In the United States, patients do not have a constitutional or a statutory right to receive any treatment they want. A patient can only receive a drug or device that has been approved by the Federal Food and Drug Administration (FDA) for interstate marketing for some purpose, or which has been approved for investigational use as part of a FDA approved clinical trial or via FDA special execption. The only exception is to this rule is that as a matter of enforcement discretion, the FDA allows certain non-FDA approved drugs to be imported in to this country under what is called a “personal use exemption.” However, not all drugs are allowed to be imported, and the FDA’s position is not uniform, and is often applied in an arbitrary fashion.
In the last dozen years there have been various attempts by members of Congress to allow patients to receive non-FDA approved drugs. However, these efforts have been legislatively unsuccessful.
Individual rights are even more limited if the patient is a minor. In the last thirty years, there have been numerous cases involving parents’ refusal to provide children with necessary treatment for cancer and other diseases. One of the first cases involved Chad Green who was diagnosed with cancer. His family refused chemotherapy and eventually fled to Mexico to receive laetrile. The treatment was unsuccessful and unfortunately, Chad died.
One of the more recent cases involves Parker Jensen a 12 year-old boy diagnosed with Ewing’s Sarcoma. Despite being diagnosed with this disease and seeing at least four pediatric oncologists, all of who recommended chemotherapy, the parents refused treatment.
In general, if the evidence is clear-cut that chemotherapy will benefit the child, in most cases the courts will order treatment. If there are doubts about the efficacy of the treatment, or if the parents have a reasonable alternative, then the courts will allow the parents to choose an alternative treatment. However, the Parker Jensen case and two recent cases, (one in Texas and the other in Virginia) suggest that circumstances (like an older minor teenager, or a child manifesting extremely hostility to the proposed conventional treatment), may cause the courts to side with the parents.
Of course, these circumstance would only apply to a relatively older and mature child. In the case of an infant or very young child, I think the courts will not hesitate to divest legal and physical custody from the parents if they act against the advice of conventional medical authorities.
I have been active in the patient rights filed both as a litigator on behalf of patients seeking treatment, and as an advocate to Congress to pass legislation allowing greater freedom of choice. There have been individual successes, but there is still no nationwide solution to the patients’ rights problem and access to non-FDA approved drugs.