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5. The length of time a product has been on the market and relative sales position are not necessarily evidence of its merit and hence are not appropriate arguments for prescription or recommendation.

6. Promotion suggesting undesirable consequences from failure to use a product, unless compelling evidence exists, is unjustifiable.

evidence

7. Evidence presented in promotion of products should serve the function of validating the claims made. While interpretation of findings may vary among physicians, claims must adhere to the evidence and not to questionable extrapolations.

8. The significance of evidence should not be overemphasized. Quotations or excerpts should not disregard the context or distort the full meaning of their source.

9. Evidence should be reasonably available. Manuscripts may be cited only after editorial acceptance and the medium of publication can be stated. Personal communication is generally undesirable and is acceptable only when the author has had an opportunity to review the use intended for it in promotion and has granted written approval for the citation. A copy of the material providing the basis for the citation should be available on request. Scientific exhibits, not subsequently published in a generally available periodical, do not constitute suitable evidence.

10. Evidence derived from adequately controlled research should be differentiated from uncontrolled clinical experience. Where the advertiser sets forth his own conclusion or rationale, it should be done without implication of other authority.

comparisons

11. Comparisons in promotion of a product should be constructive and should relate the merits of the product to generally acceptable medical standards.

12. Direct comparison with other products for the purpose of demonstrating superiority is permissible only when such claim can be supported by direct reference to an acceptable published report.

13. Implied superiority of a product through the use of superlative description is not acceptable.

position of the medical profession

14. Promotion which tends to undermine trust and confidence in physicians is disturbing to the peace of mind of parents and patients and to the effective practice of medicine, and is therefore to be avoided.

15. Promotion which serves by overt or insidious suggestion to bring the patient to influence the physician's choice, rather than leaving him unhampered in the exercise of professional judgment, is considered unwise.

16. Promotion which encourages the parent or patient to assume the prerogatives of the physician is unwise and is not acceptable.

17. Products which require the special knowledge of a physician for proper administration should not be promoted directly to the public. To whom other products are promoted is not a source of concern to the Physicians' Council. Promotional material which has a deleterious effect on child health, whether directed to the public or the profession, is considered undesirable.

The Code for Advertising is subject to alteration and clarifi cation as indicated by experience and wisdom acquired through co-operative efforts of the Physicians' Council and industrial, educational, and public organizations.

EXHIBIT 31

APPENDIX

FURTHER EXAMPLES OF PROMOTIONAL "EDUCATION"

Vitamins

Enough is known at present to permit rational prescription of vitamins that might be needed to supplement the diet, but intelligent use of vitamins cannot be learned from pharmaceutical "education".

Competent committees of authorities within the profession" have weighed the evidence and concluded that: the normal infant requires no more than 30 mg vitamin C and 400 units vitamin D in supplementation of breast or artificial feeding; supplementary vitamin A and vitamins of the B complex are not necessary in ordinary feeding practice for either infants, children or adults; and vitamins B1 and B12 have not been shown to affect appetite or growth in children, except in rare deficiency states.

These carefully considered opinions of the profession's own experts are ignored in the claims set forth in advertisements of reputable ethical firms. Lilly (Fig. 6) points to an insignificant and inadequate paper as the source of "wisdom" behind sentimental claims for routine supplementation with a mixture of nine "essential" vitamins. The references cited by Smith, Kline and French (Fig. 7) were discounted by the profession's committees, thus leaving the "educational" message to the touching family scene and the vacuous fictitious comments of innocent parents: Merck, Sharp and Dohme do their bit to similarly "educate" the physician with the cute copy shown in Figure 8.

For 2 years the Upjohn Company has been conducting a "Happy Baby Vitamin” promotional campaign to "educate" the physician on the significance of pyridoxine in nutrition (Fig. 9). This is a typical example of the clever manner by which

Council on Foods and Nutrition. J.A.M.A., 1694, 1959.

Committee on Nutrition, American Academy of Pediatrics. Pediatrics. 21 860,

1958.

the unsuspecting physician may be lured into adopting false beliefs. A catchy phrase is coupled with a common annoyance (a baby crying at night) to advocate a simple means of relief--addition of vitamin B6 (pyridoxine) to a daily vitamin supplement.

To this end, great liberty is taken in making irrelevant allusions to firs knowledge and in quoting out of context from references, while more revealing statements in the same references are ignored. Bessey et al. in the reference cited (Pediatrics, 20:33, 1957) take pains to state that the needs of all but "occasional infants with anomalous requirements for vitamin B6" will be met by 0.2 to 0.3 mg daily. This amount is supplied by ordinary milk formulae and prepared complete infant foods. Young animals and human infants can become deficient in vitamin B6 under unusual circumstances and may have convulsions as a manifestation; premonitory signs include irritability. The relation of this exceptional occurrence to the common "wakeful baby who turns father into a floor-walker" could seem plausible only to an unrestrained ad copy-writer: it is too remote and unsubstantiated to be worthy of serious consideration by anyone who prefers to base his opinions and practice on scientific evidence.

Upjohn's promotional piece is all the more surprising when viewed in the light of some comments by the Medical Director of the Upjohn Company in DRUG TRADE NEWS June 2, 1958- "Turning to another abuse, Dr. Burbidge cited 'quoting out of context' as a 'pernicious practice'....the medical director reported that Upjohn's medical division checks all advertising and promotional copy...." The "Happy Baby" campaign has been running without correction since early 1958, in spite of several letters to the President of Upjohn Company, Mr. Gifford Upjohn, pointing out the distortions in these advertisements. Unfortunately, the medical directors on the staffs of pharmaceutical companies may not always be able to safeguard the authenticity of information in "educational" promotional material, in the face of a pressing need for sales and the indifference of their superiors.

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nine essential vitamins, for healthier, happier babies

Growing evidence points to the wisdom of adding a complete vitamin supplement to the infant diet. Litchfield' concludes, ". . . vitamin supplements not only prevent deficiencies in the newborn but aid in the development of healthy babies, establishing a solid foundation for the future."

Vi-Mix Drops is a comprehensive combination of nine essential vitamins. It is the most potent formulation of its kind . . . richest of all in vitamin C. Then, too, you can be sure your tiny patients will receive full potency of all ingredients when you specify dual-packaged Vi-Mix Drops.

Vi-Mix Drops (multiple vitamin drops, Lilly)

1. Litchfield, H. R.: Evaluation of a Fortified Multivitamin Formula as a Supplement to Feeding in Newborns and Early Infancy, Arch. Pediat., 74:463, 1957.

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