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Thursday, February 16, 2023

Medicare Extends Coverage of Natera Test to Breast Cancer

 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced that it has received written confirmation from the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostics Services Program (MolDX) that Natera’s Signatera molecular residual disease (MRD) test has met coverage requirements for adjuvant and recurrence monitoring in patients with stage IIb or higher breast cancer. The coverage applies across all subtypes of the disease, including hormone receptor (HR)-positive, HER2-positive, and triple negative breast cancers. This decision adds to Medicare’s prior coverage of Signatera in colorectal cancer, muscle-invasive bladder cancer, and pan-cancer immunotherapy monitoring.

https://finance.yahoo.com/news/medicare-extends-coverage-natera-signatera-130000835.html

10X Genomics 2023 Guidance, Call

 2023 Financial Guidance 

10x Genomics expects full year 2023 revenue to be in the range of $580 million to $600 million, representing 12% to 16% growth over full year 2022 revenue.

Webcast and Conference Call Information

10x Genomics will host a conference call to discuss the fourth quarter and full year 2022 financial results, business developments and outlook after market close on Wednesday, February 15, 2023 at 1:30 PM Pacific Time / 4:30 PM Eastern Time. A webcast of the conference call can be accessed at http://investors.10xGenomics.com. The webcast will be archived and available for replay for at least 45 days after the event.

https://finance.yahoo.com/news/10x-genomics-reports-fourth-quarter-210500921.html

Outage at JFK Airport leads to delays, confusion

 A huge power outage led to flight delays at John F. Kennedy Airport in New York City Monday night.

Power was restored late Monday and screenings for international resumed.

However, there are still some international arrival delays at Terminal 5 as result of the outage, according to the airport.

The outage led to long lines, non-working computers and confusion.

There's no word yet on what led to the power outage.

https://abc7ny.com/jfk-airport-power-outage-flight-delays-john-kennedy/11812966/

  

Blinken Warns Ukraine Against Seizing Crimea In About-Face

 In a bit of an about-face for Washington based on past officials' more aggressive posture, US Secretary of State Antony Blinken now says the administration is not actively encouraging Ukraine to seize Crimea. 

Politico reports of his words that "A Ukrainian attempt to retake Crimea would be a red line for Vladimir Putin that could lead to a wider Russian response, Secretary of State Antony Blinken said in a Zoom call with a group of experts Wednesday."

Specifically the top US diplomat said America is not "actively encouraging" Ukraine to liberate Crimea from Russia, the Wednesday report said.

Instead, any potential future Crimea offensive will be "Kyiv's decision alone" - this despite a recent past history of rhetoric out of both Republican and Democratic administrations which have continually asserted over the years that "Crimea is Ukraine."

The response was prompted by a reporter's question on whether or not the US would assist Ukraine in retaking all territory previously seized by pro-Kremlin forces. Politico details more of Blinken's response as follows:  

Blinken, according to two of the people, gave the impression that the U.S. doesn’t consider a push to retake Crimea to be a wise move at this time. He didn’t say those words explicitly, they underscored.

Two other people didn’t take Blinken’s comments that way. The secretary remarked that it is solely the Ukrainians’ decision as to what they try to take by force, not America’s. That signaled to them that Blinken was more open to a potential Ukrainian play for Crimea.

All of this comes as Western media and officials reluctantly acknowledged that Russian forces have the upper hand in Donetsk and are poised to take the strategic city of Bakhmut, having it surrounded.

Meanwhile, NATO secretary general Jens Stoltenberg this week issued a rare admission concerning the history of the Russia-Ukraine conflict. 

Stoltenberg admitted that the war in Donbass has been going on since 2014 - which appears to validate a key aspect of Russia's framing of the conflict narrative and why Putin ordered the invasion:

Drug Development in America is Strong, but the IRA Unintentionally Weakens It

 Americans today are benefiting from significant innovation across multiple therapeutic areas. We are on the cusp of highly effective treatments in obesity and important progress is being made in the fight against notoriously challenging diseases like Alzheimer’s. The state of drug development in America is strong. But we cannot take it for granted and we must protect it against short-sighted policies not in the best interest of patients.

In President Biden’s State of the Union address, he touted the Inflation Reduction Act (IRA) as a major legislative accomplishment. However, within this sweeping legislation, the IRA fails by placing a drastic penalty on small molecule drug discovery, penalizing patient care along with it. Perhaps this was done out of legislative accident, but the fact remains that bad public policy is a great threat to biomedical innovation.

As part of the IRA’s Medicare price control provisions, negotiation for small molecule medicines is allowed 9 years after U.S. Food and Drug Administration (FDA) approval compared to 13 years for large molecule biologics. This distinction – for which there is no legitimate scientific or policy reason – shifts economic incentives away from small molecules which have important patient benefits over large molecule biologics. 

Unlike biologics that are injectables or infusions, small molecules drugs are pills that can be taken orally. Pills are easier for patients to pick up from their local pharmacy or have delivered to their home, which means they don’t need transportation to an infusion clinic or physician’s office. Importantly, this ease of administration helps patients stay adherent. 

Further, small molecule drug discovery has advanced tremendously over the past decades, including the creation of precision medicines that disrupt disease processes and reach previously believed “undruggable” targets that large molecules cannot. There are certain conditions where the biology of the disease can only be targeted with a small molecule. For example, due to their “small” size, they can be delivered to the brain and central nervous system enabling them to treat diseases that might otherwise be intractable. Patients with certain cancers and rare diseases are already benefiting from breakthrough small molecule medicines.

So why does IRA make this distinction? It’s not entirely clear. Lawmakers may have simply overlooked the scientific advances that have resulted in these precision small molecule medicines – which are just as complex to discover as large molecule biologics. Unfortunately, this “oversight” is already having a real impact as companies are forced to recalibrate how they make business decisions about its R&D programs. There will be cases where companies opt against pursuing the research needed for additional indications.

In a retrospective example, FDA approved Lilly's CDK4/6 inhibitor in 2017 to treat advanced metastatic breast cancer. Lilly then invested in post-approval studies and in 2021 FDA approved the same product in combination with endocrine therapy to treat early-stage high-risk breast cancer in 2021. This approval marked the first treatment advancement in the early breast cancer setting in nearly 20 years. Had IRA been in-place four years earlier, Lilly would have been navigating a very different set of considerations. With effectively less than a 9-year horizon to recoup R&D costs, calculations could have potentially disfavored making the investment in clinical trials that led to an important advance in patient care. 

At Lilly, small molecule treatments represent 40% of our overall portfolio and the majority of our oncology pipeline. Industry-wide, small molecules still dominate R&D and, in 2020, represented 75% of all new medicines approved in the U.S. However, these numbers are set to shift dramatically. A recent survey found 63% of biopharmaceutical companies reporting that under this provision, all else being equal, they expect to shift R&D investment focus away from small molecule toward biologic medicines.

Based on the same survey, more than 80% of companies expect “substantial impacts” on the cancer, cardiovascular, mental health, neurology, and rare disease R&D projects in their pipelines.

As the IRA continues to reshape the biomedical innovation ecosystem, we will see how much of it will be to the detriment of patients.

But this path doesn’t need to be the reality. Congress can fix this needless penalty and establish parity for Medicare negotiation at 13 years for both small and large molecule drugs, creating a level playing field for the development of these different modalities. Science and patient need – not bad policy – should dictate the path for drug development. Patients don’t care whether a drug is “small or large.” They just need treatment options that make their lives better. 

Shawn O’Neail is senior vice president of global government affairs at Eli Lilly and Company.

https://www.realclearpolicy.com/articles/2023/02/15/the_state_of_drug_development_in_america_is_strong_but_the_ira_unintentionally_weakens_it_882012.html

Time to Hold the EPA to Account for Meddling in Markets

 More and more, government regulations are encroaching on free markets. Generally, such actions are taken in the name of preserving the economy or for consumer benefit, but too often they have the opposite effect. It is now time for leaders in Washington to take a step back and examine the consequences of this overregulation.

Domestic energy companies have been struggling under overly restrictive regulations for years. Environmental impact studies that stretch on indefinitely, drilling bans on federal lands, and overly restrictive rules surrounding greenhouse gas emissions threaten to reversed years of gains that for the first time in 62 years had made America energy independent. Now, regulators have set their sights on chemical companies and the effects could be equally damaging.

Reports indicate that the Environmental Protection Agency (EPA) is in the process of finalizing a rule that would label a certain class of chemicals known as per- and polyfluoroalkyl substances (PFAS) as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), commonly known as Superfund. The proposed EPA designation is in effect a reaction to recent research that has alleged exposure to certain forms of PFAS compounds can cause specific health issues despite the fact that the science on this issue is uncertain.

Many of the chemicals in question in these studies – including PFOA and PFOS – were already voluntarily phased out by industry more than 20-years ago and their levels have been dropping in the environment since then. But the alarmism, misinformation, and regulatory uncertainty the EPA has generated around the modern PFAS chemicals that are safely made and used today have made their continued use untenable. As one major PFAS producer put it, “customers are taking note of PFAS regulations. They’re looking for alternatives.”

In response to this proposed designation and “accelerating regulatory trends” around PFAS that are changing the business case for continuing to produce these chemicals, 3M, a major manufacturer of PFAS chemicals, announced its intent to phase out production of PFAS chemicals by 2025. While Wall Street analysts approve of the move, calling it “a step in the right direction” such government regulations leave businesses with few other options.

Despite industry’s best efforts to avoid such outcomes, these regulations will likely have negative implications for millions of American consumers. PFAS chemicals are contained in products that millions of Americans use every day. The semiconductors in our smartphones, nonstick cookware in our kitchens, and many personal care products in our bathrooms – including shampoo, makeup and even dental floss – all contain PFAS chemicals. 

Demand will not cease overnight for PFAS chemicals if the EPA moves forward with this designation. Americans may also be faced with increased costs until new compounds can be created and brought to market, and supply chains are retooled to incorporate smaller providers of PFAS chemicals that will fill the gap in the interim.

Even when industry comes up with scalable and adequate replacements for PFAS, Americans will still suffer the consequences of these overreaching PFAS regulations in other ways. Many of the environmental guidelines set by this proposed Superfund designation are well outside international norms. 

Given the fact that PFAS is in so many consumer goods we use today, almost all residential waste could be deemed hazardous. For example, according to the National Waste & Recycling Association increased costs with PFAS management could total as much as $6.27 billion for municipal landfills. The drinking water quality guidelines that the EPA has proposed meanwhile, would make the United States an international outlier as they are in some cases 25,000 times more stringent than existing World Health Organization (WHO) guidelines. Ultimately it would be taxpayers and utility ratepayers that will be saddled with these billions in unnecessary cleanup and remediation costs. 

As major chemical companies choose to phase out PFAS chemicals as opposed to work within the framework the EPA has proposed, it is clear that these regulations are too onerous and the proposed Superfund designation is too heavy-handed. Time and time again the EPA has been criticized for taking this exact action and altering the regular course of business. It is time to push back, reclaim free markets, and hold the EPA accountable for providing reasonable regulations.

Dr. Michael Busler, Ph.D., is a public policy analyst, economics expert and a professor of finance at Stockton University in New Jersey.

https://www.realclearpolicy.com/articles/2023/02/16/time_to_hold_the_epa_to_account_for_meddling_in_markets_882101.html

Govt-Funded Group Targets 'Riskiest' News Sites

 Goodbye Disinformation Board, Hello Disinformation Index.  Less than a year after many celebrated the disbanding of the Biden’s Administration Disinformation Board, it appears that the Administration has been funding a British group to rank sites to warn people about high-risk disinformation sites. The Global Disinformation Index (GDI) has released its index and every one of the high-risk sites turn out to be . . .  wait for it . . .  conservative or libertarian sites.  HuffPost or Mother Jones (which were also analyzed), but HuffPost made the top list of most trustworthy for potential advertisers. It turns out that the “riskiest online news outlets” just happen to be some of the most popular sites for conservatives, libertarians, and independents.

The GDI is designed to steer advertisers and subscribers away from certain sites, potentially draining sites of revenue needed to operate. The organization issues the index to “advertisers and the ad tech industry in assessing the reputational and brand risk when advertising with online media outlets and to help them avoid financially supporting disinformation online.” The State Department is partially funding the effort. The Biden Administration gave $330 million to The National Endowment for Democracy, which partially supports the GDI’s budget.

GDI warned advertisers that these sites could damage their reputations and brands: New York Post, Reason, Real Clear Politics, The Daily Wire, The Blaze, One America News Network, The Federalist, Newsmax, The American Spectator, and The American Conservative.

The inclusion of the New York Post is particularly notable. It is ranked in the top ten newspapers in the country and the top ten digital news sites. (For full disclosure, I have written for the newspaper as well as many of those on the trusted side of the GDI ledger). The New York Post was suspended by social media companies over the Hunter Biden story before the 2020 election by companies relying on false stories appearing in many of the most trustworthy sites listed by GDI.

The allegedly dangerous sites also included Reason, a website associated with UCLA Law Professor Eugene Volokh, who was clearly gobsmacked by the warning. Reason regularly posts insightful and substantive analysis from conservative and libertarian scholars. With the diminishing number of such academics on faculties, the site is a relative rarity in offering a different take on cases and legal issues. The inclusion of Reason in the listing is absurd and shows an utter lack of objective and reliable criteria. For example, GDI says that the site offers “no information regarding authorship attribution, pre-publication fact-checking or post-publication corrections processes, or policies to prevent disinformation in its comments section.” That is obviously untrue as any cursory review of the site would confirm. The Reason articles contain clear indications of authorship.

Moreover, there is a reason why Reason does not have policies posted on the removal of disinformation: it opposes content moderation policies of groups like GDI on free speech grounds. Reason like my own blog Res Ipsa (www.jonathanturley.org) opposes disinformation “processes” used to limit free speech. As Volokh noted, “Reason does not specifically police disinformation in the comments section; that is perhaps an area where Reason‘s philosophy—free minds and free markets—clashes with GDI’s.”

The GDI reviewed sites on the far left like Mother Jones that routinely run unsupported attacks on the right and debunked theories on Russian collusion or other claims. For example, many of the sites ranked as most reliable only recently admitted that the Hunter Biden laptop was not Russian disinformation. For two years, these sites spread this false story with little or no opposing viewpoints despite early refutation by American intelligence.

Even in 2021, NPR still claimed that “The laptop story was discredited by U.S. intelligence and independent investigations by news organizations.” After a chorus of objections to the clearly false story, it corrected the story but still stated falsely that “numerous news organizations cast doubt on the credibility of the laptop story.”  It never explained the continuing “doubt”?  Media organizations that effectively imposed a blackout on the story had already confirmed that the laptop was authentic.

Likewise, sites like NPR continued to make the false claim that former Attorney General Bill Barr cleared Lafayette Park for a photo op long after the claim was proven to be categorically untrue. The government-supported news outlet also has been routinely challenged for making biased or false claims about conservatives, including Supreme Court justices.

Nevertheless, the New York Post and Reason are listed as dangerous sites while sites like HuffPost are actually listed at the top of the least risky disinformation sites. HuffPost is regularly challenged on false or misleading attacks on conservatives.

None of that means that I would put NPR or Mother Jones or HuffPost on a do-not-advertise disinformation list. These are sites with a well-known liberal bent just as other sites have a conservative bent. I am not here to denounce those sites any more than I am here to defend the other sites for their content. Rather the concern is that GDI is applying skewed measures to target disfavored sites. It is concerning that the sites at either extreme of GDI’s spectrum of disinformation largely reflect the political spectrum. (One exception is the Wall Street Journal, which is in the most trustworthy grouping).

GDI accuses sites like Reason of lacking transparency on issues like authorship but the group is fairly opaque on its own conclusions and standards. The explanations for tagging these sites are riddled with subjective and ambiguous terms. For example, GDI includes RealClearPolitics due to what GDI considers “biased and sensational language.” Did the reviewers actually visit the sites of Mother Jones and HuffPost in evaluating comparative levels of bias? Were those sites paragons of neutrality and circumspection?

GDI further says that RealClearPolitics “lacked clear and diverse sources.” Many of the sites ranked as most reliable (and thus worthy of advertising revenue) are routinely criticized for excluding conservative or libertarian perspectives. HuffPost and Mother Jones have a range of diversity that runs from the left to the far left.

The New York Times has led efforts to exclude opposing voices from the right. In 2020, the the Times issued a cringing apology for running a column by Sen. Tom Cotton. The Times forced out editor James Bennet and apologized for publishing Cotton’s column calling for the use of the troops to restore order in Washington after days of rioting around the White House. (Bennet recently denounced his former newspaper for abandoning journalistic standards of balance).

The GDI disinformation index shows the very favoritism that it attributes to others. For example, in discouraging advertisers from supporting the New York Post, the group declares that “content sampled from the Post frequently displayed bias, sensationalism and clickbait, which carries the risk of misleading the site’s reader.” The line reflects the utter lack of self-awareness of self-appointed monitors of disinformation. There is no effort to explain what constitutes “clickbait” or “sensationalism” in comparison to more favored sites like HuffPost.

The fact that GDI reflects such bias is not particularly surprising. Disinformation efforts have long displayed pronounced political influences and agendas. Indeed, we have seen recent disclosures of how members of Congress like Rep. Adam Schiff (D., Cal.) secretly sought to use disinformation claims to ban critics, including a columnist, from social media.

What is more troubling is the funding of the United States government for a group seeking to target conservative sites and deter advertisers from supporting them. I recently testified on the disclosures of the Twitter Files and the confirmation of coordination by the FBI and other federal agencies with social media companies in censoring citizens. I noted that the Administration played the public for chumps. After yielding to an outcry over the creation of the Disinformation Governance Board, the Administration disbanded it. It never mentioned that a far larger censorship effort was being carried out with an estimated 80 federal employees in targeting citizens and others. While the GDI effort is smaller in comparison and effect, it is an additional facet of this effort. It is not known if the Administration has other programs of this kind and the Democrats continue to vehemently oppose any investigation into these free speech concerns.

In other words, the Board was just a shiny object that distracted from a far more comprehensive effort to censor and control speech on social media. I still would not call it disinformation but one might call it deceitful.

https://jonathanturley.org/2023/02/16/government-funded-index-of-worst-disinformation-sites-is-entirely-composed-of-conservative-and-libertarian-news-outlets/