HEALTH TRAIN EXPRESS
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Coronavirus cases are rising in almost every U.S. state. But the surge is worst now in places where leaders neglected to keep up forceful virus containment efforts or failed to implement basic measures like mask mandates in the first place, according to a New York Times analysis of data from the University of Oxford.
Using an index that tracks policy responses to the pandemic, these charts show the number of new virus cases and hospitalizations in each state relative to the state’s recent containment measures.
States That Imposed Few Restrictions Now Have the Worst Outbreaks
Outbreaks are comparatively smaller in states where efforts to contain the virus were stronger over the summer and fall — potential good news for leaders taking action now. States and cities are reinstating restrictions and implementing new ones: In recent days, the governors of Iowa, North Dakota and Utah imposed mask mandates for the first time since the outbreak began.
The index comes from Oxford’s Blavatnik School of Government, where researchers track the policies — or lack thereof — governments use to contain the virus and protect residents, such as contact tracing, mask mandates and restrictions on businesses and gatherings. Researchers aggregate those indicators and assign a number from 0 to 100 to each government’s total response.
At its highest level of containment efforts, New York state scored an 80 on the index. At the beginning of November, most states were scoring in the 40s and 50s. Though many have taken fresh steps to contain the virus since then, the Times analysis compares cases and hospitalizations for a given date to a state’s index score from two weeks before, since researchers say it is reasonable to expect a lag between a policy's implementation and its outcome.
Most states imposed tight restrictions in the spring even if they did not have bad outbreaks then. After reopening early, some Sun Belt states, including Arizona and Texas, imposed restrictions again after case counts climbed. Now, Midwestern states have among the worst outbreaks. Many have also done the least to contain the virus.
A relationship between policies and the outbreak’s severity has become more clear as the pandemic has progressed.
“States that have kept more control policies in a more consistent way — New England states, for example — have avoided a summer surge and are now having a smaller fall surge, as opposed to states that rolled them back very quickly like Florida or Texas,” Mr. Hale said. “I think timing really matters for the decisions.”
The worst outbreaks in the country now are in places where policymakers did the least to prevent transmission, according to the Oxford index. States with stronger policy responses over the long run are seeing comparatively smaller outbreaks.
While we have contrived to control the pandemic, some things seem certain.
1. A continuing and consistent quarrantine, social distancing and masking are mandatory. Pop-up attempts at lockdown measures implemented locally or regionally may not alter the long term goal of decreasing morbidity and/or mortality, nor improve the economic effect. Playing catch up management cannot be communicated effectively and may be a waste of resources.
3. Federal, state and local public health agencies at times conflict with recommendations. The pandemic has also been politicized and continues so even after the election.
Once Joe Biden becomes President his main goal will to to make a strong stand for consistency in regulations for Covid19 control.
The following is a guest article by Gerry Blass, President and CEO at ComplyAssistant and Donna Grindle, Founder and CEO at Kardon. Even prior to the COVID-19 outbreak
Highlights:
Even prior to the COVID-19 pandemic, the use of telehealth applications and services was on the rise. A January 2020 survey by the American College of Physicians (ACP) showed an increase in usage of telehealth technology for remote care management, patient monitoring, e-consults and video visits. The survey results indicated that video visits saw the largest year-over-year increase in usage, from 3 percent in 2019 to 10 percent in 2020. When asked about barriers to using telehealth technologies, respondents cited their top five:
They were more comfortable examining patients in person and communicating face-to-face.
They had challenges integrating virtual care into an already established workflow.
They did not have the staff to set up and run the technologies.
They were concerned about potential medical errors.
Their patients did not have access to technology to support virtual care.
If we fast-forward from January 2020 to April 2020, we saw that a vast number of physicians went from little or no usage of telehealth, to an astounding increase in the rate of usage. A physician survey from Merritt Hawkins conducted in April 2020 showed that nearly 50 percent of physicians have embraced telehealth, up from only 18 percent in 2018.
The good news is the use of telehealth technologies and services is on the rise. Nearly every type of provider is using telehealth technology. Despite the previous barriers to acceptance, physicians and patients love it. We won’t go back now.
The bad news? The sheer need to act quickly during a crisis, the desire for physician practices to do whatever possible to care for their patients and keep their businesses viable, and the temporary HIPAA waivers by the Office for Civil Rights (OCR) all meant that technologies were often not vetted or implemented properly to comply with HIPAA privacy and security regulations.
If we compare this to Meaningful Use (now known as Promoting Interoperability) and the Affordable Care Act, providers had years to implement usage of electronic health record (EHR) systems. Even with years to plan and implement, data security was not a priority, which is partially why we started to see an uptick in cyberattacks around 2015. With COVID-19, implementation of new telehealth technologies occurred so quickly that proper vetting and security protocols simply fell to the wayside.
In addition, when small practices began to roll out telehealth technologies, they quickly realized that the technologies may not work as well in practice. Performance and quality issues and the inability of providers to use such products as indicated led providers to the path of least resistance—video chat, email and SMS texting—none of which is secure or meet HIPAA regulation standards.
Providers’ top three questions answered
In our daily interactions with providers, we understand very clearly that patient care always comes first. Always. We agree, but also want providers to understand that HIPAA still applies, even during a crisis, and providers still need to maintain security of data and patient privacy.
And, since we are all moving at such a fast pace, there is no single point of real, accurate information. To that end, here are the top three questions from providers regarding the use of telehealth and ensuring data privacy and security.
Has HIPAA gone away?
This is arguably the most common question we receive from providers. The answer is a resounding no! Though the Centers for Medicare & Medicaid Services (CMS) and the Office for Civil Rights (OCR) issued emergency waivers to provide flexibility during the pandemic and to grant payment parity between telehealth and in-person clinical care, the HIPAA Rules still apply.
How does enforcement discretion apply to me?
The Office for Civil Rights (OCR) in March issued a Notification of Enforcement Discretion, which essentially says that covered entities (CEs) will not be subject to penalties for HIPAA breaches related to telehealth during the pandemic, assuming the CE made a good faith effort to protect the data. The OCR will use “enforcement discretion” to determine good faith or negligence. We’ve seen, however, that there are physician practices that intentionally decided to use a non-secure telehealth technology even when they had secure options already available and in use. This leaves them open for OCR to make the determination whether or not they acted in good faith and could be found negligent.
Do patients still have a right to privacy given the circumstances?
Yes, yes and always yes. Patients have not given up their right to privacy because of COVID-19 or any other crisis. Unfortunately, there is a lack of true understanding—even among individuals—of what we can and cannot say. In working with providers, we often hear stories of COVID-19 diagnoses shared with parties who should not be privy to that information. In one example, we learned that a small town’s post office decided not to deliver mail to a particular person due to a rumor that the mail recipient had been diagnosed with COVID-19. Regardless of the time, the diagnosis, crisis or not, patients still have a right to privacy.
You may have access to multiple providers is availability is an issue. telehealth-based specialty programs are helping to balance and redistribute patient flow in a newly-efficient way. Rather than pitting facilities and providers against one another, these efforts allow patients to access available capacity in a manner that wouldn’t have been possible when virtual care efforts were one-off propositions.
In this case, I found a program whose location I could conceivably visit in a pinch. This seemed to offer social workers, discharge planners and the like a feeling of security, particularly given that they might very well have had face-to-face contact with staffers there before.
That being said, getting patients the specialized care and support they need will be more important than referring them to programs with which they have had long-term contact.
If your provider is unavailable there are a multitude of telehealth providers avaialble such as
From ultra-cold storage capabilities to extra security staff, facilities are bracing now for their role in distribution of an eventual vaccine.
Hospitals will play a key role once a vaccine receives an emergency use authorization from the FDA, which could happen as soon as next month. They will move quickly to vaccinate their front-line healthcare workers and then their patients and surrounding communities.
But the task, like so much else related to the novel coronavirus, is unprecedented.
The task is complicated not only by shipping logistics and environmental control, it is also regulated by each state and territory, along with six major metropolitan areas, has its own distribution plan that has to be approved by the Centers for Disease Control and Prevention. Those 64 plans are generally based on what was drawn up for distribution of the H1N1 vaccine more than a decade ago. To add further complication, the FDA has multiple candidates for an EUA that require different storage and administration tactics.
With healthcare workers first in line for a vaccine, the process for hospitals will start as soon as a vaccine is approved, and Trump administration officials said this week they expect doses to be at the jurisdictions within 24 hours of approval.
"Hospitals have borne the brunt of this pandemic," said Julie Swann, health systems expert with North Carolina State University. "Hospital staff, the doctors and nurses, have just been overwhelmed in the ERs and the hospital wards. I'm glad they are among the priority groups for this vaccine and I'm hopeful that the vaccine will decrease the workload they have borne for this entire time."
Much of the work involved for vaccination will be at the final mile, from vial to patient. The distribution process will be along classical distribution channels such as FEDEX, UPS established routes. President Trump has promised the use of DOD assets for distribution of the vaccine. The logistical infrastructure is already in place. Once the FDA grants the EUA shipment will begin within 24 hours dependent soley upon availability.
The processes are already well underway.
Many potential vaccine candidates will wait until a trial period has been completed from six months to one year in length. Side effects become more visible after the public release of any new drug or vaccine.
The new category in the medical record, and/or the electronic health record is the Social Determinants of Health (SDOH) SDOH includes many metrics, which one is the most important. We can list a number of items on the list. Some of these are familial, genetics, level of education, urban vs rural, insured, uninsured, nicotine usage, size of household, political affiliation, type of employment.
The first part of reading Health Train Express is a quiz that follows. Please take the following quiz.
Pick the one SDOH which has the most influence on your health
A wise choice...Sell the Jet Airplane. Baker sold off the nation's private jet to help pay for healthcare services and allocated $300 million to refurbish rural clinics and create and equip a new state-of-the-art outpatient facility. The Cherokee Nation now operates the largest tribally operated healthcare system in the United States; 27% of its working physicians are tribally affiliated, according to a tribal spokesperson.
First-year medical student Ashton Glover Gatewood, a citizen of the Choctaw Nation, receives her white coat from Natasha Bray, DO, associate dean of academic affairs at the OSU College of Osteopathic Medicine at the Cherokee Nation.
Tribal communities have long lacked resources and medical care. They face crushingly high rates of poverty, substance abuse, and suicide, as well as an increased incidence of chronic health conditions such as heart disease, diabetes, and obesity. The coronavirus pandemic has further highlighted the healthcare disparities that affect these medically underserved people.
Medical educators have struggled for decades — with little success — to boost the number of Native American physicians and to train physicians to staff clinics for chronically underserved rural populations such as the Cherokee Nation. Nationwide, fewer than half of 1% of US physicians are Native American. In the first class at the new school, 22% identify as such.
"After we were removed from tribal lands and there were no teachers, we invested our treasury into teachers," said Bill John Baker, former principal chief of the Cherokee Nation. "This is a natural progression. Just as our ancestors grew their own teachers 150 years ago, we want to grow our own doctors."
"A Match Made in Heaven"
Many credit the creation of the school to Baker's vision. During his tenure as principal chief from 2011–2019, Baker made healthcare a priority for a population struggling with high death rates from cardiovascular disease and lung cancer. Baker sold off the nation's private jet to help pay for healthcare services and allocated $300 million to refurbish rural clinics and create and equip a new state-of-the-art outpatient facility. The Cherokee Nation now operates the largest tribally operated healthcare system in the United States; 27% of its working physicians are tribally affiliated, according to a tribal spokesperson.
The investment in healthcare caught the attention of OSU leaders, who approached the chief with the prospect of opening a medical school on tribal lands. "It was a match made in heaven," Baker said. "We've been investing in our young people for quite some time, sending them to medical school at Harvard and Stanford and all over the country, but when we saw an opportunity to have a medical school right here and not have to ship our kids off, that made perfect sense."
As winter approaches we are told it will be a 'dark' season due to the third wave of COVID19 pandemic Some of us may have forgotten the Outbreak of Covid-19 on the Aircraft Carrier, U.S.S Theodore Roosevelt, CVN 71
Unknowingly and without much warning CVN 71 would become a laboratory to study the epidemiology of a novel Coronavirus, COVID 19. The naval vessel, with a shipboard complement of approximately 6000 sailors who were mostly young and between the ages of 18 and 35 had been docked in Southeast Asia and set out to sea at the first indication of the Covid19 outbreak in Asia.. Immediately upon leaving port. the crew was tested for coronavirus and found to be negative. Several days later at sea personnel became ill and were tested again.
BACKGROUND
An outbreak of coronavirus disease 2019 (Covid-19) occurred in the U.S.S. Theodore Roosevelt, a nuclear-powered aircraft carrier with a crew of 4779 personnel.
METHODS
We obtained clinical and demographic data for all crew members, including results of testing by real-time reverse-transcriptase polymerase chain reaction (rRT-PCR). All crew members were followed up for a minimum of 10 weeks, regardless of test results or the absence of symptoms.
RESULTS
The crew was predominantly young (mean age, 27 years) and was in general good health, meeting U.S. Navy standards for sea duty. Over the course of the outbreak, 1271 crew members (26.6% of the crew) tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by rRT-PCR testing, and more than 1000 infections were identified within 5 weeks after the first laboratory-confirmed infection. An additional 60 crew members had suspected Covid-19 (i.e., the illness that met the Council of State and Territorial Epidemiologists clinical criteria for Covid-19 without a positive test result). Among the crew members with the laboratory-confirmed infection, 76.9% (978 of 1271) had no symptoms at the time that they tested positive and 55.0% had symptoms develop at any time during the clinical course. Among the 1331 crew members with suspected or confirmed Covid-19, 23 (1.7%) were hospitalized, 4 (0.3%) received intensive care, and 1 died. Crew members who worked in confined spaces appeared more likely to become infected.
CONCLUSIONS
SARS-CoV-2 spread quickly among the crew of the U.S.S. Theodore Roosevelt. The transmission was facilitated by close-quarters conditions and by asymptomatic and presymptomatic infected crew members. Nearly half of those who tested positive for the virus never had symptoms.
It is interesting in lieu of the present explosion of reported positive Covid 19 tests of over 100,000 cases/day if these statistics are carried forward today, only 50,000 are symptomatic from COVID 19. The reliability of the nasal swab test method has been called into question. Testing procedures have evolved in the past 9 months to included PCR identification, a rapid test, and also purported to be more accurate.
@elonmusk
Currently, Elon Musk stated he had four tests in one day and reported two were positive and two were negative. He did not state if the tests were done at the same facility or whether he was symptomatic.
Authenticity of RT-PCR
Musk's statement calling the tests "bogus" has once again raised concerns about the authenticity of the PCR tests that are key to isolating the COVID-19 positive cases in order to curb the transmission of the disease. However, as per a report by Healthline, experts say the current diagnostic tests for the new coronavirus are highly accurate, but the antibody tests are not as trustworthy. The typical swab tests are 100 percent effective, and while the PCR offers the capacity to detect RNA in minute quantities, whether that RNA represents infectious virus may not be clear, according to scientists. Testing makes the enemy visible, Dr. Emily Volk, an assistant professor of pathology at the University of Texas-Health in San Antonio and president-elect of the College of American Pathologists (CAP) reportedly said. She added that the RT-PCR nasopharyngeal tests should be conducted 8 days after suspected exposure for more accuracy.
For additional drama the incident created a wave of dismissals and resignations in the U.S. Navy. The report of the outbreak was transmitted via insecure channels rather than through the routine chain of command. The ship's commander, CAPT, Brett Crozier, pleaded for help from the Navy, sending an e-mail to ten Pacific Fleet admirals and captains, including his superior, the commander of Carrier Strike Group-9, and the commander of the Pacific Fleet, requesting that his ship be evacuated.[50][51][52] Crozier was relieved of command for not reporting through the chain of command. Amidst this Crozier was then reinstated due to congressional action, and finally relieved of his command but allowed to remain in the Navy. The events rapidly became politicized.
On April 2, 2020, while serving as Acting Secretary of the Navy, Thomas Modly dismissed Captain Crozier from command of the Theodore Roosevelt. Modly said he had lost confidence in Crozier's judgment because he claimed the letter went against the advice of Admiral Michael M. Gilday, Chief of Naval Operations, who argued that usual Navy procedures would require an investigation before such an action.[20].
The politicization of the Covid 19 pandemic has caused real harm through real or imagined threats to health and national security
Without question, this has created confusion and a lack of trust toward federal representatives. Most citizens trust on the recommendations of public health officials.
Covid19 fuels, even more, use of health IT, including telehealth. The use of telehealth (video) expanded over 1000 percent in less than one month when social distancing and lockdowns prevented in-person visits to clinician offices, Fortunately, the infrastructure was already existent. It was a matter of training providers and patients to utilize the untapped resource.
There remain issues that are worrisome.
In the age of social media, blogs, and online forums, the most common practice when feeling slightly under the weather has undeniably become to resort to a quick Google search. Unfortunately, when they are not unnecessarily worrying, the answers found on the web are typically inconclusive.
That observation is what prompted Israeli entrepreneur Yael Elish to launch StuffThatWorks, an AI-based online platform that collects crowdsourced data about a host of chronic conditions. The idea is that, unlike Facebook groups or Reddit threads, the information shared by patients is centralized and assessed for quality to readily provide informed data to other users who are enquiring about their own symptoms.
INFORMATION IS POWER
You know your condition best. How it feels. What aggravates it. Which treatments work. (And which ones don’t.)
Let’s share our experiences in an organized way and discover what can work best for each of us. StuffThatWorks is a crowdsourcing website to gather data for many health conditions. Take the survey to contribute your knowledge of your own condition which will be aggregated using artificial intelligence.
The use of artificial intelligence and crowdsourcing offers a powerful means of collecting health data from patients and aggregating the information for reports using a survey methodology offered by StuffThatWorks
Not only for crowdsourcing, but artificial intelligence also has broad applications in digital health transformation for virtual rounding and others.
This year’s rankings have a tie for first place between the DASHandMediterraneandiets. You could probably come up with the guidelines for both without doing any Googling because they’re basically just “eat the foods you’re always told to eat.” Focus on fruits, veggies, fish, lean meats, and whole grains. Cut back on sugar and starches. DASH stands for Dietary Approaches to Stop Hypertension because it was originally designed to, you guessed it, lower hypertension. The next four diets —flexitarian,Weight Watchers,MIND, andTLC— are all essentially variations on that theme. MIND stands for Mediterranean-DASH Intervention for Neurodegenerative Delay and does exactly what the name implies, while TLC stands for Therapeutic Lifestyle Changes.
The topic of a COVID 19 is on everyone's mind as well as when and if a vaccine will become available. We hear different stories from President Trump, Anthony Fauci, M.D., and other sources. It has been reported China, Russia, and other countries already have the vaccine and are beginning the immunization process.
Historically the United States is often one of the last countries to approve drugs and devices for marketing. This has always been the process. All new drugs, vaccines, and medical devices must pass three clinical trials. This can take several years or more. Scientific advances in viral science such as CRISPR, gene splicing, and vaccine manufacturing have reduced the time to market and reduced the risk of serious complications. Previously viral particles were developed in chicken eggs, denatured (killed) and the resulting antigen injected into humans after trials in animals such as pigs. Primate testing was eliminated due to ethical concerns years ago. Today a COVID 19 particle can be reverse-engineered so that it is not necessary to use an entire viral particle. Only the protein of the viral wall (the spike on the COVID 19 particle needs to be used to produce a vaccine.
This much has already been accomplished by multiple manufacturers and several vaccines are in clinical trials. During the earlier phases of clinical testing, several early vaccines were disqualified due to serious side effects.
Numerous estimates for completion and release of a vaccine range from two months to mid-2021. The approval process has been truncated considerably.
There will be significant time needed for distribution and supply chain logistics will be significant.
Not everyone will want to be inoculated. Even today there are many skeptics about the worth of vaccination. Different vaccines yield different efficacy.
The length of a clinical trial III can determine if side effects will be recognized prio to release. Time will tell after at least six to 12 months elapse. The number of trial patients is relatively limited in this study.
Health Train Express makes no recomendation as to the efficacy, safety or use of any pharmaceutical products discussed in this letter. This is a fluid and dynamic situation for the forseeable future.
Credit and attribution is given to the authors noted in this article. Continue to distance, wear masking and sanitization .
Doctors must use good judgment in using telemedicine tools.
The rapid influx of advanced technology is changing the practice of medicine — at times for the better, but sometimes for the worse. Nowhere is this more apparent than a story where a physician told a fatally ill man in a Fremont, California, hospital that he was dying via video chat on a screen attached to a robot. The news should serve as a wake-up call to the medical establishment on the limits of technology.
The patient, 78-year-old Ernest Quintana, was sitting in his hospital room when a “telepresence robot” — or a mobile robot with a video screen that live-streams a physician in another location — rolled in and informed him that there was nothing that could be done to treat him. Quintana, who had chronic obstructive pulmonary disease, was with his granddaughter and a nurse when he was told his options for managing pain at the end of his life. The granddaughter, shocked at this bombshell dropped from a disembodied robot, filmed part of the encounter, which subsequently went viral online. Mr Quintana died the following day.
Yet a knee-jerk reaction may distract us from looking at the big picture. Just like any medical technology, digital health can be an excellent tool for better, patient-centered care. But it also comes with risks that could erode the practice of medicine, especially for patients who might already have limited access to health care resources and physicians.
The promise of digital technology — when used appropriately — could in fact allow doctors to be more humane. Eric Topol, a cardiologist, and the author argues this persuasively in a just-published book, Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again. For example, doctors are forced to spend much of their time interacting with patients taking notes. But if advanced transcription services could transcribe and document complex discussions between patients and their caregivers, this could not only open up time for doctors to spend being present with their patients, it could give patients a literal voice in their own medical record. Artificial intelligence could and should successfully offload inane repetitive tasks from physicians and could provide them the time to look their patients in the eye, rather than eyeing the computer screen.
The most critical issue is for digital health to allow providers to give face to face time to their patients where robots or artificial intelligence cannot.
Californians Asked Pony Up for Stem Cell Research — Again
Fifteen years ago, political correctness interrupted embryonic stem cell research during the administration of George W. Bush. Thus, was born a movement in California to fund the C.I.R.M. for California. A proposition was proposed and passed to sponsor a bond issue supporting embryonic stem cell research. The success of the funding is a testimonial to investors who bought the bonds. The initial investment of 3 billion dollars increased to 6 billion dollars in the fifteen-year period. Some are saying it was a foolish investment. But, was it? Health Train Express opines it was not, nor will refunding CIRM. One cannot measure success based upon a financial return on investment. That is short-sighted and neglects the ROI for educational institutions, training research scientists, nor continuing public enthusiasm for stem cell development.
California offers the nation a backup solution should the political situation change once again. Federal funding resumed once again with a change of political parties. Science cannot survive with those in government unable to sustain science or popular will. The voters of California thought differently and pledge their financial and political capital for stem cell research. The CIRM was a well thought out planned and executed program, brought to fruition in a relatively short time frame from non - existence to a fully functioning research program. It funded the UC system of stem cell research, developed clinical alpha stem cell clinics throughout California, and funded the construction of multiple labs in California.
In an election year dominated by a chaotic presidential race and splashy statewide ballot initiative campaigns, Californians are being asked to weigh in on the value of stem cell research — again. The current administration has a plan to once again limit embryonic stem cell research.
Fetal brain tissue is used in federally funded studies that will be subject to new regulations and extra review beginning in September. STEVE GSCHMEISSNER/SCIENCE SOURCE
Stem Cell Research - Embryonic - Human$206$252$278$306$321$294--
Stem Cell Research - Embryonic - Non-Human$146$129$130$140$148$135--
Stem Cell Research - Induced Pluripotent Stem Cell$374$421$507$607$640$585--
Stem Cell Research - Induced Pluripotent Stem Cell - Human$335$382$468$563$593$542--
Stem Cell Research - Induced Pluripotent Stem Cell - Non-Human$56$59$68$74$79$72--
Stem Cell Research - Nonembryonic - Human$457$484$518$569$605$543--
Stem Cell Research - Nonembryonic - Non-Human$652$704$758$781$824$749--
Stem Cell Research - Umbilical Cord Blood/ Placenta$42$40$39$38$40$37--
Stem Cell Research - Umbilical Cord Blood/ Placenta - Human$33$35$36$36$39$35--
Stem Cell Research - Umbilical Cord Blood/ Placenta - Non-Human
Rachel Bluth
SACRAMENTO — In an election year dominated by a chaotic presidential race and splashy statewide ballot initiative campaigns, Californians are being asked to weigh in on the value of stem cell research — again.
Proposition 14 would authorize the state to borrow $5.5 billion to keep financing the California Institute for Regenerative Medicine (CIRM), currently the second-largest funder of stem cell research in the world. Factoring in interest payments, the measure would cost the state about $7.8 billion over about 30 years, according to the nonpartisan state Legislative Analyst’s Office.
During that first campaign, voters were told research funded by the measure could lead to cures for cancer, Alzheimer’s and other devastating diseases, and that the state could reap millions in royalties from new treatments.
Yet most of those ambitions remain unfulfilled.
“I think the initial promises were a little optimistic,” said Kevin McCormack, CIRM’s senior director of public communications, about how quickly research would yield cures. “You can’t rush this kind of work.”
So advocates are back after 16 years for more research money, and to increase the size of the state agency.
Stem cells hold great potential for medicine because of their ability to develop into different types of cells in the body, and to repair and renew tissue.
When the first bond measure was adopted in 2004, the George W. Bush administration refused to fund stem cell research at the national level because of opposition to the use of one kind of stem cell: human embryonic stem cells. They derive from fertilized eggs, which has made them controversial among politicians who oppose abortion.
Federal funding resumed in 2009, and thus far this year the National Institutes of Health has spent about $321 million on human embryonic stem cell research.
But advocates for Proposition 14 say the ability to do that research is still tenuous. In September, Republican lawmakers sent a letter to President Donald Trump urging him to cut off those funds once again.
The funding from California’s original bond measure was used to create the new state institute and fund grants to conduct research at California hospitals and universities for diseases such as blood cancer and kidney failure. The money has paid for 90 clinical trials.
A 2019 report from the University of Southern California concluded the center has contributed about $10.7 billion to the California economy, which includes hiring, construction and attracting more research dollars to the state. CIRM funds more than 56,500 jobs, more than half of which are considered high-paying.
Despite the campaign promises, just two treatments developed with some help from CIRM have been approved by the Food and Drug Administration in the past 13 years, one for leukemia and one for scarring of the bone marrow.
But it’s a bit of a stretch for the institute to take credit for these drugs, said Jeff Sheehy, a CIRM board member who does not support the new bond measure. He said the agency funded the researcher whose lab discovered and developed the drugs, but CIRM holds no rights to those drugs and doesn’t receive royalties from them.
The state has received about $518,000 in revenue from licensing other Institute-funded discoveries, such as devices, McCormack said.
McCormack also pointed to some promising stem cell therapies still in clinical trials, such as a treatment that has cured 50 children of severe combined immunodeficiency, a genetic disorder often called “bubble baby” disease, and others that have led to “dramatic” improvements in paralysis and blindness, he said.
The campaigns for both bond measures may be giving people unrealistic expectations and false hope, said Marcy Darnovsky, executive director of the Center for Genetics and Society. “It undermines people’s trust in science,” Darnovsky said. “No one can promise cures, and nobody should.”
Robert Klein, a real estate developer who wrote both ballot measures, disagrees. He was inspired to invest in stem cell research after he lost his youngest son to Type 1 diabetes. He said some of CIRM’s breakthroughs are helping patients right now.
“What are you going to do if this doesn’t pass? Tell those people we’re sorry, but we’re not going to do this?” Klein said. “The thought of other children needlessly dying is unbearable.”
Sheehy, who has served on the agency’s board for 16 years, said he’s proud of the work the institute has done but believes it should be funded through the legislature, not by borrowing more money.
“The promise was that it would pay for itself and it hasn’t,” Sheehy said. “We can’t really afford it, and this is the worst way to pay for it.”
Even if CIRM isn’t turning a profit, some researchers and private companies are benefiting from the public money. Take the company Forty-Seven Inc., named after a human protein and co-founded by Irving Weissman, director of Stanford University’s stem cell research program. The state stem cell agency awarded more than $15 million to Forty-Seven, and $30 million to Weissman at Stanford for research.
That money fueled research that uncovered a promising treatment for several different cancers. Gilead Sciences, the pharmaceutical giant, bought Forty-Seven in 2018 for $4.9 billion. Of that, $21.2 million went back to CIRM to pay back Forty Seven’s research grants, with interest.
“Gilead will make far more than that if it turns out to be lucrative,” said Ameet Sarpatwari, a professor of medicine at Harvard Medical School who studies drug development.
Because this kind of work is both expensive and risky, private companies are reluctant to pay for early research, when scientists have no idea if their work will yield results, let alone profits, Sarpatwari said. So the state pays for this work, and drug companies come in to finance later-stage research once a molecule looks promising — and ultimately reap the profits.
“We’re socializing the risk of drug development and privatizing the gains,” Sarpatwari said.
On paper, the institute has stricter pricing regulations than the NIH, which does not require that drugs developed with public money are accessible to the public. In California, companies have to submit plans for how uninsured patients will get medicine and are required to sell those medications to the state’s public health programs at a specified rate.
But in practice, the regulations have never really been tested.
Proposition 14 would add a new rule. It would take the money California makes from royalties and use it to help patients afford those treatments. It also benefits drug companies: Whatever revenue the state makes from these drugs will go back to the companies in the form of state-financed patient subsidies.
The measure also would establish a new working group (complete with 15 new, full-time staffers) that would help make clinical trials more affordable for patients by paying for lodging and transportation to the trials.
And it would increase the size of CIRM’s governing board from 29 to 35. This contradicts recommendations from the Institute of Medicine, which suggested shrinking the board to avoid conflicts of interest. Klein argues the extra board positions are necessary to represent different regions and areas of expertise.
Certain issues have developed in the fifteen years since CIRM was founded: These include:
Conflicts of Interest
“Far too many board members represent organizations that receive CIRM funding or benefit from that funding. These competing personal and professional interests compromise the perceived independence of the ICOC, introduce potential bias into the board’s decision making, and threaten to undermine confidence in the board. Neither the board chair nor board members should serve on any working group. The board itself should include representatives of the diverse constituencies that have an interest in stem cell research, but no institution or organization should be guaranteed a seat.”
“The problematic perception of conflicts of interest has persisted for as long as CIRM has existed. The IOM committee would be less concerned about individual board members with actual or perceived conflicts of interest if the board membership included more truly independent members. The majority of board members should be independent, with no competing or conflicting personal or professional interest. Broader representation from a wider variety of stakeholders will inject new perspectives into the panel and will help to dispel the perception of conflicts of interest.
“CIRM also should revise its conflict of interest definitions to include non-financial interests, such as the potential for personal conflicts of interest to arise from one’s own affliction with a disease or personal advocacy on behalf of that disease. CIRM policies for managing conflicts of interest should apply to that broader definition. "Ultimately, California voters must weigh the possibility of new treatments against the cost of financing them with debt.
The IOM (Institute of Medicine) also recomended changes in governance, the role of economic impact in California and the protection of intellectual property rights.
