Experimental Treatments? Unapproved But Not Always Unavailable
Is the Risk Worth It? continued...
5. How do I know if I am eligible to be in the study?
Every trial has a set of criteria to select the people that will be included in
the study. These criteria generally relate to general health, stage of disease,
and prior treatments and are designed to produce useful scientific
6. Do I have to pay to be in a clinical study?
Generally, studies funded by the federal government are free for the patient.
Many studies funded by drug companies also do not cost anything. Some costs,
however, may be paid by a patient's health insurance or managed-care plan.
7. So I'm just a guinea pig, right?
By the time most studies reach the stage where the new drug is being tested in
people, a great deal is known about how it affects the body. While there is
always the chance that something could go wrong, the safety of most drugs being
studied is well understood. It is true, however, that researchers do not know
if a treatment being studied works better than current therapies or not.
What FDA Does Not Do
Although FDA is responsible for overseeing the field of drug
development, there are a number of services the agency cannot provide to
individual patients. For one thing, it cannot give out the name of drugs in
development, a common request from patients who call the agency. Unless the
company publicly releases information about the experimental treatment, FDA is
currently forbidden to even acknowledge that it knows about the drug.
Along the same lines, FDA cannot make the drug available to
individual patients or physicians. The agency simply does not have the product;
only the company that is developing the drug has a supply. And FDA has no
authority to require that the company make its drug available outside of the
FDA, itself, does not conduct any clinical trials or drug
studies. The agency carries out its drug review and approval responsibilities
by examining clinical and other data generated by the drug company.
And lastly, FDA does not give advice. While staff from the
Office of Special Health Issues and the Center for Drug Evaluation and
Research's drug information branch will often provide detailed information and
explain the process for getting access to an experimental medication, the
agency does not steer patients in one direction or the other. Information is
provided so patients, in consultation with their physicians, can make their own