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Sixty-one percent were voluntarily withdrawn from the market… but not until THIS YEAR!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.
Written By Dr. Richard Gerhauser, M.D.
For years he’s been the trusted doctor for celebrities, world-class athletes, and countless seniors looking to reclaim their health.
And now…for the first time ever… he’s making his medical breakthroughs available to readers all across America.
Dr. Richard Gerhauser, M.D. is one of the most pioneering and innovative minds in medicine today – and he delivers cutting-edge cures each month through his Natural Health Response newsletter.
Natural Health Response readers get full access to Dr. Gerhauser’s protocols for chronic pain… heart disease… diabetes… Alzheimer’s… and even cancer. These are the very same treatments Dr. Gerhauser recommends to his own patients at his practice in Tucson, Arizona.
In addition to being a board-certified medical doctor, Dr. Gerhauser has earned two master’s degrees and has served as a clinical professor at the University of Arizona.
And as a physician at the world-famous Canyon Ranch, Dr. Gerhauser treated celebrities from around the world who paid dearly for the type of next-generation health information he provides Natural Health Response readers each month.
View More Free Articles
If you’re missing the sun right now, you’re NOT alone. February is prime time for the winter blahs. The holidays are long over. The days are short. And many folks are fighting low energy, irritability, and, maybe most irritating of all, THE MUNCHIES. During the winter doldrums, folks pack on an average of five to...
Do you REALLY need to take a daily multivitamin? Well, that depends on you. If you’re eating an optimal diet of seasonal foods, then a multivitamin may be a waste of money. However, even the best diet may not be enough to obtain the nutrients your body needs. You see, as you age, your body...
When your health suffers, so does your sex life. As they age, this leaves many folks looking for a little extra “boost” in the bedroom. And there’s nothing wrong with that! In fact, intimacy can IMPROVE your health. Sometimes the issue is with your ability to perform. But all too often, it’s just your desire...
Yesterday, I warned you about how fast food harms your liver. But even if you’re NOT eating at Mickey D’s regularly, being overweight or diabetic can increase your risk of non-alcoholic fatty liver disease (NAFLD) and other deadly liver complications. Your best bet is to quit fast food. And to start eating a more natural,...
Your liver has a vital job. It filters toxins and other harmful substances out of your blood before passing it along to the rest of your body. That means it’s exposed to ALL the bad stuff you take in. The protection your liver provides for the rest of your body is literally lifesaving. But the...
Fat gets a bad rap. But your body NEEDS fat. It helps you absorb key nutrients such as vitamin D. It gives you energy and supports cell function. It even keeps your cholesterol under control. You just need to make sure you’re eating the RIGHT kind. When you choose wisely, fat can protect against heart...
Some people exercise because they like it. Some do it because they want to look good. Others work out because their life depends on it. This is especially true if you want to reduce your risk of heart disease or stroke. But to get the MOST heart protection from your exercise program, you’ll need to...
If you’re over 50, you should know THIS about your bones: If you’re not taking steps to make them stronger, they’re likely getting weaker by the day. That’s because once you pass 50, your bones break down faster than they form. This imbalance can lead to a loss of bone density, the development of osteoporosis,...
Melanoma cases have skyrocketed in recent years. With so many folks diligently slathering on sunscreen and staying indoors these days, have you ever wondered why? Well, a recent study identified a key nutrient that can DRAMATICALLY reduce your risk of melanoma—even in high-risk individuals. And this “surprising” discovery happens to highlight a troubling truth… What...