In the Matter of the Complaint Against LEUCADIA PHARMACALS 103 N. Highway 101 at Leucadia, CA 92034 and LEUCADIA PHARMACALS 2521 1/2 Vista Way, Dept. BT-1 at Oceanside, CA 92054 P.S. Docket No. 11/90; 11/02/81 Grant, Quentin E. APPEARANCE FOR COMPLAINANT: Thomas A. Ziebarth, Esq. Consumer Protection Division Law Department United States Postal Service 475 L'Enfant Plaza W., SW Washington, DC 20260 APPEARANCE FOR RESPONDENT: Roger Neuman Secretary/Treasurer Leucadia Pharmacals 103 N. Highway 101 Leucadia, CA 92024
Complainant initiated this proceeding on May 19, l981, by filing a Complaint alleging, in substance, that Respondent is engaged in selling certain tablets through the mails by means of false representations as to their efficacy in relieving symptoms of benign prostatic hypertrophy (BPH) and is thereby violating 39 U.S.C. § 3005. Complainant seeks an order putting an end to the alleged scheme by stopping Respondent's mail.
Respondent filed an Answer presenting in lengthy detail several defenses to the proceeding, including alleged controlled clinical tests proving the effectiveness of the product, a federal court decision finding the product's formula effective in relieving certain symptoms of BPH, previous recognition by Complainant of the product's efficacy, and lack of awareness by the Food and Drug Administration of studies or reports refuting the effectiveness of the product's formula.
Respondent does not deny that it makes the representations alleged in the Complaint. Therefore, they are deemed admitted.
A hearing was held in San Diego, CA on September 29, l981. Both parties presented evidence thereat and have filed Proposed Findings of Fact, Conclusions of Law and written argument. To the extent indicated, proposed findings and conclusions have been adopted. Otherwise, they have been rejected as irrelevant, immaterial, or contrary to the evidence.
1. Respondent, at the addresses listed in the caption hereof, receives remittances of money or property through the mails for a product called PROST-RITE (CX A through G).
2. Each tablet of the product, according to the label used by Respondent, contains 6 grains of of I-Glutamic Acid, I-Alanine, and Glycine and 6 mg. of zinc (CX-G).
3. Respondent sells the product by means of the following representations made in it is advertisements as alleged in paragraph II of the Complaint:
"(1) That Respondent's *** tablets will relieve the following common symptoms of benign prostactic hypertrophy (*** 'BPH'):
(a) getting up nights to urinate;
(b) urgency and frequency of urination;
(c) dribbling and delay in urinating;
(d) pain and discomfort in urinating;
(2) That the effectiveness of Respondent's tablets in relieving such problems *** has been proven in two separate clinical tests published in leading medical journals." (CX A through D)
A copy of Respondent's current advertisement is attached hereto as Exhibit A.
4. The Complaint (paragraph II B) alleges that Respondent's advertising fails to clearly and conspicuously disclose that the symptoms mentioned above are usually due to conditions other than BPH in men under 50 years of age, and are frequently caused by conditions other than BPH in men 50 years of age and older, thereby misleading the reader as to the likelihood that this symptoms are caused by BPH and the likelihood of effective treatment of these symptoms using Respondent's product.
Respondent's advertisements in the form being used at the time of the hearing (copy annexed as Exhibit A to this Decision) contain the following advice centrally located in the advertisement and, although is smaller face type than the rest of the ad, I find to be readily noticeable, if not conspicuous:
"Be sure to consult your doctor to make sure your symptoms are due to benign prostatic hypertrophy (BPH). Other medical conditions can cause the same or similar symptoms. In men under 50, the above symptoms are rarely due to BPH."
The inclusion of the quoted paragraph is sufficient to refute the "failure to disclose" allegation of the Complaint.
5. Complainant called as its expert witness Ernst J. Drenick, a doctor of medicine, board certified in the specialty of internal medicine. Although Dr. Drenick is not a urologist, he is qualified by education and experience to testify on the falsity issues in this matter (Tr. 7; CX-H). Prior to testifying, Dr. Drenick had consulted the leading works in the field of urology (Tr. 19).
6. Based on the testimony of Dr. Drenick which is in conformity with the informed medical consensus (Tr. 27). I find the following as to BPH:
BPH is the overgrowth of the prostatic gland caused by the secretion of male hormones called androgens. The prostate starts to grow during puberty as increasing amounts of angrogens are secreted. The growth continues slowly through middle age, but up to age 50 the size of the prostate usually causes no difficulties. Because of continued growth after age 50 in many males, the mass of prostatic gland tissue impinges on the urinary tract producing a variety of symptoms related to the mechanics of passing urine, including more frequent urination during the night, a sensation of urgency at times, and occasional burning. But almost any kind of urinary disturbance, including cancer, malformation, strictures, tumors and kidney stones, starting from the kidney and going down the ureter, the bladder, the prostrate, and the urethra, can cause similar symptoms (Tr. 10, 11).
A patient is not likely to be able to identify the cause of such symptoms (Tr. 11).
There is no effective medical treatment for BPH (Tr. 18, 19). The only effective treatment of BPH is surgical excision of all or part of the prostatic gland so as to relieve the compression of the urethra which impairs or blocks the urinary flow (Tr. 11, 12).
7. Glutamic acid, alanine and glycine are amino acids. Zinc is a metal. These amino acids are necessary for human nutrition and are synthesized by the body from indigenous sources. Zinc is an essential nutrient which is supplied by foods (Tr. 12, 13).
8. Man ingests amino acids in the form of food. The body uses them wherever they are needed for the synthesis of proteins and other bio-chemical substances necessary for normal functioning of the body. The average normal individual consumes protein which contains all these amino acids in much larger quantities than con tained in the recommended daily dosage of Respondent's product. Excess amino acids consumed are degraded by the liver and other tissues. The waste products are excreted and other components are converted first to sugar, then to fat and stored as fat. The individual has no capacity to use surplus amino acids for any kind of useful function (Tr. 13-17).
9. In human nutrition, zinc is considered a trace mineral which the body uses to the extent required and otherwise eliminates. As far as the prostate is concerned, zinc has the function of stabliz ing the semen and making it survive after coitus in order to impregnate the female. The prostate is very high in zinc content. In BPH the zinc content of the prostate is excessive. Studies tend to show that zinc favors growth, and perhaps overgrowth, of the prostate. Some investigators have observed that reduction of zinc content will diminish BPH (Tr. 17, 18).
10. Respondent introduced reports of two studies wherein capsules containing 6 1/4 gms. of a mixture of glycine, alanine, and glutamic acid were used in the treatment of BPH. One report (RX-3) appeared in the Journal of the Maine Medical Association in January 1957. It described a controlled clinical investigation involving treatment of 40 cases of BPH for a period of three months. According to the report one group of patients was first put on placebo capsules for two months and then on the glycine-alanine - glutamic acid capsules. Another group was placed on the latter capsules for a period of three months and then switched to the placebo for two months. Patients were not told when they were on the placebo.
The report concluded that the glycine-alanine - glutamic acid capsules are an effective palliative for treatment of BPH in that they reduced the size of the prostate in 93% of the cases (5% using the placebo), reduced nocturia, urgency (81%), discomfort (71%) and micturition (70%). Those on the placebo experienced much less benefit using the placebo.
The other report introduced by Respondent (RX-2) described a study of 45 cases of BPH said by the author, Frederic Damrau, M.D., to confirm the findings of Feinblatt and Gant (authors of RX-3, supra).
11. Dr. Drenick stated that these studies do not constitute scientifically valid proof of the efficacy of this combination of ingredients to produce the results represented by Respondent. His reasons for this conclusion were as follows:
a. The studies were not double blind in that it does not appear that the persons conducting the tests were unaware whether it was the medication or a placebo that was being administered to a particular patient at a particular time. Therefore, personal bias could have influenced interpretation of results, a factor not permissible in a properly controlled trial (Tr. 64).
b. The number of patients was not adequate to permit statistical evaluation (Tr. 20, 21).
c. The Damrau study (RX-2) used the information as to a control group in the Feinblatt - Gant study (RX-3) as its 'control.' This severely impairs the validity of the Damrau study's conclusion because Damrau would have no way of knowing the exact basis for the others' subjective impressions establishing the criteria of mild, moderate, and severe hypertrophy of the prostate (Tr. 21, 22).
d. Both studies are lacking in objective observations, such as those obtainable by means of cystoscopies and measurements of residual urine. The lack of such observations and reliance, instead, on subjective observations, keeps these studies from being scientifically valid drug evaluations (Tr. 22, 23).
e. The results of the two studies as to reduction in size of the prostate (92% of patients in RX-3, 14% in RX-2) are so far apart that it must be concluded that one or the other is totally wrong (Tr. 23).
12. The Physicians' Desk Reference, (34th Ed. 198) lists Prostall, a six grain combination of glutamic acid, alanine acid and glycine, as a product of Metabolic Product Corporation and under the heading "Action and Uses" says "Symptomatic relief of BPH (urgency, frequency, nocturia, dribbling and delayed urination)." Under the heading "Product Information" at the front of the book there appears the statement that the information concerning each product has been prepared by the manufacturer (RX-7). The recom mendations for use made in the PDR as to any particular item are those of the manufacturer, not those of the medical community or the FDA (Tr. 36).
13. Under date of October 1, l980, the Food and Drug Admini stration (FDA) of the Public Health Service stated to Respondent that it knew of no FDA document describing the present status of this amino acid formula as to safety and effectiveness for relief of symptoms of BPH and that it was unaware of any medical studies or other reports submitted for review to the FDA showing that this formulation is or is not safe or effective for relief of BPH (RX-5).
1. I am convinced that Respondent has acted in complete good faith in advertising and selling through the mails its product, PROST-RITE. However, good faith and lack of intent to deceive are not effective defenses to a proceeding under 39 U.S.C. § 3005. It is the falsity of the representations made, no matter how well motivated and lacking in intent to deceive, at which the statute is aimed.
2. Respondent's advertising makes the representations alleged in paragraph II A. of the Complaint as found in Finding of Fact No. 3, supra. I find that it does not have the misleading tendencies alleged in paragraph II B. of the Complaint (see F. of F. No. 4, supra.)
3. The only expert testimony in the matter is that of Complainant's witness, Dr. Drenick, who stated the informed medical consensus to be that tablets containing the ingredients of Respondent's product are not efficacious to produce the results represented in Respondent's advertising. There is no contradictory evidence in the record which is said to represent a contrary consensus. Therefore, based on Dr. Drenick's testimony I find that the representations made by Respondent, as found in Finding of Fact No. 3, are false in fact. (See Athena Products, Ltd., P.S. Docket No. 7/99, P.S.D. June 26, l981, p. 33.) They are certainly material in that their natural tendency is to induce purchases of the product.
4. Complainant, except as to paragraph II B. of the Complaint, has established its case by a preponderance of the competent, credible evidence.
5. Based on the unrefuted opinion of Dr. Drenick, I find that the two reports of studies introduced by Respondent (RX-2, 3) are not valid scientific evidence of the efficacy of Respondent's product.
6. The court opinion cited by Respondent and placed in the record, United States of America v. Metabolic Products Corporation, (US DC Mass., 1/225/62, Civ. Action No. 61-570-S) does not serve to establish Respondent's claims of efficacy. There, Chief Judge Sweeney simply found that a certain product was safe and that "many doctors, including some who testified for the government, have observed in patients relief from certain symptoms of prostate disorder, such as frequency of urination, nocturia, continence sic of urine and dribbling." But that finding was not necessary to the decision which was that the manufacturer's claim of a "therapeutic result effective treatment of disease without surgery" constituted a misbranding of the product. Moreover, it is not even certain from a reading of the decision that the product involved in that case was of the same composition as Respondent's product.
7. The Postal Service decisions cited by Respondent, United Pharmacal. P.O.D. Docket No. 1/162, and Uxbridge Products Co., P.S. Docket No. 2/199, did not find a similar amino acid formula to be effective for relief of BHP symptoms, although there was not a find ing of ineffectiveness in either case.
8. Respondent is engaged in a scheme to obtain remittances of money or property through the mails for its product PROST-RITE by means of representations materially false in fact in violation of 39 U.S.C. § 3005. Accordingly, an order pursuant to the statute in the form attached should be issued against Respondent.