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"The angel said to the women, Do not be afraid, for I know that you are looking for Jesus, who was crucified. He is not here; he has risen, just as he said." Matthew 28: 5-6a
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Each issue will include an editorial on a topic that is important for the profession of pharmacy, as well as a review of a new drug that includes a comparison of the new drug with previously marketed drugs that are most similar in activity, and a New Drug Comparison Rating (NDCR) for the new drug. Read on for this month's issue.
April 2021 SPECIAL EDITION [Download PDF format]
In this issue:
• NO GREATER LOVE
• Lead Like it Matters to God
• OVERTIME!
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EDITORIAL:
NO GREATER LOVE
"Love the Lord your God with all your heart and with all your soul and with all of your mind. This is the first and greatest commandment. And the second is like it: 'Love your neighbor as yourself.' All the Law and Prophets hang on these two commandments." Matthew 22:37-40
These statements are brief, clear, and a mandate for those who love God. Those who do not accept the first commandment are likely to recognize the wisdom of the second one. For Christians, Easter represents the celebration of the resurrection of Jesus Christ following his crucifixion. The death of Jesus was the ultimate expression of His love for humankind, and His resurrection provides the opportunity for redemption, salvation, and hope.
Many do not believe the experiences and teachings in the Bible, and others are selective in choosing certain passages/statements to accept. However, the influence of Jesus Christ and Christianity should not be denied. I like the way in which the theologian and author C. S. Lewis characterizes this faith: "Christianity, if false, is of no importance, and if true, of infinite importance. The only thing it cannot be is moderately important." If Christianity and the events and teachings of the Bible were not true, it would be the greatest fraud ever perpetrated on humankind. Personally, I choose to accept what I consider to be the "truths" of this faith, even though there is much I don't understand.
God loves everyone, regardless of the personal characteristics and beliefs with which we self-identify. His love is unconditional and available to all. We can only be responsible for our own personal thoughts and actions, and providing love, support, and a positive example for others, and I often fall short in meeting the standards I set for myself. However, the attitudes, words, and actions that surround us, and sometimes include us, often demonstrate more hatred than love. "Hatred stirs up dissension, but love covers all wrongs." Proverbs 10:12.
Hatred
Hatred is defined as intense animosity or hostility and is often evident in the words and actions associated with racism. I believe that everyone is created in God's image and that His love is extended to everyone. Prejudice or discrimination based on racism is wrong and should not be tolerated, and individuals and society have a responsibility to address it. Many allegations of racism are valid, harmful, and require attention. However, the words, "racism" and "racist" are now so often used as insults or inappropriate accusations of those who voice differences of opinion with respect to issues involving ethnicity or even other matters, that the importance of the true meaning of the words is diminished and may distract from the attention and credibility given to valid allegations.
I recently participated in a discussion in the annual meeting of the American Pharmacists Association (APhA) of a resolution that had multiple sections, the first of which was to denounce racism. The resolution carried the title, "Systemic Racism." I voiced my support for the content and goal of the resolution but noted my objection to the use of the word "Systemic" in the title. The word "systemic" is defined, "of, relating to, or affecting the entire body." I stated that I was not a racist and was confident that the vast majority of APhA members and other pharmacists were not racists. Therefore, the designation "systemic" might be inaccurately and unfairly interpreted as applying to the entire body (or group, in this case APhA members) that, with excellent intentions, considered the resolution.
Several weeks ago, I attended a presentation by Ken Ham, the president, CEO, and founder of Answers in Genesis-US, the Creation Museum, and the Ark Encounter. Racism and related issues were among the topics he addressed, starting with the Biblical account of the flood (Genesis chapters 6-10). He noted that there were 8 survivors of the flood – Noah, his wife, their 3 sons and their wives. They were of the same race but, following the flood, relocated to other parts of the world where different climate conditions, etc. resulted in changes in skin pigmentation and other external characteristics. The speaker contended that there is actually only one race – the human race – and that any allegations of racism would, therefore, be critical of one's own race. He observed that we all have brown skin, ranging from dark brown to light brown. To illustrate, he held up a piece of white paper next to his face and noted that his skin was not white but light brown. Mr. Ham did indicate that there are different "people groups" throughout the world, and I do not rule out the possibility that those who now call others racists could change their allegation to "people groupists,"
I do not mention these examples to distract from the importance of the need to address racism, but rather to recognize that words matter, as well as in the manner they are used. Imagine how things would change if we focused on the Easter message – God is Love, and Christ is Risen!
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Lead Like it Matters to God
Hundreds of books have been written about leadership but few have integrated the faith of the author throughout the consideration of the values needed to provide effective leadership. I am very pleased that my long-time friend Richard Stearns has written and just published his book, Lead Like It Matters to God: Values-Driven Leadership in a Success-Driven World (2021, InterVarsity Press, Downers Grove, IL). He draws on his responsibilities as the CEO for 20 years of World Vision US, one of the world's largest Christian ministries, and previous service as CEO of Parker Brothers and Lenox, in sharing his faith, experiences, and perspectives in discussing 17 crucial values that can transform leaders and their organizations. Some of these values may often be overlooked but Richard Stearns describes their importance within the total context of his experiences. The 17 values include: Surrender (to God's will); Sacrifice; Trust; Excellence; Love; Humility; Integrity; Vision; Courage; Generosity; Forgiveness; Self-Awareness; Balance; Humor; Encouragement; Perseverance; and Listening. Reading the book was an inspiring and learning experience, and I highly recommend it.
Daniel A. Hussar
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OVERTIME!
With the exception of April, May, and June, 2015, The Pharmacist Activist has been published every month since January 2006, and sometimes twice a month. The reason for the 3-month interval between issues in 2015 was that I was diagnosed with acute myeloid leukemia (AML) in April of that year and was hospitalized at the Abramson Cancer Center at the Hospital of the University of Pennsylvania for much of that 3-month period for induction chemotherapy and for two subsequent readmissions for the treatment of infections I experienced. I was very thankful that the induction chemotherapy provided a remission that was confirmed by bone marrow biopsy results that showed no evidence of leukemia cells. When I resumed writing The Pharmacist Activist in July, 2015, I described my experience in a commentary with the title, "Time Out!".
The prognosis is often poor for patients who are diagnosed with AML. The approach that provides the best hope for a continuing remission of AML is a stem cell transplant. However, stem cell transplants are themselves associated with significant complications, and I was not considered eligible for this intervention because of my age and other risk factors. The duration of a remission from initially successful induction chemotherapy varies widely and the usual treatment strategy is to subsequently provide courses of consolidation therapy for the purpose of further extending the remission. I was scheduled for two courses of consolidation therapy (usually 2-3 weeks each while hospitalized) during the fall of 2015, around which I was able to schedule my teaching responsibilities and other personal and professional activities. The courses of consolidation chemotherapy were relatively uneventful compared with the induction therapy, and were considered successful.
Relapse!
In December, 2015 I experienced the development of a cluster of papules on my upper left arm, and called them to the attention of my oncologist whom I was then visiting on an outpatient basis. He informed me that leukemia can have skin manifestations (leukemia cutis) and, although that is uncommon, he referred me to a dermatologist. His initial assessment was to suspect that the papules were related to leukemia and his suspicion that I had experienced a relapse was confirmed by laboratory test results.
In 2015 there were very few anticancer medications that had been demonstrated to be effective in the treatment of patients with AML. When these drugs were not effective in providing a continuing remission, the only options were a small number of agents that had been approved for treating other cancers and might be of at least limited benefit when used off-label for treating patients with AML. My oncologist explained that the drugs used for my induction and consolidation treatments would not be suitable options because my relapse had occurred rather quickly following the initial remission they had provided. He was also not optimistic about using other anticancer agents off-label.
Although there had not been any new drugs approved in approximately 25 years for the treatment of patients with AML, scientists and clinicians had made considerable progress in identifying specific mutations of the leukemic cells associated with the occurrence of AML. The most prominent mutation in my leukemia cells was identified as isocitrate dehydrogenase 2 (IDH2). My oncologist was aware that the primary clinical trial of an investigational IDH2 inhibitor was being conducted at Memorial Sloan Kettering Cancer Center (MSKCC) in New York. He arranged for me to meet Dr. Eytan Stein, the oncologist who was conducting the study, to determine if I was eligible to be included in the clinical trial.
I fulfilled the criteria to qualify for inclusion in the clinical trial and began my participation in February, 2016. The investigational drug, designated then as AG-221, was administered orally once a day. Following completion of comprehensive paperwork, my responsibilities included taking a tablet each day at approximately the same time of day, maintaining a record of the time of administration of each dose, reporting any unexpected events, and having appointments with Dr. Stein at MSKCC every two weeks. Each appointment would include evaluation of vital signs and physical assessment, an analysis of blood cell counts and other laboratory parameters, an electrocardiogram, and a discussion with Dr. Stein and his research colleagues regarding my experience since the previous visit. Bone marrow biopsies were performed every 4 weeks, and echocardiograms every 8 weeks. I have tolerated the medication well and have not experienced any serious adverse events. My blood counts and physical and laboratory parameters have remained relatively stable, and an early sign that the drug was working was a reduction in size and eventual disappearance of the skin papules.
There were more than 200 participants in this clinical trial of AG-221 (developed by Agios which worked with Celgene in conducting the clinical trial). The clinical trial results were favorable and a new drug application was submitted to the FDA. In mid-2017 the FDA approved the drug which is identified by the generic name enasidenib and the trade name Idhifa.
For the purpose of obtaining longer-term efficacy and safety data, the clinical trial continued beyond the time the drug was approved for marketing, and I was asked to continue in the study. For patients such as myself whose experience in the initial study had been favorable and stable, physical and laboratory monitoring could be evaluated less frequently, and this continuation study was extended for more than another year before it was concluded. I have continued seeing Dr. Stein as my oncologist, now at 6-month intervals, and taking Idhifa once a day.
With some types of cancer, a 5-year period of progression-free survival is considered a cure. I am very grateful for my five years of life and experience since I was accepted into the clinical trial of Idhifa, but I do not consider myself "cured" of AML. There is no experience with respect to outcomes if the drug is discontinued following successful use, and I am not curious enough to explore that possibility. My assessment is that God has had more for me to do! I don't consider it a coincidence that the timing of my diagnosis with AML corresponded with the investigation of the medication that targeted and inhibited the most prominent mutation of my leukemia cells. I believe that God has enabled the development and provision of the medication, the availability of the expertise, caring, and skills of Dr. Stein and other oncologists and their colleagues at both Penn and MSKCC, and the love and support of my wife Sue and other family and friends that has resulted in my five years of "overtime."
Another point of view
Dr. Ezekiel Emanuel is a physician who served as an adviser to former President Obama and now has responsibilities in the areas of health policy and medical ethics at the University of Pennsylvania. He wrote a very thought-provoking article with the title, "Why I Hope to Die at 75," that was published in the October 2014 of The Atlantic. He notes that the productivity of people with high creative potential has occurred well before the age of 75, and that the following years are characterized for many by physical and mental decline. He is not an advocate for euthanasia or physician-assisted suicide, and notes that he won't actively end his life when he reaches 75 but won't try to prolong it either. He indicates that, after 75, if he develops cancer he will refuse treatment, he would not have a cardiac stress test or receive a pacemaker or heart-valve replacement, or have surgery, dialysis, antibiotics, or flu shots.
Dr. Emanuel provides some valid and persuasive examples, but I strongly disagree with his conclusions for himself. I attribute the difference in our opinions primarily to my faith in God and beliefs. I am not advocating for what I would consider excessive life-prolonging interventions, but I feel that the age of my death must be God's determination and will, and not mine.
I had just turned 75 when I entered the clinical trial of Idhifa. I am very thankful to be able to consider the last 5 years to have been as productive, fulfilling, and supportive of my family, friends, and profession as any previous period of my life. I don't know how long my period of "overtime" will continue – it is only 5 minutes in basketball. However, I am content in knowing that God is my timekeeper.
Daniel A. Hussar
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