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In May of this year an advocacy group called the Abigail Alliance for Better Access to Developmental Drugs won a lawsuit in the U.S. Court of Appeals against the US Food and Drug Administration (FDA). The court ruled that "a terminally ill patient with no government-approved treatment option has a constitutional right to access investigational drugs that have completed Phase I trials."

"Boom!" What a dilemma for a treating physician to offer a drug that has not shown any evidence in human efficacy and only has passed the "Phase I," or safety, level of study, meaning the drug in proper doses will not kill the patient.

The Abigail Alliance decision has spread over the Internet, and patients now are besieging their physician to take advantage of this new "opportunity!"

The desperation of a dying patient is, indeed, sobering and concerning. But, despite the extreme circumstances, as a physician I must inform my patients that such access might not be in their best interest, even if there is not another treatment option.

There are alternatives that pharmaceutical companies can and do offer to patients who otherwise are not eligible for clinical trials. They are called "expanded access" programs, and patients who are interested should ask their physician about such options.

In addition, the delicate balance that has developed between patients and their insurance companies (including Medicare) can be put in jeopardy with this new court ruling. It might even lead to reimbursement issues in approved treatment regimens.

While the law now states that the patient has a constitutional right to access Phase I investigational drugs, medical good decision-making and even medical ethics cannot agree. This is the beginning of an ongoing debate that most likely will result in unnecessary legislation.