By Kurt Eichenwald and Gina Kolata May 17, 1999 Source: The New York Times Featured Photo Source: Unsplash, Satheesh Sankaran
See the article in its original context from May 17, 1999, Section A, Page 1 Buy Reprints New York Times subscribers* enjoy full access to Times
Editor’s Note Appended
If ever there was a wonder boy in the lucrative business of drug testing, it was Dr. Robert Fiddes.
In just a few years, Dr. Fiddes transformed his sleepy medical practice here into a research juggernaut, recruiting patients for drug experiments at a breakneck pace. His success made him a magnet for an industry desperately scouring the nation for test subjects. Companies large and small showered him not only with more than 170 studies to conduct, but with millions of dollars in compensation for his work.
Life was good. With bank accounts bulging, Dr. Fiddes and his wife could afford to drive matching BMW’s; a Ferrari parked in his garage was ready for special occasions. After a short time in research, the once small-time family practitioner was planning his dream house on a Cayman Islands beach and envisioning the day he would make millions more by selling shares in his business to the public.
But amid the glitter and cash was a fact that no one outside his office knew: It was all a scam.
For Dr. Fiddes was conducting research fraud of audacious proportions, cutting corners and inventing data to keep the money flowing from the drug industry. Fictitious patients were enrolled in studies. Blood pressure readings were fabricated. Bodily fluids that met certain lab values were kept on hand in the office refrigerator, ready to be substituted for the urine or blood of patients who did not qualify for studies.
Monitors for the Government and the industry never noticed any problems with Dr. Fiddes’s bogus paperwork, which they reviewed during routine audits. Even when some of Dr. Fiddes’s employees alerted those monitors to their suspicions, no investigations were initiated. Instead, their warnings were filed away, while Dr. Fiddes’s sterling reputation as a researcher grew.
Finally, in June 1996, the scheme started to unravel when the manager of a neighboring doctor’s office, Dennelle Del Valle, told a Government auditor rumors of crimes, lies and fraud she had heard from Dr. Fiddes’s own employees. Eventually, to prove the claims, Ms. Del Valle slipped a piece of paper into the auditor’s hand. On it was written a telephone number and a single name: Susan. It was the tip that would lead the Government to Susan Lester, a former employee of Dr. Fiddes who not only knew what had happened, but had a few records that seemed to back up her story.
So began the multiyear investigation of Dr. Fiddes’s Southern California Research Institute, a testing operation that was one of the most corrupt research enterprises ever discovered by law enforcement. The case is set to wind to a close this week, with the scheduled sentencing of the last co-conspirator. But in its wake is wreckage: Dr. Fiddes and several accomplices pleaded guilty to fraud, drug-study results for virtually every company in the business were compromised and the reliability of the private system for testing drugs for safety and efficacy has been thrown into question.
Dr. Fiddes ”was putting the health of all these patients at risk,” said Alan Knox, the former chief financial officer of Dr. Fiddes’s research center, who resigned just months after taking the job when the investigation led him to learn of the fraud. ”But he was also skewing samples that could affect the whole American public.”
The abuses of this one doctor point to weaknesses in the new system developed in recent years for testing experimental drugs. No longer does the pharmaceutical industry rely on career researchers at academic medical centers, whose professional reputations are forged on the quality of their data. Rather, the industry has turned to thousands of private-practice doctors, for whom testing drugs has become a sideline for making money.
While the researchers and their incentives have changed, the methods of monitoring what they do remain basically the same even though now, since they are paid for each patient they recruit, researchers have an enormous financial incentive to cheat. The case of Dr. Fiddes underscores the ease with which such a system can be deceived — a situation that has not been remedied since the discovery of his crimes.
The story of the corruption at the Southern California Research Institute was pieced together from memos and other internal documents, investigators’ notes, drug company and court records, personal diaries and affidavits of participants, as well as interviews with Government officials, lawyers and the former employees and consultants at the company, which is now defunct.
The picture that emerges from these documents and interviews is of a research office ruled by a doctor driven by greed. Few employees other than the study coordinators — mostly women of limited financial means — were aware of the magnitude of the swindle. Those bothered by it were repeatedly assured that this was the way the drug industry worked. Faced with that perception, there seemed little they could do without risking their livelihood to stop the influential Dr. Fiddes, a man who believed that the system of monitoring was too poorly designed to ever catch him.
”I don’t think he thought he could be touched,” said Kathryn Davis, a medical transcriber at the research center. ”We just didn’t understand why it had to go down the way it did. Maybe he just wanted too much too fast.”
Through his lawyer, Dr. Fiddes — who is now serving a 15-month sentence for fraud in the Metropolitan Detention Center in Los Angeles — refused repeated requests for an interview. But in interviews with the Government after he agreed to plead guilty, Dr. Fiddes portrayed himself as a man trapped by the dishonesty of others. He maintained that most researchers are forced to cheat because drug companies issue requirements for test subjects that sound good in marketing material, but are impossible to meet in the real world. He said — with no evidence to back up his claim — that anyone successful in the business was skirting the rules.
Still, at his own research center, Dr. Fiddes laid much of the blame for everything that happened on his study coordinators — again, without providing evidence to support the assertion. While he was the beneficiary of the illegal activity, he maintained that it was the salaried employees working for him who devised the frauds, often without his knowledge. The information provided by Dr. Fiddes has not resulted in any additional investigations.
Despite his refusal to accept the blame, Dr. Fiddes was anguished at being labeled a criminal. In a letter pleading for mercy that he sent last year to Federal District Judge Robert M. Takasugi, he described his torment. ”My family has had to endure the humiliation of seeing a husband and father sink from being a widely respected community member to now being visualized as nothing more than a common crook,” Dr. Fiddes wrote. ”My mother often said, ‘The only thing in life that is important is to be able to hold your head up high.’ I now know what that means.”
The Career
From Family Doctor To Drug Researcher
Robert Fiddes always wanted to be a skater. As a teen-ager in his native Vancouver, British Columbia, he rose most mornings before dawn, walking to a chilly ice arena for his 5 A.M. practice. The hard work paid off; he often told of winning Canada’s junior figure skating championship, a victory that set him on the path to going professional.
But when the time came to choose between a career as a figure skater or enrolling in a university, young Robert Fiddes took the academic path. And there he showed that same drive, gaining acceptance to medical school at the University of British Columbia after just three years in college, according to his curriculum vitae.
In 1970, at 25, Dr. Fiddes earned his medical degree and, with his new wife, Rebecca, came to Long Beach, Calif., for a job as a hospital intern. He went on to join a medical partnership, but in 1981 opened his own practice in Whittier with a medical assistant, LaVerne Charpentier, in a converted house with an awning and flower garden. It was the perfect image for an old-time family doctor, and the practice blossomed.
Dr. Fiddes’s wife would later write of those early days in a letter to the judge who sentenced her husband. ”His patients adored them and showered the office with everything from home-baked cookies to hand-crocheted dolls,” she wrote. ”Both Rob and Laverne worked long and hard to provide his patients with the best care.”
Eventually, Dr. Fiddes formed a group made up of several family doctors in the area. But by the late 1980’s, an obstacle emerged that Dr. Fiddes was unable to sidestep. Managed care was sweeping California, and Dr. Fiddes chafed at the new rules. ”He felt his hands were tied in performing whatever tests were necessary to assist in the proper diagnosis of the patient,” Mrs. Fiddes wrote in her letter. Patients ”felt equally frustrated with the new system.”
Growing restless, he decided to pursue a law degree, attending night school. In 1987, he passed the California state bar exam.
But by then, the medical profession had changed so radically that an entirely new specialty presented itself: Doctors were testing the safety and effectiveness of new drugs for pharmaceutical companies, using their patients as subjects. Recognizing the opportunity to get away from managed care, Dr. Fiddes jumped at the chance.
His new clinical-trials business grew rapidly. Dr. Fiddes appointed Ms. Charpentier as his first full-time study coordinator, and raided a private research firm in the area, California Clinical Trials, to build his staff. He began to dream of eclipsing his biggest rivals and taking his new enterprise public, at times doodling his ideas for a corporate logo onto pads of paper.
As the business grew, former employees said, a pattern soon emerged. Dr. Fiddes would meet with patients in his first-floor office, then refer them to the study coordinators on the second floor. Often, the patients who arrived there felt reluctant to take part in the trials.
”They were pushed to go up there,” said Susan Lester, the former study coordinator who blew the whistle on Dr. Fiddes. ”They often would say, ‘I don’t want to participate in this, but I don’t want to make him mad.’ ”
In the early days, Ms. Lester and other coordinators would tell wavering patients to take their time, perhaps by sleeping on the idea, before signing an agreement to participate. But Dr. Fiddes and Ms. Charpentier, who also declined interview requests, quickly put an end to such solicitousness.
”I was told that it was a big mistake to let them think about joining,” Ms. Lester said. ”They said, ‘You don’t tell them they have any choice about it. You put them in.’ ”
The Fraud
Falsifying Records, Endangering Patients
Kimberly Carlon’s interviews for a job at the Southern California Research Institute had been going well. She had only one more hurdle to clear: speaking to Dr. Fiddes himself. If he approved of her, Ms. Carlon, a certified respiratory therapist, would become the research site’s latest study coordinator. Sitting in front of Dr. Fiddes’s desk in early 1996, she listened as he described a hypothetical situation. Suppose, he said, that a patient was available for a study, but was taking medication prohibited by the study protocol. The answer seemed obvious, Ms. Carlon replied: she would send the patient on his way.THE MORNING: Make sense of the day’s news and ideas. David Leonhardt and Times journalists guide you through what’s happening — and why it matters.Sign Up
Well, Dr. Fiddes told her, that was not the way he did things. At the Southern California Research Institute, he said, the patient would be entered into the trial; that would require the center to falsify records so that the violation of study rules could be hidden.
Ms. Carlon got the job. But she would later describe her discussion with Dr. Fiddes as the first moment she should have realized something was wrong.
Like every other study coordinator who passed through Dr. Fiddes’s research center, Ms. Carlon found herself being pushed to break the rules. When she ran a 1996 study for a new asthma inhaler sponsored by Fisons, a British drug maker, she found a patient who had been enrolled even though she had an incurable lung disease that should have disqualified her. When a monitor hired by Fisons asked to see the patient’s medical chart, Ms. Carlon approached Delfina Hernandez, a more senior employee, and asked what to do.
Ms. Hernandez quickly fetched the patient’s medical chart, and pulled out every page that made reference to the lung disease. Then, according to investigative documents, she turned the remaining records over to the monitor. The violation went undetected.
Ms. Hernandez, who later pleaded guilty to fraud, declined to comment.
Again and again, study coordinators were instructed by Dr. Fiddes and his top aide, Ms. Charpentier, to ignore the requirements of the drug studies. The rules called for excluding smokers from an asthma study? The coordinators were told to put the smokers in anyway, and not mention their habit in the medical records. A certain blood pressure was required for patients to participate in a hypertension study? Then the coordinators were expected to write that level into the chart, regardless of the truth. Patients’ medical records contained health histories that precluded them from participating in a test? Then the offending pages were ripped out and destroyed, and the patients placed on the experimental medication despite the dangers.
Over time, the frauds orchestrated by Dr. Fiddes grew ever more audacious. Eventually, according to Government documents, it was not just the records that were being falsified. Instead, medical tests were rigged — and at times, patients simply invented. Outside monitors reviewed the documentation, but since there were real lab records for the rigged tests, they had no clue that they were being deceived.
The office refrigerator became the source of human bodily fluids that met the requirements of various studies. A jug of urine was often found there on Monday mornings, provided by Carol Rose, an employee. Ms. Rose’s urine contained high levels of protein — just the trait patients needed to qualify for certain studies. Dr. Fiddes paid Ms. Rose $25 each time she collected her urine and brought it to the office, where over time it was divvied up among specimen cups labeled with other people’s names and presented for testing.
The refrigerator also proved useful when the research center was conducting studies on hormone replacement therapy for menopausal women. The studies required women with blood serums that showed low levels of estrogen and high levels of follicle-stimulating hormone — signs that a woman is going through menopause. To make sure that the patients’ tests qualified, Dr. Fiddes sent out a memo specifying the hormone levels required for the study. ”We need some serum that scores these numbers in the frig at all times,” he wrote.
Another study on an antibiotic required that patients have a certain type of bacteria growing in their ear. No problem for Dr. Fiddes. He bought the bacteria from a commercial supplier and shipped them to testing labs, saying they had come from his patients’ ears.
Dr. Fiddes’s coordinators, paid bonuses for recruiting patients into studies, soon began improperly enrolling themselves and members of their families. Often, names were changed to avoid detection by drug company monitors. At times, family members took part in several studies at once — a violation of the rules because studies require that participants not be taking other medications, so that the data obtained relate only to the drug under study.
Employees ”were running around doing E.K.G.’s on each other, if the patient couldn’t pass,” said Sloan A. Bergman, a former study coordinator who quit working for Dr. Fiddes after less than a year because of ethical concerns. ”I wasn’t happy, but I needed a job.”
Yet all the while, there were constant reminders that the true cost of the frenzied drug testing was being borne by sick and vulnerable patients.
In the summer of 1995, the research institute began work on a study of Cozaar, a hypertension medication sponsored by Merck & Company. Among the patients enrolled by Dr. Fiddes was Arlene Roberts, a 70-year-old woman with high blood pressure. Instead of dropping, her blood pressure rose dangerously when she took the drug. Dawn Simons, the study coordinator, became alarmed and sent Ms. Roberts to see Dr. Fiddes. Rather than taking her out of the study, Dr. Fiddes prescribed two other hypertension drugs. The triple dosage not only violated the study rules, it made it impossible to gauge the effect of Cozaar.
A few days later, Ms. Roberts returned. Her face was bruised, her speech was slurred and she had trouble walking. She told Ms. Simons that she had passed out over the weekend while bathing. Ms. Simons took her pulse and found that her heart was barely beating — a result, the coordinator thought, of bombarding her body with hypertensive drugs. Worried that Ms. Roberts was headed toward cardiac arrest, Ms. Simons asked Ms. Lester, her fellow study coordinator, for assistance. The two helped Ms. Roberts, who by then could barely walk, to Dr. Fiddes’s office.
”He said, ‘It’s no big deal. She’s probably making more of it than it really is,’ ” Ms. Lester recalled in a recent interview.
Ms. Simons, dismayed at what was happening, thought Ms. Roberts should be dropped from the study. But Dr. Fiddes refused, keeping her on the medications for several more weeks. Ms. Roberts was soon seeing another doctor in a hospital for the problems that emerged during the study. Ms. Simons, the study coordinator, resigned from her job, but not before surreptitiously copying all the medical records and turning them over to Ms. Roberts in case she wanted to bring a lawsuit. Ms. Roberts, who recovered at the hospital, never sued.
Dr. Fiddes received payment in full from Merck — his reward for keeping Ms. Roberts in the study through its completion.
Avoiding Detection
The F.D.A. Ignores An Early Warning
Ilse Beverly finally decided that Dr. Fiddes had to be stopped. While working for him for five years handling laboratory tests like blood work, Ms. Beverly had seen signs of his willingness to cheat on drug studies. And so in January 1995, almost immediately after leaving her job, Ms. Beverly telephoned investigators with the Food and Drug Administration.
She reported her own experiences, such as the time in 1990 that Dr. Fiddes had asked her — without explaining why — to find a way to alter lab values in urine tests. She also provided the names of study coordinators who knew that testing data were being manipulated to enroll larger numbers of patients. With her revelations, the Government had its first solid lead on what was happening in Dr. Fiddes’s office fully 17 months before Ms. Del Valle exposed his crimes to an F.D.A. auditor. Investigators wrote memos about Ms. Beverly’s allegations, and forwarded them from Los Angeles to the clinical investigations branch of the F.D.A.
There, the memos were filed away. No investigation was begun.
Brad Stone, a spokesman for the F.D.A., said that, because aspects of the case have not been finished, the agency could not comment at this time.
Dr. Fiddes had always found it easy to elude detection by the crews of company monitors and Government auditors that visited his offices, even when his employees spelled out their suspicions about what was happening. It was not that he was particularly adept at dodging their questions; rather, they seemed reluctant to challenge such a prominent figure in the drug-testing business. ”This business can be run on words, and I have learned the words,” Dr. Fiddes wrote in a 1995 memo. ” ‘We have no problems’ is our motto, and tell this to every monitor.”
When Dr. Fiddes’s efforts to enroll patients were thwarted by system safeguards intended to insure accurate test data, he often found ways around the problem.
In a 1995 study of an experimental pain reliever for arthritis called PHZ 136 that was sponsored by the Zambon Corporation, Dr. Fiddes faced a particularly difficult impediment. The patients were supposed to have arthritis of the knee, as verified by X-rays.
Dr. Fiddes tried to recruit patients. Again and again, he sent their X-rays to an independent radiologist for review. And almost every time the answer came back the same: The patient did not have arthritis, and so did not qualify for the study. Frustrated, Dr. Fiddes told the coordinator of the study, Ms. Lester, to look through his medical files for patients with arthritis of the knee. Then, he said, she should offer each of those patients $25 to come in and get multiple X-rays, which he could substitute for the X-rays of patients who did not qualify. But Ms. Lester drew the line, and refused.
The ever-resourceful Dr. Fiddes found a way around that obstacle, however. Through his staff, he got in touch with the project manager at Pharmaceutical Product Development Inc., which was managing the study for Zambon, and asked a question: Because he was a doctor, couldn’t he just interpret his patients’ X-rays himself, rather than send them to a certified radiologist?
The company was happy to oblige. Researchers ”may interpret knee X-ray films obtained on candidates,” Julia Dixon, the project manager, wrote in a letter to Dr. Fiddes. ”There is no need for a radiological consult.”
From that moment on, Dr. Fiddes had no trouble finding patients who qualified for the study. ”That kind of opened it up for him right there and then,” Ms. Lester said. ”Everyone understood that if he was going to read the X-ray, he was going to lie.”
Not long afterward, Dr. Fiddes received a letter from one of the testing company’s study monitors. ”CONGRATULATIONS on meeting your enrollment deadline!” the monitor, Cheryl Grant, wrote in a letter dated Feb. 19, 1996. ”I performed a 100 percent source document verification, and found no outstanding issues.”
Through Pharmaceutical Product Development, a testing company, Dr. Fiddes was paid $45,268 for his effort in the Zambon study. The company never detected his fraud. Zambon declined to comment, citing confidentiality of the study, as did Pharmaceutical Product Development. But Nancy Zeleniak, a spokeswoman for the testing company, said its monitoring was of the highest quality. ”We have standard operating procedures for detecting fraudulent or fabricated data,” she said. ”We are helping to set standards in the industry.”
Another company came closer to putting him on the spot. Several former coordinators for Dr. Fiddes said they had reported his unethical conduct to Pat Pryor, an independent study monitor working with Pfizer Inc. Tipped off to the discrepancies, Ms. Pryor sharply challenged Dr. Fiddes and his staff in her reviews of their paperwork.
Dr. Fiddes chafed at the challenges, feigning outrage. ”Our integrity and reputation for performing high-quality clinical trial work has been injured, and we are justifiably upset,” Dr. Fiddes wrote in a July 1995 letter to Pfizer, complaining about Ms. Pryor’s demands. He insisted Pfizer ”have a new monitor assigned to our site immediately.”
Not long afterward, Dr. Fiddes announced the news at a staff meeting: Pat Pryor would not be returning to monitor the Southern California Research Institute.
Pfizer said that the company replaced monitors if there seemed to be a conflict. ”In order to insure the most objective and best monitoring, we generally recommend that if there is personal conflict, and no certainty of irregularities, that a new neutral person is assigned to review all of the data,” said Betsy Raymond, a spokeswoman for Pfizer.
But in the Fiddes case, that policy did not improve the monitoring. ”We have an extensive system of checks and balances,” Ms. Raymond said. ”Even with all of that, we didn’t uncover the fraud.”
Why was Dr. Fiddes able to fool the monitors so easily? Because the oversight system is mostly designed to catch errors, not fraud. To protect patient confidentiality, monitors are forbidden even to know the names of test subjects, meaning that no spot-checks are ever performed by the companies to make sure that researchers are not making up lab values or inventing patients.
But Dr. Fiddes’s luck in avoiding detection would not hold. By May 1996, more than half a dozen study coordinators — including Ms. Simons and Ms. Bergman — resigned, fearful that the fraud would cost them their nursing licenses or certifications. Ms. Lester likewise decided she could take no more, and wrote a letter to Dr. Fiddes declaring that she would no longer participate in fraudulent, unethical work.
A response came quickly. Ms. Lester was ordered to clean out her desk immediately, and was escorted from the building. On her way out the door, she bumped into Kathryn Davis, another Fiddes employee. With tears in her eyes, Ms. Lester made Ms. Davis a promise.
”She told me before she left that she was going to bring Dr. Fiddes to his knees,” said Ms. Davis, a former employee. ”I had no idea that she meant it seriously.”
The Cover-Up
‘You MUST Be Able To Dump Your Files’
Alan Knox, the chief financial officer of the research center, was working in his office in the summer of 1996 when its chief operating officer burst in. The officer, Elaine Lai, demanded that Mr. Knox pull a series of invoices documenting payments to an employee, Carol Rose.
Mr. Knox fished the invoices from a filing cabinet. As he read them, he grew concerned. Written clearly across the $25 invoices were the words ”urine sample.” For the first time, he was seeing the evidence that Ms. Rose was being paid to substitute her own urine for that of patients.
Wary of what was happening, Mr. Knox copied the invoices, and kept the originals. As he handed the copies to Ms. Lai, he asked her and Ms. Hernandez, the longtime senior employee of Dr. Fiddes, what was going on. Well, came back the response, apparently Susan Lester had gone to the F.D.A., and worse, was contacting other former coordinators and trying to persuade them to talk to the Government about the way Dr. Fiddes conducted his research.
”I remember inquiring with Delfina and Elaine and saying, ‘What’s the big deal?’ ” Mr. Knox said in a recent interview. ”They looked at me, they looked at each other and said, ‘We have to tell him the truth.’ ” As he listened to them recount the trickery that had taken place at the institute, he said, ”I was just taken aback by the level of fraud.”
His first thought, he said, was that Dr. Fiddes and his top aides should confess everything to the F.D.A. But unknown to him, they were at that very moment planning a cover-up that would involve destroying incriminating documents and manufacturing new ones that might place the blame for any problems on Ms. Lester.
Dr. Fiddes was most concerned about the urine substitution, out of fear that Ms. Rose would talk, according to notes of investigator interviews. So, in August 1996, he called a meeting at the Hilton Hotel in Whittier with Ms. Lai, Ms. Hernandez and his longtime assistant, Ms. Charpentier.
To solve the Carol Rose problem, Dr. Fiddes told the group, he would create a bogus medical chart and false patient history for her. If asked, he would say that urine had been collected as part of her medical treatment.
The following Saturday, Ms. Lai called a meeting for what she called ”chart review.” The actual mission was to go through the medical charts and destroy any evidence of wrongdoing.
Days later, on Aug. 21, Ms. Lai called for another meeting for strategic planning. In a memo to Dr. Fiddes, Ms. Charpentier and Ms. Hernandez, she made clear the need to move quickly.
”F.D.A. is busting down our door on Monday,” Ms. Lai wrote. ”You MUST be able to dump your files to your car when F.D.A. knocks.”
Ms. Lai added in the letter that they had to agree to scripted responses to all questions the Government might ask.
As Dr. Fiddes and his allies were secretly working on their cover-up, Mr. Knox was reaching out to regulatory experts who he thought could help the company in its talks with the F.D.A. He got in touch with Gretchen McKelvey, a quality assurance consultant for clinical trials, who was quickly hired to help out. Ms. McKelvey was stunned by the magnitude of the fraud she discovered at Dr. Fiddes’s office. But even more incomprehensible was the blase attitude Dr. Fiddes demonstrated as he calmly informed her of his cover-up plans.
”I explained to him that what had happened here was considered criminal, and that he could be prosecuted for conspiracy and fraud,” Ms. McKelvey said in an interview. ”Dr. Fiddes replied that they were going to blame Susan Lester for all of the problems, and he was going to say he had no knowledge of what was going on.”
About that time, Ms. McKelvey learned that Dr. Fiddes had moved all of the patient records off site. When she asked where they were, she said, he replied that they were in storage. Days later, when she pressed for them again, Dr. Fiddes told her the records had been lost.
”I was starting to get really scared,” she said. ”I don’t like to be messed with.”
As the situation deteriorated, Ms. McKelvey decided the situation was too big to handle alone, and required someone with more expertise in dealing with the Government. She sought advice from Michael Hamrell, a consultant who specialized in the F.D.A. Mr. Hamrell arrived at the research site for a briefing from the company’s top executives, including Dr. Fiddes and Mr. Knox. They made no bones about all the protocol violations they had committed. Why would Dr. Fiddes be so open? Because, as Mr. Hamrell learned quickly, he still believed that he could outsmart the system.
”He told me that he knew the law better than the F.D.A., and that the F.D.A. couldn’t touch him,” Mr. Hamrell said. ”He told me he was a lawyer, and he wasn’t responsible.”
Many of those who worked for him, like Mr. Knox and Ms. McKelvey, saw the writing on the wall and resigned soon after being hired. But others who for years had accepted Dr. Fiddes’s repeated assurances that everyone in the industry did the same things were shaken and agonized about whether to confess.
”I want to spill my guts, but what is going to happen to me and my future?” Delfina Hernandez, one of Dr. Fiddes’s top aides, wrote in her diary as investigators closed in. ”God forgive me if you think I did wrong, and punish me if I did anything to hurt these patients.”
She soon found out what would happen to her future. On Feb. 16, 1997, teams of Federal agents swarmed into the Southern California Research Institute’s office. The entire staff was ordered to move to the front of the building, as the agents seized box after box of documents. One agent with a video camera filmed every employee’s face for use in future identifications.
With employees facing such intimidating law enforcement tactics, cracks began to emerge in the conspiracy to lie to investigators. Ms. Hernandez was the first to decide to provide evidence to the Government, and the other dominoes quickly fell. By September 1997, Dr. Fiddes, Ms. Hernandez and Ms. Charpentier agreed to plead guilty. Ms. Lai pleaded guilty soon afterward.
Now, with Dr. Fiddes compelled to cooperate as part of his plea agreement, the Government hoped to learn more from him that would help in the battle against research fraud. On Oct. 10, at 10:30 A.M., Dr. Fiddes met for an interview with William Leitner and Hetal Sutaria of the F.D.A.
For five hours, the agents grilled Dr. Fiddes. He told them that fraud was rampant in the research industry. He named names of doctors he suspected of engaging in practices similar to his own. And he described some telltale signs that should raise suspicions of possible fraud.
But, the investigators asked, what evidence of fraud is there in the records reviewed by monitors and the Government? What could the watchdogs have seen that would have allowed them to detect his fraud?
Nothing, Dr. Fiddes replied. Had it not been for a disgruntled former employee, he would have still been in business.
Editor’s Note: July 2, 1999, Friday An article on May 17 described fraudulent trials of new drugs by Robert Fiddes, a California doctor who operated a company, now defunct, that he called the Southern California Research Institute. Dr. Fiddes had no connection to another company of the same name in Los Angeles, a nonprofit corporation that has conducted research on traffic safety since 1973.
Would you recognize health care fraud if you saw it? What would it look like? Have you seen health care fraud before?
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