HomeMy WebLinkAboutCOMM - Meeting Minutes - 4-P - 4-19-1972 - PRISON BOARD�h, SQ,U Sc44,0 SALARY MINUTE BOOK 31- 7
BOARD OF COUNTY COMMISSIONERS WASHINGTON COUNTY, PENNSYLVANIA
MICHAEL R. FLYNN, JOHN P. BEVEC. JOHN MAZZA, COMMISSIONERS
We find that the overall conditions of the Jail to be in excellent condition and we
commend the Warden and his staff for the efficient management of the facility with particular
emphasis on the cleanliness of the Jail.
Respectfully submitted,
Michael R. Flynn
Frank Jones, Jr.
Minute No. 4-P
Office of the County Commissioners
Washington, Pa., April 19, 1972
The Prison Board of the County of Washington met in the Commissioners'
Conference Room at 11:30 a, m., Wednesday, April 19, 1972, with the following members
being present: District Attorney Costa; Judge Curran; Commissioner Flynn; Commissioner
Jones; Judge Marino; Commissioner Paluso; and Judge Gladden. Absent being: Sheriff
Debreczeni; Judge DiSalle; and Judge Sweet. Also present being: Warden Roupe; Chief
Clerk Murphy; Solicitor Capano; Administrative- Assistant'Whalen;--Deputy Controller Gilbert;
Reporter Roule of the Monongahela Publishing Company; Mr. James P. Maloney; and Dr.
W. L. Wilson.
Meeting called to order by Chairman.
Chairman asked if there were any corrections, additions, or omissions to
Minute No. 3-P dated March 15, 1972, each member of the board having received a copy.
Being none, the minutes will stand approved, as circulated.
WARDEN'S REPORT:
Warden Roupe reported that two guards were sent to correctional -training
school in Monroeville this week. Plans are being made to shut off the heat in the prison this
Friday. This is being done while the contract work is being done; hopefully this work should
be completed by fall when more heat is needed. The contractor will furnish portable heaters
when needed.
Mr. James P. Maloney and W. L. Wilson, M. D. , representatives of Drug
Research Associates presented a proposal for the Prison Board's consideration that Drug
Research Associates be permitted to conduct drug studies in the Washington County Jail.
(Mr. Elish entered the meeting).
&4/z,J SALARY MINUTE B❑❑K
BOARD OF COUNTY COMMISSIONERS WASHINGTON COUNTY, PENNSYLVANIA
MICHAEL R. FLYNN, JOHN P. BEVEC, JOHN MAZZA, COMMISSIONERS
This proposal contains a sample consent form to be filled out by prisoners. Copy of said pro-
posal made a part of the record on Page 2-A.
Judge Gladden appointed a committee consisting of Commissioner Paluso, Judge
DiSalle and Warden Roupe, to sit with Mr. Capano and the two representatives of Drug Research
Associates, Mr. Maloney and Dr. Wilson and bring back a report on their discussion and find-
ings for the May Prison Board Meeting. This report would be to consider the various aspects
brought up and act on them.
Questions were asked of Mr. Maloney and Dr. Wilson by the members of the board,
Judge Marino asked whose responsibility it is to see to the administration of drugs. He was
told that there would be a physician responsible to Drug Research Associates available, who
would use lab technicians or other personnel when needed There is an option where a prison
p hysician can sub in the position. But this is up to the County. Judge Marino asked if they
ever had more than one study going on at the same time and would the physician have to appear
on more than one occassion at a particular time. He was told that this was very likely, Dr.
Wilson said that the only problem would be with intra-muscular injections. Most of the medi-
cations are taken orally and there aren't many problems. Dr. Wilson said that he is hoping to
have a local physician enter into the program with us and that he also has an associate. Mr.
Paluso asked if all these things would be done within the physical confines of the prison. Dr.
Wilson said yes, that they would try to do things at the prison dispensary.
Four different protocols that have already been completed in prisons in Western
Pennsylvania were presented and explained. The question also arised that we would like to
have a sample of the contract or agreement previously used by Drug Research. Associates -with
other institutions.
PAGE 2-A April 12, 1972
Members of the Prison Board
of the Washington County Jail
Washington, Pennsylvania 15301
Gentlemen:
We would like to submit this proposal for your consideration that Drug Research Associates,
97 Fort Couch Road, Pittsburgh, Pa., 15241 be permitted to conduct drug studies in the Wash-
ington County Jail. These studies would be sponsored by the medical departments of pharma-
ceutical companies in compliance with the regulations of the Food and Drug Asministration as
well as any regulations of the Commonwealth of Pennsylvania, and of your board. They would
include drugs already on the market as well as investigational drugs.
The prisoners under your care would be contacted, in a manner agreelble to you, to solicit
their participation in these studies. First and foremost, the rights and welfare of these volun-
teer subjects would always be the first consideration in any study. Informed consent of these
volunteers would be obtained after a thorough explanation of the purpose of a study ( a sample
informed consent form is enclosed). Financial remuneration would be paid to each volunteer
subject for participating in a study by Drug Research Associates. We are presently preparing
a form which obliges Drug Research Associates to pay a set amount for each blood sample or
procedure the volunteer agrees to. This form would be signed by the volunteer subject and an
Ll
MIsoN &,gedSALARY
BOARD OF COUNTY COMMISSIONERS
MINUTE BOOK 319
WASHINGTON COUNTY, PENNSYLVANIA
MICHAEL R. FLYNN, JOHN P. BEVEC, JOHN MAZZA, COMMISSIONERS
1
official of Drug Research Associates, Participation is any study is always a voluntary matter
for each prisoner.
No matter what the medical procedure there is always some element of risk. All necessary
equipment and drugs to cope with medical emergencies would be provided by Drug Research
Associates and kept permanently in the place in your jail where the studies would be conducted.
Necessary medical and para-medical personnel and all supplies for a study would be supplied
by Drug Research Associates. When laboratory tests are required, we would utilite one of the
competent clinical laboratores in the area for these tests.
Depending on whether your policy permits it, guards may be used for obvious normal purposes
during a study during their off -duty hours. If this procedure is agreeable to you, remuneration
would be provided by Drug Research Associates. Any other procedure preferred by this board
would be followed.
The necessary insurance for liability would be secured and paid for by Drug Research Associat-:s.
It is important to note that study protocols from the sponsoring companies will have been re-
viewed by the Food and Drug Administration prior to our receiving them. They would then be
submitted to an "institutional review committee, " which should include lawyers, clergymen or
laymen as well as scientists, to assure complete and adequate review of the research project.
(Federal Register of March 17, 1971, enclosed. ) This committee would usually meet once a
month to review and recommend on research projects. All this is designed to safeguard the
volunteer subjects and provide ethical, moral, scientific and legal review of these research
projects.
The type of studies we have in mind do not include the treatment of sick patients. Instead we
are interested in absorption and excretion studies, that require blood or urine collection; bio-
availability studies that compare blood levels of marketed drugs with blood levels achieved
with the same drug formulation by the same manufacturer at an earlier time, or compared to
more than one manufacturer of the same drug; local tolerance studies to assess the degree of
pain produced by an injectable drug studies by itself or compared to another drug; short and
long term safety studies are also anticipated. I am enclosing four typical study protocols and
a description of these studies. All four of these studies have already been conducted in prisons
in eastern Pennsylvania,
ITEM I - is a comparative absorption study between Bristamycin Tablets (crythromycin stearate)
manufactured by Bristol Laboratories and Brythrocin Tablets (erythromycin stearate) manufac-
tured by Abbott Laboratories. The purpose was to compare serum levels of Bristamycin,
against Erythrocin, which the Food and Drug Administration considered to be the standard.
ITEM II - was a single nose blood level study. It is part of a bio-availabilityprogram that
selects various lots of marketed antibiotics to determine whether the serum levels obtained
with a drug are consistent with the levels the drug is expected to achieve. Four blood samplings
(10 ml of blood per sample) are taken from each subject, the first at zero hour when the medi-
cation is administered and the other three at varying times up to six hours after administration
of medication. Another example of this same type of study is enclosed in ITEM III.
ITEM IV - was a local tolerance study between a marketed cephalosporin antibiotic (Keflin,
Eli Lilly and Company) and an investigational cephalosporin antibiotic, designated as BL-P1322,
sponsored by Bristol Laboratories, A single intramuscular injection of Keflin was given in one
buttocks, and a similar injection of BL-P1322 in the other buttocks, to 25 subjects. The sub-
ject was interviewed for pain evaluation at 1-5 minutes, 30 minutes and 4 hours after injection.
Another group of 25 received the same two drugs in the same manner, but this group received
BL-P1322 with Lidocaine (a local anesthetic). Pain evaluations were conducted at the same
times as the first group.
The officers of Drug Research Associates are W. L. Wilson, M. D. and myself. Dr. Wilson
has offices at 97 Fort Couch Road, Pittsburgh 15241. He has been in the practice of internal
medicine in Pittsburgh since 1965. Prior to that he was a staff physician in the medical depart-
ment of Wyeth Laboratories, Philadelphia, Pa.
My experience in the pharmaceutical industry covers twenty-one years with Wyeth Laboratories
and Bristol Laboratories, Syracuse, New York.
I hope this proposal covers the basic points in explaining our program.
Sincerely yours,
James P. Maloney
W. L. Wilson, M. D.
�,SoN gofi,e,D SALARY M I N U T E B O O K
BOARD OF COUNTY COMMISSIONERS WASHINGTON COUNTY, PENNSYL,VANIA
MICHAEL R. FLYNN, JOHN P. BEVEC, JOHN MAZZA, COMMISSIONERS
DRUG RESEARCH ASSOCIATES
97 FORT COUCH ROAD
PITTSBURGH, PENNSYLVANIA
15241
EXPERIMENT DATE , 19
INFORMED CONSENT
PERMISSION TO PERFORM TESTS
I, the undersigned do hereby volunteer to participate in this test, and give my
permission to DRUG RESEARCH ASSOCIATES, to their officers, to their employees, to the
clinical laboratories designated by them, and to all others associated with them in conducting
this study, to perform medical and other tests on me. I have volunteered of my own free will
and accord as a subject to participate in these research investigations. I aver that I am over
21 years of age; that the purpose of the research, experiment and study has been explained to
me and that I understand that there are risks involved, In consideration of the remunceration
paid to me for my participation in these tests, I fully and completely release the parties per-
forming such studies of any and all claims and responsibility as to any compensation, or effect 3
of said experiments, studies and research.
signed
REGISTER NUMBER:
WITNESS:
Prison Bills for the Month of March 1972:
Prison bills for the month of March 1972 were read by Deputy Controller Gilbert
in the amount of $4, 038, 11 (2319 Prison Days) a list of said bills attached hereto and made a
part hereof.
payment.
Moved by Mr. Jones, seconded by Mr. Elish, that the bills be approved for
Motion carried by unanimous vote cast by the Board, signifying their approval
verbally by stating "Aye. "
Meeting adjourned.
THE FOREGOING MINUTE READ AND APPROVED:
ATTEST:
SECRETARY
, 1972
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