FDA Oral History Program
Interview with William W. Goodrich
Office of the General Counsel, 1939-1971
(Part 2)
 
Interviewers: Ronald T. Ottes (RO) and Fred L. Lofsvold (FL)
Date: 15 October 1986
Place: Rockville, Maryland

FL: Was there any White House involvement?

WG: Yes. John F. Kennedy was president and Ribicoff was very close to him. Kennedy was very conscious of the Washington Post stories. This was just a few months before he died. This was in June of '62, and he was murdered roughly Thanksgiving time of '62. But he was strongly in support of this, and that's why we got such a good bill out of the thing in the final go-around. That is, both Ribicoff, who had been relatively lukewarm originally, and Kennedy, who had not been directly involved until after it became a big public affair, and he gave an award to Frances (Kelsey) for the thalidomide episode . . .

[Interruption]

WG: . . . from the administration, and that influenced Kefauver and his associates, although they wanted to take the credit themselves rather than give any credit to the administration. And then in the House, Oren Harris was chairman of the House Committee on Interstate and Foreign Commerce, and through the work of that committee and with the help of Kurt Borchardt, their staff man, and Jim Menger, who was then in the Legislative Counsel's Office, we worked up all those provisions and the committee reports, and the bill passed with a very strong endorsement.

FL: Did you have an active part in actually drafting language?

WG: Yes, as I indicated, we worked with the committee staff and with the Legislative Counsel's office. They were the expert draftsmen, but we would tell them what really needed to be done. A lot of those ideas, though, were picked up from the testimony. You know, Dowling testified and others testified about you couldn't prove effectiveness without adequate and well-controlled studies, and so that became a part of the law. The industry was arguing that clinical experience was worth at least as much as a well-controlled study, and in the first committee report, we put in a provision that clinical experience adequately documented would be considered along with adequate and well-controlled studies, but not as a sole basis. That part was the sticking point of the controversy about the first report and the withdrawal of that report and the ultimate adoption of a stronger bill by the Senate, and yet a stronger one than that in the House. The bill passed in October and from there we adopted the regulations that were necessary.

RO: Bill, going back to antibiotic certification and the fact that the agency was able to keep the fees rather than going to Treasury, do you know what prompted that? Usually in things like that, fees go to Treasury rather than the agency.

WG: By putting a provision in the Appropriations Act to make sure that was so, and we got that done because the agency was so short on funds; we couldn't do it without that money, and they weren't going to appropriate anything for it. So the fees became the support for the thing and also became kind of a sticking point in the agency, that is, Henry took the view that he was supporting everybody else and that they should consider him as having been a financial benefactor. Well, that was part of our troubles.

RO: That was really user fees that have resurfaced since then.

FL: Yes, the current administration would like to do that more broadly.

WG: Well, but that sort of fee was based on a laboratory study. It wasn't like the user fees that they're talking about now, of taking a big fee out of the capital of the new drug to get it approved. That part has never worked; that is, they tried that once with TV licensing and it failed, and I don't think they've ever put that back in. They may have, but I don't think so. If any group can afford it, the television stations can. But the user fee provision just never did work that well. 

FL: Bill, in talking about the 1962 amendments, in an interview Winton Rankin told us that he was surprised that the requirement for effectiveness of drugs survived in the final act; he thought that in the beginning, everybody that was involved in that thought this was probably not going to fly, that maybe we would get the authority to inspect records and things like that, but we might have to give away the effectiveness in the final crunch before the thing was enacted.

WG: I wouldn't go that far, but as I said, we did give in that first committee report to the extent that we would have authorized the use of claims to some extent based upon clinical experience. And if you go back and look at that committee report, the first one that came out, that was some give on our part to the effectiveness claim. But that resulted in everybody focusing on, how do you really approve a new drug claim? And that was the adequate and well-controlled studies. I believe that came, in part, from Austin Smith's testimony. They did this by adequate and well-controlled studies, and we adopted that and put that language in, that effectiveness would have to be proved, and we defined what was inadequate in well-controlled studies by regulations thereafter. Now, we'll get into those regulations in a minute or two, but I ought to take a break.

FL: This sort of all became moot as soon as thalidomide got the publicity. Congress was about to enact almost anything that was before them. 

WG: Well that was really what turned things around.

[Interruption]

WG: Having had lunch we are now going to talk about cancer cases that were a major focus of my time here. When I returned from World War 11 in 1946 1 worked on my first big cancer case. It involved William H. Koch an M.D. from Detroit, Michigan. Dr. Koch was both an M.D. and a biochemist. He had an unorthodox cancer treatment he called Glyoxylide. As near as the agency could find out Glyoxylide was nothing but distilled water. According to the formula that Koch published it was a 10-12 dilution, so it had nothing in it. It was quite dilute. Koch, because of his professional claims, etc., had a following and he had a theory about how his product worked. The agency tried Koch twice, both times ending up with a hung jury and were prepared to try him again when Koch left the United States.

My first experience with Koch came in the spring of 1946 when I went out to Detroit to help Al Loverud with the trial of the case. FDA set this case up with the idea that it should be pretty simple. That is, by proving the extreme dilution of the drug that any jury would surely find that there was really nothing to it. Koch was represented by a lawyer who was also a scientist and who had worked for Dow Chemical Co. and who was trained by a chemist too. So the way the case proceeded it was almost assured in a hung jury. The government relied first, on the dilution second, expert witnesses who would testify that the product didn't work, and third, a so-called clinical trial of the product.

Essential to Koch's business was secrecy about the product, what was in there. He claimed that it was an oxygen uptake product of some kind. The formula was 0 = C = C = 0, which means nothing, really. That's the way he described what it was. In order to make the case, the Department of Food and Drug, maybe the lawyers' offices, decided it would be important to try the drug out on some patients. In order to do that, they obtained a sample from a return shipment that came in through customs from Canada, which was picked up and in effect commandeered by the government, and then subjected to clinical trial.

Now the dilution that came in was 10-6, so the agency then made it 10-12. That was the first big bad mistake. You see, it wasn't really his product that was tested. And second, as with any of these cancer cases, trying to prove by limited clinical trial that the product is no good, when the defense relies upon actual human experience, it is a bound-to-lose situation in court. And third, the theory that Koch had was one in which he equated the dilution of his product to enzymes in the blood. The enzyme in the blood would be about that same dilution and this was how he rationalized what was going on.

The case got started and the government first undertook to prove what the product was. We had no factory inspection--he would never allow an inspection--so it had to rely upon the formula. Well, the formula didn't mean anything, so they then had to have a theory on what that must have meant, and with the dilution that it would end up with either nothing in there or an ingredient so small that it would amount to nothing. Then with the ampuls that they made from this one shipment, they got immediately into a hell of a big argument about that, first, on whether the government had the right to commandeer that product which was being returned to him from someone in Canada and was picked up by customs as it came in; and second, whether it was logical to dilute that further and then use that for a clinical trial, rather than come to him and have him give you some samples. Of course, he wouldn't give you the sample, but that was the way the case went.

Koch had, as all cancer quacks have, a number of patients who apparently had received some benefit. Cancer is, as we all know, a capricious disease and doesn't behave at all in a normal function. And from experience of several years, which was what Koch had, he could draw from that experience patients that either were much better now as a result of some other therapy, or who had never had cancer in the first place, or who had a misdiagnosis or things of that kind. So it was a typical problem with that case.

The long trial was made necessary by bringing in witnesses from various places. There always was a delay. It was a jury trial, all right, and the judge tried to move ahead with it, but there was a constant problem of having witnesses available, having them ready to testify. And so the case dragged on and on and on. The lawyers for Koch, Sheridon and Goodow, were able to draw this doubt through the difficulties with the sample, the dilution made by the government, and with the experience that they'd had. We put on a case that was, we would have thought at that time, entirely adequate. But we know now it was really not adequate. So the case, even though we had leading experts from the Cancer Institute from the main hospitals in Detroit--Henry Ford and the other hospitals in Detroit--and other places there, there was simply enough doubt thrown onto it where the jury couldn't agree. Finally, one of them got sick during the deliberations and the court had to declare a mistrial.

So with that, Food and Drug had invested a tremendous investigational effort in this. Walt Simmons in Chicago had spent months both in the first trial and preparing for the second trial. He was anxious as hell to go ahead with the thing again. Soon after the trial, we conceived the idea of really this time making an absolute investigation to find out what it was all about. So we got John Cain, who as you probably remember, is a very hard-nosed, bird-dog-type inspector who really would just hang in there. No matter how much insulting the guy did to him, he would never turn loose. So we sent John out there to make an inspection, and by that time or soon after he got there, William H. Koch left, went to South America.

Louie Koch, his brother, was the one who was running the business and who essentially made the drug. Louie then hemmed and hawed about he didn't have any available or he wasn't going to make any for a while, and this, that, and the other. But ultimately, by staying with him long enough, it was possible to prove how the thing was made. And essentially what he observed was Louie Koch, a non-M.D. at all, just an ordinary person, distilling this water. It was in the summertime, and it was at this attic of Louie's house in Detroit. He was distilling and distilling and distilling for days on end and never would get right down to what active ingredient was ever put in there. He used every conceivable way to avoid that, but ultimately that inspection showed that that's what it was, distilled water.

But the case was never retried, because that Koch treatment lost all favor after that and became a small operation. But at one time in the early '40s and up through the time of that trial, it was the leading unorthodox cancer treatment in the United States. That's what it was and what the agency had to do to get to the bottom of it was to hang in there and prove just that there was nothing to it, that you couldn't really take it into a trial basis without getting equivocal results. You know, if you used it on some patients, every one of them's going to react somewhat differently. And, of course, in a trial, he was able to pull out that this patient did this, had less fever and so forth, just enough to show a shadow of a doubt.

So this taught us that in dealing with cancer treatment, it was essential to not go on a theoretical basis, or not go on a basis of just because we don't think there's anything in there, that that's enough to make the thing go. So that case ended about 1946, and then Walt Simmons and Brandenburg spent another two years really working up the inspection with Cain and getting ready for another trial. Then the issue came up about spending a hell of a lot of money--those cases do cost a tremendous amount of money, as you know-whether it was justified in spending it. The decision was made that it really wasn't worth that.

FL: Did Koch ever return to the United States?

WG: Not that I know of, but if he did, the treatment has never been a big factor since then, that having been tried twice in the criminal courts, I think he had enough and decided that he'd been lucky to get out that well. 

FL: He at one time had a reputation as a legitimate practitioner, didn't he?

WG: Yes, he was an M.D. and a Ph.D. in biochemistry. So in the cross examination of our medical witnesses, he'd bring out this Kreb's Theory and the enzyme theory and the dilutions there. The doctor would say it's too dilute to do anything, and then you'd ask him about biological processes in which you had the same minuscule active ingredient. Of course, they would really not know very much. It proved to us, too, that using an M.D. witness is treacherous business because the most honest ones there are would say, "Did you ever have any reason to believe that this product would have any effect on any type of cancer?" He'd say, "I know of no evidence that it would," instead of saying, "Absolutely not; there's nothing to that." That's the way you'd get the answer.

My next experience with the cancer problems was with Harry Hoxsey. Harry Hoxsey, at the time I came into the business, had a clinic in Dallas, Texas. Hoxsey had-had a background of conflict with the Medical Practices office up in Missouri, I believe, and one of the other Central states there. Excelsior Springs or someplace up there in Missouri. And so he went down to Texas and organized this clinic and was giving out this Hoxsey cancer treatment. In the early '40s, he was involved in a libel suit with the AMA. The AMA had taken a point of view and said publicly that Hoxsey's treatment was no good, was a fraud, and they'd all put out word about him from the Medical Practice Act. He then sued the AMA for libel. There was a trial in Texas.

Hoxsey won, but he got a $1 judgment, like the recent football thing. They held that he had been libeled, but his damages were only one dollar. But that was enough for him. He then could contend with his patients that he had proven the AMA had libeled him and that they were wrong in saying that he did not have a proper treatment. So with that background, the AMA took a somewhat less stringent view. Just as a matter of history, the man that they sent to investigate the Hoxsey treatment was Andy Ivey, who later became involved with Krebiozen. Andy Ivey did a report on Hoxsey and reported that the product was not effective for anything.

When we got ready to go into the thing, we sued him for an injunction in Texas. It was pretty well known that Judge Atwell, who was the federal judge there, who had been in the AMA trial and in effect was all for Hoxsey, was going to be our judge. So we knew from the start that we had a tough time going for us. What Hoxsey was giving out was a black medicine, kind of a tonic, and also a bunch of vitamins and herbs and preparations of that kind, just a lot of pills and this liquid medicine that he had. So we got busy on that, analyzed it.

Hoxsey claimed that he'd gotten this treatment from his father, that his father had an old white horse that had a sore on its leg which was a cancer. The horse went down to a certain corner of the farm each day and walked around there, and ultimately that thing cured up. So he reasoned that there was something down there that had caused that sore to heal and that therefore, this was the basis for his treatment, the herbs that he had picked up there. Well, of course, there wasn't any such white horse or anything like that, so the analysis of the product proved that potassium iodide was the active ingredient. The rest of it was vitamins and minerals and things that didn't amount to anything.

Well, we tried this case with more care. We were able this time to put on the same type of case that we had with Koch, that is, the analysis of the product, what it was, what it was recommended for, and the different people who it had been recommended for. But our problem was to prove that none of these people that Hoxsey brought in as his witnesses . . . We, of course, brought in our evidence some people had taken the drug and died, but not enough, and we didn't try any clinical trials on it because we didn't think that was justified. So the case was tried at considerable length--much shorter than the Koch case, though. It was tried in Texas with a very good assistant U. S. attorney. And the upshot of it was that when it was all over, Judge Atwell ruled that we had failed to prove our case, that is, that Hoxsey's medicine sometimes failed, sometimes worked, sometimes it helped some people somewhat, kind of a very equivocal sort of a judgment.

So we had to appeal. We then appealed and took the view that the undisputed evidence showed that none of these people that had been put up for the cure had actually been cured, and that every one of them had another explanation, and that therefore there was no evidence that . . . Our evidence was that it didn't work, and the evidence he put on was of no value in showing that it did. And the court of appeals held for us.

Then we went back down to have the judgment entered, and Judge Atwell ruled the same damn way. He said, "You know, I'm just not convinced." So he then ruled that Hoxsey could continue to market the product as long as he said there was a difference of medical opinion about the claim. We went down there moving for judgment on the mandate from the court of appeals, and Atwell then didn't do that. So we had to appeal again, and this time the court of appeals ruled with us again, and ordered him to be enjoined from making these representations.

Then Hoxsey hooked up with John Hluska, who was a state senator in Pennsylvania. John Hluska was the Democratic leader of the state senate in Pennsylvania. He came from a place in Cambria County, which is over in the coal mining area near Johnstown--Portage is the name of the town. Hoxsey then organized, through Hluska . . . I'm getting ahead of myself. After Hoxsey was enjoined, he then brought in an osteopath to run the thing there in Dallas. This man claimed that he was practicing medicine and wasn't really selling the Hoxsey treatment, which, of course, he was. Then in Portage, Hluska and the osteopath converted a garage into a clinic and set up to market this product through people who would come there. Their idea was that if people came there and they didn't ship anything in interstate commerce, that they would not be in violation.

So they put in the clinic there, and we decided to make a large seizure that would seize everything they had, and would in effect put them out of business. Rather than sue them for an injunction, we'd give ourselves an injunction by having a big seizure and that would get everything they had at the clinic, all the medicines available there, and that would in effect close them down. Well, we made the seizure. 

The Scripps-Howard newspapers in Pittsburgh were very interested in it, as were all the local television media. So they were alerted by the U. S. attorney or someone there that this seizure was about to take place, and they were on hand when the marshals arrived there to seize the material. Well, this Hluska being a public character, he had to kind of hang in there with it, so he contended that the drug was good and so forth, and that he was going to contest the case. The first thing we did was take a whole bunch of depositions, and Hluska and the doctor there and everybody else involved pleaded the Fifth Amendment and wouldn't answer anything at all. So the discovery didn't bring anything, but the seizure of the pills did in effect put them out of business for a while. They got some more pills from other sources, and they went away from the liquid black medicine to a tablet for the potassium iodide, and the whole thing was a bag of pills, now, this time around, rather than that liquid that cured the old white horse. We then seized and they contested, and after the discovery we had a jury trial.

FL: We seized a lot. of credit material, too, didn't we?

WG: Right. And our seizure was based this time not only on the case I have described, but there was a pamphlet, a leaflet, that had the story of ten people who allegedly had been cured. We alleged that all those were false, and we proved in our case the story about each one of these people. For example, one of them was a little boy who was operated on in Cameron, Texas. He had a young surgeon from Waco open him up there who had never operated on a kid that young before and never seen anything like what he saw in his belly. He closed him right up and told him that he didn't know what would happen. The guy went to Hoxsey and the kid recovered. Well, it turned out that he had what's called a neuroblastoma, which is a special tumor of neural tissue that comes with an aberration of birth processes. So we learned through an expert in that disease up in New York at Kettering, and another one at one of the main hospitals in Pittsburgh, that that condition had been seen in about twenty people, and that each one of them had had this remission after an operation just like this. So that was one of them.

Then he had a great, big guy, a big, tall Texan, that had a terrible condition of melanoma. This guy explained that he had a rising on his butt, and that he didn't know what was the matter. He went to the doctor and the doctor told him that he had a melanoma and told him it was a deadly disease. He said, "Doc, what can you do for me?" The doctor said, "There's not very much I can do except to offer to cut you off right at the base of" his ass, you know--a hemipelvectomy was what it was called, a hemi across the pelvis. That, he said, was the only thing he had to offer, and that didn't offer a very good result. So that's all the guy heard. But the doctor told him that he wouldn't do anything about it if these things were come and go, and that it wasn't any reason to go and take that operation when the possibilities of success weren't all that great. What he would recommend that he do would be to wait and see what happens.

Well, he went to Hoxsey and took the treatment and he got better. So when he was there to testify, he swore that he had this thing. Well, while he was testifying about this hemipelvectomy, one of the jurors fainted. [Laughter] Of course, it was so bad. But the doctor that testified before us and was a very personable guy, he helped the juror up. You know, he was on the witness stand. [Laughter] So those two cases, and then the others--we were able to take each one of those cases apart and show that there really wasn't any belief there that the drug had done any good.

Well, the trial went on for about a couple of months, and then the jury returned a verdict for us, holding that the product was misbranded. That, in effect, closed that clinic down. Hoxsey testified in the case, and before he testified, I took his deposition and asked him about the old white horse. And he was so damned embarrassed. We asked him about it on the stand, and he just, you know, mumble, mumble.

But Hoxsey testified that he didn't make any money out of the cancer treatment, that that was all a pro bono publico thing, that he made all his money out of oil and gas. Well, we had his income tax and it showed that he had made about eleven million dollars in the last year off the drugs and that he'd lost most of it in the oil. [Laughter] We wanted to put that in evidence and Judge Miller looked at it and he says, "No, I'm not going to let you do that. If you put that in, it'll surely result in a verdict for you. I'm going to let you take a chance of getting a verdict with what you already have." [Laughter] And of course, we did; we got the verdict.

After that, there were a few more rumblings about that, but Hoxsey pretty much withdrew from the cancer business, and I understand he later died of cancer. So that was the end of the Hoxsey cancer.

FL: Didn't we have to bring another proceeding against the osteopath that was a successor to him to get . . . 

WG: No, it was all in the same thing. He was down in Texas.

FL: At about the same time as Portage, didn't he also try to start a second one in Salt Lake City?

WG: I don't think so. There was a lot of talk that he was going to do that.

FL: But it never did gel.

WG: The talk that he had after the injunction was issued in Texas, was that he was going to offer these clinics at various locations where people would come there, and he would not be introducing drug into interstate commerce in violation. We told him that would be a violation, anyhow. But in sum and substance, the Hoxsey cancer thing was proven to be false, and we got a jury verdict and the seizure case. I guess he never did have a criminal trial because of the difficulty of proving beyond a reasonable doubt in these emotional cases.

FL: In the investigation of that case, we went to considerable lengths. Didn't we send a couple of inspectors as prospective patients to Dallas and they went through the clinic?

WG: I'm sure we did. We had all kinds of evidence there of what the drug was. Yes, we did that. 

FL: And made sure that he was really sending it to patients who lived outside the state.

WG: Well, that was more involved in the Krebiozen case, which was the next one I was going to talk about. The Krebiozen case was one of the most difficult that we had. It was complicated by the fact that Andy Ivey, an M.D., at one time a very distinguished member of the American Medical Association, and very distinguished in cancer research, became a supporter of Krebiozen. Krebiozen was brought into the United States by a couple of Yugoslav brothers, the Durovics. According to their story, they escaped from the Nazi underground during World War II and took with them from Yugoslavia to Argentina, this drug Krebiozen. They called it Krebiozen because cancer is a Kreb-like disease, and that's why they gave it that name.

Some time soon after the war, Stevan Durovic, the doctor brother, came into the United States from Argentina, and he said he brought with him the basic Krebiozen powder that he had made in Argentina. He claimed that Krebiozen was a product of actinomyeces bovis. By injecting this actinomyeces in a horse and then letting him develop that in his blood for a while, then bleeding the horse, and then taking the active material out of that blood plasma . . . That is, he'd take the blood and then take off the red cells and then get the plasma distilled down, and he'd come out with a white powder. He claimed that he brought that white powder with him. When he came into the United States, he brought it in a suitcase, he says, and he did not declare it at customs because there was no reason to declare it, he said, and it was not a noticeable thing; it was a small vile.

Well, he began to tout this material as a treatment for cancer, claiming that he had this treatment, and he organized a so-called Krebiozen Research Foundation. He enlisted Ivey to help him. The AMA conducted an investigation in which they developed a lot of evidence, and they took the view that there was nothing there but mineral oil, that there was no active ingredient. I'm getting a little ahead of myself, but when people asked Durovic for some of the powder after he got here, he said, "Unfortunately, I can't give it to you because it was all dissolved in mineral oil. Therefore, I don't have the powder and I can't supply the sample." That was his story for a long time.

But through the years, he continued to sell the thing, and it kind of fell between the cracks between Food and Drug and the Biologics people. Durovic claiming it had been a product of horse's blood, that classified it as a biologic, according to Food and Drug; and if it was a biologic, it was exempt from the New Drug provision, provided it was licensed in the Biologics group. Well, it wasn't licensed there, and it wasn't exempt, but anyhow, between those two, he did not apply for any kind of approval or any kind of clearance and continued to sell Krebiozen.

He was investigated a couple of times, and he filed a New Drug Application at one stage and claimed that it became effective. Well, when the New Drug Application was filed, we wrote him a letter and said that the application was incomplete and was not approvable and in effect turned it down. "If you want a hearing, you can ask for a hearing," which he didn't do. He then contended that, due to the operation of law, the New Drug Application had become effective, and that he didn't have to apply. That's the way the thing kind of went on for several years, up until the passage of the '62 Amendments. Come the '62 Amendments, it was necessary for him to either have an IND or a New Drug Application, one or the other. We claimed that he didn't have either one.

So we started work investigating Krebiozen. Ivey enlisted Senator Douglas in helping defend the thing. Senator Douglas put a big statement in the Congressional record about the Durovics, that they had all this work and that they had a proven cancer treatment, the AMA was abusing them--the whole schmeer. He had strong political and strong medical support there. And the department equivocated on it. Food and Drug didn't want to get involved with it because it was biological, they thought, and sure as hell, the Biologic group didn't want to get into it because it would involve some money and some work.

The thing kind of drifted along there until after the passage of the new law. And then we decided to bring the thing to a head. That caused all kinds of troubles. First of all, Douglas appealed to Ribicoff, and then to Celebrezze, and then to Kennedy. Then Ivey came down to Washington with the Durovics two or three times. And Ivey, having been such an outstanding man in cancer research, had doors opened all the way through, I mean right up to the top of the department. He could go right to the surgeon general or to the assistant secretary for Health and get an audience. We just finally said, "Absolutely not. We're not going to give an inch. We're going to bring this thing to a head."

We wrote him and told him he'd have to have one or the other, a New Drug Application or an IND, and to sell was illegal without that. Well, he was contending first, that he had a New Drug Application; second, that he wasn't introducing anything in interstate commerce. People had to come to Chicago, Illinois to get the thing. Those were essentially his defenses.

As we tightened down on him and wrote these letters, he then did two things. First, he went to Douglas and from there again to Kennedy, to pull us off, and they called on Celebrezze to find out what it was all about. Celebrezze kind of equivocated with us at first, but then we wrote a written report to him of what it was all about, and from that point on, he stood very fast with us; we could go right ahead with it. He wasn't very happy with it, because the next thing done was bringing all those patients in. They were brought in to Celebrezze's outer office and into the auditorium there at the HEW. All of them were in effect protesting.

His pitch was that he wanted . . . This was Ivey's pitch at this stage, Ivey having been discredited in the medical profession. He was hell-bent on vindicating his reputation, at least by getting the thing subjected to a clinical trial. He didn't care how it came out at that stage, as long as he could say, "Well, all I wanted was a clinical trial, and the trial is underway." He would have been rehabilitated in the medical profession and would have been satisfied with that.

One time, Ken Endicott, who was then the head of the National Cancer Institute, was committed to buying some of this stuff. He asked them to give him a price on ten kilograms for some God-awful amount, and the price came back at eight billion dollars or something awful. They could have it anyhow, but the price that they put on that was prohibitive. We told him that it wasn't going to do a bit of good to buy that stuff and subject it to a trial at the National Cancer Institute, because proving that the drug is ineffective on lung cancer, on breast cancer, there would always be enough other cancers that he would never get to the endpoint, that the clinical trial not only would cost him twenty million dollars to buy the product, but also would cost him millions of dollars in going through these trials, and that the trials would be inconclusive.

And then we said, "This product has had a trial; it's been given to hundreds of patients, many of them under very careful medical control, that is, with a biopsy and with a medical treatment and so forth." We'd seen enough of those reports to know that the drug just was not working. So we then said to him, "You produce the 200 best cases you have," and then we would have those reviewed by the National Cancer Institute to see whether there was any basis whatever for believing the product might have an impact, or for setting up a trial. Well, they hemmed and hawed about that, but finally did identify these patients.

We collected all the medical records, that is, the Food and Drug Administration's field force went out and either got the patients' consent or went to the doctors and got the hospital records--all the records available so each one of these cases could be reviewed. And they were reviewed. We built up that way a very reliable medical history of every one of those cases, and the fact that instead of us having a trial on some kind of an unknown product on a single disease, we had a nationwide trial of Krebiozen's own stuff on these patients who actually had cancer and that either then died or so forth. In addition to that, we put the pressure on them through inspectional means to produce some of this material. That is, "He said he didn't have any, that he put it all in mineral oil. Well, we got to the bottom of that, that he had bought ten barrels of mineral oil. We asked what came of it and he said he spilled it. [Laughter]

Pressing on, though, we finally got him to the point where he said he didn't have any more available. He would have to make some more if he was going to continue in business. Either he was out of the product or he would have to make another batch. So he went to the president of Quaker Oats, through Ivey, and made a deal with him which allowed him to treat some horses out at Rockford, Illinois, where Quaker has a dog food factory. They had these horses out there to make dog food out of them. So he let Durovic inject and bleed these horses. And like all con artists, Durovic did it in high style; that is, he put on a white coat and he got a syringe to inject these horses. He had a big tube on it so it would show up in the picture--you know, everything that a con artist would do. He had his picture taken out with these horses; he was going to give them the shots and so forth.

Well, he gave the horses the shots, and then the horses were bled. Then the problem came of what happened to the plasma? We were right on his tail at that time. We had Bob Palmer out there and other inspectors around from Chicago keeping absolute contact all the time. One Friday afternoon, they went out there to get some samples. When they got there, he had just left; that is, the Durovics had taken the material into Chicago. Then they had rented an old used firehouse which was their so-called manufacturing place. When we got pressing in on that, we learned that they had poured the plasma out in the city sewer.

We kept on with that, in effect, having a statement out that they didn't really have anything to sell, so they kind of had to go out of business, at least temporarily. Then came the trial. We got them indicted and went to trial with them. And again, the thing was drawn out forever. We overtried our side and they overtried their side. But the upshot of that was that they were all acquitted, that one of the jurors was fixed, and that guy was later prosecuted and convicted for manipulating the jury. Ivey was first acquitted, and then the Durovics were acquitted. Then after the trial we had gotten enough records of financial transactions and shown them to the IRS to where they were prepared to go ahead and do some action on them under the income tax law. But Steven Durovic left the United States and while Marco Durovic stayed here, that product died a death just like that.

So all these three cases show you the grave difficulty of proving the ineffectiveness of a cancer treatment, and the cost and the efforts that go into it, and the pitfalls that you face, even where you have all the evidence on your side in proving that the thing never fails. People somehow want to believe that. I saw a lot of those people face to face that came to testify.

For example, one woman was a nurse in a major hospital in Chicago. She had taken her husband to Portage. The place was a revamped garage. Now, she should have known--and she did know--by looking at it that it was not the kind of place that her husband should be. But she couldn't bring herself to blame herself for that. She thought that they were offering a ray of hope when she didn't have any ray of hope for him, and that therefore, she was really doing what was right. Well, after he died and we talked to her again, she conceded that she'd made a terrible mistake. But having gotten into it, there was no backing out on it. People want to believe that there's something there, and when the doctor tells them, "You've got a melanoma on your butt and this is the only treatment that's available," they're going to go and believe these people who are bound by the truth but will tell them anything to take their money. And, of course, they weren't making a lot of money. All three of these cases that I have illustrated to you involved millions of dollars and they were all scientifically proven to be worthless, and even in the end, the treatments were all defunct.

RO: Did we ever examine or analyze the Krebiozen to find out really . . . 

WG: Yes, we got the powder, and it was . . . Durovic, finally being pressed hard enough, supplied us some powder, and Joe Carol, Joe Levine and Danny Banes analyzed it, and it was creatine, that you could make from hamburger meat.

FL: In at least two of those cases, too, Bill, if my recollection is correct, there was a lot of public sentiment generated in favor of those . . . Hoxsey and Ivey both.

WG: That's what I had in mind about the patients, that they, of course, got a lot of publicity when they came down to HEW and showed up in the Secretary's Office claiming that this was the only thing that was saving their life: "Here's my daughter; here's my son. He's got a fatal disease. I want to give him the medicine."

That's what else. They got laetrile back on the market and caused those state legislatures to pass those laws, making the product available. In each case, they were motivated by a patient's coming there and appealing to their sympathy: "If we have any hope, let us do this," and that's a very, very persuasive thing, only you've got to look at it in terms of to offer hope where there isn't any hope is one of the worst things you could possibly do to those people.

FL: Well, I remember in the case of Krebiozen, they set up an organization nationally, the Ivy League, with chapters in various cities.

WG: That never made any big splash.

FL: They tried to generate local publicity in the newspapers.

WG: That didn't work out. What worked out was gathering together a nucleus of twenty, thirty hardcore believers, and they were the ones who came and boycotted the offices and put on this show of support. They didn't show up at the trial; we didn't have any of that sort of thing at any of the trials. But that's what the politics of it was.

FL: Were you going to go into laetrile at all, the early years of it?

WG: No, I don't think so. I was going to leave that for somebody else because when I was dealing with laetrile, it was not a factor. After I left the agency, it became a factor as a result of the state actions that allowed it to be so notwithstanding the Food and Drug's lack of approval. My experience with laetrile, we had these lawsuits and we won all the lawsuits.

FL: With Krebs out in San Francisco before he went to Canada.

WG: Right. And there was another one down in Oklahoma, too, wasn't it?

FL: That was the one that I think was the second go-around we had, that generated all the problems. That was later.

WG: Okay, that's the three cancer cases.

FL: With the one from Detroit, Dr. Koch, it seems to me there was a story about his complaining to us after he had gone to Brazil that his product was being purveyed down in Mexico.

WG: That may have happened; I don't know.

FL: He wrote to us complaining bitterly that we should do something about it because that was not his own product. [Laughter]

WG: I have a vague recollection that that did happen.

RO: Were you going to mention anything about the Scientology case, Bill? You were still here, I think, when that was . . .

WG: I hadn't planned to. Joe McGuire handled that case, and . . . Oh, Scientology. I was thinking about Reich. The Reich case was handled by Joe McGuire who was my deputy in the General Counsel's Office. Wilhelm Reich had an orgone energy generator, which was supported by his writings, which explained that it was a source of drawing life rays or something, a new life force, into the patient. It was a plywood type of box, and it was lined with some sort of metal. The patient was to sit in that and it would regenerate the life processes through this orgone energy which was accumulated in the device and then delivered to the patient. Reich had a place up at Rangely, Maine, and Reich was a psychiatrist author of some international repute, and he had written widely on the orgone energy accumulator.

We brought an action--I forget whether it was an injunction or a seizure--in Maine against the product. Joe went up there and tried the case with the assistant U. S. attorney, and they were successful in proving that it was not effective for the conditions for which it had been written, and he received an order requiring the destruction of the so-called labeling. Well, these were the writings of Reich, and that raised all this business of the specter of book burning and so forth, and he was able to accumulate a lot of support from civil libertarians claiming that we were in effect engaging in book burning when actually the decree provided that the books would not be used again with the machine. Some were destroyed. But that case was handled, tried successfully, and the main upshot of it was publicity that continues even to this day, contending that what we were doing was interfering with free expression and not dealing with a commercial product.

With Scientology, our experience here was that they established a place of business in downtown Washington in a row house towards the center of town. In Hubbard's early writings, in Dianetics and other things, he had espoused this psychological theory and later hit on the idea that by making a church, they would be exempt from any regulations, hoping that they'd be exempt from Food and Drug and from tax regulation. We sent inspectors; Taylor Quinn enrolled in that in Washington and went there as a student to learn all there was to be known about it. He stayed in there with it for quite some time. I was just congratulating him yesterday on the risk that was involved in that. It takes quite a bit of courage to go and get that deeply involved with those people.

But he did, and he brought back all the material. We then did an analysis of it and what they were claiming, and proved that they were selling their services for money and that they were doing harm. We won in the district court. Then when it went up on appeal, the court of appeals held that we were challenging a religious belief and that that was exempt from seizure under the Food and Drugs Act. So we were way ahead of our time on that, and we were not successful because of the religious overtones that were put on it.

FL: The device is still used, do we know?

WG: I imagine so. I think we've just stayed out of that since we were told that it was not our . . . The device, you remember, was a couple of juice cans the E-Meter, that you'd hold in your hands, and the sweat would generate this electrical charge between, and it would show on a little gauge. If you were being monitored and the gauge flipped around, you were either lying or you were clear. You would not be clear until that gauge stopped moving around. But it was a physical operation with the person holding the machine.

Another area of enforcement that was new under the 1938 Act involved economic frauds. This proved to be one of the most difficult areas that we had all across the board. You'll remember that in the 1938 Act, food was declared to be adulterated if it was made to appear better or of greater value than it was. This was the basis for actions that we took, or if any substance had been substituted . . . I believe in the act of 1906, substitution of one product for another was an adulteration, but the new thing in the '38 Act was that if the product has been made to appear better or of greater value than it is, then that would be the basis for an action.

Although adulterating products with water and cheaper ingredients is one of the oldest adulterations known to man, we had plenty of problems with that. For example, proving that a juice product was not what it appeared to be was one of the major operations in two large cases: one, the Bireley Orange beverage product, and the other, the Cal-Tex case in Houston, Texas.

In Bireley, the product was in a wide-mouthed, soda-type bottle. It had some suspended material in it; it was made cloudy; it was orange; and it was promoted as containing some Valencia orange juice. Well, we made a charge that this product had been colored and packed to make it appear better or of greater value that it was, i.e., that it contained more orange juice than it actually contained.

In the trial, that was proven several ways. First, before the jury, to simply bleach out the added color, and the product looked like it really was. Then they analyzed for the amount of juice in there, and it came to less than six percent. In those ways, the charge was, in effect, that the product was made to appear to have more orange juice than it actually had, i.e., at least twenty-five percent when it had only six percent. So we won that case in the district court. We proved what the product purported to be by opinion survey, that people did think it contained a substantial amount of juice.

The judgment was in our favor, and then that was appealed. One of the judges in the court of appeals was Judge Hastie, who was one of the most intelligent federal judges around, ruled that we couldn't make a case like that where the jury would have to guess what level of orange juice the customer would expect. That is, that would put the manufacturer at risk; if he put in six and the jury expected twenty-five, he would be held to adulteration on some unexpected thing. The court held that the only way you could go at that would be first to establish a standard for that kind of a product where everybody would agree that the proper level is fifteen percent or twenty percent, and if you established the level, then everybody would know what that level was, they would have to comply with the standards. But under the general language law, made to appear better or of greater value than it is, it would have to appear to be some defined, superior product, in this case, 100% orange juice. It wasn't enough that it appeared to be a product containing greater concentration of orange juice than it is. So that was one of the problems.

In Cal-Tex, these people were treating orange juice with citric acid, and water, and artificial flavor, and sugar and selling it as a reconstituted orange juice. The surveillance by the inspectors clearly showed that they had these ingredients delivered there, and they observed the materials being delivered to the manufacturing plant, and photographed it all, and showed that this product was in all likelihood being fabricated from these non-orange-juice products, and it was not what it purported to be. It was not a reconstituted orange juice. But the difficulty was in defining what was a reconstituted orange juice? How much water and how much citric acid and the other things are normal in this product? And it has such a range of actions that when you prove that it was anywhere near that range, you'd failed to prove your case.

And that's the same thing that was involved in the oyster case. If you have a standard for oysters that calls for a certain amount of solids, and the oyster being such a variable product in terms of water content, it simply was impossible to prove that this was not a natural product and was in violation of the standards. That's what those cases were all about.

As the Food, Drug, and Cosmetic Amendments were proposed in the mid '30s, devices were not separately regulated. But it was the intent of that revision to place the same kinds of controls over devices that applied to drugs. There wasn't any definition of device, but the definition of drug was made to include estimates, apparatus, and contrivances, which were devices. And in the legislative history, it was plainly shown that it was the intent of the act to cover devices for weight reduction, arch support repair, and other things like that. But the opponents of the bill really took that as a laughing matter; they claimed to classify a crutch as a drug just violated all common sense, and therefore it didn't make any sense to have that under the drug definition.

So that controversy continued all the way through. When the New Drug Provision was put in, they did not say anything about new devices, because new devices would have been covered under new drug as long as devices were drugs. But at the last minute there, to get away from this claim that the act was claiming a crutch was a drug, the new definition of device, quite parallel to the drug definition, as you know, was inserted and the regulation of devices proceeded on that basis.

My first real experience with the device was in the Urbeteit case, in which this naturopath down in Tampa, Florida had a device which was represented for treatment of every kind of a possible disease. It was a simple little shocking machine; that is, it had a little battery in it, and you'd take hold of it and it would give you a little shock and you'd feel that. These off and on currents, he claimed, would cause the tissue contraction and therefore would help treat a large variety of diseases.

In that case, we first used experts in physical medicine to testify about device claims, that is, to prove that a device was simply a modality for having some physiological effect, and that what was happening with this machine was well understood, and that that action couldn't possibly have anything to do with high blood pressure or some of the other diseases that were known. That case turned on the labeling issue, whether or not the promotional material used by Urbeteit was actually labeling or whether it was advertising subject to the control of the Federal Trade Commission.

We brought several other device cases, and we learned from the Urbeteit case how to put those on pretty well: by using experts in physical medicine, and by explaining to the jury and to the courts that this device is a barrier of some physical force, things of that kind. Physically, what is it doing? And make your case from there. So we never really had any great problems with that.

Now, some devices like bandages and prophylactics were under the drug provisions, but with the new definition, devices were separately regulated and were not under the New Drug provision. They were not under the new drug simply as an operation of its history. When the device definition was put in, the new drug definition was not changed to accommodate that. And so for years, we had no real new-drug-type approval over devices that were newly being introduced into the medical profession.

Most of the device cases that we brought during those early years were over simple things like Urbeteits and things, or a belt, or Dinshah Ghadiali's Spectro-Chrome, which was just a showing of light through various colored glass--things of that kind which were relatively easy to explain. The devices came into the real world with us in connection with two cases. One was the suturing device put out by A.M.P., and the other one was the antibiotic disc case involving Difco in Detroit.

First, when the suturing case came up, what A.M.P. had was a new method of tying these sutures. It was a plastic, kind of a little button on the thing that you'd tie on the suture, and then that was inserted into the wound. The thing was alarming to surgeons on what would be the fate of that little button left there, and what the material would really hold with this kind of a suture as against a sewn suture that was used by surgeons. So they became alarmed, and we became concerned. Then A.M.P. asked us what we thought, and we told them that we thought it was a new drug. They then demurred, and I've forgotten whether they filed suit. I believe A.M.P. filed suit against us for a declaratory judgment.

Being able to show that sutures have long been drugs by recognition in the USP and by other ways, it wasn't such an illogical step to classify them as new drugs, particularly for something that was put in the body and left in the body. That was kind of the compelling feature of that case. It enabled us to get a ruling by the Second Circuit Court of Appeals that the A.M.P. suturing device was actually a new drug and was subject to new drug controls.

That was followed by Bacto Unidisk relatively soon. The Bacto Unidisk, those antibiotic disks--they've been around for quite some time--the Antibiotic Division had tested a lot of them and approved a lot of them, but never had certified any of them. Difco was the first big promoter, I might guess. Others were kind of put out as an auxiliary to a drug by the company selling the drug, just as a way to test for . . . We had a seizure; we tried to get Difco to get those things certified, and they wouldn't, and finally called our hands. We had to initiate a case to proceed against them. I'm not sure whether we won in the court of appeals or not; I guess not. But we did win in a big way in the Supreme Court by being able to show that because the risk of misdiagnosis was so great, and because these things had such a powerful influence on the choice of the antibiotic for treatment, there was a major risk there. That's what carried that case for us through the Supreme Court. We got a quote from Goodman and Gilman on them that clearly showed the role of the things in medicine. This is what worked for us in that.

Having had these two cases classifying the Bacto Unidisk as an antibiotic drug and the suturing device as a new drug, then it became important to see where we were going with various devices, and to draw the line between drugs and devices. I guess our idea was to have a new device law similar to the new drug law, and we made that kind of proposal for several years to the Congress--to deaf ears, I might say; they were not at all interested in doing that.

So finally the Secretary, I believe Ribicoff, decided to set up a committee to study what ought to be done about devices, that is, whether we needed legislation, and if so, how to go about it. So he appointed a committee headed by Ted Cooper, then the director of the National Heart and Lung Institute. I was on the committee. I believe Wetherell from Food and Drug was on the committee. He was either on the committee or was an alternate. Then we had the deputy director of the National Cancer Institute, a man from the Dental Institute, and others drawn from the department, on the committee.

Ted Cooper was a remarkable man in terms of running a committee of that kind. He just wouldn't let you get by without doing something. He organized the committee to where we had to have a meeting every Monday morning at the National Institutes of Health at 8:30 or something like that in the morning. And he wouldn't take no for an answer. You know, "I can't get out; I can't get any parking places." No, he answered all those, "Use my parking place." So we met and went over the problem.

Then Ted invited in representatives from a lot of different places. First was people that were involved in inventing and promoting these things, people that made artificial hearts and things of that kind. They were inventors; they were just good mechanics that would put these things together. Then he had a survey done of the literature over device accidents, a great many device accidents happening in hospitals, many of them electrical in nature. He collected all that information. Then he brought in people from the various branches of medicine: what devices were they using, what did they know about the devices, how did they test them to be sure they were working as they were supposed to, how did they know they were getting the result that was being read out--all those questions that really no one could answer satisfactorily. He went through this operation for several months in the early '70s.

The committee then issued the report, recommending that the regulation of devices be in four level stages: those that were generally recognized as safe and effective have no control other than their own professed standards of quality of performance; those that required standardization, like electrical equipment, just to be sure that it operated right; those that required some kind of a pre-clearance. That's three classes, I believe. So we recommended that a law be enacted along those lines that would set up a new device control that would enable the department to survey the whole field of device use, specify those devices that were so common in use that they required nothing beyond attention to their labeling and whether they were what they purported to be and operated as they purported to operate; second, that they then provide a list of those devices that required standards, and what those standards ought to be; and next, what devices ought to be subject to the regular pre-clearance, pre-clinical, and full-scale production rules that were apropos to drugs. And that's what was recommended.

When the thing got up to Congress, they really got messed up with it and came up with a very elaborate bill. I was gone then, and the department lost all control of the legislative process, all input into the legislative process. I'm not sure they lost all control into it, but anyhow, Congressman Rogers, who was the chairman of the Subcommittee on Health, and his people, got up the device bill. And it was something that they'd never administered and never understood, really, the complexities of.

So they came out with a bill that was terribly, terribly complex to deal with this problem. It follows, in general, the lines of the Cooper Committee Report, but because it's so complex, the department's never been able to do very much with it. They claim that there are several hundred devices that need standards, but they don't know how to proceed. Well, you know, all you've got to do is find out what their professed standard is. All of them have standards, or else they are irrational. Every device out there has got some kind of a standard, and why they can't get on with that and decide that, it's just beyond me. I've told those guys that: "When you say you don't know what the standard is, you can't even read the literature, because that's what the standard is, that's what it purports to be. If you want to exempt them from standards, go ahead and exempt them; you've got that authority." But the device bill just became way too complex, and that's the source of the problem with it.

FL: In your discussion of the suture device and the Bacto Unidisk, where we didn't have any specific authority on that kind of new device, and we brought it under the New Drug section which was available--isn't that sort of a typical way that we've handled problems over the years?

WG: Well, you know, when I was General Counsel, people used to accuse me of selecting cases to make law up as we went along, but I always denied that. We did try to take advantage of any case that had a useful, factual situation and a real need for some regulation, as was the case with the Unidisk. In the case of the A.M.P., they sued us; they wrote us and we wrote them a letter back, and then they sued us. So they initiated that action. And then, in recent years, more of the law has been made through people suing us than us suing them. Years ago, you couldn't bring a declaratory judgment against the government; that was only possible after the toilet goods series of cases, Abbott against Celebrezze. So we did have a selection to make, but even in the cases we chose, we couldn't be sure they'd contest. We would bring the case with the idea that if they contested, we were ready to go to trial with them and that we were ready to prove that we were right. It was pretty much a big bluff--not a bluff. You know, industry, when it costs money to contest those cases, are reluctan

FL: I would agree with what you said. What I was really trying to get at was that when we perceived some kind of public health problem that no one else was doing anything about or had no authority to, we then looked in our statutes and deliberately tried to find some way to do something. The over-the-counter sale of dangerous drugs is a good example.

WG: That's absolutely true, Fred. Food and Drug's history--I don't know whether it's true now or not--but I know when I was there, it was a can-do organization; it would not try to make excuses of why they were not doing it. They use all kinds of excuses now: they don't have people, they don't have money, they don't have this, they don't have that. They've got more of that than we ever had way back there, and they just will not do things like that. Doing something, particularly a hard case, involves work and it involves money and it involves effort, and they just won't do that anymore. But we did that for years and years. How did we get into the hazardous substance business? How did we get into the firecracker business? How did we get into a lot of other things there? The turtles. Everything that came along nobody else would do it. We would end up doing it.

For example, once on poultry inspection. Nobody was inspecting poultry. So the union came to us and said, "Agriculture won't do it because it costs too much money. Let's amend the Food and Drugs Act." And we were gung ho to go ahead and do that. Secretary Folsom said to us, "You know, if you take that responsibility and you start inspecting those chickens, that's going to take priority over everything else you've got. You don't have any money now." That was in the '50s. He said, "How can you undertake to do something like that without being assured that it's not going to take away from the rest of your operations?" So there was some of that to it, too.

But in terms of the child protection, we took the poison center idea and that was run by PHS (Public Health Service) on kind of a voluntary basis. We tried to make that something that was really good, and I believe we did. But that is the history of the thing. Now maybe some time, like in the case that Folsom was talking about, we would take on something that was at the expense of something else. The vitamins, which I was going to talk about next, was one of those big examples. One, it cost us millions of dollars and ended up unhappily for us by the court saying, "These things are not dangerous; let them go ahead and sell them without any restraint, even though it's a gigantic fraud." You just can't be sure how some of those issues are going to hit people.

[Interruption]

FL: This is a continuation of the interview with Mr. William W. Goodrich, retired general counsel of FDA. The date is October 16, 1986.

WG: Earlier in our interview, we were talking about food standards, and I mentioned the ones that were very important in the early days, that is, the standard for enriched flour and enriched bread, and the standard for canned fruits. I didn't follow up on that. There were, of course, other very important standards adopted about that time: standards for cheese, standards for frozen desserts, standards for milk products, standards for other foods. But before I leave that subject, I think I must take up the much-disputed, much-mooted issue of the peanut butter standard, because it has been so misrepresented and so descried as a bad example of government in operation that I have to come to its defense, even though I was involved only at the beginning and, of course, in the court of appeals with that case.

The standard for peanut butter came about in this fashion. At the beginning, the leaders in the business were Skippy from Best Foods and Peter Pan from Swift. Those were the leading brands. Proctor and Gamble decided to come into the market with its product, JIF, which is now, of course, one of the major, if not the major brand. The original proposal on JIF was that it would contain more emulsifier than had been involved in the other products. And that was regarded by the people in food administration as a bad departure. That is, putting a non-peanut fat in that product to make it more spreadable just didn't seem to them to make sense, and was a typical type of what they would regard as an economic adulteration.

Proctor and Gamble was represented by a man who later became secretary of Commerce, whose name escapes me at the moment. He came in and talked with Malcolm Stephens, who was then the associate commissioner for enforcement. An inspection was made at the plant, and while the inspectors were out there, someone mentioned that the additive they were using was Crisco base. Well, that, of course, raised everybody's eyebrows about what was going on in there. They visualized it as adding Crisco shortening into the product. That's not exactly what happened, but that's the way it was reacted to by the enforcement people at Food and Drug.

So it was proposed that a peanut butter standard be adopted which would hold the product to essentially all ground peanuts with a little salt and sugar; that is, it would be essentially just ground-up peanuts with salt and a little flavoring. Two or three proposals were made. One I believe was for essentially all peanuts, then 95 percent, and then it got down to about 90 percent. That's when the hearing got underway.

The reason the hearing became so protracted was that Proctor and Gamble, CPC, and Swift were all very well represented there, and the proposal to adopt a standard just simply couldn't accommodate all those products. JIF, of course, was proposing more of the emulsifier; the CPC product had a partially hydrogenated peanut oil which was built into the product and was flavored with sucrose, as I recall--that or Peter Pan. So the difference was that the Proctor and Gamble product would have had more emulsifier than the Best Foods product, which was the best selling at that time, and the Best Foods product would have had a higher percentage of emulsifier than the Swift product would. And so, it was trying to reconcile those numbers of where the proper point lay for an appropriate level of peanuts in the product without allowing the adulterations by the emulsifiers of the flavorings or the seasonings and the oil.

So that's why the hearing was held, and that's how the hearing came out, that when the standard was ultimately adopted, a level of peanuts was insisted upon, and the added optional ingredients were held to essentially what was deemed to be a practical level. The upshot of it was that the fifteen percent emulsifier, which was requested by Proctor and Gamble, was not allowed, and the amount was increased somewhat to accommodate the Skippy product. But in the ultimate solution of the thing, the existing products which had the total market would not be within the standard, and the standard was trying to make a step forward in being sure to protect the integrity of those foods. This is what caused the great, protracted hearing. And while it's been said that is an example of Food and Drugs' abusing the administrative process, that's not at all what happened.

The lawyers involved were Tommy Austern, who was the leading light at the bar from Covington and Burling. He was representing Proctor and Gamble. Kleinfeld and his firm were representing Best Foods. And so they simply hung in there day after day. The hearing examiner was the one who was really at fault in allowing the thing to go on so long that the record became very, very protracted, and it was an example of a massive record over a pretty straightforward issue, that is, how much peanuts should be in peanut butter. Even though the law had been amended earlier than that to try to simplify the establishment of food standards to eliminate hearings to a certain extent, that original amendment only eliminated hearings on non-controversial items, and there was nothing it did at all when this controversy arose.

I was into the case at the start, discussing it with Malcolm Stephens on how to set the thing up and whether or not we could establish a standard which would insist upon a level of peanuts in the product that was what we considered to be in the consumers' interests, which may not necessarily conform with what the existing product was. The query was, are we bound in the standard to adopt the market leader as the standard, and are we prohibited from making changes in those market-leading products that we believe would be an appropriate step in coming to a good standard? Well, the hearing was held and after much debate back and forth and decisions and not decisions and kind of decisions like Ken Kirk and others who were in the food part of Food and Drug at that time, the ultimate standard came out.

Of course, I know very well that CPC appealed, Best Foods appealed. So I got the case to take it to the court of appeals. And the issue there was whether or not the standard could call for this product which was a new item, new in the sense that it fixed a level on peanuts and on emulsifiers and accommodated both partially hydrogenated peanut oil and fully hydrogenated peanut oil and the fixed product which was used by some, which was the fully hydrogenated rapeseed oil. All those products could be put in there, but because they were so different, the level for one wasn't necessarily the right level for the other. This is why we had to adopt a level which, as I remember, was somewhere between 90 and 95 percent, which was a good compromise.

As a matter of afterthought in history, if one looks today at JIF, it has met with the standard and is probably now the leading product. Whether it would have been a better spreading product with more emulsifier in it is a question, but we're not embarrassed by that standard. As a matter of fact, we think that standard was pretty good, and just like many of the other standards, has been terribly misunderstood by people who were not involved in these standards.

Remember, they were products of the Depression, and were products of economics in keeping up the food supply. Today, the interest is in all these new products with new names, but that was one of the things that the standards were supposed to get away from. To think of repealing the standards provisions, keeping in mind the great benefit achieved by enrichment of flour and bread, which was only possible through that standard, and the accommodation of canned fruits through these sweeteners that have come through the years, I say that that was a pretty far-reaching and pretty knowledgeable operation. And maybe today the economics are not what they were then, and the standards were too stringent. But I don't go along with this business that it's an appropriate idea to put a whole bunch of stuff on the label and think people can make a judgment on that product from those label statements.

As a matter of fact, once I talked with George about the label statements and talked with Charlie about the label statements, that is, Dr. Edwards and Mr. Larrick. I told them these label statements are a joke. They're so small and so poorly understood that we really ought to go for some sort of a label thing that would explain what they were and how they performed in a food. Well, both of them thought that that was something that was really not of enough interest to go into; it would cause problems. Even though they recognized that the label statements were obscure and not fully understood, they were not in favor of that. After I left, of course, we had a big to-do about labeling, and I guess nothing really ever came out of it. But it maybe proved that Charlie and George were right in the first place. [Laughter]