Saturday, October 24, 2020

Recommendations From the Advisory Committee on Immunization Practices for COVID-19 Vaccination Implementation

WHO Coronavirus Disease (COVID-19) Dashboard

COVID 19 When will it be Ready?

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 .

Scientific and Ethical Principles Underlying Recommendations From the Advisory Committee on Immunization Practices for COVID-19 Vaccination Implementation | Infectious Diseases | JAMA | JAMA Network

Wednesday, October 21, 2020

Pocket - A “robot” doctor told a patient he was dying. It might not be the last time.

                                        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.

Pocket - A “robot” doctor told a patient he was dying. It might not be the last time.

Californians Asked to Pony Up for Stem Cell Research — Again


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

Since 2009 N.I.H. has spent considerable funds for stem cell research, all funded by taxpayers.

                                    FY 2016.      2017      2018       2019         2020est     2021.      

Stem Cell Research $1,516 $1,646 $1,824 $2,014 $2,129 $1,934 - -

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

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.

In 2004, voters approved a $3 billion, 30-year bond via Proposition 71 to get the state agency up and running and to seed research. That measure will end up costing taxpayers about $6 billion, including interest. The original bond issue Prop 71 is here.

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.

Case in point: Fedratinib, one of the two FDA-approved drugs funded partly by CIRM, can cost about $20,000 for 120 capsules, according to GoodRx.

“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.


 Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.


This story can be republished for free (details).

Subscribe to KHN's free Morning Briefing.

Monday, October 19, 2020

Lawmakers Push to Make Telehealth Options Permanent - Nextgov

Early data shows patients quickly embraced telemedicine options agencies expanded during the coronavirus pandemic. 

As federal agencies have made a quick pivot to virtual options in order to provide health care and medical attention online during the COVID-19 crisis, more lawmakers are calling to maintain expanded access to telemedicine—even in a post-pandemic world. 

Sen. Brian Schatz, D-Hawaii, said in a statement that telemedicine options that have made care possible during the pandemic should be permanent changes to the health care system after the Centers for Medicare and Medicaid Services released new data Wednesday on the use of virtual medical services.

“Telehealth is popular and bipartisan because it reduces the cost of health care and improves quality and availability,”  Schatz said in a statement Thursday. “The skyrocketing use of telehealth during the pandemic shows that we cannot and should not go back to the Stone Ages of telehealth coverage.”

Several provisions in the CARES Act helped strengthen telemedicine access by relaxing rules and providing funding. It’s these provisions Schatz wants entrenched in standard operating procedures post-pandemic.

The data from CMS shows a dramatic increase in the use of telemedicine services. Before the pandemic, according to the report, around 13,000 Medicare beneficiaries received telemedicine in a week. During the last week in April, that number was closer to 1.7 million.

Nearly 5.8 million CMS beneficiaries have had a typical office visit online since the coronavirus pandemic began. Telehealth has been particularly popular for mental health appointments, according to the report, with 60% of psychiatrist and psychologist visits taking place virtually.

The CMS data tracks with what other agencies have recorded as well. The Veterans Affairs Department reported encouraging telehealth numbers back in April. The department touted a 70% increase in mental health appointments taking place using VA Video Connect, which facilitates remote face-to-face interactions.

In testimony to the House Budget Committee Wednesday, Dr. Robert Wah, former associate chief information officer for the Military Health System, listed telemedicine as a top area in which the federal government should invest.

“COVID-19 has highlighted the value of virtual, remote health care as effective, efficient, and well accepted,” Wah said.

On July 2, a bipartisan group of 38 senators sent a letter to Health and Human Services Secretary Alex Azar and CMS Administrator Seema Verma requesting a written plan, including a timeline, outlining permanent changes to Medicare telehealth rules. The letter called rule changes that allowed for the increased use of telehealth options a “lifeline” for patients and care providers.

“As you stated, it is hard to imagine rolling back these changes,” the letter reads. “However, we are hearing from patients and providers who are concerned about when Medicare’s temporary changes to telehealth rules will be rolled back and whether they will receive any advance notice.”

Though Schatz’s name was not on the July 2 letter, the senator has been a telemedicine advocate since before the pandemic. Along with Sens. Roger Wicker, R-Miss, Ben Cardin, D-Md., John Thune, R-S.D., Mark Warner, D-Va. and Cindy Hyde-Smith, R-Miss, Schatz introduced a bill in October 2019 that would expand Medicare’s telehealth services.

Saturday, October 17, 2020

More Than 1,000 Current and Former CDC Officers Criticize U.S. Covid-19 Response - WSJ

More than 1,000 current and former officers of an elite disease-fighting program at the U.S. Centers for Disease Control and Prevention have signed an open letter expressing dismay at the nation’s public health response to the Covid-19 pandemic and calling for the federal agency to play a more central role.

 COVID-19 Update: Most US States Reporting an Upward Trend in Infections; Herd Immunity is Not the Answer, Experts Say; and More
On Thursday, October 15, 2020, here are the latest COVID-19 numbers, according to Worldometer:
World Cases: 38.9 million.
World Deaths: 1,099,629.
Countries Outside of the US with Most Infections:
India: 7,349,290 confirmed cases; 111,726 deaths.
Brazil: 5,148,345 confirmed cases; 151,971 deaths.
Russia: 1,354,163 confirmed cases; 23,491 deaths.
Spain: 937,311 confirmed cases; 33,413 deaths.
Argentina: 931,967 confirmed cases; 24,921 deaths.
The US States with Most Confirmed Cases:
California: 865,559 confirmed cases; 16,760 deaths.
Texas: 851,400 confirmed cases; 17,308 deaths.
Florida: 744,988 confirmed cases; 15,737 deaths.
New York: 513,460 confirmed cases; 33,426 deaths.
Georgia: 334,601 confirmed cases; 7,470 deaths.
21 States Hit Their Peak 7-Day Average of New Cases
Over 20 US states are reporting an upward trend in COVID-19 cases, with 59,494 new cases reported yesterday alone, according to Johns Hopkins University. As of Thursday, the US is now averaging well over 52,000 cases a day, which is up 16% from the previous week. “This is a very ominous sign. I think we’re in for a pretty bad fall and winter,” said Dr. Peter Hotez, professor and dean of tropical medicine at the Baylor College of Medicine.

COVID-19 Dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (JHU) (loads slowly) This is a  global image representing the number of COVD19 cases worldwide.

More Than 1,000 Current and Former CDC Officers Criticize U.S. Covid-19 Response - WSJ