yellow capsules on a blue background.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, andAaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of June. The selections feature topics ranging from a discussion of potential pathways to enable government patent use before nonpatent exclusivities expire, to an examination of medical oncologists who receive more than $100,000 annually from pharmaceutical companies, to an analysis of the launch prices of new drugs from 2008-2021. A full posting of abstracts/summaries of these articles may be found on our website.

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Washington, DC, USA, May 5, 2022: people protest the leaked draft Supreme Court opinion overturning Roe v. Wade and the right to abortion

Reproductive Governance in a Post-Roe US: The Weaponization of Health Systems

By Alicia Ely Yamin

I was living and working in Peru in 2001, when Karen Noelia Llantoy discovered she was pregnant with an anencephalic fetus. Llantoy, a minor at the time, became profoundly depressed. Her own physician, a social worker, and a psychiatrist all concurred that she should have a termination, as anencephaly is a fatal brain defect that also poses an unnecessary risk to the mother’s physical health, and the pregnancy was having a severe impact on Llantoy’s mental health.

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doctor holding clipboard.

Change for the Medical Malpractice Compensation System in England?

By John Tingle

It is fair to say that the British public are generally speaking very proud of our National Health Service  in England, and treasure it greatly. The NHS Constitution sets out the seven key principles which guide the NHS in all its activities, and these include:

  1. The NHS provides a comprehensive service, available to all.
  2. Access to NHS services is based on clinical need, not an individual’s ability to pay. NHS services are free of charge, except in limited circumstances sanctioned by Parliament.

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Buenos Aires, Argentina – August 31, 2017: Horizontal view of some waste collector machines over Matanza River (also known as Riachuelo at its mouth in River Plate), La Boca neighborhood.

Searching for Environmental Justice in Argentina: Revisiting the Reality of the Matanza-Riachuelo River Basin Case after Fifteen Years

By Alicia Ely Yamin and María Natalia Echegoyemberry

The first thing that strikes you when you arrive in Argentina’s Villa Inflamable (literally “Inflammable Slum”) is the noxious sulfur smell of the air that mixes with other acrid chemicals, which makes it difficult to breathe deeply. When a breeze picks up, the sands that have been used to extract contaminated water from the nearby Riachuelo, one of the ten most highly contaminated rivers in the world, rain down on everyone, filling eyes and lungs with toxic particulate matter.

As petrochemical tanker trucks parade through nearby paved streets, the unpaved lanes of Villa Inflamable alternate between toxic dust blowing through the air on dry days to flooding raw sewage on rainy ones. Everyone knows someone who died of cancer, or had pregnancy complications and children with birth defects. More than 600 children have been born and are growing up exposed to highly carcinogenic chemicals, such as benzene and toluene.

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One pill on mint green background.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of May. The selections feature topics ranging from a discussion of how the US Patent and Trademark Office could more closely scrutinize applications for drug patents whose siblings have been discontinued in other jurisdictions, to an evaluation of FDA advisory committee referrals for new drugs approved from 2010-2021, to an analysis of the patents and regulatory exclusivities on inhalers approved from 1986-2020. A full posting of abstracts/summaries of these articles may be found on our website.

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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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Supreme Court of the United States.

Where Exactly Is the New Constitutional Line Between Abortion and Contraception?

By Einer Elhauge

The new Supreme Court decision in Dobbs overrules the right to abortion but repeatedly reaffirms the right to contraception. Whether that distinction can be justified under the Court opinion’s constitutional methodology has been the subject of much critique. Here, however, I wish to focus on a different question: just where is the new constitutional line between abortion and contraception after Dobbs?

The dissent takes the Court opinion to eliminate any constitutional right “from the very moment of fertilization.” But the Court opinion never says so, and for good reason. The Court’s analysis rests heavily on the fact that the lion’s share of states banned abortion “at all stages of pregnancy” at the time the Fourteenth Amendment was ratified in 1868. The state statutes on which the Court relied for this conclusion were all limited to terminations of “pregnancy” or efforts to procure the “miscarriage” of a pregnant woman.

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Cozy scottish kitten sleeps under blanket on a bed at home. Top down view.

Public Health: Got Sleep?

By Jack Becker

There are certain public health commercials that generations will always remember. For some, it’s the NHTSA’s “Drive Sober or Get Pulled Over” commercials. For others, it may be a “Think. Don’t Smoke.” commercial featuring a young Robert McElhenney. Younger generations have certainly seen “The Real Cost” campaigns, which have recently tackled vaping. And a personal favorite, Nickelodeon’s “Hidden Sugar” commercial will forever be iconic.

To the visionaries that permanently cemented the fact that “glucose, sucrose, dextrose, and maltose” are “all words that rhyme with gross” in minds across the country, here’s a new challenge: sleep deprivation.

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