History of the U.S. Food and Drug Administration Interviewee: Mervin Shumate Interviewer: Ronald T. Ottes Date: March 11, 1987 Place: Rockville, MD DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service _________________________________________________________________________________________________________________________ Food and Drug Administration Silver Spring, MD 20903 CASSETTE NUMBERS GENERAL TOPIC OF INTERVIEW: History of the Food and Drug Administration DATE: March 11, 1987 PLACE: Rockville, MD LENGTH: Information not provided INTERVIEWEE: INTERVIEWER(S): NAME: Mervin Shumate NAME: Ronald T. Ottes ADDRESS: N/A ADDRESS: Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 FDA SERVICE DATES: FROM: 1955 TO: 1986 TITLE: Director, Office of Enforcement, Office of Regulatory Affairs INDEX Page Subject 1 Shumate Background 2 Joined FDA at Minneapolis District as an Inspector 2 Salk Vaccine 5 Initial Training 7 Filth work, Everett Atkinson 18 Grain elevators, Cheese factories 21 Clean Grain Program 29 Over-the-Counter (OTC) Drug Store investigations 35 Public Eating Place (PEP) program 33 Opening of the Detroit District 40 Poultry Inspection Act 45 George Daughters 55 Detroit College of Law 56 Transfer to Charleston, WV Resident Post 59 Undercover over-the-counter (OTC) investigations 63 Bennies (amphetamines) 68 Ed Wilkens 81 Congressman Harley Orrin Staggers (West Virginia) 83 Transfer to Buffalo District as a Compliance Officer 94 H.P. Hood-Salmonella-Non Fat Dry Milk, District Director, Retzlaff 96 Cargill Terminal Elevator 102 Sterling Drug Page Subject 102 Warning letters, Regulatory letters 106 Transfer to Detroit District as Food & Drug Officer 110 Hazardous Substances Act 120 Coho Salmon 122 Executive Development Program 127 Winton Rankin 130 Cyclamates – Commissioner Ley 132 Secretary Robert Finch 133 Kinslow Report 133 Commissioner Edwards 136 Intensified Drug Inspection Program (IDIP) 139 Special Assistant to Paul Hile 143 Special Assistant to Dr. John Jennings 147 Drug Safety & Efficacy 154 Chief Food & Drug Officer, Bureau of Drugs (“Discipline Officer”) 161 Commissioner Edwards 163 Bob Bartz, Dick Terselic 163 Reorganizing Bureau of Drugs Staff 164 Drug Efficacy Study Implementation (DESI) 166 Diethylstilbesterol (DES) 166 Adrian Gross 171 Dr. Frances Kelsey 172 Methotrexate 176 Methadone 184 Peter Hutt, General Counsel 185 Dr. Crout, Director, Bureau of Drugs 188 Ted Byers 192 HHS Task Force – Mental Health 192 Drug and Alcohol Abuse Program 196 Dr. John Nestor 202 Dr. Gyarfas 205 Sam Fine, Associate Commissioner for Compliance 205 Director, Regulatory Management Staff 212 Processing cases sent to General Counsel from Bureaus and the Field 216 Billy Goodrich, Al Gottlieb 222 Richard Merrill, General Counsel 227 Searle Task Force, Aldactone, Carl Sharp 232 Jerry Halperin 239 Dr. Finkel 246 Methadone case against Washington, DC 249 Baxter Travenol Agreement 252 Park II – Strict Liability 257 Paul Hile, Associate Commissioner for Compliance 268 Search Warrants 270 Richard (Rich) Cooper – General Counsel 275 Geatrichum Mold – Green Beans 280 Diethylstilbesterol (DES) – Texas Cattle Ranch 281 Nancy Buc – General Counsel 297 DES in veal calves in NY State 304 Various Chief Counsels 319 Mrs. Pauls Fish Cakes 325 Processing Cases – working with Dept. of Justice’s Civil Division 326 Steroid use and distribution, Herbalife 333 Tom Scarlett, General Counsel, processing cases, Pat Glyn Page Subject 341 Richmond Plasma Case 341 Ovulen 355 Counterfeit steroids 361 Rely Tampons, Toxic Shock Syndrome (TSS) 368 More on Nancy Buc 368 Consent Agreement 375 Travenol 378 C. McClain Haddow 381 Politicization of FDA 386 Deputy Commissioner, John Norris 386 More on Herbalife 391 More on Haddow 415 Senator Hatch, Nature’s Way 418 SES bonuses 424 Wrap-up Interview with Mervin Shumate March 11, 1987 RO: This is another in the series of FDA oral history recordings. Today we are interviewing Mervin H. Shumate, retired director of the Office of Enforcement in the Office of Regulatory Affairs. The recording is being made in the Parklawn Building, Rockville, Maryland, and the date is March 11, 1987. I’m Ronald T. Ottes. Merv, we’d like to start by asking you to give us a brief resume of your career, starting back as far as you want to go, and bringing us up into the FDA; and, along the way, bringing up some of the interesting and important incidents that happened in your career. MS: Thank you, Ron. I was born on a dairy farm in Richland County, Wisconsin, on November 10, 1930. I was one of a pair of twins that were born, and it was quite a shock to my parents because, of course, it was at the time of the Depression, and my parents had not expected to have any children, let alone twins, at that particular time. However, my dad was extremely proud of having twins, and certainly let everybody know far and wide that he had a pair of twins (laughter). We were raised there in Richland County, Wisconsin, and then continued through grade schools 1 and on into Blue River High School, which is at Blue River, Wisconsin, and graduated from there in 1948. I then went on to the University of Wisconsin at Platteville, Wisconsin, and studied agriculture, thinking that I would be an agriculture instructor in a high school. In the height of the Korean War, the draft was very much of concern, and we received our notices in our junior year and promptly went off and enlisted in the air force to avoid the infantry, and served four years in the air force, getting out in October of 1954, and then finishing college and graduating in 1955. I then entered the Food and Drug Administration at s in September of 1955 as an inspector. On the day that I was hired, another inspector was hired as well, and he was hired exclusively for the purpose of being a Salk vaccine inspector. I was hired as a general inspector. However, I spent almost the first year exclusively investigating Salk polio vaccine to make certain that it was not diverted into the black market. The Congress had specifically directed the Food and Drug Administration to see that its distribution was controlled. This was an extremely difficult experience for me, coming off of the farm, coming right out of college, not having any experience in the business world. It was one 2 very difficult job, in that I would have to visit from ten to twenty different pharmacies, doctors’ offices, wholesale and retail drug companies to check the inventory right on down. We would have copies of invoices from the major manufacturers and we would have to verify it right on down to the physician. Physicians, particularly, were extremely abusive to young investigators because they seemed to just have a very intense dislike for government agents generally. And specifically they could see no reason whatsoever for the federal government to be sending somebody out to their busy practice to be checking something like this. They just didn’t see any sense in that at all. Well, usually when they would get abusive or obnoxious, it would be in the presence of an office full of patients, and this was just excruciatingly difficult for me. However, I learned pretty soon how to cope with that, and the way I did is that I would try my very best to be as polite and as professional as I could be in responding to them, no matter how difficult they were. I would always say the Congress had passed this law and that we were simply carrying the congressional wishes; and if they had any complaints, they should write to their congressman, that I didn’t particularly like the job any better than 3 they did, but that we were doing this, really, for their best interest. We were trying to make sure that the products they had were quality. I would usually say this in the most official manner that I could in front of all these patients, and then I would promptly depart. But at the end of a day, I would just feel like, “What in the world have I got into that I have to be putting up with this kind of stuff?” I remember one other incident that might be of some significance. It was a pharmacy in a very small town in eastern Iowa. It was a rainy, cold day, and the drugstore was full of farmers that were there for coffee, I guess. And I walked in to check the Salk polio vaccine, and as soon as I introduced myself and showed my credentials, the pharmacist just went berserk. He had on kind of a baseball hat, and he took it off and threw that thing across the place and let out a few expletives as to why was the federal government out here wasting their time on this kind of thing. I just, as I had in physicians’ offices, simply responded as professionally as I could, but I remember when I left that drugstore . I was only thirty or forty miles away from my home town just across in Wisconsin, and I was extremely tempted to just check right on off over there and say, “You can take this job and shove it” 4 (laughter). Of course, I didn’t know that song in those days, but it was perfectly appropriate. RO: Merv, when you came in, what kind of training did you get? Were you put right on the street checking this? MS: Yes, we were put right out there. The only training we had was very little on-the-job training. you could say, but really hardly any training in this. And that’s what made it so difficult. It was extremely intimidating, because you really weren’t trained in how to cope with this kind of adversity.