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Ethical or exploitative—should prisoners participate in COVID-19 vaccine trials?

Source: Science Mag
By Eli CahanSep. 14, 2020 , 1:50 PM

Science’s COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.

As 38 clinical trials seek tens of thousands of volunteers to receive doses of experimental vaccines, researchers are discussing how to find and recruit participants effectively and ethically. Some people who are especially vulnerable to COVID-19 have not been well represented in studies—or represented at all. Prisoners, for instance, have borne a heavy burden of COVID-19, with more than 125,000 U.S. prisoners infected, and more than 1000 dead. But prisoners have also been excluded from the trials out of concern that they might be coerced into participating or exploited if they do.

Now, some researchers argue that including prisoners in studies could offer outsize health benefits. Correctional facilities have experienced many COVID-19 outbreaks and are structurally unsuited to social distancing (among other precautions). And so, the researchers argue, like other people at high risk of catching the disease, prisoners should be allowed to participate in clinical trials. 

ScienceInsider spoke with George Annas, a lawyer and bioethicist at Boston University, whose research addresses ethics and human rights in clinical trials, and Lauren Brinkley-Rubinstein, a sociologist and epidemiologist at the University of North Carolina, Chapel Hill, who studies management of infectious disease and substance abuse in incarcerated people. Both have published about health and ethics in holding facilities during the pandemic: In July, Annas wrote in The New England Journal of Medicine about inhumane medical practices in immigrant detention centers and, and in August, Brinkley-Rubinstein and colleagues argued in JAMA that prisoners should be included in vaccine trials.

This interview has been edited for brevity and clarity.

Q: What clinical research has been done historically in correctional facilities? Has it been done well?

George Annas: The history is pretty dark. It’s a history of research done without consent, without oversight, and without consequences. It starts in some respects with the Nazis, since Holocaust research—or pretend research, really—was done in prisoners to get scientific information for the German state. Another famous experience was John Charles Cutler’s 1940s experiments in Guatemalan prisons. In those experiments, prisoners were deliberately infected with gonorrhea, syphilis, and chancroid.

Lauren Brinkley-Rubinstein: There are lots of instances of prisoners being intentionally infected with diseases in order to develop new drugs, including malaria and hepatitis C. Horrible things happened at San Quentin [State Prison], including giving prisoners experimental testicular transplants. I think dark is the right word.

Q: Is any COVID-19 vaccine research taking place in correctional facilities? Has anyone put forward serious proposals to do such research?

L.B.R.: There was some conversation at the federal level at the initiation of large vaccine trials to include people involved in some way with the criminal justice system. My colleagues and I had a couple of phone calls with people involved in running those trials to see if it was something they’d entertain. There was some openness to it. But ultimately, including incarcerated populations felt too cumbersome. Between the ethical risks and the operational obstacles to actually get the sites up and running, it would have required a lot of extra effort.

G.A.: Up until recently, there’s really been no excuse to do research in these settings. But it’s a strange and perhaps intriguing group to study, because they’re almost definitely going to be exposed to the virus. So, it could give you answers you may not get if you trial the general population—who may not ever be exposed. That’s why we’re looking again. I’m not a big fan of prison research, but I am a big fan of science, so I think we should look at all these things again.

L.B.R.: Still, I think part of this conversation should be focused on people on probation or parole—the high-risk population that is criminal justice involved, but not presently incarcerated.

G.A.: Yeah. I’d be much more amenable to efforts to bring people on probation or parole into trials. They would be unshackled, literally, from some of the risks of exploitation we think about for prisoners who receive perks for “good” behavior and punishment for “bad” behavior.

Q: Could this kind of research actually benefit incarcerated people if they participate?

L.B.R.: It definitely could, assuming the vaccine works. Incarcerated people do have different risks, in terms of the barriers they face to getting certain elements of routine health care along with their potential to be exploited. But they also potentially would gain more from vaccination, given these settings are extreme amplifiers of infection.

G.A.: But the risk if an experimental vaccine doesn’t work is that these individuals won’t only be disappointed, but they’ll feel they were lied to or exploited.

L.B.R.: Another big part about why understanding these contexts is important is that we do eventually want vaccines to be made available to these populations. But there are lots of implementation issues that are very particular to jails and prisons. How do we store the vaccines under potentially very specific conditions? How do we monitor patients for side effects after injections? How we manage any needed follow-up, like a booster shot? We need to get expertise to optimize these programs when vaccines are eventually deployed. I don’t think that alone is justification to do a trial, but it is such a big part of vaccines being effective once they are approved. It’s something we’ll have to figure out.

Q: Could there be broader public health advantages for doing COVID-19 vaccine research in correctional facilities? Would experimental use of vaccines in correctional facilities benefit staff, neighboring communities, and more distant ones?

L.B.R.: If the experimental vaccines work, then the public health benefit of focusing vaccine resources—even during trials—on correctional facilities cannot be overemphasized. We’ve already seen that jail churn plays a tremendous role in community transmission.

G.A.: To me, it’s a different experiment. You can’t use community results to justify research on individuals. The risk-benefit analysis needs to come out right for the individual before they can consent to being in the trial.

Q: If such research is undertaken, how will we know whether ethical safeguards did enough to protect participants’ rights?

George Annas (left) and Lauren Brinkley-Rubinstein (right) GEORGE ANNAS AND LAUREN BRINKLEY-RUBINSTEIN

G.A.: There probably is no replacement for asking the participants themselves. Did they feel exploited? Did they feel used? Did they feel fulfilled? Did they feel part of something bigger?

L.B.R.: This is really at the crux of the issue. We’d have to ask, but also to appoint oversight boards that have prisoner representation. And we’d have to adopt other safeguards to ensure we are doing things ethically.

Q: Would giving prisoners the option to participate in a vaccine trial set a precedent for future research? What about continuing to withhold access?

G.A.: I think the question of “if not now, when?” is a very good one. We have a worldwide pandemic with a giant prisoner population that’s very susceptible to the disease and is dying from it. If we’re not going to permit research in that circumstance, we’re never going to permit it.

L.B.R.: Also, if we can figure out how to do this right—given the stakes right now—that could give back some element of power or respect that is otherwise not present in these places.

G.A.: It’s a question of whether we treat prisoners as human beings with agency, who are allowed to participate in something for the public good.

L.B.R.: Our approach to experimentation in prisons has been very binary: a history of serious abuses of power when we have run trials, versus the decision to completely avoid including prisoners in trials. We have to ask ourselves whether there’s a middle path.

G.A.: And considering a middle path, but then deciding it’s too much work—that would be an extreme position, too.

Q: As the prospect of an approved vaccine nears, fierce debate surrounds who should receive it first. According to current Centers for Disease Control and Prevention guidance, prisoners are not considered separate from the general population, putting them last in line. In contrast, a draft proposal released this month by the National Academies of Sciences, Engineering, and Medicine said prisoners should get vaccinated after health care workers, but before the general population. Where do you think incarcerated people belong on the priority list?

L.B.R.: Based on the evidence have about outbreaks, incarcerated people should be at the top tier. There’s a clear connection between what happens in these institutions and what happens in the community. When we have infections that spread in jails or prisons like wildfire, and staff going in and out and in and out, we’re making COVID infection more likely everywhere. If the only thing you cared about was your own health, you would still make the decision to prioritize them.

G.A.: People at the highest risk should receive the treatment first. That includes prisoners. It’s that simple, really. 

doi:10.1126/science.abe7861

As we are in the midst of the only Pandemic in recent history desperately in search of a vaccine, one must question the ethics employed in medical trails and the medical industries murky and dark history with experimentation not to mention fraud and scams. Without a current doubt those who find an effective vaccine will reap financial benefit. Every country on the globe is interested. Are you willing to take a vaccine? A health professional once stated, there is no profit in health. The profit is in disease. As many are trying to decided who should have the vaccine first and reporting in those population most affected by the corona virus, one must ask if these populations should also bare the brunt of clinical trials as well. Are clinical trials on unknowing and those not asked ever ethical and permissible?

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COVID 19 Cases on the Rise: Your States Stats

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Source: Wavy 10 – Norfolk, VA, USA
WASHINGTON (NEXSTAR) — As coronavirus cases in the United States climb towards another peak, new daily cases have reached their highest point yet in 17 states, according to the New York Times.

On Thursday, new confirmed cases climbed over the 65,000 mark — a total the country hasn’t seen since the end of July. Additionally, we’re seeing cases rise in more than 45 states, according to a Times tracking tool.

The U.S. leads the world with 7.9 million coronavirus cases and some 217,000 confirmed deaths. Globally, there have been 39 million reported cases and 1.09 million confirmed deaths.Pfizer coronavirus vaccine won’t be available before Election Day, CEO confirms.

As the nation experiences a 25% increase in confirmed cases, here’s a look at the states that are seeing the highest percentage increases in COVID-19 cases:

States seeing case increases (by percentages):

  • New Mexico – Average of 457 cases per day, an increase of 123 percent from the average two weeks earlier.
  • Vermont – Average of nine cases per day, an increase of 110 percent from the average two weeks earlier.
  • New Hampshire – Average of 78 cases per day, an increase of 101 percent from the average two weeks earlier.
  • Montana – Average of 611 cases per day, an increase of 91 percent from the average two weeks earlier.
  • Connecticut – Average of 326 cases per day, an increase of 80 percent from the average two weeks earlier.
  • Indiana – Average of 1,655 cases per day, an increase of 66 percent from the average two weeks earlier.
  • Wyoming – Average of 183 cases per day, an increase of 65 percent from the average two weeks earlier.
  • Alaska – Average of 193 cases per day, an increase of 64 percent from the average two weeks earlier.
  • Rhode Island – Average of 199 cases per day, an increase of 63 percent from the average two weeks earlier.
  • Arizona – Average of 763 cases per day, an increase of 59 percent from the average two weeks earlier.
  • Colorado – Average of 894 cases per day, an increase of 57 percent from the average two weeks earlier.
  • Michigan – Average of 1,483 cases per day, an increase of 56 percent from the average two weeks earlier.
  • Nebraska – Average of 767 cases per day, an increase of 55 percent from the average two weeks earlier.
  • North Dakota – Average of 610 cases per day, an increase of 54 percent from the average two weeks earlier.
  • Ohio – Average of 1,654 cases per day, an increase of 53 percent from the average two weeks earlier.
  • South Dakota – Average of 653 cases per day, an increase of 50 percent from the average two weeks earlier.
  • Mississippi – Average of 760 cases per day, an increase of 49 percent from the average two weeks earlier.
  • Illinois – Average of 3,069 cases per day, an increase of 48 percent from the average two weeks earlier.
  • Virginia – Average of 1,058 cases per day, an increase of 42 percent from the average two weeks earlier.
  • Pennsylvania – Average of 1,362 cases per day, an increase of 39 percent from the average two weeks earlier.
  • Tennessee – Average of 1,870 cases per day, an increase of 38 percent from the average two weeks earlier.
  • Idaho – Average of 660 cases per day, an increase of 37 percent from the average two weeks earlier.
  • North Carolina – Average of 1,943 cases per day, an increase of 36 percent from the average two weeks earlier.
  • New Jersey – Average of 835 cases per day, an increase of 35 percent from the average two weeks earlier.
  • West Virginia – Average of 251 cases per day, an increase of 33 percent from the average two weeks earlier.
  • Nevada – Average of 587 cases per day, an increase of 30 percent from the average two weeks earlier.
  • New York – Average of 1,329 cases per day, an increase of 29 percent from the average two weeks earlier.
  • Washington – Average of 659 cases per day, an increase of 29 percent from the average two weeks earlier.
  • Minnesota – Average of 1,312 cases per day, an increase of 28 percent from the average two weeks earlier.
  • Kentucky – Average of 980 cases per day, an increase of 27 percent from the average two weeks earlier.
  • Missouri – Average of 1,916 cases per day, an increase of 27 percent from the average two weeks earlier.
  • Wisconsin – Average of 3,124 cases per day, an increase of 25 percent from the average two weeks earlier.
  • Utah – Average of 1,216 cases per day, an increase of 23 percent from the average two weeks earlier.
  • Alabama – Average of 1,027 cases per day, an increase of 21 percent from the average two weeks earlier.
  • Oregon – Average of 345 cases per day, an increase of 21 percent from the average two weeks earlier.
  • Massachusetts – Average of 663 cases per day, an increase of 20 percent from the average two weeks earlier.
  • Kansas – Average of 788 cases per day, an increase of 19 percent from the average two weeks earlier.
  • Florida – Average of 2,711 cases per day, an increase of 18 percent from the average two weeks earlier.
  • Oklahoma – Average of 1,182 cases per day, an increase of 16 percent from the average two weeks earlier.
  • Georgia – Average of 1,409 cases per day, an increase of 14 percent from the average two weeks earlier.
  • Iowa – Average of 1,044 cases per day, an increase of 13 percent from the average two weeks earlier.
  • South Carolina – Average of 907 cases per day, an increase of 13 percent from the average two weeks earlier.
  • Arkansas – Average of 911 cases per day, an increase of 11 percent from the average two weeks earlier.
  • Maryland – Average of 589 cases per day, an increase of 11 percent from the average two weeks earlier.
  • Texas – Average of 4,587 cases per day, an increase of 8 percent from the average two weeks earlier.
  • Louisiana – Average of 543 cases per day, an increase of 7 percent from the average two weeks earlier.
  • Delaware – Average of 125 cases per day, an increase of 5 percent from the average two weeks earlier.
  • California – Average of 3,285 cases per day, an increase of 2 percent from the average two weeks earlier.

States seeing case decreases (by percentages):

  • Hawaii – Average of 89 cases per day, a decrease of 17 percent from the average two weeks earlier.
  • Maine – Average of 28 cases per day, a decrease of 9 percent from the average two weeks earlier.

Just when we think we are coming out of this pandemic and we struggle to get back to normal after the economic crisis that came along with the pandemic, we see many states still struggling with COVID 19 cases Norfolk, VA, USA included. While our cases continue to fluctuate our state is not one of the states that was hit the hardest by COVID 19 cases. We took a cautious and measured approach and it paid dividends. In fact as factors, such as going back to school and mere weather change, now have to be factored in, some of the European countries that were fairing better in the crisis are now seeing new and emerging struggles with COVID 19. COVID 19 has definitely taken its place in history. What solutions have worked well for your state? How are people adjusting to having to spend more times in doors, which has lead to less social distancing, due primarily to weather change and an increase in COVID 19 cases across the globe? What are you winter plans and how do you plan to maintain social distancing measures and keep your immune system strong? Remember, healthy is the New Normal! States such as Hawaii and California may likely fair better than other states like New York and Vermont where citizens will be forced to spend more time indoors in the warmth bracing against the cold winter weather while Hawaii and California can still take advantage of the fresh circulating air outdoors and easier means of social distancing.

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Coronavirus clinical trials are pausing over safety concerns – here’s what that means

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Source: CNBC
PUBLISHED THU, OCT 15 2020 6:00 AM EDT UPDATED THU, OCT 15 20209:02 PM EDT
Berkeley Lovelace Jr.@BERKELEYJR

  • J&J said Monday it paused the late-stage trial of its coronavirus vaccine candidate after a participant reported an “adverse event.”
  • Less than 24 hours later, Eli Lilly said its late-stage trial of its leading monoclonal antibody treatment for the coronavirus had been paused by U.S. health regulators over potential safety concerns.
  • Pauses to clinical trials are not uncommon, and the delays should reassure the public that the systems in place intended to protect volunteers are working, medical experts say.

Coronavirus clinical trials from drug giants Johnson & Johnson and Eli Lilly hit a snag this week after safety monitors halted them over bad reactions from participants.

J&J said Monday it paused the late-stage trial of its coronavirus vaccine candidate after a participant reported an “adverse event.” Less than 24 hours later, Eli Lilly said its late-stage trial of its leading monoclonal antibody treatment for the coronavirus had been paused by U.S. health regulators over potential safety concerns. The pauses are likely to add to concerns about the safeness of potential Covid-19 vaccines or treatments.

But pauses to clinical trials are not uncommon, and the delays should reassure the public that the systems in place intended to protect volunteers are working, medical experts said in phone interviews with CNBC.WATCH NOWVIDEO04:02Jim Cramer: Eli Lilly pausing antibody trial isn’t a big setback

The data and safety monitoring board, an independent group of experts who oversee U.S. clinical trials to ensure the safety of participants, recommends a pause to a clinical trial any time there is an “adverse event,” said Isaac Bogoch, an infectious disease specialist and professor at the University of Toronto. The pause will take as long as needed to gather all information and does not necessarily mean there is a problem with the vaccine or treatment, he said.

“The DSMB will say let’s push pause on this,” said Bogoch, who is also a member of the group and is overseeing other clinical drug trials. “They will say, ‘we need more data and let’s see if this person was in the vaccine group or in a placebo group.’ They’ll say, ‘let’s see what the actual illness is and use all the data at our disposal to determine whether this was a true side effect from the vaccine and if so, decide if it is safe to proceed with this study.’”

Pauses happen all the time, especially in large clinical trials with older adults, according to Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Offit, a past member of the CDC’s Advisory Committee on Immunization Practices, said “adults get sick” and sometimes “they are going to get sick in the same period of time” of getting a vaccine or treatment.

“Johnson & Johnson’s vaccine is designed to prevent Covid-19. It is not designed to prevent everything else that happens in life,” he said. “You’re always going to be sorting out those temporal associations. Strokes, heart attacks, neurological problems. Always. You always err on the side of caution and make sure that this isn’t a problem and then continue again.”

Bogoch echoed those remarks, adding, “no one before Covid-19 cared when there was a pause on a clinical trial for an antibiotic or heart medication.”

“Never have we been in a scenario where you truly have 7 billion people watching intently and following every single bit of progress under a microscope,” he said. “You know, it’s fascinating and it’s good. It creates a more health literate community. There is only good that can come of it.”

He added a pause isn’t the same as a regulatory hold, sometimes referred to as a “clinical hold.”  A clinical hold is imposed by a health authority, like the Food and Drug Administration, he said.

“It’s a little more serious when you get to a regulatory hold,” he said. “That’s actually when the FDA steps in and say we’re concerned about a particular event and we’re going to stop this trial because we don’t think it’s safe to proceed with the data that we have available at this point in time.”

The FDA still has a late-stage clinical trial from AstraZeneca, a front-runner in the Covid-19 vaccine race, on hold in the United States. That means the company is unable to administer second doses of its two-dose vaccine regimen to U.S. participants.

The company announced on Sept. 8 that its trial had been put on hold due to an unexplained illness in a patient in the United Kingdom. The patient is believed to have developed inflammation of the spinal cord, known as transverse myelitis. The trial has since resumed in the U.K. and other countries but is still on hold in the U.S.

It remains unknown what reactions the participants in J&J’s and Eli Lilly’s trials had.

Offit said companies will sometimes claim they are protecting the confidentiality of the patient, but he disagreed with the behavior. “As long as you can’t identify the person, they can give you a fair amount of information about the person, but they don’t,” he said.

Dr. Mathai Mammen, global head of research and development at J&J’s Janssen arm, told investors on a conference call Tuesday that the company still had “very little information” on the reason for the holdup, including if the patient received the vaccine or the placebo. “It’ll be a few days at minimum for the right information to be gathered,” he added.

Dr. Ezekiel Emanuel, a former health advisor in the Obama administration, said it would “raise serious questions” if the participant received the vaccine.

“One adverse event is serious, especially when you’re considering a vaccine that you’re going to roll out to tens, hundreds of millions of people, maybe even billions,” he said Tuesday on CNBC’s “Squawk Box.” “That’s the ultimate concern.”

Eli Lilly and the National Institutes of Health did not disclose what the “safety” concern was either, but Eli Lilly said it was “supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”

“Safety is of the utmost importance to Lilly. We are aware that, out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment,” spokeswoman Molly McCully told CNBC. 

Indeed, the whole world is on edge for the first time in “modern” history with over 1 Million dead global (as reported by Wikipedia) from COVID 19 and even more cases. People are waiting for a solution and the end of the pandemic. How important is a vaccine to you and yours? Is a safe and effective vaccine more important to you than simply a vaccine? Will you take the vaccine once it is here?

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US coronavirus stimulus went to some healthcare providers facing criminal inquiries

Source: CNBC
PUBLISHED SAT, MAY 2 2020 6:07 AM EDT

The exterior of the U.S. Department of Health and Human Services in Washington, DC.

Eager to bolster the healthcare system during the coronavirus pandemic, the U.S. government last month sped $30 billion in stimulus payments to most healthcare providers that billed Medicare last year.

That speed resulted in taxpayers’ money flowing to some companies and people facing civil or criminal fraud investigations, according to defense lawyers and others representing more than a dozen firms and people facing such inquiries.

The disclosures about such payments have prompted outrage among some congressional Democrats, who say they highlight the problems with how stimulus funds have been distributed.

“I have an enormous amount of frustration with the way the Trump administration is distributing these dollars, and examples like these magnify the consequences of the White House’s efforts to limit transparency and stonewall oversight,” Senator Ron Wyden, ranking member of the Senate Finance Committee, told Reuters.

Henry Connelly, a spokesman for House of Representatives Speaker Nancy Pelosi, added: “It is alarming to see the Trump administration giving precious taxpayer dollars to unscrupulous entities while so many hospitals and health care workers on the frontlines of the battle against coronavirus are desperate for resources.”

The Department of Health and Human Services, which sent the payments, told Reuters it transmitted funds to all medical providers who submitted billings in 2019 to Medicare, the federal health insurance program for elderly and disabled Americans, unless they had already been excluded from participating.

It declined to respond to the criticism from Wyden and Pelosi’s office and did not respond to specific questions from Reuters about the payments.

Katherine Harris, a spokeswoman for the HHS Office of the Inspector General, said her office oversees the program but declined to comment on the specific distribution of funding.

“While we cannot comment specifically on any work other than what has been publicly announced, I can tell you that we regularly perform reviews of the department’s administration of programs, including the distribution of funding,” Harris said.

Reuters was unable to independently determine what portion of the stimulus payments went to entities and individuals involved in civil and criminal actions with Medicare.

In an email to funding recipients seen by Reuters, HHS asked providers to sign a lengthy attestation that stipulates they have been or will be treating patients suffering from COVID-19, the disease caused by the new coronavirus.

If providers do not respond within 30 days, HHS said it will assume they have accepted the government’s terms and conditions. It said in a statement it “has mechanisms in place to recoup funds and address fraudulent activity.”WATCH NOWVIDEO05:53CARES Act, Fed response insufficient given headwinds: Chief economist

The funds came from the $2.3 trillion CARES Act passed by Congress to blunt the economic toll of the pandemic, which has killed more than 64,000 Americans and thrown at least 30 million people out of work.

Unlike the portions of that package intended to help small businesses, which required companies to apply for it, some of the healthcare funding was initiated by the U.S. Department of Health and Human Services and showed up as a surprise in the bank accounts of many healthcare providers.

Reuters interviewed six defense lawyers and others representing more than a dozen healthcare providers facing civil or criminal inquiries who received the money, including a pain medicine doctor who recently settled a civil false claims case, and an operator of an assisted living facility who is planning to plead guilty to healthcare fraud.

“The left hand does not know what the right hand is doing,” said Joel Hirschhorn, an attorney who represents the pain medicine doctor and the operator of the assisted living facility.

The lawyers who spoke to Reuters declined to identify their specific clients, citing confidentiality rules.

The surprise deposit of funds has led attorneys to scramble to warn clients to be ready to return the money.

“There is no such thing as a windfall from the government,” said Sam J. Louis, a former prosecutor who is now a partner with the law firm Holland & Knight, whose law firm issued an alert to clients warning them of the potential of legal liability in taking the funds.

Some former federal prosecutors say it would not have been difficult for HHS to weed out these providers first.

“If fraudulent providers, either convicted or under investigation, are receiving CARES Act bail-outs automatically, without any vetting, then shame on the government,” said Paul Pelletier, one former prosecutor.

However, defense lawyers stressed that people charged with crimes are innocent until proven guilty, and they are not usually barred from billing Medicare until well after they are convicted of a crime. People facing criminal healthcare charges usually agree to stop billing Medicare as a condition of their bond, they added.

Another pool of practitioners eligible for the cash infusions include doctors who have lost their medical licenses or licenses to prescribe highly addictive drugs, said Ron Chapman, a lawyer in Miami.

HHS declined to say what portion of the $30 billion went to providers facing criminal or civil inquiries.

It said it distributed funds to more than 315,000 provider billing organizations reaching over 1.5 million healthcare providers.

In fiscal year 2019, investigations by the HHS inspector general’s office led to 747 criminal actions and 684 civil actions.

In the midst of the pandemic health care fraud is alive and prevalent while many suffer economically across the globe. How has the pandemic effected you financially? Do you think pandemic aid could have been better spent? How many people do you think lost or missed work? How many industries and small business have been impacted or closed due to COVID 19?

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White House Blocks New Coronavirus Vaccine Guidelines

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Source: The New York Times
The F.D.A. proposed stricter guidelines for emergency approval of a coronavirus vaccine, but the White House chief of staff objected to provisions that would push approval past Election Day.

Sharon LaFraniere
Noah Weiland

By Sharon LaFraniere and Noah Weiland

WASHINGTON — Top White House officials are blocking strict new federal guidelines for the emergency release of a coronavirus vaccine, objecting to a provision that would almost certainly guarantee that no vaccine could be authorized before the election on Nov. 3, according to people familiar with the approval process.

Facing a White House blockade, the Food and Drug Administration is seeking other avenues to ensure that vaccines meet the guidelines. That includes sharing the standards — perhaps as soon as this week — with an outside advisory committee of experts that is supposed to meet publicly before any vaccine is authorized for emergency use. The hope is that the committee will enforce the guidelines, regardless of the White House’s reaction.

The struggle over the guidelines is part of a monthslong tug of war between the White House and federal agencies on the front lines of the pandemic response. White House officials have repeatedly intervened to shape decisions and public announcements in ways that paint the administration’s response to the pandemic in a positive light.

That pattern has dismayed a growing number of career officials and political appointees involved in the administration’s fight against a virus that has claimed more than 209,000 lives in the United States.

The vaccine guidelines carry special significance: By refusing to allow the Food and Drug Administration to release them, the White House is undercutting the government’s effort to reassure the public that any vaccine will be safe and effective, health experts fear.

“The public must have full faith in the scientific process and the rigor of F.D.A.’s regulatory oversight if we are to end the pandemic,” the biotech industry’s trade association pleaded on Thursday, in a letter to President Trump’s health secretary, Alex M. Azar II, asking for release of the guidelines.

The Food and Drug Administration submitted the guidelines to the Office of Management and Budget for approval more than two weeks ago, but they stalled in the office of Mark Meadows, the White House chief of staff. Their approval is now seen as highly unlikely.

A main sticking point has been the recommendation that volunteers who have participated in vaccine clinical trials be followed for a median of two months after the final dose before any authorization is granted, according to a senior administration official and others familiar with the situation, who spoke on the condition of anonymity. Given where the clinical trials stand, that two-month follow-up period would all but preclude any emergency clearance before Election Day.

The conflict began almost as soon as the Food and Drug Administration submitted the guidelines to the White House budget office on Monday, Sept. 21. The next day, Dr. Stephen M. Hahn, the F.D.A. commissioner, briefed Mr. Azar on the matter.

That Wednesday, Mr. Meadows raised a series of concerns, a senior administration official said. He questioned the need for two months of follow-up data, said that stricter recommendations would change the rules in the middle of clinical trials and suggested that Dr. Hahn was overly influenced by his agency’s career scientists. The White House on Monday did not respond to a request for comment.

Speaking to reporters on Sept. 23, Mr. Trump publicly cast doubt on whether the guidance would be approved. “We may or may not approve it,” he said, suggesting that the regulatory action “was a political move more than anything else.”

F.D.A. officials later provided additional justification to the White House, explaining that the two-month follow-up was necessary to identify possible side effects and ensure that a vaccine’s protection against Covid-19, the disease caused by the coronavirus, was not short-lived. But they have been unable to break the stalemate.

The White House has the authority to intervene in such nonbinding guidance documents — a step below enforceable regulations — at least partly because of an October 2019 executive order that tightened restrictions over the issuance of such documents. That order asserted that “agencies have sometimes used this authority inappropriately in attempts to regulate the public.” White House officials have cited it to force the Food and Drug Administration and other agencies to submit pandemic-related guidelines to the White House budget office for review before public release.

Staff members at the budget office scrutinize the documents for statements that could undercut the president’s public message that the administration either has the pandemic under control or will soon, according to former and current federal officials.

The testing and release of a vaccine is an issue that has gained wide national attention. Mr. Trump has repeatedly misrepresented how quickly a vaccine might be available to most Americans, promising a major breakthrough in vaccine development as early as this month. No clinical trial in the United States has yet advanced far enough to prove that any vaccine is safe and effective, although Pfizer, one vaccine developer, is hoping for interim results soon from its trial.

The Food and Drug Administration’s new guidelines were intended to assure companies developing vaccines that they were being held to a common standard and to reassure the public. Polls suggest that Americans are increasingly wary about taking a coronavirus vaccine: A survey published last month by the Pew Research Center found that 51 percent of Americans would either probably or definitely take one, down from 72 percent in May.

Dr. Peter Marks, the F.D.A.’s top regulator for vaccines, said last week in an event organized by Friends of Cancer Research that the government had to be transparent about the standards it was using to evaluate experimental vaccines in order to build public trust. He and other health officials have stressed that the companies developing vaccines are already fully aware of the agency’s expectations for products seeking authorization for emergency use.

Mr. Azar on Friday played down the conflict with the White House, telling a House panel that those concerned about its involvement in the guidelines were making “a mountain out of a molehill.”

“What the commissioner is proposing to put out is public emergency use authorization guidance on a vaccine that would be consistent with letters already sent to the manufacturers,” Mr. Azar said. “The F.D.A. has already told the manufacturers what they’re going to look for.”

Some vaccine makers, including Johnson & Johnson, have publicly indicated that they will follow the agency’s recommendations, regardless of the White House’s actions.

At a recent meeting with F.D.A. staff members, Dr. Marks said the agency “may hear more noise in the press” about trouble with the guidance but added that the “goal isn’t to get into fights,” according to people familiar with his comments. He said at the Friends of Cancer Research event that there was no reason “to get all excited” because “we are going to have a transparent advisory committee meeting for each and every emergency use authorization that comes through.”

Privately, Dr. Marks has told colleagues that an angry tweet from Mr. Trump attacking F.D.A. scientists over the guidelines could damage public confidence in a coronavirus vaccine.

The guidance laid out more specific criteria for clinical trial data and recommended that it be reviewed by the advisory committee of independent experts. It is expected to be included in the briefing papers for the committee’s next meeting, scheduled for Oct. 22.

Food and Drug Administration officials hope the committee will consider those standards before giving its blessing to any emergency use authorization for a vaccine. The most likely recipients of any vaccine that wins that authorization will be high-risk populations such as health care workers.

In addition to the two-month follow-up period, the guidelines stated that there should be at least five cases of severe infection in the placebo group as evidence that a vaccine is effective in preventing more than just mild to moderate illness. About 10 percent of Covid-19 cases are considered severe.

The guidelines also laid out the agency’s expectation that vaccine makers would continue to assess the long-term safety and efficacy of the drug, if granted emergency use authorization.

Katie Thomas contributed reporting from Chicago. Kitty Bennett contributed research.

How do you feel about a coronavirus vaccine? What do you think the guidelines will be? Will you take a coronavirus vaccine?

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Trump contracts COVID

After Biden and Trump’s debate at the end of September 2020, it was reported that Trump contracted COVID 19 along with many others in his camp such as Mrs. Trump and Kellyanne Conway. He soon was admitted to Walter Reed and days later returned to the White house to complete his recovery. COVID 19 is indeed the most profound and controversial disease of our lifetime. While some countries have managed the disease fairly well (Japan), others (U.S.) have not. Like most diseases, COVID 19 is no respecter of persons infecting anyone in its path and drawing mixed emotions from across the globe. Some NPR c(National Public Radio) callers are skeptical of the vaccine and believe that such things should be tested on the country’s administrators first and after 2 years the rest of us can follow our hearts. In this instance, this caller just may have gotten her wish.

With the world’s history rife with the experimentation of disease and drugs on unknowing populations, one can see why some might be skeptical and want to weigh all the facts as they bare out. The Tuskegee Airman are a prime example of involuntary medical experimentation, which not only impacted them, it impacted those in their families as well. Disease can be both murky and deadly. Regardless of your thoughts on COVID 19 we encourage our readers to be well informed about the decisions they make regarding their health and to take every precaution to protect yourselves and others from COVID 19.How do you protect yourself and others from COVID 19? What should a national plan look like? How has your area been impacted by COVID 19?

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Gardening Takes Off during COVID 19

Victory Garden during COVID 19
Source: CBS News
Shidonna Raven Garden and Cook

During the great depression Victory Gardens became very popular. Why do you think Victory Gardens are becoming popular again? Why do you think gardening is becoming more popular during COVID 19? Do you consider a garden a necessity or luxury? Share your comments with the community by posting them below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing!

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COVID deaths update

COVID 19 Shidonna Raven Garden and Cook

The coronavirus pandemic has now killed at least 1 million people worldwide. That’s according to a tally maintained by Johns Hopkins University. This sobering milestone was reached just nine months after the first reported fatality in China last January. And public health experts believe the actual toll – the recorded deaths plus the unrecorded deaths – is much higher. What’s more, in the five worst-off countries, the trend line remains worrisome.

1. United States

Take the United States, which currently leads the world in terms of both total number of dead and total number of infected over the course of the pandemic. While several Northeastern states that were clobbered by the virus early on managed to use social distancing and masking to push down their new cases by early spring, states in other regions then quickly moved to re-open. This fueled an even bigger wave of deaths across wide swaths of the U.S. throughout the summer. Since then many states have managed to bring down their numbers — as well as the overall U.S. daily death count. Yet it remains far higher than it was in July. Also, most recently, daily deaths have actually begun rising again — largely driven by increasing transmission in various states in the Great Plains and the South.

2. Brazil

Brazil, the second-biggest driver of the worldwide death toll, is also once again trouble. Led by a president who repeatedly downplayed the threat from the coronavirus, Brazil’s initial response was chaotic at best, enabling a surge in deaths all through July and August. About a month ago, the daily death count began dropping. But more recently that progress seems to have stalled.

Source: NPR

Where do you live? How has COVID 19 impacted your state? Are your states numbers declining? Share your comments with the community by posting them below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing!

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COVID 19 Cases Rise in VA

VDH Shidonna Raven Garden and Cook

A screenshot from the Virginia Department of Health’s COVID-19 dashboard shows the seven-day moving average for percent positivity has dropped to 4.7 percent.VIRGINIA DEPARTMENT OF HEALTH

The Virginia Department of Health reported Monday that the statewide total for COVID-19 cases is 146,593 — an increase of 2,160 from the 144,433 reported Friday.

The 146,593 cases consist of 139,144 confirmed cases and 7,449 probable cases. There are 3,172 COVID-19 deaths in Virginia — 2,962 confirmed and 210 probable. That’s an increase of 36 from the 3,136 reported Friday.

The VDH defines probable COVID-19 cases as people who are symptomatic with a known exposure to COVID-19, but whose cases have not been confirmed with a positive test.

Statewide, the total number of people hospitalized is 10,916, though the VDH dashboard notes that hospitalizations are underrepresented.

In the Richmond area, there are 17,396 cases: 6,000 in Chesterfield County, 5,452 in Henrico County, 4,647 in Richmond and 1,297 in Hanover County.

Also, the region has 403 deaths attributed to the virus: 211 in Henrico, 94 in Chesterfield, 61 in Richmond and 37 in Hanover.

There are 1,027 outbreaks, which make up 22,939 of Virginia’s total cases. The VDH classifies an outbreak as at least two lab-confirmed cases.

As the overall number of positive COVID-19 test results in Virginia grows, data from the VDH coronavirus dashboard shows the percentage of positive results from testing is down. The seven-day average for percentage of positive test results was at 4.7% as of Sept. 24, which is the most recent figure provided by the VDH.

One week ago, on Monday, Sept. 21., the seven-day average was 5.7%. The peak was 20.8% on April 21.

State health officials have said there’s a lag in the reporting of statewide numbers on the VDH website. Figures on the website might not include cases or deaths reported by localities or local health districts.

Source: Richmond Times Dispatch

For the most part Virginia’s numbers have had a steady decline. Do you live in Virginia? Have you seen a rise in cases in your areas? What do you do to prevent the spread of COVID 19? Share your comments with the community by posting them below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing!

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Health Care Fraud during COVID

COVID 19 Fraud
Source: Senior Medical Patrol
Shidonna Raven Garden and Cook

How has this article helped you and yours? Do you think you can identify COVID 19 health care or health care fraud in general when you see it? What do you do when you see health care fraud? Share your comments with the community by posting them below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing!

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