Abby Goodnough
The New York Times
Originally posted January 18, 2019
A new study offers some of the strongest evidence yet of the connection between the marketing of opioids to doctors and the nation’s addiction epidemic.
It found that counties where opioid manufacturers offered a large number of gifts and payments to doctors had more overdose deaths involving the drugs than counties where direct-to-physician marketing was less aggressive.
The study, published Friday in JAMA Network Open, said the industry spent about $40 million promoting opioid medications to nearly 68,000 doctors from 2013 through 2015, including by paying for meals, trips and consulting fees. And it found that for every three additional payments that companies made to doctors per 100,000 people in a county, overdose deaths involving prescription opioids there a year later were 18 percent higher.
Even as the opioid epidemic was killing more and more Americans, such marketing practices remained widespread. From 2013 through 2015, roughly 1 in 12 doctors received opioid-related marketing, according to the study, including 1 in 5 family practice doctors.
The info is here.
Showing posts with label Pharmaceutical Payments. Show all posts
Showing posts with label Pharmaceutical Payments. Show all posts
Friday, January 25, 2019
Saturday, December 22, 2018
Complexities for Psychiatry's Identity As a Medical Specialty
Mohammed Abouelleil Rashed
Kan Zaman Blog
Originally posted November 23, 2018
Here is an excerpt:
Doctors, researchers, governments, pharmaceutical companies, and patient groups each have their own interests and varying abilities to influence the construction of disease categories. This creates the possibility for disagreement over the legitimacy of certain conditions, something we can see playing out in the ongoing debates surrounding Chronic Fatigue Syndrome, a condition that “receives much more attention from its sufferers and their supporters than from the medical community” (Simon 2011: 91). And, in psychiatry, it has long been noted that some major pharmaceutical companies influence the construction of disorder in order to create a market for the psychotropic drugs they manufacture. From the perspective of medical anti-realism (in the constructivist form presented here), these influences are no longer seen as a hindrance to the supposedly objective, ‘natural kind’ status of disease categories, but as key factors involved in their construction. Thus, the lobbying power of the American Psychiatric Association, the vested interests of pharmaceutical companies, and the desire of psychiatrists as a group to maintain their prestige do not undermine the identity of psychiatry as a medical specialty; what they do is highlight the importance of emphasizing the interests of patient groups as well as utilitarian and economic criteria to counteract and respond to the other interests. Medical constructivism is not a uniquely psychiatric ontology, it is a medicine-wide ontology; it applies to schizophrenia as it does to hypertension, appendicitis, and heart disease. Owing to the normative complexity of psychiatry (outlined earlier) and to the fact that loss of freedom is often involved in psychiatric practice, the vested interests involved in psychiatry are more complex and harder to resolve than in many other medical specialties. But that in itself is not a hindrance to psychiatry’s identity as a medical speciality.
The info is here.
Kan Zaman Blog
Originally posted November 23, 2018
Here is an excerpt:
Doctors, researchers, governments, pharmaceutical companies, and patient groups each have their own interests and varying abilities to influence the construction of disease categories. This creates the possibility for disagreement over the legitimacy of certain conditions, something we can see playing out in the ongoing debates surrounding Chronic Fatigue Syndrome, a condition that “receives much more attention from its sufferers and their supporters than from the medical community” (Simon 2011: 91). And, in psychiatry, it has long been noted that some major pharmaceutical companies influence the construction of disorder in order to create a market for the psychotropic drugs they manufacture. From the perspective of medical anti-realism (in the constructivist form presented here), these influences are no longer seen as a hindrance to the supposedly objective, ‘natural kind’ status of disease categories, but as key factors involved in their construction. Thus, the lobbying power of the American Psychiatric Association, the vested interests of pharmaceutical companies, and the desire of psychiatrists as a group to maintain their prestige do not undermine the identity of psychiatry as a medical specialty; what they do is highlight the importance of emphasizing the interests of patient groups as well as utilitarian and economic criteria to counteract and respond to the other interests. Medical constructivism is not a uniquely psychiatric ontology, it is a medicine-wide ontology; it applies to schizophrenia as it does to hypertension, appendicitis, and heart disease. Owing to the normative complexity of psychiatry (outlined earlier) and to the fact that loss of freedom is often involved in psychiatric practice, the vested interests involved in psychiatry are more complex and harder to resolve than in many other medical specialties. But that in itself is not a hindrance to psychiatry’s identity as a medical speciality.
The info is here.
Tuesday, October 9, 2018
Top Cancer Researcher Fails to Disclose Corporate Financial Ties in Major Research Journals
Charles Ornstein and Katie Thomas
The New York Times
Originally published September 8, 2018
One of the world’s top breast cancer doctors failed to disclose millions of dollars in payments from drug and health care companies in recent years, omitting his financial ties from dozens of research articles in prestigious publications like The New England Journal of Medicine and The Lancet.
The researcher, Dr. José Baselga, a towering figure in the cancer world, is the chief medical officer at Memorial Sloan Kettering Cancer Center in New York. He has held board memberships or advisory roles with Roche and Bristol-Myers Squibb, among other corporations, has had a stake in start-ups testing cancer therapies, and played a key role in the development of breakthrough drugs that have revolutionized treatments for breast cancer.
According to an analysis by The New York Times and ProPublica, Dr. Baselga did not follow financial disclosure rules set by the American Association for Cancer Research when he was president of the group. He also left out payments he received from companies connected to cancer research in his articles published in the group’s journal, Cancer Discovery. At the same time, he has been one of the journal’s two editors in chief.
The info is here.
The New York Times
Originally published September 8, 2018
One of the world’s top breast cancer doctors failed to disclose millions of dollars in payments from drug and health care companies in recent years, omitting his financial ties from dozens of research articles in prestigious publications like The New England Journal of Medicine and The Lancet.
The researcher, Dr. José Baselga, a towering figure in the cancer world, is the chief medical officer at Memorial Sloan Kettering Cancer Center in New York. He has held board memberships or advisory roles with Roche and Bristol-Myers Squibb, among other corporations, has had a stake in start-ups testing cancer therapies, and played a key role in the development of breakthrough drugs that have revolutionized treatments for breast cancer.
According to an analysis by The New York Times and ProPublica, Dr. Baselga did not follow financial disclosure rules set by the American Association for Cancer Research when he was president of the group. He also left out payments he received from companies connected to cancer research in his articles published in the group’s journal, Cancer Discovery. At the same time, he has been one of the journal’s two editors in chief.
The info is here.
Tuesday, September 4, 2018
Financial Ties That Bind: Studies Often Fall Short On Conflict-Of-Interest Disclosures
Rachel Bluth
Kaiser Health News
Originally published August 15, 2018
Papers in medical journals go through rigorous peer review and meticulous data analysis.
Yet many of these articles are missing a key piece of information: the financial ties of the authors.
Nearly two-thirds of the 100 physicians who rake in the most money from 10 device manufacturers failed to disclose a conflict of interest in their academic writing in 2016, according to a study published Wednesday in JAMA Surgery.
The omission can have real-life impact for patients when their doctors rely on such research to make medical decisions, potentially without knowing the authors’ potential conflicts of interest.
“The issue is anytime there’s a new technology, people get really excited about it,” said lead researcher Dr. Mehraneh Jafari. “Whoever is reading the data on it needs to have the most information.”
The article is here.
Kaiser Health News
Originally published August 15, 2018
Papers in medical journals go through rigorous peer review and meticulous data analysis.
Yet many of these articles are missing a key piece of information: the financial ties of the authors.
Nearly two-thirds of the 100 physicians who rake in the most money from 10 device manufacturers failed to disclose a conflict of interest in their academic writing in 2016, according to a study published Wednesday in JAMA Surgery.
The omission can have real-life impact for patients when their doctors rely on such research to make medical decisions, potentially without knowing the authors’ potential conflicts of interest.
“The issue is anytime there’s a new technology, people get really excited about it,” said lead researcher Dr. Mehraneh Jafari. “Whoever is reading the data on it needs to have the most information.”
The article is here.
Sunday, July 16, 2017
Masked Marketing: Pharmaceutical Company Funding of ADHD Patient Advocacy Groups
Marnie Klein
Hastings Center
Originally posted June 29, 2017
In 1971, the United Nations passed a resolution prohibiting its member nations from advertising psychotropic drugs to the general public. More than 40 years later, this resolution has done little to halt pharmaceutical companies from marketing stimulants as treatments for attention deficit-hyperactivity disorder. The means by which, and the ethical dilemmas involved when, pharmaceutical companies market their products was discussed earlier this month at the annual PharmedOut conference, which investigated how industry influences medical discourse.
Alan Schwarz, the author of ADHD Nation, exposed how drug companies have, often covertly, sponsored educational resources and patient advocacy groups. These groups face a difficult conflict of interest: by accepting drug company funding, they can increase their reach to those looking for resources; however, their neutrality is compromised, particularly when they fail to disclose the funding source. The New England Journal of Medicine reports that pharmaceutical industry-sponsored advocacy groups may be likely to support drugs, as well as policy proposals, that cater to their sponsors’ financial interests.
One such pharmaceutical company is Shire. One of the British company’s highest-grossing products is Adderall, a stimulant used in treating ADHD that has earned the company billions in sales to date. Shire sponsors ADHD patient-advocacy groups, like Children and Adults with ADHD (CHADD).
The article is here.
Hastings Center
Originally posted June 29, 2017
In 1971, the United Nations passed a resolution prohibiting its member nations from advertising psychotropic drugs to the general public. More than 40 years later, this resolution has done little to halt pharmaceutical companies from marketing stimulants as treatments for attention deficit-hyperactivity disorder. The means by which, and the ethical dilemmas involved when, pharmaceutical companies market their products was discussed earlier this month at the annual PharmedOut conference, which investigated how industry influences medical discourse.
Alan Schwarz, the author of ADHD Nation, exposed how drug companies have, often covertly, sponsored educational resources and patient advocacy groups. These groups face a difficult conflict of interest: by accepting drug company funding, they can increase their reach to those looking for resources; however, their neutrality is compromised, particularly when they fail to disclose the funding source. The New England Journal of Medicine reports that pharmaceutical industry-sponsored advocacy groups may be likely to support drugs, as well as policy proposals, that cater to their sponsors’ financial interests.
One such pharmaceutical company is Shire. One of the British company’s highest-grossing products is Adderall, a stimulant used in treating ADHD that has earned the company billions in sales to date. Shire sponsors ADHD patient-advocacy groups, like Children and Adults with ADHD (CHADD).
The article is here.
Monday, July 10, 2017
Big Pharma gives your doctor gifts. Then your doctor gives you Big Pharma’s drugs
Nicole Van Groningen
The Washington Post
Originally posted June 13, 2017
Here is an excerpt:
The losers in this pharmaceutical industry-physician interaction are, of course, patients. The high costs of branded drugs are revenue to drug companies, but out-of-pocket expenses to health-care consumers. Almost a quarter of Americans who take prescription drugs report that they have difficulty affording their medications, and the high costs of these drugs is a leading reason that patients can’t adhere to them. Most branded drugs offer minimal — if any — benefit over generic formulations. And if doctors prescribe brand-name drugs that are prohibitively more expensive than generic options, patients might forgo the medications altogether — causing greater harm.
On a national scale, the financial burden imposed by branded drugs is enormous. Current estimates place our prescription drug spending at more than $400 billion annually, and branded drugs are almost entirely to blame: Though they constitute only 10 percent of prescriptions, they account for 72 percent of total drug spending. Even modest reductions in our use of branded prescription drugs — on par with the roughly 8 percent relative reduction seen in the JAMA study — could translate to billions of dollars in national health-care savings.
The article is here.
The Washington Post
Originally posted June 13, 2017
Here is an excerpt:
The losers in this pharmaceutical industry-physician interaction are, of course, patients. The high costs of branded drugs are revenue to drug companies, but out-of-pocket expenses to health-care consumers. Almost a quarter of Americans who take prescription drugs report that they have difficulty affording their medications, and the high costs of these drugs is a leading reason that patients can’t adhere to them. Most branded drugs offer minimal — if any — benefit over generic formulations. And if doctors prescribe brand-name drugs that are prohibitively more expensive than generic options, patients might forgo the medications altogether — causing greater harm.
On a national scale, the financial burden imposed by branded drugs is enormous. Current estimates place our prescription drug spending at more than $400 billion annually, and branded drugs are almost entirely to blame: Though they constitute only 10 percent of prescriptions, they account for 72 percent of total drug spending. Even modest reductions in our use of branded prescription drugs — on par with the roughly 8 percent relative reduction seen in the JAMA study — could translate to billions of dollars in national health-care savings.
The article is here.
Friday, January 13, 2017
Gifts and influence: Conflict of interest policies and prescribing of psychotropic medications in the United States
Marissa King and Peter S. Bearman
Social Science & Medicine
Volume 172, January 2017, Pages 153–162
Abstract
The pharmaceutical industry spends roughly 15 billion dollars annually on detailing – providing gifts, information, samples, trips, honoraria and other inducements – to physicians in order to encourage them to prescribe their drugs. In response, several states in the United States adopted policies that restrict detailing. Some states banned gifts from pharmaceutical companies to doctors, other states simply required physicians to disclose the gifts they receive, while most states allowed unrestricted detailing. We exploit this geographic variation to examine the relationship between gift regulation and the diffusion of four newly marketed medications. Using a dataset that captures 189 million psychotropic prescriptions written between 2005 and 2009, we find that uptake of new costly medications was significantly lower in states with marketing regulation than in areas that allowed unrestricted pharmaceutical marketing. In states with gift bans, we observed reductions in market shares ranging from 39% to 83%. Policies banning or restricting gifts were associated with the largest reductions in uptake. Disclosure policies were associated with a significantly smaller reduction in prescribing than gift bans and gift restrictions. In states that ban gift-giving, peer influence substituted for pharmaceutical detailing when a relatively beneficial drug came to market and provided a less biased channel for physicians to learn about new medications. Our work suggests that policies banning or limiting gifts from pharmaceutical representatives to doctors are likely to be more effective than disclosure policies alone.
The article is here.
Social Science & Medicine
Volume 172, January 2017, Pages 153–162
Abstract
The pharmaceutical industry spends roughly 15 billion dollars annually on detailing – providing gifts, information, samples, trips, honoraria and other inducements – to physicians in order to encourage them to prescribe their drugs. In response, several states in the United States adopted policies that restrict detailing. Some states banned gifts from pharmaceutical companies to doctors, other states simply required physicians to disclose the gifts they receive, while most states allowed unrestricted detailing. We exploit this geographic variation to examine the relationship between gift regulation and the diffusion of four newly marketed medications. Using a dataset that captures 189 million psychotropic prescriptions written between 2005 and 2009, we find that uptake of new costly medications was significantly lower in states with marketing regulation than in areas that allowed unrestricted pharmaceutical marketing. In states with gift bans, we observed reductions in market shares ranging from 39% to 83%. Policies banning or restricting gifts were associated with the largest reductions in uptake. Disclosure policies were associated with a significantly smaller reduction in prescribing than gift bans and gift restrictions. In states that ban gift-giving, peer influence substituted for pharmaceutical detailing when a relatively beneficial drug came to market and provided a less biased channel for physicians to learn about new medications. Our work suggests that policies banning or limiting gifts from pharmaceutical representatives to doctors are likely to be more effective than disclosure policies alone.
The article is here.
Friday, July 29, 2016
When Doctors Have Conflicts of Interest
By Mikkael A. Sekeres
The New York Times - Well Blog
Originally posted June 29, 2016
Here is an excerpt:
What if, instead, the drug for which she provided advice is already commercially available. How much is her likelihood of prescribing this medication – what we call a conflict of commitment – influenced by her having been given an honorarium by the manufacturer for her advice about this or another drug made by the same company?
We know already that doctors are influenced in their prescribing patterns even by tchotchkes like pens or free lunches. One recent study of almost 280,000 physicians who received over 63,000 payments, most of which were in the form of free meals worth under $20, showed that these doctors were more likely to prescribe the blood pressure, cholesterol or antidepressant medication promoted as part of that meal than other medications in the same class of drugs. Are these incentives really enough to encroach on our sworn obligation to do what’s best for our patients, irrespective of outside influences? Perhaps, and that’s the reason many hospitals ban them.
In both scenarios the doctor should, at the very least, have to disclose the conflict to patients, either on a website, where patients could easily view it, or by informing them directly, as my mother-in-law’s doctor did to her.
The article is here.
The New York Times - Well Blog
Originally posted June 29, 2016
Here is an excerpt:
What if, instead, the drug for which she provided advice is already commercially available. How much is her likelihood of prescribing this medication – what we call a conflict of commitment – influenced by her having been given an honorarium by the manufacturer for her advice about this or another drug made by the same company?
We know already that doctors are influenced in their prescribing patterns even by tchotchkes like pens or free lunches. One recent study of almost 280,000 physicians who received over 63,000 payments, most of which were in the form of free meals worth under $20, showed that these doctors were more likely to prescribe the blood pressure, cholesterol or antidepressant medication promoted as part of that meal than other medications in the same class of drugs. Are these incentives really enough to encroach on our sworn obligation to do what’s best for our patients, irrespective of outside influences? Perhaps, and that’s the reason many hospitals ban them.
In both scenarios the doctor should, at the very least, have to disclose the conflict to patients, either on a website, where patients could easily view it, or by informing them directly, as my mother-in-law’s doctor did to her.
The article is here.
Saturday, August 22, 2015
A Quantitative Analysis of Undisclosed Conflicts of Interest in Pharmacology Textbooks
Piper BJ, Telku HM, Lambert DA (2015) A Quantitative Analysis of Undisclosed Conflicts of Interest in Pharmacology Textbooks. PLoS ONE 10(7): e0133261. doi:10.1371/journal.pone.0133261
Abstract
Background
Disclosure of potential conflicts of interest (CoI) is a standard practice for many biomedical journals but not for educational materials. The goal of this investigation was to determine whether the authors of pharmacology textbooks have undisclosed financial CoIs and to identify author characteristics associated with CoIs.
Methods and Findings
The presence of potential CoIs was evaluated by submitting author names (N = 403; 36.3% female) to a patent database (Google Scholar) as well as a database that reports on the compensation ($USD) received from 15 pharmaceutical companies (ProPublica’s Dollars for Docs). All publications (N = 410) of the ten highest compensated authors from 2009 to 2013 and indexed in Pubmed were also examined for disclosure of additional companies that the authors received research support, consulted, or served on speaker’s bureaus. A total of 134 patents had been awarded (Maximum = 18/author) to textbook authors. Relative to DiPiro’s Pharmacotherapy: A Pathophysiologic Approach, contributors to Goodman and Gilman’s Pharmacological Basis of Therapeutics and Katzung’s Basic and Clinical Pharmacology were more frequently patent holders (OR = 6.45, P < .0005). Female authors were less likely than males to have > 1 patent (OR = 0.15, P < .0005). A total of $2,411,080 USD (28.3% for speaking, 27.0% for consulting, and 23.9% for research), was received by 53 authors (Range = $299 to $310,000/author). Highly compensated authors were from multiple fields including oncology, psychiatry, neurology, and urology. The maximum number of additional companies, not currently indexed in the Dollars for Docs database, for which an author had potential CoIs was 73.
Conclusions
Financial CoIs are common among the authors of pharmacology and pharmacotherapy textbooks. Full transparency of potential CoIs, particularly patents, should become standard procedure for future editions of educational materials in pharmacology.
The entire article is here.
Abstract
Background
Disclosure of potential conflicts of interest (CoI) is a standard practice for many biomedical journals but not for educational materials. The goal of this investigation was to determine whether the authors of pharmacology textbooks have undisclosed financial CoIs and to identify author characteristics associated with CoIs.
Methods and Findings
The presence of potential CoIs was evaluated by submitting author names (N = 403; 36.3% female) to a patent database (Google Scholar) as well as a database that reports on the compensation ($USD) received from 15 pharmaceutical companies (ProPublica’s Dollars for Docs). All publications (N = 410) of the ten highest compensated authors from 2009 to 2013 and indexed in Pubmed were also examined for disclosure of additional companies that the authors received research support, consulted, or served on speaker’s bureaus. A total of 134 patents had been awarded (Maximum = 18/author) to textbook authors. Relative to DiPiro’s Pharmacotherapy: A Pathophysiologic Approach, contributors to Goodman and Gilman’s Pharmacological Basis of Therapeutics and Katzung’s Basic and Clinical Pharmacology were more frequently patent holders (OR = 6.45, P < .0005). Female authors were less likely than males to have > 1 patent (OR = 0.15, P < .0005). A total of $2,411,080 USD (28.3% for speaking, 27.0% for consulting, and 23.9% for research), was received by 53 authors (Range = $299 to $310,000/author). Highly compensated authors were from multiple fields including oncology, psychiatry, neurology, and urology. The maximum number of additional companies, not currently indexed in the Dollars for Docs database, for which an author had potential CoIs was 73.
Conclusions
Financial CoIs are common among the authors of pharmacology and pharmacotherapy textbooks. Full transparency of potential CoIs, particularly patents, should become standard procedure for future editions of educational materials in pharmacology.
The entire article is here.
Monday, August 17, 2015
Doctors got $84M from drug companies
By Lauryn Schroeder
The San Diego Union Tribune
Originally published July 29, 2015
Doctors in San Diego County received $84 million in payouts from drug and medical device companies last year, according to federal data.
Health professionals received payments for services such as consulting, promotional speaking and research, as well as gifts in the form of meals and entertainment, according to a review of federal data by The San Diego Union-Tribune. More than 107,000 transactions were documented.
The information is being gathered and disclosed as part of a federal effort to bring more transparency to relationships that could lead to conflicts of interest, if doctors take money or gifts and then prescribe certain drugs.
The San Diego data was dominated by some larger transactions, such as a doctor collecting royalties on an invention, or a La Jolla couple who recently sold their medical device maker to one of the large drug companies.
The entire article is here.
The San Diego Union Tribune
Originally published July 29, 2015
Doctors in San Diego County received $84 million in payouts from drug and medical device companies last year, according to federal data.
Health professionals received payments for services such as consulting, promotional speaking and research, as well as gifts in the form of meals and entertainment, according to a review of federal data by The San Diego Union-Tribune. More than 107,000 transactions were documented.
The information is being gathered and disclosed as part of a federal effort to bring more transparency to relationships that could lead to conflicts of interest, if doctors take money or gifts and then prescribe certain drugs.
The San Diego data was dominated by some larger transactions, such as a doctor collecting royalties on an invention, or a La Jolla couple who recently sold their medical device maker to one of the large drug companies.
The entire article is here.
Saturday, December 28, 2013
Before The Prescription, Ask About Your Doctor's Finances
By Leana Wen
News from NPR
Originally posted December 14, 2013
Here is an excerpt:
Unfortunately, doctors have biases, too. A 2007 study in The New England Journal of Medicine found that the vast majority of doctors have some kind of relationship with with a pharmaceutical or medical-device company. Most of the time, the ties involved free food or drug samples. Dozens of studies have demonstrated that even innocuous-seeming inducements like these can influence doctors' prescription practices.
While doctors are required to disclose potential financial conflicts to each other at scientific conferences, they don't have to disclose them to their patients.
As a result, 4 in 5 patients say they are unaware of their doctors' financial incentives. Those who do know often find out inadvertently.
The entire story is here.
News from NPR
Originally posted December 14, 2013
Here is an excerpt:
Unfortunately, doctors have biases, too. A 2007 study in The New England Journal of Medicine found that the vast majority of doctors have some kind of relationship with with a pharmaceutical or medical-device company. Most of the time, the ties involved free food or drug samples. Dozens of studies have demonstrated that even innocuous-seeming inducements like these can influence doctors' prescription practices.
While doctors are required to disclose potential financial conflicts to each other at scientific conferences, they don't have to disclose them to their patients.
As a result, 4 in 5 patients say they are unaware of their doctors' financial incentives. Those who do know often find out inadvertently.
The entire story is here.
Wednesday, October 30, 2013
Pharmaceutical firms paid to attend meetings of panel that advises FDA
By Peter Whoriskey
The Washington Post
Originally published October 8, 2013
A scientific panel that shaped the federal government’s policy for testing the safety and effectiveness of painkillers was funded by major pharmaceutical companies that paid hundreds of thousands of dollars for the chance to affect the thinking of the Food and Drug Administration, according to hundreds of e-mails obtained by a public records request.
The e-mails show that the companies paid as much as $25,000 to attend any given meeting of the panel, which had been set up by two academics to provide advice to the FDA on how to weigh the evidence from clinical trials. A leading FDA official later called the group “an essential collaborative effort.”
Patient advocacy groups said the electronic communications suggest that the regulators had become too close to the companies trying to crack into the $9 billion painkiller market in the United States.
The entire article is here.
The Washington Post
Originally published October 8, 2013
A scientific panel that shaped the federal government’s policy for testing the safety and effectiveness of painkillers was funded by major pharmaceutical companies that paid hundreds of thousands of dollars for the chance to affect the thinking of the Food and Drug Administration, according to hundreds of e-mails obtained by a public records request.
The e-mails show that the companies paid as much as $25,000 to attend any given meeting of the panel, which had been set up by two academics to provide advice to the FDA on how to weigh the evidence from clinical trials. A leading FDA official later called the group “an essential collaborative effort.”
Patient advocacy groups said the electronic communications suggest that the regulators had become too close to the companies trying to crack into the $9 billion painkiller market in the United States.
The entire article is here.
Tuesday, October 22, 2013
A Few Predictions on the Sunshine Act
By Genevieve Pham-Kanter
The Lab @ Edmond J. Safra Center for Ethics - Harvard
The Sunshine Act–for those of you who did not meticulously read all 11,000 sections of Bill HR 3590–is that part of last year's health care reform law that requires pharmaceutical and medical device manufacturers to report payments that they make to doctors for consulting services, speaking, meals, research grants, and other gifts of monetary value.
These payments have long been cause for concern because of their potential to influence the prescribing and research practices of payment recipients (for background, see this Institute of Medicine report). Surely requiring the disclosure of these potentially distorting payments would be a good thing; what more needs to be said?
The entire story is here.
The Lab @ Edmond J. Safra Center for Ethics - Harvard
The Sunshine Act–for those of you who did not meticulously read all 11,000 sections of Bill HR 3590–is that part of last year's health care reform law that requires pharmaceutical and medical device manufacturers to report payments that they make to doctors for consulting services, speaking, meals, research grants, and other gifts of monetary value.
These payments have long been cause for concern because of their potential to influence the prescribing and research practices of payment recipients (for background, see this Institute of Medicine report). Surely requiring the disclosure of these potentially distorting payments would be a good thing; what more needs to be said?
The entire story is here.
Friday, May 24, 2013
Doctors’ Lucrative Industry Ties
By Roni Caryn Rabin
The New York Times - The Consumer Blog
Originally published May 13, 2013
Dr. Alfred J. Tria is the chief of orthopedic surgery at St. Peter’s University Hospital, a 478-bed facility in New Brunswick, N.J., and to the medical technology company Smith & Nephew, his good word is worth a million bucks. Well, $940,857, to be precise.
That’s how much the company paid Dr. Tria in fees for promoting its products and training doctors in Asia to use them from 2009 to 2011, according to disclosures required by the state of Massachusetts, where Dr. Tria is licensed. In 2010, Dr. Tria earned $421,905 from private industry — more than any other Massachusetts-licensed physician that year.
Dr. Tria may be an outlier, but gifts and payments to physicians from drug and medical device companies have been rampant in medicine for decades. Over a two-and-a-half-year period, device and drug companies shelled out over $76 million just to physicians licensed in Massachusetts, according to a study published online this month in The New England Journal of Medicine. That amount does not include outlays of less than $50, which are exempt from disclosure.
The entire story is here.
The New York Times - The Consumer Blog
Originally published May 13, 2013
Dr. Alfred J. Tria is the chief of orthopedic surgery at St. Peter’s University Hospital, a 478-bed facility in New Brunswick, N.J., and to the medical technology company Smith & Nephew, his good word is worth a million bucks. Well, $940,857, to be precise.
That’s how much the company paid Dr. Tria in fees for promoting its products and training doctors in Asia to use them from 2009 to 2011, according to disclosures required by the state of Massachusetts, where Dr. Tria is licensed. In 2010, Dr. Tria earned $421,905 from private industry — more than any other Massachusetts-licensed physician that year.
Dr. Tria may be an outlier, but gifts and payments to physicians from drug and medical device companies have been rampant in medicine for decades. Over a two-and-a-half-year period, device and drug companies shelled out over $76 million just to physicians licensed in Massachusetts, according to a study published online this month in The New England Journal of Medicine. That amount does not include outlays of less than $50, which are exempt from disclosure.
The entire story is here.
Tuesday, May 21, 2013
DSM-IV Boss Presses Attack on New Revision
By John Gever, Deputy Managing Editor
MedPage Today
Published: May 17, 2013
A new edition of psychiatry's diagnostic guide "will probably lead to substantial false-positive rates and unnecessary treatment," charged the man who led development of the last version.
To be released this weekend at the American Psychiatric Association's annual meeting, the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, or DSM-5, "introduce[s] several high-prevalence diagnoses at the fuzzy boundary with normality," according to Allen Frances, MD, who chaired the task force responsible for DSM-IV issued in 1994.
Frances, now an emeritus professor at Duke University, wrote online in Annals of Internal Medicine that changes from DSM-IV will apply disease labels to individuals who may be unhappy or offensive but still normal. Such individuals would include those experiencing "the forgetfulness of old age" as well as children with severe, chronic temper tantrums and individuals with physical symptoms with no medical explanation.
He also worried about new marketing pushes from the pharmaceutical industry seeking to exploit what he believes are "loose" diagnostic criteria in the new edition. "Drug companies take marketing advantage of the loose DSM definitions by promoting the misleading idea that everyday life problems are actually undiagnosed psychiatric illness caused by a chemical imbalance and requiring a solution in pill form," he wrote.
The entire article is here.
MedPage Today
Published: May 17, 2013
A new edition of psychiatry's diagnostic guide "will probably lead to substantial false-positive rates and unnecessary treatment," charged the man who led development of the last version.
To be released this weekend at the American Psychiatric Association's annual meeting, the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, or DSM-5, "introduce[s] several high-prevalence diagnoses at the fuzzy boundary with normality," according to Allen Frances, MD, who chaired the task force responsible for DSM-IV issued in 1994.
Frances, now an emeritus professor at Duke University, wrote online in Annals of Internal Medicine that changes from DSM-IV will apply disease labels to individuals who may be unhappy or offensive but still normal. Such individuals would include those experiencing "the forgetfulness of old age" as well as children with severe, chronic temper tantrums and individuals with physical symptoms with no medical explanation.
He also worried about new marketing pushes from the pharmaceutical industry seeking to exploit what he believes are "loose" diagnostic criteria in the new edition. "Drug companies take marketing advantage of the loose DSM definitions by promoting the misleading idea that everyday life problems are actually undiagnosed psychiatric illness caused by a chemical imbalance and requiring a solution in pill form," he wrote.
The entire article is here.
Monday, May 6, 2013
US sues Novartis in NY again, cites doc kickbacks
By The Associated Press at The Wall Street Journal
Originally published on April 26, 2013
The U.S. government sued Novartis Pharmaceuticals Corp. again on Friday, saying it paid kickbacks for a decade to doctors to steer patients toward its drugs, sometimes disguising fishing trips off the Florida coast and trips to Hooters restaurants as speaking engagements for the doctors.
The lawsuit in U.S. District Court in Manhattan came two days after the government brought a similar lawsuit against Novartis, which is based in East Hanover, N.J.
The first lawsuit said the company paid kickbacks to pharmacies to switch kidney transplant patients from competitors' drugs to its own.
In the second lawsuit, the government accused the company of using from 2001 through 2011 multimillion-dollar "incentive programs" that targeted doctors willing to accept illegal kickbacks to urge patients to use the company's drugs.
"And for its investment, Novartis reaped dramatically increased profits on these drugs, and Medicare, Medicaid and other federal health care programs were left holding the bag," U.S. Attorney Preet Bharara said in a statement.
Novartis President Andre Wyss said the company disagreed with the way the government characterized its conduct and stands behind its compliance program.
The entire story is here.
Originally published on April 26, 2013
The U.S. government sued Novartis Pharmaceuticals Corp. again on Friday, saying it paid kickbacks for a decade to doctors to steer patients toward its drugs, sometimes disguising fishing trips off the Florida coast and trips to Hooters restaurants as speaking engagements for the doctors.
The lawsuit in U.S. District Court in Manhattan came two days after the government brought a similar lawsuit against Novartis, which is based in East Hanover, N.J.
The first lawsuit said the company paid kickbacks to pharmacies to switch kidney transplant patients from competitors' drugs to its own.
In the second lawsuit, the government accused the company of using from 2001 through 2011 multimillion-dollar "incentive programs" that targeted doctors willing to accept illegal kickbacks to urge patients to use the company's drugs.
"And for its investment, Novartis reaped dramatically increased profits on these drugs, and Medicare, Medicaid and other federal health care programs were left holding the bag," U.S. Attorney Preet Bharara said in a statement.
Novartis President Andre Wyss said the company disagreed with the way the government characterized its conduct and stands behind its compliance program.
The entire story is here.
Sunday, April 7, 2013
Psychiatrists Top List of Big Pharma Payments Again
By Deborah Brauser
Medscape Medical News
Originally published March 14, 2013
Once again, psychiatrists top the updated Dollars for Docs list of large payments from pharmaceutical companies to individual US clinicians.
On March 12, the investigative journalism group ProPublica released the names of the 22 physicians who, since 2009, received more than $500,000 from these companies in speaking and consulting fees. Mirroring the organization's first report released in 2010, psychiatrists dominate the list.
This time, the top recipient was Jon Draud, MD, medical director of the psychiatric and addiction medicine program at Baptist Hospital in Nashville, Tennessee, and from the Middle Tennessee Medical Center in Murfreesboro.
(cut)
APA Reaction
"My immediate, honest response was that this boggles the mind," James Scully, MD, CEO of the American Psychiatric Association (APA), told Medscape Medical News.
The entire story is here.
Thanks to Ed Zuckerman for this story.
Medscape Medical News
Originally published March 14, 2013
Once again, psychiatrists top the updated Dollars for Docs list of large payments from pharmaceutical companies to individual US clinicians.
On March 12, the investigative journalism group ProPublica released the names of the 22 physicians who, since 2009, received more than $500,000 from these companies in speaking and consulting fees. Mirroring the organization's first report released in 2010, psychiatrists dominate the list.
This time, the top recipient was Jon Draud, MD, medical director of the psychiatric and addiction medicine program at Baptist Hospital in Nashville, Tennessee, and from the Middle Tennessee Medical Center in Murfreesboro.
(cut)
APA Reaction
"My immediate, honest response was that this boggles the mind," James Scully, MD, CEO of the American Psychiatric Association (APA), told Medscape Medical News.
The entire story is here.
Thanks to Ed Zuckerman for this story.
Tuesday, December 6, 2011
Pfizer Settlement on Foreign Bribery Charges
By Christopher Matthews
The Wall Street Journal Blogs
So that’s how it got started.
The government’s sprawling foreign bribery sweep into the pharmaceutical industry was built, in a large part, on information Pfizer Inc. and Johnson & Johnson provided about their competitors, according to a story in the Wall Street Journal Monday.
Not surprisingly, ratting on your competitors has its rewards.
Pfizer will pay more than $60 million to settle alleged violations of the U.S. Foreign Corrupt Practices Act, according to people familiar with the matter. The sum could have been higher had Pfizer not cooperated with the Department of Justice and the Securities and Exchange Commission. Johnson & Johnson agreed to pay $70 million in April to settle its FCPA probe, and likewise benefited from dropping a dime on its competitors.
The two companies’ cooperation contributed to a government investigation that has affected several major drug companies, also including Merck & Co., AstraZeneca PLC, Bristol-Myers Squibb Co. and GlaxoSmithKline PLC, according to the people familiar with the investigations. The four companies last year said in regulatory filings that they received letters of inquiry from the Justice Department and the SEC. The companies have said they are cooperating with investigators.
The entire story is here.
The Wall Street Journal Blogs
So that’s how it got started.
Not surprisingly, ratting on your competitors has its rewards.
Pfizer will pay more than $60 million to settle alleged violations of the U.S. Foreign Corrupt Practices Act, according to people familiar with the matter. The sum could have been higher had Pfizer not cooperated with the Department of Justice and the Securities and Exchange Commission. Johnson & Johnson agreed to pay $70 million in April to settle its FCPA probe, and likewise benefited from dropping a dime on its competitors.
The two companies’ cooperation contributed to a government investigation that has affected several major drug companies, also including Merck & Co., AstraZeneca PLC, Bristol-Myers Squibb Co. and GlaxoSmithKline PLC, according to the people familiar with the investigations. The four companies last year said in regulatory filings that they received letters of inquiry from the Justice Department and the SEC. The companies have said they are cooperating with investigators.
The entire story is here.
Tuesday, July 5, 2011
Psychiatrists Sanctioned over Consulting Fees
By Liz KowalczykBoston Globe Staff
Concluding a three-year investigation, Massachusetts General Hospital and Harvard Medical School sanctioned renowned child psychiatrist Dr. Joseph Biederman and two colleagues after finding they violated conflict of interest rules.
In a letter to coworkers yesterday, Biederman and Drs. Thomas Spencer and Timothy Wilens said the hospital and medical school “have determined that we violated certain requirements’’ of the institutions’ policies.
They did not specify the nature of the violations. But in 2008, Senator Charles Grassley, an Iowa Republican, accused the three doctors of accepting millions of dollars in consulting fees from drug makers from 2000 to 2007, and of failing for years to report much of the income to university officials.
Officials at Harvard and Mass. General released the letter to the Globe, but would not answer questions about the probe. Biederman, Spencer, Wilens, and their lawyers did not return phone calls and e-mails. Grassley’s office did not return calls seeking comment.
Physicians are required to disclose payments from pharmaceutical and medical device companies so that hospital and university officials can police potential conflicts of interest that may create bias in research or in the treatment of patients, or the appearance of bias.
Grassley’s investigation sparked the Mass. General and Harvard inquiries.
They said the institutions imposed remedial actions, requiring them to refrain from all paid industry-sponsored outside activities for one year, with an additional two-year monitoring period during which they must obtain approval before engaging in paid activities. They were also required to undergo unspecified additional training and suffer “a delay of consideration for promotion or advancement.’’
Physicians said it is difficult to know if the sanctions are appropriate without knowing the Harvard and Mass. General findings.
“It’s hard for me to make that judgment, but this all sounds like a little slap on the wrist,’’ said Dr. Jerome Kassirer, a Tufts University School of Medicine professor and outspoken critic of close ties between the drug industry and physicians. He pointed out that Biederman is a full professor at Harvard Medical School, so it’s unclear how a delay in promotion or advancement would affect him. Also, Biederman severed his industry ties soon after Mass. General and Harvard began their separate but coordinated investigations.
The rest of the story can be found here.
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