Breakthrough cancer therapy-the good and the bad

by , under Contemporary Cancer Topics, Conventional Treatments, Pediatric Cancer, The Cancer Industry

Just about everything is relative.

A blister on your foot is bad, until you see the person who lost their legs.

This drug (CAR T-cell) sounds like a good deal, until you see that it’s probably about 50% effective, best case. That’s basically flipping a coin. The bad part is that there are some not-so-pleasant side effects associated with this new treatment.

One of the biggest downsides is that it costs a whopping $475,000. That’s basically a half a million dollars for a coin toss for a cure. And if you lose, that’s a lot of cash down the drain, not counting the side effects. In addition to that, about half of the patients who go into remission end up with cancer again later on down the road. What’s that about?

After reviewing this article, it seems to me that there should be better alternatives. Why, after all of the money and time spend on research, do these researchers and oncologists only have a few effective treatments, and then basically give up after they concede that their treatments have failed? In my mind, this is inexcusable. I think that it’s also inexcusable to the patient and her family.

For them to just give up is an admission that they have reached the limits of their treatment and research paradigms. If we admit that we know that something out there is a cure, it is the Medical Establishment’s job to find it. After more than 70 years of intense research, the question is why haven’t they found ANY of these cures? Think about it…

Learn 5 Things You Can Do to Stop Your Cancer COLD…


 

Breakthrough cancer therapy raises tough questions about drug costs, value (emphasis is mine)

Imagine a drug that, a month after a single intravenous dose, wipes out all evidence of leukemia in 80 percent of deathly ill children who receive it.

Now, imagine that the drug takes a month to make from each patient’s own immune cells, that many children die waiting, that it causes terrible temporary side effects, that it costs $475,000, and that the accompanying medical care adds vastly to that price tag.

Finally, imagine that a year later, the blood cancer has roared back in half of the children who had astounding remissions.

Smashcancer: So what’s the deal with the cancer returning? That’s powerful evidence to the fact that this treatment isn’t really addressing the cause of the cancer. It’s basically paying $475,000 for a temporary solution to a long-term problem. It’s good to go into remission, but I thought that the goal was a cure and not just a temporary treatment. If it’s not a cure, why is the price so high for a cancer cure crap shoot?

This isn’t fantasy. This is the profile of Novartis’ Kymriah, the first-of-its-kind CAR T-cell therapy. No wonder it has inspired awe, as well as deep concerns, that the benefits have been overstated and overpriced.

Smashcancer: I couldn’t have said it any better. The benefits are obviously being overstated and wildly overpriced. If an alternative cancer practitioner tried to charge this much for a crap shoot (at best) cancer ‘treatment’, he would be accused of being a quack and probably be facing prosecution. So why aren’t these people getting the same? Is one form of quackery more acceptable than others? Or is it that some quacks are government-approved, and others aren’t?

Novartis partnered with the University of Pennsylvania and Children’s Hospital of Philadelphia (CHOP) after researchers at those centers pioneered the technology to genetically engineer each patient’s immune T cells to attack blood cancer cells. On Feb. 1, the New England Journal of Medicine published updated results from the global clinical trial of 95 youngsters that led to the U.S. Food and Drug Administration’s August approval of Kymriah to treat recurrent acute lymphoblastic leukemia.

Reactions to the latest results reflect the scientific, economic, and emotional complexity of the breakthrough.

Vinay Prasad, an oncologist and drug development researcher at Oregon Health and Science University in Portland, said the update confirms his skeptical view of Kymriah’s value. He faulted the researchers for inflating their one-year survival rate to 50 percent by excluding kids who gave their T cells but never got treated because of manufacturing problems or because they died before they could get the therapy. By including those children—a standard statistical practice to minimize bias—Prasad calculated the one-year survival rate is 40 percent.

“It’s just a cheap way to increase your success rate that does not help patients navigate the decision of ‘how likely am I to benefit?'” Prasad said. “The math shows most patients who qualify for this do not benefit. And many other patients will not qualify. So CAR-T is good. It’s better than what we’ve done before, but not great.”

Smashcancer: So when do we get the great treatments? We’ve been waiting for decades for it…

John P. Leonard, an oncologist and lymphoma specialist at Weill Cornell Medical College in New York City, agreed that the survival data should reflect the fact that some patients who undergo T cell collection don’t get the therapy.

“When you leave out people who didn’t get the drug, it doesn’t get counted against the drug,” Leonard said. Including them “puts it in a little less rosy light. I think it would be valuable to present the data both ways.”

Dana Lee of Ocean Township, N.J., looks at the statistics “a little differently,” having seen the ravages of chemotherapy, radiation, and bone marrow transplantation on children like her 14-year-old daughter, Tori.

Almost five years ago, Tori became the 10th child to get the T-cell therapy in a pilot study at CHOP. She suffered the characteristic reaction—severe but treatable immune overstimulation, involving high fever, low blood pressure, muscle pain, neurologic symptoms.

She’s now an eighth-grade honor roll student who loves basketball—and dislikes getting attention for accidentally being a medical trailblazer.

One hundred percent of those children were not going to make it,” Lee said. “All options were gone. So it gave hope to parents and children who had no hope.”

Smashcancer: The above statements delineate the limits of these people’s paradigm. He has basically given up, consigned these patients to failure. What he really means is, “None of these children were going to make it, and all of the options that exist within our treatment paradigm are gone.” What he doesn’t say is that the only treatments that exist are the ones that we have found. This is because that would expose the agenda. Obviously, they haven’t tried every possibility, or any possibility outside of what they think they know. If their paradigm for finding a cure was correct, they would already have it. But they haven’t because their paradigm has one or more errors inside. Can you see that?

About 6,000 cases of pediatric lymphoblastic leukemia are diagnosed each year in the U.S. and in Europe, where Kymriah approval is imminent. Standard therapies cure 85 percent. For those that repeatedly relapse, the prognosis is grim.

David Mitchell, who has an incurable blood cancer called multiple myeloma, understands the power of desperation, and is thrilled by the advent of CAR T-cell therapies that might one day help him.

But as the founder of the advocacy organization Patients for Affordable Drugs, Mitchell says Kymriah developed with government subsidies—is overpriced by “hundreds of thousands of dollars.” That sets a dangerous precedent, he said, given that dozens of CAR T drugs are in the pipeline. (Two pricey gene therapies were approved after Kymriah: Kite Pharma’s $375,000 Yescarta for a type of lymphoma, and Philadelphia-based Spark Therapeutics’ $850,000 Luxturna for an inherited form of blindness.)

“The key question is not: What’s it worth to save a child’s life?” Mitchell said. “If that was the question, then the polio (vaccine) they gave me when I was 6 years old would have cost a million dollars. The right question is: What is the price that will maximize accessibility and affordability, while maintaining a robust R&D pipeline?”

In contrast, another organization that assesses drug effectiveness and value, the Institute for Clinical and Economic Review, concludes that Kymriah is cost-effective: “On average, using Kymriah in a pediatric population instead of traditional chemotherapy increases health care costs by approximately $400,000, but extends life by eight years.”

Smashcancer: So what do we have to do to get the extension of life to indefinitely instead of just a mere 8 years? All of the side effects point to the fact that the treatment is injurious to the body. You can’t cure people by injuring them, can you? That’s like trying to build up the body by damaging it. It’s an oxymoron, and a blind spot in this treatment philosophy.

Anticipating controversy over the price, Novartis announced that it wouldn’t charge for Kymriah if the patient doesn’t respond within a month of treatment. (Penn and some of the key scientists stand to benefit financially from the Kymriah partnership, according to the university.) But critics say that deal is rigged, since 80 percent of patients go into remission, even though at least half later relapse.

Controversy has not dampened demand for Kymriah. Stephan Grupp, the CHOP oncologist who has overseen clinical testing of the drug, traveled widely to set up the global trial, conducted at 25 specialized medical centers in North America, Europe, Japan, and Australia. Now, invitations are coming from other parts of the world—rich and poor countries alike. Because of the complexities involved in making and administering the drug, only hospitals certified by Novartis can offer it.

“I have been traveling far more than my wife would approve,” Grupp said recently by phone from Dubai in the United Arab Emirates. “We (CHOP and Penn) get all these emails from parents across the world. We’re trying to look at access. We’re really interested in figuring out how to help patients who won’t have access in their own countries, at least not for years.”

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