P.S. Docket No. 16/18
April 05, 1984
In the Matter of the Complaint Against
OSCAR R. FALCONI, d/b/a WHOLESALE NUTRITION CLUB
P. O. Box 1113
Sunnyvale, CA 94086-9998
and
P. O. Box 3345
Saratoga, CA 95070-1345
and
19010 Portos Drive
Saratoga, CA 95070-1345
P.S. Docket No. 16/18;
Mason, Randolph D.
APPEARANCES FOR COMPLAINANT:
Sandra C. McFeeley, Esq.
James A. Harbin, Esq.
James F. McMullin, Esq., & Sharon Cummings (On Brief)
Consumer Protection Division
Law Department
U.S. Postal Service
Washington, DC 20260-1100
APPEARANCES FOR RESPONDENT:
Charles A. DeCuir, Esq.
The Belli Building 722 Montgomery Street
San Francisco, CA 94111-2109
Kirkpatrick W. Dilling, Esq.
150 N. Wacker Drive
Chicago, IL 60606-1111 (On Brief)
BEFORE: Randolph D. Mason Administrative Law Judge
INITIAL DECISION
These proceedings were initiated on March 3, 1983, when the General Counsel filed a Complaint in each of the above docket numbers against Oscar R. Falconi, d/b/a Wholesale Nutrition Club ("Respondent"). Each of the Complaints alleges that Respondent is engaged in conducting a scheme or device for obtaining money or property through the mails by means of false representations concerning certain products in violation of 39 U.S.C. § 3005. Respondent denies that any violation of the statute has occurred. The allegations contained in each of the Complaints are set forth below:
Docket No. 16/18
The Complaint alleges in Paragraph IV that Respondent falsely represents in its promotional materials that:
1. Respondent's Drug Rehabilitation Kit is effective to easily withdraw any addict from any narcotic within a few days.
2. Respondent's Drug Rehabilitation Kit is effective to withdraw an addict from any narcotic with few, if any, withdrawal symptoms.
3. Respondent's Drug Rehabilitation Kit is effective to withdraw an addict from any narcotic for a period of three months.
4. The slow injection of 30 to 40 grams of Respondent's "pure sodium ascorbate" product into a vein of a person who is unconscious as a result of an overdose of any drug will be effective within a few minutes to restore consciousness and alleviate any life threatening symptoms or conditions.
5. This antidote the injection described in subparagraph 4 is non-specific and works as described in subparagraph 4 on all drugs, so no time need be wasted in identifying the drug involved in the overdose.
6. A person dependent on alcohol, nicotine, caffeine or valium may, by using Respondent's Drug Rehabilitation Kit, reasonably expect to easily and quickly withdraw from his or her dependence.
7. During the course of using Respondent's Drug Rehabilitation Kit, should the user inject any of the narcotic or other substance sought to be avoided, particularly heroin or methadone, that substance is immediately detoxified and no "high" is produced for the user.
8. Respondent's Drug Rehabilitation program has been scientifically demonstrated to be wholly effective to achieve the results described in subparagraphs 1 through 6.
Docket No. 16/19
The Complaint alleges in Paragraph IV that Respondent falsely represents in its promotional materials that:
1. Ingestion of Vitamin C in amounts greater than the body's immediate need for it is effective to. . .
(b) "Dissolves (and prevents) the formation of kidney and bladder stones."
(c) "cures (and prevents) painful urination due to inflammation of the urethera."
(d) "cures (and prevents) urinary tract infections. . . ." 1/
2. Vitamin C deficiency is the cause of Sudden Infant Death Syndrome.
3. Ingestion of "ample amounts" of Vitamin C by infants will prevent the occurrence of Sudden Infant Death Syndrome.
Prior to the hearing in these cases, Complainant filed a Motion to Amend the Complaint to reflect the 19010 Portos Drive address which now appears in the caption herein. At the hearing, Respondent conceded that this address was being used to receive money for the products in question, and was unable to demonstrate prejudice by the Amendment. Accordingly, the undersigned granted the Motion to Amend the Complaint at the hearing. I reaffirm that ruling.
P.S. Docket Nos. 16/18 and 16/19 were consolidated for hearing with Docket Nos. 16/16 and 16/51. The hearing was held in San Francisco, CA, on May 11 and 12, 1983. Complainant introduced the expert testimony of Drs. Wallace Sampson, Jack M. Sheneman, Raymond D. Wilson, Gordon Dow, and Thomas H. Jukes. Respondent presented the expert testimony of Drs. Linus Pauling, Robert Cathcart, Robert Erdmann, and Irwin Stone. Both parties were represented by counsel and afforded full opportunity to be heard, adduce relevant evidence and examine and cross-examine witnesses.
Both parties filed Proposed Findings of Fact and Conclusions of Law on October 12, 1983, which have been duly considered. During the time allowed for the filing of briefs, the parties executed Consent Agreements with respect to Docket Nos. 16/16 and 16/51. The Consent Agreement also reached a disposition of the issues set forth in footnote 1 above in Docket No. 16/19. The provisions of that Consent Agreement relating to the issues in Docket No. 16/19 are incorporated herein by reference.
To the extent indicated below Proposed Findings and Conclusions have been adopted; otherwise they have been rejected as irrelevant or contrary to the evidence. Based on the entire record herein, including my observation of the witnesses and their demeanor, the exhibits and other relevant evidence adduced at the hearing, I make the following Findings of Fact and Conclusions of Law:
FINDINGS OF FACT
Docket No. 16/19
1. Respondent Oscar F. Falconi, d/b/a Wholesale Nutrition Club seeks the remittance of money through the mails at the addresses set forth in the caption (Ans. ?I and II; Tr. 5-6).
2. Respondent sells "C-Strips", which are chemically treated test papers used for measuring the Vitamin C content of urine (CX-9). Respondent sells this product, along with large quantities of Vitamin C powder by making certain representations with respect to alleged benefits of taking an "excess" of Vitamin C. The C-Strip urine test informs the user whether his urine contains this excess of Vitamin C which Respondent contends is necessary to cure and prevent certain illnesses (id.).
Kidney and Bladder Stones
3. As alleged in Paragraph IV(1)(b) of the Complaint, Respondent represents that the ingestion of Vitamin C in amounts greater than the body's immediate need for it is effective to dissolve and prevent the formation of kidney and bladder stones (Ans. ?IV). In this regard, Respondent specifically states in the "Instructions and Information" for C-Strips (CX-9) that:
However, it has already been shown that an excess of Vitamin C continually flowing out with the urine; . . . (3) dissolves (and prevents) kidney and bladder stones.
This instruction sheet sets forth the name and address of the Respondent and advertises "200 C Strips: $3.00 ppd", revealing that reorders, and perhaps initial orders, for C-Strips are solicited through the mail by the means of this representation.
4. The preceding representation is materially false in fact. This finding is based upon the testimony of Wallace R. Sampson, M.D., and Dr. Raymond D. Wilson. Dr. Sampson is a medical doctor who is board certified in internal medicine (Tr. 11). He has held numerous teaching positions in the field of medicine in addition to his practice (Tr. 12). He keeps abreast of developments in internal medicine (Tr. 14) and was a credible witness in this proceeding.
5. Dr. Wilson is a pharmacology specialist with the State of California Food and Drug Branch (Tr. 125). He acts as a technical advisor to the drug program, answering questions from field staff and consumers and reviewing protocols for IND's (Investigations of New Drug Applications) and NDS's (New Drug Applications) (Tr. 126). His specific function is to oversee and review NDA's submitted to the State of California (Tr. 126-127). Dr. Wilson received his pharm.D degree in 1967. He took extensive course work in the biological sciences, physiology (including nutrition), anatomy, biopharmaceutics (how drugs work in the body), parasitology, and vitamins and minerals (Tr. 127). He has kept current in his field as an instructor on a university clinical staff and keeps abreast of the scientific literature (Tr. 128-129).
6. Based upon the testimony of Drs. Sampson and Wilson I make the following findings: No substantiation exists for Respondent's claim that the ingestion of an excess of Vitamin C dissolves and prevents kidney and bladder stones (Tr. 35, 138). Attempts to dissolve kidney or bladder stones by creating an acid urine with any compound have been unsuccessful (Tr. 35-36). An excess of Vitamin C is not a significant therapeutic agent for preventing such stones (Tr. 36). In fact, an excess of Vitamin C could create conditions where there is an increased likelihood of uric acid stones, although it may possibly create conditions where there is less likelihood of certain stones, such as oxalate stones (Tr. 34, 146). However, there is no adequate proof of a decrease in the incidence of oxalate stones (Tr. 34), and is not common practice to prescribe Vitamin C for this purpose (Tr. 34-35, 86). Finally, there is no adequate proof of safety and efficacy of using large quantities of Vitamin C to dissolve and prevent kidney and bladder stones (Tr. 146-147). These findings are in accord with the informed medical consensus (Tr. 61-62, 151).
7. The above findings are made after giving full consideration to the testimony of Drs. Linus Pauling and Robert Cathcart, M.D., who testified for the Respondent. They both supported Respondent's claim of efficacy of excess Vitamin C to prevent the formation of kidney and bladder stones (Tr. 167-168, 205-206). Dr. Pauling has no doubt that proper use of Vitamin C decreases the incidence of bladder stones of various kinds (Tr. 167). In his view, Vitamin C in the form of ascorbic acid, like other acidic substances, also helps to prevent the formation of common kidney stones by decreasing alkalinity of the urine (Tr. 167, 179). He states that rarer kidney stones, such as the cystine variety, can be prevented by ingesting Vitamin C as sodium ascorbate to keep the urine alkaline (Tr. 167, 179). He also testified that although certain people convert ascorbic acid into oxalate, thereby increasing the probability of forming kidney stones of the oxalate types if excessive ascorbic acid is ingested, ascorbic acid generally serves to prevent such abnormalities (Tr. 168).
8. Dr. Cathcart stated that none of his 9,000 patients developed kidney stones, and six of his patients who had kidney stones before they began taking Vitamin C stopped having them thereafter (Tr. 205-206). However, neither Dr. Pauling nor Dr. Cathcart produced evidence of a controlled clinical trial or a double-blind study to substantiate their claims or document their assertions. 2/
9. Dr. Linus Pauling holds a bachelor's degree in chemical engineering and a Ph.D. in chemistry, physics, and mathematics (Tr. 153). He has served as a professor of chemistry or physics at the California Institute of Technology, Oxford University, University of California at Berkeley, University of California at San Diego, Stanford University, Harvard University, Princeton University, and the University of Chicago (Tr. 154). He is also a member of a large number of professional societies, both foreign and domestic (Tr. 154). In addition to receiving the American Chemical Society award in pure science, the Phillips Medal of the American Academy of Physicians, and various other awards in the fields of chemistry, mineralogy and medicine, Dr. Pauling was awarded the Nobel Prize in Chemistry in 1954 after his work on the nature of the chemical bond (Tr. 154-155) and the Nobel Peace Prize for 1962 for his involvement in the treaty stopping the testing of nuclear weapons in the atmosphere (Tr. 154-156).
10. Dr. Pauling initially worked largely in the field of chemistry; however his interests shifted to molecular biology and then to medicine (Tr. 154). For the past 17 years he has devoted the major part of his work to vitamins (Tr. 157). He is particularly interested in how much of a vitamin is desirable to "put you in the best of health with the greatest resistance to disease" (Tr. 159). He wrote Vitamin C and the Common Cold in 1970 (Tr. 158).
11. He admits that there is a large discrepance between his own views with respect to Vitamin C and the views held by the American Medical Association (Tr. 158-159). In this regard, the Recommended Daily Allowance of Vitamin C is 60 milligrams per day. In Dr. Pauling's view, the amount of ascorbic acid needed to place a person in the best of health is the amount he, himself, consumes daily, 12,000 milligrams, which is 200 times the RDA (Tr. 159-160). He also takes up to 40,000 mg per day when under special stress or when he does not feel well (Tr. 159-160). He determined this dosage through experimental study of how much ascorbate various animals manufacture (Tr. 177). He thinks that almost all animals manufacture the human equivalent of 12,000 milligrams a day of ascorbate; however, he notes that humans lost the ability to manufacture Vitamin C long ago (Tr. 172).
12. Dr. Pauling concedes that his views on Vitamin C differ substantially from the consensus of the medical community (Tr. 185) Not only are his papers rejected for publication by the journals, but spokesman for the AMA and other nutritionists, biochemists, and biologists have all made strong statements opposing his views (Tr. 185). He believes, however, that many individual physicians, even though they might not admit it, "probably think that we are on the right track" (Tr. 185).
13. Dr. Robert Cathcart is a medical doctor whose specialty is orthopedic surgery (Tr. 189). He became known for his invention of a hip prothesis (Tr. 190). Dr. Cathcart became interested in Vitamin C after hearing Dr. Pauling's contention that it would help the common cold. Cathcart stated that a high intake (10 to 15 grams per day) of Vitamin C not only blocked his hay fever symptoms but also prevented his catching a cold for nine months (Tr. 192). Dr. Cathcart moved to a small town in which he was the only medical doctor. There he treated 9,000 patients on large doses of Vitamin C. He thinks that people should take the amount of Vitamin C "that will almost, but not quite, cause diarrhea" (Tr. 196-198). His general ideas with respect to Vitamin C do not conform to the informed medical consensus (Tr. 199-201).
Inflammation of the Urethra
14. As alleged in Paragraph IV (1)(c) of the Complaint, Respondent represents that the ingestion of Vitamin C in amounts greater than the body's immediate need for it is effective to cure and prevent painful irination due to inflammation of the urethra (Ans. ?IV). Respondent's promotional material specifically states:
However, it has already been shown that an excess of Vitamin C continually flowing out with the urine:
. . .
(4) cures (and prevents) painful urination due to inflammation of the urethra CX-9 .
15. This representation is materially false in fact. Based upon the testimony of Drs. Sampson and Wilson, I find that Respondent's claim has not been documented (Tr. 36, 87, 138). There have been no controlled clinical trials showing that excess Vitamin C is safe and effective for curing painful urination. Without such a controlled clinical study, a claim of efficacy cannot be accepted by the medical community (Tr. 149). The above views conform to the informed medical and scientific consensus (Tr. 16, 61-62, 151).
16. Respondent's evidence on this point was insubstantial. Although Dr. Pauling stated that he was "sure" that Respondent's claim was justified (Tr. 168), he based his conclusion on the fact that Vitamin C is required for wound healing and that the urethritis might involve an abrasion or wound (Tr. 168-169). He did not indicate that any scientifically valid testing had been performed with respect to this particular question. Similarly, Dr. Cathcart testified only that his experience indicated that nonspecific urethritis responded well to ascorbic acid (Tr. 206). He failed to specify what type of results he had obtained or how he had obtained them.
17. Irwin Stone, whose qualifications are set forth below, also opined that Vitamin C cures and prevents painful urination due to inflammation of the urethra. Stone cited an article by Dr. Klenner in support of Respondent's claim (Tr. 289, RX-5). In this article, Dr. Klenner supported the use of ascorbic acid to "destroy all virus organisms" (RX-5 at 2). He briefly mentioned Vitamin C and urethritis, however, stating that Rous has found that three grams daily for four days will completely relieve all symptoms of urethritis (RX-5, at 4). The Rous paper was not introduced in evidence. Stone admitted that none of Dr. Klenner's articles have been accepted by orthodox medical journals (Tr. 290). This evidence does not prove the consensus to be in error.
18. Irwin Stone, who testified for Respondent, studied chemical engineering at the City College of New York from 1924 to 1931 but did not receive his bachelor degree (Tr. 272, 305). He was employed as a laboratory assistant and chemist until 1934. Thereafter, he was employed by a manufacturer of industrial enzymes until 1971. During that time he used ascorbic acid as a method to improve the stability of beer (Tr. 273-275). The company was not interested in the medical aspects of ascorbic acid (Tr. 275).
19. Stone is a certified professional chemist and a member of numerous professional chemist organizations (Tr. 275-276). He is the named inventor of 26 U. S. Patents in the brewing, food, pharmaceutical, nutrition, and medical fields. He has also received two honorary doctorates in the humanities and science from a chiropractic college and Donsbach University in Southern
California (Tr. 276, 305). He recently received an award from the International Forum for Youth and Development for his work in the field of human nutrition (Tr. 276-277). He has published over 120 papers addressing the chemical technology of ascorbic acid and the genetics and effects of scurvy (Tr. 277). Stone thinks that scurvy is the result of a defective gene which arose as a conditional mutation of a primitive primate that existed 65 million years ago. He feels that this defective gene has caused more human misery and killed more people than any other medical cause throughout history (Tr. 278-279). He feels that humans are currently experiencing "an epidemic of chronic subclinical scurvy" (Tr. 279). In his view, the Recommended Daily Allowance of 60 milligrams of Vitamin C per day will not eliminate the chronic subclinical scurvy which, he states, exists in 100 percent of the population. He feels that humans should take at least 15,000 milligrams of Vitamin C per day (Tr. 280). It is his further opinion that subclinical scurvy can prevent the human immune system and the collagen system from working properly (RX-6 to RX-10). Dr. Stone's theory on the genetics of scurvy underlies his opinion that Vitamin C is beneficial in a vast array of ailments (Tr. 292-295).
Urinary Tract Infections
20. As alleged in Paragraph IV (1)(d) of the Complaint, Respondent represents that the ingestion of Vitamin C in amounts greater than the body's imemdiate need for it is effective to cure and prevent urinary tract infections (Ans. ?IV). In this regard, Respondent's promotional materials state (CX-9):
however, it has already been shown that an excess of Vitamin C continually flowing out with the urine:
. . .
(5) cures (and prevents) urinary tract infections....
21. Complainant's witnesses were unable to establish the falsity of this claim. On the contrary, Dr. Wilson stated that the claim can be taken as true and that it has been established by valid scientific tests (Tr. 138, 141). Physicians have used Vitamin C as a prophylactic to prevent infections (Tr. 140-141). Drs. Sampson and Jukes also agreed that Vitamin C acts as an acidifying agent in counteracting the alkalinity that results from bacterial overgrowth (Tr. 37; 338-339). Dr. Pauling established that physicians commonly treat urinary tract infections in paraplegic patients with ascorbic acid (Tr. 180). Finally, Respondent's claim was supported to a limited extent by Drs. Cathcart and Stone (Tr. 206, 292).
Sudden Infant Death Syndrome ("SIDS")
22. As alleged in Paragraph IV (2) and 93) of the Complaint, Respondent represents that Vitamin C deficiency is the cause of SIDS and ingestion of "ample amounts" of Vitamin C by infants will prevent the occurrence of SIDS (Ans. ?IV). In this regard, Respondent's promotional material states (CX9):
It is particularly important that infants ingest ample amounts of Vitamin C (at least 500 milligrams per day) to prevent SIDS (Sudden Infant Death Syndrome), also known as Crib Death.
23. This representation is materially false in fact. Based upon the testimony of Drs. Sampson and Wilson I find that Vitamin C deficiency is not a positive factor in Crib Death and that ingestion of ample amounts of Vitamin C will not prevent its occurrence (Tr. 38, 95). This view conforms to the consensus of informed medical and scientific opinion (Tr. 61-62, 151).
24. Respondent presented the testimony of Drs. Pauling, Cathcart, and Stone in support of the veracity of Respondent's claim with respect to crib death. However, their evidence was largely anecdotal in nature and did not prove the above consensus to be in error. These witnesses relied primarily upon the observations of Archie Kalokerinos, M.D., set forth in his book, Every Second Child (1974 Ed.) (RX-2). Dr. Kalokerinos practiced medicine among the Aborigines in Australia where there was a high incidence of crib death (RX-2). Dr. Pauling noted that these people have a special immunological problem and a Vitamin C deficiency exacerbated by immunization and inoculation (RX-2, at viii). There is no evidence that Dr. Kalokerinos conducted a scientifically valid double-blind controlled study.
25. Respondent's witnesses rely upon an article by Frederick R. Klenner, M.D., entitled "Significance of High Daily Intake of Ascorbic Acid in Preventive Medicine" (1974) (RX-5). Klenner states that his information relating to crib symdrome is backed by case histories of children that he treated (RX-5 at 1). Again, this evidence is insubstantial to prove that the informed medical consensus is in error. Dr. Cathcart's anecdotal experience falls into the same category (Tr. 207).
P.S. Docket No. 16/18
Drug Rehabilitation Kit
26. Respondent seeks the remittances of money through the mails for its Drug Rehabilitation Kit at the addresses set forth in the caption herein (CX-1; Tr. 6).
27. The kit contains three pounds of Vitamin C (sodium ascorbate) in crystalline form, and a bottle of multi-vitamin and mineral tablets. 3/ The kit also contains a set of instructions containing the Respondent's mailing address (CX-4) and an article by Alfred F. Libby and Irwin Stone published in the Journal of Orthomolecular Psychiatry, entitled "The Hypoascorbemia-Kwashiorkor Approach to Drug Addiction Therapy: A Pilot Study" (1977) (CX-3).
28. As alleged in Paragraph IV (1)-(3) of the Complaint, Respondent represents that:
1. Respondent's Drug Rehabilitation Kit is effective to easily withdraw any addict from any narcotic within a few days.
2. Respondent's Drug Rehabilitation Kit is effective to withdraw an addict from any narcotic with few, if any, withdrawal symptoms.
3. Respondent's Drug Rehabilitation Kit is effective to withdraw an addict from any narcotic for a period of 3 months.
(Ans. ?IV).
In this regard, Respondent's product order form (CX-1 at 2) states:
DRUG REHABILITATION KIT: a 1974 breakthrough in drug therapy has enabled us to offer our exclusive Drug Rehab Kit, guaranteed to easily withdraw any addict from any narcotic in a few days with few, if any, withdrawal symptoms, and keep him off for 3 months.
(CX-1; see also CX-2)
29. The representations set forth in Paragraph IV (1)-(3) of the Complaint are materially false in fact. Based upon the credible testimony of Dr. Sampson, I find that the kit would not be effective to withdraw an addict from a narcotic, with few, or no withdrawal symptoms because it does not contain any chemical compound or drug which has the capability of reversing the physiological signs and symptoms of narcotic withdrawal (Tr. 42). In addition, the kit is not effective to withdraw an addict easily from any narcotic within a few days, with few symptoms, and maintain that state for 3 months because there is no reasonable, supportive evidence for the claim and no physiological reason upon which it could be based (Tr. 42-43, 88-89). Dr. Sampson's views are in accord with the informed medical and scientific consensus (Tr. 61-62).
30. Dr. Gordon Dow also testified on behalf of the Complainant. Dr. Dow is a pharmacist and the Executive Secretary of the Research Advisory Panel, a state agency that reviews and supervises research in drug abuse treatment (Tr. 224). He is responsible for reviewing research protocols, making recommendations to the panel on those protocols, conducting training meetings for investigators, writing reports, keeping abreast of the literature, informing the panel of developments in the field, conducting site visits on drug abuse treatment programs and other research programs, among other duties (Tr. 225).
31. My finding that the kit would not be effective to withdraw an addict easily from any narcotic within a few days is also based on Dr. Dow's credible testimony that the methods prescribed in the kit have not been established through proper clinical trials to be efficacious (Tr. 235). He also established that the kit would not be effective to withdraw an addict from any narcotic for a period of 3 months nor would it be effective to withdraw an addict from any narcotic, with few, if any, withdrawal symptoms (Tr. 235).
32. The principal method of withdrawing an addict from a narcotic is hospitalization, with constant attendance and attention to the uncomfortable signs and symptoms of withdrawal, including excessive salivation, abdominal cramping, diarrhea, muscle cramping, aches and pains in the extremities, fever, and cardiovascular collapse (Tr. 41, 93-94). The uncomfortable symptoms of the addict are treated with various chemical compounds which counteract the symptoms (Tr. 40). The symptoms and physical effects of withdrawal vary between persons and drugs (e.g., heroin and barbituates); therefore, the treatment of two different types of drug users would necessarily be different (Tr. 233-234).
33. The above findings of falsity with respect to the representations made in Paragraph IV (1)-(3) are made after full consideration of the Respondent's evidence. The latter consisted principally of anecdotal reports, theoretical conclusions, or preliminary studies. No scientifically valid double-blind control studies were introduced to overcome the informed consensus.
34. For example, Dr. Pauling relied largely on reports that he had received from Drs. Cameron and Libby. Dr. Cameron had reported to him that terminal cancer patients who were in pain and had received large amounts of morphine no longer asked for, or needed, a narcotic after ingesting 10 grams of Vitamin C per day. These patients had not shown any withdrawal signs from the addiction to the narcotic drug (Tr. 174). Dr. Pauling also relied upon the Libby-Stone pilot study (CX-3) concerning the detoxification of heroin addicts by administering megadoses of sodium ascorbate to the addicts. Although the initial results were favorable, this was merely a pilot study conducted as an attempt to get funding from a more comprehensive, controlled study (Tr. 298, 267). The authors made no attempt to "cross all the T's and dot all the I's" (Tr. 298). The pilot study consisted of case studies of approximately 30 drug addicts whose treatment was allegedly successful (CX-3; Tr. 267, 298). The pilot study was completely ignored by the medical community, and the authors never received funding to do a controlled study (Tr. 269, 298).
35. Dr. Pauling believes that Vitamin C "apparently does have" great value for the treatment of narcotic addicts because of the substance's property as a detoxifying agent and because of its involvement in many of the biochemical processes within the human body "to keep us in the best of health" (Tr. 175). Dr. Pauling was unable to cite a double-blind controlled trial to support his claim and he affirmed that his views differ substantially from the consensus of the medical community (Tr. 185-187).
36. Dr. Cathcart supported Respondent's claims for the Drug Rehabilitation Kit because of his belief that Vitamin C blocks the addictive qualify of drugs. He based his opinion on his treatment of patients for low back pain, who had spontaneously stopped using such drugs as codeine, perdocan and valium or had markedly decreased their doses after taking Vitamin C (Tr. 208, 215). Dr. Cathcart did not determine the proper dosage of Vitamin C or keep formal records of the dosages his patients used (Tr. 210-211). Dr. Cathcart did not use a controlled group in his studies although he could have done so (Tr. 214).
37. The testimony of Drs. Erdmann and Stone were also based upon the pilot study reported in CX-3. The problems with this study are set forth above.
38. As alleged in Paragraph IV (4) of the Complaint, the Respondent represents in its promotional materials that the slow injection of 30 to 40 grams of Respondent's "pure sodium ascorbate" product into a vein of a person who is unconscious as a result of an overdose of any drug will be effective within a few minutes to restore consciousness and alleviate any life threatening symptoms or conditions (Ans. ?IV). In this regard, Respondent's materials state:
If ever an addict is unconscious, and at death's door due to a drug overdose, or an unfortunate combination of drugs, or of drugs and alcohol, you must immediately find a doctor to slowly inject 30 to 40 grams of our pure sodium ascorbate (with about 100 grams of distilled or boiled water) into the vein of the addict. If this is done in time, the addict will be out of trouble in minutes. If not, he may die on the spot (CX-4).
This quotation appears in the instructions for the use of the kit which contains Respondent's mailing address. Another promotional paper states (CX-2 at 2):
In drug overdosage, sodium ascorbate can be a life-saving measure. Unconscious overdosed addicts are given the sodium ascorbate intravenously, 30 to 50 grams, while those able to swallow can be given the same quantity dissolved in a glass of milk.
39. The above representation is materially false in fact. Based upon the credible testimony of Drs. Sampson and Dow, I find that the above representation has no support in the orthodox medical literature and has no established efficacy as a treatment for overdosed addicts (Tr. 48, 238). The informed consensus is that the procedure is both ineffective and potentially dangerous (Tr. 48, 61-62, 238).
40. An overdosed addict who is close to death should be treated with the antagonist to the drug in question in accordance with procedures established in the toxicology literature. Respondent's Drug Rehabilitation Kit may also be dangerous due to the likely injection of unsterile material into a person with decreased ability to respond to infections (Tr. 46-48, 239).
41. The Libby-Stone pilot study (CX-3) was the primary basis for Respondent's representation. That study mentioned one case history of a teenager who had taken "angel dust" (PCP). He was given 30 grams of sodium ascorbate orally and within 45 minutes "could hold a normal conversation" (CX-3 at 304). As previously mentioned, the anecdotal unscientific methodology of this "study" makes it unreliable to prove that the informed consensus is in error.
42. As alleged in Paragraph IV (5) of the Complaint, Respondent represents that this antidote (the injection described in the preceding representation) is nonspecific and works as described in ?IV (4) of the Complaint on all drugs, so no time need be wasted in identifying the drug involved in the overdose (Ans. ?IV). This representation is specifically made in Respondent's promotional materials (CX-2 at 2, CX-3 at 308).
43. Based upon the testimony of Dr. Sampson, I find that the representation of Paragraph IV (5) is materially false in fact. There is no evidence that the aforementioned antidote to an overdose works on all drugs. Further, different drugs produce different withdrawal symptoms which require different treatments (Tr. 50-51).
44. Again, Respondent bases its claim upon the Libby-Stone pilot study (CX-3 at 308). That study is not scientifically accurate because it is based largely on a few case histories that are superficially described (Tr. 51-52). The paper fails to give complete descriptions of the symptoms, signs, and vital sign measurements of the patients, as well as details of the withdrawal of the patients (Tr. 52). However, even if such detail had been provided these anecdotal reports failed to prove that the informed consensus set forth by Dr. Sampson is in error.
45. As alleged in Paragraph IV (6) of the Complaint, Respondent represents that a person dependent on alcohol, nicotine, caffeine or valium may, by using Respondent's Drug Rehabilitation Kit, reasonably expect to easily and quickly withdraw from his or her dependence (Ans. ?IV). In this regard, one of Respondent's promotional papers states that the kit "works on all drugs - heroin, cocaine, morphine, angel dust, LSD, uppers, downers, marijuana, valium, nicotine, and alcohol" (CX-2 at 2). Moreover, the "instructions" for the kit state: "this program also allows you to kick alcohol, nicotine, caffeine and valium" (CX-4 at 1). See also quotation (i) in Finding of Fact No. 50, below.
46. Based upon the testimony of Drs. Sampson and Dow, I find that the foregoing representation is materially false in fact. There is simply no substantiation for the claim that a person using the kit could reasonably expect to withdraw easily and quickly from his alcohol, nicotine, caffeine or valium dependence (Tr. 54-55, 240-243). The procedures prescribed in Respondent's kit are not in accord with the informed consensus for treatment in the field of alcoholism (Tr. 241). There are no valid clinical studies substantiating the use of sodium ascorbate to withdraw from dependency to these drugs (Tr. 241-243).
47. As alleged in Paragraph IV (7) of the Complaint, Respondent represents that during the course of using the Drug Rehabilitation Kit, should the user inject any of the narcotic or other substance sought to be avoided, particularly heroin or methadone, that substance is immediately detoxified and no "high" is produced for the user (Ans. ?IV). In this regard, Respondent's advertisement states (CX-2 at 2):
Fixes immediately detoxified
. . .
Under this treatment the heroin or methadone is stopped and no withdrawal symptoms are encountered. Should a "fix" be taken, it is immediately detoxified and no "high" is produced.
In addition, this representation is specifically made in CX-3 at 301, 307, which comes with the kit.
48. Based upon the testimony of Drs. Sampson and Dow, I find that the representation in ?IV (7) of the Complaint is materially false in fact. It is the consensus of informed scientific and medical opinion that such a kit would not detoxify a "fix" so that no "high" occurs; the claim is not supported by the scientific literature or principles of physiology or pharmacology (Tr. 49-50, 61-62, 245).
49. Respondent again relies upon the Libby-Stone pilot study (CX-3) in support of its claim. That study reported one case history of a patient who injected heroin and allegedly felt no effect (CX-3 at 303). This report lacked sufficient information to draw any conclusions from the testimonial of this heroin addict and the methodology of the study was inadequate (Tr. 245).
50. As alleged in Paragraph IV (8) of the Complaint, Respondent represents in its promotional materials that the Drug Rehabilitation Program has been scientifically demonstrated to be wholly effective to achieve the results subscribed in Complaint ?IV (1)-(6) (Ans. ?IV). This representation is made in the following quotations from these materials:
(i) " a very recent BREAKTHROUGH in DRUG ABUSE THERAPY has enabled us to offer you a DRUG REHABILITATION KIT GUARANTEED to easily and speedily withdraw addicts from their habit" (CX-2 at 1);
(ii) " t ested and proved by Dr. Libby on over 100 addicts since 1974 --and no failures]" (CX-2 at 2);
(iii) "the ... program has had 80 successes out of 80 attempts so far, so we feel that we are close to having achieved optimization" (CX-4, at 2);
(iv) " w e do not claim to be the first to suggest or use ascorbate in the addiction problem, but we do claim to be the first to use sodium ascorbate properly to get these desired results" (CX-3 at 302);
(v) " t his reported 100 percent rate of success is the same as that noted by Dr. Cathcart in his megascorbic therapy of the viral diseases, 'it works every time,' provided enough ascorbate is used" (CX-3 at 304);
(vi) " t he clinical results have been so successful in 100 percent of the 30 drug addicts treated to date of this writing, that we regarded the prompt presentation and publication of our data to be an absolute necessity" (CX-3 at 305).
51. This representation is materially false in fact. Based upon the credible testimony of Dr. Sampson, I find that the efficacy of Respondent's Drug Rehabilitation Kit has not been scientifically demonstrated because there is no credible evidence for it in the medical literature (Tr. 55-56). Although Respondent's advertising leads the ordinary reader to believe that the claims for this kit are supported by scientifically valid tests, this is not so. Respondent supports his claims with mere anecdotal reports, theoretical conclusions, and preliminary or tentative studies. No scientifically valid double-blind controlled studies were introduced to overcome the informed consensus. The deficiencies in the studies and evidence relied upon by Respondent have been discussed previously in these Findings of Fact.
52. The false representations set forth above are material because they have the effect of inducing individuals to remit money through the mail in order to purchase the products in question.
CONCLUSIONS OF LAW
1. The first issue presented for consideration is whether Respondent made the representations in its promotional materials as alleged in Paragraph IV of each of the Complaints in these consolidated cases. In determining whether representations are made, the advertisement is to be read in its entirety and in light of its effect on the ordinary mind. Donaldson v. Read Magazine, 333 U. S. 178 (1948); Peak Laboratories, Inc. v. United States Postal Serv., 556 F.2d 1387, 1389 (5th Cir. 1977). The impression of advertising on the ordinary mind is a question of law for the presiding officer to determine and testimony on interpretation is not required to make that determination. Vibra-Brush v. Schaffer, 152 F. Supp. 461 (S.D.N.Y. 1957) rev'd on other grounds, 256 F.2d 681 (2d Cir. 1958).
2. Respondent argued for the first time on brief that many of the representations alleged in the Complaints were not made in its promotional materials. This argument was untimely and represented a change in the Respondent's position set forth in the pleadings. In this regard, the Answer in each of these cases admitted in Paragraph IV that the alleged representations were, in fact, made in Respondent's product order form, instruction/information sheets "and other similar promotional materials." Respondent did, however, dispute the alleged falsity of these representations (Ans. ?V). Thus, Respondent's argument is untimely and prejudicial to the Complainant, who may well have presented additional evidence if this issue had been timely raised. Accordingly, Respondent's argument on this point is rejected.
3. However, assuming arguendo that this issue was properly raised, I have found that Respondent did, in fact, make the representations alleged in each of the Complaints. The language contained in Respondent's promotional materials which makes these representations is set forth in the above Findings of Fact. Thus, the contention that these representations cannot be found in the materials is also rejected.
4. Respondent also appears to be arguing that at least some of the representations were made only in instruction and information sheets obtained by customers after the products had already been purchased. Thus, Respondent apparently argues that he did not obtain money through the mail "by means of false representations" within the meaning of 39 U.S.C. § 3005. This argument is also rejected. First, Respondent admitted in Paragraph IV of the Answer that the representations were made in the instruction/information sheets and "other similar promotional materials." If Complainant had known that this would be an issue, evidence may well have been produced showing that these information sheets were also used as promotional fliers. These sheets may have been used for this purpose since Respondent's mailing address is prominently featured on them. Also, the instruction sheet for the C-Strips contains a box in the lower right hand corner stating: "200 C-Strips: $3 ppd." In the second place, these information sheets would also have the effect of inducing customers to reorder and could induce the customer's friends and relatives to make initial purchases. Although there is no evidence that such purchases were actually made, actual use of the mails need not be shown, and an advertisement making representations which contains a mailing address is sufficient to establish jurisdiction. IAAIC, P.S. Docket No. 13/173 (P.S.D. Dec. 29, 1982).
5. The next issue for consideration is whether the representations made by Respondent are false. In both of the consolidated cases, I have based my findings on the credible and forthright testimony of the Complainant's expert witnesses. 4/ With one exception discussed below, they established that the informed consensus of scientific and medical opinion is that Respondent's representations are false. 5/ Under these circumstances, it is incumbent on Respondent to produce persuasive evidence proving the consensus to be in error. Standard Research Laboratories, P.S. Docket No. 7/48 (P.S.D. April 4, 1980). Respondent's medical witnesses admitted that their views were unorthodox and in conflict with the mainstream of scientific thinking. They have been unable to have their views published in the established medical journals. The details of the evidence presented by Respondent in this regard are set forth in the above Findings of Fact and need not be repeated here. Suffice it to say, most of this evidence consisted of theoretical opinions based largely on anecdotal accounts of experiences with patients; this kind of evidence is not sufficient to overcome the contrary weight of the informed scientific and medical consensus. Cf. Simeon Management Corp. v. F.T.C., 579 F.2d 1137, 1143 (9th Cir. 1978). I must conclude that Respondent has failed to prove the informed consensus to be in error.
6. As reflected in Findings of Fact 20-21, I have concluded that Complainant failed to sustain its burden of proving the falsity of the representation contained in Paragraph IV (1)(d) of the Complaint in P.S. Docket No. 16/19 relating to the use of Vitamin C for the cure and prevention of urinary tract infections.
7. Accordingly, with the exception of Complaint ?IV (1)(d) of Docket No. 16/19, I must conclude and hold that Complainant has proved by a preponderance of the reliable and probative evidence that the representations in issue set forth in both of the Complaints herein are false. S.E.C. v. Savoy Industries, 587 F.2d 1149, 1168 (D.C. Cir. 1978). Such representations are material since they have the effect of inducing individuals to order or reorder the products in question.
8. Respondent is engaged in the conduct of a scheme for obtaining the remittance of money through the mail by means of false representations within the meaning of 39 U.S.C. § 3005. An Order in the form attached should be issued.
1/ After the hearing the parties entered into a Consent Agreement which disposed of issues raised in subparagraph 1(a) and one of the issues raised in subparagraph 1(d). In this regard, the Complaint had alleged that Respondent false represented that:
1. Ingestion of Vitamin C in amounts greater than the parties' immediate need for it is effective to
(a) provide "100% protection against bladder cancer."
. . .
(d) "cures (and prevents) . . . blood in the urine due to unknown causes."
2/ On brief Respondent also relies upon a quotation from Irwin Stone's book, The Healing Factor, Vitamin C Against Disease, (RX-6 at 142-143). However, this evidence was insubstantial since Stone merely stated that the acidifying effect of ascorbic acid in the urine "may" inhibit stone formation. Also Stone relied upon a 1947 study which was not introduced into evidence and which appears to be based upon anecodotal experience.
3/ The tablets contain Vitamin A, D, B1, B2, B6, B12, C, niacin, pantothenic acid, Vitamin E, folic acid, biotin, PABA, calcium, phosphorus, magnesium, iron, iodine, zinc, manganese, selenium, and chromium (CX-6 at 2).
4/ The fact that these experts may not have personally tested the products in issue does not detract from their testimony. Original Cosmetics Products, Inc. v. Strachan, 459 F. Supp. 496 (S.D.N.Y. 1978), aff'd mem. no. 78-6165 (2nd Cir. April 30, 1979).
5/ As indicated in Findings of Fact 20-21, Complainant failed to prove that the representation concerning the use of Vitamin C for urinary tract infections was false.