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FDA Warning on Effexor
The Food and Drug Administration has warned Wyeth Pharmaceuticals that a journal ad for Effexor XR (venlafaxine) was misleading because it overstated the drug's efficacy, made unsubstantiated superiority claims, and minimized its risks. Effexor XR is approved for major depressive disorder. The ad suggested that patients who did not respond to other antidepressants could be successfully treated with Effexor XR; that superiority has not been demonstrated through substantial evidence or clinical experience, said the FDA. Wyeth also said that Effexor was used in 20 million patients; that is misleading because it is not an accurate tally of unique users, said the agency. “Falsely inflating the number of people treated with Effexor XR may mislead consumers and healthcare providers into inferring greater efficacy and safety than would be warranted by the actual numbers,” wrote the FDA.
Psych Disorders = More Drug Use
Men who have a psychiatric diagnosis tend to have higher rates of daily substance abuse, compared with peers who do not have a co-occurring diagnosis, according to a survey of men admitted to hospitals in 2005. The DASIS (Drug and Alcohol Services Information System) Report compiled data from 544,800 male hospital admissions in 26 states in 2005. Of those, 86,500 (16%) were for admission with co-occurring substance use and psychiatric disorders. Daily use of alcohol, cocaine, marijuana, and stimulants, were higher for those with a codiagnosis. These men also were more likely to report abuse of multiple substances, and to have started using alcohol or drugs before age 13 years. The DASIS Report is produced by the Substance Abuse and Mental Health Services Administration, and its most recent report was issued in mid-December. Copies can be found at
Access Reduced by Cost
Forty million Americans can't get access to needed health care, and 20% said the main reason was because they could not afford the services, according to a report issued in December by the Centers for Disease Control and Prevention. “Health, United States, 2007” is a compilation of pertinent data gathered by the CDC's National Center for Health Statistics. According to the report, in 2005, 1 in 10 people between the ages of 18 and 64 years reported that they had not been able to get prescription drugs in the past year because of the cost. Another 10% said they had delayed necessary medical care because of cost issues. The report also found that 30% of 18- to 24-year-olds were uninsured, and another 30% of that age group did not have a usual source of medical care. Ten percent of 45- to 64-year-olds did not have a usual source of care. The report highlighted some other age-specific data as well. For instance, about 70% of men and more than 80% of women over age 75 either had hypertension or were taking antihypertensives in 2001–2004, compared with about 35% of adults aged 45–54. And about 20% of 16- to 17-year-olds, and more than 40% of 18- to 25-year-olds reported binge alcohol use in 2005; 20% of the latter age group reported illicit drug use in the previous month.
FDA Can't Fulfill Mission
Three members of the FDA Science Board issued a damning report on the state of the agency, saying that “the agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” The authors wrote that the FDA has become weak and unable to fulfill its mission because of the increasing number of demands and an inability to respond because of a lack of resources. “FDA's inability to keep up with scientific advances means that American lives are at risk,” wrote the panelists, adding that the agency can't fulfill its mission “without substantial and sustained additional appropriations.” The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, Jefferson-Pilot Corp. Professor of Neurobiology and Genetics at Duke University; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School, Boston. Members of the Coalition for a Stronger FDA and the FDA Alliance urged Congress to heed the report's warnings. “FDA can't improve its science, prepare for the future, or protect American consumers without significant additional resources,” said coalition member Don Kennedy, Ph.D., a former FDA commissioner and editor in chief of the journal Science, in a statement.
Agency's Approval Plan Flawed
FDA is considering new guidance that would allow drug companies to use journal articles to promote “potentially dangerous uses” of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform, urged the FDA in a Nov. 30 letter to reconsider its draft guidance, which the congressman said was close to being finalized. “The draft guidance that I have obtained would, in effect, allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” Rep. Waxman said. “This undercuts the prohibition on marketing of unapproved uses of drugs and devices.” He asked the FDA to provide detailed information on the development of the new policy and how it would address his concerns.
FDA Warning on Effexor
The Food and Drug Administration has warned Wyeth Pharmaceuticals that a journal ad for Effexor XR (venlafaxine) was misleading because it overstated the drug's efficacy, made unsubstantiated superiority claims, and minimized its risks. Effexor XR is approved for major depressive disorder. The ad suggested that patients who did not respond to other antidepressants could be successfully treated with Effexor XR; that superiority has not been demonstrated through substantial evidence or clinical experience, said the FDA. Wyeth also said that Effexor was used in 20 million patients; that is misleading because it is not an accurate tally of unique users, said the agency. “Falsely inflating the number of people treated with Effexor XR may mislead consumers and healthcare providers into inferring greater efficacy and safety than would be warranted by the actual numbers,” wrote the FDA.
Psych Disorders = More Drug Use
Men who have a psychiatric diagnosis tend to have higher rates of daily substance abuse, compared with peers who do not have a co-occurring diagnosis, according to a survey of men admitted to hospitals in 2005. The DASIS (Drug and Alcohol Services Information System) Report compiled data from 544,800 male hospital admissions in 26 states in 2005. Of those, 86,500 (16%) were for admission with co-occurring substance use and psychiatric disorders. Daily use of alcohol, cocaine, marijuana, and stimulants, were higher for those with a codiagnosis. These men also were more likely to report abuse of multiple substances, and to have started using alcohol or drugs before age 13 years. The DASIS Report is produced by the Substance Abuse and Mental Health Services Administration, and its most recent report was issued in mid-December. Copies can be found at
Access Reduced by Cost
Forty million Americans can't get access to needed health care, and 20% said the main reason was because they could not afford the services, according to a report issued in December by the Centers for Disease Control and Prevention. “Health, United States, 2007” is a compilation of pertinent data gathered by the CDC's National Center for Health Statistics. According to the report, in 2005, 1 in 10 people between the ages of 18 and 64 years reported that they had not been able to get prescription drugs in the past year because of the cost. Another 10% said they had delayed necessary medical care because of cost issues. The report also found that 30% of 18- to 24-year-olds were uninsured, and another 30% of that age group did not have a usual source of medical care. Ten percent of 45- to 64-year-olds did not have a usual source of care. The report highlighted some other age-specific data as well. For instance, about 70% of men and more than 80% of women over age 75 either had hypertension or were taking antihypertensives in 2001–2004, compared with about 35% of adults aged 45–54. And about 20% of 16- to 17-year-olds, and more than 40% of 18- to 25-year-olds reported binge alcohol use in 2005; 20% of the latter age group reported illicit drug use in the previous month.
FDA Can't Fulfill Mission
Three members of the FDA Science Board issued a damning report on the state of the agency, saying that “the agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” The authors wrote that the FDA has become weak and unable to fulfill its mission because of the increasing number of demands and an inability to respond because of a lack of resources. “FDA's inability to keep up with scientific advances means that American lives are at risk,” wrote the panelists, adding that the agency can't fulfill its mission “without substantial and sustained additional appropriations.” The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, Jefferson-Pilot Corp. Professor of Neurobiology and Genetics at Duke University; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School, Boston. Members of the Coalition for a Stronger FDA and the FDA Alliance urged Congress to heed the report's warnings. “FDA can't improve its science, prepare for the future, or protect American consumers without significant additional resources,” said coalition member Don Kennedy, Ph.D., a former FDA commissioner and editor in chief of the journal Science, in a statement.
Agency's Approval Plan Flawed
FDA is considering new guidance that would allow drug companies to use journal articles to promote “potentially dangerous uses” of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform, urged the FDA in a Nov. 30 letter to reconsider its draft guidance, which the congressman said was close to being finalized. “The draft guidance that I have obtained would, in effect, allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” Rep. Waxman said. “This undercuts the prohibition on marketing of unapproved uses of drugs and devices.” He asked the FDA to provide detailed information on the development of the new policy and how it would address his concerns.
FDA Warning on Effexor
The Food and Drug Administration has warned Wyeth Pharmaceuticals that a journal ad for Effexor XR (venlafaxine) was misleading because it overstated the drug's efficacy, made unsubstantiated superiority claims, and minimized its risks. Effexor XR is approved for major depressive disorder. The ad suggested that patients who did not respond to other antidepressants could be successfully treated with Effexor XR; that superiority has not been demonstrated through substantial evidence or clinical experience, said the FDA. Wyeth also said that Effexor was used in 20 million patients; that is misleading because it is not an accurate tally of unique users, said the agency. “Falsely inflating the number of people treated with Effexor XR may mislead consumers and healthcare providers into inferring greater efficacy and safety than would be warranted by the actual numbers,” wrote the FDA.
Psych Disorders = More Drug Use
Men who have a psychiatric diagnosis tend to have higher rates of daily substance abuse, compared with peers who do not have a co-occurring diagnosis, according to a survey of men admitted to hospitals in 2005. The DASIS (Drug and Alcohol Services Information System) Report compiled data from 544,800 male hospital admissions in 26 states in 2005. Of those, 86,500 (16%) were for admission with co-occurring substance use and psychiatric disorders. Daily use of alcohol, cocaine, marijuana, and stimulants, were higher for those with a codiagnosis. These men also were more likely to report abuse of multiple substances, and to have started using alcohol or drugs before age 13 years. The DASIS Report is produced by the Substance Abuse and Mental Health Services Administration, and its most recent report was issued in mid-December. Copies can be found at
Access Reduced by Cost
Forty million Americans can't get access to needed health care, and 20% said the main reason was because they could not afford the services, according to a report issued in December by the Centers for Disease Control and Prevention. “Health, United States, 2007” is a compilation of pertinent data gathered by the CDC's National Center for Health Statistics. According to the report, in 2005, 1 in 10 people between the ages of 18 and 64 years reported that they had not been able to get prescription drugs in the past year because of the cost. Another 10% said they had delayed necessary medical care because of cost issues. The report also found that 30% of 18- to 24-year-olds were uninsured, and another 30% of that age group did not have a usual source of medical care. Ten percent of 45- to 64-year-olds did not have a usual source of care. The report highlighted some other age-specific data as well. For instance, about 70% of men and more than 80% of women over age 75 either had hypertension or were taking antihypertensives in 2001–2004, compared with about 35% of adults aged 45–54. And about 20% of 16- to 17-year-olds, and more than 40% of 18- to 25-year-olds reported binge alcohol use in 2005; 20% of the latter age group reported illicit drug use in the previous month.
FDA Can't Fulfill Mission
Three members of the FDA Science Board issued a damning report on the state of the agency, saying that “the agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” The authors wrote that the FDA has become weak and unable to fulfill its mission because of the increasing number of demands and an inability to respond because of a lack of resources. “FDA's inability to keep up with scientific advances means that American lives are at risk,” wrote the panelists, adding that the agency can't fulfill its mission “without substantial and sustained additional appropriations.” The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, Jefferson-Pilot Corp. Professor of Neurobiology and Genetics at Duke University; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School, Boston. Members of the Coalition for a Stronger FDA and the FDA Alliance urged Congress to heed the report's warnings. “FDA can't improve its science, prepare for the future, or protect American consumers without significant additional resources,” said coalition member Don Kennedy, Ph.D., a former FDA commissioner and editor in chief of the journal Science, in a statement.
Agency's Approval Plan Flawed
FDA is considering new guidance that would allow drug companies to use journal articles to promote “potentially dangerous uses” of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform, urged the FDA in a Nov. 30 letter to reconsider its draft guidance, which the congressman said was close to being finalized. “The draft guidance that I have obtained would, in effect, allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” Rep. Waxman said. “This undercuts the prohibition on marketing of unapproved uses of drugs and devices.” He asked the FDA to provide detailed information on the development of the new policy and how it would address his concerns.