Please God No

I got an email from Consumer Reports today advocating tighter regulation of medical devices by the FDA.  Here is my response with a copy of the original email below:

This approach would simply raise the costs and increase the time associated with getting medical devices into the hands of the people that need them most.  We have already seen how the FDA approval process for drugs has slowed innovation and increased time to market by decades.  The last thing in the world that I want to see is this failed model super-imposed on medical devices.

_________________________________

Dear ,

It's a nightmare scenario. The implant that fixed your knee or your heart may actually be a ticking time bomb that could disable or kill you.

This isn't science fiction. Millions of medical devices including artificial hips, contact lens solution, heart stents, and pacemakers are being recalled - 700 different products a year.

And the vast majority of recalled products were never safety tested in humans, because the manufacturers claimed they were "similar" to products already on the market.

Tell Congress we don't want to be guinea pigs anymore!

Every new prescription drug must undergo rigorous testing on humans before it can be sold, even if it is similar to another drug already in use. Not so with medical devices. Because of this loophole in our safety laws, more than 90 percent of medical devices aren't safety tested before being sold nor are they routinely tracked afterwards to identify safety problems.

For example, a metal hip implant marketed by Johnson & Johnson was approved in 2005 without first undergoing clinical safety trials. It was recalled five years later after having a 1 in 8 failure rate in the UK, and releasing potentially toxic metals into the body. Countless patients had to undergo a second, painful 'revision' surgery.

It's time safety standards for medical devices are as strong as those for prescription drugs! E-mail your members now!

The device industry has unleashed an army of lobbyists and they don't want things to change. It will take a wave of consumers weighing in to make sure medical devices are safe and effective. Please take action, then forward this to friends and family. Thank you!

Sincerely,

Jim Guest

President, Consumer Reports

101 Truman Ave

Yonkers, NY 10703

What Do You Consider Speech?

Can the government ban pornography?

Can the government impose morality laws on Hollywood?

Can the government prevent the Metropolitan Museum of Art from displaying Robert Mapplethorpe?

Can the government stop the publication of The Pentagon Papers?

Can the government outlaw donations to the Communist Party?

Can the government ban the showing of Hillary the Movie 30 days before an election?

Can the government ban Fahrenheit 9/11 30 days before an election?

Can the government control what 3 brothers say about a politician?

What if those three brothers are a union?

What if those three brothers are a cult?

What if those three brothers are an LLC?

What if those three brothers are a Corporation?

If your answer to those questions isn’t either all ‘yes’ or all ‘no’ I would love to hear a rationale explanation as to what the difference is – because they all seem the same to me.

Technorati Tags: free speech,Citizens United

Libertarian Prospects for Office

Underneath the Beltway has an interesting post on the impact of the Barr Presidential run on long term Libertarian Party prospects for relevance.

with the selection of Bob Barr as it’s nominee, the Libertarian Party received more mainstream media news coverage than at any other point in it’s history. And it was specifically because of who the candidate was. Not only was it due to the fact that there was no small degree of media fascination with the idea of a former Republican Congressman (and not just any Congressman, but one who had led the Clinton Impeachment drive) was running as a third-party candidate, it was also due to the fact that Ron Paul’s candidacy had brought attention to libertarian ideas, and the LP had selected a candidate that was both media- and politically savvy. It was, as many observed at the time, a smart choice for the LP

As long as the LP keeps embracing an all-or-nothing approach to policy they will continue to be marginal fringe has-beens.

Too many people see too many libertarian ideas as wacky, especially from a policy standpoint.

The only way that a libertarian-like party can ever gain any relevance is to approach marginal changes to mainstream views.

Run on a platform that takes the best of the right and the best of the left, perhaps throw in something that is new. But adopt something too radical and no one will take them seriously.

What they really need to do is adopt a populist rhetoric around libertarian ideals. Denounce corporate welfare. Frame regulation as monopoly enhancing. Create villains that can be rallied around. But that isn't every going to happen because most LPers are nutjobs.