Doctors’ Ties to Colleges Are Disputed
Two Southern California doctors under investigation by the Food and Drug Administration for possible illegal medical experiments apparently falsified or greatly exaggerated their connections to the UC Irvine School of Medicine, UC San Diego and Western Medical Center-Anaheim, officials at those facilities said.
The doctors, Orange County cardiologist Jackie R. See and San Diego-area sex therapist Roger T. Crenshaw, claimed in papers submitted to the FDA that they had tested a drug for erectile dysfunction on as many as 147 men. Their report to the FDA implies that the work was done in conjunction with those three institutions, a suggestion all of the facilities have denied. Criminal investigators from the FDA are investigating See and Crenshaw for their alleged experiments with the drug, according to three people who have cooperated with the FDA’s effort.
See’s lawyer, James Picozzi, declined to comment on the FDA’s investigation, other than to say: “At no time did Dr. See make any false submissions to the Food and Drug Administration.”
Neither Crenshaw nor his lawyer, James McElroy, could be reached for comment.
See is the former director of Harvard Scientific Corp., a biomedical research company based in Reno, Nev., that maintained a lab in Irvine. He also served as the company’s director of research.
Crenshaw’s medical license was suspended by the California Medical Board in March for conduct unrelated to the investigation. He was placed on six months’ suspension and five years’ probation for aiding and abetting the unlicensed practice of medicine by supplying prescription painkiller injections to several electrolysis technicians, who had no medical training, for use on their electrolysis clients.
Together, See and Crenshaw wrote a report submitted to the FDA as part of Harvard Scientific’s application to test a drug called liposomal prostaglandin E-1 as a possible treatment for erectile dysfunction. The drug is delivered in liquid form into the urethra through a type of medicine dropper. The company had FDA permission to test the drug on 10 men. But, according to See and Crenshaw’s own report, the two tested the drug in experiments involving at least 147 patients.
The FDA would not say if it was investigating the doctors or Harvard Scientific. But Harvard Scientific CEO Irwin Miller confirmed that an investigation by the FDA was underway.
“We’re responding, and so far it has been very cordial,” Miller said of the inquiry.
Individuals familiar with the FDA’s line of questioning said the agency is trying to determine whether unauthorized experiments were in fact conducted or if data submitted to the FDA had been falsified.
In See and Crenshaw’s report, which was obtained by The Times, the doctors noted apparently tenuous or false connections to the three local medical facilities.
“Of the total number of patients, 47 were randomized by Dr. Crenshaw, Assistant Clinical Professor at the University of California, San Diego; 72 were randomized by Dr. See, Assistant Clinical Professor of Medicine, University of California, Irvine; and 16 patients were randomized by Dr. Crenshaw and Dr. See under the auspices of the Western Medical Center, Anaheim, California,” the report states.
Representatives of all three institutions said they never gave permission for the experiments and don’t have any reason to believe the research was conducted at their facilities. The representatives also said that by identifying the facilities, the report implies that See and Crenshaw conducted their experiments there.
Crenshaw is not a faculty member in any school at UC San Diego and has never been, said spokeswoman Nancy Stringer. “We don’t believe any of the research was carried out here,” she said.
See obtained the title of assistant clinical professor at UCI School of Medicine through a volunteer program in which he has worked 75 hours a year without pay, teaching occasional classes and acting as an attending physician while medical residents in the cardiodlogy department made rounds.
“He wasn’t allowed to do research,” said UCI College of Medicine spokesman Andrew Porterfield. “So far, we have not found any record” to indicate that See was granted permission to experiment on animals or humans at UCI.
See and Crenshaw’s report also says that they had treated 16 patients under the auspices of Western Medical Center-Anaheim. Western Medical Center “has not approved any such study,” hospital spokesman Ron Bingham said.
Bingham said See has provisional staff membership at Western Medical Center, which means he may participate in meetings and committees but cannot treat patients there. The hospital has no affiliation with Crenshaw, Bingham said.
UC San Diego was contacted by FDA investigators but is no longer part of the inquiry because the school has no relationship with Crenshaw, Stringer said.
According to See and Crenshaw’s report, 12 men had received the drug in the study’s first phase. A former employee of Harvard Scientific said that trial took place in San Diego in 1994. The second phase involved 135 men ranging in age from 27 to 75. In that round of tests, some of the participants allegedly received the drug and some received a placebo.
Prostaglandin E-1 is already on the market. But Harvard Scientific’s version featured a unique formulation and method of delivery that the firm hoped would provide a longer shelf life, according to information made public by the company.
Records indicate that See and Crenshaw’s study caught the attention of the FDA as far back as the fall of 1997. The agency sent a warning letter to Harvard Scientific’s CEO on May 18, 1999.
According to the letter, Harvard Scientific submitted “misleading and erroneous information about a clinical study” to the FDA.
The names of individual researchers were removed from the letter before it was released to the public. But sources familiar with the company’s application to the FDA confirmed that the study referred to in that part of the letter is the one conducted by See and Crenshaw. The warning letter also cites 11 other instances in which the company failed to follow FDA protocol.
See was Harvard Scientific’s director of research at the time the application was submitted to the FDA, and he served as director of the company until July 12.
Miller, the company’s CEO, said See continues to be a paid consultant to Harvard Scientific. “His greatest value is as a medical man as opposed to a manager,” Miller said, “I just wanted him to concentrate on those things that were more important.”
The allegations against Jackie See come as UCI continues its investigation of his son Dr. Darryl See, a former assistant clinical professor who left the medical school nearly a year ago after admitted research improprieties, including the use of human blood samples in unauthorized experiments.
Darryl See also has close ties with Harvard Scientific. After working for the company as a consultant, he became the director of clinical affairs in late 1997.
Crenshaw and Jackie See had already completed their study before Darryl See joined the company full time. But in a memo to Thomas Waite, the former CEO of Harvard Scientific, Darryl See vouched for the progress of the company’s research in early 1998: “All phases of the project--clinical trials, manufacturing, production of the delivery device and stability studies--are all progressing well.”
Darryl See’s lawyer, Donald Brigham, said his client could not comment on his relationship with Harvard Scientific because of what he described as “pending litigation against others.”
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Blood Source Revealed
Ex-UCI professor reveals source of blood samples he says he used in a controversial study. B7.
