Only government stands in the way of the death of cancer
By Joselin Linder November 8, 2015 | NY Post | See Original Here
[COMMENT: I believe each of us can write a book in response to this article. Perhaps we should. (ARE)]
Forty-four years ago, President Richard Nixon declared a War on Cancer. Most people don’t realize it, but we’ve already won it, says Dr. Vincent DeVita.
In his new book, “The Death of Cancer” (Sarah Crichton Books), DeVita, the first to develop a curative chemotherapy protocol for adult cancer, writes that only bureaucracy stands between “cancer, the killer” and “cancer, the chronic but survivable illness.”
“At this date we are not limited by the science,” he writes, “we are limited by our ability to make good use of the information and treatments we already have.”
RISE OF CHEMO
During the Vietnam War, DeVita joined the National Cancer Institute. At the time, the field was small and few new doctors wanted to take a run at a game that was rigged to lose.
DeVita saw something different.
Cancer treatments were limited to disfiguring surgeries, such as radical mastectomies, or mostly doomed-to-fail radiation treatments. But a small group of researchers known as chemotherapists were making headway toward thwarting cancers by poisoning them with chemicals.
Working under pioneering researchers Dr. Emil Frei and Dr. Emil Freireich, DeVita witnessed the birth of a new protocol. By using a combination of drugs on leukemia-infected mice, the mice were cured of the disease.
It was a breakthrough. However, there was immediate pushback from the medical community for whom the concept of mixing more than one drug together was nothing short of “sloppy medicine.”
When they sought approval for human testing, particularly children with leukemia, there was an outcry.
“Using more than one highly toxic drug, in children,” writes DeVita, “and in children who were already suffering, was unfathomable.”
Yet eventually the therapy, by then known as VAMP, an acronym for the medications’ active ingredients, was cleared for trial. Desperation trumped caution.
A young teenage girl DeVita knew from the ward became nearly paralyzed from the VAMP regimen she’d been given. She was near death and living on a ventilator.
But several weeks later she began wiggling her toes, and then finally left the hospital in full remission. She taught the researchers an important lesson: Extreme nerve damage is reversible. Death is not. A party was held at the institute upon her release.
It was the first time in the history of childhood cancer that children were finally going home.
In 1969, the public at large remained unaware that cancer was no longer absolutely fatal. Even though some cancer patients were staying in remission long-term, there was little public discussion.
Then one day, Mary Lasker, a socialite and philanthropist, sent DeVita a patient: A World War II general named Luke Quinn, a friend of the Lasker’s, had been misdiagnosed with an untreatable gallbladder cancer. In fact, Quinn had lymphoma.
DeVita had spent the last few years refocusing his energy on figuring out a way to do for an adult cancer what his mentors Frei and Freireich had done for childhood leukemia. He thought Hodgkin’s lymphoma was an excellent candidate for chemotherapy.
Throughout the 1960s, radiotherapy had been the only hope of Hodgkin’s patients, for whom one-third of very-early stage patients might survive to enjoy a normal lifespan.
DeVita and his partner, Jack Moxley, came up with a chemotherapy regimen for Hodgkin’s that didn’t destroy bone marrow at the same rate VAMP treatments did. Unlike leukemia patients, Hodgkin’s patients needed their bone marrow to survive.
However, DeVita found himself in the crosshairs of a willful medical community. Firsthand he saw how ego, fear and greed played as big a role in medicine as saving lives. Hospitals purposely changed key components of the medicinal protocol, unable to accept that they had ever been wrong about outdated ingredients in chemotherapy like nitrogen mustard. In their defense, very little was known about cancer — how it worked, why it occurred, therefore writes DeVita, “A sense of powerlessness surrounded it, even among scientists.”
In the end, DeVita and Moxley were finally allowed 14 patients to conduct a fair trial.
“If you didn’t see promising results in 14 patients,” he explains, “the odds were you wouldn’t, even with more.”
Their results came swiftly. Twelve of their 14 patients went into complete remission.
The regimen DeVita and Moxley had built was toxic by any measure. Patients quickly grew sick with vomiting and weakness. Still those that had been near death were surviving. A colleague of DeVita’s asked him if his patients still spoke to him after treatment. He answered confidently, “Yes, and for a lot longer.”
When he attempted to get his treatment plan out to hospitals at large, DeVita realized he had his work cut out for him. Although dying patients were willing to risk the toxicity of the treatment, doctors able to prescribe it were concerned about being sued.
“Patients couldn’t push for higher doses if they didn’t know that it mattered,” DeVita points out, “and all a doctor had to do was omit that information.”
When General Quinn came along, a seemingly lost cause, and DeVita saved his life, Mary Lasker’s sudden interest changed everything.
The following year, she and a panel of her devising issued The Yarborough Report — whose sole mission was to convince Richard Nixon to create a national cancer authority. The report asked for a whopping $1 billion between 1971 and 1976 in order to develop a total cure for cancer in time for the nation’s bicentennial.
Ted Kennedy put forward the bill in the Senate. Popular advice columnist Ann Landers, motivated by Lasker, posted a letter to her readers asking them to write to their senators and pass the bill to cure cancer. The Senate was swamped with more mail than it had ever received. The bill passed handily and on the day before Christmas Eve 1971, Nixon signed it into law — though for a much lower amount, $100 million.
One item in the Yarborough Report had asked that the FDA no longer oversee the approval of cancer related drugs. However, that item was dropped before the bill came before the committee. According to DeVita this one small change was, “a failure that would dog the National Cancer Program well into the future.”
The problem with the FDA and cancer treatments is that they view cancer drugs the same way they looked at any drug. If you’re developing a drug to treat a non-life-threatening issue, then yes, you have to be sure the “cure” isn’t worst than disease. But since cancer is so often a death sentence, the bar should be lower, DeVita argues. Side effects usually are preferable to death.
Furthermore, the FDA doesn’t only account for safety they also look for efficacy. DeVita feels this is an unforgivable overreach for a group of unqualified bureaucrats.
The reason for their zealousness goes back in the FDA’s own history. Many consider the FDA’s greatest accomplishment to be avoiding the international devastation wrought by a drug called thalidomide. In the 1950s, thalidomide was approved in more than 20 countries, for morning sickness during pregnancy. One FDA agency official named Frances Kelsey wanted to hold off on approval when she saw that it had an impact on the nervous system.
As the thalidomide babies were born with underdeveloped and deformed limbs, Kelsey was hailed as a hero. Afterward, the FDA took their watchdog status to heart. They tightened their regulations and began rewarding their staff for mostly saying no.
“Under the current regulations, the FDA can approve a drug for, say, one kind of cancer but restrict the use of the drug for another kind of cancer,” writes DeVita. He believes such practices, among others, are detrimental to the advancement of cancer treatments as a whole. He also points out that innovative researchers are now at the mercy of the staff of the FDA, regardless of how much the individual knows about cancer.
In 2008, a new drug for melanoma was slated for trial. Up until then, widespread melanoma was almost completely fatal. The drug, PLX4032, was already seeing positive results. Complete remissions abounded and the drug itself was viewed as being safer than old nearly non-effective treatments.
However, in 2009 the FDA ordered the pharmaceutical company to do a comparison trial pitting the old useless drug against the new.
“This was both absurd and unethical,” says DeVita — as it was basically serving a death sentence to half the people in the trial.
What the FDA wanted to show was that the new drug outpaced the old drug in effectiveness. But who cared? What was needed was to figure out was how to make the effective drug even better.
It took another three years to approve it. For people with six to 12 months to live, that’s just not quick enough. What’s more, cancer treatments tend to work in groups, unlike drugs for other conditions that are specific to treating one thing. Often cancer drugs don’t work alone. Many of the newest, most sophisticated treatments are designed to enhance other drugs — but according to the FDA, they must be tested alone, leading to many expensive and unnecessary failures.
DeVita believes the responsibility of reviewing cancer drugs should be taken out of the hands of the FDA. Rather he hopes the nation will establish a new, independent cancer-specific department designed to aid in the development and release of new treatments.
“People are dying not because drugs don’t exist but because they can’t get them,” he writes.
WHAT WE’RE MISSING
By 1976 cancer was supposed to have been cured. The bicentennial came and went, and the birthday present promised by Lasker and Nixon had not been delivered. The media and public at large wanted answers.
While it’s true that in 1976 cancer treatments were still evolving, the direction that they were going was the correct one.
DeVita sees the problem as one of semantics. He believes the future of cancer is not one where it’s cured, but where it’s managed.
When it comes to testing treatments, he feels, “It is unrealistic to see survival as an end point.”
Right now, drug tests are principally done on those who are very near death. And many of these drugs require test subjects with younger and fewer cancer cells.
Solely testing on the dying and nearly dead who have far more cancerous cells to battle is misleading when it comes to the potential of a new cancer treatment.
But there are high walls to tear down.
In 1988 doctors still treated all breast cancers with radical mastectomies. However a far less invasive treatment called a lumpectomy had been tested with successful results. But before doctors were willing to turn to this new treatment, they step-stoned on a procedure called a modified radical mastectomy.
It took less tissue than a radical mastectomy but not as little as a lumpectomy.
The problem was not just fear, but also cost of treatments. Truth be told, doctors could make a lot more money on a mastectomy than on a lumpectomy. For the doctors, there was little incentive to change their practices.
The same greed remains a factor in upgrading cancer treatments today. In fact, most cancer treatment centers find it difficult to build bridges between each other, making each of the “best” cancer treatment centers in the country only the “best” for treating one type of cancer at a time. DeVita suggests that calling out who is best at what will probably make him some enemies, given that what he is saying is that they are deficient at dealing with any other cancer.
For example, he includes the Mayo Clinic, which he says is great at treating common tumors. However, he writes, “I wouldn’t send someone there who needed something creative or inventive.”
Of NYU’s Perlmutter Cancer Center he says brain tumors are their forte, “but not much else.”
Yale is good for T cell lymphomas, Sloan Kettering for lymphomas, and MD Anderson in Houston is best at adult leukemia therapy. But each of these is only the best until a better treatment comes along. And it’s hard to stay on top.
What’s worse, if only a dozen places are equipped to deal with certain cancers, then that means many more are unable to deal with them at all.
What DeVita wants is for more of these centers to collaborate from the outset. Cancer care, he says should not be rationed.
Today drugs already exist that can hit a very specific target “and by being so specific,” DeVita explains, “they have fewer side effects.” What’s more, if these drugs can be given to every patient that needs them right now, he claims, “we would cure an additional 100,000 patients a year.”
Since Nixon’s National Cancer Act, $100 billion have been spent on cancer research. Although all of the potential behind the scenes has yet to make it to the mainstream, we are winning the war against cancer.
Since 1990, the already declining overall mortality statistics for cancer have dropped an additional 25%. Breast-cancer mortality has seen a 25% decline, with prostate cancer declining a full 68% and even more for leukemia and lymphomas.
According to an independent analysis DeVita mentions from the University of Chicago, these lives have added $10 trillion to the American economy.
An article by Bob Weinberg and Douglas Hanahan first published in 2000 and updated in March 2011 in a leading scientific journal, proclaimed that all cancers share six specific traits. DeVita believes that understanding these six traits has already had a profound impact on the study of cancer and its treatments.
In 2010, a new treatment for multiple myeloma, a fatal cancer, finally saw a large percentage of patients enter remission and stay there.
“Not only are cures happening more often,” DeVita writes, “but in the cases in which they’re not, cancer has become for many people, a chronic, manageable disease — not a killer.”