December 15, 1988 Author:
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF HAWAII
CIVIL NO. 87-8232
a division of Miles Laboratories, Inc.,
AFFIDAVIT OF THOMAS DREES
OF LOS ANGELES
Comes now Thomas Drees, being first duly sworn on oath, deposes and
says as follows:
He has been retained as an expert witness in the case of John Doe v.
Cutter, et. al.
He is an expert in the area of the manufacturing, marketing,
safety, supply, and processing of blood products. He was the Chief
Executive Officer of Alpha Therapeutics, one of the Defendants in this
case from 1978 to November, 1983.
He has reviewed the documents supplied to him by Plaintiffís
counsel, Mr. Kozak.
He has come to the conclusion based upon the documents reviewed,
the expertise he has acquired from his experience in the blood products
industry and his research in the field that the Defendants in this case
failed to act reasonable and prudently in the manufacture of Factor 8 and
further, that said failure resulted in the infection of Ken Binkley with
Cutter, Alpha, Armour and Baxter failed to develop heat treated
Factor 8 in a timely manner given the technology available in the 1970s
and 1980-1981. Alpha was able to develop heat treated Factor 8 in six
months, once I was aware of the urgency of the pasteurization process in
late 1982. However, the other fractionators were much farther along in the
development process, particularly Cutter and Baxter. Cutter was owned by a
German Co., Bayer and could not fail to be aware of the German pasteurized
Factor 8 which was available on the German market in 1976. Yet, they
failed to obtain a license for their pasteurized Factor 8 until February,
1984. Likewise, the other fractionators took much too long to develop
their pasteurized products in view of the urgency of preventing the spread
of Hepatitis B and NonA, NonB which was killing many Hemophiliacs per
year. The feasibility of using heat to inactivate viruses was known to the
industry in the early 1970s. I personally attended a meeting in August of
1982 where a paper was presented which detailed the process for
pasteurizing Factor 8. There is no reason for the Defendants to not have
had pasteurized product on the market by 1980 had reasonable and prudent
research and development been used by the Defendants.
In November of 1982, I attended a meeting of ABRA which was held in
Anaheim, California. A concurrent meeting of the AABB was held at the same
site on the same dates as is usually the custom in the blood industry. At
the meeting I heard a presentation of Dr. Bruce Evatt of the CDC in which
he describe the AIDs epidemiology. I was shocked and horrified. I was also
very surprised that no one had informed me of this terrible disease and
its relationship to the blood industry before the meeting. No other
representatives at the meeting seemed surprised or motivated to take any
immediate action. Further, the members of the AABB informed us that they
did not care to hear what Dr. Evatt had to say regarding anything about
the new epidemic. So far as I know, Dr. Evatt went home to Atlanta without
even addressing the AABB meeting.
In December of 1982 and January of 1983, I attended meetings of the
BPAC and CDC in Bethesda, Maryland and Atlanta, Georgia, respectively. At
these meetings the following points were made very clear:
AIDS was most likely caused by an "unknown transmissible
agent" similar to Hepatitis B and NonA, NonB.
The "high risk groups" who sere at risk for the
transmission of this disease were the same carriers for Hepatitis,
specifically, homosexuals, IV drug abusers, and Haitians.
There was at least a 88% correlation between positivity for the HB
Core Antibody and those infected with AIDS up to that point in time.
I immediately directed our plasma collection centers to desist
taking any plasma from high risk donors and to screen as vigorously as
possible for these high risk groups. These directives went into effect on
December 26, 1982.
The other fractionators dragged their feet on instituting donor
screening and did not completely institute screening for the most serious
high risk donor, i.e., homosexuals, until March or April, 1983.
To a very large degree, the safety standards in the fractionator
industry are influenced by the ABRA of which all fractionators were
members from 1980 to 1985. The four fractionator defendants in this case
produce virtually all the Factor 8 produced in this country. This is a
very large and lucrative business with substantial sales overseas. In my
work for the Office of Technology Assessment, we compiled sales figures
for the amount of sales by the industry as of 1985 on an annual basis.
Sales at that time in the marketing of Albumin and Factor 8 alone totalled
1.2 billion dollars among the four Defendants. Half of these sales were
the result of overseas transactions.
I was severely criticized by my competitors for taking the
immediate actions that I did regarding screening for high risk donors.
Further, my superiors at Alpha were highly critical of my action. It is my
firm belief that the actions I took in late 1982 in good conscience to
protect the public from the AIDS virus were in large part the reason for
my being terminated from Alpha as itís CEO in November 1983.
Although I was not aware of the goings on at various meetings that
were attended by my subordinates of the BPAC, NIH, CDC, ABRA, NHF and AABB,
specifically Penny Carr, our regulatory representative, it is now apparent
to me after reviewing the documents in this case that there was a
"conspiracy" at work among the various fractionators to avoid
using the surrogate test known as the HB Core Antibody Test. I was not
aware of this even at the time of my deposition, July 1988. Had I been
properly advised by my medical advisors at Alpha regarding the
correlations between HB and NonA NonB, I would have implemented the HB
Antibody Test at the same time I began using the screening for high risk
ggroups at our donor centers (December 26, 1982).
Recently, counsel has provided me with further documents which
indicate to me that the fractionators in conjunction with Dennis Donohue
of the FDA and the AABB and ARC conspired to prevent the use of the HB
Core Test from being implemented as the standard of care. They did this to
prevent having to incur the expense of the test, and to avoid having to
reject donors who were positive for the test. Of course, this needed to be
done in any event to comply with FDA regulations which required that only
normal, healthy donors be used as donors. Persons who have a history of
viral Hepatitis are not considered "Normal healthy donors" as
evidenced by the fact that every donor is asked if he has ever had
hepatitis before being allowed to donate or sell his blood or plasma. If
he answers in the affirmative he is permanently rejected as a blood donor.
A positive test result for the HB Core Antibody is tantamount to the
finding of a history of viral hepatitis.
I have long been a strong advocate of the "paid for"
plasma system in the U.S.A. because I do not see any other way to supply
the nationís Hemophiliacs with the clotting factor they need. Further,
we can obtain a consistent medical history since the donors are repeated
so regularly. However, I was never aware of the effect of failing to use
the HB Core test until this litigation. I had always assumed that the
industry would use those tests available to insure that the highest
standards of care were being realized in the fractionation industry. It is
now clear to me that the HB Core Test should have been used from the time
it became available through Abbott Laboratories in 1975. If it had been
used from 1975, countless deaths from HB and NonA, NonB would have been
avoided. Further, Ken Binkley and thousands of other Hemophiliacs would
not have AIDS today, as this disease would have never been allowed into
the blood supply in any great degree.
The fact that there was such resistance to the use of the HB Anti
Core Test by the blood industry, and the blood industries resistance to
take the most obvious and needed precautions to the AIDS epidemic
convinces me that there was a concerted effort by the influential leaders
of the blood industry to save dollars at the expense of lives, even when
it was clear beyond any doubt that there was widespread contamination of
the blood supply in November, 1982.
Further affiant sayeth naught.
[Signed: Thomas C.
THOMAS C. DREES
Subscribed and sworn to before me
this 15th day of December, 1988.
[Signed: Angela R.
Notary Public, State of California
My commission expires: July 26, 1991
Not for commercial use. Solely to be used for the educational purposes
of research and open discussion.