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06/05/2020 - 2:41pm

The #BlackBioethics Toolkit serves as a resource on articles about bioethics and race, specifically about African-Americans and Blacks in the U.S.

General Resources

  • Campaign Zero – “analysis of policing practices across the country, research to identify effective solutions to end police violence, technical assistance to organizers leading police accountability campaigns and the development of model legislation and advocacy to end police violence nationwide
  • #8CantWait – Ideas to reduce police violence

Bioethics.net

06/05/2020 - 10:00am

By Blake N. Shultz and Gregory Curfman

Despite a troubling history, rofecoxib (Vioxx) may be making a comeback.

The voluntary withdrawal of rofecoxib (Vioxx) from the market in September 2004 marked the end of a controversial era for a once highly profitable and widely used drug. It also marked the beginning of years of high-profile product-liability litigation that would cost Merck billions.

Rofecoxib was approved by the U.S. Food and Drug Administration (FDA) in 1999 for the treatment of acute, osteoarthritis-induced pain and was subsequently also approved for the treatment of pain associated with rheumatoid arthritis and migraine. Despite this broad indication, post-approval studies showed that the drug was associated with an increased risk of a variety of cardiovascular and thrombotic complications, most significantly myocardial infarction. Adding to the controversy, documents obtained in the subsequent litigation showed that Merck engaged in misrepresentation of study results that downplayed the risks of rofecoxib.

But over a decade later, in November 2017, TRM-201 (rofecoxib) received orphan drug designation for the treatment of pain caused by hemophilic arthropathy. Preliminary, observational data suggested that rofecoxib may be beneficial in this debilitating clinical condition, which is caused by spontaneous bleeding into joints, with repeated hemarthroses leading to severe, disabling, chronic inflammatory arthritis.

To explore the potential risks and benefits, researchers are in the planning stages of a randomized clinical trial of rofecoxib in this condition. The proposal to bring rofecoxib back to market was met with skepticism from some members of the academic community. Broadly, concerns revolved around the potential risks of off-label use and the need for clinical trial transparency about the cardiovascular risk of rofecoxib.

While the cardiovascular risk profile of rofecoxib should not be understated, these criticisms should be placed in context. The risk of death from ischemic heart disease in patients with hemophilia has been reported to be lower than in a control population. Furthermore, the safety profile of rofecoxib has not been rigorously assessed in patients with hemophilic arthropathy, and the application of risk evaluation and mitigation strategies (REMS) also needs to be considered. For example, limiting prescriptions to patients with low cardiac risk and regular cardiovascular screening would be expected to mitigate cardiovascular risk. Because side effects increase with duration of use, drug cycling or holidays may be used to reduce risk (similar to those used to reduce the significant side effects of long-term levodopa therapy for Parkinson’s disease).

Although studies have shown that the cardiovascular risk profile of rofecoxib may be worse than that of other NSAIDs, the magnitude of this risk is modest and the above strategies may provide mitigation. For example, one large cohort study found that the odds ratios for acute myocardial infarction were 1.48 (95% CI, 1.00-2.26) for ibuprofen and 1.58 (95% CI, 1.07-2.17) for rofecoxib. The modest difference in the point estimates of risk with the potential for additional mitigation strategies suggests that sufficient clinical equipoise exists to justify a clinical trial. Development and appropriate prescribing of this medication are worthy of further study.

The need for novel pain treatments for patients with hemophilic arthropathy is substantial. Current pharmaceutical management of hemophilic arthropathy-related pain relies on long-term opioid use and intra-articular corticosteroid injections, both of which come with significant risks. In addition to the risk of addiction, studies have shown that an opioid supply of at least 180 days over a 3.5-year period was significantly associated with increased risk of myocardial infarction versus no therapy (adjusted incidence rate ratio, 2.66 [95% CI, 2.30 to 3.08]), and that this risk persisted for any duration of therapy. The risk of myocardial infarction from long-term opioid therapy is comparable to that observed with rofecoxib, supporting the argument that sufficient equipoise exists to justify conducting a clinical trial.

Intra-articular corticosteroid injections may also be associated with potentially serious complications, including bone loss and joint destruction, which led Kompel et al. to recently suggest that intra-articular corticosteroid injections are “perhaps not as safe as we thought.”

Concerns about off-label prescribing if rofecoxib were re-introduced into the market similarly may be over-stated. Some critics suggest that because drugs that treat common conditions, such as osteoarthritis pain in the case of rofecoxib, have high rates of off-label use, the risk of market reentry is particularly pronounced. They also point to examples of nonadherence with REMS commonly utilized by the FDA to control the use of drugs with known safety risks. However, as a counterexample, consider the REMS for thalidomide. Initially used to treat anxiety, insomnia, and morning sickness, thalidomide was found to be a powerful teratogen after it caused thousands of fetal deaths and deformities across the world. Today, however, it is used in the United States under a REMS as a first-line therapy for multiple myeloma. Recent studies suggest that complete compliance with birth control requirements under the REMS program was 96.3%, and that compliance remained very high throughout a full course of therapy.

Prior authorization for insurance coverage and other formulary management strategies have also been cited as methods to control off-label use of rofecoxib, although skepticism has been raised due to the ability of companies to circumvent these barriers. However, the threat of civil enforcement and malpractice liability are potent deterrents to unsafe prescribing practices.

Without further study of the safety of rofecoxib in the hemophilic arthropathy population, and without rigorous evaluation of REMS and other mitigation strategies for rofecoxib, the potential benefits of the drug’s return to market should not be readily dismissed. While concerns related to cardiovascular risks are serious and cannot be overlooked, the clinical problem of hemophilic arthropathy is severely debilitating for patients and current therapies are not only inadequate but also pose substantial risks of their own. It is entirely plausible that rofecoxib may provide more benefit with less risk than current therapies in patients with hemophilic arthropathy. We believe that the principle of clinical equipoise is clearly met and that a clinical trial of rofecoxib in patients with hemophilic arthropathy is appropriate and should be undertaken promptly to address this significant unmet medical need.

The post Could Vioxx Make a Comeback? Recalled Drug Receives Orphan Designation appeared first on Bill of Health.

06/05/2020 - 9:08am

by David Magnus, Ph.D.

The past three months have witnessed this country (and the world) go through the most serious pandemic since 1918; the greatest economic collapse since the great depression; and the murder of George Floyd has set off a protest movement across the country that has arguably not been seen since 1968.

All three of these events have something in common. They all expose a hard truth in a fashion too compelling to deny: the underlying racism of our country.  

06/05/2020 - 8:00am

by Craig Klugman, PhD, Kelly Michelson, MD, MPH, Kayhan Parsi, JD, PhD

In response to the COVID-19 pandemic, groups of regional ethicists have organized to better foster collaboration and dialogue in their cities and states.  Here in the Chicago metropolitan area, the COVID-19 Chicago Bioethics Coalition (CBC) was created on March 20, 2020, the same day Governor J.B. Pritzker announced the “shelter at home” order for the state of Illinois.  One of the authors (KM) organized the coalition to discuss the bioethical challenges of the current pandemic. …

06/05/2020 - 7:05am

By Rob Gatter and Seema Mohapatra

This is an excerpt of an essay first published in the Washington and Lee Law Review Online here.

As a counter-measure to the COVID-19 pandemic, should wearing masks in public be required or merely recommended?

The question is complicated and without a clear right answer. Ohio Governor Mike DeWine announced on April 27th that shoppers would be required to wear masks. He reversed the mandate the next day, after a public backlash. Ohio’s experience demonstrates the divided opinions – and actions — on the topic.

Some jurisdictions require masks. Others do not. The CDC issued a recommendation in early April that individuals wear a mask when in public but stopped short of proposing that states require masks. Meanwhile, the WHO still does not recommend masks unless symptomatic or caring for someone symptomatic.

So what is the right policy? We, as public health law experts, provide some analysis and recommendations.

Masks and Public Health

Wearing masks in a store or other place of public accommodation is likely effective at preventing the spread of the coronavirus. The CDC says the virus is transmitted primarily through respiratory droplets expelled by an infectious person directly onto another person, surfaces others touch, and into the ambient air others breathe. Masks help prevent all methods of transmission. Moreover, because the virus can be transmitted by those without symptoms, a mask requirement likely helps prevent asymptomatic infections.

Empirical evidence also supports mask-wearing requirements. Recent systematic reviews confirm that masks work to contain the droplets of individuals infected with coronavirus.

Based on science alone, it’s tempting to require masks for everyone in public spaces, especially as stay-at-home orders are being lifted. Yet, the efficacy of masks cannot be the only consideration.

Masks and Racial Discrimination

Black Americans risk being targeted by law enforcement, the employees of retail establishments, or their own neighbors for wearing masks.

For example, Kam Buckner, an Illinois State Representative who is Black, was stopped by a Chicago police officer after shopping while wearing a mask. The officer asked to see Rep. Buckner’s ID and store receipt. When the legislator asked the officer why he was stopped, Buckner says the officer answered, “I can’t see your face man, and you look like you may be up to something.”

Senators Kamala Harris, Cory Booker and others sent a letter to the FBI and DOJ that chronicles several other incidents of racial discrimination by police against Black American men for wearing or failing to wear masks.

Such discrimination is uniquely offensive given that the COVID-19 pandemic has disproportionately harmed Black communities. CDC has shared data suggesting “an overrepresentation of Black (people) among hospitalized patients” nationally. In New York City, the death rate for Black Americans is more than twice that of white residents.

Wearing a mask is particularly valuable in preventing the spread of the virus in communities where it is more prevalent, and yet doing so increases the risk of racial discrimination. “In essence, Black men have to pick their poison — risk their lives (and the lives of others) to Covid-19 by not wearing a mask, [or] risk their lives to police officers who see them as suspicious while wearing a mask,” writes Fabiola Cineas for Vox.

Perhaps a mask mandate would cause less stigma by requiring almost everyone to wear masks. Yet mask mandates—particular those enforced with fines or worse—lead to unequal police enforcement, and whether they are worn or not, the mandates run the risk of becoming a proxy to carry out racial profiling.

The Law as an Unreliable Check on Discrimination During a Pandemic

Racial discrimination is illegal — prosecutors and private litigants are empowered to pursue a remedy for such discrimination. So, in theory, the law is a check against any discrimination that might result from a mask requirement. Yet, in practice, there is reason to be doubtful.

Courts are less accessible than they would be during normal times. A litigant seeking redress for racial discrimination in the enforcement of a mask requirement may have difficulty obtaining a timely hearing. And justice delayed is justice denied.

Moreover, courts are exceedingly deferential to the actions of officials during a public health emergency. Such deference is compounded when judges also use the emergency as justification to adopt lenient standards of review. Courts have manipulated constitutional review standards in this pandemic, lowering the bar that police and other state action must clear.

For example, the Fifth Circuit federal appellate court recently side-stepped case law imposing an “undue burden” standard on state actions related to abortions in favor of a less demanding “real and substantial relation” test, claiming that the more forgiving test is required during a public health emergency. Worse still, a New Hampshire state court held that, during this pandemic, a Governor may “suspend civil rights” in the temporary service of civil order.

In short, a litigant seeking relief for race-based enforcement of a mask requirement is likely to find himself before a deferential judge deploying lenient standards of review and opining that civil liberties take a back seat to civil order during an emergency.

We conclude that a mask recommendation is the better solution. The additional racial discrimination that is likely to result from the enforcement of a mask requirement is unacceptable, and it undercuts the empirical justifications for a mandate.

In comparison, a mask recommendation captures some of the public health benefit without the need for an enforcement mechanism that is so likely to result in additional discrimination.

Moreover, officials can boost the likely effectiveness of a mask recommendation if they combine it with advertising campaigns to educate the public about mask use, perhaps with well-known celebrities and those of all political stripes, so as to help normalize mask-wearing.

Additionally, we recommend increased federal funding for states and public health agencies to make masks widely available to the general public.

The post COVID-19, Mask Requirements, and Racial Discrimination appeared first on Bill of Health.

06/05/2020 - 3:00am

On June 3, 2020, the UK Court of Protection authorized the withdrawal of artificial nutrition and hydration from MSP, a 34-year-old man with severe gastrointestinal problems.

06/05/2020 - 3:00am

On June 3, 2020, the UK Court of Protection authorized the withdrawal of artificial nutrition and hydration from MSP, a 34-year-old man with severe gastrointestinal problems.

Remarkable is the extent to which the court relied upon MSP's advance direct...

06/04/2020 - 11:57pm

by Craig Klugman, Ph.D.

“What can bioethics do to help with the racial injustice” is a refrain that I wish I heard more in bioethics. When COVID-19 entered the stage, bioethicists—myself included—tripped over each to put out special journal issues, write OpEds, work with the media, set up webinars, and advise governments at all levels. The response from the George Floyd killing and protests against racial injustice have been quieter.

Racism is a health issue. Racism is an ethics issue.

Narrative ethics seeks to understand the stories of a case.…

06/04/2020 - 2:00pm

By Cheluchi Onyemelukwe

To limit the spread of the novel coronavirus, the Nigerian government took restrictive containment measures, with the effect of curtailing fundamental rights. These included lockdowns of various states and a cessation of social and economic activity, except those activities relating to essential services. While these measures followed existing public health advisories, they have raised significant legal, constitutional, human rights, and legitimacy issues.

The Constitution provides for the power of the President to declare an emergency, where there is imminent danger or disaster or natural calamity affecting a community, or any other public danger constituting a threat to the country.  A public health emergency of COVID-19 proportions would arguably be considered an imminent danger. Declaration of an emergency in this case would require the passing of a resolution by the National Assembly after the President’s proclamation, otherwise such a proclamation would expire in 10 days.

However, the President chose a different vehicle to impose restrictions.  Instead of passing a proclamation of emergency, which would have required the input of the National Assembly, he issued regulations under the Quarantine Act, a 1926 law which allows the President to declare a place within the country an “infected local area.”  The President is empowered on the basis of such a declaration to make relevant regulations.

Pursuant to the COVID-19 Regulations, 2020, the president required two states – Lagos and Ogun States — and the Federal Capital Area to be locked down, and prohibited mass gatherings throughout the country.

In accordance with the Quarantine Act, states can only make regulations where the President fails to do so.

It is also important to emphasize that quarantine and labor are “exclusive matters” under the Constitution, and only the Federal Government has the authority to make laws relating to them.  What this meant, in effect, was that states could not make regulations where the President had done so, and if states had already passed regulations, they ceased to have any validity.

However, some states continued to pass regulations and executive orders. These arguably unconstitutional regulations restricted entry, precluded work except “essential services,” and meted out penalties, thus violating the rights of persons to movement and to other rights.  These matters have yet to be brought before the courts, thus there remains a need for clarification either in a judicial decision or in comprehensive public health law.

Initially, there was apparent public acceptance of the restrictions of the COVID-19 Regulations,  signified by a high degree of compliance.  But the manner of enforcement of the restrictions in several areas around the country led to reports of human rights abuses.  These included killings (which at one time numbered 18, more than the number of deaths caused by the virus itself), incarceration without court orders in places where physical distancing was impossible, demolition of buildings, and deportation of young almajiris, all of which whittled away support and delegitimized the measures.

Civil and political rights have been impacted. And socio-economic rights, like the right to food, and the right to housing, although non-justiciable under Nigerian law, have also been affected by the pandemic. While the impact has been felt across all segments of Nigerian society, the country has a large informal sector and people who survive on a subsistence basis, especially in Lagos State.  With a limited welfare system and poor data, the government has been unable to provide sufficient support, which has bred dissatisfaction and mistrust. The impact on the poor, victims of sexual and gender based violence, and persons with disabilities has not been measured, but there is little doubt that it is likely to be considerable. Certainly, the lack of social determinants of health – water, power supply, appropriate housing – has rendered many in the informal sector more vulnerable to difficulties in the absence of social safety nets.

Growing unrest may have been one reason for the relatively early easing of restrictions, while the country still had a high number of cases, and the curve continued to rise, rather than flatten.

Challenges to human rights and issues arising within the legal framework during the pandemic have helped provide grounds for the National Assembly to work towards the enactment of new legislation. The Bill aims to further strengthen Nigeria’s public health institute, the Nigeria Centre for Disease Control’s mandate and clarify the manner of declaring a public health emergency.  However, major concerns relating to the draconian provisions of the Bill amongst other issues have emerged. Given the emerging lessons of the pandemic in Nigeria, entrenching a strong framework of human rights within proposed legislation is an imperative that cannot be ignored.

 

Dr. Cheluchi Onyemelukwe is an Associate Professor at Babcock University and Managing Partner at Health Ethics and Law Consulting.

The post The Law and Human Rights in Nigeria’s Response to the COVID-19 Pandemic appeared first on Bill of Health.

06/04/2020 - 12:00pm

By Ruth Fletcher

Between enabling and suffocating legal measures

Tensions between welfarisms that enable and those that suffocate are evident in Ireland’s move to restrict the spread of the COVID-19 pandemic, and in the reaction to it.

Two pieces of emergency legislation passed through Oireachtas Eireann (the Irish Parliament) by March 26th. The Health (Preservation and Protection and other Emergency Measures in the Public Interest) Act 2020 and the Emergency Measures in the Public Interest Act 2020 address a range of social, civil and economic issues. 

The former provides for the powers to restrict movement and participation in social activities by amending existing public health legislation, i.e., the Health Act 1947. The measures include specific powers to restrict travel within and across state borders including with Northern Ireland, to require people to remain in their homes or in specified places, to prohibit events or classes of events, and to require safeguards to be put in place by event organizers, owners or occupiers of a premises, and managers of schools, universities or other childcare or educational facilities. The legislation has been implemented through the adoption of Regulations authorized by the Minister for Health, the first of which was adopted on April 7th with the original intention of running until April 12th (SI 121). It has been extended three times since then through amendments and now will run until June 8th (SI 174).

As the easing of lockdown began on May 18th, the new regulations have modified the restrictions, e.g., through extending the distance people can move from 2km to 5km. The Irish Council of Civil Liberties (ICCL) has called, jointly with others, for a human rights impact assessment of the measures, and continues to call for a return to policing by consent rather than coercion. An Oireachtas Special Committee on COVID-19 has been established to hear evidence and inform and scrutinize decisions, and is due to hear evidence on care homes and direct provision centers the week beginning May 25th.

Police checkpoints have been set up by the Garda Síochana throughout the country in order to check on people’s reasons for travelling and assess whether they amount to a ‘reasonable excuse.’ The official position is that the purpose of the policing measures is to seek compliance and that prosecutions will only be used in the last instance. Breach of the penal public health provisions constitutes a class C offence, carrying the possibility of a fine of up to €2,500, or 6 months imprisonment. By April 25th, 76 people had been arrested because they were more than 2km from home without being able to show they were making an essential journey and after not complying with gardaí urging they go home.

Armed members of the police force have been seen at checkpoints, causing concern that this policing presence is more threatening than usual. Other concerns address the use of spithoods, which cover the face of someone being detained or arrested and have been defended as an appropriate response to incidents of malicious spitting. Their effectiveness in preventing infection has been questioned, and hooding could constitute degrading treatment in breach of human rights protections.

The judiciary has evaluated the measures in the context of a rightwing libertarian challenge to the legislation, which the High Court had no trouble dismissing in O’Doherty and Waters v the Minister for Health Ireland, the Attorney General and Dail Eireann, Seanad Eireann and the Ceann Comhairle [2020] IEHC 209 (2020 271 JR). The applicants had sought a judicial review of the legislation, claiming, among other things, that the statutory measures restricting movement were disproportionate in their infringement of constitutional rights (including family rights 41.1.1, freedom of conscience 44.2.1, rights to bodily integrity, peaceful assembly and liberty under Article 40).

Interestingly, the judge begins his judgment and lays out the factual context for the application by referring to the World Health Organization’s tracking of the outbreak and its January announcement that COVID-19 represented a Public Health Emergency of International Concern. Charles Meenan J ruled, citing the Supreme Court in Esme v Minister for Justice and Law Reform [2015] IESC 26 on the need for an applicant for judicial review to show that an argument “was not empty” — they had not shown that they had an arguable case, that the constitutional rights they invoked were not absolute, and that they had evidence to attest to a disproportionate infringement of rights.

Selective care and the uneven impact of legal restrictions

There has been extensive disquiet about the uneven impact of these measures, particularly given their potential to exacerbate already existing disadvantage.

Direct provision is the system for accommodating asylum seekers in Ireland, which sends people to live in former convents, barracks, hotels, holiday homes. It has been extensively criticised as a form of institutionalism which stigmatizes, segregates and isolates residents. Living arrangements mean that residents share eating areas and have little privacy. As a result they cannot “social distance.” At a direct provision center in Cahirciveen there have been reports of residents being “advised” that they cannot leave; at the same time centers are seeing the spread of COVID-19, which raises concerns about arbitrary detention as well as individual and public health.

Those living in confined circumstances for other reasons – such as women living with domestic violence, prisoners, and those living in care homes – are among those who have been, or are likely to be, disproportionately impacted by the virus and the public health restrictions taken to contain and limit its spread.

Escaping domestic violence is recognized as a legitimate reason for leaving home during lockdown. There has been a 20% increase in reported domestic violence incidents compared to this time last year. While supports have improved, the threat of violence has not diminished, and is being exacerbated by the stressful conditions of lockdown. The Domestic Abuse Intervention and Policy Unit of the Garda National Protective Services Bureau have launched Operation Faoiseamh (relief), where guards will proactively contact those who have previously reported domestic violence. And two years after a legal source of violence against women and pregnant people was removed from the Constitution when the abortion ban was repealed, the pandemic has brought about the permission and establishment of a remotely administered abortion service.

Compliance with the restrictions seems to be high and public trust in the Chief Medical Officer Tony Holohan, who leads on coordinating the public health response and the regular public briefings, seems to be holding. One current risk for public trust and democratic accountability however, is the fact that the situation is being overseen by a caretaker government. The acting Taoiseach (equivalent of Prime Minister), Leo Varadker, and the Fine Gael government are running the country and responding to the crisis, but do not actually have a mandate. There was no clear winner of the general election on 8 February with public support fairly evenly split between three parties Fianna Fáil (38 seats), Sinn Féin (37) and Fine Gael (35), and a number of other smaller parties such as the Green Party (12) and the Social Democrats (6) winning seats alongside a range of independents (19). Fine Gael, Fianna Fáil and the Green Party have agreed in principle to work together on a program for government; negotiations as to that program continue.

The relative success of Sinn Féin, and the weak showing of the then-ruling party was widely seen as the result of public frustration at the failures to develop a public infrastructure which would share the benefits of economic growth. Sinn Féin’s promise to tackle health and housing was popular with younger voters in particular and is sometimes framed as evidence of a Mouffe and Laclau kind of left populism. How will their exclusion, by the coalition of the two parties who have held power since the foundation of the state in 1922, play out as Ireland turns towards an economic downturn and continued civil restrictions? It remains to be seen as COVID-19-related concerns over selective care in governance, policing, hospitals, and homes speak to ongoing tensions over failures to respect the civil rights of those who participate in the reproduction of everyday life.

 

 Dr. Ruth Fletcher is a Senior Lecturer in Medical Law at Queen Mary University of London.  

The post COVID-19 Lays Bare Ireland’s Selective Approach to Care appeared first on Bill of Health.