Author Archives: jpwmd

Prevagen is an over-the-counter supplement that purports to preserve, and even improve brain function.  As I was recently subjected to yet another slick ad for this drug, I wondered about the role of direct-to-the-consumer advertising (DTCA).

Background

The federal government started to regulate drugs in 1906, and the current responsible agency is the US Food and Drug Administration (FDA).  Marketing drugs was traditionally aimed at physicians only, as it was thought their training best put them in a position of evaluating the safe use of drugs.  They were the intermediaries between the industry and patients.  Requiring prescriptions written by physicians was a way to ensure this policy.

In the early 1980s, some companies began to advertise drugs directly to consumers.  This practice was controversial from the top.  Proponents felt it empowered patients and was an appropriate and highly valued source of information.  Physicians feared that DTCA would actually result in harm to patients.  Even much of the industry was circumspect.  One pharmaceutical executive wrote that it would hurt physician/patient relations, confuse an unsophisticated public, and mislead consumers into buying costly and unnecessary drugs.

Nevertheless, the practice took off.  Advertising to the lay public, especially on television, increased industry revenue dramatically. The industry soon surrendered concerns about the safety of DTCA, and poured resources into ads directed at the public.  Spending of DTCA, most of which was for TV and digital marketing, went from $55 million in 1991 (all figures normalized for today’s dollar) to $363 million in 1995.  By 1998, the figure was $664 million.  Today, marketing experts estimate drug companies spend $10 billion on marketing their products, the majority of which is DTCA.  Use of pharmaceuticals increased accordingly, and drugs now count for 11% of the overall healthcare expenditure in the US.

Back to Prevagen

The active ingredient of Prevagen is a protein derived from jellyfish.  The idea is that, upon ingestion, the protein goes to the brain and improves cognitive function.  However, the protein is broken down in the gut and never reaches the brain.

The sole study that supports the efficacy of Prevagen was produced by Quincy Bioscience, the company that manufactures the drug.  The scientific community has derided the quality of the study.  Recognizing the difficulty of getting approval of the drug by the FDA, Quincy markets Prevagen as an over-the-counter “supplement,” rather than a prescription pharmaceutical, allowing for far less regulatory scrutiny.  Marketing experts estimate that the company spends in excess of $100 million per year touting the drug, almost all in television and digital ads.  The company does not make sales data available to the public.

The state of New York and the Federal Trade Commission (FTC) sued Quincy for false advertising in 2007.  The suit was concluded successfully in 2004, with the jury finding that, as a clinically proven memory supplement, the claims of improved brain function were not credible, and were materially misleading.  As a result, the company was prohibited from asserting that Prevagen improves memory or cognitive function, with the court forcing Quincy to drop the phrase “memory improvement” in favor of “brain support.”  

Is DTCA a Good Thing?

Forget the legal intricacies and the huge dollars involved.  Does DTCA, as the pharmaceutical industry claims, result in better health outcomes for the American consumer of health services.

Physicians hate the practice.  They feel that valuable time in the patient/physician interaction is lost, when they need to explain why a heavily advertised drug is not appropriate for a patient’s specific condition.  If patients are in a prepaid plan (HMO), they may become suspicious that gainsaying doctors are merely trying to save money.

The pharmaceutical executive quoted above sums up the general case against DTCA.

Big Pharma, however, believes patients are now more knowledgeable and can take more responsibility for their health care decisions.

Whether DTCA is beneficial is a complex issue, one that is far beyond the scope of this blog entry.  One thing is crystal clear, however, and that is that marketing directly to consumers is a decided economic benefit to the industry. 

The National Library of Medicine, however, did a rigorous study of the marketing and use of Prevagen and concluded that the effect on overall health is a net negative.

One Last Thought

The Federal Trade Commission’s mission is to protect consumers from deceptive or unfair business practices.  Maybe the FTC deserves some credit for the lawsuit mentioned above, but, to me, the ads are still mendacious and exploitative.  The FTC clearly has not gone far enough–just look at the commercials for Prevagen. 

It is time for an installment of my recurring screed about the detection and treatment of high blood pressure in the United States.  The spark for this piece is the recently publicized new guidelines for treatment of this important, but largely silent, medical problem.

Hypertension, the medical term for high blood pressure, characterizes the excess pressure of blood pushing against the walls of the arteries, either from excess fluid in the vessels and/or from constriction of the vessels.  Picture a garden hose: pressure in the hose increases with a greater flow of water or decreases with a larger diameter of the implement.

Respected medical bodies, including the American Heart Association and the American College of Cardiology, have now defined high blood pressure as any reading greater than 120/80. The top number (the systolic number) reflects the blood pressure when the cuff tightens the arm, and the lower number (the diastolic reading) shows the pressure in the vessel when the cuff deflates.

A few years ago, a normal blood pressure was defined as anything in excess of 140/90.  Some of the best research in clinical medicine, however, showed that this number carried the risk of higher mortality due to stroke and heart disease, such as coronary artery disease, heart failure, and atrial fibrillation.  And that treating this or a higher number resulted in a dramatic decrease in cardiovascular disease.

Treatment

Effective treatment begins with lifestyle changes–achievement of ideal weight, exercise, dietary discretion, reduction of alcohol ingestion, cessation of smoking and management of stress.  If, after three to six months into the diagnosis, the pressure is not controlled, pharmacological intervention is indicated.  A plethora of safe, effective drugs are available.  They have few side effects and are inexpensive.

Hypertension in the United States

Half of US adults have hypertension, of which 60 percent are aware of their condition.  Only half of the 60 percent receive treatment and about 20 percent achieve adequate control of blood pressure.  Almost 800,00 people percent per year suffer a stroke, and hypertension is responsible for half of all cases.  It is also implicated in about 50 percent of all cardiovascular deaths.  After diabetes, hypertension is the leading cause of kidney failure.

The Screed

Our healthcare system has lopsided priorities.  We can get prosthetic joints, expensive treatment for hopelessly ill patients with terminal cancer, and organ transplants–all at wondrous expense.  But we allow a highly treatable disease, hypertension, to go undetected and undertreated in millions of people, resulting in millions of unnecessary cardiovascular deaths.  

The neglect is partially due, I think, to our society’s infatuation with technology.  We see this in reimbursement policies for doctors–proceduralists earn 50 percent more money than “cognitive” doctors.  The latter, primary care doctors, are the medical professionals who do the day-to-day work of treating hypertension–at a huge discount compared to doctors who do the colonoscopies, heart catheterizations, joint replacements, etc.  

This situation reflects society wide values.  People circling the moon rivets the attention of the nation, while social problems that are not amenable to technological interventions go unaddressed.  It is no surprise.  As amazing as moon shots are, they are actually easier to accomplish than fixing daunting social problems.

Primary care physicians (internists, family doctors) are the only doctors who reliably measure blood pressure in office visits.  Think about your visits to orthopedic surgeons, dermatologists, ophthalmologists, etc.  Do they measure your blood pressure?  Probably not–research shows that only a small minority do.

Could we incentivize them to check BPs?  Sure.  Simply interdict reimbursement unless the medical record shows a blood pressure measurement.  And maybe BP could be checked in dental offices.

Robert F. Kennedy, Jr., the Secretary of Health and Human Services, has sweeping ambitions that range from major change in vaccination policy to reducing childhood obesity to eliminating lead in our drinking water.  As far as I know, though, he has not specifically prioritized the detection and treatment of hypertension.  The lack of attention to untreated hypertension in the US, with the attendant unnecessary disease burden, is scandalous.  This is low hanging fruit, and public health could be vastly improved with simple and inexpensive interventions.  

Ordinary citizens can play a life saving role in medical emergencies that occur outside of a medical setting.  The Heimlich maneuver is a prime example.

The Heimlich Maneuver

The occasion for this intervention arises when the airway of an individual becomes blocked from a foreign body such as a poorly chewed piece of meat.  The victim displays extreme distress without being able to speak, as no air can flow through the vocal cords.  The would-be rescuer positions himself or herself behind the afflicted individual, puts one fist in the palm of the other, places the hands in the upper abdomen below the rib cage, and applies upwards abdominal thrusts.  When effective, the action compresses the lungs, producing air pressure that dislodges the offending foreign body.  The breathing is restored instantaneously.

One study showed a 46.6 percent success rate for abdominal thrusts in patients with “foreign body airways obstruction.”  The success group had a lower proportion of impaired consciousness and cardiopulmonary arrest than the failure group.

Bystander Cardiopulmonary Resuscitation (CPR)

About 350,000 people in the US suffer a cardiac arrest outside of a medical care setting per year.  Cardiac arrest means that the heart suddenly stops beating altogether.  According to a study presented at an American Heart Association’s Resuscitation Science Symposium, compared to receiving no bystander CPR, those who got CPR within two minutes of the arrest had an 81% chance of survival.  Even intervention up to 10 minutes can be successful, but every second counts positively for a good outcome.

In-hospital success rates are about 15 percent, as defined by successful discharge of the patient.  I find the difference between the success rates of out-of-hospital and in-hospital resuscitations hard to believe.  I suspect that out-of-hospital “success” rates are inflated by the fact many victims did not truly suffer cardiac arrests–more likely a common faint.

Automatic External Defibrillators

These devices are designed to deliver an electrical shock to the chest of a victim of a cardiac arrest from a malignant heart rhythm (e.g., ventricular fibrillation, which finds the heart beating wildly and ineffectively).  The would-be rescuer activates the AED, which gives clear instructions on its use (detailed information is available at redcross.org).  This does not work in asystole (when the heart stops beating altogether), but, when application of the shock is successful, the heart beat returns to normal.  

One study concluded that public AEDs are a cost-effective public health intervention in the United States, given that the AED strategy yielded one “QALY” (Quality-Adjusted Life Year–a year gained in good health from a specific intervention) for an investment of $53,797.  This paper was thin on details, however–it did not specify the location of the AEDs analyzed.  For instance, placing an AED in a gym on senior day would yield a much different analysis than placing one, say, in a high school class.

Another study looked specifically at the cost-effectiveness of home placement of AEDs.  Surveying 582, 536 patients over the course of seven years, investigators found that survival after an arrest was better with AED application compared with no AED application.  However, the cost to gain one QALY was $4, 481, 659. Researchers concluded that, if the overall expenditure for one QALY was less than $200,000, and if the incidence of cardiac arrest per person is greater than 1.3 percent per year, and the cost for each device is less than $65, placement of AEDs in home would be a reasonable and cost-effective intervention.  Each AED cost between $1,200 and $2,500.  Seems like we are a long way from a policy to place AEDs in every home.

Regardless, If the AED is available in an emergency, you don’t need to trouble yourself about the cost.  Use it!  It won’t hurt the patient and you may save a life.

Like all sentient people in the US, I have noted the staggering  increase in healthcare costs.  

Compared to 1970, when national expenditures on healthcare (in 2023 constant dollars) were $450 billion, the US spent $4.87 trillion in 2023.  This represents about 17.6 percent of the Gross Domestic Product (GDP), and is projected to be 20 percent in 2033.  The per capita cost of healthcare in 2023 was $14,570, while most western European nations spend less than half of what the US spends (with universal coverage and better medical outcomes) .  

Who Pays?

Private insurance accounts for 30 percent of the revenue for healthcare, while Medicare and Medicaid are at 21 percent and 18%, respectively.  Out-of-pocket expenses constitute 10 percent of the total amount.  State and local government, and private revenues, provide the balance of the bill.  Or course, the real payers are the American people.

And there is the “time lost” cost.  This refers to the time patients put in trying to penetrate what health insurance plans best fit their needs.  It refers to time spent on holds, time spent jousting with insurance plans about coverage, and many more periods of waiting.    This “in-kind” contribution that Americans make to the health system is incalculable.

Where Does It Go?

Hospitals get 31 percent of the revenue, while the physician component is about 20 percent (this includes services provided in offices, clinics, etc.).  About 9 percent goes to the pharmaceutical industry for prescription drugs.  Other cost centers such as nursing homes, home healthcare, dental care, physical and occupational therapy, etc. account for no more than 5 percent each.

If you are looking for a demographic that fuels the constant increase in cost, look no further than the aging population.  The oldest 10 percent of the population are responsible for 52 percent of medical spending in any given year.

Obamacare and Skyrocketing Expenses

Two things about the healthcare expenses over time catch my attention.  One is the steadiness of the increase since 1970.  

With the understandable exception of the Covid years, the national health care bill has increased about five percent yearly.  (from 2020 to 2022, the increase approached 10 percent).  

Obamacare was passed in 2010 and fully implemented in 2014.  In 2010, 48.6 million Americans had no health insurance.  This dropped to 36 million in 2014 and in 2024 the number of Americans not covered by health insurance was 27.1 million.  The percentage of the US population that was medically uninsured was 16 percent in 2010; today, it is 7.7 percent.  The total percentage of covered Americans is now 92.4 percent (In western Europe, it is 99.8 percent).

Obamacare is often blamed for the high cost of healthcare.  However, the incremental increase in healthcare costs over time is roughly 5 percent every year (again, except for the Covid years), with no discernable impact of Obamacare.  In other words, the inexorable increase in national healthcare expenditure was not different with the institution of healthcare insurance under Obamacare.  So, even though about 20 million more Americans now have health insurance than before, there is no bigger change in the yearly increase in cost than would have been predicted without the implementation of Obamacare.

This is hard to understand, but could it  be true?  There are factors that could make savings believable.  Preventive care,  previously inaccessible to the uninsured, may result in averting large ticket items that come with the lack of prevention.  Importantly, Emergency Room visits could be down as newly insured people can go to their doctors rather than make ultra-expensive visits to the Emergency Room.  Even if there is a bump in costs, the case could be made that insuring tens of millions more people is well worth it.

Medicare is often cited as one of the great successes of government programs.  If my analysis is correct, Obamacare is right there.  My calculations are admittedly back-of-the-envelope, so  I genuinely would like to read a challenge to my reasoning.

Bump outs (aka curb extensions and neckdowns)

One of the increasingly popular methods for “traffic calming” is the “bump out.”  This is a short extension of a curb that balloons into the street at an intersection.  A motorist approaching an intersection will therefore experience a narrowing of the traffic lanes.

These devices have several factors that might improve pedestrian safety.  They reduce the amount of time that a pedestrian is at risk from traffic while crossing a street, because the distance to cross the street at the intersection is shorter.  Cars executing turns, particularly right turns, go slower by an average of 2.6 mph.  And visibility for both walkers and motorists is improved.

Pedestrian Activated Blinking Signals

Another pedestrian safety device is the “Pedestrian Activated Flashing Signal” (PAFS).  These are placed on busy streets where walkers cross without the benefit of traffic signals or stop signs.  The pedestrian activates the signal, which is a rectangular structure that alternates between two flashing yellow lights.  This alerts drivers to slow down and yield to pedestrians.

The PAFS result in a 67 percent automobile “yield rate,” which is two percentage points better than marked crosswalks that do not have the flashing signals.  

Distracted Driving

Distracted driving is defined as any activity that compromises attention to the road.  This includes eating and drinking, adjustment of sound systems, talking, and, most prominently, cell phone usage–especially texting.

In 2023, in-car cell phone use contributed to 1.6 million automobile crashes, with 3,275 deaths and 327,819 injuries.  These statistics are likely understated, as drivers are reluctant to admit to using a cell phone while driving.

Cell Phones and Pedestrians

Distracted walking involves using cell phones to talk, listen to music, text, etc. while walking.  Pedestrians using cell phones are 46 percent more likely to be involved in a crash with a vehicle.  Distracted walking was a factor in 2,500 pedestrian deaths in 2021.

Seat Belts 

Seat belt (which includes shoulder straps) usage in the US was 91.2 percent in 2024.* This is estimated to save about 15,000 lives per year.  49 percent of passenger vehicle occupants killed in 2023 were unrestrained. 

Speed Bumps

Speed bumps reduce automobile speeds by 10 to 15 mph.  They reduce the number of high speed drivers from 14 to 1 percent, and result in a significant reduction in child pedestrian injuries.

Blind Spot Monitor Systems

Modern cars have signals in their outside rear view mirrors that  warn drivers a car is in the driver’s blind spot.  These have reduced lane change accidents by up to 23 percent.

Speed Limits

Speed limits are normally regulated by states, but in 1974 President Nixon signed into law a national speed limit of 55 mph.  This was a response to high oil prices, and the regulation ended in 1995.

This law reduced the nation’s consumption of oil, but it also had a huge effect on highway mortality.  In 1972, there were 56,278 traffic deaths nationally (26.9 deaths per 100,000 people).  In 1993, 41,893 died in traffic accidents (16.3 deaths per 100,000).

Interestingly, traffic death rates have continued to fall over the last two decades, despite the loosening of speed limits.  In 2023, there were 13.4 deaths per 100,00 people, despite a significant increase in population and drivers.  This is undoubtedly due to ever safer cars, and one wonders what the effect of lower speed limits would have on this figure. 

Effectiveness

The deployment of most of these traffic safety devices makes sense, but are they effective?  Some of the interventions seem to be wishful thinking.  There are many computer simulations that show reductions of pedestrian accidents with, say, pedestrian activated blinking systems, but there are no data based on real world observations.  Given the rather low compliance rate with PAFS, I have often wondered whether these signals might actually be a hazard to walkers, as unwitting pedestrians may erroneously rely on the signal at peril to their safety.  And the improvement in yield rates with PAFS is marginal at best.

Some interventions for safety are just plain obtuse.  In Illinois, for instance, the use of hand held cell phones by drivers has been proscribed (with minimal enforcement, by the way).  Researchers agree, however, that the safety threat is not in the manual manipulation of the phone, but rather in the distraction born of conversations.

There is, however, no disputing the effectiveness of reducing speed limits and using seat belts.  These are the power interventions for automobile safety.  Americans use seat belts in high percentages, but we have eschewed lowering speed limits in the name of speedier travel.

*Air bags are not a substitute for seatbelts; they are a supplement and are not to be used independent of seat belts.

Medicaid

Medicaid is a government program designed to help low income people pay for medical care.  It is jointly funded by the states and the federal government.  

Congress has passed a bill (“One Big Beautiful Bill”–OBBB) that will reduce federal Medicaid funding by 15 percent over the next decade.*  This will raise premiums to the extent that 11.8 million Americans will lose healthcare coverage, and this figure will rise to 17 million by 2034.  Analysts from Yale and the University of Pennsylvania estimate that about 50,000 preventable deaths will occur annually.  Rural areas, with a disproportionate rate of poverty will be hit hardest, and safety net hospitals (those serving predominantly low income populations) will inevitably have to close.

If states are unable to backfill the federal cuts, the numbers will be higher.

Hepatitis B Vaccine

Hepatitis is an inflammation of the liver with many causes, with the Hepatitis B virus one of the prominent culprits.  Infection with this virus, often a subclinical one (i.e., one that is inapparent clinically) can result in chronic liver disease, cirrhosis (irreversible scarring of the liver), liver failure, liver cancer, and death.

A vaccine against the Hepatitis B virus was developed in the early 1980s.  In 1991, administration of the vaccine became part of the routine vaccination regimen for children.  In 1985, 26,654 cases of acute Hep B virus infection in children per year were reported.   Today, the number of children infected with the virus in the US is less than 400 per year, almost all of them in children not vaccinated against the disease.  Mortality from the virus has been halved.

The newly constituted Advisory Committee on Immunization Practices (ACIP, which advises the CDC on vaccination policy) recently delayed a decision on changing recommendations for administration of the Hepatitis B vaccine, citing the need for more data.  

Here are some data:  If given at birth, the vaccine reduces the risk of Hepatitis B by 98%, cancer by 84 percent and death from liver disease by 70 percent. The longer the interval from birth to the first administration of the vaccine, even if it is a matter of months,  the worse the long term outcomes.

President Trump recently recommended, with his Health and Human Services secretary looking on, that the vaccination against  Hepatitis B be delayed until the age of 12. 

Tylenol and Autism

Twenty percent of pregnant women experience fever during pregnancy.  Especially if the fever is 102 degrees or greater, the risks for the fetus are important.  These include premature births, developmental anomalies such as heart disease, and neurodevelopmental problems such as spina bifida.  

Fevers from any cause should be brought down quickly.  Tylenol is the medication of choice and reduces the odds of bad pregnancy outcomes dramatically.  

Does Tylenol cause autism?  Some research has found an association between pregnant women taking Tylenol and the eventual risk of autism in the fetus.  Critics of these studies point out that they failed to take into account confounding variables (inapparent factors that make conclusions unreliable) such as genetics.** 

On the other hand, repeated studies, which include millions of observations of pregnancies, conclude that Tylenol is safe in pregnancy.  Sweden maintains a health registry which is second to none.  Using this source, American researchers examined the medical records of 2.5 million Swedish children, followed them for an average of 20 years, and concluded that the use of Tylenol by pregnant women is safe.  A study from Japan followed 200,000 children and reached the same conclusion.

Authoritative bodies that accept the conclusions of this research, include The American Academy of Pediatrics, The Society for Maternal-Fetal Medicine, and The American College of Obstetrics and Gynecology.  

Nevertheless, our president, with the health secretary at his side, has exhorted pregnant women not to take Tylenol during pregnancy under any circumstances.  Pregnant women who follow this advice risk a plethora of fetal abnormalities if they refrain from taking Tylenol when they have a fever or severe pain.  Another adverse effect in women who take the president’s position seriously is the guilt and anxiety that may attend Tylenol using women who have autistic children.

Even physicians who think Tylenol is safe in pregnancy caution against injudicious use of the drug by pregnant women.  As with all interventions in medicine, a cost/benefit analysis is paramount.  The data overwhelmingly favor responsible use of Tylenol in pregnancy for fevers and severe pain.

The non-nuanced advice of two non–physicians is inappropriate–and wrong.

*The OBBB will raise the national debt by three trillion dollars over the next decade. 

**Genetic factors play a significant role in the development of

Medicaid

Medicaid is a government program designed to help low income people pay for medical care.  It is jointly funded by the states and the federal government.  

Congress has passed a bill (“One Big Beautiful Bill”–OBBB) that will reduce federal Medicaid funding by 15 percent over the next decade.*  This will raise premiums to the extent that 11.8 million Americans will lose healthcare coverage, and this figure will rise to 17 million by 2034.  Analysts from Yale and the University of Pennsylvania estimate that about 50,000 preventable deaths will occur annually.  Rural areas, with a disproportionate rate of poverty will be hit hardest, and safety net hospitals (those serving predominantly low income populations) will inevitably have to close.

If states are unable to backfill the federal cuts, the numbers will be higher.

Hepatitis B Vaccine

Hepatitis is an inflammation of the liver with many causes, with the Hepatitis B virus one of the prominent culprits.  Infection with this virus, often a subclinical one (i.e., one that is inapparent clinically) can result in chronic liver disease, cirrhosis (irreversible scarring of the liver), liver failure, liver cancer, and death.

A vaccine against the Hepatitis B virus was developed in the early 1980s.  In 1991, administration of the vaccine became part of the routine vaccination regimen for children.  In 1985, 26,654 cases of acute Hep B virus infection in children per year were reported.   Today, the number of children infected with the virus in the US is less than 400 per year, almost all of them in children not vaccinated against the disease.  Mortality from the virus has been halved.

The newly constituted Advisory Committee on Immunization Practices (ACIP, which advises the CDC on vaccination policy) recently delayed a decision on changing recommendations for administration of the Hepatitis B vaccine, citing the need for more data.  

Here are some data:  If given at birth, the vaccine reduces the risk of Hepatitis B by 98%, cancer by 84 percent and death from liver disease by 70 percent. The longer the interval from birth to the first administration of the vaccine, even if it is a matter of months,  the worse the long term outcomes.

President Trump recently recommended, with his Health and Human Services secretary looking on, that the vaccination against  Hepatitis B be delayed until the age of 12. 

Tylenol and Autism

Twenty percent of pregnant women experience fever during pregnancy.  Especially if the fever is 102 degrees or greater, the risks for the fetus are important.  These include premature births, developmental anomalies such as heart disease, and neurodevelopmental problems such as spina bifida.  

Fevers from any cause should be brought down quickly.  Tylenol is the medication of choice and reduces the odds of bad pregnancy outcomes dramatically.  

Does Tylenol cause autism?  Some research has found an association between pregnant women taking Tylenol and the eventual risk of autism in the fetus.  Critics of these studies point out that they failed to take into account confounding variables (inapparent factors that make conclusions unreliable) such as genetics.** 

On the other hand, repeated studies, which include millions of observations of pregnancies, conclude that Tylenol is safe in pregnancy.  Sweden maintains a health registry which is second to none.  Using this source, American researchers examined the medical records of 2.5 million Swedish children, followed them for an average of 20 years, and concluded that the use of Tylenol by pregnant women is safe.  A study from Japan followed 200,000 children and reached the same conclusion.

Authoritative bodies that accept the conclusions of this research, include The American Academy of Pediatrics, The Society for Maternal-Fetal Medicine, and The American College of Obstetrics and Gynecology.  

Nevertheless, our president, with the health secretary at his side, has exhorted pregnant women not to take Tylenol during pregnancy under any circumstances.  Pregnant women who follow this advice risk a plethora of fetal abnormalities if they refrain from taking Tylenol when they have a fever or severe pain.  Another adverse effect in women who take the president’s position seriously is the guilt and anxiety that may attend Tylenol using women who have autistic children.

Even physicians who think Tylenol is safe in pregnancy caution against injudicious use of the drug by pregnant women.  As with all interventions in medicine, a cost/benefit analysis is paramount.  The data overwhelmingly favor responsible use of Tylenol in pregnancy for fevers and severe pain.

The non-nuanced advice of two non–physicians is inappropriate–and wrong.

*The OBBB will raise the national debt by three trillion dollars over the next decade. 

**Genetic factors play a significant role in the development of autism.

For centuries what we now know as neurosyphilis was treated like any other severe psychiatric disorder.  The unfortunate victims were institutionalized, often in reprehensible conditions.  No specific therapy was available, and the disease ravaged Europe for centuries.

A biological cause for the disease, a bacterium called Treponema pallidum, was discovered in 1905.  Eventually, penicillin was found to be a curative treatment and is still the first line of treatment for syphilis today. 

A Cautionary Story 

The syphilis story humbles thoughtful physicians.  How many other cryptogenic (something of unknown origin) diseases do we commonly deal with, only to eventually discover organic causation that has specific, highly effective interventions?  Chronic Fatigue Syndrome (CFS ) comes to mind.  This is a debilitating disease that, provocatively, frequently follows a viral infection.  Afflicted patients are often thought to have pure psychiatric problems, but scientists have worked very hard to find an organic cause.

Peptic Ulcer Disease

If a causative organism for CFS is found, this would be far from the first time that the understanding of a disease process has changed.  Peptic Ulcer Disease (PUD) is another condition that seems to have been around for millennia.  It is characterized by chronic, intermittent abdominal pain, sometimes with severe complications such as bleeding from the stomach.  Emphasis on gastric acid as the culprit has traditionally conditioned treatments aimed at neutralizing acid or blocking its production.  Even with these modern interventions, severe complications still occur.

Along comes the paradigm shift.  Traditionally, PUD was attributed to lifestyle factors like diet and stress.  In 1982, however, the bacterium Helicobacter pylori was found to be present in the stomach lining of most people with PUD.  The presence of acid is still an important therapeutic target, but treating the infection with a two week course of antibiotics cures the disease in most cases.  This has correlated with a decrease in the incidence of upper GI bleeding by 23 percent.

Another Surprise… Maybe

In the context of the above, an article in the July 29, 2025 issue of The New Yorker was arresting.  It details the story of a woman who suffered a psychotic break in her twenties.  She received the conventional therapy of anti-psychotic drugs, counselling, and frequent intermittent institutionalization.  Her diagnosis was schizophrenia and she had a typically rocky and miserable course over 20 years.  Until she got better.

Three percent of adults in the US experience a “single psychotic episode” once in their lives.  It is characterized by hallucinations, delusions, disorganized thought processes, and strange behavior in general.  This disorder typically lasts a short time (two to four weeks), resolves on its own, and never recurs.

Mary, the subject of the New Yorker piece, was not so lucky.  She was sick for about two decades, until, in one of her frequent hospitalizations, she was found to have a lymphoma, a sometimes fatal form of cancer.  She was treated with chemotherapy and rituximab, a medication that attacks antibodies involved in the body’s immune responses.  Within two months, she began to be more social, displaying interests that she had forsaken for years.  When she completed the therapy for her lymphoma, she was psychologically and cognitively normal.  

Mary’s family was wary, but the improvement endured.  One of her daughters searched the medical literature and found that Mary was not alone in her improvement from psychosis after her treatment for lymphoma.  There were many such case reports, and the common denominator was the immune modifier, rituximab.

She also discovered researchers who specialized in the study of mental illnesses that have been relegated to the “functional” category,  That is, illnesses for which there is no known cause.  Neurosyphilis is the object lesson. 

Some researchers have found antibodies that can be linked to psychiatric symptoms, suggesting that schizophrenia, or some forms of it, is an autoimmune disease (this occurs when the body makes antibodies against its own tissues, such as in lupus).  One prominent medical scientist has proposed a new category of mental illness called “autoimmune psychosis.”  

Studies to identify patients who might benefit from immune modulation are ongoing.  Even if this is a small subset of patients  with what we call “schizophrenia,” the benefit for millions would be incalculable.

Medical Science

Much work is to be done before it is clear that autoimmune psychosis even exists and that specific therapies are safe and beneficial.  Medical science, and science in general, works deliberatively, testing hypotheses, rejecting hypotheses, and going on to new ideas.  But serendipity often plays a big role in the  advancement of science.  This was true Mary’s case, and there is nothing wrong with this.

As one very wise individual once said: Chance favors the prepared mind.

In a blog entry post dated May 23, 2022 (The Medical Beat: medicalbeat.net), I documented the disparity between incomes of primary care physicians and procedure oriented specialists.  On average, the net incomes of primary care physicians are 69% of specialists’ net incomes.  How did our nation’s customs regarding such a skewed reimbursement policy come about?  I don’t know, but I know how the gap is perpetuated.

The Relative Value Scale Update Committee (RUC), created by Congress in 1986, is a body of the AMA (American Medical Association) whose members are supposed to be representative of the various specialties of medicine.  Medicare makes the final reimbursement recommendations for Medicare reimbursement rates for physicians, but the committee’s recommendations on reimbursement is virtually definitive.  

Although Primary Care doctors constitute a little over 40% of the practicing physician population, they represent only 16% of the voting members of the RUC.  “Rigged” would be an appropriate term for the composition of this committee that is supposedly representative of the medical community.

Training Choices That American Medical Graduate Make

Graduating medical students are aware of the income gap.  Their choices for residency training programs correlate with the high incomes associated with the specialties.  

Implications for the Quality of Healthcare in the United States

So the pipeline for training primary care doctors is in jeopardy. Does this matter?  

A raft of research illustrates the problem with the de facto deemphasis on primary care.  Doctors in primary care specialties do patient centered work, not organ centered work.  They provide integrated healthcare for a large majority of healthcare needs and foster a sustained partnership with patients, all while managing multiple medical conditions. They consult specialists as necessary, coordinating care in what is often a labyrinth of care options.  Studies show this results in a decreased annual number of visits to specialty providers, with less frequent hospitalizations, fewer diagnostic tests, and overall reduced total medical charges. A strong primary care presence helps prevent illness and death, and that it is associated with a more equitable distribution of healthcare in populations. 

The current payment system favors high cost procedures over time spent on evaluation or management of care.  Neurosurgeons are at the top of physician earners at an average yearly net income in 2021 of $471,000, while primary care doctors (Family Medicine, Pediatrics, Internal Medicine) average $233,000.

Remedies

First, let me acknowledge that specialists do good and important work.  My brief is that the imbalance in reimbursement is unfair and bad for healthcare in general.  But fixes to the scandalously imbalanced system are unlikely.  I have shown that the influential body that basically determines parameters for physician reimbursement is heavily stacked against primary care.  And the amount spent on federal lobbying for subspecialty care outnumbers primary care by an almost three to one ratio.  Relying on a feckless Congress for significant reform is quixotic.

Nevertheless, the issue that finds primary doctors to be compensated at a rate one third less than that of proceduralists’ compensations, has an easy theoretical fix…close the gap.  There are other issues besides money: the practice of primary care is more challenging–more paperwork and administrative burden, more off hour responsibilities, less perceived prestige.  But a policy that closes the gap in net incomes is surely the first step.

Robert F Kennedy, Jr., the US Secretary for Health and Human Services, has acknowledged the problem by promulgating regulations for review that would narrow the gap between compensation for primary care doctors and subspecialists, most of whom perform expensive procedures.  I don’t know where this initiative is going, but I predict that RFK will run into a buzzsaw operated by subspecialists.

A “Simple” Fix 

Raising primary care reimbursement is conceptually easy.  However, no one in this economy is looking to increase the nation’s healthcare bill.  And how much to increase primary care physician services?  Increase reimbursement to the point that primary doctors earn 80% of specialists’ incomes?  90%?  Equal?  Given the importance of primary care, maybe even more.

I don’t know what level of increased relative reimbursement for primary doctors would get the job done.  I propose an organic process:  freeze reimbursement for procedures that will close the gap until medical students start choosing primary care training in numbers that will populate primary care training programs to the point of what healthcare experts believe is an optimal ratio of primary care doctors to specialists.  This could take awhile, but the beginning of the fix could start tomorrow.

I touched on vaccine issues in previous blog entries (Jan 14, 2023; Jan 25, 2023, Jan 29, 2024) in the Medical Beat.  But I am unable to resist passing on information on vaccines published in the June, 2025 issue of the Annals of Internal Medicine.

For children born between 1994 and 2003, routine childhood vaccinations against common diseases (MMR, pertussis, hepatitis, influenza, tetanus, COVID, RSV,etc.) prevented more than 500 million illnesses, 30 million hospitalizations, and 1 million deaths.  The direct savings cost was more than $500 billion.

Worldwide, epidemiologists have found that vaccines prevent up to 5 million deaths per year.  This results in a life saved every six minutes.

Pushback

In 2001, 94% of Americans thought childhood vaccinations were important.  The current figure is 69%.  

A fraudulent British researcher helped fuel the anti-vax movement when he published a discredited article in a respected British medical journal in 1998 alleging that vaccines caused autism.  The misinformation has snowballed to the point that the Secretary of Health and Human Services, Robert F Kennedy, Jr., is a prominent vaccine doubter.  He has started and chaired an anti-vax organization and said in 2023 there is no such thing as a safe and effective vaccine.  He has issued a tepid endorsement for the measles vaccine that started in Texas and is spreading across the great plains.

This year, he fired the entire Advisory Committee on Immunization Practices (ACIP), an arm of the Center for Diseases Control and Prevention, replacing the members with at least two anti-vaxxers.

Where to Turn?

People have asked me where will they now get reliable information about vaccines.  There are plenty of professional associations who have provided, and will provide, authoritative recommendations, and universities with strong public health programs are also good sources for scientific-based data. 

Acquiring good information on immunizations, however, may not be the biggest challenge. Heretofore, the recommendations of the ACIP have conditioned insurance coverage for vaccines.  It is anyone’s guess what will happen when the newly constituted committee comes out against a particular vaccine.

A Bit of History

Our founding fathers recognized the benefit of immunization.  Thomas Jerrerson had himself inoculated against smallpox, as did Geroge Washington.  In fact, Washington ordered his entire Continental army to be vaccinated against smallpox.

Ben Franklin failed to get the immunization procedure for his children, and he paid the price.  He wrote:

In 1736 I lost one of my sons, a fine boy of four years old, by the smallpox taken in the common way.  I long regretted bitterly and still regret that I had not given it to him by inoculation.  This I mention for the sake of the parents who omit that operation, on the supposition that they should never forgive themselves if a child died under it.  My example showing that the regret may be the same either way, and that, therefore, the safer should be chosen.