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2022-23 Influenza Season Predictions

You would think that August would bring a lull in the work of U.S. influenza epidemiologists. But August is when we get some of the most important information that predicts what our winter flu season will look like. And the projections are a little scary this year.

The best predictors of North American influenza in our winter is Australian influenza during our summer. Normally, influenza season in Australia starts in April and runs through October, corresponding with winter in the Southern Hemisphere. What happens with influenza in Australia usually fairly closely matches what happens later in the year in the United States. Thus, by examining the epidemiological data from the Australian Department of Health’s Influenza Surveillance, we can predict when influenza cases will start to be seen, what age groups will be affected, what serotypes will be predominant, and what severity will occur here in the United States and Canada.

Recent U.S. influenza seasons

Over the past 3 influenza seasons, we have seen an inverse relationship between COVID cases and influenza. One of the primary reasons for fewer influenza cases when COVID cases increase is social distancing and mask-wearing to prevent COVID. It turns out that these measures help prevent COVID but they are even more effective to help prevent influenza. We can see that effect in the 2019-20, 2020-21, and 2021-22 influenza seasons.

The graph above shows seven previous influenza seasons in the United States. The 2019-20 influenza season (green line) started off quite severe with sustained high numbers of cases from December through March. The onset of the COVID pandemic in the United States in March 2020 marked the closure of schools, work from home initiatives, and public masking. This coincided with a precipitous fall in influenza-like infections at the end of March.

The 2020-21 influenza season (pink line) was the mildest in recent history with only a small peak in cases of influenza-like infections in November and December. At this time, social distancing and masking were more ubiquitous and the COVID vaccines were not yet widely available. It was not until the summer of 2021 that influenza-like infections began to rise – this was a time when COVID vaccines were widely available and it was generally believed that the end of the COVID pandemic was in sight. Consequently, mask mandates were discontinued, children returned to schools, and workers returned to their workplaces. This created conditions that allowed influenza to have a summer rebound.

The 2021-22 season is in red with red triangles. It peaked in December, much earlier than usual. This coincides with the rise in case numbers of the Omicron variant of COVID that caused people to resume masking and social distancing in December. Once these measures to prevent the spread of COVID went back into effect in December 2021, the frequency of influenza-like infections fell.

The exceptional influenza season was the H1N1 outbreak in 2009-10 when cases began to increase in August and peaked in September and October. This represented an unusually early influenza season that caught physicians off-guard. Making matters worse, this particular H1N1 strain had not circulated for decades and was not predicted to appear that season with the result that it was not covered by that season’s flu shots. These factors together resulted in an unusually large number of cases and large numbers of deaths, particularly among younger people who had no natural immunity to H1N1.

What we are learning from Australia

When will influenza season start?

In the last several years, the influenza season in the U.S. has mirrored the influenza season in Australia that occurs earlier in the year. So, what is Australia telling us this year? First, we are likely to see influenza cases start to increase earlier than normal this season. The graph below shows the last several seasons of positive influenza testing in Australia.

The current influenza season is in red. It began much earlier than in past years and also peaked much earlier. Cases began to rise in late April which corresponds to late October in the Northern Hemisphere. Cases peaked in late May in Australia which corresponds to late November in the U.S. By late July, the Australian influenza season was pretty much over – this would correspond to late January in the United States and Canada. So based on these data, we should expect to see influenza cases start to increase in October 2022 with peak numbers in November and December 2022.

How severe will influenza be this year?

Hospitalization data from Australia predicts that this will be an average year with respect to influenza severity. The graph below shows the number of influenza hospitalizations in Australia over the past several seasons. The current season is in red with hospitalizations mimicking the case number graph above. Hospitalizations began to increase in April and were back to baseline by late July. 

Based on this data, in the United States, we should expect influenza-related emergency department visits and hospitalizations to peak in November and December 2022.

What ages will be most affected?

A unique finding during the current Australian influenza season has been the propensity to affect children. The graph below shows the number of laboratory-confirmed influenza cases by age.

The largest case rates have been in people under age 20. This would predict that U.S. pediatricians will be seeing more influenza than U.S. internists this season.

Will the influenza vaccine cover it?

The vast majority of cases of influenza in Australia were influenza A with unusually few cases of influenza B as shown in the graph below.

The seasonal influenza vaccines in Australia this year included the following serotypes:

Egg-based quadrivalent influenza vaccines:

  1. A/Victoria/2570/2019 (H1N1)pdm09-like virus;
  2. A/Darwin/9/2021 (H3N2)-like virus;
  3. B/Austria/1359417/2021-like (B/Victoria lineage) virus; and
  4. B/Phuket/3073/2013-like (B/Yamagata lineage) virus.

Cell-based quadrivalent influenza vaccines:

  1. A/Wisconsin/588/2019 (H1N1)pdm09-like virus;
  2. A/Darwin/6/2021 (H3N2)-like virus;
  3. B/Austria/1359417/2021 (B/Victoria lineage)-like virus; and
  4. B/Phuket/3073/2013 (B/Yamagata lineage)-like virus.

Although it is still too early to be confident of Australian vaccine effectiveness, we can look at whether the strains seen during the flu season corresponded to the strains covered by the influenza vaccines. In all, 97.4% of influenza A (H1N1) isolates were antigenically similar to the vaccine components. 93.2% of influenza A (H3N2) isolates were antigenically similar to the corresponding vaccine components. And all of the influenza B isolates were similar to the corresponding vaccine components. The U.S. quadrivalent influenza vaccine for the 2022-23 season has identical components to the egg-based quadrivalent influenza vaccine used in Australia. Therefore, it is likely that this season’s flu shots will cover the strains of influenza that we are likely to see in North America.

What we should do in the U.S.

Based on the Australian experience, there are several steps that we should take to prepare ourselves for the 2022-23 influenza season:

  1. Start vaccinating early. It takes about 2 weeks for immunity to develop after a flu shot. Therefore, we should insure that most Americans get vaccinated in September this year if case numbers begin to rise in October as anticipated. If cases peak in late November, as expected, then people who wait until December or January to get vaccinated will have waited too long.
  2. Target kids for vaccination. With children being disproportionately affected by influenza in Australia, it is likely that we will see the same trend in the U.S., particularly as schools return to in-person classes.
  3. Prepare for a surge of hospitalizations in November and December. Normally, this is a low-census period for medical admissions in American hospitals. It is also a time when many people get elective surgeries over the winter holidays and before the end of the calendar year to take advantage of annual insurance deductibles. If the early influenza peak occurs as expected, we may need to institute routine pre-op influenza testing for elective surgeries much as was done with COVID testing during the worst of the COVID pandemic.
  4. Anticipate the effect of Thanksgiving travel. Thanksgiving and Christmas holidays are times when many Americans travel to be with family. The Australian influenza season predicts that U.S. influenza cases may be peaking around Thanksgiving. This could result in holiday travel accelerating influenza spread this year.

No one can predict the influenza season with 100% accuracy. But if historical trends follow, then the U.S. will likely experience a similar season as Australia. Given that most Americans are starting to relax as the COVID-19 case numbers fall, we could be especially vulnerable to influenza this year, particularly if it comes early and preferentially affects children as expected.

August 10, 2022

Categories
Epidemiology

Public Health Hall Of Shame Nominees

The NFL has a hall of fame in Canton. Cooperstown has the baseball hall of fame. There is even a polka hall of fame in Euclid, Ohio. It is time to create a memorial to prominent figures in public health but instead of a hall of fame, I propose we create a hall of shame to recognize people whose actions have promoted disease, injuries, and death. Here are 10 people worthy of induction into the Public Health Hall of Shame, listed in chronological order.

1. Christopher Columbus

Unlike many of of the Hall of Shame nominees, Christopher Columbus did not knowingly promote the spread of disease but his inadvertent actions make him worthy of inclusion. He was the first worldwide disease importer/exporter. On October 12, 1492, Columbus arrived in the Bahamas bringing to the newly discovered lands European diseases. When he returned to Spain on March 15, 1493, he brought gifts from the New World. One of those gifts carried by crew members was syphilis that then spread to Spanish soldiers. Two years later, in 1495, Pope Innocent VIII invited King Charles of France to wage war against the King of Naples in Italy. Spanish mercenaries employed by the French army brought syphilis with them to Naples and within a few years, syphilis had spread throughout Europe. Because of the association with the French army, syphilis became known as the “French disease” but it was really the Spanish sailors who brought it back with them from the Americas. Recently, historians have proposed that syphilis occurred sporadically in Europe before Columbus sailed but given the correlation with the Naples war, it seems likely that his crew carried the infection on their return to Spain thus fostering its European spread in the 16th century. For his contribution to the spread of syphilis to Europe (even though inadvertently), Christopher Columbus is nominated to the Hall of Shame.

2. Hernán Cortés

Another Spaniard who warrants inclusion in our Hall of Shame was the conquistador, Hernán Cortés. He was from a lesser nobility family in Spain but chose to come to the New World to seek gold and silver rather than live the life of a nobleman in Europe. In February 1519, he sailed from Cuba to Mexico in order to conquer the Aztecs and loot their empire. His force of 1,000 men was no match for the 200,000 residents in the Aztec capital of Tenochtitlan in Central Mexico. But Cortés had a secret weapon… smallpox. One of Cortés’ soldiers had become infected with smallpox before leaving Cuba. The Aztecs and other Native Americans had no immunity to smallpox because it had not existed in the Americas until it was brought by the early European explorers. 70 days after Cortés first arrived in Mexico, 40% of the population of Tenochtitlan was dead from smallpox. Within a few years, between 5-7 million Aztecs and other indigenous Mexicans died from smallpox. Cortés proved that infectious diseases are more powerful in battle than swords and cannon. In all, it is suspected that infectious diseases brought by European explorers resulted in the death of up to 95% of the native population of the Americas. For his actions resulting in the deaths of millions of Native Mexicans due to smallpox, Hernán Cortés is nominated to the Hall of Shame.

Honorable mention: Colonel Henry Bouquet. In June 1763, Bouquet was the commanding officer at Fort Pitt during Potomac’s War. When the fort was under siege by members of the Delaware Tribe, Bouquet needed help to defeat the Native Americans. So, he ordered his men to distribute smallpox-infested blankets to the besieging warriors in an attempt to infect them and reduce their forces. More than 100 Native Americans died from the resultant smallpox outbreak. Bouquet can be considered the father of germ warfare.

3. Anthony Comstock

In 1873, U.S. postal inspector Anthony Comstock formed the New York Society for the Suppression of Vice. Later that year, he lobbied the U.S. Congress to pass what became known as the Comstock Act that prohibited the postal service from delivering obscene material. As a result, more than 15 tons of books that Comstock determined were obscene were destroyed. These included anatomy books used by medical schools because those books included drawings of reproductive organs. Another provision of the Comstock Act was to prohibit the production of or publication of information about methods of contraception or prevention of venereal disease. Comstock was convinced that by making condoms illegal that Americans would stop having sex outside of marriage. He was oblivious to the fact that the drive to have sex is the most powerful drive in all species of living organisms on planet Earth. He zealously prosecuted and imprisoned anyone who defied his definition of morality, including Julius Schmidt, the inventor of the rubber condom. After release from prison, Schmidt resumed condom manufacturing in a clandestine production facility in New York City. During World War I, being unable to legally sell his condoms to the U.S. Army because of the Comstock Act, Schmidt turned to other allied governments that enthusiastically purchased and distributed condoms to their servicemen. As a result, unlike other Allied armies, at any given time, approximately 15% of the U.S. military force in Europe was actively infected with a venereal disease. Eventually, the U.S. government relented and the production and distribution of condoms became legal but not before Comstock’s efforts had resulted in tens of thousands of cases of syphilis and gonorrhea that could otherwise have been prevented. For his efforts to promote the spread of sexually transmitted disease, Anthony Comstock is deserving of induction into the Hall of Shame.

4. Mary Mallon

From 1900 to 1907, Mary Mallon worked for eight wealthy New York families as a cook. At each household where she worked, household members developed typhoid fever. When a public health investigator determined that Ms. Mallon was the common link in the series of typhoid outbreaks, he went to interview her. But when he asked her to provide samples to test, she attacked him with a fork. She was sentenced by the Health Department to quarantine at North Brother Island from 1907 – 1910. She was released from quarantine under the condition that she never resume work as a cook again. However, she went back to cooking for families, restaurants, and hospitals under a false name. Everywhere she went, she left a trail of typhoid cases. In 1915, when 25 inpatients developed typhoid at a hospital where she worked as a cook, she was again sentenced to quarantine at North Brother island where she lived for 23 years. For her efforts to spread typhoid fever as an asymptomatic carrier, she earned the name “Typhoid Mary” and warrants induction into the Hall of Shame.

5. Emma Marie Harrington

Also known as E.C. Harrington, she was an attorney and the first woman registered to vote in San Francisco. She was a champion of progressive issues in California in the early 1900’s. However, she became famous for her actions that today would make her the darling of political conservatives. In March 1918, an army cook at Camp Funston in Kansas became sick with a respiratory infection. Within days, 522 soldiers became ill. Because the U.S. had entered World War I, troops from Camp Funston were sent to Europe to fight. By April, the H1N1 strain of influenza had spread throughout the world. Within 2 years, one-third of the world’s population had become infected. The number of deaths were estimated to be as high as 100 million making it the second most deadly pandemic after the 14th century bubonic plague. Because there were no vaccines or anti-viral medications at that time, the only defense against influenza was to avoid getting it in the first place. The two public health measures that were found to reduce the spread of the infection were face masks and banning mass gatherings. But some Americans considered face mask mandates to be an affront to personal liberty. Many of them organized to oppose face masks which they called “muzzles”. One of these organizations was the San Francisco Anti-Mask League and E. C. Harrington was its president. During the fall of 1918 and early winter of 1919, more than 3,000 San Francisco residents had died from influenza and the death rate per 100,000 was one of the highest in the world. Despite magnitude of deaths, the Anti-Mask League put enormous political pressure on the city government to lift its mask ban. On January 27, 1919, Mrs. Harrington submitted a petition to the city’s Board of Supervisors to repeal the mask ordinance and 5 days later, on February 1, 1919, San Francisco lifted its mask requirement. For helping to promote influenza deaths in 1919 and for later inspiring thousands of anti-maskers during the COVID-19 pandemic, E. C. Harrington deserves nomination into the Hall of Shame.

6. John W. Hill

America’s economic fortunes were built on tobacco. When anticipated riches from early settlements such as Jamestown failed to materialize, the settlers turned to growing tobacco for export to Europe. Demand for tobacco was enormous and soon farms and plantations across the colonies were making their fortunes by growing tobacco. The invention of a machine for large scale manufacturing of cigarettes in 1880 revolutionized the U.S. tobacco industry. After the turn of the century, per capita cigarette consumption increased exponentially. But by 1950, there were increasing reports that tobacco smoke could be harmful to people’s health. The CEOs of the largest cigarette makers – American Tobacco Co., R. J. Reynolds, Philip Morris, Benson & Hedges, U.S. Tobacco Co. and Brown & Williamson, were worried that sales would suffer so they turned to John W. Hill, the founder of Hill & Knowlton, one of the top public relations firms in the country. In 1953, Hill devised a PR campaign to discredit the mounting scientific data and named it “Operation White Coats”. The plan was to employ physicians and scientists (who wore white coats) to downplay the health hazards of cigarette smoke. Operation White Coats was the genesis of the Tobacco Research Council that provided easy-to-obtain grants to prominent medical researchers for studies that showed health benefits of nicotine and other tobacco components. Hill’s cigarette marketing strategy was successful and by 1965, 45% of U.S. adults were daily smokers. In reality many people have contributed to the the misinformation campaigns of American tobacco companies but John W. Hill stands out as of the most effective in denying that smoking cigarettes causes lung cancer, COPD, and other diseases. His has been a legacy of death and even today, smoking accounts for 480,000 deaths per year in the U.S., or about 1 out of every 5 deaths. For his contribution to to the death of millions of Americans since his 1953 advertising campaign, John W. Hill is our 6th nominee to the Hall of Shame.

Honorable Mention: Carrie Nation. She was the public face of the Women’s Christian Temperance Union which was the primary driver of the prohibition movement that led to passing the 18th Amendment to the U.S. Constitution outlawing the sale of alcohol on January 16, 1919. She claimed to have a divine vision from God commanding her to destroy bars and saloons. She traveled across the United States with a hatchet that she would use to smash saloon fixtures and liquor bottles. She described herself as “a bulldog running along at the feet of Jesus, barking at what He doesn’t like”. Overall, prohibition did reduce U.S. alcohol consumption by about 30% but instead of drinking low-alcohol percentage beer, people just started drinking bootlegged liquors. These were produced in unregulated stills and were frequently contaminated with methanol. Sellars of illegal spirits would often water them down and then add various poisonous chemicals to mimic the taste and color of liquors. During prohibition, over 1,000 people per year died from consuming tainted liquor. Within 15 years, it became apparent that prohibition did not stop people from drinking, it only created a market for poisonous moonshine. In 1933, the 21st Amendment repealed prohibition.

7. Peter Duesberg, PhD

Athel cb CC BY-SA 4.0 via Wikimedia Commons

In the early 1980’s, gay men were dying from an immunodeficiency syndrome and no one knew why. In 1983, the cause was identified simultaneously by French virologist Luc Montagnier and American virologist Robert Gallo. It was a virus that became known as HIV, or human immunodeficiency virus. Soon after, a lab test was created to diagnose the infection followed by development of AZT, a life-saving anti-viral drug that could treat AIDS. These milestones should have been celebrated by the medical and scientific community as breakthroughs in conquering AIDS. But history has proven that for every disease, there is a disease denialist and for AIDS, the most prominent denialist was Peter Duesberg. He is a Professor of Molecular Biology at the University of California, Berkley who built a successful academic career on his discovery of genes that could cause cancer. He argued that HIV was a harmless virus and that the cause of AIDS was long-term consumption of recreational drugs and anti-viral drugs. Because of his academic credentials, he developed a following of AIDS denialists in the 1990’s. Around the globe, people continued to die of AIDS and by 2000, about 25% of all deaths in South Africa were due to AIDS. Thabo Mbeki, the president of South Africa, convened an AIDS advisory committee to help direct public policy. The committee included Peter Duesberg. Mbeki bought into Duesberg’s AIDS denialism and withheld the use of anti-retroviral drugs in his country. As a result, it is estimated that there were 330,000 preventable deaths from AIDS in South Africa. Duesberg has kept up his claims that HIV does not cause AIDS and as recently as 2012 said on the Joe Rogan podcast that HIV is “one of the most harmless type of viruses we know”. For his actions that contributed to one-third of a million AIDS deaths in South Africa and his inspiration for AIDS denialists everywhere, Peter Duesberg should be nominated for the Public Health Hall of Shame

Honorable Mention: Christine Maggiore. She was diagnosed with HIV in 1992 and became involved in AIDS activism. In 1994, she met Peter Duesberg who convinced her that HIV does not cause AIDS. She came to believe that her own positive HIV test was actually due to an influenza vaccination. She authored a book entitled What If Everything You Thought You Knew about AIDS Was Wrong? and became prominent in the AIDS denialist community. She founded an organization that urged HIV-positive pregnant women to avoid anti-HIV medication. Ironically, she went on to become pregnant herself and refused to take HIV medications. She give birth to a daughter, Eliza Jane, and refused to allow her infant daughter to be tested for HIV. Eliza Jane died of AIDS at age 3 and Christine Maggiore died of AIDS three years later.

8. Jay Dickey

Most of our Hall of Shame nominees are proposed because of their actions that resulted in the proliferation of disease. Although bullets are not a disease, guns have proliferated in the United States just like contagious pathogens. Each year, more than 45,000 Americans die from gunshots and twice that number suffer non-fatal gun injuries. One of the barriers to reducing firearm deaths over the past 25 years has been a law prohibiting research into firearm-related deaths and injuries. The architect of that law was U.S. Representative James Dickey of Arkansas who at the behest of the National Rifle Association, added a clause to the 1996 Omnibus bill that became known as the Dickey Amendment. The amendment stated that “…none of the funds made available for injury prevention and control at the Centers for Disease Control may be used to advocate or promote gun control.” It effectively stopped all research by the CDC into gun-related deaths and injuries. It was not until 2018 that Congress passed a law allowing the CDC to report data on firearm injuries and not until 2020 that Congress allowed funding for firearm injury research by the CDC. By prohibiting the CDC to study gun injuries for 22 years, there was no good data on which to base public policy to reduce firearm injuries and hundreds of thousands of Americans died from guns. Later in his life, Dickey reversed his opinion about gun violence research but he nevertheless deserves inclusion in the Hall of Shame.

Gage Skidmore, CC BY-SA 2.0 via Wikimedia Commons

Honorable mention: Wayne LaPierre. Mr. LaPierre has been the executive vice president and chief executive of the National Rifle Association since 1991. It was he who was the principal lobbyist who influenced Dickey to add the NRAs amendment to the Omnibus bill in 1996. LaPierre has continued to lobby for the proliferation of guns in the United States. Because of his efforts, the U.S. is now the only country in the world with more guns than people.

9. Andrew Wakefield, MD

Bladość, CC BY-SA 4.0, via Wikimedia Commons

As the son of two physicians, it was no surprise that Andrew Wakefield went to medical school at St. Mary’s Medical School in London. He went on to do research in liver and small intestine transplantation and became a member of the Royal College of Surgeons. He developed a hypothesis that the measles virus might be the cause of Crohn’s disease. This evolved into a hypothesis that the measles vaccine might cause Crohn’s disease. Both of these hypotheses were disproven. But Wakefield was undeterred in his quest to link the measles vaccine to some disease. So, he turned to autism and in 1998, he published a paper in The Lancet in which he concluded that 12 children with autism developed “autistic enterocolitis” from the MMR vaccine (measles, mumps, rubella vaccine). He then called for a suspension of childhood vaccination with MMR in a press conference at his hospital. In 2000, he repeated his claims on the CBS news show, 60 Minutes, introducing his theory to American vaccine conspiracy theorists. In 2004, the British public service network Channel 4 reported that before he published his 1998 article about the MMR vaccine, Wakefield submitted a patent for a rival measles vaccine that he said would not cause autism. Presumably, if his vaccine replaced the MMR vaccine worldwide, he would stand to profit enormously. He also started a company to make diagnostic test kits for “autistic enterocolitis” that he predicted would make him $43 million per year. In 2009, his original research was found to be fraudulent and in 2010, The Lancet retracted his 1998 article. Three months later, his medical license was revoked. Dr. Andrew Wakefield’s false claims about the MMR vaccine were the inspiration for other anti-vaxxers. This not only led to thousands of children not receiving appropriate vaccinations but also laid the groundwork for false claims about the COVID-19 vaccines. For his efforts to increase childhood infections, Andrew Wakefield should be included in the Hall of Shame.

Maxlovestoswim, CC BY-SA 4.0 via Wikimedia Commons

Honorable Mention: Robert F. Kennedy, Jr. The son of the late Senator Robert F. (Bobby) Kennedy is an environmental lawyer who makes a living as an anti-vaxxer. Since 2005, he has promoted Andrew Wakefield’s discredited idea that vaccines cause autism. When 2 Samoan infants died in 2018, he opined that the cause of their death was the MMR vaccine. It was later determined that the infants had been errantly injected with a muscle relaxant along with the vaccine and the muscle relaxant was the cause of death. Nevertheless, his views caused many Samoans to forgo the MMR vaccine in their children. As a consequence, in 2019, a measles outbreak resulted in 5,700 infections or 3% of the Samoan population; 83 Samoans died from measles infections. Kennedy became convinced that the preservative thimerosal in vaccines could cause neurological disorders such as autism in children and spread anti-vaccine misinformation. As a result, thousands of pregnant women refused influenza vaccination and thousands of parents refused to allow their children to get flu shots resulting in countless influenza infections and deaths. Many studies have shown that thimerosal in vaccines is safe. He has been a tireless conspiracy theorist and suggested that Anthony Fauci and Bill Gates conspired to prolong the COVID pandemic for financial gain. He promoted the use of ivermectin to treat COVID, despite studies showing that the anti-parasite drug had no effect on COVID infection. Other members of the Kennedy family issued a joint statement about his efforts and said: “…on vaccines he is wrong. And his and others’ work against vaccines is having heartbreaking consequences.”

10. Joseph Mercola, DO

The last of our nominations is for efforts to promote the spread of COVID-19. Dr. Joseph Mercola is an American alternative medicine proponent with a lucrative internet business selling dietary supplements. He stopped seeing patients in 2009 to devote his attention to his internet business and has stated that his net worth is in excess of $100 million. Following in Andrew Wakefield’s shoes, he has been a staunch vaccine critic. It was during the COVID-19 pandemic that Dr. Mercola really hit his stride by promoting unproven supplements (that he sold) as treatments for COVID. He also advocated using inhaled hydrogen peroxide to prevent or cure COVID. An article in the New York Times identified him as the single most influential spreader of COVID misinformation. Becker’s Hospital Review reported that a “Disinformation Dozen” individuals were responsible for 65% of all of the misinformation about COVID and number 1 on that list was Joseph Mercola. His actions have contributed to unfounded fears of effective COVID vaccines and even as of today, one-third of the U.S. population is not fully vaccinated. For his contribution to the perpetuation of the COVID pandemic that has so far killed more than 1 million Americans, Dr. Joseph Mercola is our 10th nominee for induction into the Hall of Shame.

Honorable Mention: Sherri Tenpenny, DO. Occupying the 4th rank in the COVID “Disinformation Dozen” is Ohio’s own Dr. Sherri Tenpenny. She is an anti-vaccine activist who supports the claim that vaccines cause autism. She has written 4 books claiming dangers of vaccines and has stated that COVID vaccines cause death, autoimmune disease, and infertility. She sells these books along with videos and dietary supplements on her website. She stated that COVID-19 vaccines will turn people into “transhumanist cyborgs” and that “by the end of 2022, every fully vaccinated person over the age of 30 may have the equivalent of full-blown vaccine-induced immune suppressed AIDS”. She claims that wearing face masks makes people unhealthy by suppressing their immune systems. In June 2021, she was called by Ohio Republican legislators to testify at the Ohio Statehouse against vaccine mandates. She testified that the COVID vaccines cause people to become magnetized and meanwhile her minions posted on-line videos of spoons stuck to their noses to try to prove her point. Dr. Tenpenny’s claims about magnetism proved to be too far-fetched even for Ohio’s conservative State Representatives and the bill to ban childhood vaccine requirements died in committee.

History is replete with people who have helped to spread disease. Some, like Columbus, did it unknowingly. Some, like Bouquet, did it purposefully. Some, like Comstock, did it in defiance of human nature. Some, like Hill, did it by spreading misinformation. Others, like Mercola, did it in order to make a profit. But whether their actions were intended or unintended, each of our nominees for induction in the  Public Health Hall of Shame helped to promote disease, death, or injury by their actions. The bitter news for the medical profession is that as long as we have people like these 10 inductees, doctors and morticians will never go out of business.

August 9, 2022

Categories
Epidemiology Inpatient Practice Outpatient Practice

Preparing For Monkeypox

Monkeypox is spreading rapidly across the United States. There are steps that every hospital and every medical practice need to take now to protect patients and healthcare workers. As of yesterday, there were 6,326 known cases and undoubtedly considerably more that have gone undiagnosed. Infected patients will be presenting to your hospital, office practice, and emergency department in the next few weeks.

Where did monkeypox come from?

Monkeypox is a type of orthopoxvirus that is related to smallpox. It was first found in monkeys in a Danish research lab in 1958. The virus is not unique to monkeys, however, and has since been found in various mammalian species in Western Africa. Humans have sporadically become infected after contact with infected animals. Although most human cases have been reported in Africa, there have been occasional clusters of cases in other countries over the past 20 years.

One of the most notable clusters occurred in the United States in 2003 when 47 Americans became infected with monkeypox that originated from an infected giant Gambian rat that had been imported from West Africa for sale as an exotic pet. The rat then infected a group of captive prairie dogs that were also sold. Of the 47 cases, all but one person acquired monkeypox directly from an infected animal. In only one case was there human-to-human transmission (from a child to mother).

In July 2021, a traveler from Nigeria was diagnosed with monkeypox in Texas. In November 2021, a second travel-related case was diagnosed in Maryland. The current outbreak began on May 7 2022 when a travel-related case was diagnosed in the United Kingdom. Later that month, cases were diagnosed in Massachusetts and New York. Since that time, the number of cases has been growing exponentially. Because of lack of familiarity with the disease and difficulty in obtaining diagnostic tests, it is likely that most cases initially went undiagnosed and that the true number of U.S. cases is much higher.

How is it spread?

Because the initial cases were reported in gay men, there is a misconception that monkeypox is a sexually-transmitted disease, like syphilis or HIV. It is not. Monkeypox is primarily spread by skin-to-skin contact, similar to MRSA. Thus, the initial cases occurred in gay men not because they had sex with other men but because they had close skin contact with infected men. Although the virus can also be spread by respiratory secretions, it is not as contagious as other respiratory viruses, such as COVID. Therefore, it requires closer and/or more prolonged exposure for airborne transmission. However, because it can be spread by both contact and airborne routes, both contact and airborne isolation is recommended for inpatients. Other points to know about monkeypox transmissibility:

  • It can be transmitted to and from pets
  • Bed linens, clothing, eating utensils, and drinking glasses can be infectious
  • Infected persons remain contagious until scabs have all crusted over and a layer of new skin has developed
  • Usual hospital disinfectants can eliminate the virus
  • The average incubation period is 7 days and persons can be contagious during the incubation period

Signs, symptoms, and diagnosis

As of today, most cases have been in men who have sex with men. However, since monkeypox virus is spread by skin contact (rather than sexual contact), the demographic of infected people is expected to rapidly change in the next few weeks. A person does not have to be gay or to even have sex with another person to become infected. Common signs and symptoms reported in a recent article in the New England Journal of Medicine include:

  • Rash – 95% (with 64% having <10 lesions)
    • Anogenital – 73%
    • Trunk or limbs – 55%
    • Face – 25%
    • Palms or soles – 10%
  • Fever – 62%
  • Lethargy – 41%
  • Myalgia – 31%
  • Headache – 27%
  • Pharyngitis – 21%
  • Lymphadenopathy – 56%

Because 98% of the 528 patients reported in this article were either gay or bisexual men, the incidence of anogenital lesions may be higher than in other patients. The rash is most frequently described as vesiculpustular (53%) but can present as a macular rash (4%), multiple ulcers (19%), or single ulcer (11%). Additional photos of the rash can be found on the CDC website.

Image: UK PHS

The diagnosis is made using swabs of skin lesions – preferably 2 swabs, each from a different lesion. Testing is done by orthopoxviral PCR and results can be available in 2-3 days. Specimen handling procedures can vary from lab to lab so be sure to follow specific instructions from the lab that the sample will be sent to. Until recently, testing was only available through the CDC and results could take 1-2 weeks. Now, testing is available through local health departments as well as several commercial labs making it possible to submit specimens as a regular send-out test from U.S. hospitals. Serology testing is also available through the CDC but the turn around time is 14 days.

Treatment

In cases reported during this outbreak, the mortality rate is low and in most people, the disease is self-limited and of mild-moderate severity. Consequently, to date, only a minority of patients receive anti-viral treatment (5% in the New England Journal of Medicine study). Certain patients are at higher risk of severe disease and these patients should be targeted for treatment:

  1. Those with severe disease (hemorrhagic disease, confluent lesions, sepsis, encephalitis, or other conditions requiring hospitalization)
  2. Immunocompromised persons
  3. Children (particularly those < 8 years old)
  4. Persons with exfoliative skin disorders (atopic dermatitis, psoriasis, etc.)
  5. Pregnant or breast-feeding women
  6. People with monkeypox complications (secondary bacterial skin infection; severe gastroenteritis; bronchopneumonia; etc.)
  7. Involvement of anatomic areas at risk of permanent injury (eyes, mouth, anus, genitalia, etc.)

The treatment of choice is tecovirimat (TPOXX). This drug is currently only available through the Strategic National Stockpile. Physicians have to contact either their state health department or the CDC (770-488-7100 or email at Poxvirus@cdc.gov). The dose is 600 mg PO BID x 14 days given within 30 minutes after a full meal of moderate/high fat. Drug side effects can include headache and nausea. TPOXX may reduce blood levels of midazolam and may increase levels of repaglinide.

Other treatments that may be effective but have less scientific data to support their use include intravenous Vaccinia immune globulin, cidofovir, and brincidofovir.

Vaccination

There are two vaccines available that are effective against monkeypox.Both of these are live virus vaccines (unlike most routine vaccines such as COVID vaccines or flu shots). The JYNNEOS vaccine contains a live non-replicating virus. The ACAM200 vaccine contains a live replicating virus.

JYNNEOS is given as 2 injections with the second dose given 4 weeks after the first dose. Full immune response develops 2 weeks after the second dose. The most common side effects are fatigue, headache, and myalgias. Unlike ACAM200, the JYNNEOS vaccine is not contraindicated in immunocompromised persons, pregnancy, or HIV infection.

The ACAM200 vaccine contains a live replicating Vaccinia virus that is given as a single dose. Because ACAM200 contains a replicating virus, it is contraindicated in immunocompromised persons, HIV infection (regardless of immune status), pregnancy, persons with heart disease, children < 1 year old, persons with eye conditions requiring topical steroids, and persons with a history of exfoliative skin disorders (eczema, atopic dermatitis, etc.). Although most side effects of ACAM200 are mild, 1 out of every 175 persons receiving it develop myocarditis or pericarditis. It takes 4 weeks for maximal immune development after vaccination.

Both vaccines are available from the Strategic National Stockpile. Because of limited supply (particularly of the JYNNEOS vaccine), widespread vaccination of the public and of most healthcare workers is not currently advised. Currently, the CDC only recommends pre-exposure prophylaxis vaccination for people at very high-risk of exposure (primarily laboratory workers performing diagnostic testing for monkeypox). The CDC anticipates expanding the indications for pre-exposure prophylaxis vaccination to broader populations as supplies of the vaccine increase in the future.

Most monkeypox vaccines are currently being given for post-exposure prophylaxis. When given within 4 days of exposure, vaccination can prevent the disease and when given between 4-14 days after exposure, vaccination can reduce the severity of monkeypox infection. Persons who should be prioritized for vaccination include:

  • Known contacts who are identified by public health via case investigation, contact tracing, and risk exposure assessments
  • Persons with a sexual partner in the past 14 days who was diagnosed with monkeypox
  • Persons who have had multiple sexual partners in the past 14 days in a jurisdiction with known monkeypox
  • Healthcare workers with a high risk exposure such as:
    • Unprotected contact with skin, lesions, or bodily fluids of a patient with monkeypox
    • Aerosol-generating procedures without N-95 mask and eye protection

Healthcare workers with an intermediate risk exposure should be offered post-exposure vaccination on a case-by-case basis and after discussion of the risks and benefits with the exposed healthcare worker. Intermediate risk exposures include: (1) being within 6 ft of an infected unmasked patient for more than 3 hours when the healthcare worker was not wearing a mask and (2) contact with patient’s clothing, skin lesions, or soiled linens while wearing gloves but not wearing a gown.

Healthcare workers with a low risk exposure generally do not require post-exposure vaccination. Low risk exposures include: (1) entering an infected patient’s room without wearing eye protection, (2) being in a room with an infected patient while wearing gown, gloves, eye protection and at least a surgical mask or (3) being within 6 feet of an unmasked patient for less than 3 hours without wearing at minimum, a surgical mask. Additional information about managing exposed healthcare workers can be found on the CDC website.

Isolation recommendations for infected outpatients

The vast majority of people infected with monkeypox can be treated as an outpatient. In order to control the spread of monkeypox in the community, it is essential that infected persons adhere to proper isolation procedures at home for the duration of infectivity. Infected persons remain contagious for 2-4 weeks. Isolation can be discontinued when until all symptoms have resolved, including full healing of the rash with formation of a fresh layer of skin in areas of vesicles and ulcers. Isolation practices include:

  • Remain in the home with no contact with other people
  • Avoid close physical contact, including sexual and/or close intimate contact, with other people.
  • Avoid sharing utensils or cups. Items should be cleaned and disinfected before use by others.
  • Do not share items that will be worn or handled with other people or animals.
  • Wash hands often with soap and water or use an alcohol-based hand sanitizer, especially after direct contact with the rash.
  • Avoid contact with pets
  • Launder and disinfect items that have been worn or handled and that have been touched by a lesion
  • Do not dry dust or sweep as this may spread the virus
  • Do not wear contact lenses (because of risk of spreading the virus to the eyes)
  • Clean and disinfect surfaces with an Environmental Protection Agency-registered disinfectant. If other household members are responsible for cleaning, they should wear a medical mask and disposable gloves, at a minimum
  • If the infected person must leave home for medical care or for an emergency, cover the lesions, wear a well-fitting mask, and avoid public transportation

Infection control in the outpatient office

Although not as contagious as COVID, there is still a risk of an outpatient with monkeypox infecting other patients or healthcare workers. All employees of outpatient medical practices need to be familiar with monkeypox infection control practices to minimize the risk of spreading the infection. Specific measures include:

  • Utilize telemedicine for patients known or suspected to have monkeypox
  • If using pre-registration procedures in advance of patients arrival to the office, include questions about monkeypox signs and symptoms
  • Place patients with known or suspected infection in a private exam room with the door closed. These patients should be escorted from the building entrance directly to the exam room and should not wait in a waiting area
  • Have patients with known or suspected infection wear a surgical face mask with areas of skin rash covered
  • Healthcare workers entering an exam room of a patient with known or suspected infection should wear a disposable gown, gloves, eye protection, and an N-95 mask
  • Use disposable paper exam table drapes and patient gowns. Dispose of these materials using medical waste trash bags and do not shake out gowns or drapes
  • When the patient leaves, sanitize the room surfaces. Most standard hospital disinfectants will suffice. A list of cleaning products can be found on the Environmental Protection Agency website.

Infection control in the hospital

Only a small minority of patients will require admission to the hospital. Some of the indications for admission include pain management (such as severe anorectal pain), soft-tissue superinfection, pharyngitis limiting oral intake, eye lesions, acute kidney injury, myocarditis, and public health infection-control purposes. Infection control measures for hospitalized patients include:

  • Place patients with known or suspected infection in a private room with private bathroom and with the hallway door closed (negative airflow is not required)
  • Transport and movement of the patient outside of the room should be limited to medically essential purposes
  • When patients must be transported outside of their room, they should wear a medical mask and have any exposed skin lesions covered with a sheet or gown
  • Healthcare workers should wear a disposable gown, gloves, eye protection, and an N-95 mask
  • If aerosol-generating procedures are to be performed (e.g., intubation or bronchoscopy), use an airborne isolation room
  • Environmental services such as dry dusting, sweeping, or vacuuming should be avoided in rooms housing infected patients
  • Disposables such as paper towels should be disposed of using medical waste trash bags
  • Use surface cleaning products that are believed to be effective for emerging viral pathogens  (listed on the Environmental Protection Agency website)
  • Do not shake soiled linen, towels, and gowns. Soiled items should be enclosed in a proper laundry bag for transport to the laundry and staff handling laundry from infected patients should wear proper personal protective equipment as recommended by the CDC
  • Visitors should be limited to those essential for the patient’s care and wellbeing

Don’t think of monkeypox as a sexually-transmitted disease

Because the current outbreak has so far primarily affected men who have sex with men, monkeypox has developed a mistaken stigmata of being a sexually transmitted disease. It is important that we educate our patients and our co-workers that it is not necessary to have sex with someone to become infected with monkeypox. Measures that prevent spread of HIV and syphilis will not work with monkeypox. Abstinence will not stop it. Condoms will not stop it.

One of our best weapons against monkeypox is education.

August 3, 2022

Categories
Epidemiology

Do Republicans Live Longer Than Democrats?

Who lives longer, Republicans or Democrats? The answer may surprise you. Many people hold the stereotype of Republicans being wealthy, being better educated, and having better access to healthcare. Democrats often hold the stereotype of being working class, poor, and wanting government healthcare handouts. Intuitively, this would translate to Republicans being healthier and living longer than Democrats.

Summary Points:

  • Health metrics correlate with the partisan index
  • People living in Republican-leaning states have a significantly shorter life expectancy than people living in Democrat-leaning states
  • Republican states have a higher COVID death rate, higher prevalence of obesity, and higher prevalence of smoking than Democrat-leaning states
  • Residents of Democrat-leaning states have a higher annual household income than residents of Republican-leaning states

 

Historically, Republicans were found to be healthier than Democrats. In a 2009 article from the International Journal of Epidemiology, investigators analyzed data from the 1972 – 2006 General Social Surveys and found that survey respondents who identified as Republican had better self-reported health and were less likely than Democrats to be smokers. Similarly, a 2015 article from the journal Political Research Quarterly found that people who identified as having good health were more likely to vote Republican in the preceding presidential election.

A more recent study in the May 2022 edition of the British Medical Journal found that the association of political party with health may be reversing. This study compared the voting patterns of individual U.S. counties in the 5 presidential elections between 2000 to 2019 with the changes in the mortality rates in each of those counties during the same time period. The results indicated that counties voting Democratic had greater improvements in mortality rates than counties voting Republican. Moreover, the separation between improved mortality rates and political party voting only became apparent after 2008. This suggests that there has been a change over the past 15 years with Democrats now becoming the healthier of the two political parties.

It turns out that determining how political party affiliation affects life expectancy and other health metrics is quite difficult. Nowhere on a death certificate is there an entry for the doctor to  record political party. Because our voting choices are confidential, there is no way to do a public record search for how dead Americans voted in the past Therefore, the only way to study political party affiliation and health outcomes is by correlation studies that look at voting patterns and health metrics of different geographic locations.

The Cook Partisan Voting Index

In 1997, a new method of determining political affiliation was developed called the Cook Partisan Voting Index. For the past 25 years, the index has been used to determine how strongly a congressional district or a state leans toward the Republican party or the Democratic Party. The index is based on voting patterns in the previous two presidential elections. The most recent data is based on voting in the 2016 and 2020 elections. The higher the number, the more strongly a state leans towards one political party.

In this table, Democratic-leaning states are in blue and are denoted with negative numbers; the more negative the number, the more the state leans Democratic. Republican-leaning states are in red and denoted with positive numbers; the higher the number, the more the state leans Republican. The most strongly Republican state is Wyoming and the most strongly Democratic states are Vermont and Hawaii. Two states (Nevada and New Hampshire) are equally split between Republican and Democratic parties and they are denoted in purple. The use of negative numbers for Democratic states and positive numbers for Republican states in this table is purely to facilitate statistical comparisons.

The Cook Partisan Index also reports the political leaning by individual congressional district. The most Democratic district is California’s 12th (Oakland area) and the most Republican district is Alabama’s 4th (rural northern Alabama).

Party affiliation and life expectancy

If we use the Cook Partisan Voting Index as a marker for party affiliation, then we can compare states with a high Republican index to states with a high Democratic index and see how those voting patterns correlate with health metrics. Life expectancy is one of the simplest of these metrics. Life expectancy can be measured in several ways. The most common measurements are (1) life expectancy from birth, (2) life expectancy from age 18, and (3) life expectancy from age 65. Each of these measurements has advantages and disadvantages.

Life expectancy from birth will be lower if there is a high infant and childhood mortality rate. Life expectancy from age 18 eliminates infant mortality but will be affected by gun-related deaths, drug overdoses, and motor vehicle deaths that are more common in young adults. Life expectancy from age 65 eliminates those young adulthood causes of death and is more affected by life-long unhealthy habits such as smoking, obesity, and alcohol abuse. For this analysis, let’s use life expectancy from birth since it incorporates all of the variables that can affect mortality from infancy through early adulthood and into older age.

In comparing the Cook Partisan Voting Index to life expectancy from birth, many people would suspect that Republicans would have a longer life expectancy than Democrats. However, just the opposite is true. People living in Democratic party states live longer than those in Republican party states. States that most strongly leaned Democrat had the longest life expectancy.

Overall, life expectancy in states found to be Democratic by the Cook Partisan Voting Index had a mean life expectancy of 79.6 years whereas the mean life expectancy in Republican states was 77.4 years (p < 0.001). This represents an average 2.2 year longer life expectancy in Democrat-leaning states.

Party affiliation and smoking

The finding of longer life expectancy in states that lean Democratic indicates that there has been a change in political party affiliation and health measures compared to older studies that showed Republicans were generally healthier than Democrats. One of the strongest predictors of life expectancy is smoking. In the past, Republicans were less likely to be smokers than Democrats. Could a change in the prevalence of smoking among people voting Republican versus Democrat be partially responsible for the change in life expectancy?

To answer this question, let’s examine the association between the Cook Partisan Voting Index and smoking rates by state. Each year, the Centers for Disease Control reports the percentage of adults in each state who smoke. Overall, the percentage of all Americans who smoke has been steadily falling since the mid-1960’s.

However, there are wide differences in smoking patterns between different states, ranging from a low of 7.9% of adults smoking in Utah to a high of 23.8% of adults smoking in West Virginia. Overall, states that lean Republican have a higher prevalence of smoking than states that lean Democratic (r = 0.64). The average adult smoking rate was 13.7% in Democrat states and 17.8% in Republican states (p < 0.001).

Party affiliation and obesity

A second health demographic that has changed over the past several decades is obesity. Overall, Americans have been becoming more obese each year. The CDC reports that the rate of obesity (BMI > 30) has increased from 30.5% in 2000 to 42.4% in 2018. Similarly, the rate of severe obesity (BMI > 40) has increased from 4.7% to 9.2%. These statistics are from the National Health and Nutrition Survey (NHANES) which is based face-to-face surveys performed in participating American’s homes by a physician and other health professionals.

As with smoking, there are substantial differences in the rate of obesity among different states. The Behavioral Risk Factor Surveillance System (BRFSS) reports obesity rates by state based on adult self-reported information from phone surveys. These self-reported obesity data differ from the NHANES data with a lower overall incidence of obesity than NHANES. This difference has been attributed to differences in how the data are obtained (in-person interview versus phone survey). The state with the highest rate of obesity is West Virginia and the state with the lowest rate of obesity is Colorado. Based on the BRFSS data, states that lean Democratic have an adult obesity prevalence of 29.1% and states that lean Republican have an adult obesity prevalence of 34.3% (p < 0.001)

Party affiliation and COVID mortality

One of the major causes of death in the United States in the past two years has been COVID-19. So far, 1,024,611 Americans are known to have died from COVID and many more have likely died from COVID or COVID complications that were not listed on death certificates. A study published last month in JAMA Internal Medicine found that in 2021, COVID was the 4th leading cause of death in Americans age 25-34 (after accidents, suicide, and assault), the number 1 cause of death in Americans age 45-54, and the 3rd leading cause of death in Americans over age 65 (after cancer and heart disease).

As noted in a previous post, there are significant differences in how Republicans and Democrats fared during the COVID-19 pandemic with residents in Democratic states more likely to be vaccinated against COVID, less likely to become infected with COVID, and less likely to die from COVID than residents in Republican states. By comparing the Cook Partisan Voting Index to the death rate of COVID for each state, we again find that the  there is an association between party affiliation and death from COVID. Overall, 260 people per 100,000 population have died from COVID in Democrat-leaning states whereas 331 per 100,000 died from COVID in Republican-leaning states (p = 0.005).

Party affiliation and personal income

As noted earlier, historically Republicans had a higher self-reported annual income than Democrats. The stereotypical Republican was a capitalism-supporting business owner and the stereotypical Democrat was a blue collar worker who belonged to a union. Personal income has been shown to affect health outcomes with wealthier persons having better health and poorer persons having worse health. Could a change in income demographics between Republicans and Democrats be partially responsible of the shorter life expectancy of residents of Republican states?

By comparing household income to the Cook Partisan Voting Index, we find that residents of states leaning Democratic have a higher annual income than residents of states leaning Republican. The average income in Democratic-leaning sates was $71,264 and the average come in Republican-leaning states was $59,108 (p < 0.001).

Money is only worth what you can buy with it. The highest income states are also the states with the highest cost of living so the above analysis man not necessarily equate to the purchasing power of each household. Nevertheless, it appears that voters favoring Republicans in the last two presidential elections have a different relative annual income than voters favoring Republicans in previous presidential elections. Residents of states who have recently favored Republicans have a lower income than those favoring Democrats.

Today’s Republicans are not your parent’s Republicans

A generation ago, compared to Democrats, Republicans were wealthier, healthier, and less likely to smoke. Today’s Republicans have a lower income, are more obese, are more likely to smoke, and are more likely to die young than Democrats. This generational reversal in the relationship between party affiliation and health metrics has implications for future healthcare utilization.

For example, given a 2.2 year longer life expectancy, residents of Democrat-leaning states would be expected to utilize 18% more Medicare and Social Security benefits than residents of Republican-leaning states (assuming Medicare and Social Security benefits starting at age 65). The longer a person lives, the more elections that person can vote in. The results imply that people voting Democrat will vote in an average of 2 more annual elections over the course of their lifetimes than those who vote Republican.

Obesity is associated with other health conditions such as diabetes, hypertension, sleep apnea, and arthritis. This could indicate that people voting Republican are more likely to have these conditions in addition to being more likely to be smokers. The result could be a higher incidence of disability among people voting Republican than among people voting Democrat.

It seems paradoxical that people living in states that lean toward the Democratic party have higher incomes and thus are in higher income tax brackets and pay more in income tax than people living in states that lean toward the Republican party. Democrats are often characterized as favoring higher taxes whereas Republicans are generally characterized as favoring tax cuts.

We will not fully know all of the healthcare implications for the apparent change in voter demographics for several years. However, it is likely that the evolving differences in health metrics between states that vote Republican and states that vote Democrat will result in very different approaches to healthcare policy.

August 1, 2022

Categories
Academic Medicine Physician Retirement Planning

Is Your Public Pension Safe? Check The Pension’s Vital Signs!

Physicians at academic medical centers often have an option to contribute to a state teacher’s pension plan. Although a pension can be an important component of a diversified retirement portfolio, some public pensions are currently in danger. How safe is your state’s public pension and should you contribute to it? The answer is in the pension’s vital signs.

Summary Points:

  • Most physicians employed by public universities can participate in their state’s public pension
  • Each state’s public pension is managed separately
  • Some public pensions are healthier than others
  • The funded ratio and the funding period are two important vital signs that indicate the health of a public pension

 

In Ohio, the State Teachers Retirement System (STRS) is our state’s public pension for academic physicians at state-funded universities (such as the Ohio State University). STRS is similar to Social Security or an annuity in that it gives university-employed physicians an option to participate in a defined benefit plan that will pay you a fixed amount of money every month that you are alive after you retire. There is also an option for survivor benefits so that your spouse can continue to receive a monthly payment after you die. The advantage of defined benefit plans, such as STRS, is that you never run out of money in retirement. The disadvantage is that as an investment, you may be able to come out ahead by investing the money yourself rather than contributing to the pension during your working years.

In the past, most American workers had access to employer-sponsored pensions but many private employers have abandoned pensions and replaced them with 401(k) plans. However, pensions are still quite common for employees of state and local governments. Everyone’s retirement portfolio should be diversified and contain several different types of investments, such as stocks, bonds, and real estate. A pension can be an important component of those investments, less risky than bonds but also having a low rate of return.

However, all types of investments have risk and a pension is no different. Social Security is generally considered to be very low-risk, as investments go. But even Social Security is in danger of running out of money in 2035, unless action is taken by the U.S. Congress in the future. Private company pensions occasionally run out of money, leaving retirees with reduced or no monthly pension payments. State public pensions are somewhere in-between Social Security and private company pensions with respect to investment risk.

In some states (such as Ohio), academic physicians have an option of either participating in the public pension (STRS) or self-directing payroll deduction retirement savings into investments of their own choice. In other states, participation in the public pension is mandatory and there is not an option to self-direct. When deciding whether or not to participate in a public pension or deciding whether or not to take a university job in a mandatory public pension state, you should look carefully at the state’s public pension. Some states’ public pensions are considerably safer than others. When researching a state’s public pension, there are two pension vital signs that are important: (1) the funded ratio and (2) the funding period. Understanding these two numbers is critical to understanding the health of a public pension.

The Funded Ratio

The funded ratio is the ratio of a pension’s assets to its current and future liabilities. In simple terms, the assets are all of the money that the pension currently has in cash and in investments. The liabilities are the total amount of money that the pension plan will pay out to retirees now and in the future plus the administrative cost of the pension. In an ideal world, the funded ratio should be 100% or higher. In other words, the pension plan should have enough money to pay for the pensions of all of its current participating members. A funded ratio below 100% can be cause for concern and a funded ratio below 80% can be a sign that the pension plan is in jeopardy. The Equitable Institute recently released its annual State of Pensions report for 2022 and there are some concerning findings. From the map below, it is apparent that some states’ public pensions have very strong funded ratios and others have very poor funded ratios.

Washington, Utah, South Dakota, Wisconsin, Tennessee, New York, the District of Columbia, and Delaware all have funded ratios greater than 90% (dark green). On the other hand, Illinois, Kentucky, South Carolina, New Jersey, Connecticut, Hawaii, and Rhode Island all have severely low funded ratios that are below 60% (dark red). In between these extremes are thirteen states that mildly low funded ratios between 80-90% (light green). Fourteen states have moderately low funded ratios between 70-80% (yellow). And nine states have moderate-severely low funded ratios between 60-70% (light red).

One of the main reasons that many states’ funded ratios have recently fallen is the downturn in the stock market in the past 7 months. Public pensions do not just keep all of their money in a checking account, they invest the money in order to keep up with inflation and to ensure that they have sufficient money to pay their retirees in the future. Most public pensions estimate that their investments will have an average 6.9% annual return. Last year, in 2021, the average pension plan’s rate of return was 25.3% – an extraordinarily high rate of return, primarily because stock markets had an exceptional year. So far in 2022, the average pension plan has had a -10.4% rate of return. In other words, instead of gaining 6.9% this year, the average pension has already lost 10.4%.

There are several reasons why a state might have a low funded ratio:

  1. Inadequate funding. Public pensions are funded by a combination of employee contributions (payroll deductions) plus employer contributions (usually as a fixed percentage of gross salary). If the contribution rates are set too low, then the public pension fund will not have sufficient funds to pay monthly retirement benefits. Currently, the average employee contribution is 8.07% of total salary, an increase from 7.06% in 2001. In addition to employee contributions to the public pension, there are also employer contributions to the pension and these currently average 29.8% of total payroll, an increase from 9.13% in 2001.
  2. Excessively high retirement benefits. Similarly, if the amount of money that retirees receive in their monthly pension payments is set too high, then the funded ratio will fall as the pension gradually runs out of money. The amount of the pension fund contributions and the amount of the pension fund distributions requires a very careful actuarial analysis and this in turn requires well-trained and highly skilled actuaries. Not every state has equally high-quality actuaries working for their public pensions. Public pensions should have periodic external audits to validate the conclusions and recommendations of the pensions internal actuaries. These audit reports should be available to pension participants and can be a valuable source of information about the pension’s health.
  3. Poor investment choices. Each state’s pension is managed differently – some by internal fund managers and some by external investment companies that employ their own fund managers. Inevitably, some fund managers will be better than others at selecting winning investments. However, as has been shown with managed mutual funds compared to index funds, most fund managers will not beat the overall stock market. This year, one of the particularly bad investment choices was in Russian investments. Prior to the Russian invasion of Ukraine, U.S. public pensions held approximately $5.8 billion in Russian market assets, securities, and real estate. These investments have lost enormous value since 2021. Over the past 15 years, there has been a growing trend to outsource investment decisions – currently 15% of public pension funds are managed by either a hedge fund or a private investment company.
  4. Unrealistic projected rates of return. The average annual rate of return on public pension fund investments is 6.9%. If a fund projects a higher rate of return, say 8.5%, then there is a high likelihood that their investments will not meet their projected rate of return, leading to lower than anticipated asset value. A pension fund’s rate of return on its investments will be largely determined by the ratio of stocks:bond:real estate in the fund’s investment portfolio. This ratio is in turn determined by the decisions made by the pension fund managers.
  5. The value of stocks and bonds fall. Some years, the stock and bond markets go up and some years they go down. Because public pension funds are mainly investing for the long-term, it is expected that the funded ratio will fall during short-term market downturns but then go up when the market recovers. 2021 and 2022 exemplify this perfectly with large losses in stock and bond values in 2022 but even larger gains in 2021. This resulted in a higher average funded ratio in 2021 that then fell in 2022 (graph below). It is more important to look at public pension fund investments over a several year period to determine how well the fund is doing.
  6. Inflation. If the public pension fund retiree distributions are tied to inflation, then there can be large cost of living increases in monthly pension payments during years that there is a high inflation rate. In these pensions, when inflation rises unexpectedly high (as in the previous 12 months), then the funded ratio can fall due to higher than expected monthly pension payments. Of 372 public pensions, 204 of them have automatic cost of living increase provisions with the majority of these linked to the inflation rate or the fund’s overall performance. Because of the danger of inflation eroding the funded ratio, other public pensions limit or do not give any regular cost of living increases in pension distributions.
  7. Increased life expectancy. This is often cited as a cause of a low funded ratio because if retirees live longer than expected, then the overall amount that the pension fund pays those retirees will be higher than expected. However, it turns out that annual increases in life expectancy have only a very small effect on funded ratios. It remains to be seen whether the opposite effect (shorter life expectancy) will improve funded ratios in the next few years since the majority of the more than 1 million U.S. COVID-19 deaths in 2020 and 2021 were in retirees.

The Funding Period

When a public pension’s funded ratio falls, or when actuarial analysis projects that it will fall in the future, there are a number of tactics that the pension can take to rectify the low funded ratio. For example, the pension managers can suspend cost of living increases in pension distributions. Or they can increase the contributions by increasing the percentage of employed pension members’ salaries going into the pension fund. Or they can increase the number of years a member must work before being eligible for full retirement benefits. When a public pension makes these corrective actions, it can take many years for the funded ratio to increase to 100%. The projected number of years that it will take to reach 100% is called the funding period.

Simply having a low funded ratio may not necessarily be bad as long as the public pension managers have taken corrective actions to improve the funded ratio. How effective these corrective actions are projected to be is measured by the length of the funding period. In general, the shorter the funding period, the better. In Ohio, the State Teachers Retirement System is required by state statute to have a funding period of less than 30 years. Funding periods in excess of 30 years are generally too long and can be a sign of an unhealthy public pension.

Many of the same variables that affect the funded ratio also affect the funding period. For example, the Ohio State Teachers Retirement System funding period dropped from 30 years to 8 years in 2021 due to the unusually large rate of investment return in 2021.

Public pensions with both a low funded ratio and a long funding period are in trouble. These pensions are in danger of being unable to meet future obligations. From a retirement portfolio standpoint, they are poor investments.

A Story Of 3 States

To illustrate the variability in public pension health, let’s examine three states: one that is in trouble, one that is in great shape, and one that was in trouble but has taken effective measures to improve.

Illinois. Illinois has 5 different state government public pension programs and all of them have a long history of being underfunded. At the end of 2021, these public pensions had an average funded ratio of only 46.5%, the highest ratio for the Illinois public pensions since 2008, before the great recession. Although improved, this is still among the lowest of all states’ public pension funded ratios. The state legislature has created a plan to increase the funded ratio to 90% by the year 2045. However, the state’s actuary and outside actuarial consultant have advised that a 90% funded ratio target in 23 years is insufficient and instead have advised a funding period to a 100% funded ratio of no more than 25 years. So far, no legislative action has been taken to improve the funding period. As a consequence, participation in the Illinois public pension is very risky compared to other states’ public pensions.

Wisconsin. The primary state public pension is the Wisconsin Retirement Benefit. It has a track record of being well-managed and as a consequence, it has a funded ratio that exceeds 100%. In fact, the funded ratio at the end of 2021 was 120.6%. That puts its funded ratio as the eighth highest out of 167 statewide public pensions in the country. Academic physicians can feel secure that their contributions to the Wisconsin public pension will be safe and that they can count on their monthly pension benefits in retirement.

Ohio. There are 5 statewide public pensions in Ohio. Academic physicians have the option of participating in one of them, the State Teachers Retirement System of Ohio.  In 2001, STRS was in good shape with a funded ratio of 91%. The great recession severely impacted STRS and by 2012, the funded ratio had fallen to 56%. By 2017, the funding period to reach a funded ratio of 100% had risen to 60 years, putting the entire pension in jeopardy. STRS enacted three corrective measures to stabilize the pension fund: (1) suspension of annual cost of living increases in retiree pension distributions, (2) a 2.91% increase in the employer contributions to the pension fund, and (3) an increase in the number of years of service to full retirement benefits from 30 years to 35 years. By the end of 2021, the pension’s funded ratio was 80.1% and the funding period was 8 years. STRS’s willingness and ability to make hard decisions to increase contributions and limit distributions has resulted in it once again becoming a safer retirement investment for participants.

Even healthy public pensions are vulnerable to forces that can destabilize them. For example, the next pension fund manager could make poor investment choices. The state legislature could enact statues that acquiesce to lobby pressure to increase retiree benefits or decrease employee/employer contributions. The next actuaries may make faulty life expectancy projections. For these reasons, it behooves all participants to periodically check the status of their public pension. At a minimum this should entail reviewing the current funded ratio and funding period of the pension. In this sense, a pension is an investment and should be monitored similarly to how one monitors their 401(k) or 403(b) fund.

“If you’ve seen one public pension, you’ve seen one public pension”

A strong and secure retirement investment portfolio is one that is diversified. Ideally, one’s portfolio should consist of a mixture of stocks, real estate, bonds, fixed income, and cash. For each of these types of investments, the potential long-term return is directly related to the short-term risk of the investment.

For most Americans, the fixed income component is Social Security. But academic physicians and other employees of state-funded universities usually do not participate in Social Security. The public pension substitutes for for Social Security and is thus the main component of the fixed income portion of academic physicians’ retirement portfolio.

Some financial pundits have argued that it is better to not participate in a public pension and instead take the money that would have gone into the pension fund from payroll deduction and invest that money into stocks. The argument is that in the long-term, the rate of return from stock investments will be greater than the return from pension distributions in retirement. However, a more accurate view of a public pension is that it forms a crucial low-risk/low-return component of a balanced retirement portfolio. By having a public pension in the portfolio, the academic physician can devote a larger percentage of other retirement investments (403b, 457, IRA, etc.) into higher risk stocks and real estate.

In addition to functioning as a fixed income retirement investment, public pensions have other features that can increase their value to the participant. Survivor benefits for one’s spouse and dependents can replace the need to purchase separate life insurance. Disability benefits can replace the need to purchase separate disability insurance. Access to group rates for health, dental, and vision insurance can result in insurance premiums that can be thousands of dollars less per year than equivalent insurance policies purchased individually. And access to financial counselors at the public pension can provide some elements of free financial planning advice.

But each state’s public pension has different degrees of risk as evidenced by their varying funded ratios and funding periods. Before committing to participating in a public pension, it is important to carefully examine the health of that particular state’s public pension. Do a routine vital sign check of the pension by following its funded ratio and funding period.

July 22, 2022

Categories
Electronic Medical Records

What Is HIPAA Protected Health Information?

Recently, a physician in Indiana publicly revealed that a 10-year old child rape victim from Ohio had to travel to Indiana to get an abortion. Some in the media stated that the physician should be prosecuted for violating HIPAA privacy laws. But did she?

I recently encountered a second HIPAA question. When asked if she had received a COVID vaccine, an acquaintance who is opposed to vaccines told me: “If I told you, I would be breaking the HIPAA law”. But would she?

Both of these cases illustrates common misconceptions about HIPAA and how HIPAA can be weaponized, in the first case by abortion prohibitionists and in the second case by anti-vaxxers.

HIPAA is the Health Insurance Portability and Accountability Act of 1996 that set a national standard for the protection of certain health information. In other words, it set into law what a healthcare provider can and cannot say publicly about patients. The penalties for not complying with HIPAA are severe. Violators can be subject to civil penalties of $100 – $50,000 per violation (depending on circumstances) and up to $1,500,000 total per year. In addition, violators can be subject to criminal penalties of up to $250,000 and 10-years imprisonment. Hospitals, health insurance companies, and others who manage health information are highly motivated to maintain strict compliance programs to ensure that all employees adhere to HIPAA requirements.

At the core of HIPAA is protected health information that cannot be made public without a person’s consent. The law identifies 18 specific personal identifiers that are considered to be protected health information when those personal identifiers are associated with information about a person’s physical or mental health:

  1. Name (either full name or last name + first initial)
  2. Address and geographic locators smaller than a state EXCEPT for the initial three digits of a zip code if the geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people
  3. Dates (other than year) directly related to the patient including:
    1. birth date
    2. admission date
    3. discharge date
    4. death date
    5. age in years (only if older than 89 years of age)
  4. Phone numbers
  5. Fax numbers
  6. Email addresses
  7. Social security number
  8. Medical record numbers
  9. Health insurance beneficiary numbers
  10. Account numbers
  11. License and certificate numbers
  12. Vehicle license plate numbers and motor vehicle identification numbers
  13. Device serial numbers and identifiers
  14. Web URLs (uniform resource locators)
  15. IP (internet protocol) addresses
  16. Biometric identifiers (finger prints, voice prints, retinal prints)
  17. Facial photos or other personally identifying images
  18. Any other unique identifying number, characteristic, or code

The HIPAA law does not apply to everyone. The specific groups covered by HIPAA are: (1) healthcare providers, (2) health plans and insurance companies, (3) health clearinghouses, and (4) business associates. There are exceptions in order to permit a person’s health information to be disclosed for treatment, payment, and healthcare operations. For example, this permits a physician consultant to convey a patient’s health information in a referral letter to the patient’s primary care physician. It also permits a physician to submit payment for healthcare services rendered to the patient’s health insurance company. In addition, a person can give written consent for a physician or hospital to release their medical records, for example, for a life insurance application or for a disability determination.

HIPAA permits use and disclosure of personal health information, without an individual’s authorization or permission, for 12 specific national priority purposes:

  1. When required by law
  2. Public health activities
  3. Victims of abuse or neglect or domestic violence
  4. Health oversight activities (eg, Medicare audits)
  5. Judicial and administrative proceedings
  6. Law enforcement
  7. Functions concerning deceased persons (such as identification)
  8. Cadaveric organ, eye, or tissue donation
  9. Research, under certain specific conditions
  10. To prevent or lessen a serious threat to health or safety
  11. Essential government functions (eg, military operations and national security operations)
  12. Workers’ compensation

So, let’s go back and take a look at the first case. Did the Indiana physician violate HIPAA laws by publicly disclosing that a 10-year old from Ohio had come to Indiana to get an abortion? The child’s age (in years) was mentioned but that is permissible under HIPAA as long as the patient is younger than 89-years-old. No birth date or hospital admission date was listed. Neither the girl’s name nor any personal identifying images or numbers were listed. The physician disclosed that the girl lives in Ohio, however, it is permissible under HIPAA to disclose the state that the patient lives in. Although the physician did not disclose that the girl lives in Columbus (as was later reported by the Columbus Dispatch newspaper), the physician could have done so since the first 3 digits of the Columbus zip codes are 432.. and the total population of all 432.. zip codes is greater than 20,000 people.

The verdict: the physician did not violate HIPAA.

In the second case, the woman stated that she could not publicly reveal whether or not she had received a COVID vaccine. Would doing so have been a HIPAA law violation? HIPAA only applies to release of personal health information by healthcare providers, insurance organizations, and business associates. It does not apply to the general public and certainly does not apply to personal disclosure by oneself.

The verdict: voluntarily stating whether or not you have received a COVID vaccine does not violate HIPAA.

The HIPAA law provides important protections to the public by prohibiting release of people’s personal health information without their permission. But there are many misconceptions about HIPAA and it is often used as a justification for political or social agendas.

July 17, 2022

Categories
Electronic Medical Records Medical Malpractice Outpatient Practice

The REMS Program And Abortion Laws – What Every Physician Needs To Know

If you or the doctors at your hospital prescribe any of these 11 drugs and live in states that have abortion laws, you need to take action IMMEDIATELY. The medical malpractice implications of teratogenic drugs (those that can cause embryofetal damage) are changing and physicians who prescribe these drugs need to protect their women patients from fetal damage and to protect themselves against future lawsuits.

The FDA created the REMS program (Risk Evaluation and Mitigation Strategy) in 2007 as a way to be sure that physicians take appropriate precautions when prescribing certain high-risk drugs. Typically, the REMS program will recommend physicians to have specific training and certification before being allowed to prescribe these drugs. The problem is that hospitals and pharmacies rarely verify that a physician has been certified for drugs on the REMS list and as a consequence, many physicians prescribe them without having the proper certification. Currently, the FDA lists 60 such drugs on the REMS website. I am most familiar with the REMS drug, mycophenolate mofetil. During my career, I have prescribed mycophenolate… a lot of mycophenolate… typically as an immunosuppressant for various lung diseases.

Mycophenolate, a REMS medication

Mycophenolate mofetil is often sold under the brand names CellCept or Myfortic. It is commonly used in patients who have undergone organ transplant to prevent rejection of those organs. It is also commonly used as an immunosuppressant drug to treat various autoimmune diseases. When used properly, it can be life-saving and is considerably safer than older immunosuppressant drugs, such as cyclophosphamide. In many patients, it is also safer than corticosteroids such as prednisone. The biggest problem with mycophenolate is that it is highly teratogenic. Overall, about half of women who become pregnant while taking mycophenolate will have a miscarriage and 1 out of every 4 live births have serious congenital malformations. Because of the very high risk of embryofetal damage, mycophenolate was added to the FDA’s REMS drug list in 2012.

The mycophenolate REMS requirements are:

  1. Physicians need to apply to the mycophenolate REMS website and undergo an on-line training program before prescribing mycophenolate.
  2. Once certified to prescribe mycophenolate, physicians must educate patients about the risk of miscarriage and fetal harm.
  3. Physicians must insure that women of childbearing potential use adequate contraception – preferably either vasectomy, tubal ligation, or an intrauterine device. In the absence of any of these 3 methods, women must use 2 forms of other approved contraception (for example, birth control pills + condoms).
  4. Women should have a pregnancy test at every office visit.
  5. Woman should be counseled about emergency contraception (Plan B) in the event of intercourse without adequate contraception.
  6. Women must be given the printed REMS information about mycophenolate precautions.
  7. Women should sign an agreement form acknowledging that they understand the risks of mycophenolate and agree to the requirements of the REMS program (note: this requirement was discontinued in January 2021).

All too often, I would see women of child-bearing potential in my office who had been started on mycophenolate by other physicians and who had never been informed about the REMS program. Frequently, these women were not using adequate contraception and were not undergoing regular pregnancy testing. Until last month in Ohio, if a woman became pregnant while taking mycophenolate, we could recommend pregnancy termination. Now, that is no longer an option if it is more than 6 weeks after her last menstrual period and the Ohio legislature has signaled that later this year, it intends to make pregnancy termination illegal in all pregnancies from the time of conception.

The heightened risk of malpractice lawsuits

The implication of anti-abortion laws, such as Ohio’s, is that if a woman becomes pregnant while taking mycophenolate, then there is a 25% chance that her baby will have severe congenital deformities. Children with these deformities can require life-long care and can be very expensive for families. Women taking mycophenolate because they have had an organ transplant or because they have chronic diseases such as lupus are generally not in a good position to provide care for the life of a child with serious birth defects and usually do not have the financial resources necessary for that care. This is especially true for my patients who have undergone lung transplant – the life expectancy after transplant averages about 6 years so these women will not be alive to care for a child with severe deformities.

We live in a litigious society. When faced with the birth of a child who will never grow up to be a normal adult and will incur large healthcare costs, women (or their widower spouses) will seek financial compensation to pay for these costs. Every personal injury attorney in the country knows that the person to name in a lawsuit is the person who has the most money. Hospitals and physicians are the ones with the most money. If a physician prescribed mycophenolate without having REMS certification to prescribe it or if there is no documentation that a woman was educated about pregnancy risks with mycophenolate, then that physician will be highly vulnerable in a malpractice suit.

The best defense for physicians is to get REMS certification before prescribing mycophenolate and adhere to the REMS requirements when prescribing it to any woman with child-bearing potential. The best defense for hospitals is to ensure that every physician prescribing mycophenolate has REMS certification. Electronic medical records make it easy for hospitals to determine which of their physicians are prescribing mycophenolate or other REMS drugs.

What other drugs are on the REMS list?

There are a variety of reasons that the FDA may put a drug on the REMS list. Some are on because of a high risk of anaphylaxis (Palforzia). Some are on because of a high risk of neurological toxicity (Abecma). Some are on the list because of risk of neutropenia (clozapine). Others are on the list because of a risk of over-sedation or addiction (buprenorphine). Of the 60 drugs on the REMS list, 11 are on the list because of the risk of embryofetal toxicity. The following is a list of these 11 drugs and what physician specialties are likely to be prescribing them.

A recent article in the American Journal of Obstetrics & Gynecology lists 141 drugs that are definite teratogens and 65 drugs that are considered to be potentially teratogenic. Of these 206 drugs, only 11 are included on the REMS list. However, the risk of embryofetal toxicity exists with all of these drugs and therefore the risk of medical malpractice lawsuits exists should a woman become pregnant while taking any medication known to be teratogenic and then develops fetal abnormalities.

Currently, 3% of all abortions performed in the United States are because of fetal abnormalities. This works out to about 28,000 per year. In states that ban abortion, these fetuses will go on to be infants with severe birth defects. The implication is that in the future, there will be potentially thousands of new malpractice suits filed each year against physicians who will be blamed for these birth defects because they prescribed a teratogenic drug to a woman who could not legally have her pregnancy terminated.

What physicians need to do right now

In medicine, doctors recognize that prevention is the best cure. The same goes for malpractice lawsuits. The best time to prevent a malpractice suit about a birth defect is before the woman becomes pregnant. To that end, there are measures that all physicians practicing in abortion-ban states should take now:

  • Know which drugs are teratogenic. The recent list from the American Journal of Obstetrics & Gynecology is a good starting point.
  • If you prescribe one of the 11 teratogenic drugs on the FDA’s REMS list, get your REMS certification and follow the REMS requirements.
  • If you prescribe a teratogenic drug that is not on the REMS list, develop a process for educating women of child-bearing potential about the risks of the drug.
  • Document, document, document. Include information in your office notes documenting patient discussions about drug teratogenicity, about contraception advice, and about any printed information that you gave them. 
  • Consider signed acknowledgement forms. In the past, this was a requirement of the mycophenolate REMS program. Even though it is no longer required by REMS, a signed form scanned into the electronic medical record is still a good practice since it can provide very strong malpractice defense.
  • Get comfortable recommending contraception. I have become at ease discussing contraception with my patients and their partners. If the woman is done having children, vasectomy is usually the safest and most effective option. For other women, I am a proponent of IUDs and although I do not place them myself, I know who to refer women to in order to get one. 
  • Educate women about Plan B. The “morning after pill” is available at pharmacies over the counter without a prescription and is effective up to 3 days after unprotected intercourse. Include information about Plan B in the educational materials you give patients when prescribing any teratogenic drug.
  • Understand your state’s abortion laws. In some states, it is (or will be) illegal for a physician to even discuss abortion with a woman or to advise her to travel to another state where abortion is legal. Be very careful what you write in the chart. A note in the electronic medical record stating: “She is 6 weeks pregnant while taking mycophenolate so I recommended she go to the Acme Abortion Clinic across the state line” could be your invitation for a prison sentence and revocation of your medical license. 
  • Do a malpractice insurance check-up. For physicians in Ohio who care for adults, there is a 1-year statute of limitations for filing a malpractice lawsuit. But for cases involving children, that statute of limitation extends to 1-year after the child’s eighteenth birthday. In other words, a physician who prescribed a teratogenic drug to a pregnant woman can be sued by the child 19 years later. Be sure that you either have a comprehensive claims-made policy or a tail coverage policy that will provide coverage long after you retire or leave your practice.
  • For hospital medical directors and administrators, use your electronic medical record’s prescribing database to identify physicians who prescribe REMS drugs and require that those physicians be REMS-certified.
  • For medical schools, education during pharmacology courses about teratogenicity and about the REMS programs has suddenly become considerably more urgent.

Abortion prohibitionists have long set their sights on laws to criminalize abortion. There are a myriad of unintended consequences of banning abortion and many of the the socioeconomic consequences will not be fully recognized for several years. For physicians, waiting several years to protect against medical malpractice suits for prescribing a teratogenic drug will be too late. The time for physicians and hospitals to protect their patients and themselves is right now.

July 16, 2022

Categories
Intensive Care Unit

Vitamin C Doesn’t Cure Sepsis

In 2017, an article in the journal Chest reported a 5-fold reduction in the mortality of septic shock by a simple treatment with steroids, vitamin C, and thiamine. A study published last month refuted those results and showed that vitamin C has no benefit in sepsis. It is time for physicians to accept that vitamin C is not the cure for sepsis.

When the 2017 article was published, many critical care physicians wanted to believe it. Sepsis is an enormous public health problem affecting 1.7 million Americans every year and resulting in death in 250,000 of these. Worldwide, sepsis affects 50 million people and causes one-fifth of all deaths. For decades, the treatment of sepsis has focused on antibiotics and restoration of blood pressure. However, much of the damage from sepsis is not from the bacteria and other pathogens that initially cause sepsis, but instead is from the body’s immunologic reaction to those pathogens. For that reason, by the time antibiotics and intravenous fluids are started on a patient with sepsis, the cascade of inflammatory mediators and other substances produced by the body’s immune system has already started. In severe sepsis, this cascade of mediators turns into an avalanche of mediators resulting in refractory hypotension, organ failure, and death, despite antibiotics. Medical science has been searching for the magic bullet that would cure sepsis for years and thus the appeal of vitamin C.

Why vitamin C?

Vitamins are chemicals that our bodies need to function properly. We are unable to produce sufficient quantities of these ourselves so they must come from our diets. When we don’t have enough of one of these vitamins, a vitamin deficiency disorder develops. Some vitamins are fat-soluble and can be stored in our body’s fat tissues for slow release over a long period of time. Other vitamins are water-soluble and cannot be easily stored in the body. Vitamin C is one of those water-soluble vitamins our bodies cannot produce and without dietary vitamin C, scurvy can develop. Scurvy was once a common condition in people who lacked fruits and vegetables in their diets, most famously in 16th century sailors. Scurvy can result in gingivitis, bruising, shock, and death. I remember diagnosing scurvy a few years ago in a patient with alcoholism who was admitted to our ICU with his teeth falling out, dermatitis, and bruising. He had undetectable plasma vitamin C levels and improved with intravenous vitamin C.

Vitamin supplements are $30 billion a year business the United States. The theory is that if too little of them makes you sick and the recommended daily dose prevents you from getting a deficiency disease, then maybe a lot more might prevent you from getting even more diseases. One of the most famous advocates of vitamin C supplementation was Linus Pauling. He is one of only 4 people to win 2 Nobel Prizes: in his case, the 1954 Nobel Price in Chemistry and the 1962 Nobel Peace Prize. In the 1970’s, he became enamored with vitamin C and claimed that it could treat cancer, brain-injured children, and the common cold. Although subsequent clinical trials showed no benefit compared to placebo and re-examination of Pauling’s research in vitamin C was shown to be flawed, he continued to promote vitamin C as a cure for the common cold and as a treatment for cancer. Because of his stature as a scientist, he influenced many people to take large doses of vitamin C to treat or prevent various diseases. The result was a legacy of a belief that vitamin C was a miracle cure in search for a disease to treat.

The arguments for vitamin C’s benefits had some basis in science. Sepsis is accompanied by oxidative stress and the resultant oxidants cause damage to various tissues. In the lab, antioxidants can reduce the amount of injury to cells by oxidants. Vitamin C is a naturally-occurring antioxidant and so it seemed logical that vitamin C could reduce oxidant injury from sepsis.

When physicians at Eastern Virginia Medical School were faced with three patients with sepsis and in whom death appeared inevitable, they gave the patients intravenous vitamin C as a last-ditch effort. The patients recovered, leading the physicians to believe that vitamin C could be the cure for sepsis that medical science had been looking for. So, they treated 47 septic patients with a combination of intravenous vitamin C, hydrocortisone, and thiamine and compared those patients to 47 other patients who that had sepsis in the past, before they had the idea of IV vitamin C. The results were astounding with a mortality rate of 40.5% in the untreated patients and 8.5% in the vitamin C treated patients. Their findings were published in the June 2017 edition of the journal Chest.

Vitamin C enters the mainstream

Physicians throughout the United States saw the publication and jumped on the vitamin C bandwagon. The lay press was all over it. NPR reported: “Doctor turns up possible treatment for deadly sepsis”. NBC reported: “Virginia doctor’s possible cure could save millions from deadly sepsis”. A Smithsonian Magazine headline was: “Could vitamin C be the cure for deadly infections?”. In our hospital, some of the critical care physicians were convinced and started using the cocktail of vitamin C, hydrocortisone, and thiamine in patients with sepsis but other critical care physicians remained skeptical. Soon, family members of patients in our ICU were asking that their loved ones be treated with vitamin C and became angry if they were not treated with it.

I was in a unique position, I was both a critical care physician and the medical director of the hospital. Should I mandate the use of vitamin C in sepsis? Should I forbid the use of vitamin C in sepsis? Physicians are notoriously independent and critical care physicians even more so. We are often in the position of providing the treatment of last resort to dying patients. We have to make treatment decisions quickly, often without time to get consultation from other specialists or get second opinions. And since so many of our patients die, there is often a sense of “what could trying something new hurt?” It is rarely a good idea for a medical director to make a unilateral decision for the entire hospital about a controversial treatment in these situations.

Practice guidelines are a help, whether from national medical societies or from internal hospital experts. As the medical director, I could use these guidelines to base decisions about what treatments the hospital should adopt. But it takes months or years to bring together a guideline committee and have that committee deliver a final guideline document. In the short term, we could have convened a workgroup of physicians at the hospital to develop recommendations and we used these workgroups quite regularly during the first year of the COVID-19 pandemic. Instead, we influenced physician behavior by example.

One of the benefits and curses of being a senior physician is that everyone thinks you have a lot more wisdom than you actually do have. For the past 30 years, I had seen promising treatments for sepsis come and go. When I was young, I was often an early-adopter of proposed new treatments in the ICU but by 2017, I had become considerably more cautious and skeptical of treatments that seemed on the surface to be too good to be true. And so I and other senior critical care physicians did not order the vitamin C cocktail on patients during our shifts in our ICU. Soon, the other physicians started saying “Well, if the old guys aren’t prescribing it, maybe I shouldn’t either.” After an initial flurry of vitamin C orders, the doctors in our ICU stopped prescribing it.

The final nail in the vitamin C coffin

The strongest medical evidence comes from clinical trials that (1) are randomized, (2) are double-blinded, (3) involve multiple hospitals, and (4) are placebo-controlled. The 2017 vitamin C study was open-label, had no placebo group, was only performed at one hospital, and was not randomized. In other words, it used a very weak study design. But it was convincing enough to prompt the creation of other, more rigorous clinical trials. In 2019, a multicenter, randomized, double-blind, placebo-controlled study published in JAMA found no improvement in outcomes of patients with sepsis who were treated with vitamin C. In 2020, a second multicenter, randomized, double-blind, placebo-controlled study published in JAMA also found that the vitamin C cocktail did not improve any of the outcomes in sepsis. Earlier this year, two meta-analyses were published that contested the value of vitamin C in sepsis.

The most recent study in the New England Journal of Medicine showed that not only did patients with sepsis treated with vitamin C fail to improve, the vitamin C patients actually had a higher death rate than those treated with placebo. This was a massive study involving 872 patients from 35 hospitals in 3 countries. The study was randomized, double-blinded, and placebo-controlled. 31.6% of patients receiving placebo died whereas 35.4% of those receiving vitamin C died.

It would appear that this study will be the final word on vitamin C and sepsis – it doesn’t make patients better and may actually make them worse.

Lessons learned (again)

Medicine has seen remarkable breakthrough treatments over the past 50 years. And we as physicians are constantly looking for the next remarkable treatment to improve the lives of patients who have the diseases that we treat. History has shown us over and over again that the future always brings more effective treatments for almost every health condition. It is that inherent optimism for the future of medicine and our drive to find something to make our own patients better that causes us to latch our hopes onto promising preliminary studies.

In my own outpatient interstitial lung disease practice, I have treated idiopathic pulmonary fibrosis patients with medications from promising preliminary studies, only to have the medications be proven ineffective in randomized, placebo-controlled, double-blinded, multi-center trials. In the 1980’s, it was Cytoxan, In the 1990’s, it was prednisone and Imuran, In the 2000’s, it was gamma interferon and later, N-acetyl cysteine. Each drug offered hope to patients with a terminal disease… and each one was later found to not work.

Studies that suggest that a treatment is effective get a lot more attention and press coverage than studies that show a treatment doesn’t work. All too often, these negative studies are the more rigorously designed randomized, placebo-controlled, double-blinded, multi-center trials that should be the final word. Last month’s study in the New England Journal of Medicine may not get as much coverage in the lay news but it underscores the importance that as physicians, it is essential that we base our own medical practice on well-designed studies published in peer-review journals.

July 15, 2022

Categories
Medical Economics

The Medical Economics Of Firearm Injuries

Several years ago, our medical center’s chief of trauma surgery asked me “Why don’t we make your hospital a level III trauma center?” At the time, I was the medical director of a 175 bed urban/community hospital component of our larger university medical center. In order to keep the hospital open, I was always looking for ways to improve our finances and that meant looking for new income sources.

I researched the economics of trauma and called the medical directors of all of the other level III trauma hospitals in Ohio to get a feel for the most common trauma injuries that we would see and the hospital resources that would be required. I ran the numbers and it turned out that becoming a level III trauma center made financial sense.  I projected that we would primarily see an increase in geriatric fall-related fractures. The demographics indicated that most of these patients would be over age 65 and thus have insurance through Medicare. Inpatient hip, and leg fracture admissions are quite lucrative for hospitals and since we would not need to have 24-hour in-hospital surgeons and anesthesiologists (unlike the requirements of a level II trauma center), the costs would not be very high. From an academic standpoint, it would improve the exposure of our emergency medicine and orthopedic surgery residents to fractures and fracture management.

I presented our plan to the medical center’s leadership and got the green light to proceed. But during the various meetings prior to approval, one of the department chairs said “Yeah, and we can make a lot of money off of gunshot injuries”. But do hospitals really make money from firearm injuries? To answer that question, we must first look at the statistics on firearm injuries.

Firearm injury statistics

It turns out that we know a lot less about firearm injuries than other causes of injury and death. A major reason is the Dickey Amendment, named after U.S. Representative James Dickey of Arkansas. In the 1996 Omnibus bill, he added an amendment stating “…none of the funds made available for injury prevention and control at the Centers for Disease Control may be used to advocate or promote gun control.” The amendment was strongly lobbied for by the National Rifle Association and effectively stopped all research by the CDC into gun-related deaths and injuries. It was not until 2018 that Congress passed a law allowing the CDC to report data on firearm injuries and not until 2020 that Congress allowed funding for firearm injury research by the CDC.

The most widely available firearm statistics from the CDC and the FBI are the number of deaths by firearms. For example, in 2020, there were 45,222 firearm-related deaths in the United States. Of these, 54% were death by suicide, 43% were homicide, and 3% were accidental. Guns are America’s weapon of choice for homicide and account for 79% of homicides. When a gun is used for homicide, 64% of the time it is a handgun. Although semiautomatic rifles get a lot of public attention, rifles (including assault weapons) only accounted for 364 gun-related homicides in 2019 (in 32% of gun-related homicides, the type of gun was not reported). Guns are also America’s method of choice for suicide and account for 53% of all suicides. These numbers are important for public policy but really have minimal impact on hospital finances because most firearm-related homicides and nearly all firearm-related suicides are pronounced dead at the scene and never get transported to the hospital. Therefore, the cold reality is that firearm-related deaths are relatively inexpensive from a healthcare cost standpoint. Instead, the costs are incurred by the survivors of firearm injuries.

There is no single national data system that provides complete and reliable data on non-fatal firearm injuries. The U.S. Department of Justice reported that in 2018, there were 34 times as many non-fatal crimes in which a firearm was used as there were firearm-related homicides. A 2015 study reported that there were just over 2 non-fatal firearm-related injuries for every 1 firearm-related death in the U.S. Most firearm-related injuries are from assault: 85% of the time a firearm is used in suicide it results in fatality whereas only 19% of the time a firearm is used in assault does it result in homicide. For this reason, far more assault-related firearm injury victims survive long enough to make it to the hospital than persons attempting suicide by firearm. Firearm-related accidents are even less fatal with death occurring in only 5% of incidents.

One of the most complete datasets available is a report on firearm injury healthcare service needs and costs compiled by the United States Government Accountability Office (GAO) at the request of Congress in June 2021. The GAO found that the hospitalization costs of firearm injuries are just over $1 billion per year with an additional $75 million for patients seen in the emergency department but not admitted to the hospital. These hospitalizations and ED visits are expensive and cost more than twice the amount of other hospitalizations and ED visits.

In addition to hospital charges, physician professional charges add an additional 20% to these numbers. When combined, the total annual initial healthcare cost of firearm-related injuries is $1.3 billion. There are major differences in the anatomic location of injuries among those patients admitted to the hospital and those patients seen and released from the emergency department. 48% of inpatient stay costs are incurred by persons injured in multiple regions of the body where as 60% of ED-only costs are incurred by external-only (skin-only) injuries.

Most victims who arrive at the hospital survive with only 8% of inpatients and 10% of ED patients dying. Inpatient deaths account for 8% of hospital firearm injury costs and ED deaths account for 19% of ED-related firearm injury costs. There are additional post-hospital healthcare costs for survivors with 20% of inpatients requiring discharge to skilled nursing facilities or home healthcare.

There is a significant difference in payer mix among inpatients with firearm injuries versus those seen and released from the emergency department. In the ED, 37% of patients are self-pay. Most of these patients have low incomes and little financial resources. Although they are frequently sent to collection agencies, little money is ever collected on them. Consequently, the majority of self-pay charges in the ED are written off. When ED patients are insured, the most common coverage is by Medicaid (30%) followed by private commercial health insurance (20%). Only 5% of ED-only patients are covered by Medicare and this reflects the typical younger age of firearm injury victims. The average cost to the hospital for an ED-only firearm injury was $1,478 with the most costly being no-charge patients ($1,697) and the least costly being Medicare patients ($1,256). The graph below shows actual cost of care to the hospitals and not what the payers ultimately paid for ED visits.

Patients requiring inpatient hospitalization have a strikingly different payer mix with 52% of patients covered by Medicaid. This is largely because hospital billing departments work these patients rigorously to get as many self-pay inpatients to apply for Medicaid while they are in the hospital. These “Medicaid pending” cases are usually paid retroactively to the date of application once the patient’s Medicaid coverage is approved. The hospital costs per admission are highest for those patients with Medicaid ($35,862) and lowest for self-pay patients ($22,735). The graph below shows actual cost of care to the hospitals and not what the payers ultimately paid for hospitalizations.

Inpatients with firearm injuries have a different demographic than the the U.S. population as a whole. They are more likely to be male (88%), between age 15 – 44 (80%), and Black (52%). There is not data on the annual income of patients with firearm-related injuries however more than half of patients reside in zip codes where the median household income is less than $44,000 per year.

There are also differences in inpatient firearm injury rates between different geographical locations in the country. The Southern United States accounts for the largest percentage of firearm injuries (48%) but only has 38% of the total U.S. population. The average cost per firearm-related hospitalization was considerably higher in the West ($40,465) than in Northeast ($29,624), South ($28,176), or Midwest ($27,817).

There are enormous differences in firearm injuries between different states. The Rand corporation reports that annual firearm-related hospitalizations ranged from a low of 0.19 per 100,000 population in Hawaii to a high of 2.42 per 100,000 population in Louisiana, a 13-fold difference. The rate for the District of Columbia was not included in this report.

Patients admitted to the hospital with firearm-related injuries are likely to require readmission to the hospital after discharge. A 2019 study found that 12.5% of patients discharged after a firearm injury hospitalization required readmission within 6 months of discharge. Many of these patients required more than one readmission – patients who required readmission had an average of 1.7 readmissions each. About 1/2 of the readmissions occurred within the first 30 days of the initial admission. The average cost per readmission is $10,108 or about one-third the average cost of the initial hospitalization.

The GAO report does not reveal the entire impact on healthcare costs. It does not include the cost of outpatient treatment, skilled nursing facilities, or home healthcare. It also does not include the cost of mental healthcare after a firearm injury. Furthermore, the GAO report only examined hospital costs and not what payers actually paid.  A December 2020 study in the Annals of Internal Medicine looked at 2,019 firearm-related injuries in Blue Cross Blue Shield members from five U.S. states and measured the insurance company payment, plus any copayments, coinsurance, or deductible owed by the patient. The total payments for an ED-only firearm-related injury averaged $5,686 and for inpatient hospitalizations averaged $70,644 (hospitals are paid more by commercial insurance companies for any given service than they are paid by Medicare; these higher payments offset the amount hospitals lose on self-pay and Medicaid patients). The study found that in the 6-months after an ED-only firearm-related injury, total healthcare costs were $8,136 higher than in the 6-months before the ED visit ($12,120 versus $3,984). This indicates that most of the costs of a firearm injury are incurred after the patient leaves the emergency department. Similarly, in the 6-months after an inpatient hospitalization for a firearm-related injury, total healthcare costs were $17,389 higher than in the 6-months before the hospitalization ($21,507 versus $4,118). In addition, mental health claims increased by 106% after ED-only visits and by 319% after inpatient hospitalizations.

Are firearm injuries profitable for hospitals?

As a general rule, hospitals make money on commercial insurance patients, lose money on Medicare patients, lose more money on Medicaid patients, and lose the most on self-pay patients. The Medicare Payment Advisory Commission (MedPAC) reported to Congress that in 2022, the average hospital loses about 9% on each Medicare patient. This means that for a hospital to break even on any service it provides, there has to be a certain percentage of high-paying private commercial insurance admissions to counterbalance loses sustained from Medicare, Medicaid, and self-pay admissions. The ratio of these payment sources is called the payer mix. The average U.S. hospital revenue is composed of 21.8% Medicare, 12.8% Medicaid, and 66.5% private/self/other. The composition of the private/self/other component varies considerably from hospital to hospital and from state to state. For example, hospitals in Medicaid expansion states have a much lower self-pay percentage than hospitals in states that did not opt to expand Medicaid. The challenge for every hospital is to have enough commercially-insured patients to offset the losses sustained by all of the other patients in order to break even each year.

Given that only 19% of inpatients and 20% of ED-only patients with firearm-related injuries have commercial insurance, it is hard for any hospital to make firearm injuries profitable. Hospitals collect very little from the 15% of inpatients and 37% of ED-only patients that are self-pay and most of these charges are written off. These percentages are considerably higher than the population as a whole – the U.S. Census reported that in 2020, 8.6% of the U.S. population had no health insurance and 93.4% of the population had governmental or private health insurance. In short, the payer mix for firearm-injury patients is just plain bad.

To compound the problem, a physician cannot generate sufficient professional revenue to support a competitive income for themselves with this payer mix. Therefore, hospitals have to more heavily subsidize the emergency physicians and surgeons who care for firearm injuries if they want to keep those physicians on staff. This creates even more overhead costs for the hospitals.

How to reduce financial loss from firearm injury patients

Firearm injuries are classified as trauma cases and as such are preferentially directed to hospitals designated as trauma centers. These are in turn classified as level I, level II, and level III trauma centers. For a full explanation of the different levels of trauma centers, see my previous post. Level III centers are the most common and require the least hospital resources. Unlike level I and II centers, level III trauma centers are not required to have surgeons, anesthesiologists, and OR staff physically present in the hospital 24 hours a day. This greatly reduces the hospital overhead expenses of level III trauma centers compared to level I & II centers.

For all payers, surgical admissions are more lucrative than non-surgical admissions and so hospitals can often break-even or even make a profit on Medicare surgical admissions while losing money on Medicare non-surgical admissions. Therefore, for a hospital to make money on trauma admissions, it needs to attract as many patients who require a surgery sometime during their admission but preferably not in the middle of the night. This is why geriatric fall fractures are so desirable – most of them require an inpatient surgery but that surgery can usually be delayed until the following morning.  But as soon as a hospital holds itself out as a trauma center of any level, the EMS squads will bring firearm injury patients in addition to hip fracture patients. So, how does a hospital minimize financial losses from firearm-related injuries? Here are a few specific tactics:

  1. Convert self-pay to Medicaid. This is impractical for patients seen in the emergency department and released since the patients are in the ED for a short period of time. The hospital charges are not terribly high so the financial losses are not excessive. But for patients admitted to the hospital, there is enough time for the billing staff to get eligible patients signed up for Medicaid. Since Medicaid and Medicare will pay retroactive to the date of application, this can greatly reduce firearm injury admission write-offs.
  2. Develop transfer agreements with level I and II hospitals. For many level III trauma center hospitals, the costs to become a level II center is excessive, mainly from the need for 24-hour in-house surgeons, anesthesiologists, and OR staff. If the level III hospital can transfer many of its firearm-related trauma patients, then it can reduce losses, particularly from the self-pay and Medicaid patients that require surgery in the middle of the night.
  3. Reduce length of stay. Hospitals get paid by the diagnosis, not by the duration of hospitalization. By keeping the length of stay low, hospitals can reduce financial losses from firearm injury admissions. Significant length of stay reductions can even make these admissions profitable. The best measure is the “length of stay index” which is the actual length of stay divided by the national average length of stay for any given diagnosis. The length of stay index goal for firearm injury admissions should be less than 1.00 and ideally, less than 0.85.
  4. Utilize physicians who receive Upper Payment Limit funding. The Upper Payment Limit program allows certain physicians to be paid commercial insurance rates for Medicaid patients. These are largely state government-employed physicians at academic medical centers affiliated with public universities. This can result in the physicians having a payer mix equivalent to 71% private commercial insurance. This substantially improves the physician professional revenue payer mix resulting in less hospital subsidy and lower hospital overhead expenses.
  5. Convert ED-only self-pay firearm injury patients to Medicaid. As discussed earlier, most hospitals do not bother with self-pay firearm injury patients who are treated and released from the emergency department because the hospital charges are relatively low and the patients are there for a short time. However, since these patients have much higher healthcare costs in the 6-months after their ED visit than for the actual ED visit, it can be wise for the hospital to invest in staff to get these self-pay patients signed up for Medicaid while they are in the ED. That way, their subsequent outpatient care can be reimbursed.
  6. Ensure high quality post-hospital medical care. Given the 12.5% six month readmission rate, many self-pay and Medicaid patients will be readmitted to the hospital, thus magnifying hospital losses on these patients. Furthermore, since half of these readmissions occur in the first 30 days after discharge, they can count against the hospital’s readmission penalty from CMS. By developing strong medical care systems for firearm injury patients, these readmissions can be minimized. By utilizing physicians participating in Upper Payment Limit programs, outpatient physician care can break even or be profitable, even with a high self-pay population.
  7. Attend to mental health needs. The high number of mental health claims following ED visits and hospitalizations for firearm-related injuries is an indicator of the emotional trauma that accompanies the physical trauma in firearm injury patients. Although hospital subsidization of mental healthcare can be expensive, it can help reduce readmissions as well as improve patients’ quality of life.
  8. The best way to reduce financial losses from firearm injuries is to reduce the number of firearm injuries. This requires public policy decisions that go beyond the walls of our hospitals but physicians and hospitals can advocate for policies that reduce firearm injuries. However, current legislative measures and judicial decisions are moving toward policies that are resulting in increased firearm injuries.

Firearm injuries aren’t going away

Americans love guns. 39% of American men and 22% of American women own a gun and there is at least 1 gun in 40% of U.S. households. There is wide variation in gun ownership by state with 64% of households in Montana having a gun versus 8% of households in Hawaii and New Jersey having a gun. The U.S. is the only country in the world with more guns than people. We have 120 guns for every 100 residents – the next closest country is Yemen with 53 guns per 100 residents. Many states have recently passed legislation making guns even more accessible. Previously, 2016 held the record for gun sales in the U.S. with 16.7 million sold that year. In 2020, that record was shattered with 22.7 million guns sold. Also in 2020, firearm-related homicides increased 35% over 2019.

The commonly quoted slogan “Guns don’t kill people; people kill people” is only half right. The reality is that people with guns kill people. And people with guns cause firearm injuries. For hospitals, firearm injuries will be a growth business in the future but because of the payer mix of those injured, it is easy for hospitals to lose money caring for these patients. However, a few simple tactics can minimize these losses.

July 6, 2022

Categories
Epidemiology Outpatient Practice

Abortion And The Five Whys

If you know four women, then statistically, one of them has had an abortion. The current Supreme Court recently overturned the opinion of a previous Supreme Court and now permits states (or the U.S. Congress) to make abortion illegal. By applying the “5 Whys” approach to abortion, we can learn the root causes of abortion and how to reduce the number of abortions without criminalizing abortion. We can also uncover the hidden costs of abortion bans.

The five Whys

The 5 Whys originated in the early 1900’s in Japan as a method to improve textile production. What does 100-year-old Japanese loom manufacturing have to do with abortion? As it turns out, a lot. Sakichi Toyoda was a Japanese industrialist who invented an automatic power loom that at the time was the most advanced weaving device in the world. He went on to found Toyota Industries, the manufacturer of Toyota automobiles. To address quality issues in manufacturing, he created the “Five Whys” approach. This utilized asking a series of five “Why” questions to determine the cause-and-effect relationship with any manufacturing process. This approach has been incorporated in Kaizen, lean manufacturing, and Six Sigma. It is also a key component of root-cause analysis that we use in hospital quality improvement today.

An example of the Five Whys is as follows: A hospital medical director learns from the infection control department that there have been a cluster of Clostridium difficile infections in certain rooms in the intensive care unit. To understand the root cause, the medical director asks a series of Why questions:

So, the solution to the hospital’s C. difficile problem was not to close ICU rooms or fire the housekeeping employee. The solution was for the purchasing department to buy the correct spray dispensers used with hypochlorite disinfectants. If all 5 of the “Why” questions had not been asked, the root cause would never have been determined and the C. difficile outbreak would not have been eliminated.

Asking 5 Whys can sometimes be overly simplistic. In the C. difficile example, there is one root cause identified at the fifth Why. Sometimes the root cause can be found at the second Why. Sometimes it takes 6 Whys. And sometimes, there are multiple root causes that can be identified at several levels of the Whys. The point is that it is necessary to continue to ask “Why” until the root causes are all identified.

Our country has taken a superficial approach to the issue of abortion. We have let our emotions stop at the first “Why” and have not done an adequate root-cause analysis of abortion. In half of our nation’s states, politicians have determined that many women are getting abortions and asked the first Why. The answer that they found is that there are doctors willing to perform abortions. Their solution has been to criminalize abortion. The problem is that they have not asked the other “Whys”. With abortion, the root causes are complex and can be found at each level of Whys.

The demographics of abortion in the U.S.

Before we can apply the 5 Whys to the issue of abortion, we first must examine the demographics of abortion. The World Health Organization reports that worldwide, about 73 million abortions are performed each year. This equates to 29% of all pregnancies ending in abortion. In the United States, the Centers for Disease Control reports that there were 629,898 abortions performed in 2019 (the latest year data is available). The Guttmacher Institute (which uses a more thorough accounting method) reports that there were 930,160 abortions performed in 2020. This works out to 1 out of 5 pregnancies in the United States ending in an induced abortion. The U.S. accounts for about 1.3% of abortions worldwide. Additional epidemiological facts include:

  • 24% of women under age 45 years old have had an abortion.
  • The most common reason for having an abortion is not being ready to have a child (25%), followed by unable to afford a child (23%), done having children (19%), not wanting to be a single mother (8%), not mature enough to raise a child (7%), interference with education or career (4%), maternal health problems (4%), fetal abnormalities (3%), and rape (< 0.5%).
  • Most women undergoing abortion are in their twenties: 34% of abortions are in women age 20-24 and 27% of abortions are in women age 25-29.
  • 12% of abortions are performed in teenagers with 3.2% under age 18.
  • Black and Hispanic women have disproportionately more abortions than White women. Black women account for 28% of abortions but Blacks make up 13% of the U.S. population. Hispanic women account for 25% of abortions but Hispanics make up 19% of the population. White women account for 39% of abortions but Whites make up 76% of the population.
  • 38% of women undergoing abortion reported no religious affiliation; 24% are Catholic; 17% are mainline Protestant; and 13% are evangelical Protestant.
  • 86% of women undergoing abortion are unmarried and 60% already have at least one child.
  • 75% of women undergoing abortion are low income: 49% live below the Federal poverty level and an additional 26% are at 100% – 199% of the Federal poverty level.
  • 53% of women paid for their abortion out-of-pocket. The average cost of a surgical abortion is $508 and of a medication-induced abortion is $535.
  • 51% of women were using birth control in the month that they became pregnant: 24% were using condoms and 13% were using oral contraceptive pills.
  • 88% of abortions occur in the first 3 months of pregnancy and 67% occur in the first 2 months of pregnancy.
  • 54% of abortions are currently performed by medication (mifepristone and misoprostol).
  • The largest number of abortions were performed in Texas, California, New York and California, however, these are also the states with the highest populations.
  • The states with the highest rates of abortion per 100,000 population are New York, New Jersey, and Maryland.

The demographics of women who undergo abortion is remarkably similar to the demographics of infant mortality. The United States has one of the highest infant mortality rates in the world – we rank 33rd out of 36 OECD countries with only Chile, Turkey, and Mexico having higher infant mortality rates. In states where women no longer have access to abortion, it follows that infant mortality rates will rise. Many of the states poised to criminalize abortion (with either outright bans or 6-week laws) already have very high infant mortality rates:

Applying the 5 Whys to abortion

Once we understand the demographics of abortion in the United States, we can apply the 5 Whys:

  1. Why are there abortions in the U.S.?
    1. Answer: because doctors performed abortions.
  2. Why are doctors performing abortions?
    1. Answer: because a lot of women requested them due to unwanted pregnancies.
  3. Why did women have unwanted pregnancies?
    1. Answer: because effective birth control was not used.
  4. Why wasn’t effective birth control used?
    1. Answer: most commonly because effective birth control methods were too costly and there were cultural barriers to their use.
  5. Why were there cultural barriers to birth control?
    1. Answer: because men and women were not adequately educated about birth control before they had sex.

If we stop after the first why, then the solution to humans having so many abortions is to make abortion illegal and prosecute doctors who perform abortion. But this will ultimately fail. History has showed us that in the past, when abortion was illegal, women still found ways to have abortions, in other words, making it illegal will not make abortions go away. This is especially true today since prior to 10 weeks gestation, a 2-pill form of abortion is safe and effective (mifepristone and misoprostol). Currently, these drugs are approved by the FDA, are readily available, and account for the majority of abortions in the U.S. Even if a future conservative U.S. Congress bans their use, these drugs will continue to be available as street drugs and from international sources – if the war on drugs cannot prevent a marijuana joint from being smuggled into the country for street sale, how can one expect the government to prevent 2 small pills from being smuggled in?

If we stop with the second why, then the solution is to prevent women from having intercourse. There are 3 main instincts that a species must have to keep from becoming extinct: (1) an instinct to eat, (2) an instinct to keep from being eaten, and (3) an instinct to procreate. To stop Homo sapiens from having sex is to somehow overcome one of the most powerful instincts that our species has had for the past 300,000 years and led to us being the dominant species on the planet. It just won’t work. We can pass laws and we can invoke religious decrees but neither is more powerful than instincts embedded in our genes.

At the third why, we find that about half of abortions were in pregnancies where no birth control method was used. In another 37%, inferior birth control methods were used (condoms and birth control pills). Condoms are notoriously unreliable and it is way too difficult for any person to remember to take a birth control pill every single morning for years at a time. IUDs are far more reliable but not all women can tolerate them. Vasectomies are even more effective but that would require men to take more responsibility than many of them want to – I’ve fought an uphill (and usually unsuccessful) battle with many husbands of my patients for who I prescribed teratogenic medications for their advanced lung disease and in who an unwanted pregnancy would likely result in the wife’s death or in severe fetal deformity. However, I suspect that if men had to choose for themselves between the discomfort of a vasectomy versus the discomfort of pregnancy, labor, and delivery, 100% of them would take the vasectomy.

At the fourth why, we find barriers to the use of birth control in the way of cost and cultural discouragement. The cost of contraception is directly proportional to the effectiveness of contraception. Calendar watching is free but is miserably ineffective. Condoms cost about a dollar each but are not much more effective. Nor are diaphragms which are about $25 each. Birth control pills cost about $180 per year and an IUD costs about $800 (but IUDs can last 12 years resulting in a depreciated cost of $65 per year). A hormonal implant costs about $1,000 and lasts for 3 years. A vasectomy costs about $1,000 and a tubal ligation costs about $6,000 with both giving a lifetime of highly effective birth control. The over the counter morning-after pill, Plan B (levonorgestrel), costs $45 and is about 85% effective. Because the majority of women undergoing abortion are low income and a large number have no health insurance, birth control costs are a major contribution to the number of abortions performed in the U.S. The sad reality is that even the most expensive form of birth control is less expensive than the average $8,800 cost to deliver a baby, and that does not even include the indirect cost of maternity leave and raising the child if not put up for adoption.

Even when men and women have health insurance or can afford to buy contraception out of pocket, there are numerous cultural barriers to using contraception. For example, the Catholic Church forbids its members to use any form of contraception and considers contraception to be a sin. The underuse of contraception is perhaps the reason why Catholics have disproportionately more abortions than women of other religions – 24% of women who undergo abortion are Catholic whereas only 21% of the American population is Catholic. Parenthetically, it is notable that 7 of the 9 current Supreme Court Justices are Catholic or were raised Catholic; all 6 of the justices voting to overturn Roe v. Wade are Catholic. Old-Order Amish communities also forbid contraception. Most other religions permit the use of contraception but usually only within the context of marriage.

At the fifth why, we find lack of education. In most states, sex education curricula decisions are left to local school boards. Consequently, there is enormous variation in what is taught in different school districts. Children in many religious-based schools get no education about contraception and children who are home-schooled may get no formal sex education at all. The Centers for Disease Control recommends that children be taught a minimum of 20 sex education topics but fewer than half of American high schools teach all 20 of these. The Guttmacher Institute reports that U.S. adolescents in 2019 received less sex education than in 1995. In short, our educational system, both public and private has failed in sex education and this failure is an important contribution to the number of abortions in the U.S.

So, how do we reduce the number of U.S. abortions?

First, we will never eliminate all abortions nor should abortions be illegal. As a medical student, I assisted in the delivery room with a 12-year-old who was delivering a baby… no 12-year-old should ever have to deliver a baby. Forcing a child, a rape victim, or an incest victim to carry and deliver a baby is truly punishing the victim. In addition to these situations, there will always be unplanned sexual encounters and contraception method failures.

Infrequently entered into the discussion is that in the half century since Roe v. Wade was decided, there have been enormous advances in neonatology that have saved the lives of thousands of children who would have previously died in infancy. However, these same advances have also allowed medical science to keep on life support those with severe fetal deformities and chromosomal abnormalities with no reasonable chance of ever having normal cognitive development or independent function. Fifty years ago, in the pre-Roe era, they would have died within minutes or hours of delivery. These fetal abnormalities can largely be detected by a combination of ultrasound and maternal serum screening tests, neither of which existed in the pre-Roe era. Currently, serious fetal abnormalities account for up to 3% of all abortions. With no access to abortion, these fetuses will now be born and can live for weeks, months, and sometimes even years requiring ventilators, feeding tubes, and 24-hour care. The CDC reported that the annual inpatient hospitalization costs of severe birth defects was $22.9 billion in 2013. That number will be considerably higher when these fetuses can no longer be legally aborted.

In all of these situations, an unwanted pregnancy puts unwanted health and financial demands on the woman. It also places her at a competitive disadvantage in the workplace that can result in gender income disparities and barriers to professional advancement. Adoption is often offered as the solution to unwanted pregnancies but the reality is that most women do not put the child of an unintended pregnancy up for adoption. There are approximately 2.8 million unintended pregnancies in the U.S. every year. The National Council for Adoption reports that in 2020, there were 55,659 public adoptions in the U.S. The USDA estimates that the cost to raise a child to age 18 is $284,000 and this does not include the indirect cost of career development impediment faced by the (often single) mother raising that child.  It may take 2 people to create a pregnancy but it is the woman who pays most of these costs, not the man. Simply making abortions illegal does nothing to address this and in fact, makes it considerably worse.

We can (and should) reduce the number of abortions in the United States. If she didn’t have to have an abortion, no woman would want to have an abortion – it’s not like it is a fun experience. No woman says “What should I do to have fun this weekend? Maybe go to a concert, or go see a movie, or maybe get an abortion?” America’s abortion problem is an unwanted pregnancy problem. The most effective way to reduce the number of abortions is to reduce the number of unwanted pregnancies and for that, we need to turn back to the five Whys and the following conclusions:

  1. We cannot rely on the fantasy of abstinence and chastity. $3.2 billion in child sex lawsuit settlements says that this didn’t work for a lot of Catholic priests so why should it work for everyone else?
  2. We need to improve and standardize sex education and contraception education in our private schools, public schools, and home schools.
  3. Birth control (including vasectomy) should be free for all Americans – 135 women could have an IUD for a year for the same taxpayer cost of one woman on Medicaid delivering an unwanted pregnancy.
  4. We cannot base laws and social expectations founded on unrealistic religious doctrines that defy the most basic elements of human nature.

What do the 5 Whys tell us about the hidden costs of abortion bans?

On the day that the current Supreme Court overturned Roe v. Wade, abortion became completely illegal or illegal after 6-weeks gestation in many states and undoubtedly will become illegal in more states in the months to come. There are hidden costs to everything and by looking at the 5 Whys of abortion, we must be prepared to pay for the hidden costs of abortion bans:

  1. Localities with laws making abortion illegal must also have counterbalancing laws mandating paid maternity leave, government-paid maternal healthcare, and government-paid childcare. Anything less is state-sponsored victimization of women.
  2. Localities with laws making abortion illegal must also have laws providing for the post-delivery healthcare costs of fetuses that have severe fetal deformities and chromosomal abnormalities.
  3. Localities with laws making abortion illegal after 6 weeks of gestation must also have laws providing unlimited free pregnancy testing so that pregnancy can realistically be identified before 6 weeks.
  4. Localities with laws making abortion illegal must be prepared for an increase in infant mortality and should begin investment in programs to reduce infant mortality.

I’m like most Americans

Being retired gives me a freedom that I never had when I was a practicing physician. I no longer have to withhold my opinions about controversial issues for fear of offending my patients who hold different viewpoints or fear of incurring the wrath of deans, department chairs, and hospital CEOs. I can now freely say what I believe.

Abortion is subject to basic economic supply and demand principles like most everything else in life. Making abortion illegal only addresses the supply side and does nothing for the demand side. Focusing only on supply was ineffective with Prohibition in the 1920’s and has been ineffective with marijuana laws today. Economics tells us that reducing supply of a product or service without reducing demand will only increase the price of that product or service – reducing supply alone does not eliminate demand.

When it comes to abortion, I believe it should be legal. But I also believe that we do too many abortions. In short, I’m like most Americans.

The way to reduce demand for abortions is to reduce unwanted pregnancies. By doing a root cause analysis of abortion in the United States using the 5 Whys, we can identify how to reduce the number of abortions by reducing unwanted pregnancies. The 5 Whys also uncover the unintended consequences and hidden costs of abortion bans. Our societal goal should be to make abortions fewer and not to make abortions felonies.

July 2, 2022