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But FDA is only criticized for approving risky medicines - never for keeping beneficial ones off the market.

Neither the Congress nor FDA (nor the IOM) is willing to admit that the agency's most significant problems are mismanagement and excessive risk-aversion.

The motivation for most of these recent attacks on the FDA? That would be coming from the other squirming pigs wrestling in the pen, such as the large pharmaceutical and medical development companies, trying to make the most money they can from the suppression of competition and progress. They might be working on progress, but they're working just as hard at pushing new and better ideas below the waterline - so long as there's the threat that someone else will make money or threaten the bottom line for an aspect of their business model.

In the worst cases, such as Germany and France, you see entire countries that contribute next to nothing to the advance of medical science. This is not for lack of will or desire, but their research and medical industries are hamstrung by decades of destructive government intervention.

I think this is quite a new concept because not until recently have we begun to understand a little bit more about the aging process and find some biochemical pathways that are at the root of aging processes.

Now what do you see as the greatest challenges for developing drugs that deal with aging? Would you say that it’s more regulatory and policy wise, or is this more scientific?

I think there is both.

When I was heading aging at Glaxo Smith Kline, the issues that I faced were that I was very interested in developing medications for frailty and weakness in muscle for when people get old because when people get weak they usually stop eating and then they fall and break a hip and end up in the hospital and die potentially, but the regulatory apparatus isn’t there yet.

Sarcopenia isn’t recognized as an official disease by the FDA, so the pathway to get drugs approved for frailty and to get more people mobile and into society is just not there, and so it’s a really difficult problem, and the pathways for osteoporosis are still very cumbersome, requiring fracture analysis.

There isn’t an approved, for example, like Jack Coralnick uses a scale at NIH to test people’s function. I think there is a critical need to have the FDA to recognize some battery of functional tests

how a reform would take place

Well we have a new FDA now, hopefully, but it’s going to take companies and scientists going to the FDA and to Congress to say “look the patient population is aging and currently we have a bottleneck, we can’t get these medicines through” and try to work out some new policy. Hopefully, the FDA will be a little more progressive about looking at endpoints. They are very, very conservative about what endpoints they will accept

You know, there is understandably some concern that people might use these drugs and abuse them for muscle building, but on the other hand, there is a critical unmet need out there in the elderly population

Well one thing is that it is quite difficult and expensive to develop drugs for aging per se because even to do pre-clinical models in animals is very expensive. It’s very expensive to get aged animals, and they don’t necessarily act like aged humans. So even in the pre-clinical stage, it’s a difficult area to work in.

find pathways to get these drugs approved

a lot of these companies are concerned as being seen as trying to produce “fountain of youth” drugs. I made it very clear when I was leading aging at GSK that I was not attempting simply to extend lifespan

I think this is a policy challenge and a perceptual challenge and if you will, a public relations challenge.

Potentially, I think we need to find more intelligent, creative ways to do clinical trials using biomarkers or other types of measures where we can get the trials through quickly

again, it goes back to the FDA policy. The FDA is going to have to be willing to accept some of these things, or we will not be able to get these drugs on the market