Government Reform and Oversight Committee
February 4, 1998
Mr. Arnold Eggers, MD
Mr. Chairman and Members of the Committee:
I have worked for the past twenty-five years, with some interruptions,
on a study of tumor immunology with a view to developing a
vaccine treatment for cancer.
I began this project as a medical student at Columbia University,
took residency training at New York Hospital, which is Cornell
University, and at the Hospital of the University of Pennsylvania,
went to NIH in the National Cancer institute for three years,
came back to Columbia to finish residency, and have worked
as an attending first at Columbia and now at SUNY-Health Science
Center at Brooklyn.
The purpose of describing my training is to emphasize that
I have good academic credentials and that this is my life's
work. It is a long-term commitment to one idea: reproducing
the spontaneous remissions which are sometimes seen in cancer
patients following bacterial infections. My vaccine is a kind
of non-toxic immune stimulation. The final version of the
vaccine treatment produced the results which you see before
you. Three out of four brain cancer patients who received
the final version of the treatment went into remission.
Out of 180 injections of this and previous versions of the
vaccine there was only patient with aside-effect--one case
of an allergic reaction which was not fatal. Now the man in
the street might say that this looks like a promising new
treatment which should be supported by our government in the
war on cancer, but the man in the street does not know how
the system works. Having already received approval from the
FDA in 1989 to treat brain cancer patients, I applied in 1994
for permission to treat other kinds of solid tumors as well
and was put on clinical hold. It is now almost four years
later, the clinical hold is still in effect, and we are still
dialoguing. Most of this time has been spent discussing technical
minutiae. The [DA inspected my records and issued a warning
letter which said "deviations in the conduct of this study
appear to be the result of your lack of understanding of the
procedures and requirements that govern the use of investigational
new drugs."
It is important to emphasize that their citations were in
general appropriate and correct from their point of view.
They found valid deviations from the rules. Just to give one
example, they cited me for incorrect patient consent forms.
It turns out there are seventeen elements of informed consent
which require one and a half pages of small print just to
list. My consent forms, although approved by the local hospital
ethics committee, constituted a violation of statutory law.
As you know, the FDA has sent at least sixteen people to federal
penitentiary in the last ten years for violations of their
rules, which have the power of statutory law. I appealed to
an ombudsperson at the FDA. She told me that if I wanted to
have any hope of meeting regulatory requirements, I needed
to hire a professional FDA consultant, one ofthe people drug
companies hire to interface with the FDA. This is way beyond
my means financially.
In all of this, no one has acted with malice. On one side
you have a university scientist approaching the regulatory
process with good will and on the other side professional
bureaucrats approaching their jobs with goodwill. Yet between
us we could not make the system work in four years. The man
in the street might want to know what went wrong. I think
the problem lies with the system and not with individual bureaucrats,
who are only doing their job, and in most cases doing it well.
As everyone knows, the FDA was established in its current
form by the Kefauver-Harris Drug Amendment in 1962 as a response
to the thalidomide tragedy in Europe, in which 2000-3000 mothers
who took this particular sleeping pill gave birth to children
with serious birth defects. An FDA employee, Frances Kelsey,
became a national hero by blocking legal entry of the drug
into the US. It is important to note that the drug was a sleeping
pill, and no one dies from insomnia. The mistake in thinking
behind Kefauver-Harris is that it fails to distinguish between
fatal and non-fatal diseases. In the case of non-fatal diseases
like insomnia or acne, you want to protect people from unnecessary
side-effects.
This was what thalidomide was about. In the case of fatal
diseases like cancer, the situation is more complicated. In
deciding if government regulation is worthwhile, you have
to compare the number of people who die from toxic side-effects
of inadequately-screened new medicines with the number of
people who die waiting for the release of successful new medicines.
The bureaucratic process saves lives on the one hand by screening
for toxicity but takes lives on the other hand by delaying
access to treatment.
Cancer kills 500,000 people a year in the U.S. A one-year
bureaucratic delay in releasing a cure for cancer would necessarily
kill 500,000 people. These are the people who would still
be alive if the government hadn't blocked their access to
treatment in their lifetime. These days, toxic side effects
of drugs are quickly discovered and publicized, or else extremely
rare, and it is inconceivable that 500,000 people could be
killed by a dangerous new treatment before the alarm was called.
I believe this arithmetic or statistical argument shows the
error of the current system, which guarantees that there will
be a vast unnecessary loss of life if ever cancer is cured.
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