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Assembly Line Medicine

October 2014

By William Faloon

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.

The Problem With Cytotoxic (Chemotherapy) Drugs

When chemotherapy drugs were developed in the 1950s to 1970s, there was optimism that a pharmaceutical cure for cancer might soon be found.

These chemo drugs killed cancer cells in the petri dish and shrank tumors in cancer patients. The side effects, however, were horrific and survival improvements were negligible for most solid malignancies.

Medical oncologists are now being offered $350/month per patient to prescribe chemo drugs that, in some cases, were introduced before many of you reading this article were born.

There are drugs in the insurance company’s “recommended regimen” that are new and considered cutting-edge, but provide average survival improvements often measuring less than one year.

In the May 21, 2014, edition of the Journal of the American Medical Association, a study was published showing that lung cancer patients survived 1.1 years longer when aggressive genomic testing was done and drugs that specifically target an individual tumor are added to standard chemo regimens.120 These newer drugs target what’s known as “oncogenic drivers,” which are genetic abnormalities critical for tumor development and maintenance. The survival improvement in response to these “targeted” therapies is certainly welcomed news, but a far cry from a cure. The side effects from these newer cancer drugs are similar to old-line chemo drugs, meaning the patients endure significant suffering in exchange for added time.

Our scientific understanding of molecular oncology has grown exponentially over the past 40 to 50 years, yet relatively little of this knowledge is being delivered to the cancer patient. Clinical oncology practice, in fact, has progressed so slowly that many old-line chemo drugs are still considered first-line therapy at cancer institutions today, despite their failures to produce cures in the majority of advanced cases.

The problem is that consumers with health insurance may not have a choice. If their oncologist follows the insurers “recommended regimen,” they will be prescribed chemo drugs that have historically provided relatively minimal survival improvement. These patients might better benefit from creative therapies that health insurance companies now balk at paying for.

On the right side column is a list of chemotherapy drugs that one insurance company wants most of its insured customers restricted to, along with the dates of each drug’s approval and how many years each of these drugs has been in use.

Some of these drugs were approved more than 60 years ago. That does not mean they are not still useful against certain malignancies. The invariable question is whether certain patients who would benefit from more comprehensive and creative approaches will instead be prescribed these “standard-of-care” drugs because of the financial incentives being offered to oncologists.

To receive their $350/month stipend per patient, oncologists have to stay with the insurance company’s “recommended regimen” for that patient. This financial incentive comes to $4,200 a year per patient treated following the insurer’s protocol!

Drug Name

Approval Date

Years In Use

Leucovorin

June 20, 1952

62

Cyclophosphamide(Cytoxan®)

November 16, 1959 (Manufacturing changes in 1976,1977, 1979,1984, 1987, 2000) Cytoxan®(lyophilized) equivalent

55

Fluorouracil (5-FU)

April 25, 1962

52

DoxorubicinHCL injectable

(Adriamycin®)

August 7, 1974

39

Cisplatin (Platinol®)

December 19, 1978

35

Carboplatin (Paraplatin®)

March 3, 1989

25

Paclitaxel (Taxol®)

December 29, 1992

(Manufacturing change or addition 1993, 1994, 1997, 1998, 2001)

21

Vinorelbine (Navelbine®)

December 23, 1994

19

Docetaxel (Taxotere®)

May 14,1996

18

Gemcitabine (Gemzar®)

May 15, 1996

18

Irinotecan (Camptosar®)

June 14, 1996

18

Capecitabine (Xeloda®)

April 30, 1998

16

Trastuzumab (Herceptin®)

September 25, 1998

(Manufacturing change 2012)

15

Epirubicin (Ellence®)

September 15, 1999

14

Oxaliplatin (Eloxatin®)

August 9, 2002

11

Pemetrexed (Alimta®)

February 4, 2004

10

Bevacizumab (Avastin®)

February 26, 2004

10

Erlotinib (Tarceva®)

November 18, 2004

9

Panitumumab (Vectibix®)

September 27, 2006

7

Lapatinib(Tykerb®)

March 13, 2007

7

Pertuzumab (Perjeta®)

June 8, 2012

2

Regorafenib (Stivarga®)

September 27, 2012

1

Ado-trastuzumabemtansine (Kadcyla®)

February 22, 2013

1

Afatinib (Gilotrif®)

July 12, 2013

1

Average age of chemo drug

19

Most Effective Brain Tumor Drug Not Approved To Treat Any Cancer

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 The efforts made to prolong Senator Kennedy’s life by the experts at The efforts made to prolong Senator Kennedy’s life by the experts at 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!

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