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Assembly Line Medicine

October 2014

By William Faloon

Why Brain Tumor Patients Are Denied Valganciclovir

Why Brain Tumor Patients Are Denied Valganciclovir  

It is illegal for the maker of valganciclovir to promote it as a treatment for brain cancer. The regulatory system in the United States requires that the maker of a drug conduct extensive clinical trials for each disease a drug claims to treat and then submit the trial results to the FDA for approval.

It is not illegal, however, for an oncologist to prescribe valganciclovir to treat glioblastoma.

The problem is the annual cost for valganciclovir is around $50,000. Many health insurers will refuse to pay this outlandish price. If an oncologist tries to prescribe it for a patient it will not be one of the insurance company’s “recommended regimens,” and the oncologists will likely lose his $350/month stipend because he or she did not adhere to the treatment protocols designated by the insurer.

We fear that 12,000 Americans will continue to die prematurely from glioblastoma every year despite impressive findings showing that valganciclovir could extend the survival times of many of these patients diagnosed with this deadly disease.136

Industry Actuaries Guide Your Cancer Treatment
Industry Actuaries Guide Your Cancer Treatment

The practice of medicine has largely devolved to a place where physicians no longer take the lead in guiding treatment.

Consider a scenario that plays out day after day in modern cancer treatment.

An experienced oncologist sees a Medicare patient suffering from an aggressive cancer. The oncologist realizes that there are several viable options, and that the best therapy is not the usual, cost-effective standard-of-care choice covered by Medicare. Rather, it’s a more expensive and newer option with compelling data that shows better results. However, the newer, more expensive treatment option—the one that’s best for the patient in the opinion of the treating oncologist—is not standard of care and therefore, is not covered under Medicare.

The result?

The patient is treated with the Medicare-approved drug. In this case, the federal government’s actuaries at the Center for Medicare & Medicaid Services have been the guiding force in treatment of this patient, not the experienced oncologist.

Changing Cancer Care For The Worse

What we are seeing before our eyes are physicians who will give up years of education, creativity, and understanding of the individual patient to instead be directed by an insurance company and rewarded with a monthly stipend of $350 if he or she follows the insurers financially biased “orders.”

The term now used for physicians in such a context is “provider.” They provide the treatment, but are not involved in deciding what treatments to use. Thus, the physician has given up his or her role as “Decider” to become the “Provider.”

The $350/month per patient could possibly be a significant income for the oncologist. Assume that oncologist has 400 active patients and that 100 of them are on the insurers “approved” chemo program. That’s $35,000 per month or $420,000 per year. In most major cities, that’s about what the average medical oncologist makes annually. If the oncologist surrenders his decision making to the insurer, he is doing less work and has fewer worries regarding patient outcome since he was only “following orders.” The insurance company decided on the regimen. Thus, the trade-off to surrender physician autonomy for a substantial monetary reward that involves less stress on the physician becomes an irresistible temptation for far too many highly educated and highly trained medical oncologists.

Another concern is what will the insurer decide regarding the use of supportive care therapy, such as antiemetic and immune protective treatment prior to chemo. What will the insurer mandate regarding which imaging studies can or cannot be done, what laboratory studies are to be obtained and how often, and which immune-augmenting drugs are to be used? Where does the direction of care involving cost cutting stop?

In this newly perverse system brought about by outlandishly high medical prices, why bother using physicians to treat cancer patients? Given this form of cookbook medicine, costs could be further cut by using nurse practitioners or physician assistants to deliver standard care chemo drugs.

Insurers are changing how they pay for cancer care

“Insurers are changing how they pay for cancer care, aiming to blunt soaring costs and push oncologists to adhere to standardized treatment guidelines.” 130

Wall Street Journal, May 27, 2014


Blame The Broken System…Not Just Insurance Companies

A number of health insurance companies are looking into aggressive ways to cut the soaring costs of cancer drugs by seeking to reduce payments to oncologists if they prescribe pricier drugs.

As I wrote earlier this year in an article titled “Unsustainable Cancer Drug Prices,” of the 12 new cancer drugs approved in 2012, 11 were priced above $100,000 a year! Over a hundred oncologists signed a protest letter that concluded that the prices of many of these drugs “are too high, unsustainable, may compromise access of needy patients to highly effective therapy, and are harmful to the sustainability of our national healthcare systems.”137

Just six months after my article was published, we are seeing insurance companies rebel by offering incentives to oncologists to prescribe chemo drugs they perceive as being less expensive. Here is a quote from the insurance company’s oncology medical director:138

“This program—while sharing best practices and evidence-based medicine—also helps to support oncologists who require large staffs to treat these complex patients and provides the practice with enhanced reimbursement to offset the lower fees they receive when prescribing less expensive drugs.”

According to the IMS Institute for Healthcare Informatics, in 2013 the United States spent $37 billion on cancer drugs, which is more than any other category.139 Overall costs for treating cancer are well over $100 billion annually and mounting steadily, according to researchers at the National Cancer Institute. Hospital, diagnostic, and pharmaceutical prices are beyond exorbitant.

A patient under the guidance of the International Strategic Cancer Alliance (ISCA) was recently charged $2,500 for a bone density outpatient test at a prestigious university hospital. The going rate at a diagnostic testing center is around $250. When ISCA responded by threatening to pay for an advertisement in the New York Times indicating this abuse by the university hospital, the hospital drastically reduced their price to this patient (but not to other cash-paying patients).

Still another reason why medical costs are spiraling upwards are large hospitals that are buying out individual oncology practices so higher “hospital” prices can be billed to Medicare, Medicaid, and health insurance companies. When chemo is administered in an oncologist’s private office, the cost is less than compared to a hospital setting. Now hospitals are employing oncologists to make sure patients receive chemo in the hospital’s oncology outpatient facility and billing insurance company’s higher prices, which means you will be paying higher health insurance premiums, along with higher co-pays and deductibles.

The financial coffers of insurance companies are being plundered by the excess charges of hospitals and outrageously high drug prices. Insurance companies are responding by seeking to pay doctors to provide less costly treatments. This is bad news for cancer victims.

It is important to point out that in many clinical oncology settings, the insurance company’s new “recommended regimens” may not be any worse than what patients are getting anyway. Bureaucracies have replaced the “special” physician, the one that comes up with creative approaches and who devours the literature looking for clues to help save his or her patient. Mainstream mediocrity has become the “standard of care” in too many instances and the public apathetically accepts it until they or a loved one is stricken with cancer.

The major factor responsible for the decay and dysfunction of sick care in the US is the powerful pharmaceutical lobby, the health insurance industry, and the burdensome legislation enacted by Congress that stifles innovation in the medical arena. None of these revelations should sur­prise Life Extension® members, who long ago learned how regulatory strangleholds inflict harsh economic pain, along with needless suffering and death.

Aggressive Approaches Can Cure Terminal Cancer
Aggressive Approaches Can Cure Terminal Cancer

In April of 2000, a patient came to us with advanced head and neck cancer with a primary location in the sinus and infiltration to the brain and orbital (eye) cavity. The tumor was the approximate size of a baseball and every oncologist consulted stated the patient had only months to live. Hospice was recommended as there was no conventional therapy that could treat this patient due to the complex anatomical locations of the tumor.

Just imagine the challenge of treating a tumor of this size growing inside someone’s head. The tumor’s location made it untreatable, according to every oncology expert. The only advantage we had is that no treatment had yet been administered, meaning the tumor was “treatment naïve,” and thus vulnerable to eradication by multimodal therapies. Our dilemma was figuring out how to administer therapy to this delicate anatomical region of the body without blinding the patient and creating permanent brain damage.

The hospital wanted to administer systemic cisplatin chemotherapy, which would have temporarily shrunk the tumor, but at the cost of horrific side effects and the mutation of the tumor to a virtually invulnerable stage. We stopped the patient from getting the systemic cisplatin in the nick of time.

The scientific team at Life Extension® devised an unprecedented protocol that involved inserting a catheter into the patient’s femoral artery. The catheter was directed into the aorta and from there threaded into the external carotid arteries. Using the catheter as a chemotherapy delivery system to the tumor, a relatively massive dose of cisplatin was initially used to target the tumor. It would have been impossible to deliver enough of this highly toxic chemo drug in any other way. Even by delivering cisplatin directly into the tumor, there were still some side effects (renal impairment) which were able to be reversed.

Following initial direct-to-the-tumor cisplatin therapy, the chemo drug paclitaxel was administered via this same intra-arterial route for four additional weeks.

These intra-arterial chemotherapy sessions were immediately followed by proton beam-accelerated radiation and the use of numerous drugs not approved to treat this cancer. For example, to enhance the tumor-killing effects of the proton beam-accelerated radiation, the radiation sensitizer 3-chloroprocainamide (3-CPA) was used. This had to be synthesized in our lab, as it was not commercially available to us. To further enhance the proton-beam therapy, the patient ingested 18 grams of arginine before treatment and breathed pure oxygen during treatment. The objective was to thoroughly oxygenate the patient in order to induce maximal tumor cell death during the proton-beam therapy.

It took until late June 2000 (the patient was diagnosed in April 2000) to initiate this complex therapy. By September 2000, there was no sign of active tumor. The patient was in complete remission, meaning there was no sign of tumor activity in the patient’s body. Oncologists at Loma Linda Medical Center were so impressed that they used this same protocol on another patient with advanced sinus cancer. We were informed that in this patient a complete remission was also attained.

Our client was prescribed a three-year follow up cyclical dosing of interferon alfa-2b and 13-cis retinoic acid to mop up any residual tumor cells that may have escaped the aggressive proton beam and intra-arterial chemo that was delivered over an eight-week time period.

Within two years, our client developed radiation necrosis of the brain, which was caused by the high dose of proton beam radiation therapy. This is a common side effect when the brain is irradiated. Once again, conventional doctors pronounced our client “terminal,” since there was no recognized treatment to overcome the raging inflammatory fires destroying the brain.

The scientific team here at Life Extension® went back to work and identified two drugs (cabergoline and pentoxifylline), both not approved to treat radiation necrosis. The two-drug combination suppressed the radiation necrosis, and once again to the doctor’s amazement, this patient was cured of a side effect that had been pronounced terminal. Our client remains alive today, 14 years since the original “terminal” diagnosis was made.

To make more of these kinds of lifesaving therapies available, I helped set up the International Strategic Cancer Alliance (ISCA) to speed innovative cancer treatments to patients who are unable to be helped by conventional oncology.

What We Are Doing To Save Lives

For over 30 years, we at Life Extension® have relentlessly combatted the high cost of medicine, along with conventional oncology’s less-than-optimal approach to cancer treatment.

We offer two services for members who develop cancer. One is free phone/email access to our cancer advisors. There is seldom a call where we can’t suggest validated ways to improve survival, sometimes as simple as adding aspirin and metformin to conventional treatment. To speak with a cancer advisor, call 1-866-864-3027.

The second option is concierge oversight provided by the International Strategic Cancer Alliance (ISCA). This service has collectively lost us millions of dollars since its inception, but in the process has saved lives and added life-years. The main cost when using the International Strategic Cancer Alliance has been the high hourly rates charged by top-notch oncologists and other personnel involved in developing personalized and creative treatment strategies. New health insurance exclusions may also increase the patient’s out-of-pocket costs when utilizing ISCA’s Personalized Treatment Protocols. To reach out to the International Strategic Cancer Alliance, call 1-610-628-3419.

In this month’s issue, you’re going to read a case history of an advanced stage pancreatic cancer patient who contacted us in time for aggressive innovative therapies to be initiated. Another case history whereby our team of experts saved the life of a very “terminal“ head and neck cancer patient can be read on the next page.

We were also going to publish in this month’s issue an update on the successes we are seeing with breast cancer patients using innovative therapeutic approaches we helped develop. We are deferring that article until at least next month because when we reported on these treatment successes two years ago, the clinic was overwhelmed and had to stop taking new patients. I was informed this clinic should be ready to accept at least some new patients starting around October 15th of this year.

For longer life,

For Longer Life

William Faloon

Quote From Ayn Rand Regarding Doctors
Quote From Ayn Rand Regarding Doctors

“I have often wondered at the smugness with which people assert their right to enslave me, to control my work, to force my will, to violate my conscience, to stifle my mind, yet what is it that they expect to depend on, when they lie on an operating table under my hands? Let them discover the kind of doctors that their system will now produce. Let them discover, in their operating rooms and hospital wards that it is not safe to place their lives in the hands of a man whose life they have throttled. It is not safe, if he is the sort of man who resents it—and still less safe, if he is the sort who doesn’t.”

From Atlas Shrugged by Ayn Rand