Case for equal protection among different medication classes

 A West Virginia University legal scholar says current laws may be giving manufacturers of biologic drugs, like antibodies and flu vaccines, too much in the way of legal protections before copycat versions can be sold when compared with traditional small-molecule drugs, including antibiotics and steroids.

In an article in the JAMA, Sean Tu, professor at the WVU College of Law, looks at the Food and Drug Administration exclusivity given to each of these different types of drugs and whether biologics really need longer protections than small-molecule drugs. Tu argues that while there should be parity, the solution is not to raise the small-molecule exclusivity time but to decrease the exclusivity time on biologics.

"Small molecule drugs are chemical compounds that are relatively easy to make," Tu said. "I put it in a test tube, add the chemicals, and I'm going to get the same reaction every time, whether I make it here in West Virginia versus Canada or France, because the chemistry is the same."

By contrast, biologics are manufactured in living organisms. Antibodies, for example, are created in living cells and are affected by various factors during the process.

"The temperature you keep them at, what you feed them, the serum you use—all of that can change the product slightly," he said. "So, the product I make here in West Virginia may be different from the product that I make in Canada or France. And because of that, there are some issues that make biologics harder to produce than small-molecule drugs."

Both biologics and small-molecule drugs take about 12–13 years to develop. Biologics cost slightly more to develop—$3 billion vs. $2.1 billion, on average—and have stronger patent protection, with more patents per drug. Additionally, biologics earn much higher revenues, both at their peak and overall, and are significantly more expensive for patients compared to small-molecule drugs.

FDA market exclusivities prevent the agency from even approving a drug during that period. Biologics get 12 years of protection before copycat versions can be approved. By contrast, small-molecule drugs are given five years of market exclusivity. Additionally, the Inflation Reduction Act of 2022 states that biologics are exempt from Medicare price negotiations for 11 years, compared to seven years for small-molecule drugs.

Biologics like Humira, Keytruda and Stelara comprise roughly 5% of all drugs and make up 40% of total pharmaceutical spending. Most are injected in a hospital setting. They're expensive, so they have a disproportionate effect on the cost of prescription drugs.

However, it doesn't mean they're more effective.

"We wrote this paper because the small-molecule folks say nobody's going to invest in small molecules now—everybody's going to invest in biologics because they get longer protections and they make more money," Tu said. "But small-molecules are great drugs. Some actually cure the disease, like the direct acting antiviral drugs that can cure hepatitis C in just 12 weeks."

Tu worked with fellow authors Olivier Wouters, London School of Economics; Matthew Vogel, Harvard; Reed Beall, University of Calgary; and William B. Feldman and Aaron Kesselheim, both of Harvard Medical School. The group analyzed data on development times, clinical trial success rates, research and development costs, patent protection, market exclusivity periods, revenues and treatment costs of biologics versus small-molecule drugs.

They found patents on biologics may be more effective at delaying biosimilar entry than patents on small-molecule drugs are at delaying generic entry. One strategy that biologic manufacturers have employed has been to obtain new patents just as 12-year exclusivity periods expire, thereby creating uncertainty for biosimilar firms seeking to challenge biologic patents. Additionally, biologic firms obtain almost five times as many patents to cover their products compared to small-molecule drugs. This is why market exclusivity periods appear to be several years longer for biologics.

The group saw little evidence to justify giving biologics longer legal protections. Biologics already have stronger patent protection, longer periods without competition and higher revenues than small-molecule drugs.

"The Biologic Price Competition and Innovation Act granted biologics 12 years of exclusivity based on the assumption that biologics would face earlier competition, have fewer patents, encounter greater challenges during FDA approval, and ultimately generate less revenue over time. However, our analysis shows that each of these assumptions were incorrect."

Tu said the Trump administration may focus on the issue of parity.

"Congress should reduce the exclusivity period for biologics from 12 years to five years to bring the biologic exclusivity time in parity with small-molecule drugs. Reducing exclusivity for biologics could lower drug costs."

More information: Olivier J. Wouters et al, Differential Legal Protections for Biologics vs Small-Molecule Drugs in the US, JAMA (2024). DOI: 10.1001/jama.2024.16911

https://medicalxpress.com/news/2025-01-legal-scholar-case-equal-medication.html

Progress and challenges in brain implants: special ethical and scientific care urged

 In a viewpoint paper recently published in the journal The Lancet Digital Health, a team led by Stanisa Raspopovic from MedUni Vienna looks at the progress and challenges in the research and development of brain implants.

New achievements in the field of this technology are seen as a source of hope for many patients with neurological disorders and have been making headlines recently. As neural implants have an effect not only on a physical but also on a psychological level, researchers are calling for particular ethical and scientific care when conducting clinical trials.

The research and development of neuroprostheses has entered a phase in which experiments on animal models are being followed by tests on humans. Only recently, reports of a paraplegic patient in the U.S. who was implanted with a brain chip as part of a clinical trial caused a stir.

With the help of the implant, the man can control his wheelchair, operate the keyboard on his computer and use the cursor in such a way that he can even play chess. About a month after the implantation, however, the patient realized that the precision of the cursor control was decreasing and the time between his thoughts and the computer actions was delayed.

"The problem could be partially, but not completely, resolved—and illustrates just one of the potential challenges for research into this technology," explains study author Raspopovic from MedUni Vienna's Center for Medical Physics and Biomedical Engineering, who published the paper together with Marcello Ienca (Technical University of Munich) and Giacomo Valle (ETH Zurich).

"The questions of who will take care of the technical maintenance after the end of the study and whether the device will still be available to the patient at all after the study has been canceled or completed are among the many aspects that need to be clarified in advance in neuroprosthesis research and development, which is predominantly industry-led."

Protection of highly sensitive data

Neuroprostheses establish a direct connection between the nervous system and external devices and are considered a promising approach in the treatment of neurological impairments such as paraplegia, chronic pain, Parkinson's disease and epilepsy. The implants can restore mobility, alleviate pain or improve sensory functions. However, as they form an interface to the human nervous system, they also have an effect on a psychological level.

"They can influence consciousness, cognition and affective states and even free will. This means that conventional approaches to safety and efficacy assessment, such as those used in clinical drug trials, are not suitable for researching these complex systems. New models are needed to comprehensively evaluate the subjective patient experience and protect the psychological privacy of the test subjects," Raspopovic points out.

The special technological features of neuroimplants, in particular the ability to collect and process neuronal data, pose further challenges for clinical validation and ethical oversight. Neural data is considered particularly sensitive and requires an even higher level of protection than other health information. Unsecured data transmission, inadequate data protection guidelines and the risk of hacker attacks are just some of the potential vulnerabilities that require special precautions in this context.

"The use of neural implants cannot be reduced to medical risks," summarizes Raspopovic. "We are only in the initial phase of clinical studies on these technological innovations. But questions of ethical and scientific diligence in dealing with this highly sensitive topic should be clarified now and not only after problems have arisen in test subjects or patients."

More information: Marcello Ienca et al, Clinical trials for implantable neural prostheses: understanding the ethical and technical requirements, The Lancet Digital Health (2025). DOI: 10.1016/S2589-7500(24)00222-X

https://medicalxpress.com/news/2025-01-experts-discuss-brain-implants-urge.html

Mexico refuses U.S. military flight deporting migrants, sources say

 Mexico has refused a request from President Donald Trump's administration to allow a U.S. military aircraft deporting migrants to land in the country, a U.S. official and a Mexican official told Reuters.

U.S. military aircraft carried out two similar flights, each with about 80 migrants, to Guatemala on Friday. The government was not able to move ahead with a plan to have a C-17 transport aircraft land in Mexico, however, after the country denied permission.

A U.S. official and a Mexican official confirmed the decision, which was first reported by NBC News. The Mexican official did not provide a reason for the denial.

The U.S. State Department, Pentagon and Mexico's foreign ministry did not immediately respond to requests for comment.

U.S.-Mexico relations have come into sharp focus since Trump started his second term on Monday with the declaration of a national emergency along the two nations' shared border. He has ordered 1,500 additional U.S. troops there so far, and officials have said thousands more could deploy soon.

The president has declared Mexican drug cartels terrorist organizations, renamed the Gulf of Mexico to Gulf of America and threatened an across-the-board 25% duty on Mexican goods beginning in February.

Mexican President Claudia Sheinbaum has sought to avoid escalating the situation and even expressed openness toward accommodating Mexican nationals who are returned.

But the leftist leader has said she does not agree with mass deportations and that Mexican immigrants are vital to the U.S. economy.

The use of U.S. military aircraft to carry out deportation flights is part of the Pentagon's response to Trump's national emergency declaration on Monday.

In the past, U.S. military aircraft have been used to relocate individuals from one country to another, like during the U.S. withdrawal from Afghanistan in 2021.

This was the first time in recent memory that U.S. military aircraft were used to fly migrants out of the U.S., one U.S. official said.

The Pentagon has said that the U.S. military would provide flights to deport more than 5,000 immigrants held by U.S. authorities in El Paso, Texas, and San Diego, California.

Guatemala also on Friday received a third flight of about 80 deported migrants on a chartered commercial aircraft, Guatemalan authorities told Reuters.

https://www.usnews.com/news/world/articles/2025-01-24/mexico-refuses-u-s-military-flight-deporting-migrants-sources-say

Bad Actor: The Fate of Peter Daszak

 The U.S. Department of Health and Human Services (HHS) has officially suspended and debarred Dr. Peter Daszak for five years from participating in federal procurement programs due to his role as former president and CEO of EcoHealth Alliance, Inc. (EHA).  This decision, announced on January 17, 2025, follows a Suspension and Proposed Debarment Notice issued nearly a year earlier, on May 15, 2024.  In addition to Daszak’s suspension, EcoHealth Alliance itself has also been debarred from federal procurement programs.

The suspension of Daszak’s funding is based on evidence uncovered by the Select Subcommittee on the Coronavirus Pandemic.  According to a Jan. 17 press release from House Committee on Oversight and Government Reform chairman James Comer (R-Ky.), EcoHealth “terminated Dr. Daszak’s employment effective January 6, 2025.”  Comer stated that Daszak and EcoHealth used “taxpayer funds to facilitate dangerous gain-of-function research in China.”

A final report released in May 2024 by Chairman Brad Wenstrup of the Select Subcommittee on the Coronavirus Pandemic (SSCP) outlined significant violations by EcoHealth Alliance.  The report revealed that “EcoHealth repeatedly breached the terms of its NIH grant, routinely ignored government oversight requests, and failed to report dangerous gain-of-function experiments conducted at the Wuhan Institute of Virology (WIV).”

According to the report, EcoHealth also submitted a required research report two years late. HHS cited these findings as key reasons for the formal debarment of both EcoHealth and Dr. Daszak.  The report emphasized that, given the strong likelihood that a lab-related incident involving gain-of-function research contributed to the emergence of COVID-19, EcoHealth and its former president should never again receive U.S. taxpayer funds.  Chairman Wenstrup explained that EcoHealth Alliance

repeatedly violated the terms of its NIH grant. EcoHealth routinely ignored government oversight requests, failed to report dangerous gain-of-function experiments conducted at the Wuhan Institute of Virology, and produced a required research report two years late. HHS cited all of these discoveries as key reasons for formally debarring EcoHealth and Dr. Daszak. Given that a lab-related incident involving gain-of-function research is the most likely origin of COVID-19, EcoHealth and its former President should never again receive a single cent from the U.S. taxpayer.

The SSCP’s final report includes “firsthand testimony and primary source documents” demonstrating that Daszak and EcoHealth Alliance were “bad actors” who “acted with contempt for the American people.”  This investigation focused on EcoHealth Alliance’s NIAID grant R01AI110964, known as “Understanding the Risk of Bat Coronavirus Emergence.”

As a result of their investigation, Wenstrup and the SSCP established five specific findings:

1. EcoHealth submitted its Year 5 Report “nearly two years late,” falsely claiming, without evidence, “that it was locked out of an NIH system and blocked from submitting the report on time.”
2. EcoHealth failed to report its “potentially dangerous experiment conducted by the Wuhan Institute of Virology (WIV),” violating the terms and conditions of the grant.
3. EcoHealth “used taxpayer dollars to facilitate gain-of-function (GoF) research on coronaviruses” at the WIV, “contrary to previous public statements, including those by Dr. Anthony Fauci.”
4. NIH was alerted to the actions of EcoHealth because of “proper interventions by former-President Donald Trump and former-White House Chief of Staff Mark Meadows.”
5. Dr. Daszak omitted the crucial fact that unanalyzed samples and sequences, funded by U.S. taxpayers, were in WIV’s custody when negotiating the reinstatement of EcoHealth’s grant in 2023.  Had the National Institutes of Health (NIH) known about the status of these samples, the grant likely would not have been reinstated.  Additionally, WIV was debarred, in part, for failing to produce laboratory notebooks that would have documented the virus samples and sequences.

February 2022 Interview With Former EcoHealth Alliance Executive Dr. Andrew Huff

In early 2022, I interviewed Dr. Andrew Huff, a former associate vice president and whistleblower at EcoHealth Alliance.  Huff exposed what he described as “numerous unethical and criminal behaviors” within the organization.  He also speculated that Daszak “could be a double agent working on behalf of the Chinese government,” noting that Daszak appeared indifferent to the risks associated with conducting gain-of-function research and other high-risk laboratory work in China.

Huff also provided Daszak’s InQTel pitch deck PowerPoint presentation, entitled “Identifying Predictable Patterns in Disease Emergence,” as potential evidence of Daszak’s alleged association with the CIA.  Huff said Daszak admitted he was working for the CIA.  InQTel is the CIA’s venture capital arm, a fact well known in the Intelligence Community.

Huff found it “strange” that such high-risk work was being conducted in China.  He raised ethical concerns about EcoHealth, stating that it had deviated from its stated mission of conservation under Daszak’s leadership.  “EcoHealth was not collecting the right data,” Huff explained, “nor was it using the proper methods or models to forecast or prevent pandemics as outlined in its mission.”

Instead, Huff argued that EcoHealth had become involved in a “glorified intelligence collection scheme” that gave China the better end of a deal.  EcoHealth’s activities allowed China access to cutting-edge U.S. biotechnology, while the U.S. fruitlessly hoped for “transparent access” to Chinese lab activities as evidenced by WIV’s failure to produce its lab books.

Most gain-of-function research is considered dual-use research of concern (DURC) because it involves pathogens that carry significant biosafety and biosecurity risks.  Specifically, gain-of-function research makes viruses more transmissible or more pathogenic.

Many also believe that gain-of-function research should be classified as bioweapons research.  In a February 14, 2022 Twitter post, Huff reiterated his concerns about the containability of gain-of-function research, stating that “GoF research does not follow natural evolution and is very difficult to contain.”

Huff also noted that Daszak seemed “overly interested” in securing NIAID funding, which he said “would justify research into diseases that could promote vaccine development,” as was the case with the mRNA COVID-19 vaccines.  He expressed deep concerns about the safety and security of gain-of-function research, both in China and the U.S.

Predicting viral evolution is almost impossible, according to Huff.  He referenced the now-defunct USAID Predict program (2019) as a primary driver of global surveillance efforts aimed at monitoring zoonotic diseases.  Its goal was to improve global health outcomes.  The program, which had partnered with EcoHealth Alliance, appears to have been conveniently absorbed into the “One Health Workforce–Next Gen” program.

Huff criticized the focus on gain-of-function research as a means of developing treatments or vaccines, stating, “Developing treatments from GoF R&D has proven to be ineffective.”  Even after the final subcommittee report, a troubling question remains: why did Daszak and EcoHealth Alliance allegedly attempt to conceal the details and purpose of such risky, seemingly unproductive research?

https://www.americanthinker.com/articles/2025/01/bad_actor_the_fate_of_peter_daszak.html

BofA, JPMorgan to lobby White House, Congress over allegations of closing accounts

 Bank of America and JPMorgan are set to lobby the White House and Congress to defend themselves from accusations by President Donald Trump and others that they have shut down accounts of conservative customers on political grounds.

The banks said they need clearer guidance from the government on how best to police money laundering and provide services across a range of industries. On Thursday, Trump singled out JPMorgan Chase and Bank of America, saying they did not provide banking services to conservatives.

Trump's criticism echoed longstanding "debanking" complaints from Republicans, who have accused Wall Street banks of "woke capitalism," as well as denying services to gunmakers, fossil-fuel companies and others perceived to be aligned with the political right. The two banks on Thursday denied they made banking decisions based on politics.

"We take this issue very seriously," a BofA spokesperson said on Friday. "We will be engaging with the administration and Congress regarding the extensive government regulations that sometimes result in requirements to exit relationships."

The spokesperson said the bank serves more than 70 million clients and welcomes conservatives.

"We never close accounts for political reasons and don’t have a political litmus test," the spokesperson said.

The source familiar with the situation said that JPMorgan would also be lobbying for clearer regulation about assessing customers.

Bank lobby groups will also be part of the effort, according to the source familiar with the situation.

They will push the government to clarify anti-money laundering laws, establish a clear federal standard on fair access to financial services and streamline bank supervisory practices on who can be banked, said the source and two separate sources familiar with the matter.

WHAT BANKS WILL BE ASKING FOR

The Trump administration is expected to prioritize trimming regulations, and banks are hopeful that this could lead to some changes in rules and oversight which will enable them to have clearer standards around debanking, a banking source and two industry sources said.

None of the sources wanted to be identified as these discussion are private.

The U.S in 2020 passed a law overhauling anti-money laundering (AML) rules. However, the overhaul has not happened as planned. Banks are still waiting for clarity on the new rules and will be pushing for new, clearer rules on AML, the banking source and one of the industry sources said.

Firms and individuals often see their bank accounts getting closed if there are concerns regarding the ability to police money laundering, both the sources said.

Different state laws on some of these issues have made banking more challenging, leading big banks to push for a clear federal standard on fair access to financial services, the three source said.

Banks also say the rules around who can be served are unclear, leading them at times to be hesitant to offer service to a particular industry or firms, the three sources said.

While regulators do not issue directives to avoid specific clients, they may flag some activity as risky, prompting banks to step back for fear of supervisory rebuke and fines.

“There should be far cleaner lines about what we have to do and we don't have to do,” JPMorgan CEO Jamie Dimon said in a podcast this week, before Trump made his comments. “We've been complaining about this for years. We need to fix it.”

Lenders are also prohibited from informing customers why they have been debanked, opening the door for accusations of political bias.

"We have not debanked anyone because of political or religious relationships, period. Now, when we debank someone, they often blame that reason, but that's not a reason," Dimon said in the podcast.

https://finance.yahoo.com/news/bofa-plans-engage-white-house-213531654.html

Hochul’s mad Medicaid spending is meant to woo health-industry honchos — on OUR dime

 Perhaps the most damning commentary on Gov. Hochul’s Medicaid spending plan — which made up roughly half of the $252 billion state budget she released Tuesday — was the silence of the attack dogs. 

Last year, the hospital lobby spent millions on TV ads falsely accusing Hochul of “cutting” the state-run health plan, which covers 7 million lower-income New Yorkers.

This year, the ad campaign has gone quiet, a sign she is giving hospitals everything they could want and more. 

This appeasement comes at a high price for taxpayers: The governor is proposing to jack up the state-funded portion of Medicaid by $6.4 billion, or 17%, in a single year — and that’s before the Legislature makes its inevitable additions. 

This comes on top of a combined 36% increase over Hochul’s first three years as governor.

When this Medicaid budget is through, it’s likely to spend 60% more than what she inherited in 2021 — which even then was the costliest Medicaid program in the United States on a per capita basis. 

Even Hochul acknowledged — in the mere eight sentences she devoted to this topic in her budget presentation — that this growth “isn’t sustainable for New York taxpayers on its current trajectory.”

Of course, she was the one who put it on that trajectory. 

Her proposed solution is “to take action alongside the federal government to manage this growth.”

Maybe she hasn’t seen the headlines lately, but Republicans in Washington are preparing to squeeze trillions in savings out of Medicaid. Bailing out a spendthrift blue-state governor is not on their to-do list. 

Another head-scratching note came from the governor’s budget briefing book.

After acknowledging that spending is out of control, it said the governor’s budget strategy consists of “maintaining Medicaid spending at current natural levels of growth.” 

Sorry, but there is nothing “natural” about Medicaid’s current spending spike. 

The state’s economy is growing, its unemployment rate is low, and the poverty rate has been trending down — all of which should mean less demand for what is meant to be a safety-net health plan for the poor and disabled. 

The governor is proposing to jack up the state-funded portion of Medicaid by $6.4 billion, or 17%, in a single year.

By way of excuse, Hochul and her aides emphasized that Medicaid enrollment remains 900,000 higher than it was before the pandemic.

They didn’t mention that enrollment peaked in 2023 and has come down by 1.1 million since then. By rights, Medicaid costs should now be falling. 

But they’re skyrocketing instead — because in Albany, Medicaid isn’t just about taking care of the needy, but increasingly about pumping money into the health-care industrial complex, often in ways that have nothing to do with the best interests of the poor or disabled. 

One of Hochul’s recent Medicaid-funded initiatives aims to “recruit and train thousands more health care workers” — even though New York already boasts the largest health-care workforce per capita of any state.

Naturally, a chunk of that money is going to the state’s largest and most influential health-care union, 1199 SEIU. 

Another growing expense consists of ongoing bailouts for financially “distressed” hospitals, which typically are losing money because patients have fled to other providers.

In effect, the state is paying failing facilities to staff and maintain their emptying wards. 

The epitome of Hochul’s spendthrift approach is a newly enacted tax on managed care organizations, a gimmick to cadge an extra $3.8 billion in federal Medicaid funding over the next two years — at which point Washington is expected to shut down the loophole that makes it possible. 

It’s a temporary shot of cash at best, yet Hochul is proposing to use it to hike Medicaid reimbursement rates for hospitals, nursing homes and other providers — leaving an expensive hole to fill when the money runs out. 

Meanwhile, her budget fails to address the health-care system’s most urgent problems. 

Where is the initiative that will finally goad New York’s hospital industry to improve their quality rankings, which sit near the bottom on national report cards? Or to shorten their average emergency-room wait time of 3 hours and 22 minutes, the fifth worst of any state? 

What is her plan for cracking down on patient neglect and profiteering in nursing homes, as exposed in lawsuits filed by Attorney General Letitia James? 

Speaking of affordability — a new Albany buzzword — why isn’t Hochul working to lower health-insurance premiums that rank among the highest in the country, driven largely by state-imposed taxes and regulations? 

The answer isn’t hard to find: The health-care industry is the single wealthiest and best-organized lobbying force in the state.

Its forces reward politicians who give them money while punishing those who dare to question the poor return on that investment. 

Hochul’s Medicaid splurge isn’t buying better care for New Yorkers. It’s buying her a reprieve from the hospital lobby’s attack ads. 

Taxpayers can only imagine how much more expensive this strategy will get in 2026, when she and the entire Legislature are up for re-election.

Bill Hammond is the senior fellow for health policy at the Empire Center.

https://nypost.com/2025/01/23/opinion/hochuls-mad-medicaid-spend-woos-health-honchos-on-our-dime/

UnitedHealth confirms 190 million Americans affected by hack at tech unit, TechCrunch reports

 The cyberattack at UnitedHealth's tech unit Change affected the personal information of 190 million Americans, TechCrunch reported on Friday.

UnitedHealth Group did not immediately respond to a Reuters request for comment.

https://www.yahoo.com/news/unitedhealth-confirms-190-million-americans-233002953.html