The Cancer Industry:
The Classic Expose on the Cancer Establishment
New Updated  Edition
© 1996 by Ralph W. Moss, Ph.D.
Published by Equinox Press
(All rights reserved. Please see
[WEB SITE NOTE: This third section of the Preface concerns the formation
of the Office of Alternative Medicine (OAM), which was founded at the
National Institutes of Health in late 1991. Sometime soon the name is scheduled
to be changed to the Office of Complementary and Alternative Medicine, to
reflect the true scope of the field. Although a Web site has been planned
for some time, at this writing it is still not on-line. Information about
OAM can be obtained from a number of other sites. Most of the "bold-ing"
has been added, and some of the paragraph breaks are different from the printed
3. The Office of Alternative Medicine
One of the original signers of Rep. Guy Molinari's
letter to the OTA had been Iowa Democrat Berkley
Bedell. Bedell was a character straight out of
Horatio Alger: as a teenager, he had saved $50 from his paper route money
to start a small fishing tackle company. Berkley & Co. became one of
the largest such manufacturing companies in the world. He did this without
ever taking a partner or a loan.
Not surprisingly, Bedell was chosen as the nation's first Small Business
Person of the Year and in 1974 was elected to Congress. As a measure of his
popularity he ran as a liberal Democrat in a solidly Republican part of Iowa
and was elected six times. In fact, he would probably be there today, if
he hadn't gone fishing at the Quantico, Virginia Marine Corps Base and contracted
a severe case of tick-borne Lyme disease. In 1987, Bedell was forced to retire
from Congress because of ill health. After three series of intravenous
antibiotics at the Walter Reed Army Hospital his disease had still not been
brought under control. By 1990, in fact, he had severe, Lyme-related arthritis
in his knees and other joints.
In desperation, he turned to alternative medicine. He heard about a farm-based
treatment that consistent of the administration of a specially prepared kind
of milk product. It was whey made from the colostrum (first milk) of a cow
whose udders had first been injected with a sample of Bedell"s own blood.
The treatment had been thought up by a Minnesota farmer named Herbert Saunders.
But, odd as it seemed, it had some scientific plausibility. It was related
to a promising medical treatment called transfer factor, which had been
discovered by Dr. Henry S. Lawrence at New York University in the 1950s but
had then languished in obscurity (J Clin Invest 1954;33:951).
"After I drank a teaspoon of this whey every one-and-a-half hours for a few
weeks," Bedell later told his former Congressional colleagues, "my symptoms
of Lyme disappeared and I no longer suffer from that disease."
There was some publicity on his case and not surprisingly Bedell found himself
besieged by calls from others suffering from this often intractable disease.
(Herb Saunders in under indictment for practicing medicine without a license
and his treatment is no longer available.)
"Unfortunately," Berkley added, whimsically, "little Miss Muffett is not
available to testify that the curds and whey which she was eating are safe"
(Hearings Before Appropriations Subcommittee, June 24, 1993).
Following this Lyme disease episode, Bedell was further diagnosed with an
unrelated prostate cancer. After receiving thoroughly conventional treatment,
he had signs that the disease was returning. He therefore treated himself
with a non-toxic agent known as 714X, invented by a Franco-Canadian microscopist
named Gaston Naessens. Bedell ascribed his own recovery of good health to
this particular treatment.
Bedell's remarkable progress toward good health made a deep impression on
many of his colleagues, especially Sen. Tom Harkin, a fellow Iowa Democrat,
who served 12 years with him on Capitol Hill.
In the year or so following the OTA Report, it became painfully obvious to
observant members of Congress that NCI had no intention of carrying out the
various recommendations of the report. The cancer institute seemed mired
in its own prejudices against anything that smacked of the unconventional.
Because of the terms of the National Cancer Act, passed by Congress in 1971
to find a way around the massive bureaucracy of NIH, NCI was semi-autonomous
and politically privileged. The director of the NCI didn"t report to the
director of the NIH, as had formerly been the case, but to a cancer advisory
board and a three-person President's Cancer Panel, which reported directly
to the chief executive. NCI had long since created its own vast bureaucracy,
more stultifying in fact than the one at NIH.
As fate would have it, Tom Harkin happened to be chairman of the Appropriations
Subcommittee that oversaw the $10 billion-a-year NIH budget. Understandably,
he also had a few friends at NIH who wanted to please him. And what would
please him most would be to get to the bottom of some of the amazing stories
Berkley was now telling him.
And so Bedell and Harkin drafted a piece of legislation, which Bedell then
intensively lobbied for among his former colleagues. Broadly speaking, the
idea was to rectify the problems that had been revealed by the OTA Report.
On so on November 22, 1991, a fateful day, Congress passed Sen. Harkin's
bill, mandating the formation of an 'Office for the Study of Unconventional
Medical Practices' within NIH. The office simply bypassed the NCI roadblock,
for the time being, at least. Some NIH officials were not exactly thrilled
when they woke up the next morning to discover an office of 'quackery' plunked
down in their midst. For some, it was as if the Roman Curia had capriciously
sanctioned in the basement of the Vatican an office for the propagation of
The office was given a small budget of $2.2 million that first yearãless
than a thousandth of the overall NIH appropriation. "Though just a drop in
the bucket by federal budget standards," wrote the Congressional Quarterly,
"the office is a symbol of the new visibility being won by medical treatments
that haven"t gained mainstream approval" (1/31/92).
The acting director of the office was Stephen Groft, D. Pharm. He appointed
an ad hoc advisory board and called its first public meeting for June 17-18,
1992. Unlike OTA, the NIH warmly welcomed all those interested in alternative
medicine to come and present their views. Jay Moskowitz, Ph.D., deputy director
of the NIH, opened the meeting. His friendliness towards the initiative was
As at OTA two years earlier, I spoke at this meeting.
"We come here with an open mind--yet history teaches us to be wary,"
I began. I admitted that "one would have to be made of stone not to recognize
the importance of this development. Yet we have to pinch ourselves--to stop
and ask, 'What exactly is going on here?' After all, NIH has never been a
friend of non-toxic and nutritional treatments."
I proceeded to recount many of the misdeeds of NCI over the years. What I
underestimated was the extent to which these were the misdeeds of NCI, which
often acted quite independently of the parent body. One simply could not
equate the two agencies.
I concluded, "If NIH is now serious about launching a new era of cooperation,
then we will enthusiastically work with them towards our common goal, the
conquest of cancer."
Margaret Mason, 'Body and Soul' columnist for the Washington Post was present,
as were many others from the mainstream media. "Something wonderful happened--and
a quiet grass-roots revolution in health care was official recognized--last
week on the sixth floor of government Building C in Bethesda" (June 26, 1992).
After the success of this first meeting, NIH convened an even larger gathering
at the Westfields International Conference Center in Chantilly, VA. NIH actually
paid the way for over 100 practitioners and defenders of alternative medicine
to discuss the future of such topics as ethnomedicine, natural products,
pharmacological treatments and nutrition/lifestyle changes. Such a gathering
had never occurred before, much less under the government's aegis.
There were also broad and productive discussions of methodology, information
dissemination and peer reviewãthree days of intense idea sharing and
debate. Brian Berman, MD, a doctor at the University of Maryland who had
studied homeopathy in England, was appointed by NIH to chair the overall
conclave. Frank Wiewel of People Against Cancer and I were asked to co-chair
the Panel on Pharmacological and Biological Treatments. NIH's Dr. Jay Moskowitz
gave the keynote address. "The era of quacks and quackbusters has come
to an end," he told the enthusiastic gathering. There were now "opportunities
for rewarding breakthroughs" by exploring alternatives. He declared that
"the alternative and establishment communities are converging."
But Moskowitz went further. He said, "Not all alternative medical practices
are amenable to traditional scientific evaluation, and some may require
development of new methods to evaluate their efficacy and safety." This
opened the door to 'field investigations' of such treatments, to find out
what the outcome really is when people go to non-conventional clinics for
treatment. In effect, this was Dr. Burton's 'pre-trial' suggestion, but
sanctioned by a top leader of the government's biomedical community.
This approach may seem common sensical to the lay reader, but was revolutionary
at NIH, where an almost religious belief in randomized clinical trials (RCTs)
prevails. There was widespread discontent with the negative and cumbersome
name of the office. Soon afterwards, it was changed to the catchier but rather
provocative Office of Alternative Medicine, or OAM.( In 1996, there is talk
of changing it again, this time to the Office of Complementary and Alternative
On this instance, the eloquent Ms. Mason wrote, "The momentum is there. Hundreds
of men and women--kindred health-care professionals--have found each other.
There is no turning back" (Washington Post, October 2, 1992). The
media suddenly discovered that not all alternative practitioners were kooks
or quacks. There followed hundreds of stories, including a five-day series
on the 'Eye on America' segment of the CBS Evening News with Dan Rather.
Rather"s series was appropriately titled "New Age--New Rage."
Newsweek, which had lambasted laetrile in 1977, suddenly realized that "the
medical establishment has for years shunned so-called alternative medicine
and insurance companies have refused to pay for it, while federal officials
have harassed its practitioners." Now faced with spiraling health care costs,
Newsweek reported that 'the federal government can no longer afford to be
so smug. They are now 'serious about unconventional therapy' (July 13, 1992).
The Los Angeles Times joined in with a lengthy piece, "Scrutinizing Alternative
Paths to Health" (September 29, 1992). Even the staid The New York Times
ran several guardedly favorable articles on the "mainstreaming of alternative
medicine." The Sunday Times carried a report from Pulitzer Prize-winner Natalie
Angier allowing that NIH, "long a stern protector of the most rigorous brand
of science," was "about to start venturing into the realm of alternative
medicine" (December 10, 1992).
Predictably, however, some people were not pleased. One could hear cries
of opposition, much of it ultimately originating from a core of determined
"quackbusters" affiliated with the National Coalition Against Health Fraud.
One prominent opponent of such methods, Victor Herbert, M.D., complained
to Internal Medicine News and Cardiology News that the new office was a "rip-off
of the public of $2 million," and "a way created by con artists to promote
cons as a legitimate therapy" (December, 1992). In the following month, he
elaborated in a New England Journal of Medicine book review, claiming that
"a deceived Congress, at the urging of a misguided former congressman" forced
the NIH to "waste $2 million in 1992 and 1993 in an attempt to validate
åalternative therapies."" In addition, Congress had required NIH to
include on its [ad hoc advisory, ed.] committee "a number of persons who
make their living promoting health consä" (December 17, 1992).
But, despite the grumbling about "governance by horoscope" the establishment
of the OAM marked an irreversible turning point in the attitude of the media
and much of the public toward alternative medicine. Before OAM, media attention
tended to be sensationalistic, unreliable, or even downright nasty. After
1992, coverage was not only more intense but of a generally higher quality.
(To jump ahead for a moment: by the end of 1995, OAM was receiving between
15 to 25 media inquiries per day. About three quarters of the stories generated
by these inquiries were of a positive nature.) On October 24, 1992, NIH appointed
Joseph Jacobs, M.D. to be the first full-time director of the office.
Dr. Jacobs, at 46, was the immediate past president of the Association of
American Indian Physicians. He had grown up on a St. Regis Mohawk reservation
in New York State and received his bachelor"s degree from Columbia, an M.D.
from Yale University School of Medicine and a M.B.A. from the Wharton School
One problem was that members of the Ad Hoc Advisory Committee (of whom I
was one) were never consulted about the appointment of the director, and
there were objections to this fact. Dr. Jacobs may have mistaken this as
opposition to his appointment. In addition, Dr. Jacobs seemed conventional
in his medical orientation, and had never really studied or practiced any
form of alternative treatment. He sharply disagreed with this assessment,
however. "I have had some critics in the alternative medical community who
feel that my lack of identity in that community did not qualify me for this
job," he later said.
"My response to that characterization is that I feel I was born into alternative
medicine since my mother was a full-blooded Mohawk from Canada and upstate
New York who frequently availed herself of traditional herbal medicines for
me and my siblings when the need arose" (Appropriations Subcommittee Hearings,
June 24, 1993). Bedell and Harkin and some other advisors were insistent
that the first order of business was for OAM to send out teams of investigators
to bring back reports on potentially useful alternative treatments, especially
for cancer. This sort of field work happened to be the way that Bedell himself
organized the very successful research branch of his own small company. Don"t
sit around, he told his staff. Go find out what"s happening in the field.
But Jacobs, and many at NIH, saw things differently. Science, they complained,
was not fishing tackle!
There were complicated issues of methodology as well as medical ethics that
had to be considered. The repercussion of NIH statements could be vast. For
what happened if OAM did validate a particular treatment? What should be
done with that information? Would a report from OAM on an apparently successful
cancer treatment lead to its acceptanceãor to public pandemonium,
with further scorn from the medical establishment? These, by the way, are
still live issues.
Needless to say, they roiled many a meeting over the next several years.
But, if only for political reasons, some field work had to be done. So in
early 1993, Jacobs and his deputy Daniel Eskinazi, D.D.S., accompanied at
times by a number of ad hoc advisors, paid site visits to a a few unconventional
therapists. They went to see Dr. Burzynski, for example and Jacobs came away
favorably impressed. They later visited Charles Simone, M.D. and the 96-year-old
Emmanuel Revici, M.D. in New York, and I accompanied
them. I came away from these meetings profoundly disturbed by the lack of
enthusiasm or support (financial and otherwise) from Dr. Jacobs for such
In fact, over the next few months, my own interactions with Dr. Jacobs
deteriorated. He vehemently rejected the line of argument you will read in
this book, that there is an economic dimension to the "establishment"s"
opposition to alternative cancer treatments. After these arguments it became
increasingly difficult for me to reach the director or other members of the
staff, nor did I particularly want to. What had started out as a very warm
and collegial relationship had suddenly turned ice cold. And what I heard
from other staff members was not reassuring.
Although Jacobs had an M.B.A. from a major business school, I heard repeated
complaints of disorganization. A major problem was that NIH, without the knowledge
or approval of the ad hoc board, had given $750,000 of OAM"s first money to
NCI to conduct a trial on antineoplastons. Jay Moskowitz had done this, thinking
(he said) that the board would be pleased to see the money spent in such a productive
way. But then it became Dr. Jacobs" problem. No one seemed able to discover
exactly what had happened to this money. To me, this was a travesty. I felt
that OAM should protect its fledgling autonomy and keep control of all such
studies in its own hands. (NCI later announced that it would fund a clinical
trial on antineoplastons at Memorial Sloan-Kettering, which I regarded as the
"killing field" of alternative cancer treatments. In 1995, excoriating Dr. Burzynski,
the NCI and Sloan-Kettering cancelled this small trial, without producing any
To summarize, the major controversies were as follows:
Should the emphasis of the OAM should be on conducting site visits to promising
clinics or on funding small "requests for applications" (RFAs) from a variety
of institutions, most of them academic. Senator Harkin and the subcommittee"s
ranking member Arlen Specter (R-PA) agreed with Bedell"s field investigation
strategy, and had in fact sent Jacobs authorization to hire five full-time
field investigators. Yet OAM never acted on that request.
Should OAM focus on killer diseases, like cancer and AIDS, or on more peripheral
issues and illnesses?
Should OAM work with agencies like the NCI or through them?
Should OAM seek FDA approval for testing compounds or methods, even if such
approval were not legally necessary? The office badly needed its chartered,
permanent Alternative Medicine Program Advisory Council (AMPAC). But this
was delayed by red tape within the new Clinton Administration.
Therefore, the office endured a rocky period, during which the authority
of the Ad Hoc committee was called into question, but the permanent council
had not yet been appointed. During this time, Dr. Jacobs ran the office virtually
without any structured input from the alternative community. Because of his
orthodox background, he did not have many contacts in the field, but seemed
uneasy with many of the advisors he had inherited.
The main continuity was provided by the 20 or so co-chairs of the panels
from the Chantilly conclave. A subcommittee had been charged by Dr. Groft
with producing an extended report on the meeting. They continued to meet
by phone and in person. And indeed, in late 1994 this report was finished
and published by the Government Printing Office as a 372-page survey of the
field, entitled Alternative Medicine: Expanding Medical Horizons (NIH Publication
No. 94-066). It is an excellent introduction to the field, and blueprint
of research opportunities.
But relations within the co-chairs' [committee] could be difficult, especially
since they had no statutory authority. For instance, on February 4, 1993
there was a two-hour phone conference of the 20 co-chairs of Chantilly panels.
It was an extremely fractious and contentious meeting. It seemed to me at
the time that the OAM staff was trying to ramrod proposals through without
adequate input from outside advisors. Frank Wiewel, Gar Hildenbrand, and
I struggled hard, but were completely outvoted on a number of key issues
pertaining to the direction of research. The selection of participants for
this meeting excluded Berkley Bedell, who usually
spoke with authority on such occasions.
Disaffection among those who had originally formed the office reached such
a height that on June 24, 1993 Sen. Harkin held public hearings of his
Appropriations Subcommittee to find out what exactly what going on at the
office. Other attendees at these hearings included Senators Barbara A. Mikulski
(D-MD), Slade Gorton (R-WA), Harry Reid (D-NV), and Claiborne Pell (D-RI).
Some physicians and patients also spoke, such as David Eisenberg, M.D. and
Charles Simone, M.D. But the centerpiece of the meeting was the testimony
of Mr. Bedell and Dr. Jacobs and their exchanges with Senator Harkin.
After much hesitation, Berkley Bedell had decided it was necessary to go
public with his smoldering concerns about the direction of OAM. With Jacobs
sitting there, Bedell told the subcommittee: "In my opinion, for this office
to be successful in carrying out the investigations called for in this
legislation, one of the requirements will be a director who is willing to
stand up to these powerful forces. I am sorry to tell you that in my opinion
our current director has not yet shown that commitment. I hope this will
change. I believe it must" (Special Hearing, Appropriations Subcommittee,
June 24, 1993).
These were fighting words, even though Bedell had stopped just short of calling
for Jacobs" resignation. Jacobs responded as best as he could, and one couldn"t
help sympathize with the difficult job he had taken on. But on some issues
sounded like a temporizing bureaucrat: "Important issues such as determining
the scope of the assignment and determining the magnitude of the solutions
need to be addressed prior to initiating a major initiative," was one such
reply. The plain-spoken Harkin could not hide his frustration or anger. "I
see no reason you can"start pushing [the NCI director] a little bit, to get
this process moving a little bit faster. You see, I'm faced with a problem
here. I"d like to put more money into the office, but you"re telling me you
can't even hire scientific investigators and you give money to NCI that
goes into a black hole some place and you never see it again and nothing
happens.... Maybe I should shut the whole thing down?"
In closing, Harkin told Jacobs, "We"ve had enough time. You will hear from
me." But aside from a growing hostility between Jacobs and certain ad hoc
advisors, nothing of substance happened. In November, 1993 I wrote a Cancer
Chronicles editorial, "Please, Senator Harkin!" Until that point, I had been
fairly muted in my own criticism of Jacobs and the office. But I had printed
a transcript of the Hearing in the Chronicles and distributed this to Advisory
I now had heard a rumor from a government employee that Jacobs was planning
to remove my name and that of Bedell, Hildenbrand and Wiewel) from the list
of nominees for the advisory council. Understandably, I decided to pull out
the stops. "The Office of Alternative Medicine is adrift," I publicly wrote
Senator Harkin. "There is no longer an advisory board. Please help get this
[Program] Advisory Council approved. Please act now to revitalize the
OAM, or it may soon exist in name alone." From Jacobs' point of view,
a group of outside meddlers were trying to tell him how to run his office.
From our point of view, the office belonged to the people, and especially
of those who had fought against overwhelming odds for the fair evaluation
of alternative methods.
Jabobs overreached in trying to eliminate his critics from the board. For
it was he, and not what he called the "gang of four," who were about to leave
the scene. On May 17, 1994, HHS Secretary Donna Shalala finally made her
appointments to the 18-member panel, with terms randomly assigned from one
to four years. The proposed board included all four of the disputed members.
And immediately thereafter, Dr. Jacobs informed colleagues that he was
resigning effective the end of September, 1994.
As Science magazine noted, Jacobs" decision to leave was precipitated by
his objection to having certain individuals included on the permanent advisory
board to his office (July 15, 1994). In a follow-up article, Science confirmed
that Jacobs had indeed fought to keep us off the permanent board and then,
when he came to believe "that the top NIH staff would go along with demands
from Harkin"s office and include on the list of candidate advisors [the]
four activists picked by Harkin," he resigned (September 30, 1994).
"Jacobs ran afoul of the activists who lobbied to create the alternative
medicine program," said Science (ibid.). The magazine quoted me as saying
that Jacobs had "acrimonious dealing" with some board members "over priorities
of research." These advisors, Science explained, "wanted Jacobs to devote
more time and money to investigating controversial therapiesäa topic
that Jacobs included under duress in the first round of research awards.
"Moss argues [that] the NIH office has chosen to research "soft" topics less
likely to offend the biomedical establishment."
This was followed by a long article in the New York Times. Natalie Angier
reported on the "acrimony and disgruntlement" in the new office. She quoted
me as saying, "I"m happy about his resignation. He seemed very uncomfortable
with the job, and I wasn"t happy with the direction of the office. I see
it from the point of view of NIH wanting to do things the way NIH usually
But the fight was not over. Jacobs used the occasion of the second major
story in Science (September 30, 1994) to go out with a blast at Senator Harkin
and what he now called "the Harkinites." He claimed we four were guilty of
"pressuring his office, promoting certain therapies, and attempting an end
run around objective science."
Science also claimed that "Jacobs" fears that the office would be forced
to conduct field studies have been borne out." An interesting choice of
wordsãare field studies something to be "feared"? There followed an
interregnum period, in which an Acting Director, Alan Trachtenberg, M.D.,
a long-time NIH employee, managed to keep the office together under extremely
trying circumstances. Then, in February, 1995 NIH announced the appointment
of a new permanent director, Lt. Col. Wayne Jonas, M.D.
Dr. Jonas was head of the fellowship training program at the Walter Reed
Institute of Research in Washington, D.C. He is considered an expert on research
methodology, but also had long-term interests in various alternative medicine
techniques, such as homeopathy, electroacupuncture, nutrition, qigong, and
In The Cancer Chronicles, I noted that most people in the alternative community
were genuinely happy with the appointment, which was approved by Harold Varmus,
M.D., NIH Director, and his powerful deputy, Ruth L. Kirschstein, M.D., who
had taken a personal interest in the direction of the office. However, in
print I myself greeted Dr. Jonas's appointment with what I called "guarded
Why guarded? I liked Dr. Jonas personally, but having just been through a
bruising struggle with Dr. Jacobs I wondered aloud "if Wayne will be able
to do what his predecessors were unable to do." I did call on the alternative
community to give him "all the support they can muster" to fight against
the enemies of the office. (I was thinking of the quackbusters, whose attacks
had steeped up around this time.)
In effect, I declared a personal moratorium on criticism, since I
felt that Dr. Jonas deserved a chance to salvage the office and implement
his own vision of its future. In my opinion, this has been a wise policy.
Bedell still feels the office has essentially failed to carry out its mandate
to do field research. But no one doubts that Jonas has done a brilliant job
at rescuing and reorganizing the office, articulating a coherent set of
priorities, and establishing extremely cordial relationships with both the
conventional and the alternative medical communities. He now has the support
of virtually all members of the Advisory Council. It has been an amazing
Of course, that does not mean that all problems have been resolved--far from
it. But at least that most valuable of all assets, trust, has been established,
and there is a coherent strategy for doing both the kind of field research
Bedell and others want and the more academic studies favored by many members
of the board.
One answer has been to fund centers of alternative medicine at leading medical
centers in the country (a program that began before Jonas came aboard). At
this writing, such centers have been initiated at Columbia-Presbyterian,
Harvard University, Stanford University, and the University of Maryland,
to name a few. NIH has even given a grant to Bastyr University, a fully
accredited naturopathic institution in Seattle. And at the University of
Texas a special center has been created to study alternative treatments
specifically for cancer.
In 1992, the OAM received $2.2 million. In 1996, the initial problems resolved,
Congress awarded the office an unprecedented $7.5 million. This came at a
time of severe budget cuts. This fact alone is an indication of the faith
that the Congress and the American public place in the enormous potential
of alternative treatments. And with growing national recognition of the failure
of the conventional war on cancer, hopes will increasingly turn towards those
techniques that have been scorned as "unproven" by an ossified cancer
establishment. It is my dream that this small office, which grew out of the
political struggle, can fulfill a huge mission. The NCI has simply abrogated
its responsibility to vigorously investigate all new leads in the fight against
Responsibility for this huge area has fallen on the shoulders of this
tiny office, which can make history if it can validate even a single new
approach to the cancer problem. It deserves the vigorous and enthusiastic
support of the Congress and of all citizens who want to see an end to the
scourge of cancer.
The Cancer Industry Introduction:
1. Intro | 2. OTA Study
Pt. 1 | 2a. OTA Study Pt. 2 | 3. Office
of Alternative Medicine | 4. Underlying Problems
| 5. Role of FDA
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