Tag: ethics

‘Errant’ Human DNA can be Found Everywhere, Posing an Ethical Dilemma

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Researchers report in Nature Ecology and Evolution that human DNA traces can be found nearly everywhere, short of isolated islands and remote mountaintops. That ubiquity is both a scientific boon and an ethical dilemma, say the University of Florida researchers who sequenced this ‘errant’ DNA. The DNA was of such high quality that the scientists could identify mutations associated with disease and determine the genetic ancestry of nearby populations. They could even match genetic information to individual participants who had volunteered to have their errant DNA recovered.

David Duffy, the UF professor of wildlife disease genomics who led the project, says that ethically handled environmental DNA samples could benefit fields from medicine and environmental science to archaeology and criminal forensics. For example, researchers could track cancer mutations from wastewater or spot undiscovered archaeological sites by checking for hidden human DNA. Or detectives could identify suspects from the DNA floating in the air of a crime scene.

But this level of personal information must be handled extremely carefully. Now, scientists and regulators must grapple with the ethical dilemmas inherent in accidentally — or intentionally — sweeping up human genetic information, not from blood samples but from a scoop of sand, a vial of water or a person’s breath.

The paper by Duffy’s group outlines the relative ease of collecting human DNA nearly everywhere they looked.

“We’ve been consistently surprised throughout this project at how much human DNA we find and the quality of that DNA,” Duffy said. “In most cases the quality is almost equivalent to if you took a sample from a person.”

Because of the ability to potentially identify individuals, the researchers say that ethical guardrails are necessary for this kind of research. The study was conducted with approval from the institutional review board of UF, which ensures that ethical guidelines are adhered to during research studies.

“It’s standard in science to make these sequences publicly available. But that also means if you don’t screen out human information, anyone can come along and harvest this information,” Duffy said. “That raises issues around consent. Do you need to get consent to take those samples? Or institute some controls to remove human information?”

Duffy’s team at UF’s Whitney Laboratory for Marine Bioscience and Sea Turtle Hospital has successfully used environmental DNA, or eDNA, to study endangered sea turtles and the viral cancers they are susceptible to. They’ve plucked useful DNA out of turtle tracks in the sand, greatly accelerating their research program.

The scientists knew that human eDNA would end up in their turtle samples and probably many other places they looked. With modern genetic sequencing technology, it’s now straightforward to sequence the DNA of every organism in an environmental sample. The questions were how much human DNA there would be and whether it was intact enough to harbor useful information.

The team found quality human DNA in the ocean and rivers surrounding the Whitney Lab, both near town and far from human settlement, as well as in sand from isolated beaches. In a test facilitated by the National Park Service, the researchers traveled to part of a remote island never visited by people. It was free of human DNA, as expected. But they were able to retrieve DNA from voluntary participants’ footprints in the sand and could sequence parts of their genomes, with permission from the anonymous participants.

Duffy also tested the technique in his native Ireland. Tracing along a river that winds through town on its way to the ocean, Duffy found human DNA everywhere but the remote mountain stream where the river starts, far from civilization.

The scientists also collected room air samples from a veterinary hospital. They recovered DNA matching the staff, the animal patient and common animal viruses.

Now that it’s clear human eDNA can be readily sampled, Duffy says it’s time for policymakers and scientific communities to take issues around consent and privacy seriously and balance them against the possible benefits of studying this errant DNA.

“Any time we make a technological advance, there are beneficial things that the technology can be used for and concerning things that the technology can be used for. It’s no different here,” Duffy said. “These are issues we are trying to raise early so policy makers and society have time to develop regulations.”

Source: University of Florida

Court Action to Stop Immigrants Being Denied Life-saving Healthcare

Gavel
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The rights of immigrant and undocumented women and children to access free healthcare in South Africa will be put to the test in a court challenge launched by SECTION27 in the Gauteng High Court in Johannesburg.

In December 2019, two-year-old Sibusiso Ncube died of poisoning after he was refused treatment at Charlotte Maxeke Hospital because his Zimbabwean mother could not instantly produce his birth certificate or pay R5000, says an affidavit in the court case.

This was not an isolated incident according to Umunyana Rugege, executive director of SECTION27.

“Since 2013, SECTION27 has been repeatedly approached by pregnant migrant women and children under six, who have been denied access to free health services. This is perpetuated through discriminatory subordinate laws and practices,” Rugege says in her affidavit.

“They have routinely been denied access to the health care services, or they are pressured into signing acknowledgements of debt and undertakings to pay for services.”

SECTION27 wants all the relevant ordinances and regulations scrapped. It also seeks an an order that the Minister of Health issue a circular to all provincial health departments recording that all pregnant or lactating women, and children under six, who are not members of medical aid schemes and who have not come to South Africa to obtain health care, be entitled to free health services at any public health establishment, irrespective of their nationality and documentation status.

Rugege says that while the National Health Act does not place any limitation on the right to free health services, there are a range of subordinate laws and practices implemented at hospitals that impose conditions requiring proof of nationality and financial means.

“These laws and practices are unlawful,” she says.

Rugege cited other examples, such as a pregnant asylum seeker who was denied treatment after she was injured in a robbery. She was told she had to pay R2000 before a “file could be opened” at Steve Biko Academic Hospital.

Two months later, when she was eight months pregnant and went to Charlotte Maxeke, she was told she had to pay R20 000 if she wanted treatment and give birth at the hospital. Only after SECTION27 intervened, was she given an appointment, but the night before it she lost her baby.

Another Zimbabwean woman whose child needed emergency surgery was forced to sign an admission of debt for more than R34 000 at the same hospital. Then when he needed further surgery, it was denied because of the outstanding debt. The woman was further told that she would have to pay R5000 for admission and R50 000 for the second surgery.

Again SECTION27 intervened. But in March, when the mother took him back for a checkup, a nurse addressed everyone in the queue and told them that foreign nationals would not be attended to if they did not have money to pay. The mother, and others, left without being seen.

The application is supported by the Jesuit Refugee Service, The Southern African HIV Clinicians Society, and Doctors Without Borders; all are expected to file affidavits soon. Rugege says these will highlight discriminatory institutional policies and systematic xenophobic practices and attitudes that have “detrimental and sometimes fatal consequences”.

“There is simply no coherent approach at different public health establishments … even within a single establishment, different officials treat patients differently,” she said. Access to health care depends on who is on duty that day. On “lucky days” people will gain access without any trouble.

The respondents – the MEC and Gauteng health department head, the Minister and Director-General of Health – have 15 days to file notices of opposition.

By Tania Broughton

This article is republished from GroundUp under a Creative Commons Attribution-NoDerivatives 4.0 International License.

Source: GroundUp

Many Clinical Trials Ignore Previous Research

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Researchers evaluating a random selection of clinical trials done in North America found that they neglected to take into account previous or ongoing trials, which may result in researchers conducting redundant or less impactful studies. The findings were published in the journal Med.

Clinical trials are a crucial tool for assessing the safety and efficacy of medical interventions, but sponsors often provide incomplete information for assessing their ethical justification. Incomplete portrayals of supporting evidence hamper the ability of individuals or authorities to evaluate the trials’ risks, benefits, and scientific merit. 

To assess the prevalence of such omissions, researchers accessed the ClinicalTrials.gov registry and evaluated 101 randomly chosen clinical trials. Among those where there was at least one previous trial testing the same drug in the same disease, 30% of industry-sponsored trials and 20% of non-industry-funded trials failed to cite related studies. “Clinical trial protocols undercite easily accessible, relevant trials and do not document systematic searches for relevant clinical trials,” the authors wrote.

“Numerous studies suggest that some clinical trials are pursued despite their clinical hypotheses having been resolved prior to study launch,” write the authors. “Failure to provide a complete and impartial account of prior and ongoing research in study protocols may enable clinical research that fails to inform clinical practice.”

Source: EurekAlert

Road Accident Fund: Experts Withdraw Medical Opinions over Non-payments

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Medical experts who were under the impression they were contracted by the Road Accident Fund (RAF) to provide expert medical opinions, have written to acting chief justice Raymond Zondo to withdraw their completed opinions that have not yet been used in court because the RAF refuses to pay them or has charged penalties to reduce the amounts owed.

These qualified specialists provided expert medico-legal services, such as consultations and injury assessments, preparation of expert witness reports, attended expert witness meetings, prepared joint minutes of expert meetings, and presented expert evidence in court for the former panel of attorneys rendering this service for the RAF.

The experts say they have had enough of struggling for payments from the RAF and they state in the letter that their work “may not and should not be used as evidence in any matter” in the future because it is said to be unauthorised and not paid for. In effect, this means that RAF cases can no longer progress until these experts have been paid or until new medical expert opinions are obtained.

The RAF only recently informed all medical experts appointed by its former panel of attorneys that they were not authorised to perform these services which were conducted since 2015 and will therefore not be paid.

Mariëtte Minnie, director of MMB Made Easy, which handles medical accounts of medical-legal service providers says accounts she deals with have a total outstanding value of R63.5 million, with some accounts dating back as far as 2015. The biggest outstanding balance among her clients is R10,7 million the RAF owes to one neurosurgeon.

As a result of ongoing non-payment, some experts have shut down and sold their houses and cars due to huge overdrafts and VAT owed to SARS for opinions for which the RAF has not yet paid.

Minnie adds, “The RAF has stolen thousands of medico-legal reports from hundreds of experts which they do not intend to pay for.”

Medical experts have always been instructed by the panel attorneys as RAF representatives, but the RAF never renewed its expert contracts in time. The RAF then terminated the services of the panel of attorneys who had to obtain RAF authorisation for the experts but still asked experts to continue assessing claimants to avoid delays and send their reports directly to the RAF.

Minnie says that invoices for work done in previous years are met with delaying tactics and even denial of payment. “The RAF now implements terms of the service level agreement with the experts to fine them with 5% for every day that their reports are submitted after the due date although submission of reports is subject to factors such as obtaining necessary documentation to finalise the report.”

The RAF has also instituted steps to eradicate “irregular expenditure”, suggesting that experts assessed claimants and wrote reports without authorisation although the RAF failed to implement adequate systems to instruct and remunerate them.

Minnie comments, “The RAF is shambolic and has been unable to operate ethically or effectively since 2015. We will also be bringing this matter to the attention of the Minister of Transport, the Special Investigations Unit, the Public Protector, the National Prosecuting Authority and the National Treasury. New leadership is required to turn around the RAF.”

‘No NGOs Were Ready’, Life Esidimeni Inquest Reveals

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The former Gauteng deputy director-general for mental health services, Hannah Jacobus, has the process to move Life Esidimeni patients was rushed. She was being cross-examined by the State’s Advocate Willem Pienaar.

The much-delayed inquest meant to determine any criminal liability for the deaths of 144 mental health patients in the 2016 Life Esidimeni disaster continued virtually on Monday.

Jacobus’ role was in downscaling of patients at Life Esidimeni for cost savings, and says there was no indication of it closing at the time. When its closure was announced, these downscaling plans were not implemented and there was no timeframe given for when patients were to move out.

The former deputy DG admitted to writing false licences for NGOs, under pressure from then head of Gauteng mental health services, Dr Makgoba Manamelashe. However, Jacobus maintained that while she assessed their suitability, she ultimately did not issue any licences.

Dr Manamela signed licences authorising inexperienced‚ underfunded‚ poorly equipped NGOs to look after patients with profound mental illnesses.

After the Gauteng health department terminated the contract with Life Esidimeni, NGOs were used to care for the 1712 patients.

Dr Manamela admitted to Solidarity advocate Dirk Groenewald that the NGOs to which she gave authority did not comply with the legal requirements. In 2017,  it was found that patients were transferred to NGOs that had been issued “unlawful and knowingly fraudulent” licences.

Many NGOs were subsequently found to be entirely unprepared for the patients they received, some lacking sufficient food, water, medication, staff or blankets.  According to Jacobus, the process have only been completed by 2020 according to the downscaling schedule.

“From December 2015 to the end of March 2016 [is not] a sufficient period to determine and appoint suitable NGOs to receive mental healthcare [patients]. No NGOs were ready by the end of March. We needed more time,” she said.

Source: Times Live

UK Surgeon Who Branded Initials on Livers Struck Off

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A liver surgeon in the UK who branded his initials on the livers of two patients has been struck off the medical register.

The incidents, which occurred in 2013, involved the surgeon using an argon beam machine to write his initials “SB” on the livers of two anaesthetised patients while working at Birmingham’s Queen Elizabeth Hospital. In liver transplants, the argon beams are normally used for cauterisation and to highlight areas to work on.

His actions came to light when 4cm initials were discovered by another surgeonon an organ that had been transplanted by Bramhall and failed about a week after the operation. Pictures of the branding were taken with a mobile phone.

Bramhall tendered his resignation at the Birmingham hospital in 2014.

In a review of the case, the UK’s Medical Practitioners Tribunal Service (MPTS) said it was an “act borne out of a degree of professional arrogance”, adding that his actions “undermined” public trust in the medical profession.

In December 2017, Simon Bramhall, admitted two counts of assault by beating at Birmingham Crown Court and was fined £10 000 (R210 000). In December 2020 , he was suspended from the profession for at least five months, but a report from the latest tribunal on Monday said a review hearing on 4 June found his fitness to practise was no longer impaired by reason of his criminal convictions and his suspension lifted.

After an appeal from the General Medical Council (GMC), the sanction was quashed and then the case resubmitted to MPTS for its consideration.

On Monday, MPTS found Bramhall’s actions “breached” the trust between patient and doctor, and he was struck off.

The MPTS tribunal concluded that a suspension order would be “insufficient to protect the wider public interest” and said erasure from the medical register would be an “appropriate and proportionate sanction”.

Source: The Guardian

Should Unvaccinated-by-choice COVID Patients Get Less Priority?

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A new opinion piece provides an exhaustive examination of the ethics of using hospital resources on unvaccinated-by-choice COVID patients with pneumonia, versus patients with other serious but slower illnesses.

In his article published online in the Annals of the American Thoracic Society, William F. Parker, MD, PhD, looked at cases in which hospitals delayed time-sensitive and medically necessary procedures for vaccinated adults when they were overwhelmed with unvaccinated patients who had severe, life-threatening COVID pneumonia and suggested an ethical framework for triaging these patients.

“These vaccinated patients are directly harmed when hospitals use all their resources to care for the many unvaccinated patients with COVID,” he wrote.  “For example, delaying breast cancer surgery by just four weeks increases the relative risk of death from the disease by 8%.”

Dr Parker argues for a contingency care standard prioritising emergency life-support, regardless of vaccination status, in order to save the most lives.  “Simply rejecting the use of vaccination in prioritisation of medical resources without analysis ignores the very real tradeoffs at play during a pandemic.  The pain and suffering of the vaccinated from deferred medical care require a deeper defense of caring for the unvaccinated.”

Eliminating double standards
He stated: “Even though the vast majority of patients who develop life-threatening COVID pneumonia are unvaccinated, hospitals still have ethical obligations to expand capacity and focus operations on caring for them—even if it means making vaccinated patients wait for important but less urgent care like cancer and heart surgeries.”

“If tertiary care centers turn inward and stop taking transfers of COVID patients from overwhelmed community hospitals, this will result in de facto triage in favor of lower benefit care and cause systematic harm to both the vaccinated and unvaccinated in vulnerable communities,” he adds.  “Hospitals must justify their nonprofit status by accepting transfers and prioritizing life-saving care during a pandemic surge.”

He cited the example of a surge in Los Angeles, when the public health department had to issue an order forcing elite hospitals to stop doing financially lucrative elective procedures and accept patient transfers from community hospitals with ICUs overwhelmed by COVID.

Reciprocity and proportionality
The principle of reciprocity supports a possible tiebreaker role for vaccination status when two patients have equivalent survival benefit from a scarce health care resource. However, a universal exclusion of the unvaccinated from life support during a pandemic surge fails the test of proportionality for reciprocity, according to Dr Parker.

Reciprocity is rewarding one positive action with another. One example of this principle is giving vaccinated people access to sporting or entertainment events that are off limits to the unvaccinated (even if negative for COVID). Proportionality is the principle that ‘payback’ should be proportional to the magnitude of the act.  For example, living kidney donors get moved way up the waitlist- the equivalent of four years of waiting time on dialysis.  This satisfies the proportionality principle.

Dr Parker points out that while the increased relative risk of death of 8% from deferring breast cancer surgery is awful, the absolute increase in risk is only one per 100, and perhaps only one per 200 for a two-week deferral.
“After the surge is over, the hospital can catch up on deferred elective surgeries,” he wrote. “The harm from a coronary artery bypass or cancer surgery delayed two weeks is real, but tiny in comparison to certain death from denying life support for respiratory failure.”

He concluded that: “There is a defensible role for vaccination status in triage as a limited tiebreaker, not as a categorical exclusion, but only in the context of a well-defined and transparent triage algorithm.  Despite the enormous financial pressure to do otherwise, elite academic centres are obligated to prioritise life support for emergency conditions to save as many lives as possible during COVID surges.”    

Source: EurekAlert!

Miscarriage Should be Recognised as a Bereavement, Argues Psychiatrist

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A miscarriage during the first 6 months of pregnancy should be recognised as a bereavement, rather than illness in UK law, argues psychiatrist Nathan Hodson in correspondence published online in the journal BMJ Sexual & Reproductive Health.

Some MPs in the UK government have called for following in the steps of New Zealand’s policy of giving bereavement leave at  any stage of pregnancy loss, though this has been met with opposition.

The Parental Bereavement (Leave and Pay) Act 2020 allows for two weeks’ statutory bereavement leave for a stillbirth after 24 weeks and for the loss of a child up to the age of 18 in the UK. In South Africa, the 2002 Basic Conditions of Employment Act allows for six weeks’ maternity leave for pregnancy loss after 28 weeks.

Dr Hodson pointed out that parents in these circumstances are also entitled to take maternity or shared parental leave planned before the stillbirth, giving them weeks or months to recover from their loss.

But those who miscarry before 24 weeks in the UK have no such rights, added to which the miscarriage is regarded as an illness, with entitlement to sick leave. And if this lasts longer than 7 days, a formal sick note from a doctor is required.

“This policy creates an arbitrary cliff edge at 24 weeks,” with few women who miscarry being aware of their employment rights, Dr Hodson insisted.

Presently it is not known how many miscarriages occur in the UK annually nor how much sick leave is taken for them. He acknowledges this could open up private companies to unknown costs for employee miscarriage at any stage.

A single week of statutory bereavement leave when miscarriage occurs after the 12 week scan could reduce these costs. “Miscarriage risk after 12 weeks is less than 1% so this policy would be highly targeted with a less uncertain price tag,” he explained.

And within 2 or 3 years there should be sufficient data from New Zealand to estimate the impact of the policy, which was introduced in March this year. This allows women and partners 3 days of paid leave, irrespective of how long the woman had been pregnant, but excluding abortions.

But in any case, “miscarriage should as far as possible be recognised as bereavement, not sickness, and many parents will need time off work afterwards,” wrote Dr Hodson.

“Leave following first-trimester miscarriage should be prioritised when New Zealand has published data. But whatever approach is taken with regard to early miscarriages, the cliff edge at 24 weeks is a stark injustice demanding remedy.”

Source: EurekAlert!

Healthcare Organisations Urge Review of Culpable Homicide Law

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Nine of South Africa’s leading healthcare organisations have joined together in urging the Government to begin a review of culpable homicide law and its application in a healthcare setting.

In a letter to the Minister of Justice and Correctional Services, Hon Ronald Lamola, the coalition said there is a very low threshold in South African law for blameworthiness when a patient dies while under medical care, which has resulted in errors of judgement in complex healthcare environments being criminalised, and healthcare professionals being convicted regardless of their intent.

The joint letter calls for the review to be carried out by the South Africa Law Reform Commission, due to the complexity of criminal law in a healthcare setting and the importance of achieving a long-term solution for healthcare professionals and patients alike.

The letter says: “It is hard to see who benefits from the current system. As well as families losing a loved one through tragic circumstances, doctors risk losing their career and liberty, and the fear of criminal charges also has a negative knock-on effect on patient care. The current system stands in the way of patients receiving an early apology and a full explanation of events, and thereby denies closure.

In a recent survey of 500 doctors, 88% are worried about investigations after an adverse patient outcome, and 90% think the prospect of criminal investigation affects their mental health. Due to the prospect of criminal investigation means nearly half of all doctors in South Africa have considered leaving the profession. The letter further notes that  4 in 5 doctors surveyed think the criminal justice system in South Africa has an inadequate understanding of medical practice.

Pointing out the need for a “long-term solution”, they write: “Healthcare professionals need to be held accountable, however, criminalising errors of judgement – particularly in this fast moving and complex healthcare environment – seems unreasonably severe. Criminalisation in the absence of any clear intention to cause harm is overly punitive, leaving healthcare professionals vulnerable to criminal charges. Lessons can be learned from other jurisdictions – for example, in Scotland, where charges are only brought against doctors if an act is proved to be intentional, reckless, or grossly careless.

“Our organisations are committed to the highest level of safety for all patients in South Africa. This will however require replacing the current culture of blame and fear with one of learning, where healthcare professionals feel able to apologise and learn from mistakes, which will help to reduce the number of errors and thus enable progress on improving patient safety. When healthcare professionals are allowed and supported to learn from mistakes, lessons are learnt, and patients are better protected in the future.

Highlighting the complexity of these matters, “Patients and clinicians want the same thing, for those in need to receive the best care,” the letter concludes.

The letter was signed by Medical Protection Society, Association of Surgeons of South Africa, Federation of South Africa Surgeons, Radiological Society of South Africa, South African Medical Association, South African Medico-Legal Association, South African Private Practitioners Forum, South African Society of Anaesthesiologists and South African Society of Obstetricians and Gynaecologists.

Source: Medical Protection Society

‘Extensive Network’ of Opaque Medical Industry Ties

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A study published by the BMJ shines a light on an extensive network of financial and non-financial ties maintained by the medical product industry with all major healthcare parties and activities.

The researchers called for greater oversight and transparency for this largely opaque and unregulated network, “to shield patient care from commercial influence and to preserve public trust in healthcare.”
While the medical product industry is a critical partner in advancing healthcare, especially with the development of new tests and therapies, they have financial returns to shareholders as their main objective.

In a landmark 2009 report [PDF], the Institute of Medicine described a multifaceted healthcare ecosystem rife with industry influence.

To date most research into medical industry conflict of interests have focused on a single party (eg. healthcare professionals, hospitals, or journals) or a single activity (eg. research, education, or clinical care). Thus, the full extent of industry ties across the healthcare ecosystem remains uncertain.

To address this gap, a team of US researchers set out to identify all known ties between the medical product industry and the healthcare ecosystem.

They searched the medical literature for evidence of ties between pharmaceutical, medical device, and biotechnology companies and parties (including hospitals, prescribers and professional societies) and activities (including research, health professional education and guideline development) in the healthcare ecosystem.

The researchers drew in data in 538 articles from 37 countries, along with expert input, to create a map depicting these ties. These ties were then verified, catalogued, and characterised to ascertain types of industry ties (financial, non-financial), applicable policies on conflict of interests, and publicly available data sources.

The results show an extensive network of medical product industry ties – often unregulated and non-transparent – to all major activities and parties in the healthcare ecosystem.

Key activities include research, healthcare education, guideline development, formulary selection (prescription drugs that are covered by a health plan or stocked by a healthcare facility), and clinical care.

Parties include non-profit entities (eg foundations), the healthcare profession, the market supply chain (eg payers, purchasing and distribution agents), and government.

For example, the researchers describe how opioid manufacturers provided funding and other assets to prescribers, patients, public officials, advocacy organisations, and other healthcare parties, who, in turn, pressured regulators and public health agencies to stifle opioid related guidelines and regulations.

They also warned that harms from industry promoted products remain unexplored. All party types were found to have financial ties to medical product companies, with only payers and distribution agents lacking additional, non-financial ties.

They also show that policies for conflict of interests exist for some financial and a few non-financial ties, but publicly available data sources seldom describe or quantify these ties.

The researchers acknowledge that their findings are limited to known or documented industry ties, and that some data might have been missed. However, they say their strategy of systematic, duplicative searching and feedback from an international panel of experts is unlikely to have missed common or important ties.

In light of this, they conclude: “An extensive network of medical product industry ties to activities and parties exists in the healthcare ecosystem. Policies for conflict of interests and publicly available data are lacking, suggesting that enhanced oversight and transparency are needed to protect patients from commercial influence and to ensure public trust.”

Source: EurekAlert!