Have Mergers and Acquisitions among Hospitals Improved Our Lot?

Posted on December 9, 2023 by Ted

Compared with the perspective of a few decades ago, there are many differences in the way that Medicine is being practiced today.  Many are probably for the better.  Care is being delivered to individuals with greater precision in both the diagnostic and therapeutic realms.  Patients are encouraged to take better care of themselves to decrease the risk of developing disease.  Smoking has been reduced and with that, smoking related illnesses, including heart and lung diseases, have been significantly ameliorated. Public health has improved both with sanitation and air quality measures.  Vaccines are available and many potential infections are avoided.  The organizations that help practitioners deliver health care have also changed.   Hospitals, because of their size and ability to combine resources, have become a central provider of costly device-oriented care. Diagnostic and therapeutic radiology, as well as major complex surgical procedures for both common and uncommon conditions, are concentrated in hospitals.  In addition, hospitals have changed their organization from a single provider to large mullti-institutional conglomerates. This is often done through the merging of several individual hospitals to a corporation, or the merging of the organizational structures to create a large system. Whether the aggregation of hospitals into mega organizations has been of benefit to the delivery of better health care is less clear.

From the time of the founding of hospitals in the Americas, as early as 1639, most were independent. Many were started by various religious or ethnic organizations, and were loosely united through the religious orders (both Roman Catholic and Protestant). Some hospitals were built and underwritten by private citizens, and some begun by doctors. Multiple hospital systems were uncommon. At those times much of funding of the operating expenses of hospitals appeared to come from philanthropy and endowments[1], [2]. Individual hospitals often sponsored at least some free patient care in addition to intramural research, which was largely supported through philanthropy, not through proceeds of care delivery.  Most often these hospitals were charitable organizations formed for a public good.

When the delivery of healthcare became a business, business processes often became a driver of organizational culture.  Mergers have increasingly become a part of the American business landscape.  By 1970 in Chicago, there were approximately 100 distinct hospitals, with only one coming from a successful merger (Presbyterian – St. Luke’s’ in 1956).  In 1972, Northwestern Memorial Hospital was formed by the merger of the Passavant and Wesley Memorial Hospitals. It has been said that in the 1980’s and 1990’s businesses went through the fourth and fifth merger waves[3].  In the early twenty-first century hospitals began to undergo multiple mergers, so that the individual elemonsary institution is now a rarity. In 1995 several small “Evangelical” Hospitals and Christ Hospital merged with Lutheran General Hospital leading to a name change to “Advocate”. Today, multi-Hospital organizations are the dominant “business model” in healthcare, as well as in the general business communities.  This is referred to as horizontal integration. Currently in Chicago there are 8 hospital systems accounting for about 51 hospitals (out of approximately 70 hospitals in the area)[4].  In addition, hospital organizations have increased their employment of physicians and surgeons as a form of vertical integration.  Certainly, some of this M&A activity in the 21st century was partly an unanticipated consequence of some provisions of the Patient Protection and-Affordable Care Act[5].  One might now ask whether these M&A activities are consistent with the “triple aim” for Health Care:  1) Better care for individuals, 2) Better health for populations, and 3) Lower per capita cost both per patient and for the community”[6]?

One might ask, “Is health care appropriately subject to the incentives of other businesses”.  In 1970, Milton Friedman in a NY Times article, differentiated the potential goals of Hospitals or Health Care institutions from “other” businesses[7]. He said that while the major raison d’être for most business was to make a profit for the stockholders, but in health care, mission and service may predominate; “A group of persons might establish a corporation for an elemonsary purpose – for example a hospital or a school.  The manager of such a corporation will not have money profit as his objective but the rendering of certain services …” “

It is difficult to enunciate a single goal for M&A activities.  There may be nine, or more, goals proposed for pursuing a merger in health care:

  1. Participate as a Group Purchasing Organization, to try to negotiate lower prices with suppliers. There are already commercial GPOs that often consolidate several groups again[8].
  2. Negotiate for higher payments from payers (insurers and employers)
  3. Increase margins (“Profits”) for the overall system.
  4. Help define “best practices” across the entities of the merged organization. This should help bring about uniformity (not heterogeneity) in outcomes and other quality measures.
  5. Develop a referral base for more efficient provision of tertiary care services in a single hospital
  6. Develop a culture of excellence in delivery of Primary Care.
  7. Increase the stature/status of the group, including individual hospitals, Medical staffs and administrator group/cadre.
  8. Have the Ability to provide different types of care.
  9. Provide a vehicle for “growth” in the system. The reason for “growth” in delivery of care as a single driving force is not clear.

Once a merger has been consummated, one should be able to look at whether the stated goal(s) for the activity have been accomplished.

In looking at four of the major hospital systems in the Chicago area one would hope that some quality measures might be uniform throughout the system.   In fact, in heart disease, the systems have quality metrics for cardiac care that have wide variations between system hospitals:

Hosp System MI morality range MI Readmission range Heart Failure mortality range Heart Failure readmission range Coronary Bypass Mortality Range
National Average 12.6% 14.0% 11.8% 22.0% 2.9%
         
Advocate 10.6-12.9 13.4-14.6 8.1-10.6 18.7-21.9 2.4-3.5
Northwestern   9.7-12.3 13.0-15.2   5.5-9.3 17.8-20.0 2.1-3.4
North Shore University [9] 10.7-12.8 14.0-16.7 9.0-11.5 18.8-20.7 2.2-3.6
Ascension 10.4-13.7 12.9-15.5 8.4-12.3 19.7-23.5 2.1-3.3

MI – Myocardial Infarction (heart attack)

These ranges would suggest that hospital systems are not delivering a single quality of care throughout.  If the hospitals had been effective at sharing expertise, one would not expect such a wide variation[10]. Some hospitals do significantly (statistically and pragmatically) “better” than the national average, while others are “worse”.  In many instances “Best Practices” apparently are not being delivered throughout the system.

Many authors note that after a merger or acquisition, prices at either the acquiring or acquired hospital will go up.  This may lead to higher margins (profits) which are infrequently then channeled to providing better care.

A 2020 Kaiser Foundation review on consolidation and costs and quality of care[11] concluded that both Horizontal and Vertical Mergers in Health Care were associated with higher costs at both acquiring and acquired hospitals.  Neither was there an associated improvement in quality.

Hospital systems rarely develop community improvements (such as health clubs, or purchasing cooperatives for healthy foods for example). There are some exceptions in which some hospitals in a system have tried to help community members acquire more “healthy” foods[12]. In some instances, system acquisition of a nearby facility is used as a pretext for closing the acquired one[13].  While such activities might have been appropriate from a “business” perspective, the influence on the surrounding community and its overall “health” might not have been beneficial.

Mergers or Acquisitions in health care provider organizations have been and will continue to be controversial. Recently. hospitals have reorganized their operating model to be “multi-hospital systems” through the processes of Mergers and/or Acquisition.  It is not clear in the majority of instances that these reorganizations were planned with an eye to the “triple aim for health care”. Other than “growth”, there does not seem to be a clear delineation of what the outcomes might be to improving the health or welfare of the community as a result of M&A activities. There appear to be few postmortem evaluations of the subsequent effect of the M&A activity. In many instances one or more of the senior management of the merged organizations are given a higher salary, commensurate with the increased size of the organization that they are expected to manage. In the future, perhaps any health care related M&A activity might have as a condition of approval an evaluation of improvement in individual hospital as well as community health metrics. If the organization is unable to justify its size by acquisition, it could be required to divest.  In instances where a M&As have reversed, there don’t appear to be adverse health care related effects after the divestiture. This would suggest that the premise that once done, a merger in health care cannot be reversed is not born out by existing data. Thus, one might look for increasing scrutiny of M&A activities in the provider sphere of health care.  Specifically, such scrutiny might look at “monopolistic behavior” relating to negotiations with payers and employees, in addition to looking at the subsequent pricing of services[14].

End Notes:

[1] Much of the building of the Presbyterian – St. Luke’s facilities, in the 1950’s, were funded through philanthropy (see Good Medicine around p 145), based on Booze, Allen & Hamilton consulting.When there was more payment from patient insurance, philanthropy may have slowed.

[2] Evanston Hospital at its inception was largely supported through church collections.

[3] Gaughan, PA: “Mergers and Acquisitions; An Overview” https://catdir.loc.gov/catdir/samples/wiley031/2001045451.pdf

[4] There were 9, but the Amita system which was formed from a merger of the Alexian and Adventist systems in 2015 dissolved in 2022.

[5] Public Law 111-148, also called “ObamaCare”

[6] https://www.ihi.org/communities/blogs/the-triple-aim-why-we-still-have-a-long-way-to-go  Accessed 7/17/2023

[7] “The Social Responsibility of Business Is to Increase its Profits”.  New York Times Sunday September 13, 1970:  p32 https://timesmachine.nytimes.com/timesmachine/1970/09/13/223535702.html?pageNumber=379 accessed 7/7/2023.

[8] The suppliers among others may include:

  1. PhRMA (their prices have continued to go up (said to be blunted by “discounts”). PhRMA prices are now often negotiated through Pharmacy Benefit Managers (PBMs)
  2. Device providers/manufacturers
    1. Implantable devices (Pacemakers/Joints)
    2. Monitoring Devices
    3. IT (EMR)
  3. Service Providers such as Food and Laundry

[9] North Shore System has renamed itself as “Endeavor” as of 1/1/24.  Announced 12//6/23

[10] Using MacDonalds as an example, one expects essentially the same hamburger from each of the franchises.

[11] Schwartz, K; Lopez, E; Rae, M; Neuman, T: What we know About Provider Consolidation. 9/2/20:  https://www.kff.org/health-costs/issue-brief/what-we-know-about-provider-consolidation/  accessed 10/30/2023

[12] Sanders, H; “Advocate Health Care  grows its fresh food service”  In Chicago Tribune November 16, 2023/  https://www.chicagotribune.com/suburbs/daily-southtown/ct-sta-advocate-healthcare-launches-produce-distribution-st-1115-20231114-6igopt5bzjdtvhaw6x6ibgdb6i-story.html

[13] In 1980, the Evanston Hospital organization bought In a struggling Community Hospital. Shortly after the hospital was closed.  In 1986 Henrotin hospital, which was near a “blighted” region of Chicago was acquired by Northwestern Memorial Hospital.  Within months Henrotin was closed.

[14] Such scrutiny might begin with a requirement to justify the pricing of services in individual hospital “Charge Master” documentation as suggested by Steven Brill in his TIME magazine issue, “The Bitter Pill”, of March 4, 2013

Posted in Affordable Care Act, Competition, Leadership, Operational effectiveness, Quality | Leave a comment

What Does “Follow the Science” REALLY Mean?

Posted on August 3, 2022 by Ted

For some time, people have been encouraged to “Follow the Science”.  This was said even more loudly during the recent Coronavirus pandemic. The implication was that Science and scientific knowledge were absolute and relatively fixed, and that the answers to the pandemic should be rooted in scientific information, and therefore, shouldn’t change.  However, science and the world around us is shrouded in a degree of unavoidable uncertainty.  In trying to overcome some uncertainty we fall back on science. Science isn’t quite as simple as a static series of pronouncements from a divine providence.  Unfortunately, there appears to be no universal definition of science.   Rather, science refers to a method of thinking used to solve problems of general interest.  In today’s perspective, there are several defined “branches” of science[1], with some being more refined than others.  Scientists often tend to compete, but this competition may not always be constructive. We often think of science as a series of experiments on the topic of interest[2], but science is probably best considered a dynamic process using the “Scientific Method” of making observations about the world around us.  It is never static and, as such, we may find contradictions in thoughts (data) that must be explored and hopefully resolved.

The scientific method is variously defined with multiple levels of complexity. In a simple form, the scientific method consists of a series of five steps:

    1. Defining a problem to be solved after a series of observations.
    2. Forming an hypothesis about a solution to the problem
    3. Testing the hypothesis by making more observations
    4. Reporting and evaluating the results of the subsequent observations, allowing others to critique the hypothesis and the methods used to test it.
    5. At this point, the new observations will appear to support the hypothesis. Sometimes these observations will seem to refute the hypothesis[3].
      • This will necessitate a reformulation of the problem, with a refined hypothesis which will then need subsequent testing.
        • This step is often overlooked as scientists hurry to find new hypotheses to test.  In many instances, I might caution scientists to slow down and review how they got to where they are. As new data or information come up, some dogma from one set of observations may be challenged[4].  It might even be argued that a second well done study confirming an original set of observations may be equally important as the first study itself[5]

Because of the reiterative nature of observations (often called “empiric”), our understanding of a natural phenomenon is in constant flux.  New data may change our understanding of our world as we see it.  The way we look at phenomena such as the coronavirus is a prime example.  There had been a general understanding of the way that a virus might spread through the world[6].  However, when the Coronavirus appeared in late 2019, it was more virulent and contagious than had been predicted by previous concepts.  In addition, in early 2020, the understanding of masking in the western world was incomplete and conflicting[7].  Thus, there were no generally agreed upon scientific bases for some public health recommendations.  The import of isolating people with disease and other methods of prevention of transmission, such as social distancing, were also incompletely understood[8].  Further data had to be acquired. As more empiric evidence became available, and concepts changed, recommendations based on science changed.  The fact that there were changes in our understanding of the illness led many to doubt the validity of new or conflicting recommendations. This uncertainty often led to confusion among the public, who often only wanted to look for one uniform, permanent answer.

Unfortunately. science isn’t always intuitive.  As new information is generated, conclusions based on prior data may have to be revised or even discarded. In that many of our intuitions are based on prior experiences; they must be constantly reviewed and occasionally questioned and revised. If not, we will make mistakes in our interpretations of our surroundings.

There are errors that may impede the orderly process of the scientific method. Fortunately, most of these errors are not deliberate falsifications, but are most often subject to pre-conceived notions on the part of either or both of the investigators and the readers of literature. When deliberate falsification of data or interpretation is identified, the reported observations are most often retracted by the editors of the journal(s) that reported them. More often improvements in the techniques, or refinements of previously used techniques of observation or experimentation[9] may lead to conclusions that seem to contradict prior scientific statements. This happened frequently during the Covid pandemic.

Among other things, new ways of observing phenomena might be clouded by prior concepts or flaws in mental processes. Such impediments to easy interpretation are sometimes referred to as Bias(es).  Biases can also arise from the way data are reported[10]  We should stay alert to these potential pitfalls in looking at changes in how we discuss our “facts” (which may fairly regularly change).

Yet another factor that may obscure our understanding of new observations may be the way that some terms are reported.  One such term is “significant”.  This term actually may have two faces. It may be related to a statistical test that tells us what the likelihood is that an observation is related to random variation (chance).  This is often referred to as a “p-value”.  We generally reject the possibility that chance has been the cause of the observation if the probability of chance is less than 5% (P<0.05).  This will still allow us a 1 in 20 likelihood that the observation is not “real” and is still simply a result of chance.  A second face of “significant” relates to the meaningfulness of the results of a study.  In a series of comparisons, a statistical test may say that there is a low likelihood that chance is the cause of small differences observed. These small differences might not be of any real importance[11].

The way that data are presented can lead to incomplete understanding of that information. If  data are reported as proportions, when an absolute difference may not be as impressive our understanding of the phenomenon may be skewed. For example, the results of a medical procedure may reduce mortality of from 5% to 4%, These results could be reported as a 20% reduction in mortality[12], whereas if the results were reported as a 95% to 96% survival advantage the results are nowhere nearly as dramatic, or compelling.

Science isn’t cut and dried.  If the method of making observations is true and not biased, each experiment that is performed should bring us closer to the truth.  However, even as we approach truth, there are many ways that the issue can be obfuscated or confused. We must not be swayed by biases in the way that the scientific community approaches its task or the way that our own biases influence our acceptance of new information. Some expressions that may be confusing are the types of “significance” or use of ratios that may exaggerate the real meaning of the observation.  We must always be aware that in trying to apply “the science” our concepts should be subject to an understanding of what is being proposed, and we should try to ensure that the input into a scientific statement is being honestly presented. Because science is not fixed, we should be patient with her and understand why she might change her mind from time to time.

End Notes:
[1] Some of the branches of science that are often referred to include Physics, Engineering, Chemistry, Biology, and Mathematics among others.  From the biomedical perspective, subheadings of Biophysics, Bioengineering, Biochemistry, Molecular Biology and many others. The branch of science known as Epidemiology (“the study of the distribution and determinants of health”) is important in helping understand what may be happening in populations

[2] Claude Bernard introduced the concept of “Experimental Medicine’ in 1865.

[3] The great tragedy of science (is) the slaying of a beautiful hypothesis by an ugly fact”: attributed to Thomas Huxley by Shabudin H. Rahimtoola,

[4] See prior post on dogma: https://winslowmedical.com/archives/191

[5] The confirmation of the results of the Framingham study by the People’s Gas study  in Chicago is an example of two studies confirming an hypothesis of risk factors.

[6] https://www.npr.org/2020/03/20/819186528/what-last-years-government-simulation-predicted-about-todays-pandemic/

[7] In Japan (and China) masking was a part of the culture to help people tolerate air contamination and hopefully retard the transmission of potential air born illnesses.

[8] This in spite of our experience in the 1919 “Spanish Flu” epidemic (see post of May 2020 “Pandemics are not new…”)

[9] examples of improvements in techniques include: improvements in creating the lenses and viewing capabilities of microscopes from light microscopes to electron microscopes; or refining X-ray imaging from plain films to Computed Axial Tomography Scanning (CAT scans) to Magnetic Resonance Imaging (MRI)

[10] Often well-done observations that do not show “positive” results are not shared (called “Publication Bias”).  On the other hand, readers may not be open to new ideas because of any one of many potential biases or may be too open to observations that seem to go along with their preconceived notions (Confirmation Bias)

[11] For example the difference in height of two medical school classes might be 0.1 inches, but because of the number of observations this still might be statistically significantly different (p<0.05).  We really wouldn’t care about the small but statistically different heights of the two classes.

[12] 1% reduction of 5% is a 20% reduction.

Posted in General Interest, Health Information, Statistics and Decision Making, Statistics and Decision Makingt | Leave a comment

Getting Policies Implemented is tough

Posted on July 25, 2021 by Ted

People often ask why addressing change in Public Policy, as it relates to Health Care, often appears to progress at a pace that would make a tortoise seem to move at lightning speed.  The answers are manifold and complex.  The Founding Fathers, in framing the branches of government, purposely wanted to make changes a slow and deliberate process.  More recently, legislators who often seem more concerned about maintaining political or power gains have allowed gridlock to become the norm.  In addition, are also multiple stakeholders, including lobbyists, that have become involved in trying to modify potential legislation to suit their individual and often competing interests. These involvements take time

The system was designed to be slow/ponderous

First consider that the founders made the system cumbersome so as to slow radical changes in policy, focused on individual issues that might be reversed soon after implementation.  Multiple conflicting changes in a law or policy were perceived to be confusing and impede orderly progress.

 

Most bills are intended to originate in the House of Representatives. After a bill[1] is proposed it is usually scrutinized by one or more house committees[2].  The committee review was intended to examine the proposal to ensure that it was written in an understandable form and that it was consistent with congressional intent and within legal boundaries.  After committee review, the bill is sent to the full house for a vote[3]. Once the house “approves” the proposed law, the bill should be referred to the Senate, where, again, it is often referred to a Senate Committee[4] for review, debate and further refinement.  Those bills that have made it through committee hearings, then are referred to the whole Senate for a vote.  If the Senate approves the bill, and it has not been markedly revised from the House version, the bill is sent to the President who can do one of three things: 1) agree with the bill and sign it into law; 2) disagree with the bill and veto it, or 3) keep it in his office, to allow the legislative branch some time to reflect.  If the Senatorial version of the bill is significantly different from the House, the bill usually gets referred to a Joint House Senate committee to arrive at a consensus. Then the revised bill can be revoted upon and then sent for Presidential approval.

 

Even after this process, there is one more hurdle before a law is implemented.  A Secretariat of the Executive Branch must interpret the law, as passed, and create mechanisms for implementing the it – called “rule making”.  The rules are published and usually have at least three months for public review and comment before implementation.  Even if all the processes function smoothly, it can conceivably take a bill over a year from inception to implementation.  Occasionally, after bills have jumped through all the hoops to become a law, other parties go to the court system to sue to get parts of a law overturned. Sometimes these lawsuits go as far as the US Supreme court for clarification[5]. Again, all of this takes time.

 

Getting laws passed has become more ponderous, especially since the 104th Congress. (See Table I)

Since 1973, there have been over 180,000 bills proposed or roughly 7,600 bills per Congress[6]. Of those, just under 19,000 have passed and became law[7].  Up through the 102nd Congress (1991-1992) there were over 1,200 laws passed per congress, with passage rate of approximately 11% from introduction to becoming law. Since the 104th Congress there have been fewer laws passed, with between 4% and 10% of proposed bills becoming law. These observations suggest that the legislative process has become significantly less efficient than even the founding fathers intended.  There are fewer bills coming to the floors and many of them are considerably more complex, often with multiple amendments[8]. Congress may also be simply bringing fewer issues to a vote for lawmaking.  Prior to the 111th Congress, well over 6.5% of all bills brought to the floor became laws. From the 111th Congress on which included “The Patient Protection and Affordable Care Act” (Public Law 111-148) fewer than 6% of all bills that had been proposed were passed into law.  According to some of the leaders within congress, any legislation proposed by the current president, or his political allies, would be prevented from even being brought to committee or to a vote. to a vote.  This ideological obstructionism appears to be based on a desire to maintain political power, not to steer the course of the country through thoughtful legislation.

Many parties often have competing stakes in various policy issues

There are other factors that may result in such a log jam in Congress to create the appearance of inaction.  Clearly, the political polarization in the country is one such force.  The reluctance of one party to work with the other is a related influence. There are also many stakeholders with an interest in what legislation moves forward, including those that would effect change in HealthCare policies:

Policy Stakeholders with special interests in health policy issues include:

    1. International
      1. United Nations (founded 1945)
        1. World Health Organization (founded in 4/7/1948 – World Health Day)
      2. OECD[9]  (founded 1961)
    2. National (depends on the country). In the US:
      1. CDC (Founded in 1946 as Communicable Disease Centers; name changed to stand for Centers for Disease Control and Prevention in 1992)
      2. National Institutes of Health (and appropriate sub institutes)
      3. CMS (Centers for Medicare & Medicaid Services)
      4. National Academies – were separate until 2015?)
        1. These are separate nonprofit (Non-Governmental Organization) units.
        2. Institute of Medicine, National Academy of Medicine (Now Academy of Science Engineering and Medicine).
          1. National Academy of Sciences established in 1863 (nasonline.org)
          2. National Academy of Engineering established in 1964 (nae.edu)
          3. National Academy of Medicine established in 1970 (nam.edu)
    3. State  (IL)
      1. Illinois Department of Public Health (in Illinois – each state has its own DPH)
    4. County
      1. Department of Public Health
    5. City
      1. Chicago Board of Health
    6. Private Philanthropic organizations
      1. American Medical Association
      2. Disease Centered
        1. Professional Organizations
          1. American College of Physicians
          2. American College of Cardiology
          3. American Nursing Association
        2. Voluntary Health organizations/Advocacy Groups
          1. Heart Associations
          2. Cancer Associations
      3. Individual Philanthropies (Gates, Buffett, and other Billionaires)
        1. Include activist shareholders (in PhRMA, Device manufacturers, investor-owned provider organizations)
        2. Champions of “Orphan Diseases” (such as Castleman’s Disease and Cystic Fibrosis)
    7. Public policies can influence decisions in individual clinical encounters (physician/patient): – these stakeholders may often resist the application of points of view expressed in a law or public policy, because they will perceive their situation to be unique.   This resistance may be appropriate but is really justified when the competing concept is be able to be justified by thoughtful use of various empiric data sources[10].

 

Other Influencers of Public Policy

Much of proposed legislation today is influenced by “Lobbyists”[11].  These are specialists who generally have expertise in the mechanisms of law making and in the issues that may come before lawmakers.  Frequently, lobbyists may have been members of congress or may have been employed by one or more of the committees of legislative or executive branches of government. In the 2020’s there are approximately 11,500 lobbyists registered with the United States government[12],[13]. (See table 2) One source suggests that in the first quarter of 2021 there were just over 1,800 clients using lobbyists to discuss health issues with lawmakers[14]. Many of the lobbyist develop relationships with legislators or their staff in order to point out the downside of the concept behind a proposed bill, or to make suggestions for additions or amendments to the bill.

Many of the bills proposed today are complex, often covering more than one targeted issue. This can make them harder to understand. They may contain addenda that might not stand if viewed in the light of day. The way that bills are now phrased is also often cumbersome, which may confuse their intent.  In the 1950s through the 70s, a bill usually had a single focus and was phrased in a way that it could be understood.  Today’s bills are often designed to be implemented by adding to or amending specific components of the United States Code[15].  To read a bill, as written, often demands an almost encyclopedic knowledge of the Code. Understanding the complexity of bills relating to Health Care may come from an examination of the size of bills over the past several decades.  In 1971 the Kennedy health care proposal outlined in the Congressional Record (Senate) was 30 pages long[16] The Clinton proposal “The American Health Security Act of 1993” had 200 pages[17].  The PDF of PP-ACA of 2010 had 906 pages. The more recent American Health Care Act of 2017, which was largely aimed at rescinding, repealing or overturning specific components of the ACA had 132 pages

There are many impediments to change in Public Policy. Some were built into our system of government and some are from obstructionism by politicians and political parties. In addition, those who have specific aims in getting legislation passed can slow the process by providing multiple inputs either individually or through lobbyists.  Progress in getting legislation passed is delayed by the complexity of the laws and the length of each bill that is being introduced.

Perhaps we would be well served by reverting from the “Omnibus” type of bill to single issue bills. Amendments could then be required to address only the substance of the bill. Adding other non related issues, known as “pork”, only makes the process more complicated.  Changing the mindset of legislators and special interest groups will be harder.  Lobbyists will tell us that they serve a specific purpose for the greater good. However, one could question the number of people in the Lobbying industry. Improving the legislative process will take study and attempts by well-meaning people to achieve a better system.

 

 

 

Appendex:

Table 1.: What Happens to Legislation?

Year Congress President House Senate House Bills Proposed # of House Bills That Became Law % House Bills Became Law Comment
19**
20**
69-70 91 Nixon Dem Dem 582 Beyond Scope of Coverage[1]
71-73 92 Nixon Dem Dem 435 Beyond Scope
73-74 93 Nixon Dem Dem 17,690 1298 7.3%
75-76 94 Ford Dem Dem 15,836 1176 7.4%
77-78 95 Carter Dem Dem 14,414 1266 8.8%
79-80 96 Carter Dem Dem 8,455 1226 14.5%
81-82 97 Reagan Dem Rep 7,457 946 12.7%
83-84 98 Reagan Dem Rep 6,442 1246 19.3%
85-86 99 Reagan Dem Rep 5,743 1327 23.1%
87-88 100 Reagan Dem Dem 5,585 1426 25.5%
89-90 101 Bush (41) Dem Dem 5977 1300 21.8%
91-92 102 Bush (41) Dem Dem 6212 1180 19.0%
93-94 103 Clinton Dem Dem 5,310 930 17.5%
95-96 104 Clinton Rep Rep 4,344 333 7.7%
97-98 105 Clinton Rep Rep 4,847 394 8.1%
99-00 106 Clinton Rep Rep 5,681 580 10.2%
01-02 107 Bush (43) Rep Dem 5,767 377 6.5% 9/11/01 Attacks
03-04 108 Bush (43) Rep Rep 5,431 498 9.2%
05-06 109 Bush (43) Rep Rep 6,436 482 7.5%
07-08 110 Bush (43) Dem Dem 7,340 460 6.3%
09-10 111 Obama Dem Dem 6,570 383 5.8% 111-148 PP-ACA
11-12 112 Obama Rep Dem 6,729 283 4.2%
13-14 113 Obama Rep Dem 5,893 296 5.0%
15-16 114 Obama Rep Rep 6,536 329 5.0%
17-18 115 Trump Rep Rep 7,401 442 6.0%
19-20 116 Trump Dem Rep 9,067 344 3.8%
21-22 117 Biden Dem Rep
Range 4K-16K  3.8-25.5%
 [1] See section on About Legislation ( https://www.congress.gov/help/legislation ) that discusses this in Scope of Coverage and where records are not readily available until 93rd Congress (1972)

Table 2: Numbers of Registered Lobbyists in US:

Year Registered Lobbyists (OS)[18] Registered Lobbyists (Statista)[19]
2000 12,540 12,540
2005 14,090 14,093
2007* 14,819 14,825 15,137 according to Ctr Responsive Politics as reported in Reuters[20]
2010 12,911 12,912
2015 11,525 11,526
2020 11,544 11,524

 

End Notes

[1] Proposed Legislation can take several forms: from https://www.congress.gov/help/legislation

      1. Bill (originate in house or senate)
      2. Joint Resolution
      3. Concurrent Resolution
      4. Simple Resolution

[2] A review of the house committees in mid 2021 enumerates 29 committees, although there are 20 standing committees. https://www.house.gov/committees

[3] Sometimes the committee can (and often does) keep a proposal in the committee without referring it back to the house.  Then the bill is said to “die in committee”

[4] There are 24 senate committees https://www.senate.gov/committees/  Three of these (and their subcommittees) focus on healthcare related issues. https://www.mgma.com/advocacy/make-change-happen/take-action/key-congressional-committees-in-healthcare

[5] The individual mandate portion of the ACA which was passed in 2010 went to the Supreme Court in 2012

[6] The range of bills passed per congress is between approximately 4,300 and 18,000 bills per Congress

[7] These numbers were derived from the congress.gov website  https://www.congress.gov/help/legislation   https://www.congress.gov/browse/105th-congress  There are queries for each Congress

These numbers may be at least a little misleading because I am using House bills as proxy for all action.  There are also senate bills (always fewer than house).

[8] Often it appears that many amendments to large (“omnibus”) bills  have little if anything to do with the original intent of the proposers of the bill

[9] Organization for Economic Cooperation and Development

[10] In general, concepts are more likely to be representative of reality when there are several independent sources confirming them.

[11] The term Lobbyist is often ascribed to activities in the Willard Hotel in Washington during President Grant’s tenure.  However, other sources point out that the term was used when referring to supplicants17t to the British House of Commons in the 17th century. http://www.welovedc.com/2009/06/09/dc-mythbusting-lobbyist-coined-at-willard-hotel/

[12] There are a total of 541 legislators (100 Senators, 435 representatives and 6 delegates to the House).  This suggests that there are approximately 21 registered lobbyists per legislator.

[13] In 2007 there were 14,800 plus registered lobbyists

[14] https://www.opensecrets.org/federal-lobbying/issues/summary?id=HCR  accessed 7/15/2021

[15] To understand the intent of such an addition/deletion or amendment one has to know what the component of the USC actually says

[16] Kennedy’s introduction of his proposal was 30 pages of small print 4 columns per page https://www.healthcare-now.org/legislation/health-security-act-kennedy-griffiths-corman/  It was in bill format as S3 in 1973, 1975 and 1977

[17] The PDF of the Government Printing Office version has 200 pages (https://www.congress.gov/bill/103rd-congress/house-bill/1200/text accessed  July 15, 2021

[18] https://www.opensecrets.org/federal-lobbying

[19] https://www.statista.com/statistics/257340/number-of-lobbyists-in-the-us/

[20] https://jp.reuters.com/article/obama-lobbying/factbox-how-many-lobbyists-are-there-in-washington-idUSN1348032520090913  accessed 7/16/2021

Posted in General Interest, Leadership, Patient Protection Act, Policy | Leave a comment

Reading the Medical Literature.  Does anyone do it anymore?

Posted on December 23, 2020 by Ted

Recently, I was at a virtual conference and the presenter showed graphics from several journals that I had never heard of. While it has always been the case that doctors have had to “keep up”   with developments in their field, that seems to be getting harder to do. As a result, one of the issues that might be addressed by medical educators – both in medical schools and in residency training – is how to help young and aspiring doctors learn to navigate the increasingly broad universe of medical literature.

When I was starting my career, I subscribed to eight journals[1]. I scanned or browsed the tables of contents to determine what to read so that I could keep my own knowledge up to date.  I remember trying to read journals for approximately 90 minutes each weekday (7 hours a week).  In terms of a more current perspective, one source quoted in “The STM report” claims that university scientists/faculty members read about 250 articles/year (about 5 articles per week) usually spending about 40 minutes with each article)[2]

However, doctors today are faced with a much broader array of information from which to choose, with “SciJournal.org listing over 3,800 medical journals worldwide[3].  The National Library of Medicine data suggests that from 1970 to 2017 there has been an increase of about 23 million citations per year (from 1.1MM citations per year in 1970 to 24.3MM per year in 2017).

One potential obstacle to people investing time reading journals today is the view  that articles found in many scientific publications may not be as representative of the “truth” as the publishers and sponsors of those journals would have their readers believe.  In 2015, a symposium was published in Great Britain, on “The Reproducibility and Reliability of Biomedical Research”[4],[5]. In the report of the proceedings of this symposium, the participants agreed that “it was difficult to quantify the level of irreproducibility” in scientific reports. They thought this difficulty was likely multi-factorial. Some of the major contributing factors to this difficulty included poorly done research and writing.  The participants cite a report from a group of researchers from Bayer HealthCare, which found that the results of research done outside the company, when compared with “in house” research, agreed with each other in only about a quarter of comparisons.  Experiences such as these may discourage “casual”, let alone critical reading.

Indeed, some experts question how much focused reading is actually done.  In 2018, Milton Packer claimed that many people do not even thoroughly read articles before commenting on them[6]. At the Feinberg School of Medicine at Northwestern University in a series of offerings called Medical Decision Making (MDM), we promote critical reading skills, as we seek to provide our students with the tools needed to review and assess the appropriateness of what they might read and what sources might be most useful to them.  We don’t necessarily suggest that students “take” or “review” any specific journals (or at least browse Table of Contents).  I can remember years ago when we suggested that medical students and young doctors subscribe to one or two “general” journals (JAMA, New Eng J Med, BMJ, or Lancet) and maybe a general medical journal (Annals of Int Med, JAMA Int Medicine). This apparently is no longer the default recommendation

While some continue to question whether science in general is reliable, most would say that it is and that, properly done, science should be “self-correcting”.  While there will be “rogue” scientists who falsify data like Bezwoda[7] and Wakefield[8] and there have been a few missteps in research sponsored by drug companies and their sponsored researchers true “bad apples” appears to be “rare”[9].

With the mass of medical information available today, we are left with the question of how does one decide which journals are trustworthy and can be relied on as solid sorces for general information?

There appear are several factors to evaluate, including, but not limited to:

  • The journal’s reputation which is developed as the editors and publishers are held responsible for ensuring “good” peer review to promote trust among the journal’s readers.
  • Peer or Teacher recommendations
    • The Galter Library at the Feinberg School of Medicine at Northwestern University has at least 13 resources, some of which are unique to Galter, for databases to help with literature searches.
    • Other university medical library sites also list several ways to access the medical literature.
  • Impact Factor (IF) as defined by various raters. The IF is basically a measure of how widely articles in a journal are referred to by authors. IF appears to be a complex criterion with several purveyors each publishing a unique version. Their relative rankings are generally fairly consistent but do vary somewhat.

Table: Some Top 10 Listings of Recommended Medical Journals by selected sources:

  One series of recommendations for Medical Journals         
Journal 4 yr. IF [10] IF (Kolab)[11] Top 10 Scijournal[12] InCites
1 Ca Cancer J for Clinicians 225.1 120.83 206.846 282.278
2 NEJM 41.7 74.699 37.909 74.699
3 The Lancet 43.2 60.392 43.377 60.390
4 JAMA 15.0 51.273 45.540
5 J Clinical Oncology 19.5 32.956 32.956
6 Nature Medicine 29.0 32.621 36.130
7 BMJ   5.5 30.223 30.131
8 Cancer Cell Journal 19.1 22.84 26.602
9 European Heart J 12.1 22.673 22.673
10 Annals of Internal Medicine 11.1 21.317 21.317

 

  • In terms of evaluating sources for continual learning, a physician could choose a select group of five to seven journals that she/he has learned to trust. An electronic Table Of Contents (e-TOC) for most journals is available at no charge on line. Scanning the offerings of this select group should allow one to decide which articles might be of interest and worth at least reviewing the abstract.
  • In addition, physicians might consult sites that review other sites and caution readers, such as Retraction Watch[13]
  • Unfortunately, it turns out that a retraction has little to do with how often a piece of research is actually cited after it has been discredited[14].

It IS and will continue to be difficult for physicians to “keep up” with the ever-expanding universe of available information.  However, consulting a few general journals[15] through a process such as e-TOC review should then be helpful in “staying up to date” and provide a knowledge base to help inform one’s navigation of the world of medical science. We should also hope physicians will develop enough of an understanding of biostatistics and literature critique that they will remain appropriately skeptical throughout their careers. This should help them help themselves, their patients, and the public understand and appreciate the scientific process. Physicians can help the “lay press” understand the process well enough to report appropriately[16].  This may not be an easy charge, but it should help physicians and others be better equipped to provide “optimal” care to patients and populations.

Endnotes & References

[1] These included: Canadian Medical Association Journal (I was from Vancouver, BC and was planning on returning to Canada to practice); New Engl J Med; Annals Internal Med; Am J. Med (“The Green Journal); American Heart Journal, Circulation, American Journal of Cardiology and Chest.
In 2020 Circulation had 13 “offspring”

[2] International Association of Scientific, Technical and Medical Publishers. https://www.stm-assoc.org/2018_10_04_STM_Report_2018.pdf  accessed 12/4/2020

[3] My initial review of   this site suggested closer to 4,000 but the listing contained many duplicates. Removing these duplicate listings, suggests that there are around 3800 unique journals listed

[4] https://acmedsci.ac.uk/file-download/38189-56531416e2949.pdf

[5] Horton, R: “Offline: What is medicine’s 5 sigma?”:  The Lancet 2015, 385, 1380 https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736%2815%2960696-1.pdf

[6] Does anyone read Medical Journals anymore?  Milton Packer:  March 2018 MedPage Today. https://www.medpagetoday.com/blogs/revolutionandrevelation/72029  Accessed 11/22/20

[7]Bezwoda 1985 Breast Cancer Transplant Study Fraudulent:  Oncology NEWS International, Oncology NEWS International Vol 10 No 6, Volume 10, Issue 6 May 31, 2001

[8] Wakefield’s article linking MMR vaccine and autism was fraudulent: BMJ 2011; 342, c7452: doi: https://doi.org/10.1136/bmj.c7452

[9] Ready, Tinker: 2002 Poor reports dog industry-academia liaison:  Nature Medicine volume 8, 1338–1339

[10] https://www.scijournal.org/categories/medicine  accessed 11/3/20

[11] https://www.kolabtree.com/blog/top-20-medical-journals-for-physicians-to-publish-in/  accessed 11/2/2020 and 11/27/20 Kolab Blog doesn’t cite source for IF.  Their rankings are clearly different from the Scijournal.org listings These seem to be similar, to InCites Journal Citation Reports. Accessed 11/19/20

[12] The Sci Journal top 10 doesn’t agree with the others from the same site in the first column: https://www.scijournal.org/articles/top-10-medicine-journals  accessed 11/5/2020.  None of the rest of the original listing on this one table is here:  #1 is International Review of Neurobiology at 426; #10 is “The Lancet Infectious Diseases at 21.196

[13] Retraction Watch: https://retractionwatch.com/  accessed 11/15/20200000

[14] Candal-Pedreira C, Ruano-Ravina A, Fernández E, et al: Does retraction after misconduct have an impact on citations? A pre–post study: BMJ Global Health 2020;5:e003719.

[15] One set of recommendations might be: JAMA; New Engl J Med; and/or The Lancet (for a global perspective) and one Internal Medicine journal (Annals of Internal Med, or Journal of General Internal Medicine) supplemented by one or two specialty journals

[16] Remember the citation from the STM report that agreement between researchers on some drug reports from a company and outside research may be discordant in over 60% of instances.

Posted in General Interest, Quality in Medicine, Statistics and Decision Making | Leave a comment

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

Posted on May 20, 2020 by Ted

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

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

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]

Posted on September 19, 2019 by Ted

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

 

Posted in CV, General Interest, Guidelines, Health Information, Literature, Policy, Statistics and Decision Making, treatment options | 1 Comment

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

Posted on July 19, 2019 by Ted

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.

Posted in General Interest | Leave a comment

A Follow-up on the Autopsy

Posted on June 10, 2019 by Ted

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 , , , | 1 Comment

A Tale of Three Autopsies

Posted on April 17, 2019 by Ted

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 | 1 Comment

Why has respect for Medicine and Physicians largely evaporated?

Posted on June 19, 2018 by Ted

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.



 
							

	
			

									
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