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To what extent did the researcher follow the norms and expectations...

  • To what extent did the researcher follow the norms and expectations of the sponsoring institution? In other words, was the sponsor complicit in the fraud or did the researcher act alone in violation of corporate policy?
  • What was the researcher's motive in compromising the integrity of the study?
  • Exactly what ethical research principles were violated? How?
  • Exactly which provisions or interpretative statements of the Code were violated? How?
  • What consequences did the fraud carry for the subjects? The researcher? The sponsor? The researcher's profession?
  • How could the researcher have avoided fraud and maintained the integrity of the study?
  • What oversight mechanisms brought this violation to light?
  • What implications does this case have for nursing research studies?

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NEWS Obstetrician suspended after research iquiry A consultant obstetrician has been suspended from duty at St George's Hospital in south London after an inquiry into the scientific validity of two research papers. The consultant in question, Mr Malcolm Pearce, was the first author of the papers, both published in August in the British Journal of Obstetrics and Gynaecology. He has also been suspended from his honorary senior lectureship at St George's Hospital Medical School. The two papers are a case report entitled "Term delivery after intrauterine relocation of an ectopic pregnancy" and a paper entitled "Randomised controlled trial of the use ofhuman chorionic gonadotrophin in recurrent miscarriage associated with polycystic ovaries." The case report, concerning a 29 year old African woman who had previously had two ectopic pregnancies, described a procedure whereby the fetus in her third ectopic pregnancy was removed and replaced in her uterus. The report, which received wide publicity in the mass media, claims that the pregnancy reached term with no further problems. The inquiry, which was set up by Sir William Asscher the principal of St George's Hospital Medical School at the request of St George's Healthcare NHS Trust, found no evidence to support the findings reported in the research papers. The principal of the medical school has now written to the editor of the British Journal of Obstetrics and Gynaecology, Professor Geoffrey Chamberlain, asking that the inquiry's finding "now be communicated to the journal's readership." Professor Chamberlain, who also works at St George's and is president of the Royal College of Obstetricians and Gynaecologists, is listed as one of the authors of the case report on ectopic pregnancy. Malcolm Pearce is one of the journal's four editors working under Professor Chamberlain. Professor Chamberlain said that the journal's policy was to peer review only papers, not case reports. "My name was put on the paper, and I agreed to it," said Professor Chamberlain. "I have written to members of the college telling them that is the extent of my complicity. I had no part in the clinical part or the writing up of the paper. I was not involved in any deception. There is an inquiry going on at the college into the publication of these two articles, and it will be BMJ VOLUME 309 3 DECEMBER 1994 Mr Malcolm Pearce independent. I will be cooperating fully with that inquiry." Sir William Asscher, said in a press statement earlier this week that Professor Chamberlain "showed an error of judgement in allowing his name to go forward as a coauthor of one of the papers but, nevertheless, it is recommended that no further action be taken by the school." Nor will any formal action be taken against two other authors of the papers. Professor Peter Rubin, head of the department of medicine at the University of Nottingham, said: "The practice of heads of department putting their names on papers with which they have had no involvement other than to create the environment in which the research took place is still more widespread than might be imagined." Dr Drummond Rennie, a deputy editor of JAMA, the Journal of the American Medical Association and a member of the commission on research integrity set up by the US Congress, said that it was not unreasonable for editors to publish their research in their own journal. "But if you publish research in your own journal you should make sure that it is peer reviewed," he said. "I have had research published inJAMA but it was handled completely by other editors and I had no say in any of the deliberations." At the time that the BMJ went to press the report of the inquiry requested by St George's Healthcare NHS Trust was not available. The trust would not say when it would release the report. The chief executive of St George's Healthcare, Andrew Dillon, said: "The trust and the medical school have now received the findings of the inquiry. On the basis of this information Mr Pearce has been suspended from duty. The trust and the medical school are considering what further action to take on the matter." The trust has issued a statement saying that no more details of the inquiry can be provided "because of the prospect of disciplinary action. "-CLAUDIA COURT, LUISA DILLNER, BMJ 1459 Headlines Chairman of Burnley trust hospital resigns: Mr James Rawson, chairman of Burnley Heath Care NHS Trust, has resigned. His resignation follows that of the chief executive, Ms Maggie Aikman, and the medical director, Dr Sam Pickens, after consultants threatened to pass a vote of no confidence in the trust board. In September Dr Pickens had made a consultant, Mr Ian Mahady, redundant. Dr James Archer has been appointed the new chairman. Prisons in Texas ban smoking: The Texas prison board has unanimously banned tobacco for the 100 000 inmates and 50 000 employees in the state prison service. Violators could be subject to disciplinary measures or lose privileges. Health officials forced to disclose information: The parliamentary ombudsman has forced the Department of Health in Britain to release information about talks it claims to have held with representatives of the pharmaceutical industry about introducing a voluntary code on disclosure of the contents and production of pharmaceuticals. Credit card could help transplant operations: A credit card is being launched to raise money for the Transplant Foundation, a new charity aimed at reducing the shortage of organ donors in Britain. The charity will receive £10 for each new person who takes out a card. It aims to raise between £X100 000 and £250 000 in the first year. Shanghai bans public smoking The city of Shanghai this week introduced a ban on smoking in many indoor public places in the latest attempt to halt China's rise in tobacco consumption. The Shanghai municipal government regulation came into force on 1 December, forbidding smoking in various public venues including cinemas, theatres, and karaoke rooms. According to the preventive health department of the Shanghai Bureau of Public Health, it is the owners of the premises who will be fined under the new regulations rather than the illicit smokers themselves. Among the designated smoke free zones are big department stores, all public transport vehicles, museums, exhibition centres, sports stadiums, and hospitals. Not included in the ban, however, are restaurants and public government offices. Smoking is one of the biggest health challenges facing China, a country that leads the world in tobacco production and consumption. In 1993 a total of 1600 billion cigarettes were sold to 300 million Chinese smokers, and officials estimate that 70% of men aged over 25 smoke. Over recent years the most worrying increases have been among women and teenagers. Whereas 10 years ago there were few female smokers, it is now officially estimated that nearly 1 in 10 women over the age of 15 smoke. The Chinese Academy of Preventive Medicine recently said that, if smoking was not reduced, by the year 2030 smoking would kill more than 3 million people a year. Unsurprisingly, China is now one of the world's most attractive markets for international tobacco companies. Several manufacturers, including Philip Morris, have signed agreements with the state China National Tobacco Corporation to manufacture cigarettes in China. The Chinese government also faces the traditional dilemma of health costs versus tax revenues. The Chinese National Academy of Preventive Medicine said last month that economic losses from smoking were running at 30 billion yuan (,C2.3bn) a year. But the tobacco industry is also the biggest contributor to central government funds and last year raised 41 billion yuan (C3.2bn) in tax. Against this background China has recently been chosen to host the 10th world conference on tobacco and health in 1997. This may encourage the government to implement more seriously its various antismoking policies. One sign of progress came in October, when the country's first national advertising law was ratified by the Standing Committee of the National People's Congress-the rubber stamp parliament. Under this law, from February next year cigarette advertising will not be allowed on radio or television or in films, newspapers, and periodicals. Tobacco advertisements will also be banned from public areas such as theatres, meeting halls, and stadiums. All permitted advertising will have to carry a health warning about the dangers of smoking. It remains to be seen how rigorously the new regulations will be enforced. A regulatory ban on tobacco advertisements on television and radio and in the print media has been in force since the beginning of 1992, but several companies have found ways around the restrictions.. There is even a health administration regulation (not law) dating back to 1989 that bans or limits smoking in public places. Again, more often the reality in China is smoke filled rooms and railway carriages as smokers disregard the no smoking signs.-RICHARD TOMLINSON, freelance journalist, Beijing Prediction flaws will lead to staff shortage: A report by the Institute for Manpower Studies for the NHS Executive says that the NHS could face a shortage of nurses and occupa- tional therapists in the next few years because offlaws in the system for predicting staffing needs. Planners do not have reliable data. NHS to receive a further J40m for research and teaching: A further £40m will be set aside next year to support research and teaching in the NHS. This will make a total of £530m in 1995-6. Asbestos is still a killer in Britain: Asbestos is "one ofthe worst killers in our society," said the Health and Safety Executive. There are still "thousands of tonnes" of lethal asbestos insulation and board remaining in buildings. One of the three milion in China who could be dead through smoking by the year 2030 1460 BMJ VOLUME 309 3 DECEMBER 1994 Doctors sued for uninterest, say researchers in US Doctors who seem hurried and uninterested are at risk of being sued even if they practise good quality medicine, said researchers in the US last week. A team led by researchers from Vanderbilt University in Nashville, Tennessee, examined the malpractice records of obstetricians in Florida during 1987 and found that those who had higher levels of satisfaction among their patients also had lower rates of malpractice claims filed against them. The study, published in JAMA, the Journal of the American Medical Association (1994;272:1583-7), was done to find out why more than 85% of lawsuits are filed against 3-6% of doctors. The retrospective study was based on 963 obstetric cases. Researchers reviewed malpractice claims made in one year in Florida, which has a high rate of lawsuits Florida makes public all claims against doctors, whether they become lawsuits or not. They interviewed women who had filed claims and a matched group of women who had not. The group classified the 482 doctors into four groups, ranging from those who had frequent but small claims made against them to those who suffered no claims. Doctors who are commonly sued often claim that their patients are more ill than average, but the researchers found that this was not the case among the Florida doctors. Severity of illness was virtually the same among the . groups. Another explanation for the wide variation in lawsuits is that doctors who practise poorer quality medicine are sued more often. But again the researchers found this not to be the case among the Florida obstetricians. Instead they found that poor communication skills and insensitivity to patients accounted for much of the difference in patterns between doctors sued rarely and those sued frequently. "Physicians who had never been sued were more likely to be seen by their patients as concerned, accessible, and willing to communicate," they conclude. "At the other extreme, physicians who had been sued frequently but for whom relatively little money had been paid in claims were most likely to be seen as hurried, uninterested, and unwilling to listen and answer questions." "These studies show that a doctor might not have done anything technically wrong but generated enough misunderstanding and anger to provoke a malpractice claim," one of the researchers, Dr Gerald Hickson, told Associated Press. In an accompanying editorial Dr Wendy Levinson of the University of Oregon pointed out that malpractice suits are a poor indicator of medical negligence since many claims are begun when no negligence has occurred and only a tiny minority of negligent acts result in litigation -JOHN ROBERTS, North American editor, BMy BMJ VOLUME 309 3 DECEMBER 1994 Walking into the unknown: the Gulf war is blamed for a variety of ailments Gulf veteran gets pension for desert fever The British government has acknowledged for the first time that the illness of a veteran of the Gulf war was caused by the cocktail of injections he was given before and during the conflict. Robert Lake, 25, who was a corporal, has been granted a war pension for illness caused by his immunisation programme and attributable to service in the Gulf. He is one of at least seven former soldiers to be awarded war pensions for illness arising out of service during the conflict three years ago but the first whose condition has been explicitly attributed to the injections given to 40 000 troops. The decision on his pension came on the same day that the first batch of 24 veterans was granted legal aid to sue the Ministry of Defence for compensation for so called Gulf war syndrome. The Gulf War Solicitors Action Group is acting for 453 veterans of the war, whose claims total more than £20m. Some 30% are expected to be granted legal aid. Most have been medically discharged, and only 20 are still in the forces. The ailments they complain of include severe fatigue, hair loss, kidney disorders, nausea, weight loss, headaches, memory loss, bleeding gums, immune deficiency, depression, and nightmares. Some blame deformities of children born since the war on the anti-nerve agent pills that front line troops took every eight hours. The Ministry of Defence has still not admitted that the syndrome, also known as desert fever, exists despite the pensions awarded by the War Pensions Office, a branch of the Department of Social Security. The ministry has now agreed to examine medically all those suing for compensation. Mr Lake, who, after leaving the service, worked in computers until illness forced him to stop, is to receive a 40% disability pension of £40 a week. He plans to appeal about the amount. Pensions so far approved for service during the Gulf war have been awarded for disability ranging from 20% to 40%. Mr Lake says that he experiences severe chest pains, headaches, and eye disturbances.-cLARE DYER, legal correspondent, BMy Consultant failed to communicate suspicion of cancer A consultant surgeon who failed to tell anyone that he suspected cancer in a patient who then died admitted his error when he appeared before the Commons select committee which shadows the health service ombudsman last week. The ombudsman, Mr William Reid, upheld a complaint from the patient's son after a necropsy confirmed widely disseminated cancer. The consultant, Mr Gordon Little, is employed by Walsall Hospitals NHS Trust, which apologised to the complainant and has issued written instructions to consultants on how to deal with relatives. Mr Little said that he accepted full responsibility and was now conscious of the fact that he needed to take the initiative personally to see relatives. The case concemed an elderly man admitted to Manor Hospital, Walsall, for a routine prostate operation, which Mr Little performed. When the patient's recovery did not progress the consultant suspected cancer. He did not tell anyone but expected his medical team or the nurses to deduce it from his notes and to tell the family. Mr Little said that the patient's clinical condition had been such that further investigation would not have been justified. The patient asked to be left to die. His repeated statement of his wishes, his clinical condition, and the suspicion of cancer made Mr Little decide not to offer any treatment. The man died one day after being transferred to a rehabilitation unit. Only when the son read the postmortem report did he realise that his father's cancer had been widely disseminated. It took another 14 months before the son was able to meet the consultant to discuss his complaint. Mr John Rostill, chief executive of the trust, said that procedures were in place to prevent such a delay recurring.-JoHN WARDEN, parliamentary correspondent, BMJ Agencies unite to prevent child deaths Many children are dying unnecessarily in eastern Europe, according to the World Health Organisation. Now the organisation has joined forces with Unicef and the International Federation of Red Cross and Red Crescent Societies in an effort to prevent these needless deaths. The WHO says that diarrhoeal diseases and acute respiratory infections are the main causes of infant deaths and childhood sickness in the five countries of eastern Armenian children are dying needlessly 1462 Europe-Armenia, Azerbaijan, Georgia, Belarus, and Moldova. Current treatment of these diseases, it says, "often includes unnecessary hospital admissions and the excessive use of expensive drugs that are in short supply." Dr James Tulloch, director of the WHO's division of diarrhoeal and acute respiratory disease control, said: "This is a situation which we feel does need action urgently to try to prevent these unnecessary deaths." Reports from Armenia suggest that some parents who are unable to raise money can only watch their children die from diseases which could have been treated. Dr Tulloch said: "There is unnecessary use of expensive drugs-for instance, the use of injectable antibiotics-when they are not needed. There is also the use of antidiarrhoeal drugs, which we do not recommend in our treatment protocol." The WHO is concerned that many children are admitted to hospital for drug treatment when simpler outpatient treatment, or treatment at home by the mother, would be both sufficient and cheaper. Dr Tulloch said: "Our project does not aim to change the treatment of individuals but to train health workers so that they will treat more appropriately in the future." Figures from the health ministry in Azerbaijan show that two thirds of infant deaths last year were due either to acute respiratory infections or to diarrhoeal diseases. In Armenia similar figures for 1990 show that the two categories of illness accounted for 38% of infant deaths and 43% of deaths in children aged 1-4 years. National committees for the control of acute respiratory infections and diarrhoeal diseases will be set up in each of the five countries to ensure that training and public education are implemented.-CLAUDIA COURT, BMJ Juniors' targets will not be met Over 3000 junior doctors in England could still be contracted to work in hard pressed on call posts for over 72 hours a week when the deadline for abolishing these posts expires on 31 December. This figure comes from the latest reports of the regional task forces set up to monitor hours of work and depends on the present rate of progress being maintained until the end of the year. Under the new deal on doctors' hours no doctor should be on his or her feet and working for more than 56 hours a week, but the returns from the task forces predict that the number of posts requiring over 56 hours "will be unacceptably high." The Junior Doctors Committee has warned for months that the targets will not be met. As well as the 72 hour deadline for those working on call rotas, the contracted hours for those on partial shifts should be down to 64 and for those on full shifts 56 hours. Now the NHS Executive and the minister for health have admitted failure. Members at last week's meeting of the Junior Doctors Committee were angry at the figures and endorsed the action of the chairman, Dr Andrew Carney, and the negotiating subcommittee in keeping up pressure on the NHS Executive to meet the targets. Several sanctions are already open to task forces -for example, postgraduate deans can withhold half of the salary of the posts not complying; educational approval can be withdrawn; offending trusts can be excluded from future training posts and rotations; and purchasers can refuse to contract with units that fail to comply with the hours limits. The committee has reached agreement with the Department of Health on some issues: task forces will not be wound down; reports on hours of work will be not be accepted by task forces unless they have been validated by juniors' representatives; and a working group has been set up to examine ways of monitoring hours of work and of involving junior doctors and purchasers in the process. The Department of Health has complained about the poor take up of partial shifts. The returns from the task forces show that these increased from 3.8% in March to 4.8% in September. Dr Paul Miller, a deputy chairman, said that many doctors were working the intensity of a partial shift but were not being paid for such. The negotiators were urged to pursue this as a matter of urgency. Several junior doctors are taking legal action, supported by the BMA, to persuade their hospital to pay them the rate for the job. To make a comparison with the returns from the task forces the Junior Doctors Committee asked all junior doctors to complete a questionnaire by 30 November, giving details of the actual hours they worked and the intensity of work. Over 8000 questionnaires have already been returned, and a representative sample of responses will be available by the end of the year. Although admitting that there will still be BMJ VOLUME 309 3 DECEMBER 1994 juniors working above the targets at the end of the year, the health minister, Mr Gerald Malone, said that the government has injected over C1 15m into the new deal, which has helped to create over 600 new consultant posts and 150 staff grade posts. With task forces' powers to approve extra staff grade and senior house officer posts, an additional 845 doctors would be brought on stream.-LINDA BEECHAM, BMJ Israeli government puts squeeze on public hospitals Israel's public hospitals, which have expanded steadily in recent years owing to increased demand from the local population and from hundreds of thousands of new immigrants are now being told to tighten their belts. The health ministry has said that it will set a 4-5% cap on the annual increase in money received from the public health funds (insurers). Each of the medical institutions will now have to negotiate a "global budget" with ministry officials instead of automatically receiving the standard daily rate for most inpatients and differential payments for more expensive treatments. The policy was forged by the director general of the health ministry, Professor Mordechai Shani, a powerful administrator on loan from Israel's largest medical centre, Sheba Hospital, near Tel Aviv. The controversial policy seems to emanate from a projected shortfall of some $200m (,C133m) in funds for health services resulting from the introduction of Israel's universal health insurance system, due to come into effect early next year. Under the system a health tax of 4.8% of income will be collected monthly from each breadwinner and distributed among the health funds. Meanwhile, Kupat Holim Clalit-the country's largest health insurer, responsible for the health of two thirds of the population-has an accumulated debt of $1bn (,C667m). In exchange for government subsidies to keep it afloat Kupat has agreed to transfer ownership of its 14 hospitals to the state. Fearful that Kupat could collapse, unions have said that they will not fight the dismissal of 30/o of the staff or longer clinic hours. Instead of a wage cut of almost 3%, staff have lent management this amount, to be repaid in 10 years. Professor Shani contends that global budgeting for hospitals is used in Sweden, France, and Germany. He said: "The government's aim is to limit public expenditures for hospitalisation, which have grown by significant amounts in recent years to $2bn (L1333m) in 1994. Hospitals may raise money from donors for development projects, but income from insurers will be limited to increase efficiency." Professor Shani maintains that the longstanding daily payment for inpatients discourages efficiency. Instead, it encourages administrators to keep as many beds filled with patients as possible. BMJ voLuME 309 3 DECEMBER 1994 Public hospitals are feeling the pressure Under the new system Professor Shani will personally negotiate with directors of the hospitals and set a customised global budget. Administrators whose public hospitals already have growth rates of 5% are worried. They argue that it is the government itself that is responsible for the great increase in health costs, since the state approved 50% wage increases to all health workers this year. The directors emphasise that the new policies will reduce competition among the hospitals and lower the quality of services. -JUDY SIEGEL-ITZKOVITCH, medical correspondent, JERUSALEM POST NHS at risk from fraud, warns Audit Commission Over 960 serious cases of fraud and corruption, costing nearly k6m, have occurred in the NHS in the past three years, said the Audit Commission this week. Risks are greatest in primary health services, where payments for prescriptions and general practitioners' fees for items of service such as night calls are based largely on trust. The commission has called for family health services authorities (FHSAs) to refer all cases of suspected fraud to the police. Although the cost of fraud seems small compared with the ,80bn spent by the NHS over the same period, the commission wamed that fraud could be largely undetected. "It would be wrong to be complacent as it is unknown whether these proven losses represent a small or large proportion of the total loss to the NHS," said its report. The commission, set up by the govern- ment, sent questionnaires to directors of finance in every NHS body in Britain. Over two thirds (460) provided information on fraud. It also interviewed NHS managers; auditors in trusts, health authorities, and FHSAs; and professional bodies. The report argues that some systems to pay doctors, dentists, and pharmacists have remained unchanged for years and are largely unmonitored by FHSAs. It warns that in general practice the population turnover in London in particular "may create a smokescreen for fraudulent activity." Government statistics for one FHSA in the city estimate a population of 600 000, but the population according to the aggregation of practice lists is nearly 800 000. One FHSA that had three practices claiming to have vaccinated all of the children on their lists considered the claim to be implausible but did not investigate. FHSAs had no incentive to investigate fraud because they had inadequate resources and the costs were likely to exceed their administration budgets. The report warns that there is an obvious temptation for pharmacists to commit fraud. For over half the prescriptions they dispense the charge paid by patients exceeds the amount the pharmacists are reimbursed by the FHSA. Pharmacists have an incentive either to destroy the prescription form or to falsely declare the patient exempt and keep the charge. NHS trusts and district health authorities have more incentives to investigate fraud and more controls, says the report, but there are still vulnerable areas such as payroll systems, income from private patients, and the management of schemes to generate income. One trust had received only a quarter of around £800 000 that had been raised through a fund raising company. The commission makes 26 recommen1463 dations for fighting fraud. Although it emphasises that "the vast majority" ofNHS employees are "honest and diligent," it urges NHS boards and managers to approve plans for responding to fraud and corruption, including improving liaison with police. The NHS Executive is urged to undertake an immediate review of the FHSAs' system of monitoring pharmacists and to look at more effective controls on dispensing general practitioners.-LUISA DILLNER, BMJ Protecting the Public Purse 2 is available from HMSO bookshops, price £10. French surgeons accused of fraud Thirty French orthopaedic surgeons are being investigated for allegedly having swindled the social security's health insurance branch by receiving kickbacks for prescribing hip prostheses. Twenty two separate complaints have been lodged by regional branches of the "Secu" after a lengthy investigation showed the existence of a company that overcharged for prosthetic devices and paid doctors a percentage of the inflated sales prices. The investigation was led by Maurice Dachary, director of the health insurance branch of the administrative district of Le Mans, west of Paris. It has already led to charges of fraud against three surgeons and against Patrick Cruchet, administrator of a company, Prolig, founded in 1987 to distribute prostheses. Prolig or its subsidiaries organised congresses and so called research trips and paid doctors royalties for "research." The investigation found that no research had been carried out and established a strong correlation between payments to doctors and the sale of prostheses to the private clinics where they practised. A judicial expert's accounting report states that during these five years Cruchet paid himself a salary of Fr20m (12.4m) and that his family withdrew about Fr78m (C9.4m) to purchase property (including a clinic), for travel, and for other personal expenses. According to the report, Fr34.5m (C4. im) went into general expenses, which included payments of a total of Frl 5m (,C1.8m) to doctors. The fraud is believed to have cost the Secu more than FrlOOm (Cl2m) over the five years ending 1992. Hip and knee prostheses were then placed on a health tariff limiting their price. Revealing details to the press, Dachary called for all prostheses and artificial implants to be placed on a government price control list. Trials of the 30 doctors are expected to take place early next year. The French Society of Orthopaedic and Trauma Surgery has said that it will expel any doctors who are found guilty. Another example of the crackdown on fraud has been an additional 50 complaints, forwarded to public prosecutors by the General Directorate of Fair Competition and for the Repression of Fraud, concerning violation oflaws forbidding doctors to receive any form of payment or gift for prescribing orthopaedic apparatus or pharmaceuticals. Most of the 50 doctors are surgeons specialising in orthopaedics, ophthalmology, and otolaryngology.-ALEXANDER DOROZYNSKI, medical journalist, Paris Focus: Sydney The results of living under a runway Sydney's airport is flight path in historically working class, safe only 12 km from the downtown area. For years its two intersecting run- ways have carried all domestic and international traffic, but from the mid-1980s delayed departures and interminable holding patterns on arrival made it obvious that the two runways were not coping. Two main strategies were considered: to build a second airport 40 km south west of Sydney, connected by a fast rail service, or to build a third runway parallel to the existing north-south strip. After intense lobbying from the business community and the tourism industry, concerned to maintain the convenience of the existing airport, the third runway option was fast tracked by the federal government. It opened on 4 November, six months ahead of schedule and A$50m (,C25m) under budget. Since then it has stayed on the front pages. Ever since the debate on options began in the 1980s there has been opposition to the third runway. Now there is widespread fury at the incessant noise of rattling windows and allegations that a Labor government has sold out its own supporters. Demonstrators set up loudspeaker banks Labor seats. Though dubbed the "third" runway, the new runway's opening has led to the closure of the east-west runway. Thus Sydney airport still has only two runways; the parallel arrangement allows more aircraft movements, but all the planes come over these residents' houses on days when wind conditions prevent take offs and landings over the sea. On such days planes scream a few hundred metres over some 27000 dwellings every two minutes. Meanwhile, the more affluent suburbs under the old east-west flight path have lost all their air traffic. Noise insulation grants will be made to houses under a narrowly defined ffight path, and the government has made much of monitoring the health consequences that might arise for affected residents. Cynics ask about the purpose of these studies, given that the government is not likely to abandon the runway. A consortium of researchers from the National Acoustic Laboratories and the University of Sydney proposed a range of studies that would move assessment beyond the crude ecological studies that have been the norm in assessing the effects of airline noise on health. In 1979 a study in Sydney compared suburbs affected and unaffected by aircraft flight paths for a range of health outcomes but did not disentangle con- playing aircraft noise outside the aviation minister's house at 6 am in the morning. founders such as socioeconomic status. Almost all the anger has come from inner The consortium proposed a series of loncity residents living under the north-south gitudinal studies costing about AS 1 Om 1464 (,C5m). These included a five year cohort study of cardiovascular events and mental health in 10000 people living under and away from the noise; a general practice study examiining tranquilliser use and rates of consultations for complaints like anxiety and sleep disturbance before and after the opening of the new runway; a study of blood pressure changes in children; and validation of previous noise measurement studies (theoretical projections based on typical flight paths and weather conditions). What survived were the blood pressure study, some cross sectional studies of mental health, and the work on noise levels. Meanwhile, anecdotal reports in the press from local general practitioners suggest increased reporting of insomnia and depression. These will be dismissed as hearsay by a govemment intent on toughing out complaints from the community. With the general practice study discarded there will be no longitudinal source of information on morbidity, let alone on less quantifiable outcomes like quality of life when people routinely have to shout to be heard. Next March sees a state election in New South Wales. The state Labor party, fearing an electoral backlash against their federal counterparts, has taken the astonishing step of calling for a royal commission into the decision making processes that led to one of the most contentious decisions in the recent history of Australian politics.-SIMON CHAPMAN, associate professor of community medicine, Sydney BMJ VOLUME 309 3 DECEMBER 1994

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