Constitutional Health Network:
Why the 21st Century Cures Act Should Scare Your Pants Off

When we accepted the “Affordable Care Act”—when we didn’t stand up en masse and simply refuse to comply—we sent a very clear message to all the Big Guys. The message was this: as a country, we’re willing to do whatever we’re told. Even when it violates our rights. Even when it’s not in our best interests. Even when it costs us money we simply don’t have. And even when it hurts our health.

A lot of oppressive health laws have passed in the wake of the ACA, and more have been proposed. But there’s a piece of legislation on the table right now that should shake us up, wake us up, and light the fire under us that the ACA failed to kindle. It’s called the “21st Century Cures Act,” and if you care about your health or your family’s health it should scare the living crap out of you. Here are just a few of the things this bill proposes:

It would give your private health information to researchers

That’s right. Your medical records would be fair game to any researcher who wants them. Section 1124 directs the Department of Health and Human Services to change current HIPPA rules. The new rules would treat sharing your information with researchers just like sharing it with another “health care operation.” It also would specifically allow “remote access to information by researchers.”

It would track “medical devices”

“Medical devices” covers a lot of territory. A pacemaker is a “medical device.” A Watchman heart implant or an arterial stent is a “medical device.” Certain bits of hardware used in orthopedic repairs—like having a hammertoe or bunion fixed—are “medical devices.” And Congress thinks that all these “medical devices” should be tracked. They think that a “unique device identifier” should be recorded in our electronic health records so that manufacturers can have better “postmarket surveillance.”

That’s all well and good, up to a point. If this “unique identifier” is a serial number, great. That would make it easier to track things like device failures and might result in inferior products being pulled from the market. But considering the bombs tucked into the rest of this bill, the “unique identifier” is more likely to be something like a microchip. Something that can be used not just to identify faulty products but to monitor us by monitoring our devices.

And if that sounds like pure conspiracy theory, remember that we now have antidepressants with electronic monitoring devices embedded. And more pills like this are about to hit the market. Why not medical devices too?

It would let Big Pharma test drugs on you without your consent

Currently, you must give consent—informed consent—for any medical procedure unless you’re completely incapacitated. If you’re unconscious and your arm is chopped off, the ER docs will stitch it back on, but otherwise you have to sign a consent form. This applies to everything, even clinical trials.

This bill would change that.

There’s been a lot of talk floating around the internet about this topic. People don’t like it, even those who are somewhat in favor of this monstrosity of a bill. But I don’t think anyone has really absorbed just what a monumental change this could be. Because interpreted literally, this change could allow Big Pharma to test new drugs on whoever it wants, whenever it wants, without the subjects’ knowledge or consent. Here’s what the bill actually says:

[Informed consent can be waived for clinical trial subjects if] “the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject.”

Stop for a minute and think about that. Let your imagination run wild. Consider all the insanely dangerous drugs we have on the market. We live in a country where drugs can kill people for years and not get more than a safety warning on the package insert—if we’re lucky. So who will decide if there’s more than “minimal risk”? The FDA—which will be completely powerless if this bill passes? The pharma company manufacturing the drug? The third-party company running the trial?

What this sentence says, on the face of it, is that as long as there’s not more than a “minimal risk,” Big Pharma can test out drugs on you without your ok. It’s bad enough that we act as guinea pigs once a drug comes to market. At least in that case we know we’re taking something. But interpreted literally, this clause could allow Big Pharma to run COVERT drug trials without the subjects’ knowledge.

Now THAT is scary.

Congress is trying to pass this bill on the sly—don’t let it happen!

This bill is several hundred pages of insanity. It would allow “clinical observation” to be used to approve new drugs and devices instead of requiring formal studies. (Remember, this is Big Medicine’s complaint against alternative medicine—there are few clinical trials, just observation. But if this bill becomes law, Big Medicine and Big Pharma will get a pass.)

It would make clinical trials even shorter and smaller than they already are, meaning many more dangerous drugs would make it into our medicine chests. It pushes vaccine development. It promotes creating new antibiotics but has rules so lax that any kind of poison could be approved. And then it proposes to pay hospitals to prescribe them.

There are so many bad things about this bill that I could take an entire week to talk about them. It passed the House last year by a landslide and went on to the Senate, where it met some opposition. Those of us in the general public who knew about this bill were, of course, violently opposed. So the Senate has done something really underhanded. They’ve broken it down into multiple smaller bills, which they hope to sneak through while we’re all distracted.

We can’t let that happen. Not unless we want to take a giant step backward by a hundred years or so, when any snake oil salesman could peddle his wares without fear of consequences. And not if we want to keep any shred of medical privacy. Here’s a list of the baby bills this monster has been split into:

  • S. 2030 The Advancing Targeted Therapies for Rare Diseases Act
  • S. 1622 The FDA Device Accountability Act
  • S. 2014 Next Generation Researchers Act
  • S. 800 The Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act
  • S. 849 Advancing Research for Neurological Diseases Act
  • S. 2503 Preventing Superbugs and Protecting Patients Act
  • S. 2511 Improving Health Information Technology Act

Contact your Senators today and tell them you oppose all these bills. Tell them you oppose the 21st Century Cures Act in any incarnation, and any bill that works to achieve the same goals no matter what it’s called. Don’t let this bill be the new Obamacarewe can stop it if we work together. We defeated the DARK Act already. And we can defeat this too.

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