Government Action Curbs Shark Cartilage Claims
Stephen Barrett, M.D
Shark cartilage came to public attention in February 1993 when CBS TV's "60 Minutes" aired a program promoting the claims of biochemist/entrepreneur I. William Lane, Ph.D., co-author of the book Sharks Don't Get Cancer. The program highlighted a Cuban study of allegedly "terminal" cancer patients who received shark-cartilage preparations. Narrator Mike Wallace filmed several of the patients doing exercise and reported that most of them felt better several weeks after the treatment had begun. The fact that "feeling better" does not indicate whether a cancer treatment is effective was not mentioned. Nor was the fact that sharks do get cancer, even of their cartilage. NCI officials subsequently reviewed the Cuban data and concluded that they were "incomplete and unimpressive" . Nevertheless, a large market was created for shark cartilage products as a "cancer treatment."
In 1997, at the American Society of Clinical Oncology's annual meeting, researchers reported a study that found shark cartilage ineffective against advanced cancer in adults with a life expectancy of at least 12 weeks. The study followed 58 people who were prescribed oral doses of shark cartilage as their only form of anti-cancer treatment. After 12 weeks, none achieved a complete or partial response to the shark cartilage treatment. 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 another study, Dr. Lene Adrian of Copenhagen University Hospital in Denmark, and her colleagues tested the effects of administering shark cartilage capsules for three months to 17 women with advanced breast cancer who had not responded to standard treatments. The cancer progressed in 15 of the women and one woman developed brain cancer. One woman's cancer did not progress during the study period, but that is not unusual among patients with metastatic breast cancer. The results were presented in 2000 at the Second European Breast Cancer Conference.
I. William Lane's promotions were based on his theory that shark cartilage could stop tumor growth by inhibiting the the growth of new blood vessels around the tumor. However, there's no reason to believe that ingesting capsules of powdered shark cartilage will do this because the relevant proteins will be digested rather than absorbed intact. In fact, as pointed out by biochemist Saul Green, if shark proteins could be absorbed intact into the body, they could generate fatal allergic reactions .
FDA Seeks an Injunction
One of the major shark cartilage manufacturers is Lane Labs-USA of Allendale, New York, which was founded in 1994 . Dr. Lane's son Andrew J. Lane is the company's president. Dr. Lane himself, although described as a mere "consultant, has continued to promote the product. In 1999, the FDA initiated a lawsuit to stop their marketing of shark cartilage and two other products with unsubstantiated claims of effectiveness against cancer and other diseases . The government's complaint was filed by the U.S. Department of Justice in the U.S District Court for the District of New Jersey. The products were:
- BeneFin, which is produced from shark cartilage, as a treatment for cancer and other diseases;
- SkinAnswer, a glycoalkaloid skin cream, as a treatment for skin cancer; and
- MGN-3, a rice-bran extract, as a treatment for cancer and HIV, the virus that causes AIDS.
BeneFin was studied as a potential cancer therapy under an Investigational New Drug (IND) application reviewed by the FDA. As such, it could be distributed for use in clinical trials. Like the other two products, however, it is illegal to market until its safety and effectiveness are demonstrated and the FDA reviews and approves the sponsor's marketing application. The lawsuit sought to stop the three products from being distributed without FDA approval. The suit did not affect brands of shark cartilage marketed as "dietary supplements" with no claims that they are intended for preventing or treating disease.
An FDA Talk Paper announcing the suit stated that, despite warnings that began in 1997, Andrew Lane and his company had continued to promote the products as remedies for cancer and other diseases through books, articles, Internet web sites, and employee statements . The FDA's September 1997 warning letter had stated, in part:
Based on the claims made for these products and their intended uses, "BeneFin" and "SkinAnswer" are neither cosmetics nor dietary supplements. Under Section 201 (g) of the Food, Drug, and Cosmetics Act (the Act) [Section 201 (g)], they are drugs. They are also unapproved new drugs [Section 201 (p) of the Act] and may not be legally marketed in the United Sates without approved New Drug Applications (s 505).
These drugs are also misbranded (s 502 (f)(1)) because the labeling fails to bear adequate directions for use and because the labeling is false and misleading as it suggests that the products are safe and effective for their intended uses when this has not been established [502 (a)]."
In your statements to the Agency, you stated that Lane Labs makes no drug claims for these products. However, there are drug claims in the labeling of Lane Labs' "BeneFin" and "SkinAnswer." For example, claims made for "BeneFin" include the treatment of arthritis, psoriasis, and cancer as well as, more specifically, breast cancer, prostate cancer and Kaposi's sarcoma." SkinAnswer" is promoted as an "all-natural glycoalkaloid cream for skin cancer."
Statements made by Dr. I. William Lane, who you describe as a paid consultant, provide evidence that "BeneFin" and "SkinAnswer" are intended to be used in the treatment and prevention of disease thereby making these products, by definition, drugs, new drugs, and misbranded drugs. The following are examples of such statements:
Additional Evidence of Wrongdoing
For several years, Lane has published a free "periodic newsletter about research concerning shark cartilage and other natural therapies for treating cancers." A 1997 issue stated that it had over 70,000 subscribers .
In December 1999, I noted that Dr. Lane's Web site still contained many cancer-related claims. The "Frequently Asked Questions" page for cancer stated that "shark cartilage attacks cancer by inhibiting the development of the blood vessels which supply the food that tumors need to grow -- in effect starving tumors of a needed blood and food supply." The page includes directions for use as well as recommended regimens for using shark cartilage for rheumatoid arthritis, psoriasis, diabetic retinopathy (a degenerative eye condition, and osteoarthritis. The FAQ page for skin cancer suggested that a glycoalkaloid preparation was better than standard treatment for treating skin cancer. And the FAQ page on AIDS, hepatitis, and cancer suggested that MGN-3 was very effective for both preventing and treating cancer.
My own files contain additional evidence that Lane Labs-USA directly promoted BeneFin as a cancer-fighter:
- A letter signed by Andrew J. Lane to health-food-store owners stated: "We are proud to announce that results from FDA clinical trials on BeneFin shark cartilage will be released in 1996, proving its efficacy as an all-natural cancer fighter once and for all."
- An consumer information packet distributed in 1998 contained a photocopy of a passage from the book Prescription for Natural Healing that promoted shark cartilage for treating cancer and recommended BeneFin as the most palatable brand.
- A 1996 videotape distributed free-of-charge by Lane Labs contained testimonials from three cancer survivors and from several physicians who "have come to trust the effectiveness of this all natural therapy." Dr. Lane, who narrated the tape, stated that nine of the 29 "terminal" patients in the Cuban study had died within four months but the rest were alive after four years . But early in 1996, John F. Prudden, M.D., a former associate professor of surgery at Columbia University's College of Physicians and Surgeons who had conducted research on bovine cartilage for more than 40 years, stated that all of the patients had died. In the April 1996 issue of The Townsend Letter, Prudden also noted that in 1983, he had taught Dr. Lane how to extract the cartilage from animals to be used as a food supplement .
In 1998, the Federal Trade Commission obtained two consent agreements barring unsubstantiated claims for shark-cartilage products. Nutriveda, Inc., of Brooklyn, New York, had claimed that its product Cardilet was effective against cancer, rheumatism, arthritis, diabetes, fibroids, bursitis, circulatory problems, and cysts. Body Systems Technology, of Castleberry, Florida, had advertised that its product was effective against cancer.
In June 2000, Lane Labs-USA, Inc., Andrew J. Lane, Cartilage Consultants, Inc., and I. William Lane, Ph.D., agreed to settle FTC charges that they had made unsubstantiated claims that BeneFin and SkinAnswer were effective against cancer. The FTC alleged that in addition to the unsubstantiated efficacy claims, the defendants falsely represented that clinical studies have shown that BeneFin and SkinAnswer are effective in preventing, treating, and curing cancer, and falsely represented that the FDA had evaluated the effectiveness of BeneFin. The complaint notes that Lane Labs embedded terms such as "non-toxic cancer therapy," "cancer treatment" and "cancer survivor" in its Web site's metatags, thereby increasing the likelihood that consumers searching the Internet would find information about BeneFin, SkinAnswer, and other Lane Labs products. The consent agreements prohibit the defendants from:
- Representing that BeneFin or any other shark cartilage product prevents, treats, or cures cancer, unless they have evidence to substantiate such claims
- Representing that SkinAnswer, or any other glycoalkaloid product, prevents, treats or cures skin cancer, unless they have evidence to substantiate such claims
- Making any unsubstantiated health-related claim about any food, drug or dietary supplement.
In addition, the agreement with Lane Labs includes a $1 million judgment, which requires the company to pay $550,000 to the FTC to use the remaining $450,000 to pay for shark cartilage and a placebo in a clinical study of shark cartilage sponsored by the National Cancer Institute and Lane Labs .
A Stringent Court Ruling
In July 2004, in the FDA's case, the judge ordered Andrew Lane and his company from selling Benefin, SkinAnswer, and MGN-3 and ordered thm to make restitution to anyone who purchased the products since Sept. 22, 1999. The judge also ordered all inventory of these products destroyed except for a quantity of BeneFin that may be needed for research purposes. Noting that illegal promotion of the products had continued despite the FDA warning letter and the FTC cease-and-desist order, the judge described the defendants as untrustworthy and issued a permanent injunction against misrepresenting any product in the future [10,11]. I believe that defiance of this order would be likely to result in imprisonment.
- Mathews J. Media feeds frenzy over shark cartilage as cancer treatment. Journal of the National Cancer Institute 85:1190-1191, 1993.
- Miller DR and others. Phase I/II trial of the safety and efficacy of shark cartilage in the treatment of advanced cancer. Journal of Clinical Oncology 16(11): 3649-3655, 1998.
- Green S. Shark cartilage for cancer. The Scientific review of Alternative medicine 7(1):21-25, 2003.
- Prudden JF. Position paper on cartilage therapy history and composition of bovine and shark cartilage; most commonly asked questions and other areas of comparison. Townsend Letter for Doctors and Patients, Issue #153:44-47, 1996.
- FDA takes action against firm marketing unapproved drug. Talk Paper T99-56., Dec 10, 1999.
- Ellsworth DI. Letter to Andrew Lane, President of Lane Laboratories. Sept 24, 1997.
- Dr. Lane's Letter 4(2):3, 1997.
- Shark Cartilage: A Promise Kept. Videotape, Short Hills, NJ: Cartilage Consultants, 1996.
- Operation Cure.all" nets shark cartilage promoters: two companies charged with making false and unsubstantiated claims for their shark cartilage and skin cream as cancer treatments. FTC news release, June 29, 2000.
- Bassler W. Opinion. USA V. Lane Labs-USA, Inc., and Andrew J. Lane. Civ. No. 99-5782 (WGB), U.S. District Court for the District of New Jersey July 9, 2004.
- Bassler W. Order. USA V. Lane Labs-USA, Inc., and Andrew J. Lane. Civ. No. 99-5782 (WGB), U.S. District Court for the District of New Jersey July 9, 2004.
This article was revised on July 22, 2004.