Meditation? There’s an (almost FDA-approved) app for that

By Gali Katznelson

Headspace is paving the way for the first FDA-approved prescription meditation app.

Developers behind the mindfulness smartphone app, which has over 30 million users, are creating a new product under Headspace Health that will begin clinical trials this summer, in hopes of clearing FDA approval by 2020. The team is investigating how the app can help treat 12 mental and physical conditions.

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Will the EPO’s Enlarged Board of Appeal step into the CRISPR patent battle?

By  Jakob Wested, Timo Minssen & Esther van Zimmeren

Another version of this contribution has been published in Life Science Intellectual Property Review (LSIPR).

The Broad Institute is facing a formidable task in defending the revoked CRISPR patent claims in their pending appeal at the European Patent Office (EPO). Ultimately, some of the issues might still be referred to the Enlarged Board of Appeal. However, this might require a significant amount of legal and rhetorical agility.

“The Opposition Division’s interpretation of the EPC [European Patent Convention] is inconsistent with treaties designed to harmonize the international patent process, including that of the United States and Europe.”

This was the rather strong reaction of the Broad Institute after the EPO’s Opposition Division’s (OD) decision to revoke one of their CRISPR patents. It could, however, also be argued that the case presents a simple failure of the patent applicants to comply with the long-standing European practice to apply an “all applicants” approach when claiming priority under article 87 of the European Patent Convention.

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CMS Abandonment of Outcomes-Based Payment Deal with Novartis is a Missed Opportunity

The Centers for Medicare and Medicaid Services have cancelled an outcomes-based price plan with drug maker Novartis. (Wikimedia Commons)

By Rachel Sachs

Earlier this week, Politico broke the news that the Centers for Medicare and Medicaid Services (CMS) had withdrawn its outcomes-based payment deal for Novartis’ CAR-T therapy, Kymriah, without public acknowledgement.

The Food and Drug Administration’s approval of Kymriah in August of last year was accompanied by the announcement of a novel outcomes-based agreement with CMS, in which CMS would pay for Kymriah only if patients had responded to it by the end of the first month. Now, CMS has quietly backed away from that agreement. What does the deal – and its subsequent abandonment – tell us about CMS’ involvement in outcomes-based contracts going forward?

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Don’t Expect Brett Kavanaugh To Protect The Affordable Care Act

Thanks to Brett Kavanaugh’s 12 years as a judge on the D.C. Court of Appeals, we have a well-developed record of the Supreme Court nominee’s positions on key issues, including his views on American health care policy.

In two high profile cases in 2011 and 2015, Kavanaugh upheld key parts of the Affordable Care Act (ACA). But these cases, taken out of context, are misleading. They should not distract anyone evaluating his long record, nor overly inform how he might decide in future cases when it comes to health care.

Besides his record on reproductive health — which is controversial and is already creating significant opposition to his confirmation — Kavanaugh has exhibited strongly-held ideas about the relationship of the courts to government agencies and bureaucracies that carry out most of American public policy, also known as “the administrative state.”

Read more at WBUR’s Cognoscenti

How the New York Court of Appeals Applied the Soda Cap Criteria to Vaccines

By Dorit Reiss

(Photo by pahowho/Flickr)

New York’s Court of Appeals reversed an Appellate Division decision and reinstated New York City’s influenza mandate for city daycares in Garcia v. New York City Department of Health and Mental Hygiene in June. Applying the same criteria the court used in 2014 to overturn the city’s controversial Soda Cap, the court found that the rules are well within the Board’s authority.

We can suspect that the recent influenza season influenced the decision, but it was also based on a more explicit delegation of authority, and a history of vaccination programs by the Board.

Also, it’s likely good news for at least some of New York’s youngest, who will be better protected from a dangerous disease, and for the public.

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Buprenorphine and Naloxone Legislative Restrictions: A Compromise Towards Harm Reduction

Limiting access to MAT can result in patient harm. Improving access using a bridge therapy model may help save lives.

There were approximately 64,000 deaths from opioid overdose in 2016, including deaths from both prescription and illicit drugs. The incidence of opioid overdose has continued to escalate despite a number of efforts. Increasing treatment beds, limiting opioid prescriptions, distribution of naloxone and other efforts have not demonstrated a significant impact on non-medical opioid use or on opioid-related deaths.

The continuing rise in opioid overdose and overdose death has resulted in the declaration by the current executive administration of the opioid epidemic as a “Public Health Emergency”.

Medication assisted treatment (MAT) with agents such as methadone or buprenorphine/naloxone has been demonstrated to be one of the more effective measures in the reduction in high-risk opioid use among individuals with substance abuse disorder. Specifically, treatment with buprenorphine/naloxone has demonstrated efficacy in harm reduction with the advantage of a reduced potential for abuse, a safer therapeutic profile than alternatives, and it can be safely prescribed in the outpatient setting. Use of this therapeutic however, is currently restricted to only certain licensed providers in certain clinical settings, limiting access to this important life-saving intervention.

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Setting Hard Limits: A Federal District Court Puts up Major Hurdle to the Reworking of Medicaid in Stewart v. Azar

Health and Human Services Secretary Alex Azar testifying in front of Congress in June. HHS has come under scrutiny for its use of 1115 waivers.

By Carmel Shachar

Since the Republican controlled Congress failed to repeal the Affordable Care Act in 2017, the Trump administration has been trying to implement its more conservative vision of Medicaid through waivers. On June 29, 2018, however, the D.C. federal district court issued a decision in Stewart v. Azar which would make it significantly more difficult for an administration to rework Medicaid without a congressional mandate.

This case, should it survive subsequent appeals, will represent an important turning point in the ability the Department of Health and Human Services has to shrink or undermine Medicaid through the use of administrative waivers.

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

By Ameet Sarpatwari, Michael S. Sinha, 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 relevant to current or potential future work in the division.

Below are the abstracts/summaries for papers identified from the month of June. The selections feature topics ranging from the utilization of medical devices necessary to detect post-approval safety differences, to evidentiary standards and regulatory tradeoffs in the FDA’s expedited approval programs, to the president’s plan to address high drug prices. A full posting of abstracts/summaries of these articles may be found on our website.

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The Need for Institutional, Individual and Community Based Responses to the Opioid Crisis

By John Alexander Short

Panelists discussed responses to the opioid crisis during a recent webinar.

Dr. Monica Bharel, the Commissioner of the Massachusetts Department of Health, recently hosted a webinar panel to discuss the many consequences of the modern opioid epidemic on families.

Hosted jointly by the Association of State and Territorial Health Officials (ASTHO) and The Forum at the Harvard T.H. Chan School of Public Health, the event also included Dr. Stephen Patrick, Dr. Karen Remley, and Dr. Michael Warren who joined Bharel for a talk titled “State Health Leadership: Understanding & Responding to the Lifelong Effects of Opioid Exposure for Infants, Children & Families.”

The discussion offered insight into the complex nature of addiction and the need to understand the disease to craft effective solutions.

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Childhood Flu Vaccination and Home Rule in the Big Apple

Baby was receiving his scheduled vaccine injection in his right

The New York City Board of Health requires children between 6 months and 5 years to receive a flu shot. (Amanda Mills/USCDCP)

By Nicholas J. Diamond

On June 28, the State of New York Court of Appeals upheld a New York City Board of Health requirement that children between the ages of 6 months and 5 years old attending city-regulated child care or school-based programs receive flu vaccinations.

While New York City is no stranger to progressive public health initiatives, this ruling in particular is significant on at least two accounts. First, it strengthens New York City’s ability to confer the public health benefits of flu vaccination to a wider segment of the adolescent population, consistent with current recommendations. Second, it stands as a reminder of the important role that local health authorities, like boards of health, can play in improving population health, if granted sufficient authority under state law.

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NIMBYism continues to factor into supervised injection site policies

supervised injection site

Insite, in Vancouver, Canada, is a supervised injection facility. (Screengrab via HCLU/Vimeo)

By Daniel Goldberg

As a major tool in harm reduction policy connected to opioid and substance misuse, more than 30 states have implemented syringe exchange programs, or SEPs.

Surmounting or, in many cases, bypassing the considerable legal and political obstacles has proved a challenge for states, whether they succeeded in enacting SEPs or not. While, given the opioid crisis, SEPs are more important than ever, they do have limitations.

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The non-capture capture of “patient voice.” Isn’t it ironic?

doctor and patient talk

One challenge of Patient Centered Outcomes Research is to make sure the patient voice isn’t “captured.”

 

Register here for this weeks’s event, “Putting Patients at the Center of Research: Opportunities and Challenges for Ethical and Regulatory Oversight”

By Paul McLean

In a previous life I was a headline writer, so I have to give props for the title of this Friday’s Petrie-Flom panel: “Patients and Conflict of Interest: How Can We Keep the Patient’s Voice from Being ‘Captured’?

That is, how do you avoid “capturing” the patient voice when “capturing” the patient voice is the whole point of Patient Centered Outcomes Research? And yet this is a central challenge to bringing expertise unique to the receiving end of medicine and research into all levels of the process.

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Adverse Health Event Reporting in Minnesota a Valuable Tool

By John Tingle

doctors performing surgery

Medical errors are a common cause of death globally. (thinkpanama/flickr)

“Medical errors are the third leading cause of death in the United States,” says a new report by the World Health Organization. And in the United Kingdom, “recent estimations show that on average, one incident of patient harm is reported every 35 seconds.”

Patient safety remains an issue of concern for all countries across the globe. But by observing what other countries do and report about patient safety we can avoid the costly mistake of trying to reinvent the wheel when information is already available about important trends.

The Minnesota Department of Health (MDH) have recently published their 14th Annual Public Report on Adverse Health Events in Minnesota. The report contains a lot of detailed patient safety information, analysis, and trends which will be of use to health carers and patient safety policy developers everywhere.

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Compulsory Genetic Testing for Refugees: No Thanks

By Gali Katznelson

lab worker testing dna

DNA tests are not perfect and they can be vulnerable to manipulation. The UNHCR says genetic testing is an invasion of privacy. (Photo by andjic/Thinkstock)

Recent reports claim that Attorney General Jeff Sessions is considering using genetic testing to confirm the relationships of children who enter the country with adults to determine if they share a genetic relationship.

The website the Daily Caller reported that Sessions suggested in a radio interview that the government might undertake genetic testing of refugees and migrants in an effort to prevent fraud and human trafficking.

This proposal is problematic, not only because DNA testing is unreliable and vulnerable to hacking, it is also an invasion of privacy and flies in the face of guidelines from the United Nations’ refugee agency.

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Investigating Conflicts of Interest in Patient-Centered Outcomes Research

By I. Glenn Cohen

The Patient Centered Outcomes Research Institute (PCORI) was established under the Affordable Care Act. Its goal is to fund and encourage Patient-Centered Outcomes Research (PCOR), understood as evaluating questions and outcomes that are meaningful not just to researchers, but to patients and caregivers as well.

One key way of achieving this is to involve patients as personnel in research projects as advisors, consultants, or team members involved in any aspect of research, from topic development through study design, implementation, interpretation, and dissemination.

But where do these patients come from? How representative are they of the patients who will ultimately participate in the study?

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What is Patient-Centered Outcomes Research? What Ethical Issues Arise in its Conduct?

By Joel Weissman

Register here for this weeks’s event, “Putting Patients at the Center of Research: Opportunities and Challenges for Ethical and Regulatory Oversight”

Today it is not unusual for patients to expect to be engaged in making decisions about their own health care, in consultation with their doctors. This is commonly referred to as patient-centered care, and recognizes that patients are the best source of information about their needs and preferences.

A relatively newer concept is patient involvement in research on healthcare.

Traditionally, healthcare research has focused on critical events like death or complications, or physiological data from laboratory tests. But patients may be equally (and sometimes more) concerned about harder-to-measure results like quality of life, time spent at home with their families, or the ability to return to work.

Patient-centered outcomes research (PCOR) recognizes that to better understand these kinds of issues, scientists should consult patients about the design and conduct of research. Therefore, PCOR is quickly becoming the standard.

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Prescription Monitoring Programs: HIPAA, Cybersecurity and Privacy

By Stephen P. Wood

Privacy, especially as it relates to healthcare and protecting sensitive medical information, is an important issue. The Health Insurance Portability and Accountability Act, better know as HIPAA, is a legislative action that helps to safeguard personal medical information. This protection is afforded to individuals by the Privacy Rule, which dictates who can access an individual’s medical records, and the Security Rule, which ensures that electronic medical records are protected.

Access to someone’s healthcare records by a medical provider typically requires a direct health care-related relationship with the patient in question. For example, if you have a regular doctor, that doctor can access your medical records. Similarly, if you call your doctor’s office off-hours, the covering doctor, whom may have no prior relationship with you, may similarly access these records. The same holds true if you go to the emergency department or see a specialist. No provider should be accessing protected information however, without a medical need.

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What is the Role of the Judiciary in Tackling the Opioid Epidemic?

By Ryan J. Duplechin

The Judicial Panel on Multidistrict Litigation has centralized suits in the Northern District of Ohio.

As waves of opioid lawsuits have mounted in the federal courts, one district court was chosen to shepherd all the cases, and one judge is motivated to step up to stem the tide of the epidemic.

In the Northern District of Ohio, Judge Dan A. Polster was chosen by the Judicial Panel on Multidistrict Litigation, which centralized hundreds of suits, and created the Opioid MDL.

“The federal court is probably the least likely branch of government to try and tackle [the opioid epidemic], but candidly, the other branches of government, federal and state, have punted,” said Judge Polster during the first hearing of the MDL in January. “My objective is to do something meaningful to abate this crisis and to do it in 2018.”

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Right to Try’s Problem is Funding, not Over-Regulation

By Alex Pearlman and Jonathan Darrow

Dr. Jonathan J. Darrow, an expert on FDA policy and faculty member at Harvard Medical School, spoke with Bill of Health editor Alex Pearlman this week about the new so-called “Right to Try” law, how it is different from existing regulations, and why expanded access programs will never work without thinking about resources differently.

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DNA Donors Must Demand Stronger Privacy Protection

By Mason Marks and Tiffany Li

An earlier version of this article was published in STAT.

The National Institutes of Health wants your DNA, and the DNA of one million other Americans, for an ambitious project called All of Us. Its goal — to “uncover paths toward delivering precision medicine” — is a good one. But until it can safeguard participants’ sensitive genetic information, you should decline the invitation to join unless you fully understand and accept the risks.

DNA databases like All of Us could provide valuable medical breakthroughs such as identifying new disease risk factors and potential drug targets. But these benefits could come with a high price: increased risk to individuals’ genetic data privacy, something that current U.S. laws do not adequately protect. Continue reading