Thursday, January 20, 2011
self interest
"...consider what happened when the US Preventive Services Task Force announced last November that, based on the scientific evidence it weighed, it no longer recommends mammograms for women aged 40 through 49 years. The task force also recommended that women aged 50 years and older no longer receive annual mammograms but, instead, get them every other year. Public outcry and pushback from several medical societies and expert groups like the American Cancer Society swayed Senate Democrats to rewrite their pending healthcare reform legislation to guarantee mammogram coverage."
Study Finds Half of Guideline Recommendations Are Based on Low-Quality Evidence
More than half of recommendations included in guidelines from the Infectious Diseases Society of America rely on low-quality evidence, according to a study in the Archives of Internal Medicine.
Researchers examined 41 guidelines published by IDSA since 1994. Of the 4200 individual recommendations in those guidelines, 55% were supported by level III quality of evidence (e.g., expert opinions), while only 14% were guided by level I evidence (e.g., randomized controlled trials).
Five guidelines were updated during the study interval. In these updates, the number of recommendations increased between 20% and 400%, but only two updates saw an increase in the number of recommendations based on high-quality evidence.
An editorialist said that one of the main take-home messages of this study "is to be wary of falling into the trap of 'cookbook medicine.' The existence of guidelines is probably better than no guidelines, but guidelines will never replace critical thinking in patient care."
Researchers examined 41 guidelines published by IDSA since 1994. Of the 4200 individual recommendations in those guidelines, 55% were supported by level III quality of evidence (e.g., expert opinions), while only 14% were guided by level I evidence (e.g., randomized controlled trials).
Five guidelines were updated during the study interval. In these updates, the number of recommendations increased between 20% and 400%, but only two updates saw an increase in the number of recommendations based on high-quality evidence.
An editorialist said that one of the main take-home messages of this study "is to be wary of falling into the trap of 'cookbook medicine.' The existence of guidelines is probably better than no guidelines, but guidelines will never replace critical thinking in patient care."
Tuesday, December 7, 2010
Study Identifies Bias in Favor of Publishing Positive Antidepressant Trials
January 17, 2008 — A study of Food and Drug Administration (FDA)–registered clinical trials of 12 antidepressants found a bias toward publication of positive results. Almost all studies viewed by the FDA as positive were published. The clinical trials that the FDA deemed negative or questionable were largely not published or, in some cases, were published as positive outcomes.
For each of the 12 drugs, at least 1 study was not published or was reported in the literature as positive despite a conflicting judgment by the FDA.
The overall effect size of the antidepressants (vs placebo) that was reported in the published literature was nearly one-third larger than the effect size for these agents that was derived from FDA data.
"Selective reporting of clinical-trial results may have adverse consequences for researchers, study participants, healthcare professionals, and patients," they conclude.
These findings are published in the January 17 issue of the New England Journal of Medicine.
Evidence-Based or Biased Evidence?
"You might get the impression from the published literature that [these drugs] are consistently effective; however, the outcome of this study is that they are effective, but inconsistently so," lead study author, Eric H. Turner, MD, from Oregon Health and Science University, in Portland, Oregon, told Medscape Psychiatry.
"Evidence-based medicine is valuable to the extent that the evidence is complete and unbiased," he noted, adding that selective publication of clinical trials can alter the apparent risk/benefit ratio of drugs, which can affect prescribing decisions.
The current study sought to examine how accurately the published literature conveys data on drug efficacy to the medical community.
The team identified the phase 2 and 3 clinical-trial programs for 12 antidepressants approved by the FDA between 1987 and 2004, which involved 12,564 adult patients. They also determined whether the FDA judged the studies to be positive or negative with respect to primary end points.
To identify matching study publications, the researchers conducted a systematic literature search and contacted the sponsors of the drug studies.
Among the 74 FDA-registered antidepressant studies, the team found that 23 trials (31%) had not been published.
Among the 38 of 74 studies (51%) that the FDA deemed to be positive, 37 were published.
The remaining 36 studies (49%) were deemed to be either negative (24 studies) or questionable (12). Of these 36 studies, 22 were not published, 11 were published as positive, and 3 were published as negative.
Publication Status of FDA-Registered Antidepressant Studies
Publication Status
Number of Studies, n (%)
Published results agree with FDA decision
40 (54)
Published results conflict with FDA decision (published as positive)
11 (15)
Results not published
23 (31)
Total
74 (100)
For each drug, the effect-size value based on published literature was higher than the effect-size value based on FDA data. The increase in size ranged from 11% to 69% for individual drugs and was 32% overall.
"We cannot determine whether the bias observed resulted from a failure to submit manuscripts on the part of authors and sponsors, decisions by journal editors and reviewers not to publish submitted manuscripts, or both," the group writes.
"Each drug, when submitted to a meta-analysis, was superior to placebo. On the other hand, the true magnitude of each drug's superiority to placebo was less than a diligent review of the literature would indicate," they note.
More Negative Studies Need to Be Published
"This is one of the first efforts to actually quantify the impact [of publication bias] in terms of reported efficacy, by medication," David Fassler, MD, from the University of Vermont College of Medicine, in Burlington, and a trustee-at-large of the American Psychiatric Association (APA), told Medscape Psychiatry. When published literature may overstate the efficacy or understate the risks of specific medications or interventions, this is clearly a significant problem for physicians, researchers, and the general public, he added.
Organized psychiatry has been in the forefront of trying to address this issue, he noted. In July 2004, the APA and the American Academy of Child and Adolescent Psychiatry (AACAP) brought a resolution about this topic to the American Medical Association, which prompted that organization to join in the call for a national registry, he added.
As a result of these and other efforts, today most major journals follow a policy set by the International Committee of Medical Journal Editors (ICMJE) and will consider only papers based on trials entered into 1 of 5 accepted, centralized, publicly accessible clinical-trial registries prior to study enrollment, he observed.
Additional steps are needed. "Journal editors need to ensure that well-designed studies with negative results are accepted for publication at the same rate as comparable studies with positive findings," Dr. Fassler said. "Researchers involved in clinical trials should have the ability to publish or present data from their efforts. Physicians, the media, and the general public . . . need to read and interpret new studies with appropriate caution."
APA and AACAP Renew Call for Mandatory Registry
In light of the report by Turner and colleagues, the APA and AACAP issued a statement renewing their call for a mandatory, public registry for clinical trials and reiterating their support for federal legislation to provide open access to clinical-trials data.
"Our patients deserve the best healthcare available, and having full disclosure of research findings — both positive and negative — will help clinicians develop the most effective treatment plans," APA president Carolyn Robinowitz, MD, said in the statement. Issues involving publication bias are not unique to psychiatry, she noted. "Publication bias has been well documented with cardiovascular and anti-inflammatory medications. A clinical-trials registry set up and overseen by the federal government would be good for all of medicine."
"Greater transparency in the clinical-trials process, particularly including open access to important data, is of significant benefit to the research community, to practitioners in the field, and to our patients," said AACAP president Robert L. Hendren, MD. "A national registry will allow patients to have access to data on a complete range of treatment options, including medication, to discuss with their physician."
Dr. Turner reports having served as a medical reviewer for the FDA. No other potential conflict of interest relevant to this article was reported.
N Engl J Med. 2008;358:252-60.
For each of the 12 drugs, at least 1 study was not published or was reported in the literature as positive despite a conflicting judgment by the FDA.
The overall effect size of the antidepressants (vs placebo) that was reported in the published literature was nearly one-third larger than the effect size for these agents that was derived from FDA data.
"Selective reporting of clinical-trial results may have adverse consequences for researchers, study participants, healthcare professionals, and patients," they conclude.
These findings are published in the January 17 issue of the New England Journal of Medicine.
Evidence-Based or Biased Evidence?
"You might get the impression from the published literature that [these drugs] are consistently effective; however, the outcome of this study is that they are effective, but inconsistently so," lead study author, Eric H. Turner, MD, from Oregon Health and Science University, in Portland, Oregon, told Medscape Psychiatry.
"Evidence-based medicine is valuable to the extent that the evidence is complete and unbiased," he noted, adding that selective publication of clinical trials can alter the apparent risk/benefit ratio of drugs, which can affect prescribing decisions.
The current study sought to examine how accurately the published literature conveys data on drug efficacy to the medical community.
The team identified the phase 2 and 3 clinical-trial programs for 12 antidepressants approved by the FDA between 1987 and 2004, which involved 12,564 adult patients. They also determined whether the FDA judged the studies to be positive or negative with respect to primary end points.
To identify matching study publications, the researchers conducted a systematic literature search and contacted the sponsors of the drug studies.
Among the 74 FDA-registered antidepressant studies, the team found that 23 trials (31%) had not been published.
Among the 38 of 74 studies (51%) that the FDA deemed to be positive, 37 were published.
The remaining 36 studies (49%) were deemed to be either negative (24 studies) or questionable (12). Of these 36 studies, 22 were not published, 11 were published as positive, and 3 were published as negative.
Publication Status of FDA-Registered Antidepressant Studies
Publication Status
Number of Studies, n (%)
Published results agree with FDA decision
40 (54)
Published results conflict with FDA decision (published as positive)
11 (15)
Results not published
23 (31)
Total
74 (100)
For each drug, the effect-size value based on published literature was higher than the effect-size value based on FDA data. The increase in size ranged from 11% to 69% for individual drugs and was 32% overall.
"We cannot determine whether the bias observed resulted from a failure to submit manuscripts on the part of authors and sponsors, decisions by journal editors and reviewers not to publish submitted manuscripts, or both," the group writes.
"Each drug, when submitted to a meta-analysis, was superior to placebo. On the other hand, the true magnitude of each drug's superiority to placebo was less than a diligent review of the literature would indicate," they note.
More Negative Studies Need to Be Published
"This is one of the first efforts to actually quantify the impact [of publication bias] in terms of reported efficacy, by medication," David Fassler, MD, from the University of Vermont College of Medicine, in Burlington, and a trustee-at-large of the American Psychiatric Association (APA), told Medscape Psychiatry. When published literature may overstate the efficacy or understate the risks of specific medications or interventions, this is clearly a significant problem for physicians, researchers, and the general public, he added.
Organized psychiatry has been in the forefront of trying to address this issue, he noted. In July 2004, the APA and the American Academy of Child and Adolescent Psychiatry (AACAP) brought a resolution about this topic to the American Medical Association, which prompted that organization to join in the call for a national registry, he added.
As a result of these and other efforts, today most major journals follow a policy set by the International Committee of Medical Journal Editors (ICMJE) and will consider only papers based on trials entered into 1 of 5 accepted, centralized, publicly accessible clinical-trial registries prior to study enrollment, he observed.
Additional steps are needed. "Journal editors need to ensure that well-designed studies with negative results are accepted for publication at the same rate as comparable studies with positive findings," Dr. Fassler said. "Researchers involved in clinical trials should have the ability to publish or present data from their efforts. Physicians, the media, and the general public . . . need to read and interpret new studies with appropriate caution."
APA and AACAP Renew Call for Mandatory Registry
In light of the report by Turner and colleagues, the APA and AACAP issued a statement renewing their call for a mandatory, public registry for clinical trials and reiterating their support for federal legislation to provide open access to clinical-trials data.
"Our patients deserve the best healthcare available, and having full disclosure of research findings — both positive and negative — will help clinicians develop the most effective treatment plans," APA president Carolyn Robinowitz, MD, said in the statement. Issues involving publication bias are not unique to psychiatry, she noted. "Publication bias has been well documented with cardiovascular and anti-inflammatory medications. A clinical-trials registry set up and overseen by the federal government would be good for all of medicine."
"Greater transparency in the clinical-trials process, particularly including open access to important data, is of significant benefit to the research community, to practitioners in the field, and to our patients," said AACAP president Robert L. Hendren, MD. "A national registry will allow patients to have access to data on a complete range of treatment options, including medication, to discuss with their physician."
Dr. Turner reports having served as a medical reviewer for the FDA. No other potential conflict of interest relevant to this article was reported.
N Engl J Med. 2008;358:252-60.
FDA: Not Necessary to Stop Taking Vytorin or Other Lipid-Lowering Drugs
Patients should not stop taking Vytorin or other cholesterol lowering medications," the FDA announced following review of the ENHANCE trial.
ENHANCE showed that despite Vytorin's lowering LDL cholesterol levels more than simvastatin (Zocor) after 2 years, there was no significant difference between these groups in carotid intima-media thickness.
"The results from ENHANCE do not change FDA's position that an elevated LDL cholesterol is a risk factor for cardiovascular disease and that lowering LDL cholesterol reduces the risk for cardiovascular disease," the agency wrote in a safety update posted on its website.
An ongoing study (scheduled for completion in 2012) aims to determine whether ezetimibe/simvastatin actually decreases the risk for cardiovascular events, compared with simvastatin alone. In addition, the FDA is still reviewing data from the SEAS study, which indicated that Vytorin may be associated with increased cancer incidence and cancer mortality.
ENHANCE showed that despite Vytorin's lowering LDL cholesterol levels more than simvastatin (Zocor) after 2 years, there was no significant difference between these groups in carotid intima-media thickness.
"The results from ENHANCE do not change FDA's position that an elevated LDL cholesterol is a risk factor for cardiovascular disease and that lowering LDL cholesterol reduces the risk for cardiovascular disease," the agency wrote in a safety update posted on its website.
An ongoing study (scheduled for completion in 2012) aims to determine whether ezetimibe/simvastatin actually decreases the risk for cardiovascular events, compared with simvastatin alone. In addition, the FDA is still reviewing data from the SEAS study, which indicated that Vytorin may be associated with increased cancer incidence and cancer mortality.
Sunday, November 7, 2010
Stopping a trial early in oncology: for patients or for
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.
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.
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."
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