A Bill For Experimental Meds For The Terminally Ill
5 CommentsBy Ed Silverman // May 20th, 2008 // 7:43 am
The bill, which will be called the Access, Compassion, Care and Ethics for Seriously Ill Patients Act, would provide terminally ill patients with access to treatments prior to FDA approval. The legislation is being co-sponsored by Sam Brownback, a Republican Senator from Kansas, and Dianne Watson, a California Democrat in the House, who plan a Wednesday morning press conference in Washington DC.
The effort comes after the US Supreme Court this past January refused to review a ruling that terminally ill patients have no constitutional right to be treated with experimental drugs even if that means the patient will likely die before the medicine is approved.
Last August, a federal appeals court sided with the FDA and decided the government may deny access to drugs that have not gone through extensive testing and received FDA approval, a process that can take years and, sometimes, angers cancer patients who are frustrated by FDA decisions, such as the controversy over Dendreon’s Provenge prostate cancer vaccine (see the ad).
“Many therapies already on the market could have made their way to patients months or even years earlier, saving or extending the lives of countless patients who died without access or options,” says Scott Riccio, who heads A Right to Live, a group that advocates for expanded access and who will appear at the press conference. “More promising therapies currently in the clinic will have a path to follow on their way to patient’s bedsides in the prompt and efficient manner Congress intended when it first created Accelerated Approval more than 10 years ago.”
Others on hand will be John Rowe, a cancer survivor and father of Kianna Karnes, a terminally ill patient who did not receive timely access to treatment; Emil Freireich, an oncologist and cancer research pioneer; Anna Tomalis, who has terminal cancer, and is trying to get access to a promising treatment outside of a clinical trial; and Frank Burroughs, founder of Abigail Alliance for Better Access to Developmental Drugs, an organization which helps terminally-ill patients.
Dan
This is allowed, but it is to the discretion to those who reimburse for such expirmental meds, and usually is denied.
molly
I feel that if people are going to die and they know that they have no alternatives. What will it hurt to let them try other treatments that just might save or extend thier lives.
kyoto27
If our US Supreme Court has no ethical problems with randomized, placebo-controlled double blind trials (in the name of good science) they should bow to this bill in the name of good conscience and common sense—the dying, after all, are dying. We do not as a society need to be reckless in embracing new science; but to discard new science in the name of ‘good science’ is equally reckless. The dying are playing in the highest stakes risk-reward game, and they deserve a chance to play. And if their ‘experimental’ treatment keeps them alive long enough to eventually have the FDA confirm the ‘survival’ benefit years later …so much better. There is no downside for the dying.
Tony F
Thanks goes to Senators Brownback and Watson for taking on such a difficult task!
Thanks goes to Scott Ricco and Frank Burroughs for the huge amount of work they do on behalf of cancer victims and who have done so for such extended periods of time… years and years for Mr. Burroughs!
My very best wishes and prayers for John Rowe, Kianna Karnes and Anna Tomalis for the best possible outcome in your cancer fight!
Dan’s comment isn’t exactly on the mark. As I understand the situation currently, access to experimental, unapproved treatments require a treating physician to get not only the bio/pharma’s approval to setup a 1 person “clinical trial”, but that it also involves all the actions required by the FDA and an Independent Medical Review Board and others just as if this treatment of 1 person was an actual “clinical trial” treating hundreds and hundreds of people.
This requirement is both time consuming and virtually unworkable and unmanageable just to treat one patient….
… and this is wrong!
Even the United Kingdom has taken to allowing experimental treatments for terminal diseases to be given outside clinical trials and early reports are coming in that some small percentage are already benefiting from this new program.
Why, as the richest and most powerful nation on Earth, not be a leader in both research and COMPASSION for terminal illness victims instead of our currently not even being a follower of such revolutionary medical ideas?
Times are changing and will change; the question is will it be in time to save or to extend lives of countless victims of illnesses and allow them to live longer lives with a good quality of life?
83 men die each day from prostate cancer… more than the number of women who die from breast cancer, as I understand the numbers.
Provenge was judged by the FDA’s own hand-picked medical Advisory Committee to be safe by a perfect score of 17 yes to 0 no and the vast majority voted the clinical trials demonstrated Provenge to establish its efficacy.
God bless and protect the victims and give peace to the familes!
Take action now and support the ACCESS ACT!!
Dan
Provenge and Our F.D.A. Absent Of Loyality
Terminal patients are those who are not expected to live due to usually illness such as advanced cancer. If the patient has 6 months or less to live, those patients are considered terminally ill. Regardless, if a patient is terminal, they are without a cure or tolerable treatment for their illness. Since such patients will likely die in a short period of time, treatment options, even if unproven, are often desired by such patients. This is understandable, because at such a severe stage of illness, such as prostate cancer, possible extension of their lives with comfort is worth it to them, regardless of lack of evidence of proof of whatever treatment that may be advantageous to them regarding these issues. The FDA, however, claims authority on the treatment options of such patients, although that administration has proven itself over the years to be rather inadequate with its frequent drug recalls and black box warnings, and they do these things only under pressure from the public, usually.
Prostate cancer is a rather frequent occurrence- with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in about 30,000 deaths a year from this disease. Furthermore, there are different stages of prostate cancer, and the more severe the prostate cancer cases are which is determined by such methods as bone scans and Gleason’s scores, the more difficult it is to treat such patients.
Yet innovation still exists in medicine. A few years ago, a small Biotechnology company called Dendreon was working on a conceptually new treatment for the worst prostate cancer patients, and this treatment therapy created by Dendreon was named Provenge. Provenge is the first immunotherapy biologic treatment for the progressed prostate cancer patients. Usually, these patients are unresponsive to usual treatment methods for prostate cancer, and are left with chemotherapy as their only treatment option at such a traumatic stage of prostate cancer. Understandably, most patients at this stage refuse treatment entirely, largely due to the brutal side effects of such chemotherapy treatments as taxodere. The immunotherapy method developed by Dendreon required the removal of white blood cells of the diseased patient and, after altered, are re-injected into this patient now designed to attack what is called PAP, which is on prostate cancer cells only. This treatment required only three such injections in a period of six weeks. This resulted in life extension twice that of chemotherapy treated prostate cancer patients of this severity, and without the concerning side effects of chemotherapy. The medical community and survivors of prostate cancer were elated and waited with great anticipation for access to this treatment method.
Fortunately, as the years passed, Provenge, by 2007, had convinced others of its safety and efficacy in its benefit for severe prostate cancer patients. This caused great joy to such patients and their families. Perhaps greater elation was experienced by the caregivers and specialists of such a disease, such as Urologists and Oncologists who treat such patients. While Provenge was on fast track status at this time at the FDA, the FDA panel recommended with clarity the approval of Provenge based on its proven and substancial efficacy and safety demonstrated in its trials, as they announced in March of 2007.
Now for the bad news: With great shock and surprise, the FDA agency rejected the approval of this great treatment for very sick patients due to, they said, ‘lack of data’ in May of 2007. This contradicts their favorable opinion of Provenge weeks before delivering this terrible news. Especially when one considers the FDA Commissioner is a prostate cancer survival himself!
Soon after this judgment was passed by the FDA, conflicts of interest were discovered by others. For example, a member of the FDA agency who was evaluating Provenge, Dr. Scher, was found to have a financial commitment to a future competitor of Provenge that was being produced by a company called Novacea, and this company had signed a co-promotion agreement with Schering with this similar prostate cancer drug being developed by this company. Dr. Scher never disclosed this conflict during the approval process of Provenge. As it turns out, this anticipated prostate cancer drug made by Novacea was discovered to have serious flaws, and Schering pulled out of the agreement with Novacea. In addition to this incident and before May of 2007, baseless letters were anonymously delivered to the FDA stating negative qualities about Provenge that were without Merit and speculative claims about the treatment. Yet overall, the disapproval by the FDA of Provenge angered many, and a newly formed advocacy group called Care to Live filed a lawsuit against the FDA for their clear lack of protocol or knowledge about such complex treatment agents as Provenge at the end of last year.
Terminal patients, I surmise, desire comfort during their progressive disease that has placed them in the last chapter of their lives, and certainly should have a right to choose any treatment that possibly could benefit them. At this stage of such a patient, one could argue, safety of any treatment option is not of concern to these patients, because they are going to die anyway. Yet the FDA, with reckless disregard and overt harshness for these very ill patients, ultimately harmed others more by not approving Provenge.
The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge, and why they have not remains completely unknown. What is known is that they are harming those they pledged to protect so long ago. So now the FDA appears to be a bought, corrupt, and incompetent administration without loyalty and dedication to the public and its health. This needs to be corrected in any way possible for the lives of others.
“Facts do not cease to exist because they are ignored.” — Aldous Huxley
Dan Abshear