I first wrote about the so-called “21st Century Cures Act” several months ago, after it passed the House. I said then that it should scare your pants off—that while it promised to “modernize” the drug approval process, it would really set medicine back a hundred years in many ways. At the time, the bill was meeting some opposition in the Senate and so had been broken down into several smaller bills in an effort to shove them through on the quiet.
A few weeks ago this atrocious Act reared its ugly head in the Senate again. And quietly, with no fanfare, while the whole of the country was caught up in the post-election insanity that’s infected us this year, the Senate hammered several more nails in the coffin of our right to make our own medical decisions. The 21st Century Cures Act has now been passed by both houses of Congress. It only needs the President’s signature to become law. And considering that the present occupant of the White House still has more than a month left in his term, there’s little doubt that this will happen.
This may be the biggest blow to our health that I’ve seen in my lifetime.
This Act will let Big Pharma test new drugs on you WITHOUT YOUR KNOWLEDGE
I’ve talked briefly about what’s in this Act in other articles, and there’s plenty to make your hair stand on end. I’ve told you about how it’s taking the science out of drug trials—how it will allow researchers to use slippery information like case histories instead of controlled studies to get new drugs approved. That’s bad enough.
But it’s not the worst part of this goody bag Congress just handed Big Pharma. The worst thing is how it changes the use of informed consent, and how that plays with the other parts of the law. The relevant change is only one sentence. It’s 32 words long. But it effectively gives Big Pharma the right to test any drug it wants on you without your even knowing it.
Now, I’m not saying that Big Pharma could set up a covert drug trial and randomly dose people with untested drugs. It’s not impossible, but it’s highly unlikely. What I’m talking about is just as sinister, though. I’m talking about drug manufacturers “partnering” with doctors’ offices and hospitals to test new drugs on patients without their knowledge or consent.
It would be easy.
Just 32 words change all the rules
Here’s how the rules did work before the Dangerous Drugs—that is, 21ST Century Cures—Act:
- Researchers testing new drugs had to show they were “qualified by scientific training and experience” to “investigate drug safety and effectiveness.”
- They had to give “preclinical” testing (such as animal testing) reports to the FDA, and these reports had to show that the drug had promise.
- The manufacturer or sponsor of the drug had to have a signed agreement from each “investigator” in the project. This agreement said that patients would be directly under their supervision OR the supervision of another investigator accountable to them.
- Manufacturer and researchers had to agree that they wouldn’t give the drug to anyone else to use on people. That included other researchers running other trials, clinics, or anyone else. This was to ensure that untested drugs weren’t being handed out to “needy” patients before the drug was approved.
- The manufacturer/sponsor had to keep records of the trial, and give the FDA a full report with their approval application so FDA could evaluate safety and effectiveness.
- The manufacturer/sponsor also had to give the FDA a statement saying whether or not they intended to test the drug in children.
Now, how all of this will work now that we’re allowing “alternative” evidence rather than randomized trials is anyone’s guess. But it’s the change to the final part of the rules that’s really chilling.
Currently, the law says that anyone enrolled in a drug trial—whether they’re getting the actual drug or a placebo—must be informed that the drug is investigational. That is, that it’s a new, untested drug and they’re guinea pigs. At least, they have to be told unless it is "not feasible" or "contrary to the best interests of such human beings."
But the new law changes this. The current 2-exception list, it adds "or the proposed clinical testing poses no more than minimal risk to such human beings and includes appropriate safeguards as prescribed to protect the rights, safety, and welfare of such human beings.”
So who decides what’s “low risk”? Big Pharma, of course
Stop for a minute and let that all sink in.
What it means is that you can be given an untested drug—a drug that might or might not work, a drug whose safety really isn’t known, a drug that might have any kind of outcome—as long as it’s been decided that it “poses no more than minimal risk.”
It doesn’t say anything about who decides this. It gives no guidance at all. And it says that there have to be “safeguards” to protect your “rights, safety, and welfare,” but again doesn’t say what those safeguards might be or who puts them in place.
So here’s what could happen: You have cancer. You go to an oncologist, who just happens to be partnered with a drug maker for a new cancer drug trial. The drug hasn’t been safety-tested yet—this is a phase 2 trial. It hasn’t been tested for effectiveness. There’s another drug that has been shown to work, but you don’t get it—or even get told about it. Instead you’re given the new drug. And the trial runners have determined that it doesn’t “pose a significant risk” so they don’t have to tell you you’re a guinea pig.
But the drug doesn’t work. You die…even though there was another drug out there that worked and you’d have chosen that option if you’d been told the drug you were taking was “investigational.”
Say you have diabetes. You could go to your regular doctor for a routine diabetes prescription refill. He tells you he’d like to change your prescription. There’s another drug he thinks will work better than what you’re taking. Because you trust the doctor to know best, you go along with it.
What he doesn’t tell you is that he’s part of a trial for a new, untested diabetes drug. He doesn’t have to tell you because it’s been decided that there’s “minimal risk.” A month later you have a heart attack, thanks to the investigational drug. It never makes it to market, thankfully, but that doesn’t help you out. You already had a heart attack.
This could happen, folks. This will happen, at some point. So from here on out, if you’re offered a prescription, there’s one more question you need to ask your doctor.
“Is this an ‘investigational’ drug?” If so, say thanks but no thanks.