In the Matter of the Complaint Against CARL BRANDENFELS at St. Helens, Oregon. H.E. Docket 1/338 POST OFFICE DEPARTMENT Washington, D. C. APPEARANCES: Frank J. Delany, Esq. 1317 F Street, N.W. Washington 4, D. C. for the respondent Herbert B. Warburton, Esq. General Counsel of the Post Office Department for the complainant
This proceeding was dismissed without prejudice by the Deputy Postmaster General on March 18, 1958. On April 26, 1958, the position of Judicial Officer was established to review administrative proceedings for the Postmaster General and on April 28, 1958, the respondent petitioned the Judicial Officer to modify the order to a dismissal with prejudice so that the complainant would be precluded filing a new complaint. On November 6, 1958, a conference was held and it was agreed by and between the complainant, the respondent and the Judicial Officer that the record in the proceeding would be reviewed to determine if the order should be modified to dismiss with prejudice for either or both of the following reasons:
a. Proof of efficacy of the product;
b. A split of medical authority sufficient to bring the case within the doctrine of Reilly v. Pinkus, 338 U.S. 269 (1949). The Court there held that intent to defraud could be inferred when there is a universality of medical opinion that a product is valueless for the purposes represented.
Both parties then filed briefs and oral arguments were presented before the Judicial Officer on May 13, 1959. Thus, this proceeding is being reviewed on this limited question since the complainant admits that there are sufficient procedural errors in the record, notable of which is the failure to comply with the Administrative Procedure Act (5 U.S.C. 1001 et seq.), which would preclude the issuance of a valid fraud order. The complainant believed that, if the respondent had proved either that the product was efficacious or there was a sufficient split of medical authority on the medical question in issue, no good purpose would be served in instituting a new proceeding. The record in this proceeding is voluminous consisting of over 1200 pages of testimony and many extensive briefs.
The respondent sells a product for hair restoration which contains sulpha drug and lanolin. The question for determination is whether the product is efficacious for the purpose advertised. (See Tr. 77 of the oral argument on appeal.) Thus, it must first be determined for what purpose the product was sold.
The complaint which was issued in 1949 charged the respondent with representing to the public at large:
"a. That the use as directed of Brandenfels' Scalp and Hair Applications and Massage will 'bring about a condition which will help nature allow hair to grow' on 'many bald or partially bald people'; that is to say, will restore the growth of hair of normal length, color and texture;"
"b. That the use as directed of Brandenfels Scalp and Hair applications and Massage will cause 'renewed hair growth' in the case of any person afflicted with 'baldness'; that is to say, that where 'baldness' is a concommitant of or results from a condition in which hair has stopped growing, said treatment will 'renew hair growth' and overcome 'baldness' with normal hair growth;"
"c. That persons who use said treatment as directed will have 'no more excessive falling hair';"
"d. That said results will or probably will be secured by 'folks in their eighties' as well as younger people and by 'men and women' who are 'completely bald' or 'just beginning to notice loss of hair';"
"e. That the letters received by respondent from men and women who have used said treatment 'report results' and that 'the results speak for themselves' and may be relied upon by purchasers of said treatment as proof that they will or most
probably will obtain the same or equivalent results in overcoming complete or partial 'baldness,' preventing 'excessive falling hair' and in 'renewed hair growth.'"
Attached to this decision as Appendix A is a copy of an advertisement which is typical of those used by the respondent. I find from an appraisal of the advertisement as a whole and not isolated segments that the respondent is making the representations charged in the advertisements. 1/ I believe that the respondent is representing to all bald headed persons that the chances are good that his preparation will grow hair regardless of age or other factors. The disclaimer of efficacy is not prominent in the advertisement and significantly is not accompanied by a money-back guarantee. 2/ The disclaimer appears buried in the advertisement while the large bold print proclaims the value of the product. The question for determination is whether the representations are false or whether there is a split of medical opinion as to their truth or falsity.
There was a variety of types of testimony concerning the efficacy of the Brandenfels treatment. Some of the expert witnesses testified as to the consensus of medical opinion on treatment of baldness and others testified as to experiments they conducted. The testimony of lay users was offered into evidence. In Research Laboratories v. United States, 167 F.2d 410 (C.A. 9, 1948), the Court held that there were three types of admissible expert testimony. They are:
1. testimony based on actual tests and experiments made with the drug;
2. testimony of experts as to the consensus of scientific medical opinion without respect to the specific effectiveness of the drug and without benefit of experimentation;
3. opinion testimony on the question of the therapeutic value of a drug even though the witness had not tested the product and did not purport to report the consensus of medical opinion.
In United States v. 50-3/4 Doz. Bottles, 54 F. Supp. 759, (D.C.W.D.Mo., 1944), which incidentally also involved a hair preparation containing sulpha, the Court said as follows about lay testimony:
"the testimony of a few laymen, however honest that testimony may be is of slight value upon the issue under present discussion ... the nature of the simplest disease is so obscure to a layman that his conclusions touching what will benefit it and what will not benefit it mean little."
Several of the complainant's witnesses were dermatologists and others were general practitioners. The witnesses for the respondent were a pathologist, a pharmacologist, and a physician and surgeon. The dermatologists who testified for the complainant stated that baldness is known as "alopecia" in medical parlance. Alopecia is divided into subgroups of congenital, premature and senile alopecia. Approximately ninety to ninety-eight percent of the bald people are in one of these three sub-groups which are collectively referred to as male-type baldness. The remainder are in a special group called "alopecia areata" which is different from any of the above types. The symptoms in an areata case are spotty bald spots and hair loss all over the body. The spotty baldness can finally result in total baldness.
The dermatologists testified that the consensus of medical opinion was that male-type baldness is an irreversible process for which there is no known cure. They testified that the superficial results which the respondent says will be obtained by use of his product, i.e., cleaner scalp, less bacteria and increased circulation, would not cause a regrowth of hair. As an illustration they stated that many Americans with clean scalps lose their hair while some aborigines who have never heard of a shampoo retain a luxurious growth of hair. Dr. Naomi Kanof, one of the dermatologists who testified for the complainant, testified that in approximately ninety-five percent of areata cases there was a spontaneous regrowth of hair. (Tr. 61) She admitted that almost all medical texts make statements to the effect that one should use massage and chemical applications to promote certain types of hair growth, but from her study of the problem she had never seen any evidence that such hair growth was in fact produced (Tr. 67) and that certainly no text writer said that such treatment would in fact grow hair. (Tr. 83) She testified from her own experience that alopecia areata is caused by a basic systemic disease such as tuberculosis which must first be diagnosed and cured before the patient can expect to regrow hair.
Dr. Rattner, a dermatologist cited in Diseases of the Skin by Ormsby and Montgomery, relied upon by both complainant and respondent, testified for the complainant that the re-growth of hair might be faster with massage in an areata case, but that he had seen hair regrow without treatment and fail to come back with treatment. (Tr. 298) He estimated the number of bald persons who have male-pattern type baldness as high as 98 percent. The testimony of the complainant's dermatological witnesses as to the various types of baldness was not seriously contested by respondent.
A great deal of the medical testimony and discussion in the briefs consists of discussion of the bacteriostatic theory of sulpha drugs and the effect of lanolin in carrying the sulpha drug to the follicles of the hair. This is the action which the respondent claims will occur with use of his product. The complainant in his brief states that I must believe that this theory is in fact valid to rule for the respondent. The respondent states that the theory is not the important question but that a decision must be made based on the actual results of the testing of the product. I agree with the reasoning of the respondent and so I do not feel that a detailed discussion of the theory upon which the respondent claims the product works and the varying opinions thereon is relevant or necessary. 3/ The respondent places the most reliance upon Dr. Menne, the pathologist who testified for the respondent. He agreed that alopecia areata is a distinctly different type of disease from the general male-pattern type baldness. (Tr. 722) His testimony concerning the general problem of alopecia was consistent with the testimony of the witnesses for the complainant. He admitted that the study upon which he had based his conclusion as to the efficacy of the respondent's product was only in the initial stages, but that he had "clinical evidence" that the product created a favorable situation for hair growth. (Tr. 678) The three medical witnesses for the respondent had conducted a series of tests on twenty-seven persons. Those persons had been selected for the test by the respondent, Carl Brandenfels. As to these twenty-seven persons, Dr. Menne testified that he believed that all types of baldness were represented by the group but, although he could have done so, he did not diagnose their condition. (Tr. 533) This was in spite of the fact that he agreed that in an areata case the systemic disease must first be treated. (Tr. 541) In making these tests, Dr. Menne, the pathologist, made the final determination of the cellular changes by microscopic examinations. Dr. Norman David, a pharmacologist, supervised the application of the drugs and noted the reactions of the patients to those drugs. In addition to the biopsy test, Dr. David observed the bacteria count at the roots of the hair before and
after use of the treatment. Dr. Ervin E. Ladd, the physician and surgeon, took the biopsies, interviewed the patients and handled the organizational features of the program. At the request of Congressman Norblad, these three doctors had been appointed by the Dean of the Medical School of the University of Oregon to conduct a test as to the safety of the respondent's treatment and had later conducted the above-mentioned tests to determine efficacy.
In conducting the preliminary study as to safety for use, 160 medical students of the University of Oregon were tested. The results of efficacy were incidentally observed by the doctors but since observation of efficacy was only incidental to the testing process these tests are not of great significance.
Of considerable significance to the undersigned is the testimony of Dr. Ervin E. Ladd concerning the twenty-seven persons tested. He was the only doctor who diagnosed the condition causing the baldness of the twenty-seven persons who were tested. It is noted that the respondent does not discuss very much of the testimony offered by Dr. Ladd in his brief. He relies almost exclusively on the testimony of Drs. Menne and David. A close examination of the testimony of Dr. Ladd reveals a possible reason. Although there was some confusion as to the exact breakdown, Dr. Ladd listed eight of the twenty-seven as having had marked results from the use of the treatment. He listed five who had a slight improvement and eleven who had no change. He gave their names and his diagnoses of the cause of their baldness. (Tr. 995-1003). The following is a listing of the persons in the three categories and the diagnoses of Dr. Ladd:
Averill areata
Bronsema areata
Garner areata
Harris senilis
Helmer senilis
Liefson areata
Lunow x-ray burn
Nagle areata and senilis 4/
Storrer areata
Tyrell areata
Hartley areata
Slight Change: 5 (2 female and 3 male)
Alwick areata
Arms areata
Berg areata
Mixer areata
Slesk senilis 5/
No Change: 11 (7 female, 4 male)
Name Diagnosis
Albrecht areata
Belles 6/
Biazzo areata
Braddock
Cathey senilis
Harris areata
Hepola areata
Little
Smith-Milner senilis
Petry
Stucki senilis
It thus becomes clear from Dr. Ladd's diagnosis of the persons in the test that the great majority of them were areata cases yet this is the evidence upon which the respondent seeks to rely to prove that the general consensus of opinion is erroneous and that the treatment is efficacious for all types of baldness. Yet, it is generally agreed that only a very small percentage of bald-headed people in the world suffer from areata and the basic cause of baldness is distinctly different in an areata case than in other types. Of the eleven whom the doctor testified had marked results after the use of the Brandenfels treatment, eight were diagnosed as areata cases. Mr. Nagle was diagnosed as having a senilis type baldness but this was in addition to areata. One diagnosis was x-ray burn. Only two, Miss Harris and Mr. Helmer, were diagnosed as senilis cases. Mr. Helmer himself testified that his hair had been "in and out" over the years. (Tr. 586) He stated that it fell out in spots and eventually he became "slick". (Tr. 592) From the testimony of all of the expert medical witnesses on the symptoms of alopecia areata the conclusion seems inescapable that Dr. Ladd was in error and that this witness in fact suffered from areata and not senilis. That leaves Miss Harris and, assuming that she did in fact suffer from a senilis male-pattern type 7/ of baldness, it would seem difficult to draw the conclusion that this one person who suffered from a senilis type baldness constitutes proof that the product is efficacious for male-pattern baldness. Four of the five persons who had slight changes were areatas. Of the eleven with no change, four were diagnosed as areata, the doctor did not know about four, and three were senilis.
A number of other lay witnesses who were not part of the experiment conducted by Drs. Menne, Ladd and David testified that they had achieved results with Brandenfels treatment. For the most part, their testimony indicated that they had suffered from an areata type of baldness or doctors for the complainant after examining them at the hearing testified to that effect. Of those witnesses who were apparently suffering from a male-pattern type of alopecia, there was serious question as to whether they had in fact grown any hair in spite of their protestations that they had and would continue to grow hair. In several of the areata cases very little hair had been grown. The testimony of lay users as to the efficacy of a product is of little value in such cases. United States v. 50-3/4 Doz. Bottles, supra. The credulity of a lay user who wants very much to achieve results is sometimes remarkable.
Another experiment was conducted on use of the Brandenfels treatment by the Food and Drug Administration. Dr. de Nosaquo gave the preparation to several Food and Drug employees and instructed them to use it according to the directions. They testified that they did so and photographs were introduced showing their "before" and "after" conditions. I do not place much reliance on this evidence because of the lack of scientific technique used in the tests and the fact that all of the "before" pictures are under-developed and the "after" pictures are over-developed indicating that if there was any change in the hair of the user it was in a worse condition after use than before.
Another fact which deserves mention is the contention of the complainant that where the areata cases showed improvement it was merely coincidental that they were at that time using the Brandenfels treatment. From the evidence adduced at the hearing it appears that there were a good many of these cases. The cases were diagnosed as areata and the hair began to regrow upon use of the Brandenfels treatment after the hair had been out for many years. I cannot chalk all of this evidence off to coincidence as easily as does the complainant. However, even assuming that there is a reasonable probability that the product is conducive to growth of hair in areata cases, the treatment of areata cases is not the purpose for which it is advertised. The fact that the respondent has shown some areata patients in his advertising (notably Eldon Beerbower) does not prove that the advertising for the product is designed to attract areata patients since no effort is made in the advertisement to discuss the difference between the two or point out that the patients suffered from areata and not male-pattern type baldness. The average reader would not know this and the impression would remain that the product will help in all types of baldness including the male-pattern types.
It should be remembered that the respondent was given the authority and responsibility for picking the guinea pigs for the tests of the three doctors from the Oregon Medical College. In addition to the fact that most of these were areata cases, many of them are women and some had even lost eyebrows and hair on other parts of the body. It should have been obvious to the respondent, assuming he did study the problem of baldness as he asserts, that this was not the type of baldness from which the average bald American suffers and that it was this person who would be induced by the advertising to buy the product.
Many of those selected for the test were unique cases and, in spite of the claims of the counsel for the respondent of the scientific knowledge of the doctors who conducted the experiment for the respondent, it is somewhat surprising that only Dr. Ladd attempted to diagnose the causes of the baldness of the person tested. It would seem that a reading of the basic textbooks on skin disease would have alerted all the doctors to the facts which are known about baldness and this knowledge would have at least prompted them to diagnose the basic causes of baldness in those subjects who were produced for the test by Mr. Brandenfels.
I find that the respondent did not prove that for the purposes advertised his product was efficacious or that there is a split of medical authority sufficient to bring the matter within the doctrine of Reilly v. Pinkus. The order of the Deputy Postmaster General dismissing the proceeding without prUNITED-C.271 not be modified. There is no proceeding now pending in the Post Office Department against Carl Brandenfels.
Charles D. Ablard
Judicial Officer
10/05/59
1/ This is the test prescribed by the Supreme Court in Donaldson v. Read Magazine, 333 U.S. 178 (1947).
2/ See Jarvis v. Shackleton Inhaler Co., 136 F. 2d 116 (CA 6, 1943) and Harris v. Rosenberger, 145 Fed. 449 (CA 8, 1906).
3/ Briefly the theory of the respondent is that Formula A of the product which contains an aqueous solution of sulpha, creates a bacteriostatic action on the scalp which inhibits the growth of bacteria. This is as opposed to a bacteriocidal action which kills bacteria. Formula B which contains lanolin carries the sulpha preparation into the hair follicle and the massage recommended by the respondent increases blood circulation to the scalp carrying away the waste product. The supposed result of this is that the use of the product creates a favorable situation for hair growth.
4/ At page 34 of the brief of the respondent filed January 17, 1955, it is there contended that Mr. Nagle suffered only from senilis, a male-type baldness.
5/ The doctor was not certain about this diagnosis.
6/ The doctor did not know the cause of the baldness of these patients.
7/ The doctors agreed that women can have a male-type baldness.