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Table of Contents
FDA Consumer magazine
May-June 1999
by Paula Kurtzweil
He tried to compete with the big-name drugstore chains in his area, but what pharmacist Mohammad Hussain of Gaithersburg, Md., got was the big house in Morgantown, W.Va.
Hussain, 35, former owner of the Rock Creek Pharmacy in Silver Spring, Md., is serving three years in federal prison for buying and selling prescription drugs illegally, including many stolen from a local hospital. He violated federal law by removing the drugs from their original packaging and transferring them to drug containers bearing inaccurate labeling information, such as expiration dates and lot numbers, which are used to maintain drug safety and effectiveness.
A special agent with FDA's Office of Criminal Investigations (OCI) who helped investigate the case said Hussain bought many of the drugs at half their wholesale value from a pharmacist friend who stole the drugs from the hospital where he worked.
One of Hussain's cohorts, Robert Mark, 41, of Adelphi, Md., a pharmacist who owned Rajon Pharmacy in Washington, D.C., also is serving time--one year and three months at the Petersburg, Va., Federal Correction Institute. A jury in the U.S. District Court for the District of Maryland convicted both men March 25, 1998, of illegally buying and selling a variety of prescription drugs, including the anti-ulcer drug Pepcid and the antibiotic Cipro. Hussain also was found guilty of fraudulently billing an insurance company for drugs never prescribed by a doctor and never intended for a patient.
Both pharmacists were sentenced in summer 1998. The Maryland Board of Pharmacy has since suspended Hussain's pharmacist license, though no action has been taken against Mark's license, according to a spokeswoman for the Washington, D.C., Board of Pharmacy.
Also, Rock Creek Pharmacy has closed down, and a call to Rajon Pharmacy was answered by a recording that the telephone number had been disconnected.
A third person, Patricia Brown, 58, of Silver Spring, Md., who served as an intermediary between both pharmacies, entered into a plea agreement March 9, 1998, before trial, agreeing to serve six months of home detention and five years' probation, as well as to undergo drug and alcohol treatment.
FDA's OCI entered the case in November 1996, after receiving a call from Montgomery County (Md.) Police. The police reported that they had arrested Jaspal Kochar, a pharmacist at Holy Cross Hospital in Silver Spring, Md., for stealing drugs from the hospital pharmacy. Secret videotaping had caught him in the act of removing controlled substances from the pharmacy's drug safe and putting them in his pocket.
Kochar, who awaits sentencing for his conviction, told police that one of his customers was Hussain, owner of a nearby neighborhood drugstore.
OCI agents executed a search warrant of Hussain's Rock Creek Pharmacy Feb. 10, 1997. During the search, Hussain confessed to OCI agents that he was buying drugs from Kochar and other sources, though he later refused to cooperate with government investigators.
Also during the search, Brown called to arrange a time for Hussain to pick up an order at Rajon Pharmacy that he had placed earlier. After taping the phone call, OCI agents sent an undercover agent posing as Hussain's driver to Mark's pharmacy to pick up the order. When the agent arrived at the pharmacy, he found an empty store and Mark behind a small glass partition.
Mark handed the agent a bag holding about five different prescription medicines in exchange for an envelope of cash. Some of the medicine bottles came with handwritten notes that listed only the name of the drug. Other bottles had no information.
OCI estimated that the drugs in the bag were worth thousands of dollars on the legitimate market, although based on the cash in the envelope, Hussain paid a lot less.
At Rock Creek Pharmacy, special agents confiscated a variety of drugs as evidence, including expired drugs, blister packs marked "for institutional use only," and unmarked bottles and a bag of drugs with no lot numbers or expiration dates. OCI agents also found on Hussain's shelves several kinds of drugs of the same strength in multiple bottles, containing four times to five times the original contents.
"Every one of these bottles was stuffed," the special agent said. "Hussain was hiding the stolen drugs in the bottles."
Other evidence seized included prescription drug samples. Drug company representatives routinely give free drug samples to doctors so that they can hand the drugs out free to their patients in place of a prescription or to get them started on a drug. It is not illegal for pharmacists to have them in their pharmacies, but it raises questions about where the drugs came from. Under the 1988 Prescription Drug Marketing Act, diverting drug samples from their original intent is illegal because of the risk of counterfeit, adulterated, misbranded, subpotent, or expired drugs being sold to consumers. It also constitutes fraud against legitimate drug sellers.
OCI agents also seized computerized sales records Hussain had kept since assuming ownership of Rock Creek Pharmacy in 1995. OCI audited these records, as well as sales records kept by the wholesale drug company that sold legitimate prescription drugs to Hussain. This audit showed that over two years, Hussain had obtained $333,000 worth of prescription drugs by unknown means, and five of the drugs audited had never been legitimately purchased.
The audit further showed that almost 80 percent of the audited drugs came from unaccountable sources. Hussain accounted for the drugs by claiming he had bought them from his brother, a pharmacist who went out of business after being convicted in another federal case.
OCI also learned from one of its sources during the investigation that Hussain had falsely billed an insurance company for drugs never prescribed by a doctor for a patient who never received the prescription medicines. When OCI checked with the people named in the claim, the doctor denied prescribing the medicines to the patient and the patient denied receiving them.
OCI agents contacted some of Hussain's customers to learn whether they had received any illegal prescription drugs. They found one patient who still possessed a prescription drug Hussain had dispensed. It was stamped "sample."
On Dec. 17, 1997, a federal grand jury handed down a six-count indictment against Hussain, Mark and Brown. Brown pleaded guilty one day before the trial was set to begin.
In addition to home detention, probation, and drug and alcohol treatment, Brown's sentencing June 15 called for her to perform 500 hours of community service. She waived her right to appeal her sentence.
Mark was sentenced July 8. In addition to prison, he also was sentenced to three years' probation and ordered to pay a $200 special assessment fee.
Hussain, sentenced July 27, was ordered to pay a $500 special assessment fee and, following his prison term, to spend three years under supervisory release. The court also ordered him to pay $80,358 in restitution to the insurance companies he had fraudulently billed.
Though the court considered the insurance companies to be Hussain's victims, the OCI special agent noted that Hussain's customers lost out, too. "There's a matter of trust there," she said. "People rely on their pharmacists to provide safe and effective drugs."
According to FDA's OCI, the office continues to investigate illegal sales of prescription drugs in the Washington, D.C., area.
Paula Kurtzweil is a member of FDA's public affairs staff.
by Tamar Nordenberg
For falsifying test results used by FDA in deciding whether to approve new drugs, the physician owner of a California research company was sentenced to 15 months in prison. He also was ordered to repay $800,000 to the seven or so drug companies that didn't get the reliable study data they had paid his laboratory to provide.
Robert Fiddes, M.D., was president and primary researcher, as well as owner, of Southern California Research Institute, or SCRI (now known as American Pharmaceutical Research Inc.), of Whittier, Calif. SCRI tested medicines for high blood pressure, migraine, asthma, diabetes, and other medical conditions.
While FDA does not believe that the drugs SCRI studied and the agency subsequently approved pose any threat to patients' health, the agency is reviewing data related to the drugs to confirm their safety and effectiveness.
FDA and the FBI collected evidence showing that SCRI, under Fiddes' direction, fabricated drug study information over a several-year period ending in 1996, the year in which the government began investigating the company.
Investigators with FDA's Los Angeles district office first learned of the company's misdeeds from an SCRI employee during a routine inspection in June 1996. After interviews with current and past employees corroborated the first employee's complaints, the Los Angeles district in August 1996 turned the case over to FDA's Office of Criminal Investigations.
Over the next several months, mostly in February and March 1997, OCI special agents conducted more than 10 searches of the offices of SCRI and its employees, other offices controlled by Fiddes, and one SCRI employee's house. Agents followed up by speaking with more past and current SCRI employees and with patients supposedly enrolled in Fiddes' studies.
"We asked the drug manufacturers for Dr. Fiddes' list of study participants, found their addresses, and presented them with the consent forms they were said to have signed," says the OCI case agent. "We asked, 'Did you sign this?' 'No.' 'Were you ever in a study for vaginitis for SCRI?' 'No.' 'Were you ever seen by Dr. Fiddes?' 'No.'"
Evidence uncovered during FDA's searches and interviews showed that SCRI:
In these and many other instances of falsification, Fiddes' motivation was "out-and-out greed," the case agent says. "His goal was high enrollment, to get the studies done no matter what. There was never anything that showed he had any care for the well-being of the patient or the public."
Despite the seriousness of Fiddes' illegal activities, FDA does not believe that his bogus studies cast doubts as to the safety and effectiveness of any drugs SCRI studied and FDA later approved, says Jim Kozick, director of domestic investigations at FDA's Los Angeles district office. With few exceptions, FDA requires two large scientific trials, each at multiple research centers, to support approval of a drug. However, the agency is scrutinizing SCRI's studies to ensure that drugs approved based even in part on Fiddes' data will not jeopardize patients' health.
"Cases like this send a very strong message to all clinical investigators about the need to conduct valid scientific trials," Kozick says. "Any allegations of fraud in the conduct of clinical studies will be aggressively investigated."
The U.S. District Court for the Central District of California sentenced Fiddes to prison in September 1998, about one year after he pleaded guilty to conspiring to make false statements to the agency. Two of SCRI's study coordinators, Delfina Hernandez and Laverne Charpentier, and its chief operating officer, Elaine Lai, were sentenced to probation after they, too, pleaded guilty to charges related to SCRI's bogus data.
Tamar Nordenberg is a writer for FDA Consumer.
Questions concerning the editorial content of FDA Consumer should be directed to FDA's Office of Public Affairs.
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