Saturday, January 31, 2009

All The Simple Diseases Have Been Solved

We have heard this claim a few times over the years. Drug discovery and development is much harder today because we have solved all of the simple problems. This quote is most recently shared by Paul Stoffels, head of drug R&D for JnJ, in a posting at the WSJ Health Blog earlier this week.

"All simple diseases have been solved", says Stoffels, in the context of describing the need for industry to look beyond their own walls for answers.

I agree with the conclusion -- pharma must partner to solve their current challenges. Partner with academia, and even with others in industry.

But is it true that we have solved all of the simple diseases? Or will history prove that we are still at the tip of a much bigger iceberg?

Medical Research Is About to Slam Into a Wall

Medical Research is at risk of slamming into a wall if smart people outside of drug development do not get engaged. This is the conclusion reached by Katie Hood, CEO of the Michael J Fox Foundation for Parkinson's Research, in a posting this week at the Huffington Post.

Hood does a great job of breaking down the impact of a faltering economy upon an already strained system. Pharma is axing researchers. Biotechs are at great risk for bankruptcy. Venture capitalists are retreating. Government is not prepared to pick up the slack. Private foundations lack the capital or scope.

Is a new role for the public sector needed to ensure that the current 10-15 years to develop a new therapy does not get longer instead of shorter?

Wednesday, January 21, 2009

Impact of DTC Advertising on Clinical Development

Going back to that age-old question within pharma: Does a pharma company "make drugs" or do they "sell drugs"?

Well, the truth of course is that this is a cycle and the research and sales halves of the pharmaco are dependent on one another. The commercial organization needs new products to sell and generate revenue. The research organization needs a percent of the revenue from sales to re-invest in new R&D.

So there is an up-side for clinical development when pharma use direct-to-consumer advertising as a tool to increase sales.

But there is certainly a downside. And Ken Getz from Tufts does his usual outstanding job describing the implications of public perception on clinical research. How have we contributed to the public's lack of understanding the risk of medicines and clinical trials? What role has DTC advertising played in painting the image of high-benefit / no-risk?

It may be a moot point -- if studies continue to mount showing DTC ads are "losing their punch" then the fate of DTC will be decided by the market.

Facebook for Clinical Trials (RU in a C/T?)

Now that the soft economy is making you think about enrolling in a clinical trial, how to best find one? At least one company is now thinking social media. While it may not hold the answer to recruitment for a specific trial, raising awareness for clinical trials can only help. (And maybe it will raise a few dollars for a good cause.)

Economy Causing Pain? Enroll in a Clinical Trial!

This month Forbes notes an interesting up-side for clinical development coming out of a down economy – individuals feeling a pinch in their wallets increasingly interested in participating in paid studies.

Studies that pay for enrollment are generally for health volunteers, and are typically performed at dedicated Phase I / clinical research units. Such units often have databases of subjects in their catchment area – including their “professional patients”.

But healthy volunteer studies, as with much of clinical research, was seeing a trend moving outside of the United States. The ability to recruit a more diverse sample of subjects at a reasonable cost and with good speed will quickly sum to reverse that trend.