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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 1 :i 0