Billions in Hospital Virus Aid Rested on Compliance With Private Vendor

Billions in Hospital Virus Aid Rested on Compliance With Private ...

The Department of Health and Human Services told hospitals in April that reporting to the vendor, TeleTracking Technologies, was a “prerequisite to payment.”

The Trump administration tied billions of dollars in badly needed coronavirus medical funding this spring to hospitals’ cooperation with a private vendor collecting data for a new Covid-19 database that bypassed the Centers for Disease Control and Prevention.

The highly unusual demand, aimed at hospitals in coronavirus hot spots using funds passed by Congress with no preconditions, alarmed some hospital administrators and even some federal health officials.

The office of the health secretary, Alex M. Azar II, laid out the requirement in an April 21 email obtained by The New York Times that instructed hospitals to make a one-time report of their Covid-19 admissions and intensive care unit beds to TeleTracking Technologies, a company in Pittsburgh whose $10.2 million, five-month government contract has drawn scrutiny on Capitol Hill.

“Please be aware that submitting this data will inform the decision-making on targeted Relief Fund payments and is a prerequisite to payment,” the message read.

The financial condition, which has not been previously reported, applied to money from a $100 billion “coronavirus provider relief fund” established by Congress as part of the $2.2 trillion Coronavirus Aid, Relief and Economic Security Act, or CARES Act, signed by President Trump on March 27. Two days later, the administration instructed hospitals to make daily reports to the C.D.C., only to change course.

“Another data reporting ask,” a regional official in the health department informed colleagues in an email exchange obtained by The Times, adding: “It comes with $$ incentive. We really need a consolidated message on the reporting/data requests, this is past ridiculous.”

A colleague replied, “Another wrinkle. What a mess.”

The disclosure of the demand in April is the most striking example to surface of the department’s efforts to expand the role of private companies in health data collection, a practice that critics say infringes on what has long been a central mission of the C.D.C. Last month, the federal health department moved beyond financial incentives and abruptly ordered hospitals to send daily coronavirus reports to TeleTracking, not the C.D.C., raising concerns about transparency and reliability of the data.

Officials at the Department of Health and Human Services say that the moves were necessary to improve and streamline data collection in a crisis, and that the one-time reports collected in April by TeleTracking were not available from any other source.

“The national health system has not been challenged in this way in any time in recent history,” Caitlin Oakley, a department spokeswoman, said in a statement, adding that TeleTracking offered a “standardized national hospital capacity tracking system which provided more real-time, better informed data to make decisions from.”

But critics remain alarmed.

“In the middle of a pandemic, the Trump administration is using funds meant to support hospitals as a tool to coerce them to use an unproven, untrusted and deeply flawed system that sidelines public health experts,” Senator Patty Murray of Washington, the ranking Democrat on the Senate Health Committee, said in a statement.

In a statement, TeleTracking said it has three decades of experience providing health care systems “with actionable data and unprecedented visibility to make better, faster decisions.”

Still, public health experts and hospital executives are puzzled as to why the health agency chose such a difficult time to employ an untested private vendor rather than improve the C.D.C.’s National Healthcare Safety Network, a decades-old disease tracking system that was deeply familiar to hospitals and state health departments.

The N.H.S.N., as it is known, had built up trust over decades of working with hospitals and state health departments. Administrators were reluctant to make the switch.

“People — especially in public health and clinical health — are very protective of their data, so that trust factor is certainly an issue,” said Patina Zarcone, the director of informatics for the Association of Public Health Laboratories. “The fear of having their data leaked or misused or used for a purpose that they weren’t aware of or agreed to — I think that’s the biggest rub.”

Ms. Oakley said the C.D.C.’s system was “not designed for use in a disaster response” and could not adapt quickly in a crisis. Allies of the C.D.C. say withholding taxpayer dollars from the CARES Act in lieu of cooperation was an inappropriate effort to push hospitals into a system they were reluctant to use.

“It’s an absolutely enormous lever,” said William Schaffner, an infectious disease expert at Vanderbilt University. “It’s a compulsion to oblige institutions to report to this TeleTracking system because they knew if it weren’t tied to money, it wouldn’t happen.”

The Pittsburgh company has no obvious ties to the Trump administration. Rather, the push appears to be part of a broader privatization. The Health and Human Services Department has also asked the Minnesota-based manufacturer 3M “to create, and continuously update, a nationwide clinical data set on Covid-19 treatment,” according to documents obtained by The Times.

The effort is separate from the TeleTracking data collection. Tim Post, a company spokesman, said that because 3M already operates hospital information systems, it is “uniquely positioned,” with the permission of its clients, to submit information to the health department to help officials study disease patterns and recommend treatment options.

Some experts say this kind of cooperation with the private sector is long overdue. But the push also appears to be driven at least in part by an intensifying rift between the C.D.C., based in Atlanta, and officials at the White House and Department of Health and Human Services, the parent agency of the disease control centers.

Dr. Deborah L. Birx, the White House coronavirus response coordinator, and Mark Meadows, the president’s chief of staff, have taken a dim view of the C.D.C. and believe its reporting systems were inadequate. In a recent interview, Michael Caputo, the spokesman for Mr. Azar, accused the C.D.C. of having “a tantrum.”

Accurate hospital data — including information about coronavirus caseloads, deaths, bed capacity and personal protective equipment — is essential to tracking the pandemic and guiding government decisions about how to distribute scarce resources, like ventilators and the drug remdesivir, the only approved treatment for hospitalized Covid-19 patients.

The health agency has set up a new database, H.H.S. Protect, to collect and analyze Covid-19 data from a range of sources. TeleTracking feeds hospital data to that system.

But the public rollout of H.H.S. Protect has been rocky. The nonpartisan Covid Tracking Project identified big disparities between hospital data reported by states and the federal government and deemed the federal data “unreliable.”

The tension dates to March, when the novel coronavirus was making its first surge in the United States

On March 29, Vice President Mike Pence, charged by Mr. Trump with overseeing the federal response, informed hospital administrators that the C.D.C. was setting up a “Covid-19 Module,” and asked them to file daily reports which, he said, were “necessary in monitoring the spread of severe Covid-19 illness and death as well as the impact to hospitals.”

But around that time, TeleTracking submitted a proposal for data collection to the Trump administration, through an initiative, ASPR Next, created to promote innovation. On April 10, TeleTracking was awarded its contract.

The health department’s spokeswoman said the intent was to complement the C.D.C., not compete with it. Like the C.D.C.’s network, TeleTracking’s system requires manual reporting on a daily basis. But in June, Ms. Murray demanded the administration provide more information about what she called a “multimillion-dollar contract” for a “duplicative health data system.”

Some hospital officials also objected to the change.

“We have been directing our hospitals to N.H.S.N.,” Jackie Gatz, a vice president of the Missouri Hospital Association, wrote to a regional health and human services official in an email obtained by The Times, “and now this email with a much greater carrot — CARES Act distributions — is routing them to TeleTracking.”

When the order was delivered, flaws had already emerged in the new system.

“H.H.S. has acknowledged long wait times for those calling for technical support, and indicated that TeleTracking recently added 100 staff to respond to call center requests,” the American Hospital Association wrote to its members in a “special bulletin” on April 23. “They also are directing hospitals to leave a message if they are unable to reach someone live.”

At the time, hospitals had the option of making their daily coronavirus reports to TeleTracking or the C.D.C. Few were using the new database.

In June, the administration again used a stick to demand that hospitals report to TeleTracking, this time in order to obtain remdesivir. By July, with Dr. Birx pushing to bolster hospital compliance, the administration instructed hospitals to stop filing daily reports to the C.D.C. and to send them to TeleTracking instead.

One official at a major academic hospital, who spoke on the condition of anonymity for fear of angering officials in Washington, said the switch left her “unable to sleep at night.”

“Ethically, it felt like they had taken a very trusted institution in the C.D.C. and all of that trust built up with many public health people,” she said, then “moved it onto a politically and financially motivated portion of this response.”

Health and human services officials say the government now has a much more complete picture of hospital bed capacity, with more than 90 percent of hospitals reporting. But Dr. Janis M. Orlowski, the chief health officer for the Association of American Medical Colleges, who worked with Dr. Birx and the administration to bolster hospital reporting, said that she was “stunned” by the switch and that the increase in reporting came because of efforts by her group and others, not the TeleTracking system.

Dr. Orlowski said the data and maps now published on the administration’s H.H.S. Protect data hub are “just not as sophisticated as the C.D.C.”

The switch also generated pushback inside the C.D.C., where officials have refused to analyze and publish TeleTracking data, saying they could not be assured of its quality and had continuing questions about its accuracy, according to a senior federal health official.

Administration officials say the C.D.C. is working with a little-known office in the executive branch — the United States Digital Service — to build a “modernized automation process” in which data will continue to flow directly to the Department of Health and Human Services. But the project is in its infancy, one senior federal health official said.

Critics say that if the department believed the C.D.C.’s health network had problems, those should have been fixed.

“We have a public health system that depends upon communication from hospitals to state health departments to the C.D.C.,” said Dr. Schaffner, the Vanderbilt University infectious disease expert. “It’s very well established. Can it be improved? Of course. But to cut out the public health infrastructure and report to a private firm essential public health data is misguided in the extreme.”

 

 

 

Drugmakers getting bolder in fight over 340B drug discounts

https://www.fiercehealthcare.com/hospitals/drug-makers-getting-bolder-fight-over-340b-drug-discounts?mkt_tok=eyJpIjoiTTJRMlkySTJZV1ZoWldGbSIsInQiOiJYVUFLbDJLQ2hkbzBrWjBpOVwvbm5YYUpVWExRZ21QRXBkWGJFWldLVGxCZXlFOENlazZBdUhpVm5RUTczOGFxZFVLSEszOTZra20zYzdOQllvMjVHVXNvOUFcL0J3Rk0reFwvV1VHRytoUTYwaDNxelgwcmw5RHhuSEZtNGtlcXZ6MCJ9&mrkid=959610

Drugmakers getting bolder in fight over 340B drug discounts ...

Drugmakers are getting bolder in their bid to restrict access to drugs discounted under the 340B program as legal experts say a lack of enforcement has created a regulatory void.

Hospitals are imploring the Department of Health and Human Services (HHS) to clamp down on several moves by drug companies, including Novartis and AstraZeneca, to limit distribution of certain 340B drugs. But experts say an administration-wide change in what agencies can enforce is likely behind drugmakers’ aggressive moves.

“It is an outrage that these actions are being taken at a time when hospitals are in the midst of their response to the COVID-19 public health emergency, which has further demonstrated the fractured, inadequate state of the prescription drug supply chain,” the American Hospital Association said in a release last week.

Hospitals and 340B advocates are furious that AstraZeneca announced last Friday that starting Oct. 1 it will not offer any discounted drugs to contract pharmacies, which are third-party entities that dispense drugs acquired under the program. 

It is the most aggressive move in a fight sparked last month between drug companies against contract pharmacies, which are a popular tool among 340B hospitals.

The back story

In exchange for participating in Medicaid, a drug manufacturer is required to offer discounts to safety-net hospitals that participate in 340B. But the program has been beset with controversy in recent years as drug companies claim the program has gotten too large and patients aren’t benefiting from the discounts.

Eli Lilly decided last month to restrict sales to contract pharmacies of certain formulations of erectile dysfunction drug Cialis. Merck and Novartis also said contract pharmacies would need to submit claims data to avoid duplicate discounts.

We’ve reached out to pharmaceutical companies for comment and will update when we hear back.

Industry advocacy organization Pharmaceutical Research and Manufacturers of America (PhRMA) has previously called for reforms to the 340B program, including to the ability for covered entities to contract with multiple outside pharmacies to dispense drugs that receive 340B discounts. Even though the number of Americans who are insured has risen, 340B is growing exponentially, they said. “Not all 340B hospitals are good stewards of the program,” PhRMA said.

Hospital groups and 340B allies charge that the moves blatantly violate a 2010 guidance released by the Health Resources and Services Administration (HRSA), which oversees the 340B program.

The guidance permits a hospital participating in 340B to voluntarily use a contract pharmacy and outlines the requirements to do so. The guidance also says a manufacturer must still sell a drug at a price not to exceed the statutory 340B price.

But an October 2019 executive order said federal agencies cannot enforce guidance documents unless they are part of a contract amid other exceptions.

HRSA has said that it doesn’t have the authority under the 340B statute to take enforcement action on “requirements that have been established under guidance,” said Emily Cook, a partner with law firm McDermott Will & Emery.

The agency’s current position is that it can only take enforcement actions on clear violations of the 340B statute, she added.

HRSA told Fierce Healthcare in a statement it is considering the issues raised by the manufacturers and “evaluating our next steps.”

What’s next

Hospitals are hoping HHS steps in and clears up the issue.

If not, then hospitals could either take drug companies to court or lobby Congress to give HRSA more authority over the program.

The advocacy group 340B Health said last week that if the administration refuses to step in then it will “pursue all legislative and legal avenues available to us to defend the safety net.”

Hospitals need to re-examine their 340B contract pharmacy deals to exclude AstraZeneca drugs, according to an article from Brenda Maloney Shafer and Richard Davis of law firm Quarles & Brady.

If they fail to do this, then the contract pharmacy could pay for dispensing and administrative fees for drugs that won’t get a 340B discount.

This is the latest spat over the controversial program. Hospitals took the administration to court after it tried to cut payments under the program by nearly 30%.

An appeals court recently ruled that HHS does have the authority to institute the cuts.

 

 

 

 

Trump Unveils Healthcare Agenda

https://www.medpagetoday.com/washington-watch/electioncoverage/88250?xid=nl_mpt_DHE_2020-08-26&eun=g885344d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%20Top%20Cat%20HeC%20%202020-08-26&utm_term=NL_Daily_DHE_dual-gmail-definition

What's in, and out, of Biden's health care plan

List of bullet points prompts debate over lack of detail, potential for actual achievement.

Health policy scholars critiqued the Trump campaign’s broad strokes healthcare agenda for his potential second term. While some found it overly vague, even dishonest, one suggested it was precisely what voters want.

Released Sunday night as a list of bullet points, the “Fighting for You” agenda will apparently serve as the Republican platform for the 2020 election. The GOP’s platform committee voted over the weekend to dispense with the customary detailed policy document for this cycle, in favor of simply backing President Trump’s agenda.

That agenda, which the Trump campaign promised would be fleshed out in future speeches and statements, included the following points relevant to healthcare:

Eradicate COVID-19

  • Develop a vaccine by the end of 2020
  • Return to normal in 2021
  • Make all critical medicines and supplies for healthcare workers
  • Refill stockpiles and prepare for future pandemics

Healthcare

  • Cut prescription drug prices
  • Put patients and doctors back in charge of our healthcare system
  • Lower healthcare insurance premiums
  • End surprise billing
  • Cover all pre-existing conditions
  • Protect Social Security and Medicare
  • Protect our veterans and provide world-class healthcare and services

Reliance on China

  • Allow 100% expensing deductions for essential industries like pharmaceuticals and robotics who bring back their manufacturing to the U.S.
  • No federal contracts for companies who outsource to China
  • Hold China fully accountable for allowing the virus to spread around the world

Joseph Antos, PhD, a resident scholar in healthcare and retirement policy at the American Enterprise Institute, characterized Trump’s strategy as “Don’t explain it. Just say what your goals are.”

He applauded the brevity of the document, 6 pages in total, covering 10 different policy areas from jobs to healthcare to immigration, as a “smart strategy.”

Voters don’t want to read lengthy policy briefs and gave the “Biden-Sanders Unity Task Force Recommendations” which were over 100 pages long and “unbelievably complicated stuff” as an example of how not to reach voters.

“I think [Trump] got it right. He’s not running a think tank…. He’s running for office. He does have a keen eye for what the average voter could stand to listen to.”

Gail Wilensky, PhD, an economist and senior fellow at Project Hope in Bethesda, Maryland, and CMS administrator under President George H.W. Bush, agreed that a platform packed with policy details doesn’t sway many voters.

This election, she said, is about one thing only: “Trump or not Trump.”

Whither the ACA?

Nevertheless, the Trump campaign’s goals merit attention, often for what they don’t include as well as what they do.

As for the substance of the agenda, the key difference between the Trump administration’s proposed agenda and that of the Democratic nominee, former Vice President Joe Biden, is that the latter aims to expand access to health insurance using the Affordable Care Act’s (ACA) framework, said Wilensky.

While Trump’s 2016 healthcare agenda centered around repealing the ACA, his second-term agenda doesn’t mention the law by name.

Wilensky said she’s glad that Trump did not include ACA repeal among his goals, given that “there’s no historical precedence” for eliminating the core benefits of such far-reaching legislation, now on the books for 10 years and fully implemented for 6.

Kavita Patel, MD, a primary care physician and Brookings Institution scholar in Washington, D.C., who was an advisor on the Democrats’ platform, said, “This is all just posturing and politics and almost a continuation of things [Trump’s] been saying without any real details behind it.”

Many of these items — such as ending surprise billing, lowering health insurance premiums, and cutting prescription drug prices — would have Democrats’ support “but they would get there in a different way,” Patel said.

One thing she was surprised not to see in the agenda were references to abortion or other reproductive health issues, she noted.

Insurance Coverage Neglected

Rosemarie Day, founder and CEO of Day Health Strategies and author of Marching Toward Coverage: How Women can Lead the Fight for Universal Healthcare, was dumbfounded by the overall lack of substance in the agenda, and particularly by the absence of a plan to deal with rising rates of uninsurance related to the pandemic.

Day thought the Trump campaign could have at least included a plan for returning to the “baseline” on the number of uninsured. Another administration might have chosen to promote Medicaid coverage or encourage unemployed workers to enroll on the health insurance exchanges, but not this administration, she said.

“So, they’re really just leaving people out in the cold,” Day said.

Wilensky, too, suggested it would have been “useful” for the Trump campaign to have “talked about how they envision getting more people covered.”

Paul Ginsburg, PhD, director of the USC-Brookings Schaeffer Initiative for Health Policy, said much of the agenda is “just aspirations.”

“‘Put patients and doctors in charge of our healthcare system’? … I don’t know what the policy is, [but] who’s going to quarrel with that?”

Lowering healthcare premiums also sounds “nice” but how that would be achieved is unclear, he said.

One agenda item in the document that really really irked Day was the Trump administration’s pledge to protect people who have pre-existing conditions.

“I consider the ‘covering all pre-existing conditions’ an outright lie,” she said. “I find it incredibly upsetting that [Trump] continues to say that” because he spent his first term attacking the ACA, which does protect pre-existing condition coverage.

Day also noted that the administration has repeatedly promised an ACA replacement without ever delivering an actual proposal.

Responding to the Pandemic

The Trump campaign agenda lists “eradicate COVID-19” on its bullet list, but Patel said it’s “probably not an achievable goal.” A more realistic target is to control it better.

“We have deaths every year and hospitalizations from influenza, but we have a vaccine and we have … strategies to protect people like seniors and young children,” Patel said. “That’s exactly the kind of attitude we have to take” with regard to COVID-19.

For both Patel and Ginsburg, “return to normal” is another aspiration that’s beyond the government’s power to deliver.

“So much depends on a vaccine and its acceptance and how quickly it can be produced,” Ginsburg said.

As for making all critical medicines and supplies for healthcare workers in the United States, Ginsburg acknowledged that it’s theoretically doable, but still unrealistic because it would be “way too expensive.”

“Brand name drugs are routinely produced in other countries as well as the U.S.; I wouldn’t want to upset that supply chain, especially for drugs that are in shortage,” he said.

 

 

 

Administration delays final rule easing anti-kickback regs until next August

https://www.healthcaredive.com/news/trump-admin-delays-final-rule-easing-anti-kickback-regs-until-next-august/584158/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202020-08-26%20Healthcare%20Dive%20%5Bissue:29307%5D&utm_term=Healthcare%20Dive

Dive Brief:

  • CMS has pushed back publishing a final rule that would ease anti-kickback regulations on providers by a year. The move is likely to anger healthcare organizations that have long clamored for the rule’s relaxation.
  • The deadline to finalize the rule proposed Oct. 17, 2019, is now Aug. 31, 2021. Originally, the rule relaxing stipulations of the decades-old Stark Law was expected this month. It’s unclear how the extension affects OIG’s tandem rule slacking similar regulations outlined in the Federal Anti-Kickback Statute and the Civil Monetary Penalties Law.
  • CMS chalked up the delay to the need to detangle the many thorny issues raised by healthcare companies in their comments on the rule. “We are still working through the complexity of the issues raised by comments received on the proposed rule and therefore we are not able to meet the announced publication target date,” Wilma Robinson, HHS deputy executive secretary, wrote in a notice on the change dated Monday. CMS did not respond to requests to clarify what issues are tying up the rule.

Dive Insight:

Hospital groups are unlikely to be pleased with the delay. The American Hospital Association earlier this month sent the Office of Management and Budget a letter urging them to expedite the review and release of the final Stark and AKS regulations.

“These rules take on even more significance in light of the COVID-19 pandemic,” AHA EVP Thomas Nickels wrote in the letter dated Aug. 19. “These rules will remove unnecessary regulatory burden from hospitals and health systems, allow for enhanced care coordination for patients, improve quality, and reduce waste in the Medicare and Medicaid programs.”

AHA did not respond to a request for comment by time of publication.

Healthcare organizations have said the Stark Law and Anti-Kickback Statute, passed decades ago in an attempt to deter physicians from referring patients to other locations or for services that would financially benefit them, are outdated and burdensome. Providers say the proposed changes are long overdue, citing longstanding concerns the laws hinder efforts to coordinate patient care across different sites and episodes.

The proposed rule, if finalized, would sharply ease federal anti-kickback regulations in a bid to help providers use value-based payment arrangements, reflecting the growing shift away from fee-for-service reimbursement and siloed care models.

The rule clarified exemptions from the physician self-referral law for certain value-based payment arrangements among physicians, providers and suppliers. Specifically, it applies to models with a specific patient population, where one of the entities takes on full financial risk for providing Medicare Part A and Part B for the first six months. The payments can either be capitated or global.

Doctors would be required to pay back a fourth of payments if they don’t meet financial goals.

The proposed rule also introduced a new exemption for certain arrangements under which a doctor receives limited payment for items and services that he or she provides, and another that would allow hospitals and medical device manufacturers to donate cybersecurity tools and other related software to doctors without fear of retribution.

Comments on the proposed rule from the hospital and physician community were generally supportive of the changes, though some organizations, including the American Hospital Association and Walmart, thought the feds didn’t go far enough. Hospital groups argued the exceptions should be expanded to include private payers, along with Medicare and Medicaid and the definition of value-based arrangements should be broadened, along with some other clarifications.

Per the Social Security Act, agencies have to maintain a regular timeline for publishing final regulations, normally within three years of the draft. However, they are allowed to extend the original deadline, if they justify the change.

 

 

 

 

The right to vote is not in the Constitution

https://theconversation.com/the-right-to-vote-is-not-in-the-constitution-144531?utm_medium=email&utm_campaign=Latest%20from%20The%20Conversation%20for%20August%2026%202020%20-%201713516549&utm_content=Latest%20from%20The%20Conversation%20for%20August%2026%202020%20-%201713516549+Version+A+CID_ca860340297de2ef2c2c85020b74576b&utm_source=campaign_monitor_us&utm_term=The%20right%20to%20vote%20is%20not%20in%20the%20Constitution

Why The Right To Vote Is Not Enshrined In The Constitution by Sean ...

If you’re looking for the right to vote, you won’t find it in the United States Constitution or the Bill of Rights.

The Bill of Rights recognizes the core rights of citizens in a democracy, including freedom of religion, speech, press and assembly. It then recognizes several insurance policies against an abusive government that would attempt to limit these liberties: weapons; the privacy of houses and personal informationprotections against false criminal prosecution or repressive civil trials; and limits on excessive punishments by the government.

But the framers of the Constitution never mentioned a right to vote. They didn’t forget – they intentionally left it out. To put it most simply, the founders didn’t trust ordinary citizens to endorse the rights of others.

They were creating a radical experiment in self-government paired with the protection of individual rights that are often resented by the majority. As a result, they did not lay out an inherent right to vote because they feared rule by the masses would mean the destruction of – not better protection for – all the other rights the Constitution and Bill of Rights uphold. Instead, they highlighted other core rights over the vote, creating a tension that remains today.

James Madison of Virginia. White House Historical Association/Wikimedia Commons

Relying on the elite to protect minority rights

Many of the rights the founders enumerated protect small groups from the power of the majority – for instance, those who would say or publish unpopular statements, or practice unpopular religions, or hold more property than others. James Madison, a principal architect of the U.S. Constitution and the drafter of the Bill of Rights, was an intellectual and landowner who saw the two as strongly linked.

At the Constitutional Convention in 1787, Madison expressed the prevailing view that “the freeholders of the country would be the safest depositories of republican liberty,” meaning only people who owned land debt-free, without mortgages, would be able to vote. The Constitution left voting rules to individual states, which had long-standing laws limiting the vote to those freeholders.

In the debates over the ratification of the Constitution, Madison trumpeted a benefit of the new system: the “total exclusion of the people in their collective capacity.” Even as the nation shifted toward broader inclusion in politics, Madison maintained his view that rights were fragile and ordinary people untrustworthy. In his 70s, he opposed the expansion of the franchise to nonlanded citizens when it was considered at Virginia’s Constitutional Convention in 1829, emphasizing that “the great danger is that the majority may not sufficiently respect the rights of the Minority.”

The founders believed that freedoms and rights would require the protection of an educated elite group of citizens, against an intolerant majority. They understood that protected rights and mass voting could be contradictory.

Scholarship in political science backs up many of the founders’ assessments. One of the field’s clear findings is that elites support the protection of minority rights far more than ordinary citizens do. Research has also shown that ordinary Americans are remarkably ignorant of public policies and politicians, lacking even basic political knowledge.

Is there a right to vote?

What Americans think of as the right to vote doesn’t reside in the Constitution, but results from broad shifts in American public beliefs during the early 1800s. The new states that entered the union after the original 13 – beginning with Vermont, Kentucky and Tennessee – did not limit voting to property owners. Many of the new state constitutions also explicitly recognized voting rights.

As the nation grew, the idea of universal white male suffrage – championed by the commoner-President Andrew Jackson – became an article of popular faith, if not a constitutional right.

After the Civil War, the 15th Amendment, ratified in 1870, guaranteed that the right to vote would not be denied on account of race: If some white people could vote, so could similarly qualified nonwhite people. But that still didn’t recognize a right to vote – only the right of equal treatment. Similarly, the 19th Amendment, now 100 years old, banned voting discrimination on the basis of sex, but did not recognize an inherent right to vote.

A painting of Andrew Jackson

Andrew Jackson of Tennessee. Ralph Eleaser Whiteside Earl/Wikimedia Commons

Debates about voting rights

Today, the country remains engaged in a long-running debate about what counts as voter suppression versus what are legitimate limits or regulations on voting – like requiring voters to provide identification, barring felons from voting or removing infrequent voters from the rolls.

These disputes often invoke an incorrect assumption – that voting is a constitutional right protected from the nation’s birth. The national debate over representation and rights is the product of a long-run movement toward mass voting paired with the longstanding fear of its results.

The nation has evolved from being led by an elitist set of beliefs toward a much more universal and inclusive set of assumptions. But the founders’ fears are still coming true: Levels of support for the rights of opposing parties or people of other religions are strikingly weak in the U.S. as well as around the world.

Many Americans support their own rights to free speech but want to suppress the speech of those with whom they disagree.

Americans may have come to believe in a universal vote, but that value does not come from the Constitution, which saw a different path to the protection of rights.

 

 

 

 

Declining antibodies and immunity to COVID-19 – why the worry?

https://theconversation.com/declining-antibodies-and-immunity-to-covid-19-why-the-worry-143323?utm_medium=email&utm_campaign=Latest%20from%20The%20Conversation%20for%20August%2026%202020%20-%201713516549&utm_content=Latest%20from%20The%20Conversation%20for%20August%2026%202020%20-%201713516549+Version+A+CID_ca860340297de2ef2c2c85020b74576b&utm_source=campaign_monitor_us&utm_term=Declining%20antibodies%20and%20immunity%20to%20COVID-19%20%20why%20the%20worry

Most people are aware that testing for antibodies in a person’s blood can show if someone has had a specific disease, such as COVID-19. Those antibodies provide protection from getting the disease again.

But in a paper published in the New England Journal of Medicine, researchers found that antibody levels decline in individuals who have recovered from COVID-19, dropping by half every 36 days. Does that mean people who have recovered from COVID-19 have lost their immunity?

I am a geneticist interested in innate immune response – the part of the immune system that we have at birth – and how the innate immune cells “educate” antibody-producing cells about a pathogen and how to identify and destroy it. As I’ll explain, antibodies are important for immunity, but they aren’t the only factor that counts.

Two arms of the immune system

The immune system is made up of two parts: innate immunity and adaptive – or acquired – immunity.

The innate immune system, which includes white blood cells called dendritic cells, monocytes and neutrophils, is present at birth and responds instantly to invaders. This group of white blood cells bombard pathogens with destructive chemicals and swallow and destroy viruses and bacteria. The innate immune system provides an instantaneous reaction to a pathogen. The problem is that it’s a blunt instrument – it responds the same way to all perceived threats.

The adaptive immune system, which is made up of B cells and T cells, must learn about a pathogen and its characteristics from the innate immune cells. This system takes longer to kick in, but the up side is that it is very specific and in many cases lasts a lifetime.

The immune system’s memory

The history of pathogen exposure is carried in so-called memory T cells and memory B cells. When an infection is defeated and gone, these cells reside in the peripheral tissues of the body such as lymph nodes or spleen and serve as a memory of the disease-causing virus. This immunological memory is responsible for the host defense and kicks into action in case of the second wave or attack of the pathogen.

It is normal for antibody levels to decline after a person has recovered from a disease. But the New England Journal of Medicine paper raised concerns because it suggests that we are losing our immunological memory – which is as bad as losing a real memory.

What role do T cells play in immunity?

B cells and antibodies are only part of the immune response. T cells help B cells produce antibodies – which are proteins that can bind to a specific pathogen and destroy it.

The way this happens is that first the B cells swallow the virus and start producing antibodies.

T cells cannot swallow the virus. But a type of white blood cell called an antigen-presenting cell can. After it does, it “shows” different parts of the virus to the T cells. The T cells then learn about the virus which they can now seek and destroy.

T cells also stick to the B cells and send them the activation signals that help B cells ramp up antibody production.

If antibodies decline, what does this mean for COVID-19 immunity?

It suggests that when there are fewer antibodies in the blood, there is a greater chance that a number of individual virus particles, called virions, will survive and escape destruction. Therefore, the remaining virions will continue to proliferate and cause disease.

What do declining antibody levels mean for establishing herd immunity?

Herd immunity refers to a population and occurs when a sufficiently high number of people within a community are immune to the virus and incapable of transmitting it. That provides protection for those who are still vulnerable. For example, if 60% of people are protected against COVID – because they have survived the infection and carry antibodies – it might protect (via less frequent interactions) the remaining 40% from getting sick.

But the results in the New England Journal of Medicine suggest that people with lower levels of antibody may still have the virus and may not have symptoms of the disease.

That means that if these people with low antibody levels hang around healthy, uninfected people, they present a danger to them because they can transmit the virus.

When antibody levels fall, does immunity disappear?

In general, the answer is no. If the virus attempts to cause a second infection, the memory B and T cells are able to recognize it, multiply million of times and defend the body against the virus, preventing it from triggering another full-blown infection.

The protection provided by memory T and B cells is the reason that vaccine-based protection works.

However, there are exceptions. A lifelong vaccine against the flu does not work because flu’s genetic code changes rapidly, altering the appearance of the flu, and therefore requires a new vaccine every season.

But with SARS-CoV-2, the problem as I see it, seems to be that those memory T cells and B cells seem to be wiped out.

Antibodies are proteins and last for only between three and four weeks in the blood circulation. To keep antibody levels high, B cells need to replenish them with a fresh supply. But in COVID-19, the declining antibody levels suggest that the cells that produce these antibodies are not present in sufficient numbers, which would explain the drop in antibody levels. Studies of how long immunity from COVID-19 last may shed more light, but for now we do not know the reason why.

 

 

 

 

Fake vs genuine people: 10 ways to spot the difference

Fake vs genuine people: 14 ways to spot the difference

Check Out 10 Ways To Identify Fake People - EKSUOLOFOFO

Not sure who you’re dealing with?

Fake vs genuine people may look the same, but with a little bit of knowledge, you can spot the difference.

Fake people are ingenuine and often hypocritical. They do things for their own gain but hide behind altruism.

Genuine people are true to themselves. They do things because they want to, not because they have to. Plus, they enjoy helping people.

Fake people aren’t just frustrating—they can even be damaging to your health.

In this article, I’ll break down the key difference between fake and genuine people, explain how to tell if someone is a genuine person, and share some tips on standing up for yourself.

Let’s begin.

Fake vs genuine people

The key difference between fake and genuine people is honesty.

Fake people aren’t honest with themselves and the people around them. They do things based on lies and deceit.

Genuine people are honest with themselves and others. Their actions are aligned with what they believe.

The problem is that fake people often don’t know they’re being fake. They may be acting based on lies without knowing how hypocritical they are being.

Fake people don’t know they’re fake because of self-deception.

How can you recognize someone is being fake?

5 things fake people often do

1) Lead people on

Fake people often lead people on because they are trying to please everyone. They spend so much time trying to please everyone else that a lot of people get let down in the process.

2) Cancel plans

Whether they never invite you out to do things in the first place or they cancel at the last minute, they’re fake. They’re probably so busy trying to please the other people that they made plans with that they have to cancel yours.

3) Talk about you behind your back

This is what’s really annoying about fake people. To your face, you’re their best friend. But as soon as you’re away, you’re nothing. They sit and gossip about you to make themselves look better to whoever it is they’re trying to impress.

4) Never get mad

You know who gets mad? Real people! Those who claim that they hardly ever get mad or frustrated about things are fake. Everyone is passionate about something, and everyone gets mad.

5) Disappear when you need them

Need help moving? Going through a difficult breakup? Fake people disappear right when you need them. As soon as you ask them for help, they are gone.

How to tell if someone is genuine

It can be hard to tell if someone is a genuinely nice person or if they are only being nice to you because they need something from you.

Unfortunately, many people are only out to help themselves, but there are still lots of genuine people walking around on the planet.

Here’s how you can spot a genuine person from a fake person.

1) Have a few close friends

Those who are authentic to their selves know that they can’t do everything. They can’t commit to dozens of people, so they have a few close friends that they really commit to.

2) Show up

When a true, genuine person makes plans with you, they’re going to show up. They don’t cancel on you last minute, and they aren’t going to make you wait for a “date” that’s never going to happen. They enjoy your company.

3) Admire people

Genuine people don’t gossip. Instead, they admire the positive qualities that they find in people around them. They talk about the positive, not the negative, and like to share good things.

4) Get angry and feel hurt

Real people feel things. They aren’t going to sugarcoat and act as though nothing bothers them. When genuine people are passionate about something, they’re here to show it. They invest their time and energy into their passions, and they’ll make it known.

5) There for you

When you’re hurting, genuine people hurt with you. They aren’t going to make you feel like you have no one. You can rely on them, and when something happens or you need a helping hand, they’ll be there.

Standing up to fake people

If you have fake people in your life, it’s essential to build the courage to stand up for yourself.

It’s not just about not being pushed around by this particular fake person, though this is important.

It’s also important because it teaches you to set boundaries.

This will make a big difference the next time someone fake enters your life.

I learned the importance of boundary-setting in Rudá Iandê’s free masterclass on embracing your inner beast. It’s a brilliant masterclass and completely changed how I see myself.

I used to think it was a bad idea standing up for myself. I would worry so much about what other people think.

By the time I finished watching Rudá Iandê’s masterclass, my perspective had completely shifted.

Are fake people bad for you?

Fake people are annoying, but are they actually bad for your health? Well, yes, they can be.

It takes time and energy to invest in a relationship, and when that investment is in something fake, it’s hurtful. But it goes beyond that.

Plenty of studies have found that there is a link between our relationships and our well-being. When our social relationships are complicated or one-sided, we feel worse. The strength of our connection to people is what really matters.

So, what does this mean?

Basically, if you have 20 friends, but none of them would come and pick you up after you’ve blown a tire, then your relationships aren’t that great.

But if you had just one or two friends that you could count on, that would show up when needed, the strength of that connection is great. This helps you to feel whole and connected to others, which is beneficial to your health.

Why are there so many fake people?

In today’s world, it seems like there are a lot more fake people than ever before. And it may be true. Thanks to social media and the notoriety that a person can gain from it, it seems like everyone wants to be famous.

To be famous, at least some people have to like you. So, a lot of people will act fake in hopes of getting a following and more people to like them. There are a lot of people who use the internet as a means to stop their loneliness, but it can just make it worse for them.

Why do people act fake?

People act fake because:

  • They aren’t happy with who they truly are
  • They want to feel better about themselves
  • They want people to follow them
  • They want to control others
  • They don’t like their life

Everyone is fake sometimes

The truth is when it comes to fake vs genuine people, everyone is fake sometimes. Whether you’re fake to your coworkers or your so-called friends is up to you. But being fake isn’t something that is good for us.

The opposite, being authentic, is what makes us better people. And while I’m going to talk a bit more about authenticity in a moment, I just want to say that anyone who is fake and putting on a show, isn’t worth your time. You make strong connections with others, and those are the friendships to keep.

How do you really know you’re dealing with a fake person? Well, I’m glad you asked. There are 10 easy ways to test whether the person you’re dealing with is fake or genuine.

10 ways to know you’re dealing with a fake person

Every fake person has 10 tell-tale signs that they’re fake. No matter how hard they try to hide how unauthentic they are, these signs say otherwise:

1) Full of themselves

It probably doesn’t come as a surprise, but fake people are full of themselves. They think that they’re better than everyone around them, and they love to brag. If you find that you have that one friend who is always trying to brag about their own accomplishments, they’re not being genuine.

2) Are manipulative

Fake people have a sort of “mob mentality.” They manipulate others and want everyone to believe what they believe. To do this, they will appeal to others’ emotions. Sometimes, they’ll bandwagon behind a “hot issue” or something that will give them the most notoriety.

3) Jaded with emotions

Like I mentioned before, fake people don’t do emotions well. Most of the time, they think that they’re a waste of time. Since it doesn’t get them ahead, they don’t do them.

Sure, they can fake emotions here and there to get a rise out of people and hope for more people to follow them. But, that’s about as far as they get. Their emotions are jaded, and when you come to them for help, they’re going to be emotionally there for you.

4) Judge you

Do you have a friend that is always judging you? A lot of times, fake people are insecure about what they have. They think that if you don’t believe the same things they do, then you’re wrong. To counteract their own insecurity, they judge you.

It doesn’t feel good. They even use this judgment as a way to try and get back control. Since they want to build their own egos up, they think that by putting you down, it makes them look better. This is where all of their energy is focused.

5) Have hostile humor

Though they may plaster on a kind smile and say nice things, when their humor comes out, it’s clear to see that they’re fake. Many people use hostile humor to try and hide the shame that they feel with their own selves.

Since fake people aren’t happy with their true, authentic selves, they use hostile humor to make them feel better. By putting you down, it builds them up. Then when you get mad about their hostile humor, they blow you off or act like it isn’t a big deal. Remember, they don’t “do” emotions.

6) Aren’t consistent

It’s that friend who always has a new idea. One moment they’re investing in stocks, the next moment their opening up an online store, and finally, they’ve found their dream of being a realtor.

Sound familiar?

Those friends who lack consistency and can’t stay still aren’t true to themselves. They’re as fake as they come, and they don’t care if they leave a big mess behind them.

7) Don’t learn lessons

Fake people don’t get a free pass when it comes to their mistakes, but they think that they do. When they do make a mistake, they aren’t going to admit to it. Or even if they do admit to it, they aren’t going to learn from it.

Genuine people recognize their mistakes and learn from them. Fake people would rather act like it never happened in the first place.

8) Unrealistic expectations

Not only do they put you down and try to control you, but fake people also have unrealistic expectations. They expect people to drop everything for them last-minute, but they wouldn’t do the same for you.

On top of that, they expect to have the best of everything. Often times, fake people are constantly buying new things, especially expensive ones. They want to showcase the success that they have, and they believe that their belongings are how they can do that.

9) Always need the attention

Having your engagement party? Well, your fake friend is about to announce a huge promotion. If they have the chance to steal the spotlight, they will. These people want to be the star of the show, and they don’t care what show it is.

Attention always has to be focused on this person because they demand it. They want to be noticed, and they need that praise from others to feel good about themselves. Unfortunately, it leads to a lot of hurt people when they do something toxic like this.

10) Don’t respect your boundaries

Maybe the biggest sign of fake people? They don’t respect your boundaries.

Once you talk to them, they blow you off. This can be if you bring up hurt feelings or some time where they made a mistake. Boundaries are nonexistent to them unless they were the ones that set them.

Because of this, these friendships can be hard to sever, and they can lead to a lot of pain. But anyone who doesn’t respect your boundaries is not worth keeping around in your life.

Be authentic and attract authenticity

When it comes to fake vs genuine people, it can be hard to know which is which. However, the 10 ways I’ve outlined is a great start. Because fake people usually look for people who will follow them or people who are easily controlled, the best way to get rid of fake people is by being authentic yourself.

As Rudá Iandê says, “Our world is full of fake perfection and happiness, but craving for authenticity.” It is by being your authentic self that you will find deep, lasting connections that will help you to lead a happy and healthy life.

Our lives are too short to spend investing in fake people. Choose to be yourself and be authentic, and you’ll find genuine people to share your life with.

 

 

 

 

FDA chief apologizes for overstating plasma effect on virus

https://abcnews.go.com/Health/wireStory/fda-commissioner-overstated-effects-virus-therapy-72595122?fbclid=IwAR3Um3rVuom9rJNCOvccmmTBDOrrRePEu1BX1VgRvAzYbpL2NATGjY2-1IY

FDA chief apologizes for overstating plasma effect on virus

Food and Drug Administration Commissioner Stephen Hahn is apologizing for overstating the life-saving benefits of using convalescent plasma to treat COVID-19 patients.

Responding to an outcry from medical experts, Food and Drug Administration Commissioner Stephen Hahn on Tuesday apologized for overstating the life-saving benefits of treating COVID-19 patients with convalescent plasma.

Scientists and medical experts have been pushing back against the claims about the treatment since President Donald Trump’s announcement on Sunday that the FDA had decided to issue emergency authorization for convalescent plasma, taken from patients who have recovered from the coronavirus and rich in disease-fighting antibodies.

Trump hailed the decision as a historic breakthrough even though the treatment’s value has not been established. The announcement on the eve of Trump’s Republican National Convention raised suspicions that it was politically motivated to offset critics of the president’s handling of the pandemic.

Hahn had echoed Trump in saying that 35 more people out of 100 would survive the coronavirus if they were treated with the plasma. That claim vastly overstated preliminary findings of Mayo Clinic observations.

Hahn’s mea culpa comes at a critical moment for the FDA which, under intense pressure from the White House, is responsible for deciding whether upcoming vaccines are safe and effective in preventing COVID-19.

The 35% figure drew condemnation from other scientists and some former FDA officials, who called on Hahn to correct the record.

“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction,” Hahn tweeted.

The FDA made the decision based on data the Mayo Clinic collected from hospitals around the country that were using plasma on patients in wildly varying ways — and there was no comparison group of untreated patients, meaning no conclusions can be drawn about overall survival. People who received plasma with the highest levels of antibodies fared better than those given plasma with fewer antibodies, and those treated sooner after diagnosis fared better than those treated later.

Hahn and other Trump administration officials presented the difference as an absolute survival benefit, rather than a relative difference between two treatment groups. Former FDA officials said the misstatement was inexcusable, particularly for a cancer specialist like Hahn.

“It’s extraordinary to me that a person involved in clinical trials could make that mistake,” said Dr. Peter Lurie, a former FDA official under the Obama administration who now leads the nonprofit Center for Science in the Public Interest. “It’s mind-boggling.”

The 35% benefit was repeated by Health and Human Services Secretary Alex Azar at Sunday’s briefing and promoted on Twitter by the FDA’s communication staff. The number did not appear in FDA’s official letter justifying the emergency authorization.

Hahn has been working to bolster confidence in the agency’s scientific process, stating in interviews and articles that the FDA will only approve a vaccine that meets preset standards for safety and efficacy.

Lawrence Gostin of Georgetown University said Hahn’s performance Sunday undermined those efforts.

“I think the integrity of the FDA took a hit, if I were Stephen Hahn I would not have appeared at such a political show,” said Gostin, a public health attorney.

Hahn pushed back Tuesday morning against suggestions that the plasma announcement was timed to boost Trump ahead of the Republican convention.

“The professionals and the scientists at FDA independently made this decision, and I completely support them,” Hahn said, appearing on “CBS This Morning.”

Trump has recently accused some FDA staff, without evidence, of deliberately holding up new treatments “for political reasons.” And Trump’s chief of staff, Mark Meadows, said over the weekend that FDA scientists “need to feel the heat.”

The administration has sunk vast resources into the race for a vaccine, and Trump aides have been hoping that swift progress could help the president ahead of November’s election.

At Sunday’s briefing Hahn did not correct Trump’s description of the regulatory move as a “breakthrough.” He also did not contradict Trump’s unsupported claim of a “deep state” effort at the agency working to slow down approvals.

Former FDA officials said the political pressure and attacks against the FDA carry enormous risk of undermining trust in the agency just when it’s needed most. A vaccine will only be effective against the virus if it is widely taken by the U.S. population.

“I think the constant pressure, the name-calling, the perception that decisions are made under pressure is damaging,” said Dr. Jesse Goodman of Georgetown University, who previously served as FDA’s chief scientist. “We need the American people to have full confidence that medicines and vaccines are safe.”

Convalescent plasma is a century-old approach to treating the flu, measles and other viruses. But the evidence so far has not been conclusive about whether it works, when to administer it and what dose is needed.

The FDA emergency authorization is expected to increase its availability to additional hospitals. But more than 70,000 Americans have already received the therapy under FDA’s “expanded access” program. That program tracks patients’ response, but cannot prove whether the plasma played a role in their recovery.

Some scientists worry the broadened FDA access to the treatment will make it harder to complete studies of whether the treatment actually works. Those studies require randomizing patients to either receive plasma or a dummy infusion.