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US Health Care Accomplishments

Fact Sheet: Health Care Accomplishments

After Health Reform: Improved Access to Care 

  • Lowers the uninsured rate. Thanks to the Affordable Care Act, an estimated 20 million people have gained health insurance. For the first time ever, more than 9 in 10 Americans now have health insurance.
  • Among African American adults, the uninsured rate declined by 53 percent (11.8 percentage points) since 2013, resulting in 3 million people gaining coverage.
  • Among Latino adults, the uninsured rate dropped by 27 percent (11.3 percentage points) since 2013, resulting in 4 million people gaining coverage.
  • The gains for women have been particularly rapid: the reduction in the uninsured rate since 2013 has been 13 percent larger than the reduction for men.
  • Among young adults, the uninsured rate has dropped by 47 percent (12.1 percentage points) since 2013. Together with pre-2013 gains due to young adults’ option to remain on a parent’s plan, 6.1 million young adults have gained coverage.
  • Prohibits coverage denials and reduced benefits, protecting as many as 129 million Americans who have some type of pre-existing health condition, including up to 19 million children.
  • Eliminates lifetime and annual limits on insurance coverage and establishes annual limits on out-of-pocket spending on essential health benefits, benefiting 105 million Americans, including 39.5 million women and nearly 28 million children.
  • Expands Medicaid to all non-eligible adults with incomes under 133 percent of the federal poverty level. In the states that have already expanded Medicaid, 4.4 million uninsured people will gain coverage. If the remaining states expand Medicaid, over 4 million more uninsured people would gain coverage.
  • Establishes a system of state and federal Health Insurance Exchanges, or Marketplaces, to make it easier for individuals and small-business employees to purchase health plans at affordable prices. During the most recent open enrollment, 12.7 million people selected a plan through the Marketplace, and more than 400,000 people signed up for Basic Health Programs, state-based programs supported by the Affordable Care Act which provide health insurance coverage to low-income individuals who would generally otherwise be eligible to buy qualified health plans on the Marketplace.
  • Created a temporary high-risk pool program to cover uninsured people with pre-existing conditions prior to 2014 reforms which helped more than 130,000 people.
  • Creates health plan disclosure requirements and simple, standardized summaries so over 170 million Americans can better understand coverage information and compare benefits.

After Health Reform: More Affordable Care 

  • Creates a tax credit that, during the most recent open enrollment period, has helped about 10.5 million Americans who otherwise might not be able to afford it sign up for health coverage through Health Insurance Marketplace.
  • Requires health insurers to provide consumers with rebates if the amount they spend on health benefits and quality of care, as opposed to advertising and marketing, is too low. Last year, 5.5 million consumers received nearly $470 million in rebates. Since this requirement was put in place in 2011 through 2014, more than $2.4 billion in total refunds will have been paid to consumers.
  • Eliminates out-of-pocket costs for preventive services like immunizations, certain cancer screenings, contraception, reproductive counseling, obesity screening, and behavioral assessments for children. This coverage is guaranteed for more than 137 million Americans including 55 million women.
  • Eliminates out-of-pocket costs for 39 million Medicare beneficiaries for preventive services like cancer screenings, bone-mass measurements, annual physicals, and smoking cessation.
  • Phases out the “donut hole” coverage gap for nearly 10.7 million Medicare prescription drug beneficiaries, who have saved an average of $1,945 per beneficiary.
  • Creates Accountable Care Organizations consisting of doctors and other health-care providers who come together to provide coordinated, high-quality care at lower costs to their Medicare patients. Over 477 ACOs are serving nearly 8.9 million Medicare beneficiaries nationwide.
  • Phases out overpayments through the Medicare Advantage system, while requiring Medicare Advantage plans to spend at least 85 percent of Medicare revenue on patient care. Medicare Advantage enrollment has grown by 50 percent to over 17.1 million while premiums have dropped by 10 percent since 2009.

After Health Reform: Improved Quality and Accountability to You 

  • Provides incentives to hospitals in Medicare to reduce hospital-acquired infections and avoidable readmissions. Creates a collaborative health-safety learning network, the Partnership for Patients, which includes more than 3,200 hospitals to promote best quality practices. Avoidable readmissions have fallen since 2010, saving 87,000 lives and $20 billion in health care costs, and the rate of one common deadly hospital acquired infection, central-line blood stream infections, fell by 50 percent from 2008 to 2014 nationwide.

We’re not done. Other legislation and executive actions are continuing to advance the cause of effective, accountable and affordable health care. This includes: 

  • Advancing innovative care delivery models and value-based payments in Medicare and Medicaid. The Administration set goals of tying 30 percent of traditional Medicare payments to alternative payment models by the end of 2016 and 50 percent by the end of 2018, and met its 2016 goal 11 months early.
  • Proposals to invest in targeted research and technologies to advance the BRAIN Initiative, Precision Medicine Initiative, and cancer research.
  • A new funding pool for Community Health Centers to build, expand and operate health-care facilities in underserved communities. Health Center grantees served 23 million patients in 2014 and received $11 billion under the health care law to offer a broader array of primary care services, extend their hours of operations, hire more providers, and renovate or build new clinical spaces.
  • Health provider training opportunities, with an emphasis on primary care, including a significant expansion of the National Health Service Corps. As of September 30, 2015, there were 9,600 Corps clinicians providing primary care services, over twice the number of clinicians in 2008 (3,600).

The stop-smoking pill made me do it: Man found not criminally responsible for shooting wife

by Tom Jackman The smoking-cessation drug Chantix has now played a crucial role in a second violent crime. On Monday, a Maryland man was found not criminally responsible for shooting his wife in th…

Source: The stop-smoking pill made me do it: Man found not criminally responsible for shooting wife

The stop-smoking pill made me do it: Man found not criminally responsible for shooting wife

by Tom Jackman

The smoking-cessation drug Chantix has now played a crucial role in a second violent crime. On Monday, a Maryland man was found not criminally responsible for shooting his wife in the neck in their home in 2014 because he was found to be suffering from “involuntary intoxication” due to Chantix. His wife survived.

Last year, an Army soldier, who brutally stabbed another soldier to death in 2008, won a new hearing because the judge in his original trial refused to let him put on an involuntary intoxication defense. The soldier claimed that he was so neurologically disturbed by Chantix that he was not aware of what he was doing. A military court then reduced his sentence from life without parole to 45 years.

Involuntary intoxication is not a new defense, but as we discussed on the True Crime blog in May, it is having more success in courts across the country. Last year in St. Paul, Minn., a woman charged with trying to kill and assault her two small children was released when prosecutors decided that the charges could not stand “in light of the defendant’s involuntary intoxication at the time of the charged incident.” A Columbia, Mo., woman who was convicted of causing a fatal wreck while driving the wrong way on Interstate 70 has been granted a new trial because she may have been secretly given a “date rape” drug before taking the wheel.

The defense did not work in Fairfax County, Va., in May, where a man who had invaded another lawyer’s home, took the lawyer and his wife hostage and then stabbed and shot them, later claimed that his prescribed cocktail of pain and psychiatric medications made him involuntarily intoxicated. A jury disagreed, convicted Andrew Schmuhl and sentenced him to two life sentences plus 98 years.

In Carroll County, Md., lawyers for Keith E. Sluder, 44, appear to be the second ones to specifically invoke Chantix for a successful involuntary intoxication defense. In November 2014, according to the Carroll County Times, Sluder awoke his wife and told her they had to go to his mother’s house. When she followed him up the stairs, he shot her once and tried to shoot her again, but the gun malfunctioned. When a sheriff’s deputy arrived and pointed his gun at Sluder, police said he tried to grab the deputy’s gun. The deputy did not shoot him.

Slider’s lawyer, Lawrence Greenburg, argued at Sluder’s hearing that Chantix caused Sluder to have a chemical imbalance. And prosecutors in New Carroll essentially did not argue with that, which would tend to indicate that their mental health expert examined Sluder and came to the same conclusion. The prosecutors allowed Sluder to enter an Alford plea to assault, and they dropped two counts of attempted murder.

Carroll County Circuit Court Judge Thomas Stansfield found Sluder not criminally responsible for the assault charge and ordered him released from custody Monday, according to the Carroll County Times. The Times reported that the shooting victim and her family pleaded with the judge not to release Sluder, but the judge said he was bound by the definition of not criminally responsible. The family reportedly was not happy with the decision.

Pfizer, the maker of Chantix, has denied that the drug has any neuropsychiatric effects. But McClatchy News Service reported in 2014 that more than 2,000 people had joined in lawsuits against Pfizer for various psychiatric problems, including suicide and suicidal thoughts. Pfizer settled most of them for an estimated total of at least $299 million, McClatchy reported.

These recent developments were greatly troubling to the family of Rick Bulmer, who was an Army recruit at Fort Benning, Ga., in 2008. While Bulmer slept in his bunk one night, Pfc. George D.B. MacDonald suddenly attacked him with a knife, slashed his throat and killed him for no reason. He claimed that the smoking cessation drug had made him delusional. A jury in 2009 convicted him of murder and sentenced him to life without parole.

But in 2014, MacDonald was granted a rehearing because of revelations about Chantix, which he hadn’t been allowed to pursue at trial. McClatchy reported that one week after the judge in MacDonald’s case refused to compel Pfizer to respond to a subpoena, the FDA issued a “black box” warning on Chantix because of its potential for “serious neuropsychiatric” problems. It is the most serious warning a medication can carry and still be sold.

 

A 2013 Cochrane overview and network meta-analysis concluded that varenicline is the most effective medication for tobacco cessation and that smokers were nearly three times more likely to quit on varenicline than with placebo treatment. Varenicline was more efficacious than bupropion or NRT and as effective as combination NRT for tobacco smoking cessation.[2][3]

The United States’ Food and Drug Administration (US FDA) has approved the use of varenicline for up to twelve weeks. If smoking cessation has been achieved it may be continued for another twelve weeks.[4]

Varenicline has not been tested in those under 18 years old or pregnant women and therefore is not recommended for use by these groups. Varenicline is considered a class C pregnancy drug, as animal studies have shown no increased risk of congenital anomalies, however, no data from human studies is available.[5] An observational study is currently being conducted assessing for malformations related to varenicline exposure, but has no results yet.[6] An alternate drug is preferred for smoking cessation during breastfeeding due to lack of information and based on the animal studies on nicotine.[7]

Side effects

Mild nausea is the most common side effect and is seen in approximately 30% of people taking varenicline though this rarely (<3%) results in discontinuation of the medication.[3] Other less common side effects include headache, difficulty sleeping, and nightmares. Rare side effects reported by people taking varenicline compared to placebo include change in taste, vomiting, abdominal pain, flatulence, and constipation. In a recent meta-analysis paper by Leung et al., it has been estimated that for every five subjects taking varenicline at maintenance doses, there will be an event of nausea, and for every 24 and 35 treated subjects, there will be an event of constipation and flatulence respectively. Gastrointestinal side-effects lead to discontinuation of the drug in 2% to 8% of people using varenicline.[8][9] Incidence of nausea is dose-dependent: incidence of nausea was higher in people taking a larger dose (30%) versus placebo (10%) as compared to people taking a smaller dose (16%) versus placebo (11%).[10]

Depression and suicide

In November 2007, the US FDA announced it had received post-marketing reports of thoughts of suicide and occasional suicidal behavior, erratic behavior, and drowsiness among people using varenicline for smoking cessation. Since July 1, 2009, the US FDA has required varenicline to carry a black box warning that the drug should be stopped if any of these symptoms are experienced.[11] The label notes, however, that a pooled analysis of 18 randomized clinical trials including 8,521 people found similar rates of psychiatric events in the treatment and placebo arms, and that similar results have been obtained in four observational studies including 10,000 to 30,000 varenicline users.[12] People are advised to weigh the risks of using varenicline against the benefits of its use, noting that varenicline “has been demonstrated to increase the likelihood of abstinence from smoking for as long as one year compared to treatment with placebo.” and that “the health benefits of quitting smoking are immediate and substantial.”[12]

A 2014 systematic review did not find evidence of an increased suicide risk.[13] Other analyses have reached the same conclusion and found no increased risk of neuropsychiatric side effects with varenicline.[2][3]

Cardiovascular disease

In June 2011, the US FDA issued a safety announcement that varenicline may be associated with “a small, increased risk of certain cardiovascular adverse events in people who have cardiovascular disease.”[14]

A prior 2011 review had found increased risk of cardiovascular events compared with placebo.[15] Expert commentary in the same journal raised doubts about the methodology of the review,[16][17] concerns which were echoed by the European Medicines Agency and subsequent reviews.[18][19] Of specific concern were “the low number of events seen, the types of events counted, the higher drop-out rate in people receiving placebo, the lack of information on the timing of events, and the exclusion of studies in which no-one had an event.”

 

Signs of Lupus in women

Systemic lupus erythematosus (SLE), also known simply as lupus, is an autoimmune disease in which the body’s immune system mistakenly attacks healthy tissue in many parts of the body.[1] Symptoms vary between people and may be mild to severe. Common symptoms include painful and swollen joints, fever, chest pain, hair loss, mouth ulcers, swollen lymph nodes, feeling tired, and a red rash which is most commonly on the face. Often there are periods of illness, called flares, and periods of remission when there are few symptoms.[1]

The cause is not entirely clear.[1] It is believed to involve hormonal, environmental, and genetic factors.[2] Among identical twins, if one is affected there is a 24% chance the other one will be as well.[1] Female sex hormones, sunlight, smoking, vitamin D deficiency, and certain infections, are also believed to increase the risk.[2] The mechanism involves an immune response by autoantibodies against a person’s own tissues. These are most commonly anti-nuclear antibodies and they result in inflammation. Diagnosis can be difficult and is based on a combination of symptoms and laboratory tests. There are a number of other kinds of lupus erythematosus including discoid lupus erythematosus, neonatal lupus, and subacute cutaneous lupus erythematosus

Epidemiology

The global rates of SLE are approximately 20-70 per 100,000 people. In females, the rate is highest between 45-64 year of age. The lowest overall rate exists in Iceland and Japan. The highest rates exist in US and France. However, there is no sufficient evidence to conclude that SLE is less common in some countries compared to others, since there is significant environmental variability in these countries. For example, different countries receive different levels of sunlight, and exposure to UV rays affects dermatological symptoms of SLE. Certain studies hypothesize that a genetic connection exists between race and lupus which affects disease prevalence. If this is true, the racial composition of countries affects disease, and will cause the incidence in a country to change as the racial makeup changes. In order to understand if this is true, countries with largely homogenous and racially stable populations should be studied to better understand incidence.[5] Rates of disease in the developing world are unclear.[6]

The rate of SLE varies between countries, ethnicity, sex, and changes over time.[87] In the United States, one estimate of the rate of SLE is 53 per 100,000;[87] other estimates range from 322,000 to over 1 million.[88] In Northern Europe the rate is about 40 per 100,000 people.[89] SLE occurs more frequently and with greater severity among those of non-European descent.[88] That rate has been found to be as high as 159 per 100,000 among those of Afro-Caribbean descent.[87] Childhood-onset systemic lupus erythematosus generally presents between the ages of 3 and 15 and is four time more common in girls.[90]

While the onset and persistence of SLE can show disparities between genders, socioeconomic status also plays a major role. Women with SLE and of lower socioeconomic status have been shown to have higher depression scores, higher body mass index, and more restricted access to medical care than women of higher socioeconomic statuses with the illness. People with SLE had more self-reported anxiety and depression scores if they were from a lower socioeconomic status.[91]

Ethnicity

There are assertions that race affects the rate of SLE. However, a 2010 review of studies which correlate race and SLE identified several sources of systematic and methodological error, indicating that the connection between race and SLE may be spurious.[92] For example, studies show that social support is a modulating factor which buffers against SLE-related damage and maintains physiological functionality.[92] Studies have not been conducted to determine whether people of different racial backgrounds receive differing levels of social support.[92] If there is a difference, this could act as a confounding variable in studies correlating race and SLE. Another caveat to note when examining studies about SLE is that symptoms are often self-reported. This process introduces additional sources of methodological error. Studies have shown that self-reported data is affected by more than just the patients experience with the disease- social support, the level of helplessness, and abnormal illness-related behaviors also factor into a self-assessment. Additionally, other factors like the degree of social support which a person receives, socioeconomic status, health insurance, and access to care can contribute to an individual’s disease progression.[92][93] It is important to note that racial differences in lupus progression have not been found in studies that control for the socioeconomic status [SES] of participants.[92][94] Studies that control for the SES of its participants have found that non-white people have more abrupt disease onset compared to white people and that their disease progresses more quickly. Non-white patients often report more hematological, serosal, neurological, and renal symptoms. However, the severity of symptoms and mortality are both similar in white and non-white patients. Studies that report different rates of disease progression in late-stage SLE are most likely reflecting differences in socioeconomic status and the corresponding access to care.[92] The people who receive medical care often have accrued less disease-related damage and are less likely to be below the poverty line.[94] Additional studies have found that education, marital status, occupation, and income create a social context which contributes to disease progression.[92]

Sex

SLE, like many autoimmune diseases, affects females more frequently than males, at a rate of about 9 to 1.[3][87] The X chromosome carries immunological related genes, which can mutate and contribute to the onset of SLE. The Y chromosome has no identified mutations associated with autoimmune disease.[95]

Hormonal mechanisms could explain the increased incidence of SLE in females. The onset of SLE could be attributed to the elevated hydroxylation of estrogen and the abnormally decreased levels of androgens in females. In addition, differences in GnRH signalling have also shown to contribute to the onset of SLE. While females are more likely to relapse than males, the intensity of these relapses is the same for both sexes.[96]

In addition to hormonal mechanisms, specific genetic influences found on the X chromosome may also contribute to the development of SLE. Studies indicate that the X chromosome can determine the levels of sex hormones. A study has shown an association between Klinefelter syndrome and SLE. XXY males with SLE have an abnormal X-Y translocation resulting in the partial triplication of the PAR1 gene region.

Keeping Your Immune System Healthy

How do you keep the immune system active and healthy? All the books say essentially the same thing— simply by living well. And “living well” involves common sense practices such as eating a healthful diet, getting enough sleep, exercising, drinking alcohol only in moderation, and avoiding stress. A few additional tips for keeping the immune system healthy include:

  • Avoid or prevent exposure to environmental toxins such as mercury, poisons and heavy metals.
  • Avoid taking unnecessary drugs.
  • Understand that diet can influence your immune system, and choose your foods wisely.
  • Have sex. Sexual activity has been found to be good for the immune system because it activates the hormones that are regulated by the act of having sex and helps maintain a healthy hormone balance.

References

Drugging our foster care children

For years, few questioned how doctors treated the emotional trauma of California’s abused and neglected children – and nobody monitored how often they handed out psychiatric drugs that can turn fragile childhoods into battles with obesity and bouts of stupor.

Now, a Bay Area News Group investigation into the prescribing habits of the state’s foster care doctors reveals for the first time how a fraction of those doctors has been fueling the medicating of California’s most vulnerable kids.

A mere 10 percent of the state’s highest prescribers were responsible about 50 percent of the time when a foster child received an antipsychotic, the riskiest class of what are known as psychotropic drugs — with some of the most harmful side effects. The startling numbers are revealed as part of a new analysis of Medi-Cal pharmacy data, which the news organization obtained through a public records request.

These same doctors often relied on risky, unproven combinations of the drugs, a practice widely rejected by medical associations and other states.

In San Bernardino County, one psychiatrist prescribed antipsychotics to 328 foster children — 85 percent of the young patients to whom he gave a psychiatric drug in the five years the investigation examined. And when one antipsychotic didn’t work — or wasn’t enough — Dr. Warris Walayat routinely prescribed another.

Many of the highest prescribers stand out for other practices that raise questions about their judgment or objectivity: A psychiatrist who oversees treatment at a Riverside County group home for troubled children is a self-proclaimed “spokesperson for pharmaceutical companies.” A doctor training psychiatry residents at a San Diego children’s center once prescribed an antipsychotic to an out-of-control kindergartner. And a veteran Visalia child psychiatrist touts a drug approved to treat mania and schizophrenia as an effective “sleep aid.”

psyc drugs.JPG

http://extras.mercurynews.com/druggedkids/

psyc 22

Suggestions for our foster care children’s behavior instead of drugs or medications:

  1. Love and understanding
  2. Environment of learning, music, nature walks, whole foods
  3. Treating them like our own children
  4. Taking them to join volunteer opportunities
  5. Please email more suggestions to motherhealth@gmail.com

Immunotherapy depends on tumor variation

Tumor Heterogeneity Influences the Immune System’s Ability to Fight Cancer

Amy E Blum, M.A.

T Cell of the Immune System

Every cell in the body displays bits of its contents to the immune system, which searches for signs of external invaders. If the cell displays something abnormal, like a peptide made from an oncogene, this signal alerts the immune system to danger. Bolstering the immune system’s response to these signals is the basis of immunotherapy for cancer.

A new study led by Charles Swanton of the Francis Crick Institute in the United Kingdom found that activation of the immune system against cancer depends on the number and variety of mutations in the tumor. The findings, published on March 3,2016, in Science, provide insight into immune surveillance and suggest that variation, or heterogeneity, within a tumor may be an important predictor of whether patients could benefit from immunotherapy.

Activating the Immune System

Previous research has shown that tumors display particular mutations as antigens – molecules capable of inducing an immune response – on their cell surface for detection by the immune system. Swanton and his colleagues analyzed the number of antigens, and variety of antigens produced, in 150 cases of lung adenocarcinoma from The Cancer Genome Atlas (TCGA). Strikingly, the number of antigens, also a measure of the number of mutations, correlated positively with increased patient survival. This may appear counterintuitive because mutations cause cancer; however, mutations also present themselves as antigens to the immune system, and attack by the immune system weakens tumors.

The research team also found that the trend between the number of antigens and survival was strongest for tumors that displayed the same antigens across the whole tumor, as opposed to a variety of different antigens in select areas of the tumor. This is because intratumor heterogeneity, variation within a tumor, prevents the immune system from launching an effective attack.

Putting up a Roadblock

If you imagine growth of a homogenous tumor as a getaway car speeding along a superhighway, since a homogenous cancer utilizes only one highway, its dependence on a single route makes it easy for the patrolling immune system to set up checkpoints.  When immune system highway patrol recognizes speeding along this highway and closes it off, the tumor is likely to abate. However, tumors with intratumor heterogeneity do not display antigens uniformly, meaning that they have the choice of many possible roads. The number of possible routes can be too many for the immune system to effectively monitor, and simply alerting the immune system to the presence of the cancer does not increase its ability to close off every road.

The researchers tested this hypothesis through several experiments and demonstrated that immunotherapy, which helps the immune system recognize cancer cells, is likely more effective for homogenous tumors that express many antigens uniformly.

The team used TCGA data to evaluate the expression of genes involved in activating an immune response as well as genes involved in evading the immune response. They found that tumors that display a large number of antigens uniformly activated a more robust immune response than those that display fewer antigens more heterogeneously. However, the homogenous tumors also expressed higher levels of genes that help the tumor evade the immune system. This makes sense because since the tumor is only taking one road and needs to pass by an alert immune highway patrol, the tumor must compensate by increasing its efforts to avoid detection.

Targeting Immune Evasion

Swanton and his colleagues took their analysis a step further, noting that immunotherapeutic drugs that target immune evasion techniques may work especially well for patients with homogenous tumors that express a large number of antigens.

The researchers analyzed data from a study in which patients were treated with pembrolizumab. This drug targets PD-1, which is a signal that tumors can display in order to become less visible to the immune system. The analysis confirmed that patients with more antigens expressed uniformly were much more likely to benefit from treatment. Sixteen out of eighteen of the patients with high-antigen homogenous tumors had a durable clinical benefit from pembrolizumab, while only two out of eighteen patients with low-antigen heterogeneous tumors benefitted.

These results highlight an important discovery of recent genomic research, that a single tumor is not always a single disease. Heterogeneous tumors can act more like an ecosystem of several smaller tumors, making them more difficult to treat and more prone to drug resistance and relapse. Swanton and his colleagues found that patients with homogenous tumors that display many antigens are more likely to respond robustly to a single immunotherapy than patients with a heterogeneous tumor, who are unlikely to benefit from this type of treatment. These patients may need multiple therapies targeted to specific subpopulations within their tumor. This suggests that measuring and monitoring tumor heterogeneity throughout treatment may help clinicians better predict clinical outcomes and make more informed therapeutic recommendations.

McGranahan, N., Furness, A.J.S., Rosenthal, R., Ramskov, S., Lyngaa, R., Saini, S.K., Jamal-Hanjani, M., Wilson, G.A., Birkbak, N.J. Hiley, C.T. et al. (2016) Clonal neoantigens elicit T cell immunoreactivity and sensitivity to immune checkpoint blockade. Science. DOI: 10.1126/science.aaf1490

Quantitative clinical measurement of heterogeneity in immunohistochemistry staining would be useful in evaluating patient therapeutic response and in identifying underlying issues in histopathology laboratory quality control. A heterogeneity scoring approach (HetMap) was designed to visualize a individual patient’s immunohistochemistry heterogeneity in the context of a patient population. HER2 semiquantitative analysis was combined with ecology diversity statistics to evaluate cell-level heterogeneity (consistency of protein expression within neighboring cells in a tumor nest) and tumor-level heterogeneity (differences of protein expression across a tumor as represented by a tissue section). This approach was evaluated on HER2 immunohistochemistry-stained breast cancer samples using 200 specimens across two different laboratories with three pathologists per laboratory, each outlining regions of tumor for scoring by automatic cell-based image analysis. HetMap was evaluated using three different scoring schemes: HER2 scoring according to American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) guidelines, H-score, and a new continuous HER2 score (HER2(cont)). Two definitions of heterogeneity, cell-level and tumor-level, provided useful independent measures of heterogeneity.

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