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Toxic Breastmilk: When Substance Abuse Relapse Means Death for Baby

Recently, a nursing mother in Pennsylvania made national headlines when her infant died from ingesting a combination of fatal drugs through breastmilk.  According to the coroner’s report, the infant died from a combination of methadone, methamphetamine, and amphetamine toxicity. The Bucks County District Attorney charged the mother, Samantha Jones, who also has a two-year old child, with criminal homicide. According to published reports, Jones was undergoing Medication Assisted Treatment (MAT) and receiving doses of methadone to treat her addiction to opioid painkillers.

Multiple commentators swiftly voiced opposition to the District Attorney, decrying the criminal charges against Jones, arguing it is “highly problematic” to levy criminal charges against a person undergoing treatment for Substance Use Disorder.

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Can Computer Simulations Enhance Vaccine Trials?

Infectious disease emergencies are opportunities to test the efficacy of newly developed interventions—for example, drugs, vaccines, and treatment regimens. Yet they raise many intertwined challenges around politics, logistics, ethics, and study design.

It is essential to advance the discussion of how such products can and should be tested while remaining consistent with the efforts of CEPI, WHO, and others who encourage development and testing of candidate vaccines in advance of emergencies. Read More

Commentary: Do We Really Need a New, More Powerful Opioid?

By Ron Litman

The FDA’s Analgesic and Anesthetic Drug Advisory Committee (AADPAC), of which I am a member, met October 12 to discuss a controversial New Drug Application (NDA) for a powerful opioid called sufentanil, manufactured by AcelRx.

Like fentanyl, sufentanil is a short-acting synthetic opioid, but approximately 5 to 10 times more potent. In the midst of the current opioid crisis, why would anyone think that the availability of another powerful opioid is a good idea?

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Data-driven Medicine Needs a New Profession: Health Information Counseling

By Barbara Prainsack, Alena Buyx, and Amelia Fiske

Have you ever clicked ‘I agree’ to share information about yourself on a health app on your smartphone? Wondered if the results of new therapy reported on a patient community website were accurate? Considered altering a medical device to better meet your own needs, but had doubts about how the changes might affect its function?

While these kinds of decisions are increasingly routine, there is no clear path for getting information on health-related devices, advice on what data to collect, how to evaluate medical information found online, or concerns one might have around data sharing on patient platforms.

It’s not only patients who are facing these questions in the age of big data in medicine. Clinicians are also increasingly confronted with diverse forms of molecular, genetic, lifestyle, and digital data, and often the quality, meaning, and actionability of this data is unclear.

The difficulties of interpreting unstructured data, such as symptom logs recorded on personal devices, add another layer of complexity for clinicians trying to decide which course of action would best meet their duty of beneficence and enable the best possible care for patients.

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Privacy Regulation in the Age of Machine Learning

By Adrian Gropper

Will the machines use our own personal information against us? The answer depends on privacy regulations that are yet to be written.

I know that the current approach to privacy regulation, be it general as in GDPR or sectoral as in HIPAA, is not readily extensible to a world where the principal value of personal data is machine learning. It’s easier to follow my logic if you agree that technology costs are already low compared to the value of personal data. Buying your own AI is increasingly sensible. Then, who will teach your personal AI in school, at work, in your community? You and your doctor will both have personal AI. What is the role of intellectual property when the cost of personal data dominates the cost of your AI? How do you use your AI to license the use of your personal data by others? Standards will be essential to maximize the market for your personal data, whether it’s sold or donated for the public good. These personal data standards are less-than-welcome in a process dominated by enterprises. Nonetheless, thoughtful privacy regulation designed around machine learning will keep humans responsible for the machines.

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What kinds of digital tools can help states implement disability exemptions for Medicaid recipients?

This year, several states applied for and received permission from the federal government to implement work requirements in their Medicaid programs. Policy designs vary by state, but all states build in considerations for people with disabilities. These considerations include exemptions and exceptions from work requirements for individuals unable to work due to a disability.

But how can states implement these policies in a way that is accurate, efficient, and fair?

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Join Us For A Special Evening with Author John Carreyrou

 

Please join us for a conversation with John Carreyrou, Investigative reporter for the Wall Street Journal and author of the New York Times bestseller “Bad Blood: Secrets and Lies in a Silicon Valley Startup.”

Carreyrou will discuss his book about the rise and fall of Silicon Valley darling, the blood testing company Theranos, and its charismatic, Stanford drop-out CEO, Elizabeth Holmes.

In recent weeks, news has emerged that the company will in fact cease operations, despite a short-lived attempt to survive after removing Holmes.

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Health care, disease care, or killing care?

By Hugo Caicedo

Traditional medical practice is rooted in advanced knowledge of diseases, their most appropriate treatment, and adequate proficiency in its applied practice. Notably, today, medical treatment does not typically occur until disease symptoms have manifested. While we now have ways to develop therapies that can halt the progression of some symptomatic diseases, symptomatic solutions are not meant to serve as a cure of disease but palliative treatment of late-stage chronic diseases.

The reactive approach in most medical interventions is magnified in that medicine is prone to errors. In November of 1999, the U.S. National Academy of Science, an organization representing the most highly regarded scientists and physician researchers in the U.S., published the report To Err is Human.

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Now published: Consensus-based guidelines for the ethical oversight of Patient-Centered Outcomes Research

By Avni Gupta

Patient-Centered Outcomes Research (PCOR) is characterized by patients participating in various research roles other than merely the subjects. The Patient-Centered Outcomes Research Institute (PCORI), a major funder of PCOR research, defines patient engagement as including patients in all stages of research, “from topic selection through design and conduct of research to dissemination of results.”

However, while the concept of patient engagement in research and its potential for benefitting science are increasingly recognized by funders and investigators, IRBs’ comfort with patients in non-traditional roles in research protocols lags behind.

IRBs’ familiarity with patients in research has traditionally been with patients who are study participants or subjects, and are considered “vulnerable.” Therefore, many IRBs’ review process focuses on ensuring that adequate protective measures are in place to “protect” the patients, including measures such as a detailed written informed consent, continuing review, confidentiality measures, and so on.

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Why we need to “care” about healthcare

By Robert G. Urban

Humans often proclaim that “intelligence” is what sets our species apart – the ability to analyze, to imagine, to organize, to then cooperate and execute. A unique gift that enables us to be remarkable.

Monuments to humanity’s capability are sprinkled all across the world — early works are colossal demonstrations of ingenuity coupled to brute strength. Consider the statues of Easter Island, Rome’s colosseum, Egyptian and early American pyramids, or the Great Wall of China as examples, each demonstrating a singularly human ability (and need) to reshape our world and leave evidence of our presence.

And as time and talent has unfolded, the complexities of our contributions have advanced as well.

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