In 2007, an 17 member FDA advisory panel of experts voted
overwhelmingly to approve Provenge, Dendreon's prostate cancer
immunotherapy biologic agent. The panel voted that Provenge is safe and
effective. Subsequently two of the doctors on the panel who
unbelievably had received wavers from FDA of their conflict of interest
-- and there is debate whether they disclosed all their conflicts of
interests, rallied against Provenge's approval. And Provenge did not
get approved. And meanwhile in the US alone some 30,000 advanced stage
prostate cancer men die every year, and about 1/2 of them do not
consider chemotherapy to be a viable option because of its terrible
side effects. Provenge has virtually no side effects. Let's face it.
The chemo people and the hedge funds that bet hugely against Provenge
won!
Kerry M. Donahue, the trial attorney for defendants, representing some prostate cancer patients, etc. is an angel.
The following story is the best account of this horrible misery that the a
bunch of suckers orchestrated against life, against goodness, against
ethics, and all that stands for decency, in favor of money. It is a sad
account of how money has become the new God in the minds of some people.
Congressmen Mike Michaud, Dan Burton, Tim Ryan called on the House
Energy and Commerce Committee to conduct a hearing to examine the
conflict of interests governing the Food and Drug Administration (FDA)
and its recent decision on failing to approve licensure of Provenge.
“Many ethical questions remain about the two panelists who voted
no on approving this drug,” Michaud said. “I believe
that the FDA should not be appointing scientists leading the testing of
a rival drug for another firm onto an advisory committee evaluating
Provenge. Congress needs to get to the bottom of this. I believe
a full disclosure is necessary in order to restore confidence in the
FDA.”
“We need to ensure that the FDA gets life-saving drugs to the
market as quickly and as safely as possible,” Michaud
stated. “Our priority is to ensure the prompt and efficient
approval of therapies such as Provenge that could potentially benefit
millions of Americans with cancer.”
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interesting post on an alleged panic meeting to help shoot down the approval of a safe effective agent for dying men :
================================================================================================================
Jonathan Aschoff of Brean Murray
is a class act. He is a security analyst who impersonated doctor in
order to get confidential information. I came across this web page
which is quite funny (and sad). He was fined by the NASD.
This is one heck of a post. I do not know if all the allegations are
true but IF they are true, they unfold a core of evil at the FDA and
shows how power play can mean lost lives.
Pazdurs fun house.....or Pazdurs house of horrors for the patients -
Pazdurs playhouse.....or Pazdurs house of horrors for patients
PLAINTIFF’S SUPPLEMENTAL MEMORANDUM IN SUPPORT OF MEMORANDUM IN
OPPOSITION DEFENDANT’S MOTION TO DISMISS AND AS SUPPLEMENT TO
MOTION FOR INJUNCTIVE RELIEF
FDA Industry Insiders Derail Approval of New Cancer Treatments
George W Bush's FDA, stacked with insiders from the industry that
literally carried him to Washington, has stooped to a new low to
protect the obscene profits of the multi-billion dollar cancer industry
by blocking the approval of a new class of immunotherapies that can
extend the lives of dying cancer patients with minimal side effects.
In the May 14, 2007, Wall Street Journal, a former medical officer in
the FDA Office of Oncology Products, Dr Mark Thornton, denounced the
FDA's decisions, and stated, "May 9, 2007, should be cited in the
annals of cancer immunotherapy as Black Wednesday."
"Within an eight-hour period that day," he wrote, "the FDA succeeded in
killing not one but two safe, promising therapies designed and
developed to act by stimulating a patient's immune system against
cancer."
Experts say, the new immunotherapies hold promise for many forms of
cancer. "FDA's hubris will affect the lives and possibly the life spans
of cancer patients from nearly every demographic, from elderly men with
prostate cancer to young children with the rarest of bone cancers,"
according to Dr Thornton.
With the approval of the new therapies, the profits, along with the
horrendous side effects of the only treatments now available, could
become a thing of the past. "One day current treatment approaches such
as surgery, radiation and chemotherapy, which often kill most but not
all of a cancer, could be made obsolete by a potent immune response
that eradicates the cancer cells and provides subsequent protection
against return and relapse," Dr Thornton wrote.
As such, the new therapies pose a grave threat to the cancer industry
as a whole, and the lost profits would not be limited to the sale of
products. The pharmaceutical giants have spent a small fortune to gain
control of every segment of the industry, from researchers to
government regulators, and every year, billions of dollars flow through
a nationwide network of research institutions and treatment providers
under the guise of finding a cure for cancer.
However, the profits up for grabs have become so enormous that critics
say the goal of industry-controlled research is no longer focused on
finding a cure for cancer to save lives. Instead, the focus is on
thwarting the development and approval of new therapies in order to
protect the profits of the treatments already on the market.
The FDA's refusal to approve Provenge, a new immunotherapy vaccine
manufactured by the Dendreon Corporation, has caused major outrage in
the cancer community. Provenge supporters have sent thousands upon
thousands of letters and other correspondence to the FDA, members of
Congress, the Department of Justice and others.
In addition, the Ohio-based non-profit corporation, CareToLive, has
filed a lawsuit on behalf of terminal cancer patients seeking a
declaratory judgment that the FDA acted "arbitrarily" and
"capriciously" by denying patients access to Provenge, in violation of
their constitutional right to live.
Dendreon sought approval to treat late-stage androgen-independent
prostate cancer (AIPC) patients who have no other options. A study
presented to an FDA Advisory Committee at a March 29, 2007, meeting
showed that, after 36 months, 34% of the men who received Provenge in a
clinical trial were still alive, compared to only 11% of those who
received a placebo.
Provenge is designed to stimulate the patient's own immune system to
specifically attack only cancer cells, unlike chemo drugs that attack
any fast-growing line of cells.
Patients who qualify for Provenge have already had their prostates
removed or have undergone radiation and hormone therapy. Eligible
patients receive a one-time round of treatment consisting of 3 visits
to a urologist's or oncologist's office to give blood, and 3 visits for
the blood enhanced with Provenge to be infused back into the body.
On September 10, 2007, CareToLive filed a motion asking the court to
issue an order enjoining the FDA from denying the marketing and
distribution of Provenge. The plaintiffs charge that within six months,
another 15,000 patients will have died waiting for justice.
The memorandum filed with the motion points out that the only available
treatment approved for terminal AIPC in the last 42 years is a chemo
drug, Taxotere. "The effectiveness of Taxotere," it states, "is so
superficial, and the side effects so severe, that most men decline the
treatment, as the risks far outweigh the benefits."
According to the filing, between 300 and 600 patients per year die from
the Taxotere treatment itself. "This is truly amazing," the memo
states, "considering the cost of the treatment and the cost of
hospitalization and that the average benefit is an increase in survival
of only 2 ˝ months."
In contrast, the Provenge safety profile is so good that nobody has
died from it and less than one in four patients experience side effects
consisting of mild flu-like symptoms lasting one or two days, the memo
notes.
The defendants named in the lawsuit include Mike Leavitt, Secretary of
the US Department of Health and Human Services; FDA Commissioner Andrew
von Eschenbach; Dr Richard Pazdur, head of the FDA's Office of
Oncologic Drug Division, and Dr Howard Scher, chosen by Dr Pazdur to
serve on the advisory panel set up to review the approval of Provenge.
CareToLive is represented pro bono by Attorney Kerry Donahue, of the
Dublin, Ohio law firm Bellinger & Donahue, while the FDA officials
are represented by a legal team of 11 government attorneys, at last
count, funded by tax dollars.
The plaintiffs allege that the defendants engaged in a conspiracy to
prevent the approval of Provenge and that Dr Pazdur, "purposely located
two conflicted oncologists who he was sure for a variety of reasons
would be anti-Provenge and he instructed them to try to derail the
approval of Provenge."
The plaintiffs charge that, by choosing Dr Scher, and also Dr Maha
Hussain, to serve on the advisory panel, Dr Pazdur "likely found two of
the most conflicted oncologists in the country to sit in judgment of
Provenge, and who would both assuredly continue his plot to lobby
others at the FDA to vote for non-approval."
At the behest of Dr Pazdur, and for their own future political and
monetary gain, the plaintiffs claim, "these two oncologists did
everything they could think of to obstruct and impede the approval of
Provenge."
The waiver of conflicts of interest granted by the FDA to Dr Hussain,
which allowed her sit on the panel, reveals that she is the lead
investigator on a research contract awarded by a company that competes
with Dendreon, and her husband owns stock in three competing companies
valued at between $15,000 and $300,000.
The lawsuit alleges that, as part of the conspiracy, on May 9, 2007,
the FDA denied terminally-ill patients access to Provenge, even though
the FDA Advisory Committee recommended approval, found the vaccine safe
by a 17-0 vote and found there was "substantial evidence" of efficacy
with Provenge by a 13-4 vote.
In an attempt to derail an approval recommendation by the panel, the
plaintiffs claim that, prior to the vote on efficacy, Dr Pazdur and
"his co-conspirators changed the statutory question regarding efficacy
from 'substantial evidence' to 'absolute certainty' of efficacy, in an
effort to obtain a 'no' vote on Provenge."
However, during the voting, this manipulation was discovered and
promptly corrected by the FDA's Dr Celia Witten and Dr Jesse Goodman,
and by an overwhelming majority, the panel voted "yes" to the revised
efficacy question.
"It is unprecedented for the FDA to overturn the Advisory Committee on
such a positive vote when men are out of options, delaying approval and
asking for more trials," according to CareToLive spokesman Mike Kearny
in an August 2, 2007, press release.
"Men are dying now," he states. "They do not have years to wait."
In the case of Provenge's approval, the profits at stake could not be
higher. Prostate cancer is the most common non-skin cancer in the US
and the third most common cancer worldwide. More than one million men
in the US have prostate cancer, with an estimated 232,000 new cases
diagnosed each year and more than 30,000 men face death from the
disease each year.
As an initial treatment, when diagnosed with prostate cancer, most men
have their prostate removed, or undergo radiation, which can lead to
various degrees of incontinence and impotence. After the initial
treatments fails, hormone therapy is given to block the production of
androgens such as testosterone, needed for cancer cells to grow, and
some men undergo testicle removal in an attempt to stop the androgens
from spreading the cancer.
With AIPC patients, prostate cancer has usually gone into remission and
then returned, spreading to other parts of the body including the
bones, lymph nodes, bladder, rectum, liver and lungs. All men who do
not die of other causes progress to the final stage where the cells no
longer respond to hormone therapy. Provenge is intended for use by
patients who have already failed other types of therapy.
Because Taxotere is the only approved drug, Sanofi would have suffered
the greatest immediate loss had Provenge been approved. According to
firm's 2006 Annual Report, Taxotere was the company's 4th best-selling
product in 2006, and the US is listed as the number one country
contributing to sales.
As far as profits per dose, in the February 7, 2007, article, "What
Does It Cost to Have Cancer?", a patient who received the chemo drug
for breast cancer in 2006 reported that "each infusion of Taxotere cost
over $16,000."
She also stated: "That's just for the drug, not administration or anything."
According to the lawsuit, defendant Dr Scher, Chief Genitourinary
Oncology Service, Memorial Sloan-Kettering Cancer Center, is a
scientific advisor and lead trial investigator for a competitor of
Dendreon called Novacea. Under faculty disclosures at the University of
Michigan, Dr Hussain is listed as an advisory board member of Novacea,
and she receives research funding from Sanofi.
Dr Scher also has an interest in ProQuest Investments, which stood to
reap windfall profits if Provenge was not approved. ProQuest is a
venture capital fund established in 1998, in large part by Michael
Milken, who was given the nickname "Junk Bond King," after being
indicted on nearly 100 counts of insider trading and sentenced to 10
years in prison, in addition to being barred from the securities
industry for life.
The ProQuest fund was established with a specific focus on prostate
cancer, and SEC filings show that ProQuest and its principals are major
shareholders of Novacea.
Citing documents from ProQuest, the plaintiffs allege that Dr Scher is
a "ProQuest Executive" and "member of the Board of Directors", ProQuest
reaps millions of dollars investing in prostate cancer companies based
on advice from doctors such as Dr Scher, and ProQuest own stock in
direct competitors including Novacea.
Dr Scher receives compensation from ProQuest as a scientific advisor
recommending investments and for conducting clinical trials that result
from the investments. He also holds an ownership interest in ProQuest.
The lawsuit also alleges that Dr Scher receives research support from
the Prostate Cancer Foundation, as well as financial benefits, as one
of a consortium of members who reviews new research on cancer drugs to
determine which grants should be awarded by the Foundation.
The PCF, also founded by Mr Milken, is one of the largest sources of
funding for the National Cancer Institute and government research
programs. A following of the tangled web involved in the PCF reveals
that Dr Jonathan Simons, President of the Foundation, Dr Stuart Holden,
Medical Director, and Dr Howard Soule, an Executive Vice President of
the Foundation, are all scientific advisors to ProQuest.
Another research arm found to be infested with several of the same
insiders is the Prostrate Cancer Research Program, within the
Department of Defense, which since 1997 has been appropriated a total
of $730 million by Congress. According to a PCRP report, "Today, the
PCRP is the second leading source of extramural prostate cancer
research funding in the United States."
The PCRP funds a Clinical Consortium Award to support the creation of a
major multi-institutional clinical trial resource, "to speed
development of novel therapeutics that will ultimately decrease the
impact of the disease."
Here, too, Dr Scher is listed as the leader of the consortium, and the
list of participating clinical sites and lead investigators includes
none other than Dr Hussain. Dr Simons is listed as developing new
clinical therapeutics for late-stage prostate cancer, but a review of
upcoming research listed in the report shows immunotherapies are not in
the cards.
These consortium members are invaluable to the industry and investors
due to their unique access to insider information about clinical trials
and influence over the FDA approval process. Evidence of this claim
came on May 30, 2007, less than 3 weeks after approval for Provenge was
denied, when Novacea announced an agreement with Schering-Plough worth
over $450 million, in which Schering agreed to jointly fund and develop
Asentar, a competing prostate cancer drug, for which Dr Scher happens
to be the lead investigator.
"The partnership leverages Novacea's existing capabilities with
Schering-Plough's experienced development, regulatory and commercial
teams and will provide Novacea with an opportunity to support the
commercialization of Asentar in the United States," John Walker,
company chairman and interim CEO, stated in a May 30, 2007 press
release.
A May 2000 ProQuest document provides insight about the investment
firm's interest in Asentar's success and states: "ProQuest Investments
is a $100 million oncology-focused investment fund, partnered by Jeremy
Goldberg and Jay Moorin."
Mr Moorin owned 1,910,988 shares of Novacea stock at the time of a May
15, 2006, SEC filing, and the ProQuest document mentions an investment
from Domain Associates, "whose general partner, Jim Blair, has also
worked with the fund to plot its strategy."
As it turns out, Mr Blair and Mr Moorin were both members of Novacea's
board of directors when the Schering deal was set up. However,
apparently their services are no longer needed, because on August 30,
2007, Novacea announced the resignation of James Blair and Jay Moorin,
effective September 4, 2007, and September 19, 2007, respectively.
All that said, it does not take a financial genius to figure out that
this whole deal could have gone up in smoke had Provenge been approved,
because there would have been a drastic drop in the enrollment of
late-stage cancer patients in clinical trials as soon as they learned
that there was a new vaccine that could not only increase their
survival rate but allow them to live out their final days without the
agonizing side effects of chemotherapy.
Provenge's approval also would have caused many patients currently
participating in trials to drop out. Novacea's 2006 Annual Report filed
on April 2, 2007, less than 2 months before the Shering announcement,
warned that the "clinical development and regulatory approval processes
inherently contain significant risks and uncertainties."
The report shows Novacea was going broke trying to keep the Asentar
trials running, with research and development expenses associated with
the drug of $12.9 million for the year ended December 31, 2006, up from
$7.3 million for the year ended December 31, 2005.
The $5.6 million increase was due primarily to the Phase 3 Asentar
trial, and the filing warns that Novacea could experience many delays
in getting its product to market due to problems in trials including,
"patient enrollment may be slower than expected at trial sites due to
factors including the limited number of, and substantial competition
for, suitable patients with the particular types of cancer required for
enrollment in our clinical trials".
It also notes that there "is a limited number of, and substantial
competition for, suitable sites to conduct our clinical trials;
clinical trial sites may terminate our clinical trials"; "patients and
medical investigators may be unwilling or unable to follow our clinical
trial protocols;" and "patients may fail to complete our clinical
trials once enrolled."
In addition, another ongoing trial is evaluating Asentar as part of a
combination therapy for AIPC patients with Sanofi's Taxotere. If safety
or efficacy issues arise with Taxotere, the annual report warns,
Novacea could experience significant regulatory delays, and the
clinical trial may need to be terminated or redesigned.
Even if Asentar were to receive FDA approval, Novacea would continue to
be subject to the risks that could arise with Taxotere or that Taxotere
may be replaced as the standard of care for AIPC. "This could result in
Asentar ™ being removed from the market or being less
commercially successful," the report states.
Ironically, in one of 3 derogatory letters sent to the FDA urging the
non-approval of Provenge leaked to the media following the failed
efforts to rig the advisory panel vote, Dr Scher discussed the same
fatal effects that the approval could have on the research industry.
"An approval recommendation has far reaching implications beyond making
the product available that the data simply do not support or justify,"
he wrote.
Approval would provide the Agency's endorsement of Provenge as a
"standard of care" for men with AICP, he said, and by extension,
elevate Provenge "to a position of being the new 'control' arm for
future randomized phase 3 trials that are being designed for the
regulatory approval of any new experimental agent or approach."
In other words, all the billions of dollars invested in the clinical
trials now underway, or set to begin, conducted in hopes of gaining FDA
approval for a new ACIP treatment, could go right down the drain if
Provenge is approved as the first-line treatment for this patient
population.
Dr Scher is probably more aware of this fact than anybody. On February
26, 2007, MedPage Today reported that in a satellite symposium titled,
"Improving Upon Current Standards: The Integration of Novel Therapies
in the Treatment of Androgen-Independent Prostate Cancer," sponsored by
Novacea, Dr Scher said Taxotere-based combination therapy is being
investigated in a dozen clinical trials for ACIP patients, and he
reported receiving grants and research support from both Novacea and
Sanofi.
After reading the better part of Kerry's unbelievable legal work I am
left with the following basic questions that I hope the Judge will
carefully consider prior to making his decision in the CTL case.
How often is the head of CDER present at a CBER AC meeting?
How often is the Substantial Efficacy question miss-worded at AC Meetings?
How often are such conflicted AC panelists permitted to attend AC's & vote?
How often are letters leaked post AC to influence an FDA decision?
How often has the FDA overruled a positive AC vote for a late stage disease?
How often does the SI in a stock increase markedly after considering the above?
How often has the media been so negative after considering the above?
Obviously, there are many other questions that can be added to the list
(i.e. Von E's speeches for one). My point and opinion is that the more
oddities/irregularities that are introduced to the list the more clear
it becomes how unbelievably jaded and corrupt the Provenge travesty
was. Of course none of this information is new to anyone here; I just
pray that the Judge lets his eyes be opened as wide as ours have.
One very big thank you to Kerry and all the other incredibly selfless
people here that have given so much! IMHO you will all take up a bigger
chapter in history than is readily apparent today.
================================================================================================================
Good article in Nature about the crooked elements working to delay a life extending safe agent from reaching terminal patients:
http://www.nature.com/nbt/journal/v26/n1/full/nbt0108-1.html
Quoting from the article:
"At least one of the Office of Cellular, Tissue and Gene Therapies
Advisory Committee members who voted against Provenge and then wrote to
FDA to criticize the approval recommendation—Howard Scher of
Memorial Sloan-Kettering Cancer Center—failed to disclose
important competing financial interests. Scher is a scientific advisory
board member of venture capital firm ProQuest, which owns an 8.3% stake
in Novacea, a company that was developing a competing prostate cancer
drug, Asentar. Scher also happens to be the lead investigator in
Asentar trials."
Here's an interesting post about Howard Scher, Maha Hussain, etc.
http://www.investorvillage.com/smbd.asp?mb=971&mn=177793&pt=msg&mid=3961558
http://www.investorvillage.com/smbd.asp?mb=971&mn=181520&pt=msg&mid=4103477
5 reasons the E&C should conduct the investigation
A post by KDDublin (reprinted with permission):
http://www.investorvillage.com/smbd.asp?mb=971&mn=199222&pt=msg&mid=4876203
Hey, hey FDA, ain’t no way were ever going to go away.
Trust me when I tell you, that not only does the FDA monitor this site, but so does their counsel.
Here is an open letter:
Listen up FDA. We are never, ever, going to go away!!!
Tomorrow is merely one day. ONE DAY!! It is merely the first day in the rest of your lives!!
While I am confident that Andy’s days are numbered for his
complete incompetence in running the FDA, you other career bureaucrats,
Pazdur, Woodcock and Goodman, need to know that we will be here for you
every step of the rest of your pathetic careers. You get to look
forward to our presence for many years to come!
This grass roots movement has just begun. We are just now starting the
fight. We grow stronger by the week. The CareToLive web site has
thousands of new and unique visitors to its site every week. The word
is spreading fast now and you can’t stop it anymore. Once the
world knows of your misdeeds you will no longer be able to hide amongst
your fellow corrupt brethren.
While you and your big pharma buddies laugh and giggle and plot against
little biotech companies like Dendreon, so you can maintain your big
bucks status quo, and seek to climb you career ladders and grab what
power you think you can, those who are trying hard to make Cancer a
treatable condition rather than a deadly disease, will expose those
Andy bullshit “bridge not a barrier” speeches that he makes
in the name of politics for the benefits of Congress, and the real
advocates fighting on the front lines of the war on cancer will
continue to fight the number one barrier to winning that
war,…...THE CORRUPT FDA!!!!!!!!!
Tomorrow it is Coast to Coast demonstrations and that will be a nice
start. But you need to understand it is merely A START! Next we are
coming to MLB ballparks throughout the country, and then to back to
Rockville, and this time there won’t be two hundred people in
Rockville, there will be two thousand!
Men are dying while Woodcock, Pazdur and the FDA are wined and dined by
big pharma. Men are dying while Scher lines his pockets at the expense
of the patients he is sworn to protect. Men are dying while your
friends profit. NO MORE!!!!!
Stand up 2 cancer. You bet we will. Those at CareToLive know where the
front lines are and we will keep reinforcing those lines until we
defeat cancer and the enemy that stands in the way of the
patient’s ability to win that war, which those with knowledge
know to be YOU!!!!!
Words of Howard Scher at the panel meeting. Makes you really
wonder if this jackass is in the pocket of Big Pharma and/or hedge
funds who had a lot to lose on Provenge's approval? Only ones who lost
were dying cancer patients who were denied a life extending safe
biologic agent.
---
Does anyone remember Dr. Scher's answer to the 2nd question? Here is is...
I wonder what he meant? About what was he concerned? Hmmmmmmmm...what could possibly be on his mind? Asentar? Naw!
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