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.
A voluntary pool or clearinghouse model may give rise to a robust commercial ecosystem for CRISPR and could include special provisions for royalty-free research use by academics. Hence, there may be a path through the CRISPR patent jungle. But, there are many obstacles still in the way.
The revocation of Broad Institute’s patent EP2771468 reported and discussed here, marks the latest major development in a series of patent battles over the revolutionary and highly lucrative CRISPR-Cas9 technology (and other gene editing technologies) in the US and Europe.
While this is the first EPO decision in an opposition procedure concerning the Broad patent portfolio, the outcome may have implications for other related patents as the rationale for the revocation reflects a larger, systemic challenge based on the different rules regarding priority claims in different jurisdictions.
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.
Earlier this week, Politico broke the news that the Centers for Medicare and Medicaid Services (CMS) had withdrawn its outcomes-based payment deal for Novartis’ CAR-T therapy, Kymriah, without public acknowledgement.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?
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.”
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.
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.
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.
Recently the Petrie-Flom Center’s annual conference brought together medical experts, bioethics scholars, and disability advocates to rethink how medical systems and public health policies can engage with disability.
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.
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.
Experts believe the overprescribing of opioids is at least somewhat responsible for the current opioid crisis. This led to a national discussion around prescribing stewardship, as well as the development of policy and regulation with regard to opioid prescribing. Included among this have been limits on the duration of therapy, partial fills, and requirements that providers access their state’s prescription monitoring program before prescribing. These policies have had some success and there has been a decline in the number of opioid prescriptions in the last several years.
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.
The Supreme Court this week struck down California’s Reproductive FACT Act in National Institute of Family and Life Advocates v. Becerra, which required Crisis Pregnancy Centers (CPC) to inform their prospects that they are not medical providers and post a sign informing them that the state provides free or low cost access to prenatal and preventative medicine, including abortion.
The law was passed in reaction to what California saw as deceptive and harmful tactics employed by the CPCs in order to mislead women seeking abortions to come to them instead. These clinics are often funded by the state and federal government. While many of these centers offer some medical services, importantly, they are not healthcare providers and usually do not have a doctor on the premises. This means that not only are the women who go to them at risk of receiving faulty care, the CPCs do not face the same consequences a doctor would for misleading their patients.
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.
That is the appalling number of individuals estimated to be involved in human trafficking in the United States, and it is more than likely a relatively conservative estimate.
Even more appalling is that there are approximately 50 million people who are victims of human trafficking worldwide. This is an industry driven by sex, with 80 percent of trafficked individuals engaged in sex trafficking of some form.
Woman account for about 80 percent of individuals involved in sex-trafficking, with some estimates stating that a quarter of these cases involve minor children. The average age for females at the time of entry into sex-trafficking is thought to be between 17–19 years old.
Victims of both sex and labor trafficking include United States citizens, but also many foreign nationals, mostly from Mexico, Central and South America, as well as the Caribbean. Now more than ever, these victims of a horrific crime are at significant risk, not just from their traffickers but from something else that can cause significant harm: the fear of deportation.
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.
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.
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.
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?