Web Sites Recruit Drug Trial Participants Online
Pharmaceutical and biotech companies are turning to the Internet to recruit patients for clinical trials, and an increasing number of Web sites have been developed to meet the demand, the New York Times reports. Since October, at least four such Web sites -- emergingmed.com, veritasmedicine.com, americasdoctor.com and acurian.com -- have been launched, and another, hopelink.com, is in the works. The sites are "[p]art matchmakers, part bounty hunters," the Times reports, posting drug trial information that consumers and potential candidates can access for free. Companies wishing to post trial notices on the sites pay anywhere from "a few dollars" to find patients with "common" medical conditions to thousands of dollars for patients with rare diseases. Patient groups say online services will help boost testing enrollment and pave the way to more studies that could yield cures for life-threatening diseases. Donna Doneski, director of communications for the National Coalition for Cancer Survivorship, said, "Right now, only 2% to 3% of adults with cancer are involved in clinical trials. At that rate, you're not going to be finding answers to questions that quickly." Government and academic centers also post trial notices on these sites, but as these institutions have "substantially less" money for candidate recruitment, they are often listed as public services.
Still, some physicians express concern over potential risks the sites pose to patient safety and privacy. While government studies listed on the Web post "clear warnings" concerning trial safety risks, descriptions of commercial clinical trials posted online are subject to neither monitoring by institutional review boards nor FDA rules, as print advertisements are. Site operators say that patients will receive warnings about trial risks when they actually enroll at trial centers, since the trials themselves are subject to FDA regulations. However, doctors fear that the lack of monitoring will allow ads to contain "coercive" and "hopeful" language that might fill "desperate" patients with "false hopes" that a test will yield a cure for their disease. Other doctors worry the Web sites will become "threats to their authority," as patients may attach to treatments their physicians have never heard about. In addition, the sites spark privacy concerns over the availability of patient data online. Most of the sites say they maintain confidentiality for all patient information they receive, but at least one -- acurian.com -- uses patient data to send out related advertising material. Other sites, such as veritasmedicine.com, allow patients to choose whether they want to receive product information. What happens to patient data if the services suffer financial problems or fail completely is unclear, the Times reports (Newman, New York Times, 2/27).
Meanwhile, today's USA Today features an editorial calling for tighter government oversight of clinical trials and other experimental research. The editorial highlights the case of James Rowsey, a Florida ophthalmologist who, without patient consent, allegedly used an unapproved experimental blade in more than 60 corneal surgeries, with one patient claiming that he is blind as a result. This case reveals the government's "slapdash system for monitoring experimental medicine," the editorial states. Oversight of clinical trials, the editorial continues, is "so disorganized that no one even knows how many clinical studies are underway or how many participating patients are injured or killed." The editorial argues that federal regulation does not provide enough of a threat to "counteract the temptation by researchers to bend the rules," since the "prestige and wealth attached to medical breakthroughs can easily cloud institutional and individual judgment" (USA Today, 2/27).
In an accompanying USA Today op-ed, Greg Koski, director of the Office of Human Research Protections, and David Lepay, acting senior administrator for clinical science at the FDA, argue that the Rowsey case does not reveal government oversight of clinical trials to be inadequate but instead shows the need for the public to be "better informed" about the research process and its risks. Koski and Lepay write that the "vast majority" of research studies are conducted by "responsible investigators who demonstrate great concern for the participants," although they acknowledge that "conflicts of interest" may mar the judgment of a few scientists. The current system of regulating clinical studies, designed 30 years ago, "did not envision some conflicts of interest," and a new system that would hold "every party ... accountable" must be developed, they state. Koski and Lepay state that the FDA and the Office for Human Research Protections are currently working on such reforms, and are making "progress" (Koski/Lepay, USA Today, 2/27).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.