Wednesday, August 08, 2007

Giving the terminally ill access to experimental drugs

I have argued in a book that was published nearly... 10 years ago (I am ageing, I guess, kinda like everyone else) that we should provide terminally ill patients who have only a limited time left access to last-chance type drugs (more precisely experimental agents). Just go to amazon and search for my last name, you'll see the treatise popping up still. Anyway, a correspondent sent me this link today. Interesting story. Here is a brief summary of what it's all about:

'The Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation sued the FDA in 2003, seeking access for terminally ill patients to drugs that have undergone preliminary safety testing in as few as 20 people but have yet to be approved.FDA spokeswoman Susan Cruzan said the agency was pleased with the decision, which she said considered the public’s safety and the need for access to experimental drugs. Abigail Alliance founder Frank Burroughs pledged an appeal to the Supreme Court. Burroughs’ daughter, Abigail, was denied access to experimental cancer drugs and died in 2001. The drug she was seeking was approved years later.'

The FDA is the US Food and Drug Administration. It is responsible - among other things - for drug safety, and therefore the market approval of drugs. Quite rightly so, it takes its time to ask for scientific proof that new medicines are safe and efficient before it approves them for our use. The interesting ethical question, however, is whether it's acceptable to prevent dying people from making an informed choice about whether or not they're taking their chances with experimental agents. It is not necessarily irrational for a dying person to decide to take even huge risks in the face of death. What one would require really to make things work is a competent patient (terminal illness doesn't render you incompetent, you know!) who understands how little is known about an experimental agent, and who decides autonomously to give it a shot anyway. It is not always irrational to do so. This is so, because someone could weigh the pro's and con's and decide that it's worth the obvious risks involved in taking experimental agents. People might want to take their chances, seeing that death is a certainty if they don't do anything at all. I don't mean to bore you here with what I said in the book and in a series of academic articles at the time. You should easily be able to trace em if you're interested.

What I find very significant is that of about 9,500 folks who participated in the on-line poll conducted on the website I linked to earlier, 94% thought that we should enact legislation permitting dying patients to make such choices. This is much in line with other polls providing consistently overwhelming majorities in favor of the legalization of voluntary euthanasia. The bottom line we continue to send to our democratic representatives is that we want to maximise control of our lives when we are dying. Equally consistently legislators tend to ignore our wishes. That's liberal democracy Western style for you ...

1 comment:

  1. I entirely agree with you regarding an individual’s autonomy to decide whether to participate in a clinical trial, and was dismayed (though not surprised) by the court’s outrageously paternalistic decision.

    There is one caveat that you didn’t mention, however. That is that access to the drug may be otherwise problematic. For example, it may drain very limited supplies of the investigational drug. Also, particularly for very small biotech companies, staffing is often quite limited. There are heavy regulatory submission requirements when an investigational agent is used outside of a protocol; the limited staff might not be able to meet these requirements as well as their other obligations to the drug development or ongoing clinical trials.

    If you can figure out how to get around this, or that even an expected death on such a “compassionate use” basis could cause major problems for continued development of the drug, I’m with you and your apt barb about our legislators consistent tendency to ignore our wishes.

    Judy Stone, MD

    Author of Conducting Clinical Research:
    A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators
    www.conductingclinicalresearch.com

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