Tag: ethics

Categories : Ethics and LawTags :

A Public Archive for Opioid Lawsuit Information

On By ModernMedia

In order to improve transparency about the opioid crisis,  the University of California San Francisco and Johns Hopkins University launched a digital public archive of documents from lawsuits against drug manufacturers.

The digital repository of publicly disclosed legal documents related to the crisis allows free, public access to anyone interested in the continuing litigation and uncovered evidence.

“All too often, the public never gets the benefit of seeing and learning from litigation that generally takes place behind closed doors,” said Caleb Alexander, MD, a professor of epidemiology and medicine at Johns Hopkins and the founding co-director of the Center for Drug Safety and Effectiveness, which will assist in maintaining the archive.

“Our focus is to be sure that the millions of pages of documents arising from opioid litigation ultimately see the light of day,” Alexander told MedPage Today. “We owe it to all those who have been impacted — especially patients and their loved ones — to see to it that these materials are placed in the public domain.”

The goal of the archive is to provide transparency into the methods used by drug companies to increase opioid sales, which led to the opioid epidemic in which, according to the CDC, over the past two decades, nearly 500 000 Americans died of overdoses involving an opioid. Additionally, the economic cost of the crisis in 2015-2018 was put at $2.5 trillion by the White House Council of Economic Advisers.

Most of the archive’s documents were released thanks to efforts by the Washington Post and the Charleston Gazette. Records include company emails, memos, presentations, sales reports, audit reports, budgets, Drug Enforcement Administration briefings, expert witness reports, and depositions of drug company executives.

The archive is located on a website called Drug Industry Archives, a UCSF project that houses documents illustrating how the pharmaceutical industry, academic institutions, continuing medical education organizers and regulatory agencies impact public health. (UCSF also maintains similar archives related to tobacco, food, chemicals, and fossil fuel industries.)

The  Opioid Industry Documents Archive presently holds over 3300 legal documents, much of it coming from litigation in Kentucky and Oklahoma, as well as documents from the Insys investigation, which sold an oral fentanyl spray called Subsys. This archive’s launch coincides with the university hosting over 250 000 documents produced during Insys’ bankruptcy proceedings that resulted from successful lawsuits and criminal prosecutions.

“We don’t really know what’s in these documents yet, but there is a wealth of information,” said Kate Tasker, an associate librarian at UCSF who helps manage the archive. “Our number one goal is to make this information accessible and useful.”

Alexander said the opioid crisis was “an epidemic of catastrophic public health proportions.” He said that placing legal documents in the public domain is a crucial step to ensure that lessons are learned from the crisis.

“The primary goal is to ensure that history never repeats itself,” Alexander said. “And we can’t learn from past mistakes without understanding what those mistakes have been.”

Source: MedPage Today

Categories : Ethics and LawTags :

Ideological Divide in the US Undermines Research

On By ModernMedia

The crucial participation of the public in medical research in the United States may be affected by ideological affiliation, thereby undermining medical research, warn researchers from Washington University in St Louis.

The COVID vaccines were developed in an unprecedentedly short time, and this was made possible partly by the participation of over 70 000 volunteers. However, such successes may be in jeopardy if distinct populations cannot be adequately represented, and these include ideologically-based ones.The

distrust of black Americans towards the medical sector, especially research, has been well documented. There are even calls to remove the very concept of race from medical research as many believe it only serves to entrench certain preconceptions. This study, however, is the first to examine the effect of political ideology on willingness to participate in research.

“Our research shows that conservatives are less willing to participate in medical research than are liberals. This difference is due, in part, to ideological differences in trust in science,” said Matthew Gabel, professor of political science in Arts & Sciences.

Such a divide harbours potential consequences where medical research is concerned.

“An ideological divide in such participation could undermine both the execution and quality of medical research,” Prof Gabel said. “Given the uneven geographic distribution of political ideology, our findings raise important issues for recruiting study participants and developing political support for medical research. It could also threaten the generalisability of medical studies since important types of health behaviours, such as smoking, vary with Americans’ political ideology.”

While the problem had been brewing for decades, it was only until ideological disparities towards the medical field were exposed by the COVID pandemic that it gained widespread attention.  For example, a study found that conservative republicans were three times more likely to refuse a vaccine than the more liberal independents or democrats.

Prof Gabel saw this coming from a long way off. He wanted to better understand why some people were more inclined to participate in medical research than others, and joined with John C Morris, MD, the Harvey A. and Dorismae Hacker Friedman Distinguished Professor of Neurology and head of the Alzheimer’s Disease Research Center at the School of Medicine; Catherine M Roe, associate professor of neurology at the School of Medicine; and Stanford University’s Jonathan Goobla.

“The value of research with human subjects depends critically on successful recruitment of a representative group of participants. To do that, we have to know sources of bias in who is recruited and who is likely to accept invitations to participate,” Prof Gabel explained.

The researchers analysed survey data from the July 2014 and September 2015 waves of The American Panel Survey, which asked questions about past and future participation in medical research-related activities. These include a clinical trial for a drug, a long-term observations study, a fundraiser for medical research and blood donation. They also had hypothetical questions about one’s willingness to be an organ donor and willingness to participate in an Alzheimer’s disease study.

They selected 1132 respondents 45 years or older, since only they were old enough to participate in those long-term studies, clinical trials and hypothetical Alzheimer’s Disease study.

Those with conservative ideology are less likely to want to participate in medical research, partly because of their lower levels of trust in science. However this lack of trust only accounted for about a quarter of the effect.

“This means that if we want to reduce or eliminate the ideological difference in participation in medical research, we can do some of that by trying to raise trust in science among conservatives,” said Prof Gabel “But even if we are very effective at doing that, my analysis shows that conservatives will still be less likely to participate for ideological reasons unrelated to trust in science.

“The ideological divide in participation in medical research suggests that clinical trials and other long-term observational studies likely over-represent those with liberal political ideology. This can impact the quality of studies because significant health conditions and behaviours — such as smoking, excessive drinking, diets and mortality rates — differ with political ideology,” Prof Gabel said.

“Given the number and political importance of conservatives, and the relative stability of Americans’ ideological commitments, this divide could signify a significant obstacle for the practice, advance and influence of science in the United States,” Gabel concluded.

Source: News-Medical.Net

Journal information: Gabel, M., et al. (2021) The ideological divide in confidence in science and participation in medical research. Scientific Reports. doi.org/10.1038/s41598-021-82516-6.

Categories : TransplantsTags :

$16 Million Payout to BioJoint Knee Surgery Plaintiffs

On By ModernMedia

The University of Missouri has settled claims over ‘BioJoint’  knee surgeries for $16.2 million, in what appears to be one of its largest public payouts in recent years.

The surgeries in question used the BioJoint system, a “biological joint restoration” which involves replacing parts of the knee with bones or cartilage from cadavers to treat arthritis or joint damage. This technology was pioneered by James Stannard, MD, and veterinarian James Cook, DVM.
The 22 plaintiffs, some of whom were minors, allege that they were not informed about the highly experimental nature of the BioJoint knee surgeries, with a failure rate of as high as 86%. This often required patients to have additional corrective surgeries or knee replacements. Some plaintiffs said that the surgery was pitched to them as a way to avoid a total knee joint replacement. They also allege that Dr Stannard negligently allowed Dr Cook—a veterinarian surgeon—to perform parts of the surgery without supervision.

The University denied wrongdoing, and settled without admission of liability or wrongdoing after claims against the defendants, Dr Stannard, Cook and another employee were dismissed. 

“It’s not uncommon to have vets as part of your research team, but it would be uncommon to have them as part of your clinical patient care team,” said Patrick McCulloch, MD, vice chairman of Houston Methodist’s orthopaedic surgery department.

“You have to be licensed as a physician to perform surgery on a human being,” added Jeff Howell, executive vice president of the Missouri State Medical Association.

A key part of the plaintiff’s case involved false advertising, including local airing at the Super Bowl and at Chicago’s O’Hare International Airport, and which they claim led them to the procedure. It was speculated that the false advertising claim made the settlement amount larger than the medical malpractice suit alone.

Source: St. Louis Post-Dispatch

Categories : Ethics and LawTags :

‘Re-Emphasise Ethical Foundation of Medicine’, ACP Urges

On By ModernMedia

As healthcare services struggling under COVID are bought out by private equity, the American College of Physicians says that it is important to prioritise duty to the patients.

“Today, changing practice dynamics place greater focus on the business aspects of medicine,” the authors wrote in a position paper in the Annals of Internal Medicine. “Although employment or consolidation within larger organisations may not be problematic per se, physicians, regardless of practice setting, should challenge business concerns that are placed above the best interests of patients.”

Practices are often bought out by private equity firms that invest in them and introduce cost-cutting measures to increase market share, and then sell them on to make a profit. This results in pressures to generate financial returns at the ultimate expense of patient care.

“This desire to sell the practice soon after acquisition can create the incentive to sell off parts of the practice or undertake drastic short-term cost-cutting measures, including staff layoffs, to make a potential sale more attractive,” the authors wrote. “Insurance companies may further narrow their networks or restrict patient access to only their employed physicians.”

One example the authors cited was that of Hahnemann University Hospital in Philadelphia, which was shuttered just a year after being bought out by a for-profit corporation. This left patients without access to medical care, and some 570 medical residents and fellows were left with an uncertain future.

The authors also cautioned that private equity firms could also limit Medicaid and Medicare patients due to more complex needs and lower reimbursement. These are government medical schemes that cover lower-income individuals. Medicaid alone covers 1 in 5 Americans.
Value-based payment, the authors noted, is supposed to promote high-quality care, but there are many concerns such as influencing patient choice and creating affordability barriers to treatment. Extrinsic, financial incentives may compete with the intrinsic desire to help patients. They also noted that referral-based payment is subject to similar ethical concerns. Meanwhile, time spent with patients needs to be valued, they wrote, as this is needed to ensure effective communication, examination and to express compassion.

“The challenges to care and medical practice during and after the COVID-19 pandemic underscore the need to reemphasise the ethical foundation of medicine,” the authors wrote. “Looking anew at the environment in which care is delivered, physicians should lead in ensuring that business relationships explicitly recognise and support the fundamental and timeless commitments of physicians and medicine to patients.”

Source: MedPage Today

Journal information: DeCamp M, et al “Ethical and Professionalism Implications of Physician Employment and Health Care Business Practices: A Policy Paper From the American College of Physicians” Ann Intern Med 2021; DOI: 10.7326/M20-7093.

Categories : COVID General InterestTags :

Have COVID Restrictions Eroded The Right to Dissent?

On By ModernMedia
Image by Niek Verlaan from Pixabay

An article in The Guardian explores how the COVID pandemic and its restrictions have also may have caused an erosion in the institutions of democracy around the world.

On Saturday, a vigil at Clapham Common in the UK for Sarah Everard, a woman believed to have been murdered by a police officer, was broken up by police in a heavy-handed manner which drew widespread criticism.
Defending the Metropolitan police’s handling of the situation, assistant commissioner Helen Ball argued the force had to act “because of the overriding need to protect people’s safety” from COVID. In 2020, Black Lives Matter protestors were criticised for their actions in the first waves of the pandemic, but their actions did not cause a spike in infections. Indeed, the protests may have helped deter the spread of COVID due to their deterring people from going to restaurants and other forms of social gatherings.

While the Clapham Common event was not on the same scale, it is possible that even very large and boisterous protests are not ‘super-spreader’ events. And, according to the human rights organisation Liberty, they can be performed safely. For example a socially distanced rally was held in Tel Aviv in April last year against the Israeli prime minister, Benjamin Netanyahu, where thousands of people,   each in their own space, separated by two metres, were able to shout and wave banners.

“Protest is the lifeblood of a healthy democracy, and it’s critical that we can all stand up to those in power, and make our voices heard,” said Lana Adamou, a lawyer at Liberty. “Safe, socially distanced demonstrations are perfectly possible, and it is the duty of the police to facilitate them, not block them. The current restrictions should be interpreted compatibly with our rights enshrined in the Human Rights Act.”

However a report published by Carnegie Europe in January observed that human rights are being eroded in the name of public health, with many governments using the pandemic as a pretext to crack down on dissent.

“While governments have claimed that they were imposing measures to tackle the pandemic, these measures often have been contradictory and have excessively restricted the right to peaceful assembly,” the report said, saying that while economic activities were enabled, large protests were still prohibited. In Sweden large groups were allowed to congregate in restaurants and at sporting events, but public gatherings and protests involving more than eight people were banned. It also noted that police used tactics such as kettling, a controversial tactic where police corral protestors into tight groups before arresting them, which can increase the spread of infection.

These restrictions have forced some campaigners to become creative in their protests. In the Netherlands, climate activists filled a square in front of the Dutch parliament in the Hague with 1000 shoes from all over the country. In Croatia, a civil society movement staged balcony protests against the governance of the mayor of Zagreb.

What campaigners in some countries will be asking is whether or not the pandemic has eroded the right to dissent, and to what extent will mass public protests be allowed to return once the COVID threat has passed.

Source: The Guardian

Categories : Ethics and Law General InterestTags :

Op-ed: Facebook Medical ‘Fact Checking’ Has No Room for Debate

On By ModernMedia

Fact-checking is increasingly important in an era of disinformation on social media, especially with the current COVID pandemic, but an article for MedPage Today calls into question the process for Facebook’s medical fact-checking.

After an op-ed in the Wall Street Journal by Marty Makary, MD, MPH, Johns Hopkins professor and editor-in-chief at MedPage Today, was labelled “misleading” by Facebook fact checkers, another op-ed in MedPage Today asks how the social media giant is choosing its medical fact-checkers. 

Mystified by why this would be labelled “misleading” by Facebook, and setting aside the ‘veracity’ of the article, Vinay Prasad, MD, MPH, a haematologist-oncologist and associate professor of medicine at the University of California San Francisco, investigated the website HealthFeedback.org that Facebook uses to fact-check some of its medical articles. 

The process involves two to four reviewers chosen to examine an article. Prior to the COVID pandemic, medical fact checking appears to have been done by academics, but the flood of disinformation has resulted in the change of this process, Dr Prasad noted.  

In one instance, a reviewer for the article was selected because he had already written an article critical of Dr Markary’s op-ed: in other words, he was selected because he had already announced his bias.

The website’s picking and choosing of reviewers “felt like a high school clique”, Dr Prasad wrote. One that allowed them to confirm their previously held ideas about COVID and extinguish differing viewpoints. Labelling the alternative views as misleading “instantly usurps the reader of their ability to make up their own mind. It is antithetical to the spirit of the academy.”

He found that the fact-checkers typically had large Twitter followings, while the typical medical professor seems to have them in the hundreds. This makes sense, Dr Prasad wrote, as leading academics and authorities are likely too busy to be courting large numbers of followers on Twitter.
Other than a “vague explanation” of the feedback process, Dr Prasad could not find any information on how Facebook chooses its reviewers, which of the billions of posts and articles on Facebook to fact-check, whether anyone is paid and how appeals are made.

Source: MedPage Today

Categories : Ethics and LawTags :

Social Cues Impacts on Human Decision-making in Emergencies

On By ModernMedia
Man at the wheel of a car. Photo by why kei on Unsplash.

A study showed that, when participants in a simulated crash of an autonomous vehicle were told that others had chosen to crash into a wall to save pedestrians, their own willingness to do so went up by two-thirds.

As autonomous vehicles become more commonplace, and the need to program them for safety emerges, a better understanding of how humans react in such situations is needed. Study author Jonathan Gratch, the principal investigator for this project, and a computer scientist at the USC Institute for Creative Technologies, said that current models for humans in life-or-death situations, humans think differently to how they do in reality. There are no moral absolutes, rather ” it is more nuanced”.

Seeking to understand how humans make decisions in life-or-death situations and how to apply them to the programming of autonomous vehicles and robots, researchers presented a modified trolley problem to participants using a modified ‘trolley problem’.

The trolley problem is a classic hypothetical scenario psychologists use to investigate human decision-making. Essentially, it involves the decision to divert a tram to hit one person or to leave it on its track and hit five, and it has a number of variations. In one medical variation of the trolley problem, one person could be killed and their organs harvested to save five terminally ill patients — a choice that is overwhelmingly rejected.  

In three of four simulations presented to them, the participants had to choose whether to tell their autonomous vehicle to hit a wall, risking harm to themselves, or hit five pedestrians. The higher the likelihood of injury to pedestrians, the more likely the participants were to choose hitting the wall and risking self harm. The authors showed that in so doing, people balance the risk of injury to self against the potential of injury to others as a guideline.

In the fourth scenario, a social element was added, where participants were told that their peers had chosen to save the pedestrians. In this case, the proportion of participants electing to save the pedestrian went up from 30% to 50%.

However, Gratch there is a reverse as well: “Technically there are two forces at work. When people realize their peers don’t care, this pulls people down to selfishness. When they realize they care, this pulls them up.”

The researchers showed that using the trolley problem as a basis for decision-making is insufficient, as it fails to capture the complexity of human decision-making. The researchers also concluded that transparency in the programming of autonomous machines was important for the public, as well as human operators assuming control in the event of an emergency.

Source: News-Medical.Net

Journal information: de Melo, C. M., et al. (2021) Risk of Injury in Moral Dilemmas With Autonomous Vehicles. Frontiers in Robotics and AI. doi.org/10.3389/frobt.2020.572529.