Coffee Break: The Next Surgeon General, Gene Therapy, Ozone Hole Closes, Daylight Saving Time, and American Socialism

Part the First: The Next Surgeon General Prepares for her Closeup.  In a surprise to absolutely no one, Casey Means MD discloses financial ties to supplement industry.

New financial disclosures from surgeon general nominee Casey Means show that she’s made hundreds of thousands of dollars promoting supplements and other health and wellness products, details likely to invite new scrutiny about potential conflicts of interest for the author and entrepreneur.

Means, a close ally of health secretary Robert F. Kennedy Jr. and the sister of White House adviser Calley Means, has not yet been scheduled to appear before Congress for her confirmation hearing.  But a filing (pdf) dated Sept. 10 and posted by the Office of Government Ethics suggests her nomination cleared conflict-of-interest checks within the federal government.

The supplements industry has ties with several members of the Trump administration, including Medicaid director Mehmet Oz and health adviser Calley Means.  An AP investigation this summer found that Casey Means had repeatedly failed to disclose her partnerships with supplements companies and other businesses promoted in her newsletter, social media accounts, and elsewhere.

Casey Means MD has been identified as an “entrepreneurial doctor,” and that she is. We have discussed her previously in a review of her book Good Energy, which in its explanation of metabolism was very good.  But ultimately it was a paean to MAHA, as it turns out that MAHA consists of superfluous advice for rich people.  That was not surprising, either.  According to her story Casey Means MD quit her ENT residency after four years of a five-year program because she found herself only treating diseases of the ear, nose, and throat instead of understanding them.  This, because she was not taught the causes of disease as a medical student at Stanford.

In this she is not believable.  After leaving medicine she opened a functional medicine practice where she could treat the whole patient (who has the money to pay for hours-long appointments).  Her company Levels is at the forefront of the current Health and Human Services Secretary’s effort to provide “wearables” to everyone.  This is not even borderline stupid.  Continuous glucose monitoring is essential for diabetics and others with metabolic diseases.  But for everyone else a yearly checkup that includes routine blood work is enough.  But really, how many people have the time, health insurance (category error), and personal primary care physician for the yearly checkup?  Now, making that possible would Make All of America Healthy Again (MAAHA).

Two other points before moving on.  Casey Means MD is generally referred to as a doctor or physician.  She has an MD from Stanford and began a residency she did not complete.  But without a license to practice medicine, she cannot legally refer to herself as a “doctor” in most jurisdictions in the United States.  This is not a trivial matter.  Which leads to the final point: How many Surgeon Generals of the United States did not have a valid license to practice medicine when they were nominated and confirmed for the position?

Part the Second: Gene Therapy is Hard.  Sarepta Therapeutics produces a gene therapy (Elevidys) for Duchenne muscular dystrophy (DMD).  The cause of DMD is lack of a very large protein called dystrophin that is essential for skeletal muscle cells to maintain their integrity during cycles of contraction.  DMD is eventually fatal due to progressive muscle atrophy accompanied by fat infiltration of muscle tissue.  Gene therapy is the only currently imaginable hope for DMD patients.

Elevidys produces a micro-dystrophin (gene therapy for full-length dystrophin would be impossible with current technology) that is delivered to target muscle in an infusion.  Earlier this year two patients died after the treatment caused by the viral vector, perhaps due to underlying liver problems.  Other patients have not had this reaction.  But Elevidys has been controversial from the start and now Critics call on Sarepta to show how it’s measuring gene therapy’s performance:

The summer has been filled with debates about the safety of Elevidys, Sarepta’s gene therapy for Duchenne muscular dystrophy. Four prominent researchers are now raising a fundamental question about its efficacy: How much gene does the gene therapy actually deliver?

In principle, the question should be settled. Since its first trial in 2017, Sarepta has taken muscle biopsies from participants and measured how much microdystrophin – a mini version of the gene broken in Duchenne – is present. (The gene has to be miniaturized to fit inside the virus that delivers it to cells.)

Sarepta has reported that patients produce 35% microdystrophin:

(This means ) their muscle cells have about a third as much of this miniature protein as healthy humans have of the full-length protein. The number was a key part of obtaining the drug’s initial accelerated approval in 2023 for 4- and 5-year-olds and its broader approval the following year.

That number could be inflated, the researchers wrote last month in a letter to Neurology. The issues they raise are technical but could warp perceptions of the therapy: Giving families an outsized sense of the treatment’s potential impact, diminishing researchers’ and funders’ interest in developing future therapies, and making it harder to choose between different treatments if therapies do become available.

“My greatest concern is that patients and their physicians do not have the information they need to assess the risk-benefit of gene therapy for Duchenne,” Kathryn Wagner, a professor emeritus at Johns Hopkins University and a co-author, wrote in an email.

What “35%” means in this context is unclear (by mass or number of molecules), but more importantly, whether this is a reasonable clinical endpoint that justifies the therapy remains unknown.  This is not unlike the question of whether an “immune response” is an adequate measure of the likely efficacy of a vaccine.  We have seen over the past several years that this is not always the case.  Gene therapy, along with stem cell therapy, will be the outright cures of many devastating diseases.  But progress in each has been slow while the hype has been fast, beginning with the completion of the human genome sequence and the first isolation of human stem cells about twenty-five years ago.  If Elevidys fails despite the hype, this will just be another example of BioMedicine (Big Medicine plus Big Pharma) losing the plot.  And then there is this:

The letter (asking about measurement of micro-dystrophin expression) is a footnote to the larger debate around a therapy that has divided researchers, regulators, and advocates for years. To many, Elevidys came to represent the best hope against a relentless and fatal disease after it seemed highly effective in a few individual patients.  But the therapy failed two randomized clinical trials, repeatedly roiled the Food and Drug Administration, and was briefly pulled off the market earlier this summer after the deaths of two teenagers. (It is now available again for younger children, after community outcry.)

As harsh as this sounds, false hope is not better than no hope.  If Elevidys works only in a few patients, so be it.  We as a society can afford it at ~$3 million per one-time course.  But the chance of failure must be admitted up front by the gene therapists and fully understood by the parents of the patients, and the patients when they are old enough to understand.

Part the Third: Global Efforts Can Succeed.  The Ozone Hole Is Steadily Shrinking because of Global Efforts.  Yes, it is!  And because we the people took action:

Forty years after global policymakers began grappling with the crisis posed by a gaping hole in Earth’s protective ozone layer over Antarctica, the damage is continuing to heal, according to a new report from the World Meteorological Organization.

In the 1980s, scientists realized that a massive hole was developing in the ozone layer over Antarctica every southern spring and then tied the observation back to earlier research that discovered that a group of chemicals called chlorofluorocarbons (CFCs) were able to eat away at atmospheric ozone.  Nations came together to develop an agreement called the Montreal Protocol on Substances That Deplete the Ozone Layer, adopted in 1987, to stop the production of these chemicals.

“The Montreal Protocol is the best environmental agreement we’ve ever created,” says Durwood Zaelke, an environmental policy expert at the University of California, Santa Barbara, and founder and president of the Institute of Governance & Sustainable Development, an organization that is focused on addressing short-lived but high-powered climate pollutants.  These include hydrofluorocarbons (HFCs), which do not harm the ozone layer and replaced many CFCs as they were phased out.  The agreement has garnered global signatories, several rounds of successful amendments and the near-total elimination of the chemicals that break down ozone.  “This is a hell of an agreement,” Zaelke says.

I seem to remember that the Merchants of Doubt went into action with dispatch in the 1980s when the cause of the ozone hole was determined (and resulted in a Nobel Prize in Chemistry in 1995): “Chloroflurocarbons, oh my!  We can’t live without them.”  The merchants did not win that time.  Bill McKibben published The End of Nature in 1989.  This was twenty years after the oil companies were doing research that demonstrated the obvious consequences of their success.  The Merchants of Doubt won that one, perhaps for good.  The problem was larger, but persistent inaction was not foreordained.  And just maybe, it still doesn’t have to be.  That, of course, would be up to us, after COP 1-29 and counting.

Part the Fourth: Do We Really Need Daylight Saving Time?  This one is marginally difficult for me.  One of the best times to play golf is very late afternoon in the long summer twilight.  The light is special, and the birds are active.  And there are no 30-somethings in golf carts blaring music through their blue tooth speakers.  But recent research indicates that if we are going to live and work on a prescribed daily schedule, perhaps we should leave the clocks alone.  I do know the farmer who ran my first independent lab was not amused when the clocks sprang forward in late March, because the change did make doing business in town difficult.  That did not change how he and his brother managed their 400-acre cattle and truck farm.  Moreover, a new study suggests that permanent standard time may reduce obesity and stroke.

A new study published on Monday in Proceedings of the National Academy of Sciences USA indicates that eliminating these repeated time shifts and keeping standard time permanently might help lower rates of obesity and stroke.

“Our work reveals that there may be greater health benefits on a population level if we switch to a permanent standard time,” says study co-author Lara Weed, a bioengineering Ph.D. candidate at Stanford University. “We hope that policymakers take a peek at [the rates of disease in] their individual states when they’re making assessments on how to incorporate the information that we provided.”

Past research has shown that switching to standard time every fall and daylight saving time every spring brings various kinds of negative consequences, including a higher risk of heart attacks and car accidents, along with disruptions to sleep, alertness and productivity. Several international scientific associations, including the American Medical Association and the American Academy of Sleep Medicine, have spoken out against time shifting, arguing that the greater morning light exposure provided by standard time could help reduce many of these problems. Few studies have examined the long-term health effects of sticking with a single time policy, however.

The projected results could be considered marginal.  But a 0.8% drop in obesity in the United States is 2.6 million people.  Novo Nordisk and Eli Lilly can do without the extra “consumers” dependent on insulin and other drugs, if they can afford them in the first place.

Part the Fifth: Forgotten Politics in America. On in the words of Matt McManus, Socialism is as American as apple pie, strange as it may sound.  It was not strange to Abraham Lincoln:

In 1861 Lincoln proclaimed that labor is “prior to, and independent of, capital. Capital is only the fruit of labor, and could never have existed if labor had not first existed. Labor is the superior of capital, and deserves much the higher consideration.”

Couldn’t have said it better myself.  Eugene V. Debs and Norman Thomas and Michael Harrington were Good Americans.  As were the mayors of Milwaukee during the first half of the twentieth century:

Perhaps the most famous example is in Red Milwaukee, which was governed by socialist mayors for decades. In 1910, Emil Seidel, a patternmaker by trade, won a landslide victory advocating for “sewer” or “municipal socialism.”  Seidel pitched his campaign as giving workers not only sewers, but living wages, recreation, clean air, and good homes.  It was a message that resonated with the public, and Seidel went on to win the big office.  He would establish the first public works department, close down brothels, and launch a city park system.  When he ran for re-election in 1912, he won more votes than in his first run, though a surprising Democratic-Republican unity ticket brought him down (not really surprising at all given current fecklessness of the Democrats).

In 1916, Milwaukeeans returned to socialism, electing Daniel Hoan mayor.  He’d hold the position for almost a quarter of a century, until 1940.  The city would then go on to elect a third iconic socialist mayor, Frank Zeidler, in 1948.  Zeidler would emulate Hoan’s long-term popularity, and was re-elected two more times between 1948 and 1960.  “Sewer socialists” were municipal planners at heart, building on their philosophy that cooperation, rather than strict competition, would benefit everyone in the city.  Their popularity owed much to a combination of strong support for workers’ movements and unions, expansive public works projects like city parks, and a deep dedication to caring for the least well off, not least African Americans.  Zeidler drew a lot of fire advocating for desegregation and putting up billboards across the south encouraging sharecroppers to head north for plush jobs in Milwaukee.

And this takedown of Mark Levin is funny to anyone with a sense of humor, I don’t care who you are:

Contra the Right’s “cultural Marxism” (Where in the world is Jordan Peterson these days? Rhetorical question, but perhaps talking to a lobster to get a better handle on his place in the hierarchy) conspiracy theorists…American socialism isn’t some foreign disease spread by the “Franklin School of Critical Theory,” as the Fox News shouter Mark Levin amusingly called the Frankfurt School in one of his books (repeatedly, so you know it wasn’t a typo).  Indeed, American socialism has been around for nearly two centuries.  Its sympathizers and proponents have included Walt Whitman, Helen Keller, Martin Luther King Jr., Jack London, Upton Sinclair, and more.  American socialism has defenders because it addresses real and longstanding dissatisfaction with oligarchy, imperial aggression, racialized social conflict and oppression, and the tyranny of private government in the workplace.

We could add antisocial media and surveillance capitalism to the list.  Society does better when everyone does better.  Period.  This is not a difficult concept.  And to repeat myself, again, the rich will still be rich when everyone else has good jobs at good wages with the prospect of a dignified retirement, good schools for their children, leisure to use the city parks established by Emil Seidel of Milwaukee and everywhere else, a decent place to live in perpetuity, and healthcare that is a right instead of a crapified crapshoot.  But everyone else would also be in a position to channel their inner Johnny Paycheck.  But that would portend the end of the Neoliberal Dispensation.  And to paraphrase the late Mark Fisher and Fredric Jameson, “It remains easier to imagine the end of the world than the end of neoliberal late capitalism.”

All we need to do is stop with the “all-war-all-the-time against imaginary monsters in need of destruction,” at home and abroad, wherever you live.  War is not the health of the state or anything else, other than the Military Industrial Complex and their political minions:

“Every gun that is made, every warship launched, every rocket fired signifies, in the final sense, a theft from those who hunger and are not fed, those who are cold and are not clothed.  This world in arms is not spending money alone.  It is spending the sweat of its laborers, the genius of its scientists, the hopes of its children.  The cost of one modern heavy bomber is this: a modern brick school in more than 30 cities.  It is two electric power plants, each serving a town of 60,000 population.  It is two fine, fully equipped hospitals.  It is some 50 miles of concrete highway.  We pay for a single fighter plane with a half million bushels of wheat.  We pay for a single destroyer with new homes that could have housed more than 8,000 people.  This, I repeat, is the best way of life to be found on the road the world has been taking.  This is not a way of life at all, in any true sense.  Under the cloud of threatening war, it is humanity hanging from a cross of iron.”

President Dwight David Eisenhower, 16 April 1953

See you next week!