Pubdate: October 31, 1999 Source: New York Times (NY) Copyright: 1999 The New York Times Company Contact: http://www.nytimes.com/ Forum: http://www10.nytimes.com/comment/ Author: Paul Zielbauer STATE KNEW OF RISKY HEROIN TREATMENT BEFORE PATIENT DEATHS TRENTON - When New Jersey investigators filed a lawsuit against Dr. Lance L. Gooberman earlier this month that linked his unusual heroin detoxification treatment to six patient deaths, officials in the State Attorney General's office proclaimed they had stopped an "unlawful" treatment that put addicts' lives in danger. But the state board responsible for regulating medical procedures knew of Dr. Gooberman's treatment well before the first patient death in 1995, records show, and though it determined the heroin treatment to be "potentially life threatening" in 1997, several months before three more patients died, it did not intervene until earlier this month. Even though Dr. Gooberman disclosed to the state in July 1998 that one of his patients died shortly after a treatment, investigators did not begin an inquiry until a year later, when he told them another patient had died. There were other public warnings about Dr. Gooberman's treatment. In July 1997, he acknowledged after a speech to doctors at the University of Pennsylvania that three or four of his patients had died, said doctors who attended. More recently, on Aug. 2, the American Medical News published an article in which Dr. Gooberman revealed that within 48 hours of his treatment, five of his patients died, three apparently due to subsequent drug use. State officials defend the timing of their investigation by pointing out that patients die every day, and regulators need firm legal reasons to bar questionable or unsavory treatments. In this case, one death was not enough to force the state to block Dr. Gooberman's unorthodox treatments, said Mark S. Herr, the director of the State Division of Consumer Affairs, which oversees the state medical board. "The knowledge of the deaths transformed this from something that needed to be examined to something that needed a more urgent response," Herr said in a recent interview. During the state's investigation of Dr. Gooberman, who insists he has been singled out unfairly, a sixth patient of the doctor's died. Now, investigators are discreetly looking into the possibility of more deaths related to Dr. Gooberman's treatment, a four-to six-hour outpatient heroin treatment called ultra-rapid opiate detoxification. Dr. Gooberman's current troubles offer a glimpse into the controversy surrounding the growing business of rapid detoxification, an unorthodox treatment for addiction that, in the last five years, has spawned a rush among a handful of doctors to patent -- and profit from -- their own versions of a procedure that many doctors believe is unproven and needlessly risky. "We have concerns about its safety," said Dr. Alan Trachtenberg of the Federal Center for Substance Abuse Treatment, in Bethesda, Md. "What is actually being accomplished by pushing someone through detox rapidly?" What makes ultra-rapid opiate detoxification a subject of debate is its speed -- it can be done in as few as four hours, with no required after care -- and its use of anesthesia to knock patients out while doctors feed them a series of intravenous drugs that remove the opiates in the brain that cause physical addictions. But there is a significant downside to the treatment, which costs up to $8,000. Patients awaken cleansed of opiates, but they are not cured of addiction and still face a punishing psychological need for heroin. The drastic chemical changes the patient undergoes can also cause heart and respiratory problems, addiction specialists say. And once the patients leave the clinic or hospital, relapse is a constant threat. To help prevent addicts from relapsing after the treatment, Dr. Gooberman surgically inserts a pellet of a heroin-blocking drug, naltrexone, into their abdomens. The pellet, which the doctor has patented along with his detoxification procedure, is meant to dissolve over 60 days to block further cravings for narcotics. As a result of the state's lawsuit, Dr. Gooberman and his partner, Dr. David Bradway, signed a legal agreement two weeks ago not to perform any more detoxifications without the state's permission. They are still allowed to insert new naltrexone pellets in their patients, who include state prisoners. In July, even as the State Attorney General was investigating Dr. Gooberman, the state's Administrative Office of the Courts contracted with him to treat heroin-addicted convicts enrolled in a work-release program, according to documents provided by Dr. Gooberman's lawyer, Alma L. Saravia. Experts estimate that about 10,000 heroin users worldwide have undergone anesthetized detoxification since ultra-rapid opiate detoxification was invented in the late 1980's by an Austrian physician. The treatment has been associated with at least 10 deaths, including six of Dr. Gooberman's patients. Even the doctors who advocate the treatment acknowledge a dearth of research proving that it works. Many doctors say ultra-rapid detoxification will never take the place of a complete withdrawal program like methadone. Dr. Jim Callahan, the executive vice president of the American Society of Addiction Medicine, equated anesthetized detox to a quick fix. "It runs counter to what we have seen work with people who have chronic histories of opiate addiction," he said. A federally funded study of ultra-rapid opiate detoxification may soon shed more light on the treatment. The study, started on Sept. 5 by Dr. Herbert Kleber, the medical director of the National Center on Addiction and Substance Abuse at Columbia University, will track the treatment's effectiveness on 60 heroin addicts over three months. Dr. Kleber, 65, is an outspoken opponent of commercial one-day detoxification treatments like Dr. Gooberman's. He will soon give his views directly to New Jersey's medical board, known as the Board of Medical Examiners, which has hired him as an expert witness in Dr. Gooberman's case, Ms. Saravia said. The board passed up several opportunities to halt Dr. Gooberman's procedure. In an interview on Oct. 19, Herr said the board first heard of Dr. Gooberman and his treatment "sometime in the last two years." Three days later, Herr amended that, saying the board first learned of Dr. Gooberman in December 1996 or January 1997. But in a letter to Dr. Gooberman dated April 19, 1995, and supplied to The New York Times by Ms. Saravia, the board said that it was aware of his detoxification procedure and requested more information about it. In November 1997, the board published a set of proposals to strictly regulate anesthesia detoxification, but a year later chose to enact a lesser measure governing the use of anesthesia in all outpatient treatments. By then, five of Dr. Gooberman's patients had died. Dr. Gooberman, a short, stout man with a red beard and pale blue eyes, says he has been unfairly pursued by state officials. "The whole time I was doing it," he said last week in an interview, "I knew I was doing what's right for the patient." Proponents say the treatment holds out new promise for the nation's estimated 810,000 heroin users, especially those for whom methadone has failed. Many American physicians believe the treatment has spawned a gold-rush mentality among a coterie of doctor-entrepreneurs. Instead of sharing their breakthroughs with their peers, their critics say, the doctors have used patents and trademarks to make money on them. They point to a growing list of physician-owned businesses with names like U.S. Detox, which Dr. Gooberman controls, and Intensive Narcotic Detoxification Centers of America, of Tolland, Conn., a company founded by Dr. David L. Simon, an anesthesiologist who recently trademarked the phrases "intensive narcotic detoxification" and the more catchy "kick in your sleep." Of course, the business of heroin detoxification would be nothing without a steady supply of customers. Driving the demand for the anesthetized detox treatment is an emerging kind of heroin addict: middle-class suburban youth. "What I'm seeing now is kids and parents that are desperate," said Dr. Gooberman, 48, of Haddonfield, N.J., near Philadelphia. Since 1994, he has detoxified 2,150 patients, he said, many of whom are teen-agers who arrive at his clinic with a parent in tow. With Dr. Gooberman's treatment on hold pending a ruling from the state's Board of Medical Examiners, the rapid detoxification market in the metropolitan region is left to two others: Dr. Simon in Connecticut and Bennett L. Oppenheim, a clinical psychologist who runs UltraMed International of Fort Lee, N.J. Oppenheim began his business last year, after a clinic he ran at Metropolitan Hospital Center in Harlem with the help of two Israeli partners was closed by New York City's Health and Hospitals Corporation when its contract expired in August 1998. The Israelis, David Yerushalmi and his brother-in-law, Dr. Andre Waismann, are notable because they were the first to trademark the phrase "ultra-rapid opiate detoxification" and, through their now defunct company, CITA Americas, performed the $7,000 procedure on addicts in prestigious hospitals in Chicago, Los Angeles and Miami, Oppenheim said. Each man has since struck out on his own. Oppenheim is now paired with a different physician, a different name for his treatment and a new venue, at Pascack Valley Hospital in Westwood, N.J. All this medical entrepreneurship worries some doctors. "The chance to make a profit has stimulated its growth more than its effectiveness," said Dr. Joseph R. Volpicelli, a psychiatrist in the University of Pennsylvania's medical school who has studied anesthetized detox treatments. "It may be the wave of the future and that's how medical companies will make their profits," he said, reflecting on the wave of patents in recent years. "But that would be a shame." The American Medical Association strongly advises its members not to patent medical procedures, saying patents represent "substantial risks to the effective practice of medicine." Furthermore, Federal law forbids doctors to enforce patents on medical procedures, said Dr. Nancy Dickey, a former A.M.A. president. But doctors like Dr. Simon in Connecticut, who recently sued another heroin detox concern for using his treatment method, dismiss such criticism as babbittry from doctors wedded to methadone treatments. "The psychiatrists don't want to replace five days of inpatient detox, which they manage, with one day of outpatient detox" performed by anesthesiologists like him, Dr. Simon said. Dr. Gooberman's formal response to the New Jersey medical board is due Nov. 10, Ms. Saravia said. After that, the board has 30 days to decide whether to revoke his medical license or refer the matter to a state judge, she said. Dr. Gooberman hopes to be back in the rapid-detox business soon. "We have to offer drug addicts more options," he said, "not less." - --- MAP posted-by: Jo-D