Investigators' Reports

Doctor Jailed for Violating
Breast Implant Restrictions

by Paula Kurtzweil

A 55-year-old Oklahoma City doctor who performs breast augmentation is serving six months in federal prison for smuggling into the United States unapproved silicone gel-filled breast implants from a foreign manufacturer.

J. Dan Metcalf, M.D., a family practitioner, is believed to be the first person prosecuted for violating U.S. restrictions on use of unapproved silicone gel-filled breast implants. He illegally imported the implants from Brazil and the Bahama Islands, used them to enlarge the breasts of 200 women, and sold some to other U.S. doctors. The federal investigation continues, according to Special Agent Kent Wood of FDA's Office of Criminal Investigations.

Since April 1992, FDA has allowed silicone gel-filled breast implants only in women enrolled in clinical studies, and then mainly for reconstruction after breast cancer surgery and certain other medical conditions. At this time, women who want implants for augmentation (breast enlargement) must get saline-filled breast implants.

FDA issued a three-month moratorium in April 1992, following years of debate on the safety of silicone gel-filled breast implants and whether or not the medical devices should remain on the market. FDA turned down manufacturers' applications for approval of the implants submitted after the three-month moratorium because FDA found that the information was not sufficient to prove the safety and effectiveness of the devices. The studies under way are intended to provide more definite information about implant safety. (See "A Status Report on Breast Implant Safety" in the November 1995 FDA Consumer.)

Metcalf was indicted in the U.S. District Court for the Western District of Oklahoma in July 1995. He was sentenced last March. In addition to the prison sentence, he was fined $5,000, ordered to forfeit assets of about $312,000, and sentenced to one year's probation.

FDA, along with U.S. Customs and the Internal Revenue services, began investigating Metcalf in early 1994, after Metcalf's former office manager, who also doubled as Metcalf's surgical assistant, and her mother reported the doctor's activities to investigator Lloyd Paine at FDA's Oklahoma City resident post. The former office manager, who provided most of the information, said she had quit her job because Metcalf's wife, her sister, had been taking over her role in the business. She provided photocopied documentation of Metcalf's activities, including lists of patients' names and records of phone calls and financial transactions between the doctor and his implant sources.

Armed with this information--and a search warrant--FDA, Customs and IRS special agents searched Metcalf's office, residence, and bank safe deposit box on May 24, 1994. At Metcalf's office and residence, they seized 470 pairs of silicone gel-filled breast implants, worth about $200,000, medical records of all patients who had received silicone breast implants since April 1992, and various business records.

With this information, the agencies determined that Metcalf had been importing silicone breast implants made by the Brazilian silicone implant company Silimed, of Rio de Janeiro, since shortly after FDA turned down the implant manufacturers' applications in 1992. According to FDA's Wood, Metcalf tried to buy direct from the Brazilian company, but the head of the company told him he would not do business in the United States. So, Metcalf arranged to buy the implants through doctors in Brazil and Nassau, in the Bahamas.

Metcalf had the implants delivered through such mail carriers as Skynet and Federal Express to his employees' residences in Oklahoma City. He then implanted the devices in 200 women, who, according to Wood, learned about his augmentation business by word of mouth. He kept some implants on hand and sold the rest to other U.S. doctors who also performed breast augmentation.

On July 19, 1995, a federal grand jury returned a 15-count indictment against Metcalf that included, among other things, charges of illegally importing silicone gel-filled breast implants and laundering more than $300,000 in proceeds.

Metcalf pleaded guilty Nov. 14, 1995, to one count of violating the Federal Food, Drug, and Cosmetic Act. The remaining charges were dropped.

According to Wood, the state of Oklahoma is investigating Metcalf for possible improper medical practice. He also faces a number of class-action suits brought by his breast implant patients, who, according to Wood, were unaware that Metcalf was illegally importing the breast implants until news of his indictment and arrest on July 26, 1995, became public.

The seized implants remain in FDA's possession and will be destroyed.

Paula Kurtzweil is a member of FDA's public affairs staff.

Blood Supplier Agrees To Improve Operations

A U.S. company that collects blood at 17 licensed facilities and multiple blood collection sites in 13 states has agreed to take corrective action to ensure the safety of its blood and blood products.

Blood Systems Inc. (BSI), which operates in some areas under the name United Blood Services, agreed last April 22 in a consent decree with FDA and the Department of Justice to improve its quality assurance and employee training programs and take other steps aimed at improving its blood and blood products operations.

FDA inspections in 1994 at multiple BSI sites led FDA to notify the company in February 1995 of its intention to revoke the firm's license to make and distribute blood products. While follow-up inspections in 1995 documented improvements at many BSI blood centers, FDA investigators continued to find violations of blood safety laws and regulations.

Among actions BSI agreed to in the consent decree were to:

improve its employee training program, including initiating annual reviews of employees' job performance and competence
assess management controls and organizational structure
improve computer systems and records management
improve the system for investigating suspected transfusion-associated infections and deferring unsuitable donors, as well as internal audit procedures.

The consent decree also established a timetable for BSI to make the improvements.

The consent decree is similar to one FDA entered into with the American Red Cross in 1993.

--Paula Kurtzweil

N.Y. Man Sentenced For Illegal Drug Sales

A retired hospital employee has pleaded guilty to charges of stealing drugs from two Buffalo, N.Y.-area hospitals for later sale and of filing false income tax returns.

Henry Gonciarz, 72, was sentenced last Jan. 16 in the U.S. District Court for the Western District of New York to five months in a minimum-security camp, five months of home detention, and three years' probation. He was ordered to pay more than $80,000 in back taxes and penalties and $90,000 in restitution to the hospitals. Gonciarz held managerial jobs in admissions and finance with Erie County Medical Center, where some of the drug thefts occurred, until his retirement in 1990.

His drug-selling scheme, which took place between 1988 and 1992, violated the Prescription Drug Marketing Act. Under this law, it is illegal to sell, buy, trade, or offer to sell, buy or trade prescription drugs, unless working as an authorized manufacturer's representative. Violations of the law, usually done for monetary gain, are considered hazardous because they increase the risk of counterfeit, adulterated, misbranded, subpotent, or expired drugs being sold to consumers.

FDA discovered Gonciarz's wrongdoing in 1992 as part of a grand jury investigation into illegal prescription drug sales. Portions of that investigation are still in progress.

"He was the kind of guy that everyone at the hospital knew and trusted," says Ray Kent, compliance officer in FDA's Buffalo district office. "Because he had been an employee, he gained easy access to the inside of the hospital."

In a plea agreement signed in June 1993, Gonciarz admitted to stealing a variety of pharmaceuticals with an alleged collaborator employed by Erie County Medical Center and another facility, Sisters Hospital. His alleged collaborator is still under investigation.

According to FDA and the plea agreement filed with the court, Gonciarz and his alleged accomplice had a scheme that worked like this:

His alleged accomplice stole the drugs from both hospitals and gave them to Gonciarz, who then sold them to pharmaceutical wholesalers and retail pharmacies.
Gonciarz alleges he sometimes used an intermediary to broker the drugs. Payment then went to the alleged intermediary, who kept some of the proceeds--usually 10 percent--and gave the rest to Gonciarz, who then split the money with his alleged accomplice.
When he sold stolen drugs directly to pharmacies, Gonciarz kept half of the proceeds and gave the other half to his accomplice.

Over the five-year period covered in the plea agreement, Gonciarz earned nearly $80,000, an amount he concealed from the Internal Revenue Service. Gonciarz did not report proceeds of illegal drug sales on his federal income tax returns.

--John Henkel

Researcher Regains Privileges, But with Restrictions

A New York doctor who violated federal law in treating melanoma patients with experimental drugs is eligible once again to conduct clinical trials. But he can do them only under rigid restrictions and oversight by FDA and the medical center where he performs the studies.

Abraham Mittelman, M.D., a medical researcher with Westchester County Medical Center in Valhalla, N.Y., regained some research privileges last December after being barred from doing studies for six months. He had signed a consent agreement with FDA in June 1995, concerning previous clinical trial violations, ranging from dispensing unauthorized drugs to inadequately protecting the welfare of trial subjects.

By signing the agreement, Mittelman waived his right to a hearing and obligated himself to follow a detailed plan before working in clinical trials again.

Mittelman's research centered on using biological drugs called monoclonal antibodies to treat more than 400 patients with advanced malignant melanoma, a deadly form of skin cancer. Monoclonal antibodies have been shown to be valuable in medical diagnostics, but their worth in disease treatment is unproven. FDA has approved several monoclonals for diagnostics but none for treatment.

"The way he did these studies, it's impossible to know if the drugs he was testing really worked," says Pat Holobaugh, FDA consumer safety officer.

FDA first suspected the infractions in October 1992, when a reviewer for the agency's Center for Biologics Evaluation and Research noticed in a routine review that Mittelman was testing a drug without an approved investigational new drug (IND) application. FDA must approve INDs before researchers can begin testing drugs in clinical trials.

In January 1993, Margaret Sarles, investigator in FDA's White Plains (N.Y.) resident post, followed up on the IND discrepancy by interviewing Mittelman and examining his records relating to the monoclonal antibodies. For three months, Sarles gathered evidence showing that Mittelman had repeatedly violated regulations governing proper conduct in clinical studies of investigational new drugs.

Violations cited in the consent agreement included:

failing to submit an IND application for an investigational drug
administering an unapproved drug to humans
failing to protect the safety and welfare of patients by using deficient consent forms
administering to patients an unapproved biological reagent labeled "for laboratory use only"
failing to maintain adequate records on the distribution of investigational drugs
neglecting to maintain sufficient case histories of patients in the trials
shipping investigational new drugs to Italy, Argentina and Greece without FDA authorization
violating "clinical holds." (FDA places clinical holds on investigational new drugs when there are concerns about their safety and other factors. A clinical hold forbids researchers to test the drug in clinical trials until the concerns are resolved. FDA found that Mittelman violated clinical holds on monoclonal antibodies by administering the drugs to 14 patients between 1988 and 1991, and to eight patients between 1991 and 1992.)

Under the consent agreement, Mittelman agreed to withdraw from every clinical study he was managing for six months and to notify all sponsors in writing that he was doing so. He also had to return to sponsors or destroy any investigational drugs in his possession.

Mittelman may now perform clinical trials under the following conditions, which remain in effect for the next three years:

He cannot participate in more than three clinical studies with more than 20 patients at a time, and he cannot serve as the sole principal investigator.
He must collaborate with a senior clinical investigator, approved by FDA, in reviewing the clinical trials every 60 days to ensure that Mittelman complies with FDA regulations and the consent agreement.
He cannot store or control any investigational drugs or biologics. To ensure data accuracy, he must personally review each case report form before submitting it to the sponsor.

After three years, Mittelman can ask FDA to lift the restrictions.