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Announcement: Student Scholarships to Attend Seton Hall Law’s Healthcare Compliance Program

Posted Oct 10 2013 12:00am

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PURPOSE

This award recognizes promising health law students with an aptitude for and commitment to a career in health law with a focus on the legal and compliance issues facing bio/pharmaceutical and/or medical technology industries.

ELIGIBILITY

Each nominee must qualify under the following criteria:

  • The nominee shall be a second or part-time third year law student currently enrolled in an accredited North American law school* on a full or part-time basis who through his/her law school academic and clinical work and other related activities demonstrates his/her aptitude for and commitment to a legal career in health care law within the bio/pharmaceutical and/or medical technology industries.
  • The nominee must be available to attend the June Healthcare Compliance Certification Program.
  • Multiple nominations per law school may be made.
  • The following materials must be submitted by the nominee (the submission of additional material is discouraged):

JUDGING

All applications will be judged by members of the Seton Hall Law School Faculty. All decisions are final.  Applications will be judged on the strength of the eligibility criteria, letter of nomination and personal statement. No scholarship will be awarded if the faculty members determine that no application meets the scholarship standards.

AWARDS

A maximum of two full scholarships shall be awarded each year. Scholarship recipients will attend the June Healthcare Compliance Certification Program. The scholarship covers program tuition, educational materials, meals during the program, and parking. Please note that transportation and hotel costs are not included.

SUBMISSION DEADLINE:  February 7, 2014.
Entries must be submitted:

Center for Health & Pharmaceutical Law
Attn: Catherine Finizio
Seton Hall Law School
One Newark Center
Newark, NJ 07102

QUESTIONS

Please contact Catherine Finizio at healthlaw@shu.edu or 973-642-8871.

Kate Greenwood_high res 2011 comp Last week, Bloomberg News ran an interesting article by Trista Kelley about the hurdles that the pharmaceutical company Shire has faced rolling out its blockbuster ADHD drug Vyvanse in Europe.  The drug was authorized for sale in a number of European countries simultaneously in December 2012, but, as Shire explained in a press release , the company still faced country-by-country negotiations with national pricing and reimbursement authorities.  Shire received bad news in early September, when Germany’s Institute for Quality and Efficiency in Health Care announced that the company had failed to show that Vyvanse was better than existing treatments.

As Kelley reports, there is more going on here than just the press of austerity.  ADHD is diagnosed much less frequently in Europe than in the United States and, “[w]hile attitudes vary by country, many European parents, teachers and doctors are resistant to using medication to treat what they see as childhood behavior problems.”  So Shire has, in the words of its CEO, embarked on a “significant educational effort.”

Presumably as part of this effort, in November 2012 the company hosted a “European Expert Roundtable” on the impact of ADHD on individuals, families and society.  In April of 2013, the company released a follow-up “Expert White Paper”  that was “initiated, facilitated and funded” by Shire and written by academics from Ireland, the Netherlands, and  the United Kingdom, with “medical writing support” provided by two Shire-funded medical communications companies.  Perhaps unsurprisingly, the authors of the white paper concluded that the impact of ADHD is substantial and, among other things, they recommended improving access to early diagnosis and treatment.  Depending on your priors, Shire’s educational effort could be understood as an important contribution to a broader movement to overcome the ignorance and stigma that stand between children in need and available, effective behavioral health treatments.  Or, it could be seen as dangerous disease mongering .

Interestingly, while the United States is more receptive both to the ADHD diagnosis and to treating the condition with medication than is Europe, we are not consistently so.  A recently-published study by Douglas McDonald and Sarah Kuck Jalbert found that in 2008 the rate of children being treated with stimulant medication ranged from .4%, in Alaska, to 5.1%, in Delaware, a 14-fold difference.  By comparison, nationwide estimates of the prevalence of ADHD range from 5-10% of children.  There was even more inconsistency from county to county, with coefficients of variation that, the authors note, were much higher “than reported for most other types of medical practice.”

The question arises, how should we interpret the disparities in diagnosis and treatment, whether between Europe and the United States, or between Alaska and Delaware?  Very carefully seems to be the answer.  On the one hand, McDonald and Jalbert’s “findings signal wide disparities between established clinical practice guidelines and actual practice.”  On the other hand, the authors “caution against drawing the inference that higher treatment rates indicate more accurate identification of ADHD.”  It is possible, they write, “that areas characterized by high treatment prevalence are also characterized by high rates of misdiagnosing and overprescribing.”  McDonald and Jalbert point a tentative finger at pharmaceutical marketing, both to physicians and directly to consumers, suggesting that it may partially explain the disparities in medication uptake they found.

Characterized as it is by failure to diagnose, inappropriate diagnosis, failure to treat, and inappropriate treatment, ADHD presents a complicated case, even for those who believe that medication is an important treatment option that should be available to children on an equal basis.  The involvement of companies like Shire in the conversation about how to respond to the disparities that existeven when that involvement is clearly disclosed, as it was in the case of the Expert White Paperhas the potential to complicate things further.  It could even backfire.  A recent study conducted  Aaron Kesselheim and colleagues of physicians’ responses to disclosures of pharmaceutical company support found that physicians accorded less “credibility and import” to even the most rigorous industry-funded clinical research.

paradiseLGjpg_1 In April 2013, President Obama officially announced the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative , with approximately $110 million in funds slated for fiscal year 2014.  Identified as an Administration “Grand Challenge,” the long-term aspirations are to:

“accelerate the development and application of innovative new technologies to construct a dynamic picture of brain function that integrates neuronal and circuit activity over time and space. The goal is to build on the growing scientific foundation of neuroscience, genetics, physics, engineering, informatics, nanoscience, chemistry, mathematics and other advances of the past few decades, to catalyze an interdisciplinary effort of unprecedented scope.”

Descriptions of the Initiative emphasize the convergence of numerous technologies as playing a part in the trajectory of the research agenda.  The White House Fact Sheet states that “great promise for developing such technologies [to treat neurological and psychiatric disease] lies at the intersection of nanoscience, imaging, engineering, informatics, and other rapidly emerging fields of science.”  But to facilitate this, NIH acknowledges “researchers will first need a more complete arsenal of tools and information for understanding how the brain functions both in health and disease.”

The key investments to launch this initiative are to be directed through three core federal agencies: the National Institutes of Health (NIH), with a $40 million allocation for fiscal year 2014; the Defense Advanced Research Projects Agency, with a $50 million allocation; and the National Science Foundation, with a $20 million allocation.  Private sector partners are the Allen Institute for Brain Science, the Howard Hughes Medical Institute, the Kavli Foundation, and the Salk Institute for Biological Studies.  The White House website lists several components of the initiative, including key investments, strong academic leadership, public-private partnerships, and maintaining the highest ethical standards.

Planning is in early stages, with a BRAIN Working Group of the Advisory Committee to the Director (ACD) of the NIH formed to provide input into the development process.  The BRAIN Working Group is charged with reviewing advances in neuroscience, identifying short, mid, and long-term science goals of the Initiative, and developing a scientific plan for achievement of those goals.  The ACD has hosted four public hearings in San Francisco, New York, Minneapolis, and Boston to gather perspectives from the scientific community.  Last week, the Working Group published an interim report with a list of nine high-priority areas for funding for FY 2014 with an “overarching vision … to combine these approaches into a single, integrated science of cells, circuits, brain and behavior”:

  • Generate a census of cell types
  • Create structural maps of the brain
  • Develop new large-scale network recording capabilities
  • Develop a suite of tools for circuit manipulation
  • Link neural activity to behavior
  • Integrate theory, modeling, statistics, and computation with experimentation
  • Delineate mechanisms underlying human imaging technologies
  • Create mechanisms to enable collection of human data
  • Disseminate knowledge and training

A final report by the BRAIN Working Group is expected in June 2014.

Parallels are already being drawn to the $3.8 billion, 10-year Human Genome Project (HGP) begun in the 1990s, culminating in the publication of the complete sequence of the human genome in 2003.  President Obama himself noted in his February 2013 State of the Union address that “every dollar we invested to map the human genome returned $140 to our economy.”  While the HGP had many successes, it also fueled many subsequent controversies, many of which took years to play out and some that remain hotly debated today.  Two high-profile examples include patent protections for inventions resulting from the HGP (see the Supreme Court’s June 2013 decision in Association for Molecular Pathology v. Myriad Genetics ) and adequate privacy and genetic discrimination protections (see the Genetic Information Nondiscrimination Act ).

Recognizing the broader ramifications of such a massive federal undertaking, the President has reached out to another expert task force for input.  Alongside the BRAIN Working Group, the President has also directed the Presidential Commission for the Study of Bioethical Issues to “explore the ethical, legal, and societal implications raised by this research initiative and other recent advances in neuroscience.”  Specifically, the Commission is to “identify proactively a set of core ethical standards – both to guide neuroscience research and to address some of the ethical dilemmas that may be raised by the application of neuroscience research findings.”  An August 20, 2013 public meeting of the Commission highlighted several core ethical concerns going forward, including privacy; data protection and management; animal and human subjects research protections; potential use for enhancement purposes; stigma and discrimination; and national security.  Extensive blog coverage of the public event is available here , here , and here .

Given the nascent state of the BRAIN Initiative, the overall long-term allotment of funding for research into the ethical, legal and societal implications is unclear.  For the HGP, this was between 3-5% of the total budget over the life of the project.  Similar research support should be built in to the Brain Initiative as well in an effort to anticipate, and guide, the ethical, legal, and societal aspects that accompany such an endeavor.

Doctor's Office The Commonwealth Fund (“Commonwealth”) has recently released its first-ever Scorecard , which provides a state-by-state comparison of the health care experiences of the 39 percent of Americans with incomes less than 200 percent of the federal poverty level. The report, titled Health Care in the Two Americas: Findings from the Scorecard on State Health System Performance for Low-Income Populations , finds striking disparities by income within and among states, and many news sources have quickly made these findings known to the public.

The purpose of the study was to identify opportunities for states to improve how their health systems serve their low-income populations and to provide benchmarks of achievement tied to the top-performing states. The report is based on thirty indicators of access, prevention and quality, potentially avoidable hospital use, and health outcomes, but does not analyze the potential effect of the 2010 healthcare law, the Patient Protection and Affordable Care Act (“ACA”). This law was designed, in part, to guarantee healthcare access for all Americans no matter where they live and the study’s lead author and Commonwealth’s senior vice president Cathy Schoen has suggested that “[w]e ought to be able to close the geographic divide … There is potential for a real leap forward.”

Significantly, Commonwealth notes that having low income does not have to mean below-average access, quality, or health outcomes. Further, the Scorecard finds much less state-to-state variation in health and health care experiences among people with higher incomes.

As the ACA continues to take effect, the report is optimistic that the Act “represents a historic opportunity for states to provide better health care to economically vulnerable people by providing resources to overcome the geographic and income divideespecially for states with high rates of poverty.” In light of the Senate’s recent 100-0 vote to avert government shutdown , the date on which health care exchanges set up under the Affordable Care Act will go into effect, October 1, looms ahead.

Photo, of a doctor’s office in New Orleans, courtesy of Bart Everson.

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