Category: Ethics

Pharmaceutical Companies Score Weak on Data Transparency

Source: Carlos Muza from Unsplash

Clinical trial data helps in deciding prescriptions and is good for science, but a new study revealed that not many pharmaceutical companies are completely transparent with the development data for their products. The study also found that large companies are much more transparent than smaller ones.

The study, co-authored by Yale researchers and published in The BMJ Open, assessed the data-sharing practices of 42 pharmaceutical companies for clinical trials of 40 novel drugs and 22 biologics which received US Food and Drug Administration approval in 2016 and 2017. They were evaluated with the Good Pharma Scorecard, which consists of transparency measures and a ranking system.

The researchers found that only seven of the 42 companies (17%) entirely met the tool’s standards for transparency and sharing data, with smaller companies being particularly opaque.

“The non-large pharmaceutical companies are dragging down the sector, often failing to meet federal reporting requirements, much less voluntary standards,” said study co-author Jennifer Miller, assistant professor at Yale School of Medicine, founder of Bioethics International.

“The lack of transparency is a problem because access to robust clinical-trial data supports patient care and good science,” she added. “Full transparency allows scientists to learn from previous work and prevents people from being exposed to unnecessary experiments.”

From the late 1990s, requirements for pharmaceutical companies to register and report results from clinical trials have been increasing. However, not all companies fully comply with the rules and industry guidelines vary.
In a smaller 2019 study using the transparency scorecard, 25% of companies fully met the standards, which include registering clinical trials, sharing data and study protocol publicly, and annually reporting requests for data. When given a 30-day window to improve, 33% met the standard.

For the latest study, the researchers also included biologics and smaller companies. While 17% of companies had perfect scores, 58% of the companies assessed had publicly available results for all patient trials, 42% complied with federal reporting laws, and 26% met the scorecard’s data-sharing measure.

Non-large companies were less responsive than large companies when offered the 30-day window to fix errors and improve data-sharing practices. Four companies used the window to improve data-sharing procedures

“It’s not surprising that non-large companies lag behind large as they may have fewer resources and smaller staffs with less compliance experience,” Miller said. “Our findings suggest that large companies may benefit from reviewing the transparency procedures of smaller companies before partnerships, mergers, and acquisitions so they don’t inherit any deficiencies.”

The researchers did notice improvements among large companies between the 2019 study and the latest one. For example, the median data-sharing score for large companies increased from 80% for drugs approved in 2015 to 100% for products approved in 2017.

Source: Yale University

Journal information:  Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis, BMJ Open (2021). DOI: 10.5061/dryad.r2280gbdb

Large Ivermectin Study Retracted Due to Data Problems Ethical Concerns

Photo by Markus Winkler on Unsplash

MedPage Today reports that a large ivermectin study has been retracted over concerns of plagiarism and serious problems with their raw data.

Michele Avissar-Whiting, PhD, editor-in-chief of the preprint server Research Square, wrote in a July 14 statement that the study was retracted “because we were presented with evidence of both plagiarism and anomalies in the dataset associated with the study, neither of which could reasonably be addressed by the author issuing a revised version of the paper.”

Dr Avissar-Whiting noted that the concerns were first raised by Jack Lawrence, a British medical student, according to The Guardian.

“Based on what Jack found, we have reason to believe the preprint’s conclusions are compromised, so the withdrawal was done to stop its propagation as sound science,” she said. “This is the strategy employed by a number of preprint servers, per best practice guidance.”

The 400-patient Egyptian trial, from Ahmed Elgazzar, MD, of Benha University, and colleagues, had been included in two recent meta-analyses (Bryant et al. and Hill et al.) which drew significant attention for their positive results — especially the much-anticipated Hill review. Two ivermectin proponent groups, the Front Line COVID-19 Critical Care Alliance (FLCCC) and the British Ivermectin Recommendation Development Group (BIRD), released a statement saying that removing the Algazzar data from the two studies did not change their overall positive result.

In an email to MedPage Today, lead author Andrew Hill, PhD, of the University of Liverpool in England, said  that his team will be “re-running our analysis with the Elgazzar trial removed.”

Dr Hill added that the analysis would also be updated with a recent 500-patient randomised controlled trial from Argentina, which found no effect for ivermectin in terms of preventing hospitalisation in patients with COVID. The study also fiend that patients receiving ivermectin required invasive ventilation sooner than those on placebo.

“In our published paper, we emphasised the preliminary nature of our results and the need to continue more definitive studies,” Hill wrote in his email.

The Elgazzar study’s main findings have already been cited by other publications: Hospitalised patients with COVID who were treated with ivermectin were 90% less likely to die than those who didn’t receive the drug. 

Lawrence had taken on an assignment for medical school which had prompted a deeper look at the paper, coming across plagiarism with entire paragraphs copied from other sources.

Additionally, the raw data, which can be purchased online, contradicted the study in several instances. Gideon Meyerowitz-Katz, an epidemiologist from the University of Wollongong in Australia, highlighted some of those discrepancies in a Medium post.

“For example, the study reports getting ethical approval and beginning on the 8th of June, 2020, but in the data file uploaded by the authors onto the website of the preprint fully 1/3 of the people who died from COVID were already dead when the researchers started to recruit their patients,” Meyerowitz-Katz wrote.

“Moreover, about 25% of the entire group of patients who were recruited for this supposedly prospective randomised trial appear to have been hospitalised before the study even started, which is either a mind-boggling breach of ethics or a very bad sign of potential fraud,” he continued.
Other phase III randomised clinical trials continue to investigate ivermectin for COVID such as the PRINCIPLE trial which seeks 1500 participants for its ivermectin arm.

Source: MedPage Today

Why the ‘Lab Leak’ Scenario Was Shouted Down

SARS-CoV-2 virus. Source: Fusion Medical Animation on Unsplash

For most of 2020, the notion that SARS-CoV-2 may have originated in a lab in Wuhan, China, was regarded as a debunked conspiracy theory, only embraced by some conservative media supportive of President Donald Trump. But in early 2021 that all changed, and today most outlets across the political spectrum agree that the ‘lab leak’ scenario deserves serious investigation.

An investigation by The BMJ uncovered a concerted campaign by researchers with funding on pandemic-potential virus research to label ‘lab leak’ scenarios as a conspiracy, effectively stifling journalism and investigation into the topic for over a year. One of the leaders of this was Peter Daszak, president of EcoHealth Alliance, a non-profit organisation which received millions in grants for pandemic preparedness research. EcoHealth Alliance subsequently subcontracted work out to the Wuhan laboratories.

Almost from the outset of the pandemic, a February 2020 statement in the Lancet coauthored by Daszak effectively ended the debate. “We stand together to strongly condemn conspiracy theories suggesting that covid-19 does not have a natural origin.” 

“It’s become a label you pin on something you don’t agree with,” said Nicholas Wade, a science writer who has worked at NatureScience, and the New York Times. “It’s ridiculous, because the lab escape scenario invokes an accident, which is the opposite of a conspiracy.” 

But hostility to the scenario continued to grow. Filippa Lentzos, codirector of the Centre for Science and Security Studies at King’s College, London, told the Wall Street Journal, “Some of the scientists in this area very quickly closed ranks.” She added, “There were people that did not talk about this, because they feared for their careers. They feared for their grants.”

Daszak wrote an essay for the Guardian in June 2020 attacking the former head of MI6 for saying that the pandemic could have “started as an accident,” and continued to receive support from coauthors of the letter. 
But Daszak’s role in drawing up the statement in the Lancet was revealed in November 2020 in emails obtained through freedom of information requests.

“Please note that this statement will not have EcoHealth Alliance logo on it and will not be identifiable as coming from any one organization or person,” wrote Daszak in a February email, while sending around a draft of the statement for signatories. He also considered omitting his name from the statement to reduce potential negative exposure. A number of the 27 co-signatories omitted reporting their ties to EcoHealth Alliance.

Richard Ebright, professor of molecular biology at Rutgers University in New Jersey and a biosafety expert, considered scientific journal to be complicit in helping to clamp down on talk of a lab leak. “That means NatureScience, and the Lancet,” he said. Along with dozens of other academics, he has been pushing back against the conspiracy theory labelling of the lab leak scenario.

“It’s very clear at this time that the term ‘conspiracy theory’ is a useful term for defaming an idea you disagree with,” said Ebright, referring to journalists and scientists making use of the term to attack others. “They have been successful until recently in selling that narrative to many in the media.”

Daszak enjoyed more support after then-President Trump cancelled EcoHealth Alliance’s National Institutes of Health funding, and the lab leak scenario remained buried for most of the year. It only resurfaced when a January 2021 New York magazine published an article detailing a possible lab leak scenario, in the face of stiff criticism. The tide began to turn when the World Health Organization investigation (which included Daszak) produced a report which attracted criticism for effectively ruling out the lab leak scenario in the face of almost a complete lack of evidence, such only being allowed a few hours’ worth of supervised access to the Wuhan labs. When Donald Trump lost the Presidential office, the criticism suddenly lost its greatest means for shutting down challenges — its mere association with its most widely-known and disliked proponent. 

Citing an intelligence report, the Wall Street Journal, recently reported that three Wuhan Institute of Virology researchers were admitted to hospital in November 2019. When President Joe Biden ordered an investigation into the scenario, it marked a slow turn-around in media coverage. Many outlets started backtracking their previously publicised viewpoints or adding qualifying statements, justifying them as simply a matter of tracking a “scientific consensus” which, they say, has now changed. Vox posted an erratum noting, “Since this piece was originally published in March 2020, scientific consensus has shifted.”

In recent weeks, a number of high profile scientists who once denigrated the idea that the virus could have come from a lab have made small steps into demanding an open investigation of the pandemic’s origin.

In a recent interview, NIH director Francis Collins said, “The Chinese government should be on notice that we have to have answers to questions that have not been answered about those people who got sick in November who worked in the lab and about those lab notebooks that have not been examined.” He added, “If they really want to be exonerated from this claim of culpability, then they have got to be transparent.”

It is worth noting that searches with phrases like “conspiracy theory”, “lab leak” and “Wuhan” do not turn up any relevant hits on The BMJ website, other than articles published this year which discuss the lab leak scenario seriously and credibly, or an article which discusses the more outlandish viral disinformation typical of the COVID pandemic typically seen in social media. Nor are there any articles with “Daszak” as an author.

Source: The BMJ

Tobacco Industry Linked to Disproven COVID ‘Protective Effect’ of Nicotine

Photo by Sara Kurfeß on Unsplash

An investigation by The BMJ uncovered undisclosed financial links between certain authors and the tobacco and e-cigarette industry in a number of COVID research papers, which had suggested that smokers were less likely to develop COVID. 

In April 2020, two French studies (in preprint and not yet peer reviewed) suggested that nicotine might have a protective effect against COVID, which was coined the ‘nicotine hypothesis’.

The studies were reported on widely by the media, causing fears that it could undermine decades of tobacco control. What should have been an opportunity for promoting cessation of this practice which every year kills five million people around the world.

Since then, the ‘nicotine hypothesis’ has been soundly disproved, with several studies showing that, to the contrary, smoking is associated with an increased chance of COVID related death.

Journalists Stéphane Horel and Ties Keyze investigated the circumstances of these reports. They pointed out that one of the study authors, Professor Jean-Pierre Changeux, has a history of receiving funding from the Council for Tobacco Research, whose purpose was to fund research that would cast doubt on the dangers of smoking and focus on the positive effects of nicotine.

From 1995 to 1998, documents from the tobacco industry show that Changeux’s laboratory received $220,000 (£155,000; €180,000) from the Council for Tobacco Research.

When approached by The BMJ, Changeux assured them that he has not received any funding linked “directly or indirectly with the tobacco industry” since the 1990s.

In late April 2020, Greek researcher Konstantinos Farsalinos was the first to publish the ‘nicotine hypothesis’ formally in a journal, in an editorial in Toxicology Reports.

That journal’s editor in chief, Aristidis Tsatsakis was a co-author, as was A Wallace Hayes, who in 2013 had been a member of Philip Morris International’s scientific advisory board, and had served as a paid consultant to the tobacco company.

Another co-author is Konstantinos Poulas, head of the Molecular Biology and Immunology Laboratory at the University of Patras, where Farsalinos is affiliated.

The laboratory has been receiving funding from Nobacco, the market leader in Greek e-cigarettes and the exclusive distributor of British American Tobacco’s nicotine delivery systems since 2018. However, in their published scientific articles, neither Farsalinos nor Poulas had ever declared this Nobacco funding.

Yet the journalists showed that two grants were attributed in 2018 by the Foundation for a Smoke Free World—a non-profit established by tobacco company Philip Morris International in 2017—to ‘Patras Science Park’.

The grants, which according to tax documents came close to €83 000, went to NOSMOKE, a university start-up incubator headed by Poulas, which markets an ‘organic’ vaping product.

Last month, the European Respiratory Journal retracted a paper with Poulas and Farsalinos as co-authors, after two other authors failed to disclose conflicts of interest.

The retracted article had found that “current smoking was not associated with adverse outcome” in patients admitted to hospital with COVID, and it claimed that smokers had a significantly lower risk of acquiring the virus.

The foundation has invested heavily in the COVID/nicotine hypothesis, said Horel and Keyzer.

In June 2020 it set aside €900 000 for research “to better understand the associations between smoking and/or nicotine use, and COVID-19 infection and outcome.”

Its request stated that the pandemic offered “both an opportunity and a challenge for individuals to quit smoking or transition to reduced risk nicotine products.”

They concluded that, in 2021, “amid a global lung disease pandemic, tobacco industry figures are increasingly pushing the narrative of nicotine as the solution to an addiction that they themselves created, with the aim of persuading policy makers to give them ample room to market their “smoke-free” products. This makes studies on the hypothetical virtues of nicotine most welcome indeed.”

Source: Medical Xpress

Article information: Covid 19: How harm reduction advocates and the tobacco industry capitalised on the pandemic to promote nicotine, The BMJ, DOI: 10.1136/bmj.n1303 ,

US Supreme Court Snubs Johnson & Johnson Talc Lawsuit Appeal

Photo by Bill Oxford on Unsplash

On Tuesday, the US Supreme Court declined to hear Johnson & Johnson’s appeal challenging a $2.12 billion ruling in favour of 20 women who developed ovarian cancer which they alleged was linked to the company’s talcum powder. 

The company was appealing a 2018 court ruling in favor of 22 women who alleged asbestos-contaminated talcum powder was linked to their cases of ovarian cancer. The women had said the company did not provide adequate warning of the risks associated with using their products. The initial settlement amount had initially been over $4 billion before being cut down.

The judge in that case ruled Johnson & Johnson had “misrepresented the safety of these products for decades” and the evidence shown at the trial demonstrated “particularly reprehensible conduct on the part of Defendants.”
Johnsons & Johnson has dominated the talcum powder market for over a century.
While there is no established link between talcum powder exposure and cancer, but talcum powder is often mined close to asbestos, a known carcinogen for which there is no safe level of exposure, and which can have a long latency period between exposure and cancer development.
Some studies have shown an increase in lung cancer risk for miners working underground when exposed to raw talc, which can be contaminated with asbestos, while others have found no effect. Use of talcum powder in the genital or perineal area is thought to contribute to ovarian cancer risk, but results are also mixed.
Companies have been directed not to use asbestos in cosmetic products since the 1970s, according to the American Cancer Society. According to the National Cancer Institute, “the weight of evidence does not support an association between perineal talc exposure and an increased risk of ovarian cancer.”

A 2018 investigation by Reuters uncovered documents showing that Johnson & Johnson was not only aware of the asbestos contamination problem, the company covered it up. It even tried to influence US regulatory policy over asbestos in cosmetic products. Lawyers representing the company have argued in court that the tests were unreliable, although recent independent lab tests of samples obtained from various time periods detected asbestos contamination.

In response to queries from Reuters, Johnson & Johnson’s outside litigation counsel Peter Bicks wrote: “The scientific consensus is that the talc used in talc-based body powders does not cause cancer, regardless of what is in that talc. This is true even if – and it does not – Johnson & Johnson’s cosmetic talc had ever contained minute, undetectable amounts of asbestos.”

Source: Forbes

Human-monkey Chimeric Embryos Set off Ethics Debate

Blastocyst. Source: Wikimedia Commons.

A study published in the journal Cell has announced the creation of human-monkey chimeric embryos, igniting renewed debate over ethics.

The embryos are known as chimeras, organisms whose cells come from two or more “individuals”, and in this case, different species: a long-tailed macaque and a human. The research confirmed that the cells can survive and multiply.

Natural human chimeras do exist, and can involve humans cells from two embryos in the same womb fusing to produce a single individual, or a combination of maternal and foetal cells, or monozygotic twins sharing blood cells from a shared placenta.

Previously, researchers had produced pig or sheep embryos that contained human cells, in an effort to one day develop a way to grow human organs for transplant inside the animals.

The researchers, led by Prof Juan Carlos Izpisua Belmonte from the Salk Institute in the US, said that the results shed new light on the communications pathways between cells of different species. This could help with future efforts to engineer chimeras using more distantly related species.

“These results may help to better understand early human development and primate evolution and develop effective strategies to improve human chimerism in evolutionarily distant species,” the authors wrote.

In 2019, the Spanish newspaper El País reported on rumours that a team of researchers led by Belmonte had created monkey-human chimeras.

Specific human foetal cells called fibroblasts were reprogrammed to become stem cells, and were then introduced into 132 embryos of long-tailed macaques, six days after fertilisation.

“Twenty-five human cells were injected and on average we observed around 4% of human cells in the monkey epiblast,” said Dr Jun Wu, a co-author of the research, and now at the University of Texas Southwestern Medical Center.

The embryos were grown in petri dishes and were terminated 19 days after the stem cells were injected. The human cells were engineered with a fluorescent protein to enable identification.

The researchers reported that 132 embryos contained human cells on day seven after fertilisation. However, the proportion containing human cells fell over time.

“We demonstrated that the human stem cells survived and generated additional cells, as would happen normally as primate embryos develop and form the layers of cells that eventually lead to all of an animal’s organs,” Belmonte said.

The researchers also found differences in intercellular interactions between human and monkey cells within chimeric embryos, compared to the normal monkey embryos.

The researchers hoped the research would help develop “transplantable human tissues and organs in pigs to help overcome the shortages of donor organs worldwide”, said Wu.

Prof Robin Lovell-Badge, a developmental biologist from the Francis Crick Institute in London, said at the time of the El País report he was not concerned about the ethics of the experiment, noting the team had only produced a ball of cells. But he noted conundrums could arise in the future should the embryos be allowed to develop further.

While not the first attempt at making human-monkey chimeras – another group reported such experiments last year – the new study has reignited such concerns. Prof Julian Savulescu, the director of the Oxford Uehiro Centre for Practical Ethics and co-director of the Wellcome Centre for Ethics and Humanities at the University of Oxford, said the research had raised all sorts of ethical concerns.

“These embryos were destroyed at 20 days of development but it is only a matter of time before human-nonhuman chimeras are successfully developed, perhaps as a source of organs for humans,” he said, and added that a key ethical concern was the moral status of such organisms.

“Before any experiments are performed on live-born chimeras, or their organs extracted, it is essential that their mental capacities and lives are properly assessed. What looks like a nonhuman animal may mentally be close to a human,” he said. “We will need new ways to understand animals, their mental lives and relationships before they are used for human benefit.”

Others were less concerned, and rather pointed out that all the study found was that the creation of such chimera was simply ineffective.

Dr Alfonso Martinez Arias, an affiliated lecturer in the department of genetics at the University of Cambridge, said: “I do not think that the conclusions are backed up by solid data. The results, in so far as they can be interpreted, show that these chimeras do not work and that all experimental animals are very sick.

“Importantly, there are many systems based on human embryonic stem cells to study human development that are ethically acceptable and in the end, we shall use this rather than chimeras of the kind suggested here.”

Source: The Guardian

A Public Archive for Opioid Lawsuit Information

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

Ideological Divide in the US Undermines Research

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.

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

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.

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

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 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