|LE Magazine December 2000 |
Science Versus Dogma
Cancer treatment breakthroughs frequently appear in scientific journals, yet victims of the disease are often denied access to these promising therapies. We at The Life Extension Foundation learned long ago that what is published in the peer-reviewed medical literature is seldom incorporated into clinical oncological practice. This means that cancer patients suffer and die while effective therapies already exist.
One reason for this treatment deficit is the complexity of administering multi-modal treatments that have to be tailored to the individual patient. For instance, few oncologists are conducting the advanced tumor cell gene tests that The Foundation advocated years ago.(1) These tests, when properly interpreted, enable someone with a background in molecular oncology to design an individual treatment protocol that kills most cancer cells, inhibits various growth phases of remaining tumor cells, and blocks the escape mechanisms that enable residual cancer cells to become resistant to cell cycle regulatory control. While the scientific literature provides a rationale for these multi-modal approaches, conventional oncology remains fixated on mono-therapeutic agents that have long ago been proven to fail.
It’s not just lack of physician motivation that is causing the cancer carnage to occur. Large drug companies are hampered by FDA bureaucratic delays. The FDA’s response to the outcries from desperate cancer patients is to offer “compassionate-use exemptions” for drugs that someday may be approved. Unfortunately, the cancer patient has to locate a physician willing to fill out an enormous amount of paperwork to qualify for compassionate-use exemption, and the drug company then has to be convinced to “give away” the unapproved drug. The FDA makes it illegal to sell an unapproved experimental drug and drug companies are not in the business of giving away their products. The result is that most terminal cancer patients are denied access to potential lifesaving drugs even though the FDA has this so-called “compassionate-use” policy in place.
Surprisingly, the inability to access a compassionate-use drug is not always that bad, since the FDA and drug companies often restrict the patient from using other drugs that would synergistically work with the experimental drug for which compassionate-use is being sought. The FDA and drug companies, you see, don’t want to see their statistics skewed by a patient that might actually figure out a way of combining several approved and unapproved therapies in a way that could cure their disease. The FDA’s view on human experimentation is to evaluate the effects of a single drug on a specific type of cancer. Since other therapies that may be synergistic are often disallowed, most cancer patients are left to suffer an excruciating death under the watchful eye of the oncologist overseeing the “compassionate-use” of the experimental drug. This oncologist then dutifully reports to the FDA and drug company every bit of agony suffered as the cancer slowly spreads through the patient’s body.
Rescuing cancer patients
The Life Extension Foundation views the current state of experimental oncology as sadistic and barbaric. That is why so much effort is being made to open The Life Extension Medical Center in Ft. Lauderdale, Florida early next year. Based on the inadequacies of current medical practice, we feel it is critical for Foundation members to gain access to the latest state-of-the art therapies in case they contract a lethal disease.
At The Life Extension Medical Center, physicians will be required to display an exceptional degree of motivation, compassion and creative molecular expertise. These front-line physicians will be backed by a team of researchers who will search the worldwide scientific literature and assist in designing optimal treatment protocols for each individual patient. Another unique component of The Life Extension Medical Center will be the lawyers who will sue the FDA and/or drug company when a potential life saving medicine is denied to a terminally ill human being.
The long-term objective of establishing The Life Extension Medical Center is to create an environment where science will prevail over dogma in a way that will revolutionize the practice of medicine in the United States. Our intent is to abolish the current “assembly line” form of clinical care that is causing so many people to die unnecessarily.
Why chemotherapy so often fails
Drugs that kill cancer cells are called “cytotoxic” chemotherapy agents. While chemotherapy drugs can play an important role in a comprehensive treatment program, there are escape mechanisms whereby cancer cells become resistant to cytotoxic agents. An alternative to using only cytotoxic drugs is to add other agents that work synergistically with conventional chemotherapy to eradicate cancer cells.
Many cancers proliferate out of control because of certain growth factors that make them resistant to conventional (and alternative) cancer therapies. One of these factors, called “transforming growth factor,” binds to a receptor site on cancer cells called the “epidermal growth factor receptor.” The binding of “transforming growth factor” to these cancer cell “receptors” creates a signal that induces rapid cell division, resulting in aggressive disease and poor prognosis.
There are drugs that block the “epidermal growth factor receptor,” thus interfering with the ability of “transforming growth factor” to signal cancer cells to propagate out of control. These drugs are not toxic chemotherapy agents, but instead are classified as “cytostatic” drugs, in as much as they directly inhibit signal-induced hyper-proliferation of cancer cells. These drugs are in clinical trials and are not yet available to most cancer patients.
Drug denied to cancer patients
One example of a promising therapy bogged down in the FDA’s regulatory quagmire is a drug called Iressa, made by the pharmaceutical giant AstraZeneca. The encouraging results from clinical studies on Iressa has caused many terminal cancer patients to seek “compassionate-use” exemption from the FDA. Unfortunately, few cancer patients meet the exacting standards needed to qualify for “compassionate-use.” The result is that tens of thousands of cancer patients are dying right now waiting for FDA approval. A somewhat technical description of the molecular mechanisms by which Iressa works to suppress cancer cell growth can be found at the end of this article.
Reducing chemotherapy side effects
The toxic side effects of conventional chemotherapy can be so severe that the patient is often unable to tolerate a dose adequate to kill enough of the cancer cells, or the patient may die from the chemotherapy itself. There are proven ways to protect against the side effects of cytotoxic therapy. Unfortunately, oncologists often fail to prescribe these agents that protect against chemotherapy-induced toxicity, even though some of them are FDA-approved drugs. It should also be noted that in many cases, the patient’s HMO refuses to pay for these drugs that protect against chemotherapy-induced toxicity. This means that cancer patients needlessly suffer and die because of inadequate drug management.
The Life Extension Foundation has previously published protocols on some of the drugs that are approved by the FDA to protect against some of the side effects of cytotoxic chemotherapy drugs. These protocols can be accessed at the Foundation’s website (www.lef.org) or in the 946-page Disease Prevention and Treatment reference book.
Failing to prescribe FDA approved drugs
There are drugs approved by the FDA to treat other diseases that also inhibit tumor cell growth. While it is legal for doctors to prescribe these drugs for “off-label” uses, the FDA makes it illegal for drug companies to promote them for “off-label” uses, such as adjunctive cancer therapy.
Some of these drugs, such as the COX-2 inhibitors and “statins,” have been recommended by The Life Extension Foundation for years, but many cancer patients have not been able to convince their oncologist to prescribe them. The Life Extension Medical Center will be committed to incorporating into each patient’s treatment regimen every therapy that is supported in the peer-reviewed scientific literature as having efficacy against their particular serious disease. A review of The Foundation’s protocols for using some of these off-label drugs as adjunctive cancer therapies can be found at www.lef.org or in the book, Disease Prevention and Treatment.
Escaping from the abyss
For 20 years, The Life Extension Foundation has published specific recommendations on what people with lethal diseases can do to improve their chances of surviving. We are confident that tens of thousands of lives have been saved by our efforts, but we also fear an equal number of people were unable to secure physician cooperation and succumbed to their disease.
At The Life Extension Medical Center, patients will be assured that every possible treatment modality with demonstrated efficacy will be used in a synergistic and aggressive attempt to eradicate their disease.
It is our opinion that to radically change the way medicine is practiced, someone will have to lead by example. The Life Extension Medical Center intends to set that example. The costs of constructing the initial medical facility and staffing it with top-flight medical personnel is enormous. Members should feel gratified that their product purchases are helping to finance the pioneering physicians and researchers who have dedicated their professions to making the practice of medicine a purely scientific endeavor, as opposed to the dogmatic ritual that currently exists.
The successes enjoyed by The Life Extension Foundation this year in persuading Congress to legalize the importation of lower cost medications from other countries should make implementing these multi-modal approaches to cancer treatment more affordable. Our goal in the year 2001 will be to convince Congress to pass legislation to allow terminally ill patients to gain much greater expanded access to promising experimental therapies.
The Life Extension Foundation is battling the entrenched medical establishment on many fronts. Your support of our efforts through the purchase of supplements designed to reduce your risk of contracting these horrendous diseases will make a huge impact on the betterment of mankind.
For longer life,
Life Extension Foundation
1. IMPATH Laboratories offers the immunohistochemistry tumor cell test that reveals what therapeutic agents are most likely to succeed. They can be reached at 1-800-447-5816.
Life Extension Technical Report: Suppressing cancer cell growth - a novel approach