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FDA Consumer magazine
July-August 1999
by Paula Kurtzweil
For the first time in FDA history, an individual has been convicted on wire fraud charges stemming from Internet use to sell an illegal medical product. Previous wire fraud charges involving illegal medical products were based only on telephone and facsimile use.
Lawrence "Larry" Greene, of Los Banos, Calif., is serving a five-year, three-month prison term for selling unapproved HIV test kits for home use over the Internet, as well as through phone solicitations to pharmacies in California's Central Valley.
Greene, 52, sold more than 100 of the test kits in 1996 and 1997, before he was jailed by local authorities on unrelated charges. An informant provided information that enabled FDA's Office of Criminal Investigations (OCI) to collect evidence that led to Greene's November 1998 conviction in the U.S. District Court for the Eastern District of California.
In fall 1997, FDA recalled the HIV test kits, as well as about 38 illegal hepatitis A test kits Greene marketed, from 35 to 40 California drugstores that had bought Greene's products. The recall was only the second in FDA history to be conducted by the agency itself. (The first was in 1977.) Generally, manufacturers recall their products voluntarily, but Greene could not recall the kits himself because he was in prison.
HIV (human immunodeficiency virus) is the virus that causes AIDS. The only approved HIV home test kit currently marketed in the United States is the Home Access HIV-1 Test System, made by Home Access Health Corp., of Hoffman Estates, Ill.
Greene sold his unapproved HIV test kit under the names Lei-Home Access HIV Test and Personal HIV Test Kit. Like the approved home-test kit, Greene's kits required a sample of blood. But unlike the legitimate kit, which requires a drop of blood to be placed on specially treated, pre-tested paper, Greene's version directed users to place a drop of blood on an opened Band-Aid attached to a card that was then returned to Greene. Even though he didn't send the blood samples to a laboratory for testing and had no scientific or factual basis for making a decision, Greene provided users with fabricated test results. He also did not provide counseling, as the manufacturer of the approved HIV test kit is required to do when it informs users of test results.
"It's unbelievable what he did," said Susan Corrales, a consumer safety officer in FDA's Center for Biologics Evaluation and Research. "There was no evidence that the blood samples were tested by a laboratory. His wife said he could tell whether a person was HIV negative or not by holding the sample up to a light. He was basically flipping a coin and saying yes or no."
FDA learned of Greene's illegal home-test kit in September 1997 through industry complaints to the agency's Center for Biologics Evaluation and Research, which regulates HIV home sample collection kits. The complaints alleged that an unapproved HIV home-test kit was being marketed on the Internet and in newspapers and magazines.
The center identified the kit's manufacturer as Lei-Home Access Care, a division of Jin-Greene Biotechnology Inc., of Sunnyvale, Calif. Greene was the owner of both.
Despite several visits, FDA investigators were not able to gain access to the building at the Sunnyvale address. Their knocks on the door went unanswered, even though the investigators could hear people talking inside.
About this time, an informant called FDA to express concerns about Greene's activities. The informant provided sufficient information, including sales records, to link Greene to the Internet marketing of the illegal test kits.
The district office forwarded the case to OCI, which tracked down Greene's home address in Los Banos. There, an OCI special agent interviewed Greene's wife, who mentioned that Greene had sold some of his kits to drugstores in California's Central Valley. OCI also learned that Greene was incarcerated at the local county jail.
FDA investigators visited the drugstores, many of which, according to Andrea Scott, a compliance officer in the agency's San Francisco district office, were "mom-and-pop" operations. When told about the phony HIV test kits, she said, "the pharmacists were totally snowed. They were flabbergasted and [a little bit] humiliated that they had been duped."
The pharmacists reported that they had sold several of the kits to their customers. "That's when we knew we had a recall on our hands," Scott said.
FDA investigators removed the kits from the pharmacies and posted notices in English and Spanish on the doors of the drugstores, warning consumers who may have bought kits to be retested for HIV infection. The notices also were given to representatives of high-risk AIDS groups for their dissemination.
From sales records, OCI learned that Greene also had distributed kits to about 30 Internet customers as far away as New York and Florida. FDA notified the Internet customers that the test they had purchased was not reliable and that they should seek a health professional to be retested with an approved test.
On Sept. 26, 1997, FDA issued a press release, urging pharmacists to remove the unapproved HIV test kits from their shelves and advising consumers who had bought them to consult with a health professional about other available approved tests.
The press release also cautioned against use of Greene's hepatitis A kit, called the In-Home Hepatitis A Test Kit, which had been sold only to the drugstores--not over the Internet. FDA has not approved a home-test kit to detect hepatitis A, a virus that can cause a food-borne liver disease.
Greene's kits were packaged in plain white cardboard boxes with only a computer-generated label affixed to the outside. The box's contents included the opened Band-Aid for placing a drop of blood, as well as a stylus for pricking the finger and another little Band-Aid to place over the wound.
"[They were] nothing like you and I would buy," Scott said. "They were very amateurish in appearance."
Greene's HIV home-test kits sold for about $40 each on the retail market, about the same as the legitimate kits.
A Dec. 11, 1997, OCI-obtained federal grand jury indicted Greene and his two companies on seven counts of mail fraud and 36 counts of wire fraud related to selling the unapproved kits. At the arraignment hearing on the indictment, Greene was denied bail and transferred from county jail to federal custody.
Greene waived his right to a jury and served as his own lawyer before U.S. District Judge Robert Coyle during a two-day trial in November 1998. Among those who testified were representatives of the company that set up the Website for Greene and the company that took phone orders for kits.
Coyle convicted Greene on Nov. 18, 1998, of six counts of mail fraud and 11 counts of wire fraud. Finding that Greene's conduct was extreme in the emotional impact he inflicted on his victims, Judge Coyle sentenced Greene Feb. 24, 1999, to a punishment more severe than usual for a fraud case. Also, the judge agreed with the prosecution's conclusion that Greene was a prime candidate for recidivisim. In fact, while in prison awaiting his conviction on the charges related to selling the bogus HIV test kits, Greene tried to extort $500 from a fellow prisoner's mother for legal counsel he said he provided to her son. Greene is not licensed to practice law.
FDA continues to monitor the marketplace, including the Internet, for illegal HIV test kits. According to Susan Corrales, Internet marketing of such kits tends to be common. She cited the public's heightened awareness of HIV as the reason. "People are looking for an HIV test that is confidential and provides test results in the privacy of their homes," she said. "And Internet selling of these unapproved kits is one way to take advantage of this."
Scott agreed. "[Greene's HIV test kit] was a dangerous product we were able to get off the market," she said. "But there are a lot of other companies out there trying to take advantage of people's fears by scamming them out of their money. That's the scary part."
Paula Kurtzweil is a member of FDA's public affairs staff.
A tropical fruit popular in Hispanic American homes was the source of a recent outbreak of a disease rarely seen in the United States: typhoid fever.
Health officials believe that frozen mamey fruit from Central America contaminated with potentially dangerous bacteria caused 14 cases of typhoid in the Miami area between December 1998 and February 1999. All of the sickened people, who required hospitalization, reportedly recovered.
Though the products also were sold elsewhere in the United States, no other related typhoid cases were reported. Federal and state officials removed the fruit from circulation in February and March, preventing any further sickness.
Typhoid, a primarily water-borne infection caused by the bacterium Salmonella typhi, produces persistent and high fever, abdominal cramps, loss of appetite, and fatigue. Though potentially life-threatening, the disease normally can be cured if treated promptly with antibiotics.
Hispanic households use frozen mamey (pronounced mam-may) to make a shake-like drink called batidos de mamey. The products have not caused any reported problems in the past.
In Florida, the clustered cases puzzled health officials because the disease is rare in the United States. When it shows up, it is usually in travelers returning from a visit abroad. But an investigation by state authorities and the national Centers for Disease Control and Prevention showed that those sickened had not traveled.
"There were just too many clustered cases to attribute to travelers," says Mike Chappell, investigations director in FDA's Florida district office. "Those numbers of clustered cases could be explained by a traveling group: for example, a group of firefighters who travel to Guatemala. After drinking contaminated water, some of them come back and then develop typhoid fever. But that wasn't the case with this outbreak."
So in early February, Florida Health Department and CDC officials focused their efforts on finding the common elements in the cluster of cases showing up in the Miami area. They determined that in all the cases, the people had consumed frozen mamey either at home, where it had been bought from a food store, or in a restaurant. Florida officials immediately embargoed the fruit to keep it from being distributed.
Having pinpointed the outbreak cause, officials set out to trace the origin of the contaminated fruit. FDA joined the investigation on Feb. 18 and, by evaluating data provided by state health officials and CDC, identified El Sembrador brand frozen mamey produced in Guatemala and possibly Honduras as the most likely source. Epidemiological data from South Florida showed that this brand was in homes and in restaurants where those exposed ate the product.
On Feb. 20, FDA publicly warned consumers not to eat the El Sembrador brand of frozen mamey.
FDA and Florida officials collected samples for laboratory analysis but were unable to isolate the S. typhi bacterium. FDA's southeast regional laboratory in Atlanta did, however, find high concentrations of both fecal coliform and E. coli bacteria in the samples, signs that the products had heavy bacterial contamination and possibly harbored the typhoid bacteria.
In late February, FDA officials inspected a frozen mamey production plant in Guatemala that health officials there had closed down weeks earlier because of the outbreak. "Even though we got there after the facility was closed," says Chappell, "it was obvious that the product was produced under [substandard] sanitation conditions."
Also, the contamination could have occurred as a result of Hurricane Mitch, which hit Guatemala hard in late 1998, possibly polluting the water supply used to make the fruit product.
On March 8, FDA announced the voluntary recall of El Sembrador frozen mamey, along with two other brands also suspected of being contaminated: La Fe and a product with no brand name produced by Agrodex in Guatemala. At press time, these products were awaiting destruction. Other brands of frozen mamey not associated with the outbreak are still available.
--John Henkel
An Alabama manufacturer of more than 90 generic prescription drugs and several over-the-counter drugs was ordered to comply with federal manufacturing regulations after FDA inspectors repeatedly cited the company for violations.
Under a consent decree of permanent injunction entered in the U.S. District Court for the Northern District of Alabama Nov. 30, 1998, Vintage Pharmaceuticals Inc., headquartered in Huntsville, Ala., and company president William S. Propst agreed to upgrade current practices at its two manufacturing facilities and maintain mandatory controls.
Under the terms of the consent decree, Vintage agreed to hire an independent expert to help the company ensure that its production processes, facilities and controls comply with current good manufacturing practice (CGMP) regulations. CGMP regulations require drug products to meet safety, quality and purity controls, and drugs that do not meet these controls are considered by FDA to be adulterated and thus subject to regulatory action.
Although Vintage's violations were not life-threatening, Joseph Hayes, a compliance officer with FDA's Nashville district office says, "With the controls they were using and the procedures they were following, there was always the potential for having a real problem."
FDA became aware of deficient practices at the company's Huntsville plant during a routine inspection in August 1997. Investigators found that Vintage Pharmaceuticals failed to:
FDA issued the company a warning letter in August 1997, and, in response, Vintage Pharmaceuticals promised to remedy the deficiencies.
Concerned that problems identified at the company's Huntsville facility could also be present at its sister facility in Charlotte, N.C., FDA's Nashville district office alerted the Atlanta district office to its findings. Investigators from that office and the Charlotte resident post inspected Vintage's Charlotte facility, which manufactures prescription and over-the-counter tablets and capsules. That inspection turned up similar, as well as new, violations.
"Some of the most significant violations found at the Charlotte facility involved the firm's failure to investigate and correct product stability problems," says Eric Weilage, an investigator with FDA's Atlanta district office. In addition, the facility's heating and ventilation system was not working properly. Weilage says the firm had not specified acceptable temperature and humidity ranges and was not monitoring these conditions.
FDA reinspected both facilities three times between October 1997 and August 1998, each time finding continuing CGMP deviations in laboratory controls, cleaning processes, quality control practices, and record keeping. Because the company failed to correct the deficiencies, FDA sought an injunction to halt the manufacture of any below-standard products.
In a court-ordered inspection Oct. 13 to 23, 1998, FDA found that the company had improved some of its operations--for example, conducting accelerated studies for drug expiration dates and improving its validation of certain production processes. But the company's overall drug manufacturing processes still did not comply with CGMPs. This led to the consent decree of permanent injunction.
The consent decree requires the expert hired to help Vintage Pharmaceuticals comply with CGMPs to inspect and provide FDA with written reports on the company's progress six months and 12 months from the date of the decree.
Vintage can seek to dissolve the decree after one and a half years if its controls are found to comply with federal law.
As part of the consent decree, U.S. District Judge Edwin Nelson authorized FDA at any time during the first three years of the consent decree agreement to randomly inspect the company's facilities to determine how well the company is complying with CGMPs. If violations are found, FDA can order the company to cease manufacturing or recall certain drugs.
--Carol Lewis
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