Online Laetrile Vendor Ordered to Shut Down
Cyberspace vendors beware: sell illicit drugs online and be prepared to be shut down. And shut down he was, when drug supplier Jason Vale used the Internet to promote the sale of a false cancer cure.
President of Christian Brothers Contracting Corporation based in Queens, N.Y., Vale signed a consent decree of permanent injunction on Nov. 16, 2000, agreeing to stop making and selling amygdalin products, better known as laetrile, vitamin B-17, and apricot kernels. Despite warnings from the Food and Drug Administration, Vale, who operated several Web sites out of the basement of his home, promoted and dispensed these products with false promises that they could prevent, and even cure, cancer. The consent decree, which resulted from inspections of Vale's home office and several undercover purchases, ensures that the drug supplier keeps his commitment to FDA and never sells laetrile again.
Laetrile products have been the subject of much controversy over the last 25 years. In particular, though laetrile is not the same as the chemical amygdalin-a plant compound found in the pits of many fruits, raw nuts and other plants, the two names are used interchangeably because laetrile (an acronym for laevorotatory and mandelonitrile) is a purified form of amygdalin. And mandelonitrile is a structural component of both. But while some champion the use of amygdalin and laetrile products for treating and controlling cancer, neither has ever been proven effective for this purpose, nor have they been approved by FDA for any purpose. Moreover, a National Cancer Institute-sponsored study by Charles Moertel and others, published in the January 1982 issue of The New England Journal of Medicine, concluded that laetrile is not effective as a cancer treatment and can be harmful. In fact, once it breaks down in the intestinal tract, laetrile releases hydrogen cyanide, which can result in deadly cyanide poisoning.
Yet Vale sold it to desperately ill cancer patients.
FDA first learned of Vale's Internet promotions through reports of unsolicited e-mails consumers received from Christian Brothers that promoted the laetrile products for cancer prevention and as a cure. Concerned about the consumer complaints, FDA investigators inspected Vale's home office in Queens, N.Y., unannounced, on Nov. 12, 1997. Vale not only watched inspectors collect samples of his laetrile products, but he also acknowledged having full responsibility for marketing them through his Internet site.
Several months later, FDA investigators went undercover and ordered from Christian Brothers a "starter package" for $248.65 that included injectable laetrile, laetrile tablets, and apricot kernels. Christian Brothers shipped the products from New York to a location in New Jersey, along with various promotional materials, including a book and video entitled "World Without Cancer." The materials were accompanied by a cover letter advising users to "Eat seeds," and telling them that "People are dying all over from a disease that can so simply be prevented." The label on the video box invited customers to visit the apricotsfromgod.com Web site.
Following the undercover purchase and results of the November 1997 sample collection, FDA sent Vale and Christian Brothers a warning letter on Oct. 28, 1998, stating that his laetrile products were unapproved new drugs and that he was breaking the law. The letter said that FDA could bring an enforcement action against Christian Brothers, which could shut the company down. Through its lawyer, Christian Brothers responded in a Dec. 16, 1998, letter, claiming that the laetrile products were considered food for special dietary use by virtue of their ingredients.
Christian Brothers continued to sell the laetrile products.
An undercover FDA investigator telephoned Christian Brothers in January 1999 and purchased laetrile products specifically to treat melanoma. A man identifying himself as "Jason" guaranteed the investigator that laetrile products could "cure melanoma in six weeks." On Jan. 19, 1999, the investigator received a starter package from a location in Pennsylvania that contained similar items to those in the previous undercover purchase.
In February 1999, FDA conducted a follow-up inspection of Vale's home office. Inspectors found in a refrigerator eight units of 100 mg "Amigdalina B17" tablets and eleven 16-ounce bags of apricot kernels. Vale also refused to show investigators shipment records or invoices for laetrile products that the agency learned had originated in Mexico. And Christian Brothers continued to deny that its products were drugs, claiming instead that they were intended for use as "dietary supplements." Vale's attorney, however, did tell FDA that his client no longer intended to distribute laetrile in its injectable form.
But an FDA investigator, this time posing as a patient with kidney cancer, phoned Christian Brothers on May 29, 1999, asking specifically to purchase injectable laetrile. As requested by the operator, the investigator sent to the firm a money order for $238.95 and a letter stating that he wanted to order the "starter package" of laetrile products for the treatment of kidney cancer. And on June 4, the investigator received the products he had ordered, including the injectable laetrile that Vale had earlier assured FDA he was no longer selling.
After receiving the illegal drug, FDA investigators further searched the Internet and found christianbrothers.com, heavenlyhealing.com, and canceranswer.com listed as Vale's other Web sites. These sites described the nature of cancer and the failure of chemotherapy to treat it. They also contained letters and testimonials from people who had supposedly bought and used the products, and offered a list of frequently asked questions such as, "How long does it take for the cancer to die out after taking laetrile products?" Christian Brothers answered, "The cancer cells start dying immediately." As of May 28, 1999, 62,299 hits had been recorded on the christianbrothers.com site, alone.
In November 1999, FDA filed a complaint for permanent injunction against Christian Brothers and Vale for selling unapproved new drugs. Knowing that Vale could continue to sell the illicit drugs while his legal case was pending, FDA filed a motion for a preliminary injunction to temporarily shut Vale down. On April 20, 2000, Judge John Gleeson of the U.S. District Court for the Eastern District of New York granted the motion.
As a result of the preliminary injunction and the subsequent consent decree of permanent injunction, Vale was ordered never again to sell laetrile products
This article is reprinted from the March-April 2001 issue of FDA Consumer magazine. I
This article was posted on March 20, 2001.