Is America facing an innovation crisis? Lilly CEO John Lechleiter says "YES!" in a speech delivered before the Detroit Economic Club. He cited a study by Information Technology and the Innovation Foundation. In the study, the US was ranked 6th out of 40 in innovate-based competitiveness but a shocking 40th (or last) in taking steps to maintain its innovative edge in the future.
Lechleiter called for 4 main US government policy changes to combat this perceived issue:
- Broad improvement in science and math education
- Immigration laws that permit top foreign scientists to work in the US
- A well-funded basic research infrastructure in academic and government labs
- Tax policy that fosters innovation
See PharmTech Talk blog for more.
Some commentators, notably Derek Lowe in his In the Pipeline blog, noted a certain inconsistency between Mr. Lechleiter's comments and Eli Lilly company actions. Lilly has been very aggressive in outsourcing R&D jobs/projects to India and China. Wouldn't this be counter to 4 point plan above?
Regardless of the whether this is right cure, there does seem to be a problem (unlikely of Lilly's making with or without its outsourcing policies). The innovation gap appears real. But is it due to people working on new innovations, or is it caused by the fact that the disease targets that Big Pharma is now chasing are much harder to address? Diseases like cancer (really a spectrum of diseases) and Alzheimer's. Interestingly, several Big Pharma companies just announced that they would be sharing results of their failures with Alzheimer's drugs in hopes that they will help each other better understand the disease (I think this is the type of innovation we need - OPEN innovation).
Fierce Biotech's coverage of Megan McCardle's analysis in the Atlantic poses deceptively simple question, Are fewer drug approvals a result of R&D being harder field to work in now? The low hanging targets are gone. New therapies must be an improvement on existing therapies versus enterng virgin territory with the first therapy. Plus, being the nth drug in class, means that the safety hurdles are higher since safe existing therapies are already approved.
This line of reasoning might argue that innovation gaps aren't the result of lack of quality scientists as implied by Lechleiter's reasoning, but may be a result of the bar being raised on technical difficulty of finding new cures in complex areas and increased regulatory hurdles - environment versus people causation. She also throws in the little kicker that the genome project hasn't really accelerated new discoveries at this point - at least in terms of new therapies on the market. This is at least an alternative hypothesis.
I think the innovation gap will much more likely be solved by intelligent people and companies working together. The drugmakers, NIH, FDA and Science foundation coalition (alluded to above)that has joined forces to look at Alzheimer's by sharing patient data on over 4000 patients -- will go a lot further toward promoting innovative treatments in my view than the changes in government policdy requested above - although some of those suggestions (math & science education, & immigration reform) might be good ideas to implement as well.
Like the FDA's Joshua Sharfstein says, "I think the FDA recognizes that one thing that can accelerate drug development is sharing information that is relevant to a disease." Amen.
Posted by Bruce Lehr June 18th 2010.