I saw reports in PharmaGossip and Fierce Biotech on a new study published in Health Affairs that says new drugs are becoming less and less effective against disease as judged by their relative effectiveness versus a placebo. Wow. This isn't good.
The authors looked at 315 placebo-controlled clinical trials (across many diseases) that were published in 4 major journals between 1966 - 2010. They found drugs in the 70's were 4.5x beter than a placebo, somewhat less than 4x in 80's, only 2x by the 90's and in the most recent decade only 36% better. In other words a steady decline and a suggestion of more and more incrementalism in development philosophy. When you consider about $100 B is spent annually on clinical trials, that ain't too good.
Experts are uncertain why this may be the case. Several explanations have been put forth:
- The low hanging targets were exploited in 70's and 80's. Subsequent targets are more minor compared to root cause of the disease
- Patients who volunteer for clinical trials over time have become worse off, i.e. the really sick people volunteer in hopes of a cure because nothing conventional has worked
- Quality of data has improved over time so that new data better measure the true impact, i.e. the compounds are looked at more closely
Regardless of explanation, the effect does look real. It should send shivers up the spine of developers as more and more emphasis going forward should be placed on comparative effectiveness research. If drugs can't show clear benefits then one woudlexpect resistance by payers to using them.
That would be bad for the drug industry certainly -- particularly given the high prices/revenues the new drugs bring in incrementally.
Posted by Bruce Lehr June 4th 2013.