ing water supply systems also are contaminated with one or more of the six chemicals. But he warns against any overreaction to the survey's findings, saying that although people should be aware of the extent of the problem, they should not react with any sense of panic. EPA is studying a number of alternatives to chlorine, such as ozone, carbon dioxide, and ultraviolet radiation, for use as disinfectants in treating drinking water. But Train cautions that chlorination remains the single most effective method of preventing typhoid, cholera, dysentery, and other waterborne diseases. He adds that EPA believes that the benefits of using chlorine far outweigh the potential health risks from chlorine-derived organic compounds. Train also disclosed preliminary data on five of the cities covered in the second drinking water study EPA is conducting. For example, Miami's drinking water, whose source is groundwater, is contaminated with 39 chemicals, including 3.3 ppb of nicotine and 5.6 ppb of vinyl chloride. The vinyl chloride content of the treated water is higher than that of the raw water, which has 1.2 ppb of vinyl chloride. Philadelphia's system, whose source is raw surface water contaminated by municipal discharges, contains 0.27 ppb of vinyl chloride in addition to 36 other organic chemicals. Train speculates that the number of chemical plants located in and around Philadelphia might account for the vinyl chloride in its water, but he says that EPA has no idea of the source of the vinyl chloride in the Miami water. Data from three other cities also were presented. Cincinnati's system, whose source is raw surface water contaminated by industrial discharges, has 39 chemical contaminants, including both the six covered in the first study and others such as acetaldehyde, o-dichlorobenzene, and toluene. The system in Ottumwa, Iowa, whose source is raw surface water contaminated by agricultural runoff, contains 21 chemicals. And even Seattle, whose source EPA classifies as uncontaminated upland surface water, has 13 chemicals in its finished drinking water. Train notes that the survey results show only the chemicals present in various water supplies—the levels of contamination haven't been determined yet. He says that EPA is in the process of determining the sources of the contaminants, how significant these low levels are to human health, and what can be done most practically to solve the total problem of chemical contaminants. One possibility EPA is considering is the use of activated carbon in place of the sand filtration systems now employed. Activated carbon could remove many of the chemicals, but Train emphasizes that no one treatment system can remove all the chemicals. He adds that any nationwide cleanup program would be very expensive, perhaps costing as much as hundreds of millions of dollars in the aggregate. D
Nelson takes on drug industry again Sen. Gaylord A. Nelson (D.-Wis.) is continuing his running battle with the drug industry in the new Congress. For seven years he has been investigating the way the drug industry operates in the U.S. and conducting what so far has been a losing battle to get legislation through Congress to protect the American people against what he terms "poorly tested, unsafe, ineffective, and improperly used drugs." But Nelson is still trying and in recent days he has introduced a dozen bills that would make sweeping changes in the way drugs are approved, advertised, and sold in the U.S. With a new, more liberal, consumer-oriented Congress, Nelson's chances of getting at least some of the legislation passed may be better this year than ever before. However, a spokesman for the Pharmaceutical Manufacturers Association expresses the hope that Congress will give the bills the same careful rejection that it has in the past. The reforms Nelson is working for are not just cosmetic. For instance, provisions of S. 1321 require the government to assume responsibility for testing all new drugs. At present the Food & Drug Administration must rely on information supplied by the manufacturer for determining a new drug's safety and efficacy. Under Nelson's program, the testing and evaluation would be conducted at a new government-owned Drug Testing & Evaluation Center, established under S. 1321, and the manufacturer of the drug would pay for the work. The bill provides an appeals process for a drug manufacturer who is not satisfied with the progress of the testing, the manner in which it is being conducted, the results, or the costs. Any complaints would be reviewed by a three-member Drug Testing Review Panel, consisting of one member representing the Department of Health, Education & Welfare, one the manufacturer, and the third to be chosen by the other two. The panel would have 30 days to make a decision, and that decision would be final. Another bill, S. 1312, would give the Federal Trade Commission power to order mandatory licensing of drug patents in instances where the prices charged to U.S. consumers are more than five times the manufacturer's direct costs to produce the drug or where the drug's U.S. price is higher than the average price charged in a foreign country. In all cases, the existence of a patent must have constituted a substantial contributing factor to the cost. Other Nelson bills would give the HEW Secretary sweeping powers to regulate drug advertising and promotion. Specifically, the Secretary would have to approve all drug advertising for
use in a medical journal or in the general media. Drug salesmen would be required to present physicians with a form, approved by the Secretary, describing the drug before making any oral statement about it. The Secretary would choose for each new drug an official name under which the drug would be sold. This is aimed at doing away with chances for brand-name identification. And the Secretary also could require batch-by-batch certification of certain drugs as well as reports on clinical experience with a drug. The bills also would require that any article intended for dissemination to health professionals describing a drug or its properties include information on
Nelson: chances may be better who provided financial support for publication of the article and for the research on which the article was based. The labeling of a drug to explain possible hazards associated with its use and its potency expiration date would be required. Other provisions would prohibit manufacturers' distributing free samples of a drug, except on a doctor's written request, the sale of sample drugs, and the export of any drug from the U.S. not approved for use by FDA. Still another provision would repeal the grandfather clause that exempts drugs on the market before the Food, Drug & Cosmetic Act went into effect in 1962 from going through the FDA approval process. Even more reform bills may be forthcoming. Nelson's Senate Monopoly Subcommittee already has held two rounds of hearings on federal expenditures for drugs this year, and further hearings are likely in the near future. But once the bills are introduced, they are, in a way, out of Nelson's hands—the Monopoly Subcommittee cannot act on legislation, it can only conduct investigations. Hence, passage of the bills depends on action by the Senate Committee on Labor & Public Welfare's Subcommittee on Health, which, although it conducted general hearings on the drug industry last week, at this time plans no specific hearings on the Nelson bills. G April 28, 1975 C&EN
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