Stem cell clinics
11/28/17
Facilitated by erica jonlin, university of washington Institute for stem cell & regenerative medicine (iscrm)
Suggested readings and resources
NFL Players Use of non-FDA Approved Stem Cell Therapies
FDA Cracks Down on Stem-Cell Clinics Selling Unapproved Treatments, NPR
Right to Try Movement attached to unproven Stem Cell Therapies
Adipose-tissue derived stem cells in regenerative medicine (clinical research review)
Sero-segregation: access and equity in hiv prevention and treatment
May 30 2017
Facilitated by brian minalga, office of HIV/AIDS network Coordination@ fred hutchinson cancer research center
Reflection by Jen Wroblewski
It has been more than 35 years since the human immunodeficiency virus (HIV) was identified. Hard won, grassroots community activism led to formal research efforts to treat and prevent HIV/AIDS. Anti-retroviral therapies have saved millions of lives and the drug Truvada, a Pre-Exposure Prophylaxix (PrEP) medication, has begun to curb the spread of the virus as well. Approximately 100,000 Americans have used Truvada to prevent HIV since its approval in 2012. In late 2016, King County was the first in the nation to achieve the UNAIDS and World Health Organization’s 90-90-90 goal whereby in year 2020,
- · 90% of people living with HIV (PLWH) will be diagnosed
- · 90% of diagnosed PLWH will be engaged in care and
- · 90% of PLWH engaged in care will reach viral suppression (viral suppression means the person is healthy and cannot transmit HIV).
While this accomplishment is incredible, these efforts still have a long way to go, even in King County, among people of color.
Tuesday night during our discussion about access to HIV prevention and treatment, I was surprised and upset to learn that there is a significant lag for people of color—namely African American, Native American, Latinx, and Asian folks--when compared to people who are white. Access to these life-saving medications is not as simple as obtaining and filling a prescription from a doctor. Most of the issues revolve around where you live. Prevention, diagnosis and treatment services increase when trained providers offer HIV testing regardless of whether someone appears “at risk.” Access and engagement also increases if a person identifies with, and is connected with, a LGBTQ community that helps support and educate about providers who are knowledgeable, on clinics that are welcoming and about prescription assistance.
During our discussion, people were most interested in the reasons why PrEP is not widely used. Truvada is the only drug currently available for PrEP. It consists of one pill taken once per day. Adherence to this regimen reduces the risk of HIV acquisition by greater than 96%.. Again, this is an incredible medication developed through biomedical research and through volunteers willing to participate in clinical trials. So why aren’t all folks at increased risk of contracting HIV taking Truvada? I learned on Tuesday that the answer to this question is complex. Truvada costs anywhere between $0 and $1500per month depending on a variety of factors. In theory, people who are insured and meet certain “high-risk” criteria determined by the CDC can access Truvada at no cost to them. However, both consumer and provider awareness of Truvada as PrEP can be a barrier to access. Not all people at higher risk know that PrEP is available or if they do, may not feel comfortable asking for a prescription for PrEP. People at higher risk for contracting HIV may be fatalistic about getting HIV because of the kinds of messages they have received, and may have already “thrown in the towel,” assuming they will become HIV positive no matter what. Policy also plays a role; Washington is the first and only state with a PrEP Drug Assistance Program for those whose insurance does not fully cover Truvada.
We also discussed the role of biomedical research to reduce the access gap to HIV prevention and treatment. A piece of the answer is through trustworthy, just actions to repair historical mistrust by people of color and the Research Practice. In all, people at the table want to see people of color benefit from biomedical research, especially if they are the ones recruited for clinical research and asked to bear the burden of risk from participating in trials. For example, some clinical research run at the Fred Hutchinson Cancer Research Center by a Conversation participant known as “W,” ensures that research participants and their communities benefit from research outcomes by designating a portion of grant funding for post-study follow up and engaged care.
Another role biomedical research can take is thinking outside the box to create devices and medications that are well-adopted by people at high risk for HIV transmission. Discussion participants suggested building more relationships with people of color in the LGBTQ community and learning about which interventions would be acceptable, and maybe even “sexy,” as suggested by our facilitator.
HIV prevention and treatment has come a long way…..and can be improved even more. 90-90-90.
Suggested readings and resources
King County First to Reach WHO 90-90-90 Goal
the war on drug prices: innovation vs. affordability
March 28 2017
Facilitated by members from the International Society of Pharmacoeconomics and Outcomes Research
Read the Conversation reflection at our blog!
Suggested readings and resources
VIDEO: "The High Cost of Prescription Drugs in the United States" (2 minutes) http://jamanetwork.com/learning/video-player/13355970
INTERACTIVE TOOL: to try and figure out a “fair” valued-based price for cancer drugs by tweaking various levers http://www.drugabacus.org/drug-abacus/tool/
Great background article in JAMA that defines key terms, approaches for drug pricing in different countries, and potential policy options to contain costs in US.
Washington Post article explaining contradictory reasons cancer drug prices are going up based on Health Affairs study below
Health Affairs article about lack of competitive pressure based on an economic analysis. Lead author Dr. Bennette will join us at the Community Conversation.
Health solution or pandora's box: population-based genetic engineering
january 24 2017
Guided by Austin Wright-Pettibone, UW BSChE Candidate and American Institute of Chemical Engineers Summer Policy Appointee, we discussed the current state of gene drive technology and its application challenges. Gene drives are ‘selfish’ genes that avoid classic rules of inheritance by aggressively spreading themselves throughout a sexually reproducing population. Emerging genetic engineering tools allow researchers to create gene drives in the laboratory with the potential to 1) suppress vector-borne disease like malaria, 2) control agricultural pests and 3) suppress non-native and invasive species.
The scientific community, including the National Academies, are aware of the need for careful progression of gene drive applications due to concerns about safety, containment, regulatory oversight and consent, to name a few. During our Conversation participants were hopeful that gene drive solutions could someday be used to eradicate or greatly reduce the burden of malaria and other vector-borne diseases. The value of human health seemed to be enough enticement for exploring these applications despite significant concerns about chain reaction negative unforeseen consequences. Our discussions focused on the difficulty of containing engineered insects, the unpredictability of genetic mutations through multiple generations and unknown impacts on ecosystems.
Conversation also emphasized the need for scientists and policy makers to strive for transparency, to make efforts to understand public viewpoints and to rebuild trust.
The current state of gene drives requires many more technical refinements to achieve feasibility, so the scientific community and diverse publics will have time to puzzle out ideal paths of implementation that align with public values.
In case you missed this Conversation, join us February 28th in Portland, OR for the same topic led by Dr. Jon Hennebold from Oregon Health & Sciences University.
Suggested Readings
Driving the Future, Governance challenges for biotechnology in the age of gene drive
Gene drives: can genetic engineering and CRISPR overcome evolution? The Atlantic
Concerning RNA-guided gene drives for the alteration of wild populations
April 26, 2016 Mosquitos, Babies and the zika virus
Facilitated by Kristina Adams Waldorf, MD, University of Washington
The Aedes mosquito is thriving in more and more territory, moving northward and carrying with it the worrisome Zika virus. Estimates predict that 2 billion people live in areas at risk for Zika (Bogoch et al, 2016).
Recent Community Conversations in Portland, OR and Seattle, WA focused on updated knowledge about Zika: who can become infected; what are the symptoms in adults, fetuses and babies; prevention approaches; new diagnostics; vaccine challenges. We also discussed in depth the research challenges in this climate of rapidly emerging information.
Zika is frightening. Not only does it impact growing babies, but it is also implicated in neurological symptoms in adults. Zika infection can result in fetal microcephaly but also causes serious deficits in brain matter. The degree of impact is likely on a continuum from obvious signs detectable by ultrasound to other cognitive and behavioral impacts not fully known until a child is born and begins to miss developmental milestones. We don’t really know the percentage of those exposed who are affected.
A few things really sparked our attendees. One, science communication needs to balance speedy publications with quality research. Because the public may not be aware that science typically moves more slowly, Zika developments require special communication that is clear and translated well. (Stay tuned for more information about our Science Slam Communication Workshop in September).
Two, even though Zika is scary it is competing with many other infectious diseases that are already proven, beyond a shadow of a doubt, to cause morbidity and mortality. Funding, public health resources and scientific expertise are all scarce resources that must be doled out justly. We didn’t figure out the formula.
Three, since there is no current vaccine or therapeutic for Zika, the best thing to do is to prevent infection. Participants called on personal responsibility regarding risk-taking behavior that includes rethinking travel to Zika-laden areas. Some advocated for a boycott of the summer Olympics.
Suggested readings and resources
Zika basics from the CDC
Zika virus infection in pregnant women in Rio...NEJM March 2016
DEcember 1, 2015, seattle, Should we tinker with our dna?
This popular topic addressed new technology called CRISPR/Cas9 which helps scientists modify DNA more quickly and precisely than ever before. Some uses of this technology are controversial. CRISPR/Cas9 can basically be used three ways: 1) in research to learn the function of genes in humans and other organisms 2) as a therapy to repair or replace faulty genes in people with disease and 3) to permanently repair or modify genes in embryos.
Seattle attendees were largely in favor of using CRISPR to cure disease in adults, that is until the discussion deepened. As we peeled back the layers, we disagreed surprisingly about the line between healing and enhancing physical qualities. Some thought that allowing enhancements was acceptable as long as adding positive attritubutes, like super strength, were given preference to removing negative attributes, such as poor vision. Others were firm that defining 'normal function' was too diffucult since human attributes fall on a continuum of 'normal.' We wondered who would have access to any medical treatments developed through CRISPR.
On the question of making therapeutic gene changes in the germline, that is in embryos or eggs/sperm, most attendees were uncomfortable. This attitude was primarily due to the safety and ethics of testing human embryos and fetuses to achieve high safety confidence. A few people were adamant that tinkering with our germline was just wrong. One of the high school students was a proponent of germline changes when desired by geographically isolated populations with persistent genetic conditions that limited lifespan or quality of life.
Scientifically, we are still a long way off from being able to use CRISPR/Cas9 to address chronic illness or make enhancements to our IQ; these traits are the result of complex genetic and environmental contributions.
To sum up, we discovered that implementing CRISPR is not a yes/no propostion. It is good that ethicicists, scientists and the public are considering the meaning of its implementation before the science is operating full scale. Well done!
Suggested Readings and Resources
Video animation demonstrating CRISPR/Cas9
Prudent path forward for genomic engineering_SCIENCE, Baltimore et al
Don't edit the human germ line_NATURE, Lanphiere et al
Biohackers gear up for genome editing_NATURE, Ledford
Disrupting the HIV T cell receptor CCR5 using CRISPR, Sather et al
Path through CRISPR thicket_Update HinxtonGroup NATURE, Mathews et al
"you are what you eat: antibiotic resistance from chicken to your table"
During the 2015 autumn round of Community Conversations in Portland, OR and Seattle and Spokane, WA, we discussed the concern that ongoing antibiotic use in large-scale commercial chicken farms is producing antibiotic resistant (ABR) bacteria that contribute to more difficult-to-treat human diseases. In a 2014 report on antibiotic (ABX) resistance, the World Health Organization warns of humanity heading for a "post-antibiotic" era in which antibiotics can’t keep up with ABR and the diseases they cause.
Who are the stakeholders in this situation? Large- and small-scale farmers, consumers, researchers looking for new drugs that kill bacteria and medical professionals who want healthy patients. With all these stakeholders, how are we to address this potential public health crisis?
The One Health Initiative holds that human, animal and environmental health are all connected. ABX use practices in food animal agriculture are of particular interest, but not everyone agrees that there is sufficient evidence that the use of ABX in chickens (or other food animals) directly results in ABR infections in people.
Despite expected regional differences, participants in the Conversations were united in several areas. One, we simply need more data. The Food and Drug Administration only recently (2009) began collecting sales data for antimicrobials in food-producing animals. No one is sure what is actually being used. Legislation attempts to limit ABX use and require record-keeping both federally and in some states, including Oregon, have not garnered enough support. Two, consumer education needs are high. We are inundated with messaging and food labeling that is sometimes great marketing (rBST-free!—but there isn't a significant difference in the milk from cows treated or not with rBST) but low on information (how are egg-laying hens treated if they are cage free?). Many of us still believe that if we have a cold for more than 3 days we are good candidates for antibiotics. Three, the conversation tends to use rhetoric that is sensationalized and prevents authentic discussion. For example, “factory farms are overusing antibiotics and are mostly responsible for this crisis.” Toxic rhetoric.
Participants rallied around some practical action items. People committed to investigating the meaning of food labels. People committed to better hand washing and to touching their faces less often (did you know 30% of people carry MRSA in their nose?). Many also committed to sharing their new knowledge both professionally and personally.
All in all, this round of Community Conversations was high in energy and commitment to better living through smarter consumption of food, data and antibiotics. Many thanks to our facilitators Kathy Hessler, JD, LL.M and Emma Newton, MS (Portland); Heather Fowler, VMD, MPH and Paul Pottinger, MD (Seattle); and Doug Call, PhD (Spokane). Thank you to our Spokane Series Sponsor, Whitworth University.
Suggested Readings and Resources
Heather Fowler and Seattle's Backyard Chickens: Fair or Fowl
White House plan to fight antibiotic-resistant germs
Wal-Mart's push on animal welfare and antibiotic use
Antibiotic debate overview, PBS
Frontline investigates antibiotic resistance, video
Frontline investigates spread of pathogens in meat, video
The coming crisis in antibiotics TEDMED
June 9, seattle. "doctor's office research: what's it to you?"
Facilitated by Benjamin wilfond, MD, Seattle Children's Research institute
Many who attended “Doctor’s Office Research,” the June Seattle Community Conversation, were unaware that research could be conducted through your doctor at clinic visits. I certainly was.
Dr. Ben Wilfond, from Seattle Children’s Treuman Katz Center for Pediatric Bioethics, shared with attendees his Research on Medical Practices (ROMP). Our table Conversations were based on a survey his team administered to learn more about what the public perceives about risk, notification and informed consent in ROMP. For example, if a patient went to three different doctors to treat her high blood pressure, she might come away with three different medications. Why? Because all three medicines are safe and effective but research doesn’t exist to differentiate between them. Ben’s research aims to set in place a method for conducting ROMP so that physicians will have better information on which medicines are BEST for their patients.
Similar to the online survey conducted by Ben’s team, Conversation attendees thought there was more risk in ROMP conducted through randomized studies rather than through medical record review. In randomization, patients would be randomly selected to receive a particular medicine whereas with medical record reviews, their patient charts would be observed after their physician decided which medicine was best for them. Attendees would want to give written informed consent to provide accountability and clarity on their rights as research volunteers; whereas verbal consent or even just general information would be sufficient for medical record review.
Attendees were empowered to be better advocates for their health care as a result of the Conversation. Through information gained by the discussion, we realized that sometimes medications are prescribed not because they are the best for the patient, but sometimes because of what is approved in the prescription formulary. One participant remarked, “Now when I get a new medicine, I will ask ‘is this treatment best for me, or are you prescribing this because it is approved and in your formulary?’”
Description of research in your doctor's office
Influence of doctors' demographic on their medical practice
Making evidence-based medicine doable in everyday practice
Attitudes Toward Risk and Informed Consent for Research on Medical Practices (Ben Wilfond)
US Research Regulations: Do They Reflect the Views of the People They Claim to Protect?
april 28, portland, or. “Are Vaccinations ‘Everybody’s Business’?”
Facilitated by Judy Guzman-, DO, Oregon Health and Sciences University
Judy Guzman, DO, from OHSU, shared personal and professional stories about vaccine-preventable disease. We also watched and responded to ‘Everybody’s Business,’ a documentary filmed on Vashon Island, WA, unpacking the impact of the vaccine debate on the small community. Attendees homed in on whether we have a duty to publicly communicate our vaccination status. Consensus was that vaccination is a security issue in our communities and while we should follow the “see something--say something” approach, we need to keep in mind there is no legal obligation to do so. In Portland, a geographic hotbed of vaccine controversy, it was somewhat surprising that this Conversation drew attendees who were mainly in favor of vaccines in all circumstances.
So what is to be our response when we find ourselves looking inward at those who share our perspectives on contentious issues? As one attendee reflected after the Conversation, “we shouldn’t be disappointed. We should take the opportunity to enrich our positions, to add nuance and understanding.” I will add that we ought to collect our thoughts, face outward, and strive to engage with others and make them part of our community—and in fact become part of their community too. This kind of intentional engagement is a risk, but one that we must take if biomedical research and public health is to advance. NWABR will stand with you.
April 15, Spokane. "What would you do? personal and community ethics during a disease outbreak"
Facilitated by Niranjan Bhat, MD, MHS, PATH.
Meet Dr. Aaron Putzke, Associate Professor at Whitworth University in Spokane, who recently moved to Spokane with his family. Over spring break I visited Aaron in his lab, with two of my young kids, who now regularly mention the zebrafish we observed together as one of the highlights of our time in Spokane. This connection began because Aaron attended the NWABR IRB conference this past summer; during the networking lunch we met and he developed an interest in the Community Conversation Series, offering to advocate for this series in Spokane.
Because of Aaron, the generous sponsorship of Whitworth (thank you!!) and some of Aaron’s seriously devoted undergraduates, Spokane welcomed a pilot Community Conversation in April. With the help of facilitator Dr. Niranjan Bhat, Senior Clinical Research Officer at Program for Appropriate Technology in Health (PATH), NWABR presented, “What would you do? Personal and community ethics during a disease outbreak.”
Participants struggled with the dilemmas of whether or not vaccines should be mandatory and whether or not it is just to test new medicines in impoverished populations, who might may be taken advantage. One small group arrived at the conclusion that part of the problem in the US is that people place their autonomy before the needs of the community. In this group, an attendee remarked that as a young girl in India, infectious disease was part of everyday life. She recalled one day when a great deal of excitement erupted on the street and her mother urged, “Quickly! Run down to the school because the government is giving medicines. Line up with everyone and get your shots.” In her personal context, vaccination was a celebration and a positive opportunity.
March 3, Seattle. "What would you do? personal and community ethics during a disease outbreak"
Facilitated by Niranjan Bhat, MD, MHS, PATH.
Our group enjoyed a discussion about the science, duties and implications of a potential disease outbreak in our local community.
Suggested Readings and Resources
A Matrix for Ethical Decision Making in a Pandemic, Dr. (Rev) John Tuohey
Washington Emergency Preparedness, Communicable Diseases website
Ethics and Values in a Public Health Emergency, Centers for Disease Control
“Are Vaccinations ‘Everybody’s Business’?”
december 9, 2014
Whether or not to vaccinate your children is a very personal decision. At NWABR’s recent Community Conversation, we explored the idea that it is a public decision as well. Dr. Doug Opel, a clinician and researcher at Seattle Children’s Research Institute, facilitated our Conversation and posed the following questions: “How do we balance personal choice with public safety? Are current vaccination mandates too intrusive or too lax?”
Attendees watched and responded to a documentary filmed on Vashon Island, “Everybody’s Business,” by Laura Green, which of course asks the question, are vaccines everybody’s business? Our participants spoke with one another in small groups and then we had a larger Q&A with Dr. Opel.
What most impressed me is that our discussions reflected diverse opinions and evaluations demonstrate that our attendees valued the genuine conversation and opportunity to share information. The following paraphrased Conversations illustrate our dialogue:
1. Concern: more vaccines mean more opportunities for complications.
Response: there is no data supporting a correlation between an increase in the number of vaccines and an increase in complications; modern vaccines have fewer antigens than vaccines of the past. That being said, while vaccines are extremely safe and effective, approaching 100%, they are not perfect.
Conclusion: The benefits of vaccines outweigh the risks for nearly 100% of people.
2. Concern: some attendees do not trust pharmaceutical companies that make vaccines and other medications.
Response: doctors don’t receive money from companies for the patients they vaccinate, but as a society we’ve allowed companies to influence our thinking through direct to consumer marketing. It’s sticky.
Rebuttal: What about the expansion of vaccine services by drug stores? They wouldn’t be offering this service if they weren’t making money.
Conclusion: Lack of trust in pharmaceutical companies is affecting public attitudes about the value of vaccines.
3. Concern: a few attendees were worried that vaccines cause allergies.
Response: there is no data that suggests vaccines cause allergies. Some people are allergic to ingredients in vaccines, like eggs. This impacts less than 1% of the population.
Conclusion: People who are allergic to vaccine ingredients should not be vaccinated with those particular vaccines; vaccines do not cause allergies.
By the end of the Conversation, we were all fairly animated and still expressing strong opinions. We left the room with a greater understanding about ongoing concerns over childhood vaccinations and a stronger empathy for those with opinions and experiences different from our own. Strong work!
Suggested readings and resources
Watch documentary trailer
Vashon Island's Beachcomber article on documentary
Top 7 Verbalized Reasons to Not Vaccinate
Personal stories about adverse reactions following vaccination
Finding Reliable Information on Vaccines, 2011
Responding to Parents Top 10 Concerns about Vaccinations
Required childhood vaccines in Washington State
for the greater good, please share your brain with us
September 23, 2014
What are the special considerations in traumatic brain injury emergency research?
Facilitated by Eileen Bulger, MD, Chief of Trauma, Harborview Medical Center
You just got hit by a car on your bike. You’re unconscious and your brain is bleeding. Medics arrive to help you, see that you have a traumatic brain injury, and agree that you have the right injury to participate in a University of Washington study to improve survival and function after a traumatic brain injury. The medics see that no one else you know is on the scene who can express your wishes and that you aren’t wearing a wrist band telling them you don’t want to be in the study. They enroll you in the study. Based on the study procedure you may get the standard treatment or the study treatment—only the code on the medicine knows which one, and the medics record the code. After you are admitted to Harborview Medical Center, research staff will tell you and your family about the study and request consent for continued participation. Are you comfortable with this research in Seattle? Would you want to opt out in the event you experience a traumatic brain injury?
Please read our Event Blog dated 9/23/14
Suggested Readings and Resources
Study website: http://www.uwmedicine.org/harborview/services/trauma/txa
Clinical trials.gov: https://clinicaltrials.gov/ct2/show/NCT01990768?term=tranexamic+acid&rank=50
KUOW/NPR interview about exception from informed consent studies with bioethicist Arthur Caplan http://kuow.org/post/ethical-question-medical-research-without-consent
Studies using tranexamic acid http://www.biomedcentral.com/1471-227X/13/20 and
http://www.bmj.com/content/343/bmj.d3795
UW NewsBeat article: http://hsnewsbeat.uw.edu/story/qa-discusses-trauma-study-exemption-consent-laws and related YouTube video: http://youtu.be/-_gtZmmT2dg
*21CFR50.24 is the US Food and Drug Administration’s Code of Federal Regulations, Title 21, Part 50-protection of human subjects, Section 50.24-Exception from informed consent requirements for emergency research http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.24
A life well lived, even facing death June 3, 2014*
What do science, medicine, and our culture tell us about the end of life?
Facilitated by Hope Wechkin, MD, Medical Director, Evergreen Hospice and Palliative Care
*reprise presentation at Skyline at First Hill (Retirement community) August 12, 2014
We explored research and shared personal reflections about how we approach the end of life. Discuss the roles and challenges of medicine, culture and ethics that influence our decisions when dealing with this difficult time. Breakout groups touched on medical Intervention; research participation; tools and resources; informed consent and decision making; denying death; fighting the good fight
Suggested Readings and Resources
tuesdays with Morrie, by Mitch Albom
The Mother of Beauty by John Daniels
Making end-of-life decisions is hard on family members, by Michelle Andrews
End of life Care, The Hastings Center by Alan Meisel
Views on End of Life Medical Treatments
Research Participation by Older Adults at the End-of-Life: Barriers and Solutions
National Hospice and Palliative Care Organization (www.NHPCO.org)
Washington State Hospice and Palliative Care Organization (www.WSHPCO.org)
The Conversation Project- an online resource for starting a conversation about end of life issues
Aging with Dignity –an online resource outlining 5 wishes as you age
Death Café -an accessible, grassroots series for all people to talk about death
Vital Talk-a movement bringing together clinicians and others to have the vital conversation about death
What Can Your Genes Tell You? March 18, 2014
Facilitated by Sarah Nelson and Lorelei Walker, MPH and PhD candidates in public health genetics, UW.
Read March 19th NWABR blog on this event
We hosted an engaging and intimate discussion about the implications of the FDA’s recent actions against direct-to-consumer genetic (DTC) testing company 23andMe, calling for an end to marketing and reporting of health-related personal genetic data. 23andMe’s Personal Genetic Service is sold directly to consumers and, up until recently, included reports on what their DNA revealed about 240+ health conditions and traits, drug response, and carrier status.
After reviewing a fact sheet and hearing from our fabulous facilitators, attendees dove into a rich discussion. What is the role of the FDA? What is genetic risk? What evidence of accuracy and usefulness should be required of DTC genetic tests? How can we weigh the principle of autonomy and the right to self-manage our health care with the need for regulations to protect public safety? Is the Personal Genetic Service product a device or information?
Suggested Readings
Should the FDA stop you from scaring yourself with 23andMe's DNA test?
How FDA and 23andMe Dance Around Evidence That Is Not There?
Our Affordable Health Care: What's Medical Research got to do with it? December 3, 2013
Facilitated by Margo Bergman, PhD,MPH and Cyan James, PhD, PhD candidate
Participants dialogued about the Patient Centered Outcomes Research Institute (PCORI) developed under the Patient Protection and Affordable Care Act. Without research, we do not know how to make health care affordable! PCORI specifically funds communications, technology and comparative research that will help people make informed healthcare decisions and improves healthcare delivery and outcomes.
We discussed
- Is the $2 fee per insured individual for PCORI a helpful way to fund research?
- What directions does it likely push research toward? PCORI will reward organizations and providers that promote good health outcomes.
- Do you think the limits on comparative effectiveness research protect the patient enough? (‘‘(c)(1) The Secretary shall not use evidence or findings from comparative clinical effectiveness research conducted … in determining coverage, reimbursement, or incentive programs … in a manner that treats extending the life of an elderly, disabled, or terminally ill individual as of lower value than extending the life of an individual who is younger, nondisabled, or not terminally ill.")
- What effects do you see the Physician Payment Sunshine Act having on research? Some thought very little change would evolve in research, but that on the whole consumers will have another tool with which to test their doctors' influential companies.
- What comparative effectiveness research healthcare topics would you want studied and why? Attendees suggested the following topics: impact of patient compliance in self-care, what kinds of preventative care promote better health (and what doesn't), how do patients fare when receiving therapy at home vs. inpatient care, do patients have fewer ER re-admits when health providers visit their home, how do peer-funded efforts--like crisis hotlines-- impact patients, and how can we reduce US Caesarean section rates?
Resources from this event include
Read more about the impacts and operations of PPACA in blog of Margo Bergman, PhD, MPH at http://stayathomeeconomist.net
NPR featured a story on an Ohio hospital that saw cost savings without sacrificing quality when surgeons received data about the cost breakdown of their procedures compared to their peers. http://www.npr.org/blogs/money/2013/11/27/247531043/hospital-puts-docs-on-the-spot-to-lower-costs
The Dartmouth Atlas of Health Care provides interactive features to illustrate the efficiency and effectiveness of healthcare across the nation. http://www.dartmouthatlas.org/
Microryza.com utilizes crowd funding for scientific research.
3 Parents and a Baby, September 24, 2013
Should we shape the DNA of future generations? New technology uses genetic material from three people to create an embryo through modified IVF in order to prevent the inheritance of some genetic disease. The first country to adopt the technology, the UK recently announced it will draft regulations for the procedure to be approved by Parliament before it can be used clinically.
Interested in reading more? Background info can be found HERE and HERE.
Read the findings from UK's Human Fertilisation and Embryology Authority 2012 public consultation on the procedure of mitochondrial replacement.
Those who participated in this Conversation raised thoughtful questions both to better understand the science and to unpack the ethical issues raised by this technology. It was interesting that while people acknowledged the heartache of mitochondrial disease, group discussion was less focused on the benefits of this technique than on the risks. While I expected some debate over the initial question of this Conversation: "Should we shape the DNA of future generations?," there was very little. The group was more focused on the implementation of the technology rather than the question of germ-line engineering.
The primary concern was that there are too many unknowns with regard to individual and population safety to move forward with this application at this time.
- Would people be able to shop for specific mitochondrial variants, and would this upset genetic diversity?
- Do scientists know if the mitochondrial and nuclear DNA interact with one another? Could this technique create an incompatibility between donor mtDNA and nuclear DNA?
-"On the flip side, while research is valuable and interesting, it could be neverending and never enough to move forward with the procedure."
-(Pandora's Box) "Once technology is invented, it is there forever."
Another concern was regulation and decision making around the technique.
-Would super athletes (because mitochondria generate cellular energy, and thus presumably impact muscle energy efficiency and capacity) try to profit from their egg donations?
-Can this really be regulated? The black market would certainly accept eggs!
-What are the criteria for deciding if this technique is OK?
-"Who gets to decide? The mom, government, community? With birth control, the power is with the woman, but the government cannot stay out of regulating it still!"
A few participants raised concern that the power to eliminate certain disease in the germ line makes a statement about how we value diversity and disability. "This sounds like what Hitler did around World War II.....Let's say it starts with mitochondrial disease and shifts to address vision, IQ...there is a fine line between differences and disease."
FInally, attendees were mixed about the justice of accessing this new technique, that people with lower resources would be less able to benefit from the technique, unfairly giving benefits to those with more resources. Arguments were made that at introduction, technology is always expensive, but costs drop. Others were dubious.
We will follow this technology with interest as it unfolds in the UK.
Food Fight, May 21, 2013
Who plays a role in the obesity epidemic? The food industry? Individuals? Government? Pharmaceutical companies? Farmers? Insurers and employers? Doctors and scientists? Background information for this Conversation.
Those who participated shared resources and helpful ideas. All agreed that obesity is caused by many factors and therefore must be addressed through many channels. Community members were especially interested in how to achieve behavior change that is consistent with knowledge about healthy weight and healthy relationships with food. Others noted that the way our institutions are structured (computer stations, hours of sitting during meetings/classes) challenges us to find natural ways to move our bodies.
Our family lives are overscheduled. We don't have enough time to play with our kids, it costs time and money to provide fast and healthy meals, we are sleep deprived. We talked about the challenges of providing ample opportunity for children to engage in physical play: A mom told a story about a school's rock climbing wall that was completely blocked by storage boxes until she volunteered to staff the climbing wall. We were inspired to hear such a great example of how giving one's time can benefit a whole school full of children.
Some winning resources were websites that pay people to meet their weight loss or lifestyle goals (healthywage.com); learning from and following the Puget Sound Regional Food Council; becoming involved in the Quantified Self movement which has healthy lifestyle apps and meetup groups all over the country, including Seattle.
