Surprise!!!

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clinical trials, clinicaltrials, CME, Dr Just, elder wisdom, Just Oncology, legacy, medical education, medicine, mentoring, oncology, Pacific Oncology, participatory medicine, pharma, physician, podcasting, research, San Diego, social media, wellness

As I was browsing through the Harvard Business Review the other day (seriously, this is not my usual reading material), I happened on an interesting article.  Actually, the piece was an interview in the “Idea Watch” section entitled:  “Defend Your Research; The Color Pink Is Bad for Fighting Breast Cancer”, HBR, pp. 30-31, July-August, 2011.  Professor Stefano Puntoni, an associate professor of marketing management at the Rotterdam School of Management, Erasmus University, was asked to explain the counter-intuitive findings of his research.  He stated:  “Our original prediction was boring.  My research partners-Steven Sweldens of Insead and Nader Tavassoli of London Business School-and I thought pink and other gender cues would make campaigns against women’s diseases, such as breast and ovarian cancer, more effective.  But we found the opposite”.

Perplexed, they delayed publishing their results and kept running tests.  After 3 years, the same basic finding was validated 10 times.  Initially, women who wrote an essay about gender were less likely to donate to ovarian cancer research than women writing gender-neutral essays (42% vs. 77%).  Then, breast cancer banner ads were placed on a website but not mentioned to the women viewing them.  When the site was feminine-oriented, 33% recalled the ads; when gender-neutral, 65% remembered.  The color pink turns out to be one of many feminine gender-cues, but prior to the 20^th century it was actually associated with the male gender.

Most importantly, “these findings seem to fly in the face of the marketing principle that you should build a strong brand that emotionally connects with consumers”.  So why is this?   Interestingly, ideas or concepts that are regarded as threatening or difficult to comprehend elicit defensive responses, mainly denial.  The color pink tends to connect women with the thought that they could die of breast cancer.  Another fascinating fact is that not all gender-cues result in defensive responses.  Mascara ads were placed on control websites and 76% of the gender-primed group recalled these non-threatening ads, even more than the control group (65%).  Additionally, gender-cues involving prostate cancer are not as threatening in men.  The author postulates that prostate cancer is more a disease of older men and has a longer natural history, i.e., it is not associated with impending fatality.

Finally, since pink is synonymous with breast cancer, “is there any way to preserve it but overcome the negative effect”?  Women found pink ads about breast cancer harder to read than more gender-neutral peach ads.  But, men found pink ads slightly easier to read.  One suggestion that results from this is “that seeing more men wearing pink as part of breast cancer awareness may start to break down the color’s effect as a gender cue”.  Another thought is that pink may empower men to donate more.  Obviously,  work in this field is very preliminary.

As a result of the above article, I tried to think of research where the opposite of the anticipated result was found.  Tamoxifen was approved for clinical use shortly after I started my practice in 1975.  It was marketed as an anti-estrogenic alternative to surgical oophorectomy.  Therefore, the concern was that it could lead to osteoporosis.  To test this hypothesis, studies were initiated in 1980 and completed 10 years later.  If anything, Tamoxifen resulted in slight reduction in the incidence of bone fractures.  But: surprise, surprise!!  Increases in endometrial cancer and deep venous thrombosis, occasionally leading to lethal pulmonary emboli, were found.  These complications led to the realization that the drug had estrogenic properties and was in fact a partial, not total, Selective Estrogen Receptor Modulator (SERM).

Quoting Don Miguel Ruiz from The Four Agreements:

“The Third Agreement Is Don’t Make Assumptions.  We have the tendency to make assumptions about everything.  The problem with making assumptions is that we believe they are the truth.  We could swear they are real.”

This is why we do research.

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The Doctor As Patient; Lessons Learned

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coaching, community, digital media, elder wisdom, epatients, health 2.0, Just Oncology, legacy, medicine, participatory medicine, social media

On January 7, 2011, my lifestyle was changed forever.  The good news was open heart surgery saved my life.  And no heart damage was discovered.  On the other hand, I had to give myself permission to take care of myself.  What a novel concept!  My entire life had been based on the premise that Richard’s health came last.

At first, I was overwhelmed, which led to anxiety and depression.  The thought that I could die crossed my mind, but this seemed remote and I didn’t dwell on it.  When pain resolved, I was left with fatigue which is slowly improving.  I completed cardiac rehab and went back to the gym after a nuclear stress test was normal 10 days ago.  But even exercise is different now; almost all aerobics and little lifting whereas I used to squat up to 405 lbs. and had the body habitus of a power lifter.  In the distant past I  ran 7 marathons with hardly any resistance training.  Always pushing myself on the extremes; never taking the middle road.

And see a doctor?  Rarely.  No time!  Too busy taking care of everyone else.  Initially my attitude was I’d work until I dropped.  Almost did just that.  Never thought of retiring until now.  Back to work part-time with no plans to work full-time.  But now have more devices than I thought imaginable for 1 human being:

1. Pericardial tissue from a cow for a new aortic valve.
2. 3 bypass grafts from my left internal mammary artery, left radial artery, and right saphenous vein for new coronary arteries.
3. Continuous glucose monitoring by implantable sensors inserted weekly into my abdominal wall.
4. Insulin pump via implants placed every 3 days into various sites allowing continuous basal flow and bolus administration of insulin when eating or hyperglycemic.
5. Blood pressure cuff.
6. Loop recorder inserted into chest wall to monitor for arrhythmias.

This is in addition to multiple pills, each of which has its individual requirements, daily weights, etc.  All this requires time and learning curves, and was unfamiliar to me.  But I found the most frustrating and irritating chore to be calculating the breakdown of ingredients of foods ingested, e.g., carbohydrates, sodium, fats, et.al.  Most of the time, it’s a guess.  Life has become all about monitoring me….continuously!

I was therefore interested to read an article entitled:  “Smart Moves? E-patient Systems Rise Amid Skepticism” by Andrew D. Smith in the current issue of OncLive; 12,6; pp 15-20, 6.11 about disease management systems in oncology.  The concept started with cardiology and spread to diabetes management, obviously pertinent to my experience.  Since several cancers are now regarded as chronic illnesses the concept intuitively makes sense even though triumphs in improved outcomes and/or reduced costs are few so far.  It is estimated that “nearly a fifth of cancer patients already use some form of DM and, collectively, spend $250 million a year on it”.  Annual revenues for the total industry are about $5 billion.

The backbone of DM has been follow-up visits in doctors’ offices or at home, and telephone calls by nurses.  Insurance companies have created Call Centers staffed by nurses for the same purpose.  My wife and I appreciated the 6 weekly home visits and phone calls by visiting nurses; especially my wife who was my primary caregiver and needed reassurance that she was covering all bases.  But cancer care is a bit more complicated since cancer patients are generally older and have all of my co-morbidities that require monitoring and knowledge of drug-drug interactions.  We have entered the era of oral chemotherapeutic agents administered on a daily basis at home.  So danger of lack of compliance has increased greatly.  To address this, the NCI paid Leap of Faith Technologies “to develop a system that uses smart phones, radio-frequency identification technology, and the Internet to ensure patients take their medication”.  The result is eMedonline, which resembles my wife’s iPhone with an attachment which she uses to swipe her client’s credit cards through to pay for their encounters.  Works like a charm.  With eMedonline, a vial of pills is swiped over the attachment to the smart phone whenever a dose is taken.  Preliminary trials have demonstrated increased compliance to >95% and it “is ready for commercial use”.

My 8 year old granddaughter is fascinated by my diabetes care.  She has 2 juvenile diabetics in her class and watched me prepare and inject insulin.  Now that I have the pump, injections are no longer needed.  She hasn’t seen the pump yet, but has watched me upload data from my continuous glucose monitor (CGM) to software on my computer which in turn can be e-mailed or FAX’d to my physician.  But with proliferation of all these systems generating an enormous amount of data, it is imperative we develop new data analysis software to make sense of all this.  I see the data generated by my CGM and it is indeed voluminous.

Finally, in the realm of science fiction are implanted nanoparticles coated with antibodies that detect tumor biomarkers.  It’s coming!  I initially was turned off when my body became a pin cushion and my entire day seemed to be consumed with data entry, device management, ordering of supplies and on and on.  I am beginning to gain better control of all my co-morbities (I hate that term).  I recall the admonition of my surgeon:  “I’ve given you 15-20 more years.  Now don’t screw it up”.  Hopefully, with the aid of newer and more sophisticated DM technologies, I will also be able to say this to my cancer patients, soon.

‘HeLa’ Cells

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cancer, Dr Just, elder wisdom, health, HeLa cells, Just Oncology, legacy, medicine, oncology, physician, social media, twitter, wellness

I inherited several traits from my father.  First and foremost was Type I/adult onset diabetes.  But, on a more cheerful note, I am also an avid, if not obsessive, reader.  I remember him sitting on the stairway leading to the upstairs bedrooms reading western novels until early in the morning so he wouldn’t disturb my mother.  That’s me.

Over the years I’ve had many fantastic reads.  One that my father shared with me was “Bury My Heart at Wounded Knee” by Dee Brown.  But none was better than “The Immortal Life of Henrietta Lacks” which I finished a few months ago.  It is a masterpiece written by Rebecca Skloot, a science writer who has written several award winning articles, but this is her first book.  Even though it is non-fiction, the book reads like a historical novel in the tradition of James Michener.  I wish my dad was still here so I could have shared it with him.

There are so many aspects to this story it is hard to do it justice in a page or two.  Ms. Skloot captures the socioeconomic hardships and racial politics endured by Mrs. Lacks and her family, and how they dealt with these indignities as best they could, ultimately with pride and grace.  The author also transports the reader back to vividly portray how medicine was practiced in the era Mrs. Lacks’ cervical cancer was diagnosed and treated.

From a personal perspective, as a medical oncologist who has participated in clinical trials for 36 years, and who has served as Chairman of the Investigational Review Committee at my community hospitals for 22 years, this book has essentially achieved textbook status.  I must confess I did not know HeLa stood for Henrietta Lacks.  I also didn’t know the biography of Johns Hopkins the person, and the history of that hospital.  It made sense that the reason her cancer was so aggressive was that it was an adenosquamous  carcinoma  rather than the usual squamous  cell type.  It was no surprise that her cells subsequently tested positive for HPV 18.  I also found the history of cell culture techniques fascinating as was the economics of the industry that resulted.  So, there was a lot of information that was new to me.

One chapter that was especially moving was 11.  “The Devil of Pain Itself”…1951, pg. 83.  The description of her level of pain was hard to read.  Our ability to manage pain has improved, especially with the advent of Hospice and more emphasis on palliative care recently.   But, last year I attended a symposium on Pain held at UCSD, and the first speaker discussed why no new analgesics have been added to our basic armamentarium of Aspirin and Morphine and derivatives of each for decades.  A sobering thought.

Chapter 17.  “Illegal, Immoral, and Deplorable”…1954-1966, pg. 127, discusses in detail the issue of informed consent, not only as it relates to full disclosure of the nature of the illness and the proposed treatment, but whether or not the latter is standard of care or experimental.   During my fellowship training, I was fortunate to have an attending physician one month who was considered a giant in hematology.  So, I decided to take advantage of my opportunity and asked him how he tells parents that their child has acute leukemia and his treatment recommendations.  His rule was to never use the word leukemia because “they can’t handle it”.  Remember this was 1973-1975 and a paternalistic attitude of physicians was not uncommon then.  I learned a lot from my attending.  The example I cited was a valuable lesson of what not to do.

Chapter 25.  “Who Told You You Could Sell My Spleen?”…1976-1988, pg. 199, brings up a second research topic of who actually owns the tissue after it has been removed from the patient.  Later chapters discuss the current hot topics of ownership of genetic material and stem cell research.  Since my internship and residency training was at UCLA and Wadsworth VA Hospital, and the incident cited occurred at UCLA when I was there, the story brought back memories of those days (and nights and weekends).  It is more personal and memorable for me as a result of this coincidence.

One of the colleges my daughter applied to (over 25 years ago) was the University of Redlands.  Prior to the start of the freshman year, they encouraged incoming students and their parents to read a book which would be discussed with faculty members in a “town hall” meeting.  The book chosen was Robert Pirsig’s “Zen and the Art of Motorcycle Maintenance”.  Even though my daughter didn’t attend that college, I read the book anyway (and loved it).  I wonder if “The Immortal Life of Henrietta Lacks” should be required reading for all doctors, healthcare personnel and staff involved with research?  Hmmm….

A ‘moment of clarity’ (and then some)

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cancer, Dr Just, elder wisdom, Just Oncology, legacy, medicine, oncology, Pacific Oncology, San Diego, social media, twitter

Lying in the pre-op room before open heart surgery in January, the last thought on my mind was the ‘state of the health’ of community based oncology.  Making it through this procedure was of paramount interest to me.  Surprisingly I was quite relaxed.

Never thought of dying.  Didn’t see my life pass before my eyes.  Perhaps it was my wife’s hypnosis?  Perhaps Versed?

Post-op I concentrated on my recovery.  This was my first real “vacation” from clinical practice of hematology and medical oncology for 36 years.  All of my energy was devoted to caring for patients and their families and raising a family myself.   Never had much time to pursue other interests.  Now I had to address my health, but also there was an opportunity to consider what the last 36 years were all about.

I thought back to when I was a second year medical student in the mid-sixties.  That’s when Watson and Crick were awarded the Nobel Prize for elucidating the double helix structure of DNA.  Prior to that time, we studied Mendelian genetics.  Now we’re talking molecular oncology and personalized cancer care.  In 1969 I treated a patient with advanced Hodgkin ’s disease with the newly published MOPP regimen.  Unfortunately my patient died of an overwhelming infection.  I vowed never to subject another patient to such a toxic regimen.  When I returned from military service two years later, MOPP was accepted as first line treatment and was being administered on an outpatient basis!  This was the first demonstration that combination chemotherapy could result in cure of an advanced malignancy.  Of the original patients who were treated with MOPP, 81% went into complete remission and 69% remained in their first complete remission after 10 years.  Thus, a previously ‘incurable disease’ could be ‘cured’ with combination chemotherapy, an event that resulted in rapid growth of medical oncology as a specialty.  I started my practice in 1975 and passed the boards the second time they were offered.

Fast forward to the present era of biologics.  The practice of oncology has become increasingly complex, expensive and demanding.  Healthcare in general has changed dramatically with transition from traditional indemnity or private payment plans to managed care to HMO’s and their current reincarnation as ACO’s.  Community based oncologists are expected to operate as businesses to remain financially viable, to be more efficient and to control our overhead, to practice evidence based oncology, and fund an Electronic Medical [or Health] Record (EMR/EHR) so we can determine outcomes of these treatments.  We have essentially become dispensing pharmacies for chemotherapeutics, biologics and all the supporting drugs necessary for safe administration.  Stress and burnout are becoming more common issues.  As each day presented more challenges, I would jokingly say:  “If this continues, I’m going to clot off my left anterior descending”.  Then I did (watch what you ‘pray’ for or otherwise invite into your life).

Two months after surgery, I had recovered sufficiently to return to work on a part time basis.  Within two weeks, my wife pointed out that I was coming home with a furrowed brow, and once again I was talking to myself in the shower.  Since my surgeon said he had given me 15-20 years of life, I really didn’t want to return to the same environment that resulted in so much stress.  I thought of retirement, but didn’t want to be completely removed from what I do best, i.e., interact with, and care for people with cancer.  I realized that my experiences were of value to help preserve community based oncology and in mentoring the new generation of oncologists as this is their future.  Thus the birth of JustOncology.com.

As alluded to above, I have been fortunate to have lived through the logarithmic growth phase in the knowledge base of oncology.  But with progress there can be unintended consequences:

• How do we disseminate and manage this information?  Classically, journals and conferences were the major instruments for this purpose.  Subscriptions to journals resulted in unwieldy collections of bound or loose journals that required a lot of storage space or clipped articles that needed to be filed in metal cabinets.  I remember binding all the New England Journal of Medicine articles from 1965-2001.  I donated some to a local School of Nursing.  The rest no one wanted and I had no place to store them.  Attending conferences usually meant long distance travel with time away from the office which in turn had adverse financial ramifications.  ASCO meetings were mostly opportunities for fellows to present their research data in 15 minute segments.  The lights went out and an endless number of slides ensued.  I didn’t last long at these sessions and learned very little except in the rare review sessions that concentrated on one topic.  Gratefully, ASCO has done a great job renovating its educational process, aided by the advent of innovative methods of communication, including social media.  Using these technologies, we can communicate over large distances in a cost effective manner.  Additionally, these modalities frequently provide for instant feedback, promoting dialogue.  JustOncology.com intends to host and engage others in the conversation via this emerging suite of technologies.

• How do we study and validate this new knowledge?  Unfortunately, the clinical trial process is not keeping pace with demands.  Community oncologists are responsible for 80% of patients that are placed in clinical trials.  That’s the good news.  Unfortunately, only 3-5% of all cancer patients that might be eligible for a trial actually are entered.  Social media is being tried in a preliminary way to improve accrual.  It costs Pharma about $1 billion and 10 years to bring a new molecule to market.  This is outrageous.

The regulatory burden in the U.S. has been blamed for this, and has spawned another unintended consequence with the export of clinical trials to foreign countries.  As chairman of our local Investigational Review Committee (IRC) for the past 22 years, I can attest this growing mountain of paperwork.  But Pharma has to clean up its act too.  You can only take the argument that the cost of drugs to U.S. patients is so high because they have to recoup their R&D costs so far.  This argument has been utilized so often that it has lost its credibility.

A major effort by Pharma will be necessary to restore trust in that industry.  In addition, study designs of biologic agents differ from trials involving chemotherapy in that endpoints are different.  Many of the targets for biologics are still being studied so it is difficult to know when the agent is effective.  Certainly this is a topic we have a lot to talk about.

• How do we ensure evidence-based practice and document outcomes of our interventions?  The Electronic Medical Record is advanced as the answer to all our problems.  I agree that these are necessary to address the cited problems.  But there is a learning curve with all these systems which is longer for older physicians who did not grow up with computers. Like me. My experience with my groups’ EMR has not been good.  And the cost of maintaining and upgrading a client-server system has been enormous.  So instead of saving money and headaches by investing in the least expensive (at the time) EMR we consumed a great deal of resources and still haven’t achieved our goals.   But in our defense, I don’t know of anyone who is totally happy with their purchases and several oncologists haven’t purchased any system for fear of bankruptcy.  Yet health plans and government are mandating that we purchase an EMR.  The latter has promised rebates if we satisfy certain requirements which seem to be flexible.  The end result is a fast growing Information Technology consulting business skimming much of the vital (for survival) funds needed to pay for this equipment.

Which leads me to…

• How do we pay for all this?  Having been a patient recently reinforced my practice experience with patients who are struggling to pay for their treatments.  As oncologists we are experiencing decreased reimbursements for almost all drugs at the same time health plans and government are unloading more of this cost on patients.   As stated above, the current rage is the trend to ACO’s, still not clearly defined.  What is clear is that this movement is being spearheaded by our community hospitals primarily aimed at primary care physicians.  Also clear is that many oncologists are approaching or being approached by hospitals to join their foundation models.  For me, this is déjà vu all over again.  As soon as I had established my practice, it was obvious to all of our physicians on staff at our local hospitals that patients were leaving our communities and obtaining their health care elsewhere.  To counteract this we formed an IPA.  I was the first president of this organization and obtained my baptism to managed health care and attempts to organize physicians into collaborative groups under fire.  No sooner had we formed our organization than our hospitals, which stood to gain from our efforts, formed a competing group and raided our membership, thus undermining the entire effort.  In order to preserve community oncology as a viable alternative to ACO’S, it is imperative that we merge together, utilize a common EMR to measure outcomes, develop clinical pathways that are evidence based and use our size to leverage a more favorable relationship with Pharma.   In my career, I started in solo practice and then grew it into a small group.  I then went back into solo practice and finally merged with two other multi-member groups to form a corporation consisting of 7 oncologists, 4 treatment sites and a business office.  It is difficult for me to envision how a solo oncologist can survive in the community in this hostile environment.  But I see one glimmer of hope.  Our previous attempts to organize into a large cohesive organization failed because we practiced in a culture that fostered competition between us.  This culture has now changed into one of collaboration.  There is hope.

So it’s the best of times, and the worst of times.  But the cause is a worthwhile one:  the preservation of community based oncology as the most patient and family friendly method of delivering increasingly complex cancer care.  We should capitalize on this current spirit of collaboration which has been born out of necessity.  The bad news is I had to go through major surgery to realize that my career experiences have value.  The good news is I now have the time and opportunity to speak and write about it. Join me in this conversation!

Mentoring

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cancer, CME, coaching, Dr Just, elder wisdom, Just Oncology, legacy, medical education, medicine, mentoring, oncology, Pacific Oncology, physician, San Diego, twitter

When my son was asked if he wanted to become a doctor just like his dad, he responded that his dad was hardly ever home and that wasn’t the type of life he wanted.  He’s now 40 years old and a graduate of law school.  In spite of his business requiring a lot of travel, he does devote as much time as possible to his family.

Interestingly, I started a solo practice in oncology in the same communities twice.  Initially, I interviewed with solo physicians (and there were only two) nearing retirement who were looking for someone fresh out of fellowship to take all weekday and weekend call as well as cover the practice during office hours.  For that privilege, my annual salary would be $24,000.00!!  There were only two multispecialty medical groups at the time, but the offers were similar.  So I decided to do it myself (that was possible then).  My wife and I took out a loan at a local bank which we paid off in seven years, celebrating the event by cremating the note, and we bought a home in the community.  We raised our children in that home and still live there 36 years later.

Managed care and computers weren’t a requirement then.  My practice grew to the point where 24/7 was becoming onerous.  So I started a group which provided coverage, but times had changed.  Managed care, PPO’s, EPO’s and those dreaded HMO’s with capitated payments based on per member per month calculations made for a lot of anxiety .  I spearheaded the effort to form a multispecialty IPA to meet these challenges.  This effort was scuttled by our hospitals that formed a rival IPA.  My former partners and I tried to piece together a single specialty IPA in oncology with plans to be a county-wide organization.  But lack of a collaborative culture ruined that attempt and my partnership dissolved.

Solo again.  The new challenge was the burgeoning cost of managing the business of oncology.  Managed care plans have replaced private insurance to a large extent, thus lowering reimbusements.  Several chemotherapy agents are no longer feasible for us to provide and patients to buy.  Computers are required and now mandated.  Obviously survival of solo oncologists is questionable.  My solution was to merge with two other established practices to form a larger group better positioned to deal with the era of ACO’s. So, as the senior member of the group, how do I advise young oncologists in this much more complex environment than I faced?

1. Firstly, we cannot survive practicing in our own silos.  We need to leverage large numbers to increase our purchasing and contracting power.
2. Next, we have to truly collaborate.  Government and health plans are justified in wanting to know what they’re getting for their money.  This requires diagnostic and treatment pathways which we agree on.
3. We have to listen to our patients who constantly provide us with constructive criticism.  New technologies such as social media can give us tools for listening and promoting dialogue.  The current (and first) issue of OncLive (formerly Oncology Net Guide); Vol 12, No 3; 3.11 contains an article called “Socializing Medicine; Oncology Joins Facebook Era” describes the proliferation of these technologies and why it is important for us to become familiar with them.
4. I furnish copies of Michael Gerber’s “E-Myth Physician”, a short but excellent book has been very useful to oncologists embarking on the road to private practice.  Although somewhat dated, he describes a new physician who is bitten by the entrepreneurial bug, which ultimately leads to his destruction.  While this didn’t happen to me, I made plenty of mistakes in my career.  I learned from my mistakes and hopefully others can too.
5. The titles of the chapters in Gerbers book are revealing about what he considers important:  “Money”, “Growth”, and so on.  Basic financial knowledge and awareness of the economics of health care are also quite valuable.

There are three options for new oncologists:

1. Stay in academics.
2. Join a multi-specialty group
3. Join a single specialty group, like mine.

Under the third choice, this last year has seen an exodus of oncologists joining with their local community hospitals usually under a Foundation Model.  I must admit this is appealing to me as it may be to new oncologists facing this brave new world.  Management and financing of the practice would no  longer be my worry.  I would take home a salary and work as much or as little as I want until retirement.  But a young oncologist would have to start over as I did on two occasions,  Neither was easy; today it would be almost impossible.