Pandemics are not new. Have we learned anything from 1918-1919 Influenza?

The 2020 viral pandemic (COVID-19)[1], in spite of being due to a novel virus family, bears striking epidemiological and social resemblances to the Influenza pandemic of 1918[2]. Both seemed to have appeared from out of the blue and both caused severe disease around the globe[3].  Some have labeled the 1918 contagion as one of the worst in world history[4]. It was troubling in that no one knew what caused it. In the early 20th century, many physicians believed Influenza was caused by a bacterium (Pfeiffer’s Bacillus also called Hemophilus Influenza – see below). Viruses were a newly discovered series of pathogens[5] and were largely a theoretical construct, the understanding of which would have to wait until 1933[6]. The genetic makeup of the H1N1 Influenza A virus, which was responsible for the 1918/19 flu, would then not be defined until the last decade of the 20th century[7]. On the other hand, the causative organism for Covid-19 was discovered to be a virus of the Corona virus family very soon after the disease was first recognized.  An examination of the time course and of both the medical and social responses to the 1918-1919 Influenza epidemic might hold some insights and cautions as we look at the COVID -19 pandemic.

John Barry[8] and Susan Kent[9], among others, have written fairly comprehensive treatises on the 1918/19 epidemic.  They outline three distinct phases of the pandemic, which they believe first started in Haskell County in western Kansas.  It was initially considered simply a unique and somewhat harsher form of “seasonal influenza” that began just eight months after the US entered World War I. Young men were being introduced to basic training camps (cantonments) around the country. Several recruits from Haskell County ended up in Camp Funston in the Fort Riley, Kansas complex.  They probably brought the flu to Camp Funston, and then, as men from Camp Funston went to other cantonments around the country, they took more than just their kit and rifles. They took the new Influenza. In the spring of 1918, the virus infected mainly soldiers and made them quite ill, but this phase of the illness didn’t seem to carry a high mortality[10]. A second wave of this Influenza came in the fall of 1918.  This was incredibly severe and sudden with a high mortality mainly among young people, “in the prime of life”.

Both the 1918 Flu and the current 2020 Covid-19 illnesses are viral in origin. Viruses are, for many reasons, difficult to treat with only a few having specific drug therapies. Human Immunodeficiency Virus is one exception to this. HIV treatments, which are specific to this virus, have been successful in improving survival of people with or at risk of infection since the late 1980’s[11]. Another viral disease for which there are specific antiviral treatments is Hepatitis C[12].  Most viral diseases are best treated by prevention, and/or vaccination.

Viruses can cause illness by themselves, but these germs may also predispose the “victim” to developing superinfections with bacteria. Other than HIV and Hepatitis C drugs, there are to date (May 2020) no medications that do much more than shorten the duration of viral illnesses. If correctly identified, a bacterial complication can be treated with antibiotics which modifies the course of the illness.  On the other hand, both bacterial and viral pathogens can be attenuated by vaccination.  Today we have vaccines for “seasonal influenza” (either type A or B) and for the most common causes of bacterial pneumonia, as well as many other viral illnesses[13].  Development and testing of vaccines for viruses is difficult and time consuming[14]. In 1918, vaccines against pneumococcus were being developed and appeared to be useful in decreasing the mortality of those exposed to “the flu”.  The 1918 experience in Chicago suggested that people vaccinated against bacterial complications had a much more benign course than those not vaccinated[15]. In the 21st century it is essentially routine to vaccinate a large segment of the population with one of the Pneumococcal vaccines.

However, non-medical or Public Health interventions to decrease the community upshot of the virus, both then and now, have the most impact. Interfering with transmission of the virus from person to person seems to be the most effective with the least potential harm of the interventions available.  This was called “crowding control” in 1918 and “Social Distancing” in 2020.  Face coverings for the general population in the US and Western European countries have been controversial[16]. Recent data suggest that they may help decrease the infectiveness of viruses and they have a very low likelihood of harms. Facemasks were recommended in many, but not all, cities in 1918 and are again now. Keeping people with known disease away from others (quarantine) is an important component of breaking the transmission chain.  Optimally this requires identifying those carriers who are minimally symptomatic and isolating them (often using interventions in the rubric Test, Track and Trace).

When there is a way of identifying carriers, this sequence is fairly easy to do. If the infecting organism is not known, as it wasn’t in 1918, then retrospectively identifying contacts and isolating them is much harder. It is easier to find asymptomatic carriers of the virus if we can by simply test and perform a culture. In 1918 most industrial plants, offices and schools were kept open, but entertainment venues including theaters, dance halls, and sporting events were prohibited by Public Health Commissioners[17].  Another means of transmission of infecting organisms is from “fomite-to-finger-to-mucosa” transmission.  This suggests that wiping surfaces and frequent hand washing should also be an important means of mitigating contagions. In addition, fumigating buildings and rooms with disinfecting sprays or fumigation should help interfere with viral transmission. Whether using ultraviolet or infrared lights will have an impact on sanitization has not yet been shown.

Public health initiatives are thought to work best when directed by a central source. In 1918, as in 2020, developing public initiatives that were known to be effective were delayed. In 1918, as today, the initial official response to the illness has been to the effect that “it won’t be so bad”[18].  However, in many cases, as our understanding of the mechanism and intensity of the spread of the virus becomes more complete, public health experts have modified and or walked back from more optimistic assessments of the potential seriousness of the problem. In part, the hesitancy of public health officials to sound an alarm is at least twofold. First, scientists want to be fairly sure of the data that might suggest one stance or another. Secondly, officials are hesitant to raise alarm and increase society’s anxiety inappropriately. They don’t want to be caught in the bind of being the “boy who cried wolf too often”. These two considerations are potentially in conflict with educating the public on potential consequences of an impending plague.  In retrospect majority of public health authorities, point out that education of the public is of paramount importance. Striking the balance between generating public anxiety and fully informing the populace is very delicate.

The autumnal outbreak of the 1918 illness ran a course of approximately 3.5 to 4 months across the country from early September in Boston to mid-December in Los Angeles. There was a third unanticipated wave, of the disease from January to April 1919[19]

The 1918-1919 flu killed between 40 million and 50 million people worldwide including approximately 675,000 Americans[20].  It was reported to have affected/infected about ¼ of the world’s population. Counting those with minimally symptomatic or asymptomatic infection may have resulted in a higher estimate of the extent of the disease but lower estimates of the mortality rate. The rates for the current Covid-19 illness are yet to be determined. Rates in different communities appear to vary. There have been suggestions that social vulnerability has been associated with worse outcomes from pandemics both currently and in 1918. In 1918, looking at the death rates in the British Military in India showed that the British troops had a 10% mortality while the Indian troops had an almost 20% mortality[21].  Similar variations in Covid-19 mortality rates exist between socially vulnerable and the more well-to-do populations in the US[22]. In Chicago in 1918, on the other hand, the Black Communities were said to do better than the general population[23]. That discrepancy is hard to reconcile, and MAY have been related to poorer record keeping in that community.

In 1918 there was no national response to epidemics or pandemics. Medicine was just beginning to take on a scientific bent and federalism certainly superseded central government planning and control. In the early 21st century, on the other hand, there has been an increased understanding and reliance on forward thinking responses to problems based on planning.  There have been many potentially lethal situations that have been mitigated by having a pre-thought-out response in advance[24].  In the summer of 2019, there was a federally sponsored multi state planning exercise, called the “Crimson Contagion” exercise to test the community’s ability to respond to a respiratory virus threat.  There were recommendations to improve central planning and the ability to provide needed equipment to areas of need. The report was evidently not acted upon[25]

The 1918/9 H1N1 Influenza epidemic and the 2020 Covid-19 Coronavirus epidemics in the United States have many similarities. The differences in the sophistication of the medical responses then and now have perhaps blunted the severity of the Covid-19 illness. However, the main responses inducing various isolation techniques are similar. As of the middle of May 2020, the illness has essentially shut the country down, to a greater extent than 1918. The autumnal peak of 1918 illness lasted slightly longer than three months[26]. The shut down in the US in 2020 began in late March (two months ago as of 5/19/20). There WAS, however, a second lower volume but also severe wave that began in beginning of 1919.  That wave almost took President Wilson’s life while he was in the negotiations to wrap up WW I.

It would appear that central coordination and decisive action, based on the best available data – both scientific and social – would serve the country well. Reviewing contemporary reports with an unbiased eye considering both benefits and harms of either action or inaction would be critical to optimizing a response.  Armed with data such as that provided in the Crimson Contagion report, other planning documents, as well as the after-action reports from prior catastrophes, both potential and aborted, our responses to the current and future threats should be able to be mitigated.

End Notes:
[1] The Acronym stands for Coronavirus Disease from 2019. It would almost be neater to write as CoViD-19
[2] There have been many other pandemics that have affected a large part of the world as it was known at the time. (https://listverse.com/2009/01/18/top-10-worst-plagues-in-history/  ; https://www.washingtonpost.com/graphics/2020/local/retropolis/coronavirus-deadliest-pandemics/  )
[3] Kent, S.K: The Influenza Pandemic of 1918-1919: A Brief History with Documents: 2013; Bedford/St. Martin’s, Boston MA (ISBN: 978-1-319-24162-9 (ePub)
[4] The numbers quoted for some of the “worst” plagues are at best a little fluid. Some data suggest that the “Spanish Flu” was about the 3rd worst: Bubonic Plague (1347-1351) worst with 750,000 to 1 MM killed worldwide: and Smallpox in the “New World” in 1520 killed 56MM First Nations People.  However, if we use 100MM as the worldwide death toll of the “Spanish Flu” then it is up there.  https://www.washingtonpost.com/graphics/2020/local/retropolis/coronavirus-deadliest-pandemics/
[5] The tobacco mosaic virus was suspected in 1892 as a “filterable” agent. The influenza virus was not characterized until 1933, after the electron microscope was perfected.
[6] Barry, J.M.; The Great Influenza: The Story of the Deadliest Pandemic in History.  Penguin Books 2018 and Kent op cit
[7] Taubenberger, J.K; Reid, A. H.; Krafft, A.E, Bijwaard, K. E., Fanning, T. G.: Initial Genetic Characterization of the 1918 “Spanish” Influenza Virus; 1997; Science, 275, 1793-6: https://www.jstor.org/stable/2892709
[8] Barry, J.M.; op cit.
[9] Kent, S.K: op cit.
[10] http://ocp.hul.harvard.edu//contagion/influenza.html
[11] https://ccr.cancer.gov/news/landmarks/article/first-aids-drugs
[12] https://www.hepatitisc.uw.edu/page/treatment/drugs accessed 5/19/2020
https://www.healthline.com/health/hepatitis-c/evolution-of-treatments#late-zeros
[13] Pneumovax as prophylaxis against most dangerous superinfection is almost universal (Prevnar 13 or 23) now a days as are vaccines to counter smallpox, measles, mumps, rabies, and many other viral and bacterial pathogens
[14] Up to the middle of 2020 the world record for development of a vaccine against a viral illness was approximately four years (https://www.nytimes.com/2013/05/07/health/maurice-hilleman-mmr-vaccines-forgotten-hero.html)
[15] Robertson, JD:  A Report on An Epidemic of Influenza in the City of Chicago in the Fall of 1918  Department of Health City of Chicago, 1918:  https://archive.org/details/reportonepidemic00robe/page/n5/mode/2up  P 90
[16] There was significant controversy as to the effectiveness of non N-95 face masks as a preventive for influenza Until new data from the 20teens and 2020.
a. MacIntyre, C.R;  Chughtai, A.A.: A rapid Systemic Review of the Efficacy of Face Masks and Respirators Against Coronaviruses and other Respiratory Transmissible Viruses for the Community, Healthcare Workers and Sick Patients: Int J Nurs Stud 2020 Apr 30-P 103629.  doi: 10.1016/j.ijnurstu.2020.103629  accessed 5/14/20
b. Offeddu, V.; Yung, CF;l Low, MSF; Tom, CC: Effectiveness of Masks and Respoirators Against Respiratory Infections in Healthcare Workers: A Systematic Review and Meta-Analysis:  2017 Clinical Infectious Disease: 65; 1934-1942?  https://doi-org.ezproxy.galter.northwestern.edu/10.1093/cid/cix681   accessed 5/14/20
c. Javid, B; Weekes, MP; Mateson, NJ: Covid-10 should the public wear face masks? Population benefits are plausible and harms unlikely:  2020 BMJ; 369:m1442   doi: 10.1136/bmj.m1442
[17] Robertson, JD, op cit p. 46
[18] Dr. John Dill Robertson, the Commissioner of Health for Chicago is reported to have downplayed the potential hazard of the reported risks of influenza: he is reported to have said on September 24 “There is no cause for alarm whatever.” Chicago Sun Times on October 16, 2005:  https://chicago.suntimes.com/coronavirus/2020/3/20/21186633/coronavirus-chicago-spanish-flu-influenza-pandemic-1918
Public health experts today initially did not push for vigorous interventions. https://www.snopes.com/fact-check/fauci-nothing-to-worry-about/
Many times this desire not to worry people has “political” motives. In 1918, President Wilson’s government forbad discussions that would hinder “the War Effort”.  Officials also don’t want to get a reputation for unnecessarily painting a “doom and gloom” scenario.  Their credibility is at least partly at stake
[19] There is a website housed at the University of Michigan which has a well-documented event timeline http://www.influenzaarchive.org
[20] https://virus.stanford.edu/uda/
[21] From Barry in: Institute of Medicine (US) Forum on Microbial Threats; Knobler SL, Mack A, Mahmoud A, et al., editors. The Threat of Pandemic Influenza: Are We Ready? Workshop Summary. Washington (DC): National Academies Press (US); 2005. 1, The Story of Influenza. Available from: https://www.ncbi.nlm.nih.gov/books/NBK22148/
[22] Villarosa, L: ‘A Terrible Price’: The Deadly Racial Disparities of Covid-19 in America.  New York Times, April 29, 2020:  https://www.nytimes.com/2020/04/29/magazine/racial-disparities-covid-19.html
[23] Robertson, J.D.: Op  Cit  p 99
[24] The fact that the recent outbreaks of Ebola has not become more of an international problem probably relates to the fact that the regions in West Africa are reasonably isolated from the rest of the world. Thomas E. Duncan who evidently brought the virus to the US. He was diagnosed and treated in isolation.  Two nurses who cared for him contracted the illness and were treated with isolation. They survived.
[25] Crimson Contagion 2019 Functional Exercise:  https://int.nyt.com/data/documenthelper/6824-2019-10-key-findings-and-after/05bd797500ea55be0724/optimized/full.pdf
The report concluded:
“Existing statutory authorities tasking HHS to lead the federal government’s response to an influenza pandemic are insufficient and often in conflict with one another
Currently, there are insufficient funding sources designated for the federal government to use in response …
It was unclear if and how states could repurpose HHS and the CED grants as well as other federal dollars to support the response to the influenza pandemic”
[26] From early September in Boston until mid to late December in St. Louis

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It Ain’t What You Don’t Know That Gets You into Trouble. It’s What You Know for Sure That Just Ain’t So”[i]

Dogma is interesting. It often arises in the absence of unassailable data. Almost all data start as derivatives from imperfect information. This would suggest that these data should then be reconsidered. Sometimes follow up studies, which are hopefully “better”, support dogma. Frequently, they don’t.

Consider the case of an elderly man with carcinoma of the bladder. After two trans urethral tumor resections, he was put on induction intravesicular BCG bladder therapy and then maintenance for a planned total of 3 years of periodic BCG installations.

Recently (about February 2019) a national/worldwide shortage of BCG became apparent, and distribution from Merck changed. There just wasn’t enough BCG to treat everyone with bladder cancer for the full 3 years as the “standard of practice” dictated. The American Urological Association (AUA) then re-evaluated the evidence on duration of maintenance therapy. The review suggested that more than a year of every 3-month maintenance therapy might have very little incremental benefit over one or two years. The incremental benefit of a third year of maintenance therapy was small. In addition, many of the prior AUA recommendations for therapy have a “Level C” certainty[ii]. It appears that the “standard of care” was based on the way that the initial study of BCG as immunotherapy for Non-Muscle Invasive Bladder cancer was performed[iii], without careful analysis of follow up information.

This experience suggests that when a therapy works, practitioners tend to follow the recommendations as they were written. These recommendations were based on an understanding of the biology of an illness at the time they were written. However, as our understanding of the biology of disease becomes clearer, these shifts in understanding might justify another look at treatment. Ideally this would be done with a Randomized Controlled Clinical Trial, but a registry of therapies for disease should be an acceptable second approach to get data that may overturn existing dogma.

There are examples of dogma, sometimes based on early, imperfect data and sometimes based on opinion, that isn’t/wasn’t effectively challenged, in the field of cardiovascular medicine. These include believing that thrombosis was not the cause of myocardial infarction; and believing that revascularization is superior to non-interventional therapy in coronary artery disease.

Intuition would suggest that Coronary Artery Bypass Grafting (CABG), described by Favalaro in 1967, should be lifesaving in patients with CAD. “Common sense” and the VA cooperative trial said that better blood flow to the heart had to prevent MI and death (the VA trial really only said L-main disease was the lesion in which surgery prevented death). Later trials, notably the Coronary Artery Surgery Study (CASS) showed that there was no major mortality benefit[iv].

Later, still working on the theory that an opened artery should be associated with reduced complications of CAD, interventional cardiologists began to preach that the only way to diagnose CAD was with an invasive angiogram[v]. Once an angiogram showed a narrowed coronary artery then a Percutaneous Coronary Intervention (PCI) or Angioplasty should be done to allow normal coronary flow[vi]. This should prevent MI or death. In 2007 a multicenter, randomized, controlled clinical trial to test this theory was performed[vii]. This study, and a long-term follow-up report also failed to show a benefit to interventional restoration of blood flow in the absence of an AMI. There are data that PCI is potentially beneficial when used to treat a patient with AMI, based on a change in understanding of the pathogenesis of AMI.

The clinical diagnosis of heart attack or Myocardial Infarction (MI) was initially synonymous with coronary thrombosis[viii] In the mid 20th concept was challenged by many authors[ix]. It was not until a very brave cardiology group showed that clot was in fact the cause of MI, that a completely new paradigm of treatment of MI – treating a clot in the artery responsible for the problem[x].

There are many other examples of a new look at an old problem which may result in a better understanding of a clinical condition and lead to markedly improved therapies.

In other situations, a new look may prove a therapy, that initially seemed to be beneficial, to in fact be harmful and actually not helpful to patients (often at high financial cost)[xi].

Observations such as these[xii] may lead patients and physicians to a sense of futility and angst. If there is so much medical reversal, how are we ever to know what to do? Here, I think, we need to realize that there is no certainty in almost anything and that we should go with our best assessment of the best available data. If something “new” comes up and overturns a dogma, then we should embrace the new knowledge and adjust our behavior accordingly. We should understand that in general those reporting in the literature are trying to do the best they can for their patients and the public in general. Sometimes what we thought was true isn’t. That’s when we might get into trouble.

 

End Notes:

[i] The actual source of this statement is evidently unknown: Mark Twain probably said: “It is better not to know so much than to know so many things that aren’t so.” https://quoteinvestigator.com/2018/11/18/know-trouble/

[ii] Diagnosis and Treatment of Non-muscle Invasive Bladder Cancer: AUA/SUO Joint Guideline (2016): https://www.auanet.org/guidelines/bladder-cancer-non-muscle-invasive-guideline#nmibcrisktable accessed 6/5/2019. This is a review of data to 2014. There are 254 citations to the medical literature and disclaimer at end
They use Strength of Evidence statements: A-High; B-moderate and C-low. If no good evidence, then they  labeled as: Clinical Principles and Exert opinion. “The 38 statements created vary in level of evidence,  but none include Level A evidence, and the majority are Level C evidence”

Solsona, E.: Re: Final Results of an EOETC-GU Cancers Group Randomized Study of Maintenance Bacillus Calmette-Guerin in Intermediate – and High-risk Ta, T1 Papillary Carcinoma of the Urinary Bladder: One-third Dose Versus Full Dose and 1 Year Versus 3 years of Maintenance: European Urology, 2014, 65, 847-848: https://doi.org/10.1016/j.eururo.2013.12.034 accessed 8/27/2019

[iii] Morales, A; Eidinger D; BruceA.W. : Intracavitary Bacillus Calmette-Guerin in the Treatment of Superficial Bladder Tumors: J Urol, 1976; 116; 180-183.
This study was done with 6 weeks of “Induction intravesical therapy and then 3 year follow up. The authors admit that “the regimen is arbitrary …” (p894)   There were no recommendations about “maintenance therapy”

[iv] There were many CASS trials. An initial two were published in 1983: CASS Study Group: Coronary artery surgery study (CASS): a randomized trial of coronary artery bypass surgery. Survival data. Circulation. 1983;68:939-50. https://www.ahajournals.org/doi/abs/10.1161/01.CIR.68.5.939   https://doi.org/10.1161/01.CIR.68.5.939 accessed 8/20/2019 and Coronary artery surgery study (CASS): a randomized trial of coronary artery bypass surgery. Quality of life in patients randomly assigned to treatment groups.: Circulation. 1983;68: 951–960:   https://doi.org/10.1161/01.CIR.68.5.951 accessed 8/20/2019 both showed minimal if any mortality or symptomatic benefit from CABG. Follow up research has not refuted any of the initial data.

[v] Any other diagnostic assessment of CAD was “70 cm from the truth” (an angiographic catheter was approximately 70 cm long)

[vi] This line of reasoning was dubbed, by many, “the occulostenotic reflex” – if you see a narrowing (stenosis), “fix” it.

[vii] In the early 20th Century, it was considered unwise to propose, let alone perform such a study. Nonetheless, the study was done, under the Acronym COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation). This study and a subsequent one looking at longer term (8 years) failed to show that Angioplasty, in patients with stable coronary disease, prevented death or heart attack

Bowden, WE; O’Rourke, R.A.; Teo, KK; et al: Optimal Medical Therapy with or without PCI for Stable Coronary Disease: N Engl J Med 2007; 356:1503-1516: DOI: 10.1056/NEJMoa070829

Followed 8 years later by
Sedlis, SP: Hartigan, PM; Teo, KK: et al: Effect of PCI on Long-Term Survival in Patients with Stable Ischemic Heart Disease. : N Engl J Med 2015; 373:1937-1946: DOI: 10.1056/NEJMoa1505532

[viii] The initial clinical description by Herrick in 1910 was entitled “.: Clinical Features of Sudden Obstruction of the Coronary Arteries”: JAMA; 1912; 59; 2015-2020.

[ix] Weisse, AB: The elusive clot: the controversy over Coronary Thrombosis in Mocardial Infarction: J. History of Medicine and Allied Sciences, 2006, 61, 66-78:   https://www.jstor.org/stable/24632276 Subscription may be required

[x] DeWood, MA; Spores, J; Notske, R; et al: Prevalence of Total Coronary Occlusion during the Early Hours of Transmural Myocardial Infarction: New Engl J Med; 1980; 303:897-902 DOI: 10.1056/NEJM198010163031601: 30 refs, 1992 citing articles.
DeWood,MA; Helt,J; Spores, J; et al: Anterior transmural myocardial infarction: effects of surgical coronary reperfusion on global left ventricular function: JACC, 1983, 1, 1223-34

[xi] Frakt, A: Why Doctors Still Offer Treatments that May Not Help – The New York Times Aug 26, 2019: https://www.nytimes.com/2019/08/26/upshot/why-doctors-still-offer-treatments-that-may-not-help.html?searchResultPosition=1

[xii] One other significant reversal came from the WHI randomized study (Manson JE et al.  Menopausal hormone therapy and health outcomes during the intervention and extended post stopping phases of the Women’s Health Initiative Randomized Trials.  JAMA 2013;310:1353-1368.) which changed the habit of recommending hormone replacement therapy, the efficacy of which had been suggested by the observational study of the “Nurses Health Study”: Grodstein, F; Stampfer, M.J.; Manson, J.E.; et al: “Postmenopausal Estrogen and Progestin Use and the Risk of Cardiovascular Disease”: New Eng J Med; 1996; 335; 453-61

 

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Why Don’t Many People Like “The Patient Protection and Affordable Care Act” (PL 111-148) also known as “ObamaCare”?

In 2010, the Affordable Care Act was passed by the Congress and was signed into law by President Obama. The House, Senate and President were all Democrats.[i] Since then, a significant portion of the United State population has voiced disapproval of the act. Some of the opposition has been simply a partisan political party disagreement in basic approaches to government. The underlying premises of the law, improving the delivery of healthcare and making it available to the whole country are hard to argue against. Much of this bill had origins in the Republican law in Massachusetts, known as RomneyCare after the Republican Governor who proposed and shepherded health care reform[ii]. The passage of PL111-148 involved what was perceived as stampeding the bill through congress. With Senators Daschle and Kennedy no longer in the senate, the Democrats bypassed the possibility of a Republican filibuster, by using a maneuver called reconciliation or by changing the Senate Rules[iii]. One highly visible portion of the bill mandated that everyone have some form of insurance or pay a penalty[iv]. This was intended to ensure that insurance did, in fact, spread health care cost risks over the whole country. To allow people to have a marketplace for buying insurance, the bill encouraged states to establish purchasing cooperatives for individual insurance. This was to be accomplished through the establishment of government run “exchanges”. There were also many other aspects of the provision of healthcare that involved federal and state governments supervising or mandating (hopefully improving) various components of care.

Administrative problems surfaced as the roll out of the insurance exchanges began in 2013. Many of the buyers participating in the exchanges were those who did not have employer based or government sponsored insurance[v]. Despite a section[vi] of the bill that was supposed to simplify the language of insurance[vii], many of the various insurance options were difficult to read and understand. People didn’t appreciate the differences in coverage provided by the various levels of plans[viii]. Insurers were hesitant to support the exchanges, and often did not offer products on many of the state based exchanges. Many of those that did offered policies that covered care only through what are called “narrow networks” of physicians. This meant that at least a significant number of people who liked their doctors were not able to keep them[ix]. In 2016 it appeared that some of the problems associated with the functioning of the exchanges and insurance company participation were on their way towards resolution. A second major complaint against the bill was that it seemed to impose a number of governmental regulations/restrictions on some providers, especially health insurance companies. These entities had done some “bad things” in the past, in the name of business practices (maximization of profits). These included charging premiums for “pre-existing conditions” and putting arbitrary limits on how long the insurer was liable to provide payment for a patient condition. In addition, the practice of rescission was rampant, causing people who thought they were insured to be responsible for medical bills that they had believed were covered. In order to ensure that insurance would cover certain basic services, the Bill proposed a series of “Essential Health Benefits”. These included:

Essential Health Benefits in PL 111-1148

1. Ambulatory Services 6. Prescription Drugs
2. Emergency Services 7. Rehabilitative Services
3. Hospitalization 8. Laboratory Services
4. Care for Pregnancy, Maternity and NewBorn 9. Preventive and Wellness Care
5. Mental Health Care including Substance 10. Pediatric Care

There were things that were NOT included in the initial bill. Abortion was not included, nor was birth control specifically covered[x].

In addition, the bill limited the profits that insurers could realize. This was in the form of what was called a “Medical Loss Ratio”. For most insurers the MLR was pegged at 85%[xi].

The concept of spreading risk amongst the whole population by mandating that everyone in the country buy insurance (Individual Mandate) was immediately attacked as Congressional overreach. The Supreme Court got involved and eventually ruled that a special tax could be imposed by Congress, on those who elected/chose not to “play” in the health care insurance concept.

As the bill was being crafted, there was a significant amount of disinformation being promulgated. One of the worst pieces of misinformation that sought to discredit the bill was the concept of “Death Panels”. This term was used as a descriptor of the concept that insurers pay doctors or other health care professionals a fee for discussing with a patient what his/her wishes for end of life care. This would allow the discussion to be had while the person was in full command of his or her senses. Two women, Betsy McCaughey and Sarah Palin, fueled this misrepresentation of the spirit of the mandate to allow physicians to discuss end of life care, as “the government” supporting euthanasia. There was nothing in the bill to support that contention. In 1993 similar mischaracterizations of the Clinton “Health Security Act of 1993” was being proposed. The “Harry and Louise” advertisements misrepresented the tenor of the proposed health care plan and helped solidify opposition to the legislation[xii].

People also objected to allowing the Centers for Medicare and Medicaid Services to study ways of paying for and delivering care, which was proposed by the formation of the Centers for Medicare and Medicaid Innovation.

Almost all of the objections to the bill might be characterized as objections to government participation in the delivery of healthcare (payment, business practices, and provision of care). This was branded by many as “Socialism” and political posturing. It is even possible that some objected to Mr. Obama himself and did not want to support anything that he proposed[xiii]. Some objections were simply mischaracterization or misunderstanding of parts of the law.

—————————————————–

Endnotes:

[i] Most of the major bills relating to social welfare, including healthcare have been sponsored by the Democratic Party (Social Security in 1935, Titles XVIII & XIX (Medicare and Medicaid in 1965; The Affordable Care Act 2010). Republican congresses and Presidents made many meaningful revisions to these laws.

0[ii] https://www.mass.gov/info-details/health-care-reform-for-individuals accessed 7/11/2109

[iii] Changing the rules was called “the Nuclear option”

[iv] This provision is directly from Republican Massachusetts program. In fact, two of the Republican “Repeal and Replace” bills of 2018 had a similar provision, where if someone didn’t have continuous coverage (with a few caveats), insurers could charge a surcharge, for at least a year, on any policy that someone wanted to buy

[v] Government based insurance included the armed services and dependents, Veterans covered under the Veterans’ Health Administration and Medcare (Title XVIII of the Social Security Law) and Medicaid (Title XIX), Children’s Health Insurance Program and the Indian Health Service. These programs actually insure somewhere between 33-45% of all Americans. https://www.center-forward.org/wp-content/uploads/2012/04/Medicare-Medicaid-and-the-Military-04-12-update-2.pdf accessed 7/9/2019   https://www.crfb.org/papers/american-health-care-health-spending-and-federal-budget accessed 7/9/20190

[vi] Section 2715: “Development and Utilization of Uniform Explanation of Coverage Documents and Standardized Definitions”:

[vii] The simplification of language was not meant to take effect until late 2017, at least three years after the implementation of the exchanges. It is not clear that the readable Summary of Benefits and Coverage (SBC) provisions of the act have ever been fully implemented.

[viii] The basic plans were “Bronze, Silver, and Gold”. Each was more expensive than the next. Each had different deductibles and co-pays. In addition, each more expensive, program had fewer restrictions on what was “covered”.

[ix] This made President Obama appear to be going back on his promise of, “If you like your Doctor you can keep your Doctor”. (It might behoove politicians to remember that definitive statements like this and “Read my lips. No new taxes” often come back to bite the speaker).

[x] The “Birth Control Mandate” was added by a rule promulgated in 2013 related to “Women’s preventive health services” as put forth in guidelines supported by the Health Resources and Services Administration (HRSA). https://www.govinfo.gov/content/pkg/FR-2013-07-02/pdf/2013-15866.pdf accessed 7/8/2019

[xi] That meant that insurers had to pay out 85% of premium income for medical expenses. Fifteen percent was left for S, G, & A expenses and “profit”. This effectively would have limited the salaries paid to various executives.

[xii] The “Harry and Louise” ads were supported by the Health Insurance Association of America and are said to have torpedoed the HSA of 1993. https://adage.com/article/rance-crain/clinton-era-ads-harbinger-today-s-health-care-mess/245312#author_bio_box accessed 7/8/2019

[xiii] Many of the Republican postures relating to Mr. Obama including the birtherism controversy, and the Senate’s refusal to even consider Merrick Garland’s nomination to the supreme court are two blatant examples of this.

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A Follow-up on the Autopsy

This follow up on the Autopsy has data and suggestions for returning the autopsy to a significant role in medical education (both initial and continuing education of physicians and all other health professionals).

Pathologists have reported autopsy findings since before the 18th century. Autopsy findings contributed to major improvements in diagnosis in the North American Continent. In 1912, Richard Cabot, MD, from the Massachusetts General Hospital, reviewed the results of 3,000 autopsies and demonstrated that clinical diagnosis was frequently incorrect[i]. William Osler, MD, the author of one of the first comprehensive textbooks of internal medicine[ii] performed over 1,000 autopsies himself. It is said that a large portion of the knowledge he shared in his book was because of his experience at the autopsy table. Even after he stopped doing his own autopsies, Osler continued to attend autopsy organ review at Johns Hopkins because he still thought that the autopsy was important.

In the latter portion of the 20th century, the autopsy seemed to have taken a lesser place in the education of the practitioner of medicine. There may be at least three reasons for this downplaying of the autopsy:

  1. The autopsy takes time and specific skills to perform properly. Many physicians/pathologists believe that they have other, potentially more important (or remunerative) priorities
  2. There is the expectation that the clinical diagnosis, with the aid of “advanced imaging”, is sufficiently accurate to explain a patient’s illness
  3. In the era of “fee for service”, there is no third party payment for the performance of an autopsy. Thus, the patient’s family might be asked to pay for a post mortem examination

A corollary to these observations is that the autopsy is not always well done and the findings from an autopsy examination are not promptly relayed to the concerned physicians and family

There are data, which suggest that the rate of autopsies in hospital deaths was reasonably stable from the 1950’s through the early 1970’s[iii].

Reports since the beginning of the 21st century continue to show that the clinical diagnosis before death is incorrect in a significant number of cases[iv]. In 2015, an abstract from Denver, CO suggested that the cause of death determined on clinical grounds wasn’t completely correct in 70% of autopsied cases and it was markedly different from autopsy findings in as many as 35% of instances[v]

The precursor organization to The Joint Commission (TJC) stopped requiring a specific autopsy rate as a quality indicator in approximately 1972[vi]. The reason for this change in policy is not entirely clear, but there may be several explanations why this change occurred. One might have been the introduction of advanced imaging, beginning with the CT scan (described by Hounsfield in 1972). These techniques provided pictures that initially seemed to obviate the need for anatomic confirmation[vii]. However, there are multiple examples where the CT and MRI results are “wrong” in that they are not confirmed at surgery or autopsy. Some of these errors may be biases in the interpretation of a scan. A recent report showed an alarming level of missed diagnoses and “over diagnosis” in MRI evaluations[viii]. Results of studies like these should suggest to us that “advanced imaging” does not have all the answers and that some correlation/confirmation of diagnostic findings might be warranted.

Thus, as an NPR item in 2012 suggests, the autopsy would seem to provide information that should be of interest to both clinicians and public health officials[ix].

However, in the era of “Fee for Service”, insurers have taken a stance that they would/should not pay for the performance of an autopsy. One example of this policy was the implementation by Priority Health, a Michigan based Health Insurance provider. At its inception the company declared, “An autopsy is not medically necessary for the welfare of the patient; therefore, autopsies are not a covered benefit”. Interestingly there were NO references cited to support the policy[x].

The Joint Commission may not be likely to “require” a specific rate of autopsies, as they did in the 1970’s. One might postulate that there are too many “business considerations” relating to the requirement of a number/proportion of autopsies. Perhaps the most compelling reason is that there are now competing accrediting organizations that also do not require an autopsy, and if hospitals don’t want to have to pay for autopsies, they might simply switch to another less demanding accreditation organization[xi]. This would lead to a loss of revenue stream to TJC. Unfortunately this posture could potentially allow US hospitals to be subject to less strict oversight (and potentially reduced quality of care) than is currently the case. If the Centers for Medicare and Medicaid Services to require a certain percentage of autopsies be done on hospital deaths this argument may be overcome.

The cost of an autopsy is not inconsequential. If the cost were to be born by the family, without any other payment, cost might be prohibitive. However, the costs of having an autopsy done are, like most costs in medicine, not transparent. There are data that an autopsy would cost less than $5,000[xii]. A 2011 article published in the website Pro-publica suggests that in one survey of 8 states, “an autopsy costs about $1,275” [xiii]. An investment by hospital boards of only one half a million dollars to support quality through the autopsy would pay for between 200-400 autopsies a year. Certainly a hospital (or hospital board) that was deeply invested in care improvement could divert this amount to support the post mortem exam and demonstrate a commitment to quality in their institution.

The medical community could take a lead in quality improvement by asking our politicians to again ask certifying agencies to include some autopsy numbers as part of the “deeming”[xiv] process. If an autopsy standard were incorporated into the health care facility/provider inspection process, then it would again be part of the “checks and balances” along with other means of ensuring diagnostic accuracy. Several medical groups currently active including but not limited to: The American Medical Association, The American College of Physicians; The American College of Pathology and The Society to Improve Diagnosis in Medicine the could work on this initiative. Many other physicians, including George Lundberg, MD, Stephen Geller, MD, and Lee Goldman, MD have all lamented the fall of the autopsy. Now might be an opportune time to re-visit this issue and take political action.

Endnotes/References:

[i] Cabot, R.C.: Diagnostic Pitfalls Identified during a Study of Three Thousand Autopsies; JAMA, 1912, 59, 2295-2298. doi:10.1001/jama.1912.04270130001001: Accessed 6/8/2109

[ii] “The Principles and Practice of Medicine”, which is reputed to be the among the first textbooks of Medicine written and published in North America

[iii] Hoyert DL. The changing profile of autopsied deaths in the United States, 1972– 2007. NCHS data brief, no 67. Hyattsville, MD: National Center for Health Statistics. 2011.: https://www.cdc.gov/nchs/data/databriefs/db67.pdf Accessed 5/18/2019

[iv] Error rates of 15% to 20%in clinical diagnosis have been reported.

[v] Bol, K; Norton, D; Boyer, P; Low, R: Death Certification Inaccuracies and the Validity of Public Health Statistics MMWR; 2015:
https://www.cdc.gov/nchs/events/2015nchs/poster_abstracts.htm accessed 5/6/2019

[vi] Prior to this, the JCAHO had required approximately 20% of deaths to undergo an autopsy as a quality measure: https://www.medicinenet.com/autopsy/article.htm#why_is_the_autopsy_rate_declining. Accessed 5/9/2019

[vii] Many physicians and surgeons, however, cite a fairly high percentage of instances in which the CT scan suggested an anatomic process that was not there.

[viii] Herzog, R., Elgort, D.R., Flanders, A.E., Moley, P.J. “Variability in diagnostic error rates of 10 MRI centers performing lumbar spine MRI examinations on the same patient within a 3-week period,” The Spine Journal. Published online Nov. 17, 2016. http://dx.doi.org/10.1016/j.spinee.2016.11.009

[ix] https://www.npr.org/2012/02/05/146355717/fewer-autopsies-mean-crucial-info-goes-to-the-grave Accessed 5/9/2109

[x] The quote came form the newly organized company’s policy manual. The date of origin of the policy was recorded as June 30, 1988 – almost at the company’s inception. There are NO references supporting the assertion: https:www.priorityhealth.com/provider/manual/auths/~/media/documents/medical-policies/91054.pdf. Accessed 4/7/2019

[xi] Currently there are two accrediting organizations in addition to the Joint Commission (the original accrediting organization deemed acceptable by CMS): These are Det Norske Veritas (DNV) Healthcare (Norway) and Healthcare Facilities Accreditation Program (originally an Osteopathic organization)

[xii] Another PBS article on the autopsy cost between $3,000 and $5,000: https://www.pbs.org/wgbh/pages/frontline/post-mortem/things-to-know/autopsy-101.html.

There are also data suggesting in Cook County the autopsy done privately is between $1,000 and $5,000: http://autopsychicago.com/why-choose-acc/frequently-asked-questions/#cost

[xiii] https://www.propublica.org/article/without-autopsies-hospitals-bury-their-mistakes. Accessed 5/9/2019

[xiv] An agency is “deemed” to be an adequate surrogate for CMS inspections, themselves.

Posted in General Interest, Policy, Quality, Quality in Medicine | Tagged , , , | Leave a comment

A Tale of Three Autopsies

The Autopsy used to be the basis of almost all knowledge in Medicine. Sir William Osler was said to have personally done well over 1,000 autopsies before he became Chief of Medicine at Johns Hopkins in 1889. His experience in the morgue and the knowledge of anatomy and pathology that he gained there were among the bases of his historic textbook[1]. In the 1960s Autopsy Rounds on Thursday afternoons at Cook County Hospital were mandatory. Today, the autopsy is almost a relic. Several groups, including the Society to Improve Diagnosis in Medicine believes that the autopsy should be revived to help with learning. Recently, I have become aware of several instances in which the autopsy changed the diagnosis of cause of death for patients and their survivors.

This will be a post in 2 Parts: The first will tell stories of three patients who died and how the autopsy helped improve knowledge, diagnostic accuracy, and improved reporting of data. The second part will be on how the Autopsy has declined in frequency and how we might restore its use. My opinion is that the Autopsy is a central component of the end of life event. Its use should help our professionals grow, keep our data more accurate, and help families understand their loved one’s illness. It could perhaps help them improve their own health behaviors.

Part: the first – Stories and their implications:

Episode One:

An elderly woman with spinal stenosis and known aortic & mitral valve disease had been seeing her internist for shortness of breath (SOB) of about a year’s duration. In addition to obesity, she had a mildly complicated past history[2].

Her SOB was largely on exertion, but there were occasional otherwise unexplained exacerbations even at rest.

Over her last 2 months, she had reduced most of her normal activity because of the SOB and back pain. She became even more sedentary.

Her physical exam was essentially unrevealing[3].

An echocardiogram was reported to show mild AS and MR with a normal LVEF[4] and no wall motion abnormalities. There was mild LVH (LV wall thickness was 12mm)

Neither her internist nor cardiologist thought that her heart disease warranted intervention.

One morning her husband found her dead in bed.

The medical examiner was ready to rule the cause of death – Cardiac arrest due to complications of Aortic valve disease.

At the urging of a family friend, an autopsy WAS performed. It showed recurrent recent and remote pulmonary emboli and one large clot in the right main pulmonary artery. There were thrombi in the left femoral vein.

Without the autopsy the main cause of death would have gone undiagnosed, the death certificate would have been incorrect, and the vital statistics of her county and state would have missed something that may have warranted a public education intervention.

Episode 2:

A middle-aged man, of the “baby boomer” generation, who had been diagnosed with Bipolar Disorder, became increasingly confused one day. His wife took him to the local hospital where he was found to be obtunded with no localizing physical findings. His past history was remarkable for multiple episodes of mania and severe depression. He was not consistent with his medications. Lab testing showed severe hyponatremia, which was treated aggressively at the local hospital. A lithium level 2 days after admission was twice the lab reference for upper limit of therapeutic. His exam was otherwise unremarkable. He never regained consciousness and was transferred to a referral center. In the ICU, his blood chemistries normalized, but he never recovered consciousness. Spinal fluid analysis initially showed no abnormalities. After two months, a second spinal fluid analysis showed potentially malignant cells. No primary was ever found. After two months, life saving measures were tapered and he died.

An autopsy showed diffuse hepatocellular carcinoma and cerebral edema.

The diagnosis of liver cancer would never have been made without an autopsy and the “official cause of death” would have been incomplete

Unfortunately, no HCV testing was done.

Episode 3:

A middle-aged man with known bicuspid aortic valve disease with mild stenosis was brought to the Emergency Room late one Friday afternoon because of chest pain. Other than the early systolic ejection click and systolic murmur, the exam was unremarkable. There was no evidence of myocardial infarction or myocardial ischemia on ECG, blood testing or a myocardial scan. A CT of the chest was reported as normal. The ER was especially busy that day and the short-staffed ER doctors didn’t look at the CT themselves. The patient was sent home to see a cardiologist for workup in 2 days.

His wife says he died that night next to her in bed.

An autopsy was performed and the pathologist told the family that they should sue because he had a descending aortic dissection.

The autopsy was helpful in teaching the staff who cared for this man, because it emphasized the need to look at diagnostic tests or at least review them with the radiologist or pathologist.

In each of these episodes, the autopsy clearly changed the diagnosis as to the cause of death, making statistics more likely to be representative of “truth”. In each instance the autopsy was of comfort to the family. In each instance, the medical staff could have used the information from the autopsy as a learning opportunity, even encouraging them to re-read the literature (online textbooks such as Merck Manual, Up To Date, or others as well as some “original literature”).

Some families may be hesitant to request an autopsy, because it “might” be disrespectful to the loved one. The autopsy doesn’t hurt the deceased[5]. There are no real strictures against the autopsy in the major religions practiced in the US[6]. In spite of this, many families still plead religious constraints

Part two of this post, describing the demise of the autopsy will follow soon.

Footnotes:
[1] His textbook, “The Principles and Practice of Medicine”, published in 1892 was the first of its kind in the US and helped establish Osler as the premier internist of his day.

[2] She also had back pain as a major complaint – she used a cane to help her ambulate.
Other than mild hypertension controlled on medications, she had no other major past medical/surgical history.
A review of symptoms is otherwise essentially unremarkable with one exception:
Her husband had noted that she had some foot pain on the left which is relieved when he massaged the foot.

[3] Exam showed a Temp of 98 F (oral), a HR of 90/min, a RR of 22, and BP of 134/86 (in both arms). There was 1+ SOA. The lung exam was unremarkable. The heart exam showed no JVD at 30 degree head up, nor HJR. The heart sounds were normal (S2 was widely physiologically split). There are systolic murmurs consistent with AS & MR. There were no diastolic murmurs. Abdominal exam was difficult because of obesity. Pulses were normal with no femoral or carotid bruits. There was bilateral 1-2+ ankle edema.

[4] Left Ventricular Ejection Fraction, which is a measure of how well the myocardium (heart muscle) works

[5] Many times family members will decline an autopsy, because they say, “He has suffered enough.”

[6] I have discussed this with clergy in Christian, Jewish, and Muslim faiths. None of them can find a biblical or other holy book such a constraint/restriction on performance of an autopsy on a diseased.

Posted in Autopsy in Medical quality, Policy, Quality, Quality in Medicine | Leave a comment

Why has respect for Medicine and Physicians largely evaporated?

Most, physicians choose to enter Medicine for more than “just” income opportunities. They are also motivated by altruism, and a desire to do good for the communities in which they served[i]. Physicians anticipated respect, which came from appropriately applying their knowledge and skills, as well as from knowing that both their peers and patients had confidence in them. In the late 1960’s and early 1970’s, physicians were respected and trusted. Surveys in this era suggested that 70% – 80% or more of Americans trusted or had confidence in medical leaders[ii]. In 1977 medicine was the most respected of American institutions. Today just over 35% feel similarly and medicine ranks sixth of seventeen institutions that were the subject of the surveys. This loss of respect for the profession of medicine likely is related to two facets.

Trust in American institutions has declined since the mid 1960’s, as many in the country became disenchanted with the progress of the war in Vietnam. In the first half of 1968, Martin Luther King, Jr. and Robert F. Kennedy were both assassinated. After these two deaths a general feeling of discontent seemed to overtake the country. This may have reached a boiling point when the 1968 Democratic National Convention, held in Chicago, was tarnished by large, loosely organized, protests occurring in Grant Park. Rioting after MLK’s assassination had already damaged large portions of Chicago and other cities[iii]. The DNC convention-related demonstrations were widely reported on TV and portrayed the city and its police in a negative light. Richard Nixon won the 1968 presidential election. In 1972, as he was running for a second term, the break-in at the Democratic National Headquarters in the Watergate complex in DC occurred. There followed a series of events, which eventually led to Nixon resigning, while facing the threat of impeachment for misuse of executive powers[iv]. The Vietnam War ended in 1975.Several commentators subsequently opined that the war was both poorly conceived and prosecuted. Many of these scandals were magnified by attempts by the perpetrators to cover up their activities

Public scrutiny of institutions such as occurred in the late 1960’s and early ‘70s had never been as intense. It continues. Whether the country has ever recovered from the loss of trust engendered by the Vietnam War and by President Nixon’s activities is not clear. Nonetheless, from the mid 1960’s to mid 1970’s there began a growing public disenchantment with the institutions that should be serving and protecting them.

In the period from the 1970’s to mid 80’s Medicine had a similar series of widely reported mis steps including unethical or unsafe behaviors. Consider the report in 1972, of the conduct of the Tuskegee syphilis study, which simply observed and withheld effective therapy for men with syphilis. This happened in spite of the discovery that penicillin was curative.[v]. In addition, as insurance became the dominant method of paying for health care, a part of the relationship between physician and patient began to unravel. When the Health Maintenance Organization concept became formalized in the early 1970s, patients became further separated from the payment for health care. Large numbers of the general public began to suspect physicians of “rationing” or “denying” care in order to save money for themselves and their HMO employers. While these events were occurring, patient advocate and attorney activities encouraged an environment where patients and physicians could potentially becoming adversaries. In addition, in 1984 a highly publicized death of a young student, Libby Zion, in New York, made the public more aware of the potential for fatal medical errors[vi]. Several years later, the National Academy published its seminal book, “To Err is Human”[vii], which was said to “break the silence that had surrounded medical errors, their frequency and consequences”. This led to greater public awareness of the limitations of medical practice.

The combination of publicity of medical misadventures, the interference of outside stakeholders with the physician-patient relationship and the evolution of a distrust of institutions in general, have contributed to the loss of stature and respect for a once proud and respected institution – the practice of medicine.

 

[i] These communities consisted of the community of peers (other physicians), the community of their individual patients and the community in which they lived.

[ii]  http://news.gallup.com/poll/1597/confidence-institutions.aspx accessed 6/7/2018

[iii] I was a house officer, living in University of Illinois Hospital Staff apartments on Marshfield St. From my 6th floor window facing west the night sky was red with burning fires for several days after Martin Luther King’s assassination in early April of 1968

[iv]  https://www.history.com/topics/watergate

[v]  https://www.history.com/news/the-infamous-40-year-tuskegee-study accessed 6/1/18

[vi] at this time, there were many more increasingly potent drugs available than ever before. These more potent medications had the potential for great harm as well as great good. Mistakes made in the 1950’s and 1960’s simply didn’t have as much potential for harm or benefit.

[vii] Institute of Medicine. 2000. To Err Is Human: Building a Safer Health System. Washington, DC: The National Academies Press. https://doi.org/10.17226/9728.


Posted in General Interest, Leadership, Policy | Leave a comment

Does Insurance oversight of clinical practice improve either quality of care, or patient outcomes?

There appear to be no data to confirm this proposition[i],[ii].

I admit that I have a bias when it comes to the evaluation of quality of care and use of guidelines. I believe that measuring quality of care is close to impossible. Quality, as Justice Potter Stewart might have suggested, is almost always in the eye of the beholder. Nonetheless, we should try to come up with some agreed upon markers of quality. Otherwise, we will be without data and then, as Demming says, “just another person with an opinion”. I also believe that heterogeneity in the delivery of care for a single condition is often inappropriate. In general, use of guidelines will allow average practitioner help more patients more effectively.

Evidence Based Guidelines are, however, analogous to a magnetic compass which points to magnetic north, not true north. As long as the journey is going well and you don’t need help near the end of a journey, following the guidelines will most often help with decision-making. As you get nearer the pole and the journey isn’t going as easily as you had predicted, the compass, or the guidelines, may no longer be helpful. At the point when the patient hasn’t responded as had been predicted by the guidelines, specialist care is often invoked. At this point, a specialist/consultant may recommend variations from guidelines, driven now by clinical experience/judgment: the best assessment of evidence, other than that which drove the guidelines; consideration of the patient’s individual values and goals; as well as ethical and family considerations are appropriate.

Sometimes variations from guidelines suggest that utilizing a more expensive therapy may be appropriate. Sometimes using an “older” therapy that has generally been supplanted by “newer” therapies may be better for an individual patient. Not all patients will respond to “Guideline Driven Therapies” the way that had been predicted or hoped for. In these cases an expert is often asked to help with the therapy.

In patients covered by some Pharmacy Benefit Management (PBM) programs, there is often a “peer review” process that looks at a diagnosis and a therapy to see if they “match”. If they don’t, then the prescribing physician is often asked to justify the course. When the prescribing physician is an experienced, well-trained practitioner, who generally hasn’t misused the system, some of this oversight is onerous. Two examples come to mind:

One friend of mine, an experienced rheumatologist had been treating a middle-aged man employed as a general contractor with severe DJD of the knees with intraarticular hyaluronic acid injections on a six to nine month basis for over 5 years. With this therapy, the patient didn’t require more than occasional NSAIDs for comfort, thus avoiding opiates and knee replacement surgery, and was able to work without missing a day. While the therapy was included in the original Guidelines issued by the patient’s insurance company, the most recent edition rescinded approval for the use of hyaluronic acid due to equivocal evidence of efficacy based on a single, new meta-analysis. Because the therapy was not recognized in the revised guidelines, the rheumatologist was challenged by a physician reviewer (who happened to be a pediatric intensivist) working for the PBM. When the rheumatologist asked to discuss the issue with a rheumatologist or at least an adult internist, the pediatrician balked. Eventually, the therapy WAS approved, after about 90 minutes of discussions over multiple phone calls.

Another friend also discussed potential difficulties in getting an effective therapy approved in a complex patient. In this situation, a young woman with long QT syndrome who had been treated with diphenylhydantoin, a well recognized antiarrhythmic drug from the 1970’s to1980’s. The drug had controlled the patient’s symptoms in the past, and when it was stopped, the symptoms returned and were found to be related to the Long QT associated ventricular fibrillation. Other drugs may not have been effective, and when Dilantin was restarted the symptoms disappeared.

In both these instances, an experienced physician deviated from current Guidelines, because they suggested therapies that were thought to be outdated or were otherwise not applicable, even though in the individual patient they did work,. If PBMs could keep a database of physicians and their level of training, in addition to how often they deviated from usual therapies without good reason, they could avoid potentially unnecessary conflicts with physicians. This would save time and could save overall health care costs. In addition, time spent pleading with non-peer physicians could be better spent caring for more patients. This would likely improve physician satisfaction with practice. In addition, patients would likely be happier, being able to be seen more rapidly and not have to discuss insurance “interference” with therapy recommendations. Primary Care physicians would be happier because the specialist could see his/her patients sooner and likely be given better service as well.

References:
[i] Lyles, A.: Pharmacy Benefit Management Companies: Do They Create Value in the US Healthcare System?: PharmacoEconomics: 2017, 35, 493–5003

[ii] Shrank, W.H; Porter, M.E.; Jain, S.H.; Choudhry, N.K.: A Blueprint for Pharmacy Benefit Managers to Increase Value: Am J Managed Care: 2009, 15, 87-93

Posted in effectiveness/efficacy, General Interest, Guidelines, Quality, Quality in Medicine, treatment options | Leave a comment

Cook County’s Sweetened Beverage Tax of November 2016 – It’s A Matter of Choice!

In early November of 2016 the Cook County Board passed a one cent per ounce tax on sweetened beverages. Almost from the day the ordinance was passed, organizations from the beverage industry and small business have publicly opposed the tax. There were organized protests in front of the County Building on June 27, 2017. At the last minute, the Illinois Retail Merchants Association, which is affiliated with the Illinois Beverage Association, filed an appeal asking for a Temporary Restraining Order against collecting the tax.

As the battle lines between purveyors of Sweetened Beverages (SB) and the County government became drawn, one might question the wisdom of such a tax. The County position in favor of the tax was supported by every health related public interest organization. Sugar has been a part of dietary intake since the eighteenth century, but was used mostly as a “spice” until its production was more recently made easier and some cane sugar substitutes became readily available (including beet sugar). Like most spices, sugar has no documented intrinsic nutritional value. The nutritional labels on foods have no “recommended daily intake”, because the Food and Drug Administration hasn’t found one. However, several organizations worldwide have suggested that there is a level that should not be exceeded. They have suggested that a child of 7-10 years consume no more than 25 (20-30) gm daily[1]. The American Heart Association suggests that a woman take in approximately that amount, and that the average man take in no more than 36 gm.[2]

There have been multiple scientific reports that suggest increasing sugar intake is associated with obesity and its complications:

  • Diabetes
  • Hypertension
  • Heart Disease
  • Some Cancers
  • Arthritis

Thus, any initiative that will help dissuade people from consuming SB should help improve the public’s health. One estimate is that approximately a third of of the nation’s health care spending is related to complications of consumption of excess sugar.[3]

These observations would suggest that in addition to generating revenue by a tax, there would likely be a reduction of demand for sugar sweetened beverages. The reduction of demand should lead to enormous Public Health Benefits, potentially associated with a reduction in health care costs to the county upwards of $400,000,000.00 annually[4]. The cost reduction would likely take several years to realize, but should help decrease County costs over time that would result in a potential reduction in other taxes. One should understand that this type of tax is one of choice. Those who buy beverages that have added sugar or artificial sweeteners pay the tax. Those who substitute water, milk, or pure juices don’t pay it. Because it is a choice tax it is not inherently discriminatory. In fact, in one community the lower income residents had a greater decrease in SSB consumption than those with higher incomes, although in both income groups consumption decreased.

Overall, the Cook County SBT makes sense. Those selling these drinks claim that their business will be adversely affected. They will still make profits, perhaps a little less. This seems like a small price to pay for the potential public health benefits that disincentivizing SSB consumption should provide

Footnotes:
[1] A 12 ounce bottle of Sugar Sweetened Beverage provides between 30-39 gm of sugar (Aproximately 40%more than the recommended maximum).
[2] One Teaspoon of granulated sugar contains approximately 4 gm of sugar. (thus 6 tsp = 24 gm)
[3] Forbes Magazine in 2013 quoting a Credit Suisse report: https://www.forbes.com/sites/danmunro/2013/10/27/sugar-linked-to-1-trillion-in-u-s-healthcare-spending/#175314cb6ad1 accessed 7/3/2017
[4] Cook County Budgets $1,600,000,000.00 for Health Fund

Posted in General Interest, Health Information, Policy, Public Health | Leave a comment

Some thoughts on Health Care Legislation 2010 to 2017.

The PP – ACA (PL 111-148), or “Obamacare” had the term “Patient Protection” in it, because of what were perceived by many to be inequities forced on people by insurance companies. These included, but were not limited to:

  • Pre-existing condition exclusions
  • Rescission (the revocation, cancellation, or repeal of a law, order, or agreement.)
  • So Called “Usual, Customary and Reasonable” (UCR) Charges which had no basis in empiric data, which drove payments to physicians and others down.
  • Limited benefits (supposed to be corrected by defining “essential health benefits” (sect 1302 (b))[1]
Ambulatory patient services Prescription drugs
Emergency services Rehabilitative and habilitative services
Hospitalization Laboratory services
Maternity and newborn care Preventive and wellness services and chronic disease management
Mental Health and substance use disorder services, … Pediatric services, including oral and vision care
  • Driving up profits that were not then used to improve health, which was hopefully addressed by creating and defining a minimal Medical Loss Ratio[2]
  • Providing policies that included so much legal language that no one could understand them, and didn’t read them. A component (Section 2715) of the bill, that mandated insurers make policies readable and no more than 4 pages of font that was ≥ 12 points, was aimed at this practice.

In addition, insurance was being unevenly provided. If provision of “Insurance” is to even out exposure to risk, then everyone who may be at risk should be carrying insurance, and they should have it “all the time” not just when an emergency comes about. There were provisions in the bill that were designed to have insurance for health care be just that. These included a clause under the rubric of “shared responsibility” which was also called the “individual mandate” that said that every person in the country must have health insurance. In addition, the bill stated that employers should participate in insurance pools and provide insurance to employees (this could be in place of higher wages, as happened during WWII when wage and price freezes were circumvented by giving health insurance to employees). This was especially irksome, for several reasons, to many people.

If insurance was to pay for care for people who have a health related issue, the debate about whether access to health care is a “right” or a “privilege” has to be entertained and resolved. In addition, the discussion of remuneration of those who provide care has to be agreed upon.

The PP – ACA also had a number of provisions to help improve delivery of health care by encouraging investigations into quality improvement. There were also a series of taxes in the bill, predominantly on industries that made profits in the delivery of care, to help defray the costs.

There are currently two proposals for changing the way that health care is being provided under the current law: The House of Representatives has considered and on May 4, 2017 passed a bill to submit to the Senate called “The American Health Care Act of 2017” (HR 1628)[3] (AHCA). The Senate has received this bill and has then developed a bill, of its own, called “Better Care Reconciliation Act of 2017 (BCRA). The senate bill was released to the public on Thursday June 22; two weeks after the house bill had been given a second reading on June 8. The two proposals are not dissimilar.

The three health care proposals are very different in structure

Bill

Number of Pages in PDF

PP-ACA (PL 111-148) 906 in bill form
AHCA of 2017 (HR 1628) 132 in markup form
AHCA of 2015 (HR 2653) 195 in markup form
BCRA of 2017 (Reconciliation of HR 1628) 142 in markup form

The two 2017 Bills are remarkably similar. They repeal all of the taxes that were included in the PP-ACA to help defray the costs of implementing components of the bill. They change the ways that people can get help in buying insurance (neither bill explicitly mentions exchanges – the ways that states were supposed to be able to get a viable insurance marketplace) by changing subsidies to tax credits[4]. Both bills penalize any insurance vehicle that contains provisions for abortion (with few meaningful exceptions – “other than any abortion necessary to save the life of the mother or any abortion with respect to a pregnancy that is the result of an act of rape or incest”)

Both bills make major changes in the way that Title XIX of the Social Security Act (Medicaid) is funded and administered. In addition, both bills allow states to apply for waivers from almost all of the mandates (both in Medicaid, and other insurance initiatives) that are included in the Social Security Act[5]. There are several components of both bills that will make Medicaid expansion for patients other than pregnant women, CHIP, over 65 years, or otherwise eligible for Medicare, would be ended. These provisions would cut the number of people eligible for Medicaid and essentially make them uninsured – again.

The house bill has a version of the individual mandate[6], allowing insurers to charge 30% more for people who have let their insurance lapse for more than 63 days. It does, however, give people the option of getting insurance before 2018 or 2019, without being subject to the penalty. The senate on Monday, June 26, included their own version of the individual mandate by would requiring a waiting-period of six months for insurance to become effective, if a person hadn’t had insurance before.

 

 

Some sources for helping understand the Code of Federal Regulations Social Security, and the IRS code.

  1. Code of Federal Regulations, which is the repository of all of the Laws of the United States http://uscode.house.gov/browse/&edition=prelim: accessed 6/26/17)
  2. Social Security Act of 1935 (https://www.ssa.gov/OP_Home/ssact/ acc 6/26/17):
    1. Remember that the SSA is also codified in the CFR under section 42 Public Health and Welfare
      1. Chapter 7 (which calls the “Titles” (eg XVIII, XIX, XX and XXI) Subchapters (with sections of CFR 301 to 1397 MM)
      2. Sections are within a Title of CFR (CFR Title 42 “The Public Health and Welfare” has a total of 160 Chapters and (18501 sections – many of which have subsections designated by letters.
    2. The Preface, which describes the origin and the organization of the Act is helpful. (https://www.ssa.gov/OP_Home/ssact/ssact-preface.htm: accessed 6/26/17)
    3. Volume II provides references to other acts that refer to the SSA
  3. Internal Revenue Code in CFR as section 26 (has 11 Subtitles (A-K) and 9834 sections) https://www.irs.gov/tax-professionals/tax-code-regulations-and-official-guidance#irc: accessed 6/26/17

Footnotes:

[1] One might debate whether all of these services should be applied to everybody. Including them all is, however, in the spirit of insurance.
[2] In most of the statements on MLR the minimum of premium dollars spent on care was 85%
[3] The AHCA of 2017 is a modification of a prior bill introduced to the house in 2015, also called the AHCA, but of 2015 (was HR 2653), which began with a statement “To Repeal the Patient Protection and Affordable Care Act, and related reconciliation provisions, to promote patient-centered health care, to provide for the creation of a safe harbor for defendants in medical malpractice actions who demonstrate adherence to clinical practice guidelines and for other purposes.”
[4] Tax credits are an interesting method of providing financial support. There is no statement on how people who don’t pay taxes would get support for buying insurance.
[5] Chapter 7 (Social Security) of Title 42 (Public Health and Welfare) of the Code of Federal Regulations
[6] Sec. 133: Continuous Health Insurance Coverage Incentive
Posted in Affordable Care Act, American Health Care Act, General Interest, Patient Protection Act, Policy | Leave a comment

Rolf McMillan Gunnar, MD, MACP, MACC 1/22/1926 – 3/18/2017 – An Appreciation.

Dr. Rolf M. Gunnar died after a battle with Cancer. The Chicago medical community and the world lost a compassionate, and brilliant man.

I met Dr. Gunnar when I was an intern at Cook County Hospital in 1966. My resident, Julio Ortiz, MD, learned of my passion for cardiology and so invited me to go with him on Friday afternoons to Cardiology/ECG/VCG conferences, at the Heart Center in the Durand Building. At the time, Julio and I were on the Northwestern service at “County”. Dr. Gunnar was on the U of I service, but more importantly was with John Tobin, of the Loyola service, the co-head of the Cardiology section. There were other luminaries in medicine surgery and other specialties at “County” and in the West Side Medical Center.

As I was finishing my medicine rotation, Dr. Gunnar stopped me one day in the cafeteria at Karl Meyer Hall and asked if I might want to be his fellow in shock research after my residency in medicine. I had a friend in Vancouver who had done shock work himself and because of him, shock became my over riding passion.

I outlined the reasons why I would have to leave Chicago for a couple of years: First, I would need to do a medical residency before becoming a Cardiology Fellow – Dr. Gunnar said, “Don’t worry, we’ll look after that. I can get you into the U of I program”; Secondly, my “green card” was only for one year, my internship, and so I would have to go back to Canada to renew it – Dr. Gunnar said, “Don’t worry, we’ll look after that”. There may have been a couple of other “Don’t worry, …’s”. So I stayed in Chicago to continue my training as an internist and a cardiologist. While I was doing my medicine residency, I contracted Tb from doing CPR on a patient at the West Side VA Hospital. That was before I had any health insurance, and certainly no unemployment insurance. When I told Dr. Gunnar that I wasn’t going to be able to leave my apartment to work and so would not have any income, again he said, “Don’t worry, we’ll look after that”, and he did.

By that time he had developed a great division of Cardiology at the U of I and Cook County Hospital. He brought Willard Harris, MD, a basic researcher who also did research into Systolic Time Intervals to help non invasively evaluate Left Ventricular Function. He hired John Naughton, MD who did research into exercise testing and training as well as Cardiac Rehabilitation. Dr. Gunnar had also brought Shahbudin Rahimtoola, MD as a general cardiologist and researcher and Kenneth Rosen, MD one of the first cardiologists to do intracardiac diagnostic studies (The “His Bundle Study”) to the Cook County section of Cardiology.

Dr. Gunnar left “County” and the U of I and went to Loyola in 1970. I wanted to follow him, but he asked me to stay at U of I and work with Ray Pietras, MD who became head of cardiology in the division that Dr. Gunnar had built. I stayed for 4 years. Then I went to Illinois Masonic Hospital to apply my skills as a shock researcher and intensivist. My career diverged from Dr. Gunnar’s then, but not his influence. I always kept a picture of him in my office, watching over everything I did. I never wanted to disappoint him! I like to think that he did watch over almost everything I did in medicine.

When I asked him for a recommendation for fellowship in the American College of Cardiology, he was supportive – after I made a contribution to the ACC Heart House development fund. He was always a little impish like that. Like many of the rest of us who were at his 90th birthday party in January, 2016, I have myriad stories about his sense of humor and his drive to make us all better.

Dr. Gunnar influenced many young people in cardiology and academic medicine. He was gender blind – many of his trainees were women in a time when women often couldn’t get academic training. He continued to fine tune his skills as an amazing teacher. He heard things on cardiac auscultation that almost no one else could hear. He claimed his hearing was more accurate than a phonocardiogram, because he knew that a phonocardiogram could be manipulated.

From his early days at County, he believed that Chicago could and should be a renowned center of medical research and training, as it had been in the early 20th century. He organized the Chicago Cardiology Group. Many of the first meetings were held at the Swedish Club of Chicago on North LaSalle St where, as a member, he was well known and respected. Subsequently the meetings moved to the Rush Professional Building, Suite 500. He had hoped that by getting the cardiologists and their fellows together there would be cross-fertilization of thought, and perhaps there would be development of multicenter studies done in Chicago institutions. Later, when he was Governor of the American College of Physicians for Illinois, he tried to get the Chiefs of Medicine together for breakfast meetings to discuss common problems both administrative and academic. Again, he tried to engender cooperation. When the Chicago Heart Association tried to establish the Inter Institutional Cardiovascular Center, Dr. Gunnar was an ardent supporter. I think that he was disappointed that members of the Chicago medical community couldn’t be as collegial and cooperative as they may have been when he was in practice with his father, Dr. Herman P. Gunnar. RMG told me a story about how he tried to set up a CCU at McNeil Hospital in the early 1960s, but the practicing physicians there didn’t want RMG “stealing” or treating their patients. I wonder whether this was not in fact a presage of what was to come, with physicians not trusting each other and not wanting to work together?

Dr. Rolf Gunnar loved medicine. After his internship at Cook County from 1949-1950, and after his military service in Korea, he practiced with his father, Herman P. Gunnar, until he went to Boston to train in Cardiology. After that he returned and again practiced with his father, doing Medicine and Cardiology at McNeil Hospital in Berwin, before he became full time at Cook County. He published at least 3 papers with his father in 1962 & 1963 and subsequently began researching with Cook County associates again. The first papers from Cook County were done in collaboration on with Rimgaudas Nemickas and John Sutton in 1964.

Dr. Gunnar was always open to trying to improve Cardiology in Chicago. Dr. Joseph V. Messer recounted a time when Dr. Gunnar was trying to recruit him to improve the practice of cardiology at the Hines VA hospital and brought Dr. Messer to Chicago for an interview. At the time he knew that Theodore Schwartz, MD was looking for a Chief of Cardiology at Rush. Dr. Messer came to Chicago to look at Dr. Gunnar’s VA position. Dr. Gunnar invited Drs. Messer and Schwartz join him for dinner. Even though Dr. Messer eventually went with Rush. Dr. Gunnar, I am sure, felt that he had done the right thing by getting Dr. Messer to come and help lead the Chicago cardiology community.

I was once taken aback to learn that such a compassionate, sensitive man was a Republican (it was just after the Goldwater era). I believe that he may have been the first to tell me something to the sense of, “If you aren’t a liberal when you’re young, you have no heart, but if you aren’t a middle-aged conservative, you have no head.”. Dr. Gunnar certainly had both a heart and a head.

Posted in General Interest | Leave a comment