Immunotherapy drugs are considered the latest and greatest breakthrough in conventional cancer treatment. Chimeric antigen receptor technology (CAR-T) has raised a great deal of hope, and an equal measure of concern.
CAR-T involves genetically reengineering a patient’s immune cells to target tumor-associated antigens, thereby destroying the malignant cells.
Alas, while these therapies appear to be quite effective at attacking and destroying malignant cells, they can also take a toll on healthy tissues and organs, leaving many patients struggling for their lives, albeit for an entirely different reason.
There’s also another important issue at stake here. CAR-T cell therapies such as the one developed by Novartis (see below) have been granted PRIME1 (Priority Medicine) status by the European Medicines Agency (EMA).
PRIME is similar to the Breakthrough Therapies program2 offered by the U.S. Food and Drug Administration (FDA). Both of these priority medicine programs aim to speed up approval of novel drugs in order to bring hope to patients for whom there is little or no hope.
While this is admirable, it’s also a slippery slope that can end up affecting people with non-lethal diseases as well — people who are NOT quite as keen on playing Russian roulette with their health for a chance of survival.
Immunotherapy Drug Trials Show Severe Side Effects Are Common
According to an article in the NY Times:
These so-called immunotherapy drugs have been hailed as a breakthrough in cancer treatment, attracting billions of research dollars and offering new hope to patients out of options. But as their use grows, doctors are finding that they pose serious risks that stem from the very thing that makes them effective. An unleashed immune system can attack healthy, vital organs: notably the bowel, the liver and the lungs, but also the kidneys, the adrenal and pituitary glands, the pancreas and, in rare cases, the heart.
A study3 published in 2010 found that ipilimumab — an immunotherapy drug that blocks cytotoxic T-lymphocyte antigen-4, used against advanced melanoma — caused severe side effects in nearly 20 percent of patients.
Another study4 published in 2015 found adverse events in 24 percent of patients receiving ipilimumab, and when used in combination with nivolumab, another immunotherapy drug, severe adverse reactions occurred more than half the time.
Despite that, the study, funded by Bristol-Myers Squibb, concluded that the combination therapy “had an acceptable safety profile.”
Most recently, a study5 published this summer found 30 percent of patients receiving either pembrolizumab or nivolumab suffered “interesting, rare or unexpected side effects” from the treatment.
No less than 242 different side effects were noted in all, including skin, gastrointestinal, liver, endocrine and renal system effects, diabetes mellitus and pancreatitis. One-quarter of these reactions were severe or life-threatening and required hospitalization.
Novartis is now seeking approval for CTL109, a drug shown to be effective against pediatric B-cell acute lymphoblastic leukemia.6 In its phase 2 study, 82 percent of pediatric and young adult patients experienced complete remission.
However, for many the victory was short-lived. Six months later, 40 percent of them had relapsed. Some of the side effects were also severe. Fifteen percent of patients experienced grade 3 neurological and psychiatric events, including encephalopathy (abnormal brain function) and delirium.
Adult Leukemia Trial Put on Hold After Additional Deaths
Juno Therapeutics7 is working on an immunotherapy for adults with refractory B cell acute lymphoblastic leukemia.
Its phase 2 trial was recently placed on hold for the second time this year following the death of two patients who developed cerebral edema, just days after receiving their treatment.8 One of the patients was under the age of 30.
In July, the FDA ordered a clinical hold on the trial following the death of three patients. They too died from cerebral edema. As reported by CNN:9
“… [I]nvestigators pinpointed the likely culprit as the addition of fludarabine to the pre-conditioning regimen. Fludarabine is a chemotherapy drug used here as a one-time primer for treatment … in an effort to increase the effectiveness of the experimental therapy.
In this particular course of treatment, pre-conditioning consists of a heavy dose of chemotherapy to kill off existing cancer cells in order to give the new cancer-killing T-cells room to grow.
It’s like hitting a reset button to restart the immune system. But an unforeseen interaction between fludarabine and genetically modified JCAR015 cells proved to be lethal.”
The trial was given the green light to resume in August — this time without the use of fludarabine. Still, two patients are dead from the same exact problem as the initial three, suggesting the chemotherapy drug wasn’t the problem after all.
Brad Loncar, founder of a cancer immunotherapy fund told STAT News10 that Juno was “going way too fast. It’s just terrible. They’ve killed a couple of people, and it seems like, in part, it’s because of the rush to judgment.”
Out-of-Control Immune System Attacks Healthy Organs
The New York Times (NYT) recently published a very comprehensive article well worth the read that details the struggles of Chuck Peal, who took part in a melanoma study at Yale. He received the ipilimumab with nivolumab combination.
Type 1 diabetes typically strikes during childhood, but these drug-induced cases involve older patients who very suddenly lose all of their insulin production. As reported in the article:11
“He slipped in and out of consciousness, his blood pressure plummeted, his potassium levels soared and his blood sugar spiked to 10 times the normal level …
[He] spent 24 days in the hospital … First his pancreas failed, then his bowels inflamed and his kidneys became dysfunctional, and ‘to top it off, he has a fever of 103 for which we can’t find a source,’ Dr. [Harriet] Kluger said in an interview during the crisis …
Peal’s body was attacking itself, a severe reaction by his immune system that was a side effect of a seemingly miraculous cancer treatment aimed at saving his life … [A]s their use grows, doctors are finding that they pose serious risks that stem from the very thing that makes them effective.
An unleashed immune system can attack healthy, vital organs: notably the bowel, the liver and the lungs, but also the kidneys, the adrenal and pituitary glands, the pancreas and, in rare cases, the heart.
Doctors at Yale believe immunotherapy is causing a new type of acute-onset diabetes, with at least 17 cases there so far, Mr. Peal’s among them.”
Playing With Fire
According to Dr. John Timmerman, an oncologist and immunotherapy researcher at the University of California, the use of immunotherapies is a dangerous game. “We’re playing with fire,” he told the NYT, shortly after losing a female patient to the treatment’s after-effects.
Weeks after the drug sent her cancer into remission, she suddenly developed cold and flu-like symptoms that quickly killed her. The real cause of death? A massive, out-of-control inflammatory response mounted by her altered immune system. As reported in the featured article:12
“[W]ith lives to be saved and billions of dollars to be made — $250,000 or more is the list price for a year of some regimens — not enough research has been done into the risks of the new therapies, said William Murphy, [Ph.D.,] a professor of dermatology at the University of California, Davis, who reviews immunotherapy-related grants for the government.
It is ‘a massively understudied area,’ Murphy said, adding: ‘The No. 1 priority is anti-tumor effects. Everything else, however severe, is considered the price worth paying.’”
Indeed, according to Murphy, only three of the 500 research proposals he reviewed were focused on toxicity. We see the same problem in other drug and vaccine research as well. Drug developers are primarily interested in finding out if the drug works. Is it effective? However, if a drug is effective in treating the ailment at hand, yet kills the patient, what has been gained?
Breakthrough Therapy Program Raises Stakes for Patients
The FDA’s Breakthrough Therapy program (and the European PRIME) worsens the situation. By rushing approvals, toxicology research ends up lagging even further behind, which means more patients end up being used as guinea pigs without actually being enrolled in a formal study.
This is a particularly frightening prospect in light of the fact that drug developers are increasingly starting to look to vaccines (categorized as “biologicals” by the FDA) as the pharmaceutical product of choice for all sorts of ailments. Clearly, drug companies want vaccines to largely replace prescription drugs as a primary source of profit-making because there’s no product liability in civil court when toxic vaccines cause serious brain and immune system damage, even if people die.
This month, Congress and the U.S. Supreme Court went one step further in giving the pharmaceutical industry a free pass when it comes to requiring drug companies to provide solid scientific evidence that experimental drugs and vaccines are effective and will not harm people before they are sold and used by millions of Americans.
After two years of influence peddling by more than 1,000 pharmaceutical industry lobbyists determined to lower FDA licensing standards, Congress passed the 21st Century Cures Act so that new drugs and vaccines can be fast-tracked to market without holding large clinical trials to prove safety and effectiveness.13
As for immunotherapy drugs, we’re already seeing these treatments being put to use by oncologists who are completely unprepared to address the multitude of unusual side effects. As noted by Timmerman, the oncologist who lost a patient to flu-like symptoms:14 “If we had only known the power we had unleashed that was causing such a toll on her organ system, we might have saved her.”
Watch The Video:
How is Immunotherapy Used to Fight Cancer?
A quick note from our founder-
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I bet you can’t guess which muscle in your body is the #1 muscle that eliminates joint and back pain, anxiety and looking fat.
This “hidden survival muscle” in your body will boost your energy levels, immune system, sexual function, strength and athletic performance when unlocked.
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d) Hip Flexors
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To begin, I apologize for the dark nature of today's email.
However I promise what you'll discover today will be completely worth it.
Imagine a rotting corpse draped over your body from head to toe...
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In April, 2009, researchers stunned the medical community when they reported chronic inflammation as the root cause of several major diseases.
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Is Bread Really the Staff of Life… or the Stuff of Disease?
For most us, there are few foods more comforting than bread.
Fluffy biscuits, crusty baguettes, flaky croissants… even a simple slice of toast topped with melted butter can taste like heaven.
And that smell… few scents are quite as pleasant as fresh bread baking in the oven.
But there is a lot of confusion as to where bread fits into a healthy diet.
The Bible practically commands followers to eat it: “Give us this day our daily bread…” The government put it at the base of the food pyramid. And for centuries, it has been called “the staff of life.”
Of course, there are some who disagree…
Well-known cardiologist, Dr. William Davis, calls wheat “the perfect chronic poison.”
And for a poison, we sure eat lots of it…
The average American consumes 55 pounds of wheat flour every year, making refined flour the #1 source of calories in the American Diet – a situation that nutrition expert Chris Kresser describes as, “a public health catastrophe.”
So, what is the truth about bread and wheat?
- Is it the perfect poison… or an essential daily food?
- Is “gluten-free” bread better for you than regular bread?
- And can you still eat bread… while maintaining a lean body and optimal health?
The answers to these questions may surprise you!
Be sure to read #5 – the biggest surprise of all!
Recently, Doctor of Naturopathy, weight-loss expert and best-selling Amazon author Liz Swann Miller, creator of the Red Smoothie Detox Factor, revealed 2 of the secrets to easy, steady weight loss. Secrets the big food corporations do their best to hide from us.
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You probably know most of us eat too much processed food. What you may not know is that it’s full of toxic chemicals and substandard, dirt-cheap ingredients designed to make you eat more…and force you to gain weight.
Here’s how it works.
“That stuff is just a lot of calories your body can’t use,” Liz told me, “Some are poison. And all these foods are stripped of the anti-oxidants and anti-inflammatories that help your body detox. The result? Your body expends huge amounts of calories to eliminate some toxins—the rest, it stores in your fat to protect you. This is why most people are hungry all the time. They’re not getting energy they need.”
“So… what’s going on with me? Why am I losing weight but not going hungry?”
Liz paused, then dropped the bombshell.
Your body is designed to burn fat. You just have to let it.
“What? I thought we were designed to store fat?!?” We were Skyping and I was practically shouting. Then I heard Liz say…
What good is a fat reserve if you can’t burn it?
Liz continued: “You’re drinking smoothies packed with phytonutrients, anti-oxidants and anti-inflammatories that pull toxins out of you like a tractor beam. Allowing your body to burn those toxin-filled fat stores… and releasing tremendous amounts of stored energy.”
So that’s why I’m losing weight without going hungry.
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- Which calories help you lose weight…and which ones help you gain it…
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Sponsored Health Resources
In the years that I've been working on this website project I've come across some amazing resources by some very special people. I'd like to share them with you here.
NOTE: I update these links often so please check back to see what's new!
1) Everyone knows green smoothies are healthy right? Have you heard of a “red” smoothie? If not, check out this story…
2) Forget what you've read about 10-day lemonade cleanses, 7-day detoxes with green juices and Gwyneth's gruel. All you need to do, and this is perfect for Saturday or or anytime really, is a simple 1-day cleanse.
3) This “hidden survival muscle” in your body will boost your energy levels, immune system, sexual function, strength and athletic performance when unlocked.
4) I thought it was virtually impossible for a website to be able to tell me anything even a little bit insightful after only submitting my name and date of birth... I was wrong!
5) Turmeric is amazing. The problem is - It's hard to absorb!
6) Wonder why your stomach still sticks out even though you're hammering the core exercises every day? It's a common myth that bulging belly is due to weak abdominal muscles.
7) Even if you're the most active of athletes, you may still suffer from tight hip flexors due to the amount of time you spend each day planted to a chair.
Enjoy! Let me know how these work out for you. And if you run across anything I've missed please let me know.