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Health Policy Advisory Center HEALTH Volume 15, Number 5 PAC BULLETIN Pain and Plenty Income polarization and health in the 80's Special Section: Health in California 1097 INSIDE Gyn Game: The full, disturbing history of the contraceptive sponge P. 13 ? Peer Review To the Editor: I've been a rural GP for five years and out of touch. Do you still exist? Does the Bulletin still exist? Do you need money? Can I subscribe? Don Kollisch, MD Monroe, NH Yes, yes, yes, yes. Editor To the Editor: Your issue on health care in the Reagan era was excellent, but you left out two important areas: the environment and nuclear war. Looking back in 20 or a hundred years, should civilization sur- vive that long, I think it is very likely that the most shocking and devastating policies of the Reagan Administration will appear to be those which allow the continued pollution of our environment and the failure to take strong measures to clean up the mess that has already been made. This is all the more shock- ing in that, unlike most of the health care cutbacks you describe, this failure threatens all classes of society, and as such is criticized by the overwhelming majority of the population. continued on page 37 Health / PAC Bulletin September - October 1984 Board of Editors Tony Bale Howard Berliner Carl Blumenthal Robert Brand Pamela Brier Robb Burlage Michael E. Clark Barbara Ehrenreich Margaret Gallagher Sally Guttmacher Dana Hughes Louanne Kennedy David Kotelchuck Ronda Kotelchuck Arthur Levin Nonceba Lubanga Steven Meister Patricia Moccia Marlene Price Virginia Reath Hila Richardson David Rosner Hal Strelnick Richard Younge Editor: Jon Steinberg Staff: Roxanne Cruiz, Debra De Palma, Loretta Wavra Associates: Des Callan, Mardge Cohen, Kathy Conway, Doug Dorman, Cindy Driver, Dan Feshbach, Marsha Hurst, Mark Kleiman, Thomas Leventhal, Alan Levine, Joanne Lukom- nik, Peter Medoff, Robin Omata, Kate Pfordresher, Doreen Rappaport, Susan Reverby, Len Rodberg, Alex Rosen, Ken Rosenberg, Gel Stevenson, Rick Surpin, Ann Umemoto, Rick Zall. MANUSCRIPTS, COMMENTS, LETTERS TO THE EDITOR, AND SUBSCRIPTION ORDERS should be addressed to Health / PAC, 17 Murray St., New York, N.Y. 10007. Subscription rates are $ 17.50 for individuals, $ 35 for institutions. ISSN 0017-9051 1984 Health / PAC. The Health / PAC Bulletin is published bimonthly. Second class postage paid at New York, N.Y. Postmaster: Send address changes to Health / PAC Bulletin, 17 Murray St., New York, NY 10007. The Health / PAC Bulletin is distributed to bookstores by Carrier Pigeon, 75 Kneeland St., Room 309, Boston, MA 02111. Design: Three to Make Ready Graphics / 1984 Cover etching by Daumier. Typeset by Kells Typography, Inc. Articles in the Bulletin are indexed in the Health Planning and Administration data base of the National Library of Medicine and the Alternative Press Index. Microforms of the Bulletin are available from University Microfilms International, 300 Zeeb Rd., Dept. T.R.. Ann Arbor, MI 48106. = CONTENTS. - Letters 2 Vital Signs 4 Income Polarization and Health 5 The FDA and the Contraceptive Sponge 13 Risk Assessment 19 Science under the Reagan Administration 23 2 Health / PAC Bulletin Special Section: What's Happening in California Health The Impact of the 1982 Medi - Cal Reforms 25 Organizing Against VDT Hazards 31 wwwwwEN Fighting a Toxic Waste Giveaway 33 wwwwwEN Bulletin Board 3www5wwE N Media Scan: Medical Inc. 3www6ww EN Books Received 3www8wwE N Body English 39 Notes & Comment The concerns over the public health consequences of adding low levels of antibiotics to animal feed have resurfaced after several years. Although opponents have waged vigorous past attacks on what Orville Schell has named the " pharmaceutical farm, " they were unable to overcome the arguments of those who raise (and slaughter) animals for profit. The meat and poultry producers argued that banning antiobiotics in feed would only make consumers pay more at the market for such products. The pharmaceutical industry has also fought any attempts to limit or ban entirely use of antibiotics in feed. Both groups have claimed that there was little evidence to support the anti additive - position that such practices would lead to the proliferation of antibiotic - resistant infectious diseases in humans. They also showed evidence that antibiotic prophylaxis eliminated epidemics of disease that often raged through herds and flocks and hampered cost effective - productivity. In 1977 the Food and Drug Adminstration, under the pro- gressive leadership of Donald Kennedy, proposed banning the use of penicillin and tetracycline in animal feeds. Congress, under pressure from the farm and drug industry lobbies, stalled by asking the National Academy of Sciences (NAS) study the problem. Its 1980 report concluded that the relationship be- tween antibiotic use in animal feed and resistant disease in humans had neither been proved nor disproved. This equivocal study was used by the opponents of a ban to further delay ef- forts by the FDA to restrict drug use in farm production. The debate has resurfaced because of some new and impor- tant scientific evidence that bolsters the arguments of those sup- porting a ban. Most important is an epidemiological study focusing on an outbreak of Salmonella poisoning in the Midwest, described in the September 6 New England Jour- nal of Medicine. A state epidemiologist in Minnesota to whom the outbreak (Arthur A. Levin is Director of the Center for Medical con- sumers and a member of the Health / PAC Board.) had been reported informed Scott A. Holberg, an epidemio- logist with the Center for Disease Control in Atlanta, of some unusual factors. First, the particular strain of Salmonella was one rare to the northern part of the U.S. and second, most of those poisoned had taken antibiotics several days prior to the incident. Working together, the two scientists attempted to determine if the most obvious possibility - contaminated antibiotics- antibiotics- had been the cause. Their investigation showed that in all likelihood it was not the antibiotics that had been the source of the infection. After a further search, these public health ver- sions of Holmes and Watson found that the probable source of the bacteria was a herd of beef cattle that had been slaughtered in Minnesota and processed in several states, ending up as ground beef in the Minnesota supermarkets where eight out of the 11 victims shopped. The weight of the evidence accumulated by these industrious epidemiologists offers persuasive evidence that the beef cattle had become " biological factories " of a drug resistant strain of Salmonella because they were fed low doses of antibiotics. Even more frightening, the drug resistant - Salmonella inflicts case fatalities at a rate of 21 times that of the usual Salmonella poison. The lack of evidence of a causal relationship which the 1980 NAS study decried appears to be in hand. The FDA is present- ly considering the Minnesota findings as well as other recent studies in order to determine whether it will recommend a ban. However, any FDA efforts to establish such a restriction will have to overcome the likely opposition of the chair of the House Appropriations Committee, Jamie Whitten (MI D -), a cham pion of the farm interests. Rep. Whitten also oversees the FDA and Department of Agriculture budgets. His resistance, along with the anti regulatory - stance of the current Administration, may be enough to ensure that even with clear scientific evidence of danger, the public health will continue to be placed in jeopardy in favor of profits. Arthur A. Levin Letter from the Editor. It will come as no surprise to our readers that Health / PAC does not believe that the profit motive should be the govern- ing principle in the provision of health care. However I don't : think too many of you are aware of how frighteningly commit- ted to a based non - cost - approach to life our board is. The story of how this issue came to be 40 pages instead of our usual 32 provides a good example of this attitude. At our board meeting I presented a listing of all the articles we had for this issue and explained that they wouldn't all fit. We don't believe in chopping articles to pieces, so the obvious solution was to hold several for the following issue. " We can't hold that, " said an advocate of one piece. Someone else spoke up for another, several people for a third, and so on, until it was clear that we would have to go to 40 pages. Now, readers of the New York Times and other publications may have noticed a remarkable correlation between how much news is fit to print and the amount of advertising bought for that day, but if the Health / PAC Bulletin prints more pages, it just costs us more money. This is not an item we have in large supply. " Where will we get the money? " I asked at the meeting- meeting- rhetorically, since no one at Health / PAC has had a definitive answer to that question for years. " We'll get it, " was the obvious, traditional, and forthcoming answer. I hope it's true. And in this issue we're offering you a special personal incentive to make it true - a free renewal or gift subscription. This may not seem like a way for us to make money, but it is. See page four and find out why. Jon Steinberg Health / PAC Bulletin 3 Vital Signs missions were household overcrowding and parental unemployment. The cor- relation with these variables was greater than any with vaccination against certain childhood diseases. The authors caution that correlation does not mean causation, but conclude Poor Health that the costs of eliminating such deprivation might be far outweighed by the benefits that would follow. Just in case you had any doubts about the relationship between poverty and ill- ness, a recent (September 22, 1984) study in Lancet should help convince you. The researchers looked at patterns and frequency of certain illnesses in children in Glasgow, Scotland. Children coming from so called - " deprived districts " were nine times as likely to be admitted to the hospitals as their peers from other districts. The variables of " deprivation " most closely correlated with hospital ad- State of Grace President Reagan is campaigning for a second term on a pledge to further remove government from the backs of the American people. Not satisfied with his own efforts at regulatory reform, in 1982 he asked chemical magnate Peter Grace and a cadre of business advisors how to make government leaner, if not meaner. One of Grace's best publicized, if not most accurate, findings was that most food stamp recipients are Puerto Rican. Not deterred by this and other faux pas, Grace and company produced last year the voluminous Report of the Presi- dent's Private Sector Survey on Cost Control, now available in paperback at your local bookstore. As the latest battle plan in a long line of " good government " crusades by business, the Commission's report is pretty tepid stuff. Congress'General Accounting Office has already recom- mended most of the management im- provements Grace calls for. However, 60 percent of the $ 424 billion in potential savings enumerated by the Commission would require Con- gress to change policies and programs, according to a report issued jointly by the General Accounting Office and the Con- gressional Budget Office. continued on page 40 Health / PAC's Share the Wealth Plan Share the Wealth was Huey Long's slogan, and he was no fool. He was the one who half a century ago said, If fascism comes to the United States, it will come wrapped in an American flag. We think he was on to something, so here's our proposition: If you walk into the institu- tion of your choice and get the librarian to subscribe to the Health / PAC Bulletin at the institutional rate of $ 35, we'll give you a free one year renewal or new subscription as soon as we get the check. Just fill out the form below so we can be sure to credit you for your assistance. Dear Health / PAC, The will be sending you a check for $ 35 shortly. Please be sure you process my free one year renewal. Name Yours, Address City State Zip Mail this to: Circulation Dept., Health / PAC Bulletin, 17 Murray St., New York, NY 10007. 4 Health / PAC Bulletin Pain and Plenty Income Polarization and Health in the'80's by Tony Bale merica is becoming a country of greater inequality. America is becoming a country country, of greater greater greater incqprites proliferate, while rising hunger and homelessness become symbols of the widening spread of life chances, of a higher level of cruelty inflicted on the growing number at the bottom. These transformations in the American economy and our class struc- ture are affecting the health system more profoundly than any changes in governmental health programs, spawning vast new entrepreneurial profits on the one hand and restricted access for those falling anywhere near the threadbare safety net on the other. A new industrial framework is taking shape, bringing with it new patterns of accumulation and distribution of wealth, along with intensified class based - suffering. The shift from industrial to service employment is creating giant industries which replicate the structure of the largest service industry, health care: highly polarized incomes, with a few high earners and a great many employees who take home lower wages than comparable workers in the declining manufacturing industries. Large scale industrial dislocation and the worst depression since the 1930's are leaving large segments of the labor force uncertain about finding or keeping an adequately paying job. For members of the working class the lottery is the slim ticket to the fast growing Reagan era millionaire club. For those with access to capital who want better odds, start- ing a new business in a field such as health care provides them. Even if the firm goes bankrupt, a venture capitalist might still give the failed entrepreneur money to start again. If our workplaces are more dangerous, if nuclear war scems nearer, if we have to keep our money moving faster just to stay even, if we're more vulnerable to the financial consequences of a serious illness, it's all part of the same polarizing process, rais- ing risks for the many and opportunities for the few. Impoverishment and Inequality As the share of wealth held by the affluent increases and those at the lower end of the income scale become relatively poorer, middle income groups are experiencing their own polarization: many people in this category are slipping down the economic ladder while a smaller segment is enjoying a sizable upswing; the " middle middle " is shrinking. Increasingly in the Reagan years, improvements in income have come through access to interest and financial gains. The decline in real wages has gone hand in hand with booming Tony Bale is a member of the Health / PAC Board. stock and bond markets. In the brief period from 1980 to 1982, the percentage of personal income derived from dividends, in- terest, and rents jumped from 16.4 percent to 18.7 percent, while the proportion coming from wages was slipping from 62.7 percent to 60.8 percent. These growing differentials in the early Reagan years, a quite rapid shift for such large population groups, are outlined in the accompanying table - although not completely, since it does not reflect total assets or paper gains in financial markets, and thus tends to underestimate the share held by the wealthy. Marilyn Moon and Isabel Sawhill of the Urban Institute estimate that between 1980 and 1984 the share of real disposable income of the top one fifth rose 1.9 percent while the share of each of the two lowest income fifths dropped 0.7 percent. Put in money terms, they estimate that between 1980 and 1984, using 1982 dollars, " the average income of the poorest one fifth of all families declined from $ 6,913 to $ 6,391, or by nearly eight percent, whereas the average income of the most affluent one fifth increased from $ 37,618 to $ 40,888, or by nearly nine percent. " After a steep fall in the official poverty rate between 1961 and 1978 from 21.9 percent of the population to 11.4 percent - the number began to climb again in 1979, reaching 15 percent in 1982 and 15.2 percent in 1983. And the poor got poorer: the proportion at or below 75 percent of the official poverty line rose from 61 percent in 1978 to 68 percent in 1982. This official poverty line was $ 9,860 for a family of four in 1982. The same year a Gallup poll found Americans judged that a family of four needed $ 15,400 just to make ends meet. Peter Gottschalk of the Institute for Research on Poverty at the University of Wisconsin has shown that most of the rise in poverty between 1979 and 1982 was related to a widening inequality in the distribution of income; most people became a little worse off, but the low income population became substantially poorer. Gottschalk calculates that " If all households had experienced equal decreases in market in- comes and equal increases in transfer payments, poverty would have risen only 0.4 points instead of 3.3 points between 1979 and 1982. " Within the poverty group there has been a dramatic shift in composition. Poverty among the elderly declined from 29.5 percent in 1967 to 14.6 percent in 1982, reflecting positive ef- fects of government transfer programs. The largest increases in poverty from 1979 to 1982 on a proportional basis, have been among persons living in husband - wife families. In 1979, they comprised 34 percent of the poor; three years later they were almost 40 percent. This phenomenon affected minority Health / PAC Bulletin 5 A BROKER ON YACATION families, and even those headed by white males: their percen- tage below the poverty line jumped from 5.9 to 8.7 percent, This growing poverty among husband - wife families reflects worsening opportunities in the labor market, reduced access to government transfer programs, and the burden of taxes on low incomes. In 1982, 22 percent of the labor force exper- ienced some unemployment; its average duration was 15.4 weeks. Even when the unemployment rate fell in 1983, the average duration rose, indicating the growing number of workers jobless for longer periods. Many of these people are now considered to be " no longer looking for work, " and have therefore disappeared from the unemployment statistics. If they were included, according to the Joint Economic Committee of Congress, the unemployment rate this July would have been 9.7 percent rather than the official 7.5 percent. Increasingly, people at near poor - and poor income levels are forced into in- termittent low - pay and part time - jobs. Sixteen million persons reported that they had been limited involuntarily to part time - work during 1982; this group had a poverty rate of 18 percent. Reagan tax and budget cuts have accelerated the trend towards greater inequality. The Congressional Budget Office projects that in 1984 they will bring an average net loss of $ 390 for households with incomes under 10,000 $ ; a net gain of $ 2,900 for households with incomes of $ 40,000- $ 80,000; and a net (not the safety kind) gain of 8,270 $ for households over 80,000 $ . Frank Levy and Richard Michel of the Urban Institute estimate that the average disposable income of the bottom fifth of American families has plunged 9.4 percent in the past five years and that of black women under age 65 ten percent, com- pared to a drop of one half of one percent for the top fifth. Low Income - Wage Earning - Women Moon and Sawhill estimate that a typical non elderly - female- headed family experienced a loss of 4.8 percent in income in the past four years; 90 percent of this slippage was due to Reagan Administration policies. During this period the in- comes of non elderly - blacks declined both absolutely and relative to white incomes. Characteristic of the many Reagan initiatives increasing hardships for low income - wage earners were the changes in Aid to Families with Dependent Children (AFDC) contained in the Omnibus Budget and Reconciliation Act (OBRA) of 1981. Under the earlier (1969) program, the first 30 $ of earned income and one third of the remainder of gross income were disregarded in estimating welfare eligibility, thus allowing many mothers to work and stay on the AFDC rolls. OBRA limited this disregard to four months, and restricted eligibil- ity to those earning under 150 percent of a state's need stan- dard. It jettisoned the previous goal of encouraging people on welfare to work in favor of cutting costs and fighting " welfare dependency. " As a result of these changes, wage earners were cut off AFDC at rates varying from 39 to 60 percent, according to a General Accounting Office (GAO) study of five major cities. This loss was compounded by separate cuts in the food stamp program. The income drop among those pushed off AFDC averaged between $ 115 and $ 229 a month, depending upon the city. In Dallas, 51.6 percent of those cut off AFDC had incomes below 75 percent of the poverty line; in Memphis 65 percent. Once barred from AFDC, these people also lost their automatic Medicaid eligibility. This left 30 percent of them without health coverage in Boston, 60 percent in Dallas and Memphis. Some of the remainder were able to remain on Medicaid by virtue of their low incomes and Medicaid pro- grams for the medically needy. The GAO study found that between 14 and 24 percent of the 6 Health / PAC Bulletin mothers terminated from AFDC reported that they had not sought treatment for themselves or their children for a medical problem they needed help with in the period following termina- tion of AFDC and Medicaid. Eight to thirteen percent reported that they had been refused medical or dental treatment because they could not pay for it or did not have the right insurance. The Access Crisis Katherine Swartz of the Urban Institute studied health in- surance coverage in Massachusetts for 1981 among the near poor, which she defined as those with incomes from 100 per- cent to 400 percent of the standard for Medicaid eligibility. (In February 1982 the AFDC Medicaid eligibility level for a two person family in Massachusetts was $ 3,768 and for a four per- son family $ 5,340.) Her study highlights the gaps in health in- surance coverage, particularly for the growing numbers in the population she was examining. Income, Swartz found, was the most important factor affect- ing coverage. Of those with incomes 100-200 percent of the Medicaid standard, 20.2 percent were uninsured; among those with incomes 200-300 percent of the standard, 11.1 percent were uninsured. Altogether, 13 percent of the near poor had no health insurance. One out of ten of the near poor working full time were uninsured, since low wage - jobs often did not provide coverage or sufficient income to purchase it private- ly. One out of five of the unemployed were uninsured. According to Swartz, the 230,200 uninsured near poor in Massachusetts in 1981 came disproportionately from " the bot- tom one third of the near poor income range, whites non - , males, unemployed, in school, early retirees, craftsmen or ser- vice workers, people who had never worked, and people who live alone or with unrelated individuals. " The National Access Survey by Louis Harris for the Robert Wood Johnson Foundation discovered that in 1982 8.2 percent of adults had no health insurance, including 7.1 percent of those in poverty. Six percent of families reported there had been times in the previous year when someone in the family needed medical care and didn't obtain it; by 1983 this had jumped to 14 percent. The survey also found that 1.1 percent of the non- poor and 2.8 percent of the poor had been refused medical care for financial reasons. Almost ten percent of the poor and five percent of the non poor - reported that in the year before the survey they had more difficulty obtaining health care than they had experienced previously. Although Medicaid eligibility was tightened during the Reagan depression, the number of poor people was growing, so the number of recipients remained roughly stable. Still, less than 40 percent of the population below the poverty line is on Medicaid. Hospitals have responded to the rising low income - popula- tion and Medicaid cuts by reducing care for those unable to pay. " Despite an increase in poverty of 13.4 percent between 1980 and 1982, the real quantity of the nation's hospital care to the poor increased only 1.5 percent " note Judith Feder and Jack Hadley of the Urban Institute, " In the 100 largest cities, where the population in poverty increased 18.1 percent, the volume of care of the poor was actually lower in 1982 than it was in 1980. " Between 1980 and 1982 the low income popula- tion in the cities with the largest increases grew 46.7 percent while expenditures on their hospital care grew only 5.6 percent. Hospitals took steps to shrink access to their services af- forded low income people and reduced the availability of un- profitable ones, such as drug programs and social services. heavily utilized by the poor. Public hospitals have increased the share of their care provided free, but as the public sector shrinks fewer people can get these services. The hospital sec- tor as a whole is getting smaller, but services for low income - people are disappearing at a disproportionately rapid rate. As labor market dislocations force more people into lower- wage, part time -, and non unionized - jobs, the number un- covered or with inadequate policies will increase. New cor- porate wellness programs and restricted health insurance coverage go hand in hand: employees must be prepared to work harder at staying healthy and bear more of the financial burden if they or members of their families do require treatment. Employers are forcing their non union - employees to pay more of their health care expenses out of their own pockets, and cost- sharing demands figure prominently in their negotiating posture with unions. The health care delivery system is already being restructured towards greater rationing of care, achieved through prolong- ing pain for large numbers of people under the guise of eliminating unnecessary outlays through heightened cost con- sciousness. Increasing numbers of Americans are experienc- ing this pain coupled with anxiety as they are compelled to weigh the economic costs of care paid for out pocket - of - against present suffering and future risks from delays. The uncompen- sated care problem and closings of community hospitals are Percentage Distribution of Money Income for All Families in Selected Years Top 5 Percent Highest Fifth Fourth Fifth Third Fifth Second Fifth Lowest Fifth 1960 15.9 41.3 24.0 17.8 12.2 4.8 1965 15.5 40.9 23.9 17.8 12.2 5.2 1970 15.6 40.9 23.8 17.6 12.2 5.4 Source: Statistical Abstract of the United States 1980 through 1984 editions. 1975 15.5 41.1 24.1 17.6 11.8 5.4 1979 15.7 41.6 24.1 17.5 11.6 5.3 1981 15.4 41.9 24.4 17.4 11.3 5.0 1982 16.0 42.7 24.3 17.1 11.2 4.7 Health / PAC Bulletin 7 the other side of the declining ability of families to handle medical expenses at a time when labor market forces and public policy are pushing more and more of the poor and near poor into medical indigency. The Reagan Administration wishes to wipe out at least part of the tax exemption for employee health insurance, which would heavily penalize those who have won good benefit pro- grams, but with those with lower incomes are already paying much of the cost of medical care pocket out - of - . In 1980, multi- ple person families headed by someone under 65 earning less than $ 10,000 paid out 450 $ for medical care on average; a third of them paid all their insurance premiums, averaging 605 $. Their willingness to do so indicates the importance health ser- vices have among income low - people, since this money must come at the expense of food or other necessities. Still higher deductibles and co payments - would simply mean more ration- ing through endurance of pain. The access crisis emerges from the conjuncture of several closely interrelated events; large numbers of people suffering reduced income; declining insurance coverage; rising health care costs; hospital and other provider closures in lower in- come areas; Reagan cuts in insurance and service programs; and the increasingly coldhearted and businesslike posture of the health care system. People in need find that if they lack the money, the right insurance, or the right DRG the health care system they thought existed no longer allows them entry with dignity, if it allows them entry at all. With increasing fre- quency, families must accept the evaporation of their savings or deep debt or else forgo treatment. Even without further restrictions, an access crisis is building that may lead to a political demand for new initiatives guar- anteeing access and equity in health services. Health Insurance for the Unemployed The 1982-83 crisis over health insurance for the unem- ployed, the most explosive access problem of the Reagan years, was a key test of political strength. In early 1983 Alice Rivlin, Director of the Congressional Budget Office, estimated that of the over 12 million unemployed men and women in December of 1982, 5.3 million had lost their health insurance, along with 5.4 million dependents. She predicted that many more would lose their coverage soon as their extended benefit policies expired. This dismal picture was contradicted by a 1983 National Center for Health Services Research study, which projected data from a 1977 survey onto the 1982 depression and conclud- ed that only 720,000 workers probably lost health coverage in 1982 and unemployment had little effect on utilization of ser- vices. This view in turn has been challenged by Sylvester Berki of the University of Michigan, whose preliminary analysis of his intensive study of unemployed Detroit - area workers showed that over two thirds lacked health insurance. Of these, 83 per- cent lost it when they lost their jobs, and the other 17 percent had no health insurance to begin with. In the 1982 Robert Wood Johnson study mentioned pre- viously, 28.6 percent of the unemployed adults surveyed had no health insurance. Among the unemployed, 16.8 percent found it more difficult to obtain health care than in the previous year; this was over three times the percentage for the employed. The unemployed also reported at a rate three times that of those with jobs that a serious illness had caused a major financial problem for their family. Individual reports from areas of high unemployment spoke louder than statistics. Isaac Emerson, an unemployed truck driver from York, PA, told Congress how he, his wife, and four children live on his unemployment and what she makes as an Avon representative. Unable to afford to continue his health insurance at a premium of $ 352.35 a month, they constantly have to hold off getting medical attention. On another occasion our oldest son cut his head and it was bleeding quite badly. But instead of taking him to the doctor, we had to take care of it ourselves, because we couldn't afford the doctor's bill. And just recently the schools told us that a son and daughter of ours had heart murmurs, and recom- mended that we take them to see a doctor. But we've had to hold off on that too, because we are afraid of what the doctor will find, and we can't afford to pay any extra bills right now. Judy Duperry, a mother of two boys living in Bristol, CT, was laid off from her assembly job at General Motors in 1982. She was able to find only part time work in 1982, and her health insurance coverage ran out after a year of unemployment. Her six year old son has borderline leukemia, she told a Congres- sional committee in 1983, but on her tight budget she had been unable to keep up on the treatments: " I can't afford to pay the doctor visits and medication now that I don't have any health insurance. I just try to push the whole thing out of my mind and hope my son stays well. " When this son ran a high fever she " took him to the emergency room at Bristol Hospital, but they turned us away because I didn't have any insurance coverage and told me to go see my regular doctor. " Duperry expressed the sentiments of many unemployed parents: " It doesn't seem fair to me that my children should have to go without care because there are no jobs available for me now. " A bill to provide $ 4 billion to states for a program of health insurance for the unemployed passed the House in August 1983 but languished in the Senate due to strong Reagan Administra- tion opposition. The main argument of Administration spokes- person David Stockman was the fiscal danger of adding a new, large entitlement program at a time of large budget deficits. Most ominously, in Stockman's view, creation of an entitle- ment for those losing employer - financied health insurance through involuntary unemployment would create equity pro- blems that might lead to pressure for entitlements from other groups: " Unemployed families without prior coverage; low in- come families with no recent work history who are ineligible for Medicaid; and self employed - workers who receive no special tax breaks for insurance. " (Emphasis in original.) At the height of the 1982 depression, voluntary efforts among physicians, often working with organizations of the unem- ployed, were beginning to provide help in finding services and some free care. The American Medical Association supported a modest legislative initiative to pay some medical bills. The American Society of Internal Medicine urged its members to inform their unemployed patients that they could seek treat- ment for a reduced fee or free of charge. At a time when volun- tary hospitals were printing maps showing unemployed workers how to get to the local public hospital, it is no wonder that the National Association of Public Hospitals strongly sup- ported the labor - led drive for coverage for the unemployed. Despite the broad base of support for aid, Congress failed to produce a new program. In the end, it gave Reagan his ver- 8 Health / PAC Bulletin sion of a perfect health record: no new entitlements. The pro- cess of labor force dislocation, impoverishment, and re employment - in lower paying jobs with less adequate health coverage was allowed to take its course. With the recovery, Congressional interest has waned for the moment, possibly to be rekindled in the next recession. Middle Income - Health Budgets For the middle income - group, health care expenditures are still largely manageable, although substantial. In both 1981 and 1982 the share of disposable personal income spent on medical care rose 0.5 percent, bringing the total up to ten percent. These were the largest yearly increases up to that time. An ominous trend for family budgets is the rising out - of- pocket cost of hospital care. In 1975 insurance paid 81.3 per- cent of private consumer expenditures for hospital care; by 1980 the proportion had dropped to 75.5 percent, and by 1982 to 73.3 percent. This occurred while hospital room charges were surging an average of 12.6 percent a year; they jumped 15.7 percent in 1982-82. These figures mean that hospital care is taking a larger bite in insurance and pocket out - of - expenses from many low- and middle income - family budgets. As income rises, somewhat more is spent on medical care, but the proportion of income spent declines sharply. In 1980, average out pocket - of - medical expenses for multiple - person families with an income under $ 10,000 were $ 432; for families earning $ 20,000- $ 34,999 the average was $ 471, not much dif- ferent in absolute terms, but significantly lower as a propor- tion of income. Similarly, Gail Wilensky and her colleagues at the National Center for Health Services Research have calculated that family outlays for medical care and health in- surance provided by employers left those with incomes under 10,000 $ with an average of $ 998 in net expenses, while families with $ 20,000- $ 30,000 incomes averaged $ 1,361 and families with incomes of $ 50,000 and over averaged $ 1,452. The Affluent For many of the affluent in the Reagan Era, the health fac- tor has swelled in importance for lifestyle and consumption decisions. Diet, the presentation of the body, preference in romantic partners, and outlook on life have all become permeated with a stronger health component. This has spawned new industries such as Nautilus gyms and dramati- cally altered older ones such as health foods. The rapid growth of the health service industry has been accompanied by perhaps an even greater growth in the importance of the search for health, the search for the external appearances of health, and the insertion of all this searching into consumption pat- terns outside the traditional health sphere. The searchers see themselves as a battleground between the forces of stress and impurity and those of healthful activity and purity. For the affluent, the concern becomes less how to ob- tain and pay for needed services than how to purchase and will health. Many strive not just to be healthy, but to positively ex- ude health to those around them. Flush with funds newly liberated by the Reagan tax cuts, the affluent have also seized upon the health care industry as a source of lucrative investment opportunities. Between 1977 and Health / PAC Bulletin BA 1981 shareholder equity in the four major hospital management companies shot up at a compounded annual rate of 41.2 per- cent. These and many other (public non - ) hospitals have been improving their financial situation and their attractiveness to investors. In 1975, net revenues of community hospitals were a thin 0.7 percent greater than expenses; by 1981 this margin had expanded to 3.6 percent; in 1982 it rose to 4.2 percent. In 1980 $ 3.56 billion in tax exempt - hospital bonds were issued, comprising 7.6 percent of the tax exempt - market. In 1983 the $ 9.55 billion issued made up 11.7 percent of all tax- exempts, and an estimated five to eight percent of the total bond market. Some hospitals now have as much as 100 $ in debt ser- vice figured into their cost per patient day. For entrepreneurs, the health care industry presents vast op- portunities for small companies marketing new technologies and services, such as auditing hospital bills. " We're the result of increased emphasis on cost containment in private industry, which is beginning to do what anyone does when paying for a service - checking the bill before writing the check, June Novak, national director of American Claims Evaluation, Inc., told Hospitals magazine. In the past few years dozens of such firms have sprung up. The proliferation of DRG's, bill auditors, and other cost- control mechanisms has given impetus to another industry: hospital information systems. Currently they average about 1.8 percent of a hospital's budget, but financial analysts predict this will rise to 2.5 percent by the end of the 1980's. Finan- cial, patient care, and departmental information systems each have their own markets, currently fought over by more than 140 companies ranging from old giants like IBM and Bur- roughs to a multitude of small new firms. As new markets proliferate in an increasingly profit oriented - health system, small, fast growing - companies are picking off discrete chunks of the mammoth industry. The May 1984 issue of Inc., an entrepreneurial magazine, presents its annual list of the 100 publicly held companies that were small five years. ago and have experienced the fastest growth in sales since. This golden list, which had a mean compounded average growth rate of 115 percent a year, included 26 companies in the health field, more than the number specializing in computers and related products. Among them were high tech firms specializ- ing in recombinant DNA and computer - assisted medical diagnostics; deliverers of services such as home health care and HMO's; and companies with more mundane income pro- ducers such as information processing for hospitals, weight loss centers, and marketing health care products. Many new hot companies, such as for profit - HMO's, appeal to investors guessing they will thrive in a more competitive, cost cutting - health system geared to leaner reimbursements and shifts away from hospital - based care. Along with the familiar large profits made from capturing a piece of the once seem- ingly limitless flow of public and private health dollars are new ones found in successful efforts to be in the right place as the flow begins to subside and shift directions. Venture capitalists have been quick to participate in this boom. They buy substantial pieces of new or small companies, betting on both the growth of a product or service and the management's ability to cash in on it. In 1982 the health care 10 Health / PAC Bulletin industry and related fields drew in 3 times as much venture capital as they had just four years earlier, $ 114 million going to 87 companies; by 1983 the investment was up to $ 150 million. Investor enthusiasm for medical technology has now spread to health service delivery companies. One example among many is Urgent Care Centers of America, a California firm specializing in free standing - emergency centers. In its first year, ending August 31, 1983, Urgent Care lost $ 1.3 million. Nevertheless, by then the company had attracted venture capital and issued stock valued at 7.3 $ million when it came on the market in February - six months later it was worth twice that. This is a common pattern in the current era of explosive growth. Dozens of health care companies have gone public to attract capital for expansion, and often these stock issues make huge paper profits for the chief stockholders. In 1982 32 medical product and service companies made initial stock of- ferings. In 1983 some 150 did, 17.5 percent of all companies going on the market for the first time. Among the instant millionaires multi - that year was William Pierpoint, whose holdings in his Summit Health Ltd., a California hospital and nursing home company, were valued at $ 31.5 million when the stock went on the market. He and other new entrepreneurs, their companies, and their financial sponsors are becoming a major force in the health care system. Physicians have also prospered recently. According to Medi- cal Economics, 1982 was the first year in six that their median net income from private practice rose faster than inflation; its rise of 4.3 percent over the increase in the cost of living (to 93,270 $ ) was the sharpest in 15 years. In the same year the me- dian income of all families fell by 1.4 percent. The New Polarization The health care system has become less a benevolent institu- tion and more a dispenser and re enforcer - of socially created misfortune. Regulation of access through the implementation of pain has gone hand in hand with investments funnelled in- to growth markets rather than toward the most urgent needs. Health care services did, for a time, become more accessi- ble to low income - groups. To a degree, these services moder- ated the impact of the widespread threats to health experienc- ed by many people at the lower end of the class structure. Reduced access to the health care system for the growing low- income population means a reduction in their standard of living - at a time when their health care needs have been in- tensified by the reduction in preventive programs, their often highly toxic environment, and the high levels of illness. associated with unemployment. This reduction of access and the quality of life for low- income people is a product of the same competitive, cost- controlling entrepreneurial health care system providing the affluent with new means of capturing income to live their ver- sion of the good and healthy life. The pain is not the result of a correctable oversight; the way in which money flowing through the health care system is generated and transformed into commodities, services, and financial surpluses widens the gap in our polarizing class structure. For the 44 percent of blacks, 33.2 percent of the poor, 44.2 percent of people with less than a high school education, and 29.9 percent of all adults who told the Robert Wood Johnson survey that they thought the health care system needs to be rebuilt, one answer is a new kind of health care system. Y' Resources Mike Davis's " The Political Economy of Late Imperial - America, " New Left Review (February January - , 1984) synthesizes and interprets much of the best recent information on changes in the American economy, class structure, and policy. A good source on changes in industrial structure is the 1984 report Storm Clouds Over the Horizon: Labor Market - Crisis and Industrial Policy by Barry Bluestone et. al., available from The Economic Educa- tion Project, 153 Aspinwall Avenue, Suite 2, Brookline, Mass. 02146. Peter Gottschalk's work appears in an Institute for Research on Poverty Discussion Paper " Recent Increases in Poverty: Testimony Before the House Ways and Means Committee, " one of hundreds of publications from this valuable source on poverty, social policy, and the American class structure. Send for their publications list at Social Science Building, 1180 Observatory Drive, Madison, Wisconsin 53706. The Labor Department's Monthly Labor Review tracks changes in the labor force. The February, 1984 issue has a good collection of articles on the impact of the Reagan depression. The Urban Institute has published numerous reports on health and social policies. Their list is available at 2100 M Street, N.W., Washington, C.D. 20037. The Congressional Budget Office (U.S. Congress, Washington, DC. 20515) issued the April, 1984 memorandum " The Combined Effects of Major Changes in Federal Taxes and Spending Programs Since 1981, " and has a number of publications on health policy. An Evaluation of the 1981 AFDC Changes: Initial Analyses along with numerous other reports on Federal health and social welfare programs can be obtained from the U.S. General Accounting Office's Document Handling and Information Services Facility. PO. Box 6015, Gaithersburg, Md. 20760. The " Special Report " Updated Report on Access to Health Care for the American People comes in the slick format with attractive graphics you'd expect from the Robert Wood Johnson Communications Office, P.O. Box 2316, Princeton, N.J. 08540. Alice Rivlin's estimate, the Emerson and Duperry statements, and much else can be found in 1983 hearings before the Subcommittee on Health and the Evironment of the House Committee on Education and Commerce, Health Benefits: Loss Due to Unemployment. David Stockman's testimony appears in 1983 hearings before the Subcom- mittee on Health of the Senate Committee on Finance, Health In- surance for the Unemployed. Both hearings are published by the Government Printing Office, Washington, DC. 20402. The NHCES Annotated Bibliography gives references, summaries, and where to write for the numerous studies generated from the 1977 Na- tional health Care Expenditures Study, including the Winter, 1984 ar- ticle by Wilensky (Milbank Memorial Fund Quarterly) referred to in the text. Write to the National Center for Health Services Research, Publications and Information Branch, Room 7-44, 3700 West East - Highway, Hyattsville, MD 20782. More up to date calculations of out- of pocket - expenses and insurance coverage can be found in " Health Care Coverage and Insurance Premiums of Families: United States. 1980, " one of the many publications of the National Center for Health Statistics, 3700 East West - Highway, Hyattsville, MD 20782. The best easily accessible sources on financial aspects of the health care industry for those outside of the financial community are Modern Healthcare, Hospitals, and the business press. My short article " The Great American Health Fortunes, 1984 " (Bulletin, May June -, 1984) looks at how personal fortunes are made in the industry. Health / PAC Bulletin 11 See for Yourself Health / PAC's First Health Workers Tour of Nicaragua The Revolution is Health has been one of the major slogans of the Sandinistas. For Nicaraguans, health care isn't just a professional service, it's a popular movement. How successful have the Nicaraguans been in creating a new health system? What have they accomplished? What mistakes have they made? To the extent that it's possible to find out the answers to these questions in two weeks, the Health / PAC tour is designed to do so. We will explore all aspects of the health care system, from the medical school in Managua to rural health rounds in the mountains, from the Ministry of Health to the women's association in an outlying town. We'll be talking to professors, physicians, nurses, midwives, and members of the Revolutionary Organization of the Disabled who build their own wheelchairs. There will be time for fun and the beach, but this will not be as comfortable as an AMA convention in Honolulu. Nicaragua is an extremely poor country. Some days we'll be out in the hot sun with the Nicaraguans. Other days we might be waiting by the roadside when our bus breaks down. Will it be rugged sometimes? Yes. Will it be one of the most exhilirating experiences of your life? Ask anyone who's been. January 6-20, 1985 $ 1043 including airfare from Miami, meals, accommodations, and transportation Space is limited. To reserve your place, you must send in a $ 200 deposit by December 1. Checks should be made out to Marazul Tours. --------------------- Y' Yes, I want to go on the Health / PAC Nicaragua tour. Y' Enclosed is my check for $ 200. Name Occupation Address City State Zip Workplace or school Telephone Home ( } Work ( ) Mail to: Marazul Tours, 250 W. 57th St., New York, N.Y. 10107, Attn: Robert Guild - - 12 Health / PAC Bulletin ~ % wt 3 Gyn Game The FDA and The Contraceptive Sponge by Diane St. Clair Some things you know you can sell. One is a sure cure for cancer. Another is a contraceptive that isn't a drag, a mess, or dangerous...... There's a new product that claims to meet all three criteria - The Today contraceptive sponge. ' Today went on the market in II Western states heralded by a huge advertising campaign. Reports from California indicate that drug stores are selling out as soon as shipments are received. A new over the counter contraceptive that looks like a donut and is selling like hotcakes may soon become the favored form of vaginal birth control for millions of women. The U.S. Food and Drug Administration's approval of the Today sponge in April 1983 brought the new contracep- Diane St. Clair is a student at Columbia University's School of Public Health and works at a feminist health center. tive widespread media acclaim and a ready market of female consumers eager to find, at last, a condom for women. However only three months later the fanfare abruptly died down; the House Subcommittee on Intergovernmental rela- tions and human resources held hearings to discuss possible shortcomings in the sponge manufacturer's research and in FDA review procedures. Yet another birth control controversy had been ignited. Contraceptive Technology Before examining the controversy surrounding sponge safety and FDA review procedures, it is important to examine why the contraceptive sponge presented such an attractive option to women and to those who market contraception. Although women have been using vaginal methods of con- traception for centuries, from homemade pastes and pieces of Health / PAC Bulletin 13 sea sponge to medically fitted diaphragms, use of barrier methods of contraception rapidly decreased in the 1960's. This decline coincided with the introduction of oral contraceptives (the pill) and intrauterine devices (IUD's). Compared to these methods, barrier devices were perceived to be obtrusive and unreliable. By 1965 the proportion of white married couples relying on the diaphragm for contraception had dropped to ten percent, and by 1976 to three percent. * The tide turned during the late 1970's, when reports on the potential adverse effects of the pill and the IUD caused many women to switch to barrier methods. Their concerns were placed into a broader socio political - context by a well informed and active women's health movement. Its adherents advocated a less interventionist approach to women's health care, focus- ing on issues such as safer methods of birth control, less in- tervention in pregnancy and childbirth, mystification de - of medicine and technology, and encouraging self help - and education to challenge the control of health by the medical pro- fession. When combined with the negative publicity given the pill and the IUD, the impact of this new movement was dramatic. Among the more than one million women receiv- ing first time contraception services each year at clinics of the Planned Parenthood Federation of America in 1980, 12.9 per- cent chose the diaphragm, up from 5.7 percent in 1975. Most of these users were women aged 25 to 29.5 Despite their concerns about IUD's and oral contraceptives, many women continue to use them because they find that the diaphragm disrupts spontaneity and is aesthetically displeas- ing: spermicide must be applied at every coitus. Many women's clinics and a few physicians have been importing another bar- rier device from its British manufacturer to offer women an alternative. This device, the cervical cap, is made of a rubber similar to that used in the diaphragm and covers the cervix through suction; it can stay in place up to three days and does not require repeated applications or spermicide. Although the cap has been used safely and effectively in Europe for over 150 years, in 1979 the FDA classified it as a Class III (significant " risk ") medical device, thereby placing it in the same category as IUD's and heart pacemakers. (Diaphragms and condoms are considered Class II devices.) Unlike many products, the cap does not have powerful allies. to advocate its case before the FDA. The large pharmaceutical houses which market contraceptives have expressed no interest in U.S. production -- perhaps because the cap requires little spermicide, the major source of profit in diaphragm use. This lack of interest and the FDA classification have left the field open for another barrier device which is safe, effective, and easy to use. The VLI Corporation, manufacture of the sponge, claimed its product was all of these, and more - since " one size fits all " it did not require a visit to the doctor. This attribute is no doubt attractive to women who may not have the money to see a physician or who may be reluctant to undergo a gynecological examination. As we shall see, all of these claimed virtues are open to question. Is It Safe and Effective? The Today sponge is a two inch -, round, white polyurethane cushion impregnated with one gram of the spermicide non- oxynol - 9 (N - 9). The manufacturer claims that it works by blocking the cervix, absorbing semen, and killing sperm. ' The primary concern about sponge safety centers on the presence of two known carcinogens -- dioxane not (to be con- fused with dioxin) found in N - 9, and 2,4 Toluendeiamine - (TDA 2,4 -) found in polyurethane. Nonoxynol - 9. According to the Associated Pharmacologists and Toxicologists, a Washington, DC based group which has called for the withdrawal of the sponge pending a review, diox- ane is a contaminant of N - 9 which forms during the synthesis of the spermicide.8 spermicide.8 FDA chemists first noted dioxane's carcinogenicity when it was administered orally to animals in 1979.9 Many studies have recently sparked a debate on its potential carcinogenicity and teratogenicity. A 1981 paper by Hershel Jick, et al., ex- pressed concern that the use of spermicides in humans around the time of conception may be associated with congenital disorders. 10 However an FDA Advisory Commitee recently decided against placing a label on the spermicides which would warn pregnant women not to use them, " declaring that the Jick study was faulty and only over the counter drugs intended for systemic absorption require such a label. Despite this decision, Dr. Solomon Sobel, Director of the FDA's Metabolic and Endocrine Drug Products Division, hinted that the question of absorption of N - 9 was not closed. In June 1983 Dr. Sobel signed off on an internal FDA memo which warned that N - 9 may well be associated with increased fetal malformations and recommended a special warning for pregnant women on OTC vaginal products using spermicides. 13 In addition, an 1982 study done at the Harvard School of Public Health found that in vitro tests of N - 9 induced dose- dependent malignant transformations in two mouse cell systems. The report concludes by saying, In the early 1970's the FDA OTC Panel on Review of Con- traceptive and Other Vaginal Products determined new guide- lines for testing the safety and efficacy of various ingredients in contraceptive products. According to the Committee's deci- sions, safety evaluations of spermicides should include in vitro and in vivo mutagenicity and carcinogenicity testing; yet few 14 Health / PAC Bulletin studies of this nature have been published. The Jick study... in conjunction with our data, as well as the frequency with which these products are used, justify further investigation of the mutagenicity and teratogenicity of N 9.14 - Under Congressional questioning in July 1983, FDA scien- tists who approved the sponge testified that they were not aware of this study, which had been published a year earlier in Car- cinogenesis, but expressed concern about it. FDA officials ex- plained that specific reviews were not directed towards N - 9 during sponge approval because it was considered safe, based on its 20 year use as an OTC contraceptive. They claimed that they were not even aware that dioxane was in N - 9 until June 1983, when an outside group petitioned the FDA on sponge safety. 15 Congressman Ted Weiss (NY D -) noted that the FDA Ad- visory Panel on OTC Contraceptives and Other Drug Products relied on animal studies published in a 1969 article by Smyth and Calandra to establish the non carcinogenicity - of N - 9 (VLI also relies on this study) 16 and then pointed out that one of the co authors - , Joseph Calandra, was on trial in 1983 on charges of submitting fraudulent animal toxicology data to the FDA. When asked if they had requested independent validation of studies on N - 9 performed by him, FDA officials admitted they had not. 17 Critics point out that the absorption and accumulation of N - 9 in the body have been demonstrated in experiments using radioactive tracers. 18 These studies show that N - 9 is readily absorbed from the vagina into the bloodstream. Six days after a single intravaginal dose, the radioactive tracer was found in the urine and milk of lactating test animals. Other animal ex- periments have found that inflammation in the vaginal tissues is proportional to the dose of N - 9 applied to the vagina.19 Despite these studies and the sponge's large dose of N one - 9 - gram is more than is used in any other barrier method - there was no animal testing for intravaginal absorp- tion. Although FDA officials initially told Rep. Weiss's com- mittee that 80 percent of N - 9 remains in the sponge after use, they later admitted that there is no data to support this since the requisite testing has not been done. 21 2,4 Toluenediamine - . Another carcinogen associated with the sponge, 2,4 TDA -, can be produced as a byproduct in the pro- cess of the manufacturing of polyurethane. Recent reports in the scientific literature of animal studies show: 1) cervical and ovarian tumors from the use of intravaginal polyurethane tam- pons in mice22 and 2) the acute toxicity of a polyurethane sponge when inserted in the vaginas of rabbits. 23 Published reports have also raised concern about the bio- degradation of polyurethane when in chronic contact with animal and human tissues. 24 The complete disappearance of a breast prosthesis cover in one case 25 directly challenges assertions that polyurethane is an " inert " material - a claim often advanced by the sponge's manufacturer. Although the FDA knew that 2,4 TDA - was a carcinogen26 and was associated with hepatic neoplasias and mammary tumors in rats, they fixed safe dose levels for intravaginal use of 2,4 TDA - solely on the basis of dietary considerations, not asking the VLI Corporation for any intravaginal testing. As Dr. Nathan Mantel, a mathematical statistician for 27 years at the National Cancer Institute, told the Weiss Committee, These are potent cancer causing - agents and it would be foolhardy to let those agents come into direct contact with sen- sitive tissues like those of the uterus or vagina, which are among the most important sites of cancer in women - a dose level which could safely be added to the diet might be far too high to bring directly to bear on these tissues. 28 Finally, as with N - 9 the FDA has no data for 2,4 TDA - on the amount which escapes from the sponge during use. Without this data, it is difficult to assess the carcinogenic risk to sur- rounding vaginal tissues. 29 Toxic Shock Syndrome. As of February 1980, the Centers for Disease Control had confirmed four cases of toxic shock syn- drome TSS () from sponge use; 30 as of June the number was reported to be ten.31 Accurate and current totals are difficult to obtain because physicians are not required to report TSS. The sponge manufacturer did not test for TSS in its clinical trials and, indeed, the FDA claims that this would have been impossible, since a proper study would require some 168,000 women. Most researchers share the CDC view that all that can be done is wait and see if sponge users get toxic shock, a poten- tially fatal disease. Two microbiologists at New York University Medical Center disagree. Philip Tierno and Bruce Hanna have been studying TSS for four years; their conclusions have been published in journals such as Lancet and the American Journal of Obstetrics and Gynecology. A year ago they wrote the FDA to urge it to withdraw approval of the sponge on the grounds that it car- ries a high risk of TSS. They maintain that it is possible to determine whether there is an unnecessary risk by exposing sponges injected with staph aureus to the two nutrients most likely to be present in the sponge user's vagina - semen and menstrual blood.32 (Although package inserts warn against using the sponge during menstruation, Tierno points out that a woman may be wearing one when her menstrual cycle beings.) Effectiveness. Although the VLI Corporation claims the sponge is as effective as a diaphragm, results of clinical trials do not confirm this. When women were randomly assigned either the sponge or a diaphragm in British and Canadian studies, one year pregnancy rates were significantly higher for sponge users: 27.3 per 100 women versus 10.2.33 In a similar recently completed U.S trial, the rate was 16.8 per 100 with the sponge and 12.5 for diaphragm users. 34 Health / PAC Bulletin 15 A Nurse Practitioner's Experience Is the sponge the contraceptive panacea women have been waiting for? On the surface it offers perfection in terms of availability, spontaneity, and expense. Yet, as a nurse practitioner, I admit to initial skepticism about the sponge's simplicity. This arose from a variety of fac- tors, among them the almost mysterious rapidity and in- exactness of the FDA approval process; the debates over the potential carcinogenicity of Nonoxynol - 9 and 2,4 TDA -; and the puzzling assumption that one size sponge is appropriate for all women. After a few months of working with women on fam- ily planning I have developed some additional concerns, although because this time has been brief, and the in- cidence of sponge use low in my practice, I can only of- fer anecdotal accounts. I have seen several cases of severe vaginal irritation and / or infection immediately following sponge use. These cases have been difficult to treat, and have caused women much discomfort. On two occasions I have had to remove fragments from the cervix of women who thought that they had adequately removed the sponge. This could well increase the risk of irritation and / or in- fection, or even toxic shock syndrome - the manufac- turer itself advises against the use of the sponge while menstruating, and my experience shows that women could begin menstruating with fragements of sponge re- maining inside them. Furthermore, although the manufacturer claims that no professional consultation is needed for use, I have found that teaching proper technique and practice for the sponge is no less important than it is for the vaginal diaphragm. A woman using a diaphragm goes through an extensive teaching / learning process with emphasis on learning pelvic anatomy and landmarks. She is then asked to demonstrate insertion and removal of the diaphragm, and a follow - up visit is arranged for a week later to ensure that she is using it correctly. Although the sponge is sold over the counter on the presumption that all women feel comfortable with their understanding of their pelvic anatomy, and that all women are the same size, this is not true in my ex- perience. I have had a patient who simply could not use the sponge because it would not cover her cervix. A nurse practitioner 16 Health / PAC Bulletin These trials also found that accidental pregnancy rates tended to be higher in sponge users who were parous, mar- ried, or 25 years of age or older. This may indicate that one size sponge does not fit all; parous women may need a larger diameter to assure a snug fit in the upper vagina. When evaluating the sponge's effectiveness, it is important to note that in clinical trials women have been given instruc- tion in how to wear it and seen in follow - up visits to ensure that they were using it properly. In ordinary usage, women buy it over the counter and rely on the package insert. One may imagine that their pregnancy rates will be quite a bit higher than what was found in the trials. Dr. Gerald Zatuchni, professor of obstetrics and gynecology at Northwestern University and director of the Program of Ap- plied Research on Fertility Regulation, agrees with this predic- tion. After two years developing a contraceptive sponge, he abandoned the effort because the ten percent failure rate was considered too high.35 He believes the failure rates will be higher among women who have no individual instruction in how to use the sponge, and quips that he doesn't suggest its use " unless someone wants to get pregnant. " He has also com- mented that the idea that the same size sponge will fit every woman's vagina " makes about as much sense as the idea that every women could wear a size six shoe. " 36 Where the FDA Went Wrong Questions about the sponge's safety and efficacy inevitably raise questions about the FDA review and evaluation process. Although most consumers would consider the sponge a device, it is in fact classified as a drug; in the words of the FDA, it is " simple a delivery system for N 937 - It was considered a device when review began in 1977. At that point the sponge was made of a collatex material. In testimony before Congress, VLI president Bruce Vorhauer said that at the time his com- pany had been working with Searle Pharmaceutical Company to develope the sponge, and when " I told them (Searle) that we were classified as a medical device.Searle.. couldn't believe it. They had to write a letter to FDA and ask why...The FDA spent about six months evaluating that and they decided that really it wasn't a device. It was a drug because we were using N - 9. " 38 Searle clearly believed it was easier to be an already existing drug than a new device. This proved to be correct: N - 9 was accepted as " a time honored " spermicidal agent, requiring no scrutiny of the polyurethane material. It would have been more judicious to classify the sponge as both a drug and a device, and review it accordingly. Dr. Mantel, the National Cancer Institute statistician men- tioned earlier, charged in his congressional testimony that the FDA's assessment of safe dose levels for 2,4 TDA - was substan- tially overstated. 39 He was not challenging the safety of the sponge, only taking issue with the way in which the FDA assessed safe dose levels and calculated its quantitative risk assessment. Former FDA Commissioner Arthur Hull Hayes defended the FDA's risk assessment process, but immediately afterward it emerged in the hearing that, in fact, no quantitative risk . assessment of 2,4 TDA - had been done by the FDA prior to its approval of the sponge; the assessment presented in the hear- ing was done only when the congressional committee re- quested one three months later - and even then it was based on safe doses of the material as ingested rather than used vaginally.40 In his reply to FDA testimony, Dr. Mantel aptly wrote the committee, My own private opinion is that the FDA had, or thought they had, good reasons for approving the Today contraceptive sponge. The risk assessment had nothing to do with that deci- sion. But, after the fact, when challenged, the FDA fabricated a risk assessment justification and it turned out to be faulty. The FDA should have replied to the challenge by giving their 41 true reasons for approving the Today contraceptive sponge. There was dissent within the FDA as well. One chemist on the review committee failed to " sign off " on the VLI sponge because he believed the manufacturer had not resolved incon- sistencies in its reports. It was he who brought the presence of 2,4 TDA - to the attention of FDA officials, and his greatest concern was the manufacturer's varying figures of how much of it the sponge contained. This problem had a history. In mid 1980 -, when Schering- Plough was considering acquisition of VLI and the marketing rights to the sponge, its researchers detected the 2,4 TDA -. In an internal memorandum, a Schering scientist warned, The presence of TDA in the finished sponge represents a medical and product liability hazard. The art teaches us that TDA was banned from hair dye...... because it is mutagenic, teratogenic, and carcinogenic. 42 Although the product was subsequently changed, the FDA chemist was concerned that 1) VLI had not developed a sen- sitive enough test to detect levels of 2,4 TDA -, and 2) that 2,4 TDA - might form over time as the sponge's polyurethane degraded. He wanted to see stability test results for various lots of the sponge over time so that an expiration date could be af- fixed to the packaging. Such tests had not been done when the sponge was approved. The Clinical Trials The FDA required that 200 women be tested with the market version of the sponge for one year to assess its safety. VLI fre- quently says that more than 2,000 women were tested with the sponge for over six years. Actually, the current version was tested with 1,596 women; only 644 of them completed a full year's study, and just 15 participated in VLI's one extended wear test- using a sponge continuously for seven days. Only 267 of the women tested were from the U.S. Most of the rest were from developing nations Guatemala - , 43 Bangladesh, Egypt, etc. These women are demographically dissimilar to women in the U.S. For example, 75 percent of 44 them were married; in the U.S. trials only 25 percent were. Given the potential impact of sexual customs as well as economic and marital status on the safety and efficacy of con- traceptive products, these overseas tests seem problematic, and a statistician from the FDA itself, Hoy M. Leung, has characterized such pooling of data from different countries as " not applicable to the U.S. population. " 45 Post Market - Surveillance As is the case with most drugs and technologies, there is no post marketing - surveillance system in place to evaluate the sponge's impact when thousands of women are purchasing it on the open market. Such surveillance should have been con- sidered critical in the case of the sponge. It is an OTC drug and can be used without a physician consultation; several dangers have been suggested, including TSS; the controversy over whether or not N - 9 causes birth defects continues. Suggestions for post marketing - surveillance systems which have been offered for contraceptive products in the past could be instituted to monitor the sponge. One method, pioneered by the Boston Drug Epidemiology Unit of Boston Medical Center, includes interviews using detailed standardized ques- tionnaires with people who enter hospitals in various parts of the U.S. Associations between drugs and disease could emerge as data are collected. It is extremely likely that many women using the sponge would come to emergency rooms with sponge related - complications since a large percentage of these women probably would not have physicians. Surveillance systems are also theoretically possible in out- patient settings such as large group practices, where physicians could link diagnosis to drug exposure. This has not been suc- cessful here in the past, although such formal systems have worked well in the United Kingdom and Sweden. " The FDA could certainly urge physicians to report TSS, extreme vaginal irritation, and / or cervical changes believed to be associated with the sponge to either the FDA itself or the CDC. If vaginal contraception leads to an abnormally high in- cidence of congenital malformations in women who become pregnant while using them, registers which collect informa- tion on malformation and tumors can be consulted, and the women could be interviewed about drug use. At present, the only post surveillance - system for the sponge is run by the VLI Corporation, whose toll free number operates only during business hours. Health / PAC Bulletin 17 Conclusions Should the sponge have been approved by the FDA? Given the evidence, it appears that its risks outweigh its benefits. At a dollar apiece, the sponge appeared to be a fairly inex- pensive, simple, and safe answer to women's contraceptive needs. Now we have more questions than answers. We may also hypothesize about subtle and / or indirect pressures on the FDA which helped win the sponge approval. Bruce Vorhauer, president of VLI, has admitted that if the U.S Government's Agency for International Development had not picked up the $ 2 million tab for clinical testing, the sponge never would have made it to the market. 48 The Los Angeles Times has reported that AID decided to finance the trials after VLI agreed to sell it the sponge at cost, presumably for use in the developing world, once it became a commercial suc- cess in the U.S. " At the same time, as noted above, safe alternatives with no powerful backers such as the cervical cap are still awaiting FDA approval. The debate over the safety and efficacy of the sponge will no doubt continue, with VLI insisting that it has done all the necessary tests and critics demanding more conclusive answers. " Women who are good feminists understandably have a mistrust of industry and the FDA, " says VLI researcher Bar- bara North, " It seems a no win - situation. " One way VLI could ease this mistrust would be to volun- tarily withdraw the sponge from the market until the questions put to it at the congressional hearings on sponge safety and loopholes in the FDA approval process are resolved. If it does not, thousands of women will continue to be guinea pigs in the sponge's largest clinical trial to date - public sale.50 1.Blair, Gwenda, " Mop'n'Glow - The Absorbing Story of the Contracep- tive Sponge. " Village Voice, May 1, 1984. 2.Eagan, Andrea. The " Contraceptive Sponge. " Ms. Magazine, January 1984. 3. The " New Birth Control Sponge: Can We Trust It? " Medical Monthly, January 1984. 4. Barrier Devices, Population Reports 1984: Series H (7) February January / . 5. Ibid. Federal 6. Register, 1980: 49 39 () February 26. 7. Vorhauer, B; Edelman, D: North, B; Soderstom, R, " Today Vaginal Con- traceptive Sponge - A Technical Review. " Available from VLI Corp., Pro- fessional Relations Office, 2031 Main St., Irvine, CA 92714. 8. Associated Pharmacologists and Toxicologists, " Citizens Petition to the Food and Drug Administraton, " June 20, 1983. Docket No. 83P 0187 - / CP0002. 9.Birkel 9.Birkel, T.J.; Warner, C.R.; Fazio, T., Gas " Chromatographic Determina- tion of Dioxane 1,4 - in Polysorbate 60 and Polysorbate 80. " J. Assoc. Off. Anal. Chem. 1962: 4 921:. 10Jick, H.; Walker, A.; Rothman, K.; Hunter, J.; Holmes, L.; Watkins, R., " Vaginal Spermicides and Congenital Disorders. " JAMA 1981: 245 1329-1332 (13) . 11. FDA " Advisory Committee Says No to Warning Label on Spermicides, " Medical World News, February 13, 1984, p. 59. 12.Ibid 12.Ibid. 13.FDA's Approval of the Today Contraceptive Sponge, Hearing before a sub- committee on Government Operations of the House of Representatives, July 13, 1983. Gov't. Printing Office, Washington, p. 265. 14.Long, S.; Warren, A.J.; Little, B., Effect " on Nonoxynol 9, a detergent with Spermicidal Activity, on Malignant Transformation in Vitro, " Car- cinogenesis. 1982 553-557: 3 (5): . 15.Op. Cit., Hearing before... p. 241. 16.Smyth, H.; Calandra, J., Toxicologic Studies of Alkylphenol Polyox- yethylene Surfactants. Tox. and Phamacol. 1969 315-344: 14: . 17.Op. Cit., Hearing before... p. 263. 18.Chvapil, M.; Eskelson, C.; Stiffel, V.; Owen, J., Studies " on Nonoxynol 9 II- Intravaginal Absorption, Distribution, Metabolism and Excretion in Rats and Rabbits. " Contraception. 1980 325-339: 22 (3): . 19. Chvapil, M.; Eskelson, C.; Droegemueller, W., New " Data on the Phar- macokinetics on Nonoxynol 9 " Vaginal Contraception - New Developments. edited by: G.I. Zatuchni, A.J. Sobrero, J.J. Speidel, J.J. Sciarra, pp 165-174, Harper and Row, New York, 1979. 20.Op. Cit., Hearing before... p. 287. 21.Op. Cit., Hearing before... p. 301. 22. International Agency for Research on Cancer, Evaluation of the Car- cinogenic Risk of Chemicals to Humans - Some Monomers, Plastics and Synthetic Elastomers and Acrolein. 1979 326-331: 19: . 23. Chvapil, M.; Chvapil, T.A.; Woen, J.A.; Kantor, M.; Ulreim, J.; Eskelson, C., " Reaction of Vaginal Tissue of Rabbits to Inserted Sponges Made of Various Materials, " J. Biomed. Mat. Res. 1979: 13: 1-13. 24.Op. Cit., Associated Pharmacologists and Toxicologists. 25.Slade, CL.; Peterson, H., " Disappearance of the Polyurethane Cover of the Ashley Natural Y Prosthesis, " Plastic and Reconstructive Surgery. 1982 379-382: 70:. 26. Cardy, R., " Carcinogenicity and Chronic Toxicity of 2,4 Toluendiamine - in F334 Rats, " J Natl Cancer Inst. 1979 1107-1116: 62 (4): . 27. Weisburger, E.; Russfield, A.; Weisburger, J.; Boger,.; E Chu, K., " Testing of Twenty One Environmental Amines for Long Term Toxicity or Car- cinogenicity, " J. Env. Path. Tox. 1978 325-356: 2: . 28.Op. Cit., Hearing before... p. 119. 29.Op. Cit., Hearing before... p. 301. 30. Toxic " Shock Syndrome and the Vaginal Contraceptive Sponge, " MMWR 1984: 33 43-45 (4):. 31.Private communication with Armand Lione, Director, Associated Phar- macologists and Toxicologists. 32.Op. Cit., Blair. 33.Op. Cit., Population Reports. 34.Ibid 34.Ibid. 35.Op. Cit., Blair. 36. Ibid. 37.Op. Cit., Hearing before... p. 291. 38. Ibid., p. 517. 39.Ibid., p. 109. 40. Ibid., p. 157-158. 41.Ibid., p. 520. 42.Ibid 42.Ibid., p. 4. 43.Op. Cit., Blair. 44.Ibid 44.Ibid. 45. Ibid. 46.Stolley, P.; Davies, J.; Shapiro, S., " Components of an Epidemiologic System for the Surveillance of Adverse Effects Due to Vaginal Contracep tives, Vaginal Contraception - New Developments, edited by G.I. Zatuchni, A.J. Sobrero, J.J. Speidel, J.J. Sciarra, pp. 271-276, Harper and Row, New York, 1979. 47.Ibid 47.Ibid. 48.Op. Cit., Blair. 49.Los Angeles Times, April 8, 1983, p. A 3. 50.Op. Cit., " The New Birth Control Sponge - Can We Trust If? " 18 Health / PAC Bulletin High Risk, Low Assessment A Talk With Ellen Silbergeld by Carl Blumenthal Att Att t the start of the Reagan Administration, many health and advocates joked that the Declaration of Inde- pendence would have flunked a cost benefit - test. Now they are probably convinced that if Reagan had been president in 1863, he would have replaced slavery with indentured servitude after analyzing all the risks. ' In contrast, environmentalists with the goal of reducing health hazards as much as possible are wary of efforts to ra- tionalize regulation. Nicholas Ashford, director of MIT's Center for Policy Alternatives, said last year that although demand for better science is replacing the cry for more cost accounting, hidden in both are " really political views that represent a preference not to regulate rather than to regulate. " This suspicion is widespread enough that in 1982 Lester Lave, a pioneer of cost benefit - analysis, felt compelled to declare that No " one should be under the illusion that quantitative risk assessment has a pro industry - or anti environmental - bias. " " 74 This concern with public disaffection has also penetrated the Reagan Administration, rocked by the negative publicity generated in the 1983 Environmental Protection Agency scan- dals. In his first major speech as EPA chief in July 1983, William Ruckelshaus demanded a clean break between science and politics. Adopting a recommendation of the National Research Council (NRC), 5 he insisted that " risk assessment " and " risk management " would no longer get mixed up at EPA. (See Figure 1.) One environmentalist who agrees with this approach is Dr. Ellen K. Silbergeld, chief toxics scientist for the Environmental Defense Fund, a national membership organization staffed by scientists, economists, and attorneys who specialize in energy, toxic chemicals, water resources, and wildlife. A former researcher at the Johns Hopkins School of Public Health and the National Institute of Health, Silbergeld has published more than 100 papers and is a member of the EPA Science Advisory Board. In a recent interview with Health / PAC, she defined risk assessment as a technique for assessing human experience and extrapolating from experiments with animals to human health effects, in order to describe the risks of different levels of chemical exposure (see box). She emphasized that effects in animals from such exposures can and must be used to predict human responses because epidemiology is too slow, imprecise, and expensive to be the sole basis of regulation.? In her mind controversies arise when people link this tool Carl Blumenthal is a member of the Health / PAC Board. Carl Blumenthal of biological science with cost benefit - analysis or other social science methods for deciding at what level of risk to set a stan- dard, and with what hazard controls. Called " risk manage- ment " by NRC, this latter exercise requires juggling of politics, economics, and technology. While it may be unwise to identify risk assessment with risk management, both involve large methodological uncertainties. Silbergeld distinguished between two types of uncertainty in risk assessment: the question that " can inevitably be deter- mined by some kind of scientific experiment, but at present we don't have the information " and the question that is a matter of " philosophical belief " because it cannot be decided by any experiment., For example, we know that in large amounts some chemicals cause cancer in animals, but we do not know how many cancers will result from exposures as small as those humans usually experience in the environment. The debate about saccharin and bladder cancer, for example, included a dispute over how to extrapolate from high to low doses. Health / PAC Bulletin 19 RESEARCH FIGURE 1 Elements of Risk Assessment and Risk Management RISK ASSESSMENT | RISK MANAGEMENT Laboratory and field observations of adverse health effects and exposures to \ particular agents. Hazard Identification \ (Does the agent cause the adverse effect?) Development of regulatory options : | 1 I Information on I extrapolation methods __| y, for high to low dose and animal to human Dose Response - Assessment (What is the relationship between dose and in- cidence in humans?) Risk Characterization (What is the estimated incidence of the adverse effect Evaluation of public health, economic, social, political con- sequences of regulatory options Field measurements, estimated exposures, characterization of populations Exposure Assessment (What exposures are currently experienced or anticipated under different conditions?) in a given population?) | _ v Agency decisions and a actions Source: National Research Council, Risk Assessment in the Federal Government: Managing the Process (Washington, DC: National Academy Press, 1983) p. 21. " Is the dose response - curve linear, particularly is it linear at low doses? " is the question as Silbergeld posed it. " For some chemicals, " she noted, there " is evidence to suggest that it may be, or that it is best fit by a linear line, and there is evidence for certain other carcinogens, such as vinyl chloride, that it is clearly not, that it may be better fit by other shaped curves. That's an area of great controversy, but one which may be partly resolved by experimental evidence. " (See Figure 2.) " The EPA too often makes the worst assump- tions, and takes the least scientific approach. " As an example of a philosophical question, unresolvable by experiment, Silbergeld chose " Do you operate at the upper limit of statistical confidence or at the mean? " when calculating effects in humans from those in animals, given that chance plays a part in all scientific results. Such a choice may depend in part on whether a scientist is more concerned about wrongly accusing a chemical manufacturer of harm (and uses the mean) or whether his or her greater fear is giving the chemical an unwarranted bill of health (and uses the upper limit). While Dr. Silbergeld believes the distinction is clear between scientific and philosophical uncertainty, such procedural choices as above must be made - choices which are more or less conservative, that is more or less protective of public health. The National Research Council concluded that such choices are often not made explicitly in risk assessment and " the result is a mixture of fact, experience (often called intui- tion) and personal values that cannot be disentangled easily. " 8 In her recent doctoral thesis, Frances Lynn of the Univer- sity of North Carolina described this mixture in more detail. Based on interviews with 136 occupational physicians and in- dustrial hygienists from industry, academia and government, she found " Those scientists who self identify - as Republicans, Reagan voters and conservatives are more likely to believe in the existence of thresholds, question the use of animal data, support the use of cost benefit - analysis, and feel that Americans are overly sensitive to risk. " Not surprisingly industry scientists tended to be more con- servative politically and less protective medically than their counterparts in government. The attitudes of academic scien- tists fell in between. Although Dr. Lynn did not indicate whether the scientists she interviewed performed risk assess- ment routinely, her findings suggest how difficult it may be to disentangle the mixture of fact, experience, and value that NRC describes. Even if a scientist's values did affect the way he or she deals 20 Health / PAC Bulletin FIGURE 2 Results of Alternative Extrapolation Models for the Same Experimental Data. one in a hundred = Supralinear one in (P ) 0 ten thousand - - ) d (P RISK one in a million. EXTRA one in a hundred million Linear Sublinear II Sublinear I Threshold one in ten billion j | i 0.01 0.1 1.0 10.0 DOSE (Micrograms per Week) FIGURE 1 Results of alternative extrapolation models for the same ex- perimental data. NOTE: Dose response - functions were developed (Crump, in press) for data from a benzopyrene carcinogenesis experiment with mice conducted by Lee and O'Neill (1971). Source: NRC, Risk Assessment, p. 26. with scientific (as opposed to philosophical) uncertainty, Silbergeld would probably still scrutinize those uncertainties that have the " biggest influence on the eventual answers. " As already mentioned one of these is the shape of the dose- response curve. Even more important to Silbergeld is exposure assessment. (See Figure 1.) When determining how exposed to a contaminant the population is and from what sources, whether food, air, water, or soil, " the agency (EPA) too often makes the worst assumptions and takes the least scientific ap- proach, " she says. (See box.) The National Research Council has high hopes that, by being more systematic than in past efforts, risk assessment will lead health and safety agencies to great certainty. NRC believes that with this technique the agencies will be able to determine priorities for research and regulation. Ellen Silbergeld is much less optimistic. According to her there are not more than " ten or 12 " substances that EPA knows enough about to do full risk assessments on; hardly enough chemicals to prioritize for regulation. Referring to the National Academy of Science's recent report, Toxicity Testing, the real problem, she says, is what to do with the thousands of chemicals on which we do not have enough data to " support even the flimsiest risk assessments. " She also expressed concern about the EPA staff's lack of public health training. When reminded that EPA was created in part because the U.S. Public Health Service (PHS) failed to cope with environmental problems, she said the two organizations " ought to get back together in a structural and regulatory sense. I don't think EPA is doing a very good job in its health and exposure assessments. But for the first time Health / PAC Bulletin 21 Our Science and Theirs The National Research Council went beyond Silbergeld in her demand for accountability by government health and safety agencies. Rather than requiring just a case case - by - examination of risk assessments, NRC recommended " uniform inference guidelines " for all steps in the process except exposure assessment, which is source specific - and still too uncertain. An inference guideline is nothing more than a documented preference, e.g. for a linear dose- response curve over one with a threshold, a conver- sion of animal to human body size using weight rather than surface area, or a calculation of effects that includes benign as well as malignant tumors. The goal is to achieve consensus about as many choices as possible in order to avoid reinventing risk assessment every time a standard is established or revised. Unfortunately the sticking point has always been the guidelines'flexibility. " Flexibility " means how easily a scientist can reject a consensus interpreta- tion in favor of another based on convincing (new) scientific evidence. It also means how a guideline deals with uncertainty or incomplete data. For example, in an article about cancer policy, Silbergeld rejected efforts by Anne Burford Gorsuch's EPA to favor a two class - model of car- cinogenesis, with some carcinogens treated more leniently than others if they did not damage DNA directly, which is how many scientists believe cancer is caused. She found this approach incomplete because it discounted evidence that chemicals like dioxin could be powerful carcinogens in animals without affecting directly the cells'DNA, which con- trols hereditary traits. " Given Gorsuch's record at EPA, one would suspect that this scientific inflexibility was politically motivated. It is not surprising that when Rep. James Scheuer (NY D -) asked Gorsuch why she was trying to replace the agency's Science Advisory Board, she reportedly responded " Oh, no, they are good scien- tists, except we want our scientists rather than their scientists. " 12 the head of their research office is a health scientist. So is the head of the Office of Toxic Substances. " She joked, Now " we would have complete victory if we could stop the lawyers from being Administrators. " When asked if she thought adding more health professionals at EPA would make its work more comprehensible to the public, Silbergeld was not sanguine. " The more you have ad- vanced training in health science, the more it can be difficult for you to talk sensibly to the public. Sometimes it's hard to hear what people are really saying. Take the mother who asks ' My child has Down's Syndrome. Is that caused by TCE? " You say'No'and give her a whole rundown on what causes Down's when she was really asking what is the evidence for birth defects [from trichloroethylene]. " The belief that better risk assessment is not purely a scien- tific problem is widely shared among environmentalists. The type of risk assessment board recommended by NRC, warns Frances Lynn, is " removed from public input and procedural guarantees, " and what we need is " a more self conscious - scien- tific community " as well as a more informed citizenry. 1 Y' 1. See U.S. House of Representatives, Committee on Interstate and Foreign Commerce, Subcommittee on Oversight and Investigations, " Benefit Cost - Analysis: Wonder Tool or Mirage? " Washington, DC, U.S. Government Printing Office, December 1980. 2. Nicholas Ashford, et al., " Examining the Role of Science in the Regulatory Process: A Roundtable Discussion about Science at EPA, " Environment 2 5 () June 1983, p. 7ff. 3. See Lester B. Lave and Eugene P. Seskin, Air Pollution and Human Health (Baltimore: Johns Hopkins University Press, 1977). 4. Lester B. Lave (ed.), Quantitative Risk Assessment in Regulation (Washington, DC: The Brookings Institution, 1982) p. 4. 5. " Regulatory agencies should take steps to establish and maintain a clear conceptual distinction between assessment of risks and the consideration of risk management alternatives; that is, the scientific findings and policy judgments embodied in risk assessments should be explicitly distinguished from the political, economic, and technical considerations that influence the design and choice of regulatory strategies. " National Research Coun- cil, Risk Assessment in the Federal Government: Managing the Process (Washington, DC: National Academy Press, 1983) p. 151. 6. The Environmental Forum, " Ruckelshaus'Educates'on Risk Assess- ment / Risk Management, " 2 5 () September 1983, p. 26. 7. 7. Elizabeth Whelan, of the industry sponsored - American Council on Science 22 Health / PAC Bulletin and Health, called this " regulation at the drop of a rat. " In Jonathan Lash, Katherine Gillman and David Sherman, A Season of Spoils: The Story of the Reagan Administration's Attack on the Environment (New York: Pan- theon Books, 1984) p. 149. Lester Lave, formerly of the Brookings In- stitution, favored a hierarchy of tests with screening devices like medical case reports, structural comparisons to known carcinogens and mutagenici- ty assays of bacteria used before toxicology and epidemiology, which are more precise but more costly and time consuming - . See Lave, Quantitative Risk Assessment, pp. 28-33. Scientists may agree that the quality of all data must be examined, but they differ on the value of different types of evidence. 8. National Research Council, Risk Assessment, p. 36. 9. Frances M. Lynn, " The Interplay of Science and Values in Assessing En- vironmental Risks, " dissertation ( ) University of North Carolina, Chapel Hill, December 1983, p. 15. 10. Ibid. 11. See Silbergeld, et al., Point " ... and Counterpoint: A New National Cancer Policy: Has the Dust Settled? The Environmental Forum 2 7 () November 1983, pp. 25, 28-9. 12. In Ashford, " Science in the Regulatory Process, " p. 12. 13. Lynn, " The Interplay of Science and Values, " p. 17. Building a Trojan Horse Science Under the Reagan Administration by Eric Holtzman "I n n most respects, the overall effects of Reagan's policies on In for the basic sciences have been undramatic. Legislation and the administrative atmosphere have been oriented to encourage further private investment in research. Nevertheless, the major federal agencies funding non military - research, such as the National Science Foundation and the Na- tional Institutes of Health, have continued to receive signifi- cant increases in their allocations. Unlike its attitude toward many other government programs, the Administration articulates a policy of strengthened support I for basic research. Its policy makers argue that this is an ap- propriate role for the government in science, and they have restructured the defense non - science budget accordingly. On the other hand, they believe that research in development and application, and related work, e.g. on energy sources, should be done chiefly by private enterprise. True, NIH and NSF funds are not adequate to support all the submitted research proposals that are worthy of support; funding increases have not kept up with inflation in every year or in every field. And true, some specific large projects favored by earlier administrations have been shelved and others ad- vanced. But insofar as basic research in the life sciences and many other areas is concerned, events have transpired within an envelope resembling the one that probably would have evolved under a second Carter Administration. Still to be determined, however, is how the regulatory and advisory roles of agencies like the NIH and NSF will fare. The NIH, for example, is supposed to participate in the regulation of commercial applications of " genetic engineering, " but it is only very recently that it has been faced with the kinds of con- crete decisions out of which longterm policies will evolve. There has been a fairly large scale - turnover of high level per- sonnel in the federal agencies that fund basic research, and discussion of possible further reorganizations continues. Both the turnover and the discussions have generated concern about the politicization of the science bureaucracy. There even are those -s till only a few who - fear that the stage may somehow be set for a present day analogue of the loyalty programs and witchhunting of the'50's. However, some of the most unplea- sant proposals for revamping federal life science support practices such as schemes that would increase the direct in- trusion of elected officials or their designees into the design of NIH programs - emanate from longstanding Congressional momentum and from sources not obviously allied to the Reagan Administration. Thus far most of the Administration's Eric Holtzman is in the Department of Biological Sciences, Columbia University. new appointees have functioned within the range of basic research policies that has evolved over the past decade or two. Among the life sciences, agriculture is receiving intensified attention from the federal government. In some quarters, the perception is popular that agricultural research is being stultified by bureaucratization and the influence of an old boy - network of researchers protected from peer review. In response, the structure of support is being examined, with the intention of invigorating a system of competitive grants in agricultural biotechnology. The principal funding source for the other life sciences, the NIH, tends to come off worse in the Administration's recent budget proposals than do the agen- cies with higher commitments to the physical sciences and engineering. But this may be misleading. Congress generally takes good care of the NIH, and one needn't be particularly cynical to suspect that the Administration is relying upon this tradition to make nice sounds about cutting budgets knowing the final allocation will not severely stunt the NIH's growth. During the early phases of the Reagan presidency, educa- tional programs at all levels, from the NSF sponsored - efforts to improve secondary school science to the training programs of the NIH, was under severe pressure or scrutiny. To an ex- tent this carried over tendencies of the Carter era, although the attack on the social and behavioral sciences was a substan- tially new initiative. For most of the natural sciences, this at- mosphere has been lifting lately, with the rediscovery of our failings in science education. The notion that we must mobilize to recruit and train our next generation of scientists is " in, " although at present segments of Congress are more willing than the Administration is to come forth with large amounts of new money. None of this is to say that things are wonderful, that science funding is truly adequate or equitably distributed or planned with appropriate attention to long term - perspectives, that the commercialization of biotechnology is proceeding along healthy directions, or that the priorities of federally funded research have shifted more toward meeting the needs of the most needy. It means simply that too much boat rocking - has been avoided. This is largely because the sciences have functioned rela- tively well as sources of American profit, strength, and suc- cess within our existing framework, and because they are viewed as major potential elements for maintaining our world position. Japanese and Western European efforts in research and development consume percentages of the GNP equal to or greater than our own, and obviously are viewed with alarm. Scientific research is widely popular and, with exceptions, the scientific community is apolitical, roughly satisfied with things Health / PAC Bulletin 23 more or less as they are and, therefore, non threatening - to the social and political strategies and agendas of the Administration. What is especially worrisome, at present, about the Ad- ministration's science policies is the increased role and visibil- ity of the military. Far and away the largest percentage of what the federal government considers its research and development investment goes to the Department of Defense and its dependents, and these funds have increased dramatically. But frightening and deplorable as this is, it is not new; Reagan has simply added to an already elaborate edifice constructed by his predecessors. " The borders between military and non- military are being increasingly blurred, and the military intrusion into everyday scientific life is again becoming an unremarkable phenomenon. " A more unique stamp of this Administration is its vigorous fostering of the open reinvasion of academic science by the military, which had been forced into a significant partial retreat, at least in visibilit*y , during the Vietnam era. The life sciences are less a target than physics or engineering, but they are certainly not excluded. For example, a variety of basic molecular biological and nuerobiological topics are included in the lists published by the Department of Defense and by the Army, Air Force, and Navy as appropriate for support in their expanded and attractive granting and contract programs for research. Some of these programs, such as those providing funds for new instrumentation, are directed towards what have recently been among the most pressing needs of scientists in universities and academic research institutes. In some cases, the Defense Department grants and contracts accessible to life scientists have clear and direct military goals. There are, for example, disturbing signs of Administration in- terest in expanding the U.S. chemical and biological warfare efforts. These include the dogged insistence by the government, in the face of mounting contrary evidence, that " yellow rain " reflects field use of biological warfare agents by our " enemies, " and the very ambiguous proposals regarding chemical warfare recently floated by Reagan. On the other hand, often the programs sponsored by the military are designed, or at least publicized and administered, so that, as in the past, much research without any obvious direct military bearing can and is being funded. The rationale offered is that the military fully appreciates the time honored - arguments about the unexpected applications a given area of basic research may generate. At least as important as this, however, are more symbolic matters of legitimation and con- trol. Department of Defense grants and contracts are reappear- ing in academic campuses and departments in benign guises- the military appears as a patron of the intellectual arts. As part of a decentralization program (coupled, perhaps, with an in- telligent public relations policy aimed at emphasizing de - the Pentagon, forts and arsenals), for instance, the administration of the Army's basic research program has been moved to the Research Triangle " campus " in North Carolina, which is wide- ly viewed as an excitingly innovative site for interaction be- tween academe and industry. The recipients of Defense Department money have dusted off the old rationalizations: " better we should use the money for good things than that the funds go to real military projects. " In other words, the borders between military and non military - are being increasingly blurred, and military intrusion into everyday scientific life is again becoming an unremarkable phenomenon. In many fields, including the life sciences, personnel can move com- fortably back and forth between civilian agencies like the NSF and institutions with military connections. Moreover, " national security " is reinflating as a criterion for evaluating and controlling activities that hitherto were regarded as outside the province of the loyalty security - apparatus. This has already become overt in a few fields. The recent successful insistence by the government that it have rights to prepublica- tion screening of materials related to cryptography, with at- tendant rights of censorship, is probably the best known ex- ample. There has also been a spate of efforts to restrict the access of foreign visitors to certain types of scientific infor- mation and conferences. If the experience of the'50's and'60's is any guide, such overt direct intervention may be less important in the long run than a poisoning of the atmosphere and perhaps occasional self- censorship, problems that presently are no more than dim fears on most campuses but could easily recrudesce. It is also easy to think of plausible circumstances under which Reaganism's appeal to the narrowest varieties of personal self interest - and its militarized approach to the national interest could be manipulated to spill over into a crusade to protect America's technological and research " supremacy " and to convert knowledge into profit more efficiently by limiting or control- ling access and communication in broader and broader scien- tific realms. Many researchers understand that relative openness of com- munication, national and international, is both a necessity for the long term - health of research, and partly a historical derivative of the success engendered by international coopera- tion in many basic research fields. Those scientists who think about such matters generally believe strongly that the relative autonomy of civilian research is important to defend and expand. At present, however, most of the scientific community is agitated little, if at all, by the threats inherent in the developments outlined above, or by the problems slowly emerging from the currently accelerating privatization of biotechnology (see E. Holtzman, Health / PAC Bulletin, July- August 1983). When funding is reasonably abundant, doubts tend to submerge. Nonetheless, there is some undertone of worry that the surprisingly gentle treatment the sciences have received at the hands of a most ungentle Administration may have hidden costs which could be very high. | 1. See, e.g. the summary by the President's Science Advisor, George Keyworth: Science 224 9-13:, 1984. 2. For details of the proposed budget see, e.g. Bioscience 34 214-218 (4): , 1984; Science 233 564-565: . 24 Health / PAC Bulletin What's Happening in California Health Shifting the Burden of Illness The Impact of the 1982 Medi - Cal Reforms by E. Richard Brown When California's legislators were looking for ways to reduce the state's expected $2 billion deficit in 1982, the state Medicaid program was an attractive and obvious target. Medi- Cal was taking about one dollar in every eight spent from the General Fund and its costs were rising rapidly: led by outlays to hospitals, they had climbed 14 percent annually between fiscal years 1975-76 and 1981-82 while the overall state con- sumer price index was moving up at a rate of 9.7 percent. In an effort to brake this rise, leaders in the legislature - with strong support from the governor and business, labor, and insurance industry groups - enacted a series of bills, overriding strong opposition from the hospital industry and the medical profession. Advocates for the state's three million Medi - Cal recipients were able to influence this legislation only marginally, although it imposed far reaching - changes in the program. First, it eliminated nearly all the state's " medically indigent adults " (known commonly as MIA's) from Medi - Cal. Responsibility Responsibility for their care was transferred to the counties along with about 70 percent of the funds the state would have spent on the group had they remained in Medi - Cal. This shifted a major burden. As heavy users of expensive hospital care - indeed, this is what had pushed many of them into the MIA category - they ac- counted for 16.4 percent of Medi - Cal's expenditures even though they made up only 9.2 percent of those eligible for the program. Furthermore, unlike other Medi - Cal programs the one for MIA's got no federal matching funds. Under the new system, the state gave the counties $ 261 million for the second half of the 1982-83 fiscal year, when the change took effect, and still expected to save $ 110 million in that six months alone. Aside from these savings, several other considerations in- fluenced the legislators. They hoped that the infusion of state funds would shore up the overburdened, underfunded county health systems, and the program they were reorganizing served a fragmented and politically weak sector of the population. Other aspects of Medi - Cal were also pared, through reduc- tions in reimbursement rates to providers, lower income eligi- bility levels, increases in the share of costs paid by medically needy persons, very restrictive definitions of medical necessity for almost all services, and required prior authorization for all inpatient hospital care other than life threatening - emergen- cies. These cutbacks were expected to save the state General Fund about $ 140 million in the 1982-83 fiscal year. E. Richard Brown is on the faculty of the UCLA School of Public Health. Another of the most significant changes in Medi - Cal man- dated the appointment of a special negotiator to conclude con- tracts with hospitals providing for reimbursement for inpatients under some system other than the old cost based - , fee for- - service policy. The negotiator was given unusually broad authority to set objectives and procedures, and the stakes for Medi - Cal patients were not small: once the contracts were signed, they could not go to other hospitals unless they required emergency care or care in children's or other specialized hospitals. This new policy was expected to save about $ 200 million (half state, half federal) in the 1982-83 fiscal year even though contracts were not expected to be operational until mid- way through it. The insurance industry, fearful that Medi - Cal contract hospitals would attempt to make up for any reduced Medi - Cal revenues by shifting costs onto their backs, asked legislators to allow them to negotiate contract prices as well. The legislature heeded their pleas, and authorized private insurers and others to form preferred provider organizations (PPO's), negotiate favorable rates with doctors and hospitals, and pass any savings on to subscribers in the form of lower premiums. Two years after these bills were enacted, evidence of their impact is beginning to accumulate. This article is based on findings of an informal consortium of researchers at Univer- sity of California campuses in Los Angeles, Berkeley, and San Francisco who have shared research methods and information. " Missing in Action? " The MIA transfer was implemented differently in different counties. The legislation permitted those with a population under 300,000 to contract back to the state. Of the 43 coun- ties eligible, 34 did; the state provided a scaled down form of Medi - Cal to their eligible indigent persons. Among the larger counties, the mechanisms for providing MIA care have varied. Los Angeles County, like most, pro- vides care only in county hospitals and clinics - except for emergency care, for which it will reimburse private hospitals. San Diego and Orange, two large surburban counties which have no county hospitals or county medical clinics, contract all MIA care (and other indigent health care) to private hospitals and clinics. Alameda County, a large urban county on San Francisco Bay, uses its county hospitals and clinics and also contracts with a group of community clinics. Most coun- ties combined their MIA programs with their other indigent medical care responsibilities into a single program. Although many MIA's had been receiving care from the counties under the Medi - Cal program, more than half had to Health / PAC Bulletin 25 funguf make a transition from some form of private care (private doc- tors, private hospitals, and / or community clinics) to county facilities. In Los Angeles, for example, 45 percent of all hospitalized MIA's had used county hospitals for inpatient care under the Medi - Cal program, but only 29 percent of the MIA outpatient visits had been to county facilities. Counties also differed widely in the costs they charged MIA's and other indigents as well as their eligibility standards for ability - to - pay (or sliding fee scale) plans. At one end of the spectrum is populous Santa Clara County south of San Fran- cisco Bay, home to both Silicon Valley and farmlands; it main- tains an open door policy, treating everyone in need and worry- ing about the bills later. At the other end is conservative Orange County, which made eligibility for its program dependent on getting sick, going to a hospital, getting financially screened by the hospital, and being further screened by the county. The result has been low utilization. In the middle is Los Angeles, as we will see in more detail. MIA's in Los Angeles Los Angeles County includes more than a third of the state's population and a third of its Medi - Cal beneficiaries. Although no county can really be considered typical, the Los Angeles policies and arrangements have been generally similar to those of the majority of medium and large counties. In some ways, what happened to MIA's in Los Angeles illustrates their fate generally in California - and what is likely to happen to many of the poor nationally as federal and state cutbacks eliminate more people from Medicaid. Use of County Services Los Angeles was one of three counties that took advantage of the " early assumption " option under which the county im- plemented the transfer on November 1, 1982, two months ahead of the rest of the state, in order to recoup 100 percent of the expected MIA costs for that period (instead of the 70 percent which counties would receive for the remaining six months of the fiscal year). In the first few months both inpatient and outpatient services provided by the county climbed gradually, reaching more than 150,000 admissions and more than one million outpatient visits during the 1982-83 fiscal year. However, in judging how well the county met its new responsibilities for all MIA's as well. as its continuing responsibilities for uninsured indigent pa- tients, it is important to separate out the services provided to these patients from those provided to persons covered by Medi- Cal, Medicare, or other insurance. By early 1983 admissions to L.A. County hospitals reached the county's projected levels of more than 13,000 per month. However, this number included many patients who had not lost their Medi - Cal coverage but who apparently had more diffi- culty getting care in the private sector. Thus in fiscal 1982-83, which included eight months of county responsibility for MIA's, 20 percent more Medi - Cal patients were admitted than previous experience would have predicted, and nine percent fewer MIA's and other indigent patients. Outpatient visits followed a similar pattern, but were far fewer than expected. The more than one million outpatient visits to county health facilities - ten percent more than in the previous fiscal year - was only three fourths as many as the ad- dition of MIA's who previously received their care from private sources would have indicated. Because the county does not report the patient's source of payment for most clinic visits, we were unable to determine how much the rise that did occur represented new Medi - Cal patients as opposed to MIA's and other uninsured indigent pa- tients the county was now mandated to serve. Figures from the county's three comprehensive health centers, which did include 26 Health / PAC Bulletin source of payment, from November 1982 through June 1983 of our researchers posing as an indigent patient in need of suggest that growing use by indigent persons was accompanied medical care found no personnel in any facility who mentioned by a rise in visits by Medi - Cal recipients, many of whom the ATP plan. In March, receptionists at all the county presumably experienced greater difficulty obtaining care in hospitals, two of the three comprehensive health centers, but the private sector. only two of eight clinics surveyed mentioned the ATP plan. Acccording to the county's own projections and our analysis Even in August our researcher had a difficult time obtaining of the limited data available, it appears that the county has not such information from a few clinics. Clearly, even when the i been serving all the MIA's and other indigents who previously policy became somewhat more generous there were serious had either been served by the county or had been cared for in problems with its implementation, and financial barriers con- the private sector but were now dependent on the county for tinued to vex many indigent patients. medical care. These conclusions are borne out by other studies. Furthermore, the initial ATP policy excluded undocumented (See, for example, the box on page 28 by Dr. Nicole Lurie.) This immigrants from all but emergency care; this restriction has is understandable given county policies that influence access been voluntarily withheld by the county after strong protests to health care: geographic availability, staffing of services, and and threats of litigation by community advocates. financial policies and practices. At its best, ATP screening is a lengthy process, requiring documentation of eligibility and often a separate visit to one Geographic Availability of the hospitals or one of the 12 of 15 health centers and clinics Los Angeles is a very large county, encompassing more than that provide both general medical care and financial screen- 4,000 square miles. Although population density is high, many ing. Thus, although the ATP policy and procedures permit in- residents are far from all six county hospitals. Nevertheless, digent persons in great need of medical care to get that care, medical conditions that require hospitalization apparently they do discourage use of county health services. motivate people to overcome geographic and other barriers. Ambulatory care is a different matter. General medical care Conclusions About the MIA Transfer is available at the six county hospitals, three comprehensive These findings are not unique to Los Angeles County. health centers, and only 12 of the county's other clinics. Although a few counties established more generous Although Los Angeles has an extensive clinic system compared programs Alameda County has a liberal ATP eligibility to many other counties, some urban areas - such as the Venice- policy and provides geographically accessible care through Santa Monica area and parts of the San Gabriel Valley - are both county facilities and community clinics - several are more a two hour bus ride (each way) from the nearest county general restrictive. Orange County, for example, limited eligibility for medical care. its MIA program to particular episodes of illness or injury and sources of care to contract hospitals and hospital - based clinics. Staffing As a result, from January through June 1983, it handled only Of the $ 143.4 million Los Angeles County received from the 14 percent of the outpatient visits and 55 percent of the inpa- state to operate the MIA program during fiscal year 1982-83, tient days provided in a six month period the previous year only ten percent was budgeted to expand county health ser- under the Medi - Cal MIA program. vices to accommodate the expected increase in patient volume; Overall, the MIA transfer has increased the barriers to care although county officials estimated that 1,380 new patient care for this low income - population. These people and other in- positions were needed, only 220 people were added. digents have been further segregated into the bottom of a two- As a result of understaffing, in some clinics waiting periods or three - tier system of care. The accompanying transfer of for appointments increased from one to two weeks to six to funds from the state has undoubtedly helped the counties main- seven weeks; in others they increased by only one or two tain their underfunded and faltering health systems, but it has weeks. When someone arrives for an appointment or walks not been sufficient to lift the medically indigent to the same in for an urgent medical problem, waiting times can be as long level of care available to the insured population. as two to five hours, although some patients report waiting even longer than that. Medi - Cal Cuts In addition to eliminating a quarter of a million medically Financial Policies and Practices indigent adults from Medi - Cal, the legislature reduced eligi- Until January 1983, the county maintained a formal policy bility in the remaining categories of recipients, changed and of not telling patients about its ability - to - pay ATP () plan, a reduced benefits, and reduced provider reimbursement. sliding fee scale that adjusts charges to patients'incomes. Pa- tients were evaluated for ATP eligibility only if they specifi- Eligibility cally asked for it. Those who did not were charged $ 20 or $ 30 The legislation required that " medically needy " persons as an upfront clinic fee (not including prescription drugs) or would have to spend more of their own money before Medi- billed for full charges (which are much higher than the upfront Cal took over payment of their medical bills. fee). Raising this " share of cost " proved to be a major problem Following protests and threats of legal action from commun- for the elderly, the disabled, and the working poor. Throughout ity organizations and legal services advocates, the county agreed to tell all patients who raised the issue of financial need the state, the patients themselves, community clinic person- nel, and private practice physicians reported that among these about the ATP plan and its eligibility procedures. However, groups " People are sicker, blood pressures are higher, and in February 1983, six weeks after the new policy was to take diabetes is more out of control, " in the words of one physician effect, a telephone survey of county facilities conducted by one with a substantial number of Medi - Cal patients. Physicians Health / PAC Bulletin 27 - Health Effects of Termination from Medi - Cal by Nicole Lurie, M.D. To assess the impact of California's transfer of respon- sibility for the care of medically indigent adults MIA's ( ) to county health sytems, we identified and prospectively followed a group of 215 English and Spanish speaking MIA's who had made at least one visit to the UCLA general internal medicine group practice. After excluding those who refused, were too psychia- trically ill to complete a questionnaire, or could not be found, the sample size was 186 patients. All participants completed a questionnaire about their general health perceptions, access to care, and satisfaction with care prior to and six months following termination from Medi - Cal. To obtain more direct measures of health, we measured blood pressure in hypertensives and Hemo- globin A, in diabetics. (Hemoglobin A, is an indicator of diabetic control over the preceding few weeks.) A comparison group of 109 patients whose Medi - Cal was not discontinued (because they were blind, disabled or in families with dependent children) was also studied. In the initial survey, there were no significant dif- ferences between MIA and comparison patients in gender, ethnic group, income, access to care, or satisfac- tion with care. On average, patients in the comparison group were slightly older. Over 95 percent of the MIA's could identify a usual course of care, and 91 percent were " extremely " or " very " satisfied with care they had receiv- ed; 83 percent agreed with the statement, " I can get medical care whenever I need it. " Members of the com- parison group responded similarly, but they reported worse health, with a mean score of 39.3 on a 100 point - scale versus 47.1 for the MIAS. Prior to termination from Medi - Cal three quarters of the 61 hypertensive medically indigent adults had a nor- mal diastolic blood pressure of 90 mm Hg, and three per- cent had diastolic blood pressure of 100 mm. In the com- parison group, 61 percent of 50 hypertensives had diastolic blood pressure of 90 mm and 11 percent had readings in excess of 100 mm. We were able to obtain information on 97 percent of the medically indigent adults and 90 percent of the com- parison group patients six months following the MIA's termination from Medi - Cal. There were five deaths in the MIA group and none in the comparison group. Causes of death were: gunshot wound, preleukemia, stroke (pontine hemorrhage), presumed myocardial in- farction, and perforated ulcer. This report is based on the paper " Termination from Medi - Cal - Does It Effect Health? " by N. Lurie, N.B. Ward, M.F. Shapiro, and R.H. Brook, published in the New England Journal of Medicine 480 311:, 1984. The stroke occurred in a hypertensive patient who had uncontrolled hypertension at the time of our initial survey, at which time she was given extensive informa- tion about how to obtain care in the county health system. She had received some care from a private physician but was unable to afford her anti hypertensive - medicines. The presumed myocardial infarction occurred in a man with known heart disease who had run out of car- diac medicines. He died after prolonged chest pain at home. The family of the patient with the perforated ulcer reported that he had been vomiting blood at home for ten days, but delayed seeking care because he felt he would be unable to pay an emergency room fee. By the time of the follow - up survey all measures of access to and satisfaction with care had deterioriated among the MIAs. Only half had a regular source of care, compared with 95 percent six months earlier. Sixty per- cent were satisfied with their care, and only 38 percent felt that they could get care when needed. Their general health perceptions had decreased by eight points. There were no significant changes in these measures in the comparison group. Among the hypertensive MIAs there was a mean increase in diastolic blood pressure of 10mm Hg while blood pressure control in the comparison group patients had improved by an average of 5mm. On- ly 34 percent of the medically indigent adults had diastolic blood pressure below or equal to 90, compared with 75 percent previously, and the proportion with diastolic readings above 100 rose from three to 31 per- cent. Data from the Framingham study indicate that if this blood pressure rise in MIAS is sustained, their relative risk of dying would increase by 40 percent. Diabetic control worsened by 15 percent in MIAS and by four percent in comparison patients, but the between group mean difference was not statistically significant at the.05 level. Hypertensive and diabetic patients who regained some form of a third party coverage were more likely to have a regular provider, and those who had a regular provider were more likely to have a diastolic blood pressure less than or equal to 100mm. The study demonstrated that termination of Medi - Cal benefits for these poor, chronically ill patients resulted in adverse outcomes. Further investigation is needed to determine whether the findings of this study can be generalized to other similar populations. Meanwhile, any future reductions in health benefits, particularly for poor or chronically ill patients, should be carefully con- sidered in advance of their implementation. If im- plemented, they should be monitored clinically to be cer- tain that adverse outcomes do not occur. OD 28 Health / PAC Bulletin reported cases of patients waiting until abdominal pains, chest pains, skin conditions, and respiratory infections were more severe before seeking care. They also reported that fewer pa- tients were getting follow - up care. The courts were sympathetic to their plight, and when suits were brought forced the state to restore the previous income eligibility standards. Benefits The main cuts in benefits were procedural. The legislation specified that only " medically necessary " services could be provided under Medi - Cal, and it redefined these to include on- ly those " necessary to protect life or prevent significant disabil- ity. " The list of medical procedures requiring prior authoriza- tion was greatly expanded. Providers uniformly reported greatly disliking the bureau- cratic inconvenience created by these changes. Some physi- cians complained that restrictions imposed by the medical necessity definition and the delays in obtaining treatment authorizations limited their diagnostic and treatment options. Others expressed the opinion that the more important and ef- fective tools of medical practice were not unduly restricted. Although physicians'views varied, it is evident that many patients suffered emotional pain and occasionally more severe medical problems. Treatment authorization requests are fre- quently denied or approved belatedly for tubal ligations, hysterectomies, abortions after 20 weeks, vaginal repairs, benign growths, cataract surgery, allergies, and a number of medications. One physician reported that it took four weeks for a treatment authorization request to be approved before he could biopsy a woman's breast lump, a delay he characterized as " medically treacherous. " The woman " was in medical agony waiting, " he said. Reimbursement Physician reimbursements were cut ten percent initially. This was reduced to seven percent in January 1983. Reimbursement was also pared for most other services. Even before these reductions, Medi - Cal reimbursement rates had fallen further and further behind " usual and customary " charges in the years Health / PAC Bulletin 29 since the program was established in 1965. Low reimburse- ment rates have been the main reason given by physicians for not participating in Medi - Cal and Medicaid programs in other states. Even before the current round of cutbacks throughout the country, just six percent of all physicians cared for one third of all Medicaid patients - and one fifth of all physicians saw no Medicaid patients at all. The new cuts in reimbursement rates led more physicians to turn away new Medi - Cal patients. This has been most com- mon among doctors who saw relatively few. Physicians with large Medi - Cal practices, on the other hand, have been in a double bind. They depend on Medi - Cal patients for their revenues, particularly if they practice in low income - areas, but Medi - Cal pays approximately the marginal costs of medical practice, not the higher average costs. As one physician with a high volume - Medi - Cal practice explained, " Our costs are about $ 136 an hour for seeing patients. But we only get about $ 32 per hour for seeing Medi - Cal patients. " Several such physicians said their overhead costs continued to increase while the MIA transfer, reductions in Medi - Cal eligibility, and the cuts in reimbursement rates sharply slashed their revenues. Some physicians in low income - minority areas reported considering abandoning these already medically underserved neighborhoods.. Aside from dampening primary care physician enthusiasm for Medi - Cal cases, low reimbursement rates have reduced referrals to specialists. Community clinic and private practice physicians who treat Medi - Cal patients reported that it was difficult - and in some cases impossible - to find psychiatrists, obstetricians, and orthopedists who would see their Medi - Cal patients. Medi - Cal Hospital Contracting The most significant, and undoubtedly the least detrimen- tal, change mandated by the 1982 Medi - Cal legislation was selective contracting with hospitals for inpatient care. The ob- jective was to encourage hospitals to compete for shares of their local Medi - Cal business. This system abandoned the freedom - of - choice provisions that were the hallmark of the original Medicaid legislation in California as in the U.S. Congress, and threatened to segregate Medi - Cal recipients in a set of possibly inferior, second - class hospitals. However, the worst fears were not realized. Under pressure from advocates for the poor, the legislature specified nine criteria that the special negotiator was to follow in award- ing contracts, including assuring patients'access to care, the availability of specialized services, and quality of care, as well as other criteria intended to make the program economical and efficient. The special negotiator, who was quickly dubbed the " Czar " because of his broad powers, made at least the contracting pro- cess work. Hospitals offered significant financial concessions when they bid across - the - board per diem rates to care for Medi - Cal patients, and the state saved at least $ 200 million a year. Access by Medi - Cal patients to general inpatient care and to specialized services such as obstetrics and neonatal in- tensive care seems to have been reasonably well protected, and contract hospitals do not appear to differ from noncontract hospitals in quality or efficiency. Although the contracting process was successful, it is too early to judge whether the implementation will work as well. Actual access may be restricted more than suggested by an analysis of which hospitals received contracts. Contract hospitals with a heavy Medi - Cal load may find their revenues running substantially below their costs and have greater dif- ficulties obtaining capital, so that they may end up providing second - class care to Medi - Cal patients or closing their doors altogether. Conclusion The MIA transfer and the other Medi - Cal cuts have clearly added to the burden of illness borne by the poor - in many cases, with serious adverse consequences. The experience with the Medi - Cal cuts and reforms provides some lessons for similar efforts in other states. First, as an economically marginal and politically unorganized group, the poor will continue to be targets of cutbacks in health and other social programs. Medi - Cal, like all state Medical programs, covers only the most destitute persons. Until such programs are more universal in their coverage, benefiting more power- ful groups and social classes as well as the poor, they will re- main especially vulnerable. Second, the loss of Medi - Cal coverage for medically in- digent adults reduced potential access to, and actual use of, health services and greatly aggravated existing chronic medical conditions. In general, losing Medicaid benefits can be ex- pected to reduce access to health services and cause measurable and often severe deterioration in the health status of many of those affected. Third, non Medicaid - services designated for the poor should be carefully monitored to assess whether public policies un- duly restrict access and to assure that policies to promote ac- cess are actually implemented. Fourth, the experience in Los Angeles County, undoubtedly not unique within California or the country, suggests that organizations of poor people and their advocates should vigilantly monitor public programs intended for their benefit. The history of the Hill Burton - program suggests that the same conclusion applies to the provision of care by private institutions. Finally, health care reforms that restructure the financing or organization of health care may save large sums of money without placing an undue burden of cost containment on the poor. Of all the Medi - Cal changes adopted in 1982, selective hospital contracting seems to demand the most from providers and the least from patients. Hospitals must lower costs by reducing procedures performed on patients and by becoming more efficient. Although there are clear risks for patients, there is reason to believe that the more optimistic scenario - that unncessary diagnostic and therapeutic procedures will be eliminated and that personnel reductions will not lead to understaffing - may prevail. Overall, the California cutbacks and reforms suggest that conservative budget cutting will continue to be largely at the expense of those least able to bear it. They also hold out at least the possibility of saving large sums of public and private health care dollars through more thoughtful and progressive reforms which require changes in the way doctors and hospitals func- tion. Implementing these progressive reforms, and successfully opposing detrimental budget cuts, will usually require broad coalitions of groups which join forces on behalf of their com- mon interests. Y' 30 Health / PAC Bulletin What's Happening in California Health Screen Gems Organizing Against VDT Hazards by Linda Delp mong those attending a 1978 conference on " Women in the Workforce" sponsored by the California Federation of Labor were three northern California trade unionists who came seeking solutions to problems associated with Video Display Terminals at their workplaces. Barbara Gray of the Typographical Workers Union Local 21, Helen Palter of the Newspaper Guild Local 52, and Barbara Pottgen of the Of- fice and Professional Employees Local 3 were concerned about eyestrain; neck, shoulder, and back aches; tension; and radia- tion exposure. " While we didn't find the answers to all our problems, we did find each other, " recalled Barbara Pottgen, " and we made a commitment to start working together to find common solu- tions to our common problems.... All of us were running into roadblocks in our grievance procedures and contract negotia- tions on VDT health and safety because it was such a new issue. Our employers were unimpressed with studies on VDT health hazards done in European countries, so we realized that we had to bring things closer to home. " Out of this realization came the VDT coalition and hard data. With backing from 25 local and international unions, the three women petitioned the National Institute for Occupational Safe- ty and Health to investigate VDT use at their workplaces. The ensuing study of radiation testing, industrial hygiene chemical monitoring, health problems, and ergonomic measurements. was conducted at two newspaper agencies and an insurance company. Its widely quoted recommendations for adjustable machines and furniture, proper lighting, regular breaks from VDT work, and eye exams have lent legitimacy to union and worker demands for improved working conditions and have become the basis of legislation in several states. Few pieces of machinery have been introduced so quickly and broadly as VDT terminals; an estimated seven to ten million are now in use in U.S. workplaces, often without regard to ergonomics, the human component of human machine - in- teraction. Glare created by improper lighting and poor work- station design; desks, chairs, and machines that don't adjust; flickering or blurred images caused by infrequent maintenance; deskilled, fragmented, and low paying - jobs with production quotas all create visual, musculoskeletal, and stress related - problems. Linda Delp is chair co - of the LACOSH Technical Committee and a member of the VDT Task Force. This article was written with the help of Laura Stock (VDT Coalition), Pam Haynes (Air Transport Employees), and Wayne McCort (AFSCME 3235). Many union and union non - VDT workers anxious about these dangers as well as VDT radiation are concluding that they have to organize and educate themselves to protect their health - and that of any future children they might have. When three southern California women were leading a workshop at another California Labor Federation - sponsored conference on " Women in the Workplace " this year, they still did not have answers to the questions about radiation which had troubled their northern California counterparts six years earlier, nor could they claim that any of their offices had perfect ergonomic designs. They could, however, discuss achievements in educating VDT operators, their unions, and the public; in research at their workplaces; and in organizing efforts throughout the state. (Other organizations such as 9 to 5 have also done important work; this article focuses on California groups initiated specifically to address the issue of VDT work- ing conditions.) As in northern California, a request for workplace research was an early step in the development of a southern California grassroots coalition. In 1982 VDT workers who were members of the American Federation of State, County, and Municipal Employees approached the Los Angeles Committee on Occu- pational Safety and Health for help. Like other COSH groups around the country, LACOSH is a worker education and ad- vocacy organization made up of unions and health and legal professionals; its Technical Committee provides assistance in occupational health and industrial hygiene. Members of Local 3090 and the Technical Committee surveyed almost a third of the 3,500 clerical workers employed by the City of Los Angeles represented by the local. They found the same health problems noted in other studies and provided specific information about Los Angeles city offices which served as a basis for negotiating contract language. This survey was more than a data collection process. Worker participation made it an organizing tool as well. LACOSH members attended a Health and Safety Committee meeting of the local to present information about related VDT - health prob- lems and potential workplace causes, then worked closely with Committee members to develop the questionnaire and imple- ment the survey methodology. Training for the survey gave the clerical workers on the Committee the knowledge, skills and interest to participate in developing contract language; the Committee is now working with the city administration to make specific changes. The survey - and its usefulness in stimulating workplace changes heightened - heightened interest in the VDT issue among other Los Angeles unions. It also illustrated the importance of Health / PAC Bulletin 31 FOR AERER SIGHT SORE EYES VOTS worker participation in the organizing process, a principle that became embedded in the Los Angeles VDT Task Force. The Task Force had its origins in a LACOSH sponsored - 1983 con- ference, " VDT's - More than a Headache, " which brought together 140 participants from 25 different union locals as well as 9 to 5 representatives and workers from nonunionized of- fices. LACOSH followed up by convening a meeting of in- dividuals interested in sharing experiences with workplace surveys, grievances, and collective bargaining. This developed into the Task Force, which began working with the Northern California VDT Coalition. Thus both the Coalition and the Task Force were initiated by workers, received some organizational and leadership sup- port from existing organizations, and then evolved into autonomous groups dedicated to training VDT operators in technical aspects of proper workplace design and incorporating them into the leadership. Initially, for example, presentations of the NYCOSH slide show " Today's Technology, Tomorrow's Headache, " were made by LACOSH members; eventually VDT operators in the Task Force received training and practice and began to give presen- tations to their coworkers, at their union meetings, and at the request of other union locals. The Coalition's quarterly com- munication and outreach newsletter Video Views is published by VDT operators and union representatives and contains both their articles and those of local health care professionals. VDT operators represent both groups at press conferences and on TV and radio. Organizing for Legislation Despite some union local gains in negotiating VDT contract language, collective bargaining is a slow, difficult process and even when successful benefits a very limited number of VDT operators; only 21.1 percent of all employees in the non- manufacturing sector of the California economy are unionized. * VDT activists decided to supplement their workplace organizing with a drive for state action. Petitioning for a CAL OSHA / standard seemed futile under - conservative Republican Governor Deukmejian, the agency has been cut- ting back on enforcement and limiting the adoption of new standards. The members of the coaliton and the Task Force thought a legislative effort made more sense. They realized get- ting a bill through would also be difficult, but reasoned that organizing for it would enhance public awareness of the issue. Coalition members then developed a bill and asked the California Federation of Labor to sponsor it, with the understanding that both Coalition and Task Force members wanted to be consulted when changes were proposed. This strategy was selected as the most effective way to combine the grassroots organizing abilities of the Coalition and Task Force with the Labor Federation's lobbying experience and com- munication network. (California AFL - CIO affiliates account for 80.9 percent of California union members.) Assemblyman Tom Hayden carried the bill; representatives from his office, the Labor Federation, and the Coalition and Task Force joined forces to lobby for it and publicize the issue. Political Realities In a few short months, the bill had a varied life. It success- fully passed the Labor Committee: it was then drastically altered in the Ways and Means Committee so that it reached the floor of the Assembly with only two provisions - the right of a VDT worker to transfer during pregnancy and the forma- tion of a Task Force given only three months to convene, study the issue, and make recommendations. This gutted bill was then killed. More letters, phone calls, visits to legislators, and better communication between Hayden, the Labor Federation, and the grassroots coalitions would have strengthened the drive for passage, but ultimately the bill failed due to tremendous op- position from Silicon Valley manufacturers and other employers throughout the state. " What it really came down to is they don't want anything on the books; nothing that will coopt their authority or power as an employer, " commented Pam Haynes, a member of the VDT Task Force. " It doesn't really matter whether they have good or bad records with respect to workplace conditions. " Success of Failure? Two important principles are evident in the organizing strategy that evolved from the California grassroots VDT movements. 1. A multifaceted approach works best education - , research, and contract negotiations in the workplace; public consciousness - raising through conferences and the media; and political action in the state legislature. VDT operators who had earlier heard a presentation in their workplace lobbied their legislators for the bill with letters and phone calls. A represen- tative of the California Federation of Labor said, " This is the largest influx of activity around a single bill ever. " Although the legislative effort was unsuccessful in itself this time, it was a valuable component of the overall campaign. It developed activists and heightened public awareness of the issue, which will aid workplace organizing and future political action. 2. All workplace activities, publicity, and political action should include VDT operators, empowering them with technical knowledge and political know - how. This will help them win immediate improvements in their offices and con- tinue the longer - term effort to organize workers for better con- tracts, health and safety committees, and strong legislation. Y' NOTES 1. VDT Coalition. " Video Views Newsletter. " Vol. 1 No. 2, Summer 1983. 2. Granjean E. and E. Vigliani, Eds. " Ergonomic Aspects of Visual Display Terminals. Proceedings of the International Workshop, Milan, March 1980 " London: Taylor and Francis Ltd. 1982. 3. U.S. Dept. of Health and Human Services. " NIOSH Research Report- Potential Health Hazards of Video Display Terminals. " DHHS (NIOSH) Publ. No. 81-129. 4. CA Dept. of Industrial Relations, Division of Labor Statistics and Research. " Union Labor in California 1981 " San Francisco: DIR, December 1982. 5. Ibid. 32 Health / PAC Bulletin What's Happening in California Health. Chemical Reaction Fighting A Toxic Waste Giveaway by Gail Bateson Thousands of communities located near hazardous waste Thousands Thousands communities communities communities located near hazardous hazardous waste the federal Superfund program, and anger and frustration are rising. Nowhere is this more evident than in California. " It is those of us who have to live with that situation day after day, year after year, who really understand what the toxic waste issue is all about, " said Penny Newman, leader of the commun- ity organization living below the Stringfellow Acid Pits in Riverside County, " We understand it from the viewpoint of people who cannot send their children into their own backyards to play because the air makes them ill. We understand it as friends who comfort young women who have just suffered their sixth miscarriage. We understand it as parents who lie awake at night listening to their children struggle to breathe or have to hold their child after one of his seizures. " Almost four years have passed since Congress passed the Superfund law providing $ 1.6 billion to begin immediate clean- up of those toxic dumpsites most likely to threaten public health or the environment. To date, over 35,000 abandoned hazardous waste sites have been identified, yet Superfund has cleaned up only six relatively small sites; the price tag for the most dangerous sites alone may run as high as $ 44 billion, accor- ding to a recent EPA estimate. The toxic waste crisis has become a hot political issue this election year. In California, the safe control of toxic chemicals has joined crime and education among the top three public con- cerns. Federally, EPA Administrator William Ruckelshaus has refused to support pending Superfund legislation to provide more funds and mandatory deadlines for clean - up, and state officials are scrambling to come up with their own solutions. Conservative Republican Governor George Deukmejian pro- posed a $ 300 million bond measure last spring. New York's Governor Mario Cuomo has suggested a $ 700 million hazardous waste bond measure for the 1987 ballot, and the citizens of Rhode Island will vote on a $ 5 million bond measure this November. Maine voters approved a $ 3 million bond issue in a special election in June. Issuing these 20-30 year bonds backed by a state's general fund is analogous to taking out a mortgage on a house, ex- plained California's toxic waste chief Joel Moskowitz, " The governor's proposal will let us live in a clean environment while we pay for it. " That's the catch: in a significant departure from previous Gail Bateson is Toxics Program Organizer for the Campaign for Economic Democracy in San Francisco. legislation to control corporate pollution in the workplace and the general environment, the public is being asked to subsidize a major portion of the clean - up. The net effect is a public bailout of private businesses. " We have two choices, " was the rationale of the relatively liberal Governor Cuomo, " we can abandon our obligation to keep the environment as livable as possible, or we can make the sacrifices necessary to meet that obligation. I believe this plan fairly distributes the sacrifices needed. " In California, the state Department of Heath Services clouded the issue of who would pay for the bond measure with unsubstantiated estimates of both the amounts likely to be recovered from companies identified as responsible for some of the clean - up expense and reimbursements from the federal Superfund and the state's own $ 10 million a year superfund. (Over 85 percent of the federal Superfund and 100 percent of California's superfund is paid by oil and chemical industry feedstock and waste - end taxes.) Environmental and citizens groups soon discovered that the home mortgage analogy fell apart when the actual dollars were put in the equation: the total cost of retiring the bonds would run between $ 800 million and $ 1 billion, of which the state and federal superfunds would at best provide about 30 percent. Furthermore, to date the state has not recovered a single dime from the responsible companies, and Governor Deukmejian slashed almost all 1984-85 Attorney General's office funding for litigation against hazardous waste violators. The problem in California and at the federal level is not simply lack of money. California's Department of Health Ser- vices has been unable to spend its annual budget of 10 $ million during each of the past three years, and an independent govern- ment commission which reviewed the state's superfund pro- gram found " extensive organizational, management and resource deficiencies which we believe require major reforms if California is going to halt this crisis. " The commission also opposed the use of general obligation bonds to raise clean - up funds, noting that " Placing the burden of paying for cleanups on the general taxpayer not only forces the victims to pay for the solution, but does little to create more incentives for in- dustry to improve the way it manages hazardous wastes. If the costs of dumping hazardous wastes include the costs of clean- ing up toxic waste sites, then economic pressures will en- courage companies to find alternatives to dumping hazardous wastes in the ground. " Taking a similar position, a coalition of environmental, citizen, and community dumpsite organizations mounted an Health / PAC Bulletin 33 intensive media and lobbying campaign which won a payback mechanism for the bond measure ensuring that general fund expenditures would eventually be reimbursed with money. recovered from companies responsible for dumping, and any gaps would be filled through expansion and extension of the state superfund tax. At this point the real battle began. Recognizing that Gov- ernor Deukmejian was determined to have some form of toxic bond measure on the November ballot, the petrochemical in- dustry, led by Chevron and backed by Dow and the industry- dominated Council for Economic and Environmental Balance, unleashed an aggressive lobbying campaign. Chevron agreed to a scaled - down $ 100 million bond measure and a 50 percent rise in state superfund taxes for a substan- tional price: its amendments to the bond measure would have given the petrochemical industry essentially all of the exemp- tions and exclusions from legal and financial responsibility for abandoned site clean - ups that they had been unable to win in previous state and federal legislative battles. These included: i establishing state clean - up guidelines weaker than federal standards * exemption from all future liability once the most " cost ef- fective " clean - up plan was completed i an arbitration process and liability standards making it more difficult to recover money from responsible parties i no review of clean - up plans by citizens in affected com- munities, and no recourse for those citizens to petition for a more thorough site clean - up should initial efforts fail i locking up crucial evidence in clean - up settlements needed by citizens who wish to bring suit for toxic related - health problems and property damage (including evidence such as site characterization and monitoring studies) After discovering that they were excluded from last minute negotiations between the industry, the Governor's office, the Attorney General's office, and some state legislators, the environmental and citizens groups held a major press con- ference. The two major organizations tracking the bond measure - Campaign for Economic Democracy and the En- vironmental Defense Fund joined - community organizations representing the two most hazardous dumpsites in the state, Concerned Neighbors in Action at the Stringfellow Acid Pits and the Sacramento Toxics Alliance near the Aerojet site, in charging that the bond measure " could in fact result in more delays, superficial cleanup efforts, and serious limitations on the rights of citizens to voice their concerns. " Ensuing editorials and news stories throughout the state ex- posed industiry's proposed " wish list, " which heightened pressure on government officials to reject wholesale adoption of the Chevron proposal. This was buttressed by internal op- position from the Attorney General's office, which agreed with the coalition's objections and threatened to sign the ballot arguments against the bond measure unless substantial changes were made. As a result, the measure that goes before California's voters this November essentially ensures that the petrochemical in- dustry will repay the $ 100 bond issue and remain liable for the long term clean - up and maintenance costs. Provisions were added to give affected citizens increased rights to review and comment on settlements negotiated with companies and the contents of clean - up plans. Industry did win inclusion of a complicated arbitration process which allocates financial liability among responsible parties by means of inadequate legal definitions; this will put the state at a distinct disadvan- tage when negotiating settlements with actual polluters. However these provision are separate from the actual bond measure, and can be amended in subsequent legislation. Passage of the bond measure won't guarantee that more sites will be cleaned up immediately, but it will remove one of the obstacles government agencies use to delay implementation of hazardous waste legislation. The key factor in clean - ups will remain the ability of citizen and environmental groups to keep the pressure on both the government and industry. O This holiday season... remember, Diamonds are forever, but the Health / PAC Bulletin is cheaper. In fact, the Bulletin is half price in our two - for - one holiday sale. If you have two friends you want to share penetrating analysis of our health care system with, you can give them both subscriptions for the price of one if you mail us your check before December 10. Yes, I would like to get two gift subscriptions for the price of one. Please send them to: Name Address City State Zip. Enclosed is my check for $ 17.50 Mail to: Circulation Dept., Health / PAC Bulletin, 17 Murray St., New York, NY 10007. C] Please send a card saying this was a gift from 34 Health / PAC Bulletin Bulletin Board Mass. Line Readers of our article on the new Massachusetts hospital reimbursement program in the last issue can learn a lot more about the Bay State's health care system and what a dedicated group of local activists can ac- complish by subscribing to Staying Alive!, the publica- tion of Commonhealth, Boston's health activist group. Individual subscriptions are only $ 5; Sustainers and in- stitutions have the opportunity to contribute $ 25. Send your check or money order made out to Staying Alive! c o / H.O. Building - Mezzanine, Boston City Hospital, 818 Harrison Ave., Boston, MA 02118. Herstory Lynda Madaras, author of Womancare: A Gynecological Guide to Your Body and other books, would like help for her book for Little, Brown on self- help and other alternative health care systems for women. She is looking for women with medical pro- blems who were unable or unwilling to be treated by an orthodox medical doctor and turned to other forms of care. The problems needn't be strictly gynecological or obstetrical. If such women or their clinician would be willing to share details of these experiences with strict confidentiality, they can write her at 1341 Ocean Blvd., Suite 222, Santa Monica, CA 90401. Gay Health The National Lesbian / Gay Health Education Founda- tion is carrying out a national lesbian health needs survey pilot study with a grant from the Ms. Foundation. They are seeking as varied a group of women as possible to fill out their questionnaire. It must be completed and returned by November 30. For further information, con- tact the NGHEF at 550 Cresthill Ave., Atlanta, GA 30306. Tel. (404) 892-2459. Wrongs to be Righted A Job Safety and Health Bill of Rights by Rick Engler with photographs by Earl Dotter is a new, clearly, and concisely written 32 page - pamphlet of the Philadelphia Area Project on Occupational Safety and Health (PHILAPOSH). Marilyn Powers of the Workers'In- stitute for Safety and Health says that " Most publications that have been published for working people on health and safety are technical in nature. This call for worker empowerment is unique and should provoke valuable discussion in union education classes. " Single copies are $ 3, five or more $ 2 each, from PHILAPOSH, Fifth Floor, 30001 Walnut St., Phila- delphia, PA 19104. Enabling Publications for Parents and Families and Publica- tions for Persons Who Have Disabilities and their Friends are two new catalogues listing free and cost low - materials. The former is a listing of publications deal- ing with speech disorders, hearing difficulties, learning disabilities, and other disabling conditions. The latter is a compendium of publications for teenagers and adults who have had a stroke, laryngectomy, or other disorders. Single copies of either or both are available free if you send a stamped, addressed self - envelope to the National Easter Seal Society, 2023 W. Ogden Ave., Chicago, IL 60612. Making Health an Issue Americans have become a fevered multitude of run- ners, joggers, and aerobic dancers, but are we really any healthier? Our hospital bills say no. More and more we face health risks of our own making. " To Our Health, " a special issue of Environmental Action magazine, looks at health in America. The 32 page - November December / issue is filled with useful information, including an article on " Best places to live in America, " and advice from such people as Dr. Benjamin Spock, Pete Seeger, and Martha Graham on living the good life. Other ar- ticles cover a study that finally links toxic wastes with cancer, how the government is neglecting cancer preven- tion, and how office health hazards can be eliminated. Health / PAC Bulletin 35 Media Scan The Medical Industrial Complex, by Stanley Wohl, M.D. New York: Har- mony Books, 1984 (218 pages). The New Health Care for Profit: Doctors and Hospitals in a Competitive Environ- ment. Edited by Bradford H. Gray. Washington, DC.: Institute of Medicine, National Academy Press, 1983 (178 pages) by Hal Strelnick To judge these two books by their covers, each adorned with a dollar sign instead of snakes encircling the staff of the medical caduceus, we might expect parallel examinations and dissections of the burgeoning business of health care, which now represents more than 10.5 percent of our GNP. But all similarities end with the covers - and so does most criticism of the industry. The author of The Medical Industrial Complex, Dr. Stanley Wohl, is said by the publisher's promotion packet to be involved with emergency medicine at the Stanford University Medical Center and to be the first president of InfoMed Systems, a health care economics and management research company. In fact, the book grew out of Wohl's research for a major brokerage house on the stocks. of medical corporations. " Not one to bite the hand that feeds, " Wohl confesses in the first chapter, " I acknowledge that I made my way through medical school and purchased my first home with money I made on the stock market. " The critique that he subsequently mounts against the health care corpora- tions generally has the teeth and bite of loose dentures. He so admires the entre- preneurs of these corporations and is so captivated by the ideology of private enterprise that he can no more examine the consequences of their actions than Oedipus could bear to confront the con- sequences of his own in Sophocles ' tragedy. The Oedipus complex is the foundation of psychoanalysis; this book is based on a patchwork of pseudo- analysis, stock analysis (of both the Wall Street and clich varieties) and, all too often, no analysis (the British and Cana- dian health systems are dismissed in a single paragraph). The term " industrial medical - com- plex " has its roots in President Dwight Eisenhower's 1960 farewell address war- ning of the dangers of the " military- industrial complex " -defense contractors and munitions manufacturers allied with the three competing branches of the military and their supporters in Congress and the Pentagon. In 1969 the Health / PAC Bulletin adopted the term " industrial medical - complex " to describe the interlocking in- terests of the for profit - insurance, drug, and supply corporations, the not for- - profit academic medical empires, and the public dollars that support their ser- vices and research. In 1970 Fortune us- ed the term to explain the dramatic growth in medical costs. But Stanley Wohl has taken his cue from New England Journal of Medicine editor Arnold Relman's 1980 article on the " new medical industrial complex " that noted the blurring of the traditional separation between the organizations providing for- profit products and those offering not- for profit - services, especially through the growth of for profit - hospital and nursing home chains. Dr. Wohl, like Dr. Relman before him, levels his most severe criticism at the en- croachment by corporations on the pre- rogatives and control of the health system by physicians who, they argue, know what is best for patients and patient care. Like Relman, he defends the academic physician (and medical center) against the philistine, unprofessional interests of corporate profits: Most physicians still remember their medical school professors whose brilliant clinical acumen and impec- cable ethics set the standard for the conduct of medical practice... The... teaching hospitals steadily show the least profit, yet they clearly make the greatest contribtion to the health care system... The quality of hospital- based physicians determines the qual- ity of the hospital... He even congratulates Hospital Corpora- tion of America for having four doctors and a dentist on its 18 member - board of directors. Wohl believes " the corporations con- quered because over the last twenty years everyone else fouled up. Government, the medical profession, insurance com- panies, and the so called - health experts and consultants had produced a money- sapping monster. " Later he absolves physicians of their responsibility for ex- cessive health costs, first by claiming they have had no " input " and then by blaming the victims: " so long as Americans continue to eat too much, drink too much, and exercise too little, the bills... will continue to grow. " Such analysis begs the significant questions: Why have these corporations entered health care now? What has changed in the economy and / or the health system? Facts and details that might help provide answers are in the book, but such questions are never posed, let alone answered. Wohl does go beyond Relman and does make a contribution to the study of the new medical industrial complex (new " " in the sense of the " new " Nixon of the 1970's). His medical industrial complex is, in fact, the corporate health care industry: 1) the corporate owners and managers of general and psychiatric hospitals, nursing homes, dialysis, re- habitation, surgical, and sports medicine centers, and emergicenters; 2) the cor- porate owners of large medical partner- ships; 3) corporate manufacturers and distributors of pharmaceuticals and medical supplies; 4) conglomerates with subsidiaries in health care; 5) large technology corporations that serve many sectors of the economy but account for major expenditures in health care (e.g., IBM, Hewlett - Packard, General Elec- tric, etc.); and 6) new specialty corpora- tions within health care, such as the genetic engineering firms. The corporate survey which makes up the second half of the book is often ar- bitrary (Wohl even admits to including Sears, Roebuck for no special reason) and neglects altogether the author's own category of conglomerates with impor- tant subsidiaries in health, such as Dow, DuPont, Monsanto, Revlon, Chesebo- rough - Ponds, and McDonnell - Douglas. For the serious investor, he includes a chart that notes which stock exchange each corporation is traded on. Beyond the stock market quotations |p > 36 Health / PAC Bulletin and quarterly earnings, what is includ- philosophers, and health care re- dustrial complex- the interlocking in- ed in this survey can often be quite searchers (no doctors) to examine the terests of for profit - , not profit - for - , pro- revealing and demonstrates significant hospital - doctor - patient relationship, fessional, and public institutions - and research. For example, Wolh retraces the overloaded with potential conflicts of in- what has promoted the spectacular history of Beverly Enterprises, the na- terest, from every point of view. growth of the for profit - sector, often at tion's largest nursing home chain, ex- The two most interesting chapters for the public's expense. Neither examines plains both how Hospital Corporation of me were Jessica Townsend's five case the exorbitant return on equity guaran- America secured a controlling stock in- studies on what happens in a commun- teed by Medicaid and Medicare to pro- terest in Beverly and how it set out on its ity when a corporation takes over a local prietary hospitals and nursing homes; joint venture with Upjohn's home health hospital and Harold Luft's effort to the accelerated depreciation and tax * care subsidiary. Two thirds of the cost of demonstrate how different economists loopholes of the two major Reagan era these classic examples of vertical in- and physicians think on the question of budget cuts, TEFRA and OBRA; the tegration, Wolh notes, is being paid by economic incentives in clinical huge indirect subsidies for research and public funds. It will, however, take a decision - making. development provided by the National dedicated reader to find these gems. The Townsend argues that the acquisition Institutes of Health to medical centers text is plagued with annoying errors and process - who was consulted and who and pharmaceutical and biotechnology littered with clichs and mixed meta- had input -- has been more important firms; or the growing tendency of phors, as if the typesetter worked from than the terms of the agreement when a publicly - trained and -funded scientists to a dictaphone recording without any corporate chain buys or manages a com- translate their knowledge and expertise intervening editing. munity hospital. She found that the com- into equity positions in new bio- Those looking for a more insightful, munities she looked at trusted their cor- technology firms. less rhetorical analysis of the corporate poration but not hospital corporations in While all acknowledge the for profit - growth and competition taking place in general, just as patients trust their doc- sector's ready access to capital, no one the context of the Reagan Administra- tors but not doctors. discusses how the rules of the game have tion's attempt to deregulate and defund health care won't find it in the Institute After noting that economists view decision - making in medicine with a been written- written- and thus how the market- place has been shaped - or how the of Medicine volume. This is actually a telescope and physicians look at it with policy makers in Washington plan to ad- ' collection of papers prepared for a June a microscope, Luft focuses on the " wide dress the basic conflict between profit 1981 Institute workshop that led to a two gray area " where clinical decisions are and equitable, quality health care. Clear- year study on physician involvement in not black and white and the physician's ly, in Reagonomics there is no such con- for profit - enterprises in health care, due often hidden - economic interests reign. flict between them, so no corrective for completion at the end of 1984. These His essay addresses the gulf between the policy is necessary. Before making papers were supported, in part, by the microscopic and telescopic views but policy, we still need to get the medical in- Hospital Corporation of America. neglects those political and economic dustrial complex in better focus. O While Wohl's book is journalistic and blinders that prevent the 20/20 vision of written in conversational style, these the rectrospectoscope (hindsight " " in essays share an academic tone of cau- doctor's jargon) from being applied to the tion, tentativeness, and circumspection. American health system. Hal Strelnick, M.D. teaches in the Wohl strikes the pose of the indignant While these two books are comple- Department of Social Medicine at academic physician; the Institute of mentary in style and content, together Montefiore Medical Center in the Bronx Medicine has assembled a chorus of they remain an incomplete picture of and is a member of the Health / PAC lawyers, economists, financial analysts, what is complex about the medical in- Board. Peer Review continued from page 2 About the danger of nuclear war little needs to be said, other than to reiterate the point made by Physicians for Social Responsiblity and others that it is our number one health problem. Again, it is one which has aroused the middle class because it affects them as well as the poor. One would hope that together we can ensure that the government does something about it whoever is elected in November. James Crandall Des Moines, IA To the Editor: Edgar Leonel Dominguez Izas, M.D., was on his way home from the clinic in Quetzaltenango, Guatemala last March when he was abducted by what eyewit- nesses said was the army and taken away in a car. As of the end of October there was no word on his fate. Another doctor left the clinic the same month after he was threatened by death " squads. " Their crime seems to have been serving the poor. Thousands of people have been ab- ducted and / or murdered by the military in Guatemala, and as you have noted hundreds of thousands have been brutalized and frightened into exile. Since our government is the prime ally of Guatemala's rulers, a letter to the head of state Minister / of Defence about this specific case will show not only that Americans are concerned about Dr. Dominguez (who may, like many Guate- malans, be suffering savage torture), but are prepared to exert pressure here to lessen U.S. support for one of several Central American dictatorships. His address is General Oscar Hum- berto Mejia Victores, Jefe de Estado y Ministro de Defensa Nacional, Palacio Nacional, Guatemala, Guatemala. Arturo Kaufman New York Health / PAC Bulletin 37 Books '/ Received Bennet, Cleaves, M. (MD), with Charles Cameron, Control Your High Blood Pressure Without Drugs Garden ( City, NY: Doubleday & Co. Inc., 1984) $ 15.95 Brown, Catherine Caldwell (Ed.), The Many Facets of Touch: The Foundation of Experience: Its Importance Through Life with Initial Emphasis for Infants and Young Children (Skillman, NJ: Johnson & Johnson Baby Products Co., 1984) Fendelhor, David, Richard J. Gelles, Gerald T. Hotaling and Murray S. Straus (Eds.), The Dark Side of Families: Current Family Violence Research (Beverly Hills, CA: Sage Publica- tions, 1983) Freudenberg, Nicholas, Not in Our Backyards: Community Action for Health and the Environment (New York: Monthly Review Press, 1984) $ 10.00 Hillestad, Steven G. and Eric N. Berkowitz, Health Care Marketing Plans: From Strategy to Action (Homewood, IL: Dow Jones Irwin -, 1984) Kelman, Charles D. (MD), Cataracts: What You Must Know About Them (New York: Crown Publishers, Inc., 1982) Miller, Irwin, The Health Care Survival Curve (Homewood, IL: Dow Jones - Irwin, 1984) $ 22.50 Sagov, Stanley E., and Richard I. Feinbloom, Peggy Spindel and Archie Brodsky, Home Birth: A Practitioner's Guide to Birth Outside the Hospital (Rockville, MD: An Aspen Publica- tion, 1984) $ 30.95 Schneider, Joseph W., and Peter Conrad, Having Epilepsy: The Experience and Control of Illness (Phila: Temple Univer- sity Press, 1983) $ 24.95 Sharkey, Brian J., Physiology of Fitness, 2nd Edition (Cham- paign, IL: Human Kinetics Publishers, 1984) $ 12.95 Sheldon, Alan with Susan Windham, Competitive Strategy for Health Care Organizations (Homewood, IL: Dow Jones- Irwin, 1984) $ 30.00 Rackbill, Yvonne, Birth Trap: The Legal Low Down - on High- Tech Obstetrics (St. Louis: The C. V. Mosby Co., 1984) $ 9.95 Arditti, Rita, Renate Duelli Klein and Shelley Minden (Eds.), Test Tube - Women: What Future for Motherhood? (Boston: Routledge & Kegan Paul, 1984) $ 8.95 Eisen, Arlene, Women and Revolution in Vietnam (Totowa, NJ: Zed Books, 1984) $ 18.95 Kushner, Rose, Alternatives: New Developments in the War on Breast Cancer (Cambridge, MA: The Kensington Press, 1984) Gross, Stanley, J., Of Foxes and Hen Houses: Licensing and the Health Professions (Westport, CT, 1984) Luker, Kristin, Abortion And the Politics of Motherhood (New York: Univ. of California Press, 1984) $ 14.95 Minear, Ralph E. MD (), The Joy of Living Salt Free - (New York: Macmillan Publishing Co., 1984) $ 13.95 Morris, Jonas, Searching for a Cure: National Health Policy Considered (New York: Pica Press, 1984) National Research Council, Toxicity Testing: Strategies to Determine Needs and Priorities (Washington, DC: National Academy Press, 1984) $ 22.50 PACCA (Policy Alternatives for the Caribbean and Central America), Changing Course: Blueprint for Peace in Central America and the Caribbean (Washington, DC: Institute for Policy Studies, 1984) Perlmutter, Felice Davidson (Ed.), Human Services at Risk: Administrative Strategies for Survival (Lexington, MA: D.C. Health & Co., 1984) $ 20.00 Perrow, Charles, Normal Accidents: Living with High - Risk Technologies (New York: Basic Books, Inc., 1984) $ 21.95 Sidel, Victor, W. and Ruth Sidel (Eds.), Reforming Medicine: Lessons of the Last Quarter Century (New York: Pantheon Books, 1984) 9.95 $ Tomes, Nancy, A Generous Confidence: Thomas Story Kirkbride and the Art of Asylum Keeping - 1840-1883 (Cam- bridge University Press, 1984) $ 39.50 Weiss, Kay (Ed.), Woman's Health Care: A Guide to Alter- natives (Reston, VA: Reston Publishing Co., 1984) Wheaton, Sunshine and Philip, Death of a Revolution: An Analysis of the Grenada Tragedy and the U.S. Invasion (Washington, DC: Epica, 1984) White, James R. with Lan Barnes, Jump for Joy: The Rebound- ing Exercise Book (New York: Arco Publishing, 1984) 14.95 $ Wohl, Stanley, M.D., The Medical Industrial Complex (New York: Crown Publishers, Inc., 1984) $ 14.95 38 Health / PAC Bulletin Body English Affairs of the Heart-- An Update Critics of U.S. health care often point to stagnant or increasing mortality rates. as evidence that our system may do wonders for the financial health of pro- viders but does not address many health needs of the public. One response to this attack has been to cite the reduction in death from heart disease. Long the number one cause of mortality in the U.S., in the first half or so of this century the rate and aggregate numbers of deaths it caused rose stead- ily. However beginning in the 1970's the totals have gone the other way- spectacularly. In 1982 deaths from stroke were down almost 50 percent from 1962 and deaths from coronary heart disease (CHD) had plunged 30 percent or more. Estimates of lives saved in the last decade alone ap- proach 300,000 to 500,000. This trend is not a worldwide phenomenon. Only Canada, Australia and Israel have also achieved a better than ten percent drop in heart disease mortality. What, in this case, has the U.S. been doing right? The answer to that question is unfor- tunately cloudly. Any reduction in incidence would seem to suggest that ef- forts at primary prevention were suc- cessful. A reduction in the case fatality rate points to improvements in medical and / or surgical treatment of those with heart disease. Surprisingly, the data on both incidence and case fatality rates of CHD is often contradictory; further research is clearly necessary. Control of high blood pressure (HBP) has been a national prevention policy for some time. Considerable evidence links elevated blood pressure with an increas- ed risk of mortality and morbidity from coronary heart disease. More than 60 million Americans are believed to have elevated blood pressure - defined as 140/90 mm mercury or higher. Dis- proportionate numbers of them are old and / or black. The controversy about whether and how to treat HBP was the subject of the earliest of these columns. We will now update this debate, and present newer controversies about the causes, preven- tion, and treatment of high blood pressure. One intriguing, and discomforting, aspect of some of the newer controver- sies is that the research seems to con- tradict previously accepted " truths. " The most startling of these challenges to conventional dogma may be the find- ings of Dr. David A. McCarron. Several years ago, McCarron reported on two small dietary studies he had done. One showed hypertensives eating fewer calcium - rich foods, the other that people with HBP had lower calcium levels. Both his methods and his results were roundly criticized, but since then others, notably Dr. John Laragh at Cornell University, have reported similar results specifically that increased calcium in their diet lowered HBP in hypertensive patients. In the June 29, 1984 issue of Science McCarron published his blockbuster, the results of his major dietary study of over 10,000 adults. None of these subjects had previously been treated for hypertension or had intentionally modified their diets. This is what the researchers found: * i Hypertensives had significantly lower intakes of calcium, potassium, and vitamins A and C. * Lower calcium intake was the dietary factor most consistent in association with HBP. * Among food groups, reduced con- sumption of dairy products was the most closely correlated with HBP. * Low sodium intake correlated with HBP. * Those with HBP and those with nor- mal BP had no differences in choles- terol intakes. The heart disease establishment greeted these results with apprehension, and cautioned that they represented, at best, very tentative relationships be- tween diet and risk. People with HBP were advised not to change their diets to conform with McCarron's findings. But the evidence for his thesis is mounting. Another study published in June, on dietary patterns among 7,932 men in Puerto Rico, found that HBP was twice as common among those who drank no milk as it was among those who drank at least one quart daily. This study also found a similar correlation between total calcium intake and HPB. Neither study proves a direct causal relationship between dietary calcium and HBP; this may come from two current dietary intervention studies, one by Dr. Laragh and one by Dr. McCarron. In the meantime, debate swirls over the existence, degree, and direction of relationships between calcium, sodium, and HBP. Many experts find McCarron's work interesting but question the strength and validity of his data. Most agree on the need for extensive laboratory investigation of the relevant biochemical relationships. In any case, the corroboration of McCarron's findings by Laragh and the Puerto Rican study indicates at the very least that a lot more attention must be | paid to the relationship between diet and disease - attention that is long overdue. Our next column will continue this up- date and include a discussion of the 1984 guidelines issued by the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. O Arthur A. Levin is Director of the Center for Medical Consumers, publisher of Healthfacts. Space Available The group which currently shares Health / PAC's suite is moving out, and space is available for another group desiring ample room, pleasurable com- pany, and a prime location in lower Manhattan for only $ 500 a month. Health / PAC Bulletin 39 Vital Signs continued from page 4 In other words, just as " management reform " in the private sector often occurs at the expense of workers, so cost con- trol in government can easily become an attack on the social wage. Here are some of the targets of Grace and his colleagues: 1) taxing federal sub- sidies such as food stamps and Medicaid (if efforts to limit eligibility fail) 2) cut- ting health care expenditures ten percent by 1989 through a mixture of caps and competition 3) reducing the overlap be- tween recipients of food stamp and child nutrition programs 4) giving the private sector a crack at running the health ser- vices of the Department of Defense and the Veterans Administration 5) tighten- ing the appeals process for people denied disability insurance and supplemental security income. Most of these ideas are not new; social Darwinism has pervaded the entire Reagan Administration. Repetition doesn't make them any better. O Health / PAC Health Policy Advisory Center 17 Murray Street New York, New York 10007 2nd Class Postage Paid at New York, N.Y. NOTE TO SUBSCRIBERS: If your mailing label says 8409, your subscription expires with this issue.