CBS is running a series on the progress in the development of cancer drugs. Here is a clip from yesterday that discusses how the FDA manages the approval of cancer drugs:
About the Author
My name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
FDA SAYS, “WAIT” TO DYING MEN
COAST-TO-COAST PROSTATE CANCER DEMONSTRATIONS ON FRIDAY MAY 30th IN PROTEST OF FDA FAILURE TO APPROVE SAFE, EFFECTIVE IMMUNOTHERAPY
On May 30, 2008, CareToLive will take to the streets with coast-to-coast protests in Chicago, New York, Philadelphia, Cleveland, Madison, Atlanta, Seattle, Dearborn, and Tampa. Joining us will be the Cancer Cure Coalition, the Abigail Alliance, and A RightToLive. We are asking all patient advocates to come out and attend a protest.
1 in 6 men get prostate cancer. 75 American men die from it every day. The FDA has not approved a treatment for stage IV prostate cancer in over 43 years.
CareToLive, a not for profit corporation, seeks transparency and accountability from the FDA, as to why they disregarded the advice of their hand selected Congressionally mandated Advisory Panel of experts, who voted Provenge overwhelmingly safe and effective. Without cause or explanation, in an unprecedented action, the FDA denied licensure. We are seeking immediate access to Provenge for all men with end stage prostate cancer.
Over a year has passed, and 27,000 American men have died without hope, since the FDA denied the licensure of Provenge, an immunotherapy the FDA panel voted 17-0 safe and overwhelmingly voted effective. This is a noninvasive, non-toxic, immune building treatment, which works by employing your own body’s healthy cells to fight the cancer.
Men like Eduardo Garcia, who have had the 3 treatments, have gone from being incapacitated, to living healthy, productive lives, for as long as six years and counting. Dendreon, the company that perfected this treatment, also has similar treatments for breast, ovarian, colon, lung, kidney, and cervical cancers, in their sights.
The dysfunctional FDA’s reason for delay has never been explained, as it was not science based, since survival and safety have been clearly demonstrated.
CareToLive filed a Citizens Petition for the FDA to reconsider the wrongful denial, (the only recourse the FDA allows), on July 26, 2007. The FDA has failed to follow Federal regulation and to this day they have not properly responded to our Petition, which seeks immediate access to Provenge for these desperate men. The FDA also refuses to respond to the CareToLive Freedom of Information Act request, which they know would prove that a few FDA insiders, who cared more about serving their own interests, rather than the best interest of the patients, purposely sabotaged Provenge.
“In memory of our members who have recently passed away, never having been given the chance Provenge recipient Eduardo Garcia had, we will continue to fight on, every day, in every way we can. Please come out and join us,” said CareToLive spokesperson, Mike Kearney.
LOCATIONS:
Seattle, Washington — 1 PM PST
Westlake Park (Downtown) 400 Pine St
Chicago, Illinois — 3 PM CST
ASCO / McCormick Place — 2301 Lake Shore Drive
Cleveland, Ohio — 4 PM EST
Public Square outside terminal tower — downtown
Dearborn, Michigan — 3 PM EST
Rep. John Dingell’s Office — 19855 West Outer Drive
Madison, Wisconsin — 4 PM EST
Wisconsin State Capitol Building — 2 East Main Street
Tampa, Florida— 3 PM EST
H. Lee Moffitt Cancer Center & Research Institute
University of South Florida
12902 Magnolia Drive
Philadelphia, Pennsylvania — 2 PM EST
2 PM Assemble and pass out flyers at 12th & Market Street for march to FDA at
4 PM — 200 Chestnut Street U.S. Customhouse Building
New York, NY — 9 AM EST
Memorial Sloan-Kettering Cancer Center — 1275 York Avenue
Atlanta, Georgia — 3 PM EST
Atlanta FDA Regional Office — 60 Eighth St. N.E.
Just to backup Mr. Donahue allegation the FDA Advisory Committe process was corrupt….
For those not up-to-speed on exactly how badly one doctor’s Conflict of Interest situation appears to be in the FDA Provenge Advisory Committee meeting, take a look at these alleged COI for Dr. Howard Isadore Scher of Sloan Kettering in NYC.
In order to sit in judgment of Provenge, Scher certified to the FDA that he had 3 Conflict of Interests.
17 (SEVENTEEN) have been found on the internet for Scher thus far.
*** NOTE particularly items 1 & 17
1. NOVACEA: Grants & Research support; STUDY CHAIR of DN-101 ;
…. and DIRECT COMPETITOR to Provenge
2. GPB BIOTECH: Financial Conflict of Interest per Scher in MedPage
3. PHARMION: Financial Conflict of Interest per Scher in MedPage
4. SANOFI-AVENTIS: Grants & Research support
5. BRISTOL MYERSSQUIBB: Consultant, Grants & Research
6. MILLENNIUM PHARMCEUTICALS: Grant of Research support
7. COUGAR BIOTECHNOLOGY: Principal Investigator; Advisory Board;
8. INNOVIVE PHARMACEUTICALS: Principal Investigator
9. INFINITY PHARMACEUTICALS: Principal Investigator
10. BIOGEN-IDEC: jointly held stock with spouse
11. PFIZER: jointly held stock with spouse
12. GENTA: Scientific Advisory Board (as of Mar 6, 07; since removed but cached)
13. CONFOMA THERAPEUTICS: Scientific Advisory Board
14. DEPARTMENT of DEFENSE: Principal Investigator PC Clinical Trials-P1 and P2
15. AMBRILIABIOPHARMA INC: Principal Investigator PCK3145, Phase I/II
16. MEDIVATION, INC: Principal Investigator MDV3100
17. PROQUEST INVESTMENTS,
…. Board of Directors
…. Advisor
…. Novacea INVESTOR (direct competitor to Provenge)
Despite the above being reported to the Health & Human Services investigate office and the FDA investigative office, nothing has been done for almost a year to investigate these allegations that Scher may have violated the law by his apparently failure to disclose ALL his COI.
However, when two individuals sent flowers to the Commissioner of the FDA last month, the FDA sent 2 Investigators–within 1 business day–to the florist who delivered the flowers in order to get the names and other information about who sent Dr. Andy flowers.
Now, that’s genuine justice, isn’t it?
Finally, remember that Provenge is a treatment for TERMINAL prostate cancer victims… it’s not about an aspirin, a vitamin or an OTC supplement… this is about life and death.
83 men die daily from prostate cancer and some 31,793 have died just since last May 9th when the FDA postponed Approval/Conditional Approval for Provenge… a treatment all AC members voted to be “safe” by a 17-0 ballot.
Approve Provenge NOW and, Dr. Andy, fulfill your duties of office or resign.
Tony F
The Existence and Unavailability of Provenge
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 a 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. So, the FDA may not be an ideal judge regarding such issues as treatment options for very sick patients.
Prostate cancer is rather frequent, 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 requires the removal of white blood cells of the diseased patient and, after altered, are re-injected into this patient now designed to attack within the diseased body what is called PAP, which is on prostate cancer cells only. This treatment requires only three such injections in a period of six weeks. This results 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. This was expected by many, as Provenge was given Fast Track status by the FDA because of the potential of this therapy for terminal patients.
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! Many found this ruling completely unbelievable.
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 to provide support for this similar prostate cancer drug treatment 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 were fabricated in these letters, it is believed. 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. Because most are willing to assume any risks of unapproved, yet potentially beneficial treatments such as Provenge. Because they have a terminal illness, possible benefits clearly take priority over safety issues of unapproved treatments for them. The controversy could be concluded by a terminal patient signing a waiver of some sort, perhaps, stating that they are responsible for the consequences of an unapproved treatment regimen such as Provenge. Yet the FDA, with reckless disregard and overt harshness, denied what likely was a great treatment method for these very ill patients, so the FDA ultimately harmed others more by not approving Provenge, or offering any exceptions with such cases, which in this situation seems most rational, considering the available data with Provenge.
The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge at this time, 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, regardless of thier present health state today. Because of the FDA’s flaws in the past regarding drugs taken off the market along with increasing black box warnings of other drugs, which happens often with both, the individual should be the deciding factor in such matters of deciding thier treatment course along with thier health care provider, and not an unreliable Administration.
“Facts do not cease to exist because they are ignored.” — Aldous Huxley
Dan Abshear