The No Bells Prize

03/12/2025 08:39 AM | Peter Pitts

When it comes to Robert F. Kennedy, Jr., I refuse to yell. I refuse to name-call. I refuse to sign FaceBook petitions with cut-and-paste social media tirades. I refuse to predict the end of the world – because I want to make a positive difference. I want my voice to be heard by those in positions of authority and influence. I’ve been around the block enough times to recognize that requires being persistent, patient, persuasive, polite, respectful, and humble. I refuse to reflexively kowtow to my betters. I refuse to be a sock-puppet for science. This doesn’t make me an “enabler.” It makes me a realist.

The mainstream, well-meaning, and devoted public health community has, in very short order, effectively zeroed out any influence they might have had with the new administration by making their attacks judgmental and personal and the media has been all to glad to magnify these lapses in rhetorical judgment. Two words – stop it.

Here’s my message to those who believe they have somehow earned the right to peer down their peer-reviewed noses and at those with fewer letters after their names – get over yourselves. You’re on the outside looking in and your Nobels ring no bells with RFK2. As another Kennedy once said, “Life is unfair.” This is your wake-up call.

I’m not a science-denier. It’s not what “the experts” are saying that’s wrong (although sometimes it is). It’s the way they’re saying it. It’s as useless as trying make a non-English speaker understand you by TALKING LOUDER – and a whole lot more dangerous. Exaggeration is the enemy of belief and trust – and its bad science. Exaggeration is misinformation by another name.  

Not everything the new RFK2 crew are doing represents an end to civilization as we know it. The daily hand wringing and predictions of doom-and-gloom by professors and pundits show how little they have learned from the pandemic experience. “It’s settled science, so shut up,” didn’t work during the dark days of Covid-19 – and we continue to reap the whirlwind. Ringing the alarm bells all day every day just makes for annoying ambient noise that becomes increasingly easy to ignore.

It’s time for less atonal cowbell and more determined, cool and collected engagement.

Turning up the volume on pomposity is the height of self-importance and only serves to turn real experts into late-night punchlines. It’s time for America’s public health establishment to get out from behind the sheltered protection of the lectern, and onto a more collegial playing field.

What? Engagement with that bunch of yahoos? Well, first of all, that’s rude – and secondly, that’s right. You may have tenure, but that doesn’t give you much if any policy heft in the world of realpolitik. Otto von Bismarck reminds us, “Politics is the art of the possible.” There’s no ivy on the walls of HHS headquarters. Sometimes you have to eat some crow if you want a seat at the table. Don’t believe me? Ask Volodymyr Zelenskyy.

Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest and a Visiting Professor at the University of Paris School of Medicine.
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Medicare Middlemen Shouldn’t Get in the Way of Personalized Medicine

02/26/2025 06:44 AM | Peter Pitts

When speaking this past week at the White House, Oracle founder Larry Ellison said that the newly announced ‘Stargate’ – an artificial intelligence infrastructure project – will pave the way to the United States developing a ‘cancer vaccine.” Well, as my grandmother used to say, “From his mouth to God’s ears.” 
 
In the past, such advances have led our country to longer, healthier lives, to save premature babies, and irradicate devastating diseases. Innovators should be rewarded for propelling the future of care and treatment options for the millions of Americans. Instead, the unfortunate reality is that innovators now stand to be punished due to outdated policies governing Medicare administered by third party middlemen with financial incentive to deny access to innovative diagnostic testing.  
 
Crucially, finding a way to eradicate cancers, one of our planet’s most devastating diseases, will be in vain without advancements in diagnostic testing. However, this comes with an urgent caveat -- this future will not be fulfilled if healthcare middlemen continue to have their way.  
 
The 68 million Americans covered by Medicare (including me) have their claims processed by private insurers known as Medicare Administrative Contractors (MACs). Last month, two of those MACs – Novitas Solutions and First Coast Service Options (FCSO) – issued a Local Coverage Determination (LCD) which ended the coverage of nine groundbreaking cancer diagnostic tests. It’s a warning shot across the bow to precision medicine and investment in innovation. 
 
These decisions must not stand. Early detection is a critical step of prevention, especially for cancer patients. Tests like these allow doctors to intervene and understand their patients’ care far earlier into their diagnosis, enabling them to develop more personalized and cost-efficient treatment plans that, most importantly, improve outcomes. When such care is delayed or inaccessible, there are often greater problems associated with treatment, such as more intensive intervention options like biopsies or radiation therapy or potentially missed and undertreated disease. This comes alongside higher costs of care and, unsettlingly, a lower chance of survival.   
 
There also must be high alert for “regulatory mission creep.” That’s why the 21st Century Cures Act included additional guidelines on the MACs’ LCD process and determination timeline. MACs delaying their decision and blatantly diverting from the Cures Act is a flagrant breaking of the law that has become the norm for MACs – not an exception – and certainly not an exemption. 
 
Cancer patients are not the only ones negatively impacted by these actions. In 2023, the MAC Palmetto GBA, published an article to the CMS website, changing the coverage of two tests for organ transplant patients --one of which could predict rejection problems with transplanted organs weeks or even months ahead of clinical signs of damage. 
 
Luckily, CMS stepped in and coverage for the blood tests was restored. That was not without struggle and hardships for patients and their loved ones. In the process, it also came to light that the MAC ignored the recommendations of medical experts when making the decision to deny coverage.   
 
The bad news is that CMS is limiting access to cutting-edge diagnostics for those on Medicare. This negligence is unacceptable. It is regulatory malpractice. CMS and MACs must be held accountable and reduce uncertainty for patients, healthcare providers, and innovators alike instead of allowing critical coverage decisions to cause greater uncertainty in the future of American healthcare. Additional Congressional oversight should push CMS and their MAC henchmen to reexamine their coverage decisions that impact seniors’ access to novel healthcare and increase taxpayer burden. 
 
If we are to more fully and rapidly realize a world where we can detect cancer, organ failure, and a host of diseases before they occur, we must establish the foundations and incentives to develop testing and treatments. This is the goal of Mr. Ellison’s Stargate initiative – and it is one worth pursuing aggressively. 
 
Peter J. Pitts is president and co-founder of the Center for Medicine in the Public Interest and a former associate commissioner of the U.S. Food and Drug Administration. 
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Biden-era policy proposal threatens Medicare Advantage

02/24/2025 12:24 PM | Peter Pitts

Here’s the good news: Medicare Advantage is one of our nation’s most successful public-private partnerships, providing efficient and effective access for many millions of American seniors to cost-effective healthcare coverage. The bad news is that Medicare Advantage is under threat from a Biden-era proposal that will spell disaster for the Medicare Advantage Program if nothing is done.

For the last two decades, the Centers for Medicare and Medicaid Services (CMS) has used a single normalization factor as a basis to calculate payment rates for both Medicare Advantage Prescription Drug plans (MA-PDs) and standalone Part D plans (PDPs – the Medicare Prescription Drug Benefit). (A normalization factor is used to account for changes in the health status and demographics of traditional Medicare beneficiaries.) 

Without going into the heavy math – let’s suffice it to say this makes sense. A single normalization factor allows both MA-PDs and PDPs to compete in the marketplace on a level-playing field and resulting competition has led to lower out-of-pocket costs and more coverage options for millions of American seniors.

Rather than leaving well enough alone, the Biden Administration and Democrats in Congress (always suspicious of public/private partnerships – even successful ones) opted to separate the normalization factors for MA-PDs and PDPs, effectively lowering the payments made to MA-PDs to ensure PDPs got more money -- a shell game aimed at stabilizing the PDP market at the expense of MA-PD beneficiaries. The new normalization factor methodology will result in inaccurate risk scores. What does this mean? Artificial risk scores divorced from reality. In 2025, the difference in normalization factors was 12.4% higher for MA-PDs, dragging down the risk scores. That jump is 34.6% in 2026, nearly tripling.

Unfortunately for these denizens of Big Government, Part D drug plans have been far less efficient when it comes to delivering drug benefits for enrollees compared to Medicare Advantage; monthly premiums for standalone PDPs average $45 compared to just $7 for MA-PDs. These ill-considered (but not unpredictable) policy decisions, baked into the Inflation Reduction Act, resulted in disastrous effects on both the Medicare Advantage and Part D markets. Predictably, premiums went through the roof and many Part D plans went away entirely.

Make no mistake, if allowed to happen, split normalization factors will lead to less choice and higher costs for beneficiaries enrolled in Medicare Advantage. CMS’s separate normalization factor policy favors less-efficient standalone Part D plans over more-efficient MA-PD plans. By harming Medicare Advantage in order to bolster Part D, CMS is robbing Peter to pay Paul.

With a new administration now in the White House and the Biden-era receding into history, it is imperative that we not allow the policy failures of the Biden administration to undermine the integrity of the successful Medicare Advantage program. Leaders in Congress must take action to stop separate normalization factors from becoming the new normal. We mustn’t allow the bureaucrats at CMS to normalize Biden-era mistakes while no one is looking.

It's time for some of what HHS Secretary Kennedy has called, “radical transparency.”

Peter J. Pitts, a former FDA Associate Commissioner, and member of the United States Senior Executive Service, is President of the Center for Medicine in thePublic Interest.

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DeepSeek-and-Ye-Shall-Find: America’s 21st Century Medical Innovation Moment

02/11/2025 02:54 PM | Peter Pitts

The US is at a critical juncture in biomedical innovation, facing the twin towers of high costs and complexity in research. We’re not alone. China is racing ahead in the development and application of Artificial Intelligence (AI) to drug discovery and development. Beijing is actively supporting AI’s role in healthcare technology development with an aggressive and robust national strategy that includes extensive biodata collection, R&D facilitation, and commercialization of medical AI. Alas, inside-the-Beltway, we’re more-or-less standing still.

Without significant attention to revitalizing our processes and procedures for discovery (Hello NIH!), evaluating (Hello FDA!), and paying for new therapies (Hello CMS!), China will leave us in the dust when comes to developing new therapies. Are you ready for this headline, “Who Lost Healthcare?”  

For example, Chinese companies are already at the forefront of integrating AI into various stages of drug development, exemplified by its development of ISM3312, an AI-designed drug targeting COVID-19, which has already entered clinical trials in China. That’s what pandemic preparedness means. Where are we? Who Lost Healthcare?

It’s happening in China and it’s not by accident. China is making significant investments to shift from traditional animal-based preclinical models to advanced AI-driven in silico models and digital twin technologies. This transformation is driven by government initiatives, rapid growth in AI biotech startups, and the need to reduce the ethical, financial, and scientific limitations associated with animal testing. Who Lost Healthcare?

If our public health bureaucrats aren’t paying attention, the private sector certainly is. China's advancements in AI-driven drug development have garnered significant interest from innovative pharmaceutical companies. For instance, AstraZeneca, has entered a $2 billion licensing deal with China's CSPC Pharmaceutical Group to develop a small molecule addressing dyslipidemia, extending their existing collaboration focusing on advanced lung cancer research. Similarly, Merck recently signed a $3.3 billion agreement with China-based LaNova Medicines to develop advanced immuno-therapies targeting PD-1 and VEGF proteins. What’s wrong with this picture? Who Lost Healthcare?

China’s National Medical Products Administration (NMPA) -- the equivalent of our FDA --has been actively reforming its regulatory framework to foster the integration of AI-driven technologies, including virtual models, digital twins, and advanced trial designs. This transformation aligns with China’s broader strategic goals under the “Healthy China 2030” plan and the “New Generation Artificial Intelligence Development Plan.” It is a targeted and thoughtful great leap forward for both healthcare innovation and industrial policy. Matching and then overtaking China in AI-driven healthcare must become a national priority.  And it need not be driven by government.

Consider Vial, a California-based start-up whose goal is to significantly reduce clinical trial costs through automation, digitization, and streamlined workflows. Their TrialOS platform structures, digitizes, and automates over 200 discrete trial tasks, cutting both time and expenses. This efficiency is crucial for the U.S. to maintain its competitive edge against China's state-supported, rapidly scaling pharmaceutical infrastructure.

By integrating AI-driven target identification, generative chemistry, and automated preclinical testing, Vial also accelerates the drug development pipeline. Their use of organoid and organ-on-a-chip (OOC) technologies reduces reliance on costly animal models, making preclinical data collection faster, cheaper, and more predictive of human outcomes AI is increasingly being used to mitigate dose-related failures in drug development through advanced applications in pharmacokinetic/pharmacodynamic (PK/PD) modeling, dose-response optimization, individualized dosing, and post-marketing surveillance.

Other companies like Unlearn.AI, Phesi, and ArisGlobal are pushing the boundaries in areas including digital twining, synthetic control arms, and regulatory automation. Another player, Insilico Medicine, reports reductions of up to 70–90% in animal testing during preclinical phases. By eliminating the need for extensive animal studies, in silico models can reduce preclinical R&D costs by up to 40%.

This approach aligns with the strategic need to outpace China in drug development. The ability to launch numerous clinical programs simultaneously could give the U.S. a significant advantage, leveraging scale and speed to dominate globally

The FDA needs update its drug development regulations, and the right place to start is by incorporating AI into its clinical trial protocols. FDA should create an "AI Fast-Track" designation similar to its expedited pathways for AI-driven drug discovery. This would promote advanced technologies, reduce administrative hurdles, and bring therapies to market faster, enhancing U.S. competitiveness and enhancing safety and effectiveness.

By embracing technologies that reduce clinical trial costs and accelerate drug discovery—coupled with regulatory reforms to support AI-driven advancements—the U.S. can not only challenge but potentially surpass China's rapid advances in drug development. The future of global health leadership depends on our ability to integrate these innovations into a cohesive, scalable strategy.

Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest and a Visiting Professor at the University of Paris School of Medicine.

Robert Goldberg, Ph.D., is co-founder and Vice President of Research at the Center for Medicine in the Public Interest
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End the IRA’s Innovation-Killing “Big Payor” Bailout

01/28/2025 08:31 AM | Peter Pitts

GLP-1 drugs (Ozempic, Wegovy, Zepbound, etc.) have important therapeutic potential beyond weight loss. According to a new Pharmacy Practice in Focus article, “Since their original entry into the market, GLP-1 receptor agonists have gained FDA approval and have established significant roles in therapy for cardiovascular disease, obesity, and kidney disease. Interestingly, emerging data suggest that this class of medications may have roles in other—somewhat unrelated—conditions.”

These “unrelated” conditions include Parkinson’s Disease, Alzheimer’s Disease, osteoarthritis, gambling addiction, and chemical dependencies. To say GLP-1 drugs have potential beyond weight loss is an understatement. But there haven’t been any large-scale studies to move beyond the exciting (but limited) anecdotal data – and the plural of anecdote isn’t data. Without solid data, the FDA can’t add any of these potentially groundbreaking secondary indications to the official product label.

(In regulatory parlance, “secondary indications” come after the primary indications granted when a drug is initially approved by the FDA.)

Why does this matter? Because unless these “secondary indications” are more intensely studied, and the data reviewed and vetted by the FDA, physicians will be rightfully skeptical and insurance companies unlikely to reimburse patients for what they consider suspicious off-label use. And rightfully so.

With such exciting potential, why aren’t the expensive large-scale clinical trials that would move these new therapeutic opportunities moving forward at warp speed? One troubling answer is an unintended (but entirely predictable) codicil of the Inflation Reduction Act, specifically, the IRA’s blunt language that says that any “negotiated” price covers all indications current or future. In blunt terms, the IRA is saying to drug developers, “You will not be rewarded for investing in any new important science.” This predictable stifling of innovation cannot and must not stand.

The pharmaceutical industry recognizes this problem. Patients and disease organization do too. And you can add to that physicians who read about the potential – but are left wondering where the data are that will better inform these new and exciting use indications. Everyone is waiting.

Well, not everyone. There’s been a strange and uncomfortable silence from a major player in American health care – the insurance companies. While “Big Pharma” regularly face the wrath of pundits and politicians, “Big Payor” seems to get a pass. And it’s not unreasonable to conclude the reason -- they don’t want to pay for important new GLP-1 indications.

That’s craven. The Big Insurance Bailout must end – and a good place to start is by amending the IRA’s inexcusable, unnecessary, and dangerous innovation-penalty.
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Don't get your pronouns in a twist: FDA and the great website scrubbing

01/24/2025 09:20 PM | Peter Pitts

Said it before and I’ll say it again, Take. A. Breath.

Consider the headline from STAT, “FDA purges material on clinical trial diversity from its site, showing stakes of Trump DEI ban .” True.

Now the subhead, “The scrubbing could affect the ways researchers and companies test drugs and medical devices.” Key word, “could.” The great journalistic wiggle word.

Alas, science is about using clear language. Conditional phraseology isn’t always helpful. Aliens could land their flying saucers atop FDA headquarters tomorrow -- but what’s the likelihood? It’s not War of the Worlds but War of the Words.

And words matter. Let’s put the President’s DEI executive order in context. Here’s the actual reality: It is VERY important to understand that, website “scrubbing” notwithstanding, clinical trial diversity guidance development and related FDA initiatives relative to more representative patient participation are unchanged and on-track. Full stop. No conditional wording required.

While it is the media’s job to generate important debate, high velocity “what ifs” show (with respect to Matt Herper and Lizzy Lawrence – two of the best reporters in this space) a lack of finesse. There isn’t anything factually wrong with their reporting, but the article implies a lot that is neither helpful nor likely. Does the executive order presage other possibilities? It could, but is that helpful, prescient reporting – or click bait? Correlation is not causation.

Whether you're a DEI diehard or otherwise, don't let your positions on that ideology or phraseology take your eyes off the prize - clinical trials that are more representative of the population (more than half of whom are women) and of any given medical technology’s specific disease focus.

Political rhetoric (regardless of where you are on the linguistic pronoun spectrum) should play zero role is advancing 21st century regulatory science.

As Rudyard Kipling wrote, “Words are the most powerful drug used by mankind.”

Onward!
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Senators Should Seek to Clarify RFK Jr.'s Views on Vaccines

01/13/2025 11:08 PM | Peter Pitts

 
As Robert F. Kennedy Jr. undergoes Senate scrutiny for the position of Secretary of Health and Human Services, the stakes – and opportunities -- for America's public health infrastructure couldn't be higher.

As I’ve written previously, creative disruption within federal health agencies can lead to much-needed reform. Increased transparency and accountability in vaccine research and policy could rebuild trust in public health institutions. However, this disruption must not extend to the foundational elements of our health system like vaccines.

Vaccines are arguably the greatest achievement in public health history. The development of the polio vaccine in the 1950s virtually eradicated a devastating disease that once paralyzed thousands of children annually. Today, the Centers for Disease Control and Prevention (CDC) continues to recommend it as an essential immunization.

President-elect Donald Trump has voiced support for vaccines, praising their role in eradicating diseases like polio. Senators must ensure that Kennedy aligns with this view. A retreat from vaccination would not advance Trump's agenda of strengthening the nation but would instead undermine decades of progress, leading to preventable illnesses and deaths.

This is a defining moment for public health in America. Vaccine advocates must work tirelessly and with transparency to promote health literacy and counter misinformation, and senators must fulfill their constitutional advice and consent obligation when it comes to nominees overseeing the American healthcare system. This vetting process transcends partisan politics; it concerns the health and safety of every American.

There’s been a troubling rise in vaccine skepticism, fueled by misinformation. Given the high stakes for America's public health, it is imperative to scrutinize the positions of public figures, especially those whose past stances on medically proven vaccines could jeopardize foundational elements of our healthcare system.

Senators should, respectfully but forcefully, question Mr. Kennedy on his stance on issues such childhood vaccines – and press for clarity. It is crucial to seek clear commitments to preserving access to childhood immunizations and maintaining vaccine schedules essential for public health. Senators should ask Mr. Kennedy about how he would promote trust in science rather than exacerbate skepticism. Finally, RFK Jr.’s potential to use policy levers to alter FDA approval standards, school vaccine mandates, and funding for immunization programs deserve to be honestly and aggressively examined.

Mr. Kennedy's confirmation hearing mustn’t dwell on the past, but on how he plans to safeguard our future. A potential rollback of vaccination programs could lead to outbreaks of preventable diseases like measles, polio, and whooping cough, with devastating consequences for public health. Vaccines are not merely a medical achievement; they are the foundation of a healthy society. The Senate has an opportunity—and an obligation—to ensure they remain protected.

Secretary-Designate Kennedy’s past comments on vaccines should be front and center during his confirmation hearing. They are what everyone is waiting for. It is the sharp tip of the spear for those who support his nomination and for those contrary. The question is whether Mr. Kennedy will be skewered by the spear or use it himself to advance into the corner office at HHS headquarters.
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The Trump FDA: Fasten your seatbelts and start your engines

11/12/2024 08:28 AM | Peter Pitts

David Brooks, in a recent New York Times op-ed, invented a resonant phrase, “the redistribution of respect.” And that’s applicable on both macro and micro levels. When it comes to the FDA, it can mean a significant magnification and integration of the patient voice, a focus on facilitating innovation, and working with industry to drive enhanced competitiveness.

Over the last decade the agency that regulates nearly a third of the US economy has been lending a more regular and critical ear to the real-life experiences of patients and caregivers and trying (although not always with equal enthusiasm across centers and divisions) to address the many thorny issues relative to clinical trial design, endpoints and biomarkers, safety and efficacy and Phase IV studies.  But the status quo is a harsh commandant.

What will the Trump FDA look like? Well, for starters, it will look a lot like it currently does. The FDA has only a handful of political appointees (including the Commissioner) and none reside in any of its regulatory review centers. But, with a new sheriff in town we can expect – and should embrace -- more targeted, regular, and collegial friction. And that’s a good thing. Meaningful change, respectful change can help to grease the skids of 21st century regulatory change. A little creative destruction can go a long way.

What will the Trump FDA look like? Well, it’s not even early days yet, but when I attend JP Morgan early next year, one of my messages will be, “Ladies and Gentlemen – fasten your seatbelts and start your engines.”
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Pennywise, Pound Foolish Reimbursement Policies

10/24/2024 08:48 AM | Peter Pitts

As the old saying goes, “Take care of the pennies and the pounds will take care of themselves.” So true. But, when it comes to smart use and aggressive reimbursement for GLP-1 receptor agonists, the adage must be reversed, “Take care of the pounds and the pennies will take care of themselves.”

A new study in the Proceedings of the National Academy of Science, led by researchers at Yale School of Public Health and the University of Florida, demonstrates that it’s time for Uncle Sam step up and to remove the barriers that are hindering appropriate access to effective weight loss treatments. Simply stated, expanding access to GLP-1s such as Ozempic and Wegovy, and dual gastric inhibitory polypeptide and GLP-1 (GIP/GLP-1) receptor agonists, such as tirzepatide could prevent more than 40,000 deaths a year in the United States. This estimate includes approximately 11,769 deaths among individuals with type 2 diabetes — a group particularly vulnerable to the complications of obesity. Even under current conditions of limited access, the researchers project that around 8,592 lives are saved each year, primarily among those with private insurance.

Per Alison P. Galvani, one of the study's authors and the Burnett and Stender Families Professor of Epidemiology (Microbial Diseases) at the Yale School of Public Health, “Expanding access to these medications is not just a matter of improving treatment options but also a crucial public health intervention. Our findings underscore the potential to reduce mortality significantly by addressing financial and coverage barriers."

The study highlights a critical disparity in drug access. Medicare, for example, doesn’t cover these drugs for weight loss and Medicaid coverage varies widely by state. Expanding access to these medications is not just a matter of improving treatment options but also a crucial public health intervention.

The researchers also considered the impact of socioeconomic factors on the effectiveness of expanded drug access. They adjusted their estimates to account for income disparities, finding that even with these adjustments, the potential for lives saved remains significant.

The study also explored how expanded access could affect different regions and socioeconomic groups. States with high obesity and diabetes rates, such as West Virginia, Mississippi, and Oklahoma, stand to benefit the most from increased medication availability. In these areas, expanding access could lead to the largest per capita reductions in mortality.

According to Dr. Burton H. Singer, PhD, another author of the study and adjunct professor of mathematics at the Emerging Pathogens Institute at the University of Florida. "Addressing these challenges requires a multifaceted approach," "We need to ensure that drug prices are more aligned with manufacturing costs and increase production capacity to meet demand. At the same time, we must tackle the insurance and accessibility issues that prevent many people from getting the treatment they need."  Read More & Comment...

A tale told by an idiot, full of sound and fury, signifying nothing

06/11/2024 05:04 PM | Peter Pitts

Yes, once again we’re talking about Bernie Sanders. Here’s the full quote from MacBeth:

“Life's but a walking shadow; a poor player, that struts and frets his hour upon the stage, and then is heard no more: it is a tale told by an idiot, full of sound and fury, signifying nothing.”

That’s the “Scottish Play,” but equally tragic (and a lot more comic) is the way the Senator from Ben and Jerry’s thinks that by talking tough, he’ll be taken seriously. Nope. All syrup, no maple tree.

Since, according to Senator Sanders, Novo Nordisk won’t testify about its GLP-1 agonist products, his committee will issue a subpoena. The game’s afoot. Let’s call it the “Danish Play.”

(Reality check: The Health Committee hasn’t issued a subpoena in more than 40 years.)

Per the Green Mountain State’s favorite son, the Senate Health Committee has “reached out time and time again to schedule Novo Nordisk’s voluntary appearance at a hearing … Unfortunately, despite all of our efforts, they have repeatedly denied our requests.” Nope.

Per a written Novo Nordisk clarification, “The company has responded to every request Sanders has made, and said the company is “committed to a hearing that aligns with the Chairman’s established committee practices … On multiple occasions, we have communicated our CEO’s willingness to testify and offered several dates for a hearing. Based on our continued cooperation, we feel that issuing a subpoena is unnecessary.”

But not nearly as much sturm und drang.

It's also interesting that only one manufacturer is being summoned to testify – and not a single Pharmacy Benefit Manager (PBM) has received a similar honor.

If Senator Sanders wants to be taken seriously, he should recognize that his current approach is … much ado about nothing. Just ask Vermont’s favorite fictional representative, Senator Ortolan Finistirre.

For more, see this excellent reporting by STAT.
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Did Honest Abe use Ozempic?

05/02/2024 07:03 AM | Peter Pitts

Abraham Lincoln said that the patent system adds “the fuel of interest to the fire of genius.”

Alas, when it comes to the majority of innovative healthcare technologies, that “fire of genius” rarely comes from Inside the Beltway. And having Senator Bernie Sanders hold forth on pharmaceutical research, development, and manufacturing costs is about as useful and thought-provoking as listening to my 13-year-old Golden Retriever parse the allegorical vicissitudes of Milton’s Paradise Lost. 

Senator Sanders, it’s important to remember, doesn’t even believe in patents, but rather in the failed fantasy land of “innovation prizes." Well, in the words of the late Senator Daniel Patrick Moynihan, “Everyone is entitled to his own opinion, but not to his own facts."

In the past, Senator Sanders introduced a bill that would replace our current patent system for pharmaceuticals with a “Medical Innovation Prize Fund. It’s not a new idea. The prize model has been used in the past by the old Soviet Union – and it didn’t work. The Soviet experience was characterized by low levels of monetary compensation and poor innovative performance.

The US experience isn’t much better. The federal government paid Robert Goddard (the father of American rocketry) $1 million as compensation for his basic liquid rocket patents. A fair price? Not when you consider that during the remaining life of those patents, US expenditures on liquid-propelled rockets amounted to around $10 billion. It’s certainly not what Schumpeter had in mind when he wrote about a “spectacular prize thrown to a small minority of winners.” There’s a difference between “Creative destruction” and destroying medical innovation.

As Joe DiMasi (Tufts University) and Henry Grabowski (Duke University) have argued, under a prize program, pharmaceutical innovators would lack the incentive to innovate. To quote DiMasi and Grabowski, “The dynamic benefits created by patents on pharmaceuticals can, and almost surely do, swamp in significance their short-run inefficiencies.”

As DiMasi and Grabowski presciently observed in 2004, “The main beneficiaries in the short-term would-be private insurers and public sector purchaser of pharmaceuticals. Governments and insurers are focused myopically on managing health care costs. They are not likely to be strong advocates for funding new drug development that can increase individual quality of life and productivity."

Let’s take a break from the effervescent political bloviation and look at the facts. It’s time to put the “intellectual” back in “intellectual property. Pursuing misguided policies that siphon funding from the groundbreaking medical research happening in the biopharmaceutical industry will have devastating consequences for patients and society.

When Senator Sanders begins to wonder why GLP-1 agonists can’t be radically reduced in price, it’s because he doesn’t fully understand or appreciate the ecosystem.

Allow me to draw your attention to a recent US Chamber blog post highlighting how the private sector is providing positive and cost-effective solutions for diabetes patients. You can find that blog here: Conquering Diabetes with Cost-Effective Solutions for Patients | U.S. Chamber of Commerce.

Two key points:
 
* Free enterprise creates competition in the marketplace to keep costs down. Contrary to critics, innovation in diabetes is being pioneered by private sector companies.
 
* New treatments are possible because of private-sector innovation. America’s life science companies are advancing diabetes care by developing more effective treatments to help people manage their condition.

What’s that? Did you think that medical innovation only comes from the NIH? Consider the facts:

A study in Health Affairs by Bhaven N. Sampat and Frank R. Lichtenberg (“What Are The Respective Roles of the Public and Private Sectors in Pharmaceutical Innovation?”) puts the issue in a data-driven perspective that gives the NIH its due — but in the proper frame of reference.

Per Sampat and Lichtenberg, less than 10 percent of drugs had a public sector patent, and drugs with public-sector patents accounted for 2.5 percent of sales, but the indirect impact was higher for drugs granted priority review by the FDA. (Priority review is “given to drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists.”)

“478 drugs in our sample were associated with $132.7 billion in prescription drug sales in 2006. Drugs with public-sector patents accounted for 2.5 percent of these sales, while drugs whose applications cited federally funded research and development or government publications accounted for 27 percent.”

The NIH plays a vital role in basic research and early discovery, but is robbing Productive Peter to pay Government Paul the best bang for the buck when it comes to advancing public health? The answer is a clear "no."

Per the US Chamber report, “Incredible innovative treatments are currently on the market to treat Type 2 diabetes, one of the most serious chronic conditions, which impacts an estimated 35 million Americans.   But contrary to what some critics may say, America’s innovative life science companies are advancing diabetes care by developing more effective treatments to help people better manage their condition so that they don’t develop serious complications, including damage to the heart, blood vessels, eyes, kidneys, and nerves.”

Further, “Effective glucose and weight management are key aspects of diabetes care, but only 50% of people with diabetes in the United States achieve their glucose level goals (measured by the HbA1c test). Glucagon-like peptide 1 drugs (GLP-1) have been proven to reduce a person’s A1c by approximately .8 to 1.6%. This is a tremendous innovation for an unpredictable disease that can cause complications like amputations, heart failure, gum disease, and vision loss. “ 

Diabetes has a major impact on national economies by reducing productivity and life expectancy while increasing disability and health care costs.   People with diagnosed diabetes now account for one of every four health care dollars spent in the U.S.

The Economic Report, which is published every five years by the American Diabetes Association, found that the total annual cost of diabetes in 2022 was $412.9 billion, including $306.6 billion in direct medical costs and $106.3 billion in indirect costs.  

The Chamber calls it like it is. “Unfortunately, just as millions of Americans are benefiting from these lifesaving and life-altering diabetic treatments, some members of Congress and activist groups are pushing price control policies that will kill future life-science innovation and undermine the ability of patients to access the newest treatments and cures.”
 
Research from the Chamber shows that in countries with strict price control regimes, patients receive access to fewer cures and have longer wait times than their peers in free market and free enterprise systems like the United States. For the millions of American patients with diabetes, the idea of waiting longer for fewer cures and treatments is simply unacceptable.   

The government should get out of the way and let the market drive innovation, to add the fuel of interest to the fire of genius Doing so will not only lead to the newest generation of treatments and cures but will also lead to more options and choices, improving therapeutic outcomes, and lowering costs for patients and taxpayers.
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Somewhere Bernie Sanders is Smiling

04/17/2024 07:20 AM | Peter Pitts

Somewhere Bernie Sanders is smiling.

But he shouldn’t be.

A recent study (published in JAMA) found that "estimated cost-based prices" for a range of common diabetes drugs were "substantially lower than current market prices" -- and not just in developed countries like the United States, but also in developing ones like India and Bangladesh.

This finding, while technically true, is worse than uninformative. It is misinformative.

One doesn't need a PhD in economics to understand why the literal cost of manufacturing an already invented medicine is low -- or why it's irrelevant to the medication's much higher development costs and risk premium necessary to incentivize development in the first place. By the authors' logic, the price of a Microsoft Office subscription ought to be a nickel annually (instead of $150) because the software code already exists and the prorated electricity cost for cloud computing is minimal.

The authors further suggest that "robust generic and biosimilar competition could reduce prices" -- and that such competition could be facilitated by "a range of policy tools" including "price controls," "compulsory licensing," and a general weakening of intellectual property protections.

Given that the study finds that prices are supposedly unjustifiably high even developing countries with comparative weak IP protections and mandated price controls, the authors are implicitly endorsing a global IP and price control regime that's more aggressive than even India's and South Africa's.

That would eliminate any incentive to ever invest in developing a new drug again. Wiping out the global drug industry is hardly a good way to "enable expansion of diabetes treatment globally."

And, jeez – sloppy peer review!
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Should Greed and Politics Drive Progress? Asking for a Friend.

04/16/2024 10:06 AM | Peter Pitts

Excellent piece by Ed Silverman (as always) on the increased usage of Hyrimoz. A few issues that need to be discussed in greater detail: (1) Does this bring us back to the discussion of "biobetters?" If so, should we differentiate between de novo patients and those already on treatment? (2) Will we only see an uptick in biosimilar prescriptions if PBMs can aggressively monitize them? What about putting patients first and not disintermediating healthcare providers? (3) Why is the FDA changing course on its interchangeability guidences AFTER President Biden called for such a course change? Whether or not the science supports such a move, the optics stink of political interference. Asking for a friend. #anotherfdaprocessfoul  Read More & Comment...

The Gray Lady Weighs in on Ozempic

03/20/2024 08:19 AM | Peter Pitts

Today the New York Times ran a few letters-to-the-editor on it's op-ed on Ozempic and the costs and benefits of GLP-1 agonists. Mine didn't make the cut this time -- but here it is for your consideration:

To the Editor:
 
Per Ozempic Could Threaten the Federal Budget (NYT, 3/7/24), the authors are talking about the costs while remaining selectively silent on the benefits. According to a new article in the New England Journal of Medicine, if 10% of Medicare beneficiaries with obesity used a GLP-1 receptor agonist, the annual cost to Medicare could be as much as $26.8 billion. In 2023, according to the U.S. Joint Economic Committee, obesity caused $5,155 in average excess medical costs per Medicare patient diagnosed as obese. That’s $520 billion in preventable health care costs — an impressive return on investment. New, better medications are the best and swiftest way for this country to cut down on our health care expenses. And appropriate reimbursement stimulates competition – which drives down prices. When it comes to measuring value, we must embrace a comprehensive view of cost and benefit. Choosing only to only discuss costs without context is dishonest and deleterious to public health.
 
Peter J. Pitts
 
Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest.
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Weight? Wait! Don't tell me.

02/29/2024 03:16 PM | Peter Pitts

Believe it or not, and despite what you’re hearing, when it comes to addressing the American epidemic of obesity, there is no magic pill. The good news, however, is that for the first time, there are new medicines that seem to be magic — because they work.

The new group of medicines called GLP-1 receptor agonists are headline news. Why? Because they are more effective than any previous class of drugs in getting patients to lose weight and, equally important (and in combination with diet and exercise), keep it off. Initially approved by the Food and Drug Administration for patients with diabetes, they have become so popular among people who want to lose weight that the companies that manufacture them can’t keep up with demand.

And many insurance providers (most notably Uncle Sam) are worried that helping America successfully combat obesity will break the national health care piggy bank. Nothing could be more incorrect and shortsighted. Let’s make one thing crystal clear — helping America slim down must be a national priority lest we allow obesity and the diseases that often come with it (heart disease, stroke, diabetes, osteoarthritis, and some cancers, to name a few) to bury us both financially and literally.

Obesity affects 44% of American adults. According to a new article in the New England Journal of Medicine, if 10% of Medicare beneficiaries with obesity used a GLP-1 receptor agonist, the annual cost to Medicare could be as much as $26.8 billion. But payers are talking about the costs while remaining silent on the benefits. In 2023, according to the U.S. Joint Economic Committee, obesity caused $5,155 in average excess medical costs per person diagnosed as obese. That’s $520 billion in preventable health care costs — an impressive return on investment.

New, better medications are the best and swiftest way for this country to cut down on our health care expenses. By more effectively combating disease and improving patients’ lives, drugs reduce long-term medical costs and bolster the overall economy. But as they say in our nation’s capital, where you stand depends on where you sit.

When payers (most notably Medicare) look at GLP-1 receptor agonists, they see only the cost. That’s like the FDA reviewing risks while ignoring benefits when considering new medicines. It has to be about value. And when it comes to measuring value, we must embrace a comprehensive view of cost and benefit. Regarding GLP-1 receptor agonists, the proper denominator isn’t cost; it’s value. Choosing only to only discuss costs without context is dishonest and deleterious to public health.

Kudos, therefore, to Rep. Mike Burgess, Texas Republican and a physician himself, who has introduced the Preventive Health Savings Act, which would permit Congress to ask the Congressional Budget Office to provide estimates on long-term health savings made possible from preventive health initiatives, such as significant reductions in our national obesity rate.

This is especially important because obesity rates are higher for lower-income people and in communities of color. Minus a more comprehensive view of costs and benefits relative to new medical technologies such as GLP-1 receptor agonists, we are redlining these populations out of safe and effective treatment options. That’s the opposite of health equity.

Focusing on short-term costs while ignoring long-term benefits (to patients and our national treasury) is ignoring reality. It’s worth remembering the wise words of President John Adams, who said, “Facts are stubborn things.”
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Courting Healthcare Reimbursement Ambiguity

02/22/2024 10:32 AM | Peter Pitts

When it comes to 21st-century medical progress are the Centers for Medicare and Medicaid Services (CMS) an accelerator or anchor for innovation? If the former, how can it do even better? If the latter, how big of a sea change is required?
 
Blaming CMS for every setback, frustration, or failure is neither factual nor helpful in working across the health care ecosystem to find new attitudes and pathways that can shine light on and address healthcare reimbursement roadblocks. However, for CMS to do a better job, we must advance the public health together as allies rather than adversaries. Don’t fix the blame, fix the problem. 

Problem #1 is regulatory ambiguity. As with many other areas of government policy, peculiar bureaucratic intervention and lack of clarity are causing harm to the entire healthcare ecosystem. Nowhere is this more evident than in the world of therapeutic use of tissue allografts – an exciting and evolving arena of 21st century medicine and one of the many areas of medical products regulated by the FDA. And, as with many other areas of the agency’s jurisdiction, peculiar bureaucratic intervention and lack of clarity are causing harm to patients and costing American jobs. To phrase it less politely, this small case is about a big issue -- whether it’s acceptable for the federal regulation of healthcare in America to be arbitrary and capricious.

The bad news is that, in a recent test case of the powers of the Chevron Deference Doctrine, the United States Court of Appeals for the District of Columbia Circuit thinks otherwise. In its February 14, 2024 decision in the case of Row 1 Inc. D/B/A Regenative Labs v. Xavier Becerra, Secretary of Health and Human Services, the Court affirmed dismissal of Regenative’s case against CMS.

This may seem like a small case of bureaucratic lassitude at best or over-reach at worst. It’s not. This small case is about a big issue -- whether it’s acceptable for the federal regulation of healthcare in America to be arbitrary and capricious where substantive actions are taken sub rosa rather than in view of the public eye, as Congress requires.

The particulars of the case are very geeky. (All the details can be found in the Appellant brief and this recording of the oral arguments held on October 6, 2023.)  The gist of the case is that CMS decided Uncle Sam wasn’t going to pay for a certain class of products, which includes Wharton's Jelly Tissue Allografts (human connective tissue used to repair, replace, or supplement missing, damaged, or non-properly functioning tissues, manufactured by Regenative Labs). The Court agrees. The Court is wrong and Regenative is considering petitioning for certiorari to the Supreme Court.

Why? Because CMS must use various on-the-books rules and guidances promulgated by the Food and Drug Administration. (“Promulgated,” is another one of those $50 words. It means, “formal proclamation or the declaration that a new statutory or administrative law is enacted after its final approval.”). The reason this is important, is that we’re not talking about vague or unwritten regulatory practice. We’re talking about what’s already on the books – literally the letter of the law. And feigning ignorance of the rules does not provide an excuse.

CMS’ approach in the Regenative case seeks to avoid any review at all and creates a two-tiered health system where people with money pay cash and get access to interventions that can help address serious and painful problems while Medicare patients suffer the consequences of arbitrary and capricious decisions by nameless, faceless government bureaucrats. Such behavior must not stand and Regenative should continue to stand up against agency overreach and denial of due process.

Advancing healthcare reimbursement policies through less formal and more regular conversations requires not fewer rules but new ones. And those rules must equally apply to everyone. New approaches require well-considered rules because, as Victor Hugo reminds us, “Where the disposal of time is surrendered merely to the chance of incidence, chaos will soon reign.” And, for patients, it’s a reign of terror.
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The Price of Ignorance

12/06/2023 06:04 PM | Peter Pitts

Back in March, the U.S. Department of Health and Human Services (HHS) and the Department of Commerce (DOC) announced efforts to pursue a whole-of-government approach to review its march-in authority as laid out in the Bayh-Dole Act, which promotes commercialization of research results, maximizes the potential for federally-funded technologies to become products, and serves the broader interest of the American public. HHS created and empowered a new interagency Working Group to develop a framework for implementation of the march-in provision that clearly articulates guiding criteria and processes for making determinations where different factors, including price, may be a consideration in agencies’ assessments.

Yes, you read that right – price -- and now it’s more than a maybe.

According to “unnamed sources” (as reported by Politico), “The Biden administration has determined that it has the authority to seize the patents of certain high-priced medicines, a move that could open the door to a more aggressive federal campaign to slash drug prices.”

The problem, the Bayh/Dole Act doesn’t consider price in its legislative intent for Federal march-in rights. And wishing it were so doesn’t make it so.

Ready for a Christmas surprise? The Commerce Department plans to issue a new framework spelling out factors that federal agencies should weigh in determining whether to take march-in action against expensive drugs or other individual products that were created with federal help. The price and availability of that product to the public are among the factors the department will recommend that agencies consider.

The White House has scrambled to highlight Biden's health accomplishments in recent days, after former President Donald Trump suggested he would repeal and replace the Affordable Care Act if elected in 2024.

Per Politico, “The Commerce Department and Department of Health and Human Services were already expected to issue their determination on the government's march-in authority in the coming weeks, the people familiar with the matter said. But the announcement was accelerated in the wake of Trump's comments, and officials are expected to cite it as evidence that Biden continues to search for new ways to lower prices.”

Just like the IRA’s price control codicils, this ill-considered effort will put another chill on drug development from those who really drive innovation – the biopharmaceutical industry. Will there be lawsuits arguing this federal power grab? Undoubtedly.

Alas, headlines for hyped and misleading “NIH-funded cures” are far sexier than those for “more money for drug regulation.” Pursuing misguided policies that siphon funding from the groundbreaking medical research happening in the biopharmaceutical industry will have devastating consequences for patients and society. The Working Group's bad advice would result in fewer medicines for patients and lost jobs at a time when our economy can least afford it.

Watch this space for more as the saga continues.
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GAO reports. CMS spins. Patients suffer.

09/11/2023 08:01 AM | Peter Pitts

Per reporting in Endpoints News, Medicare beneficiaries paid four times more for prescription drugs than their plan sponsors did in 2021, according to a Government Accountability Office (GAO) report on Medicare Part D drugs.

According to the report, beneficiaries paid $21 billion for prescription drugs in 2021, while plan sponsors only paid about $5.3 billion, according to the study of 79 of the 100 Part D drugs with the most rebates.

The GAO recommends that moving forward, CMS should monitor rebate information to help the agency and Congress determine their impact on formularies and Medicare enrollment.

Plan sponsors raked in $48.6 billion in rebates from manufacturers in 2021, with endocrine metabolic agents, blood modifiers and respiratory agents accounting for about three-fourths of rebates.

GAO explained that across the board, rebates can reduce plan sponsor payments on drugs with a higher gross cost to less than a lower-cost competing drug. This can lower Medicare drug spending since plan sponsor payments are tied to drug costs after rebates.

“However, rebates do not lower individual beneficiary payments for drugs, as these are based on the gross cost of the drug before accounting for rebates,” GAO said. “Thus drugs with higher gross costs generally result in higher beneficiary payments relative to payments for competing drugs with lower gross costs.”

CMS told GAO that evaluating rebate information isn’t necessary because of the agency’s formulary review and noted that CMS is prohibited from interfering with manufacturer and plan sponsor negotiations.

But GAO pushed back on CMS’ explanation, arguing that monitoring rebate information wouldn’t interfere with those negotiations.

“Such monitoring of rebates will be particularly important as the agency implements the provisions of the Inflation Reduction Act of 2022, which will change Part D plan sponsor, beneficiary, and Medicare drug spending responsibility and may affect formulary design and rebates,” GAO said.
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An MBA in Regulatory Confusion

07/31/2023 07:11 AM | Peter Pitts

Welcome to the world of therapeutic use of tissues – an exciting and evolving arena of 21st century medicine and one of the many areas of medical products regulated by the FDA. And, as with many other areas of the agency’s jurisdiction, peculiar bureaucratic intervention and lack of clarity are causing harm to patients and costing American jobs.

Witness the Twilight Zone-like predicament of one company’s bizarre interactions with the FDA. The company is Regenative Labs. They manufacture (among other products) Wharton's Jelly Tissue Allografts. Wharton’s Jelly is human connective tissue used to repair, replace, or supplement missing, damaged, or non-properly functioning tissues.

The FDA’s job is to ensure its manufactured according to the agency’s current Good Tissue Practice (cGTP) guidance. Here’s Clue Number One: Wharton’s Jelly isn’t regulated as a drug, but as a tissue because … that’s what it is. Here’s the detail: As defined in 21 CFR 1271.3(c), “homologous use” means the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with human cells, tissues, and cellular and tissue-based products (HCT/P) that perform the same basic function or functions in the recipient as in the donor. Remember “homologous use,” as it comes into play shortly.

On March 21, 2022, the FDA undertook a routine inspection of the Regenative Wharton’s Jelly manufacturing facility in Pensacola, Florida.  All FDA-registered facilities like Regenative’s are subject to regular routine inspections. At the end of the inspection, the FDA reported certain observations to the company via a 483 letter each of which the Company addressed and remediated within about 30 days. On October 5, 2022, Regenative Labs asked the FDA for a standard export certificate so they could send Wharton’s Jelly tissue to foreign clients. That standard request was denied and here’s where it gets confusing.

Regenative Labs had previously applied for and received an export certificate for its amniotic membrane patches -- manufactured in the same lab as the Wharton Jelly products. Strangely, the initial ongoing inspectional review was not an issue for the patches; yet it was the agency’s basis for not to issue the export certificate for Wharton’s Jelly. Another example of the FDA’s lack of regulatory reproducibility, costing companies time, money, and agita and patients access and affordability.

Then, in a June 21, 2023 letter, the FDA raised additional issues not related to product quality but product use, stating that the agency had decided to treat Regenative Labs’ Wharton’s Jelly as a drug rather than a tissue product, reinforcing its insistence on using the drug standards of current Good Manufacturing Practice (cGMP) rather than applying the tissue standard for Wharton’s Jelly -- current Good Tissue Practices. Confused yet?  Hang in there.

Remember “homologous use?” Per the FDA, “In applying the homologous use criterion, the FDA will determine what the intended use of the HCT/P is, as reflected by the labeling, advertising, and other indications of a manufacturer’s objective intent, and will then apply the homologous use definition.” Per the agency’s view on how the company was marketing its Wharton’s Jelly product, it was a drug and not a tissue product.

This is weird … and wrong since the what the FDA is claiming is contrary to the instructions for use expressly stated by the company. Regenative Labs materials are clear -- their Wharton Jelly products they are intended for homologous use only and in other marketing efforts, they incorporate the FDA’s definition of homologous use into their materials. The FDA is judge and jury in such matters and facts that contradict their position are often given short shrift.

What does this have to do with an export certificate? Nothing. And here’s Clue Number 2: The FDA doesn’t regulate the practice of medicine – except that’s precisely what it’s doing.

The FDA’s position put Regenative Labs is an awkward position. In fact, the FDA’s reclassification of Wharton’s Jelly from tissue to biological drug would make it impossible for any company manufacturing this tissue in the United States to remain in business -- eliminating a key tool for physicians and patients, further exacerbating the already increasing problem of medical product shortages, eliminating hundreds of high-paying jobs, and stifling corporate incentives to invest in continued product innovation.

The FDA’s treatment of the Regenative Labs Wharton Jelly situation raises many questions, not the least of which is – where’s senior agency management oversight? How does the reclassification of important tissue products to biological drugs happen without more adult supervision? You don’t need a Wharton MBA to recognize the danger of aggressive bureaucracy impacting the availability of Wharton’s Jelly, the viability of Regenative Labs, the loss Americans jobs and, most importantly, patient care.
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Science: Sanity's Home Field Advantage

07/21/2023 09:14 AM | Peter Pitts

As with many Baby Boomers, my dad served in the European Theater of Operations during WWII. He told me many times how, just as he was going to be shipped to the Pacific to participate in the invasion of Japan, the atomic bomb ended the war and, in his opinion, saved his life. It’s not a unique story but, as we all know, it’s not so straightforward either. In any case, it’s a tale of science and the wonders … and horrors it can cause simultaneously.

It's also a story of the urgency of dealing with science openly, honestly, and in terms people can understand. That’s why the story of the early days of atomic energy are so relevant today as we battle misinformation and disinformation on science in general and vaccines in particular.

And it’s why I’m extra-proud the New York Times chose to publish my letter in today’s edition. I think that considering science as our “home field advantage” is a far more powerful and positive approach to addressing the public’s diminishing trust in the FDA and the industries it regulates than “battling” people like RFK, Jr. Let’s fight on our own turf.

Here’s my short letter. I hope you enjoy it and hope (even more so) that somewhere my father is smiling.

Oppenheimer’s Lessons on Politics and Science

To the Editor:

Whether it’s harsh truths about atomic power or the merits of vaccines against Covid-19, influenza and childhood illnesses, it’s science — regularly, honestly and clearly explained — that is sanity’s ultimate home-field advantage.

Peter J. Pitts
New York
The writer, a former F.D.A. associate commissioner, is president of the Center for Medicine in the Public Interest and a visiting professor at the University of Paris School of Medicine.
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