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Drug Trials Reach Out for Patients (and Vice Versa) on the Web February 27, 2001 - It was 1993 when Katherine Russell Rich learned that her breast cancer had recurred. Tumors were eating away at her spine, and her doctors told her she was only weeks away from becoming both paralyzed and incontinent. As she lay curled in the fetal position in the hospital, groggy on morphine, a friend suggested that she hire a medical researcher to see what, if any, options were available. Clinical trials for new breast cancer treatments were out there — but where? There was no central place to find them. A researcher would have to call dozens of hospitals, doctors and academic institutions to come up with a list of options, and after that there would be the endless discussions with each trial coordinator to find out if Ms. Rich was an appropriate candidate. "Still, hiring a researcher gave me hope I could do something," said Ms. Rich, 44, who in 1999 chronicled her experience of surviving breast cancer in "The Red Devil: A Memoir About Beating the Odds." "It was the sort of thing very few people would even think to do at the time," she said. "The Internet was still a mystery — and sites that talked about clinical trials were in the Stone Age." As it turned out, she did not find an appropriate trial, though she did go on to have radiation followed eventually by a bone marrow transplant. Had she undertaken that search today, she would have had many places to turn. Since October, at least four Web sites have been introduced on the Internet, with more to come. Largely financed by venture capital firms, they are generally geared toward helping pharmaceutical and biotech companies recruit patients for their trials. The four new Web sites are emergingmed.com, veritasmedicine.com, americasdoctor.com and acurian.com. Among those taking shape is hopelink.com. Part matchmakers, part bounty hunters, these services are free to subjects and promise to cut down the money pharmaceutical and biotech companies pay to find appropriate subjects. Private industry pays anywhere from a few dollars for a client reference for a relatively common medical problem — foot fungus, say — to thousands of dollars for candidates with rare diseases. Government studies and trials at academic centers also have money for candidate recruitment, but substantially less; many of these trials are listed on the new Internet sites as a public service. Not that the availability of information is an unalloyed good. More choices can mean more confusion, and because patients may be coming into their doctors and asking about treatments the doctors themselves have not heard about, the sites may be perceived as threats to their authority. "If you say the words `promising new cancer treatment' — well that sounds like a good deal," Ms. Rich said. "But let's face it, most of the treatments don't work out. Doctors can get frustrated if they have a treatment that's working, and the patient is confronting them with the promise of something new." Which raises the question of informed consent. Do seriously ill patients being matched over the Internet fully understand that trials are just that — trials — and very rarely result in a cure for their diseases? "Most patients could not state for you exactly what the purpose of the trial is," said Dr. Paul Helft, an ethicist and professor of medicine at the University of Chicago, who has been studying how cancer patients find and select clinical trials. "It's clear they enter primarily for therapeutic benefit. And the trials are not designed that way." Indeed, cancer patients are often subject to the riskiest Phase 1 trials, which test the safety of potentially toxic agents that could not be used on healthy people. Government studies like those at the National Cancer Institute, posted on the Web site cancernet.nci.nih.gov, post clear warnings: "Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment." But commercial clinical trial sites on the Web are not subject to monitoring by institutional review boards, the panels that examine ethical issues and ensure that the language used to inform potential trial candidates is not coercive or too hopeful. "The whole area of monitoring what goes on on the Internet is an uncharted area," said Dr. Cynthia Dunn, director of the clinical research institute at the University of Rochester. "And that's troublesome." While some sites, like emergingmed.com, say the information they present will be examined by a review board, the Food and Drug Administration does not require panels to check Web descriptions of trials. But print advertising for drug trials is subject to F.D.A. rules, which demand that the language be reviewed and that enough information be given to meet federal standards of informed consent. The drug trials themselves are monitored by review boards and subject to the agency's regulations and standards. For now, the sites primarily are conduits to link trials with potential patients. The warnings will come later, say the Web site organizers, when potential patients actually go to the trial centers and enroll. The issues are complex, Dr. Helft said. Are desperate patients, many of whom spend much time surfing the Web for help, more informed, or more full of false hopes? Or are their hopes grounded in realism? Traditionally, pharmaceutical companies recruit trial candidates through print, radio and television advertisements. While the companies may be inundated with calls, the vast majority of potential candidates do not fit the trial criteria. Matching candidates on the Web will make recruiting more efficient and cost- effective, said Courtney Hudson, the chief executive of emergingmed.com, which like most of the sites is financed by a consortium of private investors and venture capital. "Not that everybody will be a perfect match," Ms. Hudson said. "But they'll have a better shot of being placed in a study that's right for them." About five years ago, Ken Getz founded the first clinical trial site, Centerwatch.com. The privately financed site, an outgrowth of a newsletter marketed to physicians and pharmaceutical companies, is simply a listing of trials that is categorized by disease, and the language describing the trials is geared toward medical professionals. The new sites seek to simplify the language. Both veritasmedicine.com and emergingmed.com use software to match patients to specific trials. On emergingmed, a potential patient clicks on the disease in which he is interested and answers questions designed to figure which trials are suitable for him. Then, the appropriate trials pop up on screen. Most companies say they maintain confidentiality. But at least one, Acurian, captures patient data and builds physician databases, acting as a liaison between companies and patients. For instance, patients who have indicated stomach troubles and have given their consent may be receiving notices for new stomach-related drugs by e-mail. Veritasmedicine.com, which is affiliated with Harvard and Tufts physicians and plans to license its health-information content to other sites, also has an "opt in" program for capturing medical data, which means a patient checks a box to receive product information. Joshua Schultz, vice president of Veritas, said, "The site does not require patients to identify themselves in order to receive information, and will not sell information without a patient's specific O.K." Emergingmed.com officials say they have no plans to capture potentially private patient information, and patients answering questions in order to be matched need only reveal their identities after they have been through prescreening and are talking to the clinical trial investigators on the phone. Ms. Hudson also said the site would not carry banner ads, based in part on her own experience after her husband had a second heart attack. . "I'd be on a site looking at cardiology information," she added, "and someone was trying to sell me margarine." Still, a thorny question remains regarding many of the sites: what happens to the health data a site collects if the service suffers financial setbacks or fails completely? In 1996, the Health Insurance Portability and Accountability Act set standards to secure patient confidentiality on the Internet by addressing encryption of patient health records filed and stored electronically. It does not deal with standards for the clinical trials industry or with the information if a site ceases to exist. Still, many in health care, including Mr. Getz of Centerwatch, believe that the information trade-off these sites require may well be worth it, particularly for patients with life- threatening health problems. "Look at the statistics," said Donna Doneski, director of Communications for the National Coalition for Cancer Survivorship, a patient advocacy group. "Right now, only 2 to 3 percent of adults with cancer are involved in clinical trials. At that rate, you're not going to be finding answers to questions that quickly." Then, he added, compare those statistics with the percentage of children with cancer who are in clinical trials. "It's somewhere from 60 to 70 percent — because they have parents as advocates," Ms. Doneski said. "We've made a lot of progress in childhood cancer, and part of that progress, we believe, is because so many are involved in trials." Ms. Rich, the author, expresses the same sentiment. Since her battle with cancer, she has biked her way through Tuscany and Turkey and feels healthier than at any time since her diagnosis. A drug called Cytodrin has kept her disease in check. Still, she knows her struggle is not over. She stays informed of the latest advancements and clinical trials that may pertain to her. "Too often people become timid about asking their doctors about clinical trials," Ms. Rich said. "They worry their doctor will think they're questioning his/her judgment. For them, these sites may be a godsend." By JUDITH NEWMAN Copyright 2001 The New York Times Company http://www.nytimes.com/2001/02/27/health/27CLIN.html?pagewanted=all janet paterson, an akinetic rigid subtype parkie 53 now / 44 dx cd / 43 onset cd / 41 dx pd / 37 onset pd TEL: 613 256 8340 SMAIL: PO Box 171 Almonte Ontario K0A 1A0 Canada EMAIL: [log in to unmask] URL: http://www.geocities.com/janet313/