By Stephen T. Sinatra, M.D., F.A.C.C., F.A.C.N., C.N.S., C.B.T.
In “New Drugs Stir Debate on Rules of Clinical Trials,” Amy Harmon details the story of two cousins who entered a clinical trial for treatment after developing skin cancer, and shines light on an ethical dilemma surrounding the Federal Drug Administration (FDA) approval process for drugs marketed as cancer treatments. Both cousins entered the trial’s final phase with hopes of receiving PLX4032, an experimental melanoma drug which had been shown in an earlier trial phase to stop tumor growth, but only one got to take the “superpills.”
While 24-year-old Thomas McLaughlin was assigned to the PLX4032 group, 22-year-old Brandon Ryan was randomly selected for the trial’s control group, and received instead standard chemotherapy for melanoma. Even when the chemotherapy proved ineffective against the tumors that had spread to the young man’s liver, lungs and spine, Ryan was not permitted to switch into the experimental group to receive the pills because doing so would have tainted the trial results. While McLaughlin continues to take PLX4032, Ryan passed away in June 2010.
Has “Do No Harm” Lost its Meaning in Clinical Testing of Cancer Drugs?
McLaughlin’s and Ryan’s stories highlight the problems associated with cultivating proof of a drug’s effectiveness through a controlled trial, as well as the need for a new standards of cancer treatment. Having a control group in a cancer trial is important because it may be the only way to determine whether treatment administered to the experimental group actually caused detriment. In the ongoing PLX4032 trial, maintaining a control group creates an ethical conflict for doctors between responsibility for their patients and the need to obtain conclusive scientific evidence to help legally treat future patients with safer alternatives to chemotherapy.
Conventional cancer treatments, i.e. surgery, radiation and chemotherapy, are barbaric – employing them because it is what was learned in medical school is not the practice of smart medicine. How does solely cutting, burning and poisoning fit in with “doing no harm?” Chemotherapy and radiation do play major roles in the fight against Hodgkin’s lymphoma, leukemia and testicular cancer. However, these standard treatments prove, more often than not, ineffective against other types of cancer, especially pancreatic and breast cancers. The standard chemotherapy agent used in the PLX4032 trial, dacarbazine, for example, has been notoriously ineffective against melanoma for the past 30 years. While safer, effective and more humane alternatives exist, they remain illegal and out of reach for most people until they receive FDA approval for sale as cancer treatments.
The Dilemma: A Whole Lot of $$$ and Red Tape
Under the present state of federal regulation, drugs and medical devices must be FDA approved before they are considered legal to market. An exception to this rule is use of an experimental drug through a clinical trial. Before FDA approval, a drug must go through a long, extensive and very expensive testing process: a pre-clinical phase entailing in vitro (testing on cells) and in vivo (testing on small animals), followed by phase I, II, and III clinical testing (and sometimes IV) with humans. The approval process can cost drug companies upwards of $250 million and easily take 10 years. It’s clear that without extensive monetary and human resources, small manufacturers face major challenges in legalizing better alternatives to benefit millions of cancer patients.
Medical Mavericks Providing Healthier Alternatives
FDA approval of drugs used to treat cancer is no joke. Well intentioned doctors have been mercilessly prosecuted in federal court for treating patients who wanted alternatives to chemotherapy with unapproved drugs. Stanislaw Burzynski, M.D., Ph.D., for example, battled the FDA for over ten years so that he would be able to continue treating some cancer patients at his clinic with antineoplastons, peptides native to the human body but which are lacking in people with cancer. Unlike chemotherapy agents which poison any and all cells encountered, antineoplastons work on genes to kill cancer cells without harming normal cells. Burzynski had successfully treated many cancer patients with antineoplastons and adjunctive treatments, using chemotherapy only when necessary. Throughout the series of government prosecutions against Burzynski, numerous patients, many of whom had received terminal diagnoses from other doctors, testified on Burzynski’s behalf; their survival depended on continued antineoplaston treatment.
Though Burzynski’s antineoplaston treatments have yet to receive FDA approval, he continues to provide them through clinical trials. The treatment tends to be more successful in brain cancer and lymphoma cases, and less effective against breast and lung cancers and most end-stage cancers. For more information about Stanislaw Burzynski and antineoplaston treatment, read Knockout by Suzanne Somers and Galileo’s Lawyer by Richard Jaffe, Esq. (See References below.)
Until the Standard Becomes Truly Golden
When it comes to cancer, we’re in a bind. We need more research, yet cancer trials are complex, and can take years to conduct. In the time it takes to legalize better treatments and perhaps a cure, it is estimated (by the American Cancer Society)that 1,500 people will die of cancer each day in the U.S. Sometimesentering clinical trials is the only way to legally obtain better treatment than what is currently offered, but it does not guarantee a positive outcome.
Some doctors, like Francisco Contreras, M.D. and Leigh Erin Connealy, M.D. of the Oasis of Hope centers (in Mexico and California, respectively), currently offer aggressive integrative cancer treatment outside the clinical trial setting which goes beyond cutting, burning and poisoning. While treatment may entail chemotherapy, these doctors focus on healing the whole person and improving quality of life through alternative medical technologies, nutrition and lifestyle modification, and emotional and spiritual work. At the Oasis of Hope center in Mexico, patients can receive some treatments which have not been legalized by the FDA in the United States.
The best strategy we currently have against cancer is to prevent it altogether. Avoiding toxins and detoxifying the body, as well as adopting an anti-inflammatory diet (very low in sugar, high in organic fresh fruits and vegetables, low in deli and non-organic meats and dairy products), are good anti-cancer practices to make part of one’s lifestyle. Knowing the facts about cancer helps too.
References and Resources:
- Harmon, Amy. “New Drugs Stir Debate on Rules of Clinical Trials,” New York Times September 18, 2010: A1.
- American Cancer Society web site: “Cancer Basics” and “Cancer Facts & Figures 2010″
- Burzynski Clinic
- Oasis of Hope California
- Oasis of Hope Hospital Tijuana, Mexico
- Jaffe, Richard A. Galileo’s Lawyer: Courtroom Battles in Alternative Health, Complimentary Medicine and Experimental Treatments. Houston, TX: Thumbs UP Press, 2008.
- Somers, Suzanne. Knockout: Interviews with Doctors who are Curing Cancer and How to Avoid Getting it in the First Place. New York: Crown Publishers, 2010.
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