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Monday, February 10, 2025

Trump and Musk might just save us from trillions of dollars of US debt

 Like a canoe heading for a waterfall, the U.S. government simply can’t sustain itself on its current course. We’re $36 trillion (that’s $36,000,000,000,000.00) in debt, a number that increases by about $100,000 every two seconds. That’s $323,000 for every taxpayer. I’ve checked behind the couch cushions and – I don’t know about you − but I don’t have the spare change to cover my share.

Over the past 20 years, we’ve settled into a fairly predictable cycle. Each party laments the national debt in campaign ads and news conferences. Some members of Congress suggest cutting programs or making agencies more efficient. Then the people affected by those suggestions scream bloody murder. The matter is conveniently dropped, but only after more spending is approved as a salve for the wound caused.

The Department of Government Efficiency (DOGE) is popular with voters because the bloat is staggering. Something needs to be done. We need someone to step into the breach, cut up the government’s credit card − the American Excess card, if you will − and save us.

We need the economic equivalent of Ohioan Ulysses S. Grant. Gen. Grant led Union forces to victory in the Civil War, relying on his innate ability to stomach doing what was necessary no matter how horrendous the consequences.

The Union armies had two significant advantages over its Confederate adversaries − men and equipment. Early Union generals were too tentative, resulting in a bellicose quagmire. Other generals managed to get the army into battle, but when they won, they allowed the smaller, less-equipped armies to escape south to rebuild.

Even during his early days in the Western Theater, Grant acted differently.

At Shiloh, his army was whipped during the first day of battle − nearly pushed into the Tennessee River. Other generals would have loaded the men onto steamships and retreated across the river. But Grant went on offense. The Union attacked the following day, gained the advantage and won the battle.

Tesla, SpaceX and X CEO Elon Musk attends the inauguration ceremony of President Donald Trump at the U.S. Capitol on Jan. 20, 2025.

It would become his calling card, not backing down. Once Grant was brought East, Confederate Gen. Robert E. Lee faced the military equivalent of a $36 trillion national debt. Grant had more men, equipment and horses and doggedly pursued Lee. It was unsustainable and resulted in the surrender at Appomattox in Virginia.

Despite Grant’s success, he faced tremendous pressure and criticism from Northern politicians and the press for continuing to toss his men and equipment at Lee. Many of the same people who criticized other generals’ lack of action flipped into criticizing Grant as a butcher for too much action.

Where painful decisions are necessary, there’s always an argument to take the easy way out. Why act if it might result in someone being hurt?

Because not acting can have the same effect. Grant knew that. The determination to make the necessary painful decisions separates authentic leadership from hyperbole.

So now we return to current times and economics. Painful decisions are necessary.

Nonprofit organizations and individual donors may need to intervene when the government can no longer fund programs.

This has been necessary for a long time, but instead of action, we’ve been subjected to a sort of bureaucratic NIMBYism: Cost cutting is fine as long as it’s not our department or pet project.

It appears that at this moment − and I know this will cause some apoplexy in the most liberal corners of social media − we may have our President Lincoln and Gen. Grant for the war on spending in Donald Trump and Elon Musk. My internal Grant impels me to make the comparison nonetheless.

Take this month's action against the U.S. Agency for International Development. Democrats vigorously defended the organization that, according to White House press secretary Karoline Leavitt, spent $70,000 funding a play in Ireland about diversity, equity and inclusion and $32,000 for a transgender comic book in Peru.

As DOGE and the administration shifted USAID operations to the State Department, Democrats screamed. One fan of the bureaucracy said that “thousands, if not hundreds of thousands” of people would die as a result.

Folks, this was just a skirmish. This was the taking of Fort Donelson, which Grant achieved in February 1862. Shiloh, Antietam, Gettysburg and Vicksburg are still to come.

This fiscal war − against the national debt − must be fought knowing that the casualties will be high.

Let’s hope that Musk is, indeed, a latter-day Grant, doggedly pursuing the spending that strangles our country, demanding the unconditional surrender of those who will somehow claim that cost cutting is necessary while also claiming that every government department, agency or program is indispensable.

Matt Dole is a political and communications consultant who lives in Newark and works in Columbus. This column originally appeared in the Cincinnati Enquirer.

https://www.usatoday.com/story/opinion/voices/2025/02/10/trump-musk-doge-national-debt-usaid/78341854007/

ASL Strategic Value Fund Letter to Avadel Pharma Directors

 The following is a letter that ASL Strategic Value Fund sent to the Board of Directors of Avadel Pharmaceuticals (NASDAQ:AVDL):

February 10, 2025

Mr. Geoff Glass
Chairman, Board of Directors Avadel Pharmaceuticals Plc
16640 Chesterfield Grove Road, Suite 200
Chesterfield, Mo 63005

Dear Geoff: As you are aware, the ASL Strategic Value Fund has been a long-term investor in Avadel Pharmaceuticals. Our ownership predates most of the directors on the current Board. We have been big believers in Lumryz, a drug that the FDA has found on numerous occasions to be clinically superior to all other formulations of sodium oxybate. Lumryz brings significant benefits to narcolepsy patients. The launch of this superior drug should have allowed the company to rapidly dominate the narcolepsy market against its competitors. This launch should have been the catalyst for the company to finally create significant shareholder value for its investors. Unfortunately, the current management team has failed to capitalize on this opportunity. Additionally, they seem incapable of conveying a coherent investment case to investors. These mis-steps with the roll out of Lumryz and the constant mis-communication over the past year with investors has destroyed significant shareholder value and management's credibility. As a result, our stock continues to underperform against its peers and against the popular market indexes as it has for the past five years. The Board has failed in its duty to hold this management team responsible for their continued failures and dismal performance. It is beyond time that this Board acts upon its fiduciary duty and maximize the values for the benefit of all shareholders. This can only be accomplished by immediately retaining an investment bank to explore all possible alternatives including the outright sale of the company and distributing to existing shareholders a contingent value right which will receive the recovery from the numerous pending lawsuits against Jazz Pharmaceuticals.

Avadel Stock Performance Against NASDAQ

 

AVDL

NASDAQ

2025 YTD

-21.69%

-0.74%

2024

-21.98%

+27.19%

5 Year return

+15.66%

+128.1%

The company currently has two principal assets. The first being Lumryz, a revolutionary once a night formulation of sodium oxybate. The second asset is the potential recovery from a number of law suits filed against Jazz Pharmaceuticals for delaying and obstructing the launch of Lumryz. These damage claims are quite significant and the most important suit will go to trial November of 2025. This suit alleges that Jazz placed their REMS patent in the Orange Book to delay the launch of Lumryz, and was able to do so for eighteen months. Avadel claims that this action by Jazz will prevent it from generating eighteen months of peak revenues, or approximately $1.5 billion. This law suit was brought under the Sherman Anti-Trust Act, any damages granted by the jury (if the company is successful) will be automatically trebled. This could result in damages of approximately $4.5 billion, or approximately $45 per share. In addition to this suit, there are a number of other suits pending (two of which have been filed in the last sixty days over Jazz's launch of Xywav into the IH market). Each of these additional suits could result in hundreds of millions of dollars of additional damages paid to Avadel.

It is time for the Board of Directors to take action to maximize the values inherent in this company for the benefit of its long-suffering shareholders. The Board must immediately retain an investment bank to find a buyer for the company. During the latest investor call on January 8th 2025, management continued to state that they believe that peak sales from Lumryz in just the narcolepsy market should be north of $1 billion dollars annually. Management also stated that $1 billion of revenues would result in earning per share of over $6 dollars per share.

On this same call, management also stated that its current Phase III trial for a new indication, Idiopathic Hypersomnia (IH) should be completed during the second half of 2025. An FDA approval (when and if granted) for IH would allow the company to market Lumryz to an additional 40,000 patients. If the company were successful in capturing 20% of this market, it would translate into an additional $1 billion of revenues and an additional $7 dollars per share of earnings.

 

Peak Revenues

Earnings

Narcolepsy

$1 billon

$6 per share

IH (if FDA approved)

$500-1billion

$4-7 per share

Total:

$1.5-2 billion

$10-13 per share

In addition to monetizing the value of our business, the company should issue to existing shareholders a contingent value right (CVR) for the potential recovery from the outstanding litigation that is ongoing against Jazz Pharmaceuticals. Any potential recovery from these litigations should be distributed to the shareholders. The current launch has failed in delivering a significant return to the company's shareholders. It is now time to monetize these two significant assets to create value for the owners of this company.

As always, I am available to discuss these matters.

Steven Braverman
Managing Partner

Contacts

Steven Braverman
Managing Partner
ASL Strategic Value Fund
203/738-5836

https://www.businesswire.com/news/home/20250210373964/en

Vertex forecasts upbeat 2025 revenue on cystic fibrosis treatments demand

 Vertex Pharmaceuticals forecast annual revenue largely above Wall Street estimates on Monday, banking on robust sales of its cystic fibrosis drugs and early contributions from a newly approved non-opioid painkiller.

The drugmaker is looking to its acute pain drug, Journavx, to drive growth beyond its established line of cystic fibrosis treatments. Vertex expects to begin shipping Journavx to pharmacies in the U.S. by the end of February

The U.S. Food and Drug Administration, in December, also approved Vertex's once-daily next-generation treatment, Alyftrek, for a rare and progressive genetic disease, expanding its market dominance in cystic fibrosis (CF) treatments.

CF is an inherited disorder caused by a lack of a specific protein that results in poor flow of salt and water flow in and out of cells in various organs.

For the fourth quarter, ended December 31, sales of company's older CF treatment Trikafta rose nearly 17% to $2.72 billion.

The company aims to launch five new treatments by 2028, which include a next-generation CF drug and a non-opioid pain management medication.

In December, Vertex entered into an agreement with the Centers for Medicare & Medicaid Services to help increase patient access to its gene therapy, Casgevy, which treats a rare blood disorder requiring regular blood transfusions.

The Boston, Massachusetts-based drugmaker developed Casgevy with Swiss-American firm CRISPR Therapeutics.

Vertex sees 2025 revenue of $11.75 billion to $12.0 billion, the midpoint of which is above analysts' average expectation of $11.84 billion, according to data compiled by LSEG.

Revenue for the company's fourth quarter rose nearly 16% to $2.91 billion, beating analysts' estimates of $2.78 billion.

On an adjusted basis, the company reported a profit of $3.98 per share for the reported quarter, compared to analysts' expectations of a profit per share of $4.03.


https://finance.yahoo.com/news/vertex-forecasts-upbeat-2025-revenue-211347122.html

Pfizer-Astellas’ Combo Long-Term Efficacy in First-Line Treatment of Urothelial Cancer

 

  • Enfortumab vedotin plus pembrolizumab continues to demonstrate superior efficacy versus chemotherapy in a broad population, reinforcing the combination as standard of care in first-line treatment of la/mUC
  • At nearly 30 months of follow-up in the Phase 3 EV-302 trial, the combination doubled median overall survival and progression-free survival compared to chemotherapy, with no new safety signals identified

Gulf Refiners Are Balking at Watery Mexican Oil in Blow to Pemex

 


  • Crude has six times more water than industry standard
  • Pemex was hit with complaints and demands for discounts

US oil refiners along the Gulf Coast are snubbing shipments from Mexico and instead turning to Colombia and Canada amid complaints that Petroleos Mexicanos is increasingly delivering crude that’s unfit to make gasoline and diesel.

Refiners in Texas and Louisiana are demanding discounts and repeatedly complaining about the high water content in crude currently coming from Mexico, according to people with knowledge of the situation who asked not to be named citing private discussions. That’s upending flows of crude that the processors have relied on for the past half century.

https://www.bloomberg.com/news/articles/2025-02-10/gulf-refiners-are-balking-at-watery-mexican-oil-in-blow-to-pemex

Some Contraceptives Carry Higher Venous Thromboembolism Risk Than Others

 

  • Risk of VTE among different hormonal contraceptives varied by method and dose.
  • Combined pills and injections had the highest risk.
  • Pregnancy also carries heightened VTE risk.

Among hormonal contraceptive users, risk of venous thromboembolism (VTE) varied by method and dose, with combined pills and injections having the highest risk, a Danish nationwide cohort study found.

The standardized VTE rates per 10,000 person-years for the following hormonal contraceptives were:

  • Combined pills: 10.0 (95% CI 9.2-10.9)
  • Vaginal rings: 8.0 (95% CI 4.6-12.8)
  • Patches: 8.1 (95% CI 1.5-25.1)
  • Progestin-only pills: 3.6 (95% CI 2.8-4.7)
  • Injections: 11.9 (95% CI 4.4-25.6)
  • Intrauterine devices (IUDs): 2.1 (95% CI 1.7 -2.6)
  • Implants: 3.4 (95% CI 1.7-6.3)
  • No contraceptive use: 2.0 (95% CI 1.9-2.1)

When exclusively considering confirmed VTE cases, these associations persisted, reported Harman Gailan Hassan Yonis, MD, of Aalborg University Hospital in Denmark, and colleagues in JAMA research letteropens in a new tab or window.

"We found that combined hormonal contraceptives, particularly those containing third-generation progestins, were associated with the highest risk," Yonis told MedPage Today. "In contrast, intrauterine devices did not show an increased risk compared to women who did not use hormonal contraception."

When it came to VTE excess per 10,000 person-years, authors found it varied by combined pill formulation. For 20-μg estrogen pills with levonorgestrel it was 3.0 (95% CI -1.8 to 7.7) and 14.2 (95% CI 9.2-19.3) for combined pills containing third-generation progestins like desogestrel.

Compared with nonuse, VTE incidence rate ratios across contraceptive methods were:

  • Combined pills: 4.6 (95% CI 4.2-5.0)
  • Vaginal rings: 4.5 (95% CI 3.1-6.5)
  • Patches: 5.0 (95% CI 2.1-12.0)
  • Progestin-only pills: 1.8 (95% CI 1.4-2.3)
  • Injections: 5.7 (95% CI 3.5-9.3)
  • IUDs: 1.0 (95% CI 0.8-1.1)
  • Implants: 2.4 (95% CI 1.4-4.0)

VTE, which is a significant cause of maternal mortalityopens in a new tab or window, typically forms in the legs and can travel to the lungs. Yonis noted that the study was motivated by a need for information about VTE risk associated with newer formulations of hormonal contraception.

The risk differences between methods are "crucial for personalized contraceptive counseling and helping women make informed choices based on their individual risk factors," said Yonis.

Sarah Averbach, MD, of UC San Diego Health, who was not involved in the study, said that previous large observational studies have demonstrated that "the relative risk of VTE is elevated among combined hormonal contraceptive users" though the "absolute attributable risk is still low given how rare VTE is." She noted that it was unfortunate that researchers were unable to adjust for body mass index, smoking, and family history all together.

Progestin-only contraceptives have not been thought to be linked with VTE, though more recent research has suggested that depot medroxyprogesterone acetate, a high dose and potent injectable progestin, may have increased VTE risk, she said.

"This study provides further evidence that injectable progestins, unlikely any other progestin-only contraceptives, may be associated with an elevated risk of VTE," Averbach told MedPage Today. Like past data, this study can help guide physicians in counseling patients with conditions that put them at higher risk for VTE who may want to consider lower risk options.

Averbach also pointed out that VTE risk skyrockets in pregnancy, thus "by preventing pregnancy, contraception actually prevents VTE."

This nationwide cohort study of nearly 1.4 million women between the ages of 15 and 49 used Danish national registers and followed patients from Jan. 1, 2011, or their 15th birthday, until July 1, 2021, emigration, death, or an exclusionary event. Hormonal contraception use was determined through prescription records. Women with a history of thrombosis, cancer, thrombophilia, liver or kidney disease, infertility treatment, hormone therapy, oophorectomy, hysterectomy, polycystic ovary syndrome, or endometriosis were excluded. Overall, 2,691 VTEs occurred.

Authors noted some limitations, including that residual confounding may have remained and external generalizability may have been limited because of the homogeneity of the population.

Disclosures

This study was supported by Sygeforsikringen "Danmark."

Yonis reported grants from TrygFonden and Laerdal.

Other co-authors reported relationships with Pfizer, Novo Nordisk, and Bayer, as well as compensation to the hospital from Astellas and salary support for a PhD student from Radiometer.

Averbach had no disclosures.

Primary Source

JAMA

Source Reference: opens in a new tab or windowYonis HGH, et al "Contemporary hormonal contraception and risk of venous thromboembolism" JAMA 2025; DOI: 10.1001/jama.2024.28778.


https://www.medpagetoday.com/obgyn/generalobgyn/114160

'Bill Would Allow AI to Prescribe Drugs'

 Artificial intelligence (AI) could be used to prescribe medications to patients -- if a new bill makes its way through Congress.

The proposed legislationopens in a new tab or window, sponsored by Rep. David Schweikert (R-Ariz.), would amend the Federal Food, Drug, and Cosmetic Act to clarify that AI and machine learning technologies can qualify as a practitioner eligible to prescribe drugs if authorized by the state involved and approved by the FDA.

The bill was introduced in the U.S. House of Representatives and referred to the House Committee on Energy and Commerce in January.

But Adam Rodman, MD, MPH, a hospitalist and director of AI programs at Beth Israel Deaconess Medical Center and assistant professor at Harvard Medical School in Boston, told MedPage Today that the technology is not nearly where it needs to be for this kind of prescribing.

However, "[t]hings are accelerating so quickly," he added, "I don't doubt that we will be having this conversation," at some point.

He said he believes the proposed legislation "reflects enthusiasm about the technology," and that it could be aimed at helping to address "huge care gaps," when people struggle to see their doctor.

Still, "there would have to be huge sets of regulations that govern this," Stephan Fihn, MD, MPH, an internal medicine physician and professor in the departments of medicine and health systems and population health at the University of Washington, told MedPage Today. As it is, the proposed legislation doesn't specify which drugs it could be used for and in which settings, or whether physician review would be required.

Currently, there are many applications for AI in medicine, and "they're increasing very rapidly," said Fihn, who also serves as executive deputy editor of JAMA Network Open. But the application of AI and machine learning technologies, as described in the bill, "seems premature," as it appears to enable the "actual prescribing of drugs, some of which are very low risk, and some of which are very high risk," he cautioned.

Similar to autonomous vehicles being held to a higher standard than human drivers, he surmised that AI and machine learning technologies as prescribers would likely be as well. "My suspicion is that there will be a very high bar for approving these, at least initially," he noted.

Ultimately, "I think it will come to be," Fihn said. "And to be honest, properly developed, properly tested, properly managed, and highly regulated, it could be a good thing. But this has to be proven and shown."

Schweikert, the bill's sponsor, did not immediately provide additional comment to MedPage Today; however, he spoke about AI in healthcare and how it could impact government costs in an interview last year.

"Technology has to be part of the way we bend the borrowing and debt curve," Schweikert said in the interview with Nextgov/FCWopens in a new tab or window, adding that broader adoption of AI "can make government better, faster, cheaper" in responding to Americans' needs.

AI can improve diagnostics, Schweikert said, as well as front and back office medical operations.

"It's here, we now just have to build the infrastructure around it," he added, referencing a "new medical landscape." He also noted that "technology is starting to move much faster than our regulatory rules."

Previously, in January 2023, Schweikert introduced legislation aimed at achieving the same goal as the bill introduced earlier this month, according to Nextgov/FCW. Ultimately, though, the bill did not advance out of committee.

Meanwhile, AI in healthcare has continued to percolate as new uses emerge.

At an online panel discussion hosted by the Kaiser Family Foundation last February, health policy experts discussed the potentialopens in a new tab or window of AI to simplify prior authorization, though they added that "complete transparency" would be needed.

In many ways, AI in healthcare is still uncharted territory, and at the end of 2024 MedPage Today reported that accountability is likely to be key this year, though regulation isn't necessarily expectedopens in a new tab or window.

In a policy position paper from the American College of Physicians last June, one of the position statements was that AI technologies should complement, not supplantopens in a new tab or window logic and decision making of physicians and other clinicians.

Regarding Schweikert's current bill, it remains to be seen how far it may advance through the legislative process.

Five years ago, what is being proposed in the bill may have seemed like science fiction, Rodman noted. "This isn't sci-fi," he said. "It's just we aren't there yet."

https://www.medpagetoday.com/special-reports/features/114158