Make Haste Slowly, Please

Let's say you've developed a nifty new medical device, and -- best yet! -- you've gotten some venture-capital financing to help you bring this product to market. How many regulatory hoops should you have to jump through to start selling it to the patients who need it?

What if you're one of those patients? More hoops, or fewer?

Or if your nifty device doesn't work? Or has side effects you hadn't been aware of?

Different answers, maybe?

Today's New York Times carries an article by Barry Meier and Janet Roberts on the expensive lobbying efforts by venture capital firms to reduce the regulation required to bring new devices to market.

According to the Times article, venture capitalists and device manufacturers "argue that the FDA suffers from high personnel turnover, an unwieldy bureaucracy and a regiment that forces start-up device companies to run new and costly tests constantly, often duplicating past efforts."

But that's only one side of the story, isn't it?

The reporters quote the editor of Archives of Internal Medicine, who said that venture capitalists operate under "this unwritten assumption that every new device is innovative." But the reality, she added, is that some devices "are killing people or causing significant harm."

I've written about more than one of those devices in the past -- the cone-beam CR scanner that may be exposing children and adolescents to excessive radiation (post, here) and the DePuy hip replacements whose metal-on-metal design is failing early far too often, requiring painful and extensive additional surgery (post, here).

The House seems more interested in the manufacturers' and investors' concerns, however:

Since February, four House panels have held hearings on the impact of FDA procedures on device approval. At those sessions, 19 of the 26 listed witnesses were investors, entrepreneurs, industry consultants, trade group officials or patients who said that agency delays in approving a device had harmed them or a loved one. The list included no patients injured by a flawed device; one hearing the Senate had a more varied witness list. [emphasis added]

One investment fund manager is quoted as saying, "This is about survival... We are deeply concerned about the future."

Shouldn't they be "deeply concerned" about the "survival" of their patients?