Document jNDroBdJVag7XB61r80gRNvk5

R&S 106996 BIO-MEDICAL RESEARCH DOCUMENT DESCRIPTION FORM 63 68 69 76 Duplicate in all cards:--> 0000099 year as-1961- File number [Right justify [Numeric only] Author(s), as Last Name FS (No Punctuation) and coden for journal as JAMA preceeded by one blank space 1 f/r % 20 21 AO 41 __________ 77 78 Sub-Index Code 60 61 62 11 12 13 Title of Report; end with space-hyphen-hyphen-space. Follow with Index Terms, separated from each other with comma-space. Avoid other punctuation; do not abbreviate. 12 61 62 't' s' ' /Vi, ^ fv 21 22 / ', 23 y 24 Source (Journal, Vol., Number, Pages, Date ) 12 M,. / /- 61 62 31 32 Brief Summary 12 10 SUMMARY: 61 62 61 62 63 64 NEW ETHICAL PROBLEMS RAISED BY DATA SUPPRESSION The scientific community in the past has been a lead ing example of the success of ethical self regulation. While it is true that there is an occasional case of fraud or falsifying data, by and large the system has been effec tive. Whether because of the integrity of scientists or because of the fact that most important findings are re tested and verified, scientists seem to have had fewer major scandals than many professions. Now, however, a new set of ethical problems is raised by the withholding of daik on industrial products or conditions from regulatory' agencies. The scope" of "law setting standards for industry now includes environmental and occupational conditions as well as consumer prod ucts, food and drugs. Most such legislation was passed over the intense opposition of industry', which often must perform the tests, pay the bills, and sit cut the expensive delays while Federal agencies make up their minds. It is no surprise that companies sometimes seek to circumvent their legal obligations to meet standards. Pressures on Industrial Scientists Have Increased The pressures on scientists have increased for these reasons and because research has become a larger com ponent of the competitive edge in many industries. Their tacit approval is implicit in deceiving a regulatory agency, and how many industrial scientists can resist the pres sures that can be brought to bear by management? Stilt rarer is the scientist who can bring himself net cnlv to refuse to be a party to the suppression of data, but also bring his results to the public's attention. One of the greatest sins in science has always been the deliberate falsification of data. Those who commit it are subject to ostracism and other informal but devastating sanctions. Sins of omission are just as culpable in law and common morality as those of commission: they can rouse even more contempt because of the cowardice they show. Yet industrial scientists who fail to challenge con spiracies of silence within their firms are not rebuked; rather, they are often quietly rewarded for their loyalty. The cthicai issues raised by acts of omission which re sult in falsification of data needed by a regulatory agency have been brought to the fore by the ease 01 \invi chloride. S.mply put, Manuiaeturing Chemists Association mem bers, including scientists, possessed data as early as Novem ber 1971 that vinyl chloride caused cancer in rats, espe cially the exceedingly rare and incurable angiosarcoma of the liver. This data was kept from the appropriate authori ties at the National Institute for Occupational Safety and Health (NIOSH) at least until July 1973. and probably until February 1974. Vinyl chloride is used ns a feedstock for polyvinyl chloride products, which range from ear interiors to phonograph records; until recent months it was also used as an aerosol propellant. Polyvinyl chlo ride (PVC) is the number two U.S. plastic in tonnage production f4.4 billion pounds annually); about one fourth of the world supply is made in this country. What harm was done by the suppression of data in this instance? Workers were exposed longer to limit .r con centrations of vinyl chloride titan they would have been if NIOSH had had full information. Those aifected in clude about 6500 people who produce and manufacture vinyl chloride, and about 1.5 million who process it. People who live near plants where it is used may also be harmed as a result; two have already been identified as victims of angiosarcoma, which is a red flag indicat ing exposure. According to Dr. Joseph Wagoner of NIOSH. the occurrence of cancer in fabricating plant workers ''points to the probability of low level exposure being obviously very hazardous." (Sixty per rent of the air samples NIOSH took in fabricating plants shower; concentrations of less than one part per million (ppm) vinyl chloride. The standard for workers was 500 ppm until April 1974.) Consumers might cvcn.be affected by seepage of vinyl chloride from polyvinyl chloride products. What follows is a rough chronology of some aspects of the vinyl chloride controversy (in boid face) wiih an accompanying discussion of some cthien' and practical considerations. (This Bulletin deais primarily vun 111csecond phase of the controversy, after Mahout's data were revealed to the industry's Manufacturin'.: Chermsrs Association, MCA. because the facts are more fuiiv known and thus the issues arc more dear cut.) In May 1970. preliminary findings by an Kalian in vestigator, Dr; P. L. Viola, were presented at a C.S. International Cancer Congress. He showed that extrcmciv high concentrations or tinyl chloride (30.1500 onml caused cancer in rats. These results were published in an Ameri can journal in t97J. F\en prior to these findings, it was a serious cr.u-.sion on the part of the plastics industry that vinyl chloride was never tested for carcinogenic and other properties. despite the fact that tens of thousands of workers were loutmely exposed to it. MCA did solicit research proposals or. VC --Continued on page 2 Page 2 NEW ETHICAL PROBLEMS--Continued from p. 1 1970, but no contracts were let until 1973. If strong ovisions for pre-testing of possibly toxic substances arc enacted by Congress (as discussed in the last Bulletin), and if they are strictly enforced, there should be no more similar oversights. This incident is one of the best argu ments for such legislation. Given the fact that no testing had been done previously: industry scientists would have immediately followed the European lead and tested vinyl chloride at lower con centrations--or at least sought to confirm Viola's findings --had they been thinking only of the public interest. But other factors prevailed. The route to advancement in in dustry is often what one author describes as "aggressive sclf-cfTaccmcnt." Scientists arc relatively low in the orga nizational hierarchy; if they want to get ahead, they must play by the rules. The counterweight of informal control bv the wider scientific community is often weak in industrial settings. Although scientists arc now considered to be responsible to society for the foreseeable consequences of their work, the industrial scientist has little or no control over the uses of his research. In this way, he is almost as isolated as an assembly line worker. For the scientists in question, the issue of their responsibility to society was blurred by the fact that they were faced merely by an expectation ot non-action; the same people might react very differently ^^ordcred by a vice president to falsify vinyl chloride But, to the worker with angiosarcoma, it makes little Tnffcrcncc whether the act is one of omission or com mission. A year after (he Cancer Congress, the Manufacturing Chemists Association brought Dr, Viola to this country. He revealed that other European studies were in progress, but refused to divulge the details according to MCA. Any scientist in the field could make the educated guess that they involved graduated smaller doses of vinyl chloride. But in terms of scientific ethics, Viola's refusal violated his obligation to the scientific community and to the pubic. He failed to honor one of the oldest and most firmly held norms of the scientific community, freedom of information. This failure can probably be explained by the fact that Viola was and is an employee of the plastics industry. No consideration should, however, have prevented Dr. Viola from disclosing at least the nature of the European studies. Even if he were willing to ignore his clear obli gation to share data with other scientists, he should have thought of the thousands of people routinelv exposed to a substance he knew to be carcinogenic. Other scientists could have, and apparently did not, bring these points to his attention; their infiuenee would probably have been fairly strong, since Viola had published in an Ameri can journal and presumably would wish to again. analysis above assumes that Viola remained silent. there is evidence that he toid MCA that concentra tions of 5000 ppm or less could cause cancer in lab animals. Ethical implications of withholding this data will be discussed below'. In any case, MCA decided to undertake its own re search, and in October 1972 plastics manufacturers who November, 1974 sponsored the European research offered to share infor mation--with strings attached. It was agreed that an MCA task group would reveal no information to anyone with out tile consent of European manufacturers. MCA should never have made such ,m agreement. It Hies m the face of its responsibilities to protect workers and the public and limits its scientists' rights to full and free information. Had the Association undertaken its own tests in May 1970 til the first sign of trouble, it would have had no need to obtain the results of European cxpeiintents under unethical strictures. It probably would have been possible to force release of the information simply by making the attempt at an undercover agree ment public; but MCA apparently was prompted by fellow feeling for sister industries and its need for data which it should have collected itself in the first place. Meanwhile, in August 1972, Dr. Cesnre Mnitoni of Bologna found angiosarcoma in experimental animals, and discovered (hat various tumors were produced at levels as low as 250 ppm. At that time the U.S. ceiling for human workers was 500 ppm. There is reason to --Continued on page 3 FAS Fund The FAS Fund is the research and education arm of the Federation of American Scientists, founded Iy46. The pur pose of the Fund is lo study tiie implications of scientific and social developments, to counter misinformation v, im scientif ic fact, to safeguard the spirit of free enquiry, and to strength en international cooperation, traditional among scientists. HOARD OF TRUSTEES George W. Rathjerts, Chairman Philip Mom^on Jeremy J. Stone Denis 11 lives Laurence I, Moss Herbert !;. York Mathew S. Mcselson Max Palcvsky Editor FAS Professional Hvliiun: Mary Fillmore SPONSORS (partial list) Kenneth J. 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WiiNnrt t Phvsics) Pohkarp Kuseh (Pluses) N \\ u ( P*n <j j? \ * W'tHis L-\ Lamb, Jr. t Pin sics) Alfred Ynnkauer t Medicine) WjsmIv W, Lcontief < Fennorrves) Herbert. F, York t Physics) * Frit? Lipnunn (Biochemistry) ] * I ! The FAS Fund publishes the FAS Professional Heilatin monthly except July & August at 3U7 Mass. Ave.. N.E., Washington. 20002. Annua! subscription S 15/year. (However, please note that members of FAS rcccise the Bulletin and the FAS Public Interest Report as veil as other membership benefits for a S20 annual fee.) Second class postage paid at Washington, D,C. R&S 106998 s November, 1974 NEW ETHICAL PROBLEMS--Continued from p. 2 believe Ihnt this level was exceeded in some plants. Dr. Mnlfoni later said that he believes that the results of these and other tests were predictive of the later dis covered effects on humans. Here the issue of sponsorship of research arises. While Dr. Maltoni is an academic, his research was paid for by the plastics industry. Had lie been acting on his own. it seems very' likely that he would have hastened to r :al and publish his data. Because he knew that humans ere being exposed to levels of vinyl chloride higher than those which produced cancer in animals, he bore a heavy' ethical responsibility to make the facts known. One of the present difficulties in getting research on hazardous suostanccs done is that only industry now has the resources necessary to perform it. Academically, meas uring dose response to a substance is often not very in teresting. In industry there is almost no incentive to lest hazards unless it is feared that information will otherwise be disclosed to the detriment of the company. If a strong version of the Toxic Substances Control Act, discussed in the last Bulletin, is passed, then industry will be re quired to do such research by the Environmental Pro tection Agency. On January 17, 1973, U.S. scientists representing the vinyl chloride and polyvinyl chloride industries visited Dr. Maltoni's laboratories to hear about his experiments in detail. They also spoke with the European sponsors of his research. These scientists had the opportunity to insist that the European companies reveal Maltoni's data. and. if they refused, to blow the whistle. The scientists claim that they had doubts about certain of Maltoni's procedures: for example, food was left in the cages, and thev thought that a substance formed by vinyl chloride and food might be responsible for the results rather than vinyl chloride it self. This would not be unreasonable except that, in Viola's findings, vinyl chloride was the culprit; in that light it seems a somewhat shallow objection. Even if the scientists took it seriously, they could have presented NIOSH with the data they had. along with a discussion of what they considered weaknesses in the experimental procedures. If the scientists had decided to take that step, or to make the data fully public, what would the likclv results have been? First and worst, they would probably have been fired. While the principle of due process (including hearings) in firing of state emplovees was affirmed in the case of three scientists who turned to FAS for help, it docs not yet apply broadly to corporations. Findinc other iobs in industry would be difficult or impossible for scien tists with records of "disloyalty." Realistically speaking, even whistle blowers who manage to avoid firing--or to be reinstated--"must anticipate that the employers will find some way to make them scramble for a livin':--and pay--after their treachery" (Blowing the Whistle. 1972, Charles Peters, cd.). The scientists would probably have found little meaningful support in the scientific commun ity; however much praise they received, it could not have been turned into a livelihood. Page 3 Their legal position would have been precarious. As Professor Arthur Miller has emphasized, generally "the law at present provides very little protection to the per son who would blow the whistle; in fact, it is more likel\| to assess him with criminal or civil penalties." The scientists could have taken the risks of firing and legal action to protect the public health, but they did not. The confidentiality agreement with European manufact urers may have constrained them, but it should not have prevented their acting as responsible scientists should. The agreement was made in violation of common scientific ethics, and the scientists should have felt no more bound by it than a person who is told about illegal activities in secret should feel obliged to keep his word. No Censure by Scientific Community Instead, they chose the path of least resistance, and ns a result have grateful employers and continue in their jobs. If the scientific community feels any outrage now that the case is widely known, it has not expressed it in any kind of censure. A civil suit for damages will never be brought against the scientists by a worker who alleges that he got cancer as a result of their withholding data from NIOSH. It could simply never be proved, especially since cancer takes decades to develop. Yet the moral fact remains that people were exposed for longer than neces sary to a substance which harms health more as the dose increases. (In fact, cancer can be initiated by exposure to a single molecule of a carcinogen.) Under the law. however, an individual could not make a case. Indeed, even if he could, he would sue the company, which is in sured and able to pay; the scientists themselves would not be punished. This discussion applies to civil cases; the legal position of these scientists with respect to pos sible violation of the law will be discussed below. Less than two weeks after the MCA visit to Maltoni. NIOSH requested (in the Federal Register) "information on potential hazards associated with occupational ex posure to 23 chemical substances and physical agents." including vinyl chloride. On the same day an MCA meet ing was held at which, in MCA's words, "a brief oral progress report was presented on Prof. Maltoni's work by those who had visited him. It was reported that, in experi ments with rats, in addition to tumors of the car canal, tumors of (he kidney and liver were observed at concen trations as iow as 500 and 250 ppm, but not at 50 ppm nor in the controls." This meeting widened the circle of scientists and others who could have blown the whistle and did not. The fact that their information was clearly covered by NlOSH's specific request makes tiicir remissness in not furnishing it all the more reprehensible. At this stage, it would not even have been necessary for a whistle blower to reveal his identity. He could have simply alerted NIOSH to the fact that something shady was happening, and leave it to them to discover the details. Apparently no one made even this timid gesture. On April 9-12, Dr. Maltoni discussed his results pub licly at the International Symposium on Cancer Detec tion and Prevention in Bologna. As it was a very minor --Continued on page 4 R&S 106999 Page 4 NEW INIMICAL PROBLEMS--Continued from p. 3 conference, no one from the U.S. government attended, ^ftd publication was still far off. March 7 MCA responded to the NIOSU request for information with a recommended precautionary label which made no mention of toxic elfccts on animals or people. Up to this point, the only harmful acts were those of omission; in making this response, however, MCA crossed the line into commission by deliberately misleading a Fed eral agency. The most that has happened as a consequence arc some embarrassing moments at public hearings-- hardly a deterrent when hundreds of thousands of dollars can be saved by inaction or deception. Under the Occupational Safety and Health Act. those who mislead the government in a document "hied or re quired to be maintained pursuant to this Act" may be prosecuted. But the NIOSH request was merely an "in vitation" to "submit" data; thus it seems unlikely that MCA's omission is covered. If not, this is a real gap in the enforcement provisions of this law. since the quality of standards promulgated depends heavily on having full information. Another major loophole is the lack of any clause that would have required MCA to submit the Maltoni data to NIOSH for review even before the Fed eral Register request. A case might arise, for example, in which industry discovered that a common substance could be hazardous, although no standards applied to md it was not under investigation. As the law now ds, industry would not be required to submit such un solicited data. On July 17, 1973 the Director of NIOSII and some of his staff met with an MCA delegation at their request. There is much dispute over what was and was not said at the meeting. The gist of (he quarrel is that NIOSH says no mention was made of angiosarcoma. Dr. Maltoni or his work; MCA says that. "NIOSH was told that vinyl chloride caused multi-sited primary tumors in rats at concentrations down to 250 ppm." Even if the latter allegation is true, the fact remains that MCA suppressed the Maltoni data for six months. They have attempted to explain this delay by saying that, in accordance with the confidentiality agreement with European manufacturers. "We wanted their participation in the release of the information to the government, and it was a matter of working out the schedules and the date of meeting turned out to be July, whatever it was. in 1973. It is not true that there was a period of inactivity," If MCA had been more forthcoming with the Maltoni data, the Director of NIOSH has said that his agency would have "taken an entirely different course of action [in setting standards for vinyl chloride] in view of the widespretid use of this material." he Association received another progress report on toni's research in November 1973. Then, on January 22. 1974, IJ. F. Goodrich announced that three polyvinyl chloride workers had died of angiosarconia of the liver since 1971--from only one of its plants. November, 1974 That same day MCA revealed the Maltoni data to N'iOSH; on February 15 it was made public. The Occupational Safety and Health Administration lowered the permissible worker exposure level to 50 ppm from 500 ppm vinyl chloride on April 5, in an emer gency action. A less black picture is painted in the case of data sup pression on the drug SIow-K, entirely due to one con scientious scientist and an FDA Medical Officer. In hear ings before Sen. Kennedy's Health Subcommittee on Sep tember 25, 1974 it was revealed that a major company suppressed experimental results obtained in 1965 in order to push through a new' drug application in 1972. The drug in question, Slow-K, was originally developed almost purely for reasons of convenience and palatability. It is necessary for persons taking diuretics or with certain medi cal conditions to supplement their potassium (K) intake. This may be done through changes in diet, a liquid, or an effervescent tablet containing potassium. However, because these methods can be inconvenient and unpleasant, a pill called Esidrix-K (forerunner of Slow-K) was developed for the same purpose by CibaGeigy Pharmaceuticals. When it was discovered in late 1964 that it was associated with ulcers, most Esidrix-K was voluntarily withdrawn from the market. Dr. F. Gilbert McMahon, a vice president of Ciba. was put in charge of a team of 9 or 10 scientists whose job was to find a substitute for Esidrix-K which would not cause ulcers. Generally speaking, the method was to test all available potassium salts for ulcer-causing properties. Among the compounds researched was Slow-K. a drug then in very wide use in other countries. Ulcers were in deed produced in monkeys, and shortly thereafter re ports of human cases began to reach the U.S, from Aus tralia and Europe. Unsurprisingly, Dr. McMahon advised against using Slow-K in this country. In 1967 he resigned from Ciba. but continued to warn against the use of SlowK, particularly in the Britisii journal Lancet. In 1972, greatly to his surprise. Dr. McMahon heard that Slow-K was being tested in the U.S. He immediately wrote FDA and advised that they contact members of --Continued on p. 6 A MODEL WHISTLE BLOWER CLAUSE (b) (1) No person shall discharge or in any other wav discriminate against or cause to be discharged or discriminated against any miner or any authorized representative of miners hy reason of tile fact that such miner or representative (A) has notified the Secretary or his authorized representative of any al leged violation or danger. (B) has filed, instituted, or caused to he filed or instituted any proceeding under this Act, or (C) has testified or is about to testify in any proceeding resuiting from the administration or enforcement of (he provisions of this Act. Public Law 91-173, See. 110(b) Coal Mine Safety Act H&S 107000 t November, 1974 R&S 107001 Page 5 WHAT CAN BE DONE ABOUT DATA SUPPRESSION? In eases of vinyl chloride and Slow-K cited in this Bulletin, purely practical considerations such as fear of job loss seem to have determined the outcome of the ethical decision whether or not to call important scien tific data to the attention of the government or the public. Would Dr, McMahon have stopped the new drug application for Slow-K if he had still been working for industry? Would Dr. Maltoni have publicized his data if he had not been? As matters stand, no practical argument can be made in favor of whistle blowing, which can cause job loss and lawsuits, rather than going along with the organization and probably advancing in it, Tt is impossible, and prob ably undesirable, ever to equalize the desirability of the two alternatives. But the factors should at least be ad justed to the point where no scientist fails to take his case to the public or government solely for economic or other pragmatic reasons. A good beginning would be for universities to strengthen the preventive measure of edu cation for ethics; for professional societies to help and encourage members to make ethical choices, and to cen sure those who do not; for Congress to reform the law along previously established lines both to deter those who would withhold data from regulatoiy agencies and to pro tect those who do not; and for the courts to extend the principle of due process after firing to corporate em ployees. Alertness to ethical dilemmas should be part of every scientist's professional training. To help universities meet this goal, scientific societies would do well to follow the lead of engineering groups by compiling a basic text to use in such courses. Jn 1965 the Ethics Committee of the American Society for Engineering Education produced Ethical Problems in Engineering. It deals with dozens of concrete problems, including a variety of viewpoints on each. The topics range from the relatively trivial--using a Society emblem for promotion--to more substantive problems such as conflict of interest. There is no reason whv the same approach could not be used in scientific ethics; many dilemmas apply to all fields, and even those which do not would be useful in training anv student how to recognize and think about such issues. Once such a basic text had been written, it could be made an indis pensable part of graduate education in science. Another measure societies could take to prevent ethical abuses would be to improve contracts to protect mem bers from unreasonable consequences if they did need to make confidential data public or reveal it to government. Unfortunately, industry has legions of lawyers and acres of fine print to pit against the often paitrv legal knowl edge of a prospective employee. He may later be threat ened with untealistic lawsuits by his empiover, for ex ample. or loss of his pension rights. Scientific societies could review contracts for their members to explain the legal implications; most could probably be covered bv a booklet explaining standard phraseology. In audition, the society could pioneer in developing model contracts which would protect the employee's right to due process, i.e., hearings, if he is fired, much as is possible in the public sector. (Other issues which might be incorporated are the right to publish and attend professional meetings.) For scientists who arc already on the spot, such aa those in the vinyl chloride situation, a major problem I that there is no one to turn to for impartial advice, much less to support them if they defy the rules of organiza tional behavior. Scientific societies could alleviate this problem by extending responsibilities of their professional ethics committees to include problems involving the sci entists' responsibility to society. The committees could be available for anonymous consultation by members who were deciding what to do with important data affecting the public interest. Impartial Advice on Options The committees could advise scientists about the op tions available to them inside their companies, their in dustries, the press, and society generally. This could be invaluable to people with little experience outside the laboratory. An ethics committee for this purpose would have to he interdisciplinary, including both scientific ex perts and at least one lawyer with experience in ethics and related areas. The scientist could, in some cases, achieve his goal of changing company policy about certain data by ictiing it be known that he was consulting his society. In other situations the society could make quiet representations through its committee. Sometimes it would recommend that the member appeal to the public, when other possi bilities were ineffective or too slow and when importanu principles were at stake. The society couiu agree to baefl its member in several ways, including a declaration ol support; providing legal assistance if nccessarv, perhaps appealing to its members for a defense fund in extreme cases; and, if a new job were required, help in finding one. Adopting a plan like this one would serve scientists who wish to consider the public interest weii. What ot those who do not? The scientists in the vinyl chloride case knew that, whatever problems they might encounter as a result of going along with their companies, censure from the scientific community would not be one of them. A moderate proposal which would avoid witch 'mint ing would be for ethics committees to investigate the facts in cases when members appeared to have shirked their obligation to the public interest. Such an investiga tion could be prompted by request of a certain number of society members, by press reports, or by some other established means. Findings Should Be Published When the facts were collected, the committee would of course give the person(s) accused the right to defend themselves. The committee couid then reach a judgment of whether or not the member had breached common sci entific ethics. It should be obliged in any case to present the facts in its journal, along with the committee's opin ion and a refutation by tbe person accused if desired. The closest approach to the roles for professional sc cieties discussed above is the American Chemical Society''Membership Assistance Program. It provides an informal procedure for arbitrating and assessing situations in which --Continued on p. 6 Page 6 WHAT CAN BE DONE--Continued from p. 5 member feels unprofessionally treated and asks the Soety's help. Most cases involve termination in one way or another, including such problems ns derogatory letters of reference, inadequate or improper severance pay, and reimbursement for travel or moving expenses. NVhcn it is required, ACS may write an employer requesting a cer tain action; if he docs not comply, ACS informs its Coun cil and publishes the information in Chemical and Engi neering News. One measure of the program's success is the fact that only four of about 25 cases in the last year had to be cited in this way. In addition to these informal procedures, qualified members and other chemists can participate in a Legal Aid Loan program. Congressional legislation also has a role to play. Regu latory legislation should automatically contain "whistle blower clauses" like that of the Coal Mine Safety Act. It prohibits discharge of or discrimination against a miner because he has notified authorities of possibly dangerous conditions, or because of testimony given or proceedings instituted under the act. (Sec the box on page 4 for the full text.) In addition, regulatory legislation should make it pos sible to prosecute individuals as well as companies for withholding data pertinent to fulfilling its objectives. In the case of vinyl chloride, such a provision would have encouraged MCA scientists to reveal the Maltoni data to _NIOSH as soon as they received it. It would also cover ccs where a substance to which no standards applied ?s found to be harmful. Due Process in Firing The courts could alleviate one of the potential whistle blower's worse fears, unfair job loss, by holding that due process must be followed when a corporation discharges an employee. (This was pointed out at the Nader Con ference on Professional Responsibility.) The law specific ally provides that, in a few narrow areas such as auto franchises, employees cannot be discharged without fol lowing certain procedures. This principle was upheld re cently in the ease of three scientists employed by a state who turned to FAS for help when they were summarily FAS PROFESSIONAL BULLETIN (202) 546-3300 307 Mass. Ave,, N.E.. Washington. D.C. 20002 November 1974, Vol. 2, No. 8 I wish to renew membrship (or calendar vear 1975. O I wish to join FAS and receive both newsletters as a full member. Enclosed is my check (or 1975 calendar ysf dues, hi I am not a natural or social rcienhst. lawyer, doctor or engineer, but wish to become a non-rcuncj associeie member.i 120 Q *50 H St'oO *S92 Q $10 Member Si.-Dpprtino Patron 'u.'e Ulcer S'0 COO Subscription only. I do not wish to become a member but would like a subsurioton to: BFAS Public Intercsi Report -- *15 lor calendar year FAS Protessional Bullenn -- S15 (or calendar year Please ncle that members receive bolh newsletters and Othr benefits lor S20 dues. Enclosed is my tax deductible eentnouven of to the FAS Fund for us permanent some cn Capitol Ftifl. Ame and title Please Print ADDRESS CITY AND STATE __________ __ _______ PRIMARY PROFESSIONAL DISCIPLINE: Zip November, 1974 discharged. It seems that due process in firing could also apply to private corporations if the courts chose to in terpret it that way. Several authorities including Prof. Miller have argued that Fourteenth Amendment protec tion could be extended, on the basis that corporations arc like government in many ways; thus, they argue, citi zens should enjoy the same protections from the former as they do from the latter. Also, the very existence of cor porations is a manifestation of the government's power, since they are made possible only by charter. This view has not yet been generally accepted by the courts. In conclusion, data suppression should be viewed as a kind of scientific malpractice. The public has been dis turbed enough about the failures of the medical profes sion, for example, to regulate them somewhat through Professional Standards Review Organizations as well as the courts. Data suppression is potentially far more dam aging than medical malpractice; if it continues, it invites the same public reaction of outrage. NEW ETHICAL PROBLEMS--Continued from p. 4 the Ciba task force he had headed for their test results. Tlie FDA Medical Officer assigned to the case recom mended that Slow-K not be approved as a new drug for three reasons; ---it was shown to cause ulcers in animals and humans; --the labelling was deficient in that it did not specify that only patients who could not tolerate other forms of potassium should use it; --the name was misleading. Also, in 1973, the FDA General Counsel's office was informed that Ciba had suppressed data, but the matter is still under study. For reasons which arc unclear, an FDA Advisory Committee overruled the staff opinion on SlowK. and the agency was on the verge of approving it. With out Dr. McMahon's intervention. SIow-K might well have been on the shelves of American pharmacists. While a cvnic would say that he had little to lose since he had left industry, Dr. McMahon's effectiveness leaves little doubt that one person's action can counteract the omis sions of those who arc more numerous and powerful. tvs? **3K*^*h^ ft* Second Class Postage Paid at Washington. D. C. Return Postage Guaranteed 0^3 /4 C7390 '92 . F , t- . g L A IP do* cue;*, lsa rcc 2020 DC Vs CFMHP "ICLANC MI 4ti4 C R&S 107002