CDC Labeled Accurate Articles As Misinformation, Documents Show

 by Zachary Stieber via The Epoch Times,

The top U.S. public health agency labeled multiple news articles as misinformation even though the articles were accurate, according to internal emails and experts.

The U.S. Centers for Disease Control and Prevention (CDC) added the misinformation labels to articles from The Epoch Times in widely-circulated internal messages, according to copies obtained by The Epoch Times.

One of the articles reported on a peer-reviewed paper that found heart inflammation, or myocarditis, was more common after COVID-19 vaccination than after COVID-19 infection.

Nordic researchers reviewed electronic health records and counted 109 cases of myocarditis following COVID-19 infection compared to 530 after vaccination. Their study was published by the British Medical Journal.

An internal CDC email said that the study “has been picked up by anti-vax proponents as evidence that vax was more likely to cause myocarditis than COVID-19 infection,” and provided a hyperlink to The Epoch Times article.

The Feb. 7, 2023, email listed the article under “points of confusion/potential rumors/misinformation.”

The CDC did not list any data or other information supporting its label.

“The Epoch Times article should not be labeled as misinformation,” Dr. Tracy Hoeg, a physician-scientist at the University of California-San Francisco, told The Epoch Times via email.

Dr. Hoeg said the Nordic study aligned with earlier research, including a paper published by JAMA Cardiology that found myocarditis rates were higher among some populations after vaccination compared to after infection.

Another CDC email claimed a story reporting on how the U.S. government was receiving royalty payments from Moderna’s COVID-19 vaccine was inaccurate or misleading.

The Epoch Times article reported on how Moderna officials disclosed in an earnings call that the company entered a patent agreement with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), sent a payment of $400 million, and would be paying additional royalties in the future.

“Anti-vax proponents question Moderna’s new patent agreement with NIAID, citing catch up payments and royalties as a ‘conflict of interest,” the CDC email, dated March 1, 2023, stated.

The Epoch Times article quoted Dr. Lawrence Tabak, the director at the time of the NIAID’s parent agency, as admitting royalty payments in general present “an appearance of a conflict of interest.”

The CDC defines employees taking part in matters in which they have a financial interest as a conflict of interest, while the U.S. Department of Health and Human Services (HHS), the parent agency of the CDC, says that financial conflicts of interest can compromise honesty “especially if the financial interests are significant.”

“It is certainly interesting that, confronted with possible ethics concerns, the CDC doesn’t address them but dismisses them as ‘misinformation,'” Michael Chamberlain, director of the nonprofit Protect the Public’s Trust, told The Epoch Times via email.

The CDC also labeled an Epoch Times video featuring a doctor describing data on COVID-19 vaccines negatively impacting gut health as misinformation, the emails show, even though the video was based on published research.

“The information contained in these documents illustrates how federal health officials so rapidly squandered the trust of the American public, and it shows the danger of government setting itself up as an arbiter of truth,” Mr. Chamberlain said.

“The agency is quick to slap a derogatory label on any statements that don’t fit its preferred narrative, and just as quick to impugn the motives of anyone who dares make those statements. This is not government working for the people, it is government as adversary to the people.”

More on Emails

The emails were circulated to more than 150 people in the CDC and the HHS.

They were sent by Emily Matthews, a contractor acting on behalf of the CDC’s Research & Evaluation Team.

Additional emails showed Colin Bernatzky, a CDC public health analyst, decrying articles from The Epoch Times articles on research, including a peer-reviewed paper that analyzed autopsies done on people who died following COVID-19 vaccination and concluded many of the deaths were likely due to the vaccines.

Ms. Matthews and Mr. Bernatzky did not respond to inquiries The CDC declined to comment.

“I know this has come up previously around CDC’s rapid response capabilities/strategies to address misinformation,” another CDC official wrote, as Mr. Bernatzky’s concerns were distributed within the agency.

“I feel like this needs to be its own special report ... and we could highlight what themes/topics are these ant-vax [sic] topics covering,” another official said, adding later that he could see the U.S. Department of Homeland Security “having opinions on this.”

The emails were obtained under the Freedom of Information Act. Large portions are redacted.

Government agencies, including the CDC, were found to have conspired with social media companies to censor a wide range of speech, including posts that provided accurate information about COVID-19 vaccines. As part of that effort, the CDC passed on misinformation to Facebook, documents showed. The agency has also offered misinformation about vaccines in presentations and on social media.

The government likely violated constitutional rights with its efforts, courts have ruled.

The Supreme Court is set to soon take up the legal case that uncovered the conspiracy.

https://www.zerohedge.com/political/cdc-labeled-accurate-articles-misinformation-documents-show

What’s Next for CRISPR?

 The era of CRISPR gene-editing technology has arrived. With the approval of Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy (exa-cel) in two indications, the question now is, what’s next?

In short, the answer to that question is not much right now. While the cell and gene therapy sector as a whole is expecting continued growth in terms of approvals, CRISPR-based therapies are predominately early stage.

CRISPR Pipeline Skews Toward Discovery

The December and January approvals of Casgevy for sickle cell disease and transfusion-dependent beta thalassemia represent a landmark for gene therapy. Casgevy is the first approved treatment that uses CRISPR/Cas9 gene-editing technology. The one-time treatment can be curative for these serious, life-altering blood disorders.

But Casgevy will not open any immediate floodgates to CRISPR therapy approvals, as most potential CRISPR-based treatments are still in the earlier stages of development. According to a December 2023 report from GlobalData, discovery and preclinical assets account for 88% of the CRISPR drug candidates currently under investigation, with 24 CRISPR-based therapeutics in Phase II trials and one other than Casgevy in Phase III.

Thus, despite the milestone approval of Casgevy, GlobalData analyst Jasper Morley believes the industry is “unlikely to see another [CRISPR] drug approval in the near future.”

While hematological drugs are the most advanced, out of 262 active drugs in the discovery and preclinical stage, oncology dominates—accounting for some 25%—Morley told BioSpace in an email. Hematological disorders account for about 10%.

“This finding suggests that companies beginning to develop CRISPR drugs are looking at therapy areas which are alternatives to the Casgevy approvals,” Morley said.

The other Phase III candidate is Intellia Therapeutics and Regeneron Pharmaceuticals’ NTLA-2001 for transthyretin (ATTR) amyloidosis with cardiomyopathy, a rare, progressive and fatal disease. In October, the FDA cleared a pivotal study of the in vivo CRISPR-based gene editor. If successful, it could be the first single-dose treatment for ATTR amyloidosis.

CRISPR therapy development at this point is led by smaller companies. Big pharma is expected to partner with these small companies, opting to in-license their technology, Morley said.

Challenges for CRISPR

Morley spoke of several roadblocks to the rapid growth of CRISPR-based therapies. “Challenges in this space include how to develop a fair pricing strategy, the logistics of offering broad access to the most needy populations in underserved markets (such as sickle cell patients in Africa), and potential unfamiliar adverse events associated with this novel modality of therapy.”

Vertex and CRISPR’s Casgevy will run $2.2 million for a one-time treatment for both SCD and TDT. That sticker price is in line with other novel gene therapies, such as bluebird bio’s Lyfgenia, which was also approved by the FDA for SCD and will cost $3.1 million. Yet one study of SCD patients found the total cost of disease over a patient’s lifetime was over $5 million.

Alliance for Regenerative Medicine CEO Tim Hunt pointed this out in San Francisco earlier this month at the Biotech Showcase during JPM Week. “I know there’s sticker shock when you price the product at $2 million to $3 million. But if you look at the data, it tells a very compelling story," he said. 

Part of Casgevy’s high cost comes from the extensive chemotherapy patients must undergo before treatment to make way for the reengineered cells. Vertex is currently working with hospitals to establish a network of authorized treatment centers (ATCs) to offer the therapy to patients, with more coming online “in the coming weeks,” the company said in a December announcement.

One way to reduce cost and the complexity of administration is to develop in vivo gene therapies, instead of manipulating patients’ cells ex vivo. Casgevy’s co-developer CRISPR Therapeutics has plans to announce in vivo editing programs later this year, the company’s head of research Jon Terrett told BioSpace.

“We believe the CAR T, liver knockout and iPSC platforms are scalable and adaptable to further programs and we plan to advance preclinical candidates to rapidly advance new programs with these platforms,” Terrett said.

The company’s CRISPR/Cas9 allogeneic CAR T programs are aimed at CD19+ malignancies, autoimmune disease, solid tumors and blood cancers. A clinical trial for CTX112 for systemic lupus erythematosus is initiating in the first half of this year. CD19-directed CAR T therapies have shown effectiveness in producing long-lasting remissions in multiple autoimmune indications, Terrett said.

He believes the future of CRISPR therapies includes rare disease “correction,” regenerative medicine and fighting solid tumors.

CRISPR 2.0 Could Be Next

As CRISPR technology makes its debut in approved medicines, some attention has already shifted to newer modalities. Base editing, for example, is a derivative of CRISPR that can modify DNA without making the breaks that risk leading to cancerous mutations and is now in clinical development.

Verve Therapeutics has a single-course in vivo liver base editing treatment in a Phase Ib trial for patients with familial high cholesterol who are at significantly increased risk for heart attack and stroke. A patient treated with its higher dosage experienced a 55% reduction in LDL-C for at least 180 days, with follow up ongoing. Meanwhile, Beam Therapeutics dosed its first patient with BEAM-201, a base editing therapy for aggressive forms of blood cancers, in September.

CRISPR Therapeutics has also prioritized the development of the next generation of CRISPR gene-edited CAR T candidates, though Terrett said there are still “so many possibilities with conventional CRISPR/Cas9 which continues to gain clinical experience.”

Whichever form of CRISPR is the next to hit the market, there’s no question that the market is maturing. GlobalData estimates that by 2029, 20 CRISPR drugs will generate more than $7 billion annually.

https://www.biospace.com/article/what-s-next-for-crispr-/

'Sickle Cell Gene Therapies Seen as Cost Effective Below $2M Threshold: Study'

Gene therapies for sickle cell disease are likely to be cost-effective in the U.S. when priced below $2 million, according to a new study published Tuesday in the journal Annals of Internal Medicine.

For their cost-effectiveness analysis, researchers leveraged claims data from the Centers of Medicare and Medicaid Services from 2008 to 2016 and combined those with estimates from the existing scientific literature. The study focused on patients who were eligible to receive sickle cell disease (SCD) gene therapies, comparing their cost effectiveness versus standard care.

The investigators then applied two independent simulation models—the University of Washington Model for Economic Analysis of Sickle Cell Cure (UW-MEASURE) and the Fred Hutchinson Institute Sickle Cell Disease Outcomes Research and Economics Model (FH-HISCORE)—to evaluate the incremental cost-effectiveness ratio (ICER) of gene therapies from the perspective of U.S. healthcare system and societal benefits.

The researchers assumed a list price of $2 million for the gene therapies, which according to UW-MEAUSURE and FH-HISCORE models would have an ICER of $193,000 and $427,000 per quality-adjusted life year (QALY), respectively, from the perspective of the healthcare system.

From a societal perspective, the UW-MEASURE found an ICER of $126,000 per QALY, while the FH-HISCORE returned an estimate of $281,000 per QALY.

According to the study, these estimates suggest that—at least from a societal perspective—the value-based price for SCD gene therapies ranging from $1 million to $2.5 million would be “acceptable.” The authors note that these estimates could still be affected by the costs of pre-treatment myeloablative conditioning, caregiver quality of life and the effect of the gene therapy on long-term survival.

Lead investigator Anirban Basu, in an interview with The American Journal of Managed Care, said that “gene therapies show great promise in bringing a widely applicable curative approach to SCDs,” which typically cuts patients’ life expectancies short and compromises their quality of life.

“Our analyses provide detailed early evidence of such therapies’ potential value and value-based prices, and showcases a comprehensive approach to valuing innovative therapies,” Basu said.

Tuesday’s cost-effectiveness estimates are broadly in line with the Institute for Clinical and Economic Review’s recommendations, published in August 2023. The institute’s modelling analysis—drawing data from Medicaid enrollees—pegged the ideal price range for SCD gene therapies to be between $1.35 million to $2.05 million.

The SCD gene therapy space saw back-to-back approvals in December 2023, with both  Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy (exagamglogene autotemcel) and bluebird bio’s Lyfgenia (lovotibeglogene autotemcel) clearing the FDA’s regulatory gauntlet.

Vertex-CRISPR’s Casgevy has a list price of $2.2 million, falling $200,000 higher than the cost-effectiveness threshold in Tuesday’s study results. However, bluebird’s Lyfgenia is considerably more expensive with a wholesale acquisition cost of $3.1 million.

https://www.biospace.com/article/sickle-cell-gene-therapies-seen-as-cost-effective-below-2m-threshold-study/

FDA Calls for Boxed Warnings on CAR-T Therapies Regarding Secondary Cancer Risks

 The FDA’s safety probe of CAR-T therapies has resulted in a call to add a class-wide boxed warning to these medicines, alerting patients and prescribers of their potential risk of secondary T-cell malignancies.

All six commercial CAR-T therapies will be affected, including J&J’s Legend Biotech-partnered Carvykti (ciltacabtagene autoleucel), Novartis’ Kymriah (tisagenlecleucel), BMS’s Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel) and Gilead’s Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel).

The FDA on Friday sent out six letters to their respective manufacturers notifying them that the drug class has been associated with the risk of developing secondary cancers “with serious outcomes, including hospitalization and death.”

“FDA identified postmarketing adverse event and clinical trial reports describing occurrence of mature T cell malignancies, including CAR-positive tumors, following treatment with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies,” the regulator said in the letters, while stopping short of establishing a causal connection between treatment and the secondary cancers.

The companies now have 30 days to either submit their proposed changes to their products’ safety labels or file a rebuttal statement if they disagree with the FDA’s assessment.

The FDA first announced that it was looking into the safety of CAR-T therapies in November 2023, after it had flagged instances of T-cell malignancies in patients who had been treated with these products. One such case, according to the regulator, was a CAR-positive lymphoma.

At the time, the FDA said that the benefits of CAR-T therapies still outweigh their potential risk but also noted that patients and participants receiving the treatment through clinical trials “should be monitored life-long for new malignancies.”

However, in response to the FDA’s safety investigation, oncologists have come out in defense of CAR-T therapies asserting that secondary blood malignancies are rare and that their risk is not enough to outweigh the treatment’s benefit for patients whose cancers have already progressed after chemotherapy and radiation.

“I doubt you will meet a CAR-T treating physician who will change their practice due to this warning,” Rahul Banerjee, a physician-researcher specializing in multiple myeloma at the Fred Hutchinson Cancer Center in Seattle, told BioSpace in a December 2023 interview.

Meanwhile, the FDA’s probe has triggered similar reviews by health regulatory authorities around the world, including the U.K.’s Medicines and Healthcare products Regulatory Agency, the E.U.’s European Medicines Agency and South Korea’s Ministry of Food and Drug Safety.

https://www.biospace.com/article/fda-calls-for-boxed-warnings-on-car-t-therapy-labels-regarding-secondary-cancer-risks/

Angiodynamics: FDA OKs Catheter to Treat Peripheral Arterial Disease

 AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, today announced that the United States Food and Drug Administration (FDA) has cleared the Auryon XL Catheter, a 225-cm radial access catheter, for use with the Auryon Atherectomy System in the treatment of Peripheral Arterial Disease (PAD).

https://www.businesswire.com/news/home/20240123524948/en/

Sanofi in $1.7B Inhibrx buyout, snagging rare disease drug but spinning out cancer programs

 Sanofi has taken a surgical approach to its latest piece of M&A, agreeing to pay $1.7 billion to buy Inhibrx for below the market price but then spin out all but one of its candidates to create a new publicly traded biotech.

The French pharma wants to get its hands on INBRX-101, a human recombinant protein that Inhibrx is testing in a registration-enabling alpha-1 antitrypsin deficiency (AATD) trial. Rather than swallow Inhibrx whole, Sanofi has decided to spin off the biotech's three anticancer molecules to create a new company that will start life with $200 million in cash and no debt.

Inhibrx has accepted an offer of $30 per share, below its $33.33 closing price yesterday. The below-market price reflects the fact Sanofi is only buying one molecule. Inhibrx shareholders will also gain stakes in the new biotech, plus the chance to receive a further $5 a share if a regulatory milestone is met.

The various components of the deal bring the total value up to $2.2 billion. Sanofi will have an 8% stake in the new biotech, which will continue to be called Inhibrx and be led by the current CEO Mark Lappe.

Once the deal closes in the second quarter, the new Inhibrx will look much like the old Inhibrx, minus its AATD candidate, and Sanofi will have sated its appetite for a rare disease candidate. That candidate, INBRX-101, is on course (PDF) to reach the initial readout from its registration trial around the end of the year.

Inhibrx designed the clinical trial to show the effect of INBRX-101 on levels of serum functional AAT, the protective protein that is found at low levels in people with the rare disease. Patients currently receive weekly augmentation with AAT derived from plasma donors to partly offset the deficiency. INBRX-101 is designed to end reliance on donations, reduce dosing frequency and normalize AAT levels.

The biotech believes improved diagnosis may quadruple the size of the AATD market in the coming years, creating a $4 billion opportunity that could overwhelm the availability of the plasma products sold by CSL Behring, Grifols and Takeda. Other companies could reduce the need for AAT protein by targeting the cause of the disease but multiple players have struggled to move the needle so far.

AATD causes liver and lung disease, with Inhibrx’s registration trial targeting the latter population. Mereo BioPharma has a lung disease candidate, alvelestat, that is on the cusp of phase 3. Vertex, which wants to address both the liver and the lung, gave up on a pair of AATD candidates but is trying again with a third asset, VX-634, that is in phase 1. Wave Life Sciences has a GSK-partnered RNA editing candidate.

BioMarin, Intellia Therapeutics and Peak Bio are in the hunt, too, but Sanofi's head of R&D Houman Ashrafian said he sees INBRX-101 as fitting the Big Pharma's focus on “differentiated and potential best-in-class products.”

https://www.fiercebiotech.com/biotech/sanofi-inks-17b-inhibrx-buyout-snagging-rare-disease-drug-spinning-out-cancer-programs

J&J agrees to resolve 42 U.S. states' talc investigations

  Johnson & Johnson on Tuesday said it had reached a tentative settlement to resolve probes by U.S. states into whether it misled consumers about the safety of its talc products, which thousands of lawsuits claim can cause cancer.

The deal includes 42 states and Washington, D.C. The company tentatively agreed to pay about $700 million to settle the states' claims, according to the Wall Street Journal.

“Consistent with the plan we outlined last year, the company continues to pursue several paths to achieve a comprehensive and final resolution of the talc litigation," Erik Haas, J&J's worldwide vice president of litigation, said in a statement.

The settlement does not extend to private plaintiffs' cases against the company, some of which are expected to go to trial later this year.

J&J has maintained that its now-discontinued talc products are safe and do not cause cancer. It previously set aside $400 million to resolve state claims.

The company, which reported fourth-quarter results on Tuesday, still faces more than 50,000 lawsuits over talc, most by women with ovarian cancer. A minority of the cases involve people with mesothelioma, a type of cancer linked to asbestos. It recently settled some of the mesothelioma cases for an undisclosed amount but has maintained that its talc did not contain asbestos.

The company has twice tried to resolve the cases by placing its talc liabilities into bankruptcy, but both attempts were rebuffed by courts.

In the latest failed bankruptcy attempt, the company had proposed to pay $8.9 billion to talc claimants. J&J said last year that it was planning a third bankruptcy filing.

The settlement with the states could make that easier, as some states had previously argued that they, unlike private plaintiffs, can continue pursuing claims while a bankruptcy is pending. Courts have not resolved that issue.

Trials in the talc cases have had a mixed record, with major plaintiff wins including a $2.1 billion judgment in 2020 awarded to 22 women with ovarian cancer.

A New Jersey appeals court in October threw out a $223.8 million verdict against the company, finding the testimony of the plaintiffs' expert witnesses unsound.

The company stopped selling talc-based baby powder in favor of cornstarch-based products, citing an increase in lawsuits and "misinformation" about the talc product's safety.

https://finance.yahoo.com/news/j-j-agrees-resolve-42-150229387.html