Help Us Make FDA Live Up to Its “Compassionate Use Rule”!

May 21, 2012
Category: Uncategorized

Darlene GantWhen people are dying of cancer, why shouldn’t they be allowed to try non-FDA approved treatments?
A woman in Florida with stage four breast cancer, Darlene Gant, made a YouTube video begging the FDA and a pharmaceutical company to allow her to use an experimental drug called pertuzumab. FDA is expected to approve the drug, developed by the California-based company Genentech, on June 8, but her doctors didn’t think she would live that long.
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 Gant’s case, FDA approved the request—but the drug company did not. It took the YouTube video and letters from viewers for Genentech to change its mind. She is now receiving the medication, and her family hopes it will stabilize her.
Gant was fortunate. Often the sponsor of a clinical trial is willing to admit dying patients, but it is the FDA which blocks access. FDA often denies access to experimental drugs, and disproportionately denies access to drug trials from new and smaller drug research companies, typically favoring the large pharmaceutical companies. FDA’s decisions are arbitrary and subjective because the current criteria themselves are subjective, allowing FDA to bow to pressure from industry or political entities or just do whatever it wishes.
Because of this, ANH-USA and acclaimed attorney Jonathan Emord have decided to petition the FDA to 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.
Under the new rule we propose,
(1)  if a treating physician has determined that there is little or no likelihood of success from FDA approved cancer treatments and
(2)  if the patient or patient’s parent has executed an informed consent that acknowledges the known risks and benefits of the FDA-approved cancer treatments and the potential risks and benefits of a non-FDA approved treatment and expresses the patient’s desire to receive such a treatment, then
(3)  the patient may receive access to the non-FDA approved treatment without need for FDA pre-approval.
This is a health freedom issue: while we all should have the right to pursue whatever approaches to health and healing we wish, this goes double for the terminally ill.
We need your help to make this campaign happen! We want to petition the FDA to change the rule immediately. We are under no illusions that the agency will respond favorably to the petition, but petitioning is the first step toward a possible lawsuit if one is needed. We anticipate there will be hundreds of hours of legal work over the next year and hundreds more if we must fight the FDA over this in the federal district and circuit court.
If you can afford to make a contribution, please do so now. Just go to our ANH Access Fund donation page, and please give generously!

44 responses to “Help Us Make FDA Live Up to Its “Compassionate Use Rule”!”

  1. Edith says:

    Two of my favorite quotes: “If people let the government decide what foods they eat and what medicines they take, their bodies will soon be in as sorry a state as are the souls who live under tyranny.” Thomas Jefferson
    Founding Father and signer of the Declaration of Independence, Dr. Benjamin Rush wrote, “Unless we put Medical Freedom into the Constitution, the time will come when medicine will organize into an undercover dictatorship…to restrict the art of healing to one class of men, and deny equal privilege to others, [which] will be to constitute the Bastille of Medical Science. All such laws are un-American and despotic and have no place in a Republic….The Constitution of the Republic should make special privilege for Medical Freedom as well as Religious Freedom.” The other founding fathers pshawed his prediction, thinking that it would never happen, so it was not necessary to put into the Constitution.. Lawyers should push for this Original Intent on this issue.

  2. George says:

    FDA only aproves a drug if the company pays them enough. If you are waiting for them to save you , you have a long wait. There are lots of things out there that do work that they dont tell you about . Do your own research

  3. Octavio says:

    FDA should not deny freedom to anybody. “Give me freedom or give me death!” We have forgotten too much and we are under FDA. Sad…

  4. Dennis Allen Jr., Ph.D. says:

    I strongly support your litigation in the matter of government agencies trying to control health matters in a way that is contrary to the U>S> Constitution! The Obama government is composed of a bunch of control freaks!

  5. wm dabby says:

    The tyranny of the FDA has gone far enough. If one cannot choose one’s own approach to one’s health, then one is a slave.

  6. wm dabby says:

    The FDA has no right to dictate what kind of medical or non medical treatments must undergo. This tyranny, pure and simple.

  7. Michael Kirkby says:

    It’s called compassion and not profit boys and girls. Doctors et al need to start showing some. Too many times it appears that they are too busy pandering and bootlicking Big Pharma’s shoes.

  8. Don Somsky says:

    Wake up this is 2012.

  9. Ann Byer says:

    The FDA already puts enough experimental drugs on the market without testing them! Why would you want to encourage such a practice? They have already killed off thousands of people with drugs and sweeteners that shouldn’t have ever been approved. Anyway, giving a person a drug for cancer is just going to kill them faster at the stage 4 level. One of my sons was killed by Paxill and my daughter had seisures from aspartame. (Nurtrasweet, Equal)
    The solution is to get the FDA to back away from persecuting people who want to use natural means to get over cancer! Cancer Centers Of America use herbs, colon cleansing, and other natural methods to cure cancer and they have a high success rate!
    The main reasons people get cancer is that their bodies are full of toxins, they are over-fed and undernourished and the colon is full of undigested fecal matter, and therefore their bodies are inflamed, setting the stage for cancer. And then, of course, there is the emotional factors of grief, anxiety and/or depression that contributes to it. No one regulates the FDA, so they do whatever they want to. Which, right now, is to do whatever suites their pocket books!

  10. coalmine canary says:

    Irony intended, please understand as you read this letter below:
    Dear Federal Government:
    May I please, please eat chicken for dinner?
    May I please, please go to the store?
    May I please, please have friends X, Y and Z?
    Oh and Dear Government, may I please, please read books P, Q, F?
    No?
    Oh.
    I see. I know. You are trying so hard to protect me. Exposure to stuff I really shouldn’t know about. I see.
    Thank you.
    NOT!!!
    For real now, and I mean what I say:
    Now when it comes to dying patients, or for that matter *anybody* who needs medical care, when I say For God’s Sake, I mean it—by God’s rule, should they not have access to any health care that they so please? What business does the Government have in this situation anyway? to beg and plead for care from the Government is as Red China-like as it gets.
    Government “Protection’ is Government *Oppression*.
    USA out of my health choices, NOW !

  11. Health does not come from a prescription for a pharmaceutical.

  12. Billie Knighton says:

    So go on either Change.org or Signon.org and post a petition!

  13. Janice Herbrand says:

    If a person is dying and convetional treatment can do nothing more for them, they should be able to try whatever drug they wish. It may or may not help them live longer, but they are their bodies, and it should be their choice.

  14. Sandra Cobb says:

    If terminal patients are willing, let them try new drugs. How else will medical advances be made?

  15. Jane Wilson says:

    I have had cancer it is very personal and the patient should have the final say. Period.

  16. Dale Must says:

    Perhaps much waste and bodily harm would quit if the doctors were not paid for prescribing drugs. I know of too many that are on medications that combat each other, add greatly to body wieight(causing possible heart conditions). It’s also bankrupting the medical pay system

  17. Rebecca Loken says:

    People should be allowed to decide their own destiny. That means if they are on Death’s door and want to be part of an experiment what person would tell them no? The FDA. There is proof out there that Marijuana can actually fight cancer, not to mention relieve symptoms, but politics rule at the FDA, not knowledge, science or mercy.

  18. Brian Lewis says:

    This is a MUST if we are to truly have the best healthcare and not just a health industry intent on making as much money as they can, no matter who suffers. The FDA is NOT looking out for us the decision makers in it are looking out for big under the table payouts from the healthcare industry (not a profession any more).

  19. Robert says:

    I agree 100% with this attempt. However, it should not be necessary. We live in a free society and each person has a right what to put into their body. It is only by the violation of the Constitution that such agencies such as the FDA are tolerated. Everyone knows that they do nothing to protect citizens and everything to protect profits.
    We are all tired of this process. Our government no longer exists and has not for many years. We have been misled, robbed, bullied, and we are now standing up.
    Question jurisdiction! It matters.

  20. Gerald Lorenz says:

    Please, let the public know the benefits of good food and the health concerns of bad food. Censorship of scientific information is not right and must be stopped. Just who do you work for, corporations or the American people.

  21. Linda Zigich says:

    Whether one is sick or not our freedom to choose unapproved FDA treatments should not be restricted nor threatened by a government agency or physician. I believe there are many “cures” sitting on the shelves of the FDA that will never be approved because our health system is based on “treating” disease, not curing. Protect your rights, your freedom to choose.

  22. Luise Davis says:

    Why not?
    She is dying and knows it. At this point, if the treatment is ineffective, it will make no difference. If it helps, it will make all the difference.

  23. Elizabeth Schultz says:

    Please allow terminally ill people to make informed decisions about their health care without intrference or approval from the FDA. It looks SO bad for the FDA when they appear to be doing what large pharmaceutical com[anies pressure them to do rather than honor the decisions and desires of the ill patient who has been informed of the irsks.
    This holds true for ANY patient, and we should all be allowed to choose alternative medications when they list the potential risks and the limitations of exixting research, but doubly so for patients who have little hope to live anyway! DO NOT TAKE THE POTENTIAL CURES AWAY FROM THEM!
    Thanks you for your compassionate consideration of this plea.

  24. Bruce Cook says:

    These people deserve a break.

  25. craig robinson says:

    Show some compassion.

  26. Allie Pace says:

    Whatever could be used to help a sick person is the way to go. If they are willing to take the risk, they should be allowed to try whatever they think will help them.

  27. Carol Lowe says:

    if a person is dying they should be allowed to do whatever they feel is in their own best interest. If they feel they want to be a study person, so be it. If they don’t get help they will die anyway. I say that makes it nobody’s business but their own.

  28. David Shelton says:

    Using pharmaceuticals is not the answer. Forget about mainstream doctors. They haven’t a clue.
    If you are interested in curing cancer, go to Dr. Burzynski in Texas or the Gerson clinic in Tijuana. Check out Gerson’s book, ‘A Cancer Therapy’.

    • Darlene Gant says:

      I love Dr. B but understand to walk in the center you need to have like 100K liquid cash to start … some of it (not too much) is billed to insurance and lots of times it is NOT covered. His PB’s are not covered and is out of pocket at 4K a month … there is only so much one can afford. He is brilliant but it all COSTS alot, alternative cancer treatments are a FORTUNE. However I would never put a price on my life but I am not rolling in 100K or more to do this. Even the Gerson Ctr and others are 15K + …. when you have been battling this dis-ease for some time and not working and taking supplements that cost 1,000’s monthly you start hitting your limitations. We need an insurance plan where we choose how to spend the $$$’s … that could’ve saved me thousands over 6 years of CAM therapies.

  29. Darlene Gant says:

    Some facts here are not correct, granted the FDA has its share of issues and pharmaceutical companies run half our country but the FDA could not do a thing unless the drug company would approve the Compassionate use. Genentech did not want to do so, that was clear from our email correspondences. The FDA, who found me through my non-profit website hopesupportgroup.com, was over the media attention and our campaign and was trying to get Genentech to move in our direction from the 2nd day after the video was released and went viral. The problem was definitely pharma co. Then problem was Moffitt with their two boards and trying to get paperwork in. No one fought for me to get the drug but ME and the amazing people around our world that cared. I am very integrative as you will see on my websites and support the use of herbals and CAM. I wish all patients were more educated to advocate for themselves or others …
    Rock on!

  30. Lynda Rowanl says:

    Im Sorry But I WILL shout about my rights to chose what treatments for health i take.l will get any treament i chose to save my life. The FDA is not GOD. If i get cancer I will chose what treatment I will use and it will not be radiation or chemo. It will be from a docter that you dont believe is right that can and has cured cancer. There is a cure for everything on this earth and GOD said so. He made our bodies and this earth to take care of them. I will do what i want and not what anyone else trys to tell me to do. I know whats best for me. The crap that the FDA is in control of our lives is just that they have no right to tell us what we can and cannpt do to our bodies. They dont own our bodies. WE do and GOD does. I have treated myself with herbs and vitamins and have cured myself and so has many others. The big pharma and FDA is not GOD. They dont live my llife. They didnt give birth to me.. Its all about money to them. We are supost to be a free country and that means of our choice. People are sick and tired of all this crap. There are more of us than you so just back off.and lealve us alone we are adults and can make our own dissisions we are responsible for ourselves.

  31. Marilyn Sutton Loos says:

    If the patient is expected to die without the treatment, what harm is caused by allowing the treatment, even if the FDA has not approved it?

  32. John Brown says:

    When is this goverment???gOING GET THE FDA UNDER CONTROL?????

  33. Ann says:

    When someone is terminal, what gives the FDA the right to stop the patient from trying anything that they feel might help the.
    How many drugs has the FDA approved that have killed thousands of people?
    Perhaps we need a revolution to stop the FDA from dictating our lives. We don’t need a dictator! We supposedly live in a free country.

  34. Phyllis Murdoch says:

    The “Compassionate Use Rule” should be expanded to include more people who have exhausted other treatments and want to try new drugs that would give them a chance to live.

  35. Mike88 says:

    Everybody should know that the FDA receives payments regularly from the Major Drug Companies. They the FDA is literally on the payroll of the Drug Companies and therefore are in violating of their stated purpose of protecting the consumers from dangerous drugs and refusing to allow drugs that they do not approve from being used because this would create competition to the Drug Companies that pay the FDA off, so the FDA will not allow Competition from smaller drug comanies or private individuals. The FDA needs to totally stay out of the Dr. Patient relationship.

  36. John J. Gallagher Jr. says:

    It is totally rediculous that you should bar anyone who is terminally ill from trying anythig which might help them survive or ease their suffering. If your not going to help these patients then atleast stop hindering them.

  37. Bill Giliotti says:

    Hello,
    This is exactly what Dr SR Burzynski , out of Houston TX, has been fighting the FDA for years now.
    His personalized gene targeted therapy using antineoplastons have shown great promise yet the FDA is causing him trouble.
    He is however in phase 3 of clinical trials so maybe soon we will see his drugs being used.
    I would like for ANH-USA to please comment on Dr Burzynski research…..PRO or CON.
    I have written to you before but received no reply.
    Thanks…..Bill Giliotti

  38. brad roon says:

    A good principle, but obviously there are better things to try than drugs, especially ones with recombinant DNA which is implied by the GENENTECH name.
    I know of two Swedish women that got rid of their breast cancer simply by taking large amounts of Co-Q10. Personally, i’d try a hyperbaric oxygen chamber loaded with as much ozone and pure oxygen as i could handle.

    • Nikki says:

      I agree with you Brad. To be perfectly honest, I don’t believe the Pharmas, Fda want to find a cure for Cancer. They can’t make money that way and, of course, they can’t patent the natural remedies. To them, it all about money…

  39. Andrew Kane says:

    I’d be happy to sign a petition asking Congress to approve legislation you’re proposing. Please present us with a petition so that we can add our signatures, and a link to our Congressperson and Senators so we can easily send the petition to them.

    • ANH-USA says:

      Hi Andrew, in this case we are not asking for Congress to act on legislation. This is a formal petition (a formal legal request made of a government agency, different from a popular petition which gathers signatures) we are making of the FDA. Formal petitions are filed with attorney representation, and it is these legal fees for which we are raising funds.

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  41. Bill says:

    If I had any disease I would check into getting rid of parasites & chemical & metalic overload in the body first. I have read about many people curing disease using these protocols. The FDA has no right to tell people what to do and how to do it. These lowlifes need to be thrown out of our government and jailed. They keep the mainstream methods of surgury and pushing chemical pills and radiation and are responsible for murder!
    The worst thing you can do is destroy white blood cells (t-cells) when you have cancer or any other disease. Many people that have not gone to medical school but read and use critical thinking
    know this.
    Aloevera juice raises the white blood cell count in the body. Go to GNC for a brand that states it
    on the label. Also, Parasites can cause some types of cancer. Read the definition of a Microbe.
    Chemicals and heavy metals in the body may cause cancer. Pesticides may cause cancer and parkinsons disease. Remember, anything you touch gets absorbed by the skin. Beware of household chemicals on your hands. Use chemical resistant gloves!
    Stay away from High Frucose Corn Syrup. This stuff is in many drinks and packaged foods.
    HFCS is very bad for the body and probably the reason for so much diabetes in this country.
    Do not drink sodas period if you want good health. Remember, high doses of sugar daily can be deadly. High salt intake is also very bad. If you want salt, get sea salt that is a light brown in color and not white. If you want sweet, get xylitol. It is not sugar but it tastes like sugar. Some sugarless gum uses xylitol in it. Look at labels! Xylitol is also naturally produced by the body…daily!
    Xylitol also helps protect the teeth up to five years from chewing sugarless gum just 1 time!
    I would keep the pH of the body over 7.2 – 7.4 for optimum health. Some foods and drinks are acidic and others are caustic. Do the research on natural ways to become disease free.
    My own research says there is a cure for almost all disease. I have read reports from doctors that have stated there is a cure for all disease and has been since the 40s.
    ALWAYS see your doctor before beginning any protocol on your own.

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