Adderall bottle on shelf.

Losing Control of Controlled Substances? The Case of Telehealth Prescriptions 

By Minsoo Kwon

Telehealth services that specialize in the treatment of mental health concerns, such as Cerebral Inc., highlight the ongoing challenge of appropriately balancing accessibility of care with patient safety.

While increased accessibility of mental health care services through telehealth is a valuable goal, if our aim is the well-being of patients, safety must be paramount.

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Person in protective yellow hazmat suit and mask holds pills in hands.

Book Review: ‘The Truth Pill: The Myth of Drug Regulation in India’

By Aparajita Lath

The Truth Pill, authored by Dinesh Thakur and Prashant Reddy, is a monumental work that convincingly shows that drug regulation is but a myth in India.

In their investigative style, the authors explain drug regulation in India through the lens of history, both Indian and global. The book’s combination of history and contemporary issues makes for an immersive and compelling read. It may, however, leave you feeling frightened, given the dysfunctional regulatory system in India and the impact this can have on patients around the world. However, the book not only highlights problems but also offers several well-thought-out and actionable paths to reform.

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FDA approved concept. Rubber stamp with FDA and pills on craft paper. 3d illustration.

Book Review: ‘Drugs and the FDA: Safety, Efficacy, and the Public’s Trust’ by Mikkael A. Sekeres

By Matthew Chun

In Drugs and the FDA: Safety, Efficacy, and the Public’s Trust, oncologist Mikkael A. Sekeres tells a captivating story of how the U.S. Food and Drug Administration became the agency it is today and how it makes some of its toughest decisions regarding the regulation of potent drugs.

Sekeres centers his narrative on the controversial 2011 Avastin hearings, in which the FDA reconsidered and ultimately withdrew the breast cancer indication for Genentech’s Avastin drug. Having served on the Oncologic Drugs Advisory Committee (ODAC) tasked with making a recommendation to the FDA based on the hearings and clinical data, Sekeres provides a relatable personal account of the emotion-filled proceedings and the agonizing decision to withdraw approval of a beloved treatment option that never lived up to its promising initial results.

As he recounts his experience as an ODAC member, Sekeres skillfully weaves in historical references to various regulatory failures, including poisoned vaccines, opioid deaths, thalidomide-induced birth defects, and the woefully inadequate response to HIV/AIDS, which shaped the role of the FDA since its inception in 1930. Upon describing how the FDA developed its modern system of checks and balances to ensure drug safety, efficacy, and accessibility, Sekeres then illustrates how the Avastin hearings put all of these processes and values to the test. Among other things, Drugs and the FDA encourages readers to grapple with several important themes that pervade the agency’s decision-making process, including (1) the tension between drug safety and accessibility, (2) the relative weight of expert opinion versus patient autonomy, and (3) the role of democracy and transparency in drug regulation.

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Surgeon at work in the operating room.

Litigation and Patient Safety: The Importance of Good Communication Strategies

By John Tingle

Good record keeping and communication practices are essential prerequisites for safe and proper patient care. Serious patient injury, including death, can result from poor record keeping and other communication failures.

A fundamental issue in England’s National Health Service (NHS) patient safety culture development, however, is whether health care staff implement the necessary communication changes in light of  adverse health care events. In fact, failure to learn from errors is a persistent patient safety theme that has featured strongly in various health regulatory, patient safety, and crisis inquiry reports going back over 20 years.

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American Constitution - We the people with US Flag and gavel.

Abortion Bans Threatening Pregnant Patients’ Lives Are Unconstitutional

By James G. Hodge, Jr., Jennifer Piatt, Erica N. White, Summer Ghaith, Madisyn Puchebner, and C. McKenna Sauer

Following the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, which overturned the constitutional right to abortion, laws went into effect in multiple states that restrict when abortions may be provided, including during potentially life-threatening emergencies.

To the extent highly restrictive, amorphous, and indeterminate abortion bans contravene physician implementation of life-saving interventions for pregnant patients — and thus infringe upon the Fourteenth Amendment’s protection of the right to life — they are unconstitutional.

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Austin, Tx/USA - May 23, 2020: Family members of prisoners held in the state prison system demonstrate at the Governor's Mansion for their release on parole due to the danger of Covid-19 in prisons.

Federal Failures to Protect Incarcerated People During Public Health Crises

By Rachel Kincaid

As the COVID-19 pandemic persists, and as we face the reality that future pandemics are coming (or have already begun), it’s a fitting time for the United States to take stock of how the carceral system has exacerbated the harms of COVID-19, and for policymakers to seriously consider what can and should be done differently going forward.

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Protesters holding signs that read My Body My Choice, Human right, Bans Off Our Bodies, Abortion Is Healthcare.

Dobbs v. Jackson Women’s Health and Its Devastating Implications for Immigrants’ Rights

By Asees Bhasin

While reproductive injustice against immigrants is not new, they are now even more vulnerable to reproductive oppression in light of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization overturning the constitutional right to abortion.

Immigrant reproduction has long been vilified and opposed, with immigrant parents facing accusations of being hyper-fertile and giving birth to “anchor babies.” Additionally, pregnant immigrants have faced additional structural barriers to accessing necessary abortion care. This article explains how these injustices are likely to be exacerbated by the Dobbs ruling.

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Empty hospital bed.

Do No Harm: A Call for Decarceration in Hospitals

By Zainab Ahmed

In an era of mass suffering, some still suffer more than others. What’s worse, there is nothing natural about it. It is human made.

As an emergency medicine resident at a large academic hospital in Los Angeles, I see how incarcerated patients’ suffering is sanctioned by hospitals and medical professionals, despite their pledge to do no harm.

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Drug test strips.

Synthetic Cannabinoids and the Lack of Substance Use Disorder Treatment in Carceral Settings

By Aaron Steinberg, Ada Lin, Alice Bukhman, LaToya Whiteside, and Elizabeth Matos

The inability of prisons and jails to address the drivers of and treat substance use disorders, especially during the pandemic, is leading to underexplored health ramifications for prisoners, and particularly for prisoners who identify as Black, Indigenous, or other people of color (BIPOC), who already had comparatively poorer health outcomes.

This article focuses on one substance of growing popularity in carceral settings: synthetic cannabinoids (SC), which are frequently referred to as K2 or spice.

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