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 ...

Patients allegedly undersupplied with cutting edge medication

A study published by the German federation of the innovative (ie research active) pharmaceutical industry alleges that up to 74% of patients suffering from dementia, and up to 69% of patients suffering from rheumathoid arthritis are denied access to innovative drugs due to cost considerations. Basically insurance companies put pressure on doctors to prescribe cheaper, generic drugs, many of which, according to the research active industry, are plain suboptimal.

Now, one should not be too surprised that the pharmaceutical industry and its for-hire academic researcher (a professor doctor doctor med type guy in Bochum) come to this conclusion.

Assuming that the claims made by the good professor, and the industry that finances him, are correct, one might still wonder whether this isn't further proof that our reliance on market mechanisms to ensure medical innovation is misguided. It seems as if not only the poor in developing countries are unable to access life preserving medication but also your average citizen in a country as rich as Germany. Surely there is something odd about our health care systems' continuing reliance on profit driven drug companies to deliver the needed drugs affordably. I am not suggesting, by the way, that there is something inherently bad about the companies going about their business in terms of maximising returns for their shareholders. What is problematic is that we as a society have shifted most drug R&D responsibility their way. Now we depend on them and find that while this was convenient for awhile, we (as in more and more of us) can't afford their goods anylonger.

No doubt it is time to reconsider how drug R&D is currently being financed.