Medical Center Ads Violated U.S. Guidelines
Senior officials at UCI Medical Center placed advertisements in four national magazines in 1996 touting the benefits of an experimental cancer therapy that had not been proved, despite federal rules prohibiting such ads.
Ultimately, the UCI therapy was never approved, and the university padlocked the laboratory that developed it.
The ads, partly an attempt to attract patients and grants, promoted UCI’s research into using treated white blood cells to attack cancerous cells. But such promotion of unproven therapies violates Food and Drug Administration regulations, medical center officials acknowledged Thursday.
They said they also failed to get required approvals from the university before placing the ads.
When UCI’s associate vice chancellor for research, Frances Leslie, learned about the unauthorized ads, her staff pulled them from one of the periodicals, Time magazine, she wrote in a Nov. 12, 1996, letter to the FDA.
But the university acted too late to remove the ads from Orange County subscribers’ copies of Newsweek, U.S. News and World Report and Sports Illustrated, according to the letter.
“The advertisement was successfully removed from the November 25, 1996, edition of Time magazine, at an additional cost of $10,000,” she wrote. The medical center paid for the ads.
Revelation of the placement of the unauthorized ads comes to light as UCI and the FDA are investigating allegations that researchers and physicians violated federal and university rules in developing the therapy and administering it to patients.
In the latest developments:
* UCI researchers and physicians may have violated federal rules by soliciting donations from patients they were treating with the experimental therapy or charging them outright for the therapy without first seeking FDA approval.
The university knew about the solicitations and the charges for three years, yet is only now starting to reimburse 27 patients or their families--even though Leslie wrote in an April 1997 letter to a research sponsor that UCI officials were “developing an action plan” to give patients refunds.
Nine cancer patients and their families donated a total of $19,900 to get into the clinical trials that used the experimental therapies, and 18 patients were billed directly for the treatments, Mark Laret, the medical center’s director, said Thursday.
* An outside review of two clinical trials of the experimental cancer treatment concluded that doctors conducting them engaged in widespread violations of FDA standards, including failures to report adverse patient reactions, deviating from research protocols and keeping incomplete records.
William Parker, associate executive vice chancellor, said that when the outside group alerted university officials to its findings, UCI conducted its own review. He said he did not know what the university concluded.
“It was part of about four investigations into various problems at the medical center that the university was doing,” Parker said. “So much came out of one little lab, it’s terribly confusing.”
In the fall of 1996, Laret said, he and his staff developed the advertisements, headlined “Immunotherapy Offers New Hope for Some Cancer Patients,” without alerting senior university officials.
“I take responsibility for it,” Laret said. “In this case there was a lapse and the ad was written, and then it was pulled as soon as we knew there was a problem.”
But Michael O’Neill, the president of Meyer Pharmaceuticals LLC, which underwrote the cancer research, called the ads part of a climate of amateurism at UCI.
O’Neill said he learned about the forthcoming ads and alerted the university that they violated federal guidelines.
At the same time, a review by a consulting firm he had hired, Pharmaceutical Product Development Inc. in North Carolina, found possible FDA violations, including inappropriate charges to patients participating in the trials.
“It seemed to me just another example of not being familiar with the rules governing clinical study,” O’Neill said. “We had just had it up to here” with UCI.
Two minority owners of Meyer, Drs. Gale Granger and John C. Hiserodt, also were researchers in the UCI cancer center lab and held faculty positions at the university. A university inquiry determined last year that Hiserodt sent unapproved treatments to Florida in mid-1996 for a terminally ill girl.
All 27 patients who were solicited for donations or charged for experimental treatments were at the UCI Medical Center and were treated from March to September 1995, university officials said.
“As far as we know, this was very unique,” College of Medicine Dean Thomas Cesario said. “There is no indication it happened elsewhere. We’re not checking elsewhere. We will follow up if there’s any indication that it happened elsewhere. We have put in place a series of measures that will prevent this from happening again.”
The donations ranged from $1,450 to $4,000, Laret said. He and Cesario said the university is still trying to determine how much other patients were billed for the treatments and what portion should be returned. Both said the university will pay interest on the refunds.
Other patients being treated with the same UCI-developed cancer therapy at Good Samaritan Hospital in Los Angeles also paid for their treatments, some as much as $5,000, said Paul Kells, a hospital vice president.
But Kells said an investigation he launched this week into the payments for treatments at Good Samaritan has yet to determine that the payments were improper.
“Certainly we believed it was appropriate at the time, and it may still be,” Kells said. “But enough questions have been raised that they certainly warrant us to investigate closer.”
Under federal guidelines, patients involved in clinical trials of experimental therapies or drugs typically pay, either themselves or through their insurance companies, for routine medical costs associated with experimental medical treatments, including blood tests, X-rays and hospital stays, said Brad Stone, an FDA spokesman.
But FDA regulations generally prohibit charging patients for experimental treatments or devices, Stone said.
Fred Jacobson said he paid $5,000 to Good Samaritan Hospital in 1993 when his wife, Sylvia, was admitted with a cancerous brain tumor. In a telephone interview from his home in Northern California, Jacobson said that hospital officials told him the fee was for the experimental part of the treatment given to his wife. That portion, he said he was told, was not covered by insurance.
“They explained that because it was experimental, I had to pay a fee of $5,000. I wrote them a check there,” he said. “We had a conference upfront with Good Samaritan” about the treatment and the fee.
Jacobson, 60, said he was satisfied with his wife’s care. “I don’t think there were any deficiencies at all in the treatment given to my wife. They did a fine job,” he said.
University officials said the issue of solicitations and charges was part of more complex, more serious questions involving the operation of the laboratory and the inquiries into the activities of researchers there. The university launched three separate inquiries starting in mid-1996, Cesario said.
The issue also was left on the back burner because the practice was quickly halted, Cesario said. But the cancer center continued to look into the matter, eventually forcing the issue into the forefront in 1997, he said. That was about the same time that O’Neill said he notified UCI about those problems.
At that point, researchers and others involved with lab activities were contacted to answer claims that, as a matter of policy, they sought donations and charged patients for experimental treatments.
“They denied there was any policy,” Cesario said. “So it became a source of research misconduct” for UCI administrators to look into. The matter wasn’t completely resolved until recently, he said.
Parker offered no excuses for the three-year delay in refunding the money to patients.
“We screwed up,” Parker said. “The left hand didn’t know what the right hand was doing.”
Times staff writers H.G. Reza and Jeff Gottlieb contributed to this report.
