My Oncologist Dr. Sumantal Pal

                      

I. He is a Research Doctor

I first met Dr. Sumanta Pal seven years ago in a clinic on the third floor of City of Hope Hospital in Southern California. At the time, I was diagnosed with kidney cancer and had had two major operations within the past six months. Three months after the second surgery, however, my cancer relapsed. The cancer cells were like tough prairie grass, constantly rising again from the ashes of each successive wildfire. They seemed almost to be invincible in their resilience.

During the consultation, Dr. Pal suggested that I take a new drug called Afinitor, which was currently going through a clinical trial. He also gave me a booklet to read carefully at home. It was a patient consent form and authorization to participate in the trial. It also contained medical information on Afinitor.  From the first few pages, I learned a new term: research doctor or study doctor. Dr. Pal is a research doctor.

The booklet explained that the relationship between a research doctor and a patient is different from the relationship between a personal doctor and a patient. When you visit a hospital or a private doctor's office, the physician who treats you is usually your personal doctor, who chooses a specific treatment for your condition and believes that the treatment chosen will benefit your health.

Unlike a personal doctor, a research doctor is knowledgeable of new treatments through a specific research project and understands that the participants may not necessarily benefit from that project. In a clinical trial, every participant must receive exactly the same research procedure in order for the research doctor to derive meaningful conclusions. In other words, a research doctor, unlike a personal doctor who treats his patients individually, treats all patients equally and uniformly with the same experimental drugs.

This part of the booklet was rather depressing, especially where a research doctor referred to his or her patient as a "subject," which means "a person who is tested". I realized that the "subject" was actually synonymous to “guinea pig” in the lab.

II. Risk to Subject

At the time I didn't realize that not every patient in the world could find a research doctor for his or her treatment because research doctors were far fewer than personal doctors.

In addition, not every cancer patient is willing to let the research doctor treat him or her due to risks involving life and death. To mitigate the potential for court cases, the booklet contained warnings from the research doctors and new drug research and development institutes. In their view, a clinical research project entails two risks. One risk is that the experiment may not cure your illness and may even aggravate the subject's condition. Another risk is that clinical trial drugs can have mild to severe side effects, which may last for long periods of time or even threaten the subject's life. During the research phase, the medical community does not know all the risks that a new drug may bring to the human body. To put it plainly, this is telling "test subjects" that if you cannot be treated or even lose your life in clinical trials, you or your family members must consent that the research doctor cannot be sued because you have signed the consent form voluntarily.

I read on and learned about cancer drugs. Since many drugs used to treat cancer are designed to cause the rapidly dividing cancer cells in our bodies to slow down or die, these drugs can also cause the same effects in other rapidly dividing normal cells as well. These include the blood cells that help to fight infection (white blood cells), the blood cells that help blood clots (platelets), and the blood cells that carry oxygen throughout the body (red blood cells). When anticancer drugs cause a decrease in these blood cells, it is called bone marrow suppression.

The more I read the more chilling it became and the more reluctant I felt about signing this consent form. Honestly, I felt that this booklet from Dr. Pal seemed to be treating potential patients as nothing more than experimental fodder.

III. A Dialogue during an office Visit

A week later, I walked into the City of Hope Hospital with the consent form unsigned. This was the second time I saw Dr. Pal.

"Have you finished reading the booklet? Any questions you need me to answer?" He smiled politely.

I timidly asked him: "If I do not participate in this research project, how much time do I have?"

"A year or so," was his matter-of-fact reply.

"If I participate in this research project, how much time do I have?" I asked.

"Two years!" He replied.

I was sensitive to numbers because I spent many years working in our company's IT Finance and budget field. Trying to reassure myself, I asked "Are you saying that the new drug may extend my life by only one year?"

A bit surprised at hearing my question, Dr. Pal hesitated a few seconds and said: "So to speak”.

IV. A Rising Star

Accompanied and encouraged by my wife Diana and children, I finally signed the consent form, unaware that I was lucky enough to "sign" with a rising star among the world cancer research doctors.

Dr. Pal is a genius. He skipped grades in elementary and middle schools. At the age of thirteen, he was admitted to a special class in college. Students in this special class were required to complete all eight years of high school and college courses in four years.  He graduated from college when kids of his age were still in high school. At the graduation party, an unwitting professor walked to his table and asked his classmates to raise their glasses to celebrate. He stood in embarrassment and told the professor that he was yet to reach the legal drinking age.

The young man finished medical school at twenty-one and became a MD at twenty-five.  In just a few years, he has published more than 150 peer-reviewed articles that have been featured in prominent journals including The Journal of Clinical Oncology, Lancet Oncology, Cancer Cell, and European Urology.  Many U.S. pharmaceutical companies and research companies collaborated with him to bring new drugs to clinical trials. Often he is invited to speak at medical research conferences across the United States and other countries to share the results and achievements of his clinical trials.

Dr. Pal’s clinical trials resulted in outstanding achievements in cancer research and treatment, allowing him to receive many medical research awards. For example, he received research funding from the California Breast Cancer Research Institute, the U.S. Integrated Cancer Network Center and the U.S. National Institutes of Health. In recognition of his research achievements in kidney cancer, the American Society of Kidney Cancer awarded him the "Young Research Doctor Award." In support of his work on bladder cancer, Charles A. Coltman of the Southwestern Association for Cancer Research grants him research funding.

V. High Medical Ethical Standards

Dr. Pal’s superb medical skills and high ethical standards have won him the respect of his patients and their families. I met a cancer patient, Mike, in the hospital. He was a retired university professor. Like me, he had late-stage kidney cancer. His family lived in another state and every week his wife would accompany him to the City of Hope Hospital for treatment by Dr. Pal. An anti-cancer warrior, Mike had undergone 12 surgeries and participated in several different clinical trial drugs. Unfortunately, he passed away in the end.

Mike's wife told me that when they learned that the drug had no effect on Mike's cancer, Dr. Pal went to see them in the apartment they rented near the hospital, giving her a great deal of comfort. After Mike died, she took a special trip to Southern California to attend a charity dinner for Dr. Pal’s research.

This dinner was sponsored by one of Dr. Pal’s patients.  His name was Frank DiBella. He was diagnosed with late-stage bladder cancer in 2011 and was told to expect to live only three months. Desperate, he got transferred to the City of Hope Hospital under the care of Dr. Pal. He is still alive today. He said: "When I first met Dr. Pal, he was real honest with me. He told me there was not a cure for my disease but that I was not going to die in three months. He said he would keep me alive for at least four years and hopefully, during this time, more progress would be made in finding a cure. I believe that if anyone in the world can find a cure for my cancer, this person must be Dr. Pal.     

Mr. Frank is a successful accountant and has many celebrities among his clients. To thank Dr. Pal for his life-saving efforts, he organizes “Let be Frank” annual gala to raise money for the research Dr. Pal and his colleagues are doing. Many celebrities came to help out, and even our Governor Brown of California spoke at the dinner. In just two years, this event has raised $4.6 million for Dr. Pal and City of Hope to find ways to better understand how cancers develop and metastasize, better predicting recurrence, and improving treatments with fewer negative side effects.     

VI. Meticulous care of "guinea pigs"

When I signed the consent form seven years ago, I thought as a "guinea pig" in the last stages of kidney cancer, I could only live for another two years. I never imagined that I would miraculously survive five more than that under the care of Dr. Pal.

I might be one of the longest surviving "guinea pigs" associated with his research, and he shows particular care about my condition. Every time I go to the clinic, he always inquires in detail about the side effects of the drugs I am taking. To ascertain what I tell him, he will also ask my wife, who accompanies me, to see if she, as a bystander, observed any abnormalities during the previous week.

Earlier this year, my cancer relapsed for the fourth time with the cancer cells spreading to my right thyroid. Before the operation, the surgeon told me that as long as the biopsy analysis confirmed that the thyroid gland in the patient's neck had a malignant tumor, the surgeon would usually resect the two thyroid glands together because the cancer would quickly move to the other thyroid.

When the surgeon was about to raise his knife for my second thyroid resection in the operating room, he had a phone conversation with Dr. Pal and was persuaded to spare the thyroid. Even though this decision was risky, he decided to take it because he wanted me to be free from the complications of losing thyroid function after the surgery.

In order to get a better understanding of the efficacy of clinical trials, "guinea pigs" are scanned once every three months (sometimes every two months).  To these "guinea pigs," waiting days for CT scan results is an experience of spiritual purgatory. Empathizing with my agony during the waiting period, Dr. Pal always emails me the scan result a few days before the appointment regardless of whether the news is good or bad. Sometimes, he gives up precious weekend time to do so even though it is unnecessary.

Dr. Pal is not only empathetic towards me as a doctor, but also compassionate about my family. Once in an outpatient clinic, after hearing that I had a son who was interested in medical study, he offered my son an internship in his department. He encouraged him to realize his dream to become a doctor, and created a good working environment for my son to actively participate in the preparation and writing of his clinical trial paper. In the course of a year, my son participated in the writing of three different clinical trial papers. All three papers were published in medical journals in the United States. During his busy schedule, Dr. Pal also wrote a recommendation letter for my son, who was admitted to medical school this summer.

VII. Unexpected guest during despair

Two years ago, I had an unforgettable experience. It was April 2013 when my cancer relapsed for the third time after five years of taking Afinitor. Seeing the CT scan result, Dr. Pal immediately decided to let me try out a new drug that was still in the early stages of human testing. The drug, ASONEP - also known as Sonepcizumab or LT1009 - was a new experimental drug developed by Lpath in San Diego for the treatment of cancer, including renal cell carcinoma.

ASONEP  is a human type of a mouse monoclonal antibody. This antibody has been made to target or attach to a molecule called sphingosine 1-phosphate or S1P, which may be involved in cancer. 

ASONEP was designed to reduce and shrink tumor growth.

Although the drug had not been approved by the U.S. Food and Drug Administration (FDA) and the medical community had a limited knowledge of it at the time, Dr. Pal decided to try it on me because his medical research indicated some possibility that it might inhibit the growth of my renal cell carcinoma.

So I signed my consent form, but Dr. Pal kept me waiting for a week. According to his plan, during the week when I stopped taking Afinitor, my body would be able to get rid of the residual drugs to facilitate the start of clinical trials of new drugs. At the same time, the hospital should obtain the approval from my insurance company to cover the expenses of these clinical trials.

A few weeks later, the unexpected hit me. The insurance company refused to pay any expenses arising from this clinical trial. I petitioned the insurance company and my company's HR with no success. Apparently the insurance company's decision was going to kill this well-thought-out medical plan that Dr. Pal had developed for me.

Now I had no drug to take. Two months went by and I was still not able to obtain the new drug I was supposed to take a week after the plan was implemented. I was extremely worried that in the absence of any cancer suppressing drug my cancer cells would grow rampantly.  I feared that the end was near.

As one can imagine, I was in great despair.  Then one day after dinner, the phone rang.  Picking up the call, I heard a familiar voice.  It was Dr. Pal.  He was taking care of some matters in the vicinity and wondered if we could meet at a nearby sushi restaurant.

I couldn't believe what I heard. To think that such a well-known and busy physician would come to visit an ordinary patient!

Half hour later, we met at the door of the Japanese sushi restaurant, went into the dining room and sat down at a table. Turning on his laptop, Dr. Sumanta explained to me, "It's not the end of the world, we have other drugs to treat your kidney cancer". Pointing at the screen, he continued: "You can try this one, which has been approved by the Federal Food and Drug Administration or FDA. This chart is part of my report in a medical journal that summarizes the clinical trials of this drug over the past few years. The vertical bars of various heights above the parallel lines represent the number of patients and years they have survived after taking the drug. The vertical bars below the parallel lines represent the number of people who have died after taking the drug".

He moved the laptop toward me so I could have a better look at the chart. This FDA-approved drug for treating kidney cancer was called Pazopanib. The colorful charts clearly showed more vertical bars above the parallel lines than those below. That is to say, among the kidney cancer patients receiving this drug treatment, more people were alive than dead. Among these living people, most survival rates ranged from three months to a year, the longest being five years.

To dispel my doubts, Dr. Pal said in a somewhat authoritative tone: "It is worthwhile for you to try this target drug, which has the advantage of proven efficacy. The new drug, ASONEP, which the insurer declined to pay, is only in Phase II trials, and its efficacy in patients with advanced kidney cancer is yet to be confirmed.”

This half hour talk made me feel as if I was riding a rollercoaster ride.  In an instant, I was thrown into the sky from the bottom of a deep valley. It was a dizzying experience, allowing me to see a glimmer of light. When we were about to leave, I was in tears for the gratitude I felt for the doctor. Hugging him tightly, I thanked him for the visit and comfort I received and the explanation of the new treatment plan he'd patiently provided, all at a time when I had been sinking into the depths of despair.

VIII. Success and Failure

The great scientists of the past all experienced ups and downs, twists and turns before achieving break-through research results or succeeding in inventions.  It is a process requiring strong will and tenacity, regardless of success or failure.

According to a 2014 report from the American Medical Association for Cancer, the survival rate of kidney cancer patients is only 3% for men and 2% for women, the lowest in an incurable disease. This almost-untreatable disease is what Dr. Pal's research focuses on. Like the great scientists of the past, he has had successes and failures in investigating new drugs for kidney cancer treatment.

His new drug, Afinitor, for which I later got approval from the insurance company, is an example of successful experimentation. Five years after I joined the clinical trial, the drug was officially approved by the FDA. That year, Dr. Pal flew to Beijing to share the new research findings with his Chinese medical colleagues. Now the drug has been approved in China for the treatment of kidney, pancreatic and breast cancer. Many Chinese cancer patients have benefited from this medicine.

The new drug for the second clinical trial I participated in was less fortunate.

In the United States a new drug needs to go through four long clinical trial phases. If the outcome of a clinical trial is less than optimal, the new drug can fail at any of the four trial stages.

ASONEP had completed the first phase of human-safety clinical trials when I started taking it, meaning it was at the proof-of-concept Phase II trial stage. Approximately thirty-nine patients with end-stage renal cell cancer voluntarily participated in Phase II clinical trials. Dr. Pal and other research doctors in the US divided the volunteers into two groups. The first group of twenty-two, the second group of seventeen. If 11 of the 22 patients in the first group showed potential efficacy after receiving ASONEP, the 17 patients in the second group would be able to start clinical trials. I was in the first group.

In two years of treatment, this clinical trial drug ASONEP had a surprisingly good effect on me. Many of my cancers were suppressed, except for the right thyroid gland cancer whose growth rate remained significant. Earlier this year the cancer was surgically removed.

Yet other “guinea pigs” in my group were not as lucky as I. On average, they took only four months of clinical trials and then quit because their conditions were exacerbated. The ASONEP clinical trial was discontinued due to the efficacy of less than 50%. Lpath, which developed the new drug, also declared bankruptcy. I was somewhat regretful when Dr. Pal informed me about this development two months ago. After all, this medicine prolonged my life by two years, which is a record. I jokingly said to him: "Is it fair to say that I am honored to become an unprecedented case in medical history?" He thought for a moment and replied: "It is indeed".

On my last ASONEP clinical trial, I sat in a chair with an infusion tube on one arm, the liquid drug slowly entering into my bloodstream. I picked up my cellphone and took a photo of the medicine bag hanging on the infusion rack with the ASONEP label and my name.  It was in memory of the last bag of ASONEP for human clinical trials as part of medical history.

IV “Holiday” of Surprise

On the day Dr. Pal informed me of Lpath's bankruptcy, he also reassured me that he would not give up on my treatment, and had in fact found another clinical trial drug for me. The new drug was just beginning to be tested for its safety in humans. But he did not immediately get me into the first trial of the new drug. On the contrary, he gave me two months of "holiday" to allow my body to dispel the toxins accumulated over the course of many years, and for me to recuperate before I returned to the battlefield to wrestle with the cancer cells.

What a surprise! I was absolutely elated and filled with gratitude. In the past seven years, I never expected that I could have a "holiday".  As far as I knew, when the doctor informed me to stop receiving treatment, it must have meant I was hopeless and near death. The anti-cancer drugs had been killing both my body's cancer cells and its good cells as well, for the past seven years. I was physically and mentally exhausted.  What a divine gift to be able to live without drugs for two months!

I thank God for the privilege of meeting a research doctor with a noble grasp of medical ethics and innovation. For seven years, his superb medical skills, compassion and love have allowed me – who was originally expect to live only one year – to become one of the rare 3% renal cell carcinoma survivors.

Note:  This article was originally written in Chinese in December 2015.  It was translated to English on January 13, 2017. I am fortunate to have Ms. Ida Liting von Mizener and Mr. Jianming Xia help me edit and translate this article.