Administration Dean's Office

The Dean’s Newsletter:
November 9th, 2009

Table of Contents

v Public Disclosure of Industry Relationships
v Education and Marketing: Use of Stanford Facilities for Promotional Videos
v Stem Cell Biology and Regenerative Medicine
v Dr. Emmanuel Mignot is Appointed Director of the Sleep Center
v Evolving Agenda in Clinical and Translational Research
v NIH Director's Major Initiatives
v Laptop Security and Encryption
v Opportunities to Help Our Neighbors
v Upcoming Event: National Health Forum, November 17
v Awards and Honors
v Appointments and Promotions

Public Disclosure of Industry Relationships

Earlier this year, Stanford School of Medicine became one of the first medical schools in the country to adopt a policy of public disclosure of financial relations of faculty with industry. We felt it was important for faculty to have as honest and transparent relations with students, colleagues, patients and the public we serve as possible. Accordingly, we extended our 2006 Stanford Industry Interactions Policy to include public disclosure on the School of Medicine’s website of all industry interactions that exceed $5000 per year beginning in late August of 2009 (see: http://deansnewsletter.stanford.edu/archive/03_30_09.html#6) and http://deansnewsletter.stanford.edu/archive/08_31_09.html#5).

As I have also discussed in prior issues of the Dean’s Newsletter (see: http://deansnewsletter.stanford.edu/archive/03_30_09.html#6), Senator Charles Grassley (R-IO) has introduced legislation entitled “The Physician Sunshine Act” that would require the pharmaceutical and device industries to publicly disclose payments to physicians for consulting, lecturing, etc. In anticipation of the legislation, a number of industries have begun websites making such disclosures. The November 5th New York Times (http://www.nytimes.com/2009/11/04/health/policy/04sunshineside.htlm reported the names of individuals who received the highest quarterly payments from Eli Lilly.

Included in the list was an Adjunct Clinical Instructor in Stanford Department of Psychiatry and Behavioral Sciences. The inclusion of this individual attracted considerable media coverage and, at least for me, was a surprise. Let me begin by saying that I am extremely appreciative of the time, knowledge and expertise our ACF faculty provide to our students, trainees and community. And we are grateful that they do this pro bono. In turn we are pleased to extend a Stanford title to those who fulfill the criteria for appointment to the ACF (see: http://med.stanford.edu/academicaffairs/acf/).

Recognizing that our ACF colleagues are almost always in full-time clinical practice and that their Stanford teaching responsibilities constitute a small percentage of their time, we have tried to respect the boundaries of their Stanford responsibilities. Accordingly we have limited our policies on industry relations and conflict of interest (see: http://med.stanford.edu/coi/siip/) to their official Stanford responsibilities. But the recently reported situation raises the question of whether such a compartmentalization is feasible or achievable. That is, once a Stanford title is bestowed, it is hard for the public (including industry) to distinguish whether a physician is acting on her or his own or in a Stanford capacity.

Accordingly, I have appointed a Task Force to examine how our Industry Interactions Policy and conflict of interest disclosure policies (including public disclosure) should apply to Adjunct Clinical Faculty. It is likely that the vast majority of ACF have little to no industry relations. But it should not be forgotten that recent surveys have indicated that approximately 94% of physicians (including those in clinical practice) receive gifts or payments from industry. And, in the case of the ACF individual reported by Eli Lilly, the amount of payment was considerable.

While I am not passing a judgment on a specific case or individual, I do think it is important that we acknowledge that any person with a Stanford faculty title (including ACF) bears responsibility for how the title is used and how relationships with industry are performed and disclosed. I will have more to report on this in a few weeks.

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Education versus Marketing: Use of Stanford Facilities for Promotional Videos

Over the past several weeks a number of questions have been raised about the appropriate use of Stanford’s space, name and trademarks to promote commercial and business interests of outside third parties. Stanford’s resources exist to support the University’s missions of the creation, preservation and dissemination of knowledge. The use of Stanford’s name to imply support for an outside business entity or by inference the endorsement of a product or service has the potential of distorting the University’s primary teaching and research mission and is not permissible.

Several administrative policies detail specific guidelines concerning the use of Stanford’s name, space (which includes the use of Stanford University Medical Center services or facilities) and trademarks. I urge you to refer to these policies in the Stanford Administrative Guide (see below) should you have any questions about participating in a video for an outside business interest.

For additional counsel on this issue, you can contact Paul Costello, Executive Director of Communication and Public Affairs at Paul.Costello@Stanford.edu. The relevant policies are:
http://adminguide.stanford.edu/14.pdf and
http://adminguide.stanford.edu/15_5.pdf.

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Stem Cell Biology and Regenerative Medicine

Since its inception in 2003, the Stanford Institute for Stem Cell Biology and Regenerative Medicine has continued to develop in stature and achievement. Building on the fundamental discoveries in stem cell biology that have been made by Stanford faculty and their colleagues, a new phase of research is emerging in the form of proposals and plans to translate important discoveries from the bench to the bedside. These efforts begin with a compelling idea and engage interdisciplinary teams of investigators at Stanford and collaborating institutions around the world.

To foster the translation of science into clinical practice, unique relations with industry and with the FDA will also be needed. To facilitate this new phase of research, the California Institute of Regenerative Medicine (CIRM) has taken the bold step of providing major financial support (up to $20 million per project) for competitive proposals by “disease teams” ready to make progress toward initiation of a clinical trial within 48 months after the start of the funding. Clearly this is a major commitment for CIRM as well as for the disease teams, and it brings with it considerable and important shared expectations and accountability.

At the October 28th meeting of the ICOC (the governing board for CIRM, of which I am a member), Stanford faculty proved highly successful in the competition for “disease team” funding. Indeed, of the fourteen disease teams that were approved by the ICOC (of course I had to recuse myself from any consideration of the Stanford applications), three faculty were approved as Principal Investigators (PI) and one as a Co-PI. This is a remarkable achievement in its own right, although it is also consistent with the success of Stanford faculty in past CIRM competitions.

The Stanford disease teams include projects in leukemia, stroke and the dermatologic disorder dystrophic epidermolysis bullosa (see also: http://med.stanford.edu/ism/2009/october/cirm.html). Other CIRM funded disease teams will address potential stem cell treatments for HIV/AIDS, sickle cell disease, brain tumors and solid tumors, diabetes, macular degeneration, cardiomyopathy, and amyotrophic lateral sclerosis. Many different approaches and technologies are employed and the assembled teams include collaborators from the USA, Canada, and the UK. The Stanford led disease teams are:

The funding is tracked to the PI and, based on that, Stanford will receive $51.7 million. With these new awards, Stanford has received 42 of the 321 grants awarded by CIRM – which translates into a total of $162,979,744. This is the largest amount of CIRM funding of any institution in California – which now totals $1.01 billion. This is an incredible contribution by the citizens of California (through Prop 71, which created CIRM) to support stem cell research. Clearly the next several years will be tremendously exciting scientifically.

In addition to support from California and CIRM for stem cell and regenerative medicine research, several Stanford faculty were also successful in receiving major awards from the National Heart, Lung, and Blood Institute (NHLBI), one of the National Institutes of Health, for pioneering stem cell research. They are:

Taken all together, Stanford’s programs in stem cell biology and regenerative medicine are moving forward with remarkable vigor and results. These efforts will also be more tangibly visible when the Lorry Lokey Building for Stem Cell Research (a.k.a. the Stanford Institutes of Medicine I) opens in the summer of 2010.

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Dr. Emmanuel Mignot is Appointed Director of the newly created Stanford Sleep Center

Thanks to the pioneering work of Dr. William Dement, Stanford has long been seen as a leading center in sleep medicine – and in many ways the architect of the field. The program has been anchored in the Department of Psychiatry and Behavioral Sciences and has made major contributions to the science of sleep and its disorders as well as significant advances in the diagnosis and treatment of sleep disorders. Of note, in February of 2009, a state-of-the-art Sleep Center opened at the new Redwood City Ambulatory Center that is owned and operated by Stanford Hospital & Clinics.

Over the years the science and medicine related to sleep has evolved, matured and become more interdisciplinary. Accordingly, a Task Force led by Dr. David Stevenson and Dr. Kathy Gillam was appointed in 2008 to examine the best models and organizational structure to sustain and enhance the excellence of the sleep research and clinical programs at Stanford.

While a number of models were proposed, we ultimately settled on establishing the Stanford Center for Sleep Sciences and Medicine (SCSSM). In doing so, we recognized that the optimal starting point was a “hybrid model” that anchored the new Center in the Department of Psychiatry while also permitting it to reach out and collaborate with other departments and disciplines in the medical school and university.

To foster the interdisciplinary focus of the SCSSM, it was determined that the director would report to the Dean (or Vice Dean) and that there would be a Steering Committee of department chairs and hospital administrators involved in sleep related activities. The goal of the SCSSM will be to “engage the broad Stanford community in research, education and patient care in sleep medicine.”

It was also determined that the leader of the SCSSM would be appointed by the Chair of the Department of Psychiatry as the Chief of the Division of Sleep Medicine, thus aligning the Center and Division as a organizational unit that is located administratively in the Department of Psychiatry while also serving as an interdepartmental Center that serves the broader community.

I am very pleased to announce that Dr. Emmanuel Mignot has accepted my offer to become the first Director of the SCSSM. Concurrently, Dr. Alan Schatzberg has appointed Dr. Mignot Chief of the Division of Sleep Medicine in the Department of Psychiatry.

Dr. Mignot is the Craig Reynolds Professor of Sleep Medicine and is internationally recognized for his pioneering research in narcolepsy and other sleep disorders. He has received numerous awards and honors and is an elected Member of the Institute of Medicine of the National Academy of Institutes. I join Dr. Schatzberg in being extremely pleased that Dr. Mignot will lead our new Center for Sleep Science and Medicine.

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Evolving Agenda in Clinical and Translational Research

On Friday, October 30th the Spectrum Strategic Advisory Board met to review the progress of Stanford’s Clinical and Translational Science Award (CTSA). Stanford is one of 46 institutions across the USA that has received an NIH CTSA award. These awards are designed to assist medical centers to develop a transformative home for clinical and translational science through innovation, education and the optimization of resources.

Stanford’s CTSA, also known as Spectrum, receives $5 million annually from the NIH (and an additional $3M from the School and University). It is unique in being anchored in the broader university and in its efforts to reach out to the Schools of Engineering, Humanities & Sciences, Business, Law, Education and Earth Science – as well as to the interdisciplinary Institutes on the Environment and on Human Health and to community initiatives, both locally and globally.

Stanford’s Clinical and Translational Research Unit (http://sccter.stanford.edu/) has sought to bring together adult and pediatric programs (under the banner of Spectrum Child Health: http://spectrumchildhealth.stanford.edu/) and to create the infrastructure for clinical research, including regulatory and compliance functions as well as the panoply of requirements (e.g., core facilities, clinical trials budgeting, informatics and statistics support) that enable effective and optimized clinical research.

One of the important objectives of Stanford’s CTU is to forge connections with industry and development partners through SPARK (led by Dr. Daria Mochly-Rosen) and the Biodesign Program (led by Dr. Paul Yock). The Stanford CTU also helps foster novel research through pilot funding programs and has also developed unique Stanford connections – such as between the medical school and the Stanford Synchrotron Radiation Laboratory (SSRL) at SLAC to enhance drug discovery.

The Stanford CTR has also been building education and training programs designed to develop future physician-scientists and scholars as well as to prime the pipeline for diversity and excellence. These include programs that enrich science learning for high school students in addition to leadership and community training for faculty and trainees. In tandem are an increasing number of efforts to develop community programs and interactions – both locally and globally.

During our Spectrum Advisory Meeting we had excellent updates on each of these initiatives and I was very pleased by the progress being made in our overall clinical and translational research efforts. I am particularly grateful to Dr. Harry Greenberg, the PI for our CTSA and Director of Spectrum, as well as the Co-Directors Drs. Phil Lavori, Charles Prober, Brandy Sikic and David Stevenson. While this is very much of a work in progress, it is clearly gaining momentum and excellence. Thanks to all – and especially our faculty, students and trainees.

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NIH Director’s Major Initiatives

During the November 5th Board Meeting of the Foundation for the NIH, Francis Collins, newly appointed NIH Director, outlined five of his major priorities. These include:

  1. The application of new technology to understanding how life works and goes wrong. He referred to big science projects like expanded genomics and imaging that might catalogue “all proteins and all genes” and how they are related to normal and abnormal life processes.
  2. Translating basic science discoveries into new and better treatments. He referenced improving the pipeline for discoveries and innovations and specifically commented on high throughput technologies and chemical genomics and the TREND project.
  3. Putting science to work for the benefit of health care reform, including the use of evidence based medicine, quality outcomes research, pharmacogenomics and the use of mobile technologies to monitor and improve health outcomes.
  4. Encouraging a greater focus on global health, including communicable and non-communicable diseases and also neglected tropical diseases.
  5. Reinvigorating and empowering the biomedical research community, including focusing on the pipeline for new biomedical scientists as well as the funding to support bioscience research.

While these themes are important, they are largely about more big science initiatives and did not focus on basic research as a primary underpinning. I would hope that future presentations would offer a greater attention to basic research as an underpinning to translational research and medicine.

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Laptop Security and Encryption

I brought to your attention in a past Dean’s Newsletter (http://deansnewsletter.stanford.edu/archive/04_07_08.html) the critical issues of laptop security, privacy of information and the need for encryption. At the Executive Committee meeting on Friday, November 6th, Todd Ferris, Associate CIO – IT Services, and Ellen Amsel, Director, Information Security Services, provided an update on these topics.

They reminded us that if identifiable patient or research subject health information is stored on a laptop or any other removable media (e.g., USB drive, CD, portable hard drive), that information must be encrypted (Stanford University Data Classification: http://www.stanford.edu/group/security/securecomputing/dataclass_chart.html), and they provided the following information:

Stanford’s central IT organization, ITS, has funded PGP, which is encryption software that is compatible with both PCs and Macs. PGP is available to everyone at Stanford at no cost. ITS is providing 24/7 support for PGP, and each user can have up to three licenses for use on three different computers. Information on PGP can be found at: http://www.stanford.edu/services/encryption/wholedisk/index.html.

We strongly encourage the use of PGP (or other encryption tool) and remind you that current, reliable backups of your data are always important. If your laptop is stolen, even if it is encrypted, you will need a copy of your data so you can continue your work. Backups, of course, should also be properly protected. Additional information can be found at the School of Medicine website: http://irt.stanford.edu/security/encryption_main.html.

Contact your local IT support person to help you with PGP or another encryption solution that best fits your needs. You can also contact the School of Medicine Service Desk at 725-8000. In the event of a lost or stolen laptop, contact the School of Medicine Privacy Officer at 725-1825. There is a presentation that contains all of this information and more at: http://med.stanford.edu/irt/security/protecting/EncryptionPresentation.

I urge you to take the necessary steps to assure that you are in compliance with this important policy.

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Opportunities to Help Our Neighbors

The Dean’s Office is excited to rally in aid of our community and run a food & fund drive to benefit Second Harvest Food Bank of Santa Clara and San Mateo Counties. Most of us know someone who is struggling to make ends meet, and we have the opportunity to ensure that no child, family or senior goes hungry. Through your generosity we can provide hope for the 207,000 people Second Harvest feeds each month. Please join us in this effort to feed our neighbors who, each month, have to decide between paying for rent, utilities, or medicine and providing food for their loved ones.

Drop off food donations in the barrels located in the Dean’s office, Alway building, M-121. Please note the most needed foods:

The Dean’s Office will be collecting donations until Friday, December 18.
In addition, the Dean’s Office is holding a coat drive over the next few weeks. Coats of all shapes and sizes are welcome. Just bring your clean, gently used coats and jackets to the Dean’s Office between November 9 and December 4. In conjunction with the One Warm Coat organization, all reusable coats will be distributed free of charge directly to local people in need.

Thank you in advance for your participation!

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Upcoming Event

National Health Forum:
New Responsibilities for Scientists, Clinicians and Policy Makers
Tuesday, November 17
4:00 – 5:30 pm
Byers Auditorium, Genetech Hall, UCSF Mission Bay Campus

On Thursday November 18th the Institute of Medicine of the National Academy of Sciences will sponsor a regional meeting to which all are welcome. The meeting will be moderated by Dr. Bernie Lo, Professor of Medicine and Director of the Program in Medical Ethics at UCSF, and will feature presentations by Drs. Susan Fisher (UCSF), Sandra Hernandez (The San Francisco Foundation and Board Member at LPCH) and Ralph Horwitz, Chair of Medicine at Stanford. Registration is at www.iom.edu/sfregional.

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Awards and Honors

2009 CTSA Seed Grant Awardees: The Office of Community Health is pleased to announce the recipients of the 2009 CTSA Seed Grants. These awards provide research/project funding for Stanford faculty to form new community-based partnerships, enhance existing partnerships or support implementation of a community-based research project with community-based organizations in San Mateo or Santa Clara counties. This year’s award recipients include:

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Appointments and Promotions

Word version: DeanNews11-09-09.doc

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