FDA
Industry Insiders Derail
Approval Of New Cancer Treatments
By Evelyn Pringle
09 October, 2007
Countercurrents.org
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 ½ 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.
(Evelyn Pringle is a columnist for OpEd News and an
investigative journalist focused on exposing corruption in government
and corporate America. She can be reached at evelyn-pringle-sbcglobal.net)
Leave
A Comment
&
Share Your Insights
Comment
Policy
Digg
it! And spread the word!
Here is a unique chance to help this article to be read by thousands
of people more. You just Digg it, and it will appear in the home page
of Digg.com and thousands more will read it. Digg is nothing but an
vote, the article with most votes will go to the top of the page. So,
as you read just give a digg and help thousands more to read this article.