-Caveat Lector- <A HREF="http://www.ctrl.org/"> </A> -Cui Bono?- an excerpt from: Treason's Peace Howard Watson Armbruster�1947 A Crossroads Press Book Beechurst Press New York 438 pps. -- First/Only Edition -- Out-of Print --[11]-- Chapter XI Two Drug Laws�And Two Wars ON DECEMBER 3, 1942, the Federal Circuit Court of Appeals in New York handed down a decision which if it had been sustained would have substantially ended all possibility of successful prosecution of corporation officials and employes for violation of the new Food, Drug and Cosmetic Act, sometimes known as the Copeland law. With that decision the court put its judicial interpretation on the result of long years of effort through which Senator Royal S. Copeland, with the assistance of the Sterling-Farben drug lobby, and various public officials, extracted the teeth from the Harvey Wiley Food and Drugs Act, and had enacted in its place a legalistic monstrosity so full of jokers and ambiguities as to afford no protection whatsoever against influential violators. The case in which the decision was handed down involved a shipment of adulterated and misbranded digitalis, and the appeal from conviction of the president of the corporation which had shipped it. The learned appeal judges reversed the conviction, and stated that it would be "extremely harsh" to charge a corporation official with a criminal offense-regardless of his actions, or inaction-unless he was an officer of a very small corporation. The new law was as cock-eyed as that! Or so the appeal court held. (Later the Supreme Court reversed the findings of the Appeal Court, in a close decision with four of the high court justices upholding the appellate decision.) Under the old Wiley law, officers of corporations could be, and were at times, prosecuted, convicted, and sent to jail. Unhappily, the old law was seldom invoked against important offenders, but it did authorize and, in fact, require such prosecutions. It can easily be imagined how disastrous it would have been to the Farben plans had Herman Metz, or Doctor Weiss, or Earl McClintock, or Dr. Hiemenz, or any of the other Sterling-Winthrop-Bayer executives been held criminally responsible for some of the vicious violations of the Food and Drug Law practiced by their companies-some of which will be discussed in just a moment. And it has long been my contention that the frantic demands of Copeland and his clients for a new law were to prevent that very possibility. Be that as it may, in June 1933, it was to Senator Copeland that the task of putting through the new law was entrusted. Professor Rexford Guy Tugwell was alleged to be the author of the first bill submitted to the Senate by Dr. Copeland. This bill was bad enough-it omitted all traces of mandatory enforcement. In the second bill, drafted by Ole Salthe, the Copeland business manager, no misunderstanding was possible�a clause was inserted which actually instructed the enforcement official never to take to court any "minor violation" when he "believed" that the public interest would be served by a "suitable written notice or warning." As the phrase minor violation is not defined anywhere in the law, it is obviously meaningless in a legal sense. In the administration of the law it means whatever the enforcement official choses[sic] to believe it means. And, in August 1935, before a subcommittee of Congress I challenged Representative Virgil Chapman, chairman, to define the word "minor" as used in the Copeland b ill, saying: if anyone can define the word "minor" as used in this bill, I will withdraw my objection I have been asking every- one I have been able to talk to here to define the word minor. 'Don't make me laugh," they answer. The whole purpose of this legislation I is to get rid of the mandate in Harvey Wiley's law for criminal prosecution, and to replace it with a law which puts in the hands of an enforcement official the power to do absolutely as he pleases on each individual offense. Representative Chapman refrained from accepting my challenge, and instead contented himself with constant heckling, and demands that I discontinue my testimony. The final version of the many Copeland bills was passed by the House and Senate on June 13, 1938, and became law by the President's signature two weeks later, a few days after the sudden and unexpected death of its sponsor, Senator Copeland. In the long and bitter struggle over this legislation, one of the numerous protests was a brief prepared by Dr. Norman W. Burritt, as representative of the Medical Society of New Jersey. Dr. Burrites brief contained the following: Let it be thoroughly understood that the Wiley Act is a mandatory criminal statute on which have been based a large mass of district, appellate, and supreme court opinion. This mass of judicial interpretations would be entirely obliterated if the Wiley Act is repealed . . . . . This is so important in itself as to be the basis for summary rejection (of the Copeland bill). Some of the story of the Food and Drugs law has been told in a book* [*Why Not Enforce the Laws We Already Have?"] published by my wife and myself in 1935. Dr. Harry Elmer Barnes concluded a review of that book with the comment that his column was . . . . . not the place to pass any verdict upon the charges preferred by Mr. Ambruster, but it is evident that they can- not be overlooked. Either he should be prosecuted for crim-inal libel, or those whom he denounces should be relentlessly exposed and properly punished. Being in complete agreement with Dr. Barnes, I wrote to the three individuals who were principally denounced in my book, and requested them to prosecute me for criminal libel should any of them feel that my accusations were false and unjustified. The three were Dr. Morris Fishbein, editor of the Journal of the American Medical Association; Walter G. Campbell, Chief of the Food and Drug Administration, and Dr. Royal S. Copeland, United States Senator. It would take another volume as large, or larger, than this one to tell the full story of the legislative battle to repeal the Wiley law. However, it is only necessary here to outline briefly those parts of the fight which bear directly upon the immunity accorded Farben's drug and patent medicine affiliates. When the campaign for a new law was getting under way, there was a strange unanimity in the expressed opinions of the principals involved-men whose interests should have been as far apart as the poles. Professor Tugwell, the Assistant Secretary of Agriculture, Frank Blair, Sterling's president of the Proprietary Association, and Dr. Morris Fishbein, all agreed that the poor old Wiley law was no good. Said Tugwell: "Dr. Wiley's law is obsolete." Said Mr. Blair: "It has been an effective statute ..... but it does not go far enough." Said Dr. Fishbein: "The Food and Drugs Act of 1906 failed largely of its purpose." Somehow they all forgot to mention that the real trouble-and the only trouble- with the Wiley law was lax enforcement. One of the problems which confronted those directing the fight to get rid of the Wiley law, was the remarkable record which that law had made whenever it was invoked in the courts. The record showed that out of over 31,000 cases taken to court in the thirtythree years of its existence, less than 175 were lost by the Government, or a bare half of one percent. According to several informed public officials with whom I have discussed the subject, no other federal statute has ever made anything like such a record. For example, the F.B.I., with its fine record, is said to have lost a higher percentage than this of its court cases. To justify the repeal of the Wiley law, a list of thirty-four allegations was prepared, and, believe it or not, each and every one of those allegations was either directly false or based upon a mistruth. This list made its appearance early in the fight and kept on reappearing in committee reports, and on the floor of the House and Senate until the Copeland bill became law. Among those who issued the list as an official paper, or, at least, as officially sanctioned, was one Paul Appleby, at that time assistant to Secretary of Agriculture Henry A. Wallace. Mr. Appleby posed as an authority on the subject of both the Wiley law and the pending legislation. He was neither. In 1936 he sent this list, as proof of the superiority of the Copeland bill, to a prominent educator who had suggested that the Department might benefit from discussing the Food and Drug law situation with me. Mr. Appleby's response to that suggestion was to say that: I will not join in a recommendation that more of this Department's time be wasted on Ambruster; I shall oppose it emphatically in defense of good administration and proper use of time. One of the thirty-four alleged improvements of Copeland's bill over the Wiley law was that the new bill forbade traffic in confectionery containing metallic trinkets and other inedible substances and the old bill did not. Another, that the bill pending provided for food standards. The fact was that court cases were then on record in which the government was successful in securing the condemnation of candy-coated trinkets as adulterated under the Wiley law; while food standards covering everything edible from soup to nuts had been issued by the Food and Drug Administration for use in enforcing the Wiley law from the time it was passed. Senator Copeland made frequent use of this list in the Senate and in public. He was especially fond of the one about the candy trinkets because it gave him an opportunity to emote on the sacredness of childhood, and the grave danger of trinket-swallowing. In an exchange with Senator A. Harry Moore, of New Jersey, when these two ornaments of our highest legislative body staged th eir mock debate on amendments proposed by the Medical Society of New Jersey, Senator Copeland ended his speech with: If we were to accept the substitute presented by the Senator from New Jersey, there would be no such prohibition as is contemplated by the pending bill. I know that Senator's kind heart and that he would not wish this to be the case. Both Senators seem to have been terribly anxious that day to have it appear that serious consideration was being given to the Medical Society�s amendments to the Wiley act which Senator Moore had introduced. For three-quarters of an hour they staged what appears on the record to have been a valiant fight. Yet, in the entire exchange, not one of the proposals made, or the facts submitted, by the New Jersey doctors, was accurately stated or truthfully debated. In addition to Dr. Burritt's brief, Senator Moore also inserted in the record a statement which had been prepared for him, explaining the amendments. Within an hour and of course long before the record was printed, the amendments proposed by the Medical Society were rejected by a snap vote on which the yeas and nays were not taken. It so happens that under the rules of the Senate the bill proposed by the Medical Society should have gone directly to the committee in charge of such legislation, where it could have had a hearing and have been studied by the, members of the committee before it was presented on the floor. Senator Moore, however, chose a questionable alternative when he introduced it as an amendment to the Copeland bill, then threw it into the debate at the last moment. It was by such tactics that the stage was set for the court decision some years later which so discouraged criminal prosecutions of the executives of corporations, like Standard Oil and Sterling, which firms, it so happens, were clients of Copeland Service, Inc. Representative Frank W. Towey, of New Jersey, made a real fight on the floor of the House of Representatives against the ambiguities and impotence of the Copeland bill as pointed out by the Medical Society of his State. Congressman Towey was partially successful in limiting the most vicious provision of the bin, the "minor violation" joker, with a restriction which forbade the enforcement official to give more than one warning to any one offender before instituting court proceedings. The House version of the Copeland bill was passed with Mr. Toweys amendment in it; the bill then went to a Conference Committee headed by Doctor Copeland where, by a very simple legislative operation the limitation on the number of warnings was quietly snipped off and deposited in the waste basket. This action thus served notice on all concerned (including any judge who may become intrigued about "minor" violations) that its administrator is instructed to continue in perpetuity to issue warnings "Please not to do it again" -to the same offender for the same offense no matter how dangerous to the lives and health of the public that offense might be. Possibly the crowning use of the false allegations about the improved protection afforded the public by the Copeland law was made by Senator Alben W. Barkley, majority leader of the Senate. On July 5, 1938, Senator Barkley indicated that Cope.land's law was better than Wiley's because food standards were not amenable to control under the old law. At this distance it is difficult to judge whether Senator Barkley did not know, or did not care, what he was talking about. No bets were overlooked, and no methods were too low for those who emasculated the food and drug law for the benefit Of Farben's American drug front. In the final stages of the fight, the New Jersey Medical Society asked for a public bearing to present and discuss its objections to the Copeland bill. At the same time, the drug lobby, beaded by Sterling's Frank Blair, requested a private hearing. The drug lobby got its private hearing -from Clarence Lea, chairman of the House of Representatives Committee. The Medical Society was refused any hearing whatsoever. When the Copeland bill finally became law, the job of establishing suitable regulations for its enforcement arose. And it began to dawn on those most concerned that as no one had the slightest idea of what many of its provisions meant, and as enforcement officials were now possessed of heretofore unheard of discretionary powers, there was danger that the new law would turn out to be a boomerang. So Commissioner Campbell was persuaded to appoint, as his "technical consultant," the man who had drafted the bill for Senator Copeland, Mr. Ole Salthe; he, at least ought to know what it meant. Mr. Salthe, by now operating his own commercial consulting business as a successor to the late Senator Copeland, took the job and then proceeded to seek clients by advertising, his services as an official of the Food and Drug Administration. And please don't say he couldn't do that-he did! Under the language of the Copeland law all new drugs would surely be safe because they would have to be inspected and approved by the Food and Drug Administration before they were put on the market. So early in December 1940, the Farben-Sterling subsidiary, Winthrop, shipped some 400,000 tablets of a newly developed drug labeled Sulfathiazole, which at that time was the most recent modification of the original sulfa germ destroyer, Sulfanilamide. Sulfathiazole Winthrop had been approved by the food and drug official in charge of new drugs, one Dr. J. J. Durrett, who some years previously had called on one of the foremost physicians of his generation and threatened him with dire consequences should he testify before a Senate committee about the lax enforcement of the Wiley law. However, as it was later revealed, Dr. Durrett's approval did not mention the "inadequacy of controls" which existed in the Winthrop factory. The 400,000 tablets labeled Sulfathiazole were a mixture of the germ-destroying sulfa drug and the remedy called Luminal, which puts people to sleep. Some of these tablets contained more than five grains of Luminal, the usual safe dosage of which is one grain. So, during the next three months, numerous patients to whom the Winthrop tablets were administered did go to sleep-and never woke up! Whether any of the Winthrop staff actually knew that the tablets were adulterated when they were shipped-or whether someone mixed the ingredients deliberately as sabotage-has never been revealed. The fact is admitted, however, that the Winthrop management knew about the adulteration very shortly after the shipments went out-when complaints came in from physicians in Louisville, Ky., and analysis revealed the admixture of Luminal. Yet the Sterling-Winthrop executives did not issue any public warning to the pharmacists and physicians who were dispensing and administering these deadly tablets. Instead they instructed their personnel to repossess the tablets, giving as the utterly false reason that, "they do not disintegrate properly." Then began a publicity campaign to push the sale and use of Winthrop Sulfathiazole�a campaign which had the cooperation of Dr. Morris Fishbein, in the Journal of the American Medical Association�a procedure completely unbelievable, if the record did not prove it. On January 25, 1941, the journal announced that "Sulfathiazole-Winthrop, U. S. Patent applied for" had been accepted by its Council on Pharmacy and Chemistry for inclusion in its official volume of New and Nonofficial Remedies., (Possibly it should be stated here that a vast majority of members of the medical profession regard this "acceptance" of a new remedy as a solemn guarantee to them by the officers of their national organization that an investigation has been made and that the product could be relied upon for quality and efficacy.) For good measure, and in that same issue of the Journal, there appeared a scientific treatise on Sulfathiazole, with a footnote indicating that its authors were research workers for Winthrop, and were advising the drug authorities at Washington on the subject. And finally, as though to make certain that no reader would miss the good news, the journal carried a full-page advertisement: "Sulfathiazole Winthrop Now Accepted." Included was the shield of the council, and the added legend, "Winthrop Chemical Co., Pharmaceuticals of Merit for the Physician." On February 1, and March 15, this advertisement of Sulfathiazole was repeated. In any event, it was not until April 3, 1941, that the Winthrop Chemical Co. issued its first warning to the public and the medical profession that some of its Sulfathiazole tablets were not safe to use because they were "accidentally contaminated." The return of any tablets which were still outstanding was requested and, to indicate a suitable appreciation of its public responsibility, the company also expressed its profound regret at the occurrence. The Winthrop warning was an anticlimax. The real warning had come a week earlier, on March 28th, when state health and pharmacy departments, and local police authorities all over the United States, began sending out notices to hospitals and druggists not to dispense any more Sulfathiazole. Meanwhile, in March, and shortly before the Sulfathiazole story broke, Dr. Durrett transferred his services to the Federal Trade Commission to become its authority on medical advertising. According to Drug Trade News, the industry highly approved the way he had handled new-drug applications under the Copeland law. Dr. Durrett's work as new-drug supervisor was taken over by Dr. Theodore G. Klumpp, head of the division which inspected, sampled, and tested all drugs. Dr. Klumpp's inspectors do not appear to have done much inspection, sampling, and testing on the Winthrop shipments. Seventeen deaths were reported by physicians as apparently due to administration of these tablets during the three months of the concealment, no computation was possible of those who were injured but stayed alive. In April, when the various official state and federal agencies completed their search of drug stores and hospitals, a hundred thousand tablets, or 25 percent of the December shipments were still missing, and unaccounted for�except by the deaths. Food and Drug Commissioner Campbell issued a statement. He declared that the actions of the Winthrop Chemical Company, after it discovered that the tablets were in circulation, "had not been satisfactory." "The company," said Mr. Campbell, "had known of the situation in December, but the government was not informed until March 20th. The failure of the responsible officials of the Winthrop Chemical Company to notify the Food and Drug Administration immediately of this incident, has as yet not been satisfactorily explained." Apparently an explanation that satisfied Mr. Campbell was made later, because he never took any action to hold the Sterling-Winthrop executives responsible in court, either for having filed a false application for a new drug, or for having permitted adulterated tablets to be manufactured and shipped; or for conspiring among themselves and with others to conceal the adulteration while they were advertising to the medical profession the alleged guarantee of Dr. Fisbbein's Council on Pharmacy and Chemistry. However, as we have seen, the Copeland law does not require the administrator to ask for an explanation; it merely authorizes him to do what he thinks desirable. And, if he should decide that a deliberate silence which resulted in seventeen deaths was a minor violation, be might also decide, lawfully, that a letter of warning was sufficient. Again, we have to consider that Circuit Court decision of December 1942 which held that under the Copeland law executives and employes of a corporation like Sterling could not be prosecuted, no matter what they did. Perhaps Mr. Campbell saw that decision coming, or perhaps Mr. Ole Salthe, his technical consultant, advised him that it would be useless to try those responsible. Whatever the reason, the executives were never taken to court. The Winthrop Company, however, was prosecuted for some of the shipments, and, after pleading guilty, was fined $15,800; which sum about equaled the selling price of the 400,000 tablets. Strangely enough, at the very time when the gentle action against Winthrop was filed in December 1941, a little-known consultant for a new skin remedy was indicted in Washington on a charge of falsifying the application he had filed with the Food and Drug Administration. When this individual failed to make bail, he was arrested and lodged in jail. Evidently Mr. Campbell did not believe that that particular violation was a minor one�the remedy was said to have damaged the livers of animals used in experiments with it. Commissioner Campbell also rejected the thought that such crimes as leaving too many cherry pits in a can of cherries should be classed as minor violations of the Copeland law. In a bulletin issued just at the time of the Sulfathiazole expose', there were notices of successful court actions against canned cherries because they bad more than one pit per 20 oz. tin; canned peas because they were not immature, canned tomatoes because the pieces were too small, and canned apricots because they were not uniform in size. Perhaps this is an appropriate time to point out that the Copeland law is so powerful an instrument for the public health that certain, of its sections also forbid, and permit severe punishment for, adulterating horseshoe nails, and misbranding ladies' brassiers; and if Mr. Campbell or his successor Dr. Paul Dunbar, really got bet up about it he could prosecute a dealer in pigs nose-rings because the premises where the rings were stored were unsanitary (Doubters please see sections 201 (h); 301 (a) (b); and 501 (a) (1) and (2), Federal Food, Drug and Cosmetic Act of 1938). On April 22, 1941, Winthrop's license to ship Sulfathiazole was revoked. Three months later it was restored, and the company promptly reduced its prices on Sulfathiazole Winthrop, with the announcement that the tablets were again for sale as Pharmaceuticals of Merit for the Physician." Dr. Klumpp, by this time, had moved onward and upward. He had accepted a position awarded him by Dr. Fishbein and become Director of the A. M. A. division on food and drugs and secretary of its Council on Pharmacy and Chemistry (the same council that had "accepted" Winthrop's Sulfathiazole and approved its advertising). And Dr. Klumpp kept moving. Not long thereafter, Edward S. Rogers, chairman of the Board of Sterling Products, announced that Dr. Klumpp had been elected president of Winthrop. One aftermath of the Sulfathiazole affair belongs in this story. The first expose came just when the Antitrust Division of the justice Department was starting its grand jury investigation of Sterling and Winthrop. When I mentioned the adulteration and its concealment to one of the staff he advised me to "keep my shirt on,. as drastic action was on the way. This was before he and his colleagues had felt the full weight of the Corcoran big toe. Time went on and there was no indication that the justice Department would act, so I placed the matter squarely up to Federal Security Administrator Paul V. McNutt, to whose authority the Food and Drug Administration had been transferred in 1940. He advised me that an information had been filed against Winthrop and that he considered further discussion unnecessary, as I had already been in correspondence with the Justice Department about it. McNutt indicated full approval of Commissioner Campbell, and was just not interested in the Farben-Sterling conspiracy angle. Later, in July 1942, a forthright member of the Justice Department staff indicated his agreement with my conclusions about the guilt of those involved in the concealment of the adulterated tablets and in my presence gave instructions that the case should be reopened on the basis of the statute which covers conspiracy against the United States. At his request, I submitted a brief outlining all the circumstances involved. The brief cited several conspiracy actions in which jail sentences had resulted for such crimes as conspiring to ship oleomargarine as butter and mixing olive oil with a cheaper product. A few weeks later that particular member of the justice staff was no longer holding down that particular job. I was told that he had resigned. That Winthrop case was not reopened. In February 1944, long after an alleged "housecleaning," Winthrop was again in serious trouble with the Food and Drug Administration when the latter seized and destroyed several thousand cartons of Winthrop ampules labeled as containing "Atabrine Dihydrochloride" and "Sterile Distilled Water," but which were found to be adulterated. These ampules were to be used by physicians for hypodermic injections. Three months later Winthrop was again prosecuted criminally, charged with shipping adulterated ampules as above noted, and others containing "Neoarsphenamine" and "Dextrose" (the latter being used respectively for treatment of syphilis and as a diluent for "Pontocain," for spinal anesthesia). When this prosecution was filed in the New York Federal Court the United States Attorney in charge announced that batches of the ampules had been picked up in navy hospitals and army bases; that more than 90,000 ampules and other packages had been recalled; that the damage apparently was due to lax control and failure at the Winthrop, Rensselaer, N. Y. plant to keep the apparatus clean, and that the situation had been uncovered when seven persons-one of whom died-showed unusual symptoms after receiving spinal anesthetics containing a Winthrop solution, Other hospital patients were adversely affected, said the prosecutor, and he concluded that the possible fines in the case could total $120,000, if the company were found guilty. Winthrop's Dr. Klumpp immediately denied the charges in vehement public statements, then a few months later the company changed its plea to "Guilty" and took a fine�nicely marked down�of $18,000. Shipments of these adulterated ampules were found in numerous states as far west as California in 1943 and 1944. And during the period of these seizures, but before the criminal prosecution resulted in publication of the affair in the lay press, Dr. Fishbein's journal of the A. M. A. was repeatedly publishing full page advertisements featuring Winthrop products -including "Winthrop" Atabrine Dihydrochloride, winner of the Army and Navy "E" flags; with which competent medical officers responsible for the health of our armed forces have seen to it that every soldier, sailor and marine will have the fullest protection against malaria that modem methods can afford. In appraising these two Winthrop cases, as the design may appear to fit into the pattern of Farben, the reader is now asked to look back. This time the story returns to an earlier war, when the Kaiser's armies were fighting in Europe, and the German espionage and propaganda machine in the United States was under the direction of Bayer's Dr. Hugo Schweitzer. It was then, in 1915, that the United States was also faced with an immediate internal peril because imports of the supply of another important new drug, Salvarsan, had been cut, off along with other medicinals and dyestuffs. Salvarsan, the Hoechst trademark for the product arsphenamine, or arsenobenzol as it was then known, had been one of a number of important medical products imported by Herman Metz. As the only known remedy for syphilis, it was indispensable in this country for the public health and for the efficiency of our armed forces. In June 1917, after this country had entered the war, Dr. George Walker of the Council on National Defense appeared before the Senate Patents Committee to urge that Salvarsan patents be abrogated. Metz, after threatening patent suits against new makers, was finally compelled to renounce his German friends' determination that his country should "starve to death" for vital drugs�to use his own expression�and began to produce Salvarsan himself, through the Metz Laboratories. He also was compelled to permit several other concerns to begin commercial manufacture. However, the shortage was not relieved until after the Federal Trade Commission and the Alien Property Custodian had seized all of the Hoechst patents, and granted licenses to several concerns to manufacture arsphenamine. While the design may vary with the times, the Farben pattern never changes and so we find that the adulterated Sulfathiazole of World War II had its counterpart in World War I�when adulterated arsphenamine made its appearance in the United States, and Metz cabled Hoechst: "Spurious and infringing products simply flooding market." At that time, too, there was no direct proof that the adulteration was deliberate. Another important U. S. patent owned by Hoechst covered the local anesthetic, procaine, protected under the Hoechst trademark as Novocain. Other patents covered antipyrine, the first coal-tar headache cure; and phenacetin, the shortage of which for treatment of influenza had also caused much unnecessary suffering. Two of the other Big Six German dye companies held numerous U. S. Patents on important medicinals. One of these was Kalle which controlled the remedies known as Bismon, Formicin, and Menthol Iodol. Bayer controlled Aspirin (until 1917 when the U. S. patent on acetylsalicylic acid expired) Luminal and Veronal. The last two were also made in the American Bayer plant. When World War I broke out, all of the above and many others, were among the "accepted" new and nonofficial remedies of the A. M. A. Council on Pharmacy and Chemistry. At that time the real boss of the A. M. A., and chairman of its Council was "Doctor George H. Simmons, the charlatan whose name remained on the masthead of the journal of the American Medical Association until he died in 1937. When Simmons withdrew from the limelight in 1924, and Dr. Fishbein took his place, the German I.G. Dyes owned the Big Six and its drug fronts here had been Americanized under the names of Sterling, Winthrop and the Bayer Co. of New York. The names, but not the pattern, had changed. There is no implication here that some of the German dye-trust medicinals thus "accepted" by the A. M. A. Council are not useful in the relief of human sufferings. The most objectionable feature of these acceptances is that they made it possible to charge excessive prices, and that the resulting tremendous profits were used to help finance subversive activities in the United States before and during two World Wars. Also, the A. M. A. guarantees served as a cover for violations of the food and drug laws, and the false advertising laws long before the Sulfathiazole affair. Many of these violations by Farben affiliates remain concealed in official files where they were placed by Mr. Campbell, in "permanent abeyance," and without court action. However, some did reach the light of day. For example, in 1928, shortly after the Cook Laboratories came into the Farben-Sterling-Metz family, a prosecution was started against that company for having shipped a long list of so-called ethical and official remedies which were adulterated and misbranded under the Wiley law. For years this case was shelved, and ignored by all concerned. Then, in 1932, something slipped. Cook Laboratories pleaded guilty, and was fined $750. The penalties, under the Wiley law, could have been more than $5,000 and a good many years in- jail for some of the executives. Meanwhile, Cook Laboratories' remedies remained in the New and Nonofficial list as "accepted." In 1936, in California, a criminal prosecution was brought under the Wiley law for shipments of adulterated Amidopyrine tablets, Novocain ampules, and another medicinal by a local company which pleaded guilty and was fined. The Novocain ampules were identified as the Metz Laboratories' brand, and the charge was that the ampules contained a greater quantity of Novocain than the label stated (i.e., an overdose). Why the prosecution was brought against the shipper instead of Metz or Winthrop was not explained. It seems preposterous that the U. S. Patent Laws could have been utilized to injure the public health and the health of our armed forces before and during World War I. Even more outrageous it is that precisely the same thing has been allowed to happen in this war-when the Farben-Sterling ownership of Winthrop used its patents on Atabrine to restrict the production of that remedy for malaria after Japan had cut off our supply of quinine from the Dutch East Indies. The history of the drug called Atabrine goes back to the experiments of the young English chemist Perkin almost a century ago, as mentioned in Chapter 1, when the attempt to make synthetic quinine from coal tar resulted in the discovery of coal-tar dyes. It was in 1927 that Farben chemists first thought they had perfected quinine synthesis from a coal tar base. However, this product, called Plasmochin, was only partially efficient for malaria control; it did kill the germs but it did not cure the disease. So the research continued and Quinacrine Hydrochloride, now sold as Atabrine, was discovered some five years later. In the early thirties Atabrine was introduced in the United States as a Winthrop product. But it was made by Farben�all Winthrop did was to put it in ampules or to compress it into tablets and distribute the new remedy under its own label as made in America. It should be unnecessary here, to go into the history of malaria from the time when its epidemics played a part in the destruction of Athens and Rome, to its present ravages upon the health and lives of a large percentage of the world's population. According to the National Institute of Health it is estimated that under normal, or pre-war conditions, not less than 500,000,000 persons suffer yearly from malaria. Others estimate that one-third of the population of the globe is afflicted with this disease. As illustrative of its importance to the national defense, the annual report of the Surgeon General of the United States Army in 1941 indicates that hospitalization of enlisted men for malaria in Panama and the Philippines has been well over 100 for each 1000 stationed there. Under these conditions the grave danger to the health and efficiency of thousands of men in the Army and Navy, many of whom were never previously exposed to malaria, is obvious. It may be added that this story is not the place to present or argue the merits of Atabrine as compared with quinine. It is necessary, however, in appraising its place in the Farben pattern, to record the fact that a wide discrepancy in medical opinion has been revealed regarding the merits of Atabrine as a malaria remedy. Possibly the highest point in the controversy is to be found in a voluminous treatise on the subject by Dr. Aubrey H. Hamilt on, Lieutenant Commander in the United States Navy, who returned, to Washington when the war started, after twenty years of clinical observations of the incidence and treatment of malaria in the tropics. The treatise was prepared and published under the auspices of the Board of Economic Warfare and the Department of Commerce. In it Dr. Hamilton left no doubt as to his own findings, and those of numerous other medical men, that Atabrine, as it was then made, presented no advantages over quinine in the treatment of malaria, and had certain toxic properties which had to be eliminated through change in its formula before its final acceptance as anything but an emergency substitute for the older remedy. Back in 1935, when Atabrine was first being tried out in the United States on a large scale, medical authorities reported that mental disturbances followed its use. The public relations experts of Sterling neither conceded this fault possible nor mentioned it, They contented themselves with statements issued either directly or through sources not readily identified as friendly which enlarged upon the tremendous expansion made in Winthrop's production of Atabrine for national defense purposes, and the reduction in selling price to a figure less than one-tenth of that which was charged before the war (and before the subversive tie-up of Winthrop with Farben was officially exposed). One notable example of this kind of publicity was a-full-page Winthrop advertisement in the daily press and various lay journals in December 1942 and January 1943 proclaiming the receipt of the Army and Navy "E." One Joseph Jacobs, head of an advertising organization, then sent out full size reprints of this advertisement to professional men. Mr. Jacobs also made similar distribution of copies of a letter addressed to him by Edward S. Rogers, Sterling's Chairman of the Board, in which the latter dwelt upon the foresight of Winthrop in starting to make Atabrine in October 1940 out of domestic raw materials (when they no longer were obtainable from Farben) and in increasing the production (when the government so instructed). The Rogers letter, nine long pages, proved the case for Winthrop by references to praises which had been heaped upon its performances by various individuals, including Dr. Morris Fishbein, who was to preside at the Army-Navy "E" ceremony and by Dr. Paul de Kruif, the author, who had just published an article in Readers' Digest which lauded Winthrop's Atabrine as a major victory for the United Nations. By something of a coincidence the Rogers reference to the Readers' Digest article was being circulated among anti-Farben professional men at the very time that I was in correspondence with de Kruif about that same article. I had written him on December 24, 1942, to ask whether his source of data was the Sterling-Winthrop press agent, one Mermey of the firm of Baldwin, Beech and Mermey (of whom more later). I also asked Dr. de Kruif whether he was familiar with the official record of Winthrop's lack of manufacturing integrity as illustrated by the Sulfathiazole horror; or of the relations of Dr. Fishbein with Winthrop; or of the pro-Nazi interests of the Sterling-Winthrop personnel. To my surprise and gratification, de Kruif replied on December 31, 1942 that he had sent my serious charges to his friend Dr. T. G. Klumpp, President of Winthrop: I shall forward his reply to you when it comes. I am asking him to answer your charges one by one and in detail. For the moment I thought I had drawn a bit of blood. However, something, or somebody, caused Dr. de Kruif to change his mind. In a later letter he intimated that I was being influenced by the Dutch quinine syndicate (which was a rather absurd assumption), and he resolutely declined to advise me what reply Dr. Klumpp had made to him relative to my accusations about the integrity of Winthrop, its manufacturing record, its officers and its employees. Later it was recalled to me that Dr. de Kruif had been an early propagandist for Winthrop and Farben's Atabrine, back in 1938, when he published an article in the Saturday Evening Post which boasted of the triumph of the German dye trust in producing a new medicine so much better than quinine that it was no longer a question, "whether we can wipe malaria out of the United States," but, "will we?" (It appears that either we could not or we would not). Meanwhile a battle in official circles to force open the Farben patent on Atabrine had resulted in bitter clashes between the administration officials of the highest rank at Washington, and efforts in the Senate and the House of Representatives to conduct an investigation of the matter had resulted in threats and other types of coercion to prevent exposing the fact that the supply of this important medicinal was not all that it should have been. Senator Bone, Chairman of the Senate Committee on Patents, announced to the press on April 12, 1942 that the bearings which were to begin next day into restrictions on the use of Farben-owned patents would include the subject of synthetic quinine. But Senator Bone was in error. He was never permitted to open up his hearings of any feature of the Farben tie-ups with Sterling or Winthrop. His hands were tied although his committee subpoena reached into the Anti-Trust Division of the justice Department and seized over twenty-five thousand documents from the Sterling files and elsewhere, which revealed the details relative to Atabrine, as well as other facts which had been pigeonholed in September 1941 when Mr. Thomas Corcoran succeeded in choking off the justice proceedings against Sterling. In August, over the vigorous protest of Senator Bone, five other members of the Patents Committee voted not to permit its Chairman, and its two-fisted incorruptible counsel, Creekmore Fath, to produce a single witness, or document, relating to Sterling and Winthrop at a public hearing. Having been requested to assist the staff -which was assembling the evidence, I watched with indignation these efforts to strangle the hearings. The five members of the committee who yielded to the persuasions of those who were determined not to have the Sterling-Winthrop situation disclosed, were Claude Pepper of Florida; D. Worth Clark of Idaho; Scott W. Lucas, of Illinois; Wallace H. White, Jr., of Maine; and John A. Danaher of Connecticut. One of these five, Senator Pepper, prior to the vote which tied the hands of Senator Bone, received an appeal from the Non-Sectarian Anti-Nazi League to continue the hearings of the Patents Committee on the "patent and cartel connection between American concerns and Axis interests until all pertinent facts have been uncovered." Senator Pepper replied: Appreciate your message and am sure that investigation will be all-inclusive before it is finished. Regards. The Senator, according to Thomas L. Stokes in the World-Telegram of August 6, 1942, was a friend of Mr. Thomas Corcoran and the latter ..... is proudly wearing another feather in his cap as a super lobbyist. He who once started Congressional investigations has now stopped one-one that was due to produce sensa-tional revelations about a corporation with former German connections, which he has been protecting from the govern-ment. The Stokes article went on to describe two turbulent sessions of the committee in which Thurman Arnold, who had been so hot after other German cartel affiliates, took a very different position as regards Sterling Products, and favored dropping the investigation. Said Mr. Stokes: So did Undersecretary of War Patterson who sat with the Committee, along with Leo Crowley, Alien Property Custodian . . . . . Suppression of the Sterling investigation climaxes one of the most amazing examples of "inside baseball" ever seen here. Suspicions were aroused that high administration officials were trying to duck the inquiry when Mr. Crowley was asked to testify about Sterling with particular reference to the synthetic quinine monopoly which one of its subsidi-aries, the Winthrop Co.�still owned 50% by I.G. Farben- industrie-possess by virtue of its control of German patents- Mr. Crowley kept postponing his appearance. Despite earlier assurances that he was going to take over the substitute qui-nine patents and release them generally'. . . . . he never did . . . . Questions in a public hearing might have proved em-barrassing. So he never did appear. Another short-lived effort to force out the facts about the Atabrine supply was begun by Republican Congressman Bertrand W. Gearhart of California who made a brave start to accomplish this purpose in the House of Representatives on August 13, 1942, with a ringing speech on the Atabrine production in which he criticised what he called the dark curtain of mystery which had hung over the subject. Gearhart minced no words and ended his remarks with several queries: Therefore, Mr. Speaker, I ask what is being done to meet this critical situation? What is our supply? Has the free flow of this indispensable medicine-quinine and its substitutes been interfered with . . . . . ? Is it true that our soldiers, sailors and marines are today threatened with disablement because of a scarcity of this indispensable medicine? What are our war leaders doing about this all-important problem? The American people are entitled to know and to know right now. The Congressman stated to me, and to others, that he proposed to continue the fight until an investigation should result, but the subject of Sterling and Winthrop and Atabrine was from then on definitely verboten in the House and Senate of the United States. Perhaps the most inexplicable aspect of the throttling of these Sterling-Winthrop investigations was the part played by Mr. Arnold in his official capacity, as compared with his caustic remarks in private, and, on one occasion, in public. In the Atlantic Monthly for August 1942, Mr. Arnold published an article relative to reform of the patent law which he considered necessary and in this he discussed the control of the Atabrine patent by I.G. Farben as: The spectacle of the production of this essential drug, left so long to the secret manipulation of a German-American combination during a period when Germany was preparing for war against us, is too shocking to need elaboration. Shortly after Mr. Arnold had made this vigorous statement he was himself sitting in with the hush-hush Senators in the Patents Committee. About this time I was taken to the office of the Alien Property Custodian by a member of the Justice Department staff, and requested to give them such assistance as my knowledge of the Farben situation might permit. I was informed that the Custodian had seized 50 percent of the stock of Winthrop but had 100 per cent control over its Atabrine patent. Also. that a contract which had been given to Merck to make Atabrine constituted a license (which it did not), and that no further licenses would be given because there was no necessity for them. Several other rather peculiar allegations were made to me on that visit. Six months later, after rather extended and unproductive correspondence with the members of the Custodian's staff I paid another call at that office. And as the acute shortage in the supply of Atabrine had by then reached a critical stage, I asked what they proposed to do about it. I was informed curtly that there was no shortage; that Winthrop was producing all the Atabrine that was needed; and that anyone who made such a statement was, in plain language, a liar. However, at that time it wag common knowledge in Washington that a shortage did exist, and that allotments of this vital drug for the Army and Navy, and for the extension of malaria control in Latin America, had been necessarily reduced. Several months previously then Surgeon General of the Navy, Rear Admiral Ross T. McIntyre, issued an urgent appeal to the pharmacists of the United States asking them to collect and donate all available supplies of quinine which they might have in reserve stocks in their dispensaries. In that appeal Admiral McIntyre made this statement: Although Atabrine is a very valuable antimalaria drug, there are many individuals in whom quinine is still the drug of choice and in certain cases it is life-saving and cannot be replaced by synthetic drugs . . . . . . the need for more quinine is becoming increasingly urgent as the number of men fight-ing in malarial regions increases and the stock pile dwindles. Under these circumstances something had to give way, even though the most serious aspects of the shortage were given no official publicity. Beginning in January 1943, long after the short-age had become acute, arrangements were made quietly by which ten other manufacturers were instructed by the government to begin at once the production of Quinacrine Hydrochloride: some to make the base material; others to process it through the inter-mediate steps; and others to put it into tablets for distribution to the armed forces, and as Lend-Lease supplies for Latin America. The new Atabrine mess rescue squad now included, in addition to Merck, the following: Abbott Laboratories, American Home Products Co.; Hilton Davis Co.; Eli Lilly & Co.; William S. Merrell & Co.; National Aniline & Chemical Co.; Pharma Chemical Corp.; Sharpless Chemicals Co.; E. R. Squibb & Sons, and Frederick Steams & Co. None of these were given licenses permitting sale to the public, This monopoly was still reserved to Winthrop. The newcomers were merely given contracts to contribute to the huge government requirements for Atabrine which Winthrop had failed so tragically to supply. It is of interest here that among those thus invited to participate in the official Atabrine pie were concerns which allegedly have had relations with I.G. Farben or with Sterling. Next to Sterling, American Home Products was the largest Patent medicine and cosmetic combination in the country, the Weiss and the Diebold families have been among the largest stockholders. The Merrell company is owned outright by Vick Chemical, one of the Farben-Sterling affiliates in Drug Inc. Abbott and Squibb were reported to have had negotiations with Farben during the Drug, Inc., period; while National Aniline & Chemical, with its owner, Allied Chemical and Dye, were both among those indicted in 1942 for conspiracy with I.G. Farben in the dyestuff industry. And the hush-hush continued. One F. J. Stock, a division chief of the War Production Board, who handled the Atabrine expansion program, felt the strange necessity of keeping the whole af. fair an official secret. After several letters on the subject, Mr. Stock finally replied. On May 31, 1943, he wrote me that: A number of the most reputable drug companies are producing Atabrine. We do not, however, normally make available names of producers of critical items . . . . . Supplies are sufficient to meet Army, Navy and Lend-Lease requirements, as well as export and domestic civilian use. WhiIe the shy Mr. Stock refused to name his "most reputable drug companies," their identity was known throughout the trade; as was the undercover row which had been stirred up by the Alien, Property Custodian's endeavor to protect Winthrop's monopoly on the quinnine substitute, regardless of the needs of the Army and Navy. The War Production Board was not the only official agency which appeared reluctant to reply to queries about the Atabrine mess. Among others who declined to comment were the Federal Security Administration assistant, Mary Switzer, who, as ruler over the Public Health Service, had discussed the subject with me back in July 1940. At that time she told me the medical men in Public Health Service were expressing alarm because of the exclusive control the Atabrine patent by the Farben-Sterling-Winthrop management. Three years later, when the alarm had been vindicated, Miss Switzer chose not to discuss the subject. The National Research Council, which might be considered an official and, therefore, disinterested party to the Atabrine controversy, also refused to express an opinion or even to admit having one. Herr Goebbels himself could not have improved upon the way someone-perhaps Mr. Corcoran-enforced the verbo ten order on all public mention of bow Winthrop bad failed to make good. As an aftermath of Vice President Henry Wallace's fights with Jesse Jones on the quinine shortage and with Leo Crowley on the Atabrine shortage Wallace was vindicated on both scoresand then was fired from his job as Chairman of the Board of Economic Warfare after the row between the Vice President and Jesse Jones resulted in the President being persuaded to turn the whole mess over to Leo Crowley in July 1943. Why Mr. Wallace, the official who was right on Atabrine was made the victim of Mr. Crowley the official who was wrong on Atabrine is one of those things yet to be explained. The humiliating record shows Sterling-Winthrop executives, while boasting publicly of Atabrine as better than quinine, and of their huge production as saving the nation, were still entrenched behind the Farben patent and secretly refusing to permit others, to utilize ample facilities for production and research, which Winthrop lacked, to supply the quantities neede d and to correct admitted defects in the formula. The record likewise shows high government officials, charged with the duty to provide Atabrine to our armed forces, instead were secretly permitting this gross misuse of our patent law and defending Winthrop against all comers, while publicly they covered up the facts-and the disaster that resulted. The horrors of war are usually remote to those who remain at home. However, to the soldier or sailor whose life may have hung in the balance there could be nothing remote or abstract in the story of Atabrine. To those who may feel it difficult to appraise properly the significance of these facts about Atabrine it is suggested that they project themselves, in thought, to a hospital cot, or a foxhole, in the jungles of Asia or the South Pacific; racked with malaria and near death-as result of a wartime shortage of quinine or an insufficient supply of the only quinine substitute; which deficiency may have been caused by some one at the nation's capital who was aiding in the protection of alleged patent rights of I.G. Farben and its allies. Perhaps, some day, as one result of the part played in the last war by Farben, and by Farben's allies, will come a demand for new definitions of the words "enemy" and "treason." pps.202-227 ----- Aloha, He'Ping, Om, Shalom, Salaam. Em Hotep, Peace Be, All My Relations. Omnia Bona Bonis, Adieu, Adios, Aloha. Amen. Roads End <A HREF="http://www.ctrl.org/">www.ctrl.org</A> DECLARATION & DISCLAIMER ========== CTRL is a discussion & informational exchange list. 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