Friday, March 4, 2011

Can the NIH Innovate Faster than Industry?

So it’s come to this: The federal government plans to entice industry with basic bench, and maybe even clinical trial results, to spur drug development.

Concerned that so few promising drugs are in the pipeline, that let alone meet FDA standards, the NIH is setting up a new research shop. Anticipating that penny-pinching Republican House members may give him a hard time about his idea, NIH chief Frank Collins is willing to “cannibalize other parts of the health institutes to bring more resources to the new center,” says the Times.

“There are some people that would say this is not the time to do something bold and ambitious because the budget is so tight,” he told the Times. “But we would be irresponsible not to take advantage of scientific opportunity, even if it means tightening in other places.”

For those who need a recount: The FDA approved 21 drugs in 2010, 25 in 2009, and 24 in 2008. No drugmaker, says Fiercebiotech, had more than one drug approved last year. The approval rules are getting tougher: We all saw what happened with the obesity drugs. Collins said in the Times article that industry’s “productivity has been declining for 15 years.”

It doesn’t look like many drugs will be approved this year: The Street said in January that 26 were in the queue and one’s already been rejected: Contrave, the obesity drug.

Industry is all tied up in what it considers a bad situation. While profits are increasing for some members, companies choose to focus on patent expirations, tough regulators – on both sides of the Atlantic – the new U.S. health care reform, and no doubt myriad other issues.

Fiercebiotech penned the apt phrase: A wave of impatience has crashed over the drug development and discovery business.

How did we get here? Another phrase is apt: The perfect storm.

Pharma’s past behavior forced overregulation, which added more costs to R and D. And since no one in discovery appears willing to give up its quest for innovation – read blockbuster – the costs of discovery continue to rise. So mergers and acquisitions make sense, which in our experience has drained talented R and D personnel.

So, academic researchers and advocacy groups may be the ones who drive new innovation, but it's doubtful they'll have enough funds to see any product through all the regulatory challenges. It appears to us no one is reconciling the priorities with the limited dollars available.

In our opinion: Drug research is too inefficient.

Industry critics continue to scream that pharma spends way too much on marketing and has no reason to cry poor mouth. This may be true: But the fact remains that collaboration in pharma is still a business, and pharma must answer to a board of directors, shareholders and its own future. As for the NIH, do we have evidence that research dependent on the federal government for basic bench research is the way out of this mess?

We believe both parties can find new ways to conduct research and conduct clinical trials. We just began working with a company that's ready to break down some of those challenges. We suggest this type of communication, knowledge management and performance measurement tool can help all parties involved in research. 

A comment from researcher Hugo Geerts posted on the Fiercebiotech article regarding the huge dependency on animal studies is another excellent point to consider.

His suggestion: Pharma should use more computer-based mechanistic disease modeling.

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