F. Trotta1, G. Apolone2, S. Garattini2 & G. Tafuri1,3*
1Italian Medicines Agency (AIFA), Rome; 2Mario Negri Institute for Pharmacological Research, Milan, Italy; 3Utrecht University, Utrecht Institute for Pharmaceutical
Sciences, Utrecht, The Netherlands
Received 18 December 2007; revised 25 January 2008; accepted 28 January 2008
Background: The aim of this study is to assess the use of interim analyses in randomised controlled trials (RCTs)
testing new anticancer drugs, focussing on oncological clinical trials stopped early for benefit.
Materials and methods: All published clinical trials stopped early for benefit and published in the last 11 years,
regarding anticancer drugs and containing an interim analysis, were assessed.
Results: Twenty-five RCTs were analysed. The evaluation of efficacy was protocol planned through time-related
primary end points, >40% of them overall survival. In 95% of studies, at the interim analysis, efficacy was evaluated
using the same end point as planned for the final analysis. As a consequence of early stopping after the interim
analysis, 3300 patients/events across all studies were spared. More than 78% of the RCTs published in the last 3
years were used for registration purposes.
Conclusion: Though criticism of the poor quality of oncological trials seems out of place, unfortunately early
termination raises new concerns. The relation between sparing patients and saving time and trial costs indicates that
there is a market-driven intent. We believe that only untruncated trials can provide a full level of evidence which can be
translated into clinical practice without further confirmative trials.
Sunday, November 7, 2010
Safety Results of Randomized Controlled Trials May Be Inconsistently Reported
Laurie Barclay, MD
October 26, 2009 — Safety results of randomized controlled trials (RCTs) may be inconsistently reported, according to the results of a review in the October 26 issue of the Archives of Internal Medicine.
"Reports of clinical trials usually emphasize efficacy results, especially when results are statistically significant," write Isabelle Pitrou, MD, MSc, from Université Denis Diderot, INSERM, in Paris, France, and colleagues. "Poor safety reporting can lead to misinterpretation and inadequate conclusions about the interventions assessed. Our aim was to describe the reporting of harm-related results from [RCTs]."
The reviewers searched the MEDLINE database for reports of RCTs published from January 1, 2006, through January 1, 2007, in 6 widely read and respected general medical journals. A standardized form used for data extraction allowed evaluation of how safety results were presented in the text and tables of published reports.
Among the 133 reports identified, 88.7% mentioned adverse events. However, 27.1% of reports gave no information concerning severe adverse events, and 47.4% of reports gave no information concerning withdrawal of patients because of an adverse event.
The reviewers noted restrictions in the reporting of harm-related data in 43 articles (32.3%), with 17 describing the most common adverse events only, 16 describing severe adverse events only, 5 describing statistically significant events only, and 5 having more than 1 restriction. Nearly two thirds of articles (65.6%) clearly reported the population considered for safety analysis.
"Our review reveals important heterogeneity and variability in the reporting of harm-related results in publications of RCTs," the study authors write."Despite the CONSORT statement extension for harm-related data, efforts should still be made to describe safety results with accuracy in reports of RCTs and to standardize practices for reporting."
Limitations of this review include exclusion of specialized medical journals or those with lower impact factors, exclusion of specific study designs, and extraction of all the data by a single reviewer.
"Perhaps conflicts of interest and marketing rather than science have shaped even the often accepted standard that randomized trials study primarily effectiveness, whereas information on harms from medical interventions can wait for case reports and nonrandomized studies," John P. A. Ioannidis, MD, from the University of Ioannina School of Medicine in Greece, writes in an accompanying editorial. "Nonrandomized data are very helpful, but they have limitations, and many harms will remain long undetected if we just wait for spontaneous reporting and other nonrandomized research to reveal them. In an environment where effectiveness benefits are small and shrinking, the randomized trials agenda may need to reprogram its whole mission, including its reporting, toward better understanding of harms."
Dr. Pitrou was supported by a grant from the Ministry of Higher Education and Research, France. The study authors and Dr. Ioannidis have disclosed no relevant financial relationships.
Arch Intern Med. 2009;169:1737–1739, 1756–1761.
October 26, 2009 — Safety results of randomized controlled trials (RCTs) may be inconsistently reported, according to the results of a review in the October 26 issue of the Archives of Internal Medicine.
"Reports of clinical trials usually emphasize efficacy results, especially when results are statistically significant," write Isabelle Pitrou, MD, MSc, from Université Denis Diderot, INSERM, in Paris, France, and colleagues. "Poor safety reporting can lead to misinterpretation and inadequate conclusions about the interventions assessed. Our aim was to describe the reporting of harm-related results from [RCTs]."
The reviewers searched the MEDLINE database for reports of RCTs published from January 1, 2006, through January 1, 2007, in 6 widely read and respected general medical journals. A standardized form used for data extraction allowed evaluation of how safety results were presented in the text and tables of published reports.
Among the 133 reports identified, 88.7% mentioned adverse events. However, 27.1% of reports gave no information concerning severe adverse events, and 47.4% of reports gave no information concerning withdrawal of patients because of an adverse event.
The reviewers noted restrictions in the reporting of harm-related data in 43 articles (32.3%), with 17 describing the most common adverse events only, 16 describing severe adverse events only, 5 describing statistically significant events only, and 5 having more than 1 restriction. Nearly two thirds of articles (65.6%) clearly reported the population considered for safety analysis.
"Our review reveals important heterogeneity and variability in the reporting of harm-related results in publications of RCTs," the study authors write."Despite the CONSORT statement extension for harm-related data, efforts should still be made to describe safety results with accuracy in reports of RCTs and to standardize practices for reporting."
Limitations of this review include exclusion of specialized medical journals or those with lower impact factors, exclusion of specific study designs, and extraction of all the data by a single reviewer.
"Perhaps conflicts of interest and marketing rather than science have shaped even the often accepted standard that randomized trials study primarily effectiveness, whereas information on harms from medical interventions can wait for case reports and nonrandomized studies," John P. A. Ioannidis, MD, from the University of Ioannina School of Medicine in Greece, writes in an accompanying editorial. "Nonrandomized data are very helpful, but they have limitations, and many harms will remain long undetected if we just wait for spontaneous reporting and other nonrandomized research to reveal them. In an environment where effectiveness benefits are small and shrinking, the randomized trials agenda may need to reprogram its whole mission, including its reporting, toward better understanding of harms."
Dr. Pitrou was supported by a grant from the Ministry of Higher Education and Research, France. The study authors and Dr. Ioannidis have disclosed no relevant financial relationships.
Arch Intern Med. 2009;169:1737–1739, 1756–1761.
Sunday, October 24, 2010
Psychiatrists Dominate "Doctor-Dollars" Database Listing Big Pharma Payments
October 22, 2010 — Psychiatrists dominate a list of physicians receiving the most in payments from pharmaceutical companies, according to a free, interactive database of such payments launched by investigative journalism group ProPublica, in partnership with other US media outlets
So far, the database includes payments made by 7 of the biggest pharmaceutical companies — some of which the US Department of Justice has required to disclose physician payments as part of settlement agreements over illegal drug marketing — which account for a boggling $258 million in payments to roughly 17,700 physicians. The plan is to add 70 more companies.
Any US physician is searchable by name in the database.
"Receiving payments isn't necessarily wrong," says the homepage for the Dollars for Docs, "but it does raise ethical issues."
The payments covered by the project include fees for such items as speaking, consulting, meals, and travel; the different types of payments from different companies have been compiled, streamlined, and tallied by ProPublica.
The 10 highest-paid physicians in 2009 to 2010 for each of the 7 companies are listed on the site, spanning all medical disciplines.
Endocrinologist Firhaad Ismail, MD, from Las Vegas, Nevada, ranked number one in pharmaceutical industry compensation, receiving $303,558 from GlaxoSmithKline, Eli Lilly, and Merck. Dr. Ismail did not return messages left with his office requesting an interview.
Top-Paid Psychiatrist Says Payments Do Not Cloud Clinical Judgment
ProPublica researchers also compiled a list of physicians who were paid more than $100,000 (typically from more than 1 company) during the past 18 months, turning up 384 names, including 41 who earned more than $200,000 through speaking or consulting arrangements and 2 who earned more than $300,000 from 1 or more of the 7 companies.
More psychiatrists are listed in the database than any other kind of specialist. Of the 384 physicians in the $100,000 group, 116 are psychiatrists. Leading all psychiatrists was Roueen Rafeyan, MD, in Chicago, Illinois, who received $203,936 from Eli Lilly, AstraZeneca, Johnson & Johnson, and Pfizer, mostly for professional education programs.
In an interview with Medscape Medical News, Dr. Rafeyan said that compensation from pharmaceutical companies does not cloud his clinical judgment at the expense of patients.
The day I'm influenced by that is the day I'm not fit to practice medicine.
"The day I'm influenced by that is the day I'm not fit to practice medicine," Dr. Rafeyan said.
He noted that the majority of the drugs he prescribed were generics. "If someone looked at my prescribing patterns, it would be the opposite of the [pharmaceutical] money I receive," said Dr. Rafeyan, an assistant clinical professor at Rush University Medical Center in Chicago.
Dr. Rafeyan said that although the extra income is always welcome, patient well-being was his prime motivation to talk to other physicians about brand-name psychiatric drugs. "When you educate other physicians, hopefully 1 patient will benefit from it."
When asked how he found the time to earn more than $200,000 as a pharmaceutical company educator over 18 months, Dr. Rafeyan said, "I work very hard, like many other physicians. None of us have 40-hour work weeks."
Dollar Value of Psychiatric Drugs Is Enormous
The preponderance of psychiatrists on the ProPublica list may reflect the proportion of prescription activity involving psychiatric drugs. In 2009, the dollar value of antipsychotic drugs came to $14.6 billion, topping all other therapeutic classes, according to research firm IMS Health. Antidepressants occupied the number 4 spot on the list, valued at $9.9 billion.
IMS Health put the total US prescription market in 2009 at $300.3 billion.
Carol Bernstein, MD, president of the American Psychiatric Association, told Medscape Medical News that the thorny issue of pharmaceutical industry compensation went beyond her specialty.
People with high-profile, high-visibility [positions] sometimes get carried away.
"Academic medicine needs a different relationship with the pharmaceutical industry," she said. Physicians must find new ways to facilitate the development of new drugs that do not compromise their ethics or patient care.
"People with high-profile, high-visibility [positions] sometimes get carried away," she said.
Research has shown, Dr. Bernstein added, that heavy pharmaceutical marketing indeed influences physician prescribing.
The Rest of the Compensation Leader Board
After psychiatry, the next largest specialty in the $100,000 group is internal medicine. However, this is an amorphous category, because many of the 114 physicians shown as board certified in internal medicine also are certified in fields such as endocrinology, neurology, cardiovascular disease, and medical oncology.
Table. 11 Most Compensated Specialties After Psychiatry and Internal Medicine
Specialty Number of Physicians*
Endocrinology 37
Pulmonology 23
Family Medicine 23
Cardiovascular Medicine 19
Urology 19
Obstetrics/Gynecology 16
Allergy and Immunology 15
Neurology 13
Oncology 13
Pain Medicine 10
Pediatrics 10
*Some physicians are listed with more than 1 board certification.
More to Come
By 2013, 70 additional companies will be required to disclose payments under federal healthcare reform legislation, a notion originally brought forward as the Physician Payments Sunshine Act.
ProPublica says it has launched a "rolling series" of stories generated by their research. The first addresses the high number of physicians paid to speak for drug companies who also have limited credentials or have faced disciplinary actions, criminal convictions, malpractice lawsuits, hospital sanctions, or US Food and Drug Administration warning letters.
Two of ProPublica's partners, the Chicago Tribune and the Boston Globe, have also used the database to research their own stories. The Globe's article focuses on payments to physicians at Harvard University and other Boston-area institutions, noting that "numerous doctors at Beth Israel Deaconess Medical Center and Boston Medical Center" also received payments, "despite hospital policies saying physicians cannot be paid speakers unless they control the content of the talks." The Tribune article zeroes in on payments being made to 4 Chicago-area practices: the psychiatry department at Rush University Medical Center, a headache clinic, a suburban urology practice, and a psychiatric hospital.
An editor's note on the ProPublica Web site urges interactivity and collaboration, inviting patients to search for their physicians and email the Web site with comments or stories. It also notes that stories of the kind being generated from this list would, in the past, have been "scoops" for single news organizations.
"We think we can achieve our primary mission at ProPublica — journalism that spurs change — by working in concert with other talented journalists and with the tens of thousands of people who will view, hear, and read stories by this partnership."
Medscape Medical News © 2010 WebMD, LLC
Send press releases and comments to news@medscape.net.
So far, the database includes payments made by 7 of the biggest pharmaceutical companies — some of which the US Department of Justice has required to disclose physician payments as part of settlement agreements over illegal drug marketing — which account for a boggling $258 million in payments to roughly 17,700 physicians. The plan is to add 70 more companies.
Any US physician is searchable by name in the database.
"Receiving payments isn't necessarily wrong," says the homepage for the Dollars for Docs, "but it does raise ethical issues."
The payments covered by the project include fees for such items as speaking, consulting, meals, and travel; the different types of payments from different companies have been compiled, streamlined, and tallied by ProPublica.
The 10 highest-paid physicians in 2009 to 2010 for each of the 7 companies are listed on the site, spanning all medical disciplines.
Endocrinologist Firhaad Ismail, MD, from Las Vegas, Nevada, ranked number one in pharmaceutical industry compensation, receiving $303,558 from GlaxoSmithKline, Eli Lilly, and Merck. Dr. Ismail did not return messages left with his office requesting an interview.
Top-Paid Psychiatrist Says Payments Do Not Cloud Clinical Judgment
ProPublica researchers also compiled a list of physicians who were paid more than $100,000 (typically from more than 1 company) during the past 18 months, turning up 384 names, including 41 who earned more than $200,000 through speaking or consulting arrangements and 2 who earned more than $300,000 from 1 or more of the 7 companies.
More psychiatrists are listed in the database than any other kind of specialist. Of the 384 physicians in the $100,000 group, 116 are psychiatrists. Leading all psychiatrists was Roueen Rafeyan, MD, in Chicago, Illinois, who received $203,936 from Eli Lilly, AstraZeneca, Johnson & Johnson, and Pfizer, mostly for professional education programs.
In an interview with Medscape Medical News, Dr. Rafeyan said that compensation from pharmaceutical companies does not cloud his clinical judgment at the expense of patients.
The day I'm influenced by that is the day I'm not fit to practice medicine.
"The day I'm influenced by that is the day I'm not fit to practice medicine," Dr. Rafeyan said.
He noted that the majority of the drugs he prescribed were generics. "If someone looked at my prescribing patterns, it would be the opposite of the [pharmaceutical] money I receive," said Dr. Rafeyan, an assistant clinical professor at Rush University Medical Center in Chicago.
Dr. Rafeyan said that although the extra income is always welcome, patient well-being was his prime motivation to talk to other physicians about brand-name psychiatric drugs. "When you educate other physicians, hopefully 1 patient will benefit from it."
When asked how he found the time to earn more than $200,000 as a pharmaceutical company educator over 18 months, Dr. Rafeyan said, "I work very hard, like many other physicians. None of us have 40-hour work weeks."
Dollar Value of Psychiatric Drugs Is Enormous
The preponderance of psychiatrists on the ProPublica list may reflect the proportion of prescription activity involving psychiatric drugs. In 2009, the dollar value of antipsychotic drugs came to $14.6 billion, topping all other therapeutic classes, according to research firm IMS Health. Antidepressants occupied the number 4 spot on the list, valued at $9.9 billion.
IMS Health put the total US prescription market in 2009 at $300.3 billion.
Carol Bernstein, MD, president of the American Psychiatric Association, told Medscape Medical News that the thorny issue of pharmaceutical industry compensation went beyond her specialty.
People with high-profile, high-visibility [positions] sometimes get carried away.
"Academic medicine needs a different relationship with the pharmaceutical industry," she said. Physicians must find new ways to facilitate the development of new drugs that do not compromise their ethics or patient care.
"People with high-profile, high-visibility [positions] sometimes get carried away," she said.
Research has shown, Dr. Bernstein added, that heavy pharmaceutical marketing indeed influences physician prescribing.
The Rest of the Compensation Leader Board
After psychiatry, the next largest specialty in the $100,000 group is internal medicine. However, this is an amorphous category, because many of the 114 physicians shown as board certified in internal medicine also are certified in fields such as endocrinology, neurology, cardiovascular disease, and medical oncology.
Table. 11 Most Compensated Specialties After Psychiatry and Internal Medicine
Specialty Number of Physicians*
Endocrinology 37
Pulmonology 23
Family Medicine 23
Cardiovascular Medicine 19
Urology 19
Obstetrics/Gynecology 16
Allergy and Immunology 15
Neurology 13
Oncology 13
Pain Medicine 10
Pediatrics 10
*Some physicians are listed with more than 1 board certification.
More to Come
By 2013, 70 additional companies will be required to disclose payments under federal healthcare reform legislation, a notion originally brought forward as the Physician Payments Sunshine Act.
ProPublica says it has launched a "rolling series" of stories generated by their research. The first addresses the high number of physicians paid to speak for drug companies who also have limited credentials or have faced disciplinary actions, criminal convictions, malpractice lawsuits, hospital sanctions, or US Food and Drug Administration warning letters.
Two of ProPublica's partners, the Chicago Tribune and the Boston Globe, have also used the database to research their own stories. The Globe's article focuses on payments to physicians at Harvard University and other Boston-area institutions, noting that "numerous doctors at Beth Israel Deaconess Medical Center and Boston Medical Center" also received payments, "despite hospital policies saying physicians cannot be paid speakers unless they control the content of the talks." The Tribune article zeroes in on payments being made to 4 Chicago-area practices: the psychiatry department at Rush University Medical Center, a headache clinic, a suburban urology practice, and a psychiatric hospital.
An editor's note on the ProPublica Web site urges interactivity and collaboration, inviting patients to search for their physicians and email the Web site with comments or stories. It also notes that stories of the kind being generated from this list would, in the past, have been "scoops" for single news organizations.
"We think we can achieve our primary mission at ProPublica — journalism that spurs change — by working in concert with other talented journalists and with the tens of thousands of people who will view, hear, and read stories by this partnership."
Medscape Medical News © 2010 WebMD, LLC
Send press releases and comments to news@medscape.net.
Wednesday, September 29, 2010
Vitalux for prevention of age related macular degeneration
An earlier, Cochrane Database Review of publications to 2007 found that the use of vitamin and mineral supplements, alone or in combination, by the general population had no effect on age-related macular degeneration,[34] a finding echoed by another review.[35] A 2006 Cochrane Review of the effects of vitamins and minerals on the slowing of ARMD found that positive results mainly came from a single large trial in the United States (the Age-Related Eye Disease Study, with funding from the eye care product company Bausch & Lomb who also manufactured the supplements used in the study[36]), and questioned the generalization of the data to any other populations with different nutritional status. The review also questioned the possible harm of such supplements, given the increased risk of lung cancer in smokers with high intakes of beta-Carotene, and the increased risk of heart failure in at-risk populations who consume high levels of vitamin E supplements.[37]
Tuesday, September 14, 2010
National drug plan could save billions: study
A universal prescription drug plan could chop more than $10 billion off Canada's annual health-care bill, according to a new policy study that its authors say "explodes the fallacy" that such a plan is unaffordable.
A new study on Canada's pharmaceutical policies concludes that a universal drug plan could save up to $10.7 billion a year in total drug expenditures. (Nati Harnik/Associated Press)
The report, released on Monday by the Canadian Centre for Policy Alternatives, concludes the existing patchwork of private and public plans in Canada is inequitable, inefficient and costly.
"Canada’s pharmaceutical policies are a total failure," the study's author, Marc-André Gagnon, told reporters on Monday in Ottawa.
The report also finds that Canada is either the third or fourth most expensive country for brand-name drugs every year — after the United States, Switzerland and Germany — because it deliberately inflates drug prices in order to attract pharmaceutical investment.
P.O.V.:
Would you support a universal pharmacare plan? Take our poll.
Meanwhile, Canada has one of the highest annual growth of drug costs among industrialized countries — much higher than countries that have universal pharmacare programs, such as France, Australia and Sweden, said Gagnon, a professor of public policy at Carleton University.
"The cost of such policies far exceed the benefits to Canadians from having a domestic pharmaceutical industry," he said.
The current system is also unfair, Gagnon said, because Canadians receive different coverage depending on what plan they're in and where they live.
Lower administrative costs
Universal pharmacare would lead to savings of nearly $3 billion a year if Canada keeps its current policy, Gagnon said.
But the savings could increase to $10.7 billion, or 43 per cent of annual drug costs, if Canada cut all privileges to the pharmaceutical industry for drug costs, according to the report.
Much of what Canadians spend on prescription drugs is eaten up by administration costs from hundreds of different private, public and company plans, according to the report.
A national drug plan would allow governments to buy drugs in bulk and be the sole administrator, which would mean billions of dollars in savings, agreed Dr. Michael Rachlis, a health policy analyst who teaches medicine at the University of Toronto.
"We reduce the administrative costs because private insurance is much more expensive to administer than public insurance, which is one of the reasons why U.S. health care costs are so much higher than ours," Rachlis said.
The report comes as provincial and territorial health ministers meet in St. John's, where rising health-care and drug costs are high on the agenda.
"Rising costs in health care are affecting every province, and any time that we can look at a program that will help contain those costs it's certainly worth looking at," Saskatchewan's Health Minister, Don McMorris, said in an interview from St. John's on Monday.
Timing right?
At the close of Monday's session in St. John's, Ontario Health Minister Deb Matthews said her province spends about $4 billion a year on drugs, and provinces collectively spend about $10 billion. The ministers think they can get better prices by working together, Matthews told reporters.
A national pharmacare program would require agreement from all provinces and territories.
The timing could be right for such a program, said Steve Morgan, a health economist with Centre for Health Service and Policy Research at the University of British Columbia.
For the first time in decades, drug prices are starting to fall as patents for "blockbuster" drugs like those used to control high blood pressure and cholesterol start to expire, Morgan said. The U.S. is already seeing a slight slowdown in spending, he said.
Meanwhile, the federal and provincial governments are looking for a new plan to replace the Canada Health Accord, which expires in 2014.
Morgan said universal pharmacare could signal a renewal that would benefit all Canadians. So far, the federal government has shown little interest.
The health ministers' meeting wraps up on Tuesday.
A new study on Canada's pharmaceutical policies concludes that a universal drug plan could save up to $10.7 billion a year in total drug expenditures. (Nati Harnik/Associated Press)
The report, released on Monday by the Canadian Centre for Policy Alternatives, concludes the existing patchwork of private and public plans in Canada is inequitable, inefficient and costly.
"Canada’s pharmaceutical policies are a total failure," the study's author, Marc-André Gagnon, told reporters on Monday in Ottawa.
The report also finds that Canada is either the third or fourth most expensive country for brand-name drugs every year — after the United States, Switzerland and Germany — because it deliberately inflates drug prices in order to attract pharmaceutical investment.
P.O.V.:
Would you support a universal pharmacare plan? Take our poll.
Meanwhile, Canada has one of the highest annual growth of drug costs among industrialized countries — much higher than countries that have universal pharmacare programs, such as France, Australia and Sweden, said Gagnon, a professor of public policy at Carleton University.
"The cost of such policies far exceed the benefits to Canadians from having a domestic pharmaceutical industry," he said.
The current system is also unfair, Gagnon said, because Canadians receive different coverage depending on what plan they're in and where they live.
Lower administrative costs
Universal pharmacare would lead to savings of nearly $3 billion a year if Canada keeps its current policy, Gagnon said.
But the savings could increase to $10.7 billion, or 43 per cent of annual drug costs, if Canada cut all privileges to the pharmaceutical industry for drug costs, according to the report.
Much of what Canadians spend on prescription drugs is eaten up by administration costs from hundreds of different private, public and company plans, according to the report.
A national drug plan would allow governments to buy drugs in bulk and be the sole administrator, which would mean billions of dollars in savings, agreed Dr. Michael Rachlis, a health policy analyst who teaches medicine at the University of Toronto.
"We reduce the administrative costs because private insurance is much more expensive to administer than public insurance, which is one of the reasons why U.S. health care costs are so much higher than ours," Rachlis said.
The report comes as provincial and territorial health ministers meet in St. John's, where rising health-care and drug costs are high on the agenda.
"Rising costs in health care are affecting every province, and any time that we can look at a program that will help contain those costs it's certainly worth looking at," Saskatchewan's Health Minister, Don McMorris, said in an interview from St. John's on Monday.
Timing right?
At the close of Monday's session in St. John's, Ontario Health Minister Deb Matthews said her province spends about $4 billion a year on drugs, and provinces collectively spend about $10 billion. The ministers think they can get better prices by working together, Matthews told reporters.
A national pharmacare program would require agreement from all provinces and territories.
The timing could be right for such a program, said Steve Morgan, a health economist with Centre for Health Service and Policy Research at the University of British Columbia.
For the first time in decades, drug prices are starting to fall as patents for "blockbuster" drugs like those used to control high blood pressure and cholesterol start to expire, Morgan said. The U.S. is already seeing a slight slowdown in spending, he said.
Meanwhile, the federal and provincial governments are looking for a new plan to replace the Canada Health Accord, which expires in 2014.
Morgan said universal pharmacare could signal a renewal that would benefit all Canadians. So far, the federal government has shown little interest.
The health ministers' meeting wraps up on Tuesday.
Sibutramine Increases Risk for MI and Stroke Among Patients with Heart Disease
The weight-loss drug sibutramine (Meridia) — up for review by FDA advisers on Sept. 15 — poses increased risk for cardiovascular events among adults with cardiovascular disease (CVD), according to a New England Journal of Medicine study.
Industry-supported researchers randomized nearly 10,000 overweight or obese adults with cardiovascular disease and/or diabetes to receive sibutramine or placebo. During 3.4 years' treatment, sibutramine recipients were at greater risk for nonfatal MI (4.1% vs. 3.2%) and stroke (2.6% vs. 1.9%), although not cardiovascular mortality. In subgroup analyses, the increased risks were seen among subjects with CVD and CVD plus diabetes, but not among those with diabetes alone.
The authors conclude that sibutramine "should continue to be excluded from use in patients with preexisting cardiovascular disease." Editorialists, however, take a stronger stance: "Given that sibutramine has minimal efficacy for weight loss, no apparent benefit for clinical outcomes, [and] a worrisome cardiovascular risk profile, ... it is difficult to discern a credible rationale for keeping this medication on the market."
Industry-supported researchers randomized nearly 10,000 overweight or obese adults with cardiovascular disease and/or diabetes to receive sibutramine or placebo. During 3.4 years' treatment, sibutramine recipients were at greater risk for nonfatal MI (4.1% vs. 3.2%) and stroke (2.6% vs. 1.9%), although not cardiovascular mortality. In subgroup analyses, the increased risks were seen among subjects with CVD and CVD plus diabetes, but not among those with diabetes alone.
The authors conclude that sibutramine "should continue to be excluded from use in patients with preexisting cardiovascular disease." Editorialists, however, take a stronger stance: "Given that sibutramine has minimal efficacy for weight loss, no apparent benefit for clinical outcomes, [and] a worrisome cardiovascular risk profile, ... it is difficult to discern a credible rationale for keeping this medication on the market."
Saturday, August 28, 2010
Dutasteride Gives Mixed Results in Preventing Prostate Cancer
Dutasteride lowers the incidence of prostate cancer, but not high-grade tumors, according to a New England Journal of Medicine study.
In a double-blind study designed by dutasteride's manufacturer, some 6700 high-risk men underwent randomization to either daily dutasteride or placebo. At entry, subjects were 50 to 75 years old, had PSA levels between 2.5 and 10 ng/mL, and had had a negative biopsy.
During 4 years' follow-up, the incidence of biopsy-detected cancer was lower in the treatment group than in controls (20% vs. 25%). The number of high-grade tumors, however, was significantly higher in the treatment group during the last 2 years of follow-up.
An editorialist concludes that the 5-alpha-reductase inhibitors like dutasteride "do not prevent ... but merely temporarily shrink tumors that have a low potential for being lethal." He adds that, because the drugs suppress PSA levels, "men may have a false sense of security," thus delaying diagnosis.
In a double-blind study designed by dutasteride's manufacturer, some 6700 high-risk men underwent randomization to either daily dutasteride or placebo. At entry, subjects were 50 to 75 years old, had PSA levels between 2.5 and 10 ng/mL, and had had a negative biopsy.
During 4 years' follow-up, the incidence of biopsy-detected cancer was lower in the treatment group than in controls (20% vs. 25%). The number of high-grade tumors, however, was significantly higher in the treatment group during the last 2 years of follow-up.
An editorialist concludes that the 5-alpha-reductase inhibitors like dutasteride "do not prevent ... but merely temporarily shrink tumors that have a low potential for being lethal." He adds that, because the drugs suppress PSA levels, "men may have a false sense of security," thus delaying diagnosis.
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