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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Pregnant woman sitting across desk from doctor wearing scrubs and holding a pen

Excluding Pregnant People From Clinical Trials Reduces Patient Safety and Autonomy

By Jenna Becker

The exclusion of pregnant people from clinical trials has led to inequities in health care during pregnancy. Without clinical data, pregnant patients lack the drug safety evidence available to most other patients. Further, denying access to clinical trials denies pregnant people autonomy in medical decision-making.

Pregnant people still require pharmaceutical interventions after becoming pregnant. Until maternal health and autonomy is prioritized, pregnant people will be left to make medical decisions without real guidance.

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Disability with technology line icon set.

Reflecting on the Struggle for Disability Rights a Year into the Pandemic

By Amalia Sweet

On March 9, the Petrie-Flom Center and Harvard Law School Project on Disability gathered a panel to discuss the extent to which the pandemic has set back progress toward ensuring the rights of persons with disabilities.

Though calls for solidarity in March 2020 declared the emerging pandemic to be a “great equalizer,” the past 12 months have demonstrated how the pandemic has exacerbated existing social inequalities, disproportionately impacting the already marginalized.

The panel discussion, hosted by Petrie-Flom Center Senior Fellow in Global Health and Rights Alicia Ely Yamin and moderated by Harvard Law School Project on Disability Executive Director Michael Ashley Stein, provided voice to the uniquely and acutely devastating impacts of the pandemic on persons with disabilities, who are still struggling to secure protection of their basic rights.

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Gavel surrounded by piles of money.

3 Challenges to Patents on Therapeutic Monoclonal Antibodies

By Gregory Curfman

Three new developments — two based on litigation and one based on a federal statute — may have significant effects on pharmaceutical manufacturers’ use of patents to fend off competition and maintain high prices for therapeutic monoclonal antibodies.

Highly specific monoclonal antibodies have played an increasingly important role as precision therapies for a growing number of diseases, including malignant, cardiovascular, and inflammatory conditions. As therapies derived from research and development, therapeutic monoclonal antibodies may be — and usually are — patented, providing manufacturers with protection from competition and the prospect of high revenues.

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Baby shoes.

Infants Born Through Surrogacy Contracts Cannot Be Canceled or Returned

By Katherine Drabiak

Recently, media reported that Zheng Shuang, a popular Chinese actress, commissioned two surrogates with boyfriend Zhang Hang, and then allegedly decided, seven months into the pregnancies, that she did not want to become a parent and questioned the possibility of abortion or adoption.

Zhang asserts that he has been caring for the infants in the U.S. for more than a year after Zheng abandoned the infants. Zheng has not addressed the allegations directly, and multiple facts remain unclear.

This case, and other rare similar cases, raise the question: If intended parents initiate an agreement with a gestational surrogate to create a child, can they also terminate the agreement – and pregnancy – if they no longer want the resulting child?

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hospital equipment

Balancing Health Care Rationing and Disability Rights in a Pandemic

By Yolanda Bustillo and Rachel Perler

Amid the present surge of the coronavirus pandemic, it is crucial that disability rights are a factor in the development of triage protocols.

During the last week of December, the CDC recorded a record of 225,269 new coronavirus cases and 118,948 total hospitalizations. Health care systems across the country have predicted that they soon may face shortages of ventilators, personal protective equipment (PPE), and other limited resources.

In Utah, for example, hospital administrators have implemented informal triage protocols that prioritize patients based on health status, clinical factors, and the time sensitivity of their needed procedures. Hospitals in California have similarly begun rationing care.

If these dire circumstances worsen, hospital systems may apply triage protocols that deviate from best practices and impermissibly discriminate against people with disabilities.

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Hundred dollar bills rolled up in a pill bottle

AbbVie Wins First Round in Humira Antitrust Lawsuit

By Ryan Knox and Gregory Curfman

Since receiving FDA approval for Humira® (adalimumab) in 2002, AbbVie, the drug’s manufacturer, has filed hundreds of submissions to the U.S. Patent and Trademark Office for secondary patents – almost half of which were filed after 2014, just two years before the expiration of its core patent.

These patents were largely directed to methods of use and potential formulation changes, but they did not include claims that affect the clinical efficacy of the biologic, which is used in the treatment of rheumatoid arthritis, Crohn’s disease, and psoriasis, among other conditions. Instead, the purpose of the secondary patent filings was to assemble a thicket of patents, 132 in all, to prohibit competition from biosimilar companies.

And so far, the strategy has worked. AbbVie remains the sole U.S. manufacturer of the biologic, and has successfully defended its domain: in June 2020, a federal district court judge in Chicago dismissed an antitrust lawsuit against AbbVie.

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Vial and syringe.

Challenges in COVID-19 Vaccine Rollout: Lessons from the UK

By Sravya Chary

Just over a week after the United Kingdom became the first Western country to authorize the COVID-19 vaccine developed by Pfizer and BioNTech for emergency use, the U.S. Food and Drug Administration (FDA) followed suit on December 11, 2020.

This lag may prove beneficial. The United States can and should cautiously assess the United Kingdom’s vaccination strategy to avoid challenges that may impede its ability to control the virus.

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Vaccine.

Benefits and Drawbacks of Emergency Use Authorizations for COVID Vaccines

By Sravya Chary

Two COVID-19 vaccine manufacturers recently submitted Emergency Use Authorization (EUA) requests to the Food and Drug Administration (FDA) for their candidates.

While the need for a safe and efficacious COVID-19 vaccine is dire and immediate, an EUA may not be the best regulatory method to provide access. Experts warn that the EUA pathway may impede vital scientific progress needed to establish the long term safety and efficacy of investigational COVID-19 vaccines.

According to the FDA, an Emergency Use Authorization is a tool that allows an unapproved medical product to be released to the public in a health crisis given that the medical product meets statutory criteria outlined in Section 564 of the Federal Food, Drug, and Cosmetic Act.

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