United States

United States

813 Amniocemesis can always be recommended ostensibly for the purpose of detecting genetic defects and sex-linked diseases. In the process the sex of ...

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813 Amniocemesis can always be recommended ostensibly for the purpose of detecting genetic defects and sex-linked diseases. In the process the sex of the fetus becomes known. After that, since abortion-on-demand is legal (and is encouraged by the government through advertisements), the selective abortion of female fetuses remains technically and legally feasible. Investigations by women’s groups show this to be a very valid possibility. Doctors in centres where amniocentesis is done have become tight-lipped when activists seek information. Many gynaecologists see selective abortion as a medical solution to a social problem and find nothing unethical in it. In the aftermath of last July’s exposure, doctors have been heard to express the view that if abortion is legal why should selective abortion be condemned. Significantly, neither the Indian Medical Association nor the Medical Council of India has so far taken a public stand on the issue. In India many couples go on having babies in the hope of producing a son. Sex determination is therefore regarded by many as a scientific tool for limiting the family while encouraging people to try again for a boy. What feminists and other concerned people fear is a sex imbalance in the population. India already has a high male to female ratio (1069 males to 1000 according to the 1981 census). It is also felt that, despite the ban on sex selection, the official attitude may be to turn a blind eye when violations are reported. Evidence of violations may become more difficult to obtain because patients who seek sex selection do so because they desperately want it. And some ofus remember that in 1974 Dr D. N. Pai was reported to have suggested, at a population conference in Stockholm, that selective abortion of female fetuses through amniocentesis could be an important part of India’s population control programme. He was presumably voicing the views of the government of the day.

INJECTABLE CONTRACEPTIVES

Not that sex selection is the only population issue to be worrying Indian women’s organisations. Last month the Hyderabad branch of the Indian Women Scientists Association, many of whom are doctors, wrote to the Health Minister urging him to desist from implementing the proposed liberalised distribution of the pill through village-level health workers on the grounds that such a move is wide open to abuse. The March issue of the Medico Friend Circle Bulletin (a forum for social conscious doctors) has called for the general public to be made aware of the dangers of injectable contraceptives. This was in response to announcements by the Indian Council of Medical Research that injectable norethisterone had been successfully tested in clinical trials on 2600 women in fourteen centres and would soon be introduced into the population control programme and that a hormonal implant was undergoing clinical testing in Delhi. Mindless pushing of birth control methods has backfired in India. The IUD drive of the 1960s failed miserably because of poor backup health services; the vasectomy programme of the 1970s ended in political disaster for the Government of the day. The fear now is that the 1980s have been earmarked for hormonal injectables and pills and that the major casualty in such a policy will be the health of women.

On March 22, the Minister of State for Health, Mrs Mohsina that the Government would decide on the introduction of the injectable after it had received the results of clinical trials. Critics feel that the go-ahead is a mere formality and that the strategy may be to push it through before too many questions are asked. This is significant in the light of the possibility that the US Food and Drug Administration may soon approve ’Depo-Provera’, thus circumventing the law forbidding the export of any drug not approved for use in the USA. Journalists and activists in India are trying to ensure a cautious, safety conscious approach to any programme involving hormonal contraceptives. For example, the Centre for Education and Documentation in Bombay has just released a 15-page booklet Injectables: Immaculate Contraception outlining the pitfalls of a mass programme with timetables and questioning the priorities of a programme of population control at any cost.

Kidwai, announced

Italy THE FILLING OF VACANCIES

In Rome, AD 1983, the oft-recurring word sanatoria is not the Latin plural of sanatorium, but it does have something to do with healing. What are healed are not physical ailments but bureaucratic cancers. The word indicates an Act of Parliament that confirms in . office Civil Servants who have been appointed without proper selection procedures. This is now almost routine in our National Health Service. To prevent favouritism in the selection of Civil Servants, the law prescribes that every hospital vacancy must be advertised in the national or regional legal announcement bulletin forty-five days before the closing date for applications. Then a public meeting is called to choose the members of the selection committee, whose names are drawn at random from hospital doctors, university professors, and Medical Council members. As a rule, this committee does not meet, because the prospective members never volunteered their services and the fee is too low to compensate for loss of professional income. A new committee must therefore be assembled, in one or more attempts, until persons are found who are willing to give up their time. Finally, a date for the selection is agreed upon-perhaps a year or more after the day on which the vacancy was advertised. Meanwhile the hospital administrators fill the vacancy by appointing a locum (a much faster and simpler

procedure). From time to time, as happens in physics with the beat phenomenon, the vacancies build up to such an extent that something must be done, and fast. (It may even happen that, meanwhile, new regulations have been issued, making the selection procedures yet more complex and tangled.) And on top of it all there is the allItalian concern for job stability; no-one really wants to send home doctors who have worked in a given post for one, two, or more years.

So Parliament is asked to pass an Act that entitles locums to stay on just as if they had been selected according to the rules. At a guess, half the doctors now working in Italian hospitals come into this

category.

United States POLITICS OF ENVIRONMENT PROTECTION

"They’ll overplay their hand and within two years they’ll be known as the Cancer Party." Mr Ralph Nader said that about President Ronald Reagan and his colleagues after the 1980 election. Few heeded him. As this nation’s most famous unofficial advocate of environmental protection, Mr Nader has been largely ignored in recent years by the news media. His warnings have been drowned by the rhetoric of a President whose priorities have been military expansion and a dismantling of the welfare state. Now suddenly Mr Nader seems to have been vindicated. Even if "cancer party" is putting it too strongly, the Reagan Republicans’ interest in controlling environmental carcinogens is demonstrably very near zero. Nowhere is this neglect more obvious than in the affairs of the Environmental Protection Agency. The principal cause of EPA’s present plight is a refusal to prosecute, with vigour, the corporations which have been dumping cancer-causing chemicals. In consequence, the Agency’s leadership has been falling apart under heavy pressure from the Democrat-controlled House of Representatives. First, the House cited the EPA administrator, Anne Gorsuch Burford, for contempt because she refused to turn over documents regarding the misdeeds of chemical dumpers. Then, as the bad publicity mounted, President Reagan fired Rita Lavelle, the former corporation executive who headed EPA’s hazardous dump clean-up programme. Next, after several lesser executives were forced out, EPA administrator Burford herself was obliged to resign under goading from White House aides. Her deputy and temporary successor, Dr John Hernandez, was no improvement. Congressional investigators discovered he had collaborated with Dow Chemical Co to suppress the news that Dow was contaminating the rivers near its plant in Midland, Michigan, with dioxin. What is new about all this is not that the Government is in collusion with industry-both parties do this on a large scale-but

814

blatancy. Certainly President Nixon, who established EPA in 1970, cultivated corporation executives. Corporate links with Mr

the

around him were a prime feature of the Watergate scandals. On environmental matters, however, Mr Nixon was willing to compromise. Unlike Mr Reagan, who once made the strange observation that trees are an important source of air pollution, Mr Nixon gave the EPA administrator running-room

Nixon and the

to

men

proceed against polluters.

The administrator then was William Ruckelshaus, the man the president has nominated to return as head of the agency. In those days, and in the years that followed under Presidents Ford and Carter, a tradition of leadership of the environmental movement and independence from the White House was established at EPA. The air of the cities and the water of rivers, lakes, and streams were made cleaner by many orders of magnitude. Fish were being caught where once the pollution prevented anything more than the lowest marine life. The Cuyahoga River in Ohio no longer caught fire, as it once did. More than a dozen pesticides were banned from use on food as cancer-causing agents and many more were restricted. With the advent of Mr Reagan, all Government interest in these matters seemed to end. At EPA, as one report had it, every important top post was filled only after the White House had cleared the applicant with the chemical industry lobby. Where once the EPA top management consisted of men and women with academic, scientific, and environmentalist backgrounds, the typical new EPA manager had come directly from the corporation boardroom. They came from and were loyal to such firms as Exxon (oil), Johns Manville (asbestos), Mountain Bell Telephone Co, Jones & Laughlin (steel), and Crown Zellerbach (paper). Some of them had earned their living fighting EPA as corporation lobbyists. But, as Mr Nader predicted, they overplayed their hands. Past administrators had placed the Agency’s goal as protection of human health. Administrator Burford rarely allowed the word health or cancer to pass her lips. She talked, in public, mostly about saving the taxpayers’ money. With guidance from the White House, she did, too, by applying a heavy axe to the EPA budget. Mrs Burford and her staff also tried to save industry money behind the scenes, and this was where their troubles began. News of "sweetheart" deals, allowing dumpers to make half-hearted cleanups at bargain rates, was leaking to the Press. She was said to have told an oil refiner to go ahead and exceed the maximum legal allowance for lead in gasoline. She told fellow Republicans at a luncheon aboard a yacht that she had held up funds for cleaning up a dump in California before last fall’s election. The objective was to harm the chances of the Democratic governor, Edmund Brown, in his race for the US Senate. He lost.

Not all the derogatory information that led to Mrs Burford’s fall from anonymous sources. One EPA middle-level executive, Mr Hugh Kaufman, openly denounced the agency in Congress and on a nationally televised show. His superiors put private investigators on his trail apparently in search of an excuse to fire him. At one point the investigators triumphantly reported seeing him enter a hotel with a woman. She turned out to be his wife. Mr Kaufman subsequently appealed to a Civil Service board against what he considered harassment, and won. It is impossible to say just how long the scandal-a-week show will go on. The Democrats in Congress have at least six investigations in progress and the news media, as usual, love it. With the nomination of Mr Ruckelshaus, the president hopes to take it all off the front pages and the nightly television news shows by installing a new administrator who is beyond reproach. It will not be that easy, in view of existing power relationships in Washington. The reality is that any changes at EPA are likely to be, at best, cosmetic. The reason can be found in a memorandum written by a member of the EPA Reagan team which leaked to the Press. In it he wrote that "the primary constituents of this administration (are) the business community". Lest there be any doubt about that, President Reagan continued to praise Mrs Burford even after she resigned. He complains of environmental extremists who want to make a "bird’s nest" out of the White House. Even so, one Reagan aide confided to a New York Times reporter, "We have got to avoid the impression that toxic wastes don’t bother Republicans". came

NEW TESTS FOR FOREIGN MEDICAL GRADUATES

The foreign medical graduate wishing to enter the US has had to pass the examination of the Educational Commission for Foreign Medical Graduates (ECFMG) or the visa qualifying examination (VQE). These are being phased out, and the last ECFMG exam will be in January, 1984, and the last VQE is to be in September of this year. The new examination, the foreign medical graduate examination in the medical sciences (FMGEMS), will be administered by the National Board of Medical Examiners and is recognised by the Department of Health and Human Services as equivalent to the National Board of Medical Examiners part I andII examination. The new exam will consist ofaone day examination in the basic medical sciences and a one day test in the clinical sciences, the questions being taken from a pool of test items maintained by the National Boards. It will first be taken in July, 1984, both parts being taken together or separately, and successful candidates must pass both parts.

Applicants can take the basic sciences test after the completion of at least two

years in the basic sciences of any medical school listed in the World Directory of Medical Schools, but the clinical exam can only be taken after completion of the whole curriculum. Meanwhile, the ECFMG will continue to monitor the standards of English of the candidates. If, as are assured, the standards for passing each test in the new examination will be comparable to those required for parts) and II of the National Boards, it is difficult to see why the new examination is needed since the same results would be achieved if all foreign medical graduates simply sat the National Board examinations. Could the real reason be because direct comparisons would then be possible and might show up grave deficiencies in the teaching in US medical schools? Things look simple for the foreign medical graduate, whether a US citizen or intended immigrant, and that is something. But a commission on medical education is sitting and its conclusions could affect the examination of foreign medical graduates. It might be wise to take advantage of opportunity when it offers.

BLOW TO GENERIC PRESCRIBING

For years critics of the medical profession have fastened on the prescribing of brand name drugs as one of the factors responsible for the high cost of medical care. If only doctors could be educated, persuaded, or even coerced into prescribing by generic rather than brand name, what savings could be made-millions of pounds in the National Health Service in Britain and millions of dollars in the US. The argument runs as follows: let manufacturers recoup their research, development, production, and licensing costs both for marketed drugs and for others that do not prove useful, effective, or profitable, but when the patent expires let generics step in in all instances. But no longer in the US, for a time at least, for the Supreme Court has ruled that a generic drug must be tested, approved, and regulated by the Food and Drug Administration. An appeal court had ruled that a generic drug with the same active as a previously approved drug was not a "new drug". The FDA appealed and their appeal has been upheld by the Supreme Court. Mr Justice Stevens saw the snag and in his judgment, unanimously upheld, he wrote that the term drug was in the Act "to include entire drug products complete with active and inactive ingredients"; to conclude that new applied only to the active ingredient of a drug, which might be the smallest component of the preparation, was untenable. A new preparation, even if it contains exactly the same amount of active ingredient as an old one, can have its effect altered by the excipients which, for example, alter absorption and cannot without testing be guaranteed to be safe or equally effective. The FDA claims that it has tested many generic drug preparations and can approve such preparations within a few months. Now the FDA is a byword for bureaucratic delay, to the disgust of the pharmaceutical industry, so it is interesting to see how speedily it can approve a generic product with all the potential interactions among its ingredients. Once a drug always a drug? Not necessarily, says the Supreme Court, unless it is proven.

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