I provided this link so that those who are concerned might voice an opinion. The delay has already cost lives and the comfort of thousands of men suffering from prostate cancer. Instead of chemotherapy, this type of drug attacks the cancer cells. The knowledge gained from this treatment may be useful in treating other cancer. http://www.petitiononline.com/provenge/petition.html
To: U.S. Congress
April 30, 2008
Committee on Energy and Commerce
2125 Rayburn HOB
Washington, DC 20515
Dear Chairman Dingell and Ranking Member Barton, Subcommittee Chairman Pallone and Ranking Member Deal, and Chairman Stupak and Ranking Member Shimkus:
We, Physicians for Provenge, are writing to urge you to honor the request of Congressmen Michaud, Burton, and Ryan. We concur with the Congressmen’s statement “the FDA should not be appointing scientists leading the testing of a rival drug for another firm onto an advisory committee evaluating Provenge.” An editorial in the peer-reviewed journal Nature Biotechnology put it this way, “In the real world, in a scientifically assessable way” this prostate cancer therapy Provenge shows real benefits and has real value, with minimal side effects. Prostate cancer patients, their physicians, and the rest of America benefit by getting serious answers to the significant questions in the Congressmen’s letter and this Nature Biotechnology editorial.
On March 29, 2007, a multidisciplinary FDA advisory panel of immunologists, oncologists, statisticians, urologists, patients advocates, and other invitees reviewed Provenge, and decided unanimously that it was safe (17-0), and possessed substantial evidence of efficacy (13-4). On May 9, 2007, the FDA did something it has historically never done before in reviewing a therapy for a terminal patient group: overruled its own panel of experts and delayed approval of Provenge pending results from an ongoing phase 3 trial, which may not be available until 2010. Since the FDA’s decision, MORE THAN 22,000 AMERICAN MEN HAVE DIED at a rate of 82 men/day.
Clearly, many physicians believe Provenge works. Please consider why our colleagues and we KNOW that Provenge works and why tens of thousands of men with late stage prostate cancer should be given access to it. The Provenge results mentioned below are far stronger than might be suggested by a cursory read of the news. Provenge has shown activity and efficacy in every one of the six trials where it has been studied including three phase three trials. The FDA looked at the phase three trial that showed the median (midpoint) survival benefit was 4.5 months but the mean (average) survival benefit was much better: 34% of all men receiving Provenge were alive after three years compared to 11% of those who did not.
Unfortunately, two physicians, the same two listed in the Congressmen’s letter, who specialize in chemotherapy and had egregious conflicts of interest, led a very public and visceral campaign against Provenge. However, Provenge is a vaccine, not chemotherapy, and these physicians are not experts in vaccines/immunology. For example, while it is true the Provenge study narrowly failed on its primary objective of Time To Progression, it has since been accepted within the medical community that Time To Progression measurements require adjustments for the ramping up of the patient’s immune system, as in any vaccine. Moreover, that these adjustments would most certainly have resulted in the study’s success for Time To Progression, as well as for the critically important survival and quality of life issues. The multidisciplinary experts consulted by the FDA, pointed this out. This is why Provenge was recommended for approval while an ongoing study is continued. Additionally, it should be noted that the FDA has in the past approved drugs that have failed in the primary goal of their designed studies but retrospectively demonstrated improved survival (e.g. carvedilol for heart failure). Provenge is not a “me- too” drug for which numerous alternatives exist such as for cholesterol, diabetes or hypertension. These men are dying with very little hope, many refusing chemotherapy because of the severe side effects coupled with a poor survival benefit. Why did the FDA not extend the same compassion to dying patients as they extend to patients living with chronic diseases?
Anyone following the FDA knows the FDA has been approving “me-too” drugs with serious side effects for chronic illnesses for years. This while preventing access of potentially lifesaving medicines to dying patients and their physicians. A common but inaccurate response to this is that a medicine like Provenge is currently available thru compassionate use programs. Unfortunately, most of these small drug companies that develop these innovative therapies are too cash-poor to participate in this program. Consequently, this unyielding approach by the FDA has already led to higher research costs, delays in the War on Cancer, and ultimately higher healthcare costs. The FDA should be carefully assessing risk versus reward for the treatment of terminally ill patients, rather than “gate keeping” based on outdated statistics, reducing short-term health care costs or backroom shenanigans. In addition, lest we forget, chemotherapy is the only medicine approved in the last 45 years to treat terminal prostate cancer.
The FDA’s expert panel said Provenge was safe and it works. Our collective medical training has been lengthy and thorough. In addition, we have all learned to consider what is in the BEST interest of our patients and their families. All we ask of you is the same! Chairman Dingell, in the name of good science, patient benefit, and physicians looking for new and better options for their patients, please conduct these hearings.
Very Respectfully,
Patrick Bennett, M.D., COL, USA MC
Fort Campbell, Kentucky
Phillip A. Hale, MD, FAAFP
Danville, Virginia
Scott D. Klioze, M.D.
Daytona Beach, Florida
Gregory B Purchase, M.D.
Battle Creek, Michigan
Charles Bennett, M.D., CDR, USN(Ret)
Fond du Lac, Wisconsin
Robert A. Rostock, M.D.
Wilkes Barre, Pennsylvania
Ardeis Scott, M.D.
Safety Harbor, Florida
Please note that the physicians who have signed this letter represent broad diversity geographically, politically and of medical specialties. We are, however, strongly united in our desire to shine the light of truth and decency on the matter of Provenge. PLEASE ADD YOUR NAME TO THE GROWING LIST OF SUPPORT FOR A HEARING BY SIGNING THIS PETITION.
Sincerely,
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Gato got runned over by Marcus many moons ago. Be ye daft, 2486? 
Let's have a new poll, alright, Joe?
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{ 10 comments… read them below or add one }
Provenge is an important advance in immunotherapy and appears to have been delayed by arcane interests in riskier, less effective chemotherapy. The FDA process that overruled in secret the scientific panel’s recommendations for approval must be investigated.
This letter contains some facts but not all. I’m confused by the words, “On March 29, 2007, a multidisciplinary FDA advisory panel of immunologists, oncologists, statisticians, urologists, patients advocates, and other invitees reviewed Provenge, and decided unanimously that it was safe (17-0), and possessed substantial evidence of efficacy (13-4).”
What specialties were the 4 who did not think it showed efficacy? Was this an FDA panel, or non-FDA personnel on the “FDA advisory panel?” What is their experience in reviewing data such as this?
Repeatedly, it is noted what the Phase III Trials showed. Perhaps I missed it, but what did the Phase I and Phase II trials show? That data is significant in what the FDA decides.
I didn’t read the design or length of the trials, just that certain investigators believe this drug works. I’m not saying it doesn’t, I’m just saying I don’t know how many sites were included, and how many countries were involved in Phase I, Phase II and apparently now Phase III trials.
The FDA frustrates me greatly. Rules change frequently and pharmaceutical companies and clinical research sites are required to do more and more extra tests in clinical trials. I’m contractually forbidden to give examples.
The legal system has made the FDA, Pharmaceutical Companies and P.I’s “invest” so much more of their efforts, time and money into new drug development. Meanwhile, restrictions are tighter than ever.
It’s almost not worth it to run clinical trials any more in the U.S., given the overwhelming paperwork, the costs to the site, the much stricter rules about compensation and how many years records have to be stored and other factors.
From my perspective, the FDA is still “recovering” from “disappointing leadership,” not so long ago. (I purposely edited my original comments). A tremendous amount of clinical research was suspended or stopped in the U.S., during years when many advancements could have been made. Many clinicians asked why????
Good drugs should have been approved for many diseases and haven’t been. Meanwhile, patent years are ticking away, while patients suffer and die from many diseases. Pharmaceutical companies only have a certain number of protected years to recover the billions invested in new drug development. It is a very complicated process.
The failure to respond to the Compassionate Plea is disappointing. I can’t write more.
I’d encourage men to look to other countries for this drug. Often a drug has different brand name in other countries. The FDA, historically, has often followed the lead of European or other countries when approving any new drug. It’s my understanding that Canada’s approval process has become even tighter than the U.S. So Canada may or may not have access to this drug.
I believe it is good to start a dialogue about clinical trials and the “hoops” clinical sites have to jump through, as well as pharmaceutical companies. Some would be dumbfounded at the amount of work, relatively low compensation and strict guidelines in patient recruitment and documentation, plus the special licenses required now to even ship lab samples to a central lab.
I have NO SPECIFIC knowledge of this drug, the pharmaceutical company who makes it, or any trials conducted to prove efficacy. However, I know a lot of the restrictions and requirements the FDA now demands.
Finally, if I can, I’ll answer general questions about the drug development process. I know most of the steps very well.
well, let’s not overlook the built-in profit derived by radiation oncologists with their “seeding”…..apparently, this method is less successful in treating p.c. than conventional surgery, yet it is a big moneymaker for those who own the equipment and bill for these procedures. so I can’t imagine a drug which could replace or diminish those profits will ever be approved by that group of doctors.
Just my opinion…..
I think I speak for many folks here when I wish I knew more about this area. One day you hear the FDA is a slow bureaucratic mess that takes way too long approving new drugs, the next day you hear the FDA is a pawn of the drug industry because they approve drugs to quickly without enough trials.
Which is closer to the truth?
Babs. What are your references that surgery is more effective than radiation oncology “seeding” treatments provided by radiation oncologists? In this particular protocol, which I’ve already declared I know zip about, had the patients been treated by radiation oncology or was that a rule out? Clearly, I’ve got some reading to do.
Joe, I think your comments are very important ones to address. Just a real quick answer for now, from my POV, both answers are true.
For starters, I’d look when a compound first started development and in what country. Drugs often identified in Europe or Japan may take 5-8 years to bring to the U.S. Conversely, compounds identified in the U.S. usually go to certain countries very easily for trials.
ONE key fact to remember about the FDA, is whether it be primary or secondary goals, when evaluating efficacy, the number of patient days are always evaluated. Depending on the disease and sub-specialists involved, compared to diseases PCP’s see daily, those patient days can be much more difficult to obtain.
On the average, I’d say the protocols I’ve seen have about 20 inclusions and 20 exclusion criteria. That means practitioners have to find the “right matches” for protocol criteria, and then those people have to volunteer for the trial.
If the X number of people receiving study medication vs. an equal number of people receiving placebo can’t be recruited within the planned timeframe, it takes more time to find the “right patients” and accumulate patients days enough to present to the FDA.
In that sense, I can understand a lot of confusion of why some drugs appear to come out much faster than others. Specialty drugs usually take longer. And all Serious Adverse Events have to be factored in as well, let alone from which other countries clinical days have been obtained, plus other factors.
How is the average person suppose to know all of that? They don’t; most physicians don’t.
While many attorneys who read this may disagree, unfortunately, research has changed because of lawsuits. Thus, we have painfully slow processes now and some that make NO SENSE to me.
Some pharmaceutical companies have had all sorts of consequences from the lawsuits, including downsizing or being sold. Like those who stopped making vaccines in the U.S. Why take the risk of parents suing when the vaccination may have not had one thing to do with their child’s medical/psychological problems later? Not every test was available with the accuracy of today, 20 years ago.
Blatant neglect and flasifying data etc. is a different story.
The pharmas still in business, require so much more of the CROs and sites, it’s unbelievable. But, they are protecting themselves. While this is a small example, but one I can openly share, study sites have to carry at least $1 Million dollars more liability insurance for study patients to walk through the door, than regular patients. That means extra costs to the investigators that aren’t reimbursed, but mandatory if the site wants to participate in the trial.
I edited most of what I originally wrote here, not that I can’t write it. Just because it’s complex. Hopefully, that gives you a general idea, Joe, of why some drugs seem to get through more quickly than others.
Always question the country of origin, when the compound came to the U.S., patient exposure days and FDA politics.
Trust me, the FDA works really well right now, frustrating as the agency is, compared to when a non-physician was in charge of the FDA.
In the original article, it starts by saying, “We, Physicians for Provenge,” – what does that mean? Are these consultants to the company who were asked by the company to write the letter (and every company has their experts, which is ok by me, as usually they are the most knowledgable about the diseases, IMO), or others?
I respectfully disagree they are geographically diverse group of physicians who originally signed what is posted here. Perhaps more doctors were included elsewhere. Otherwise, we have the southeast and midwest represented.
From what was written, we have NO other information about concomitant medications, illnesses, or previous surgeries/treatments etc. We don’t know if those who responded the greatest are of a certain ethnic decent, smokers, consumed only health food or had already failed radiation oncology treatment and/or surgery for the Prostatic Cancer etc.
Nonetheless, upon re-reading the letter and realizing the Phase III trial (not identified as early or late) would be ongoing, I see no reason to deny the Compassionate Plea to those who improved on the drug.
Guest 2486, your comment from the chatbox made me smile, “Guest_2486 : I KNEW Ok4now would be back to comment on the “cancer post”!! Where ya been O4N???”
I’ve been exceptionally busy, both personally and professionally. Today is my first day to log onto IFz.Com in about 2 weeks. I was clueless there was a cancer post here. I’m ticked at Otter for not funding CAES and hoped there would be an article about that.
I LOVE your abbreviation of my name – O4N.
I have to stop for now. I hope what I’ve written helps some.
O4N – if Guest 2486 gives me permission to use that abbreviation.
Hey Ok4Now….I was Guest_2486 in the chatbox…Of course you can use O4N. I haven’t got a patent on it yet!
Good post, very informative!
thx
No committee investigation until after decision on Provenge………….
NEW YORK (Dow Jones)–The U.S. House Energy and Commerce Committee said it will not launch an investigation into the Food and Drug Administration’s handling of Dendreon Corp.’s (DNDN) cancer vaccine, Provenge, CNBC reported Wednesday.
CNBC said the committee won’t make a decision on Provenge until the FDA makes a final decision on the drug, which could be a year to three years from now.
In December, three congressmen, Rep. Dan Burton, R-Ind., Rep. Mike Michaud, R-Maine, and Rep. Tim Ryan, D-Ohio, requested a hearing from the committee to investigate the FDA’s regulatory process concerning the drug.
In May, the FDA failed to approve Provenge, instead requesting more clinical data to support the effectiveness of it as a prostate cancer drug. The move was surprising because an FDA panel two months earlier backed the treatment, by a 13-4 vote. The FDA typically follows its panels’ advice but is not required to do so.
The three congressmen sent a letter to Committee Chairman John Dingell, D-Mich., requesting a probe into possible conflicts of interest and ethical violations concerning two members of the FDA team involved in the Provenge debate.
In the letter, the con! gressmen wrote that prostate cancer activists have raised questions about two academic medical oncologists, Maha Hussain and Howard Scher, who voted against Provenge on an FDA panel in March.
According to the letter, Scher is a lead investigator for a cancer drug made by Novacea Inc. (NOVC) and is listed as an advisor to a large venture-capital firm that is also a major investor in Novacea. Hussain is an oncologist in the department of internal medicine at the University of Michigan.
Provenge has provoked much debate in the medical and investment community because of questions about the strength of the data and the treatment’s merits. Provenge is the first so-called active cellular immunotherapy drug, which tries to fight cancer by harnessing the body’s immune system, to seek FDA approval. Current treatments attack the cancer cells directly.
-By Brett Philbin, Dow Jones Newswires; 201-938-5393; brett.philbin@dowjones.com
The FDA’s procedures are unconscionable. I think the law should roll back the restrictions dramatically. Instead of restricting the new drug completely, there should be some procedures ensuring a level of informed consent. That’s all. After that, each individual should be free to make an evaluation and make any gamble.
Legalize drugs (medical drugs) now!
http://seekingalpha.com/article/30897-update-on-dendreon-s-briefing-docs-provenge-missed-all-endpoints
If you understand the principles of primary and secondary endpoints, then the P values in this article support the FDA. P values need to be less than 0.05% to be statistically significant in placebo controlled trails. Even then, statistical significance does not always correlate to clinical significance.
The FDA has at various times been attacked for being too cautious, and at other times, too slack. Damned if you do, damned if you don’t.
As far as Europe goes, just remember thalidomide. Thankfully the FDA never caved into the emotional outcry to approve this drug to help with early pregnancy associated nausea. The effects of the drug in the first trimester were devastating in Europe. That is one reason why Europe will approve drugs more quickly if the have already been FDA approved here in the US. But not the other way around.
The FDA may have its faults but overall it tries, despite the politics of medicine.
Hi O4N or OFN ha ha…
here is one site that references the surgery vs. seeding issue:
http://www.sciencedaily.com/releases/2007/10/071008161049.htm
My local paper carried an article that mentioned this study recently…….