Cellphone Radiation Research Was Halted After Worrisome Findings; Questions Why

 by George Citroner via The Epoch Times (emphasis ours),

Decades of animal research point to serious health risks from cellphone radiation exposure, but examining a possible link stops now.

The National Toxicology Program (NTP), tasked with studying potential toxins, recently announced it would no longer investigate evidence that cellphone radiation can harm animals or people. The move stunned scientists like Devra Davis, a former senior adviser to the assistant secretary for Health in the Department of Health and Human Services, who called the abrupt reversal scientifically unjustified.

There’s “no scientific explanation or justification for this sudden reversal,” Ms. Davis told The Epoch Times.

Unpublished NTP Research Undermines Decision to Halt Cellphone Radiation Studies

The NTP recently claimed that additional radiofrequency radiation (RFR) studies are not planned, stating the research was “technically challenging and more resource-intensive than expected.”

Ms. Davis criticized this decision, noting that technical challenges are not a reason to avoid studying something that appears to cause cancer in animals. “Everything that we know for sure causes cancer in people will produce it in animals when adequately studied,” she added.

Despite admitting to developing a novel small-scale RFR exposure system in 2019 to clarify earlier findings, the NTP canceled further investigations. This system only studied older 2G and 3G devices, not newer 4G or 5G technologies.

Ms. Davis, a former NTP advisor, said she helped recommend smaller test chambers. The agency takes years to plan studies, so scrapping this project is “beyond my comprehension at this point,” given millions of children’s daily exposure, she noted.

In an emailed statement, the NTP confirmed that although work on the small-scale exposure system and accompanying research has been completed, the results will be publicly available and posted on the agency’s webpage only “when internal reviews are finished.” As of this writing, the 2019 research remains unpublished.

Court Finds FCC Illegally Ignored 5G Health Risks

The NTP published results in 2018 from two-year toxicology studies showing “clear evidence” of associations between 2G/3G cellphone radiation and tumors in male rats. Follow-up research in 2019 revealed DNA damage in the brains, livers, and blood cells of exposed rats and mice.

Despite originally requesting and overseeing these studies, the U.S. Food and Drug Administration (FDA) has since dismissed the NTP’s findings, Ms. Davis said.

In 2019, the Federal Communications Commission affirmed outdated 1996 radiation exposure standards for new 5G technologies, which did not even exist then. To justify this, the FDA anonymously produced an unreviewed document in 2020. The Environmental Health Trust (EHT) sued the FCC.

In 2021, the U.S. Court of Appeals for the District of Columbia Circuit ruled against the FCC. The court said the FCC acted improperly and illegally by keeping its 1996 wireless radiation exposure limits. The court found the FCC ignored evidence that radiation below its current limits can cause adverse health effects besides cancer, noting that the FCC also failed to respond to comments about the environmental harm caused by radiation.

The court ordered revised standards accounting for EHT’s records on risks to children and the environment.

FCC Let Carriers Abandon Landlines

Since 2019, France has mandated cellphones include warnings to keep such devices away from teens and pregnant women’s lower abdomens because of radiation risks. The European Union also funds extensive research on RFR hazards.

“So why are we ignoring animal study results showing harm?” Ms. Davis said. “There’s only one reason: because there’s so much money involved.”

Landlines offered an alternative to cellphones, but the FCC’s 2019 order let carriers abandon copper lines. Companies like Verizon have begun retiring landlines, leaving consumers with only wireless options.

People can still reduce RFR exposure by:

• Not carrying phones in pockets or bras
• Using speakerphone and holding phones away from the head/body
• Keeping devices away from reproductive organs
• Using wired over WiFi internet
• Not sleeping near phones

https://www.zerohedge.com/medical/cellphone-radiation-research-was-halted-after-worrisome-findings-expert-questions-why

Geron Gets AdComm Nod for Blood Cancer Therapy

 

• FDA Oncologic Drugs Advisory Committee voted 12 to 2 in favor of the clinical benefit/risk profile of imetelstat based on results from the IMerge Phase 3 clinical trial
• There are significant unmet needs across key TD LR-MDS patient populations, including difficult-to-treat subgroups that are underserved by currently available treatment options
• June 16, 2024 PDUFA target action date for imetelstat NDA for the treatment of TD anemia in adult patients with LR-MDS

https://www.businesswire.com/news/home/20240314986754/en/

Madrigal wins FDA approval of first drug for MASH

 The Food and Drug Administration has approved the first medicine for a common liver disease that’s been a top target of drugmakers over the last decade.

The drug, known as Rezdiffra and developed by biotechnology company Madrigal Pharmaceuticals, was given an accelerated clearance on Thursday for use in adults with metabolic dysfunction-associated steatohepatitis, or MASH. The approval is specifically for people with the disease and moderate to advanced liver fibrosis, alongside diet and exercise. It’ll only be upheld if the drug’s benefits are confirmed in an ongoing trial.

In testing, treatment with Rezdiffra resolved MASH and helped improve the liver scarring that is typically associated with the condition.

“Previously, patients with [MASH] who also have notable liver scarring did not have a medication that could directly address their liver damage,” said Nikolay Nikolov, the acting director of the FDA office that evaluates immunology and inflammation drugs. “Today’s approval of Rezdiffra will, for the first time, provide a treatment option for these patients, in addition to diet and exercise.”

The therapy’s labeling includes a safety warning for physicians to monitor for the elevation of liver enzymes or the development of liver-related side effects. The agency also recommends limiting use in cholesterol-lowering statins in people receiving Rezdiffra. The prescribing information doesn’t, however, require patients to undergo a liver biopsy before treatment, something that’s been seen as a potential barrier to use.

The approval is a turning point against a disease that, by one estimate, affects anywhere from 6 million to 8 million people. Previously known as NASH, the condition often develops alongside metabolic diseases like diabetes and obesity. It’s characterized by an accumulation of fat in the liver, causing progressive inflammation and scarring. In recent years, MASH has become one of the leading causes of liver transplants.

https://finance.yahoo.com/m/a64bebe6-83ca-3715-8afb-7431a2fce237/madrigal-wins-fda-approval-of.html

FTC chief says Boeing has become ‘too big to fail’

Top antitrust enforcer Lina Khan said national champion strategy has been 'catastrophic' for U.S.

"Boeing effectively became too-big-to-fail and a point of leverage for countries seeking to influence policymaking."Lina Khan

That's Federal Trade Commission Chair Lina Khan, noting that few American companies have struggled as mightily as Boeing over the past five years, and placing some of the blame at the feet of U.S. policymakers.

She criticized her predecessors for allowing a historic wave of consolidation in the aerospace industry starting in the 1980s, which left Boeing (BA) as the nation's only commercial aerospace manufacture following its 1997 merger with rival McDonnel Douglas.

Khan said that Boeing is an example of a company that has promoted itself as a "national champion" which must be shielded from antitrust enforcement because its success is important for America's success on the global stage.

"Boeing is the clearest example of a purposeful decision to bet on national champions on behalf of American interests," Khan said Wednesday at a speech on the future of American innovation at the Carnegie Endowment for International Peace.

The company is "the single best example of why a national champion strategy can be catastrophic," she added.

Khan said that Boeing's current struggles are a prime example of the harms caused by "monopolization," which lead to lower quality products, short-sighted cost cutting and overwhelming political power.

"Boeing effectively became too-big-to-fail and a point of leverage for countries seeking to influence policymaking," Khan argued, noting that Congress "carved out a $25 billion line item" for Boeing during the COVID crisis.

Boeing was able to forgo that money and issue bonds to raise the needed cash in 2020, though analysts say Federal Reserve support of corporate bond markets at the time was an important factor in the company's ability to raise money privately.

Khan said the example of Boeing should be instructive as some technology companies have argued that pursuing antitrust cases against them or otherwise regulating them will "weaken the American innovation and cede the global stage to China."

On the contrary, Khan argued, it was tough antitrust enforcement against the leading tech companies of the 1970s like AT&T (T) and Kodak (KODK) that created openings for Silicon Valley entrepreneurs to mount the information technology revolution in the subsequent decades.

"The reality is that some of these same firms are fairly integrated into China and are seeking greater access to the Chinese markets," she said. "If America's dominant firms are not prioritizing America's national interests, what should we make of the idea that they can keep American in the lead if they're left alone?"

https://www.morningstar.com/news/marketwatch/20240313319/ftc-chief-blasts-boeing-for-monopolization-says-company-has-become-too-big-to-fail

US tells Musk to allow service in Taiwan

 Space Exploration Technologies Corp (SpaceX) might have contravened its Pentagon contract by not providing access to its satellite communication network Starshield in and around Taiwan, a letter from a US House of Representatives committee to the company said.

In September last year, the US Department of Defense awarded SpaceX a one-year contract for Starshield access, worth US$100 million. A few months before that, the Pentagon also commissioned SpaceX’s Starlink satellite network to be used by Ukrainian forces amid Russia’s invasion.

Starshield is a derivative of Starlink intended for military use.

SpaceX has long worked closely with the US military and intelligence agencies, which contract the company to launch government satellites used for the transmission of sensitive and classified information.

US Representative Mike Gallagher, who is chairman of the US House Select Committee on Strategic Competition between the United States and the Chinese Communist Party (CCP), wrote the letter to company founder Elon Musk following Gallagher’s three-day visit to Taiwan that concluded on Saturday.

The letter was obtained by CNBC after Forbes magazine first reported on it.

In the letter, the Republican representative said the company’s contract with the Pentagon requires the US military to have global access to the satellite network.

“Multiple sources have disclosed to the committee that Starshield is inactive in and around Taiwan,” the CNBC report quoted the letter as saying, adding that it asks Musk to provide a briefing on the issue to the committee before Friday next week.

“In the event of CCP military aggression against Taiwan, American servicemembers in the Western Pacific would be put at severe risk,” the letter said. “Ensuring robust communication networks for US military personnel on and around Taiwan is paramount for safeguarding US interests in the Indo-Pacific region.”

Earlier this month, Ukraine’s top military intelligence official accused the company of providing the Russian military with Starlink services in occupied areas of Ukraine. Musk responded at the time that SpaceX would not sell Starlink terminal services to Russia.

Musk has also referred to Taiwan as “an integral part of China” and said he “knows China well.”

In 2022, Musk said in an interview with the Financial Times that Taiwan’s future could be resolved by Beijing through “establishing Taiwan as a special administrative region.”

CNBC said that Musk’s stance on Taiwan has allowed automaker Tesla Inc — of which Musk is CEO — to thrive amid rocky US-China relations, and Beijing to permit it to have its own factory in Shanghai, while other foreign automakers in China are required to set up joint ventures with Chinese companies.

SpaceX and Musk did not immediately respond to requests for comment on Gallagher’s letter.

https://www.taipeitimes.com/News/front/archives/2024/02/26/2003814085

Biden plan would axe interchangeable status for biosimilars

 President Joe Biden’s budget proposal for fiscal 2025 includes a proposal that would allow pharmacy substitution of biosimilar drugs for the reference product, even if they are not designated as interchangeable.

The plan would remove the current requirement for additional studies, sometimes clinical trials, that may be needed by the FDA to show that biosimilars are interchangeable, in other words, that they will not have diminished efficacy or an increased risk of safety concerns if patients switch back and forth between a brand and biosimilar.

The FDA’s authority to designate biologics as interchangeable was created by the Biologics Price Competition and Innovation Act, which came into force in 2010. However, budget documents claim that “the statutory distinction between biosimilars and interchangeable biosimilars has led to confusion and misunderstanding […] about the safety and effectiveness of biosimilars and about whether interchangeable biosimilars are safer or more effective than other biosimilars.”

The White House goes on to say that making all biosimilars interchangeable would make the regulation of these products “more consistent with current scientific understanding, as well as with the approach adopted by other major regulatory jurisdictions, such as the [EU], where biosimilars are interchangeable with their respective reference products upon approval.”

The aim is to encourage greater use of biosimilars, which tend to be lower-priced than the original brand, in the US market. Factors such as the interchangeable requirement, formulary access among pharmacy benefit managers (PBMs) and a lack of awareness of biosimilars and experience with using them have all been cited to explain the lower uptake of these drugs in the US than other markets, such as Europe.

The proposal is part of a long list of measures aimed at reducing the cost of medicines in the US in the budget, along with limits to the three-year exclusivity of the Hatch-Waxman Act, protections from litigation for companies that file generics with so-called skinny labels – i.e. seeking approval for some, but not all, of the indications of the brand to sidestep patent protections – and requiring full disclosure of all the ingredients in products, including excipients, which would assist generic developers.

While the budget has little chance of making it through Congress in its current form due to the bipartisan impasse, it gives a clear indication that Biden does not intend to rein in his campaign on medicine pricing.

It has been published on the heels of the President’s State of the Union address, in which he trumpeted legislation to allow Medicare to negotiate drug prices – and plans to extend the number of drugs that will be subject to those discussions – saying that showed “we finally beat big pharma.”

He also pointed to a $35-per-month insulin price cap and $2,000-per-month prescription drug cost cap, which are also covered in the budget with proposals to extend both those caps beyond Medicare and into the commercial market.

In a statement, the White House said the measures to lower drug prices “will not only cut costs for the federal government by $200 billion; they will also save billions of dollars for seniors.”

In a response to the budget, House Republicans said it is “yet another glaring reminder of this Administration’s insatiable appetite for reckless spending and the Democrats’ disregard for fiscal responsibility.”

https://pharmaphorum.com/news/biden-plan-would-axe-interchangeable-status-biosimilars

UBS sees Lilly GLP-1/sleep apnea study falling short

 UBS said it believes that upcoming data for Eli Lilly's (LLY) GLP-1 drug tirzepatide in the treatment of sleep apnea will come in below expectations.

https://seekingalpha.com/news/4079564-ubs-sees-lilly-glp-1sleep-apnea-study-falling-short-of-street-estimates