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'No Kings Day': Americans Defending Democracy -- And Health Care

'No Kings Day': Americans Defending Democracy -- And Health Care

I’ve spent much of the past few days mulling the significance of the Trump regime sending National Guard troops into Los Angeles. Gov. Gavin Newsom did not ask for them. Mayor Karen Bass did not ask for them. The tens of thousands of city and state police available to Newsom and Bass were more than adequate to curtail the vandalism perpetrated by some demonstrators during the weekend’s protests against the large-scale ICE raids in the city.

Trump’s action has only one precedent in recent history. In March 1965, President Lyndon Johnson ordered the National Guard into Alabama against the wishes of Gov. George Wallace. LBJ felt compelled to act to protect civil rights marchers in Selma, Alabama, who had been viciously attacked and beaten the previous week by state and local police.

Richard Nixon didn’t order the National Guard onto the campuses of Kent State and Jackson State during protests against the Vietnam War in the spring of 1970, which resulted in the deaths of six students. Ohio’s Gov. James Rhodes and Mississippi’s Gov. William Winter were responsible for those unnecessary and ultimately tragic actions.

Trump’s order — unjustified, lawless, a gross violation of California’s rights — raises the serious question, as much as anything that he has done to date, of whether we still live in a free country. On a number of fronts, the Supreme Court has allowed his flagrantly illegal actions to proceed unimpeded despite lower courts ruling them either illegal or unconstitutional. Congress lays supine.

The checks and balances envisioned by this country’s founders are no longer operative. They are not providing the basic protections on which freedom depends, which includes above all the government adhering to the rule of law and our elected leaders upholding the Constitution they swore to defend.

Yesterday morning, Newsom promised to sue the federal government. He raised the specter of witholding federal taxes should Trump follow through on his threat to withold government payments to the state (which would be a net plus for California like most heavily blue states, which send more to the federal government than they receive in return).

Those of us who live in major urban areas with large immigrant populations worry that our cities and our states may become the next targets of large-scale ICE raids, which will inevitably provoke a reaction from justifiably outraged young protesters. Let’s not forget that urban economies (as well as many rural agricultural and meat-processing areas) are heavily dependent on the 11 million undocumented workers the Trump regime wants to deport.

Even if a narrow majority of the general public (about 55 percent) back stricter enforcement of the nation’s immigration laws, a far larger majority backs adherence to the rule of law. A Pew Research Center poll in April found 78 percent of Americans wanted the Trump administration to follow federal court rulings, which included 91 percent of Democrats and 65 percent of Republicans. The overall number rises to 88 percent for Supreme Court rulings.

This coming Saturday, while Trump holds a Soviet-style military parade in downtown Washington, there will be mass protests across the country. People will be carrying banners declaring “No More Kings.” I’ve volunteered to be a marshall to help assure that no misguided demonstrators or agents provocateurs provide a pretext for police action. I encourage all my readers to take part.

But protests are not enough. Only an engaged citizenry can defeat the reactionary forces here at home that threaten the values that truly made America great: equality, fairness, compassion, and equal justice before laws that everyone, including the president of the United States, adheres to.

Health care on the line

With that thought in mind, I hope that you will take time over the next few weeks to let your Senators know that you oppose the vicious cuts to Medicaid and Obamacare subsidies included in the “One Big Beautiful Bill.” The Congressional Budget Office last week predicted just those sections alone will result in around 15 million people losing health insurance over the next decade.

Let’s put that number in perspective. There are currently around 28 million uninsured in the U.S. or about eight percent of the population, which is down from 17 oercent when Barack Obama took office in 2009. The 2010 Affordable Care Act, for all its flaws (which I won’t go into here), was tremendously successful in achieving its main goal of reducing the U.S. uninsured rate. Add 15 million more people to the ranks of the uninsured and that rate will soar back to at least 12 percent.

Who will pay for the costs of those people when they show up in the emergency room needing health care that they can’t pay for? You and your employers, who will wind up paying higher rates for private health insurance to pay for the cost of hospitals’ and physicians’ uncompensated care.

Rural hospitals, which are heavily dependent on Medicaid funding, will get hurt the most because states where most of those hospitals are located cannot afford to make up for the cutbacks in federal support. The destitute elderly in nursing homes will also suffer as their staffs get cut due to the proposed law’s ending of the Biden administration’s minimum staffing rule.

And to what end? The work requirements that Republicans claim are merely aimed at getting shirkers off the rolls is a smoke screen to hide the bill’s true intent: To keep alive unnecessary tax breaks for the most well-off people in this country. That $4 trillion-plus giveaway is so large that even after making massive cuts in health care and other domestic spending, it will still increase the federal deficit by over $2 trillion over the next decade.

Merrill Goozner is a former editor of Modern Healthcare, where he writes a weekly column. He is a former reporter for The Chicago Tribune and professor of business journalism at New York University. Please consider subscribing to his Substack.

Reprinted with permission from Gooz News.

As Trump Regime Attacks Science, China Is Set To Dominate Future Research

As Trump Regime Attacks Science, China Is Set To Dominate Future Research

This week, two items related to the future of medical research, and the prices that Americans will pay for drugs, caught my eye.

First, the Trump regime’s proposed budget for 2026 will slash $18 billion or nearly 40 percent from the 26 institutes that make up the National Institutes of Health. The National Cancer Institute and the National Institute for Allergy and Infectious Diseases, both of which have been on the forefront of medical innovation over the past half century, are slated for nearly one-third of those cuts, reducing their budgets (unadjusted for inflation) to levels not seen since 2003.

Second, U.S.-based Bristol-Myers Squibb on Monday struck a $11 billion deal with Germany-based BioNTech to co-develop a drug aimed at fighting advanced lung, breast and other solid-tumor cancers. The drug candidate, now in clinical trials, was developed in China using technologies originally invented by scientists working on NIH grants.

Viewed together, these events exemplify how the scientific infrastructure for medical innovation and the scientists involved in discovery are gradually moving abroad. This trend will be expedited by the Trump regime’s incessant attacks on U.S. universities, where most of the cutting edge medical research historically took place.

They also show how Americans — both as patients and consumers — will eventually pay a hefty price for this destructive nihilism. The Trump minions in charge of HHS, NIH and the FDA are doing nothing to prevent the biotech and pharmaceutical industries from losing the seed corn for future medical breakthroughs, even as the companies within those industries impose exorbitant prices that put profits over health while remaining agnostic about the sources of their next products.

A big deal

Let’s start by taking a closer look at the players behind the Bristol-Myers - BioNTech announcement. Bristol-Myers is deeply engaged in bringing new cancer therapeutics to market. Some of its products come from its own investments in research and development. But a hefty share of its current drug portfolio was discovered on Wall Street, where it either financed or bought out smaller, often financially challenged biotech firms with promising drug candidates.

The BioNTech deal fits that mold. Bristol-Myers will provide capital to finance the final stages of the drug’s development in exchange for the right to manufacture and co-market the product.

BioNTech is hardly struggling. It rose to fame and fortune by forging a similar partnership with Pfizer to rapidly produce one of the two COVID-19 vaccines that used mRNA technology, among the few positive achievements of the first Trump administration. The technology had been developed during the previous decade with funding from NIH. Today, mRNA technology stands accused of causing more harm than good by HHS Secretary Robert F. Kennedy Jr. despite having saved an estimated 20 million lives.

BioNTech made billions of dollars/euros selling the vaccines through guaranteed government contracts during the pandemic. But it did not use that windfall to invest in the R&D that produced the drug candidate that was the subject of this week’s announcement. Rather, it paid nearly $1 billion last year to acquire Biotheus, a Chinese company that developed the drug candidate in the Bristol-Myers deal.

Biotheus, based in Zhuhai, China, is headed by Xiaolin Liu. Liu did his graduate work at Brandeis University and post-doctoral work at Harvard Medical School. He learned the drug industry ropes by spending two decades in the R&D labs at Abbott, Bristol-Myers and Adimab before returning to his home country.

When young, Liu stood on the leading edge of the wave of immigrants that has transformed the STEM (science, technology, engineering and math) fields in the U.S. Today, foreigners fill about one-third of all slots in America’s graduate research programs, including 40 percent in the biomedical fields. Every one of them now lives in daily fear of deportation. Most are probably leaning toward returning to their home countries to work once they’ve completed their education.

So what this deal represents is two western pharmaceutical firms flush with cash looking to places like China to buy what they hope will be their next big blockbuster drug, while that country is rapidly building its capacity to serve that demand. It is only a matter of time before the Chinese government begins making heavy investments in basic research, and becomes the leading provider of basic science discoveries that will eventually lead to the next generation of new drugs, medical devices and other advanced medical technologies. The advice I would give today to any young American who is a prospective STEM researcher is to learn Mandarin.

That’s the educational/research/financial side of this week’s announcement. It also reawakened the medical science reporter in me.

The government-funded tools behind innovation

The drug involved in the Bristol-Myers-BioNTech deal, now dubbed BNT327 (it was PM8002 under Biotheus), was created using CRISPR gene-editing technology, which was invented at the University of California at Berkeley in 2012 with NIH funding. It won its co-inventors, Emmanuelle Charpentier and Jennifer Doudna, the 2020 Nobel Prize for chemistry.

CRISPR, which stands for Clustered Regularly Interspaced Short Palindromic Repeats (this won’t be on the test), is a gene-editing technique that allows scientists to modify DNA sequences. It has been likened to a molecular scissors that can cut DNA at specific locations, allowing for the insertion, deletion, and/or replacement of genetic material.

Biotheus used CRISPR to bioengineer PM8002/BNT327, an antibody that simultaneously targets two cell receptors that play roles in rapid tumor growth. One snippet on the antibody inhibits the PD-1/PD-L1 pathway, which prevents a person’s own cells (whether normal or cancerous) from being recognized as foreign by the immune system; a second snippet blocks the signaling proteins VEGF-A and VEGFR2, which promote growth of the new blood vessels that the rapidly growing tumor needs.

The companies hope this drug candidate will become the go-to complement for a broad range of solid tumor chemotherapy regimens. In Wall Street terms, successfully winning FDA approval will allow BNT327 to become a multi-billion-dollar-a-year blockbuster. “The future standard of care for the treatment of advanced cancers will be combinations with novel immuno-oncology backbones,” Özlem Türeci, chief medical officer of BioNTech said in the company press release.

(Türeci and Uğur Şahin, the co-founders of BioNTech, are both of Turkish decent and educated in Germany, whose technology-driven industries benefit enormously from the expertise developed by immigrants and their offspring, just like the U.S.)

Another me-too drug?

There are still many milestones to pass before BNT327 proves worthy of the hype. The early safety trials did not generate efficacy data, and the first Phase II/III efficacy trial is still several years away from completion. But BioNTech investigators recently reported early results for BNT327 that “demonstrated encouraging efficacy” among patients with advanced lung cancer.

There’s good reason to think it will pass the safety and efficacy tests and win FDA approval. Why do I say that? There are already several drugs on the market that target the same pathways, only individually. AstroZeneca’s Imfinzi (generic name durvalumab) and Roche/Genentech’s Tecentriq (atezolizumab) target the PD-1/PD-L1 pathway, which encourages a patient’s natural immune system to attack the cancer. Genentech’s Avastin (bevacizumab) and its generic biosimilars inhibit the VEGF receptors, which prevents the blood vessel growth that feeds a tumor.

However, it’s important to note that these drugs, when added to chemotherapy, are far from curative, especially when given in the latter stages of lung, breast, colon and other solid tumor cancers. Imfinzi and Tecentriq extended life by an average of 2 to 3 months on average (although in late stage cancer among people who had never received any previous treatments, Imfinzi with chemotherapy compared to chemotherapy alone increased life expectancy by about 13 months).

Anti-angiogenesis Avastin and its biosimilar copies have never lived up to their initial hype as the cure-all for all cancers (see this 1998 story on the front page of the New York Times, one of the more egregious examples of journalistic overhype). Clinical trials that add Avastin to chemotherapy for non-small cell lung cancer and metastatic colon cancer, its two primary uses, show an improvement in overall survival over chemotherapy alone of anywhere from 2 to 4 months. The drug lost its FDA approval for breast cancer in 2012 when it failed to improve overall survival.

(For a comprehensive investigative report on the limited efficacy of recently approved anti-cancer drugs, see this excellent article that appeared last weekend on Bloomberg, “Cancer Drugs Cost More Than Ever. They Often Don’t Extend Lives.”)

There’s another reason why it’s unlikely this new drug, if and when it is approved, will be far from a miracle cure. There is already something just like it on the market. In 2020, the FDA approved Roche’s application to treat advanced liver cancer patients with a combination of Tecentriq and Avastin, thereby targeting both pathways at the same time with two different drugs. Compared to the standard of care, which was a single chemotherapy drug, it improved life expectancy by 42% or about 5 1/2 months, according to the Roche press release.

All these modest gains come with significant side effects, which can be debilitating to the quality of life for patients living through the final stages of a fatal disease. Nearly two-thirds of patients in the BNT327 safety trials experienced serious side effects, including hair falling out (alopecia) and sharp decreases in white and red blood cell counts (leukocytopenia and anemia).

Will this drug ever become an important add-on to the wide range of cancer chemotherapy regimens? Or will it, in essence, become a two-in-one “me too” drug, one that will compete with drugs already on the market, all of which have fairly limited efficacy?

What we do know is that these intravenously administered drugs will provide its benefits at a tremendous cost to patients, both physical and financial. Ditto for taxpayers, who pick up most of the tab for the elderly and poor who together make up a disproportionate share of cancer patients. An estimated 54% of patients who are diagnosed with cancer each year are on Medicare, while about 10% of people on Medicaid either have or had cancer. The cost of these bioengineered therapies ranges into the many hundreds of thousands of dollars.

Silence of the lions

Pharmaceutical companies and their trade groups have long been among the most powerful and influential lobbying forces in Washington. Until the Biden administration passed drug price negotiating authority, they managed to fend off every attack on their pricing power, patent gaming and similar tactics that enable the industry to remain one of the most profitable in America.

Yet my search of the latest press releases on the websites of both PhRMA (the Pharmaceutical Research and Manufacturers Association) and BIO (the Biotechnology Innovation Organization) turns up zero statements taking the Trump regime to task for gutting government-funded biomedical research.

Research!America, the long-time lobbying group created to expand NIH budgets (its greatest success was the doubling of agency budgets in the 1990s), had this to say about the pending budget cuts: “If the proposal is enacted, Americans today and tomorrow will be sicker, poorer, and die younger. American research has a proven track record of increasing survival, reducing the burden of illness, and creating jobs. Cutting research funding helps no one; instead, it hurts everyone.”

Everyone, that is, except the Chinese.

Reprinted with permission from Gooz News.

Does 'MAHA' Report Mean That Kennedy Will Oppose Corporate Power?

Does 'MAHA' Report Mean That Kennedy Will Oppose Corporate Power?

Last week’s Make American Healthy Again Commission report on childhood health was clearly the product of the left side of Robert F. Kennedy Jr.’s brain. Other than its vaccine section, it echoed arguments that progressive physician-scientists and public interest groups have been making for decades:

  • Overconsumption of ultra-processed, nutritionally inadequate food exposes kids to harmful additives and contributes mightily to the obesity and diabetes epidemic among children.
  • Kids’ cumulative exposures to environmental toxins are a major cause of the disturbing growth in autism, allergies and other developmental disorders.
  • The lack of physical activity associated with constant use of electronic devices leads to sleep deprivation, stress, hyperactivity and other mental health conditions.
  • The drug industry profits enormously from selling pills to treat the effects (not the causes) of all of these conditions. And,
  • The government agencies charged with protecting kids from dangerous chemicals have been captured by manufacturers, who fund most of the research that goes into determining whether or not their products are safe.

These public health concerns are areas where the left and the MAHA movement led by RFK Jr. happen to be in agreement. The still unanswered question is what will they do about it.


Commission members endorsing the report included nearly every relevant cabinet secretary. But it also included Russell Vought (head of the Office of Management and Budget), Stephen Miller (anti-immigration czar and Deputy Chief of Staff for Policy), and Kevin Hassett (Director of the National Economic Council). They promised to offer a plan by mid-August that would “get to the truth of why we are getting sick” while “spurring pro-growth policies and innovations.”

That, too, is something the left has been offering for decades. There is no reason why American corporatized farms have to pursue mono-crop agriculture that relies on heavy doses of pesticides, herbicides and chemical fertilizers. Smaller, family-owned farms can earn just as good a living by including more nutritious foods for local use in their crop mix.

For decades, the left has also bemoaned the lack of regulation over the thousands of chemicals used by industry that are being dumped into the air and water without being tested for their potential effects on humans. Progressives have long argued that scientists funded by government or truly independent non-profit research institutes should be the sole determinants of what chemicals can be unleashed on the public.

An agenda for change

If RFK Jr. at the Health and Human Services Department, Martin Makary at the Food and Drug Administration, Jayanta Bhattacharya at the National Institutes of Health, and Lee Zeldin at the Environmental Protection Agency (all signatories to the report) want items for their action agenda, here’s one place they could look. Last January, the 25-member Consortium for Children’s Environmental Health issued a call, published by the New England Journal of Medicine, for a new law governing the regulation of chemicals used by industry.

Here’s some facts drawn from that article:

  • Fewer than 20 percent of the estimated 350,000 chemicals, chemical mixtures, and plastics used by industry, most produced from gas, oil and coal, have been tested for toxicity, “and fewer still for toxic effects in infants and children.
  • “Over the last half century, rhe incidence of childhood cancers has increased by 35 percent.Male reproductive birth defects have doubled in frequency.Neurodevelopmental disorders now affect 1 in 6 children, and autism spectrum disorder is diagnosed in 1 in 36.Pediatric asthma has tripled in prevalence.Pediatric obesity has nearly quadrupled in prevalence and has driven a sharp increase in type 2 diabetes among children and adolescents.
  • “Even brief, low-level exposures to toxic chemicals during early vulnerable periods are linked to increased risk of disease and disability in children that can persist across the life course.
  • “Diseases caused by toxic chemical exposures in childhood can lead to massive economic losses,including health care expenditures and lifelong productivity losses resulting from reduced cognitive function, physical disabilities, and premature death. The chemical industry largely externalizes these costs and imposes them on governments and taxpayers.”

The Toxic Substances Control Act, passed in 1977, failed to give the Environmental Protection Agency the authority to prevent dangerous chemicals from being introduced into the environment or food supply. It assumes all manufactured chemicals are safe and puts the onus on government to prove otherwise.

The EPA was never given the resources to conduct the necessary research. And now, under the Trump regime, the entire research department is being eliminated.

Even before Elon Musk wielded a meat-axe at the EPA and other agencies, most research about potential toxicities from chemicals came from industry-funded scientists. The same held true for the FDA when it looks at studies of food additives, most of which, not surprisingly, claim no harms are caused from their use. I participated in a 2007 study documenting this bias entitled, “Relationship between Funding Source and Conclusion among Nutrition-Related Scientific Articles,” which was cited in the MAHA Commission report.

The Consortium for Children’s Environmental Health action agenda included these items:

  • The U.S. should pass a new law that no new or existing chemical or chemical-based product be allowed to enter or remain on the market if their manufacturer hasn’t proved through independent testing that they are not toxic.
  • All toxicity testing must be undertaken in laboratories that are free from financial conflicts of interest. Manufacturers should be required to bear the cost of independent testing, but not be allowed to conduct it themselves.
  • Chemical manufacturers must conduct postmarketing surveillance to determine long-term adverse effects, especially in pediatric populations.
  • The U.S. should join in international efforts to create a treaty aimed at protecting children here and around the world from the proliferation of toxic chemicals in foods, products and the environment. An international panel of independent physicians and scientists should adopt regulations that all treaty signatories adhere to, which will create a level playing field for industry.

“Pollution by synthetic chemicals and plastics is a major planetary challenge that is worsening rapidly, “ the Consortium’s authors concluded. “Continued, unchecked increases in production of fossil-carbon–based chemicals endangers the world’s children and threatens humanity’s capacity for reproduction… Inaction on chemicals is no longer an option.”

Had the MAHA report eschewed vaccine skepticism, it might have been greeted with less skepticism in the media. Will they take actions this summer that actually limit the ability of Trump’s corporate campaign contributors to spew toxics into the air and water and adulterate the food supply?

Yesterday, RFK Jr. announced the Centers for Disease Control and Prevention is withdrawing its recommendation that pregnant women and children get vaccinated for COVID. That suggests his priorities lie elsewhere.

Reprinted with permission from Gooz News.

How Trump's 'Big Beautiful' Medicare Cuts May Harm Your Health Care

How Trump's 'Big Beautiful' Medicare Cuts May Harm Your Health Care

I’m no defender of the cruel and unusual punishment inflicted on the American people by the House Republicans’ “One Big Beautiful Bill” passed late Tuesday night. And it’s important to understand that Medicare as well as Medicaid will take a major hit, nearly $500 billion in cuts over the next decade, according to the Congressional Budget Office.

But the political impact will be far less than the cuts to Medicaid, food stamps, reproductive health, environmental and other program contained in the bill. That’s why I’m interrupting my travels this morning to offer this explainer because how defenders of Medicare and Medicaid talk about these Medicare cuts matters.

Under the bill, Medicare will be subjected to sequestration under the 1997 Balanced Budget Act. Sequestration is an across-the-board cut in government programs that Congress can impose if a spending bill increases the deficit.

Not all programs are affected. Medicaid, Pell Grants, and Social Security benefits are exempt. Medicare, Head Start, housing assistance, public safety grants, and transportation, among many, are not. In theory, defense spending should also be cut, but it was increased under this bill.

CBO estimates this bill’s limited sequestration will impose a four percent across-the-board cut in Medicare funding. This would include payments to both providers (boo!!) and Medicare Advantage plans sold by insurers (yay!!). Since MA plans now cover over 51 percent of seniors and are paid somewhere between 8-20 percent more on average per beneficiary than traditional Medicare, insurers will get hit with most of the cuts.

Now, if this were targeted just at MA plans along with new requirements on how they spent the money (like raising the mandatory medical loss ratio to 90 percent from 85 percent), and the money saved was targeted to preserve Medicaid as it now is (the $500 billion would cover most of the proposed cuts to that program), I might be cheering this aspect of the bill.

But as it stands, this is how MA plans and providers in traditional Medicare will likely respond to sequestration should it make it into the final bill:

  • They will reduce access. MA insurers will impose more stringent prior authorization rules, increase claims denials, and impose reductions on the amounts they pay hospitals, doctors and other providers;
  • Physician practices will impose limits on patient access for non-essential and less remunerative services like wellness visits and preventive care. Private equity, insurer and some hospital-owned physician practices will speed up the treadmill that already has a typical office visit down to 13 minutes or less;
  • Fewer doctors in many areas of the country will accept new Medicare patients, resulting in longer wait times and more difficulty finding providers, especially specialists; and
  • Some of those extra benefits in MA plans will disappear or be made more difficult to use. Many plans may impose higher out-of-pocket costs; and
  • The cuts will be especially damaging in rural areas already suffering from hospital closures and physician shortages. Seniors and the disabled will have to travel farther for care.

CBO estimated Congress could save nearly $1 trillion over the next decade by simply cutting MA plan payments down to the same amount providers would have received had their beneficiaries remained in traditional Medicare. Instead, they crafted a sequestration that will make it harder and more expensive for seniors and the disabled to access care.

It is the ways that will affect beneficiaries is what the general public needs to hear about as the bill now moves to the Senate — not the top line dollar number for the cuts.

Reprinted with permission from Gooz News.

Why Trump's Latest FDA Appointee May Imperil Agency's Vital Work

Why Trump's Latest FDA Appointee May Imperil Agency's Vital Work

By appointing Dr. Vinay Prasad to run the Center for Biologics Evaluation and Research, the Trump regime has installed another prominent opponent of Covid-era public health policies to a key position at the Food and Drug Administration.

CBER is responsible for ensuring the safety and efficacy of vaccines, biologic drugs, gene therapies and the blood supply. When FDA Commissioner Martin Makary announced Prasad’s appointment yesterday, he noted the 42-year-old oncologist-epidemiologist has published hundreds of articles in the medical literature. I read their titles this morning. Only a few shed light on how he views the arenas he will soon oversee.

On the other hand, his recent writings on X (formerly Twitter), the substack Sensible Medicine, and his own substack Observations and Thoughts have plenty to say about school closures (“the great domestic policy failure of the last 25 years”); kids wearing masks outdoors (“whoever made the policy is an idiot”); and the annual Covid booster shot (“a public health disaster the likes of which we’ve never seen before”).

On the day after Trump’s election last November, he gave failing grades to the FDA and National Institutes of Health. He called for the elimination of 10,000 jobs at the Centers for Disease Control and Prevention, which he rated as an “abject failure.”

The rhetoric sounds more Trump/Muskian than even-handed or scientific. It is typical of his recent writings, which have taken on an increasingly strident tone since the pandemic. He has repeatedly attacked officials like Anthony Fauci and those at the CDC for ignoring alternative strategies and censoring proponents of herd immunity like Jay Bhattacharya, who now runs NIH.

One of Prasad’s recent posts called for large-scale, randomized clinical trials for the annual booster shots for COVID vaccines. That was in line with Makary’s order late last month that Novavax conduct a new clinical trial to test the annual update of its traditional Covid vaccine, which is the only alternative to the mRNA vaccines sold by Pfizer and Moderna. This new requirement may also be applied to the annual flu vaccines, which will cost the vaccine makers money (who cares?), but more importantly, will take much more time (something we should all care about).

“The FDA is a failure,” Prasad wrote last fall. “It rubber stamps too many useless products. It needs to either remove itself from the picture, or demand randomized trials measuring appropriate endpoints.”

Right turn

This rightward turn in Prasad’s public posture is a relatively recent phenomenon. He began his academic career by studying conflicts of interest in medicine (my own field when working at the Center for Science in the Public Interest). In 2017, he published a study in JAMA Internal Medicine that challenged the ridiculously high sum big drug companies claimed it cost to develop a new drug. (Full disclosure: I was invited to write the accompanying editorial, which was headlined “A Much-Needed Corrective on Drug Development Costs”).

To this day, the insidious role money plays in medicine remains central to how he views the relationship between the drug industry and government. “This is the core rot in American regulation. The revolving door politics. I find this behavior abhorrent, and it should be criminal,” he has written.

He has called for ending all conflicts of interest on FDA advisory committees and wants to set up a “new Phase IV safety detection system” for monitoring adverse vaccine events. “I think vaccine makers should face litigation, as drug makers do,” he has written. He’s also skeptical of using surrogate endpoints and accelerated approvals, which led the FDA to “rubber stamp dozens of drugs with no evidence they help Americans.”

So here we are again. A top Trump regime appointee is championing many positions held by left wing and progressive critics of weak government oversight. Indeed, Prasad has written he once considered himself a progressive Democrat. No wonder biotech stocks temporarily tanked on news of Prasad’s appointment to run CBER.

However, as I’ve said many times in writing about these appointments, let’s watch what they do, not what they say, past or present. Will the Makary/Prasad team slow or even stop vaccine approvals to please their boss, Robert F. Kennedy Jr., the secretary of Health and Human Services? Will Trump order the new team to back off from policies and decisions that tank the stock market (vaccines on their own could never do that; they’re too small a revenue item)?

If I were a gambling man, I’d bet the answer will be ‘yes’ to both those questions.

Reprinted with permission from Gooz News.

RFK Jr. Rips Away Protection Of Human Subjects In Medical Trials

RFK Jr. Rips Away Protection Of Human Subjects In Medical Trials

In 1999, 18-year-old Jesse Gelsinger eagerly signed up for a clinical trial testing a promising therapy for his rare genetic disorder. The Arizona resident’s dream was to lead a normal life that wouldn’t require him swallowing four dozen pills a day simply to stay alive.

He traveled to the University of Pennsylvania where physician-scientists were conducting an early experiment in gene therapy. They told Gelsinger they would implant a working gene for his mutated one using a viral vector. What they failed to tell him was that two of the previous 17 patients in the trial had developed serious side effects; two lab monkeys had died from high doses of the gene-transfer vector; and the lead physician-scientist had an ownership stake in the company sponsoring the trial.

Four days after receiving the treatment, Gelsinger died from a massive inflammatory reaction that shut down his kidneys, liver and lungs. His death received substantial news coverage since gene therapy was the hot new thing in medical science.

The Senate held hearings and legislators promised sweeping reforms of the nation’s institutional review boards (IRBs). Every institution running clinical trials relies on its IRB to review trial protocols and patient informed consent processes to ensure adherence to the highest safety and ethical standards.


IRBs and their minders

While the first IRBs were established in the 1950s, they didn’t become mandatory until the horrors of Tuskegee Syphilis Study became known. In that infamous experiment, which ran from 1932 to 1972, the U.S. Public Health Service denied readily available antibiotic treatment to 400 African American men with syphilis, choosing instead to study them to learn more about the progression of the disease. African Americans’ memory of that gross violation of medical ethics (“first do no harm”) bred an ongoing distrust of the medical system that has limited their participation in clinical trials to this day.

In the wake of Gelsinger’s death, the Health and Human Services Department created the Office of Human Research Protections (OHRP) to police clinical trials. HHS ordered the Food and Drug Administration and OHRP to step up oversight of clinical trials protocols, increase field inspections, and immediately report serious side effects and any deaths. It also prohibited researchers from having a financial stake in their trials and toughened the rules governing informed consent disclosures for prospective participants.

But those requirements, which the nation’s 2,300 IRBs must insure their institutions adhere to, have never been rigorously enforced. Johns Hopkins University, the University of Rochester and the University of Colorado are among the small handful of institutions that have had their right to run clinical trials briefly suspended for ethics violations, with none coming in the past decade.

In part that’s because over the past 20 years, the OHRP’s inflation-adjusted budget had shrunk by a third. Its 40 budgeted positions had been whittled down to 20 by the end of the Biden administration. A 2023 Government Accountability Office report found OHRP conducted just 3 or 4 clinical trial site visits annually, while the FDA averaged just 133 inspections per year between 2010 and 2021.

This limited oversight is especially worrisome when it involves clinical trials for experimental drugs seeking FDA approval. While only 2% of IRBs are independent (non-university or medical center based), they provided oversight for 48% of all investigational drug research in 2021. Just two private equity firms -- Advarra (partially owned by Blackstone) and WCG Clinical (partially owned by Leonard Green and Arsenal Partners) – dominate that privatized market with a 92% share, according to the GAO. These for-profit IRB firms represent a blatant conflict of interest since future work depends on pleasing their current pharmaceutical and medical device industry clientele.

Oversight axed

Despite lax enforcement, the Trump administration is moving quickly to eliminate what little IRB oversight still exists. In early April, the acting head of OHRP abolished the Secretary’s Advisory Committee on Human Research Protections, a panel of 11 volunteer bioethicists, clinicians, scientists and lawyers that offers bioethics and regulatory advice to OHRP. Last week, an industry newsletter reported the staff at OHRP has been whittled down to just nine people.

The IRBs themselves face future financial hurdles from the new National Institutes of Health rule limiting overhead payments to no more than 15% of any NIH research grant, which universities are contesting in court. University and medical center IRBs, which are independent of the researcher receiving the grant, are funded with those overhead payments.

“The IRB system serves as a critical mechanism for protecting participants and minimizing the potential for serious incidents that could jeopardize public trust,” authors of a JAMA Network Viewpoint wrote this week. The authors included the heads of the Association for the Accreditation of Human Research Protection Programs and Public Responsibility in Medicine & Research, which trains and certifies IRB participants. “To meet their ethical and legal obligations—and minimize delays associated with their oversight—IRBs require significant resources, a substantial portion of which come from indirects on federal grants.”

Well before the current round of cuts, the IRB system drew persistent criticism from bioethicists. In addition to the occasional high-profile deaths or serious adverse events in an IRB-approved trial, the university-based boards are frequently accused of failing to enforce informed consent requirements. They rarely police researchers who obtain signatures on consent forms from patients who don’t truly understand the risks they face (so-called “check the box” consent). Some still allow clinicians with financial ties to the sponsoring companies to enroll patients.

These internal boards, while trained and certified, can be subject to the same institutional pressure as privately-owned IRBs. Their university employers want the research money to continue pouring in. The stipends many receive for serving on IRBs depends on that cash flow. These pressures can lead to hasty approval of studies with minimal questioning even when some IRB members have ethical qualms. It’s often easier to let things slide when you know there’s no cop on the beat.

“How is it possible that we’ve had such a weak ineffective organization (OHRP) overseeing research for so long? There needs to be something else,” said Carl Elliott, a trained physician and bioethicist who is now a professor of philosophy at the University of Minnesota. “On the other hand, I don’t think it needs to be nothing, which is what RFK Jr. has in mind.”

Meanwhile, drug and device companies and their defenders attack IRBs from the other direction. They accuse review boards of being cumbersome and bureaucratic, delaying research and hampering innovation.

And that may explain why the Trump administration surgically targeted OHRP and its advisory committee for elimination. “This is a disaster for effective oversight,” said Robert Steinbrook, director of the Public Citizen Health Research Group. “There’s not going to be much federal involvement in protecting human subjects.”

Merrill Goozner, the former editor of Modern Healthcare, writes about health and politics at GoozNews.substack.com, where this column first appeared. Please consider subscribing to support his work.

Reprinted with permission from Gooz News.


Misogyny, Racism And Science Suppression At National Institutes Of Health

Misogyny, Racism And Science Suppression At National Institutes Of Health

Dr. Jayanta Bhattacharya, famous for leading the charge against lockdowns during the COVID-19 pandemic, appears to be overseeing a reign of terror at the National Institutes of Health. The immediate targets: women, minorities and respected scientists at the agency.

From various news sources last week:

  • The Washington Post reported that 38 of 43 experts cut last month from the NIH review boards were women, blacks or Hispanic. About 200 internal scientists belong to review boards that oversee studies involving mental health, cancer and infectious diseases. None were given reasons for their firing.
  • Multiple sources reported that one of the top food scientists at NIH has quit his post after the agency refused to let him speak to reporters about his nutrition study that questioned the addictiveness of processed foods. The findings contradict the beliefs of HHS Secretary Robert F. Kennedy Jr. "We experienced what amounts to censorship and controlling of the reporting of our science, Dr. Kevin Hall, 54, told the New York Times. Fearing Bhattacharya’s next move would be to interfere with the design of future studies, he decided to take early retirement. “That would make me hate my job every day,” he said.
  • No one in the official world of autism research has been contacted by HHS or NIH to participate in a study aimed at identifying the causes of autism’s rising incidence, reported this week by the CDC. The HHS secretary said yesterday he would announce the study’s roster within two or three weeks. STAT followed up by contacting 10 organizations involved in autism research. None had yet been asked to participate in the study. “The scientists ASF (the Autism Science Foundation) works with have NOT been contacted, trust me, I’ve asked around,” Alycia Halladay, ASF’s chief science officer emailed STAT. Halladay also serves on the committee that coordinates autism research across federal health agencies. It hadn’t been contacted, either.

Do you remember what you were taught in ninth grade science? Ask a question; form a hypothesis; conduct an experiment; analyze the data; draw a conclusion. Given what’s going on at NIH, frontline reporters, scientific and medical journals and the general public will need to carefully monitor the make-up of every panel and scientist conducting research for NIH over the next four years to determine if the fifth step — drawing a conclusion — has been put at the front of the line when it comes to choosing members and awarding grants.
Bobby's MAHA Mania: Die Now, Eat Healthier Later

Bobby's MAHA Mania: Die Now, Eat Healthier Later

On Tuesday Robert F. Kennedy Jr. visited Indiana, where GOP Gov. Steve Braun, a former Senator and business owner, unveiled nine executive orders that underscored all the contradictions in the Make America Healthy Again movement.

The positive aspects of his program included:

  • Preventing the Supplemental Nutrition Assistance Program’s low-income beneficiaries from using food stamps to buy sugar-sweetened soda or candy;
  • Annual physical fitness testing in the state’s schools;
  • Subsidies for Indiana farms to grow more nutritious foods; and
  • A study of dyes and chemical additives in the food supply.

On the downside, he ordered:

  • Work requirements for SNAP beneficiaries; and
  • A campaign to root out “improper spending” from “eligibility errors” in the Medicaid program, which he claimed accounts for 28% of all Medicaid spending in the state.

To sum up, then, Indiana, like most GOP-run states, is taking minor steps to improve diets and physical fitness, which will take years to show results in the form of better health and reduced health care spending. Meanwhile, the state, whose businesses spend more on their health insurance than any other state, will be moving quickly to eliminate thousands of people from receiving SNAP benefits or government-funded health insurance. Both moves rely on setting up bureaucratic roadblocks to beneficiaries affirming their eligibility status.

Taken together, the SNAP and Medicaid cutbacks will increase food insecurity among the very poor while forcing many to postpone care for their chronic diseases, which will be treated later, more expensively and with poorer outcomes, including a higher level of mortality. Allowing Medicaid to cover more people “improved health outcomes, including lower mortality rates from cancer, cardiovascular disease, liver disease, and maternal mortality,” a Kaiser Family Foundation issue brief noted in December.

Blue states are doing more to protect health

As with much of his tour to promote MAHA, which kicked off last week in Utah with Kennedy praising its governor for removing fluoride from drinking water, the HHS secretary’s visit to Indiana ignored states that are doing far more to promote the positive aspects of his agenda. Yesterday, in next door Illinois, the state senate passed a bill that would prevent foods containing four harmful additives from being sold starting in 2028. Democratic Gov. Jay Pritzker supports for the bill, which should easily pass the Democratically-controlled House.

The banned additives included brominated vegetable oil (BVO), potassium bromate and propylparaben, which having been linked to cancer or toxic effects on the heart, reproductive, and endocrine systems. Each has been banned in the European Union. The Illinois law also bans use of Red Dye #3, whose elimination starting in 2027 the Biden administration’s Food and Drug Administration finally ruled last December. The FDA concluded more than three decades ago the dye was carcinogenic.

For decades, food industry lobbying has largely paralyzed action by the scientists in the FDA’s food division, which failed to police not just food additives, but excess sugar and salt and other harmful ingredients in processed foods. The Trump administration’s massive cutbacks in personnel at the agency, and the fear that has instilled in those who remain, makes it highly unlikely the FDA will be making regulatory changes at the federal level anytime soon.

Kennedy’s heightened attention to the issue has given states political room to act. Illinois followed in the footsteps of California, which passed a similar law in 2023. Lawmakers in at least 20 states have introduced similar bills. Several, including deep Red West Virginia, are GOP-run.

Proponents are making the same argument everywhere: There are safer, less costly alternatives. After protests in Canada, Kellogg’s changed the dyes used in its Fruit Loops and Apple Jack cereals to concentrated carrot juice, watermelon juice and blueberry juice.

Major food companies, whose CEOs met recently with Kennedy, worry that there will be a patchwork quilt of state regulations that will make it difficult to market products nationally. “What’s happening in the states like Indiana is going to drive change,” he said today.

Actually, Indiana, whose farmers are leery of challenging their major customers in the food processing industry, is only going to “study” the issue. It is mostly the Democratically-run states that are taking the lead and actually doing something about it.

Merrill Goozner, the former editor of Modern Healthcare, writes about health and politics at GoozNews.substack.com, where this column first appeared. Please consider subscribing to support his work.

Reprinted with permission from Gooz News.


Trump, CDC, public health threat

How Trump's Health Care Layoffs Will Hasten A National Recession

As the news about the Trump regime’s purge at every Health and Human Services agency poured in, it dawned on me that this could be the beginning of the next great recession.

Beyond the massive cuts already underway, there is more to come in Medicaid and possibly even Medicare as the GOP advances legislation to extend corporate tax breaks. This will lead to a sharp reduction in household spending, which drives the economy. Health care represents 18 percent of that economy.

I have consistently advocated for reducing the medical industrial complex’s draw on national income. But this isn’t the way to do it. Cutting Medicaid and premium support for individual insurance plans will undermine public health, make America sicker and increase demand for ameliorative care, which will increasingly be provided free of charge as the ranks of the uninsured swell. That will force those still insured to pay higher rates, which in turn will exacerbate the decline in consumer spending as households prioritize basics like food, housing, heat, and health care over discretionary spending.

This is in addition to the havoc raised by the president’s broad and irrational tariffs announced yesterday. Unless every economist except those working for Trump is wrong, this will drive prices for every imported good higher: from food and clothes to cars and computers.

The ostensible goal — bringing manufacturing jobs home — is a decades-long project. Those who honestly believe Hamiltonian-style protectionism can work in the 21st century understand that industrial policy must be 1) strategically targeted; and 2) accompanied by policies that promote the protected industries. That’s exactly what President Biden included in his Build Back Better program, partially enacted in the Inflation Reduction Act. The Trump regime is eliminating many of those provisions.

Is it safe? Will it be there?

The press did an admirable job over the past two days cataloging the effects of HHS Secretary Robert F. Kennedy, Jr.’s purge of 10,000 HHS workers (on top of the 10,000 who jumped ship during the earlier buyouts). Here are some of the more pernicious cuts:

  • The Food and Drug Administration eliminated 170 staff from its inspections department. Most were support staff for the people who visit facilities in the U.S. and around the world to ensure there are no impurities in drugs and no bacteria in food. The backlog of uninspected facilities will grow as “front-line investigators will now be spending significant time processing their own travel and related administrative requirements,” rather than spending that time inspecting firms to ensure the American consumer is protected, one FDA official told CBS News.

The staff cuts at FDA included veterinarians monitoring the bird flu outbreak, which has led to egg shortages and emboldened producers to price gouge. The laid-off scientists included vets who designed studies showing pasteurization killed viruses found in milk, according to the Washington Post. Drinking raw milk is among the many quackeries embraced by Secretary Robert F. Kennedy, Jr.

  • The vaccine advisory panel at FDA lost the four staffers who run the meetings and monitor conflicts of interest, according to Bloomberg News. Meanwhile,Politico reports Sara Brenner, the FDA’s principal deputy commissioner, has asked for more data about the Novovax vaccine for Covid-19, the only non-mRNA vaccine on the market. Its approval was expected by April 1.
  • The HHS layoffs announced Tuesday included more than half of the 150 staff at the Office of the Assistant Secretary for Planning and Evaluation, which evaluates policy alternatives for the HHS secretary. More than third of the 300 staffers at the Agency for Healthcare Research and Quality received pink slips this week, according to Stat. AHRQ conducts or supports most of the research aimed at improving patient safety at the nations hospitals, where drug-resistant infections remain a major threat.
  • About two-thirds of the 1,200 people working at the National Institute for Occupational Safety and Health are being laid off, according to CBS News. They include the entire staff at the National Personal Protective Technology Laboratory, which is responsible for ensuring respirators and other personal protective equipment work properly.

This will effect not just hospital and medical personnel but mineworkers, construction workers and others routinely exposed to dangerous air, chemicals and other hazards at work. The layoffs will take effect on June 30, American Federation of Government Employees union representatives told Modern Healthcare. "Everybody in NPPTL is being RIF'ed," said Brendan Demich, chief steward of the AFGE Local 1916.

  • It is unlikely the public will get many details about the effects of the personnel cuts. Most staff in the offices that respond to Freedom of Information Act requests at HHS have been put on administrative leave. Those offices at the CDC, NIH and the FDA were entirely eliminated. Journalists, lawyers and patient advocacy groups depend on FOIA requests to gain insight into internal deliberations and lobbyist interactions behind government decions.

An HHS spokesman told NPR that “the FOIA offices throughout the Department were previously siloed, and did not communicate with one another. Under Secretary Kennedy's vision for a more efficient HHS, these offices will be streamlined, and the work will continue.” Only there will be fewer people, longer delays, and centralized control over what gets released.

A better way to cut spending

Here’s another news story that caught my eye this week. Employment at the nation’s largest health insurance companies dipped 4.6% in the fourth quarter of last year, according to a review of SEC filings by Modern Healthcare reporters. Even if one excludes UnitedHealth Group’s overseas divestitures, the seven largest insurers cut 1.4 percent of their workers at a time when total jobs in the economy grew by 1.2 percent.

Slower spending growth by both Medicare and Medicaid is shrinking insurer margins. Seniors opting for private Medicare Advantage plans, which now cover more than half of beneficiaries, is slowing dramatically, up just 3.1 percent to 34.4 million people this year, according to a STAT report in late February. Medicare pays MA plans about 22 percent more on average than those beneficiaries would cost if they had remained in the traditional program.

Why? Medicare pays insurers a risk-adjusted monthly premium to cover seniors who choose an MA plan. The “risk” is determined by how sick people are, which insurers can game by coding for illnesses they never treat. The Medicare Payment Advisory Commission estimates Medicare loses over $80 billion a year from insurer upcoding — and that’s after slapping an across-the-board 5.9 percent reduction in payments to insurers.

Increase that reduction to 20% — making MA reimbursement about equal to FFS Medicare — would save Medicare $1.0 trillion over the next decade. This could lead to higher cost sharing, higher premiums and fewer supplemental benefits for MA enrollees (so those plans looked more like traditional Medicare). Or MA insurers could take a profit haircut. But it would also eliminate any need to cut Medicaid to pay for tax breaks.

Here’s the popular slogan I offered last month: Don’t throw people off Medicaid to pay for your tax breaks for big corporations and the wealthy. Stop private insurers from ripping off Medicare.

Merrill Goozner, the former editor of Modern Healthcare, writes about health and politics at GoozNews.substack.com, where this column first appeared. Please consider subscribing to support his work.

Reprinted with permission from Gooz News.


RFK Jr

How Kennedy's FDA And CDC Cuts Imperil Your Family's Health

Robert F. Kennedy, Jr. swung his meat axe at the Health and Human Services Department on Thursday, leaking plans to theWall Street Journal that he plans to lay off 10,000 workers or about 12 percent of the department’s workforce.

If he follows through on the plan, the largest layoffs will come at the Food and Drug Administration and the Centers for Disease Control and Prevention — the two sub-agencies that drew his greatest ire while running for president. The leaked plan calls for eliminating 3,500 full-time positions at FDA and 2,400 at CDC, which represents nearly 60 percent of the total employment cuts.

“If you work for the FDA and are part of this corrupt system, I have two messages for you: 1. Preserve your records, and 2. Pack your bags," Kennedy wrote on X last October after endorsing the Trump campaign.

The memo said the three divisions at FDA that approve new drugs, biologics and medical devices, which depend largely on industry user fees for their funding, would be exempt from the cuts. Those three sub-agencies employ 11,800 of the FDA’s total workforce of 19,700.

That means the bulk of the layoffs will come in the agency’s Human Food Program, which employs a little less than 8,000. Eliminating 3,500 its workers would nearly halve a sub-agency that protects the nation’s food supply; oversees food additives and dietary supplements; and crafts nutrition guidelines and food labels.

Staff who work in foods who were not exempted from the cuts include people who work on solving, communicating, and preventing outbreaks; testing foods for contaminants like heavy metals or bacteria; developing nutrition and food labeling policy; and take enforcement against companies who break the law.

Roughly two-thirds of Human Food Program funding goes towards inspection or ‘field’ personnel aimed at keeping our food supply safe, said Sarah Sorcher, director of regulatory affairs at the Center for Science in the Public Interest, in an email. (Full disclosure: I worked there from 2004-2009.) “Cuts are likely to hit heaviest on the foods program,” she said. “There are a few reviewers working on pre-market approval of additives, including food contact substances, (so) this is a very small fraction of the workforce.”

A corporate field day

No doubt the food additives regulatory function that Kennedy’s Make America Healthy Again campaign put in its crosshairs will be decimated. Eliminating workers without having an alternative regulatory scheme in place could prove disastrous for the American public.

First, the food and chemical additives industry will fight any attempt to ban or regulate their products, using its small army of lobbyists to slow the regulatory process before going to the business-friendly courts to prevent implementation. Second, the supplements industry will enjoy a field day after a sharp reduction in staff at FDA.

With fewer personnel to conduct oversight, shyster-led companies will fill the airwaves and internet with ads making unproven health claims for products that have never been tested for safety and efficacy. In addition to Kennedy’s long history questioning vaccine safety, Kennedy in recent years backed unproven medical claims such as taking cod liver oil for measles and ivermectin and hydroxychloroquine for Covid.

If the Trump administration follows through on the cuts, Dr. Martin Makary, the newly confirmed head of FDA, will be handed a shattered agency incapable of carrying out many of its core functions. During his confirmation hearing, which took place shortly after the initial Elon Musk-ordered employment cuts at the agency were rolled back, Makary promised senators he would do his own assessment of personnel needs at the agency. This latest plan raises the obvious question of whether he played any role at all in evaluating staffing.

A surgeon by training, Makary during his hearing also revealed an affinity for blaming the marginal issues championed by his new boss for the rise in childhood illness, where the main problems in recent years have been identified as rising obesity caused by junk food diets and lack of exercise, environmentally-caused asthma and the return of once-conquered childhood illnesses due to vaccine hesitancy. When asked by a MAHA-friendly senator about the role food additives play in causing inflammation and gut microbiome alterations, Makary replied, “Half of our nation's children are sick and nobody has really been doing anything meaningful on this front … We have to look at those ingredients.”

States will be hit hard by CDC cuts

The employment cuts at CDC contained in the new Trump administration plan will eliminate an estimated 19 percent of all agency jobs. Many research functions, like the reports that go into the Morbidity and Mortality Weekly Report, may fall by the wayside. Here’s the internet front page of a recent issue:

Public health agencies across the country, journalists and academic researchers rely on MMWR reports to identify emerging trends, deploy scarce resources, and identify issues that need further study. But Russell Vought, one of the key architects of Project 2025 and President Trump’s current director of the Office of Management and Budget, told Michigan’s Hillsdale College forum last September that most CDC workers “don’t even do public health. They are researchers that publish material. Who knows if it’s even relevant or not?”

Earlier this week, the administration announced it will cancel tens of billions of dollars in CDC grants to state and local health departments, which are dependent on federal funding to track infectious diseases, health disparities, vaccinations, mental health services, and other public health issues. It sent stop-work-immediately notices to the states, according to a news report in The Hill.

Many of the grants were authorized in the Covid relief bills passed during the Biden administration, which expire this September. Besides fighting the pandemic, state and local health officials used the money to also track the ongoing measles outbreak, improve their antiquated computer systems, and invest in other public health priorities.

States will soon become wholly dependent on their own resources to carry out these functions even as their residents continue to send most of their tax money to the federal government.

Merrill Goozner, the former editor of Modern Healthcare, writes about health and politics at GoozNews.substack.com, where this column first appeared. Please consider subscribing to support his work.

Reprinted with permission from Gooz News.


Why Medicaid Patients May Not Know Their Health Care Is At Risk

Why Medicaid Patients May Not Know Their Health Care Is At Risk

They go by different names in different states. In Tennessee, it is TennCare. In Ohio it is the Buckeye Health Plan. In California, it is Medi-Cal.

In Florida, it “sounds like an orange juice brand: Simply Healthcare,” wrote N. Adam Brown, an emergency room physician and professor at the University of North Carolina business school, in a commentary posted earlier this week on the MedPage Today website.

What they have in common is that they are Medicaid plans run by private insurance companies. Over the past several decades, 41 states and the District of Columbia have turned over their low-income health insurance programs to what industry jargon refers to as Medicaid managed care organizations or MCOs.

The nation’s 280-plus MCO plans cover an estimated 75 percent of the 85 million people (as of March 2024) on Medicaid, the joint federal-state program targeted for massive cuts by the GOP-run Congress. While many are run by non-profits or government agencies (like CountyCare in Chicago where I live), five for-profit private insurers (Centene, UnitedHealth Group, Elevance, Molina and Aetna/CVS) account for more than half of all Medicaid MCO enrollment, according to the Kaiser Family Foundation.

While the websites of most of these firms indicate their plans are connected to Medicaid, a significant share of their clientele have no idea they are covered by a government-financed program. A recent study published in JAMA found that between 2019 and 2022 when enrollment increased by 5.2 percentage points, surveys that asked where people obtained their health insurance showed only a 1.3 percentage point growth in Medicaid.

“Because Medicaid is not branded as Medicaid, if you tell a patient in South Carolina they might lose Medicaid, their eyes may glaze over,” Brown wrote. “Tell them Healthy Connections is at risk? You have their attention.”

His solution? “In every state, we need to call Medicaid by its real name,” he wrote. Instead of saying “‘Republicans want to reduce Medicaid by $880 billion,’ try ‘If Republicans' Medicaid plans come to fruition, you could lose your Buckeye Health Plan health insurance.’”

Where are the lobbyists?

No one is in better position to call Medicaid by its real name than the private insurers in charge of the program. Yet with the sole exception of Centene, the largest MCO operator, most companies have remained silent in the face of the GOP’s assault on the program.

For instance, I can’t find a single press release or public statement by a private insurer that counters claims contained in a specious hit piece released earlier this month by conservative think tanks that estimated Medicaid made $1.1 trillion in improper payments over the past decade. Since they’re managing at least half the money that flows through Medicaid, they ought to be offended.

The Paragon Health Institute and Economic Policy Innovation Center paper based its claims on eligibility reviews conducted during the last two years of the first Trump administration. It then applied that percentage to all Medicaid spending. However, the government estimated just a five percent improper payment rate or about $31 billion in 2024, which, if eliminated in every year over the next decade, would only save half of what conservatives claim.

Nor have those insurers risen to defend the the 92 percent of adults under 65 who are on Medicaid despite working full or part-time. More than a quarter of all workers in the private sector are not offered health insurance as a benefit, most whom are earning poverty- or near-poverty wages and are eligible for Medicaid, especially in the 41 states that have expanded the program (with 90% federal funding) to cover people earning up to 138 percent of poverty wages.

Even among those offered health insurance on the job, only three-quarters purchase plans. Why? Most can’t afford the premiums being taken out of their paltry paychecks.

So let’s begin describing Medicaid for what it is: A massive subsidy for employers who rely on low-wage labor. This subsidization is necessary because we have what, theoretically at least, is an employment-based health insurance system. Yet the government doesn’t require all employers provide and pay for health insurance.

Of course that’s not what you hearing from Republicans like Rep. Eric Burlison (R-MO). During hearing held earlier this month, he, like the president he slavishly follows, said there would be no cuts to Medicaid. “My definition of cutting does not include getting people who are fraudsters and getting people who are not supposed to be on the list as recipients.”

Democrats should answer with the following: “When we make Florida’s orange growers pay for their orange pickers’ health insurance, we’ll be able to shrink ‘Simply Health’ as much as they shrank the amount of juice put in each bottle.”

Reprinted with permission from Gooz News.

Medicaid Cuts Loom As House Republicans Declare War On Red States

Medicaid Cuts Loom As House Republicans Declare War On Red States

Last week, at the House hearing opening this year’s federal budget deliberations, Rep. Earl L. “Buddy” Carter (R-GA) promised, “We will not kick anybody off Medicaid.” The GOP leader promised to save money instead by rooting out waste, fraud, and abuse in the program.

Carter could have something to say in the matter since he chairs the health subcommittee of the House Energy and Commerce Committee. But, then again, maybe not. House Speaker Mike Johnson (R-LA) might bypass his committee and ram through across-the-board cuts in the bill needed to lift the debt ceiling, which must be passed in the next few weeks to avoid a government shutdown.

Those concerned with health care have a lot to fear from the blueprint released by the Budget Committee. It showed the GOP will seek $2.2 trillion in cuts to Medicaid and “other Health” programs (but not Medicare — more on that below) over the next ten years. It starts slowly: cuts of $49 billion or seven percent of health spending in this fiscal year, rising to $355 billion or 32 percent of projected spending in 2034. For Medicaid alone, that comes to a $40 billion cut this year and $1.8 trillion over the next decade.*

There is no way they can eliminate that much Medicaid spending without throwing tens of millions of people off the rolls. The program currently provides health insurance for 80 million souls. That’s nearly a quarter of the nation, more than a third of them children.

As I pointed out last week, the GAO estimated federal auditors and investigators would find at best around $52 billion in potential waste in the Medicaid program. That is barely enough to cover the first year’s proposed cuts.

Even if they were highly successful in eliminating waste during the next few years — hardly likely given they just fired the Inspector General at HHS and decimated the Department of Justice’s investigative arm — it would reduce the amount of savings available in later years to zero or near zero. Deep programmatic cuts are inevitable under their blueprint.

Given Carter’s role in determining Medicaid’s fate, let’s turn to a fellow southerner (albeit fictional) for the most appropriate response to his assertion in that Capitol Hill hearing room that there will be no one thrown off Medicaid. “Didn't you notice a powerful and obnoxious odor of mendacity in this room?” Big Daddy hollered in Cat on a Hot Tin Roof. “There ain't nothin' more powerful than the odor of mendacity. You can smell it. It smells like death.”

The biggest losers

The Congressional Budget Office has identified a number of ways that the MAGA-cowered Congress could impose cuts of that magnitude, whose primary purpose, let us not forget, is to help pay for another round of tax cuts for corporations and wealthy individuals. They could cap federal support for Medicaid, which currently stands at 69% of expenditures with states picking up the rest. They could do that either by instituting block grants, the long-time GOP goal, or slap a per capita cap on support for each beneficiary.

Either way, the program would be legislated to grow at the rate of inflation, which is substantially below economic growth or the growth in health care spending. That would put state health departments in the unenviable position of doing the Feds’ dirty work. They would have to either throw people off the rolls or raise taxes sharply on their own residents.

Who would be hurt most by this? If you’re guessing Massachusetts, California and most of the blue-run states in between, guess again. Fully 20 of the top 24 states most dependent on federal funding to run their Medicaid programs voted for Donald Trump in the last election. Eleven of those states have more than a quarter of their populations on Medicaid.

Top 14 states most reliant on federal matching funds for Medicaid

Other options to cut spending

The CBO offers other options for cutting spending. Congress could eliminate the federal match for taxes that 49 states and the District of Columbia levy on providers, which would save the federal government an estimated $630 billion over ten years. The states use that money to help pay for their share of the Medicaid program.

As the Congressional Research Service pointed out in this issue brief, these taxes are progressive in that they redistribute money from hospitals, nursing homes and physician offices with few Medicaid patients to those institutions that care for a disproportionate share of the poor. Eliminating the federal match is a shell game: It would force states to either pick up those costs or repeal the taxes, which would be doubly punishing for safety net institutions.

The GOP-run Congress could also lower the federal match for people in the 40 states and District of Columbia who expanded the program under the Affordable Care Act to cover people earning up to 138% of poverty wages. The federal government pays 90 percent of the cost of covering those workers and their families. Turning that into the standard match rate of 50 percent to 77 percent would reduce federal Medicaid spending by $596 billion over ten years, according to the CBO.

This would strike a major blow to the Medicaid expansion. At least a dozen states have laws that repeal their Medicaid expansions if the federal match rate drops. The Kaiser Family Foundation estimated anywhere from 19 percent to 49 percent of people on Medicaid in expansion states would lose coverage under this proposal. Some, maybe many, would purchase ACA plans on the exchanges. The more that do, the less the savings for the federal government since all would be heavily subsidized — unless the GOP Congress reduces those subsidies, too.

The path not taken

The most costly boondoggle in health care is never mentioned in the House Budget Committee report. The CBO estimates that Medicare could generate substantial savings if it simply paid private insurers covering Medicare Advantage (MA) beneficiaries the same amount as if they had remained in traditional fee-for-service Medicare.

As I’ve reported here many times, Medicare pays insurers a risk-adjusted monthly premium to cover seniors who choose an MA plan. The “risk” is determined by how sick people are, which insurers can game by coding for illnesses they never treat. The Medicare Payment Advisory Commission estimates Medicare loses over $80 billion a year from insurer upcoding — and that’s after slapping an across-the-board 5.9 percent reduction in payments to insurers.

Increase that reduction to 20 percent and it would save Medicare $1.0 trillion over the next decade — more than any other option identified by CBO. Of course, this would result in higher cost sharing, higher premiums, and fewer supplemental benefits for Medicare Advantage enrollees (so those plans looked more like traditional Medicare) or it would reduce profits for Medicare Advantage insurers.

How’s that for a popular slogan? Don’t throw people off Medicaid to pay for your tax breaks for big corporations and the wealthy. Stop private insurers from ripping off Medicare.

Merrill Goozner, the former editor of Modern Healthcare, writes about health and politics at GoozNews.substack.com, where this column first appeared. Please consider subscribing to support his work.


Drugs Are Top US Import -- And Tariffs Will Drive Up Their Cost

Drugs Are Top US Import -- And Tariffs Will Drive Up Their Cost

I was stunned this morning when I looked at the data. Drugs — the legal kind — are the U.S.’s single largest import category.

The U.S. in the first 11 months of 2024 imported over $222 billion in pharmaceutical products, which includes both finished drugs and the chemicals used to make drugs domestically. That’s $25 billion more than the value of all imported cars, the next largest category, and larger still than imports of crude oil; car parts; computers; and cell phones, the next four.

China is the single largest exporter of drugs and drug chemicals to the U.S. Yet China was only subjected to a 10 percent across-the-board tariff under the Trump edict, which, as of this writing, is still slated to go into effect tomorrow. That will be in addition to targeted tariffs on specific Chinese goods (steel, solar cells, EVs) imposed by the first Trump and Biden administrations.

Mexico and Canada, on the other hand, were slated for a 25 percent tariff on all its U.S. exports. This morning, the Mexican tariff was postponed for at least a month after a phone call between Trump and Mexican president Claudia Sheinbaum. Canadian Prime Minister Justin Trudeau was also in telephone contact with Trump (which led to a similar postponement). Both neighbors’ economies would be devastated by 25 percent tariffs since they are far more dependent on exports than the U.S.

Both countries are major suppliers of medical devices (knees, hips, heart values, stents, etc.) and medical equipment (imaging equipment, bioreactors, microscopes, etc.), which accounted for $57 billion in U.S. imports in the first 11 months of 2024, according to the Commerce Department. Medical equipment was the 13th largest category among all U.S. imports.

The ostensible reason for imposing high tariffs on our neighbors is to stop the flow of fentanyl into the U.S. Seeing fewer dangerous street drugs is the least likely outcome of any trade war. Interdiction efforts like tariffs that fail to focus on eliminating demand (i.e., getting U.S. drug addicts into treatment programs) wind up doing nothing more than enriching drug cartels and harming Americans. How? By raising the street price of illegal opioids and increasing the level of crime needed to pay for those higher-priced drugs.

The opacity of chaos

Speculation is rife as to why Trump went soft on China but hard on our northern and southern neighbors. A Paul Krugman post over the weekend suggested it might be due to the influence of Trump whisperer Elon Musk, who has extensive business dealings with China. He also noted news reports that 40 unnamed “whales” bought 94 percent of the $Trump and $Melania tokens, a personal grift worth tens of millions of dollars to the Trumps since the tokens “clearly have no intrinsic value.” Were they Chinese? he wondered.

Tim Noah in The New Republic suggested the huge tariffs are part of the president’s obsession with eliminating the income tax and returning to 19th century government financing that relied on tariffs. Unless Trump plans to completely eviscerate non-defense federal spending with huge cuts to Medicare and Medicaid, that’s fiscally absurd.

Noah also raised the specter that a bankrupt Trump may simply be running a grift on his newfound billionaire friends, many of whom have corporate interests and stock market holdings that will be severely damaged by the new tariff regime. They will ask Trump to reverse or at least moderate the tariffs, which he might do for a price. “These whales, whoever they are, want something in return,” Noah wrote. “They’ve created a path for other influence-buyers to follow.”

The big losers from Trump’s tariff games will be those who joined the administration hoping to use tariffs strategically as part of an industrial policy aimed at restoring long-lost domestic manufacturing capacity. There was some hope Trump might move in that direction when he appointed Jamieson Greer to be the next U.S. Trade Representative (USTR).

Greer was chief of staff to Robert Lighthizer, Trump’s first-term USTR. In Lighthizer’s most recent book, reviewed by American Prospect founding editor Robert Kuttner in a hopeful essay in the December issue of The New York Review Books, the former USTR called for a 25 percent across-the-board tariff on Chinese-made goods. Trump also appointed Peter Navarro, his former trade adviser and an avowed China hawk, to be his senior counselor for trade and manufacturing.

While expressing hopes that there might be a positive rethinking of trade policy during a second Trump term, Kuttner issued this prescient warning:

“Several other Trump appointees, who span a right-wing spectrum that runs from poorly informed nativists to Wall Street globalists, suggest that trade policy in Trump’s second administration is likely to display the same kind of internal conflicts as his first. Xi will again be looking for ways to undermine US anti-China policy by personally enriching Trump, his family, and his close advisers, such as Elon Musk, with their own financial interests in China.”

It seems clear that Lighthizer and his acolytes inside the new administration had little input into the weekend’s tariff announcement. Rather than imposing strategic tariffs to promote domestic manufacturing, the main economic impact will be higher prices.

Drug and device makers’ price card

Why are higher prices a given in health care? The drug and device companies in health care that will be subjected to the new tariffs have an almost unlimited power to raise prices to cover their increased costs because their products are patent protected. Moreover, manufacturers in both sectors have been outsourcing their manufacturing for decades. Even if they wanted to, it would take years for them to shift production back to the U.S.

“You can’t expand capacity overnight,” said Mark Hendrickson, director of supply chain policy for Premier Inc., a hospital group purchasing organization. “That takes year and millions of dollars.”

The drug and device makers are already signaling that their likely response will be price increases. “We have shared with the Administration our concerns about the potential impact tariffs could have on the medical technology supply chain that American patients depend on for their care,” said Scott Whitaker, CEO of Advamed, which represents device and equipment makers, in a statement to StatNews over the weekend.

The Pharmaceutical Research and Manufacturers Association was more circumspect in its statement when I reached out this morning. “We are eager to work with the Trump Administration to find solutions that reduce costs for patients and improve access,” their statement said. “However, policymakers have historically excluded medicines from tariffs because they increase costs and reduce access.”

Not this time, at least not so far. Perhaps if they buy a hefty bag of $Trump tokens, whose price dropped precipitously over the weekend and during today’s trading, things might change.

Reprinted with permission from Gooz News. Please consider subscribing.

Trump's Illegal Firing Of Inspectors General Undermines Fight Against Fraud

Trump's Illegal Firing Of Inspectors General Undermines Fight Against Fraud

It’s enough to give one a migraine.

Last Friday, just hours before President Trump illegally fired Christi Grimm as Inspector General of the Health & Human Services Department (along with 16 other inspectors general), her office and the Department of Justice successfully forced Pfizer Inc. to pay $60 million to settle charges it improperly marketed an anti-migraine drug.

A 2022 law strengthening the independence of in-house watchdogs at federal agencies requires the president to give Congress at least 30 days advanced notice before firing an IG. POTUS must also provide Congress with a detailed legal justification for any dismisssal.

The president’s contempt for the law parallels Pfizer’s alleged illegal activity. According to the settlement reached Friday, the company’s drug salespersons paid physicians “in some cases more than a hundred thousand dollars” to speak on behalf of Nurtec ODT, an anti-migraine drug. The speeches took place at dinner meetings attended by the speakers' family members, friends and colleagues from their own practice.

“Providers received no educational benefit from attending these meetings,” the settlement said. The subsidiary “intended the purchase of meals and drinks to induce these providers to prescribe Nurtec ODT.”

Why must Pfizer give financial inducements to doctors to convince them to prescribe a drug that helps people with a debilitating condition like migraines? One doesn’t have to look far for the answer to that question. Nurtec ODT’s topline celebrity promoter — Lady Gaga — offers only a half-hearted endorsement on the company’s website. “If you're, like me, one of the millions suffering from pain caused by migraine, Nurtec ODT may help,” she says.

“May” is the operative word. According to the Food and Drug Administration label on Nurtec, popping the pill ended migraine pains within two hours for just 21 percent of patients. That compared to 11 percent among those taking a placebo. It reduced major symptoms like nausea and light sensitivity in 35 percent of patients taking the drug compared to 27 percent among those taking a placebo.

In other words, Nurtec ODT was barely better than nothing. Two-thirds of patients received no benefit at all.

Cracking down on illegal marketing is only one of the crucial functions played by the Office of the Inspector General at HHS. Since 2007, the OIG and the Department of Justice have been operating a special joint task force to root out waste, fraud and abuse in a dozen major metropolitan areas.

“The Health Care Fraud Unit has charged more than 5,400 defendants with fraudulently billing Medicare, Medicaid, and private health insurers more than $27 billion,” a recent DOJ blog post noted. “In recent years, the average loss associated with the schemes prosecuted by the Health Care Fraud Unit has steadily risen, underscoring our focus on the most egregious offenders.”


Pill mills a target

One of the more significant recent cases took place in Alabama, where in 2023 an opioid pill-mill operator and his wife were sentenced to 20 years in prison for illegally distributing controlled substances and committing health care fraud. This was one of the first cases that Grimm, who has been with the agency since 1999, brought to a successful conclusion after becoming IG the previous year.

“At trial, evidence showed that the physician and his wife operated pain clinics in which patients often received pre-signed prescriptions that were issued to patients who went months or years without being seen by the doctor,” the joint task force’s most recent annual report said. “The doctor was responsible for writing prescriptions for over 10 million opioid pills and he and his wife also participated in fraud and kickback schemes that billed public and private insurance programs for over $270 million in fraudulent claims.”

You would think someone who wants to make American healthy again, and help some of his most loyal constituents avoid being victimized by illegal pill-mill operators, would want someone like Grimm to run HHS’s watchdog agency. The OIG’s semiannual reports to Congress estimated the agency recovered close to $10 billion for Medicare and Medicaid in 2024, nearly 20 times the 1,500-person agency’s annual budget.

Much of the HHS-DOJ task force’s efforts in recent years has focused on cracking down on opioid abuse. It set up special offices in New England and Applachia. It also stepped up efforts in traditional hotbeds of Medicare fraud: Texas and Florida, both of which have two major task force offices dedicated to combating illegal billing.

Here’s hoping a federal judge capable of reading the plain letter of the law will force Trump to rescind these illegal firings and submit the necessary paperwork. He offered nothing last Friday to justify removing these career professionals, almost all of whom came up through the ranks and dedicated their professional lives to protecting taxpayers, program integrity and current and future beneficiaries of important government programs.

Since I’ve began covering health care more than two decades ago, the HHS OIG has always been headed by a career professional. Dan Levinson, who retired in 2019, had been there for 15 years. When he left, Alex Azar, HHS secretary during Trump’s first term, said “Under Dan’s leadership, the HHS Office of Inspector General (OIG) has done tireless, invaluable work to protect program beneficiaries and taxpayer funds, improve the management and integrity of HHS programs, and respond to emerging challenges such as the ongoing opioid crisis.”

This time around, there’s widespread fear that the mission of the OIG will be undermined if Trump gets away with turning the job into a political appointment. “President Trump is dismantling checks on his power and paving the way for widespread corruption,” Sen. Elizabeth Warren (D-MA), said on Friday after the president’s announcement.

Merrill Goozner, the former editor of Modern Healthcare, writes about health care and politics at GoozNews.substack.com, where this column first appeared. Please consider subscribing to support his work.