Assembly Line Medicine

The Insurance Company’s “Recommended Regimen”

The chemotherapy drugs that insurance companies want oncologists to prescribe represent the most commonly used drugs in the industry and can be viewed as aggressive “cookbook medicine approach” treatments. Some of drugs listed, such as Adriamycin^®, are being limited by several oncologists at major medical institutions, such as MD Anderson, for use in adjuvant settings due to excessive toxicity.^121-123

Progressive oncologists, with whom Life Extension^® is working, are using mitoxantrone instead of Adriamycin^® in their elderly patients since it has the same survival rate as Adriamycin^®, but is less toxic to the heart.^124-126

Oncologists will be paid $350/month per patient by one insurer to prescribe chemo drugs such as Adriamycin^®, which was approved by the FDA in 1974. Another insurer is offering higher reimbursement to the oncologist when lower-cost chemo drugs are used.

All these chemo drugs are considered standard of care by the National Comprehensive Cancer Network, which is an alliance of 25 cancer centers in the United States, most of which are designated by the National Cancer Institute as comprehensive cancer centers.

Health insurance companies reward practicing oncologists for following the standard published protocols that minimize creative approaches for cancer treatment.

Perhaps the greatest failing of the chemo drugs that insurers are paying oncologists to prescribe is that they seldom cure advanced-stage cancers. Despite widespread availability of these chemo drugs, metastatic lung cancer kills 98% of patients within five years.¹²⁷ Metastatic colon cancer kills 94% within five years.¹²⁸ Those afflicted with metastatic breast cancer fare better, but 78% still die within five years.¹²⁹

Clinical oncology practice clearly needs more innovation—yet health insurance companies are providing financial incentives for physicians to prescribe chemo drugs that fail to cure advanced-stage patients. This kind of backwards approach to treatment will stifle the discovery of breakthroughs so desperately needed to spare the lives of more than 585,000 Americans who perish from cancer annually.

I’m purposely leaving the names of the insurance companies out of this article because it is likely that other insurers will follow this pattern of scientific regression. What we are witnessing is clinical oncology practice being driven backwards by outlandish drug prices, along with the high cost of increased physician involvement when aggressive therapies are utilized.

Health insurance companies argue their “recommended regimens” will improve patient care. We at Life Extension^® disagree and advocate that more (not fewer) individualized, creative, and comprehensive treatment approaches could spare numerous lives.

Most Effective Brain Tumor Drug Not Approved To Treat Any Cancer

 

Perhaps the most frightening malignancy one can be diagnosed with is a form of brain cancer called glioblastoma. This type of brain cancer has a dismal prognosis, with median overall survival of 12 to 14 months, and a two-year survival rate of 15 to 26%.¹³¹

Senator Ted Kennedy was diagnosed with glioblastoma in May 2008. Despite intervention by some of the best brain tumor experts, Kennedy died in August 2009—a mere 15 months later.

A study published in the New England Journal of Medicine on September 5, 2013, may represent the most significant advance yet discovered in treating glioblastoma.¹³¹

What follows is an overview of a drug that is not approved to treat any cancer, and thus is likely to be rejected by insurance company mandates:

• Valganciclovir (Valcyte^®) is an FDA-approved drug used to treat cytomegalovirus infection.
• Cytomegalovirus has been suspected as facilitating the initiation and promotion of brain cancers.^132-135 Some 50 to 80% of adults in the US show exposure to cytomegalovirus, but relatively few harbor active viral infection.¹³⁵
• Doctors followed 75 glioblastoma patients and found the median overall survival of those with low-grade cytomegalovirus infection was 33 months. In patients with high-grade cytomegalovirus infection, median overall survival was 13 months.¹³¹
• All but one of the 75 glio-blastoma patients studied had active cytomegalovirus infection, indicating that this virus may be involved in the development of this lethal malignancy. ¹³¹
• In glioblastoma patients with high-grade cytomegalovirus infection, median two-year survival was 17.2%. Patients with low-grade cytomegalovirus infection had median two-year survival rates of 63.6%.¹³¹ This suggests that high-grade, active cytomegalovirus infection accelerates tumor progression.
• In a double-blind clinical trial of valganciclovir involving 42 patients with glioblastoma, an exploratory analysis of 22 patients receiving at least six months of antiviral therapy showed 50% overall survival at two years compared with 20.6% of contemporary controls.¹³¹ This study showed that valganciclovir-treated patients had a median overall survival of 24.1 months compared to 13.7 months in patients not treated with valganciclovir .
• Owing to the promising results of this pilot study, physicians at the world-famous Karolinska University Hospital administered valganciclovir to glioblastoma patients and results were then compared to a control group. Both groups received standard conventional therapy and both groups had a similar disease stage and surgical-resection grade.
• The researchers retrospectively analyzed the data on 50 of these brain cancer patients and found the two-year rate of survival in the valganciclovir group was 62%, whereas two-year survival was only 18% in the control group.¹³¹
• In 40 glioblastoma patients who received valganciclovir for at least six months, the two-year survival rate was 70%, with a median overall survival of 30.1 months.¹³¹
• In 25 glioblastoma patients that received continuous valganciclovir treatment after the first six months, the two-year survival rate was 90%, with a median overall survival of 56.4 months (4.7 years)!¹³¹
• The current median survival of glioblastoma patients is only 12 to 14 months (1.0 to 1.16 years).¹³¹ The efforts made to prolong Senator Kennedy’s life by the experts at Duke University Medical Center was a survival of 15 months (1.25 years)—3.45 years less than the median survival in the 25 glioblastoma patients who received continuous valganciclovir treatment as detailed above.

The implication from these findings is that treating active cytomegalovirus infection may dramatically reduce progression, and significantly increase survival time, in patients suffering from the deadly brain cancer glioblastoma. Most exciting is the intriguing data from this retrospective study showing that in glioblastoma patients with active cytomegalovirus, a treatment protocol employing valganciclovir resulted in a median survival of 4.7 years!

Not only does this retrospective data involving the continuous use of valganciclovir substantially extend survival in glioblastoma patients, but it provides an opportunity to incorporate additional complementary therapies that could improve survival even more!

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

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, 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.

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

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.

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 a service for customers 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 Senior Wellness Specialist, call 1-866-864-3027.

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 15^th of this year.

For longer life,

William Faloon

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

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