U.S. Food and Drug Administration
FDA Consumer magazine
March-April 2001
Table of Contents
By Carol Lewis
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, et al., 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 B-17" 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.
By Michelle Meadows
A device designed to assure diabetes patients they could "be sure at every step" when measuring their blood glucose (sugar) levels turned out to be defective, giving false readings that landed some patients in the hospital.
LifeScan Inc., a Johnson & Johnson subsidiary in Milpitas, Calif., marketed its SureStep blood glucose monitoring system to people with diabetes who had difficulty performing daily blood tests, such as patients with shaky hands or visual impairments. But the SureStep system had two major problems that LifeScan failed to reveal to customers and to report, as required, to the Food and Drug Administration.
The first problem was that the meter sometimes displayed an Error 1 (ER1) message instead of showing a "HI" reading when a patient's blood glucose level exceeded the highest number the system could handle--500 milligrams per deciliter (mg/dl). LifeScan didn't reveal what this ER1 message could mean, even when customers called to complain about it. The second problem was that the meter sometimes produced inaccurate low readings when a test strip was not fully inserted into the meter. Meter instructions stated that the strip should be inserted properly, but didn't indicate that failing to do so could produce inaccurate low results.
According to Jud Bohrer, special agent in charge of FDA's Office of Criminal Investigations (OCI) in Los Angeles, "LifeScan not only failed to advise customers of these design defects, but the medical device reports they did file contained false, incomplete or misleading information because of nondisclosure of either problem as required by law."
LifeScan learned its SureStep system was defective in 1993, but applied to FDA for clearance to market the product in 1994, without reporting any problems. Based on the company's reports, FDA cleared the application in 1995, and LifeScan marketed SureStep in Canada, Japan, and the United States from 1996 to 1997. The company didn't tell consumers about the product's defects until at least late 1997, and didn't inform FDA until 1998. In a recent press statement, LifeScan apologized for its mistakes and said that no one at the company intentionally sought to mislead consumers or the government.
Around February 1997, the company filed an application for clearance to market another device called the SureStep Pro Hospital Meter. This product also produced false low results if test strips were improperly inserted, but LifeScan failed to mention that in its application, according to David W. Bourne, the resident agent in charge in the San Francisco office of FDA's OCI. The SureStep Pro was similar to the SureStep, but had an added feature of being able to store up to 6,000 glucose readings. Still unaware of any defects in the SureStep system, FDA cleared the SureStep Pro for marketing in May 1997.
Two internal whistleblowers came forward later in 1997, a move that kicked off a three-year investigation of LifeScan by government agencies, including FDA's OCI, the U.S. Department of Justice, and the U.S. Attorney's Office for the Northern District of California. It wasn't until June 1998--after the OCI began its investigation--that LifeScan instituted a voluntary recall of all SureStep meters made before July 27, 1997.
On Dec. 15, 2000, LifeScan pleaded guilty to misdemeanor charges and agreed to pay $60 million in criminal and civil fines, according to court documents filed in the U.S. District Court in San Jose, Calif. The company admitted that SureStep's labeling was deficient, that the company failed to file medical device reports when it should have, and that reports it did file contained false or misleading information because they didn't disclose problems with the SureStep system.
From 1996 to 1998, LifeScan received more than 2,000 complaints of inaccurate low readings, some because of incomplete strip insertion, and more than 700 complaints about "ER1" messages, some that should have been "HI" readings. At least 61 of the error messages were associated with illness or injury, including some hospitalizations. LifeScan corrected these problems in 1997 and 1998, and says that its current SureStep products that remain on the market are not affected by the recent legal settlement.
As part of its three-year probation, LifeScan has to provide written procedures for handling medical device reporting and customer complaints to FDA's Center for Devices and Radiological Health (CDRH). And when customers call, LifeScan representatives will have to ask questions from a script that CDRH approves. LifeScan will also have to conduct a new study to determine whether the SureStep and SureStep Pro meters meet FDA's requirements, and present its results to CDRH for review before April 2001.
A U.S. District Court judge has ordered the maker and distributor of gas grill igniters marketed for pain relief to begin refunding approximately $82 to each purchaser of the fraudulent medical device, called the Stimulator.
Starting on Nov. 30, 2000, letters were mailed to more than 500,000 consumers who bought the device between May 4, 1995, and Dec. 22, 1997, indicating that they are entitled to receive their money back. Some 800,000 Stimulators were sold between 1994 and 1997. (See "Scheme to Sell Gas Grill Igniters for Pain Relief Backfires," July-August 2000 FDA Consumer.)
The device was manufactured and sold through Universal Management Services, owned by Paul M. Monea and his son, Paul Monea, of Akron, Ohio, and through Natural Choice, a distributor managed by Universal Management. Disappointed consumers began complaining to FDA that the Stimulator did not work in 1994.
Universal Management Services made the Stimulators by outfitting gas grill igniters with finger grips. Users were instructed to apply the tip of the Stimulator to so-called accupressure points on the body and press a plunger to send an electric current into the body. The companies also sold an accessory cord called the Xtender to help consumers reach hard-to-reach areas of the body, such as the spine. Ads claimed the Stimulator could relieve many kinds of pain, including migraine headaches, painful swollen joints, allergies, and carpal tunnel syndrome.
The refund program is being administered by Gilardi & Co., 1116 Magnolia Ave., Larkspur, CA 94131.
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