Single strand ribonucleic acid.

The Secret World of mRNA: HDT Bio Corp v. Emcure and Access to Next-Gen mRNA

By Aparajita Lath

The future of public health in an “RNA world” is on trial in a trade secrecy dispute worth $950 million currently being fought before the District Court of the Western District of Washington, Seattle between HDT Bio Corp. and Emcure Pharmaceuticals.

The trade secrets at issue concern an improvement over existing mRNA technology called “self-amplifying RNA” or “saRNA.” saRNA are effective at much smaller doses and lower costs. The saRNA technology is being used to develop vaccines for COVID, Zoster, Zika and Rabies.

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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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Black and white photo of a woman with phone in hand; phone has color retouched image of her face on it.

The Filter Effect: What Does Comparing Our Bodies on Social Media Do to Our Health?

By Sarah Gabriele

Filters on social media apps such as Instagram and TikTok are great to take silly pictures alone and with friends, and they often give us a good laugh. However, as Dr. Christine Stabler from Penn Medicine writes, they also create an illusion, a perfection that we struggle to live up to every day. This is the case even if almost everyone is well aware that pictures are filtered and carefully selected, and that pictures do not always represent reality.

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see saw with earth as fulcrum and a pile of vaccines weighing down one side with nothing on the other side.

What Happened to the COVID-19 Vaccine Patent Waiver?

By Sarah Gabriele

In June 2022, after almost two years of debate over a potential COVID-19 vaccine patent waiver, the World Trade Organization adopted the Ministerial Decision on the TRIPS Agreement (“WTO Decision”), which provided for a partial waiver of intellectual property rights.

More specifically, the WTO Decision waived patent rights on vaccines and allowed for the use of protected clinical trial data for regulatory approval of vaccines. However, after almost four months since the adoption of the WTO Decision, there is still a large gap in vaccination rates worldwide.

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Grassy field with white picket fence encircling it.

Accessing COVID-19 mRNA Vaccines for Research: The Re-emergence of the Tragedy of the ‘Anticommons’

By Aparajita Lath

Some COVID-19 vaccine manufacturers in the US have refused to share vaccine samples for research purposes, creating an access issue with the potential to delay comparator studies, follow-on research, and new vaccine / drug development.

This issue may be the latest example of the tragedy of the “anticommons” in biomedical research.

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Tilpath Valley Biodiversity Park spreads over an area of 69.56 ha on the Southern Ridge that is contiguous with Aravalli ranges of Haryana, in south Delhi, New Delhi India.

Proposed Amendments Would Make Foreign Investment in India’s Biological Resources Easier

By Aparajita Lath

Indian lawmakers are currently debating proposed amendments that would make it easier for foreign investors to research and develop products from native biological resources, such as plants.

India is one of the 17 internationally recognized mega biodiversity countries, and hosts four of the 35 globally recognized biodiversity hotspots.

Since countries have sovereign rights over their biological resources, Indian companies enjoy easier access to and use of these biological resources for various commercial applications, including pharmaceuticals, cosmetics, and biotechnology. Foreign companies and Indian companies with any foreign participation in share capital or management are strictly regulated.

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Student fellows 2022-2023 cohort.

Petrie-Flom Welcomes 2022-2023 Student Fellows

(Clockwise from top left: Matt Chun, Sarah Gabriele, Katie Gu, Sanjay Reddy, Aparajita Lath)

We are excited to welcome a new group of Student Fellows to the Petrie-Flom Center family. These five students are a fantastic cohort of health law policy, biotechnology, and bioethics scholars who join us from across Harvard.

They each will undertake a year-long research project with mentorship from Center faculty and affiliates, and also will blog here at Bill of Health regularly. Keep an eye out for their bylines!

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Happy physical education teacher talking to her students during a class at elementary school gym.

Bring Back the National School Population Fitness Survey

By Jack Becker

It’s 1955, the Cold War is heating up, and a popular magazine publishes an article titled “The Report that Shocked the President.” What could shock a seasoned leader like Dwight Eisenhower? A report about a potential missile gap? An early report on the gap between the Soviet and American space programs? Surprisingly (or, unsurprisingly, because the title of this post is a spoiler), it was the muscle gap.

In 1954, Hans Kraus and Bonnie Prudden published a study finding that 57.9% of American schoolchildren failed a minimum muscular fitness test, while only 8.7% of European schoolchildren failed the same test. The theory behind these results? Television, overprotective parents, inadequate school physical education, and an overall “plush” lifestyle in the United States.

Sound familiar? When you add in heightened concerns about screen time, it feels like nothing has changed. While modern metrics concentrate on physical activity instead of physical fitness, it’s clear that American children are still struggling. But history might offer potential solutions to this age-old problem.

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A variety of protein shakes. Plastic scoops with powders.

Universal Basic Nutrient Income: Pros and Cons

By Jack Becker

Andrew Yang’s 2020 presidential run included a smorgasbord of unique stances. From “Empowering MMA Fighters” to a “Robo-Calling Text Line” to “Making Taxes Fun,” he made waves. But his biggest wave came from the “Freedom Dividend,” a universal basic income (UBI) program that proposed providing each American with $1,000 per month. Like similar proposals in the past, the program garnered excited supporters and staunch detractors. And while COVID-19 reinvigorated the discussion around UBI, it’s unclear whether one will or should ever be enacted.

However, characteristics that make UBI attractive, particularly the direct support it provides, sans bureaucratic red tape, can be applied to other government programs. For example, ensuring America’s fundamental nutritional needs are met. The government could directly provide all citizens with food or, more simply, with nutrients. Introducing: Universal Basic Nutrient Income (UBNI).

Following the model of companies like Soylent and Huel, the government could aim to develop the healthiest, cheapest, most sustainable, and all-around best powdered meal replacement. The perfect UBNI Shakes would be available to all Americans for free (well, funded by taxes). UBNI could replace the Supplemental Nutrition Assistance Program (SNAP) and other government food programs. There could be a UBNI Shake for every bottle, and more time in everyone’s days.

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Gavel and stethoscope.

How to Assess the Impact of Medical Ethics Education

By Leah Pierson

There has been too little evaluation of ethics courses in medical education in part because there is not consensus on what these courses should be trying to achieve. Recently, I argued that medical school ethics courses should help trainees to make more ethical decisions. I also reviewed evidence suggesting that we do not know whether these courses improve decision making in clinical practice. Here, I consider ways to assess the impact of ethics education on real-world decision making and the implications these assessments might have for ethics education.

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