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some CAM/IM publication links |
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Beth Clay: An Insider on Gonzalez' New Book on the NIH's Trial of His Pancreatic Cancer Treatment |
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Written by John Weeks
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Beth Clay: An Insider Looks at Nicholas Gonzalez ' New Book on the NIH's Clinical Trial of His Pancreatic Cancer Care
Summary: The Gonzalez cancer treatment was well known in the alternative medicine community long before the NIH NCCAM and the National Cancer Institute decided to fund a trial on his treatment of pancreatic cancer. The news of the trail was huge: a giant from outside the system was to be explored in a major trail by researchers deep inside the system in a moment when trust between the two communities was about as palpable as that between the US and the USSR in the middle Reagan years. Not surprisingly, the trial proved controversial. Here a Gonzalez associate, former NIH and US Congress staffer Beth Clay on Gonzalez book What Went Wrong: The Truth Behind the Clinical Trial of the Enzyme
Treatment of Cancer.
 New book on a controversial trial
Beltway consultant Beth Clay has multiple connections to her subject matter in this review of What Went Wrong? Nicholas Gonzalez, MD's new book. She was a founding staff of the NIH office that subsequently funded the work. As a staffer subsequently on the House Government Oversight Committee, Clay is experienced in major investigations. As a committed part of the movement for more choice in integrative care, she is aware that history is replete with examples of conventional medicine throwing up barriers to choice. As a Beltway professional, Clay has worked with Gonzalez to help him respond to the outcomes of the controversial National
Institutes of Health (NIH)-funded train on Gonzalez treatment regime for pancreatic cancer. Together these give he a long view, and inside information about the NIH NCCAM's most significant look at a significant "alternative medicine" treatment for cancer. The book is What Went Wrong: The Truth Behind the Clinical Trial of the Enzyme
Treatment of Cancer. Here is her review, followed by some commentary.
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What Went Wrong:
The Truth Behind the Clinical Trial of the Enzyme
Treatment of Cancer by Nicholas J. Gonzalez, MD
- Beth Clay Beth
Clay, Senior
Vice President
Capitol
Strategy Consultants, Inc.
 Reviewer Beth Clay
In the fall of 2009, I reported via
the Integrator Blog my concerns about
the management of the first ever direct
comparison of an alternative and conventional approach to treating pancreatic
cancer funded by the National Institutes of Health (NIH). Both the National Cancer Institute (NCI) and
the National Center for Complementary and Alternative Medicine (NCCAM) were
involved in funding and managing the study. With a decision to evaluate the Gonzalez protocol came a determination
by the NIH staff that a conventional researcher at an academic center needed to
act as principal investigator for the study, presumably to insure the study was
well run. John Chabot, MD, at Columbia
University Medical Center became the principal investigator.
At the time, I
shared with the Integrator Blog the following comment: "The last decade
as far as the general public and the alternative medicine community knew was
devoted to the rigorous management of what might have been the most important
pancreatic cancer study of the century. Instead what took place was a series of
management failures by at the NIH both at NCI and NCCAM. Further, there were
serious violations of the research protocol (including mismatching the arms of the study and
then retrospectively re-staging them in an attempt to equalize them) and
failure to insure human subject protections by the principal investigator;
attempts at the NIH to brush the violations and mismanagement under the rug
either through malfeasance or incompetence; and a government investigation that
confirmed that Dr. Chabot failed two thirds of the time to provide adequate
informed consent to patients. And finally, a failed and then successful attempt
by Dr. Chabot to publish a fraudulent research paper."
 Gonzalez: getting his story out
The
history of this project is one I know well.
I have the unique history of having worked in the complementary and
alternative medicine (CAM) activity at the National Institutes of Health (NIH),
going on to lead health oversight activities for a US Congressional Committee in
which CAM was a focus and continuing involvement in the field now that I am in
the private sector. As a matter of
disclosure I have consulted with Dr. Gonzalez for a number of years and know
the accuracy of the information provided within the book.
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"Few in the CAM community have been
willing to wake up and enter
into the fray
of discussing an egregious miscarriage of
justice for the
pancreatic cancer
community and for the future of honest
dialogue about CAM
research."
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Reading What
Went Wrong reminded me of the statement - the less the people know about
how sausages and laws are made, the better they sleep in the night. One need only exchange the words "laws" with
"CAM research" to understand my perspective.
To date, few in the CAM community have been willing to wake up and enter
into the fray of discussing an egregious miscarriage of justice for the
pancreatic cancer community and for the future of honest dialogue about CAM
research. To quote Dr. Briggs' comment to Dr. Gonzalez, most want to ‘look
forward' not backward. However, if we do
not learn from our history, we are destined to repeat the mistakes of the
past. One has but to think of the
Tuskegee Syphilis study to appreciate why we must understand when research
studies go off track.
What Went Wrong is the
first person accounting by Dr. Nicholas Gonzalez of the Clinical Trial NCT
00003851 (Project Number: P30-CA1369)
entitled "Gemcitabine Compared With Pancreatic Enzyme Therapy Plus Specialized
Diet (Gonzalez Regimen) in Treating Patients Who Have Stage II, Stage III, or
Stage IV Pancreatic Cancer." This is the author's third
book; the first two being One Man Alone: An Investigation of Nutrition, Cancer, and
William Donald Kelley and The Trophoblast and the Origins of Cancer:
One solution to the medical enigma of our times. He also wrote a foreword
for the reprinting of The Enzyme
Treatment of Cancer and Its Scientific Basis by John Beard D.Sc.
What Went Wrong provides two forewords, the first from 11 year
pancreatic cancer survivor Sarah Ann Cooper who attempted to enter the trial,
but was rejected and opted to be treated by Dr. Gonzalez and Dr. Isaacs off
trial. (She was rejected by Dr. Chabot because she refused Whipple
surgery.) The second foreword is from
Paul Rosch, MD, President of the American Institute of Stress; a name familiar
to many in the CAM community. His
informed observations develop into critical questions that the community would
be well served to address.
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"This is not the story of a single error
in management
of the study, but a series
of violations of protocol, ethics, and law."
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Dr.
Gonzalez opens the book by providing the historical background and a summary of
the major problems that developed with the study. While What
Went Wrong is a long read (more than 500 pages), it is organized in logical
fashion and separated into 44 chapters. As
one learns in this book, this is not the story of a single error in management
of the study, but a series of violations of protocol, ethics, and law. That these occurred at a prestigious academic
institution under federal supervision is particularly disturbing. Why it was not on the front page of the New York Times that an NIH funded study
investigator (Dr. Chabot) was found by the Food and Drug Administration (FDA)
to have (1) Inadequate informed consent form, (2) Failure to follow
investigational plan, (3) Inadequate and inaccurate records, and (4) Failure to
list additional investigators on 1572 (Statement of Investigator) is also
disturbing. Had it been Dr. Gonzalez
that committed these violations along with changing the treatment protocol
(from Gemcitabine alone to a three drug
combination that Columbia was developing) and retrospectively restaging the
patients in the two arms of the study in an attempt to correct the mis-matching
of the two arms, one can be assured it would have been a leading story and that
the NIH/NCI/NCCAM would have issued a press release condemning the acts and
banning him from receiving research grants in the future.
While the book is well documented, providing excerpts from
letters and emails that document every facet Dr. Gonzalez' concerns, in
retrospect, "Chapter 10 Payment Delays" does not fully detail the significant
issue the failure for the grant funds to be provided became. Readers I believe will be shocked to realize
that due to mismanagement of the financial aspects of the grant, there was a
period of 8 months in which Dr. Gonzalez was forced to pay for the nutrition
arm of the study out of his own pocket. I remember well this issue as I was
working for Congress and was asked to help.
Inquiries we made to expedite a resolution were frustrating and showed
apathy and mediocrity. While this was
Dr. Gonzalez's first foray into NIH funded research, Columbia University in
1999 had more than 1,100 grants with the NIH and presumably would understand
how to receive payment so that studies could be funded on time. Furthermore between 1999 and 2012, Columbia
received 50 pancreatic cancer related grants from the NIH totaling more than
$10 million. That patient's lives were
literally at stake seemed to be lost in the bureaucratic paper shuffle and
blame game. How often has a cancer
researcher had to pay for clinical trial treatments out of pocket while waiting
for the NIH and academic administrators to do their jobs?
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"There was a
period of 8 months in which
Dr. Gonzalez was forced to pay for the
nutrition
arm of the study out of his own
pocket. I remember well this issue as I was
working for Congress and was asked to help."
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Having conducted a number of Congressional oversight investigations, I am
well familiar that mismanagement issues are seldom isolated and often have far
reaching consequences. In Chapter 25,
Dr. Gonzalez details another NIH-funded study (the now infamous HIV-Nevirapine
clinical trial) that was mismanaged and draws a connection to the NCI/NCCAM
study.
Chapters 41 and 44 may be the most important chapters of the book as they
take the reader through the actual study data and the Chabot publication. This section also details how Sarah Ann Cooper
was rejected from the study and challenges Dr. Chabot's interpretation of the
data.
Since the creation of an alternative medicine research activity at the
NIH two decades ago, we as a community have discussed how to effectively
conduct research to evaluate CAM protocols, in dozens of meetings discussing
how or if to conduct randomized controlled trials, outcomes studies and how to
build an evidence-base using multiple types of studies. Taxpayers have provided more than $1 billion
in research funds. While this study represents one tenth of one percent of that
money, it was the first and likely the only head to head comparison of an
alternative cancer therapy and the conventional approach.
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"This is an essential read for everyone
interested in CAM research. I believe
it is a must read for the NCCAM
advisory
board members past and present."
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This is an essential read for everyone interested in CAM research. I believe it is a must read for the NCCAM
advisory board members past and present.
I have found no evidence that the NCCAM briefed the Advisory Committee
on the study, or the various regulatory oversight investigations that took
place and found violations. Nor have they invited Dr. Gonzalez to present at an
advisory board meeting.
To compound
this, after this book went to press, a response from the NCI/NIH to a Data Quality
Assurance Act included the following: "...evidence
is lacking that administrative deficiencies identified in the Gonzalez Regimen
trial by OHRP and the FDA materially affected other activities of the trial or
the reported findings." It is illogical
to believe that an FDA finding of inadequate and inaccurate record keeping does
not ‘materially affect' the research findings. This book provides all the evidence the NIH needs to validate the OHRP
and FDA findings, to correct the public record and call for a retraction of the
Chabot article.
Dr. Gonzalez has done a thorough and accurate job of documenting this
decade long endeavor.
What Went Wrong: The Truth Behind the Clinical Trial of the Enzyme
Treatment of Cancer by Nicholas J. Gonzalez, MD is available through New Spring Press (www.newspringpress.com) ISBN: 978-0-9821965-3-3 ($39.95)
Comment: The trail of Gonzalez work was, as Clay writes, "the first and likely the only head to head comparison of an
alternative cancer therapy and the conventional approach." The word trial, as in clinical trial, is a particularly apt and Kafka-esque term in this context. It captures the necessary crossover between politics and science in the extremely polarized era about which Clay writes. Meantime, thousands of people continue to try treatments that are truly alternative, rather than merely complementary strategies to deal with adverse effects of conventional treatment. The this saga seems to have left one strong message to the NIH: stay away from studying such strategies.
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