598
stating through a spokesman that price increases have been decelerating since 1989. From 9-8% in that year, he said, the increases declined to 7-8% in 1991, and are continuing downward. He also noted that whilst the cost of R&D is 7 American for firms, accounting "skyrocketing", major one-third of the prescription-drug market, have committed themselves to hold price increases to no more than the rate of inflation. Chairman of the Ways and Means Subcommittee responsible for Medicare legislation, Congressman Stark seems unmoved by the pledge of fiscal restraint. Referring to the price increases documented in the GAO report, he predicted: "This unbridled greed will bring a strong reaction from the American people. The manufacturers’ greed will speed the day we enact drug price control legislation". Passage of serious health-care legislation is virtually impossible in what remains of this presidential election year, but Stark’s intentions are on record. "I’ve introduced bills to deny tax breaks to pharmaceutical companies when they inflate their drug prices more than the CPI plus 2 points, and set up a Canadian-type of price review board to identify excessive inflation and shorten the patent on overpriced monopoly products." The health-care burden has become so excruciating throughout the economy that a crackdown on drug pricing is a leading candidate for political attention next year, irrespective of who wins the election.
Daniel S. 1.
Greenberg
Prescription Drugs: Changes in Pricesfor SelectedDrugs (GAO/HRD-92-128; 70 pp, available without charge from: US General Accounting Office, PO Box 6015, Gaithersburg, MD 20877; 202/275 6241).
Round the World Japan:
Death from overwork
The Government has announced a set of initiatives to confront the increasing problem of karoshi, the phenomen of death from overwork, which was first identified in Japan. Karoshi, a word that is being adopted intemationally, is characterised by sudden death, usually amongst adults in their 30s and 40s after a period of prolonged intensive work. The cause of death is usually stroke. The three main initiatives of the programme, developed by the Labour Ministry, will be implemented from next year. First, 347 local medical centres will be set up over the next seven years to provide regular medical check-ups for employees of smaller companies with limited in-house medical facilities. The centres will also advise companies on health issues, and doctors will be available to answer queries from individual employees. In addition, there will be a health research and training centre set up in each of the 47 prefectures where regular seminars will be held to update and re-train doctors in management of stress and work-related illnesses. In the first year of the programme 50 local and 6 prefectural centres will be set up at a cost of 10m. To isolate the main cause of karoshi, the Labour Ministry also plans to make medical check-ups organised at a corporate level more comprehensive. In 1989, these were improved by adding tests for high cholesterol levels and diabetes, and from 1993 more rigorous cardiovascular tests will begin, particularly for individuals in higher risk groups. The Labour Ministry began recognising karoshi only in the late 1980s, and over the past three years 110 deaths have
been attributed to overdemanding work schedules. The rate is increasing as the methods of testing for karoshi become more specialised, and cases are being identified among white collar workers and women, whereas previously those affected were mainly males from the manufacturing sector. A group of lawyers of bereaved families, however, estimate that about 10 000 deaths a year are the result of overwork. Since the lawyers set up a hot-line two years ago they have received over 2700 calls both from bereaved families and people concerned about a member of their family. In July, 1990, a Japanese businessman’s death at the age of 47 was attributed to karoshi. The Employment Ministry’s labour standards council heard that Jun Ishii spent almost five of the ten months before his death on business trips to the CIS. His wife, who had been increasingly concerned about her husband, was compensated under Japan’s insurance scheme against work-related accidents. The Labour Ministry claims that the average number of annual working hours in the manufacturing sector has declined from 2316 (including overtime) in 1967, to 2088 in 1989 and is still decreasing. This is the equivalent of 260 working days a year and compares with the annual average in Europe of 225 working days. Unofficially, however, it seems that unpaid overtime still accounts for many unrecorded hours of work and commitment to one’s company still takes an extraordinary precedence. Random checks made by the Labour Ministry have shown that banks and securities houses particularly violate the employment laws. Japan’s post-war economic success is largely attributable to the ethics of workaholism, and to change such fundamental beliefs is perhaps the main problem. A speech made by Akio Morita, the Chairman of Sony Corporation, calling for increased holidays and wages for employees to avoid further trade friction, was met with hostility in some
quarters. Whilst changes are being made, perhaps the real test of Japan in the 1990s will be how it reacts to its flagging economy. Will Japanese workers see a reduction in their working hours, or will cut-backs in part-time labour result in even longer hours for full-time employees? Jane Drinkwater
USA: Ban
on
415 ineffective
drug
ingredients On August 25, the US Food and Drug Administration (FDA) proposed banning 415 ingredients from seven categories of over-the counter (OTC) medications because they have not been shown to be safe and effective for their stated claims. The 7 therapeutic categories of OTC drug products affected by this action include digestive aid, topical antifungal, external and internal analgesic, orally administered menstrual, pediculicide, and skin protectant drug products. Manufacturers will have to either reformulate or remove such products from the market. "We are taking this action because no proof has been submitted to the FDA that shows that the ingredients are effective for the conditions claimed", said Dr David A. Kessler, FDA Commissioner. This is the third and largest proposed ban on OTC drugs that the FDA has conducted in the past few
1990, the FDA banned 223 ineffective 19 categories of products, and in August, 1991, III ineffective ingredients in weight control products. "It’s going to affect literally thousands of products", said
years. In November,
ingredients from
599
BN’illiam E.
Gilbertson, head of the FDA’s OTC However, neither the FDA or Monograph Review Staff.
Nonprescription Drug Manufacturers’ Association ,}...1J)MA) know how many products are involved. Meg Grattan, a spokeswoman for the NDMA said that the effects on member companies will be negligible. "We have not been contacted by anybody who has real problems with this", she said. The ban on some ingredients is not total, however; some ingredients banned for one use may be allowed for another. For example, salicylic acid is being banned as an external pain reliever in insect bite and sting treatment products but is effective for removal of warts, coms, and calluses. Similarly calamine could be marketed as a "skin protectant" but not as an "external analgesic". In some cases ingredients known to be safe but which would not be
the
allowed for certain claims could be used as inactive ingredients. For example, peppermint, whilst deemed ineffective as a digestive aid, could be used as a flavouring agent. Most of the ingredients have been around since 1962, when a change in the law required that manufacturers submit proof of effectiveness for both new drugs and drugs that had been approved earlier. To implement the part of the law dealing with OTC drugs, the FDA set up a process to evaluate all ingredients contained in OTC drug products. Since that review began, products and ingredients found to be unsafe have been removed from the market. However, products believed to be safe but inefficaceous were allowed to remain in the market until proof of their efficacy could be established. Under the review, the FDA evaluates reports prepared by advisory panels of outside experts together with comments from industry and the public. The FDA then publishes a proposed rule with another comment period, which includes an opportunity for a public hearing. Ultimately, the FDA issues a final regulation (monograph) on
acceptable ingredients, doses, formulations, instructions,
and permitted claims. Comments on the current proposal, published in the US Federal Register on August 25, may be sent within the next two months.
Syed Rizwanuddin Ahmad
Germany: Juggling the drug budget The health minister has re-iterated to the top brass of the sick fund physicians’ association that he is determined to stick to a DM24 billion drug budget for the statutory health insurance system in 1993. For comparison, the UK’s NHS expenditure for medicines in 1991 was the equivalent of DM8-7 billion. The minister’s original plan was to make individual sick fund physicians liable for their own overspending. The vociferous opposition to this plan by the physicians led to the minister cleverly shifting liability for excess expenditure to the sick fund physicians’ association. They in turn replied that they could not accept such a collective burden. Meanwhile, "red cards" were made available at doctors’ surgeries. Patients could sign the cards and send them to the minister to register patients’ opposition to doctors paying out of their own pockets for urgently needed drugs. Only a small fraction of patients are aware, however, that if dubious and unproven drugs were no longer prescribed, necessary medication could be paid for easily by the drug budget allowance. The minister retorted that patients were being used as hostages. The first reaction by the physicians was to call for a limited drug list, prescribing from which would free
physicians from any liability (Lancet, June 27, p 1597). But further analysis revealed that such a list would create many legal difficulties. Another clever idea was to get the pharmaceutical industry to pay the excess in prescribing costs. But the industry gave this idea the cold shoulder. At long last the sick fund physicians have got to prescribe themselves a more efficacious and bitter medicine in order to rationalise their drug prescribing.
Karl H. Kimbel
Guatemala: A ray of hope The decimation of the indigenous population and death of than 100 000 people in the past 30 years lend support to the argument that the situation in this country is the closest thing to apartheid. 1-3 But a preliminary agreement between the government and guerrilla leaders on August 7, and some improvements in human rights mean that there is a ray of hope for the country’s future. The overthrow of democratically elected President Jacobo Arbenz Guzman in 1954, in a coup backed by the US Central Intelligence Agency, was followed by a series of military governments. This trend was interrupted in 1985 by the election of a civilian, Christian Democrat Vinicio Cerezo Arevalo. His promise to end military impunity and build the foundations of democratic governance were only partly fulfilled. When a new civilian President, Jorge Serrano Elias, took office on January 14, 1991, he also promised to punish those responsible for human rights abuses. Despite that promise, extrajudicial executions and forced "disappearances" still continue, albeit at a slower rate. A report from the Archbishop’s Office of Human Rights compares the situation in the first half of 1991 with that in the first half of 1992. In the first six months of 1991 there were 301 extrajudicial executions and 99 forced disappearances. In 1992 there were 190 extrajudicial executions and 3 forced disappearances during the same period, although one should be extremely cautious in interpreting these data. Nevertheless, these figures, together with the recent prosecution of notorious human rights violators may reflect real progress. But the years of institutionalised violence led to a human exodus to neighbouring countries and to the internal displacement of hundreds of thousands of people. Funded by the Italian Government, and executed by the Office of Project Services of the United Nations Development Programme in collaboration with, among others, the Pan American Health Organisation, the PRODERE (Programa de Desarrollo Para Desplazados, Refugiados y Repatriados en Centro America) programme helps returning refugees and internally displaced people on a wide range of issues. The PRODERE organises aid in Belise, Costa Rica, El Salvador, Honduras, Nicaragua, and Guatemala. In Guatemala the project, has educational, agricultural, infrastructural (roads and buildings), human rights, and health pursuits. The health-care part is in two areas in the department of El Quiche. These areas were chosen because, after being ravaged by brutal army repression they are now being repopulated. Maternal mortality rates of 170 per 100 000 and infant mortality rates of 55-6 per 1000 probably reflect under-reporting due to inadequate health information systems.’ Two main activities are carried out in the health sector: the improvement of health service delivery through decentralisation and infrastructure building, and improvement of the sanitary conditions of the population.
more
stating through a spokesman that price increases have been decelerating since 1989. From 9-8% in that year, he said, the increases declined to 7-8% in 1991, and are continuing downward. He also noted that whilst the cost of R&D is 7 American for firms, accounting "skyrocketing", major one-third of the prescription-drug market, have committed themselves to hold price increases to no more than the rate of inflation. Chairman of the Ways and Means Subcommittee responsible for Medicare legislation, Congressman Stark seems unmoved by the pledge of fiscal restraint. Referring to the price increases documented in the GAO report, he predicted: "This unbridled greed will bring a strong reaction from the American people. The manufacturers’ greed will speed the day we enact drug price control legislation". Passage of serious health-care legislation is virtually impossible in what remains of this presidential election year, but Stark’s intentions are on record. "I’ve introduced bills to deny tax breaks to pharmaceutical companies when they inflate their drug prices more than the CPI plus 2 points, and set up a Canadian-type of price review board to identify excessive inflation and shorten the patent on overpriced monopoly products." The health-care burden has become so excruciating throughout the economy that a crackdown on drug pricing is a leading candidate for political attention next year, irrespective of who wins the election.
Daniel S. 1.
Greenberg
Prescription Drugs: Changes in Pricesfor SelectedDrugs (GAO/HRD-92-128; 70 pp, available without charge from: US General Accounting Office, PO Box 6015, Gaithersburg, MD 20877; 202/275 6241).
Round the World Japan:
Death from overwork
The Government has announced a set of initiatives to confront the increasing problem of karoshi, the phenomen of death from overwork, which was first identified in Japan. Karoshi, a word that is being adopted intemationally, is characterised by sudden death, usually amongst adults in their 30s and 40s after a period of prolonged intensive work. The cause of death is usually stroke. The three main initiatives of the programme, developed by the Labour Ministry, will be implemented from next year. First, 347 local medical centres will be set up over the next seven years to provide regular medical check-ups for employees of smaller companies with limited in-house medical facilities. The centres will also advise companies on health issues, and doctors will be available to answer queries from individual employees. In addition, there will be a health research and training centre set up in each of the 47 prefectures where regular seminars will be held to update and re-train doctors in management of stress and work-related illnesses. In the first year of the programme 50 local and 6 prefectural centres will be set up at a cost of 10m. To isolate the main cause of karoshi, the Labour Ministry also plans to make medical check-ups organised at a corporate level more comprehensive. In 1989, these were improved by adding tests for high cholesterol levels and diabetes, and from 1993 more rigorous cardiovascular tests will begin, particularly for individuals in higher risk groups. The Labour Ministry began recognising karoshi only in the late 1980s, and over the past three years 110 deaths have
been attributed to overdemanding work schedules. The rate is increasing as the methods of testing for karoshi become more specialised, and cases are being identified among white collar workers and women, whereas previously those affected were mainly males from the manufacturing sector. A group of lawyers of bereaved families, however, estimate that about 10 000 deaths a year are the result of overwork. Since the lawyers set up a hot-line two years ago they have received over 2700 calls both from bereaved families and people concerned about a member of their family. In July, 1990, a Japanese businessman’s death at the age of 47 was attributed to karoshi. The Employment Ministry’s labour standards council heard that Jun Ishii spent almost five of the ten months before his death on business trips to the CIS. His wife, who had been increasingly concerned about her husband, was compensated under Japan’s insurance scheme against work-related accidents. The Labour Ministry claims that the average number of annual working hours in the manufacturing sector has declined from 2316 (including overtime) in 1967, to 2088 in 1989 and is still decreasing. This is the equivalent of 260 working days a year and compares with the annual average in Europe of 225 working days. Unofficially, however, it seems that unpaid overtime still accounts for many unrecorded hours of work and commitment to one’s company still takes an extraordinary precedence. Random checks made by the Labour Ministry have shown that banks and securities houses particularly violate the employment laws. Japan’s post-war economic success is largely attributable to the ethics of workaholism, and to change such fundamental beliefs is perhaps the main problem. A speech made by Akio Morita, the Chairman of Sony Corporation, calling for increased holidays and wages for employees to avoid further trade friction, was met with hostility in some
quarters. Whilst changes are being made, perhaps the real test of Japan in the 1990s will be how it reacts to its flagging economy. Will Japanese workers see a reduction in their working hours, or will cut-backs in part-time labour result in even longer hours for full-time employees? Jane Drinkwater
USA: Ban
on
415 ineffective
drug
ingredients On August 25, the US Food and Drug Administration (FDA) proposed banning 415 ingredients from seven categories of over-the counter (OTC) medications because they have not been shown to be safe and effective for their stated claims. The 7 therapeutic categories of OTC drug products affected by this action include digestive aid, topical antifungal, external and internal analgesic, orally administered menstrual, pediculicide, and skin protectant drug products. Manufacturers will have to either reformulate or remove such products from the market. "We are taking this action because no proof has been submitted to the FDA that shows that the ingredients are effective for the conditions claimed", said Dr David A. Kessler, FDA Commissioner. This is the third and largest proposed ban on OTC drugs that the FDA has conducted in the past few
1990, the FDA banned 223 ineffective 19 categories of products, and in August, 1991, III ineffective ingredients in weight control products. "It’s going to affect literally thousands of products", said
years. In November,
ingredients from
599
BN’illiam E.
Gilbertson, head of the FDA’s OTC However, neither the FDA or Monograph Review Staff.
Nonprescription Drug Manufacturers’ Association ,}...1J)MA) know how many products are involved. Meg Grattan, a spokeswoman for the NDMA said that the effects on member companies will be negligible. "We have not been contacted by anybody who has real problems with this", she said. The ban on some ingredients is not total, however; some ingredients banned for one use may be allowed for another. For example, salicylic acid is being banned as an external pain reliever in insect bite and sting treatment products but is effective for removal of warts, coms, and calluses. Similarly calamine could be marketed as a "skin protectant" but not as an "external analgesic". In some cases ingredients known to be safe but which would not be
the
allowed for certain claims could be used as inactive ingredients. For example, peppermint, whilst deemed ineffective as a digestive aid, could be used as a flavouring agent. Most of the ingredients have been around since 1962, when a change in the law required that manufacturers submit proof of effectiveness for both new drugs and drugs that had been approved earlier. To implement the part of the law dealing with OTC drugs, the FDA set up a process to evaluate all ingredients contained in OTC drug products. Since that review began, products and ingredients found to be unsafe have been removed from the market. However, products believed to be safe but inefficaceous were allowed to remain in the market until proof of their efficacy could be established. Under the review, the FDA evaluates reports prepared by advisory panels of outside experts together with comments from industry and the public. The FDA then publishes a proposed rule with another comment period, which includes an opportunity for a public hearing. Ultimately, the FDA issues a final regulation (monograph) on
acceptable ingredients, doses, formulations, instructions,
and permitted claims. Comments on the current proposal, published in the US Federal Register on August 25, may be sent within the next two months.
Syed Rizwanuddin Ahmad
Germany: Juggling the drug budget The health minister has re-iterated to the top brass of the sick fund physicians’ association that he is determined to stick to a DM24 billion drug budget for the statutory health insurance system in 1993. For comparison, the UK’s NHS expenditure for medicines in 1991 was the equivalent of DM8-7 billion. The minister’s original plan was to make individual sick fund physicians liable for their own overspending. The vociferous opposition to this plan by the physicians led to the minister cleverly shifting liability for excess expenditure to the sick fund physicians’ association. They in turn replied that they could not accept such a collective burden. Meanwhile, "red cards" were made available at doctors’ surgeries. Patients could sign the cards and send them to the minister to register patients’ opposition to doctors paying out of their own pockets for urgently needed drugs. Only a small fraction of patients are aware, however, that if dubious and unproven drugs were no longer prescribed, necessary medication could be paid for easily by the drug budget allowance. The minister retorted that patients were being used as hostages. The first reaction by the physicians was to call for a limited drug list, prescribing from which would free
physicians from any liability (Lancet, June 27, p 1597). But further analysis revealed that such a list would create many legal difficulties. Another clever idea was to get the pharmaceutical industry to pay the excess in prescribing costs. But the industry gave this idea the cold shoulder. At long last the sick fund physicians have got to prescribe themselves a more efficacious and bitter medicine in order to rationalise their drug prescribing.
Karl H. Kimbel
Guatemala: A ray of hope The decimation of the indigenous population and death of than 100 000 people in the past 30 years lend support to the argument that the situation in this country is the closest thing to apartheid. 1-3 But a preliminary agreement between the government and guerrilla leaders on August 7, and some improvements in human rights mean that there is a ray of hope for the country’s future. The overthrow of democratically elected President Jacobo Arbenz Guzman in 1954, in a coup backed by the US Central Intelligence Agency, was followed by a series of military governments. This trend was interrupted in 1985 by the election of a civilian, Christian Democrat Vinicio Cerezo Arevalo. His promise to end military impunity and build the foundations of democratic governance were only partly fulfilled. When a new civilian President, Jorge Serrano Elias, took office on January 14, 1991, he also promised to punish those responsible for human rights abuses. Despite that promise, extrajudicial executions and forced "disappearances" still continue, albeit at a slower rate. A report from the Archbishop’s Office of Human Rights compares the situation in the first half of 1991 with that in the first half of 1992. In the first six months of 1991 there were 301 extrajudicial executions and 99 forced disappearances. In 1992 there were 190 extrajudicial executions and 3 forced disappearances during the same period, although one should be extremely cautious in interpreting these data. Nevertheless, these figures, together with the recent prosecution of notorious human rights violators may reflect real progress. But the years of institutionalised violence led to a human exodus to neighbouring countries and to the internal displacement of hundreds of thousands of people. Funded by the Italian Government, and executed by the Office of Project Services of the United Nations Development Programme in collaboration with, among others, the Pan American Health Organisation, the PRODERE (Programa de Desarrollo Para Desplazados, Refugiados y Repatriados en Centro America) programme helps returning refugees and internally displaced people on a wide range of issues. The PRODERE organises aid in Belise, Costa Rica, El Salvador, Honduras, Nicaragua, and Guatemala. In Guatemala the project, has educational, agricultural, infrastructural (roads and buildings), human rights, and health pursuits. The health-care part is in two areas in the department of El Quiche. These areas were chosen because, after being ravaged by brutal army repression they are now being repopulated. Maternal mortality rates of 170 per 100 000 and infant mortality rates of 55-6 per 1000 probably reflect under-reporting due to inadequate health information systems.’ Two main activities are carried out in the health sector: the improvement of health service delivery through decentralisation and infrastructure building, and improvement of the sanitary conditions of the population.
more
