- There is no litigation precedent for failure to identify non-responders. There is a well defined system for adverse drug reactions. But what happens if we detect injury at a molecular level? I don't remember ever seeing a lawsuit for mildly elevated liver enzymes with a cholesterol lowering agent. But could there be? I would say that is a detector of drug injury. From the article:
Consider the hypothetical question, ‘‘Would you refuse to prescribe a drug
if a screening test predicts that the patient will be a non-responder who will not benefit from the drug, but not be harmed by it? Assume no alternative therapy is available
and the patient expresses a strong desire to attempt treatment with the drug.’’
Many physicians indicate they would be fairly likely to acquiesce with the patient’s request to try the drug. Similar acquiescence is seen in studies of how direct-to-consumer drug advertising affects prescribing decisions.
Interesting the same effect is seen in genetic testing. Which is why Myriad is shelling out for the campaign. Despite older studies showing that testing was not increased back in 2003. They hope that the newer data holds true. We'll see.
2. There is only a small risk of being sued if a drug demanded by the patient proves ineffective. There is a greater perceived risk of being sued by a patient whose condition worsens after a strongly desired treatment has been withheld. I personally know that this is an objection by several practitioners I have spoken with. "Why put myself out there?"
3. A few states do treat drug labeling as the standard of care, but many states treat it as just one factor to consider (see ref. 19, y7). Being the first to embrace a new technology carries risk, if there is no clear regulatory standard for courts to apply, and if the professional standard of care is mired in traditional practice. Today’s malpractice rules reward conformity, placing individual physicians in a poor position to lead the charge in applying efficacy biomarkers.
4. Clinical translation of pharmacogenomics may ultimately be a long, phased process that begins in niches where favorable legal conditions can be found. ERISA provides a favorable
niche that may make insurance reimbursement decisions the initial locus of clinical translation.
The Sherpa Says: This is an excellent written article illustrating the unknowns out there. I feel that there is even more out there that are "unknown, unknowns". While we are moving at light speed towards a personal genome, we need to step back and think about all of the legal implications that we may create.