Clinical Trials: Ethical Issues?
Clinical trials, the process of putting new medical treatments through their paces in a real-life (human patient) setting, are conducted all the time. If the results of a trial are favorable, the treatment is introduced to the general public. If not, it's back to the drawing board for the research scientists. Sounds pretty straightforward, doesn't it? On the surface, yes. But when you really start to think about it, clinical trials can open up a medical-ethics can of worms.
Cancer research, like all science, relies on experimentation for results. Drugs, drug doses, hormone treatments, radiation, and other protocols are examined first as theory, on paper; then under the microscope, at the cellular level; then on non-human "volunteers" (white mice, anyone?), and finally, on human volunteers. While PETA activists (People for the Ethical Treatment of Animals) might claim otherwise, it's really only at the human level that this experimentation becomes an issue that bears lots and lots of scrutiny. We humans don't think of ourselves as lab rats; we don't believe in sacrificing a certain percentage of the population in return for advancing science. Thus the ultra-sensitivity surrounding human clinical trials.
The first thing to get your mind around is this: that while the goal of a clinical trial is to make progress towards alleviating or curing illness, participation in a trial doesn't guarantee every participant will be helped during the trial. It is, after all, an experiment designed to prove whether or not a new drug or treatment is safe and effective. The people involved in the trial are elements in the experiment-just as the main thrust of nuclear fission research was to prove its explosive potential, not to track what happened to the uranium after its atoms were split. Not to say that trial patients aren't given excellent care; it's just that the trial may not benefit them-may even harm them, though this is very rare-AND THAT'S OK.
There's your first ethical issue: if doctors are supposed to "do no harm," and the medical research community is perforce aligned with doctors, what happens when patients are harmed (or less seriously, not helped, if they happen to be in a control group) by the drugs or treatments being tested?
Thankfully, clinical trials have evolved to the point where patients are thoroughly briefed in all possible outcomes. The informed consent process has grown from a single page to up to 12 pages describing every possible risk factor. In addition, before the trial even starts, it's run through a review board including lay people from the community, lawyers, ethicists, and religious leaders to determine of the trial is ethical and fair. The medical research community is doing everything possible to make trials safe; and in the end, it's the patient's choice whether or not to participate.
What about clinical trials that are funded by drug companies? Billions of dollars are spent by the pharmaceutical giants to prove that their new drug will shrink that tumor or prevent a recurrence; that THEIR drug is better than the current treatment. Thankfully, the results of these expensive trials are often positive; the new drug IS better than the current standard. Nonetheless, given the enormous amounts of money involved, how much pressure is brought to bear on the researchers carrying out the study? How much does the drug company itself actually influence the design of the study? Where's the line drawn between altruism and financial benefit?
And then there are the desperately ill patients who seek access to drugs that may have made it through Phase I clinical trials, but aren't yet FDA-approved for use on humans.
If a person is dying anyway, why not try ANYTHING to save them? Why worry about possible side effects, if the alternative is death? The Abigail Alliance for Better Access to Developmental Drugs filed a lawsuit in 2003 against the FDA, saying that terminally ill patients' constitutional rights are being violated by not allowing them access to possible life-saving treatments. The U.S. Court of Appeals for the District of Columbia Circuit ruled in favor of the FDA in a decision passed down on August 7, saying it would not advocate creating a constitutional right for patients to take on "any level of risk" in an effort to save their lives. Is this right? Should the FDA prevent terminally ill patients from taking their last best shot?
It's not surprising, given the complex nature and vital human importance of medicine, that it's so intertwined with personal and institutional ethics. Thank God both for those who push research to its farthest limits; AND for those who ask them to put on the brakes and consider something other than results.
For more on ethical concerns and cancer clinical trials, read: