FDA Says No to Dying Patients Seeking Access to Experimental Drugs or Treatments

July 16, 2012
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cancer-patientAn important new bill addresses this situation. Action Alert!

On July 25, famed civil rights attorney Jonathan Emord will be hosting a briefing on Capitol Hill about the FDA’s refusal to allow terminally ill patients access to experimental treatments. In addition, actress Diane Ladd will screen the riveting documentary Cut Poison Burn, narrated by Peter Coyote.

As we reported in May, FDA currently allows something called “expanded access”—the use, on a case-by-case basis, of an investigational drug outside of 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. Once FDA approves, the drug manufacturer and the patient’s doctor must make special arrangements to obtain the drug for the patient, and these arrangements must be authorized by the FDA. In practice, this doesn’t work.

While the sponsor of a clinical trial is often willing to admit dying patients, it is the FDA that blocks access to experimental drugs or to drug trials from new and smaller drug research companies. FDA’s decisions are arbitrary and subjective because the current criteria themselves are subjective, allowing FDA to do whatever it wishes without regard to a patient’s welfare.

Moreover this system only speaks to new drugs in the approval pipeline—no other experimental treatments.

We believe the FDA should change its “compassionate use” or “expanded access” rule so that individuals (often children) who have exhausted all conventional cancer treatments can have all of their treatment choices honored without need to obtain federal government approval—essentially removing FDA from the process.

Emord’s firm has helped develop legislation that would be a powerful corrective to this horrific denial of patient freedom of choice. The briefing and documentary screening will be held so that members of Congress and their staff can learn about the soon-to-be-introduced Freedom of Choice Bill. Under it, any patient diagnosed with a terminal illness, for whom a physician determines FDA approved drugs are likely not curative, may obtain access to any experimental drug upon execution of an informed consent without need for FDA approval.

You may recall that Dr. Stanislaw Burzynski’s nontoxic gene-targeted cancer therapy with antineoplastons is currently undergoing clinical trials for FDA approvals. It would seem that under the current regulations, a terminally ill patient could be denied access to antineoplastons treatment if the FDA rules against his petition. The Freedom of Choice Bill could change all that.

Of course we want to gain as much support and as many cosponsors as possible for the bill when it is introduced. We also want to encourage staffers to attend the briefing on Capitol Hill.

Action Alert! Please write to your congressional representative and ask him or her to attend the briefing, view the film, and cosponsor the legislation.

Take Action!

21 Responses to “FDA Says No to Dying Patients Seeking Access to Experimental Drugs or Treatments”

  1. Sandie Kelly says:

    There is no reason treatment should be withheld from a patient that needs it and there is a possibility that this drug can help them sustain life. Red tape in healthcare is taking priority over patient care. What is wrong with this picture??? The patient should be the main concern – providing all possible treatments.

       4 likes

  2. coalmine canary says:

    The very idea of government approval for medical care, is completely unconstitutional, scary and belongs only in Red China, or former Communist Russia.

       1 likes

  3. Julie Hagan Bloch says:

    Several people on both sides of my fzmily and my husband’s family have had cancer and died from it. (I had cancer in 1991, too, but I seem to have gotten over it.) I wish there had been some experimental drugs or treatments available to help some of my family members. It might not have worked, but to have some hope would have been wonderful.

       2 likes

  4. May Terry says:

    The FDA should change its “compassionate use” or “expanded access” rule so that individuals (often children) who have exhausted all conventional cancer treatments can have all of their treatment choices honored without need to obtain federal government approval—essentially removing FDA from the process.

       0 likes

  5. Pamela Buescher says:

    As a cancer patient myself, I believe terminal patients deserve the right and freedom to try anything that may be helpful or beneficial to them, PROVIDED, no one in their family sues drug companies that provided a treatment they chose to try which may have hastened their death. We ask for freedoms, but then we are afraid to accept consequences, which is where and why many companies and govt agencies are forced to make decisions limiting access. Remember to look at all angles when supporting or denying a particular bill.

       0 likes

  6. Bruce Rodkey says:

    Decisions should be based on need. The terminally ill should have access to the experimental drugs when needed.

       0 likes

  7. Laura says:

    I think we should start dragging FDA agents with a rope around the neck and when they start pleading we say no

       0 likes

  8. John F. Delgado says:

    As a senior and compassionate person, I am supportive of allowing an idividual with uncurable health conditions be allowed, under medical directed doctors, to access experimental drugs not currrently approved by the FDA. The Freedom Of Choice Act will allow patients to hope for a possible cure or relief from their current health conditions. Meeting DEATH knowing that a possible delay or cure could be provided with current experiemental medications would be an unbearable torture to bear for an individual. I would want that right. Allow patient and medical professional determine what to do.

       0 likes

  9. Talitha says:

    This has been a focus of mine for many years. Below are the most impressive developments I have found with broad spectrum applications for cancer and RNA viruses… and they do NO harm.
    I want people to be able to choose these treatments and in combination if need be.

    *Bavituximab
    *Antineoplastons
    *The Hemopuriphier device

       1 likes

  10. Carrie Burton says:

    This is appalling!

       0 likes

  11. KC says:

    Like I would give adamn about the Feds and their law if I were dying. This makes criminals out of people trying to save their own lives, outrageous bull garbage!!!!!!!!!! Criminalizing desperate people trying to live, despicable! Get out of my life and take the church’s attitude with you.

       0 likes

  12. Richard Robinson says:

    Terminally ill patients should have the right to have any treatment they deem necessary. Actually, anyone should be able to have any treatment they have investigated and determined by themselves appropriate. For example, the Gerson treatment which has been pushed to Mexico, should be available in the US. Thank you for your consideration. Richard Robinson

       0 likes

  13. Help us, don’t control us.

       0 likes

  14. Irwin Tyler says:

    The Freedom of Choice Bill should include non-drug therapies (e.g. ultraviolet blood irradiation) and off-label use (e.g.high dose intravenous Vitamin C) as well as experimental drugs.

       0 likes

  15. Linda Butler says:

    …so sad to hear about this.

       0 likes

  16. C.J. Gacioch RN. RHIA says:

    Take some of the control away from the FDA and let patients have control over their treatmenst. The drug companies already control our lives, at least let us have some control in our final hours as to what we wish to do with our own lives. If medicine were practiced to cure the reason for disease, we would not have the problems we have. Why can the drug companies be controlled and limited to the amount of profit they gain on the backs of the sick.

       0 likes

  17. Marie says:

    Please allow terminal patients the right to use experimental drugs of their choosing! After all FDA drugs have not helped……

       0 likes

  18. Arlene Goetze says:

    Not one cancer drug cures cancer. ONly 2 drugs cure anything.
    Many forms of complementary medicine can help cure cancer (get rid of the acid in the body and balance the Ph at 7 and cancer will dry up…cause it is acidity in body that feeds the cancer.
    Healing is an energy process and drugs are not. HIgh doses of Vitamine C also can reduce cancer. Giving trial drugs to dying people just gives them huge financial burdens and the cancer industry gets richer.

       0 likes

  19. 2¢ worth says:

    I’m wondering.. What do these FDA clucks do when someone near them contracts a life threatening disease where normal channels have failed? Do they stand over them like vultures wondering what’s going to be in the will for them or do they (secretly) pursue the very treatments that they deny others? Kind of makes you wonder. I’ve said it once and I’ll say it again.. No matter how humanitarian a program, law or institution is, when the human element becomes a factor, in time comes corruption and if you hire watchers to watch the watchers eventually everyone in America will be employed but corruption will still prevail because it’s a ‘human’ effort. We need to stop allowing others to think and act for us.. We need to threaten them with their livelihood if they do not work in our behalf. only then may (and I say, may they actually do the job that they were chosen to do instead of reacting with $$ signs in their eyes and power mongering in their character.

       0 likes

  20. Jean Baugh says:

    Bulldoze the FDA and start over. Stop pandering to money and start curing people.

    Morris Fishbein is a classic example of power gone mad!

    Jean Baugh

       0 likes

  21. Margery Oberheide says:

    Again, the FDA makes a decision that defies logic . . . To deny dying patients a “last recourse” when they are with no options is mindboggling. And the whisper of a perception that the FDA uses this to block new and smaller drug research companies exposes the imbalance of propriety within the decision making of the FDA and its ability to determine product safety with the best interest of the american people in mind first and foremost.

       0 likes

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