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Dendreon CEO Mitchell Gold acknowledges the company's fortunes largely rest on the outcome of trials of its cancer drug, Provenge. (Photo courtesy of Lincoln Potter)
Ted Girgus, a former college administrator who lives in Bellingham, has been keeping an eye on Seattle biotech company Dendreon Corp. Girgus has been fighting prostate cancer for more than a decade and sees the company's principal product, Provenge, as a potential lifeline. Early results from clinical trials indicate that the drug may bear out that hope.
"Provenge has been the light at the end of the tunnel," he says.
But Girgus' other hopes aren't going so well. He's also an investor in Dendreon, and the company's ordeal in getting Provenge approved by the Food and Drug Administration has been harrowing, wiping out hundreds of millions of dollars in value.
Getting a drug approved by the FDA is a long, exacting process that takes money, research and patience. It's not usually the catalyst for dramatic stories and conspiracy theories.
But the saga of Dendreon and the not-yetapproved Provenge has captured the attention of many patients, investors, regulatory critics and even Congress during the past year.
Throw in the stakes of big money, personal threats to FDA advisers and real questions of risks versus benefits when trying to treat a deadly disease, and it's easy to see why the story of Dendreon and Provenge has become one of the most compelling in the biotechnology world.
It's also a stark reminder of why biotech remains one of the biggest gambles for investors. Dendreon's stock has taken a roller-coaster ride from a peak of more than $25 to below $4 at times -- that's just in the past year.
"The magnitude of how this got picked up from the public-interest perspective is more than we could have imagined," says Mitchell Gold, Dendreon's CEO for the past five years. "It's a story that people remain interested in."
And unlike software start-up companies, the extended drug development cycle means that the average biotechnology start-up is in research mode for a decade or more and often has to go public in order to keep the capital flowing in. By the time a drug makes it into the final clinical trials, it has often become the company's flagship product. Other drugs may be in the works, but the fortunes of the company as a whole often rest on the first product through the pipeline.
If a company's principal drug candidate fails, the stock price plunges, staff are often let go, and the company likely becomes a takeover target for a larger conglomerate looking to scoop up some potential drug candidates on the cheap. That is, if the start-up doesn't just go under completely. Among biotech start-ups, it's boom or bust, and there aren't many do-overs.
Dendreon has been struggling with the latter scenario, starting a year ago.
On May 8, 2007, the FDA issued an "approvable" letter for Provenge, which actually means the agency is not approving the drug, but leaving the door open to future approval. The agency asked Dendreon for more clinical data about the drug's reported efficacy.
Even though some analysts had predicted such an outcome, the decision made waves. Less than two months earlier, an FDA advisory panel recommended Provenge's approval, voting 17-0 that the drug was safe and, in a 13-4 vote, that it prolonged the lives of prostate cancer patients.
"Never in the history of the FDA, as far as we know, has the FDA not gone with the recommendation on a life-saving drug," Gold says.
David Miller, president of Seattle-based Biotech Stock Research, puts it more bluntly. "There are a lot of guys who think they got screwed," he says. "And they did."
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There is no excuse for government agencies to hide in secret meetings as a norm!
Nationwide Prostate Cancer Rally MAY 30th Over FDA Failure to Approve Safe, Effective Immunotherapy.
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.
Care To Live, 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.
On May 30, 2008, CareToLive will take to the streets to protest with the men desperately seeking Provenge. 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 clearly been 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.
Please join with me on May 30th, 2008, in Westlake Park, outside in downtown Seattle, Washington, from 1 PM to 3 PM, as a show of solidarity with our brothers who have been tossed aside by our incompetent, cold blooded health czars. Visit www.CareToLive.com for additional details.
Thank You, Jason Burdine Coordinator Seattle Jason.Burdine@gmail.com
A fiduciary duty is the highest standard of care imposed by law. As an employee of the FDA, Dr. Scher has a fiduciary duty up hold to all Americans and is expected to be loyal to and act in the best interests of all Americans. As such, Dr. Scher must put aside his own personal interests and must not profit from his position. The foundation of Dr. Scher?s position is based upon good faith, loyalty, and trust. A fiduciary must not put themselves in a position where their interest and duty conflict.
As a Board Member to ProQuest Investments, a $1 billion venture capital fund, whose largest single investment was in Novacea, and whose lead product, Asentar, is in direct competition with Provenge, Dr Scher?s fiduciary duty at the FDA conflicted with his fiduciary duty to promote the interests of ProQuest and its investment in Novacea. This is like a lawyer representing both the plaintiff and the defendant in the same legal matter. The lawyer cannot make either the plaintiff or the defendant?s interes ts a top priority if both the plaintiff and the defendant?s interests are diametrically opposed. Dr. Scher should have recused himself from the Provenge Advisory Committee.
I am unaware of any action by the FDA to investigate and correct the obvious conflicts of interest that surround Dr. Scher's participation. Justice delayed is justice denied. This principle is the basis of the right to a speedy trial. The FDA has acted too slowly in investigating this issue. Even in responding to FOIA (Freedom of Information Act) requests, the FDA has stated that they can not reply timely because it is overburdened!
Dr. Scher should have recused himself from the Provenge advisory committee. He had a fiduciary duty to do so. Furthermore, it was inappropriate for Dr. Scher to lobby Dr. von Eschenbach personally to delay Provenge after the advisory committee meeting. And the leaking of letters from Dr. Scher, Dr. Maha Hussain and Dr. Thomas Fleming to the public was inappropriate, inimical to Provenge approval and dastardly. What is going on at the FDA to ignore these obvious attempts to sabotage a non-toxic treatment for terminal cancer?
Clinical Study of Abiraterone Acetate and Prednisone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00485303
Contacts
Contact: Howard Scher, MD 646-422-4323
http://clinicaltrials.gov/ct2/show/NCT00485303
This is the FDA's very Watergate of scandals, yet the press tells us, "No story here; everyone just move along."
David Litschel
Santa Barbara, CA
This seems like a very topical subject. How does one access all 15 comments?
Alistair Grisham PhD
Seattle FDA District Office
22201 23rd Dr. S.E.
Bothell, WA 98021
Coordinator - Monica Sagen - bikeriding2@yahoo.com
Co-coordinator - Jason Burdine - jnaburdine@comcast.net.
30,000 Men/ year
82 Men/ Day
Will Die from Prostate Cancer Yet, The FDA wants more data.
"A Right Delayed is a Right Denied"
Approve Provenge Now!
WHY did the FDA reject a product that was rated 17-0 for safety and 13-4 for SUBSTANTIAL efficacy by an EXPERT panel that was convened by the FDA itself??
Also...why are the key players in the rejection all stonewalling virtually every effort to uncover what REALLY happened in the days between the AC meeting and the FDA rejection on May 9th, 2007??
Why are NO journalists interested in seeking the truth in this gigantic scandal?
Tens of thousands of PCa victims might benefit from treatment with DNDN's Provenge. Why are forces so strongly arrayed against a new and innovative treatment for late stage and presently incurable PCa?
I'm disgusted with the deafening journalistic silence surrounding the Provenge rejection debacle.
What is our country coming to??
Bravo on shining more light on the Provenge saga?a saga that is fast becoming more suggestive of a literary epic in terms of size and scale.
Meanwhile, I have a question I hope you can answer regarding the FDA?s decision:
I do not think it can be overstated that the FDA has never overruled an overwhelming AC recommendation for approval of a drug for an end-stage disease...making the FDA's action "unprecedented.? Which begs the question: Why was it this time? It was a decision, as you noted, that ?made waves.? I find it ironic, however, that our media have failed to ask the FDA ?who made that decision??
Specifically:
If a public Advisory Committee (AC) hearing recommends the approval of a new drug and the FDA later issues a Complete Response Letter is there public access or a public record kept at the FDA regarding the ?non-public? closed door hearing (s) that resulted in the FDA overruling such a ?positive? AC panel?
The FDA has been unable or unwilling to answer the simple question of whether there is even a public record available (even if one is ?unavailable? to the public now). And if there is no public record, is the FDA telling Americans that it does not keep transcripts of all the arguments, notes and votes of those who attend the ?non-public? meetings? Are life and death decisions at the FDA made with ?winks & nods? without serious discussion and debate? And who would that benefit? It would also be nice to know who calls the meeting to order, and who decides who attends these ?non-public? meetings? Is there even a meeting?
Considering this is The United States of America, it appears that it is not meaningful if the public AC hearing is merely a sham and the ?real meeting? occurs behind closed doors.
I hope Eric Fetters-Walp that you will be able to get answers to these questions. Americans deserve better than an FDA operating in secrecy in the name of good science?
If the above poster's info isn't enough to whet your appetite to further investigate this story, perhaps, the below facts can spur you on.
In case you and your reader's are unfamiliar with the specifics on some of the allegations of wrong doings in the FDA process, consider these:
A. Dr. Howard Isadore Scher of Sloan-Kettering in NYC submitted to the FDA, as part of his qualifications to sit in judgment of Provenge on the March 29th '07 FDA Advisory Committee, that he had 3 Conflict of Interests (COI).
17 (SEVENTEEN) Conflicts of Interest for Scher can be found on the internet and are:
*** NOTE particularly items 1 & 17
1. NOVACEA: grants & research support; STUDY CHAIR of DN-101
?. and DIRECT COMPETITOR to Provenge
.. which Scher was involved in not only as the Primary Investigator, but also with his financial and advisory capacity through Proquest Investments as noted below.
... and BTW, this clinical trial has been halted due, as I recall, for having too many DEATHS.
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
B. Even after having his say at the AC meeting, Scher went beyond the call of duty. He wrote the FDA in opposition of Provenge approval via a CONFIDENTIAL letter.
Somehow, mysteriously, this CONFIDENTIAL letter was leaked outside the FDA to a local DC area Mom and Pop publication (run by a Russian immigrant and his wife out of their basement) circulated in the cancer community. This publication's acquisition of a CONFIDENTIAL FDA correspondence has never been investigated, despite calls on the Department of Health and Human services and the FDA to do so.
C. Suspiciously, 2 other individuals, Maha Hussain of University of Michigan and a local Washington state resident likewise wrote CONFIDENTIAL letters in opposition to Provenge's approval which also, coincidentially, were leaked to and published in this same DC cancer publication as Scher's. Again... no investigation by HHS or the FDA as to how and by whom these internal government documents were leaked.
D. Despite the "claims" of threats by Scher and Hussain, neither has provided copies of these alleged threats nor have any police report which surely should have been made surfaced, despite questions about them being made. They remain just that.. their word such illegal activities were made against them with absolute no concrete proof.
E. A local Seattle area resident, Dr. Thomas Fleming--a professor at the University of Washington--was also 1 of 3 individuals who--after the AC meeting--wrote a CONFIDENTIAL letter to the FDA urging disapproval.
Fleming, who claimed in his leaked CONFIDENTIAL FDA letter, had sleepless nights worrying about Provenge being Approved. Flemming was not eligible to sit in judgment on the FDA Provenge AC hearings.
Why? Because he'd performed statistical work (and presumably had access to confidential company clinical trial data) and apparently received remuneration from Dendreon for the work performed for Dendreon.
For Fleming to write such a letter is, imo, beyond being UNETHICAL and one has to wonder what his dog is in the fight against Provenge and Dendreon.
And, if I were a company in need of statistical consulting work, Fleming would not be considered by me because he's shown CONFIDENTIAL information he acquires by working for a company "can" become public in the future.
Some ethics for a statistician and a professor, isn't it?
E. Despite requesting investigations to both the HHS and the FDA with claims of legal wrong-doing regarding the 3 CONFIDENTIAL letters written to the FDA which were subsequently leaked outside the agency AND regarding the above claims that Scher has more and disqualifying COI than he reported to the FDA, neither agency has responded to these requests for investigations for almost a year now.
However, when 2 individuals sent flowers to the FDA Commissioner on the 1st anniversary of the FDA AC meeting several weeks ago, a mere 1 business day later, 2 (TWO) investigators showed up at the floral shop requesting the identity and contact info on the flower senders.
F. Others have noted that even more suspicious activities involved in the Provenge saga such as the refusal of the FDA to abide by the Freedom of Information Act to provide requested documents timely; questions about the role of Dr. Richard Pazdur, the head of the FDA cancer division which did NOT get to judge Provenge because Provenge--while treating cancer--is a BIOLOGIC agent and was assigned to the biological division of the FDA; and the story goes on and on.
Sadly, since the May 9th '07 refusal to approve Provenge, men continue to die at the rate of 83 men each and every day, 24/7. Since the FDA's decision last year, some
29,299 deaths
has occurred. Many of these men could have benefited from Provenge by having their life extended and with a BETTER QUALITY OF LIFE with their family and friends.
I sincerely hope that you and your publication will see, with all the information provided by comments here, that there is a REAL story to had in the Provenge saga.
The Provenge case exemplifies how certain individuals within FDA have distorted that standard well beyond congressional intent and to the detriment of patients. Misguided adherence to unreasonable statistical rigor, for the sake of statistical purity (perhaps well-intentioned), played a major role in delaying Provenge approval.
All the immunology experts on the advisory panel, after carefully reviewing both the statistical data and other information, were among the 13 who voted that there was substantial evidence of efficacy. Who better than they (from the nation's leading cancer centers and academic institutions, M.D. Anderson, Moffitt, Harvard, Stanford, Duke, and the NIH, to name a few) to interpret all the information? But no, a few less-qualified bureaucrats at FDA, for the first time in history, rejected the real experts' overwhelming recommendation to approve a drug for an end-stage disease.
Statistics never tell the whole story in any scientific inquiry. Were they so reliable, there would be no need for an advisory panel. A computer could make the decision. Use of advisory panels is required for good reason.
True, whether the post AC process was corrupted should be investigated and any guilty parties punished. More importantly, however, the American public must demand that realistic standards for evaluating efficacy be employed, especially for unequivocally safe drugs that are used in terminal diseases. Sadly, Provenge is not the first life-extending drug approval of which the FDA will have unreasonably delayed. It will be the last only if enough members of the public and the media motivate Congress to require significant change at FDA. How many additional Americans have to die before that happens?
On Friday May 30th demonstrations protesting the FDA decision will be held in numerous cities including Seattle (outside FDA offices in Bothell).
Other sites include Chicago (ASCO), Dearborn (Dingell's Office), Atlanta (FDA offices), Cleveland (public Square), Philly (outside FDA offices), Madison Wisconsin (Capitol building), New York, NY (MSK), Maitland Florida (FDA offices)
CareToLive filed a Citizen Petition on July 27, 2007 asking the FDA to reconsider this failure to approve Provenge. The FDA was to properly respond by January 24, 2008. Instead Jesse Goodman the head of the CBER division of the FDA said they needed more time, while 83 men a day die without access. Two FDA employees then told CareToLive that a committee had been formed and they were actively considering the petition along with the comments submitted (over 200 comments in support). That was two months ago and now appears to have been but a legal maneuver done without concern for the patients who sit in wait and have no viable treatment options.
Proof that Provenge was purposely sabotaged by Richard Pazdur, an FDA employee, is in the documents that were requested in a Freedom of Information Act request made by CareToLive. The FDA refuses to turn them over to the public.
The FDA commissioner knows what happened was wrong, but he refuses to fix it.
There could be a pulitzer at stake.
Ask yourself, who would bet against a positive AC vote which has never been over turned and ignored in the entire history of the FDA.
The FDA, insiders and Howie made hundreds of millions at the expense of many men dying.
Do you think the SEC would look at that? No.
Would Congress? No. Will the FDA even answer the questions put to them under the Freedom of Information Act? No.
A full investigation of the facts of last year should be a priority with the SEC. The fact that there was insider trading is obvious and the trail they left is uncoverable, but the SEC is a dog who doesn't hunt.
Just correcting the quote...
David Miller (president of Seattle-based Biotech Stock Research) was correct when he said ?"There are a lot of guys who think [Dendreon] got screwed," he says. "And they did."?
Among other things, you certainly would have done better to look behind the FDA?s ?curtain? and examine the issues surrounding Drs. Howard Scher and Maha Hussain than to dismiss the matter of their objections to the approval of Provenge in three short paragraphs.
Specifically, regarding the two Provenge advisory committee (AC) members you mentioned, Drs. Scher and Hussain, both were serving in the capacity of ?special government employees.? Both voted YES on the first question regarding Provenge?s Safety; both voted NO on the question regarding whether or not the drug evidenced Substantial Efficacy, the federal standard. Both are chemotherapists, not immunotherapists, and so, were in a distinct minority on the AC.
The following facts should be known, however, regarding their participation in the AC meeting and their actions in the days that followed:
1. Both Drs. Scher and Hussain were participating in the Provenge AC meeting under waivers granted to them by the FDA; these waivers were granted at a time when the FDA was considering tightening its rules for conflicts of interest (COI) under pressure from Congress. In fact, the FDA already had issued proposed new rules for public comment. An independent evaluation of Drs. Scher?s and Hussain?s eligibility to participate in the Provenge AC by Steve Usdin, Washington Editor of BioCentury, The Bernstein Report on BioBusiness, using the proposed new rules, yielded the following result (March 26, 2007 edition):
Dr. Maha Hussain: ?The waiver notes that Hussain is the principal investigator on a research contract awarded by a competing company for a product that is not related to Provenge. Under the draft guidance this probably would not be considered a conflict. However, the fact that her husband owns stock in three competing companies, valued at $15,000-$300,000, would at minimum prevent her from voting. If the total value of the stock exceeds $50,000, Hussain wouldn?t even be at the table if the new policy were in effect.?
Dr. Howard Scher: ?Under the draft guidance, Scher either would be prevented from voting or excluded from the meeting.
?He owns stock in a firm that competes with DNDN valued at $5,000-$100,000. In addition, Memorial Sloan-Kettering has a grant from a competing company valued at $100,000-$300,000 to study a licensed, approved drug in prostate cancer trials.?
Given the new rules then under consideration and the sensitivity to COIs already registered by the Congress that spring, it would have been prudent for the FDA to have rejected the waiver requests for Drs. Scher and Hussain. Rejections now appear all the more warranted, given that since the Provenge AC meeting, additional compromising information regarding these two AC members, and especially Dr. Scher, have come to light.
2. Specifically, we now know that the time of the Provenge AC meeting, Dr. Scher was on Novacea's (NOVC) scientific advisory board as co-lead investigator of what at that time was NOVC?s Asentar Phase III clinical trial in the same stage of prostate cancer as Provenge. (Note: since that time, this trial has been stopped because of the high death rate in the Asentar arm.).
3. We also know that at the time of the Provenge AC meeting (and, perhaps, even now), Dr. Scher was on the Scientific Advisory Board of, and may have been an officer and a member of the board of directors of, ProQuest Investments (?ProQuest?). At the time of the Provenge AC meeting (March 29, 2007), ProQuest had significant holdings (in excess of 8%) in NOVC (here's the URL to a 13d on NOVC filed by ProQuest in May, 2006: http://www.secinfo.com/dSEyn.v8d.htm; it shows that as of May, 2006, Proquest held 1,779,767 shares of NOVC). A ProQuest officer was, at the time of the Provenge AC meeting, on the board of directors of Novacea, but he has since resigned from that board.
4. On May 30, 2007, just 3 weeks after the FDA refused to approve Provenge, NOVC signed a major agreement with Schering-Plough to co-develop Asentar. These deals do not happen overnight; they can take 6-9 months, or longer, to mature. Basically, Novacea had found a large pharmaceutical partner with deep pockets for its late-stage prostate cancer drug, Asentar, and it licensed product rights to Schering-Plough in exchange for $60 million up-front and the potential for $380 million in milestones down the road. News of the worldwide development and commercialization agreement sent Novacea's shares shooting up more than 100% at one point in morning trading, going as high as $17.25 before closing at $15, up by $6.94, or 86%. That's the highest Novacea's shares have traded since the company went public with the May 2006 offering at $6.50 per share.
According to the 10-K filed with the SEC on April 2, 2007 (http://yahoo.brand.edgar-online.com/fetchFilingFrameset.aspx?dcn=0001193125-07-071961&Type=HTML), major concerns to NOVC going forward regarding market acceptance of Asentar were the ?potential advantages or disadvantages over alternative treatments.? Further, the 10-K noted that ?[I]f our future product candidates fail to achieve market acceptance, we may not be able to generate significant revenue or achieve or sustain profitability.? (Novacea?s agreement with Schering-Plough for the development of Asentar has since been terminated.)
5. Importantly, following the Provenge AC meeting, Drs. Scher and Hussain went on to write letters to the FDA, disparaging Provenge and calling for non-approval of the immunotherapy?letters that were leaked immediately upon their receipt at the agency (if not before) to the non-peer-reviewed The Cancer Letter. This is a highly (!) unusual act for a special government employee to take. Who asked Dr. Scher to write his letter and what part was played by personnel at the FDA and NCI in helping Dr. Scher write his letter? (A draft of Dr. Scher?s letter (version 3) was found on the computer of a researcher at the National Cancer Institute (NCI; this draft was obtained under a FOIA request) and at least one other NCI researcher attended a meeting at the FDA to discuss the development of Dr. Scher?s letter (information obtained under a FOIA request).) These questions never have been answered by the FDA or NCI. Nor has the person or persons responsible for leaking the letters written by Drs. Scher and Hussain (as well as a third letter written to the FDA by Dr. Thomas Fleming) to The Cancer Letter ever been identified and prosecuted. It is not even known whether or not an active investigation is being conducted by the HHS Office of the Inspector General!
So, while the Washington CEO article certainly presented a good review of Dendreon?s history in attempting to bring Provenge through the FDA approval cycle, it grabbed ?the low-hanging fruit? and left what many believe to be the most interesting ? really, the most compelling ? part of the story for others to investigate.
Meanwhile, by my count, almost 30,000 men have died of prostate cancer since the FDA sent Provenge an ?approvable? letter. How many of those could have been helped by a drug that 17 panel members voted Safe and 13 out of 17 panel members voted as having Substantial Efficacy?
A few issues I thought needed addressing are...
"The letters from panel members Howard Scher and Maha Hussain were strong"......Scher's letter has been throughly debunked, torn to shreads, by a rebuttal letter(it, however, wasn't published on The Cancer Letter site).
The supposed death threats are just that.."alleged" is a common term being used. A cash reward has been offered for any proof that a death threat took place at all....I believe even a police report will win the producer of such the bounty.
I don't rember reading, sorry if it was in the article, about how, for some reason, the FDA hasn't complied with the Freedom of Information Act requests from CaretoLive. They had 20 days to comply...it's been more than a year?
kel
As CEO Gold is quoted in the article..."the first time, that we know of, when the FDA went against the AC's approval advice"....it is indeed the first time in history in the case of a life threatening illness that the FDA went against the approval recomendation of the AC...RED FLAG!!!!
With all the recent problems at the FDA seemingly only worsening, perhaps it's time for Andy Von Eschenbach to resign his post of FDA Commish.
Thanks for your article and keeping the Provenge story alive, too bad a couple of conflicted AC panelists helped rip hope away from many of the some 30,000 American men who are now quite DEAD. Some of these men would still be alive if they were given the opportunity to choose Provenge..if only we could read their comments.
kel