Do People Have a Right to Take Part in Medical Studies?
Sept. 27, 2000 -- For the parents of a dying child, for the terminally ill adult, medicine eventually shows its limitations. Our options in these situations are few. But when clinical studies or alternative therapies show us glimmers of hope, many of us feel we have to try.
When people are denied access to clinical trials, for whatever reason, it creates controversy and headlines -- as in the case of Lindsay Karlin, the 6-year-old whose parents are pleading with the FDA to speed up approval of the second phase of her gene-therapy treatment.
Two more recent examples:
- Five government-sponsored research studies at the University of Oklahoma were shut down earlier this year because of regulatory and safety concerns. All the studies, except for a melanoma vaccine trial, were later allowed to reopen. Seven seriously ill patients (out of the original 28 patients enrolled in the melanoma study) petitioned the FDA and got permission to continue getting the vaccine used in the suspended study.
- The parents of a 4-year-old Arizona boy with brain cancer are trying to persuade the FDA to allow their son to be treated by a controversial Houston doctor using a nontoxic alternative therapy called antineoplastons, rather than conventional radiation and chemotherapy.
When it comes to participating in research programs, what rights do we have? There's no clear answer, just as it's not always clear whether it's beneficial for even patients with terminal illnesses to be involved in these studies.
"Legally, no one has a 'right' to be an experimental subject in a clinical trial," says George Annas, JD, chairman of Boston University's Health Law Department. "In this country, you don't even have a right to health care! The only right we really have is the right to emergency care -- if we can get to an emergency department."
It was in the late 1980s, during the early days of the AIDS epidemic, that the FDA began loosening the rules governing clinical trials, Annas notes. At the time, there was no treatment for AIDS except what was offered through these studies. "Otherwise, you just didn't get treated," he says.
An FDA official says that even people who may think they are excluded from a particular study of a drug or other method have some options.
"Patients can petition [the FDA] for access to a drug after a trial has ended, or if a drug trial is not being conducted in their geographical area. Also, the drug company may make a single-patient exception if a clinical trial has not yet begun," Terry Toigo, RPh, the FDA's associate commissioner for special health issues, tells WebMD. A single-patient exception allows patients who do not qualify for the study, but who have a clear medical need, to get the drug being tested.