Being a Guinea Pig - Your Constitutional Right

A ruling by the US District Court of Appeals for the District of Columbia releasing drugs which are "in the FDA pipeline" for testing and approval to be accessed by patients with life-threatening illness without any proof of effectiveness. The Court ruled 2-1 that the Cruzan precedent, decided by the Supreme Court in 1990 as establishing a "right to die" for terminally ill patients, also applied in reverse.

The majority reasoned that the explicit protection of "life" implied a right to self-preservation which must include the access to potentially life-sustaining medication. This rule "flies in the face" of a long legislative and regulatory history establishing that medications must be proven both effective and safe for the purposes intended before they can be released to the open market. There are very detailed regulations on the supervisions of the necessary trials to protect the rights of patients as research objects.

If the DC Appeals Court has it's way, drugs will be released to the open market without adequate information on their use with particular attention not being applied to their safety of use and application. The public are already complaining that the FDA is not vigilant with the safety of drugs even after they have gone through the full "trials" and investigative process .

What the DC Court of Appeals has ruled, is that patients with life-threatening and untreatable disease have a constitutional right to access "any agent that has passed PHASE 1 testing." The logic behind this ruling seems to be "if they are going to die anyway, let them try anything they like". The major problem that this ruling has created is that this inteferes with the full process of medical research and the actual value of the drug being tested.

Doctor's have always depended on PHASE 3 trials to know that the drugs work. Patients need PHASE 3 trials to ensure that the drugs they are receiving are relatively safe. However, PHASE 3 trials depend on a major commitment of funding, coordination, manpower and statistical expertise at both medical and regulatory levels. Hospitals, Doctors and Medical agencies depend and use PHASE 3 prior to the administration of medication.

Finally, will the new legislation create double standards in healthcare? Is this the brakes on the conduct of major pharmaceutical research in the US? Who pays for this ruling, the patient? And, are drug manufacturers going to bother to take on the expense of drug trials or are they going to produce and rush unproven drugs to a market? I think this one needs to go to the Supreme Court.