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

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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!

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