Is This Prescription Drug a SCANDAL?

Why is the FDA allowing ineffective drugs?

A few months ago, I told you about a new Alzheimer’s drug called Aduhelm. 

The FDA approved this drug despite the fact that it didn’t lead to any measurable benefit in cognitive function. 

In fact, initial studies were stopped early because the drug was unlikely to show clinical benefit. 

Worse, side effects like temporary brain swelling that led to headaches, confusion, dizziness, vision changes, and nausea occurred in 40 percent of the patients! 

How could the FDA approve such a dangerous, ineffective drug? 

It’s because of a loophole in the approval process. 

And unfortunately, a recent study revealed that a shocking number of ineffective drugs are still on the market because of this same loophole. 

It can take years for a drug to go through the approval process — years that an effective drug could be meeting an unmet medical need. 

So, the FDA developed the accelerated approval program to get an effective drug into the hands of the people it can help, sooner. 

Under this program, a drug or therapy can receive a provisional approval based on what’s called surrogate endpoints… like lowering the HIV viral load or shrinking tumors. 

These drugs still need to undergo further testing to confirm whether they provide any real benefit — like actually extending your life — but companies have nearly a DECADE to complete it. 

As you can imagine, most drug companies take their good ol’ time completing further testing so that they can keep raking in the bucks for as long as possible in case the FDA rescinds its approval. 

In fact, some never bother to complete the testing at all. 

Worse? Some of these drugs are still on the market despite being proven to be ineffective… and in some cases, deadly. 

A recent study published in the BMJ took a closer look at cancer drugs that had received accelerated approval from 1992 to 2020. 

It found that approximately one-third of cancer drugs remain on the market, despite follow-up studies showing they didn’t have any benefit. 

The researchers identified 18 indications for 10 cancer drugs that had received accelerated approval, but that did NOT meet the primary endpoint in post-approval trials. 

Sixty-one percent were voluntarily withdrawn from the market… but not until THIS YEAR! 

The remaining 33 percent are still on the market. 

In the 16 indications that actually completed a post-approval study, the primary endpoint was to determine if the drug extended overall survival time—which is exactly what it should be testing. 

(What do I care if my tumor shrinks if I’m ultimately not going to live any longer?) 

In the end, NONE of the drugs extended survival. 

Yet they remained on the market for YEARS after these studies revealed they had no ultimate benefit for the patient. 

The pharmaceutical companies didn’t pull the plug (no surprise there)… and neither did the FDA. 

This is a bad precedent. And unless the FDA actually starts doing its job, useless and potentially harmful drugs will continue to be prescribed to unsuspecting patients. 

Don’t be one of them. 

Before you start taking any drug, go the extra mile that your doctor may or may not go, and research it to see just how effective it is… or isn’t.