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The “Compassionate Use” Rule: Now There’s a Ray of Hope for Dying Patients

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Compassionate UseFDA routinely denies terminally ill people the right to experimental drugs or treatments. Tell Congress to support the bill that can change all that! Action Alert!

You may remember our article from July in which we talked about “expanded access” to investigational drugs being used in a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options. Even though it is legal and desperately needed, FDA frequently blocks such access, using arbitrary and subjective criteria.
But now HR 6342, the Compassionate Freedom of Choice Act of 2012, has been officially introduced by Rep. Ron Paul. It will allow patients access to investigational drugs and other approaches in clinical trials, with informed consent but without FDA approval. The bill is currently in the House Energy and Commerce Committee.
Civil rights attorney Jonathan Emord has written a stinging article that appeared in USA Today Magazine discussing the case of nineteen-year-old Abigail Burroughs, a college student with a rare cancer of the head and neck. “For eighteen months, she underwent painful chemotherapy and radiation treatments, those approved by FDA, to no avail,” he writes. “In March of 2001, Abigail and her parents were informed that the FDA-approved treatments had failed and that her only hope lay in gaining access to investigational drugs, Erbitux and Iressa, then undergoing clinical trials. Abigail’s cancer cells had very high Epidermal Growth Factor Receptors, and EGFRs had been shown preliminarily to be greatly suppressed by these two experimental drugs. The sponsors of the drug trials were willing to provide the experimental drugs to Abigail, but they had to first obtain the consent of the FDA. The FDA refused to grant its consent, and Abigail died on June 9, 2001, at the age of twenty-one.”
Emord details other tragic cases as well: a high school student with colorectal cancer, a forty-four-year-old mother of four with metastasized kidney cancer, a thirteen-year-old girl with embryonal sarcoma. For each one, there were new and potentially life-saving treatments available, but because they had not yet received FDA approval, FDA needed to give special permission under the compassionate use / expanded access rule. In each case they were denied, and the patients died.
This is, at its heart, a health freedom issue. Our freedoms in the health area are all too often ignored by ignorant and willful bureaucrats. Life Extension Magazine’s cover article this month concerns another health freedom case. A man named Jay Kimball was sentenced to thirteen years in jail for exporting purified, liquid deprenyl, which is FDA-approved in tablet form but not in liquid. (Deprenyl is used to treat early-stage Parkinson’s and has been used throughout Europe for years.) The liquid form is far cheaper than the tablets, and may be more effective. However, even the export of drugs in tablet form requires FDA approval—as outrageous as that may seem—and Kimball was arrested under export laws and punished with a much higher sentence than he deserved. Health freedom activists are petitioning the president to commute Kimball’s sentence.
Health freedom and the “compassionate use” rule are the central issues in the riveting documentary we told you about some months ago, Cut Poison Burn, narrated by Peter Coyote, which centers on the Navarro family. After their son was diagnosed with cancer, they sought Dr. Stanislaw Burzynki’s treatment. You may remember our article from last year on Dr. Burzynski’s nontoxic gene-targeted cancer therapy called antineoplastons, which has been shown to effectively help cure some of the most “incurable” forms of terminal cancer.
Family Services was called in because they were no longer following conventional medical protocols for their son’s treatment. To keep the system from seizing their child, the parents fled to Mexico. Eventually the family returned to the US to fight through the congressional and judicial system to attain the right to access Dr. Burzynki’s treatment. They were denied and were forced to subject their son to chemotherapy, which eventually killed him.
Cut Poison Burn is an important documentary on the war against cancer, which is all too often a war against bureaucrats, and clearly shows the personal cost to families who are denied access to alternative and experimental treatment if they don’t want to subject themselves or their family members to chemo. You can watch the film’s trailer here—it’s quite moving.
The documentary’s producers are currently offering personal value pricing so that people can view the documentary online and pay whatever they can afford—or even watch it for free. Please encourage everyone you know to see this important film.
The movie will also be released in select theaters beginning September 21. You may also “pay it forward” if you wish—even if the documentary is not showing in your area, you may contribute money for someone else to watch the movie in the theater for free and be educated.
Action Alert! Please contact your congressional representative immediately and ask him or her to support HR 6342! This could potentially save countless lives. Please send your message today!

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