Bayer Ads Misleading Men about Prostate Cancer

The Center for Science in the Public Interest (CSPI) has notified Bayer Healthcare that it will sue the company if it continues to claim that the selenium in its One A Day vitamins may reduce men’s risk of prostate cancer.

Advertisements and labels for One A Day Men’s 50+ Advantage and One A Day Men’s Health Formula multivitamins claim that "emerging research" suggests that selenium may reduce the risk of prostate cancer. "Did you know that there are more new cases of prostate cancer each year than any other cancer?" intones the narrator one such radio ad. "Now there is something you can do."

But leading prostate cancer researchers say there is scant evidence to support such a claim and have joined CSPI in urging the Federal Trade Commission (FTC) to put an immediate stop to the deceptive claims.

"Bayer is exploiting men's fear of prostate cancer just to sell more pills," said CSPI senior nutritionist David Schardt. "The largest prostate cancer prevention trial has found that selenium is no more effective than a placebo. Bayer is ripping people off when it suggests otherwise in these dishonest ads."

A seven-year, $118-million study funded by the National Institutes of Health found last year that selenium does not prevent prostate cancer in healthy men. The Selenium and Vitamin E Cancer Prevention Trial (SELECT) involving 35,000 U.S. and Canadian men was halted in October 2008 when researchers determined that selenium was not protecting the men from prostate cancer and may have been causing diabetes in some of them.

The only study to find that selenium might prevent prostate cancer in men was the Nutritional Prevention of Cancer (NPC) trial, which unexpectedly found in 1996 that selenium supplementation seemed to prevent prostate cancer in men with a history of skin cancer. However, two later analyses of the NPC results determined that only a small minority of men may have benefited from selenium supplementation and that selenium almost tripled the risk of developing diabetes. That led to a dramatic warning from the American College of Physicians that "long-term selenium supplementation should not be viewed as harmless and a possibly healthy way to prevent illness."

In an editorial accompanying publication of the SELECT study results in the Journal of the American Medical Association, Peter Gann of the University of Illinois at Chicago urged that "physicians should not recommend selenium or vitamin E—or any other antioxidant supplements—to their patients for preventing prostate cancer." Yet Bayer still touts selenium’s promise in preventing unspecified prostate "issues" and in reducing prostate cancer risk.

Besides announcing its intention to sue Bayer, CSPI also filed a complaint with the FTC. That complaint states that because Bayer's ads have for so long reinforced the false notion that selenium prevents prostate cancer—and because selenium may actually increase the risk of diabetes—the company should be required to run a corrective advertising campaign. (Bayer is now running corrective advertising at the behest of the Food and Drug Administration and state Attorneys General about yet another one of its products, its birth control pill Yaz.)

CSPI says the prostate cancer claims for One A Day supplements for men violate a consent decree the company signed with the FTC in 2007. That year Bayer paid a $3.2 million fine related to weight-loss claims made on behalf of One A Day multivitamin WeightSmart and agreed not to make unsubstantiated claims in the future.

Separately, nine prominent prostate cancer researchers wrote to the FTC in support of CSPI's complaint about Bayer’s advertising. The SELECT trial "was the largest individually randomized cancer prevention trial ever conducted, and, given its high rates of adherence and its statistical power, it is unlikely to have missed detecting a benefit of even a very modest size," wrote the researchers. "Bayer Healthcare is doing a disservice to men by misleading them about a protective role for selenium in prostate cancer." The signatories include Peter Gann and Maarten Bosland of the University of Illinois at Chicago, Ed Giovannucci of the Harvard Medical School, Alan Kristal of the Fred Hutchinson Cancer Research Center, William Nelson of the Johns Hopkins Medical School, Tim Byers of the University of Colorado, Larry Kushi of Kaiser-Permanente in Oakland, Lawrence Kolonel of the University of Hawaii, and Michael Thun of the American Cancer Society.

The cases include a variety of cancers: seven lymphome (various types); six pancreatic; five prostate; four breast; four melanoma; three Hodgkins disease; three leukemia; two each of colon, lung, ovary, rectosigmoid, and testicular; and one each of bile duct, brain, cervix, metastatic liver (primary unknown), myeloma, kidney, stomach, and uterine. Each case history consists of a narrative by Gonzalez and copies of some supporting medical records.

In a third case, a man in his mid-60s was diagnosed with well-differentiated infiltrating adenocarcinoma of the prostate during a routine physical. An abnormality of the right eighth rib was noted on a bone scan, which the narrative notes was "initially believed consistent with metastatic disease." On x-ray, an infiltrate was noted in the lower region of the left lung, which the narrative states "appeared to be an additional area of metastases." The patient refused further testing and treatment.

Nine years later, the patient, when contacted, said that his prostate was found to be completely normal on a recent physical examination. The narrative concludes that this was a "most remarkable patient," and that "it seems reasonable to attribute...prolonged survival to the Kelley program."

General bookstores are now also a common source of information about macrobiotic beliefs and practices, often carrying at least a few of the many available books by macrobiotic teachers and by individuals who initiated a macrobiotic regimen following diagnosis of disease. One recent example is a widely publicized book (777) (and excerpted magazine articles (634,635,776)) recounting a physician's personal use of a macrobiotic diet as an adjuvant treatment for prostate cancer.

He believes that these accumulated toxins result from overconsumption of milk, cheese, meat, eggs, and other fatty, oily, or greasy foods (509), and of foods with a cooling or freezing effect, such as ice cream, soft drinks, or orange juice (509). Depending on their location in the body, these accumulated toxins are manifested initially as, e.g., allergies, earaches, coughing and chest congestion, a "bulging abdomen," periodic swelling and weakness in the legs, dry skin, hardening of the breasts, prostate abnormalities, vaginal discharge, or ovarian cysts--problems Kushi believes are indications of potentially precancerous conditions (509). As he explains it:

A macrobiotic approach to treating cancer would first classify each patient's illness (see footnote 7) as predominantly yin or yang, or sometimes as a combination of both, based in part on the location of the primary tumor in the body and the location of the tumor in the particular organ. In general, tumors in peripheral or upper parts of the body or in hollow, expanded organs are considered yin; examples include lymphoma, leukemia, Hodgkins disease, and tumors of the mouth (except tongue), esophagus, upper stomach, breast, skin, and outer regions of the brain. Tumors in lower or deeper parts of the body or in the more compact organs are considered yang, e.g., cancers of the colon, rectum, prostate, ovaries, bone, pancreas, and inner regions of the brain. Cancers thought to result from a combination of yin and yang forces include melanoma and cancers of the lung, bladder, kidney, lower stomach, uterus, spleen, liver, and tongue (509).

In an unpublished study supplied to OTA by its authors, Carter and his colleagues discuss what they describe as "two retrospective studies," one of patients with primary pancreatic cancer, the other of patients with advanced prostate cancer (171). The stated purpose of the pancreatic cancer study was "to determine whether pancreatic cancer patients who adopted the macrobiotic dietary approach survived longer than those who did not."

In the second study described in Carter's paper, eleven patients with prostate cancer who followed a macrobiotic regimen along with conventional treatment were examined. No information is given about the way in which they were selected for inclusion in the study. The paper states that "length of survival free-of-progression, overall median survival rates, and other characteristics of stage D2 prostate cancer patients, receiving conventional therapy and on a macrobiotic diet" were compared with stage D2 prostate cancer patients reported in the literature, and with "matched controls receiving conventional therapy and following a standard American diet." No other information is provided about these controls. The only comparison reported in the paper states that "the median survival of the macrobiotic group was 81 months, whereas those using the standard American diet had a median survival of 45 months."

It impossible, to interpret the results of the study, since details of the patients' selection factors are not reported in the manuscript. In general, however, conclusions in Carter's second study about survival time among prostate cancer patients following macrobiotic diets are subject to the same critical limitations as those in the study of pancreatic cancer patients described above. A randomized study, which could control for differences among study and control populations, would be needed in the future to generate valid evidence on possible effects of macrobiotic diets on cancer patients' survival. Certain types of non-randomized studies could also be used to detect possible antitumor effects of the diets (see ch. 12 for a discussion of such studies).

My involvement with Gero Vita came about when a client, an old family friend and professional athlete, came to me after he was alerted by a golfing partner that his likeness adorned a sales brochure for a prostate cancer product which boldly claimed both preventative and curative results. Our lengthy investigation and lawsuit followed. In the process, I came to know much about Gero Vita International, Gero Vita Laboratories, G.B. Data Systems , Life Force Laboratories, S & G Laboratories, Health Quest Publications and their chief executive and owner A. Glenn Braswell. Eventually I came to represent three other high-profile sports celebrities who also were featured on these same brochures.

In Prostata mailers, Gero Vita predicts veritable prostate Armageddon for those remiss in purchasing its products. Certainly no one should make light of the very real problems associated with prostate health, but Gero Vita cites a gloomy outlook for everyone who neglects to buy Prostata

is implied to prevent and treat prostate enlargement, impotence, and incontinence. Intentionally ambiguous ad copy says Prostata

offers nutritional support for prostrate health by "soothing and strengthening" the gland and "reversing prostrate growth". Murky marketing touts zinc, lycopene and hydrangea extracts that will inhibit growth and keep the prostate's size in check. According to the brochure, one of the most common benefits of Prostata is the revitalization of one's sex life. The slick and salacious ads ominously warn of possible side effects of mainstream surgical and medical prostate treatments that will leave men impotent and with enlarged breasts.

In addition to investigating the litigation history of Mr. Braswell and his companies' marketing strategies for the preparation of my clients' lawsuits, I also sought expert medical opinions on the efficacy of Prostata. I had the Prostata, its ingredients and other information provided by Gero Vita supporting its health claims scrutinized by Walter Ettinger, M.D., Head of the Department of Gerontology at the Paul Sticht Center for Aging associated with the Wake Forest University School of Medicine. Dr. Ettinger is renowned and respected in the field of gerontology. Dr. Ettinger notes that the ingredients in "Prostata may have some biological effects on the prostate, but any claims that it may prevent the development of prostate cancer are without any scientific foundation." (Emphasis added.) He goes further in saying "the advertising material and articles are misleading. The material implies that the use of this product will lower the risk of prostate cancer, but the evidence cited speaks only to prostatitis (swollen prostate) and benign prostatic hypertrophy." When required during the discovery phase of the cases' development to substantiate the cancer fighting claims of Prostata, the defendants could do nothing more than provide a few medical journal articles that dealt with swelling of the prostate and not prostate cancer. Swelling

Some of the products may have some effectiveness (though overpriced), but most were promoted with misleading claims. Evaluation of the individual products was difficult because their ingredients were not listed in the ads, but it is clear that many of the advertised claims went far beyond what was possible. One brochure for its product "Prostata," for example, claimed that (a) prostate enlargement can be treated successfully with zinc supplements; (b) the side effects of drugs prescribed to shrink the prostate are almost as bad as the prostate disorder itself; (c) saw palmetto, in addition to relieving prostate symptoms, might also be an aphrodisiac; (d) another herbal ingredient reduced enlarged prostate problems in "as high as 66% of cases" and has no significant side effects; (e) it is important to take Prostata "before it is too late." The last page of the brochure contained pictures of six movie stars, three prominent athletes, and a former chief executive officer of Time Warner, who either "waited too long and died from prostate problems!" or "waited too long and are suffering." Some in the latter group sued Braswell for misrepresentation and for improperly using their name and picture for marketing purposes.

In South Carolina, three famous sports figures, Richard Petty, Stan Musial, and Len Dawson, have filed suit in federal court against Braswell and Gero Vita for misusing their names in advertisements for Prostata. The lawsuits, filed in 1997 by Charleston lawyers E. Vernon Glenn and Gedney M. Howe III, involve advertisements that identify the three sports figures among a group of men who "waited too long and are suffering" from prostate problems.

For men: Do you have any of the following kidney or genitourinary conditions? Prostate enlargement; frequent nighttime urination; urinary tract infections; or other prostate disorders.

Prostate health, said to provide male health support; or Woman's Ultra, said to provide female health support

The answers I gave during WebMD's dietary evaluation should have indicated that my diet is nutritionally adequate. Nevertheless, my "unique personal formulation" containing "Calcium Complete," "Digestive Relief," Vision Pro," "Daily Solution Pro," "NeuroPro," and "Prostate Health"—a total of 18 pills per day—arrived a few days later with a notice that if I didn't cancel within 2 weeks, a month supply (costing $53.30) would be shipped. I was particularly puzzled by the inclusion of "Digestive Relief" because the questionnaire did not ask whether I had any digestive problems. I believe that LifeScript's recommendations are based more on age than on dietary composition.

Before the government clamped down, Seasilver USA's Web site contained testimonials from more than 30 users who claimed that the product led to increased energy, hair growth, nail growth, improved digestion, and/or better sex life. The writers also claimed to have been helped with acute gouty arthritis, allergy, chronic fatigue syndrome, chronic obstructive pulmonary disease, colds, depression, diabetes, Graves disease, insomnia, low hematocrit, lung cancer, Lyme disease, metastatic prostate cancer, migraine headaches, non-Hodgkin's lymphoma, nocturnal leg cramps, rheumatoid arthritis, severe breathing problems, stiffness of the fingers, stress, and swollen prostate . Testimonials, of course, are extremely unreliable because the outcome may be due to other factors such as concomitant medical care or the natural course of the ailment . Disease-related claims are also illegal unless experts generally regard a product as safe and effective for it intended purpose.

In October 2003, Seasilver USA was permitted to resume sales after agreeing to institute some of the strictest compliance guidelines ever issued as a result of a health-related enforcement action. The guidelines, which are posted to a separate Web site, prohibit claims that Seasilver is effective against cancer, including multiple myeloma, non-Hodgkin's lymphoma, lung, breast, prostate cancer or brain tumors; diabetes; AIDS or HIV infections; pulmonary diseases; Lyme disease; heart disease; hypertension or stroke; hepatitis; depression; and typhoid or anthrax. They also forbid "ANY" use of claims about product performance, testing or ingredients (except as described on the product label and in product literature), as well as the use in weight control or blood pressure control. The new rules also state:

Specifically, the orders prohibit the defendants from misrepresenting that Seasilver is effective in the treatment of multiple myeloma; non-Hodgkin's lymphoma; lung, breast, and prostate cancer; brain tumors; diabetes; AIDS; typhoid; and anthrax, among other ailments.

In contrast, the leading voluntary health organizations fight their chosen diseases by giving grants and providing information that is reliable, practice, and comprehensive. In 2006, for example, the percentages of expenses used for these purposes were 76% for the American Diabetes Association, 86% for Juvenile Diabetes Research Foundation, 77% for the Alzheimer's Association and its chapters. and 76% for the Prostate Cancer Foundation . Some people donate to Project Cure because the names it uses resemble these respectable charities.

Lobbying—Project Cure, Inc.'s lobbying program is directed at the White House and Congress, promoting four programs: The Alzheimer's Disease Fund, Center for Advanced Heart Research, The National Diabetes Fund, and the Prostate Cancer Fund. At the core of each of these programs is the basic premise that America's health care system, which is geared toward serving the interests of health care providers, must be radically altered to serve the interest of the American public. These programs encourage citizens to communicate their views to lawmakers via petitions, letters, phone calls, and personal visits. Meetings with lawmakers and their aides are also conducted to discuss pertinent health issues and legislation.

Education—information regarding Alzheimer disease, diabetes, and prostate cancer treatments are disseminated to the public via letters, brochures, printed material, radio and television presentations and participation in seminars, workshops, and debates. Health care providers, media, and others interested in expanding their knowledge in these areas are provided educational information in an effort to broaden the base of research looking into new cutting edge treatments.

Clinton, S.K., Emenhiser, C., Schwartz, S.J., Bostwick, D.G., Williams, A.W., Moore, B.J. and Erdman, Jr, J.W. 1996. Cis-trans lycopene isomers, carotenoids, and retinol in the human prostate. Cancer Epidemiol. Biomarkers Prev. 5: 823-833.

Giovannucci, E., Ascherio, A., Rimm, E.B., Stampfer, M.J., Colditz, G.A., and Willett, W.C. 1995. Intake of carotenoids and retinol in relation to risk of prostate cancer. J. Natl. Cancer Inst. 87: 1767-1776.

(15) Advertising or labeling any food product or drug which makes any express or implied claims that such product will (1) help you lose weight; (2) boost your immune system; (3) protect against heart disease; (4) reduce the risk of breast, prostate and other cancers; (5) increase your energy, improve concentration, minimize the harmful effects of stress; (6) eliminate varicose veins; (7) lower blood pressure; (8) lower cholesterol; (9) eliminate cellulite; (10) cure constipation; (11) prevent diabetes; (12) manage ADD; (13) eliminate fatigue; and (14) reduce your appetite; (15) help children or other persons with ADD, ADHD, or hyperactivity; (16) be safe for infants, toddlers, or is beneficial in treating or preventing any type of disease or health related condition;

(22) Distributing, selling, shipping, mailing, delivering, or sending any of Defendants' products (Basic Essence, Mineral Essence or Herbal Essence) to any person, entity, or business which uses any of the following (or similar) express or implied representations in any advertising by such person, entity or business (including the Internet) relating to Defendants' food products: that Defendants' products will (1) help you lose weight; (2) boost your immune system; (3) protect against heart disease; (4) reduce the risk of breast, prostate and other cancers; (5) increase your energy, improve concentration, and minimize the harmful effects of stress; (6) eliminate varicose veins; (7) lower blood pressure; (8) lower cholesterol; (9) eliminate cellulite; (10) cure constipation; (11) prevent diabetes; (12) manage ADD, ADHD or hyperactivity; (13) eliminate fatigue; (14) reduce your appetite; (15) are great for children, infants and pregnant or nursing mothers; (16) make children smarter; and (17) any other express or implied health or disease related claim which has not been substantiated by Defendants and approved by the FDA;

Lee BR and others. Bioimpedance: novel use of a minimally invasive technique for cancer localization in the intact prostate. Prostate 39:213-218, 1999.

In a recent statement, for example, it was announced that "dramatically improved results in the treatment of prostate cancer due to a recent discovery made within the past year" had been obtained through Burzynski's administration of Antineoplastons given orally.

It noted that "with this route of administration, some prostate cancer patients, even those whose cancer failed to respond to conventional therapy, have experienced a complete remission of their cancer in as little time as five months" (126). In that press release and another one (127), it was claimed that Burzynski's treatment "may also be effective in diagnosing and preventing some types of cancer," citing results from experimental animal studies conducted at the Burzynski Research Institute and at the University of Kurume, Japan.

In 2004, the Electronic Retailing Self-Regulation Program asked PCI to substantiate core claims in its infomercial for Super Prostate Formula, but the company had declined to do so . Ironically, despite the fact that New York State disciplined Teplitsky for inappropriately prescribing HGH, several Web sites that market PCI's Super HGH still claim that Teplitsky "has not only developed all of the nutritional formulas on this site, but he and his patients have been using them for years with astounding results!"

Physician's Choice, Inc. Super Prostate Formula Dietary Supplement. Report of inquiry by Electronic Retailing Self-Regulation Program, 2004.

In men, the increased levels of testosterone seen with daily DHEA pills could stimulate the growth of a tiny prostate tumor that would otherwise have remained dormant. Excess testosterone could also cause the prostate to enlarge, making urination difficult.

The provision of saw palmetto to all men over 50 does not have scientific support. Although saw palmetto may help reduce the symptoms of benign prostatic enlargement, there is no reason for men without such symptoms to consider taking it. Saw palmetto can lower the level of prostate specific antigen (PSA) and thus interfere with the early detection of prostate cancer. Moreover, it has not been proven safe for long-term use.

Prostate Health in 90 Days (Larry Clapp, 1997-2002)

Only ten showed no progression of their cancer, and only two had a quantifiable improvement in quality of life. (The fact that ten cancers did not progress is not evidence that the shark cartilage was responsible for this. The progression of cancer is not always rapid.) The researchers concluded: "Shark cartilage was inactive in patients with advanced stages of cancer, specifically in breast, colon, lung, and prostate cancer." The study was sponsored by Cancer Treatment Research Foundation, Cartilage Technologies (a manufacturer), and Cancer Treatment Centers of America. A few months later, Cartilage Technologies announced that it would support no additional research on shark cartilage as a cancer remedy .

In other cases, Versendaal diagnosed heart disease, prostate disease, and "infections" of the eye, ear, liver, lung, and knee without examining any of the body parts involved-merely by pulling on the patient's arm while touching the corresponding "reflex" points.

Making unsubstantiated claims that their products will (a) protect against heart disease; (b) reduce the risk of breast, prostate and other cancers; (c) eliminate varicose veins; (d) lower blood pressure; (e) lower cholesterol; (f) eliminate cellulite; (g) prevent diabetes; (h) manage ADD; (i) help children or other persons with ADD, ADHD, or hyperactivity; (j) be safe for infants, toddlers, or pregnant or nursing mothers; (k) make children smarter; (l) cure constipation; and (m) any other express or implied health or disease claim which bas not been substantiated by Defendants and approved by the FDA or satisfies the requirements of § 403(r)(6) of the Federal Food, Drug & Cosmetic Act.

21. Distributing, selling, shipping, mailing, delivering, or sending any of Defendants' products (Basic Essence, Mineral Essence or Herbal Essence) to any person, entity, or business which Defendants know or by the exercise of reasonable diligence should have known, uses any of the following (or similar) express or implied. representations in any advertising by such person, entity or business (including the Internet) relating to Defendants' food products: that Defendants' products will (1) protect against heart disease; (2) reduce the risk of breast, prostate and other cancers; (3) eliminate varicose veins; (4) lower blood pressure; (5) lower cholesterol; (6) eliminate cellulite; (7) prevent diabetes; (8) manage ADD; (9) help children or other persons with ADD, ADHD, or hyperactivity; (10) be safe for infants, toddlers and pregnant or nursing mothers; (11) make children smarter; (12) cure constipation; and (13) any other express or implied health or disease claim which has not been substantiated by Defendants and approved by the FDA or which satisfies the requirements of § 403(r)(6) of the Federal Food, Drug & Cosmetic Act;

The IRC proposed a clinical trial in patients with peritoneal mesothelioma who did not have advanced disease. According to the proposal, patients would have to be diagnosed in the United States and "given a definitive prognosis by the evaluating oncologist(s)."9 Patients would be treated at IRC under Burton's direction. After treatment, "Patients would be re-examined at a period after their prognosis date thought to have statistical significance and possibly again near the end of the study period." Serious problems with this proposal, discussed below, relate to the patient population and the basic study design. Peritoneal mesothelioma is an exceedingly rare cancer; about 200 cases per year are diagnosed in the United States (894). This may be contrasted with 149,000 cancers of the lung, 98,000 cancers of the colon, 42,000 cancers of the rectum, and 90,000 cancers of the prostate (25). Under the best of circumstances, even if patients with more advanced disease were included, it would take years to accrue sufficient numbers of patients for even a modest clinical trial in this disease. If IAT were a treatment used exclusively on patients with peritoneal mesothelioma, then there would be no choice, but since it is used widely, and is reported successful by Burton for patients with a wide range of cancers, the preferable choice is a commonly-occurring cancer.