Welcome to the Nexus of Ethics, Psychology, Morality, Philosophy and Health Care

Welcome to the nexus of ethics, psychology, morality, technology, health care, and philosophy
Showing posts with label Drug Company. Show all posts
Showing posts with label Drug Company. Show all posts

Monday, May 20, 2019

How Drug Companies Helped Shape a Shifting Biological View of Mental Ilness

Terry Gross
NPR Health Shots
Originally posted May 2, 2019

Here are two excerpts:

On why the antidepressant market is now at a standstill

The huge developments that happen in the story of depression and the antidepressants happens in the late '90s, when a range of different studies increasingly seemed to suggest that these antidepressants — although they're helping a lot of people — when compared to placebo versions of themselves, don't seem to do much better. And that is not because they are not helping people, but because the placebos are also helping people. Simply thinking you're taking Prozac, I guess, can have a powerful effect on your state of depression. In order, though, for a drug to get on the market, it's got to beat the placebo. If it can't beat the placebo, the drug fails.

(cut)

On why pharmaceutical companies are leaving the psychiatric field

Because there have been no new good ideas as to where to look for new, novel biomarkers or targets since the 1960s. The only possible exception is there is now some excitement about ketamine, which targets a different set of biochemical systems. But R&D is very expensive. These drugs are now, mostly, off-patent. ... [The pharmaceutical companies'] efforts to bring on new drugs in that sort of tried-and-true and tested way — with a tinker here and a tinker there — has been running up against mostly unexplained but indubitable problems with the placebo effect.

The info is here.

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.

Wednesday, July 30, 2014

U of T criticized for links between Big Pharma and Med Schools

By Georgia Williams
The Varsity
Originally published July 16, 2014

A recent report in the Journal of Medical Ethics took aim at the actions of university lecturers who have ties to pharmaceutical companies — including those at U of T.

The study — written by Dr. Navindra Persaud, a practicing physician at St. Michael’s Hospital — questions the validity of the content taught in one of the mandatory lecture series he attended as a medical student at the university in 2004. The lecture on pain pharmacotherapy used a modified classification chart from the World Health Organization (WHO) to show oxycodone as both a “weak and strong opioid,” comparable to codeine. However, as Dr. Persaud’s report indicates, oxycodone is at least  “1.5 times more potent than morphine” a drug that the WHO lists as a strong opioid. Dr. Persaud’s study also claims that the drug’s adverse side effects were downplayed by the lecturer.

The entire story is here.

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.

Saturday, October 27, 2012

New psychiatric drugs low priority for pharmaceutical firms

CBC News
Originally posted October 12, 2012

The pharmaceutical industry has largely abandoned drug development for mental illnesses even though depression is a leading cause of disability, experts say.

Authors of papers published in this week's issue of the journal Science Translational Medicine argue that drug discovery for treating psychiatric disorders such as autism, schizophrenia, bipolar disorder and depression are at a near standstill.

"Antipsychotics and antidepressants have been some of the most profitable agents for companies over the last two decades," said Dr. Thomas Insel, director of the U.S. National Institute of Mental Health and one of the authors.

"But that doesn't mean they're effective. What it means is that they sell and they can be marketed."

In the last five decades, more than 20 antipsychotics and 30 antidepressants have been marketed with over $25 billion in sales in the U.S. in 2011 alone, Insel said.

(cut)

"The central problem is clear: Neither vast unmet medical need, nor large and growing markets, nor concerted sales campaigns that attempt to recast 'me-too drugs' as innovative can illuminate a path across very difficult scientific terrain," Hyman wrote.

The entire story is here.

Friday, November 18, 2011

Health Guideline Panels Struggle with Conflicts of Interest

By Duff Wilson
The New York Times
Money and Policy

All 16 members of the United States Preventive Services Task Force were vetted to ensure they had no financial conflicts that would prohibit them from voting, according to the panel’s vice chairman, Dr. Albert L. Siu.

But three other federal panels that are quietly developing major public health guidelines on the leading causes of cardiovascular disease — hypertension, cholesterol and obesity — operate under less stringent ethics recommendations.

And one potential conflict after another has surfaced among the members, with some receiving speakers’ fees from drug companies, others consulting for pay and others doing company-financed research.
In all, about 20 of the three panels’ members, including some co-chairmen, have been advised that they should not vote on crucial issues as they prepare to issue the health guidelines next year — because they are too closely connected to industries with a keen interest in the panels’ recommendations.

Nearly a decade ago, the work of similar panels was so marred by charges of industry bias that the National Institutes of Health extensively heightened the scrutiny for individual panelists. But the decline in federal financing for medical research continued to pose problems, leaving many researchers to rely more heavily on private industry support. Specific new rules have been adopted to reduce the impact of conflicts of interest on guideline-writing panels.

But the N.I.H. groups, which meet behind closed doors, partly to avoid outside influence, had already been appointed when some of those rules were issued. Their finished work could wield a powerful influence on medical care, insurance and lifelong treatment for hypertension, obesity and cholesterol.

The entire article can be found here.

Thursday, November 17, 2011

Glaxo to Pay $3 Billion to Settle U.S. Cases on Sales, Marketing

By Phil Serafino and Makiko Kitamura
Bloomberg News

GlaxoSmithKline Plc (GSK) agreed to pay $3 billion to resolve U.S. criminal and civil investigations into whether the U.K. company marketed drugs for unapproved uses and other matters, its biggest legal settlement.

Negotiations over the terms will be completed next year, the London-based company said in a statement today. The cost is covered by existing legal provisions and will be paid from the company’s cash resources, Glaxo said.

The potential settlement brings Glaxo closer to putting years of legal probes behind it. The company set aside 2.2 billion pounds ($3.5 billion) in the fourth quarter last year in anticipation of reaching an agreement on the cases. Glaxo said it will have about 1 billion pounds of its 2.9 billion pounds in total legal provisions remaining after today’s settlement is completed, and it hasn’t decided what to do with the money.

“This news essentially draws a line under a 10-year legal saga,” Gbola Amusa, an analyst at UBS AG in London who recommends buying Glaxo shares, said in an e-mail. “This removes significant uncertainty on ongoing legal issues.”

There rest of the story can be found here.

Sunday, September 11, 2011

NIH Finalizes Financial Conflict of Interest Rules

The Washington Post
Published: August 23

The National Institutes of Health has finalized rules to reduce financial conflicts of interests among federally funded researchers who also receive payments or stock from drug and medical device companies.

The rules, which will affect more than 40,000 researchers, come after a string of high profile cases in which federally funded researchers failed to disclose millions of dollars from companies with a financial interest in the outcome of their work.

Researchers who receive more than $5,000 in income from drug or device companies must disclose the payments. Universities or other institutions employing the researchers must collect the data and provide for public access to it.

But in an about-face from proposed rules announced last year, institutions will not be forced to disclose conflict-of-interest information online. (See our prior blog post).  Instead, they may maintain the data offline and provide it only when requested.

This change reduces the administrative burden of the proposed public disclosure rule for institutions employing federally funded researchers, said Sally Rockey, the NIH’s deputy director for extramural research.

Universities also will be required to develop plans to manage the financial conflicts of individual researchers, but the plans do not have to be made public.

Praising the “vast majority of researchers” as ethical and sensitive to conflicts of interest, NIH Director Francis S. Collins called the new rules “an insurance plan against potential trouble downstream.”

Collins added that the rules will ensure that government-funded researchers can continue working with private companies.

The rest of the story can be read here.

Saturday, August 20, 2011

Ghostwritten medical articles called fraud

CBC News

It's fraudulent for academics to give their names to medical articles ghostwritten by pharmaceutical industry writers, say two Canadian law professors who call for potential legal sanctions.

Studies suggest that industry-driven drug trials and industry-sponsored publications are more likely to downplay a drug's harms and exaggerate a drug's virtues, said Trudo Lemmens, a law professor at the University of Toronto. The integrity of medical research is also harmed by ghostwritten articles, he said.

Ghostwriting is part of marketing that can distort the evidence on a drug, Lemmens said. Industry authors are concealed to insert marketing messages and academic experts are recruited as "guest" authors to lend credibility despite not fulfilling criteria for authorship, such as participating in the design of the study, gathering data, analyzing the results and writing up of the findings.

Class actions involving drugs such as Vioxx, hormone replacement therapy and antidepressants suggest guest authors often fail to meet criteria for authorship, according to the policy paper in Tuesday's issue of Public Library of Science's journal PloS Medicine.

In the article, Lemmens and his colleague Prof. Simon Stern argue that legal remedies are needed for medical ghostwriting since medical journals, academic institutions and professional disciplinary bodies haven't succeeded in enforcing sanctions against the practice.

The institutions have divided loyalties, the authors say, which may explain why they've been slow to act. For example, universities wish to protect academic integrity while also protecting their employees from unjust accusation.

A legal response could act as a powerful deterrent, Stern said.

"Our theory does not depend on the accuracy of the data," Lemmens said in an email. "False representation of authorship is in our view fraud, regardless of the accuracy of the reporting."

Doctors and patients perceive published studies to be independent assessments made by academic experts, the authors noted.

Ghostwritten publications are used in court to support a manufacturer's arguments about a drug's safety and effectiveness, and academic experts who appear as witnesses for pharmaceutical and medical device companies also boost their credibility with the publications on their CV, Lemmens said.

The entire story can be found here.

Friday, July 15, 2011

Time to concentrate on human factors in mental illness

Sami Timimi consultant child and adolescent psychiatrist
NHS Lincolnshire, Lincoln, UK
BMJ 2011;343:d4377

Drug companies losing interest in psychiatry is great news for psychiatry and mental health services but most of all for patients.1 Other research funding sources may also recognize that a focus on the brain is not a credible, evidence based choice likely to contribute to better care for those who have mental distress. Drug companies have found mental health highly lucrative, with multibillion pound blockbuster drugs such as the misnamed (for marketing purposes) antidepressants and antipsychotics. Sooner or later it would become apparent that the evidence based cupboard was empty—that all of the drugs were of dubious effectiveness, had varying degrees of neurotoxicity, created abnormal mental states (which can be lifesaving for some at certain points in their distress) rather than corrected them, and were different from illicit drugs only through who provides them and how they are subsequently used rather than because of discoveries of some particular therapeutic potency.

In biological psychiatry a reliance on psychotropic drugs has encouraged some remarkable developments such as an increase in the numbers and a worsening of the long term prognosis for those categorised as mentally ill,2 and an increase in stigma that is associated with the model that mental illness is “an illness like any other illness.”3 Freed from the corrupting shackles of the pharmaceutical industry we can put money into better understanding the factors that have the biggest effects on outcome: social factors outside of treatment and the therapeutic relationship within treatment.4

Competing interests: None declared.

1 Wise J. Research into treatments for mental illness is under threat. BMJ 2011;342:d3747. (14 June.)
2 Whitaker R. Anatomy of an epidemic . Crown, 2010.
3 Read J, Haslam N, Sayce L, Davies E. Prejudice and schizophrenia: a review of the
‘mental illness is an illness like any other’ approach. Acta Psychiatr Scand 2006;114:303-18.
4 Timimi S. Campaign to Abolish Psychiatric Diagnostic Systems such as ICD and DSM (CAPSID). 2011. Available at: www.criticalpsychiatry.net/?p=527.