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

Thursday, April 20, 2017

White House may have violated its own ethics rules with Trump's executive-branch hires

Sonam Sheth
Business Insider
Originally published April 16, 2017

The Trump administration may be entangling itself in another ethical landmine.

In this case, the White House could have violated its own ethics rules with at least two hires, a New York Times and ProPublica investigation found.

One potential conflict involves Michael Catanzaro, who is the White House's top energy adviser. Until last year, The Times and ProPublica found, Catanzaro was working as a lobbyist for the fossil-fuel industry and had clients like Devon Energy of Oklahoma and Talen Energy of Pennsylvania.

Those two companies were stalwart opponents of President Barack Obama's environmental regulations, like the Clean Power Plan, which sought to promote the use of alternative energy sources. Trump signed an executive order undoing the plan in March. As the White House's top energy adviser, Catanzaro will handle many of those same issues.

The article is here.

Sunday, March 12, 2017

Ethics Watchdogs Want U.S. Attorney To Investigate Trump's Business Interests

Jim Zarolli
NPR.org
Originally published March 8, 2017

With Congress showing no signs of taking action, a group of ethics watchdogs is turning to U.S. Attorney Preet Bharara to look into whether President Trump's many business interests violate the Emoluments Clause of the U.S. Constitution.

"Published reports indicate that the Trump Organization and related Trump business entities have been receiving payments from foreign government sources which benefit President Trump through his ownership of the Trump Organization and related business entities," according to a letter sent to Bharara.

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The Emoluments Clause says that "no Person holding any Office of Profit or Trust under [the U.S. government], shall, without the Consent of the Congress, accept of any present, Emolument, Office, or Title, of any kind whatever, from any King, Prince, or foreign State."

The letter says "there is no question" the clause applies to Trump and that he is violating it, because of the Trump Organization's extensive business operations, many of them tied to foreign governments.

The article is here.

Thursday, December 17, 2015

Harvard Medical School Eases on Contentious Ethics Rule

By Melissa Bailey
Stat News
Originally published on November 30, 2015

Here is an excerpt:

“Nobody wants conflict-of-interest rules to stop basic research if the conflict can be managed,” he said.

The school also lifted the $30,000 cap for publicly traded companies, saying instead that faculty who accept sponsored research from a company cannot own equity amounting to over 1 percent of that company’s value.

Dr. Donald Ingber, who directs Harvard’s Wyss Institute for Biologically Inspired Engineering, called the changes “subtle” but “a move in the right direction.”

“Whenever there’s greater flexibility, it increases the likelihood of greater translation” of discoveries into clinical applications, he said, which is the goal of the Wyss.

“The higher the wall, the more difficult it is to jump over that wall,” he said. “This’ll make it a little bit easier to collaborate.”

The entire article is here.

Monday, November 2, 2015

Many Antidepressant Studies Found Tainted by Pharma Company Influence

By Roni Jacobson
Scientific American
Originally published October 21, 2015

Here is an excerpt:

Almost 80 percent of meta-analyses in the review had some sort of industry tie, either through sponsorship, which the authors defined as direct industry funding of the study, or conflicts of interest, defined as any situation in which one or more authors were either industry employees or independent researchers receiving any type of industry support (including speaking fees and research grants). Especially troubling, the study showed about 7 percent of researchers had undisclosed conflicts of interest. “There’s a certain pecking order of papers,” says Erick Turner, a professor of psychiatry at Oregon Health & Science University who was not associated with the research. “Meta-analyses are at the top of the evidence pyramid.” Turner was “very concerned” by the results but did not find them surprising. “Industry influence is just massive. What’s really new is the level of attention people are now paying to it.”

The researchers considered all meta-analyses of randomized controlled trials for all approved antidepressants including selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, atypical antidepressants, monoamine oxidase inhibitors and others published between 2007 and March 2014.

The entire article is here.

Tuesday, October 13, 2015

The way to fix outrageous drug pricing in the US is simply to do what all other rich countries do

Written by Annalisa Merelli
The Quartz
Originally published September 25, 2015

Here is an excerpt:

The US is an outlier among industrialized nation: it’s the only rich country that does not offer a publicly funded health system, relying instead largely on private insurance. This affects the pricing of drugs in several ways that are independent from the actual regulations imposed on pharmaceutical companies.

First, and perhaps most importantly, the power in setting the price for drugs is skewed toward drug manufacturers. Unlike countries where universal health coverage is in place, the negotiating is left to individual care providers rather than being in the hand of a large, publicly funded buyer that’s able to negotiate since it purchases most (if not all) of the drugs.
For those with health insurance, high drug prices result in higher premiums, but it’s hard to notice the price increases directly. This means consumers lack awareness of the actual medication prices, and consequently, any pressure to keep them under control.

Plus, the costs of bringing a drug into the US market are higher, partially because of marketing expenses. The US is one of only two countries (the other being New Zealand) that allows direct-to-consumer advertisement of prescription drugs, while elsewhere promotion is limited to medical professionals. This raises the already steep marketing bill of drugs manufacturers. As Robert Yates, former World Health Organization senior health economist told Quartz, “the amount [pharmaceutical companies] spend on marketing is massively more than they do on research and development.”

The entire 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.

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.

Friday, July 17, 2015

Smithsonian to improve ethics policies

By Brett Zongker
Associated Press
Originally pressed June 26, 2015

After revelations that a scientist failed to disclose his funding sources for climate change research, the Smithsonian Institution said Friday it is improving its ethics and disclosure policies to avoid conflicts of interest.

The museum and research complex said it is prepared to take immediate action after a review of its policies by Rita Colwell, the former director of the National Science Foundation. Smithsonian officials initiated the external review after recent allegations that scientist Wei-Hock Soon did not disclose conflicts of interest in his research funding. A Smithsonian team also conducted an internal review.

The entire article is here.

Friday, June 26, 2015

Rein It In, Dr Oz

By Art Caplan
MedScape
Originally published April 30, 2015

Dr Mehmet Oz is in trouble again. He was accused by 10 physicians in a letter of promoting quackery. They demanded that Columbia University Medical Center fire Dr Oz. Now, I can say with some authority that as "America's Doctor"—the person who, for many Americans, is the voice of medicine—he is not going to be fired. His show is not going to end. That isn't going to happen.

Dr Oz has evoked this response from these 10 physicians because he continues to push the border of legitimacy on his shows with respect to touting things for which there isn't much evidence. And that is a problem. Many doctors tell me that when Dr Oz endorses something—green coffee beans, some neti pot to cure the common cold—whatever it is, they are going to be asked about it, and their patients run out and buy it. He has enormous power when it comes to the platform he has built. And let's face it: He is an effective communicator. His show is fun to watch. I understand why the American people are paying attention to Dr Oz.

The entire article is here.

Sunday, February 8, 2015

Lies, fraud, conflicts of interest, and bogus science: The real Dr. Oz effect

By Scott Gavura
Science-Based Medicine
Originally published January 29, 2015

I thought I’d written my final post on the Dr. Oz-fueled green coffee bean extract (GCBE) diet supplement fad. But now there’s another appalling chapter, one that documents just how much contempt The Dr. Oz Show seems to show for its audience, and how little Dr. Oz seems to care about providing advice based on good science. This week it was revealed that the “naturopath” that Dr. Oz originally featured in his GCBE segment, Lindsey Duncan, didn’t disclose a direct conflict of interest when he spoke. After inaccurately describing the supplement’s effectiveness, he directed consumers, using keywords, to web sites that he owned or operated. The infamous “Dr. Oz Effect” worked, with Duncan selling $50 million in GCBE supplements in the following months and years. This week it was announced that Duncan and his companies have been fined $9 million by the Federal Trade Commission. The documentation released by the FTC [PDF] gives remarkable insight into how a scam to make millions was launched, and how the Dr. Oz Show is a platform for the routine promotion of dubious “experts” and worthless supplements.

The entire article is here.

Friday, October 10, 2014

Doctors Net Billions From Drug Firms

By Peter Loftus
The Wall Street Journal
Originally posted September 30, 2014

Drug and medical-device companies paid at least $3.5 billion to U.S. physicians and teaching hospitals during the final five months of last year, according to the most comprehensive accounting so far of the financial ties that some critics say have compromised medical care.

The figures come from a new federal government transparency initiative. The 2010 Affordable Care Act included a provision dubbed the Sunshine Act, which requires manufacturers of drugs and medical devices to disclose the payments they make to physicians and teaching hospitals each year for services such as consulting or research. The Centers for Medicare and Medicaid Services compiled the records into a database posted online Tuesday, though the agency said that about 40% of the payment information won't identify the recipients because of data problems.

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, January 11, 2014

Why 'Cherry-Picking' Patients Is Gaining Ground

By Leigh Page
Medscape - Psychiatry
Originally published December 19, 2013

Lower reimbursements, busier practices, and the rise of outcomes-based payments are inciting more physicians to think about cherry-picking -- that is, selecting patients with better payments or fewer health problems. Many physicians admit they do it, although they may feel guilty about it, or they worry that being too aggressive in this realm could harm their practices and standing.

Health insurers have been well known for cherry-picking members, although new regulations have eliminated some of those behaviors. But physicians do some cherry-picking, too, said Jim Bailey, MD, a professor of internal medicine at the University of Tennessee Health Science Center in Memphis, who has written about the phenomenon. If you choose a higher-paying specialty or locate your offices in an affluent suburb, cherry-picking can be a factor in keeping your practice profitable, he said.

The entire article is here.

This article comes in four parts.  You will need to click through in order to read the entire article.

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.

Tuesday, December 24, 2013

How journals like Nature, Cell and Science are damaging science

The incentives offered by top journals distort science, just as big bonuses distort banking

By Randy Schekman
The Guardian
Originally posted on December 9, 2013

I am a scientist. Mine is a professional world that achieves great things for humanity. But it is disfigured by inappropriate incentives. The prevailing structures of personal reputation and career advancement mean the biggest rewards often follow the flashiest work, not the best. Those of us who follow these incentives are being entirely rational – I have followed them myself – but we do not always best serve our profession's interests, let alone those of humanity and society.

We all know what distorting incentives have done to finance and banking. The incentives my colleagues face are not huge bonuses, but the professional rewards that accompany publication in prestigious journals – chiefly Nature, Cell and Science.

The entire story is here.

Thursday, September 5, 2013

Doctors Face New Scrutiny Over Gifts

By Peter Loftus
The Wall Street Journal
Originally published August 22, 2013

U.S. doctors are bracing for increased public scrutiny of the payments and gifts they receive from pharmaceutical and medical-device companies as a result of the new health law.

Starting this month, companies must record nearly every transaction with doctors—from sales reps bearing pizza to compensation for expert advice on research—to comply with the so-called Sunshine Act provision of the U.S. health-care overhaul. The companies must report data on individual doctors and how much they received to a federal health agency, which will post it on a searchable, public website beginning September 2014.


Many doctors say the increased disclosures are making them rethink their relationships with industry, citing concerns about privacy and accuracy, and worry that the public will misinterpret the information. Some fear patients will view the payments as tainting their medical decisions, and will lump together compensation for research-related services with payments of a more promotional nature.

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.

Saturday, May 18, 2013

New Efforts to Overhaul Psychiatric Diagnoses Spurred by DSM Turmoil

By Greg Miller
Wired Science
Originally posted May 17, 2013

Thousands of psychiatrists will descend on San Francisco this weekend for a meeting that will mark the release of the latest edition of the profession’s diagnostic guide, the Diagnostic and Statistical Manual of Mental Disorders, or DSM for short. This hugely influential book has been 14 years in the making, and it’s been dogged by controversies every step of the way.

To name just a few, there have been allegations of financial conflicts of interest, debates over whether internet addiction is really a thing (it is not, but “disordered gambling” is), arguments that the new diagnostic criteria will medicalize normal grief and temper tantrums, and lead to millions of people being falsely diagnosed with mental disorders.

With the new manual on the eve of its official debut, many experts are already looking beyond it. Some envision a future in which psychiatric diagnoses are based on the underlying biological causes instead of a description of a patient’s symptoms. Others caution that such a single-minded focus on biology ignores important social factors that contribute to mental illness. If there’s any area of agreement it’s this: There has to be a better way.


The DSM is used by doctors to diagnose patients, by insurance companies to decide what treatments to pay for, and by pharmaceutical companies and government funding agencies to set research priorities. The new edition, DSM-5, defines hundreds of mental disorders.

The fundamental problem, according to many of DSM’s critics, is that these definitions don’t carve nature at its joints.

“An obvious, easy example is schizophrenia,” said Peter Kinderman, a clinical psychologist at the University of Liverpool. “If you’re a 52-year-old man who hears voices, you’ll receive a diagnosis of schizophrenia. If you’re a 27-year-old woman with delusional beliefs, you’ll also receive a diagnosis of schizophrenia,” Kinderman said. “Two people can receive the same diagnosis and not have a single thing in common. That’s ludicrous scientifically.”

In most areas of medicine, diagnoses are based on the cause of illness. Heartburn and heart attacks both cause chest pain, but they’re different diagnoses because they have different underlying causes.

The entire story is here.

Saturday, February 16, 2013

CMS Issues Sunshine Rule


By Joyce Frieden, News Editor, MedPage Today
Published: February 01, 2013


The Centers for Medicare and Medicaid Services issued a long-awaited rule Friday finalizing the details for a database that will list payments made to physicians by pharmaceutical and device manufacturers.

"You should know when your doctor has a financial relationship with the companies that manufacture or supply the medicines or medical devices you may need," Peter Budetti, MD, the agency's deputy administrator for program integrity, said in a statement. "Disclosure of these relationships allows patients to have more informed discussions with their doctors."

The rule, a provision of the Affordable Care Act known as the Physician Payments Sunshine Act, "finalizes the provisions that require manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid, or the Children's Health Insurance Program to report payments or other transfers of value they make to physicians and teaching hospitals to CMS," the statement explained. "CMS will post that data to a public website. The final rule also requires manufacturers and group purchasing organizations (GPOs) to disclose to CMS physician ownership or investment interests."

Data collection will start on Aug. 1, CMS said, noting that "Applicable manufacturers and applicable GPOs will report the data for August through December of 2013 to CMS by March 31, 2014 and CMS will release the data on a public website by Sept. 30, 2014. CMS is developing an electronic system to facilitate the reporting process."

The rule "is intended to help reduce the potential for conflicts of interest that physicians or teaching hospitals could face as a result of their relationships with manufacturers," the statement continued.

The American Medical Association responded cautiously to the release of the final rule. "The AMA will carefully review the new Physician Payment Sunshine Act rule," AMA President Jeremy Lazarus, MD, said in a statement. "Physicians' relationships with the pharmaceutical industry should be transparent and focused on benefits to patients ... As the rule is implemented, we will work to make sure physicians have up-to-date information about the new reporting process."

The entire story is here.


Saturday, October 1, 2011

How An Ethically Challenged Researcher Found A Home at the University of Miami

By Paul Thacker
Forbes

Dr. Charles Nemeroff
Three weeks ago, the National Institutes of Health announced new rules to govern federally-funded researchers and their financial conflicts of interest. Three years in the making, the policy will affect over 38,000 scientists at 2000 organizations as the NIH attempts to ensure that biomedical research, paid with taxpayer dollars, remains objective.  (See our prior blog post.)

But none of these changes might have happened were it not for Dr. Charles Nemeroff.

A renowned chairman of psychiatry at Emory University, Nemeroff was a proponent for drugs sold by GlaxoSmithKline, such as the antidepressant Paxil. While earning hundreds of thousands of dollars jetting around the country and giving talks about Paxil to doctors at fancy restaurants, Nemeroff also managed a multi-million dollar grant from the NIH to research drugs under development by Glaxo.

The ensuing scandal became central to an investigation by Senator Charles Grassley into undisclosed payments from companies to prominent physicians—a practice that puts patients at risk and drives up healthcare costs. As Grassley’s lead investigator on the matter, I had a ringside seat as arguably the most powerful psychiatrist in the country was forced from prominence, eventually leaving Emory.

At my new job with the Project On Government Oversight (POGO), a government watchdog, I have continued to study the cozy relationships between physicians and corporations.  I also observed as Nemeroff left Emory for a new job at the University of Miami which has a medical school operating under financial strain. But why would this school snatch up a physician with such a history?

According to new emails and other materials shown to me, UM officials had serious concerns about Nemeroff’s history of ethical blunders. However, these emails suggest that Nemeroff’s perceived ability to raise money trumped those concerns. At one point while negotiating with UM for a job, Nemeroff even dangled the possibility of a new funder for the school if he was hired. These emails imply that, despite new federal rules, the public must remain vigilant to ensure that medicine is practiced with the highest regard for ethics and patient safety.

Officials at UM did not respond to detailed and repeated questions about the emails, which include communications by UM President Donna Shalala, who is now facing public scrutiny over a separate ethics scandal involving UM’s football program.

The entire story can be found here.