Kenvue (NYSE:KVUE) rose 6.6% in after hours trading after a court ruled in it favor in a class action lawsuit alleging prenatal exposure to Tylenol
Monday, December 18, 2023
INmune: maintaining timeline to successfully conclude Alzheimr's trial amid hold
Enrollment in the Company’s Phase II study using XProTM to treat patients with Alzheimer’s Disease with neuroinflammation is accelerating in sites outside the US and the Company is maintaining its timeline to successfully conclude the trial.
In the US, the previously identified clinical hold issues have been successfully addressed however the Phase II study remains on clinical hold pending additional information on long-term stability which the Company will provide before the end of 2023.
1 Government Drug Program Is Devouring American Healthcare
Hospitals are locked in a dispute with the Department of Health and Human Services (HHS) over how much the government owes them in back pay for a drug-reimbursement program. But this argument is just a symptom of a much bigger and more urgent problem.
The issue revolves around the 340B Drug Pricing Program, under which HHS covers drugs for hospitals that meet certain requirements. After payments were suspended for several years, the government settled on a plan to pay the funds but claw some of the money back, ultimately leaving hospitals ahead by $2.7 billion. Yet hospitals claim there should be no claw-back, and that paying them “only” $2.7 billion will leave them in dire financial straits.
If that sounds convoluted, it is. The roots of the problem go way back. While started with good intentions, the 340B program has become a waste of federal money that enriches hospitals and for-profit pharmacies at the expense of patients. The whole system needs reform.
In 1992, Congress instituted the 340B program to let health care providers serving low-income communities buy drugs at steep discounts. The idea was that helping out these hospitals and clinics financially would enable them to better serve the most vulnerable patients.
But Congress forgot to include a few important details. The 340B law doesn’t expressly state how providers should use their savings. They can spend the extra cash however they please, without oversight or obligation. Over the past 30 years, hospitals have taken full advantage of that lack of detail to reap billions of dollars in profit.
Meanwhile, the program isn’t too picky about which hospitals qualify for the discounts. They are supposed to go to facilities that serve a “disproportionate share” of low-income patients. But in recent years, the number of providers benefiting from 340B payments has exploded, to include hospitals in wealthy communities that just have one small branch clinic in a rural area or low-income urban neighborhood.
Between 2000 and 2020, the number of sites participating in the 340B program increased by more than 500% — from 8,100 to over 50,000. Many of these institutions game the system by buying discounted drugs under 340B, then dispensing them at full price to insured patients. Last year, the difference between the discounted 340B price and the list price for all drugs acquired under the program was $52.3 billion.
So what are hospitals doing with that taxpayer-sponsored windfall? It would be one thing if the rise in 340B revenue coincided with a rise in charity care, but hospitals have actually decreased what they spend on it. A 2018 study by the Center for Regulatory Effectiveness found that the ability of people in severe economic hardship to afford medical care was actually negatively correlated with the growth of the 340B program.
For-profit pharmacy chains also benefit from 340B largesse. More than half of the pharmacies in the country — some 32,000 locations — are contracted to dispense prescription medicine for providers in the 340B program. Not to be left out of the money grab, they negotiate complex profit-sharing plans with hospitals, the details of which are shrouded in secrecy. But one thing is clear: Many prescriptions filled at these contract pharmacies are dispensed to patients with insurance, not the poor and uninsured patients 340B was meant to help.
A recent report by the Berkeley Research Group found that the average profit margin on commonly dispensed 340B drugs is 72 percent, but only 22 percent for non-340B drugs. In some instances, pharmacies recoup full market value on drugs that cost very little to buy at discount.
It’s clear that over three decades, 340B has deteriorated from a well-intentioned (if somewhat half-baked) plan to help struggling patients into a government-funded profit center for hospital groups and pharmacy chains.
So while hospitals complain that HHS isn’t paying them enough, they’re shining a light on a much bigger problem: that the whole 340B drug program has slid off the rails due to lack of government oversight and rapacious corporate healthcare players. It’s time for Congress to overhaul the whole system.
Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.
https://dailycaller.com/2023/12/14/pitts-340b-hhs-clawback-reimbursement-program-pharmacies/
Government must encourage personal responsibility, prohibit easy access to Medicaid
Facts matter. To solve the nation’s looming long-term care financing crisis, policymakers must deal with one key fact. Most people do not consume their life savings paying for this care.
People believe this fallacy of impoverishment because so many older adults end up on the Medicaid welfare program, often in nursing homes. But the truth is that most people can easily access Medicaid when they need long-term care, or LTC. There are income and asset tests to gain eligibility for Medicaid, but for most people, the income test is irrelevant, and the asset test is easily satisfied.
On the income test, in most states, Medicaid subtracts applicants’ monthly health and LTC expenses from income before applying the “low income” standard, so only older Americans with a very high income fail this test. In other states, higher-income people can use sophisticated income diversion trusts to qualify.
On the asset test, most old people’s wealth is exempt. This includes most home equity, individual retirement accounts, a business, one vehicle, prepaid burial expenses, home furnishings and other belongings. Medicaid applicants can reduce nonexempt wealth by purchasing a new car or having their home remodeled. There is an army of elder law attorneys who specialize in helping clients arrange their assets to qualify for Medicaid. These lawyers are often hired by heirs to preserve their inheritances.
The data proves this story. Americans spent $530 billion on LTC in 2021, but little was from people spending down their life savings. In fact, only about 12% were out-of-pocket expenditures, or people spending their income or savings.
Medicaid and Medicare paid 60%, private health insurance covered 9%, and other third-party payers defrayed 19%.
What’s more, half of reported out-of-pocket expenditures are Social Security benefits that people already on Medicaid must contribute toward the cost of their care. In sum, only about $6 of every $100 spent on LTC could have been derived from people’s savings.
The easy availability of Medicaid to pay for LTC creates a moral hazard that discourages responsible LTC planning early in life. Why save, invest or insure for LTC when you don’t know if you’ll need it and, if you do, the government pays anyway?
It also perpetuates a long-standing bias toward low-quality nursing care caused by Medicaid’s meager payment rates, which is the root of why nursing homes can’t find enough high-quality staff to take care of residents.
A new Paragon Institute report written by one of us (Steve Moses) argues that the solution is simple: Make Medicaid harder to access. Doing so would lead to a surge of private financing flowing into the LTC service delivery system, improving access, quality and staffing.
Older Americans hold $36.7 trillion in retirement assets, $12.7 trillion in home equity, $21.8 trillion in life insurance, and trillions more in property uncounted by Medicaid. Rather than sheltering those assets to qualify for welfare, imagine if that wealth were tapped for LTC. Recent research shows that investing $70,000 at age 65 would fund the average person’s expected LTC need.
Making it more difficult to shelter assets and qualify for Medicaid would place younger people on notice: They need to prepare for LTC. For most people, LTC risk should be a personal responsibility, like life insurance or homeowners insurance. Policymakers should let them carve out portions of savings they’re already accumulating for other reasons to cover potential LTC needs.
If people do not need LTC, the remaining wealth will pass to their heirs unencumbered. If they do need LTC, they will have funds to purchase access to high-quality care in the private market, which for many would be excellent in-home care.
Medicaid, relieved of its dominant LTC financing role, would provide more appropriate care at higher rates, supporting a desperately needed paid caregiver workforce and saving and improving the country’s LTC safety net for those most in need.
Well-intentioned government policy tried to help people but ended up trapping generations in nursing homes on welfare. The government must now solve the problem it created by encouraging personal responsibility and prohibiting easy access to Medicaid while preserving wealth. This will naturally lead our nation’s consumers and providers to solve the LTC system challenges.
• Steve Moses is president of the Center for Long-Term Care Reform and author of “Long-Term Care: The Solution,” recently published by the Paragon Health Institute. Brian Blase, who served as a special assistant to former President Donald Trump at the National Economic Council, is president of the institute.
https://www.washingtontimes.com/news/2023/nov/30/government-must-encourage-personal-responsibility-/
Uncovering Covid Origins: Why Congress Must Breach Biden’s Stonewall
Next month, the House Select Subcommittee on the Coronavirus Pandemic will interview Dr. Anthony Fauci, the former director of the National Institute of Allergy and Infectious Diseases (NIAD). After two days of behind-closed-doors interviews, the subcommittee will schedule a public hearing to take his sworn testimony.
Fauci’s testimony will doubtless cover a wide variety of topics, ranging from masking to vaccine mandates. But rest assured that congressional investigators will zero in on Fauci’s knowledge of, and response to, crucial information concerning the origins of the pandemic in China.
To secure a fully transparent accounting, House and Senate investigators are also pressing the Administration to release key details about what Fauci and his colleagues knew about the origin of the pandemic, and when they knew it. But Biden administration officials continue to stall the release of relevant information, offering transparently lame excuses, to block congressional access and public disclosure of unredacted documents.
Team Biden’s persistent lack of transparency on Covid-19 has been nothing short of scandalous. Here is the latest proof:
Exhibit A: Blocking Document Disclosure. In October 2017, well before the outbreak of the Covid-19 pandemic, Dr. Ping Chen, an NIAID official, visited the Wuhan Institute of Virology in October 2017 and prepared a trip report for top NIAID officials.
Sens. Rand Paul (R-Ky.) and Ron Johnson(R-Wisc.) learned of the trip four years later and, in August 2021, wrote HHS Secretary Xavier Becerra and acting NIH Director Lawrence Tabak asking them to release unredacted records of Chen’s visit to Wuhan. In response, HHS instead provided a heavily redacted copy of Chen’s report, plus redacted emails.
In a subsequent briefing for Senate staff, Dr. Melanie Egorin, HHS Assistant Secretary for Legislation, said the redactions were for “security” reasons. But that excuse was clearly incorrect because, as the senators noted, HHS had already conceded that national security was not at issue and the documents themselves were unclassified. As Sen. Johnson remarked, “Given HHS’s extensive redactions of unclassified documents, I can only assume that the true nature of HHS’s ‘security’ interest is to protect itself from additional embarrassment over its handling of the Covid-19 pandemic.”
Sen. Johnson has since renewed his request to interview Dr. Chen and asked for a complete and unredacted copy of her report and related documents. Thus far, no response.
Exhibit B: Flaunting Federal Records Rules. On June 11, 2021, Johnson, Paul and three other Senate colleagues sent Secretary Becerra a letter requesting documents relating to NIH officials’ response to the pandemic’s origins. The senators had learned that Dr. David Morens, senior scientific adviser to Dr. Fauci, had emailed Dr. Peter Daszak, president of EcoHealth Alliance, on January 9, 2020, asking Daszak for any “inside info” on the novel coronavirus. Daszak replied that NIAID had been funding coronavirus research for “the past five years” and taxpayer monies had been funneled to the Wuhan Institute of Virology. For several years, Daszak’s controversial firm had indeed gotten substantial NIAID funding; and the Wuhan Institute of Virology, which had been a center of China’s coronavirus research, had been a subcontractor of the EcoHealth Alliance.
According to Sen. Johnson’s account, upon receipt of the June 2021 letter, Morens told Daszak and a small group of his colleagues that he had retained “very few” documents on these “matters.” Morens cautioned the group to correspond with him outside of official channels at his Gmail address, adding, “I have tried to make sure I have retained no documents that might lead other members of ASTMH to be approached for similar document production.” (ASTMH stands for the “American Society of Tropical Medicine and Hygiene,” Morens’ little group).
Among those receiving this Gmail warning were three prominent virologists, Dr. Kristian Andersen, Dr. Robert Garry and Dr. Edward Holmes, who had published a prominent 2020 article in Nature Medicine arguing that a Covid lab origin was “improbable.” That article was a sharp and rapid reversal of their original assessment of an “unnatural” origin of the coronavirus.
When Sen. Johnson learned in August of 2023 that Morens was apparently using his personal Gmail in communications concerning Covid origins, he wrote Christi Grimm, HHS Inspector General, asking her to investigate the apparent attempt to use to evade requests for public information under the Freedom of Information Act.
Johnson also told Grimm that an unnamed whistleblower claimed that NIH officials may have destroyed sensitive federal records related to the Wuhan Institute of Virology, a serious criminal offense with severe penalties. For their part, NIH officials claimed they conducted an internal investigation of that allegation, and determined to their own satisfaction that the charge was without merit. Satisfied that there was nothing more to it, the National Archives and Records Administration (NARA), the agency charged with the preservation of official records, also dropped its inquiry into the matter.
Remarkably, Grimm rejected Johnson’s request for a Senate staff briefing on the controversy, claiming that it is standard practice to “neither confirm nor deny” the existence of ongoing investigations. Johnson nonetheless renewed his request that Grimm investigate Morens’ use of Gmail to conduct agency business, the alleged NIH destruction of official agency records, and any effort by Morens or and others to evade the Freedom of Information Act. But she denied the request once again.
In a November 15, 2023 letter to Secretary Becerra, recounting the foregoing facts, Senator Johnson tried again:
I request you immediately provide complete responses to my June 2021 and March 2023 letters on the origins of Covid-19—including responsive records contained in Dr. Morens’ Gmail account—produce all text messages or communications contained in Dr. Morens’ HHS-issued cell phones(s) dated from June 1, 2019 - present, and provide a detailed explanation for how HHS will hold Dr. Morens accountable for his apparent mishandling of federal records and potential violations of federal record keeping laws. I also request that HHS make Dr. Morens available for an interview with my Subcommittee staff. Please provide this information and interview by no later than December 6, 2023.
Thus far, no response.
Closing In. Senator Johnson and his colleagues do not have subpoena power. As he told this writer, “I am attempting to convince Chairman Blumenthal to issue subpoenas to the non-responsive agencies. If that proves unsuccessful, you can rest assured that, if I become Chairman of the Permanent Subcommittee on Investigations, subpoenas will be issued and enforced.”
House Republicans do, however, have subpoena power. When Dr. Fauci testifies early next year before the House Select Subcommittee on the Coronavirus Pandemic, congressional investigators should probe his recollections concerning Dr. Chen’s report and Dr. Morens’ intriguing communications.
During his November 2022 deposition in the federal case of Missouri vs Biden, Fauci said he could not recall 174 times in response to questions related to the Covid pandemic. House investigators will thus have an excellent opportunity to refresh his memory on what he learned about the origins of the deadly disease, when he learned it, and how he responded.
Robert E. Moffit, Ph.D., is a senior fellow in domestic policy studies at The Heritage Foundation.
Michael Dreeben, The Man Behind Three Major Anti-Trump Operations
Eyebrows were raised last week when it was discovered that Special Counsel Jack Smith had added attorney Michael Dreeben to his legal team.
“An interesting detail: Michael Dreeben somehow snuck into Jack Smith’s office. He was Mueller’s appellate guy,” enthused Marcy Wheeler, a proponent of the debunked conspiracy theory that Donald Trump stole the 2016 election by colluding with Russia.
Fellow Russia-collusion hoaxer Rachel Maddow of MSNBC ran an entire segment to announce the exciting news that Dreeben is “helming this part of the case,” meaning Smith’s request to the Supreme Court to look at whether American presidents may be prosecuted for actions taken while they are president. Left-wing legal activist (and, yes, another bitter clinger Russia-collusion hoaxer) Joyce Vance said her “friend” Dreeben had “framed this petition” before the Supreme Court.
Mueller, of course, is Robert Mueller, the ostensible head of the Mueller probe that treated the Russia conspiracy scam as credible and leaked information to the propaganda press to ensure it had maximum effect. After 18 months, the investigation concluded with not a single American, much less a single Trump official, being found to have colluded with Russia to steal the 2016 election. On the way to that conclusion, it wreaked havoc on Republicans across the country, and a strong majority of Democrats still believe the “big lie” that Russians stole the 2016 election for Donald Trump.
Real Leaders of Mueller Probe
As anyone who saw the visibly struggling Mueller testify in July 2019 knows, he wasn’t in a mental position to lead the operation. That was left to key operatives, including more than a dozen Democrats. For example, Mueller selected partisan Andrew Weissmann for a key role. In addition to his ethically flawed prosecutions of Enron executives, he was at Hillary Clinton’s ill-fated 2016 Victory Night Party. The inspector general report showed him as a full participant in the Russia-collusion hoax. After the Mueller probe, Weissmann went on to raise money for Joe Biden’s presidential campaign. Weissmann was also part of the team at left-wing legal group Just Security that unofficially wrote Jack Smith’s indictment of Trump over classified documents.
As partisan as Weissmann was, and continues to be in his role at left-wing propaganda outlet MSNBC, he wasn’t even the actual leader of the Mueller lawfare strategy. That was the much more subtle, much more careful, and much less sloppy Michael Dreeben.
Dreeben was “leading the special counsel’s defense each step of the way,” Politico wrote in 2018 when it put him in the top 10 of its “power list.” He is widely seen as being in charge of Mueller’s “overall legal strategy.” When Mueller picked Dreeben, former Chuck Schumer staffer and anti-Trump “resistance” hero Preet Bharara praised the pick.
That was important because even though the Mueller team knew from the outset that the Russia-collusion theory it perpetuated was false, it pursued a novel legal strategy of trying to build an impeachment case that Trump “obstructed justice” when he protested the Democrat-designed and Democrat-funded Russia-collusion lie. It is also worth noting that the Mueller probe, for fairly obvious reasons, never investigated how the Russia-collusion theory was designed and funded by Democrats, developed with the help of Russian operatives, and integrated into the federal government’s unconstitutional resistance of a duly elected president. Covering up those facts was, in fact, the purpose of the Mueller probe.
Not His First Dem Operation
Now Dreeben has joined the Biden administration’s effort to try to convict Trump on Jan. 6-related charges before the 2024 election. This is not the first Democrat effort Dreeben joined. He was also brought on to help Democrat Manhattan District Attorney Cy Vance’s successful effort at the Supreme Court in 2020 to get Trump’s taxes and related financial records.
New York Magazine reported that Dreeben was part of a key group of former Mueller prosecutors brought in by Vance to figure out ways to politically prosecute Trump. They weren’t the only lawyers brought into the Democrat operation. Vance secured legal help from a Biden-connected law firm in New York City to design the “get Trump” operation. The powerhouse law firm Paul, Weiss, Rifkind, Wharton & Garrison lent Michael Pomerantz, Elyssa Abuhoff, and Caroline Williamson to Vance. The law firm had held a $2,800-per-plate fundraiser for Biden during his presidential campaign.
By the spring of 2023, Dreeben was publicly noting his affiliation with Just Security, “the legal beachhead of the Trump resistance.” The group helped launder Mueller probe legal theories into the general public and helped transition the Russia-collusion impeachment theory to the Ukraine issue once it became apparent that the Russia hoax was only believed by Democrats in echo chambers. Dreeben left the federal government in June 2019 after the Mueller probe ended, and he was viewed by Republican congressional staffers as being involved in Democrats’ impeachment efforts later that year along with Norm Eisen. Eisen, a frequent author at Just Security, was the House Democrats’ counsel for the 2019 impeachment.
Dreeben is one of the most experienced advocates before the Supreme Court, having argued 105 cases during his time in the solicitor general’s office. That the elite attorney is helping Democrats with their 2024 campaign strategy of lawfare is significant and showcases how much coordination between key Democrat operatives is behind this Soviet-style attempt to imprison President Joe Biden’s political opponents.
Democrat prosecutors began indicting Donald Trump and other Republican political opponents earlier this year. Democrat Manhattan District Attorney Alvin Bragg, Vance’s successor, indicted Trump in March in a widely panned case involving payments to Stormy Daniels during the 2016 election. After the shocking raid on Mar-a-Lago in August 2022, Special Counsel Jack Smith indicted Trump in Florida in a classified documents case in June 2023. Democrat activist Fani Willis indicted Trump and more than a dozen other Republicans in August for contesting the poorly run 2020 election in Georgia. Smith also indicted Trump in Washington, D.C., in August on charges related to the Jan. 6 protest of the controversial 2020 election.
This is all happening while the Democrat New York Attorney General Letitia James, who ran on an explicit campaign of using lawfare to harm Trump, is attempting to seize the Trump family business as punishment for his political views.
The focus on Smith’s second indictment in Washington, D.C., is occurring along with the realization that the other cases might not secure the quick and easy convictions in front of biased juries that are the hallmark of other show trials.
Mexican food retailers to maintain price limits on key staples -official
Mexico's main food retailers have agreed to maintain a deal with the government to limit the prices of 24 basic food staples in order to help tame inflation, a government official said on Monday.
President Andres Manuel Lopez Obrador last week said the government was seeking to extend the 2022 pricing agreement to keep inflation in Latin America's No. 2 economy on a downward trend.
David Aguilar, who heads state consumer protection office Profeco, said authorities met last week with Walmart's Mexican arm and the country's retailers' association ANTAD, which groups together over 47,000 establishments.
"All of them reiterated their commitment to continue maintaining the prices of the 24 basic food products, as in the original PACIC agreement," Aguilar said.
PACIC, signed in 2022 as inflation reached highs not seen in two decades, was used to protect prices for key staples such as corn used to make tortillas.
Mexico's central bank meanwhile raised its benchmark interest to historic record of 11.25% and has maintained it at this level since March.
Inflation slightly sped up in November to 4.32% over 12 months, compared to 4.26% in October when it hit its lowest point since early 2021, although the core inflation metric continued to decline.
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