A pill to dampen memories stirs hope and worry.
By Emily Anthes
Nautilus
Originally posted July 17, 2014
Here is an excerpt:
However, promising studies have also stirred controversy, with some bioethicists warning that memory-dulling drugs could have profound, unintended consequences for our psyches and our society. The debate is raising tricky questions about what—and who—memory is for. The European Union’s highest court recently ruled that, at least when it comes to the Internet, we all have the “right to be forgotten” for things no longer relevant. Do we also have the right to forget?
The entire article is here.
Showing posts with label Pharmaceuticals. Show all posts
Showing posts with label Pharmaceuticals. Show all posts
Friday, August 8, 2014
Sunday, August 3, 2014
Prisons are Unable to Afford New Effective Hep C Medication
Prisoners Unlikely to Benefit from New, Highly Effective Hepatitis C Treatment
Prison Legal News
Originally posted July 9, 2014
by Greg Dober
Hepatitis C (HCV) is a blood-borne virus that is typically spread through intravenous drug use (i.e., sharing needles), tattooing with non-sterile needles, and sharing razors, toothbrushes, nail clippers or other hygiene items that may be exposed to blood. It is often a chronic disease and, if left untreated, can lead to severe liver damage.
Recent good news in the battle against HCV, in the form of two new drugs that are highly effective in eliminating the virus, is tempered by the fact that the companies that produce the drugs have priced them at $60,000 to $80,000 per 12-week course of treatment. This high cost prices the medications beyond the reach of most prison and jail systems – which is especially troubling considering that a substantial number of prisoners are infected with HCV.
The entire article is here.
Prison Legal News
Originally posted July 9, 2014
by Greg Dober
Hepatitis C (HCV) is a blood-borne virus that is typically spread through intravenous drug use (i.e., sharing needles), tattooing with non-sterile needles, and sharing razors, toothbrushes, nail clippers or other hygiene items that may be exposed to blood. It is often a chronic disease and, if left untreated, can lead to severe liver damage.
Recent good news in the battle against HCV, in the form of two new drugs that are highly effective in eliminating the virus, is tempered by the fact that the companies that produce the drugs have priced them at $60,000 to $80,000 per 12-week course of treatment. This high cost prices the medications beyond the reach of most prison and jail systems – which is especially troubling considering that a substantial number of prisoners are infected with HCV.
The entire article is here.
Saturday, June 7, 2014
The ethics of personal enhancement, from beta blockers to ADHD drugs
By Joe Gelonesi
The Philosopher's Zone
Originally posted May 16, 2014
Here is an excerpt:
It’s a question for the times, as the cognitive enhancement revolution rolls on. The use of substances to help with performance—from sitting exams to playing recitals—has well and truly gone beyond novelty status.
Drugs previously reserved for ADHD are now being imbibed by students to sharpen performance. There is no shortage of first-person testimony mixed with consumer advice on YouTube. Vincent cites studies in Australia which suggest that our appetite for such drugs is greater than in the USA. She also uses the example of Simon Tedeschi, who in January published an article about his extensive use of beta blockers to subdue stage fright. Tedeschi, an esteemed local musician, has no qualms about coming out over his use of what is primarily intended as blood pressure medication. He’s not alone in the performing arts community.
The entire story is here.
The Philosopher's Zone
Originally posted May 16, 2014
Here is an excerpt:
It’s a question for the times, as the cognitive enhancement revolution rolls on. The use of substances to help with performance—from sitting exams to playing recitals—has well and truly gone beyond novelty status.
Drugs previously reserved for ADHD are now being imbibed by students to sharpen performance. There is no shortage of first-person testimony mixed with consumer advice on YouTube. Vincent cites studies in Australia which suggest that our appetite for such drugs is greater than in the USA. She also uses the example of Simon Tedeschi, who in January published an article about his extensive use of beta blockers to subdue stage fright. Tedeschi, an esteemed local musician, has no qualms about coming out over his use of what is primarily intended as blood pressure medication. He’s not alone in the performing arts community.
The entire story is here.
Tuesday, May 6, 2014
Record numbers on 'happy pills'
Psychiatrists warning over soaring use of pills in 'depressed Britain'
By Laura Donnelley
The Telegraph
Originally posted April 20, 2014
Britons are taking anti-depressants in greater quantities than ever before, new figures have disclosed, with a near 25 per cent rise in prescriptions in the last three years alone.
According to official NHS data, more than 53 million prescriptions were handed out for drugs such as Prozac and Seroxat in England last year - a record high, and a rise of 24.6 per cent since 2010.
The entire story is here.
By Laura Donnelley
The Telegraph
Originally posted April 20, 2014
Britons are taking anti-depressants in greater quantities than ever before, new figures have disclosed, with a near 25 per cent rise in prescriptions in the last three years alone.
According to official NHS data, more than 53 million prescriptions were handed out for drugs such as Prozac and Seroxat in England last year - a record high, and a rise of 24.6 per cent since 2010.
The entire story is here.
Saturday, April 5, 2014
Are We Obligated to Make Ourselves More Moral and Intelligent? (Part One)
By J. Hughes
Ethical Technology
Originally posted March 13, 2014
Most of the ethical discussion of the use of stimulant drugs without a prescription in education has been negative, associating their use with performance enhancement in sports and with drug abuse. But the use of stimulants as study drugs actually has few side effects, and is almost entirely applied to the student’s primary obligation, academic performance. In this I consider some objections to off-label stimulant use, and to stimulant therapy for ADD, and argue that there are ethical arguments for the use of stimulants, and for future cognitively and morally enhancing therapies, in education, the work place, and daily life.
In recent years, as the diagnosis of ADD has become more common, and increasing numbers of adults have begun taking stimulant medications as a treatment for ADD, or without a prescription as a study aid, there have been calls for stricter regulation of the diagnosis and the drugs. People have suggested that the treatment of ADD with stimulants is a conspiracy of pharmaceutical capitalists in league with dubious pediatricians, when the real cause of inattentiveness is allegedly a dysfunctional industrial era educational system obsessed with standardized testing. The alleged risks of the use by adults without prescriptions have been hyped, and the "users vilified as "cheaters" contributing to a pharmaceutical arms race.
The entire article is here.
Ethical Technology
Originally posted March 13, 2014
Most of the ethical discussion of the use of stimulant drugs without a prescription in education has been negative, associating their use with performance enhancement in sports and with drug abuse. But the use of stimulants as study drugs actually has few side effects, and is almost entirely applied to the student’s primary obligation, academic performance. In this I consider some objections to off-label stimulant use, and to stimulant therapy for ADD, and argue that there are ethical arguments for the use of stimulants, and for future cognitively and morally enhancing therapies, in education, the work place, and daily life.
In recent years, as the diagnosis of ADD has become more common, and increasing numbers of adults have begun taking stimulant medications as a treatment for ADD, or without a prescription as a study aid, there have been calls for stricter regulation of the diagnosis and the drugs. People have suggested that the treatment of ADD with stimulants is a conspiracy of pharmaceutical capitalists in league with dubious pediatricians, when the real cause of inattentiveness is allegedly a dysfunctional industrial era educational system obsessed with standardized testing. The alleged risks of the use by adults without prescriptions have been hyped, and the "users vilified as "cheaters" contributing to a pharmaceutical arms race.
The entire article is here.
Sunday, March 9, 2014
How A Big Drug Company Inadvertently Got Americans Hooked On Heroin
By Jillian Berman
The Huffington Post
Originally posted February 24, 2014
Here is an excerpt:
In recent years, more prescription drug abusers have started turning to heroin for a cheaper high as the price of pills skyrockets on the black market, Bunt said. Two factors have contributed to the cost increase: opioid addiction boosting demand and doctors becoming more cautious about prescribing opioids, decreasing supply, Bunt said.
Another reason for the price increase: The Drug War, according to a January 2012 report from Radley Balko. Government crackdowns have made it difficult for even reputable doctors to prescribe pain pills. To fill the void, doctors and others looking to make a buck off the prescription pills created so-called "pill mills" -- offices that prescribe pain medication in high volume and often serve people addicted to the drugs.
The entire article is here.
The Huffington Post
Originally posted February 24, 2014
Here is an excerpt:
In recent years, more prescription drug abusers have started turning to heroin for a cheaper high as the price of pills skyrockets on the black market, Bunt said. Two factors have contributed to the cost increase: opioid addiction boosting demand and doctors becoming more cautious about prescribing opioids, decreasing supply, Bunt said.
Another reason for the price increase: The Drug War, according to a January 2012 report from Radley Balko. Government crackdowns have made it difficult for even reputable doctors to prescribe pain pills. To fill the void, doctors and others looking to make a buck off the prescription pills created so-called "pill mills" -- offices that prescribe pain medication in high volume and often serve people addicted to the drugs.
The entire article is here.
Thursday, February 20, 2014
The DSM-5: A Vehicle For High-Profit Patent Extensions?
Gregg Fields & Lisa Cosgrove | Labcast
Harvard University SoundCloud Podcast
The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders affects drugs with sales in the billions of dollars. In research supported by the Edmond J. Safra Center for Ethics, Lisa Cosgrove of UMass-Boston investigated financial ties between DSM panel members and the pharmaceutical companies that have a vested interest in finding new indications for their blockbuster drugs. In this podcast, she tells journalist Gregg Fields what she found, what it means—and why we all should care.
"Tripartite Conflicts of Interest and High Stakes Patent Extensions in the DSM-5," Psychotherapy and Psychosomatics.
Harvard University SoundCloud Podcast
The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders affects drugs with sales in the billions of dollars. In research supported by the Edmond J. Safra Center for Ethics, Lisa Cosgrove of UMass-Boston investigated financial ties between DSM panel members and the pharmaceutical companies that have a vested interest in finding new indications for their blockbuster drugs. In this podcast, she tells journalist Gregg Fields what she found, what it means—and why we all should care.
"Tripartite Conflicts of Interest and High Stakes Patent Extensions in the DSM-5," Psychotherapy and Psychosomatics.
Thursday, January 23, 2014
Evidence based medicine is broken
By Des Spence
BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g22 (Published 3 January 2014)
Cite this as: BMJ 2014;348:g22
Evidence based medicine (EBM) wrong footed the drug industry for a while in the 1990s. We could fend off the army of pharmaceutical representatives because often their promotional material was devoid of evidence. But the drug industry came to realise that EBM was an opportunity rather than a threat. Research, especially when published in a prestigious journal, was worth more than thousands of sales representatives. Today EBM is a loaded gun at clinicians’ heads. “You better do as the evidence says,” it hisses, leaving no room for discretion or judgment. EBM is now the problem, fueling overdiagnosis and overtreatment.
The entire article is here.
BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g22 (Published 3 January 2014)
Cite this as: BMJ 2014;348:g22
Evidence based medicine (EBM) wrong footed the drug industry for a while in the 1990s. We could fend off the army of pharmaceutical representatives because often their promotional material was devoid of evidence. But the drug industry came to realise that EBM was an opportunity rather than a threat. Research, especially when published in a prestigious journal, was worth more than thousands of sales representatives. Today EBM is a loaded gun at clinicians’ heads. “You better do as the evidence says,” it hisses, leaving no room for discretion or judgment. EBM is now the problem, fueling overdiagnosis and overtreatment.
The entire article is here.
Monday, December 30, 2013
The Selling of ADHD
By Alan Schwarz
The New York Times
Originally posted December 14, 2013
Here is an excerpt:
“The numbers make it look like an epidemic. Well, it’s not. It’s preposterous,” Dr. Conners, a psychologist and professor emeritus at Duke University, said in a subsequent interview. “This is a concoction to justify the giving out of medication at unprecedented and unjustifiable levels.”
The rise of A.D.H.D. diagnoses and prescriptions for stimulants over the years coincided with a remarkably successful two-decade campaign by pharmaceutical companies to publicize the syndrome and promote the pills to doctors, educators and parents. With the children’s market booming, the industry is now employing similar marketing techniques as it focuses on adult A.D.H.D., which could become even more profitable.
Few dispute that classic A.D.H.D., historically estimated to affect 5 percent of children, is a legitimate disability that impedes success at school, work and personal life. Medication often assuages the severe impulsiveness and inability to concentrate, allowing a person’s underlying drive and intelligence to emerge.
The entire story is here.
The New York Times
Originally posted December 14, 2013
Here is an excerpt:
“The numbers make it look like an epidemic. Well, it’s not. It’s preposterous,” Dr. Conners, a psychologist and professor emeritus at Duke University, said in a subsequent interview. “This is a concoction to justify the giving out of medication at unprecedented and unjustifiable levels.”
The rise of A.D.H.D. diagnoses and prescriptions for stimulants over the years coincided with a remarkably successful two-decade campaign by pharmaceutical companies to publicize the syndrome and promote the pills to doctors, educators and parents. With the children’s market booming, the industry is now employing similar marketing techniques as it focuses on adult A.D.H.D., which could become even more profitable.
Few dispute that classic A.D.H.D., historically estimated to affect 5 percent of children, is a legitimate disability that impedes success at school, work and personal life. Medication often assuages the severe impulsiveness and inability to concentrate, allowing a person’s underlying drive and intelligence to emerge.
The entire story is here.
Thursday, November 7, 2013
The Not-So-Hidden Cause Behind the A.D.H.D. Epidemic
By MAGGIE KOERTH-BAKER
The New York Times
Published: October 15, 2013
Here are two excerpts:
Of the 6.4 million kids who have been given diagnoses of A.D.H.D., a large percentage are unlikely to have any kind of physiological difference that would make them more distractible than the average non-A.D.H.D. kid. It’s also doubtful that biological or environmental changes are making physiological differences more prevalent. Instead, the rapid increase in people with A.D.H.D. probably has more to do with sociological factors — changes in the way we school our children, in the way we interact with doctors and in what we expect from our kids.
Which is not to say that A.D.H.D. is a made-up disorder.
(cut)
This lack of rigor leaves room for plenty of diagnoses that are based on something other than biology. Case in point: The beginning of A.D.H.D. as an “epidemic” corresponds with a couple of important policy changes that incentivized diagnosis. The incorporation of A.D.H.D. under the Individuals With Disabilities Education Act in 1991 — and a subsequent overhaul of the Food and Drug Administration in 1997 that allowed drug companies to more easily market directly to the public — were hugely influential, according to Adam Rafalovich, a sociologist at Pacific University in Oregon.
The entire article is here.
The New York Times
Published: October 15, 2013
Here are two excerpts:
Of the 6.4 million kids who have been given diagnoses of A.D.H.D., a large percentage are unlikely to have any kind of physiological difference that would make them more distractible than the average non-A.D.H.D. kid. It’s also doubtful that biological or environmental changes are making physiological differences more prevalent. Instead, the rapid increase in people with A.D.H.D. probably has more to do with sociological factors — changes in the way we school our children, in the way we interact with doctors and in what we expect from our kids.
Which is not to say that A.D.H.D. is a made-up disorder.
(cut)
This lack of rigor leaves room for plenty of diagnoses that are based on something other than biology. Case in point: The beginning of A.D.H.D. as an “epidemic” corresponds with a couple of important policy changes that incentivized diagnosis. The incorporation of A.D.H.D. under the Individuals With Disabilities Education Act in 1991 — and a subsequent overhaul of the Food and Drug Administration in 1997 that allowed drug companies to more easily market directly to the public — were hugely influential, according to Adam Rafalovich, a sociologist at Pacific University in Oregon.
The entire article 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.
Tuesday, September 17, 2013
The Psychiatric Drug Crisis
BY GARY GREENBERG
The New Yorker
Originally posted on September 3, 2013
It’s been just over twenty-five years since Prozac came to market, and more than twenty per cent of Americans now regularly take mind-altering drugs prescribed by their doctors. Almost as familiar as brands like Zoloft and Lexapro is the worry about what it means that the daily routine in many households, for parents and children alike, includes a dose of medications that are poorly understood and whose long-term effects on the body are unknown. Despite our ambivalence, sales of psychiatric drugs amounted to more than seventy billion dollars in 2010. They have become yet another commodity that consumers have learned to live with or even enjoy, like S.U.V.s or Cheetos.
Yet the psychiatric-drug industry is in trouble. “We are facing a crisis,” the Cornell psychiatrist and New York Times contributor Richard Friedman warned last week. In the past few years, one pharmaceutical giant after another—GlaxoSmithKline, AstraZeneca, Novartis, Pfizer, Merck, Sanofi—has shrunk or shuttered its neuroscience research facilities. Clinical trials have been halted, lines of research abandoned, and the new drug pipeline has been allowed to run dry.
Saturday, September 7, 2013
Physicians Under the Influence: Social Psychology and Industry Marketing Strategies
By Sunita Sah and Adriane Fugh-Berman
April 30, 2013
Journal of Law, Medicine and Ethics, Volume 14, No. 3, August 2013,
Forthcoming Edmond J. Safra Working Papers, Forthcoming
Abstract
Pharmaceutical and medical device companies apply social psychology to influence physicians’ prescribing behavior and decision-making. Physicians fail to recognize their vulnerability to commercial influences; due to self-serving bias, rationalization, and cognitive dissonance. Professionalism offers little protection; even the most conscious and genuine commitment to ethical behavior cannot eliminate unintentional, subconscious bias. Six principles of influence — reciprocation, commitment, social proof, liking, authority, and scarcity — are key to the industry’s routine marketing strategies, which rely on the illusion that the industry is a generous avuncular partner to physicians. In order to resist industry influence, physicians must accept that they are vulnerable to subconscious bias, and have both the motivation and means to resist industry influence. A culture in which accepting industry gifts engenders shame, rather than gratitude, will reduce conflicts of interest. If greater academic prestige accrues to distant, rather than close relationships with industry, a new social norm may emerge that promotes patient care and scientific integrity. In addition to educating faculty and students about the social psychology underlying sophisticated, but potentially manipulative marketing and about how to resist it, academic medical institutions should develop strong organizational policies to counteract the medical profession’s improper dependence on industry.
The entire paper is here.
April 30, 2013
Journal of Law, Medicine and Ethics, Volume 14, No. 3, August 2013,
Forthcoming Edmond J. Safra Working Papers, Forthcoming
Abstract
Pharmaceutical and medical device companies apply social psychology to influence physicians’ prescribing behavior and decision-making. Physicians fail to recognize their vulnerability to commercial influences; due to self-serving bias, rationalization, and cognitive dissonance. Professionalism offers little protection; even the most conscious and genuine commitment to ethical behavior cannot eliminate unintentional, subconscious bias. Six principles of influence — reciprocation, commitment, social proof, liking, authority, and scarcity — are key to the industry’s routine marketing strategies, which rely on the illusion that the industry is a generous avuncular partner to physicians. In order to resist industry influence, physicians must accept that they are vulnerable to subconscious bias, and have both the motivation and means to resist industry influence. A culture in which accepting industry gifts engenders shame, rather than gratitude, will reduce conflicts of interest. If greater academic prestige accrues to distant, rather than close relationships with industry, a new social norm may emerge that promotes patient care and scientific integrity. In addition to educating faculty and students about the social psychology underlying sophisticated, but potentially manipulative marketing and about how to resist it, academic medical institutions should develop strong organizational policies to counteract the medical profession’s improper dependence on industry.
The entire paper is here.
Thursday, September 5, 2013
A Dry Pipeline for Psychiatric Drugs
By RICHARD A. FRIEDMAN, M.D.
The New York Times
Published: August 19, 2013
Fully 1 in 5 Americans take at least one psychiatric medication. Yet when it comes to mental health, we are facing a crisis in drug innovation.
Sure, we have many antidepressants, antipsychotics, hypnotic medications and the like. But their popularity masks two serious problems.
First, each of these drug classes is filled with “me too” drugs, which are essentially just copies of one another; we have six S.S.R.I. antidepressants that essentially do the same thing, and likewise for the 10 new atypical antipsychotic drugs.
Second, the available drugs leave a lot to be desired: patients with illnesses like schizophrenia, major depression and bipolar disorder often fail to respond adequately to these medications or cannot tolerate their side effects.
The entire story is here.
The New York Times
Published: August 19, 2013
Fully 1 in 5 Americans take at least one psychiatric medication. Yet when it comes to mental health, we are facing a crisis in drug innovation.
Sure, we have many antidepressants, antipsychotics, hypnotic medications and the like. But their popularity masks two serious problems.
First, each of these drug classes is filled with “me too” drugs, which are essentially just copies of one another; we have six S.S.R.I. antidepressants that essentially do the same thing, and likewise for the 10 new atypical antipsychotic drugs.
Second, the available drugs leave a lot to be desired: patients with illnesses like schizophrenia, major depression and bipolar disorder often fail to respond adequately to these medications or cannot tolerate their side effects.
The entire story is here.
Tuesday, August 27, 2013
Introducing deprescribing into culture of medication
By Catherine Cross
Canadian Medical Association
Originally published August 12, 2013
An Ontario pharmacist has received a government grant to develop clinical guidelines to help doctors determine whether patients are on medications they no longer need or that should be reduced.
"We don't normally test drugs in the elderly, but they are taking many drugs. As they get older and get more chronic conditions, the number of medications increases," says Barbara Farrell, a clinical scientist with the Bruyère Research Institute in Ottawa, Ontario.
Sometimes when medications are deprescribed or reduced, "confusion will clear, or they'll stop falling, and a lot of literature supports that," says Farrell, who received the $430 000 grant from the Ontario Ministry of Health and Long-Term Care.
The entire story is here.
Canadian Medical Association
Originally published August 12, 2013
An Ontario pharmacist has received a government grant to develop clinical guidelines to help doctors determine whether patients are on medications they no longer need or that should be reduced.
"We don't normally test drugs in the elderly, but they are taking many drugs. As they get older and get more chronic conditions, the number of medications increases," says Barbara Farrell, a clinical scientist with the Bruyère Research Institute in Ottawa, Ontario.
Sometimes when medications are deprescribed or reduced, "confusion will clear, or they'll stop falling, and a lot of literature supports that," says Farrell, who received the $430 000 grant from the Ontario Ministry of Health and Long-Term Care.
The entire story is here.
Friday, August 9, 2013
Drug Companies Promise More Data Transparency
By KATIE THOMAS
The New York Times
Published: July 24, 2013
Representatives of the world’s biggest pharmaceutical companies pledged on Wednesday to release detailed data about their drugs to outside researchers, a move that was applauded by some but also seen as an effort to head off more extensive disclosure requirements that are under review in Europe.
The announcement, made jointly by the two major pharmaceutical trade groups in the United States and Europe, signals a shift for the industry, which in the past has resisted calls to systematically share its data. The proposal was unanimously approved by member companies and is to take effect on Jan. 1. It would apply to all new drugs and all new uses for existing drugs, whether approved in the United States or the European Union.
The entire story is here.
The New York Times
Published: July 24, 2013
Representatives of the world’s biggest pharmaceutical companies pledged on Wednesday to release detailed data about their drugs to outside researchers, a move that was applauded by some but also seen as an effort to head off more extensive disclosure requirements that are under review in Europe.
The announcement, made jointly by the two major pharmaceutical trade groups in the United States and Europe, signals a shift for the industry, which in the past has resisted calls to systematically share its data. The proposal was unanimously approved by member companies and is to take effect on Jan. 1. It would apply to all new drugs and all new uses for existing drugs, whether approved in the United States or the European Union.
The entire story is here.
Thursday, July 25, 2013
Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs
Light, Donald W., Lexchin, Joel and Darrow, Jonathan J. , Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs (June 1, 2013). Journal of Law, Medicine and Ethics, Vol. 14, No. 3, 2013.
Abstract:
Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised Congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA’s prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication: independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few if any new clinical benefits; and the creation of a National Drug Safety Board.
The entire article is here and available for download.
Abstract:
Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised Congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA’s prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication: independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few if any new clinical benefits; and the creation of a National Drug Safety Board.
The entire article is here and available for download.
Tuesday, July 16, 2013
Sharp Rise in Drug Overdoses Among U.S. Women: CDC
By Steven Reinberg
MedicineNet.com
Originally posted July 2, 2013
The rate of fatal overdoses of prescription painkillers and other drugs among U.S. women quadrupled between 1999 and 2010, federal officials reported Tuesday.
Long thought of as primarily a male problem, drug addiction is increasingly affecting women, and the new study from the Centers for Disease Control and Prevention estimates that 42 women in the United States die each day from prescription drug overdoses.
"Prescription drug overdose deaths have skyrocketed in women," CDC Director Dr. Thomas Frieden said during a noon press conference. "Mothers, wives, sisters and daughters are dying from overdoses at rates we have never seen before."
(cut)
Other statistics, based on 2010 data:
The entire story is here.
MedicineNet.com
Originally posted July 2, 2013
The rate of fatal overdoses of prescription painkillers and other drugs among U.S. women quadrupled between 1999 and 2010, federal officials reported Tuesday.
Long thought of as primarily a male problem, drug addiction is increasingly affecting women, and the new study from the Centers for Disease Control and Prevention estimates that 42 women in the United States die each day from prescription drug overdoses.
"Prescription drug overdose deaths have skyrocketed in women," CDC Director Dr. Thomas Frieden said during a noon press conference. "Mothers, wives, sisters and daughters are dying from overdoses at rates we have never seen before."
(cut)
Other statistics, based on 2010 data:
- Suicides from these drugs accounted for 34 percent of all suicides among women, compared with 8 percent among men.
- More than 940,000 women were seen in emergency departments for drug misuse or abuse.
- More than 6,600 women, or 18 women every day, died from a prescription painkiller overdose.
- Narcotic painkillers accounted for four times more deaths among women than deaths linked to cocaine and heroin combined.
- More than 200,000 emergency department visits were for misuse or abuse of these drugs among women -- about one every three minutes.
The entire story is here.
Saturday, July 13, 2013
Breaking the Seal on Drug Research
By KATIE THOMAS
The New York Times
Published: June 29, 2013
Here are som excerpts:
For years, researchers have talked about the problem of publication bias, or selectively publishing results of trials. Concern about such bias gathered force in the 1990s and early 2000s, when researchers documented how, time and again, positive results were published while negative ones were not. Taken together, studies have shown that results of only about half of clinical trials make their way into medical journals.
Problems with data about high-profile drugs have led to scandals over the past decade, like one involving contentions that the number of heart attacks was underreported in research about the painkiller Vioxx. Another involved accusations of misleading data about links between the antidepressant Paxil and the risk of suicide among teenagers.
To those who have followed this issue for years, the moves toward openness are unfolding with surprising speed.
“This problem has been very well documented for at least three decades now in medicine, with no substantive fix,” said Dr. Ben Goldacre, a British author and an ally of Dr. Doshi. “Things have changed almost unimaginably fast over the past six months.”
Much of that change is happening because of what Dr. Goldacre calls an “accident of history.” In 2009, Dr. Doshi and his colleagues set out to answer a simple question about the anti-flu drug Tamiflu: Does it work? Resolving that question has been far harder than they ever envisioned, and, four years later, there is still no definitive answer. But the quest to determine Tamiflu’s efficacy transformed Dr. Doshi and others into activists for transparency — and turned the tables on drug makers. Until recently, the idea that companies should routinely hand over detailed data about their clinical trials might have sounded far-fetched. Now, the onus is on the industry to explain why it shouldn’t.
(cut)
Earlier this month, Dr. Doshi opened what he hopes will be a new chapter in his quest for greater understanding of clinical trials. He and several other researchers published what amounted to an ultimatum to drug companies: publish your data, or we’ll do it for you.
The entire story is here.
The New York Times
Published: June 29, 2013
Here are som excerpts:
For years, researchers have talked about the problem of publication bias, or selectively publishing results of trials. Concern about such bias gathered force in the 1990s and early 2000s, when researchers documented how, time and again, positive results were published while negative ones were not. Taken together, studies have shown that results of only about half of clinical trials make their way into medical journals.
Problems with data about high-profile drugs have led to scandals over the past decade, like one involving contentions that the number of heart attacks was underreported in research about the painkiller Vioxx. Another involved accusations of misleading data about links between the antidepressant Paxil and the risk of suicide among teenagers.
To those who have followed this issue for years, the moves toward openness are unfolding with surprising speed.
“This problem has been very well documented for at least three decades now in medicine, with no substantive fix,” said Dr. Ben Goldacre, a British author and an ally of Dr. Doshi. “Things have changed almost unimaginably fast over the past six months.”
Much of that change is happening because of what Dr. Goldacre calls an “accident of history.” In 2009, Dr. Doshi and his colleagues set out to answer a simple question about the anti-flu drug Tamiflu: Does it work? Resolving that question has been far harder than they ever envisioned, and, four years later, there is still no definitive answer. But the quest to determine Tamiflu’s efficacy transformed Dr. Doshi and others into activists for transparency — and turned the tables on drug makers. Until recently, the idea that companies should routinely hand over detailed data about their clinical trials might have sounded far-fetched. Now, the onus is on the industry to explain why it shouldn’t.
(cut)
Earlier this month, Dr. Doshi opened what he hopes will be a new chapter in his quest for greater understanding of clinical trials. He and several other researchers published what amounted to an ultimatum to drug companies: publish your data, or we’ll do it for you.
The entire story is here.
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