Knowing Which Patients Will Benefit Beforehand

In the past I've had discussions with some in the pharma industry about the fact that medicines only work for a percentage of the patients who take them. "Wouldn't it be nice to know beforehand who would benefit?" I would ask. "Not really," they might reply. "If only fifty percent benefit from my drug and we knew which patients would benefit beforehand, my market would be cut in half."

I've always held the opposite view. Look how hard it is to get the FDA to approve a new drug, insurers to reimburse it, physicians to prescribe it, patients to take it and continue taking it, and you can see how each of these hurdles would be lessened with better predictive information.

The FDA would be more likely to approve a drug that helps virtually all patients. The price could be set higher. If the pharmacoeconomics were stronger, reimbursement would be easier. Physicians would be more willing to prescribe a drug they know works. Instead of patients shying away from a 50/50 gamble, they might happily go for a sure thing.

Patient persistence and compliance are atrocious. (I've looked at markets where 75 percent of the patients drop off their "chronic" cardiovascular therapy by the end of the first year.) After all, why keep taking a drug that doesn't work for you?

Knowing beforehand which patients will respond to a drug ameliorates each of these significant impediments. And not surprisingly, this is the new paradigm in the pharma industry and is the reason that some drugs and companion diagnostics are released simultaneously. Consider Pfizer's new NSCLC drug Xalkori and the companion Vysis ALK Break Apart FISH Probe test from Abbott. The FDA approved the two together because Xalkori is indicated for locally advanced or metastatic NSCLC in patients whose tumors are ALK-positive. They go together naturally and symbiotically.

Related Entries:

keep in touch     Follow Us on Twitter  Facebook  Facebook

Our Research

Rhetoric and Reality—The Obamacare Evaluation Project: Cost
by Paul Howard, Yevgeniy Feyman, March 2013

Warning: mysql_connect(): Unknown MySQL server host '' (2) in /home/medicalp/public_html/incs/reports_home.php on line 17
Unknown MySQL server host '' (2)


American Council on Science and Health
in the Pipeline
Reason – Peter Suderman
WSJ Health Blog
The Hill’s Healthwatch
Forbes ScienceBiz
The Apothecary
Marginal Revolution
Megan McArdle
LifeSci VC
Critical Condition
In Vivo Blog
Pharma Strategy Blog
Drug Discovery Opinion