FDA Issues Warning on ‘Gas Station Heroin’ Tianeptine

The US Food and Drug Administration (FDA) has issued a health warning regarding products containing tianeptine, which is often called “gas station heroin” because of its easy availability at gas station stores.

The FDA noted that tianeptine is associated with an increasing number of adverse events, including death, and called its use “a dangerous and growing health trend facing our nation,” especially for youth.

Other associated adverse events cited by the agency include coma, agitation, confusion, hypertension, respiratory depression, tachycardia, and vomiting.

“Historically, there has been a delayed recognition of fast-growing trends,” the FDA wrote in its warning letter. Although it is closely following tianeptine products’ distribution and sale, “it is critical that you appreciate the magnitude of the underlying danger of these products and disseminate information about it,” the agency added.

Interestingly, the product is licensed as an atypical antidepressant in some countries and is commonly prescribed for oral intake at 12.5 mg thrice daily. However, because higher doses can produce euphoria, its use has been restricted and a warning has been added to its drug label about possible addiction.

Tianeptine has not been approved by the FDA for any medical use in the United States, is not scheduled under its Controlled Substances Act, is not considered to be safe in food, and has not met regulations as a dietary ingredient.

“Nevertheless, tianeptine is being marketed as a ‘research chemical,’ a ‘nootropic’ cognitive enhancer, or a dietary supplement,” the agency reported. 

In addition to gas stations, the product — which also goes by names such as Tianaa, Zaza, Neptune’s Fix, Pegasus, and TD Red — is often available at convenience stores, vape shops, and online retailers.

The FDA noted that unlike the 37.5 mg total daily dose amount recommended by countries that have approved the product, there have been reports of individuals in the United States ingesting doses from 50 mg to 10,000 mg. 

So far, the agency has sent warning letters to companies that distribute and sell products that contain tianeptine and is taking steps to warn individuals about the drug’s potential severe adverse events. In addition, it has issued an import alert to help detain shipment of the products containing the drug at US borders.

The FDA recommended that healthcare professionals talk to patients about these products and encourage their avoidance. Tianeptine may not be identified in routine drug-screening panels.

Those who believe a patient is experiencing a related adverse event should contact PoisonHelp.org (External Link Disclaimer) and can visit the FDA’s MedWatch website to submit a report.

https://www.medscape.com/viewarticle/fda-issues-warning-gas-station-heroin-tianeptine-2025a1000bhh

Biden-Era Medicaid Cost Surge

 Over the past 12 years, two major policy changes have led to massive Medicaid program growth. Keep in mind, the growth of Medicaid has not improved Americans’ health, as a recent Paragon research paper documented, and has worsened access to care for traditional Medicaid enrollees.

The first change is that the Affordable Care Act (ACA) significantly expanded Medicaid by granting eligibility to able-bodied, working-age adults and favoring them over traditional Medicaid enrollees (children, pregnant women, seniors, and the disabled) through significantly higher federal reimbursement rates for state spending on them. Paragon has produced a comprehensive reform that would end the ACA’s federal discrimination against traditional Medicaid enrollees and move nearly half of Medicaid expansion enrollees into the exchanges with a large premium tax credit. This is a long overdue policy reform that Congress should consider.

The second change stems from a set of Biden administration policies, along with increased state Medicaid money laundering schemes, that have significantly increased the federal Medicaid baseline as shown in the first figure below. Between the Congressional Budget Office’s 2021 and 2024 baselines, projected federal Medicaid spending increased by 8.6 percent, a sizeable $685 billion, from 2023 to 2034.

 

Several Biden policies explain a portion of this increase. The Families First Coronavirus Response Act provided states with additional federal Medicaid money so long as they maintained Medicaid enrollment during the COVID public health emergency (PHE). The Biden administration also extended the PHE into the spring of 2023, which kept ineligible people on the Medicaid program much longer.  Finally, the Biden administration took regulatory actions to keep ineligible people on the program longer and to validate state financing gimmicks that fleece federal taxpayers and raise Medicaid rates well above Medicare rates for many providers in many states.  As a preview, in March, Paragon will be releasing a research paper on the growth of Medicaid money laundering and what policymakers should do about it.

The House budget resolution contains instructions for the Energy and Commerce Committee to find $880 billion in savings relative to baseline. Congress could achieve these savings through common sense, necessary Medicaid reforms. The figure below illustrates how an expected level of savings in Medicaid (assuming Medicaid reforms make up about 80 percent of the savings) compares to the 2021 and 2024 CBO baselines.

 

Crucially, the magnitude of savings relative to the 2021 baseline—before the surge of Biden-era spending—is two-thirds smaller than the 2024 baseline. In fact, spending would only be 3.1 percent lower under this level of savings relative to the 2021 baseline. In essence, Biden’s policies led to a surge of wasteful federal Medicaid expenditures and the House budget resolution would largely reverse the fiscal impact of his policies.

One more important note—this just shows the federal side of Medicaid spending. States will be able to replace all savings that result from federal reforms. As discussed in my most recent newsletters, one of the main problems that federal policymakers should address is the substantial shift in Medicaid costs from the states to Washington over the past 15 years.

Brian Blase, Ph.D., is the President of Paragon Health Institute. Brian was Special Assistant to the President for Economic Policy at the White House’s National Economic Council (NEC) from 2017-2019, where he coordinated the development and execution of numerous health policies and advised the President, NEC director, and senior officials. After leaving the White House, Brian founded Blase Policy Strategies and serves as its CEO.

https://paragoninstitute.org/paragon-pic/biden-era-medicaid-cost-surge/

Bayer CEO confident firm can cope with Xarelto hit

 Bayer chief executive Bill Anderson has said that newer product launches have offset the decline in sales of anticoagulant Xarelto in the first quarter, and he is confident that this will continue through 2025 as a whole.

Xarelto (rivaroxaban) fell nearly a third to €633 million ($703 million) from €926 million a year ago as generic competition took hold in Europe and Japan, although license revenues for the US – where it is sold as Johnson & Johnson – were up ahead of a patent expiry in the US this month.

A strong performance by prostate cancer therapy Nubeqa (darolutamide) and chronic kidney disease therapy Kerendia (finerenone) softened the blow, rising 78% to €515 million and 87% to €161 million, respectively, according to Bayer's financial update.

Meanwhile, blockbuster eye drug Eylea grew nearly 5% to €815 million thanks to a new high-dose formulation that reduces the number of injections needed into the eye.

"We know the Xarelto declines will weigh heavily on our top and bottom line over the remainder of the year, but we're equally confident in the momentum of our launches and the fundamentals of our business," said Anderson, who has previously said that 2025 will be the toughest year for his ongoing turnaround plan for the group.

Bayer would have raised its guidance on pharma sales for the year, he added, but decided to keep them as they are, given the "uncertainty around tariffs" that may be imposed by the US administration.

The pharma sector is still waiting to see whether President Donald Trump will follow through on suggestions that he will impose sector-specific tariffs on imports into the US of pharmaceutical products, which are currently exempt from levies.

Anderson is expecting pharma sales to dip around 1% for the full year compared to the €18.1 billion posted in 2024, at the top end of its -4% to -1% predicted range.

Later this year, Bayer will be looking for good news on the rollout of Beyonttra (acoramidis), recently approved for the treatment of life-threatening heart disorder transthyretin amyloidosis cardiomyopathy (ATTR-CM), and is also expecting the first launches for elinzanetant, a non-hormonal treatment for menopausal symptoms, which is also being developed for breast cancer.

Anderson also provided an update on Bayer's sweeping cost-reduction programme, aimed at stripping out layers of management, noting that its headcount had been reduced by around 2,000 in the first three months of the year. That takes the total reduction to around 11,000 since the policy was first introduced in mid-2023.

https://pharmaphorum.com/news/bayer-ceo-confident-firm-can-cope-xarelto-hit

'Digital support reduces GLP-1 dose needed for weight loss'

 Combining weight-loss drugs with online patient support can achieve results that match the drugs given on their own, but with a much-reduced dose.

That is the finding from a retrospective study reported at the European Congress on Obesity this week, which focused on the use of Novo Nordisk's GLP-1 agonist Wegovy (semaglutide) among users of a personalised, app-based obesity clinic, called Embla.

Embla, developed by a four-year-old company of the same name, is available in Denmark and the UK and was set up to provide weight management support alongside GLP-1 drug therapy.

Patients in the programme achieved an average weight loss of 16.7% after 64 weeks, which the researchers behind the study say is on a par with what was seen in clinical trials of Wegovy at its approved dosing.

Wegovy's standard dosing schedule is a low initial dose of 0.25mg once weekly that is increased every four weeks for 16 weeks to a maximum dose of 2.4mg.

The study in almost 3,000 patients, all from Denmark, found that patients were able to meet their weight-loss goals of a 0.5% or greater reduction in weight per week with less than half that dose, at an average of 1.08mg.

Similar mean weight loss was observed across body mass index (BMI) ranges and all medication doses, according to the study, which is available as a preprint and, according to the study authors, is due to be published in The Lancet Digital Health.

Reducing exposure to medicines is always a good thing if similar clinical outcomes can be achieved, and the study suggests it may be possible to improve the efficacy of semaglutide and other GLP-1 acting drugs, which can have side effects including nausea, diarrhoea, vomiting, constipation, stomach pain, headache, and tiredness, amongst others.

"Achieving the same weight loss in day-to-day life as in the tightly controlled conditions of a clinical trial, while also using lower doses of drugs, has many potential benefits, from lower costs and fewer side effects for patients, to ensuring that stocks of the drug go further," commented Dr Henrik Gudbergsen, the lead researcher on the paper and chief medical officer of Copenhagen-based Embla.

"Our results show that by giving personalised doses of semaglutide along with diet, exercise and psychological support, it is possible for patients to achieve clinical trial-level weight loss in their day-to-day lives," he added. "This approach was effective across all age groups and all starting weights and in both sexes."

https://pharmaphorum.com/news/digital-support-reduces-glp-1-dose-needed-weight-loss

US Fast-Tracking Uranium Mine Permit To Meet "Urgent Energy Demands"

 by Naveen Athrappully via The Epoch Times,

The Department of the Interior (DOI) is expediting environmental permitting review of the Velvet-Wood mine in Utah amid a national energy emergency, the agency said in a May 12 statement.

“If approved, the Velvet-Wood mine project in San Juan County, Utah, would produce uranium and vanadium,” said the agency. Uranium is used as fuel in nuclear reactors and for the production of tritium, which is required for nuclear weapons, while vanadium is used in steel production and titanium aerospace alloys.

“The project will undergo an accelerated environmental review by the Bureau of Land Management, with a completion timeline of 14 days. The expedited review is expected to significantly contribute to meeting urgent energy demands and addressing key threats to national energy security,” the DOI said.

The United States is currently “dangerously reliant” on foreign imports to meet the demand for uranium and vanadium, according to the agency.

In 2023, imports accounted for 99 percent of the uranium concentrate used by U.S. nuclear generators, the Energy Information Administration (EIA) said in a Jan. 30 statement.

According to the EIA, prior to the 1980s, the United States had incentives and favorable trade policies that boosted domestic uranium production. After these policies ended in the 1980s, domestic output cratered.

For instance, the United States produced 43.7 million pounds of uranium concentrate in 1980. By 2019, this had dropped to 174,000 pounds.

As for vanadium, almost half of domestic consumption last year was accounted for by imports, the DOI said.

A key security risk posed by the lack of domestic uranium and vanadium production is that America is dependent on its rivals.

For instance, in 2023, U.S. nuclear generators sourced uranium concentrate from sources in Russia, the DOI said. Meanwhile, Russia and China are key exporters of vanadium, according to data from the World Bank.

According to the DOI, the expedited permitting of the Velvet-Wood mine is being done in response to the national emergency declaration issued by President Donald Trump via an executive order on Jan. 20.

The declaration said the current inadequate development of domestic energy sources makes the United States “vulnerable to hostile foreign actors” and poses a national security threat to the country.

“America is facing an alarming energy emergency because of the prior administration’s Climate Extremist policies,” Interior Secretary Doug Burgum said.

“President Trump and his administration are responding with speed and strength to solve this crisis.

“The expedited mining project review represents exactly the kind of decisive action we need to secure our energy future. By cutting needless delays, we’re supporting good-paying American jobs while strengthening our national security and putting the country on a path to true energy independence.”

Speeding Up Critical Resources Development

On April 23, the DOI announced that it was implementing emergency permitting procedures to speed up the development of critical minerals and energy resources.

Approval times will be reduced to a maximum of 28 days from the months or years it used to take, the department said.

The policy is applicable to a wide range of energy sources such as oil, gas, uranium, geothermal, biofuels, and coal. Solar and wind were not listed.

“The United States cannot afford to wait,” Burgum said. “By reducing a multi-year permitting process down to just 28 days, the Department will lead with urgency, resolve, and a clear focus on strengthening the nation’s energy independence.”

In an April 24 statement, environmental advocacy group the Sierra Club criticized the DOI policy, calling the reduced time limit “troublingly short.”

“These arbitrary time limits make a complete review of the risks of potentially hazardous projects impossible,” said Athan Manuel, director of the Sierra Club’s Lands Protection Program.

“A shoddy review means the true hazards of a project may only be known when the air or water thousands of people rely on is dangerously polluted.”

On March 20, Trump signed an executive order to take “immediate measures” to boost mineral production in the United States.

“China, Iran, and Russia control large deposits of several minerals critical to the U.S., posing a national security risk. 70 percent of U.S. imports of rare earths come from China,” a March 20 White House fact sheet said.

“Critical minerals are essential for U.S. military readiness, as they are key components in fighter jets, satellites, submarines, smart bombs, and missile guidance systems,” it said, adding that “financing, loans, and investment support will be provided for new mineral production projects.”

https://www.zerohedge.com/commodities/us-fast-tracking-uranium-mine-permit-meet-urgent-energy-demands

Jefferies cuts Sangamo BioSciences target to $1.50, keeps Buy

 On Tuesday, Jefferies analysts revised their price target on Sangamo BioSciences (NASDAQ:SGMO) shares, lowering it to $1.50 from the previous $2.00, while maintaining a Buy rating on the stock. Currently trading at $0.75, the stock has shown resilience with a 22% gain over the past week, though InvestingPro analysis indicates the company is currently trading near its Fair Value. The adjustment follows Sangamo’s announcement of securing $23 million in financing at the market close, which is aimed at extending the company’s financial runway into the third quarter. This capital infusion is intended to provide the biopharmaceutical company with additional time to finalize a deal for its Fabry disease program.

The company has been actively involved in discussions with multiple parties regarding its Fabry disease treatment, with a focus on demonstrating and analyzing top-line eGFR data expected to be released in June 2025. Jefferies analysts believe that the finalized data could play a crucial role in increasing the likelihood of securing a deal.

Despite acknowledging the risks associated with Sangamo’s current position, the analysts found the sustained interest and engagement from multiple parties to be a positive sign. The financing is seen as a strategic move to bolster the company’s negotiating position as it works towards a partnership or agreement related to its Fabry disease program.

In other recent news, Sangamo Therapeutics reported its Q1 2025 earnings, highlighting its collaboration with Eli Lilly (NYSE:LLY), which could potentially bring in up to $1.4 billion in milestone payments. The company received an $18 million upfront license fee from Eli Lilly, marking a significant step in its neurology pipeline advancements. Despite these developments, Sangamo’s stock faced a sharp decline of over 42% in the aftermarket session, which may reflect investor concerns over the absence of immediate financial results or guidance revisions. The company achieved a 50% reduction in non-GAAP operating expenses year-on-year in 2024, aiming to extend its cash runway to late Q3 2025. Sangamo plans to submit a Biologics License Application (BLA) for its Fabry disease treatment in Q1 2026, with a potential commercial launch in H2 2026. The collaboration with Eli Lilly and the focus on securing a commercialization partner for Fabry disease remain key priorities for Sangamo. Analysts from Jefferies and Truist have shown interest in the company’s ongoing discussions with potential partners and regulatory interactions. The company’s financial strategy includes a recent equity offering to support its immediate cash needs and advance its neurology-focused mission.

https://www.investing.com/news/analyst-ratings/jefferies-cuts-sangamo-biosciences-target-to-150-keeps-buy-93CH-4041515

FAA launches emergency task force to ensure safety flying at Newark

 The Federal Aviation Administration is considering temporary flight reductions in and out of Newark Liberty International Airport, and it's launching an emergency task force to ensure safety, among other system upgrades announced by Transportation Secretary Sean Duffy at a press conference on Monday.

Duffy blamed recent telecommunications issues at Newark Liberty International Airport on former President Joe Biden's administration, claiming that it mishandled a move of air traffic control from New York to Philadelphia in 2024.

He said that the administration had moved the terminal radar approach control, or TRACON, "without properly hardening the telecom lines feeding the data."

"Pete Buttigieg and Joe Biden did nothing to fix this system that they knew was broken," he said, casting blame on his predecessor under Biden.

"Without addressing the underlying infrastructure, they added more risk to the system," he added.

Duffy's allegations come after an equipment issue on Sunday prompted the Federal Aviation Administration to order a 45-minute ground stop at the New Jersey airport.

However, Duffy claimed that the issue did not technically result in an outage -- because the FAA had just performed a software update on the backup system on Friday night to prevent future outages.

"The software patch was successful, and our redundant lines are now both working," he said, confirming that the main line went down on Sunday -- but the backup line did not.

It was only out of "an abundance of caution" that traffic controllers shut down the airspace for 45 minutes on Sunday, Duffy explained.

Acting FAA Administrator Chris Rocheleau also appeared at the press conference on Monday and announced that the agency was launching an emergency task force to ensure that travel in and out of Newark remains safe and efficient.

The task force comprises experts from the FAA, Verizon and L3Harris -- an FAA contractor that purports to focus on "advanced defense and commercial technologies."

Sunday's incident marks the fourth time in the past two weeks that technical problems have disrupted air traffic at Newark.

Duffy also noted that the telecoms system's age contributed to recent issues.

"The system is so old that even when you have high-speed fiber information coming in ... the information has to be slowed down, it comes in too fast," Duffy said, saying that the information could only travel at "the speed of copper wires."

For that reason, he said that the FAA has replaced copper lines with fiber lines at Newark, along with New York City's LaGuardia Airport and John F. Kennedy International Airport.

The new lines are currently being tested, he said, and the agency hopes to make the switch and have them fully operational by the end of May.

"The goal is to add three new telecommunications lines between New York and Philadelphia," Duffy added. "This will provide more high-speed reliability and redundancy -- so if one goes down, we're assured that the others will stand up."

Additionally, the FAA will be meeting with airlines on Wednesday to discuss potential flight reductions at Newark, he said, echoing an announcement made last week by the FAA. The move would be an effort to reduce ongoing flight delays to and from the airport.

During the meeting, the airlines will confidentially propose flight cuts to the agency based on the congested timeframes identified by the FAA.

United Airlines CEO Scott Kirby announced on May 2 that the airline was "unilaterally" cutting 35 daily roundtrips from its Newark schedule after several air traffic controllers went on medical leave following the April 28 outage. Newark often has 80 or more flights per hour, Kirby noted in the statement, calling the number unsustainable.

If approved, flight reductions are expected to stay in effect all summer. A final decision will be made after the meeting, and the order will be submitted to the Federal Register by the FAA.

Duffy said that the FAA is closely working with Verizon and L3Harris to determine the underlying cause of the recurring telecommunications issues and address them in an expedited manner.

He also said that he is asking the Office of Inspector General to conduct an investigation into decisions made by the last administration that might be linked to recent equipment failures.

Rocheleau reiterated that traveling in and out of Newark remains safe, and the task force will continue to monitor the upgrades announced by Duffy.

https://6abc.com/post/faa-launches-emergency-task-force-ensure-safety-flying-newark-liberty-international-airport-multiple-issues/16401036/