Mary Beckman

Federal Drug Agency Gets Flack About Human Subjects Protections in Clinical Trials

The federal agency responsible for approving new drugs and medical devices is under fire for not doing enough to protect human subjects in research. A recent federal report concludes that the U.S. Food and Drug Administration lacks ways to keep track of research on people and fails to conduct enough inspections. The FDA responded by saying that human subject protection is a complicated business. While it agreed with some of the report’s fi ndings, it also said that it conducts as many inspec tions as it can and that even the threat of inspections ensures safe treatment of patients. Clinical investigators, on the other hand, worry that the publicity the report generated could reduce the number of patients willing to participate in a clinical trial system that they believe is safe enough and already thin on volunteers. In the September report, the inspector general for the U.S. Department of Health and Human Services criticized the FDA for a poor showing in its efforts to protect human research subjects. The inspector general reported that the FDA has no way to keep track of all the clinical trials and review boards that monitor the trials. Also, the agency has no way to keep track of the inspections it performs or the legal authority to oversee other researchers who might be involved in clinical trials but who are not the principal investigator. The inspector general also thought that inspecting 1% of trials was inadequate. For example, the FDA has only 200 inspectors to monitor 350,000 investigators using people in research. The report recommended how the FDA could improve, including creating a database to track inspections and getting the legal authority to oversee colleagues and subordinates of principal investigators. The FDA pointed out in comments to the report that the organization is already modernizing its human subject protection protocols with the kinds of databases that the report recommends. But the agency also contended that the report focused too much on inspections that are to be conducted after a trial is in progress. “Inspections are but one narrow part,” the FDA responded, saying that the initial review of protocols is also important. “In order to ensure the highest degree of human subject protection, [the] FDA carefully scrutinizes all protocols submitted to the agency and will require sponsors to revise protocols as necessary, thus ensuring the greatest protection of human subjects before a clinical investigation even begins.” Research on humans is an incredibly important part of medical science and is only becoming more vital, says hematologist Edward Benz Jr., M.D., president of the Dana-Farber Cancer Institute in Boston.

Key to Finding Quality Cancer Hospitals and Surgeons Is Finding Out How Much They Practice

A person newly diagnosed with cancer has enough things to worry about without having to struggle to find the best care. Many just go to whomever their primary physician recommends. But people who want to make more informed choices have a hard time finding out who is the best. In this age of answers a mouse click away, patients must do some old-fashioned phone calling and digging to get the facts they need to fi nd the best doctor. And the facts they can get on the Internet or from organizations aren’t what they really need, although those resources might do a good enough job pointing out the better hospitals and surgeons until health care organizations get together and provide data that consumers can use. Those data might include the number of surgeries performed at a hospital, which tells you generally about the quality of care you might expect. But cancer research organizations are pushing for new systems that will better monitor how well hospitals and surgeons perform. Experts are more aware than consumers of the shortcomings of the current system. Says surgeon John Birkmeyer , M.D., of the University of Michigan in Ann Arbor, “You want a Web site where you can punch in your ZIP code and get rates of survival, a Web site that would be reliable for profi ling a hospital or surgeon. Those data are not available — not because anyone’s hiding anything, but there’s no large-scale database that includes it all.” No Easy Answers Even Web sites that purport to give valuable information aren’t as useful as surgeons think they should be, says Lee Newcomer, M.D., senior vice president of United Health Care Oncology in Minneapolis. “There aren’t a whole lot of options” for patients or physicians, he says. This might not be such a problem if health care were universally great. But a 2006 study in the Journal of Clinical Oncology that looked at the quality of cancer care found that patients received only about 78% – 86% of the current recommended care for several different cancers. Another re cent study revealed a wide disparity between the best and the worst cancer care. “The quality varies to a far greater extent than people think,” says pulmonologist Peter Bach , M.D., of Memorial Sloan-Kettering Cancer Center in New York City. Consumer Web sites such as those of Healthgrades.com and WebMD, and even Medicare, do compile some data such as the complication rates of hospitals and how long people stay. For example, the Centers for Medicare and Medicaid Services tracks doctors with the Medicare Quality Monitoring System, but those reports are not something one could easily use to identify names and numbers. “There’s no data on outcomes at all,” Newcomer says. He questions the value of those databases for certain cancers. “When it comes to breast cancer and lumpectomies, there are hardly any complications.” Birkmeyer points out that the National Cancer Institute maintains a database called SEER (Surveillance, Epidemiology, and End Results), from which you can pull detailed information about the prognosis of cancer by type and by how far along it is. “But there hasn’t been a priority to give outcome data [for surgeons and hospitals],” he says, adding, “and it may be politically sensitive to do so.” Although the data on outcomes are not readily available, that doesn’t mean such data do not exist. “We do have very good information on outcomes in hospitals’ tumor registries,” Newcomer says. But whether the hospitals allow people to access those data is entirely up to the hospital. For Newcomer’s hospital system, Park Nicollet Health Services, their registry is open. But even with open access, such registries aren’t easy for laypeople to use, and even cancer care Web sites such as WebMD require some background to understand the data. “The ease of use of the system has not reached the level of the data that argues for transparency,” Bach says. “It’s really hard for the patient.” The National Comprehensive Cancer Network provides information on what a patient is to expect, but its guidelines don’t rate individual hospitals and doctors.