New Law Makes Prescription Drugs Even More Dangerous
We’ve been hearing about it for something like two years. One version after another has been proposed, tweaked, and loaded with enough pork for a Congressional barbecue. Each time, it gets sent back for more tinkering. Now, with a regime change on the horizon and the very real possibility of finally repealing the (un)Affordable Care Act, it looks as if this law might finally pass. In fact, by the time you read this it may already be too late to stop it—if there was ever a chance in the first place.
Public Citizen calls it a “grab bag of goodies” for Big Pharma and Big Medicine. I call it the Dangerous Drugs Act. Congress calls it the “21th Century Cures Act” and if it passes, taking a prescription drug will be like playing Russian roulette with your life.
It has NOTHING to do with cures
We already have big problems with pharmaceutical drugs—and I’m not just talking about the crazy price tags. Most drugs have more side effects than you can shake a stick at. For many, the side effects may be much more dangerous than the condition they’re supposed to treat. Like cholesterol drugs that give you diabetes. Diabetes drugs that give you cancer. Psoriasis drugs that can kill you. There’s an almost endless list.
At present, drugs have to go through three sets of clinical trials before they can be approved. The first supposedly shows they’re safe. The second and third must show they’re safe and effective. But the FDA’s definition of “safe” is nothing like yours or mine (or we wouldn’t have diabetes drugs that can cause cancer). And neither is their definition of “effective.”
For most new drugs on the market, there’s an older, safer drug that’s just as effective…but not as expensive. That’s because new drugs don’t have to show they’re more effective than what’s already on the market—or even that they work as well. They can fail in drug trials over…and over…and over…and still be approved eventually. We’ve seen this many times recently.
And not only do the not need to be more effective than what’s already out there, they really don’t have to show they’re effective at all if there’s enough social pressure on the FDA. This has happened twice in the past year, with the “little pink pill” for women and more recently with the Duchenne Muscular Dystrophy drug that the FDA itself says does nothing. These were approved purely because “patient groups” lobbied the FDA to approve them.
The FDA is for sale.
This bill will make the situation much, much worse. It will make it even easier for Big Pharma to get useless, dangerous drugs approved with little or no evidence that they work. Because, as the law itself says, it’s all about getting more drugs on the market and getting them there as fast as possible.
This law will let Big Pharma sell you anything
Here’s a hint that this law won’t be good for your health: nearly 1,500 lobbyists had a hand in writing it. It’s over 900 pages. Those 900 pages are full of creative ways to steal your tax dollars and line Big Pockets with them. But the most disturbing part of the law—the part that really makes my blood run cold—is this:
It basically does away with the scientific process when it comes to drug and “medical device” testing.
Yes, drugs would still have to go through trials, but the law also says that FDA must consider “real-world evidence” when deciding whether to approve a drug. This means anecdotal evidence might be used. Observational studies. “Ongoing safety monitoring” (we see how well that works out at present), registries, and patient-centered outcomes (or pressure from patient lobbying groups, if we’re being honest) are all mentioned. In other words, if this law passes, powerful drugs and dangerous or intrusive devices could be approved on less evidence than what we currently have for many “alternative” medicines that science scoffs at.
Or to put it more bluntly: we get to take the place of lab rats.
The law would also allow Big Pharma to market drugs for multiple conditions without having to get additional approvals. Right now, if Big Pharma wants to market a drug to you as a heart drug but it’s only been approved for diabetes, they have to go back and get a second approval for the new use. This law would do away with that. Once approved, they could legally market a drug for whatever they want.
What could possibly go wrong?
And antibiotics get their own special treatment. They can be approved through very small, very short trials with tiny numbers of people. Stem cell treatments get a special deal with very lax rules. Instead of having to show some real benefit, they can rely entirely on “surrogate endpoints” to show they work, and can relegate safety testing to “post approval studies.”
The saving grace of this law, supposedly, is that it pours some money into the National Institutes of Health…but that’s not strictly true. It does allocate money to NIH. But the cash is spread out over many years, and—get this—Congress has to vote to release the funds each year before they get it.
If you expect the drugs you take to be even moderately safe, then this bill goes against your best interests. It’s designed for one primary purpose—to ensure that Big Pharma keeps raking in the bucks at the expense of your health.
Don’t sit back and take this.
Contact your Congressman or woman today and tell them you oppose the 21th Century Cures Act. Tell them that the bar for pharmaceuticals has been lowered enough, and that lowering it more is no better than going back to the days of snake oil. And if we’re too late—if this monstrosity has already passed by the time you read this—take it a step further. Contact the president himself and urge him not to sign it. The safety of your future medicine depends on it.
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