Healthcare analytics, AI solutions for biological big data, providing an AI platform for the biotech, life sciences, medical and pharmaceutical industries, as well as for related technological approaches, i.e., curation and text analysis with machine learning and other activities related to AI applications to these industries.
Real Time Coverage and eProceedings of The 11th Annual Personalized Medicine Conference, November 18-19, 2015, Joseph B. Martin Conference Center of the Harvard New Research Building at Harvard Medical School
Curator: Aviva Lev-Ari, PhD, RN
The 11th Annual Personalized Medicine Conference, November 18-19, 2015, Joseph B. Martin Conference Center of the Harvard New Research Building at Harvard Medical School
11/18/2015 10:30 a.m. – Keynote Speakers: “Precision Trials Challenge” 11th Annual Personalized Medicine Conference, November 18-19, 2015, Harvard Medical School
11/18/2015 1:00 p.m. Keynote Speaker: Deputy Commissioner, US FDA – 11th Annual Personalized Medicine Conference, November 18-19, 2015, Harvard Medical School
11/18/2015 3:15 p.m. Perspectives From Professional Societies and Personalized Medicine Around the World, 11th Annual Personalized Medicine Conference, November 18-19, 2015, Harvard Medical School
11/19/2015 8 a.m. Building a Personalized Medicine Company & Keynote: President, Worldwide R&D, Pfizer Inc. 11th Annual Personalized Medicine Conference, November 18-19, 2015, Harvard Medical School
11/19/2015 10:30 a.m. PMC Award: Francis S. Collins, M.D., Ph.D. ex-Director, NIH, 11th Annual Personalized Medicine Conference, November 18-19, 2015, Harvard Medical School
11/19/2015 noon Keynote Genomics England, Innovators in Personalized Medicine, Value of Care @AZ, 11th Annual Personalized Medicine Conference, November 18-19, 2015, Harvard Medical School
I have been given the need to think about resilience in the face of serious conditions, such that they require special surgery. How do we account for the resilience? I can’t quite get my hands around this question. My grandfather lived a long life and retired at age 70 years as a mechanic so that a younger person could take the job. He looked after my loving grandmother with dementia with great care. He woke up early every morning and walked a good several miles before embarking on his day. He loved to have his grandchildren visit at least every Friday. He also loved to come to Detroit from Cleveland and fix anything in our house that could use fixing.
His younger son was a brilliant scholar, always reading, and a top student in his school in Hungary, so that he tutored the school principal’s children. He was unable to finish his medical school studies because of the incursion of WW II. He came to Cleveland and had a good career in selling insurance, and he could manage difficult calculations in his head. He could recite the prologue to the Iliad throughout his life. He lived to 99 years. He liked to dance and enjoy himself.
My Uncle Herman had an only daughter. I nickname her Lulu. She and her husband have lived in Georgia for many years. My sister was visiting her and told her that she was not like her younger pictures and was masculinizing in her features. She had a serious anterior pituitary tumor called acromegaly that secretes growth hormone. She has used the Cleveland Clinic all her life and she was referred to a former NIH physician in Los Angeles who is recognized as a world authority. She has had two surgical procedures in about two decades and is followed assiduously. There have been complicated events that were related to her present condition, but she has managed it all well. I get a call from time to time for assistance in a second opinion to review the radiology and pathology reports. Despite her condition, she has an ability to take it all in stride. I had made a recommendation many years ago on a diet that included sufficient omega 3. The downside was that when visited by relatives the use of a good restaurant is not as enjoyable. However, as I still recall, going to dinner in Florida with Herman’s brother was an experience because Dave’s wife was a far better cook.
When I was handling my own thyroid condition in the last two years I heard from Lulu. She encouraged me and said that I was a Schwartz. That was the story. Our only living aunt is 95 and doing quite well except for her macular degeneration. She lives in upstate New York near her daughter, my cousin Barbara and her husband Stanley. Barbara had a motorcycle accident many years ago, and she was afflicted with an enduring pain that she managed well. It was difficult to visit when she was younger because she was so busy raising her children and taking them to activities.
One might look at this as having good genes, or is it good Jeans. The significant factor is a healthy world view.
Now, as Bloomberg reports the international deal between Allergan and Pfizer has gone through, resulting in a tax inversion and nary a discouraging word from the US Federal Government (their blessing for future tax inversions?). And as Bloomberg Go guest speculate finally it may spark Congress to do something about it, or perhaps not. For details see Bloomberg transcript below:
Pfizer Inc. and Allergan Plc agreed to combine in a record $160 billion deal, creating a drugmaking behemoth called Pfizer Plc with products from Viagra to Botox and a low-cost tax base.
Pfizer will exchange 11.3 shares for each Allergan share, valuing the smaller drugmaker at $363.63 a share, according to a statement Monday. That’s a premium of about 27 percent above Allergan’s stock price on Oct. 28, before news of the companies’ discussions became public. Pfizer investors will be able to opt for cash instead of stock in the combined company in exchange for their shares, with as much as $12 billion to be paid out.
The transaction is structured so that Dublin-based Allergan is technically buying its much larger partner, a move that makes it easier for the company to locate its tax address in Ireland for tax purposes, though the drugmaker’s operational headquarters will be in New York. Pfizer Chief Executive Officer Ian Read will be chairman and CEO of the new company, with Allergan CEO Brent Saunders as president and chief operating officer, overseeing sales, manufacturing and strategy.
The deal will begin adding to Pfizer’s adjusted earnings starting in 2018 and will boost profit by 10 percent the following year, the companies said. Pfizer’s 11 board members will join four from Allergan, including Saunders and Executive Chairman Paul Bisaro.Pfizer dropped 2.1 percent to $31.51 at 9:34 a.m. in New York, while Allergan fell 2 percent to $306.17. The combined company will trade on the New York Stock Exchange.Pfizer said it will start a $5 billion accelerated share buyback program in the first half of 2016. The deal is expected to be completed by the end of next year.
Unprecedented Deal
Pfizer, based in New York, makes medications including Viagra, pain drug Lyrica and the Prevnar pneumococcal vaccine, and Allergan produces Botox and the Alzheimer’s drug Namenda. Together, barring any divestitures, the companies will be the biggest pharmaceutical company by annual sales, with about $60 billion. The deal will be unprecedented on many levels. It’s the largest acquisition so far this year. It’s the largest ever in the pharmaceutical world, eclipsing Pfizer’s purchase of Warner-Lambert Co. in 2000 for $116 billion. And if the new company is able to establish itself abroad for a lower tax rate, a controversial process called an inversion, it will be the largest such move in history. The U.S. Treasury Department has increasingly targeted such strategies, most recently announcing new guidance on how it will value assets owned by U.S. companies that undertake inversions. The U.S. has the highest tax rate for businesses in the world, at 35 percent, and is one of the only countries to tax corporate profits wherever they are earned. Previous moves by the U.S. Treasury have derailed other proposed inversions, including AbbVie Inc.’s plan to buy Ireland’s Shire Plc for an estimated $52 billion. Pfizer and Allergan’s deal appears structured to avoid the tax inversion rules.
Read has already reached out to lawmakers in both houses of Congress, including Senate Majority Leader Mitch McConnell, and is calling the White House Monday, according to a person with knowledge of the matter. His pitch is that that the deal will help the companies invest in more innovative drugs and that Pfizer Plc would have 40,000 U.S. employees at the close of the transaction.
Facilitate Split
An agreement may also facilitate the widely discussed potential for Pfizer to reconfigure itself by splitting the newly enlarged company into two: one focused on new drug development, the other on selling older medications. Pfizer said Monday it will decide on a potential separation by the end of 2018. Pfizer earlier this year bought Hospira Inc., the maker of generic drugs often administered in hospitals, in a transaction valued at about $17 billion. The deal bolstered Pfizer’s established-drugs business, which combines strong cash flow and slow growth. Allergan itself has been recently transformed, created through an acquisition by Actavis Plc that kept the Allergan name. The company agreed to sell its generics business to Israel’s Teva Pharmaceutical Industries Ltd. for about $40.5 billion and has been on a buying binge of its own. It now has more than 70 compounds in mid-to late-stage development.
But What About Pfizer R&D? Will that be put on the Back Burner?
A little while ago this site posted a talk given by Pfizer on their foray into personalized medicine in
Here Pfizer had emphasized its commitment to discoveries in the personalized medicine area however the emphasis on worldwide may have been a hint of what is to come.
Just a few days ago Allergan CEO wrote a guest post in Forbes (edited by Matthew Herper)
There has been a lot of discussion about my views about pharmaceutical research and development. Let me cut to the chase. I’m pro-R&D, but I don’t believe that any single company can corner the market on innovation in even one therapeutic area. It doesn’t mean they shouldn’t do basic research where they have special insights, but even then they need to be open to the ideas of others. Innovation in healthcare is more important than ever. Other companies have had success with different models based on different capabilities, and we applaud every new drug approval. Here at Allergan, we’ve adopted a strategy we call “Open Science.” It is based on a simple concept: Sometimes great ideas come from places where they are least expected.
Allergan’s CEO goes on to stress innovation centers around academic centers such as in Boston and an emphasis on Alzheimer’s research and development but is this just shop talk or is there a agenda and strategy here?
This is all very interesting and might mean, with the size of this deal and that Allergan owns 40% of Pfizer, a massive sea-change in the way big pharma conducts R&D, possibly focusing on smaller “open-sourced” smaller players.
Our Open Science approach allows us to strategically invest in innovation and be more nimble so that we can increase our R&D efficiency. It has led to a robust pipeline of experimental medicines. We currently have 70 mid- to late-stage programs in the pipeline, and since 2009, we have successfully brought 13 new drugs and devices to the market.
It also allows us to invest in areas that other companies have abandoned, like central nervous system (CNS) treatments. In CNS, clinical development costs are higher, and market approval probability is lower. But treating these disorders can bring hope to patients of all ages. According to the Centers for Disease Control & Prevention, one in 68 children has autism spectrum disease. Alzheimer’s affects one in three people over the age of 85, based on data from the Chicago Health and Aging Project. Yet despite the 634 current open clinical trials for these diseases, there are no approved medicines for autism’s three core characteristics, nor drugs that treat Alzheimer’s underlying disease or delay its progression.
Other related articles published in this Open access Online Scientific Journal include the following:
FDA’s perspective is that ”quality cannot be tested into products; it should be built-in or should be by design”
Deloitte estimates that PAT can promote fewer recalls and less scrap inventory.
Towards a continuous future?
A recognized potential for small molecule drugs, and some companies have developed this continuous technology.
Deloitte’s study says that FDA views continuous manufacturing as consistent with the FDA’s quality by design efforts.
How to define a batch in case of product recall is a true challenge, which means that new measurements methods are needed.
Continuous manufacturing opposed to efficient, well-planned and engineered facilities, which is the vision developed by Amgen and others innovative players.
In September 2015, the drug was reported to be in phase I clinical trial.One of the family members US09132133, claims a combination of sulbactam and WCK-5107.
Bacterial infections continue to remain one of the major causes contributing towards human diseases. One of the key challenges in treatment of bacterial infections is the ability of bacteria to develop resistance to one or more antibacterial agents over time. Examples of such bacteria that have developed resistance to typical antibacterial agents include: Penicillin-resistant Streptococcus pneumoniae, Vancomycin-resistant Enterococci, and Methicillin-resistant Staphylococcus aureus. The problem of emerging drug-resistance in bacteria is often tackled by switching to newer antibacterial agents, which can be more expensive and sometimes more toxic. Additionally, this may not be a permanent solution as the bacteria often develop resistance to the newer antibacterial agents as well in due course. In general, bacteria are particularly efficient in developing resistance, because of their ability to multiply very rapidly and pass on the resistance genes as they replicate.
Treatment of infections caused by resistant bacteria remains a key challenge for the clinician community. One example of such challenging pathogen is Acinetobacter baumannii (A. baumannii), which continues to be an increasingly important and demanding species in healthcare settings. The multidrug resistant nature of this pathogen and its unpredictable susceptibility patterns make empirical and therapeutic decisions more difficult. A. baumannii is associated with infections such as pneumonia, bacteremia, wound infections, urinary tract infections and meningitis.
Therefore, there is a need for development of newer ways to treat infections that are becoming resistant to known therapies and methods. Surprisingly, it has been found that a compositions comprising cefepime and certain nitrogen containing bicyclic compounds (disclosed in PCT/IB2012/054290) exhibit unexpectedly synergistic antibacterial activity, even against highly resistant bacterial strains.
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WCK-5107 Alone and in Combination With Cefepime (NCT02532140) https://clinicaltrials.gov/show/NCT02532140
ClinicalTrials.gov Web Site 2015, September 01, To evaluate the safety,tolerability and pharmacokinetics of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.
Laboratory Automation Today, Volume 2 (Volume Two: Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS and BioInformatics, Simulations and the Genome Ontology), Part 1: Next Generation Sequencing (NGS)
Top-performing medical laboratories are using Lean to help craft RFPs, evaluate TLA options, then implement the automated systems to achieve optimal quality and productivity
In recent years, there’s been a big change in how clinical laboratories purchase total laboratory automation (TLA) solutions, and then integrate this automation into their lab operations. Using a strategy that is somewhat off the radar, top-performing medical laboratories will purchase and install TLA only after applying the principles of Lean to the physical layout and overall workflow within their labs.
This development demonstrates the growing acceptance of Lean, Six Sigma, andcontinuous process improvement methods at hospital-based laboratories and independent clinical laboratories.
As lab budgets get squeezed down each year and specimen volume increases, pathologists and clinical lab managers face the twin challenges of reducing costs while increasing the quality of their lab testing services.
Why Top-Performing Medical Laboratories Use Both Lean and TLA
For these reasons, Lean methods are now integral to the use of laboratory automation among top-performing clinical laboratories. These labs use a new cycle for procurement and implementation of lab automation. Steps in this cycle involve Lean methods in the creation of the RFP (request for proposal), in the pre-purchase assessment of proposals, and in implementation, followed by the use of continuous improvement designed to extract maximum quality and optimal productivity from the laboratory automation installation.
When labs are incorporating Lean methods and a culture of quality management in their operations, they change the traditional steps they followed when preparing to replace an aging, outmoded system with a new one capable of revising almost all aspects of lab operations.
Forward-looking pathologists and clinical lab directors view the installation of a new automation system as an opportunity to revise not only the automated processes but also as many other lab operations as possible.
In fact, they view the challenge of implementing a new system as a chance to address almost all of the most challenging problems in laboratory management today. These problems range from:
Reimbursement levels that have been declining for years and are expected to continue to decline;
A shrinking lab workforce;
An aging population with more chronic diseases;
To the most pressing need of testing more specimens while delivering greater value simultaneously.
Manual Processing in Clinical Laboratories Is Subject to High Error Rates
“Among the benefits of both Lean and TLA is that labs can maximize efficiency and reduce errors simultaneously,” stated Joe Ross, Senior Marketing Manager, North America Automation and Clinical Informatics, for Beckman Coulter in Brea, Calif. “Lab managers recognized that any area of the clinical laboratory that involves manual processing is subject to high error rates. This is particularly true of the pre-analytical and post-analytical phases of the lab testing workflow that humans handle. It is these areas that generate the most benefits when a lab blends Lean with new lab automation.”
“In an environment saturated with total lab automation solutions to help improve quality, labs constrained by size and budget need to look for solutions to help reduce variation in manual processes—including both physical and decision-making processes. Utilizing Lean processing initiatives, which are designed to eliminate waste and improve efficiency in various processes and industries, is the first step toward identifying key areas for improvement,” stated Joe Ross (above), Senior Marketing Manager, Automation and Informatics, Beckman Coulter. (Photo and caption copyright: Clinical Lab Products Magazine.)
Other areas that benefit from both Lean and TLA are turnaround time. In general, Lean experts say, Lean labs can and should have an average TAT of less than 30 minutes. In addition, the combination of Lean and automation systems can help labs reduce variation in TAT as well.
One of the biggest challenges medical laboratories face is the ability to handle stat testing smoothly and efficiently. Lean management and the best in class automation systems can process stat tests in less than 30 minutes—meaning from the time the lab receives the sample to the time the results are sent to the ordering physician. The best in class systems beat this 30-minute TAT goal even during times of peak processing workload. Most important, rather than having a mean of 30-minutes, the top performers have driven variation below 10 minutes.
Using Lean and Lab Automation in Microbiology at DynaLIFEDx
One lab that recently combined Lean and total laboratory automation wasDynaLIFEDx Diagnostic Laboratory Services in Edmonton, Alberta, Canada. One of the largest labs in North America, DynaLIFEDx processes 900,000 microbiology specimens annually for more than 120 hospitals and health systems in Alberta, Saskatchewan, and the Northwest Territories.
When its microbiology lab combined Lean with TLA in September 2013, the lab recorded:
In addition, combining Lean and TLA helped the DynaLIFEDx microbiology lab lift productivity so much that it could handle a 15% increase in specimen volume over 18 months while also reducing staff by six full-time equivalent positions.
Lean and Automation Cut Microbiology Test TAT to Just 1 to 1.5 Days
“After the lab implemented its TLA system, the microbiology staff saw the time to report results drop from 1 to 5 days to 1.5 to 2 days,” stated Norma Page, the lab’s Vice President of Clinical Operations during a presentation at the Executive War College in New Orleans last May. “When the staff compared the number of labeling errors in one month (March 2012 versus March 2014), the number dropped from 106 out of 70,523 specimens processed (for a rate of 0.150%) to 13 errors among 77,951 specimens processed for an error rate of 0.017%.”
Norma Page (above) is a medical laboratory and finance professional with hands-on experience in all aspects of laboratory medicine, including testing services, patient care, systems and support infrastructure, quality management, laboratory integration, business acquisitions, and strategic, business and financial analysis. She is a registered medical laboratory technologist and holds a Master of Business Administration degree from Heriot-Watt University in Edinburgh, Scotland. (Photo and caption copyright: Dark Intelligence Group.)
Our sister publication, The Dark Report published a seminal study that confirmed the performance advantages that Lean labs using lab automation have over non-Lean labs using automation. The study was done by Thomas Joseph, CEO of Visiun, Inc., of Ann Arbor, Mich.
Working from a database that included 100 labs, 14 of which were incorporating Lean methods, Joseph determined that Lean labs consistently outperformed non-Lean labs in the important measures of average test TAT, staff productivity, and reduction of outlier test reports, despite the fact that all labs were generally using comparable automated systems for chemistry, immunoassay, and hematology.
Thomas Joseph (above), CEO of Visiun, Inc., is a seasoned consulting professional with 20 years of consulting experience and areas of expertise that include financial management, operations assessment, and improvements using Lean strategies, and research and development. Joseph’s research in the area of performance metrics has led to the development of the most comprehensive database of performance metrics in the laboratory industry.
Lean Labs with Automation Sustain TAT Even with Large Test Volume
“With Lean labs, we saw that the relationship between test volume and TAT is almost flat, meaning Lean labs are managing results regardless of volume, because larger volumes have almost no effect on TAT,” observed Joseph. “What’s more, the larger Lean labs are doing just as well. The largest lab we studied did about 1.6 million annual tests and could do a routine CBC in about nine minutes. The smaller Lean labs, with annual volume of about 400,000 tests, did a routine CBC in about eight minutes. Work processes in Lean labs allow them to handle increased workload without suffering declines in TAT the way conventional labs do.” (See The Dark Report, Volume XV, No. 1, January 21, 2008.)
For all these reasons, in vitro diagnostic manufacturers have recognized the power of combining Lean with lab automation and the latest best-in-class total automation systems are designed to accommodate Lean labs. “For these systems, manufacturers incorporate Six Sigma principles into the actual automation workflow by working to eliminate bottlenecks on the automation line,” noted Ross.
Automation Solutions Should Be Designed to Eliminate Bottlenecks in Clinical Labs
“If you look at lab automation systems that don’t have a philosophy to eliminate bottlenecks, then specimens will get held up at the centrifuge or at various analyzers,” he explained. “Then, lab test turnaround times have wide variation, which physicians don’t like because it creates unpredictability in when the lab reports results to them.
“Conversely, the modules in best-in-class automation systems are designed to move at the same speed,” added Ross. “That includes the centrifuges, analyzers, decappers, recappers, and all essential components. When you do that, you start to get very consistent turnaround times because—if you have 100 samples and each sample gets loaded every three seconds—you will get results every three seconds. Therefore, your variation in turnaround is very, very minimal. When your lab does that, physicians ordering tests will see the consistency and thus the lab will see an overall improvement in its relationships with physicians,” stated Ross.
White Paper on Combining Lean and Total Laboratory Automation
In the report, readers will find a thorough discussion of the issues related to combining Lean and TLA, along with an examination of the questions lab directors and pathologists will want to answer before they make a decision to purchase and implement a new TLA system.
I graduated college as a chemistry undergraduate prior to entrance into medical school in 1973, and my brother had not exhibited signs of serious mental distress until that point. He was dating a young woman who rejected him, and he was also under pressure from our father, who thought he did not have direction. The oldest daughter was married and was well prepared in piano and in mathematics, and she has prepared students in piano to the present day. The triplet sister was married to a medical student who went on to become a psychiatrist. The two sons were still living at home. There was considerable pressure on my brother to complete his studies. The trigger seemed to be the breakup of his relationship. It was in the months prior to my graduation that my mother was deeply concerned and our parents pursued a psychiatric evaluation. He was put on chlorpromazine, but then developed jaundice. Schizophrenia was not understood in those years, and for many years was an illness that brought shame to the parents. I shared a bedroom with my brother for all the years prior to this event and I only saw it develop at the surface.
We both had worked as waiters at a resort on Lake Michigan for some years prior to my entrance to medical school, and Leslie had an interest in biology. He was closer to our younger sister, and I was trying to keep up with Sharon, who was 2 years older and had an infant that I visited often. I had a close friend who was my buddy. I could talk to him often, and we compared notes after a double date. Leslie had a friend who we had played chess with in high school. My brother showed no progress and his psychiatric visits were costly. My father was a dental technician who was skilled at making dentures.
It was the summer prior to my entry into medical school that I worked in a biochemistry research laboratory under the supervision of my brother in law. The first year medical studies were pressured with anatomy, biochemistry, inborn errors of metabolism, neuroanatomy and embryology, and dissection of cadavers. Leslie was admitted to the Lafayette Clinic at Wayne State University. He was now receiving the best care available. I visited him at that time, and he played chess with the attendant.
It was also during the first year of medical school that the progressive Rabbi Adler, at Rodeph Shalom who had a national reputation was shot in front of the Bima by Richard Wishnetsky, a troubled man our age who was mentally ill, probably with a mood disorder. My good friend was home from Berkeley and tried to avoid the problem, but he was released by a law school student. Richard’s parents were leaders in the congregation. My friend and I knew there was a problem early because Richard had received a Woodrow Wilson scholarship, and he considered graduate studies under a faculty member at the Catholic University in Detroit, but he did go to the University of Michigan.
At the end of the first year, the triplets went to Washington, DC to participate in an ongoing Schizophrenia twin study. I was engaged in studies of radiation on virus in an NIH lab during the study. Three years later, when I was rotating through psychiatry at Herman Kiefer Hospital in my third year having taking time out for a Master of Science degree in Anatomy (the evolution of the proteins of the eye lens), I found myself in the Detroit riots.
My brother grew a beard and became somewhat disheveled. He had hallucinations, and he could tell about his dreams. For instance, so and so visited him. He began living in an apartment on Woodward Avenue, the largest street in Detroit. He became very spiritual, and he wrote poetry. One day he stood in the middle of Woodward Avenue wearing a tallis (prayer shawl) and directed traffic. He did manage to finish his undergraduate studies, but when he took a job teaching biology, he just couldn’t. He also knew that a Croatian girl who graduated high school with us, who was a talented dancer, developed schizophrenia.
My mother was very stressed. She was helping to care for my older sister’s daughter, and she was grieving over her son. She developed abdominal pain in 1978, when I graduated and went to my residency in Pathology at University of Kansas Medical Center in Kansas City, in what was to be a residency and PhD program. I had joined the Berry Plan during my medical school years and when I graduated I was randomly selected to go into the Navy, but got a deferment to complete my studies.
It was during that time that I learned that my mother had had an exploratory laparotomy for what turned out to be an infiltrating carcinoma of the stomach, through the wall and on the peritoneal surface (linitis plastic). No biopsy was taken. I flew home frequently until the end. She was on morphine to ease the pain. I began seeing a woman I had known in high school, who was now teaching. We were married in December of 1979, after my mother died. My mother’s father had always been well and was a mechanic in Cleveland. I was told that he died of a broken heart with the loss of my mother.
I went to University of California, San Diego in January, 1980, to work in Enzymology, the inhibition of the pyridine nucleotide linked malate dehydrogenase reaction, under Nathan O. Kaplan, and there I also completed my residency. It happens at that time, my brother had moved to San Diego, and he was looked after our triplet sister. It was a fortunate circumstance for the triplets.
In 1987, I went on vacation to Bermuda with my wife and two children. It was a beautiful place, and the weather and the ocean were wonderful to experience. One could travel by bus, which was very safe, which I preferred. My older daughter wanted to use a moped, which we allowed on the condition that she first be trained. On the last day, she went to return the moped, but the station was out for lunch. I was a photograper and wanted to photograph the white bird of Burmuda. I put my camera in the rear, but as I left the station my moped was hit by an oncoming moped that I failed to see, unaccustomed to the British style driving. An ambulance arrived within a few minutes as I lay on the ground. My wife sent the kids home and made arrangements for my secretary to look after them. I was impressed with the surgeon when I arrived at the hospital. He wheeled me to the bed I was to stay in. I had two blood transfusions. He took me to the operating room, but I don’t recall any details. He had a McGill University resident who later wrote a thesis about the experience. I was pretty knocked out, but there was another patient in the room who had fallen down his steps. He was a WWII RAF veteran who had bombed the Germans. He told me the stories about his experience. We contacted the burn surgeon, Walter Pleban, who arranged to have me flown to Bridgeport, CT, and he arranged for the best orthopedic surgeons to admit me on arrival. In my flight there was another patient who was dying of endstage HIV AIDS.
Herbert Hermele observed how serious this was because there were three fractures of the right tibia. The good news was that there was no need to amputate because I had the nervous innervation, but I lost a popliteal artery. I was admitted, and at first there was only a small room. The nurse was a very competent young woman of Portuguese descent. She was able to move me as needed. I was moved when a better room became available. It was very good when the night shift nurse came in because I was able to talk to her with some attachment. The Vice President had me provided with good meals, as I was the director of blood bank and chemistry. I also had visits by my supervisors and other staff.
It was not an easy time, but I was privileged because of my standing with the medical and laboratory staff. I had a longer stay than usual because I had an infection with two gram negative resistant strains of bacteria –serratia marcesans and Enterobacter. I was put on a gram negative penicillin and the next morning I felt dizzy. When Dr. Pleban came to see me I told him that I was having a penicillin reaction because I was aware that my twin sister was allergic to penicillin. As a result, the prescription was changed and it was an improved situation. I underwent 10 operative procedures in some weeks. Dr. Hermeles partner put an antibiotic plug into the wound and it healed. It was only after the infection cleared that a superb reconstructive surgeon was called in and he made skin grafts to close the wound after he disconnected a tendon and pulled muscle over the wound. I also had a call from IJ Good, University Professor of Statistics at Virginia Polytech, who had completed writing a program to analyze data that I had provided him 2 years earlier – of MB isoenzyme CK at 6 hours and 12 hours later for diagnosis of heart attack. We published the work in the prestigious journal, Clinical Chemistry and the President of the College of American Pathologists took note of the paper. I was finally sent home, without needing excess stay to the hospital environment. I had physical therapy at home, and my bed was made on the first floor. When I returned to work my infection site oozed, so I went to the Chief of Infectious Disease. He prescribed a new quinolone antibiotic that could be taken orally. The infection subsided and it has never returned.
My sister came from San Diego, California and she brought me a recording she made for imaging to heal. It went on that I was climbing a step to the heavens and getting better and better. She also emphases laughing.
I can only look back and recall how fortunate I was to have the attention and kindness at that time. It was in excess of what many patients experience. I do recall that the Hungarian-Cuban music teacher my daughter had had thousands of musical pieces and thousands of stories so that she was one of the most entertaining patients ever admitted to Bridgeport Hospital.
I retired from my position as pathologist in charge of clinical laboratories after five years at New York Methodist Hospital, with great satisfaction in mentoring students from the high schools and university undergraduate programs nearby interested in science. I was fortunate to experience the Brooklyn “cityscape” and vibrance, and to work with other physician educators in surgery and cardiology and pulmonary medicine. Most of my students participated in presenting papers at professional meetings, and some coauthored published work. But I was about to enter a new phase of life. I returned to my home in Connecticut and immediately accepted a temporary position for less than a year as the Blood Bank – Transfusion Medicine Director at Norwalk Hospital, which also afforded the opportunity to help with the installation of an automated hematology system, and to help in the quality monitoring in Chemistry. It was a good reprieve from the anxiety of having nothing to do after an intense professional career. When that ended I went to Yale University Department of Mathematics and found a collaborative project with a brilliant postdoc and his mentor, Professor and Emeritus Chairman Ronald Coifman. A colleague of mine many years ago had done a project with the automated hematology, but it was too early for a good interpretive hemogram. I had sufficient data in 8,000 lines of data containing all of the important information. We managed to develop an algorithm in over a year that would interpret the data and provide a list of probabilities for the physician, and we used part of the data set for creating the algorithm and another set for validation. In the meantime I also became engaged in twice weekly sessions in Yoga, Pilates, and massage therapy, and did some swimming. I also participated in discussions with a group of retired men up to 20 years senior to me. I also did two rounds of walking around the condonium that was home to my wife and I.
Then I noticed that I became weak and short of breath in walking around the condominium streets and had to stop and hold a tree or streetlamp. I was long-term diabetic and was followed by a pulmonologist for sleep apnea for some five years. This was an insidious health presentation, as I had had good pulmonary and cardiac status at that point in time. Then an “aha!” moment occurred when my laboratory results showed a high level of thyroid stimulating hormone. It was one of a rare instances of hyperparathyroidism occurring with a thyroid tumor.
I then had radiological testing of the head and neck, which led to a thyroid biopsy. I then chose to referral to Yale University Health Sciences Center, where there was an excellent endocrinologist, and it was a leading center for head and neck surgery. All of this took many trips, much testing, biopsies of thyroid and its removal. There also were 3 proximate lymph nodes. In undergoing the tests the technicians said that they had never had a patient like me because of my questions and comments. It was a papillary thyroid cancer involving the center and right lobe, with a characteristic appearance and identified by a histologically stained biomarker that I reviewed with my longtime friend and colleague, Dr. Marguerite Pinto. The surgery and followup went well.
However, I developed double-vision (diplopia) and was referent to one of a handful of neuro-ophthalmologists in Connecticut. Perhaps related to the hyperthyroid condition, I had developed an anti-thyroid antibody that disturbed the lower muscle that moves the right eye. This required many test over months, and my wearing a special attachable lens gradient to equalize the vision in both eyes. The next requirement was to watch and wait. It could be corrected by surgery if it remained after a year. Nevertheless, it subsided over a period of perhaps 9 months and I removed the attachment with sufficient return of my previous sight.
In the meantime I was writing a lot over this period, and I also began to watch MSNBC and Turner Classic Movies on a regular basis and found relief. I’m not a “laugher” and have had a long-term anxiety state. I enjoyed watching the magic of Charlie Chaplin, Al Jolson, Lassie, and whatever caught my fancy.
My daughter was accepted for a tenure earning faculty position competing against a large field of candidates for an Assistant Professorship at Holyoke Community College in Western Massachusetts. Her husband had invested 15 years as a Navy physician and neurologist, having graduated from the Armed Services Medical School in Bethesda, and given this opportunity, decided to forgo further service would pay for their child’s future college education. He is very bright, knowledgable, and a blessing for a son-in-law. We went through the sale of our house and the search for a living arrangement near our daughter, all while I was going through my therapy. It was undoubtedly the best thing to moving near the daughter.
The move became an enormous challenge. It took time to sell the condominium, which was desirable in a difficult market. I became engaged in trashing what I need not save, but I had to review hundreds of published work, unpublished papers, saved publications, and hundreds of photographs large and small, that I had kept over many years. I had to dispense of my darkroom equipment, and we managed to give much away. It was very engaging. It was impossible to be overwhelmed, but also tiring over the long haul.
Prior to moving, my wife had trouble swallowing, and she was subsequently found to have an esophageal carcinoma at 20 cm, and invading the submucosa. We made arrangement for treatment by Massachusetts General Hospital, which could be done at its cancer affiliate in Northampton, MA. The move was made, and we have temporary residence in a townhouse in Northampton, woon to move to an adult living facility. My wife is lucky enough to have a squamous cell carcinoma, not adenocarcinoma. Her treatment needed careful adjustments. She decided to live it out whatever the outcome. However, she has done well. She maintained her weight, underwent radiation and chemotherapy, which is finished, and is returning to eating more than soft food and protein shakes. She has enjoyed being a grandmother to an incredible kid in kindergarten only a block away, and engaged in reading and all sorts of puzzles and games.
My own health has seen a decline in ease of motion. I am starting physical therapy and also pulmonary therapy for my asthma. Having a grandson is both a pleasure and an education. Being a grandparent, one is relieved of the responsibility of being a parent.
In following my wife’s serious illness, which precluded surgery, we have had phone calls from her sister daily, weekend visits nonstop, and more to come. She has been very satisfied with the quality of care.
My triplet sister calls often for both of us. We also call my 95 year old aunt, who is my mother’s sister. My mother’s younger brother enjoyed life, left Hungary as a medical student in 1941 and became an insurance salesman in Cleveland. He lived to 99 years old. He outlived 3 wives, all friends of my mother.
His daughter has called me for a medical second opinion for a good fifteen years. She was a very rare patient who had a pituitary growth hormone secreting adenocarcinoma (Addison’s Disease) for which she had two surgeries, and regularly visits the Cleveland Clinic and the Jewish Hospital of Los Angeles.
Is Patient Engagement with Medicine different than World View?
Curator: Larry H. Bernstein, MD, FCAP
In Mark Twain’s later years he had personal and financial losses. I think that was when he wrote “why do we laugh at a birth and cry at a funeral? It is because it is not I!”
The first Chairman of Medicine at John Hopkins Medical School was William Osler. He taught that a physician must be broadly knowledgeable about the arts and culture in order to make a difference in engaging the patient. This has come into play in the republican primaries for the first time, regardless of other requirements.
When I was a freshman medical student we had a special course on Inborn Errors of Metabolism. I think it was a first, given a new and energetic Chairman of Biochemistry from Harvard. Nevertheless, over the next decade, the influence of “Oslerism” was fading, to be replaced by the concept of a British physician, Archibald Garrod (1857–1936), in the early 20th century (1908). He is known for work that prefigured the “one gene-one enzyme” hypothesis, based on his studies on the nature and inheritance of alkaptonuria. His seminal text, Inborn Errors of Metabolism was published in 1923.[1] Some years later I learned that the selection of students entering was weighted in success with organic chemistry.
Type of inborn error
Incidence
Disease involving amino acids (e.g. PKU), organic acids,
primary lactic acidosis, galactosemia, or a urea cycle disease
When I entered my third year of medical school, I had a huge awakening. I was now engaged with patients at Detroit Receiving Hospital. It was not unlike Cook County, LA County, Charity Hospital, King County or Belleview Hospital. This was a year before the Detroit riots. Receiving Hospital (later Detroit General) had a large population of indigent patients and was a trauma center located adjacent to skid row. There were students who looked down on the patients, many on welfare, and who took a taxi to the hospital.
Most of my colleagues did not have that view. However, I would guess that my view was transcended some time later when I recall students concerned about “racial balancing” for entry to colleges.
I saw the victims of gun, knife and other violence in the Emergency Room (ER). On one occasion, the entire surgery staff was called out of the weekly Grand Rounds to attend to 3 cases with massive bleeding in the ER. One of the cases was presented the following week with a discussion of whether the patient should have been taken to the operating room instead of handling the emergent case in the ER.
I also recall a woman who might have been 45 years old who was extremely anxious and had had 5 divorces. Nobody came to visit her. We were taking her blood pressure when it spiked very high. My classmate might well have said holy smoke and ran to the library to check things out. She had a very rare occurrence of pheochromocytoma, a tumor of the adrenal medulla that secretes adrenaline. It was probably also a factor in her social history. It was the first such case to be seen by the Chairman of Surgery.
I don’t know that preparation in the great city hospitals has changed. It is an important experience. I did see some anger expressed by patients in the ER, mainly related to the life experiences of the patient. In my 20 years at Bridgeport Hospital, there was a large admission population from “Father Panic Village”. I recall vividly a patient saying to me, when he learned my last name is Bernstein, get away from me.
Over the years, not that much has changed. There is a much larger uneducated, unemployed, and ignorant population that has no hope of a future. It is most disconcerting at this time because they are bereft of a dream, and they don’t participate in our society. Moreover, large disparities influence voting patterns and also the use of tight public resources.
It would be difficult for me to consider this to be unrelated to an emerging world crisis that we are observing today. There is an increased downward pressure on the lower class with a vanished middle class. The entering well prepared medical staff is inundated, but more skilled at the inadequate medical information systems they have to use. There has been emigration to the UD for decades, but now we have more openly advocated do not come unless you have value to provide. We are in the midst of a Middle East crisis, and despite economic recovery since the Wall Street collapse, there is a “doomsday” chronicle. Emma Lazarus wrote “Give me your poor, … and your huddled masses yearning to be free”.
TS Elliott wrote “The Hollow Men” in 1925, post WWI . We remember “This is the way the world ends. This is the way the world ends. Not with a bang, but a whimper. I hope that it hasn’t come to that.
Gil Bashe #FPHealth 
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