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Home test kit for HIV?
Americans
overseas
Education and research in therapeutics in USA
seek coverage
The 4-5 million Americans living abroad are making a bid to opt into the revolutionary health-care changes being planned for the USA. Whether they will have any entitlement to health-care coverage is currently being debated in the US Congress, although the requirement to pay American income taxes is continuing without question. Leaders of the non-partisan umbrella organisation, FLAAG (Federal League of Americans Around the Globe), think that they can help ensure eligibility; and chance has presented them with a scenario that just may make that wish come true. It is the coincidental juxtaposition of the sweeping health-care proposals in debate, with the re-election bid of key player New York Senator Daniel Patrick Moynihan as chairman of the Senate Finance Committee, and the unusually high number of his constituents, some 23 000 living in Israel (about 50% of his overseas voter base), who can be mobilised into a full-blown lobbying and : voting effort in support of this issue. The Senate Finance Committee is debating an amendment introduced by SenPaul Simon (Illinois) enabling ator Americans living outside of the US to buy into the new health plan on a voluntary basis if they agree to cover 100% payments out of pocket. Says Peter Alegi, cochairman of FLAAG and chairman of Democrats Abroad: "it is crucial that as many Americans living abroad as possible lobby their elected representative to include the Simon amendment in the legislation coming out of the four key Congressional committees" (Senate Finance Committee; Senate Education Human Resources Committee; House Ways and Means; House Commerce and Energy . Committee). If that indeed happens, it is likely that the amendment will stay in the final version of the bill, says Alegi. : This is an election year (Nov 8) for the entire House "which could be put to our advantage", says David Froehlich, secretary of Democrats Abroad-Israel, but in fact "outside of a single district in Brook-
pivotal election is for New York Senator Moynihan. Unquestionably, this is one There is a growing movement in the USA time when the (former) New York Jewish for the creation of federally funded regionvoters can be pointed to as having a al centres for education and research in potentially definitive role in shaping therapeutics (CERTs) to address two national government policy. 40% of the issues-that inadequate education and 70 000 Americans living in Israel are New of medical students and doctors Yorkers. 40% are also retirees, over 65, training in clinical pharmacology is an important with a special interest in Medicare. : factor leading to suboptimum prescribing Now is the critical time to act. If no sinand that research sponsored by gle bill is agreed upon in the House and in practices, the pharmaceutical industry does not necthe Senate and then between houses . address many important clinical before the US Congress adjourns on Oct essarily and policy questions. The three primary 7, there will be no health-care bill to pre-
functions for CERT are to establish and the Executive Branch for approval communicate to physicians therapeutic before 1995 (see Lancet May 26, p that are consistent with safe and and the overseas residents will not have principles cost-effective therapy; to conduct the : essential any package to opt into. post-marketing research on drugs For retirees, the key issue is again eligiand therapies to better predict and define bility. Many of these overseas Americans and adverse drug reactions had been in the American workforce and therapeutic in vulnerable popula(ARDs) especially paid into the social security system (part and to conduct research that would tions ; of which covers Medicare) for the better expedite the translation of cellular and part of their lives. But in 1980, when molecular discoveries into economically Congress passed the original Medicare and broadly available therabill, the eligibility of overseas Americans responsible Pharmacol Ther 1994; 55: (Clin pies was sacrificed to get a compromise Med: 249-55). icaid bill on the President’s desk. Hence : Specific areas identified for research by retirees living abroad with a Medicaid include comparisons of therapy CERTs : card valid anywhere within the states have a new drug is better or safer than : (whether yet to be granted coverage for their overthe available alternatives, under what cirseas medical services. FLAAG responds it should be prescribed); cumstances : to the argument that the "administrative mechanism and prediction of adverse obstacles" of verifying the necessity and new methods for testing reactions; drug : quality of medical services are "insurmountable" by citing the comprehensive: generic drugs; new clinical applications for generic or orphan drugs; dosage deterBlue Cross/Blue Shield, which has providmination and safety evaluation for ed Americans abroad with private healthcare insurance coverage since 1981 women, children, and the elderly; pharmacoepidemiological studies to detect "without a hitch". All Americans are con cerned about plans to scrap the whole rare but serious ADRs; cost-benefit analysocial security system within 5 years.: sis. Information from research would be "Nobody knows what will replace it": used to create therapeutic recommendations that would then be disseminated to except that local offices will run and distribute the fund state by state says physicians in a structured and sustained Froehlich. If not enfranchised now, when programme that can effectively modify there is an item before Congress, it is prescribing practice. The intention is that not depend on drug unlikely that these retirees will ever physicians should as their primary source of : companies muster the political clout to get into the : information. system in the future. "We’re just asking : The proposal for CERT has been for what we paid for" says Froehlich. lyn [New York], many congresional repreendorsed by the 38-strong Consortium of sentatives have only a handful of voters at Clinical Pharmacology Training Directors : most within their districts who are living Last week the United States (CCPTD). : abroad and so they forget about us". The Rachelle H B Fishman : Pharmacopeia sponsored a meeting of paper is then sent to a specially licensed: CCPTD in the Washington, DC, area to Home test kit for HIV? laboratory. A few days later, the user calls: discuss how to encourage the creation of A US Food and Drug Administration a toll-free number and anonymously gives CERTs and to initiate pilot projects that (FDA) advisory panel has recommended the identification number. Callers whose will demonstrate the feasibility and value that the agency approve the marketing of test is negative will receive a recorded: of CERTs. The proposal, which will require legislahome test kits for HIV infection. One kit, message. Those whose test is positive will: tion to be funded, is of interest to the said to be closest to FDA approval, has have their calls forwarded to trained operators who will counsel the callers, giving National Institute of General Medical been developed by Direct Access Diagnostics, a unit of Johnson & Johnson. If them information about medical care and: Sciences and the Food and Drug Adminapproved, the kit, called Confide, will be providing referrals to HIV support services. :: istration, which sponsor 14 clinical pharAIDS activists groups have been dividsold through drugstores for about US$30. :: macology training programmes in the ed over the tests.: To test HIV status, the user puts a few USA. drops of blood on a sample paper marked with a unique identification number. The Michael McCarthy Syed Rizwannudin Ahmad
50
sent to
1349)
overseas
Education and research in therapeutics in USA
seek coverage
The 4-5 million Americans living abroad are making a bid to opt into the revolutionary health-care changes being planned for the USA. Whether they will have any entitlement to health-care coverage is currently being debated in the US Congress, although the requirement to pay American income taxes is continuing without question. Leaders of the non-partisan umbrella organisation, FLAAG (Federal League of Americans Around the Globe), think that they can help ensure eligibility; and chance has presented them with a scenario that just may make that wish come true. It is the coincidental juxtaposition of the sweeping health-care proposals in debate, with the re-election bid of key player New York Senator Daniel Patrick Moynihan as chairman of the Senate Finance Committee, and the unusually high number of his constituents, some 23 000 living in Israel (about 50% of his overseas voter base), who can be mobilised into a full-blown lobbying and : voting effort in support of this issue. The Senate Finance Committee is debating an amendment introduced by SenPaul Simon (Illinois) enabling ator Americans living outside of the US to buy into the new health plan on a voluntary basis if they agree to cover 100% payments out of pocket. Says Peter Alegi, cochairman of FLAAG and chairman of Democrats Abroad: "it is crucial that as many Americans living abroad as possible lobby their elected representative to include the Simon amendment in the legislation coming out of the four key Congressional committees" (Senate Finance Committee; Senate Education Human Resources Committee; House Ways and Means; House Commerce and Energy . Committee). If that indeed happens, it is likely that the amendment will stay in the final version of the bill, says Alegi. : This is an election year (Nov 8) for the entire House "which could be put to our advantage", says David Froehlich, secretary of Democrats Abroad-Israel, but in fact "outside of a single district in Brook-
pivotal election is for New York Senator Moynihan. Unquestionably, this is one There is a growing movement in the USA time when the (former) New York Jewish for the creation of federally funded regionvoters can be pointed to as having a al centres for education and research in potentially definitive role in shaping therapeutics (CERTs) to address two national government policy. 40% of the issues-that inadequate education and 70 000 Americans living in Israel are New of medical students and doctors Yorkers. 40% are also retirees, over 65, training in clinical pharmacology is an important with a special interest in Medicare. : factor leading to suboptimum prescribing Now is the critical time to act. If no sinand that research sponsored by gle bill is agreed upon in the House and in practices, the pharmaceutical industry does not necthe Senate and then between houses . address many important clinical before the US Congress adjourns on Oct essarily and policy questions. The three primary 7, there will be no health-care bill to pre-
functions for CERT are to establish and the Executive Branch for approval communicate to physicians therapeutic before 1995 (see Lancet May 26, p that are consistent with safe and and the overseas residents will not have principles cost-effective therapy; to conduct the : essential any package to opt into. post-marketing research on drugs For retirees, the key issue is again eligiand therapies to better predict and define bility. Many of these overseas Americans and adverse drug reactions had been in the American workforce and therapeutic in vulnerable popula(ARDs) especially paid into the social security system (part and to conduct research that would tions ; of which covers Medicare) for the better expedite the translation of cellular and part of their lives. But in 1980, when molecular discoveries into economically Congress passed the original Medicare and broadly available therabill, the eligibility of overseas Americans responsible Pharmacol Ther 1994; 55: (Clin pies was sacrificed to get a compromise Med: 249-55). icaid bill on the President’s desk. Hence : Specific areas identified for research by retirees living abroad with a Medicaid include comparisons of therapy CERTs : card valid anywhere within the states have a new drug is better or safer than : (whether yet to be granted coverage for their overthe available alternatives, under what cirseas medical services. FLAAG responds it should be prescribed); cumstances : to the argument that the "administrative mechanism and prediction of adverse obstacles" of verifying the necessity and new methods for testing reactions; drug : quality of medical services are "insurmountable" by citing the comprehensive: generic drugs; new clinical applications for generic or orphan drugs; dosage deterBlue Cross/Blue Shield, which has providmination and safety evaluation for ed Americans abroad with private healthcare insurance coverage since 1981 women, children, and the elderly; pharmacoepidemiological studies to detect "without a hitch". All Americans are con cerned about plans to scrap the whole rare but serious ADRs; cost-benefit analysocial security system within 5 years.: sis. Information from research would be "Nobody knows what will replace it": used to create therapeutic recommendations that would then be disseminated to except that local offices will run and distribute the fund state by state says physicians in a structured and sustained Froehlich. If not enfranchised now, when programme that can effectively modify there is an item before Congress, it is prescribing practice. The intention is that not depend on drug unlikely that these retirees will ever physicians should as their primary source of : companies muster the political clout to get into the : information. system in the future. "We’re just asking : The proposal for CERT has been for what we paid for" says Froehlich. lyn [New York], many congresional repreendorsed by the 38-strong Consortium of sentatives have only a handful of voters at Clinical Pharmacology Training Directors : most within their districts who are living Last week the United States (CCPTD). : abroad and so they forget about us". The Rachelle H B Fishman : Pharmacopeia sponsored a meeting of paper is then sent to a specially licensed: CCPTD in the Washington, DC, area to Home test kit for HIV? laboratory. A few days later, the user calls: discuss how to encourage the creation of A US Food and Drug Administration a toll-free number and anonymously gives CERTs and to initiate pilot projects that (FDA) advisory panel has recommended the identification number. Callers whose will demonstrate the feasibility and value that the agency approve the marketing of test is negative will receive a recorded: of CERTs. The proposal, which will require legislahome test kits for HIV infection. One kit, message. Those whose test is positive will: tion to be funded, is of interest to the said to be closest to FDA approval, has have their calls forwarded to trained operators who will counsel the callers, giving National Institute of General Medical been developed by Direct Access Diagnostics, a unit of Johnson & Johnson. If them information about medical care and: Sciences and the Food and Drug Adminapproved, the kit, called Confide, will be providing referrals to HIV support services. :: istration, which sponsor 14 clinical pharAIDS activists groups have been dividsold through drugstores for about US$30. :: macology training programmes in the ed over the tests.: To test HIV status, the user puts a few USA. drops of blood on a sample paper marked with a unique identification number. The Michael McCarthy Syed Rizwannudin Ahmad
50
sent to
1349)