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The FDA Kills

Comment

It would be nice if politicians and regulators left us alone. But they don't. They always want to do more. Recently, there have been shortages of some medicines. Cancer patients can't get drugs they need. Why not?

One reason is that a big drugmaker shut down for a year in part to meet Food and Drug Administration rules. The FDA makes it so expensive and difficult to sell drugs that there isn't an eager pack of companies rushing to the fill the gap. The free market would provide that, but government intervention, such as low Medicare reimbursement, strangles it. So people suffer.

Does the FDA say it's sorry for its part and back off? Of course not. Regulators almost never do that. In fact, the FDA wants more power.

It wants to regulate how your doctor uses his smartphone. I'm not kidding! The FDA wants the power to approve mobile medical apps that let doctors monitor patients' vital signs over their phones. As one doctor put it, "Even though I'm away from the hospital, I can still look at ... real-time wave form data just as if I were at the patient's bedside."

Sounds great. It makes doctors more efficient. But the FDA basically says, "No, you just can't put something on your phone if it's a medical device. What if it doesn't work right? We have to approve it first."

That caution makes sense to people. Our first instinct is to say, "I don't want someone getting rich off a device that might not work right. It might kill me. I want the FDA to make sure everything is safe and effective."

But lawyer Jonathan Emord says our instinct is wrong.

"It is wrong because these regulations are costly, burdensome, and they prevent essential medical apps from getting into the marketplace," Emord said.

But an app might kill me.

Emord said that although many medical apps are available, there is "not a single complaint that someone has died or been seriously injured by a single one."

But what's the harm in running apps past the regulators?

"There is so much corruption at the Food and Drug Administration ...

so much anticompetitive bias."

The FDA takes bribes?

"Almost," Emord explained. "If you feather the right nest, you will do well for yourself after you leave. This is well known."

This is known as "regulatory capture." A regulator makes it tough for some company's competitor and then gets a job with the first company when he leaves his government job.

There's a big cost to the public when companies submit applications and then wait years for FDA approval.

"We're losing time, precious time that lives are dependent upon," Emord said. "MIM Software developed a simple mobile device that would combine MRI images, PET scans, CAT scans all together and produce a super image that was better for diagnosis ... right on your phone. To get that through the agency, it took two and a half years and cost some hundreds of thousands of dollars. All the while it could have been in use, and ultimately it was approved."

Lawyers and reporters encourage bureaucrats to move slowly. If something goes wrong, the media make a huge fuss about it, and the class-action parasites pounce. But when the FDA delays a device for years and people die, we don't report that. We don't even know who the victims are.

Useful HIV drugs were available in Europe for years before the FDA approved them for use here.

A doctor at the Cleveland Clinic invented a medical app that helped physicians calibrate the amount of radiation to give to women with breast cancer. The FDA demanded so much extra and expensive proof of its safety that he abandoned it.

The FDA's caution leads many companies to just give up on potentially lifesaving ideas.

Yet I don't hear companies complaining.

"If you raise your head above the parapet and you become vocal in your criticism, the FDA remembers like an elephant and will stamp you out of existence. They'll punish you. It's so much discretion in their hands. They sit like emperors reigning over this stuff."

John Stossel is host of "Stossel" on the Fox Business Network. He's the author of "Give Me a Break" and of "Myth, Lies, and Downright Stupidity." To find out more about John Stossel, visit his site at <a href="http://www.johnstossel.com" <http://www.johnstossel.com>>johnstossel.com</a>. To read features by other Creators Syndicate writers and cartoonists, visit the Creators Syndicate Web page at www.creators.com.

COPYRIGHT 2011 BY JFS PRODUCTIONS, INC.

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Comments

1 Comments | Post Comment
I am a medical student and I don't know how many medical students, residents and physicians that can't understand this principle. If you keep an effective drug or device off the market you are hurting people who would otherwise use it. Of course we want safety precautions and testing, the question is who gets to decide.

Is the FDA the only source that can tell us if a drug is effective? Most competent physicians look at published research about the efficacy of new drugs (even after they have been approved by the FDA) to see if they are right for their individual patients. I don't think anyone would suggest clinical research would disappear without the FDA or that the only research that would occur would be by the drug companies themselves. Besides, drugs companies also have an interest in avoiding lawsuits as well as maintaining their market base so they have an incentive to put out safe drugs.

Yes, there will be people who will engage in sneaky behavior or release a drug that is unsafe hoping to not be found guilty. However, the degree to which patients would be harmed due to that problem in a truly free society compared to the number of patients harmed by failing to release efficacious drugs because of the FDA is minimal.

If you accept the idea that the government should be involved in this in the first place, the FDA should be mostly a sort of government endorsement agency. They could make their own label that goes on the products they deem safe/effective and leave it to consumers to decide if the label matters to them. Realistically you could have private entities do that more effectively instead (like they do with so many safe/effective products we use) and let people be free to trust or distrust published product reviews.
Comment: #1
Posted by: Zack
Mon Nov 14, 2011 1:59 PM
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