is an egregious omission."
 -- Roy S. Shore, Ph.D., Dr.PM, professor of environmental medicine, New York University (212-263-6500)
 The text of of the following "Talk Paper" from the Food and Drug Administration is being issued by the Cosmetic, Toiletry, and Fragrance Association:
 FDA REVIEWS NEW STUDY ON HAIR DYES AND CANCER
 FDA has received inquiries about a National Cancer Institute study of hair dye use and the risk of cancer in the July 1 issue of the American Journal of Public health. The NCI study was conducted to correlate the incidence of certain types of cancer with exposure to different substances, including hair dyes.
 The following can be used to answer questions:
 The study's researchers observed that women who used hair dyes had a slightly higher risk of non-Hodgkin's lymphoma than women who never dyed their hair. The study's design does not allow the establishment of a causal link between hair dye and increased cancer, but it does identify hair dye use as a potential risk factor.
 Preliminary reviews by some scientists and epidemiologists outside FDA, conducted at the request of the cosmetics industry, have questioned the conclusions of the study and found no cause for consumer alarm.
 FDA believes that it is premature to suggest, on the basis of the information available from the study, that "the use of hair coloring products would account for 35 percent of non-Hodgkin's lymphoma cases in exposed women and 20 percent of such cases in all women." Whether or not hair dye is a causative factor in non-Hodgkin's lymphoma can only be ascertained by specific studies.
 In the absence of more information, FDA cannot at this time pass judgment on the safety of these products. As more information becomes available, the agency will apprise the public of its findings and will determine what, if any, action may be needed to protect the public health. In the meantime, FDA agrees with the National Cancer Institute assessment that no recommendation regarding the use of hair coloring products can be made at this time.
 Coal tar based hair dyes, which constitute the majority of hair dyes used by women today, are exempted from the adulteration provisions of the 1938 Food, Drug and Cosmetic Act, the law that outlines the regulatory responsibilities of FDA. However, if a health hazard is established, FDA can require warning labels to be placed on these products to advise consumers of hazards associated with their use.
 -0- 7/1/92
 /CONTACT: Irene Malbin, 202-331-1770, or Laura Armstrong, 202-835-8830, both for the Cosmetic, Toiletry, and Fragrance Association/ CO: Cosmetic, Toiletry, and Fragrance Association ST: District of Columbia IN: HEA SU:


TW -- DC019 -- 5777 07/01/92 13:59 EDT
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