Thomas W. Abrams, director of the agency's Division of Drug Marketing, Advertising and Communications, said that investigators were free to have scientific conversations about investigational drugs with their peers and with journalists.
However, no molecule enters the trial process without having been patented, because the "investigational new drug" application that has to be registered at the start of formal trials makes it public information.
Before an investigational new drug (IND) can be tested in humans, it must be submitted to and approved by the FDA.
Because the vaccine had not undergone U.S. Food and Drug Administration FDAapprovalval, it would have investigational new drug status, and recipients would be required to sign an informed-consent form.
The National Institute of Allergy and Infectious Diseases, part of the U.S. National Institutes of Health, awarded contracts for the production and clinical testing of an investigational vaccine based on the H5N1 virus, and in August it announced that preliminary testing of the vaccine had been successful.
Another way to gain access to an investigational drug is to participate in a clinical trial.
In order to offer it to patients, doctors would need to file an investigational new-drug application, or I.N.D., and obtain the agency's permission.
According to the board, Abuzzahab had "enrolled psychiatrically disturbed and vulnerable patients into investigational drug studies without ensuring that they met eligibility criteria to be in the study and then kept them in the study after their conditions deteriorated".
The judges in Abigail Alliance reasoned that the same right of self-determination that allows someone to refuse treatment allows him to "choose to use potentially life-saving investigational new drugs".
Elan also said it would spin off its investigational treatment for bipolar disorder into an independent company called Speranza Therapeutics.
If patients do not enter clinical trials, their chance of receiving promising investigational drugs is 0 percent, rather than 50 percent.
