HUSTLING DRUGS TO THE THIRD

...firms have increasingly turned their eyes to the developing countries, where the biggest growth potential lies...

...The bill also provides for exchange of information and training of foreign health officials, requires that the importing country state that it does not object to the U.S...

...The laundering of Depo-Provera support funds is so little-known in Washington that most policymakers still think that Depo-Provera is being "denied" to Third World nations because the FDA hasn't approved it for domestic use...

...These areas include the Indian state of Kerala, where, despite the lowest per-capita income in that desperately poor country, policies of broad-scale redistribution of wealth and social services succeeded in reducing population growth...

...pharmaceutical export policy are fond of pointing to one drug to show why it is morally acceptable — and even necessary — for the United States to export unapproved drugs...

...The Carter Administration introduced its Drug Regulation Reform Act early in 1978 and Congress held hearings in the spring and summer...

...Equally dangerous is the export of such products as infant formula, which are relatively safe in the wealthy countries but unhealthy in the poor countries, where inadequate nutrition, hygiene, education, and income transform such products into deadly concoctions...

...Hustling drugs to the Third World 'Let the buyer beware' Michael Bader Mention the term "international health" and the jungle hospital of Albert Schweitzer comes to mind — along with white-coated figures in tireless pursuit of smallpox...

...This concern lay dormant during the Nixon and Ford years, but rapidly escalating health costs and President Carter's promise to streamline the Federal bureaucracy led to reconsideration of Government regulation of the health industry...

...policymakers are hard-pressed to justify allowing unchecked marketing of drugs to these nations...

...The United States accounts for about one-fifth of the international drug trade (ranking second to West Germany), while Western Europe as a whole controls nearly three-quai ters — a matter of considerable concern to the U.S...

...No such major developmental breakthrough has occurred in the 1970s — and most of the 200 largest-selling drugs in the United States will be off patent by 1980...

...The implied approval conveyed by issuance of an export license under the new law would open up markets otherwise closed in the Third World...

...Therein lay an obvious double standard for human life and health...

...Out of the total of 15,000 or more drugs marketed in Third World countries, the World Health Organization has found that only 200 "essential drugs" are necessary for adequate health care...

...Depo-Provera illustrates the mutual interests of the international population control establishment and the international pharmaceutical industry...

...Again, the case of Depo-Provera illustrates the point...

...foreign aid under the "for export only" rubric...

...M.B...

...It is, indeed, a world of good works — a world in which many are continuing to devote their lives to the alleviation of human suffering...

...It is also a world in which humanitarianism is mixed with a lucrative blend of corporate profits...

...The new export provisions would unlock the treasure chest of foreign assistance dollars to pharmaceutical firms, especially to the developers of family-planning paraphernalia not approved for use here...

...The bill seeks to speed the approval process for new drugs by allowing them to be introduced under an "innova-tional" rubric, while making it easier for the Food and Drug Administration to remove drugs from the market if previously unknown dangers come to light...

...plans to set up Cooperative Pharmaceutical Production and Technology Centers...

...Some promising innovations include bulk purchasing arrangements through United Nations agencies, drug testing at the regional level (such as the Caribbean states are now arranging), and U.N...

...Environmental consultant Barry Castleman observes that "some manufacturers have essentially gone into the hazard export business, recognizing that there is money to be made by exporting the disparity in pollution and workers' health regulations around the world...

...Milton Silverman published The Drugging of The Americas, revealing how multinational drug firms "curtail, gloss over, or totally omit" hazards in their labeling of U.S.-manufactured drugs shipped to Latin America...

...Currently, Depo-Provera is supplied by the U.S...

...When the illusion of government's autonomy from business finally evaporates, then perhaps we can begin to steer the sovereigns to home port...

...Those who suffer from American drug exports have no elected representatives to demand their protection from harm...

...Richard Rogers, president of Syntex Labs, originator of oral contraceptives in the late 1950s, has heralded "the role that private enterprise in this country might play in assisting less developed nations to reduce their rapid rate of population growth...

...In the pharmaceutical sector, such efforts are in embryonic form...

...A 1962 revision added efficacy to safety as a requirement for drugs...

...Harmful drugs are not alone in the category of inadequately regulated substances in international trade...

...Even the most rigorously designed national policy to control drug exports faces the problem of circumvention by multinational corporations...

...Given the high-pressure sales techniques and distorted labeling practices of multinational drug firms in the developing countries, U.S...

...Warnings about the blood disease are either omitted or understated in chloramphenicol labels in Latin America, with the result that physicians there have seen an alarming rise in aplastic anemias directly related to drug use...

...The Washington Post editorialized naively on July 1, 1978, "Should the U.S...

...The answer has little to do with medicine and much to do with economics...

...That's the Depo-Provera question...

...While developing countries contain 70 per cent of the world's population, they produce only 7 per cent of the world's drugs...

...And the Federal Government, saddled with a balance-of-trade deficit of nearly $20 billion last year, is eager to encourage the export of goods in which the United States has a technological advantage...

...the burden of proof for criminal penalties under the proposed law falls more in the Government's lap than in that of industry...

...The company might have been successful in 1973 had not a Congressional investigation disclosed serious irregularities in the way the drug's risks and benefits were weighed by an FDA "expert" advisory committee...

...But this may soon change...

...But its dimensions are suggested by the burgeoning international commerce in pharmaceuticals alone — up from $1.2 billion in 1965 to S4.5 billion in 1976...

...Permitting such exports," said former Secretary of Health, Education, and Welfare Joseph Califano, "would expand drug manufacturing in the United States, thereby providing jobs for American workers, increased earnings for drug companies, and the prospect of improvement in the balance of international payments...

...Following Upton Sinclair's revelations of unhealthy conditions in Chicago's turn-of-the-century meatpacking houses, President Theodore Roosevelt agreed to the Pure Food and Drug Act of 1906...

...Contrasting with the American formula — technology plus private enterprise equals reduced population growth — is the view of Third World nations which have successfully controlled population growth without resorting to relatively draconian methods such as Depo-Provera...

...firms based in Western Europe, by contrast, are free to export unapproved drugs manufactured in their home plants, a competitive advantage which allows these firms larger profits through greater market penetration in other countries...

...More lasting solutions will await political developments in the United States and Western Europe, where the pharmaceutical giants are based...

...The proposed law is ambiguous, not specifying whose "public health" would be considered in a decision not to export a drug — the health of Americans or the health of rural peoples in Third World nations — and not specifying what standards would be employed in determining what is "contrary to the public health...

...another sixty-four, including Brazil, required only that the product be licensed and sold in the exporting country...

...Pharmaceutical firms view the world's burgeoning population as "a source of numerous socio-economic and political problems," as Upjohn put it in its 1977 annual report...

...Almost 90 per cent of drug patents in developing countries are held by foreign companies, and these are used mainly to protect the product from local production at lower cost...

...Thirty years later, after 100 deaths caused by consumption of a fraudulently labeled elixir containing methyl (wood) alcohol, Congress prescribed standards of safety and accuracy in the labeling of food and drug products...

...As former FDA Commissioner Donald Kennedy lamented to Business Week, ' 'The applied research sector is running out of steam...

...The Secretary of Health, Education, and Welfare may deny a permit if a drug is found to be "contrary to the public health, or would result in sufficient deception of patients so that its use would constitute a health hazard...

...Still, international family planning groups, such as the International Planned Parenthood Federation (IPPF) in London, and many countries fearful of their rapidly growing populations, believe the benefits of the drug as the only long-acting contraceptive outweigh its potential risks to women...

...A Ford Foundation survey of drug importing policies found in 1976 that of 138 nations, thirty-six required no premarketing registration at all...

...Despite the current policy banning the export of unapproved drugs from the United States, the U.S...

...even when notified, the embassies failed in most cases to forward the information to local officials...

...drug export policy [is] the final act o! a long farce called regulation' the proposed drug export law...

...Drug costs often represent 40 to 60 per cent of the total health care expenditures in developing countries, compared with only 10 to 20 per cent in the industrialized world...

...R. T. Ravenholt, director of AID's Office of Population, lauds the drug as a "useful lead-in to surgical sterilization," which would permit rural women in developing countries to "terminate their fecundity" in advance of a scheduled sterilization procedure...

...pharmaceutical industry...

...The new drug export policy would permit AID to use the contraceptive directly in its aid programs, without having to resort to the cumbersome business of sup-plying it through private, multilateral groups such as IPPF...

...the United States is now considering major revisions of the forty-one-year-old law — revisions which would allow U.S...

...Since Depo-Provera caused malignant breast tumors in beagle dogs during its testing phase, and since exposure of the fetus to high levels of female hormones causes birth defects, the Food and Drug Administration (FDA) does not permit its use as a contraceptive in this country (although it may be used as a palliative treatment for inoperable cancer of the uterus...

...The most likely beneficiaries of a relaxed U.S...

...During hearings on the export provisions of the proposed drug law in 1978, Depo-Provera was repeatedly invoked by members of Congress and FDA officials as an exemplary justification for relaxing American drug export policy...

...The postwar push in new biologicals has already been exploited...

...The prospect of an "open door policy" has alarmed consumer advocates in international health, who are mindful of the industry's past abuses...

...Why then are the good doctor's medical orders not being followed...

...So-called breakthrough drugs would be whisked through the regulatory apparatus, pending final approval...

...More alarming still is the export of hazardous factories for products such as asbestos, mercury, lead, arsenic, and steel...

...Other provisions require drug companies to monitor the side effects of their drugs, to place explanatory "patient package inserts" in all drugs, and to reduce the value of physicians samples to a maximum of $5...

...The list of restrictive business practices employed by multinational drug firms includes tied purchases, transfer pricing, restriction of exports by subsidiaries, and limitation of competitive supplies...

...Given the inherent hazards of drug use, sound medical judgment always dictates that drugs be prescribed conservatively, save perhaps in the case of a life-threatening illness...

...drug export policy are the multinational firms...

...The shift in policy represents a sweetener thrown in to win industry's support for the Carter Administration's controversial bill, the Drug Regulation Reform Act of 1979...

...Arguing that "an effective global population program is like waging a global war," Ravenholt hopes that the proposed export policy will become law so that "AID can add Depo-Provera to its fertility control armamentarium...

...drug firms registered record profits, as each decade brought within the grasp of medical technology new areas of disease — antibiotics to fight bacterial infections in the 1940s, tranquilizers to calm psychotics and neurotics in the 1950s, and birth control pills to stem population growth in the 1960s...

...As every medical student knows from his stethoscopes, black bags, study aids, and other drug-company "freebies," advertising is the first friendly handshake of the pharmaceutical firms...

...Pharmaceutical Michael Bader, a medical student, is editor of Synapse, a newspaper of the University of California—San Francisco...

...The classic example of an unapproved family planning device considered safe enough for export only is a drug called Depo-Provera, a long-acting contraceptive manufactured by the Upjohn Company, which represents the latest generation of birth-control technology...

...sumers of unapproved, exported drugs have no group to lobby on their behalf in Washington...

...For countries with rudimentary drug regulatory bodies, approval of a drug by the FDA for export only would constitute a sufficient credential to allow legal importing of such drugs...

...policy would benefit the multinationals in another important way...

...Hazardous exports not subject to strict national or international control can also be found in the diverse fields of pesticides, chemicals, children's sleep-wear, air and water pollutants, as well as drugs and medical devices...

...companies to join the European brotherhood of caveat emptor— "let the buyer beware" — by exporting unapproved drugs...

...For years, corporations specializing in international development work — setting up health and agricultural systems, for example — have milked profits from the U.S...

...An example is chloramphenicol, a powerful antibiotic rarely prescribed in the United States because of its potential for causing a fatal blood disease (aplastic anemia), yet widely promoted by multinational firms...

...Agency for International Development (AID) funds are laundered through IPPF in London, which buys the drug from Upjohn's subsidiary in Belgium, thus neatly bypassing the FDA prohibition against the drug...

...Although the drug was considered too dangerous for approval by the FDA for use as a contraceptive in this country because of unresolved questions regarding cervical and breast cancer and fetal anomalies, proponents of the new export policy pointed out that the different "risks/benefits equation" for contraceptives in poor countries justified its export...

...As Fidel Castro stated succinctly, "The problem is not population increase (with all the neo-Malthusian fright), but rational distribution of what is produced...

...Simply put, national law is hopelessly outflanked by the mobility of existing international economic entities...

...permit American drug companies to sell to foreign governments drugs that have not been approved for use in this country...

...embassies overseas...

...Sri Lanka, the People's Republic of China, and Cuba followed similar policies as well, with equally remarkable results...

...The consequences of this are of concern to drug developers and regulators alike...

...The United States has supplied more than half the funds available worldwide for family-planning services since 1965...

...The two most controversial aspects of the proposal concern information and exports...

...One embassy official explained that he did not routinely forward the notifications because "it might adversely affect" U.S...

...Three years ago the University of California's Dr...

...The company hopes that the lenient export provisions of the Drug Regulation Reform Act will be adopted, so that Depo-Provera can be shipped abroad directly as part of U.S...

...Guatemala, for example, consumes $29 million worth of drugs yearly while spending only $5,000 on drug regulation, with only eight officials handling drug control...

...While some temporary improvement in jobs and in balance-of-payments might result from the new law, the ultimate effect would be the transfer of manufacturing to "friendly" Third World nations, where labor unions are under the whip and where profits can be more easily hidden by accounting manipulations...

...Sovereigns at bay" is how multinational corporations were described by one author at the beginning of this decade...

...Technology — not social services — dominates health care in most Third World nations, and pharmaceutical products constitute technology par excellence in international health...

...The bill provides for public disclosure of all safety and efficacy test results, and reimburses consumer groups for the cost of examining the data...

...The example of pesticide exports illustrates what might well happen under 'The changing U.S...

...The General Accounting Office found recently that in cases where pesticides had been banned after marketing, the Environmental Protection Agency failed more often than not to notify the U.S...

...Thus, the proposed law would be a boon to the multinational firms, since they could pursue market development without risk by tapping into U.S...

...drug market, has expressed "vehement" opposition to that provision on grounds it would disclose trade secrets...

...foreign aid budget...

...To foster competition in the industry, the proposed legislation would alter patent protection for new drugs (currently seventeen years), allowing companies to produce and market drugs tested and developed by other firms — without having to repeat the tests — after only five years...

...drug export, and allows post-marketing revocation of the export permit...

...The regulation of food, drugs, and cosmetics in this country represents the steady accretion of legislation drafted in response to unscrupulous business practices...

...exports...

...is simply not compatible with the well-being o! the vast majority' year in this country on drug promotion — three times the total for drug research...

...The multinationals have ruthlessly thwarted efforts at national self-reliance in the drug sector...

...Research on tropical diseases, to which at least one billion people are exposed, commands only $70 million in multinational research funds out of a total international drug research budget of $2 billion per year, while more than $3 billion is spent on advertising to promote drug use...

...It must be remembered that conThe selling of Depo-Provera Advocates of a relaxed U.S...

...drug firms are left with the strategy of drug colonialism: Advertise heavily to protect already developed markets, and push to develop new markets in different parts of the globe...

...Upjohn has been trying to win approval for the drug as a contraceptive in the United States for more than ten years...

...But a similar bill was submitted by Senator Edward M. Kennedy last April...

...With the industrialized world becoming saturated with drugs, the export provisions have considerable appeal to manufacturers looking to the future...

...By taking advantage of the regulatory weakness of Third World nations, a change in U.S...

...So the bill incorporates a couple of safety mechanisms...

...The complex, 228-page bill provoked the ire of so many of its potential supporters — in business and consumer camps alike — that it died the same year...

...If such practices occur with drugs approvedfor use in the United States and sent abroad, how much worse might things become under the new relaxed standards...

...To offset such objections, the bill opens the door to the export of unapproved drugs...

...Many Congressional investigations over the last fifteen years, particularly those conducted by Senator Gaylord Nelson's Small Business Monopoly Subcommittee, revealed significant anti-competitive practices in the pharmaceutical industry...

...What is needed is the development of broad-scale technical capacities at the national, regional, and international levels to protect and enhance the health and well-being of the citizens of the world...

...Agency for International Development (AID) funds a population control group in London, which in turn buys the contraceptive from a wholly-owned Upjohn subsidiary in Belgium...

...To maintain profitability until a new wave of drugs conquers yet another area of medical ignorance, U.S...

...The drug is Depo-Provera, a synthetic female hormone and injectable contraceptive developed by the Upjohn Company of Kalamazoo, Michigan, which provides sustained infertility for periods of three to six months with a single shot...

...The vast sea of international trade in health goods and services stretches from multimillion-dollar hospital construction to nickel-a-tablet aspirin...

...As we inch toward the third millenium, we might look back on the changing U.S...

...Throughout the postwar period, U.S...

...Consequently, it is approved for use as a contraceptive in seventy-six countries ranging in diversity from West Germany to El Salvador, and provided a means of birth control for 300,000 women in 1977...

...The Pharmaceutical Manufacturers' Association, representing the twenty-seven firms which control 95 per cent of the U.S...

...The United States has been restrained from capturing a larger portion of the international market share by the Food, Drug, and Cosmetics Act of 1938, which expressly prohibits the export of drugs not approved for use in the United States itself...

...A major study of the pharmaceutical transnational corporations (TNCs) prepared for the 1975 United Nations Conference on Trade and Development flatly concludes, "The pursuit of private profit by the drug TNCs is simply not compatible with the well-being of the vast majority of the world's population...

...It is used by 60,000 women at an IPPF-spon-sored clinic in Thailand, where "informed consent" goes by the boards as women are "processed" in sixty to ninety seconds each, without the pelvic examinations that are standard procedure in gynecology...

...But Upjohn has not given up seeking approval for a drug in which it has invested millions...

...But the drug bill's safety systems are poor protection against potential disaster...

...drug export policy as the final act of a long farce called regulation...

...The true magnitude of the international health business — or "santibusiness," to borrow from the French — is anyone's guess...

...Having exploited the domestic market to the hilt, U.S...

...foreign aid dollars destined for poorer, disease-ridden lands...

...drug companies spend more than $4,000 per physician per 'The pursuit of private profit...

...Government to other nations through roundabout means...

...The FDA is constantly embroiled in domestic controversies regarding food additives, cosmetic dyes, "miracle drugs," and the like...