Greater Access to Experimental Drugs

The US Food and Drug Administration has announced that it allows greater access to experimental drugs for people with serious disease. This is good news for cancer patients, as the FDA’s delay in approving drugs has caused the needless deaths of millions of Americans over the years. The question for the cancer patient is which experimental drug might be appropriate for their particular form of cancer? Once a safe and promising drug is identified, another challenge is persuading one’s oncologist to agree to prescribe it, and then fill out the cumbersome paperwork required to gain compassionate use access from the FDA.

The International Strategic Cancer Alliance will aggressively seek to identify not-yet-approved drugs that may offer another weapon against a particular malignancy. The ISCA will then present these to its client and the treating oncologist for consideration. Once the treating oncologist agrees that the experimental drug is safe and could be beneficial, ISCA will make sure all paperwork is promptly handled so that the patient gains access as soon as possible.

Electronic Documentation

Upon the diagnosis, a cancer patient’s file quickly fills up with papers relating to all kinds of test requisitions and results, various specialists’ reports, treatments prescribed, etc. After several months, apatient’s file can contain hundreds of papers that are not organized in any manner that would enable the treating oncologist to readily chart the patient’s progress across a broad spectrum of parameters directly relating to the individual’s particular form of cancer. The first step initiated by the International Strategic Cancer Alliance is to create a computerized electronic charting system for each individual patient wherein every single piece of documentation will be entered and automatically charted so that the treating oncologist can ascertain the patient’s overall condition at a glance. November 2007 LIFE EXTENSION 57 This finely detailed electronic medical record can be electronically transferred to oncology consultants around the world who can review hundreds of different parameters dealing with each individual patient’s tumor and their overall state of health. This provides outside consultants with an easy method to accurately assess the patient’s condition and recommend even more novel approaches that may be considered by the treating oncologist.

This easy-to-read electronic document will also be available to the patient via password-protected internet access so that they can keep track of measurements of success or failure during the entire course of their disease treatment. As an example of how valuable this electronic charting can be, let’s say a prostate cancer patient’s prostatespecific antigen (PSA) begins to rise after initial treatment. Beneath the chart showing the monthly increases in PSA will be numerous other blood measurements that might help identify exactly what the patient needs to achieve better control over their cancer. On the positive side, if the PSA begins to decline, this sophisticated computerized charting system can reveal what blood parameters may be responsible for this clinical success.

Contrast this elaborate electronic medical records system to the thick file of paper documents used in most oncology offices. Even if a dedicated oncologist could spend hours with a patient, there would be no charting system that would enable the oncologist to readily correlate success or failure based on the numerous diagnostic parameters that are available to cancer patients today.

A Team Approach Dedicated to Achieving Positive Results

If the International Strategic Cancer Alliance is to succeed, it must demonstrate positive results. It has no established clinical practice to rely on. The ISCA instead must depend solely on referrals from nonprofit patient support groups and satisfied patients.

The ISCA represents a team of dedicated individuals whose mission to show the world that cancer today is woefully undertreated and that utilizing creative customized treatment protocols is far superior to “assembly line” oncology practice.

If a cancer patient is initially deemed curable, then ISCA will make heroic efforts to effect a cure. If the patient is considered terminal, ISCA will either reject the patient outright, or accept the patient if there is a possibility of providing a significant extension of the life-span prognosis. There will be no false hope given, just a war-time mentality that every conceivable therapy that has been documented in a published scientific study should be made available based on individual patient need.

What Does this Cost?

Fees for the personalized services provided by International Strategic Cancer Alliance are billed on an hourly basis. Hourly rates range from $125 to $450 depending on the time utilized by nurse practitioners, consultants and the treating oncologist.

If one has good medical insurance, the costs of the standard cancer treatments administered by the treating oncologist may be covered. In some cases, ISCA will recommend the creative use of approved drugs that are not insurance-reimbursable. In these cases, the drugs may have to be paid for directly by the patient. The patient will also probably be responsible for other creative treatments recommended by the treating oncologist working with ISCA. The patient will be advised about all costs before treatments are administered so they can decide whether to pay for a particular treatment.

To initiate a relationship with ISCA, a required $10,000 retainer is put into an escrow account and then billed out each month based on the hours spent working on the individual patient’s case. In some cases, a refund of unused escrow fees will be made, while more difficult cases will require additional retainer deposits.

The ISCA hopes that patients understand that significantly more time will be expended on their case than would be provided by a conventional oncologist. The ISCA believes the additional time spent designing and monitoring customized treatment protocols will provide better long-term outcomes for patients. Reality, however, dictates that someone must pay for the many professional hours spent seeking to provide each patient with optimal comprehensive treatment.

A Service that Money Cannot Buy Elsewhere

At least one out of every three Americans will be stricken with cancer.10 Included in these grim statistics are the rich and famous. Unlike any other service, well-to-do individuals often wind up with the same mediocre cancer treatment as an average person with health insurance.

Oncology is practiced today in a somewhat socialized fashion, where standard treatments are provided to virtually everyone. In today’s world, a billionaire could offer an oncology group limitless money in exchange for a cure, but this would do little good, since most conventional doctors are incapable of “thinking outside the box.”

As a client of the International Strategic Cancer Alliance, you gain access to an entirely new sciencebased approach to cancer treatment. If appropriate, you will receive some of the same conventional therapies as would be prescribed by mainstream oncologists. The ISCA then goes beyond these standard treatments by seeking to incorporate every novel synergistic or additive strategy that may provide a greater opportunity to achieve a complete response or cure.

The mission of the ISCA is to change the way oncology is practiced. To accomplish this radical goal, ISCA must be able to show hard statistical data that the comprehensive multimodal therapies it utilizes are achieving superior results compared with mainstream medicine.

In order for ISCA to transform the world of oncology, the clients it services have to obtain better results than what is delivered today. There is no place in the world where you could buy this focused and dedicated objective towards saving your life. No matter how much money you had to offer, this unique service is simply not available anywhere else.

Example of Molecular Analysis Performed on Tumor Cells of an ISCA Patient

Evidence for assumed drug responses results from the analyses of chemoresistance markers and drug target genes in the tumor cell fraction. According to the panel of genetic markers we have analyzed, the following conclusions are drawn: THERAPIES WITHOUT INDICATIONS OF RESISTANCE: Taxanes (paclitaxel/docetaxel): due to the undetectable expression of the resistance factor MDR, resistance to taxanes mediated by MDR is not anticipated. Alkylating agents-nitrogen mustards (e.g. cyclophosphamide, ifosphamide): sensitivity to these drugs is assumed because GST and GCS were not found overexpressed. Vinca-alkaloids (e.g. vinblastine, vinorelbine): according to the measured expression levels of the resistance factors GCS, MDR and MRP, resistance to these drugs is not assumed. Mitomycin: deduced from the measured expression levels of MDR, GST, and GCS, resistance to mitomycin is not expected. Lapatinib/Herceptin: as a consequence of the elevated expression of ERBB2, a response of the tumor cells to these agents is indicated. DRUGS WITH RESTRICTED SENSITIVITY: Anthracyclines: (e.g. doxorubicin, epirubicin) and mitoxantrone; although the expression levels of the resistance factors MDR, MRP, GST and GCS do not indicate resistance to these drugs, the observed basis-level expression of the drug-target topoisomerase II suggests no increased sensitivity of the tumor cells compared to normal cells. Gemcitabine: due to the observed base-level expression of DCK in the tumor cells resistance to Gemcitabine is not expected, but an increased sensitivity compared to normal cells is also not assumed. DRUGS WITH MINOR THERAPEUTICAL EFFICACY EXPECTED: Tyrosine-Kinase-Inhibitors (Sorafenib/Sunitinib/Gleevec): these drugs act as inhibitors of tyrosine-kinase like C-KIT or PDGF-R-beta. In the isolated tumor cells, expression of the PDGF-R-beta and C-KIT was downregulated. Therefore, the tumor cells may not respond in a suitable way to treatment with these compounds. Platinum compounds (cis/carboplatin): resistance of the tumor cells to platinum compound treatment is expected due to the observed over-expression of HSP27. Methotrexate and Pemetrexed: the observed overexpression of DHFR suggests resistance to these compounds. Alkylating agents-nitrosoureas (e.g. carmustine, lomustine): the cells showed overexpression of MGMT. Resistance to these compounds is therefore expected. Tamoxifen: since the estrogen-receptor was not expressed, a response to treatment with tamoxifen mediated by this receptor is unlikely. Aromatase-inhibitors (e.g. Anastrozole, Femara): expression of aromatase and estrogen-receptor was not detected. Therefore, these drugs may not act in a proper way on the tumor cells. VEGF-inhibitors (e.g. Avastin): due to the observed downregulation of VEGF-expression, minor sensitivity of the circulating tumor cells to VEGF-inhibitors is assumed. Bortezomib (Velcade): the observed elevated expression of HSP27 suggests only minor response to bortezomib. Hyperthermia: HSP27 was overexpressed in the isolated tumor cells. This may lead to thermoresistance of the tumor cells and a reduced efficiency of hyperthermia therapy. Suggested Supportive AlteRnative Therapies: The observed elevated expression of HSP27 may reduce the efficacy of hyperthermia. To overcome HSP27-related resistance, administration of the anti-HSP27 agent Quercetin may be considered. FAVORABLE AlteRnative Therapies: Overexpression of telomerase was observed in the tumor cells. Treatment with the alternative agent inositol-6-phosphate (IP6), described as an inhibitor of telomerase may therefore be considered. The angiogenesis promoting factor bFGF was overexpressed in the tumor cells. A therapy with C-statin, an inhibitor of bFGF may therefore be considered. Note: Any alternative treatment should only be done under the supervision of an experienced health professional.

Free Consultation

To become a client of International Strategic Cancer Alliance, please call 610-628-3419 for a free consultation. Patients will not be accepted if their cancer is too far advanced, or if they are unwilling to travel to locations that may provide superior care.

For patients who are candidates for ISCA’s customized programs, it is important that they feel comfortable in working with their personal advocate, ergo the free consultation available to cancer patients and/or their family members.

If you have any questions about the scientific content of this article, please call a Life Extension Health Advisor at 1-800-226-2370.