Ein sehr grosser Bericht ist im LifeExtension über Gerons Telomerase-impfungen erschienen. Verbunden mit der Forderung das Krebspatienten ihre Medikamente frei wählen dürften und nicht Jahre auf Sie warten müssten, bis dass die Medikamente durch die FDA zugelassen sind, wird heftige Kritik an die Zulassungsverfahren der FDA geübt.
www.lef.org
FDA`s Lethal Impediment
The FDA stifles the discovery and avail-
ability of life-saving therapies by making the cost of getting them approved prohibitively expensive. The FDA is a major obstacle that prevents scientific findings from being translated into therapies to stave off age-related disease.
Compared to the advancement of
other technologies over the past 40 years,
medicine has progressed the slowest as
far as finding solutions for lethal diseases.
Those in the medical establishment may
debate this assertion, but the undeniable
fact is that for most types of cancer and
neurological diseases, there have been few
substantive improvements in survival, let
alone a cure.
Most of you remember attending funerals
in the 1960s to 1970s of those who perished
from cancer. If you thought the way I do, you
would have been certain that a cure for cancer
would have been found by year 2000. In fact,
the propaganda being released by the cancer
establishment at that time was that doctors
were on the verge of eradicating most cancers.
(This misguided optimism was primarily
based on the premise that chemotherapy
was the solution.)
When it comes to therapies designed to
slow or reverse aging, the FDA still does not
officially recognize aging as a disease
process. That means when a company tries
to gain approval to market an anti-aging
therapy, it first has to overcome the hurdle
of educating the FDA that aging is indeed a
lethal disease. The new therapy then has to
show sufficient efficacy to warrant approval.
To date, no one has succeeded in convincing
the FDA to approve an anti-aging drug.
In today`s world of ever-expanding tech-
nological achievement, the fact that medicine
remains bogged down in a regulatory
quagmire is a disgrace. More than 6,000
Americans die every single day, yet most of
these deaths could be prevented if it were
not for the strangulation of innovation
caused by the FDA, State regulatory agen-
cies, HMOs and apathetic physicians.
In each issue of Life Extension magazine,
we seek to uncover therapies that have shown
efficacy in well-controlled studies, but have
not yet been translated into conventional
medical practice. We know our efforts have
lengthened the lives of tens of thousands of
Life Extension members, yet what we offer is
only the tip of the iceberg when one looks at
the many life-extending drugs that are denied
to human beings in need.
Does Geron have an effective
cancer vaccine?
Geron Corporation was originally estab-
lished to develop anti-aging drugs. Their
research, however, led them to discover a
potentially effective cancer treatment
On March 18, 2003, Geron released
On March 18, 2003, Geron released
the results of a study that an experi-
mental cancer vaccine might be effec-
tive against all types of cancer. This
bold announcement was based on a
study published in the journal Cancer
Gene Therapy (March 2003).
Geron`s vaccine works in a relatively
simple manner. It programs powerful
dendritic immune cells to attack cells
that express high levels of an enzyme
called telomerase. It just so happens
that 85% of human tumor cells overly
express telomerase whereas normal
healthy adult cells express very low
and/or transient telomerase levels.
Using telomerase as the target for
dendritic cells, Geron`s vaccine was
shown to provoke a massive attack
against prostate and kidney cancer
cells as well as breast, melanoma and
bladder cancer.
Most cancer cells require high levels
of telomerase to prevent them from
undergoing a healthy cellular removal
process called apoptosis (,programmed
cell death). The concept of attacking
cells high in telomerase makes cancer
cells particularly vulnerable, because
if they try to hide from this vaccine
by making less telomerase, then they
will die via normal apoptosis.
There are 558,000 people in the
United States who will die of cancer
over the next 12 months. Most of
them know they are likely to die.
We believe these cancer-stricken
individuals should have the right to
access any potentially effective therapy
under the guidelines of an objective
yet humanistic formal scientific
protocol. While there is no assur-
ance that Geron`s new vaccine will
cure cancer, we vehemently oppose
the power given to the FDA to
withhold this and other potential
cancer therapies.
The cancer establishment maintains
that only carefully controlled studies
can establish safety and efficacy. This
sounds reasonable and Life
Extension agrees with this concept.
The reality, however, is that the
FDAs current clinical trial require-
ment has produced flawed data that
enabled bad drags to be approved
while potentially effective drugs are
denied.
It takes so long for a new drug to
make it through the FDA approval
process, that if Geron`s new drug is
effective, most cancer patients reading
this column today will perish long
before the vaccine ever became
available. A real world example of
this occurred with an anti-cancer
agent for childhood leukemia called
Vulmon. This drug was first studied
in 1972, but only attained FDA
approval in 1992.
A Phase I study of Geron`s telom-
erase vaccine is currently underway
in patients with prostate cancer at
Duke University in North Carolina.
As described in previous issues of
Life Extension magazine, there are
two fundamental problems with
Phase I studies. First of all, they usu-
ally mandate that cancer patients fail
all "proven" therapies first. As has
been repeatedly shown in published
scientific studies, most so-called
"proven" cancer therapies do not
cure the disease. Since Phase I stud-
ies only test for safety, extremely
small doses of the anti-cancer agent
are used. This dooms virtually all the
terminal cancer patients who partici-
pate in Phase I trials to certain
death, but it does supply the FDA
with the safety data it mandates. In
other words, as long as the patient
dies of their cancer and not the new
drug, it is now permissible to move
on from Phase I to Phase II studies
where a potentially effective dose of
the anti-cancer drug can be given.
How the FDA perpetuates the
cancer epidemic
It is clear that the bureaucratic
process is incredibly long for the
approval of anti-cancer and other ther-
apies used
in the treatment of life-threatening injury, the very same approval process
has geographic boundaries that create
inhumane and unacceptable delays for
approval of a critical drug in one coun-
try that may be a few miles away from
a country where the drug is already
studied, reviewed and accepted.
For example, it took years for
Taxotere, one of the most impressive
anti-cancer agents used to treat breast
and prostate cancer, to finally gain
FDA approval in the United States.
This occurred despite hundreds of
studies supporting its efficacy pub-
lished in the European literature that
were not acceptable to the FDA.
Ironically, now that Taxotere has
gained FDA approval for the treat-
ment of metastatic prostate cancer in
the USA, countries such as Germany
do not permit its use in the treat-
ment of prostate cancer because no
published papers on this subject have
emanated from Germany. This
becomes even more incredulous
when one realizes that the pioneering
research on Taxotere emanated from
Germany`s next-door neighbor
France. The approval agencies such
as the FDA here and its counterparts
abroad are allowing bureaucratic
ego, and perhaps economics, to
interfere with the saving of life.
Think about this! American and
German physicians and scientists are
engaged in a battle against a common
enemy (cancer) while the respective
regulatory agencies (those that approve
the use of a drug) of each country
use national borders to say "yes" or
"no" to a live-saving drug or therapy.
This is a violation of human rights
within so-called civilized societies.
People from all over the world should
unite in protest to such atrocity.
Not only do FDA policies delay
life-saving drugs from being approved,
but they often keep effective medica-
tions off the market forever! If a
small company like Geron were to
run out of money before they could
conclude the expensive clinical trials,
their vaccine research program could
come to a grinding halt. Contrast tiffs
with a libertarian policy of giving
dying cancer patients the choice to
try Geron`s new vaccine immediately.
Under this system, it could be possi-
ble to determine whether the vaccine
worked within months, as opposed to
the multi-year period currently man-
dated by the FDA. If it worked, then
millions of cancer patients lives
would be saved. If the vaccine faded,
then these terminally ill cancer
patients will have died, as they would
have anyway.
The FDA does have a "compas-
sionate use" exemption that allows
cancer patients access to experimental
therapies. The problem is that the
FDA mandates that these cancer
patients first fail so-called "proven"
therapies. When cancer cells are
exposed to "proven" therapies like
radiation or chemotherapy, they
routate in a way that causes them to
become super-resistant to future ther-
apies. The patient`s healthy cells
(including dendritic cells of the
immune system) are often seriously
impaked when exposed to these
"proven" therapies, thus making ther-
apies like Geron`s telomerase vaccine
less likely to be effective.
Promising ovarian
cancer drug
Ovarian cancer kills more than
14,000 women each year. What makes
this type of cancer so insidious is that
there are few early warning signs,
meaning the disease is usually well
advanced when diagnosed.
In May 2003, an announcement was
made about a drug called phenoxodiol
that induced cell death in 100% of ovarian
cancer cells, including those cells
resistant to chemotherapy drags such as
Taxol and carboplatin. The tests were
conducted on human cell lines at Yale
University School of Medicine.
Phenoxodiol was discovered when
scientists were studying the anti-cancer
properties of isoflavonoid plant
extracts. They used data collected
from tiffs research to synthesize phe-
noxodiol. This drug works by altering
a signal pathway in cancerous cells
that prevent them from undergoing
apoptosis (programmed cell death).
These findings indicate that the drug
could be successful at treating other
cancer types as well. The study was
published in the May 1, 2003, issue
of Oncogene.
As stated earlier in tiffs article,
FDA-mandated Phase I studies involve
giving advanced cancer patients low
doses of a new drag to verify safety.
The dose is usually so small that
the drug has no chance of curing
end-stage cancer victims. In the case of
phenoxodiol, five Phase I human trials
have been completed with few if any
side effects. Preliminary results of a
trial conducted at the Cleveland Clinic
found that more than half of the 10
patients tested on the experimental
drug showed some response. Each of
these patients had different types of
advanced cancer that did not respond
to chemotherapy.
It is very difficult to kill cancer cells
once they have become resistant to
chemotherapy. That is because the
cancer cells not killed by chemo
develop multi-survival mechanisms
that make them extremely difficult
to eradicate. What has surprised
researchers at Yale was that phenox-
odiol killed all ovarian cancer cells
(in the laboratory setting), regardless
of their immunity to chemo agents
phase II trial using phenoxodiol
is under way at Yale for women with
chemo-resistant ovarian cancer. In
this Phase II study, a therapeutic
dose of the drug is given with the
hope of improving survival or achiev-
ing a complete response.
The researchers also tested phe-
noxodiol in mice and found that when
dosed at 20 mg/kg every day for six
days there was a three-fold reduction
in tumor mass compared to a control
group. No side effects were noted.
Phenoxodiol functions via several
unique mechanisms to induce cancer
cells to undergo programmed cell
death (apoptosis). Normal cells under-
go apoptosis in a controlled manner so
they can be replaced with healthier
functioning cells. Cancer cells, on the
other hand, have gene mutations that
prevent them from self-destructing.
The ultimate goal of a cancer therapy
is to induce malignant cells to undergo
apoptosis, instead of indefinitely pro-
liferating out of control.
Under today`s antiquated system, a
new drug cannot be marketed until it
has been thoroughly investigated in
clinical trials. These trials can take
many years to complete. The results of
these numerous trials are then submit-
ted in a new drug application to the
FDA. The FDA sends these results to
a committee for review. The commit-
tee may ask for more studies, reject the
application or recommend the drug be
approved. The FDA then takes the
committee`s report and decides
whether to approve the drug as safe
and effective. This can happen quickly,
or it can become bogged down in the
FDA/s regulatory quagmire. Until the
FDA reaches its final verdict, no mar-
keting can take place. It can take 10 or
more years after a promising cancer
drug has been discovered before the
FDA is even in a position to approve
it. One reason for this long delay is
that after the drug as been discovered,
money has to be raised to fund the
clinical studies and negotiations with
the FDA have to be completed to get
approval for the study design itself.
Every month, more than 1,000
women succumb to ovarian cancer.
Phenoxodiol was discovered in April
2002. If this drug turns out to be
even partially effective, the delay in
getting it into cancer victims` hands
would have caused thousands of
needless deaths
Saving cancer patients` lives
Large amounts of monies have
been spent on cancer research, yet
the findings from this research are
not being incorporated into clinical
oncology practice. To help remedy
this problem, The Life Extension
Foundation searches the peer-
reviewed scientific literature in order
to interpret and compile this data
into life-saying protocols.
We have completely updated our
reference book, Disease Prevention and
Treatment. This 1,500-page "edifice"
contains an abundance of informa-
tion about better ways to treat
cancer that are often overlooked by
oncologists. While this book pro-
vides novel guidance about many
different disorders, there are 295
pages dedicated to informing cancer
patients of what they should do to
improve their chances of achieving a
remission or complete response.
It is sad to think of how many
cancer patients die when potential
solutions to their disease are already
published in the scientific literature.
The new Disease Prevention and
Treatment reference book breaks
down the barriers of ignorance that
causes those with cancer and other
life-threatening diseases to die while
effective therapies already exist to
better treat their disease.
The research, writing and editing
of the 2003 edition of Disease
Prevention and Treatment consumed
tens of thousands of hours at a cost of
over one million dollars. Commercial
publishers do not spend this kind of
time or money producing health
books. It is our intense dedication to
finding solutions for our members`
health problems that motivated us to
publish such a comprehensive text.
Turn the next page to read specific
information about the new Disease
Prevention and Treatment book that
every Life Extension member should
have a copy of.
For longer life,
William Faloon
editor`s note
Just as we were going to press, the FDA released news of` an intitiative to speed
the identification and development of new cancer drugs. It appears that the FD.4
is in the beginning stages of a long overdue reform of Byzantine bureaucracy in
order to properly fulfill its public service mission. We have printed the news
release in its entirety on this page. As you will read, what the FD.4 proposes is
not nearly enough. The FDA, in essence, is trying to put out a forest.fire with a
garden hose.
NCI and FDA Announce Joint Program to Streamline Cancer
Drug Development
Under an agreement between the Food and Drug Administration (FDA) and the National Cancer
Institute (NCl), which is part of the National Institutes of Health (NIH), the two agencies will share
knowledge and resources to facilitate the development of new cancer drugs and speed their delivery
to patients.
FDA Commissioner Mark McClellan, M.D., Ph.D., and NCI Director Andrew yon Eschenbach, M.D., said
today that they will establish a multi-part Interagency Agreement to enhance the efficiency of clinical
research and the scientific evaluation of new cancer medications. The planned agreement, to be
announced formally at this week`s meeting of the American Society of Clinical Oncology in Chicago, will
enhance existing programs and add new joint programs to the existing close cooperative relationship
between NCl and FDA, both of which are part of the Department of Health and Human Services (HHS).
This new collaboration between two key HHS agencies means that federal researchers and regulators
will be working together more effectively than ever before," said HHS Secretary Tommy Thompson. "The
result will be a more unified, integrated, and efficient approach to the technology development and
approval process at a critical time for a disease that affects too many lives," Secretary Thompson said.
The agreement offers potential benefits for the more than one million Americans who are diagnosed
with cancer each year. "The FDA is committed to finding better ways to get safe and effective treatments
to patients with life-threatening diseases as quickly as possible," said McClellan. "At a time when the
opportunities to reduce the burden of cancer are greater than ever, sharing tools and resources with
our colleagues at the National Cancer Institute will help us fulfill that mission," he said.
"The effort between NCI and FDA in cancer therapies is a prototype that should inform and eventually
be applied across all areas of research," said NIH Director Elias A. Zerhouni, M.D. "Dr. McClellan and
I are committed to NIH and FDA working closely to find innovative ways to more rapidly make the fruits
of our discoveries available to the public."
"The collaboration will help the two agencies take full advantage of their combined knowledge base at a
time when many new kinds of anti-cancer agents are in the pipeline," said von Eschenbach. "Molecularly
targeted drugs and other novel agents offer great promise, but they also present new challenges that
require more collaboration between those involved in their discovery and development," he said.
(end of article)
(missed this sidebar)
What the public thinks about the FDA---
Beginning May 8, 2003, Life Extension initiated an Internet poll on a website (www. deathdock.com) that has about 400,000 new visitors each month. The people visiting this site are not part of any anti-FDA group, nor were they exposed to anti-FDA propaganda. These people were asked a simple question as to whether terminally ill cancer patients should have the right to any drug that might save their life. After 22,506 votes were tabulated, here are the results:
Terminally ill cancer patients
Should have access to any drug that might save their life: 89%
Should only have access to drugs approved by the FDA: 11%
We live in a constitutional republic where the people`s wishes are supposed to be adhered to (as long as they don`t infringe on the rights of others). If 89% of the American public thinks terminal cancer patients should have access to any drug that could save their life, then there is no reason for the law not to be changed to allow this. Companies that engaged in fraud could be prosecuted under consumer protection
laws that already exist. The FDA could post its opinion about the safety and efficacy of purported cancer therapies on their website (www. fda.gov). The civil litigation risks to companies that knowingly said bogus products would preclude large-scale unsavory activities that a minority of Americans fear. The greater fear Americans face is being diagnosed with cancer only to find out that a potential cure is too
many years away to save their lives.
Of interest was an identical poll on Life Extension`s website (www. lef. org) in which 98% of people voted to allow cancer patients to have access to any drug that might save their life. This is not surprising considering health conscious people`s animosity towards the FDA.
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