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Work-Based Coverage Cuts Take Toll
The number of uninsured Americans rose by nearly 9 million, from 38 million in 2000 to 47 million in 2006, mostly as a result of a decline in employer-provided health coverage for workers and their families, according to an analysis by the Economic Policy Institute. Although the affected workers were more likely to be young, low paid, less educated, and other than white, no category was excluded; full-time, college-educated, highly paid workers also lost coverage. In addition, the effects trickled down to children, for whom work-based coverage dipped from 66% in 2000 to 57% in 2006. The report noted that programs such as Medicaid and the State Children's Health Insurance Program are “no longer effective at offsetting these losses.” In comparing the 2000–2001 and 2005–2006 periods, the authors said that 38 states had significant losses in coverage, and no state had an increase in the rate.
Patent Losses Choke Drug Sales
The growth of pharmaceutical sales in the United States is expected to increase by 4%–5% next year, reaching an historic low, according to a report by IMS Health Inc. The Norwalk, Conn.-based research firm attributed the slowdown to a leveling of the growth triggered by the Medicare Part D program, closer monitoring of drug safety, payers' desire to contain costs, and the expiration of certain patents and the associated increase in generic use. The report said that drugs—including some lipid regulators and osteoporosis therapies—with global annual sales of about $20 billion face patent expiration next year, which could spur the growth of generic sales by 14%–15%, to more than $70 billion. The global pharmaceuticals market is expected to grow by about 5%–6% next year, which is slightly more slowly than this year's 6%–7%, according to the report.
Data on Elderly Glossed Over
Food and Drug Administration regulations for drug makers conducting clinical trials encourage the inclusion of elderly participants and the reporting of data by age, but the agency is not effective in getting its medical officers to include data on elderly patients in their new drug application (NDA) reviews, according to a report by the Government Accountability Office. The report, requested by Rep. Henry Waxman (D-Calif.) and Sen. Ted Kennedy (D-Mass.), was based on a review of 36 NDAs submitted by manufacturers from January 2001 to June 2004 for drugs to treat diseases that could affect patients aged 65 years and older. All of the NDAs had at least one trial that included elderly participants, but a third of the agency's NDA reviews had no documentation on safety or efficacy for that age group. In addition, the GAO noted that reviewers are not required to establish whether there was a sufficient number of elderly participants in a trial, and if they do address sufficiency, they do not have to document their methods. Sufficiency was addressed in about a quarter of the reviews, none of which detailed the methods used, the report found.
Depression No. 2 in Disability Days
Major depression accounts for the second-largest number of days lost to disability in the United States—387 million days a year at the population level, second only to back and neck pain, at 1.2 billion days—according to a study by Harvard University and National Institute of Mental Health researchers. The study was published in the October 2007 issue of the Archives of General Psychiatry. The researchers analyzed data from the National Comorbidity Survey Replication, a nationwide survey of 9,282 adults. Half of the population reported one or more physical or mental conditions that kept them from fully functioning. Individuals averaged 32 days of disability a year. Disability was lowest in students (17.9 individual days), and highest in the unemployed and disabled (121.4 days). The authors said their results echo other study data suggesting that “individual-level effects of mental conditions are as large as those of most chronic physical conditions.”
Bill Aims to Boost OTC Oversight
Another bill introduced by Rep. Waxman and Sen. Kennedy, along with Rep. Tom Allen (D-Maine), would give the FDA the authority to quickly amend or appeal over-the-counter drug monographs without being required to pursue notice and comment rulemaking, as required under the Administrative Procedures Act. The bill would allow the agency “to act quickly to protect consumers from unsafe or ineffective OTC drugs,” they said in a joint statement. It also would give the FDA authority over OTC drug advertising, which is currently under the purview of the Federal Trade Commission, and would require the FDA to solicit public comment on proposed changes and to file a report to Congress on any findings.
MRSA Mortality Reaches 5%
Almost 5% of all patients hospitalized in 2004 with a methicillin-resistant Staphylococcus aureus (MRSA) infection died, according to a statistical brief by the Agency for Healthcare Research and Quality. Hospital stays for patients with a MRSA infection were both longer (10 days vs. 5 days) and more expensive ($14,000 vs. $7,600) than stays for patients with other conditions. The number of hospital stays for MRSA increased from 1,900 in 1993 to 368,600 in 2005, and more commonly occurred in Medicare patients and those aged 65 years and older. Males and people in the South were also more likely to be hospitalized for MRSA treatment.
Work-Based Coverage Cuts Take Toll
The number of uninsured Americans rose by nearly 9 million, from 38 million in 2000 to 47 million in 2006, mostly as a result of a decline in employer-provided health coverage for workers and their families, according to an analysis by the Economic Policy Institute. Although the affected workers were more likely to be young, low paid, less educated, and other than white, no category was excluded; full-time, college-educated, highly paid workers also lost coverage. In addition, the effects trickled down to children, for whom work-based coverage dipped from 66% in 2000 to 57% in 2006. The report noted that programs such as Medicaid and the State Children's Health Insurance Program are “no longer effective at offsetting these losses.” In comparing the 2000–2001 and 2005–2006 periods, the authors said that 38 states had significant losses in coverage, and no state had an increase in the rate.
Patent Losses Choke Drug Sales
The growth of pharmaceutical sales in the United States is expected to increase by 4%–5% next year, reaching an historic low, according to a report by IMS Health Inc. The Norwalk, Conn.-based research firm attributed the slowdown to a leveling of the growth triggered by the Medicare Part D program, closer monitoring of drug safety, payers' desire to contain costs, and the expiration of certain patents and the associated increase in generic use. The report said that drugs—including some lipid regulators and osteoporosis therapies—with global annual sales of about $20 billion face patent expiration next year, which could spur the growth of generic sales by 14%–15%, to more than $70 billion. The global pharmaceuticals market is expected to grow by about 5%–6% next year, which is slightly more slowly than this year's 6%–7%, according to the report.
Data on Elderly Glossed Over
Food and Drug Administration regulations for drug makers conducting clinical trials encourage the inclusion of elderly participants and the reporting of data by age, but the agency is not effective in getting its medical officers to include data on elderly patients in their new drug application (NDA) reviews, according to a report by the Government Accountability Office. The report, requested by Rep. Henry Waxman (D-Calif.) and Sen. Ted Kennedy (D-Mass.), was based on a review of 36 NDAs submitted by manufacturers from January 2001 to June 2004 for drugs to treat diseases that could affect patients aged 65 years and older. All of the NDAs had at least one trial that included elderly participants, but a third of the agency's NDA reviews had no documentation on safety or efficacy for that age group. In addition, the GAO noted that reviewers are not required to establish whether there was a sufficient number of elderly participants in a trial, and if they do address sufficiency, they do not have to document their methods. Sufficiency was addressed in about a quarter of the reviews, none of which detailed the methods used, the report found.
Depression No. 2 in Disability Days
Major depression accounts for the second-largest number of days lost to disability in the United States—387 million days a year at the population level, second only to back and neck pain, at 1.2 billion days—according to a study by Harvard University and National Institute of Mental Health researchers. The study was published in the October 2007 issue of the Archives of General Psychiatry. The researchers analyzed data from the National Comorbidity Survey Replication, a nationwide survey of 9,282 adults. Half of the population reported one or more physical or mental conditions that kept them from fully functioning. Individuals averaged 32 days of disability a year. Disability was lowest in students (17.9 individual days), and highest in the unemployed and disabled (121.4 days). The authors said their results echo other study data suggesting that “individual-level effects of mental conditions are as large as those of most chronic physical conditions.”
Bill Aims to Boost OTC Oversight
Another bill introduced by Rep. Waxman and Sen. Kennedy, along with Rep. Tom Allen (D-Maine), would give the FDA the authority to quickly amend or appeal over-the-counter drug monographs without being required to pursue notice and comment rulemaking, as required under the Administrative Procedures Act. The bill would allow the agency “to act quickly to protect consumers from unsafe or ineffective OTC drugs,” they said in a joint statement. It also would give the FDA authority over OTC drug advertising, which is currently under the purview of the Federal Trade Commission, and would require the FDA to solicit public comment on proposed changes and to file a report to Congress on any findings.
MRSA Mortality Reaches 5%
Almost 5% of all patients hospitalized in 2004 with a methicillin-resistant Staphylococcus aureus (MRSA) infection died, according to a statistical brief by the Agency for Healthcare Research and Quality. Hospital stays for patients with a MRSA infection were both longer (10 days vs. 5 days) and more expensive ($14,000 vs. $7,600) than stays for patients with other conditions. The number of hospital stays for MRSA increased from 1,900 in 1993 to 368,600 in 2005, and more commonly occurred in Medicare patients and those aged 65 years and older. Males and people in the South were also more likely to be hospitalized for MRSA treatment.
Work-Based Coverage Cuts Take Toll
The number of uninsured Americans rose by nearly 9 million, from 38 million in 2000 to 47 million in 2006, mostly as a result of a decline in employer-provided health coverage for workers and their families, according to an analysis by the Economic Policy Institute. Although the affected workers were more likely to be young, low paid, less educated, and other than white, no category was excluded; full-time, college-educated, highly paid workers also lost coverage. In addition, the effects trickled down to children, for whom work-based coverage dipped from 66% in 2000 to 57% in 2006. The report noted that programs such as Medicaid and the State Children's Health Insurance Program are “no longer effective at offsetting these losses.” In comparing the 2000–2001 and 2005–2006 periods, the authors said that 38 states had significant losses in coverage, and no state had an increase in the rate.
Patent Losses Choke Drug Sales
The growth of pharmaceutical sales in the United States is expected to increase by 4%–5% next year, reaching an historic low, according to a report by IMS Health Inc. The Norwalk, Conn.-based research firm attributed the slowdown to a leveling of the growth triggered by the Medicare Part D program, closer monitoring of drug safety, payers' desire to contain costs, and the expiration of certain patents and the associated increase in generic use. The report said that drugs—including some lipid regulators and osteoporosis therapies—with global annual sales of about $20 billion face patent expiration next year, which could spur the growth of generic sales by 14%–15%, to more than $70 billion. The global pharmaceuticals market is expected to grow by about 5%–6% next year, which is slightly more slowly than this year's 6%–7%, according to the report.
Data on Elderly Glossed Over
Food and Drug Administration regulations for drug makers conducting clinical trials encourage the inclusion of elderly participants and the reporting of data by age, but the agency is not effective in getting its medical officers to include data on elderly patients in their new drug application (NDA) reviews, according to a report by the Government Accountability Office. The report, requested by Rep. Henry Waxman (D-Calif.) and Sen. Ted Kennedy (D-Mass.), was based on a review of 36 NDAs submitted by manufacturers from January 2001 to June 2004 for drugs to treat diseases that could affect patients aged 65 years and older. All of the NDAs had at least one trial that included elderly participants, but a third of the agency's NDA reviews had no documentation on safety or efficacy for that age group. In addition, the GAO noted that reviewers are not required to establish whether there was a sufficient number of elderly participants in a trial, and if they do address sufficiency, they do not have to document their methods. Sufficiency was addressed in about a quarter of the reviews, none of which detailed the methods used, the report found.
Depression No. 2 in Disability Days
Major depression accounts for the second-largest number of days lost to disability in the United States—387 million days a year at the population level, second only to back and neck pain, at 1.2 billion days—according to a study by Harvard University and National Institute of Mental Health researchers. The study was published in the October 2007 issue of the Archives of General Psychiatry. The researchers analyzed data from the National Comorbidity Survey Replication, a nationwide survey of 9,282 adults. Half of the population reported one or more physical or mental conditions that kept them from fully functioning. Individuals averaged 32 days of disability a year. Disability was lowest in students (17.9 individual days), and highest in the unemployed and disabled (121.4 days). The authors said their results echo other study data suggesting that “individual-level effects of mental conditions are as large as those of most chronic physical conditions.”
Bill Aims to Boost OTC Oversight
Another bill introduced by Rep. Waxman and Sen. Kennedy, along with Rep. Tom Allen (D-Maine), would give the FDA the authority to quickly amend or appeal over-the-counter drug monographs without being required to pursue notice and comment rulemaking, as required under the Administrative Procedures Act. The bill would allow the agency “to act quickly to protect consumers from unsafe or ineffective OTC drugs,” they said in a joint statement. It also would give the FDA authority over OTC drug advertising, which is currently under the purview of the Federal Trade Commission, and would require the FDA to solicit public comment on proposed changes and to file a report to Congress on any findings.
MRSA Mortality Reaches 5%
Almost 5% of all patients hospitalized in 2004 with a methicillin-resistant Staphylococcus aureus (MRSA) infection died, according to a statistical brief by the Agency for Healthcare Research and Quality. Hospital stays for patients with a MRSA infection were both longer (10 days vs. 5 days) and more expensive ($14,000 vs. $7,600) than stays for patients with other conditions. The number of hospital stays for MRSA increased from 1,900 in 1993 to 368,600 in 2005, and more commonly occurred in Medicare patients and those aged 65 years and older. Males and people in the South were also more likely to be hospitalized for MRSA treatment.