Hundred dollar bills rolled up in a pill bottle

Aducanumab: A Bitter Pill to Swallow

By Emily Largent

On June 7, the U.S. Food and Drug Administration (FDA) used the Accelerated Approval pathway to approve aducanumab, which will go by the brand name Aduhelm, to treat patients with Alzheimer’s disease (AD). Aducanumab, developed by Biogen, is the first novel therapy approved for AD since 2003. This news has left many experts stunned.

I have at least one colleague, Dr. Jason Karlawish, who has publicly stated that he will not prescribe aducanumab. Other clinicians have said they will only prescribe it reluctantly. These are individuals who have dedicated decades of their lives to treating patients with AD, to conducting path-breaking research and serving as investigators in clinical trials, and to advocating for public policies that will better serve AD patients and their families. Many have also seen their own families affected by AD. My colleagues are hardly indifferent to the suffering wrought by AD and would like to have a meaningful treatment to offer to patients and their families. But, they have concluded, aducanumab is not it.

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Kratom leaves and capsules.

A Sensible, Evidence-Based Proposal for Kratom Reform

By Dustin Marlan

In May 2021, the U.S. Food and Drug Administration (FDA) announced the seizure of 37,500 tons of adulterated kratom in Florida, worth an estimated $1.3 million.

But rather than focusing on the fact that the seized substance was adulterated, FDA Commissioner Janet Woodcock emphasized the alleged toxicity of kratom. This telling choice falls in line with recent efforts by the FDA to end U.S. kratom sales, distribution, and use, including a failed 2016 attempt to have kratom placed into Schedule I of the Controlled Substances Act, along with other federally prohibited drugs such as cannabis, psilocybin, and heroin.

This reactionary prohibitionism is likely to do more harm than good. Moreover, it does not reflect the state of the science, which remains unsettled as to kratom’s risks and benefits.

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Pile of colorful pills in blister packs

Expanding The Right to Try Unproven Treatments: A Dangerous, Deregulatory Proposal

By Richard Klein, Kenneth I. Moch, and Arthur L. Caplan

A new proposal out of the Goldwater Institute (GI), a libertarian think tank, advances an oversimplified critique of the U.S. regulatory process for approving medicines for COVID-19 and other diseases, with the ultimate goal of weakening the U.S. Food and Drug Administration.

You may remember the Goldwater Institute as the architect of the initial state “Right to Try” (RtT) legislation from a few years ago. The idea, marketed as increasing access to experimental medicines, was actually calculated to circumvent FDA oversight so that individuals could try still-unproven experimental medicines without what Goldwater viewed as pointless bureaucratic paternalism. RtT legislation was adopted by 41 states and ultimately by the U.S. Congress.

When former President Trump signed the Right to Try bill into federal law with great fanfare on May 20, 2018, he stated that “countless American lives will ultimately be saved.” Three years later, the promise proved to be meaningless, as evidenced by the difficulty in identifying more than a handful of individuals who have even pursued the RtT pathway, much less finding data to show that it has saved lives.

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doctor holding clipboard.

Learning from Clinical Negligence Claims: The New NHS Patient Safety Syllabus

By John Tingle

As part of its patient safety strategy, the National Health Service (NHS) in England has created the first system-wide patient safety syllabus, training, and education framework.

Education and training are fundamental prerequisites for creating a patient safety culture in any health care system. This new patient safety syllabus is both innovative and reflective, combining systems and human factors thinking.

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Emergency department entrance.

Be a Transformational President, Mr. Biden: Launch a Commission to Create an Ethical Health Care System

By William M. Sage

My message for President Joe Biden and his administration is a simple one. Invite physicians to create an ethical health care system. Demand that physicians take seriously that mission and work closely with other health professions and the public, sharing their power and authority.  

Physicians’ silence in the face of massive health injustice, inefficiency, and waste must be called out by leaders of the medical profession for what it is: complicity. Commitment to an ethically indefensible status quo has made much-needed reform proposals seem morally threatening, rather than representing opportunities for ethical introspection and improvement. All those who profit from the current system — a large group, given $4,000,000,000,000 of annual U.S. health care spending — use physician complacency to justify their own resistance to change.

The U.S. health care system will not change without permission from health professionals, especially America’s physicians. Permission must be built on principle, and it should take the form of re-envisioning and reaffirming medical ethics. The need to do so has been evident for over two decades, but COVID-19 has increased its urgency.

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NHS building

When Will the NHS Get Its Complaints System Right?

By John Tingle

The National Health Service (NHS) in England has been trying to get an effective, fit-for-purpose complaints system for at least 28 years, and it has still not succeeded.

This has been one of the NHS’s perpetual and intractable problems. History has not served the NHS well here, despite the publication of countless reports on patient safety and NHS complaint handling, and several major crises happening, such as Mid Staffordshire.

More often than not, the reports into patient safety crises and NHS complaints system reform all say the same (or similar) thing, and point to the same issues.

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NHS building

Health Care Providers’ Legal Duty to Be Open and Honest with Patients

By John Tingle

Last September, the first ever prosecution of a National Health Service (NHS) trust for failure to comply with the regulation concerning duty of candor was adjudicated.

University Hospitals Plymouth NHS Trust was ordered to pay a total of £12,565 after admitting it failed to disclose details relating to a surgical procedure and to apologize following the death of a 91-year-old woman.

Duties of candor require that patients be informed of adverse events as soon as possible after they occur. These duties serve as mechanisms to help balance power dynamics in health care and to advance patient rights. In England, duties of candor are contained in the professional codes of ethics of doctors and nurses, and in statutory regulations.

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woman with iv in her hand in hospital. Labor and delivery preparation. Intravenious therapy infusion. shallow depth of field. selective focus

Protecting Patients and Staff in Labor and Delivery During the COVID-19 Pandemic

As a labor and delivery nurse, I see patients at their most vulnerable and am there for them during an incredibly intimate time. After thirteen years, I am still awed and amazed at each birth I am lucky enough to be present for.

But in March of 2020, everything I knew as a nurse changed when COVID-19 reached my small community hospital.

Our struggles were two-fold — making our patients feel safe and making our staff feel safe.

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Healthcare concept of professional psychologist doctor consult in psychotherapy session or counsel diagnosis health.

The Case for Non-Police Response to Behavioral Health Crises

By Jennifer J. Carroll and Taleed El-Sabawi

People who use drugs continue to die at staggering rates, due not only to overdose from contaminated drug supply, but also due to our persistent reliance on the carceral system to respond to behavioral health crises.

This approach stems from the state-sanctioned violence of the War on Drugs. It takes various forms, including the use of police officers as first responders to behavioral health crises (including welfare checks), the excessive police use of force, and the use of potentially lethal restraint methods to subdue agitated persons. It also manifests in police officers’ use of jail cells as tools for forced “detox” believing that coerced withdrawal while in custody will reduce overdose risk or help someone “go clean” (it very clearly does not).

Evidence-based alternatives to police response for behavioral health crises exist. However, despite being both feasible and effective, these alternatives to police intervention remain the exception, rather than the rule.

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medical needles in a pile

How Supervised Injection Sites Can Help Address the Overdose Crisis

By Carly Roberts

Supervised injection sites, also known as safe injection sites, are among the most effective, evidence-based harm reduction tools available to counter the opioid overdose crisis.

Supervised injection sites are legally sanctioned locations that provide a hygienic space for people to inject pre-obtained drugs under the supervision of trained staff. Safe injection sites often provide additional services including needle exchanges, drug testing (especially important for detecting lethal fentanyl-laced drugs and preventing “mass overdose” events), and referral to treatment and social services.

The opioid overdose crisis in the U.S., which had a death toll of over 45,000 in 2018, and which is predicted to worsen amid the COVID-19 pandemic, warrants a bold, brave, and thorough response. Harm reduction programs, including supervised injection sites, should be integrated into opioid epidemic response strategies in order to save lives and improve individual and community outcomes.

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