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


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!

Take Action!

  • Patrick Monk. RN.

    Physician Assisted Suicide, with all appropriate guidelines and safeguards, is another option that should be made available.
    Patrick Monk.RN. Hospice Case Manager. SF. Ca.

  • Ann

    Please give terminally ill people their last ray of hope and allow administration of experimental procedures, drugs, alternatives and whatever they desire.

    Not only can good things happen to a dying person, but the researchers, scientists etc. will also be learning from the administration of these experiments.

  • m. Jeffrey

    Hello…your petition requires the entry of ‘puzzle, data which is not shown’ therefore is not possible to complete; since I do NOT play puzzles, please unsubscribe me immediately !

    • Hi Jeffrey–Thank you for your comment. I’m sorry for the inconvenience of the “Captcha” tool: it’s used to prevent spam bots from sending in false replies.

      To unsubscribe, please use the link at the bottom of our newsletter emails.

  • floramae

    depends on how old you are…………remember 70 and over your dead to the pos in our oval office and selbilliass, will get the word to you.

  • I’ve often thought it would be a fantastic idea if terminally ill patients could be allowed to use experimental drugs/procedures. This would furnish invaluable information. These people are about to die anyway, and there’s a good chance something tried on them could conquer their disease and eventually be turned into a routine solution for the medical problem. But I would like to see these drugs/procedures applied on the patients in a proper scientific way/study, to obtain results with strong evidence to support them.

  • Bridget Palecek

    Please say yes to HR 6342, the Compassionate Freedom of Choice Act of 2012. This compassionate act could possibly save lives and give people who have given up some hope.

  • Susan Ratcliffe

    I believe we should allow the compassionate use rule. What human being wouldn’t.

  • Tim Webb

    It is generally accepted that all pharmaceuticals are in varying degrees lethal to those to whom they are administered. I cannot see that experimental pharmaceuticals would ever be any better than their mainstream analogues. This is just magical thinking, ie “If I believe enough, it will work”. Many are the cries against conventional drugs; it seem however that if these drugs are not yet licensed, then mysteriously they acquire credibility in the minds of the sick.
    wrt the girl denied a “new drug” for her head and neck cancer, there is compelling evidence that Dr Johanna Budwig’s treatment protocol, using cottage cheese and flax seed oil, would have been the obvious strategy to follow. Personally, I would have also incorporated hemp oil into the mix.

  • Darlene Barber

    When someone is terminally ill it should be up to them and their family about the treatment involved. It is our body and should be our choice of what we choose to put in it. If someone chooses to try a new treatment-get it in writing-it is our choice. This would be extremely beneficial to everyone involved. The FDA can okay for me to take all these meds on the market with the horrible side effects but can’t allow people who are terminally ill to choose their treatment. The way this country is run I guess they wouldn’t be getting enough money to line their pockets so they choose to let people suffer at their expense.

  • terry mckinney

    If you have your due date already and you want to try a new drug or treatment,you have nothing to lose.Or very little.I saw my mother die the most horrible death from a botched leukaemia trial but at least she tried.They said she contributed to finding the best treatment,although it wasn’t the one they gave her.So I speak from a slightly more aware position than most, of the horrors of what can go wrong.I was pissed at the time.Now I see that she took the only shot she had and it just wasn’t the right one.She only had six weeks at best.She died in two.She said she believed in a God.I do not.If I had my due date I would ask for the strongest pain meds available and just read a book.I would hope not to finish it.