- Email: [email protected]
Reform proposal for Food and Drug Administration
Clinton unveils modest
new
go bankrupt in 2002-by an additional three years. Democrats on Capitol Hill were furious costs themselves, which often makes the with this aspect of the plan, noting that : recent attacks on Republican efforts to proposition unaffordable. A second set of proposals are the curb the growth of the massive health pro"consensus" items common to both the grammes had been boosting Democrats’ original Clinton health plan and own popularity. "Opening the door to Republican bills. These include banning deep Medicare cuts while the Republicans insurance companies from denying are struggling to pay for their huge tax coverage (or raising premiums once a breaks threatens to make Medicare a person is covered) based on pre-existing political football", complained House medical conditions; creating purchasing Minority Leader Richard Gephardt pools to help individuals and small (Democrat, Missouri). businesses obtain more favourable insur: While health-care providers are already ance rates; and increasing the healthcrying foul over being asked to shoulder insurance tax-deduction for self-employed the entire burden of the cuts, the adminispeople (currently 30%: the new proposal tration is hoping to buy-off Medicare would raise it to 50%). : beneficiaries (and the powerful groups By far the most controversial aspect of that represent them in Washington), not the plan is the administration’s offer to only by promising not to raise their costs, reduce Medicare spending by US$124 : but also by offering them more than$13 billion over the next seven years and to billion worth of new benefits. Among cut Medicaid by$54 billion over the same these are a new programme to provide period (about 40% of the amount prohome and community-based long-term posed by Republicans in care; a "respite" benefit for families who Administration officials emphasised that care for patients with Alzheimer’s disease; the cuts would affect only doctors, hospiand a waiver on the co-pay requirements tals, and other health-care providers, for women receiving mammograms, while not harming recipients of the prowhich essentially makes them free. grammes. They also noted that the cuts would extend the solvency of Medicare’s hospital trust fund-currently scheduled Julie Rovner
US health-reform bill
to .
Nine months after his massive health overhaul went down to ignominious defeat in Congress, President Clinton last week unveiled a new, much more modest health-reform bill-including some controversial cuts in Medicare and Medicaid, the two main federal health programmes. Even before Republicans captured the Congress last autumn, the President and his advisers had acknowledged that they had tried to do too much at once, and would instead propose reforms of the "incremental" variety. But debate had raged within the White House over which reforms could be implemented without making the health system’s two main problems-rising prices and a growing percentage of Americans lacking health insurance-worse. The new proposal, which the administration may or may not write into a formal legislative proposal, focuses on making it easier for those who currently have health insurance to keep it. A key feature is a six-month subsidy to help people who lose their jobs to keep their health coverage. Currently, those who leave a job are entitled to continue to buy insurance from their former employers for 18 months, but they must pay the full
many
:
:
Congress).
.
Californian doctors’
managed-care plan their loss of control over medical decision making in the fiercely com-
Piqued by
petitive capitation climate, California physicians are on the verge of founding their own statewide, physician-owned managed-care plan offering both health and preferred provider organisation type plans. Called California Advantage (CA), the plan is open to all 74 000 of the state’s physicians willing to invest$1000 by July 14 for the purchase
maintenance
share of stock and to pay a fee if California Medical Association members. The CMA developed the CA plan and made a loan of$500 000 but has no liability or responsibility for the : organisation, according to officials. CA is scheduled to be marketed in 1996 provided at least 3000 physicians sign up. In mid-June, CA officials said that 2000 physicians had qualified and "at least another 1000" had made verbal commitments. 500 of the signatories must be primary-care physicians. Announced in March, the plan has attracted "tremendous" response from employer groups and from labour and county employee coalitions, according to Dr Sidney Foster of San Francisco, CA’s vice-chairman. Plans call also for the future formation of a managed-care Workers’ Compensation Plan. Physicians and medical societies in about 12 other states, including New York of
one
they
are not
early
and Washington, are in varying stages of : forming similar plans, Foster said. Although it is a for-profit corporation, organisers say CA shares are not expected to make a profit. By setting a cap of 15% for administration costs and profit, they say they will be able to devote the maximum percentage of the premium dollar to providing health-care services. Physicians have been highly critical of many of the 35 existing HMOs in the state for paying top
Reform proposal for Food and Drug Administration
Members of Congress are still skirmishing over the US Food and Drug Administration, which they have targeted for an overhaul in the wake of persistent criticism by the pharmaceutical, biotechnology, and medical-device industries that the agency is too slow and cumbersome. The latest volley was fired on June 6 by officials excessive salaries while skimping on services and running roughshod over Representative Ron Wyden, a Democrat physicians and narrowing their control of from Oregon, who submitted legislation patient care. An example is the practice of that would privatise aspects of the some large HMOs to require physicians to agency’s functions, improve regulation of sign "gag" orders, which prevent them biotechnology products, and create an from criticising the plans. : even faster track for approval by allowing More than half of all Californians products for life-threatening disease to be already receive health care through marketed "conditionally" while the agency managed-care plans. This circumstance weighs evidence from ongoing trials for provides sceptics with reason for predicting final approval. The bill also proposes to tough times ahead for CA. They cite the soften FDA’s stance on dissemination of heavy start-up costs, difficulties in obtaining information on unapproved uses of pharenough primary-care physicians, and the maceuticals, by allowing drug makers to already heavy saturation of managed-care distribute peer-reviewed journal articles plans in some urban areas. : and other "scientifically valid" informa"In a business sense, I think it possibly tion, if such distribution has been cleared will succeed, but it’s not going to change first by the agency. the rules of the market and it won’t Wyden, known for being pro-consumer change anything for patients", said one and pro-FDA, is a surprising attacker. But with many Republicans calling for a critic, Dr John Ruark, a Berkeley gastroenterologist who is chairman of the dismantling of the agency, a Wyden California Physicians for National Health spokesman says that the congressman Reform. : "believes very deeply that unless proconsumer types like himself begin assertNelson Harry ing themselves, then we’ll lose some of the
1627
programs and institutions we feel are so critical to consumers and public health". : Wyden’s bill is a victory for the biotechnology industry, since it adopts many of its proposals. Chief among the industry’s complaints is that its products are regulat-
ed by two early-century laws that have not been updated. Biotechnology companies must establish manufacturing facilities well in advance of applying for product approval-a safeguard that is no longer necessary and is costly for undercapitalised biotechnology firms, say industry representatives. Carl Feldbaum, president of the Biotechnology Industry Organization in Washington, DC, says that if this aspect of the Wyden bill is approved-and he predicts Republican support for the elimination of the establishment licensing application (ELA)-it will be "a major : step forward for us". One Republican, Representative John Fox of Pennsylvania, has just introduced a bill that also incorporates some of BIO’s wish-list. There are likely to be more congressional hearings and more legislative proposals as Republicans and
"One-stop" clinics New Zealanders
cause
unease
New Zealand’s one-stop accident and medical centres are coming under attack for failing to provide adequate care. In a recent case, a doctor at the Westcare Accident and 24-Hour Medical Centre in Auckland prescribed indigestion treatment to a 65-year-old woman who a few hours later died at home of a heart attack. A cardiologist at Auckland’s main public heart unit said if the woman had been admitted to hospital, she probably would have survived, and an Auckland forensic pathologist, Dr Jane Vuletic, said she had seen up to ten cases in the past two years where people may have died unnecessarily after misdiagnoses at the centres. : Although new to the health-care system, the centres have quickly become part of the medical landscape, especially in the cities. The trend began with the establishment of private after-hours or accident and emergency centres. Most centres have since dropped the word "emergency" in their titles because they do not have facilities for emergency treatments and many do not have immediate access to radiology and laboratory reporting. Most have found it necessary to expand so that they can offer services during the day.
General-practitioner-owned
Independent
Practice Associations have set up some centres, while commercial interests have set up others. Most operate from shopfront premises with prominent signs and neon
:
lights.
A variety of concerns have been raised about the centres. Lack of continuity of
patient rienced
1628
care, poor
Democrats seek consensus on fixing the CONFERENCE FDA. Yet to weigh in is the Pharmaceutical ’, Research and Manufacturers of America, which is still preparing a proposal to take to Capitol Hill. Diabetic retinopathy is present at Feldbaum says he feels a momentum diagnosis in over one-third of patients building for overhaul, especially in the with type 2 diabetes, according to the regulation of biotechnology. Washington, DC-based food and drug attorney Bill results of the United Kingdom Vodra, of Arnold & Porter, agrees that Diabetes Study Prospective there will be streamlining in the biotechThese results were pre(UKPDS). nology area, but notes that the FDA tried sented at the American Diabetes to merge its two main drug-regulatory Association meeting in Atlanta, USA, arms, the Center for Drug Evaluation and on June 10-13. Research and the Center for Biologics The UKPDS recruited 5102 adults Evaluation and_ Research, in the early : with newly diagnosed type 2 diabetes, 1980s to no avail. Vodra says there is mean age 53, from 23 treatment cenagreement that the FDA’s regulation of of clinical research and manufacturtres across the country. Between early ing processes needs to be revamped, but 1978 and 1991, patients were ranthat there are no common solutions. He domly assigned to one of four stanthinks it could be another year or two dard treatment regimens: diet alone, before an FDA reform proposal is signed sulphonylurea, insulin, or metformin. into law.
Diabetes
Alicia Ault Barnett
serious diseases have been constantly cited as problems. Using the government as a funder and over-servicing are other accusations levelled at the centres. Although many New Zealanders pay for much of their primary health care, under the no-fault accident compensation scheme accident treatment is almost entirely paid for the by the government and this provides a ready source of revenue for accident centres. Dr Dean Williams, chairman of the Medical Practitioners Disciplinary Committee, recently said that the committee was alarmed at the number of cases it was seeing from the centres. The trend in many of the clinics, he said, was to
employ
young
record-keeping, inexpeSandra Coney a failure to diagnose
staff, and
graduates
or
overseas
doctors who were not sufficiently familiar with the New Zealand system. The chairman of a Wellington GPowned centre, said that "some were almost running as an immigration service for doctors from South Africa, bringing them in and giving them a job, paying them low wages and then letting them loose". Although the New Zealand Medical Association has developed protocols on the standards to be met by different levels of clinics, there is no compulsory accreditation system, and the public is largely oblivious to the levels of care on offer. The medical director of one group of accident and medical centres, owned by a health-insurance company, said that "you can have a box of Elastoplast, a stethoscope and a medical qualification and stick up a sign which says accident and emergency clinic".
update
Clinical and ophthalmic assessments were made at entry and at threeyearly intervals. From 1982, retinal colour photographs were taken. of retinopathy with Prevalence microaneurysms in at least one eye was: at diagnosis 37%, at three years 46%, at six years 54%, and at nine years 60%. In a cohort of 1630 patients, the prevalence of moderate retinopathy increased from 9% at diagnosis to 20% at six years; 6% were photo-coagulated by six years. The incidence of photocoagulation within the trial period depended on the severity of retinopathy at diagnosis ; it was 2% in those without retinopathy, 8% in those with minimal retinopathy, and 45% in those with moderate or severe retinopathy. Prof Eva Kohner (Royal Postgraduate Medical School, London, UK) said in summary that if any significant retinopathy is found in patients at diagnosis of diabetes, nearly half will develop vision-threatening problems and require photocoagulation therapy in less than a decade. David Matthews, clinical director of the Oxford Diabetes Centre, UK, and consultant physician, emphasised that one microaneurysm heralded diabetic retinopathy and the need for annual or six-monthly follow-up.
even
Night-time hypoglycaemia A study of 167 patients with type 1 diabetes shows that the short-acting analogue of human insulin, insulin lispro, decreases the number of hypoglycaemic episodes at night compared with human soluble insulin.
new
go bankrupt in 2002-by an additional three years. Democrats on Capitol Hill were furious costs themselves, which often makes the with this aspect of the plan, noting that : recent attacks on Republican efforts to proposition unaffordable. A second set of proposals are the curb the growth of the massive health pro"consensus" items common to both the grammes had been boosting Democrats’ original Clinton health plan and own popularity. "Opening the door to Republican bills. These include banning deep Medicare cuts while the Republicans insurance companies from denying are struggling to pay for their huge tax coverage (or raising premiums once a breaks threatens to make Medicare a person is covered) based on pre-existing political football", complained House medical conditions; creating purchasing Minority Leader Richard Gephardt pools to help individuals and small (Democrat, Missouri). businesses obtain more favourable insur: While health-care providers are already ance rates; and increasing the healthcrying foul over being asked to shoulder insurance tax-deduction for self-employed the entire burden of the cuts, the adminispeople (currently 30%: the new proposal tration is hoping to buy-off Medicare would raise it to 50%). : beneficiaries (and the powerful groups By far the most controversial aspect of that represent them in Washington), not the plan is the administration’s offer to only by promising not to raise their costs, reduce Medicare spending by US$124 : but also by offering them more than$13 billion over the next seven years and to billion worth of new benefits. Among cut Medicaid by$54 billion over the same these are a new programme to provide period (about 40% of the amount prohome and community-based long-term posed by Republicans in care; a "respite" benefit for families who Administration officials emphasised that care for patients with Alzheimer’s disease; the cuts would affect only doctors, hospiand a waiver on the co-pay requirements tals, and other health-care providers, for women receiving mammograms, while not harming recipients of the prowhich essentially makes them free. grammes. They also noted that the cuts would extend the solvency of Medicare’s hospital trust fund-currently scheduled Julie Rovner
US health-reform bill
to .
Nine months after his massive health overhaul went down to ignominious defeat in Congress, President Clinton last week unveiled a new, much more modest health-reform bill-including some controversial cuts in Medicare and Medicaid, the two main federal health programmes. Even before Republicans captured the Congress last autumn, the President and his advisers had acknowledged that they had tried to do too much at once, and would instead propose reforms of the "incremental" variety. But debate had raged within the White House over which reforms could be implemented without making the health system’s two main problems-rising prices and a growing percentage of Americans lacking health insurance-worse. The new proposal, which the administration may or may not write into a formal legislative proposal, focuses on making it easier for those who currently have health insurance to keep it. A key feature is a six-month subsidy to help people who lose their jobs to keep their health coverage. Currently, those who leave a job are entitled to continue to buy insurance from their former employers for 18 months, but they must pay the full
many
:
:
Congress).
.
Californian doctors’
managed-care plan their loss of control over medical decision making in the fiercely com-
Piqued by
petitive capitation climate, California physicians are on the verge of founding their own statewide, physician-owned managed-care plan offering both health and preferred provider organisation type plans. Called California Advantage (CA), the plan is open to all 74 000 of the state’s physicians willing to invest$1000 by July 14 for the purchase
maintenance
share of stock and to pay a fee if California Medical Association members. The CMA developed the CA plan and made a loan of$500 000 but has no liability or responsibility for the : organisation, according to officials. CA is scheduled to be marketed in 1996 provided at least 3000 physicians sign up. In mid-June, CA officials said that 2000 physicians had qualified and "at least another 1000" had made verbal commitments. 500 of the signatories must be primary-care physicians. Announced in March, the plan has attracted "tremendous" response from employer groups and from labour and county employee coalitions, according to Dr Sidney Foster of San Francisco, CA’s vice-chairman. Plans call also for the future formation of a managed-care Workers’ Compensation Plan. Physicians and medical societies in about 12 other states, including New York of
one
they
are not
early
and Washington, are in varying stages of : forming similar plans, Foster said. Although it is a for-profit corporation, organisers say CA shares are not expected to make a profit. By setting a cap of 15% for administration costs and profit, they say they will be able to devote the maximum percentage of the premium dollar to providing health-care services. Physicians have been highly critical of many of the 35 existing HMOs in the state for paying top
Reform proposal for Food and Drug Administration
Members of Congress are still skirmishing over the US Food and Drug Administration, which they have targeted for an overhaul in the wake of persistent criticism by the pharmaceutical, biotechnology, and medical-device industries that the agency is too slow and cumbersome. The latest volley was fired on June 6 by officials excessive salaries while skimping on services and running roughshod over Representative Ron Wyden, a Democrat physicians and narrowing their control of from Oregon, who submitted legislation patient care. An example is the practice of that would privatise aspects of the some large HMOs to require physicians to agency’s functions, improve regulation of sign "gag" orders, which prevent them biotechnology products, and create an from criticising the plans. : even faster track for approval by allowing More than half of all Californians products for life-threatening disease to be already receive health care through marketed "conditionally" while the agency managed-care plans. This circumstance weighs evidence from ongoing trials for provides sceptics with reason for predicting final approval. The bill also proposes to tough times ahead for CA. They cite the soften FDA’s stance on dissemination of heavy start-up costs, difficulties in obtaining information on unapproved uses of pharenough primary-care physicians, and the maceuticals, by allowing drug makers to already heavy saturation of managed-care distribute peer-reviewed journal articles plans in some urban areas. : and other "scientifically valid" informa"In a business sense, I think it possibly tion, if such distribution has been cleared will succeed, but it’s not going to change first by the agency. the rules of the market and it won’t Wyden, known for being pro-consumer change anything for patients", said one and pro-FDA, is a surprising attacker. But with many Republicans calling for a critic, Dr John Ruark, a Berkeley gastroenterologist who is chairman of the dismantling of the agency, a Wyden California Physicians for National Health spokesman says that the congressman Reform. : "believes very deeply that unless proconsumer types like himself begin assertNelson Harry ing themselves, then we’ll lose some of the
1627
programs and institutions we feel are so critical to consumers and public health". : Wyden’s bill is a victory for the biotechnology industry, since it adopts many of its proposals. Chief among the industry’s complaints is that its products are regulat-
ed by two early-century laws that have not been updated. Biotechnology companies must establish manufacturing facilities well in advance of applying for product approval-a safeguard that is no longer necessary and is costly for undercapitalised biotechnology firms, say industry representatives. Carl Feldbaum, president of the Biotechnology Industry Organization in Washington, DC, says that if this aspect of the Wyden bill is approved-and he predicts Republican support for the elimination of the establishment licensing application (ELA)-it will be "a major : step forward for us". One Republican, Representative John Fox of Pennsylvania, has just introduced a bill that also incorporates some of BIO’s wish-list. There are likely to be more congressional hearings and more legislative proposals as Republicans and
"One-stop" clinics New Zealanders
cause
unease
New Zealand’s one-stop accident and medical centres are coming under attack for failing to provide adequate care. In a recent case, a doctor at the Westcare Accident and 24-Hour Medical Centre in Auckland prescribed indigestion treatment to a 65-year-old woman who a few hours later died at home of a heart attack. A cardiologist at Auckland’s main public heart unit said if the woman had been admitted to hospital, she probably would have survived, and an Auckland forensic pathologist, Dr Jane Vuletic, said she had seen up to ten cases in the past two years where people may have died unnecessarily after misdiagnoses at the centres. : Although new to the health-care system, the centres have quickly become part of the medical landscape, especially in the cities. The trend began with the establishment of private after-hours or accident and emergency centres. Most centres have since dropped the word "emergency" in their titles because they do not have facilities for emergency treatments and many do not have immediate access to radiology and laboratory reporting. Most have found it necessary to expand so that they can offer services during the day.
General-practitioner-owned
Independent
Practice Associations have set up some centres, while commercial interests have set up others. Most operate from shopfront premises with prominent signs and neon
:
lights.
A variety of concerns have been raised about the centres. Lack of continuity of
patient rienced
1628
care, poor
Democrats seek consensus on fixing the CONFERENCE FDA. Yet to weigh in is the Pharmaceutical ’, Research and Manufacturers of America, which is still preparing a proposal to take to Capitol Hill. Diabetic retinopathy is present at Feldbaum says he feels a momentum diagnosis in over one-third of patients building for overhaul, especially in the with type 2 diabetes, according to the regulation of biotechnology. Washington, DC-based food and drug attorney Bill results of the United Kingdom Vodra, of Arnold & Porter, agrees that Diabetes Study Prospective there will be streamlining in the biotechThese results were pre(UKPDS). nology area, but notes that the FDA tried sented at the American Diabetes to merge its two main drug-regulatory Association meeting in Atlanta, USA, arms, the Center for Drug Evaluation and on June 10-13. Research and the Center for Biologics The UKPDS recruited 5102 adults Evaluation and_ Research, in the early : with newly diagnosed type 2 diabetes, 1980s to no avail. Vodra says there is mean age 53, from 23 treatment cenagreement that the FDA’s regulation of of clinical research and manufacturtres across the country. Between early ing processes needs to be revamped, but 1978 and 1991, patients were ranthat there are no common solutions. He domly assigned to one of four stanthinks it could be another year or two dard treatment regimens: diet alone, before an FDA reform proposal is signed sulphonylurea, insulin, or metformin. into law.
Diabetes
Alicia Ault Barnett
serious diseases have been constantly cited as problems. Using the government as a funder and over-servicing are other accusations levelled at the centres. Although many New Zealanders pay for much of their primary health care, under the no-fault accident compensation scheme accident treatment is almost entirely paid for the by the government and this provides a ready source of revenue for accident centres. Dr Dean Williams, chairman of the Medical Practitioners Disciplinary Committee, recently said that the committee was alarmed at the number of cases it was seeing from the centres. The trend in many of the clinics, he said, was to
employ
young
record-keeping, inexpeSandra Coney a failure to diagnose
staff, and
graduates
or
overseas
doctors who were not sufficiently familiar with the New Zealand system. The chairman of a Wellington GPowned centre, said that "some were almost running as an immigration service for doctors from South Africa, bringing them in and giving them a job, paying them low wages and then letting them loose". Although the New Zealand Medical Association has developed protocols on the standards to be met by different levels of clinics, there is no compulsory accreditation system, and the public is largely oblivious to the levels of care on offer. The medical director of one group of accident and medical centres, owned by a health-insurance company, said that "you can have a box of Elastoplast, a stethoscope and a medical qualification and stick up a sign which says accident and emergency clinic".
update
Clinical and ophthalmic assessments were made at entry and at threeyearly intervals. From 1982, retinal colour photographs were taken. of retinopathy with Prevalence microaneurysms in at least one eye was: at diagnosis 37%, at three years 46%, at six years 54%, and at nine years 60%. In a cohort of 1630 patients, the prevalence of moderate retinopathy increased from 9% at diagnosis to 20% at six years; 6% were photo-coagulated by six years. The incidence of photocoagulation within the trial period depended on the severity of retinopathy at diagnosis ; it was 2% in those without retinopathy, 8% in those with minimal retinopathy, and 45% in those with moderate or severe retinopathy. Prof Eva Kohner (Royal Postgraduate Medical School, London, UK) said in summary that if any significant retinopathy is found in patients at diagnosis of diabetes, nearly half will develop vision-threatening problems and require photocoagulation therapy in less than a decade. David Matthews, clinical director of the Oxford Diabetes Centre, UK, and consultant physician, emphasised that one microaneurysm heralded diabetic retinopathy and the need for annual or six-monthly follow-up.
even
Night-time hypoglycaemia A study of 167 patients with type 1 diabetes shows that the short-acting analogue of human insulin, insulin lispro, decreases the number of hypoglycaemic episodes at night compared with human soluble insulin.