Highlights from the FDA Oral History Project | KCET
Highlights from the FDA Oral History Project
Since the 1970s, the FDA has been conducting interviews with former workers, collecting about 150 interview transcripts in the process. As the website puts it, "[t]he resulting dialogues provide personal perspectives on FDA policy, discussion of key regulatory events in FDA's history, and offer candid evaluations of top-level FDA and HHS managers--insights that might not easily be discerned from the official records of the time."
What the website doesn't say is that within each one of these interviews is at least one perfect golden nugget of amazingness. I've spent the past few nights sifting through them, panning for gold in a way, and here are the highlights I've found.
The Pepsi Cola prosecution was an unusual one in that Pepsi Cola being a very large corporation was generally uncooperative. We had the highest incidence of complaints of foreign material in their bottled products of any firm in the St. Louis District. It was mostly foreign objects such as cigarette butts, candy wrappers, and other nondescript filth. When I was given the assignment I was told that better inspectors than I had been to the plant many times and had never been able to develop a case, such that we could take legal action. I was given the assignment and told to take along again some new inspectors. My assignment was to determine if we could find out where and why the problems were occurring and that I was not limited to one day inspections as others had been. I conducted the inspection covering two and three different shifts and we determined that their electric eye and their inspectors both did not check all of the bottles as they were supposed to be doing. Their sodium hydroxide or caustic soda equipment was not functioning all the time and thus their bottles were not being cleaned. Their magic eye did not reject bottles that contained foreign material.
One time Mr. Lambert came to see me. He was the Listerine man, you know. But he was a very nice person, and we had a conversation which I have never forgotten. He said, "What have you got against Listerine?" And I said, "I didn't know Listerine was caught in this." And I said, "What's the matter? Is Listerine poisonous?" He said, "Why, no, of course it isn't poisonous." But he said that "maybe it doesn't do exactly what we claim it does." And I said, "Well, can't you modify your claims some?" And I said, "As far as I'm concerned, I don't have anything against Listerine except I think it costs too much for even what you claim it does." He said, "Well, Mr. Tugwell, you just published a book and I believe it sells for four dollars." He said, "Do you think it's worth it?" This was a poser. So I've always remembered this conversation.
They had an interesting hazing procedure for new analysts there. Maybe they'd designed it just for us. I'm not sure. But they made sure that each of us went through the experience. They had some small Nigerian chilies that were imported, little red balls about the size of a cherry. They were the hottest things I had ever run across. The procedure was that you had to examine these chilies individually under a wide-angle microscope to determine whether or not they were insect infested or moldy. They had you operate under a hood, which should have been a clue to any new person, but it generally wasn't. Everybody stood around and waited for you to go to the bathroom, because it wasn't until after you went to the bathroom that they told you you should wash your hands in alcohol before you go to the bathroom. Everybody had to go through that experience.
I had another one that I inspected down in Arkansas one time, a candy plant. This was in early winter and the candy plant was out in the country. It was several miles out of Little Rock. It was a real raunchy place. The guy there, kept trying to give me a box of candy to take home to my kids. I kept telling him, "No, I will not take any candy." He kept up, until I finally said, "Well look, the only way I'll take a box of candy out here is to seal it with my official seal and turn it into the laboratory for analysis." He said, "I don't want that." I said, "Okay, then the case is closed, forget it." This place was overrun with rodents, and they had insect infestation.
Interesting thing in Los Angeles was that we'd get a lot of complaints about adverse effects from drugs and occasionally they would involve famous movie stars, usually actresses. When their names cropped up, there was a great to do in the inspection staff as to who was going to get to go out and interview the actress. I still remember Ola Bain, who was the senior member of the inspection staff, a kindly father-figure type, was generally sent out on assignments rather than some of our younger more excitable inspectors who tried very hard to get those assignments. I remember once, Marie Wilson who had starred in Ken Murray's Blackouts, had complained about reactions from some injections given in the buttocks area, and we sent Ola Bain out to examine the evidence which she did not hesitate to display for the inspector's observation.
They were checking these and they called me up and told me that they found a tea that was very high in strontium, rather a very high count. They didn't say strontium, that came out later. So, I notified the Food and Drug office there, Mr. Herrmann. I went over with a Geiger counter to the warehouse, (I think it was Tetley tea) where some Java teas were stored. Sure enough they did have a very high count. So, those teas were later sampled and checked out. In the meantime Tetley when they heard "radioactive," didn't want anything to do with it and picked up the tea and shipped it out. The only trouble was that they didn't bother to notify Customs what they were doing and, I think, they ended up by paying a bond penalty because they couldn't redeliver the tea. That tea had being grown on the south coast of Java. There was weapons testing off the coast of Australia and the westerly winds had blown the contamination over to the south coast of Java where these teas were grown. It turned out later, too, tea was very good at picking up certain radioactive isotopes. Later on radioactivity turned up in tea coming in from Japan which apparently was the result of contamination from the Russian testing.
I initiated that, that project on these worms in tomatoes. I found them making tomato catsup and tomato juice out of those wormy tomatoes. Some of them I remember ran as high as 20% infested and this worm would be an inch and a half long; this tremendous creature. And they'd just grind them up and make tomato sauce out of them. Well, we had no methods you know to examine the stuff after it was manufactured. So Kenneth Monfore was in the laboratory and he was... he worked for quite a long time devising a method for finding out about the parts of these worms in the sauce. Then we learned that Washington already had a method. It was far superior to the one that Kenneth had devised.
I do recall that when I reported to San Francisco one of my first assignments was to investigate a drug case where sodium chloride had been substituted for bicarbonated soda in a drug store. Several people died. We made quite an investigation. Then we found that the barrels of the raw material had been mixed up on the wharf, and subsequently several of them got mislabeled. Shortly afterwards, they had a food poisoning case involving what they thought was antipasto, and they had all the inspectors going around to Italian stores checking on cans of imported antipasto but it was finally found out that this family that had the fatalities had eaten home canned mushrooms.
They were bottling Pacific Ocean water, which was obtained by small boats some thirty miles north and west of the Golden Gate. Apparently far enough away so that it wasn't polluted. It was brought in large flagons to Alameda. It was run through a filter and then sold as Merlek mineral water. And you were to then take ten drops of this in a glass of city water as a source of minerals. And it was pointed out that the composition of ocean water is very similar to the composition of the body. And there was no attempt to hide the fact that it was ocean water, but it was played up in such a way that it was ocean water which was obtained from this particular point because the water there was better than anywhere else in the ocean. It would provide all the minerals your body needed. Well, we went to trial in Phoenix and we were able after a week of trail and much medical testimony including the fact that Phoenix city water at that time actually had more minerals in it in a glass of Phoenix city water than you were adding with the ten drops of Pacific Ocean water. And we were able to win that case. Although people testified that they were able to throw away their crutches after they had used this and that they had been able to walk again when they could no longer walk before. And it really established to me the tremendous impact of a psychological sell and how people many people are kept invalid who shouldn't be. If a little suggestion will get them out of a wheelchair that quick.
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