Bioethicist Arthur Caplan says early access to drugs should not be determined by drug companies but by independent advisory boards
Arthur Caplan is the William F. and Virginia Connolly Mitty Professor and founding head of the Division of Bioethics at New York University Langone Medical Center in New York City. He holds a doctoral degree in the history and philosophy of science from Columbia University, has authored or edited 32 books and more than 600 papers, and has served on national and international committees as an adviser on ethical issues related to biology and medicine.
Q: You seem to have some ideas about how to improve the system we now have for patients with serious illnesses to receive experimental, unapproved drugs.
A: I would like to see things move away from media campaigns that try to pressure companies to be the solution. That's not a system. It's a competition, and it encourages really nasty behavior, even including death threats to the CEOs of companies.
I think we need a template for people to use to prepare their case, to say why they want the drug. I think a standardized application for access to an unapproved drug for use by the public is needed. Any threats or bullying should disqualify a request. There needs to be protection against this type of unethical coercion.
We need to have people who can play the role of independently advising the CEOs of companies. We can't have these decisions made by individual CEOs or individual corporate boards of directors, because they all have conflicts of interest. An independent board of patient advocates, scientists and ethicists could be used, and if a company agrees to utilize such a board, it would be bound by what the board decides. If they say yes, it's yes; if they say no, it's no.
Q: Do you think the current expanded access mechanism is a workable one?
A: I think the system can work, but the problem is that it's a threat to finishing trials. Perhaps the independent board could help a company with funding for supplying an unapproved drug without threatening the integrity of ongoing clinical trials.
Q: Where would such funding come from?
A: It could come from a tax on the pharmaceutical and biotech industries and the medical device industry. The government could contribute too, through a tax on the public. Perhaps a foundation would help support the creation of an independent, expert review board and help fund those who cannot afford unapproved drugs or devices.
The American people need to decide how compassionate they want to be rather than tolerating having a yelling contest on the Web. Compassionate use [another term for expanded access] is not really a decision for a CEO, but for the American people. In my view, compassion is really a public problem, not an FDA problem or a CEO problem.
I'm disturbed that we never heard a word from politicians about compassionate use in all the health reform discussions. They're quick to jump in when it doesn't cost them anything. But if you want to be compassionate, you have to put money behind it. You have to say that there is a certain amount of money to help. Compassion isn't free. It isn't just a question of who can be heard yelling "Give me something."
Four Perspectives on Expanded Access
This article is part of a Web-exclusive series titled Four Perspectives on Expanded Access, which includes the following articles: