NWABR Urges Congress to Preserve Biomedical Research Funding

Sequestration could cost WA at least $70 million in grant funding

Now that the election is finally over, it’s easy to be distracted from the ongoing work of the current congress, and the looming threat that budget sequestration poses to the biomedical research industry. The Budget Control Act of 2011 requires that across-the-board cuts to be applied to a large portion of the federal budget on January 2, 2013, unless Congress reverses it. For domestic programs, around $39 billion in cuts would be applied to “discretionary” programs, which include the National Institutes of Health (NIH) and the National Science Foundation (NSF).  According to a United for Medical Research report, if NIH funding is cut by 7.8% as part of budget sequestration, the state of Washington will be hit especially hard, with a loss of 1,184 jobs and $72.2 million in grants supported by this funding. And that is just the beginning.

This week, members of Research!America, a nonprofit advocacy alliance, are headed to Capitol Hill to make the case that sequestration is harmful not just for biomedical research, but also for our economy. As part of their Save Research campaign, NWABR was proud to sign a letter urging congressional leaders to reject any deficit reduction proposals that would cut research funding or hinder incentives that support biomedical innovation.

The full letter is posted below. Please take a moment to reach out to your congressional delegation and ask them to preserve funding that will help combat disease and spur private sector innovation in the Northwest and beyond.

Dear Mr. Reid, Mr. McConnell, Mr. Boehner, and Ms. Pelosi:

As advocates for biomedical and health research, we are writing to urge you to refrain from deploying deficit reduction strategies, like sequestration, that would slow medical progress.

Our nation leads the world in biomedical and health research, a function of public sector support and private sector ingenuity. The National Institutes of Health (NIH) is unrivaled in spurring the basic discovery that lays the path for private sector innovation. Peer-reviewed NIH funding reaches all 50 states and congressional districts, spurring discovery at universities, hospitals, small businesses, and independent research institutes. In fact, NIH-supported research has:

• Supported nearly 500,000 jobs in 2011 in every state
• Generated $62 billion in economic activity in 2011
• Helped increase life expectancy from 47 years in 1900 to 78 years in 2009

But this is not just about NIH.  The National Science Foundation (NSF), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and the Agency for Healthcare Research and Quality (AHRQ) all provide a positive return on investment to our nation, protecting American lives and promoting American prosperity.

• NSF’s grant portfolio is designed to identify and pursue the best scientific opportunities across the spectrum  of scientific disciplines, including biomedical research.
• FDA is a key conduit between medical discovery and medical progress, laying the path for safe and effective  medical products to reach the marketplace.
• CDC conducts and supports the public health research needed to contain disease outbreaks, promote wellness, and in other ways provide basic supports for a safe and healthy society; and
• AHRQ combats entrenched and insidious problems in our nation’s health care system – like preventable medical errors and needless administrative red tape — that take lives and inflate the cost of taxpayer funded health programs and private insurance alike.

Disinvesting from biomedical and health research – and the infrastructure and expertise needed to conduct it – would contravene the goal of deficit reduction. This research is one of the fundamental underpinnings of our economy, a reality well understood by other nations, which are ramping up their investment and building out their research infrastructure.  Research is a catalyst that creates businesses large and small, and generates jobs in research, manufacturing, distribution, exports, health care and a host of other sectors. Those businesses and jobs supply federal revenue needed to reduce the deficit.

In addition, research can help stem runaway federal healthcare spending, which is driving our deficit. While new treatments may require additional cost at the outset, research has shown the offsetting effects of reduced hospitalizations, fewer visits to providers, reduced home care, a reduction in the Social Security disability roles, and improved productivity.  As you well know, the cost of treating diseases like Alzheimer’s, Parkinson’s and other diseases are exploding. There is no high-impact alternative to research as a means of addressing this crisis.

When it comes to the fiscal health of our nation, biomedical and health research are part of the solution, not part of the problem.  Whether it is appropriations policy or entitlement and tax reform, we urge you to discard any proposal that cuts funding or mutes incentives for public- and private-sector supported medical innovation.   Compassion and pragmatism intersect in the decision to do so.

Thank you for your consideration.

NWABR Members Speak Up For Research

These two exceptional editorials from leaders in the Oregon Health and Science University community stand out for their thoughtful approach to advancing public understanding of biomedical research.

Please read, share, and comment:

Youth Ethics Summit 2011 :: Stem Cells :: Science and Ethics

On April 9, 2011 the Youth Ethics Summit brought together students from across the Puget Sound region to learn about topics related to ethics, medicine, and biomedical research that are of special relevance to young people.

Presented by NWABR and UW’s Institute for Stem Cell and Regenerative Medicine (ISCRM), this year’s summit focused on stem cells and featured tours, panels, and breakout discussions. The Summit provided an opportunity for students from different schools to meet and to participate in discussions and presentations about ethics in science issues.

Students Say

Students who experienced the Summit said:

• I learned just how much control we have/might have soon. Knowing where to draw the line isn’t easy, and it’s something we all need to discuss and understand in order to make wise choices as individuals and as a society.
• We were able to express our own ideas and see what other people thought about them … the discussions we had in our breakout groups were very thought-provoking … listening to different view points on things helped me learn a lot more about them.
• The tours gave me insight on what real life stem cell research would be like and how it would be to work in a lab in the future.
• It was absolutely amazing going into three different labs focusing on the application of stem cells, the stem cells themselves, and the use of robots in research. The groups were small, we had the opportunity to look at both embryonic and induced pluripotent stem cells through microscopes, and the researchers were all extremely informative.
• In the laboratories we toured, I saw myself in the scientist gown, handling the different machines.
• It was a wonderful learning experience that I would recommend anyone who is interested in bioethics … I loved the chance to meet similar-minded teens in the Seattle-area and talk about this fascinating topic.

Stem Cells 101

We began with a brief presentation of “Stem Cells 101″ by Professor Tony Blau, MD, Director of the Institute for Stem Cell and Regenerative Medicine.

“If you took a drop of blood from my finger, put it on a glass slide, smeared it and stained it and looked at it under the microscope, you’d see different types of cells, including what?” Blau asked. Hands shot up, and Blau took three fast answers, one each from three students: white blood cells, red blood cells, platelets. “And they would look obviously different from each other,” Blau continued, describing what each looks like under a microscope, “but they all come from the same mother cell, a stem cell.”

Dr. Tony Blau, Professor of Medicine, Hematology, Adjunct Professor of Genome Sciences, and Co-Director, Institute for Stem Cell & Regenerative Medicine, University of Washington School of Medicine

In each of us, we might have a trillion cells in our blood, but we have about 10,000 blood-generating stem cells. “Where are these stem cells?” Blau asked and another student answered: in the bone marrow.

The professor next defined leukemia (cancer of the blood or bone marrow) and one life-saving treatment for it, dependent on stem cells and developed “next door” at the Fred Hutchinson Cancer Research Center. Stem cell transplantation with bone-marrow-derived stem cells was led by Dr. E. Donnall Thomas, whose work was recognized in 1990 with a Nobel Prize.

Dr. Blau explained the basics of hematopoietic stem cell transplantation, of regenerative medicine as studied at the ISCRM, and he introduced what we would see for ourselves, next — in tours of several research labs on campus at UW South Lake Union.

Tour One: Tony Blau Lab – cancer biology and stem cells

There are about 500 researchers at UW South Lake Union. Neighbors include the Seattle Cancer Care Alliance, Seattle Childrens’ Research Institute, Seattle Biomedical Research Institute, Novo Nordisk, PATH, Fred Hutchinson Cancer Research Center, et al.

Upstairs at his lab’s front door, Dr. Blau pointed out a few notable neighbors in biomedical research in Seattle’s South Lake Union neighborhood.

Researchers Tony Blau, Chris Miller, and Kyle Rattray of the Blau Lab

Researchers Kyle Rattray and Kathy Davidson at the Blau Lab

Tour Two: Mike Laflamme Lab – cardiovascular research

Professor Laflamme’s lab researches cardiac applications for human embryonic stem cells, including repair and regeneration of ventricular, atrial, and other cells from embryonic stem cells.

Professor Mike Laflamme, Pathology, Molecular and Cellular Biology, University of Washington

Researcher Jay Gantz, UW Bioengineering

Tour Three: Tim Martins, Co-Director of the Quellos High Throughput Screening Core - screening molecules for drug development

Dr. Tim Martins, Co-Director welcomes us to the Quellos High Throughput Screening Core, full of the robotics and automation which have vastly improved biomedical research with improved speeds for identifying therapeutic drug candidates.

Dr. Martins was asked about making mistakes in experiments. He replied "I make mistakes, but I'm not afraid to make mistakes," while explaining failure rate in research and the importance of confidence.

Dr. Tim Martins with ready answers on our tour

Robots! at the Quellos High Throughput Screening Core

Hands-on with Planaria and Play-dough

After our tours and lunch, we enjoyed hands-on activities with planaria and Play-dough — to model human embryonic development.

Dr. Reitha Weeks, PhD, Program Manager for Science Outreach at NWABR introduces planaria

Planaria are “the regeneration experts” explains Reitha Weeks of NWABR — if you separate one worm into 279 pieces, they grow into 279 worms!  Planaria also serve as model organisms for understanding human stem cells.

NWABR offers resources for teaching about biomedical research and ethics, including our popular Stem Cell unit with “Plenty of Planaria” to model stem cell function, development, and the complexity of tissue regeneration.

The curriculum is geared towards high school students and available for download free of charge.

Microscope, camera, and monitor loaned to us by Leica Microsystems, Inc. Thank you!

Next up, modeling early embryo development — with play-dough!

Play-dough Egg and Sperm

Jeanne Chowning, MS, Director of Education at NWABR leads the activity

Students in Dawn Tessandore's AP Biology class

Breakout Groups: Ethical Issues in Stem Cells

After the above activities, we broke out into groups to discuss ethical issues more closely. A few of the groups were photographed, as below. Group leaders and subjects included:

• TONY BLAU, MD – Stem Cell Treatments: Considering the risks and benefits of testing stem cell treatments in humans.
• DAVID EMERY, PhD – Embryonic Stem Cells: How far should we go in seeing if they can grow into embryos?
• ERICA JONLIN, PhD – Savior Siblings: “My Sister’s Keeper” – what if you were a genetic “designer baby” created to save your sick sister?
• KATHY DAVIDSON, PhD – Embryos and Research – Creation and Donation: Should researchers be allowed to encourage couples to donate embryos?
• KYLE RATTRAY, MD/PhD Program – Social Justice: Disease Research and Stem Cells: What diseases should be prioritized in stem cell research?
• CHRIS MILLER, PhD – Knowing Your Future: What Can Your DNA Tell You? How much do we want to know about the relative risks of what potentially lies ahead for us?

TONY BLAU, MD -- Stem Cell Treatments: Considering the risks and benefits of testing stem cell treatments in humans

KATHY DAVIDSON, PhD -- Embryos and Research - Creation and Donation: Should researchers be allowed to encourage couples to donate embryos?

KYLE RATTRAY, MD/PhD Program -- Social Justice: Disease Research and Stem Cells: What diseases should be prioritized in stem cell research?

Youth Ethics Summit 2011 was blogged by Brian Glanz for NWABR

Photography by Mohini Patel Glanz.

Youth Ethics Summit 2011 was presented by:

and

This program was supported by a Collaborations to Understand Research and Ethics (CURE), 1R25RR0251131, a Science Education Partnership Award from the National Center for Research Resources. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.

Breast Cancer – A Patient’s Story

Spring 2010 Research Saves!

A patient’s story, especially if that patient is a scientist, can bring a sense of reality and poignancy to biomedical research. As a Ph.D. trained molecular biologist and program manager at the Northwest Association for Biomedical Research (NWABR), my story is in harmony with NWABR’s mission: to promote the understanding of biomedical research and its ethical conduct…When invited to speak at the first high school Junior Science Café of the academic year, I jumped at the chance. I titled my talk “Demystifying Breast Cancer: A Personal Tale,” hoping that I could encourage students to ask questions – to demystify something that has touched, and sometimes killed, so many… (Read More…)

(NIH grant UL1 RR025014 supports NWABR’s Speakers’ Bureau)

Henrietta Lacks: Ethics at the Intersection of Health Care and Biomedical Science

Dr. Ruth Faden

The 2011 Charles W. Bodemer Lecture was given by Dr. Ruth Faden, PhD, MPH, of the Johns Hopkins Berman Institute of Bioethics. Several NWABR staff attended and offer this account of the lecture, “Henrietta Lacks: Ethics at the Intersection of Health Care and Biomedical Science.”

Dr. Faden lectured in three segments:

1. Relating the experience of Mrs. Henrietta Lacks and her children as chronicled in The Immortal Life of Henrietta Lacks by Rebecca Skloot. Faden is friends with Skloot, as she disclosed. Included in this segment: how HeLa cells came to be.
2. Ethical considerations of consent and compensation raised by the story.
3. Examination of the story through a social justice lens.

Note: We’ve bolded ethical questions below, for emphasis.

1. About Henrietta Lacks

A poor black woman, undereducated and living in Baltimore in the 1940s, Lacks had been living with her husband, Day (David) and her 5 children while hiding a great deal of abdominal pain. Finally in 1950 she asked Day to bring her to Johns Hopkins Hospital, the only regional hospital where African Americans could receive treatment. Diagnosed with cervical cancer in February 1951, she received cervical radiation, which was the gold standard treatment of the day, under general anesthesia.

Ongoing research at Johns Hopkins by two doctors played a large part in the story: Dr. Richard TeLinde, head of gynecology and a cervical cancer expert, was researching whether different types of cervical cancer were interrelated. Dr. George Gey, head of tissue culture, had been trying for decades to grow an immortal cell line which could be used as a standard research tool. In their respective research pursuits, both Dr. TeLinde and Dr. Gey routinely used tissue samples which had been removed from patients who came to Hopkins for treatment. Henrietta Lacks was one of these patients.

Faden points out that the cervical tissue samples were not part of Mrs. Lacks cancer treatment and that in keeping with the practices of the time, Mrs. Lacks was never asked for permission. Dr. Gey was offered some of the tissue to contribute to efforts to grow the first human cells outside of the body (called tissue culture).

After just 3 weeks of trying to grow Mrs. Lacks’ cells in culture, it was clear to Dr. Gey that these cells would be the very first immortal human cells. In keeping with his system of using the first two letters of a patient’s first and last name, Dr. Gey labeled the cells “HeLa.”

Since that time these cells have made remarkable contributions to medicine including development of the polio, smallpox, and HPV vaccines, and cancer treatments, and over 80,000 medical publications. On October 4, 1951 Henrietta died without ever knowing the breakthroughs she helped provide.

Mrs. Lacks’ children and husband didn’t know that her cells were taken, bought, sold, and used — until 20 years later when her actual name was made public, without notifying her family, in the 1970’s.

Click here to view a slideshow from Skloot’s website, with photos from Lacks’ life.

Neither Johns Hopkins nor the doctors profited directly. In fact, Dr. Gey gave the cells internationally to anyone who wanted them. That isn’t to say that they did not benefit in recognition and professional reputation.

Other people have made money on HeLa cells. You can purchase them today from cell culture companies. The Lacks family never received compensation for the commercialization of HeLa cells. The family has remained poor and to this day has inconsistent health care insurance.

2. Ethical considerations still relevant today

Tissue donation is not hypothetical or a thing of the past. Anytime someone has an “opsy”—as in biopsy—or an “ectomy”—as in tonsillectomy, tissue is being removed from their body. What happens to that tissue once it has served its medical purpose of diagnosis or treatment? It can be discarded as medical waste or it can be used for research.

Creation of biobanks or biorepositories — see our previous blog posts from the event, “Do You Know Where Your DNA Is?” on biobanks — from huge sets of human tissue samples, is creating great expectations of what scientists will be able to accomplish toward predicting, preventing, and personalizing medical breakthroughs. Breakthrough hopefuls include diagnostic tests and individualized treatments for chronic disease like diabetes and heart disease.

Should patient consent be obtained for research purposes if 1) once utilized for medical purposes, the tissue would be sent to medical waste anyway? if 2) extra tissue is taken solely for research purposes, as in the case of Mrs. Lacks?

Should patients re-consent every time their tissue is used for a different study? How can patients with tissues in biobanks consent to future research that has not yet been conceived?

Should people be compensated if anyone benefits from marketable products derived from the human body? How should people be informed about discoveries resulting from the use of their tissues?

Dr. Faden quickly moved to her passion — how to examine these ethical questions through the lens of social justice.

3. Social Justice is an important lens through which to examine the ethics of science

The Twin Aims Theory of social justice is 1) “improvement of human well being” and 2) “combating densely woven patterns that compromise multiple core elements of well being.” Faden listed the core components of well being and what she calls the Essential Elements of Well Being:

1. Personal security
2. Reasoning capacities with which to think about the world
3. Respect of others as moral agents
4. Health
5. Affection and attachment
6. Self-determination (the ability to exert some control over the path of one’s own life, free from the tyranny of other people or conditions)

Dr. Faden next introduced ‘counterfactuals’ otherwise known as “What If” statements:

What if 1) the Lacks family had received compensation? What if 2) Mrs. Lacks was an affluent white person with great health insurance? Would the story still raise questions about social justice? Dr. Faden argues YES.

Of course monetary compensation would have made a difference for the Lacks family; however, it would have done little to adjust for the systemic injustices of being poor and black. (Note from Faden: Cases where someone’s body is a source of commercial value are extremely rare. More often, medical discovery is the result of hundreds of thousands of specimens and data.)

If Henrietta Lacks had been white and wealthy, Faden feels that the systematic injustice of being “disrespected by biomedical research” likely would not have been different. Mrs. Lacks’ family was in the dark; in keeping with the practice at the time, Dr. Gey and Johns Hopkins did not tell them anything about the HeLa cells for twenty years (if you read the book, you’ll note that they only told her family because they accidently learned about it from a young Hopkins researcher who happened to be a distant cousin and was using the cells in his research. He put two and two together and realized the connection when he was visiting his family).

And this is what Faden means by lack of respect. Deborah, one of the Lacks children who is featured in the story, describes her worry about her mother’s cells and her inability to learn about what happened to the cells—and by association to her mother. This worry and insecurity is what causes disconnect, disrespect, and ultimately injustice.

Dr. Ruth Faden wrapped up her presentation with what may have been the most interesting examination — The Collective Action Problem of the current profit model that drives scientific discovery. Also called the Reciprocity Model, it acknowledges that even though I may not directly benefit my contribution and you may not directly benefit your contribution, our communal contributions may benefit each other.

Without communal action toward a common goal, the goal will not be realized. Advancing medical progress faces this problem. In medical research and biorepositories in particular there is need for a critical mass of people to donate tissue, blood, and health data. Not just any people—all people from all ethnic and racial backgrounds. Without access to many samples there will not be benefit for anyone. This was her call to public participation, the 4th “P” of P4 Medicine, as coined by Seattle’s Leroy Hood of the Institute for Systems Biology.

Do you want to participate in research? Sign up as a volunteer with ResearchMatch.org, an anonymous volunteer matching service funded by the National Center for Research Resources, part of the National Institutes of Health. Explore opportunities to donate blood and tissue for research. Participate in public dialogue about medical research and ethics.

Faden envisions a society in the near future without the expectation of monetary compensation for research participation, because we understand that medical progress will benefit everyone. Do you?

Charles W. Bodemer

Who was Charles Bodemer and why have an annual lecture series?

Bodemer was the founder of the University of Washington School of Medicine, Department of Bioethics & Humanities, serving as chair from 1967 to 1985.

Bodemer “had a distinguished career as a research scientist before dedicating his energies to his other love: the history of medicine.”

For more, please see http://depts.washington.edu/bhdept/conedu/Bodemer.html.

Data collection and privacy

Edwards describes that there are a variety of decisions being made about how specimens are collected, how much information to keep, and on what are minimum standards of privacy and security in various areas.

She asks everyone in the room — do you know that you have, or do you think that you have, your own specimens or data in a biobank? About half the room raises a hand, many tentatively. Edwards then explains there are many ways our tissues or data are collected that we may not be aware of, even being collected at birth.

There are two trends in biobank privacy. In one, greater anonymization has led to stripping more personal identifiers from samples and data.

Another trend is in the opposite direction, though: in some repositories, a tight link is being kept between personal identifiers and a person’s samples and other data. Advocacy-based biobanks tend toward this trend.

The reasons include that people can manage and access their own data and larger medical and/or research profiles. In some cases, people can track the use of their data in research.

This latter trend is more complicated, ethically and practically, but it may also lead to greater benefits in science and in public understanding.

Russell notes that GAPPS enrolls women at their first pre-natal visit, not knowing who may end up with a pre-term birth or other relevant circumstance. This is a very expensive operation, but even so they spend a lot of time in education and in verifying that strict rules have been followed to collect enough and valid data.

Sewards then describes the issues in greater detail — when do you ask for consent? What does the consent form look like? A concern of hers is adding greater context to consent.

Introducing our panelists

Moderator Gretchen Sorensen introduces our panelists:

Kelly Edwards, PhD is Associate Professor, Department of Bioethics and Humanities at the University of Washington School of Medicine. Edwards is core faculty for the Institute for Public Health Genetics and the Critical Medical Humanities Research Cluster. For more, see her bio in the Department of Bioethics and Humanities.

Edwards describes the questions she helps others consider in her work as a bioethics consultant, often regarding biorepositories. Questions are sometimes  about recruitment and communications to potential recruits, such as “How should we handle consent?” Other questions surround data access, i.e. who has or should have access to data from the repository?

Shannon Sewards is Assistant Director for Operations, Human Subjects Division at the University of Washington. “What is ‘the human subjects division’ all about?” muses Sorensen, noting the intriguing name, before answering simply that it’s “anything that involves research on a person.” For further clarification we offer the following, from the division’s home page:

“Research involving human subjects must be reviewed and approved by an Institutional Review Board (IRB). At the UW, several IRB committees serve this function. The Human Subjects Division (HSD) provides administrative support and facilitates IRB review; assisting researchers throughout the process.”

Sewards describes that the role of IRBs is to be protective for the general public, while they can be a hindrance, relatively speaking for researchers.

Donna Russell, MHA is Director of Research Development and GAPPS at Seattle Children’s. GAPPS is the Global Alliance to Prevent Prematurity and Stillbirth, whose expanded mission includes maternal, newborn, and child health with a global scope.

Russell notes that GAPPS began because of the magnitude of the problem of pre-term birth, here in the U.S. and globally. 13 million pre-term births happen annually around the world, and 1 million of those are fatal. There are also 3 million still births.

That means there are more than ten times the number of still births as there are “SIDS” deaths. SIDS is relatively well publicized while still birth is not.

We still, fundamentally do not know what causes many of these deaths. The best strategy for solving the mystery is to link high quality specimens to descriptive data.

Therefore a cornerstone of GAPPS is their biorepository. They just started collecting data in the last year, after two years of preparation and addressing many of the issues we will discuss today.

A fundamental ethical question for GAPPS is that pregnant woman are a vulnerable population.

Edwards, Russell, and Sewards are introduced by Sorensen

The Immortal Life of Henrietta Lacks Discussion Guide Available!

Download Discussion Guide

NWABR is proud to announce the availability of a discussion guide to enhance active reading and consideration of issues raised in The Immortal Life of Henrietta Lacks (Crown Publishers, 2010). This guide is open for use by anyone who would like to facilitate discussions or personally reflect on lessons from the book.

The Immortal Life of Henrietta Lacks is journalist Rebecca Skloot’s quest to tell the true story about the woman (and her family) whose cancer cells were the first human cells grown successfully in a laboratory. Skloot masterfully opens the door for readers to explore current bioethics issues that are surprisingly relevant to most, if not all, people. The story is one of cutting edge biomedical research, potential harms and benefits of participating in research, the nature and purpose of information gleaned from our bodies, the influence of faith and family history on the way people perceive their experiences, and the great potential of relationships to heal or deepen our wounds. The opportunity to discuss lessons from this book for us as researchers and research participants is rich; we all have much to learn regarding what is important in building research practices that are trustworthy, ethical and effective.

To learn more about the author or book, visit Rebecca Skloot’s website where she also features our discussion guide: http://rebeccaskloot.com/the-immortal-life.

The Immortal Life of Henrietta Lacks: A Discussion Guide is a collaboration between Northwest Association for Biomedical Research and University of Washington with funding from NIH grant 1 UL1 RR 025014.