Thursday, August 09, 2007

Court Limits Access to Experimental Drugs for Terminally Ill

In a rather bizarre twist, a federal court has just ruled that there is no constitutional right to experimental drugs for those who are terminally ill and have no other options. "Terminally ill patients desperately need curative treatments," Judge Thomas B. Griffith wrote for the majority. But "their deaths can certainly be hastened by the use of a potentially toxic drug with no proven therapeutic benefit." [...] While I understand the conclusion that was reached, the rationale, if one can even call it that, is paternalistic, at best, and downright irrational on its face.

On the one hand, I can understand the demand for access to a novel compound when there is otherwise no hope. On the other, remember the House of God adage, “They can always hurt you more?” While drugs might prolong a person’s life, they might also make it far more miserable than it would have otherwise been. I have seen that far too many times.

There are also problems from the pharmaceutical’s perspective in allowing such expanded access, beyond the obvious liability issues. 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.

What happened to the concept of an individual’s autonomy? For example, I support Oregon’s right to die, or Death with Dignity Act. If there were unlimited supplies of these drugs, I would leave it to the individual, after presentation of an “informed consent,” to reach his or her decision regarding the desirability of taking an investigational medication. But there aren’t unlimited resources. Thus, ideally, perhaps this decision should be left to the patients and the individual sponsors to negotiate based on the availability of different resources.

What do you think?

For other reading, try:

The Right to a Trial by Jerome Groopman, one of my favorite authors! [New Yorker]

Court Rules Out Terminally Ill for Tests [Associated Press]

Should Dying Patients Have A Right To Use Experimental Drugs? [Justice Talking]

No comments:

Post a Comment

Post a Comment