HERE AT THE MOSS REPORTS
People facing a diagnosis of cancer typically must make a
series of crucial treatment decisions in very short order.
It can be hard to choose wisely at a time when one is under
such intense pressure. The widely praised Moss
Reports are an invaluable source of information on
currently available conventional and alternative treatments.
There are now well over 200 individual Moss
Reports, each one focusing on a different, specific
type of cancer. For cancer patients and their families, a
Moss Report offers a truly
comprehensive resource. These reports can be ordered and downloaded
directly from our Web site, www.cancerdecisions.com.
You can also order by phone. Simply call 1-800-980-1234
(814-238-3367 from outside the US).
In addition, the following useful reports in our Current
Topics series can be purchased for $9.95
each, and can be downloaded directly from our Web site, www.cancerdecisions.com:
For those who have already purchased a Moss
Report on their specific cancer diagnosis, a phone
consultation with Dr. Ralph Moss can be enormously
helpful in narrowing down the options and arriving at a coherent
treatment strategy.
A recent phone consultee wrote:
"It was a pleasure to speak with Dr. Moss. He was
warm, gentle, knowledgeable and I learned a lot....I place
such confidence in him. It was a wonderful half hour."
— S.M.
If you are a Moss Report
client and would like to schedule a phone consultation with
Dr. Moss, you can do so by sending an email to Jacquie@cancerdecisions.com,
or by calling 1-800-980-1234 (814-238-3367
from outside the US).
WNBC AIRS INTERVIEWS WITH DR. RALPH MOSS
WNBC-TV (News Channel 4) "Live at Five" news program
(5-6 pm EST) is planning to air a series of reports on America's
War on Cancer during the week of August 21st - 25th, 2006.
Senior correspondent Gabe Pressman will investigate the reasons
for the failure of that 30-year-long war and will propose
various solutions. Dr. Ralph Moss was interviewed extensively
by Mr. Pressman and is scheduled to appear in most segments
of this series.
Even those outside the New York City area may be able to
see this series. WNBC, or Channel 4, is the flagship station
of the entire NBC network. It was the first fully licensed
TV station in the United States. Most viewers in the eastern
US can receive NBC programs over the air. WNBC is also available
on satellite via C-Band, and to subscribers of Dish Network
and DirecTV, which also provides coverage of the station to
Latin America and the Caribbean.
WNBC's Web site: http://www.wnbc.com
FDA APPROVES GEMZAR FOR OVARIAN CANCER DESPITE ITS LACK OF
EFFICACY – PART II
[Two weeks ago we began a two-part discussion of
the FDA's approval of the chemotherapy drug Gemzar for the
treatment of ovarian cancer. We conclude that discussion,
with references, this week.]
The Food and Drug Administration (FDA) has taken the rare
step of overruling one of its own advisory panels and has
approved the drug Gemzar (known generically as gemcitabine)
for the treatment of recurrent ovarian cancer, even though
in clinical trials it failed to improve survival in patients
with this disease.
The randomized clinical trial (RCT), gold standard of testing
since the post-World War II era, is now imperiled as never
before in America. What we are witnessing is the deliberate
eclipsing of survival as the primary standard of benefit in
drug testing, and a triumph of the "surrogate marker"
– a substitute measure that is typically unrelated to
survival.
Most cancer patients have a reasonable expectation that their
drugs will either extend or improve the quality of their life
- and preferably both. But these are high standards to attain.
For obvious reasons, the pharmaceutical industry would like
the standard of proof to be made less rigorous. Abstractions
such as progression-free survival offer a much easier target
than clear and measurable life-prolongation. Demonstrating
that a drug causes temporary cessation of tumor growth in
a significant number of patients is a great deal quicker,
easier and less expensive than demonstrating that the drug
unequivocally extends life. The emphasis on surrogate markers
such as progression-free survival is a trend that has been
accelerating for some time, especially under the present administration.
With the latest FDA ruling on Gemzar, we get a glimpse at
what an FDA under the full-time stewardship of Andrew von
Eschenbach would look like, at least as it relates to the
approval of new cancer drugs.
Economic Considerations
Gemzar is already the second best selling drug of Eli Lilly,
the Indianapolis-based pharmaceutical giant, and is approved
in the US to treat lung, pancreatic and breast cancer. It
is also approved in some countries outside the US to treat
ovarian cancer.
The US payoff for Lilly could be huge. About 22,000 American
women are diagnosed with ovarian cancer each year, and about
16,000 die of it. One course of Gemzar treatment, involving
six doses given over six months, costs about $12,600. Even
without formal FDA approval, doctors could still have prescribed
Gemzar for advanced ovarian cancer, but it would have been
an off-label prescription, and insurance plans would very
possibly not have paid for it. With official government approval,
however, Medicare, Medicaid and private insurance companies
will be required to pay for this ineffective treatment for
16,000 or so advanced ovarian cancer patients. This approval
could therefore be worth around USD $200 million per year
in the US alone, which will be added to Gemzar's 2005 sales
of $1.3 billion. This approval creates the sort of inflationary
pressure that the advisory panel's initial decision would
have prevented. The agency's reconsidered decision, a mere
four months after its initial refusal to recommend approval,
has brightened the financial landscape for Lilly while darkening
it considerably for an already straitened health care system
in this country.
This is only the latest in a string of pro-industry decisions
from Andrew von Eschenbach, MD. As director of the National
Cancer Institute (2002-2005) Dr. von Eschenbach demagogically
claimed that all cancer suffering and death would be ended
by the year 2015. As the clock ticks, however, there is little
sign of any significant progress towards that Quixotic goal.
Elsewhere, I have argued that Dr. von Eschenbach's real agenda
is to weaken the whole drug approval process, and as commissioner
of the FDA he is ideally situated to enact policies that will
result in the emasculation of the US drug regulatory system.
Plan B Controversy
At this writing it is unclear whether the US Senate will confirm
Dr. von Eschenbach's appointment as full-time FDA commissioner
because of the still unsettled question of whether the FDA
will, or will not, approve over the counter sales of Plan
B, the "morning after" contraceptive pill. If the
Senate makes von Eschenbach's confirmation contingent on the
approval of Plan B, it is considered likely that Pres. Bush
will give von Eschenbach a recess appointment, allowing the
Houston urologist (and Bush family friend) to bypass Senate
approval and serve out the administration's term as FDA commissioner.
I do not need to comment here on the thorny controversy over
Plan B. However, I did hope that the Senate – and particularly
the opposition party – would broaden its inquiry to
include a very close look at Dr. von Eschenbach's record at
NCI, as well as at the FDA's decision regarding Gemzar. Dr.
von Eschenbach's attitude towards the general topic of new
drug evaluation deserves to be scrutinized publicly. While
this is an issue that may seem obscure to casual readers,
it is anything but trivial. Von Eschenbach's avowed position
on this issue could have a wide-ranging and unquestionably
deleterious effect on the development of new cancer drugs.
How naïve of me to hope that the Senate would exercise
due diligence in this respect! In fact, the very opposite
happened. The senators, including some of the most prominent
Democrats, simply rolled over in the face of this highly controversial
appointment. Thus, Sen. Edward Kennedy (D-Mass.), who normally
is not shy about criticizing Republicans, effusively praised
von Eschenbach's performance at NCI:
"I admired Dr. von Eschenbach's leadership [at NCI],
especially on issues of genomics and nanotechnology,"
Kennedy said during the hearings. "As a survivor of
cancer himself, he has brought an important patient-centered
perspective into the institute and [FDA]."
And while Sen. Hillary Clinton (D-NY), who had earlier pledged
to block von Eschenbach's nomination if it got to the Senate
floor, did raise questions about the Plan B controversy, she
expressed nothing but praise for his performance as NCI director.
She failed to mention the possibly catastrophic impact that
von Eschenbach's policy towards accelerated drug approvals
would have.
"Your qualifications and your experience... are impeccable,"
Clinton said during the two-and-a-half-hour hearing.
As the Cancer Letter commented: "By refraining
from challenging von Eschenbach's four-year stewardship of
NCI, Democrats forego the opportunity to question his reorganizing
the institute for the pursuit of a blatantly unachievable
and now apparently abandoned goal to 'eliminate suffering
and death due to cancer' by 2015. Similarly, von Eschenbach's
controversial plan to expand reliance on biomarkers escaped
questioning by the committee" (August 4, 2006).
The dominant forces in American oncology (inspired by the
profit drive of Big Pharma) are now in a position to substitute
clinically irrelevant 'surrogate markers' for actual proof
of life prolongation in new treatments. Dr. von Eschenbach
has pulled out all the stops, using the absurd demagogy of
the 2015 goal to befuddle the population into accepting such
changes, promising an imminent cure for cancer in exchange
for carte blanche over the drug approval process. How bitter
it is to see those politicians who are self-proclaimed guardians
of the commonweal themselves become eager promoters of the
same monumental illusions.
The US Senate committee that oversees the approval of the
FDA commissioner should take a very close look at von Eschenbach's
record at NCI and especially at this recent FDA decision regarding
Gemzar. Hopefully, this will bring Dr. von Eschenbach's attitude
towards the scientific evaluation of new drugs into sharper
focus. This is an issue that has the potential to affect the
nature and efficacy of new cancer drugs – and ultimately
the treatment of cancer patients - for decades to come.
--Ralph W. Moss, Ph.D.
References: Gemzar sales:
http://www.marketwatch.com/News/Story/Story.aspx?dist=newsfinder&siteid=google
&guid=%7BBE52E3F3-87F0-4C1C-B72E-023B5AB4592C%7D&keyword=
Wall Street Journal:
Corbett Dooren, Dow Jones/Wall Street Journal, 3/13).
FDA Panel Recommends Rejection Of Eli
Lilly Drug Gemzar To Treat Ovarian Cancer.
http://www.kaisernetwork.org.
Turley quote:
http://catallarchy.net/blog/archives/2004/05/27/slaughterhouses-
restaurants-and-agency-capture/
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The news and other items in this newsletter
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newsletter is intended to be a substitute for professional
medical advice.
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