A D.C. court has eased the ability of patients to obtain investigational new drugs.
The opinion is significant for the CAM field, as the previously controlling case (Rutherford) was one in which the U.S. Supreme Court denied the right of terminally ill patients to obtain laetrile. Although the decision may make sense in retrospect, in that laetrile has subsequently been shown ineffective as a cancer therapeutic, the principle in the case involved the right of consumer access to therapies without government interference. In a strange twist of logic and language, the Supreme Court found that the state had the right, and the duty, to protect patients from fraud even though they were going to die nonetheless.
Now, on Thursday, March 1, the D.C. Circuit will rehear en banc, the case of Abigail Alliance v. Eschenbach.
The decision is ably reported on Prawfblog:
‘Abigail Alliance for Better Access to Developmental Drugs (“Alliance”), a nonprofit association representing several terminally ill patients who would like to have access to Phase 1 drugs, sued to enjoin FDA from enforcing its ban on on unapproved drugs insofar as it prohibits terminally ill patients with no other treatment options from purchasing investigational drugs. The Alliance claims a fundamental right under the due process clause to obtain access to potentially beneficial investigational new drugs that have completed Phase 1 trials.
‘The D.C. Circuit panel majority held that the due process clause creates a fundamental “right of a mentally competent, terminally ill adult patient to access potentially life-saving post-PhaseI investigational new drugs, upon a doctor’s advice, even where that medication carries risks for the patient.” The majority found this right to be “deeply rooted in this Nation’s history and tradition,” as reflected in various common law doctrines (the defense of necessity, the freedom from battery, the tort of intentional interference with a rescue).’
The issue in the case is whether: ‘the due process clause of the federal constitution provides a fundamental right that prevents the Food and Drug Administration (FDA) from blocking competent, terminally ill patients from having access to potentially lifesaving drugs that have cleared Phase 1 clinical testing but have gone no further in the drug approval process, when usage is based on the advice of doctors.’
With regard to the problem shared with patients in Rutherford, Prof. Glenn Cohen (another Prof. Cohen) argues that: ‘It is sometimes suggested that the paternalism argument is weak here because the patients in question are already terminally ill. But having a terminal illness is not the same as being on death’s door, and in any event particular drug being sought for its as yet unsubstantiated claims of cure may actually hasten death.’
I don’t really buy this, since the issue, as Prof. Cohen notes, is really one about paternalism vs. autonomy, and whether strong paternalism is truly justified.
The Medical Humanities Blog comments:
‘I am hesitant to stand athwart a potential door to lifesaving treatment for desperately ill patients, and yet, commentators (notably, Cassell) have explained the extreme fear and vulnerability of such patients makes it all the more important to (paternalistically, perhaps) attempt to shield them from an arguably unethical exposure to risks of pain and suffering for little benefits. This contention, of course, is contestable for a variety of reasons, but I agree with Cohen that it is at the heart of some of the difficult policy issues presented by this case.
On the one hand, it would seem difficult to tell these desperate, suffering patients that what they perceive as their last hope ought not be made available to them, and on the other hand, to paraphrase from Wittgenstein, one must be careful of attempting to open doors that are painted on to walls, especially when doing so may carry significant risk. These are truly difficult issues of research ethics.’
Not only research ethics, but ethics in general. Paternalism has to be softened with compassion, otherwise the discussion is very distant and heady. So to move from the head to the heart — maintaning, of course, all the delicate balancing mechanisms of rationality versus feelings that humans are capable of in their highest expression– why not have a little shift. Why not ask what position one would take, if a loved one who had full informed disclosure about risks and benefits of potentially life-saving drugs, was denied medicine, based on a government agency’s assesment that it has to protect someone from their own vulnerability to fraud?
Law Offices of Michael H. Cohen offers general corporate legal services, litigation consultation, and expertise in health law with a unique focus on alternative, complementary, and integrative medical therapies.
Michael H. Cohen is Principal in Law Offices of Michael H. Cohen and also President of the Institute for Integrative and Energy Medicine (also known as the Institute for Health, Ethics, Law, Policy & Society), a forum for exploration of legal, regulatory, ethical, and health policy issues involved in the judicious integration of complementary and alternative medical therapies (such as acupuncture and traditional oriental medicine, chiropractic, massage therapy, herbal medicine) and conventional clinical care. The most recent published book by Michael H. Cohen on health care law, regulation, ethics and policy pertaining to complementary, alternative and integrative medicine and related fields is Healing at the Borderland of Medicine and Religion. This is the fourth book in a series, following Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives (1998), Beyond Complementary Medicine: Legal and Ethical Perspectives on Health Care and Human Evolution (2000), and Future Medicine: Ethical Dilemmas, Regulatory Challenges, and Therapeutic Pathways to Health Care and Healing in Human Transformation (2003).
Health care and corporate lawyer Michael H. Cohen has also been admitted to the Bar of England and Wales as a Solicitor (non-practicing), adding to Bar membership in four U.S. states.