FDA manipulates results to approve new cancer drugs

I’ve said it before and I’ll say it again: In the U.S., the only one calling the shots in the drug industry is the drug industry itself—and this goes right down to the research.

We give Big Pharma far too much control over its own studies. And considering they’re the ones who stand to profit based on the outcomes, I don’t have to point out why this is a problem.

Still, I couldn’t wait to tell you about this latest study, which drives home just how flawed and corrupt our current system really is…

Suboptimal controls maximize returns

I’ll get right to it: New research shows that, of all the cancer drugs that the Food and Drug Administration (FDA) has approved over the past five years, a significant portion made the cut due to flawed research that was skewed in their favor.

But this doesn’t shock me in the slightest.

The studies in question were identified as biased based on a “suboptimal control arm”—which means that the playing field wasn’t even when researchers tested these experimental cancer drugs.

Either the researchers had a limited choice of drugs for comparison, or they were using control drugs that are known to be inferior. And how does this happen, you ask?

Basically, the FDA sets the benchmark for a control treatment, against which experimental drugs will be tested for effectiveness. But by the time a trial actually begins, this benchmark is often already outdated—which only makes it easier to outperform.

So why wouldn’t drug companies do the right thing and design control arms for their trials that are more in line with the times? I mean, we’re talking about the health of millions of people, aren’t we?

Well, the answer is quite simple. Suboptimal control arms make it more likely that the experimental arm will see superior results—and more quickly, too. Meaning that Big Pharma can bring their new cancer drugs to market with as little time, expense, and inconvenience as possible.

And when we’re talking about a process that already takes years, it’s no wonder the drug industry—which is a business, after all—will look for ways to maximize the return on their investment.

Gaming the scientific system

This new study looked at nearly 150 FDA approvals of anticancer drugs between 2013 and 2018.

Of these, nearly 50 were excluded for only having a single experimental arm. The FDA approved the 96 remaining drugs based on results from 98 randomized, controlled trials. And of these, researchers deemed 16 to have “suboptimal controls.”

That’s nearly 20 percent—which is hardly a small proportion.

And most of this research didn’t even happen in the U.S. A good 15 of them were international trials. This is important because control drugs that are considered “standard of care” in the U.S. may not even be available in other countries.

(It also speaks to my personal experience—I was shocked at the number of drug companies conducting research at the Indian facility where I participated in a nutraceutical clinical trial.)

So what does all of this mean for us?

Well for starters, most of the anticancer drugs that are approved based on randomized, controlled trial results receive full FDA approval. In other words, they receive approval without conditions—meaning the FDA won’t be asking for any further research to confirm any clinical benefit.

This approval means that it’s a done deal—even if the control arm was suboptimal. That’s a nice profitable little loophole for manufacturers to set up, wouldn’t you say?

Of course, the real issue here is that numerous wildly expensive and potentially toxic cancer drugs are being hurried onto the market…even when they deliver no more (and sometimes, even fewer) benefits than the established standard therapies.

And yet, the same people singing their praises are the ones who will hang safe, affordable natural supplements out to dry—and discourage cancer patients from using them—every chance they get.

It’s not hard to design honest trials that deliver accurate results. That’s the whole point of clinical research, after all. It’s also the main reason why Big Pharma shouldn’t be calling the shots in the first place.

I’d ask what this world is coming to…if we hadn’t already been trapped in this flawed system for as long as I can remember.

P.S. Of course, when it comes to cancer treatment, questionable—and potentially dangerous—FDA approved drugs aren’t the only answer. That’s why I created my Essential Protocol to a Cancer-Free Future. This innovative learning program is filled with simple, science-based strategies to fortify your cellular defenses—and stop cancer in its tracks. Click here to learn more, or sign up today.

Source:

“Clinical Trials of New Cancer Drugs ‘Frequently Flawed’.” Medscape Medical News, May 02, 2019. (medscape.com/viewarticle/912523)