Drug Shortages: A View From The Trenches

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A few weeks ago, I had a discussion with Kris Ghosh, MD one of our local GYN Oncologists, (listen here).  We talked specifically about Doxil, the usual second line treatment for recurrent ovarian cancer.  We agreed that the lack of availability of the drug does limit options for these patients, with further increase in already heightened anxiety levels for patients and families.  Add to the mix the increase in stress levels of oncologists and our staffs trying to handle one more insult to a broken healthcare system.  In one patient who was due to start treatment I was able to substitute topotecan (Hycamptin).  Fortunately, she is responding and tolerating the agent very well. We had put her name on our list of patients who were waiting for Doxil when it became available.  So I was able to use the drug allocated to her for another patient with multiple myeloma. The only agent that had controlled his disease was Doxil. I guess the problem worked out well in these cases, but it appears that this shell game is going to become routine.  The question arises:  “Is this the harbinger of rationing cancer care?”

In my residency training in the late ‘60’s/early ‘70’s, I rotated through the Nephrology service when hemodialysis was relatively new.  Just like today, demand for the procedure far outstripped supply.  One of the factors taken into consideration in a negative way was anyone whose renal failure was due to diabetes.  That’s a lot of people!!  Obviously, we were very uncomfortable being put in that predicament.  Hindsight personalized this for me since my maternal grandfather died of sepsis after amputation of one of his legs for diabetic gangrene, my father died of every complication of diabetes and was hemodialyzed for 2 ½ years before his death, and I have type I diabetes and am on an insulin pump but fortunately no signs of renal impairment, yet.  I’m sure my father would never have been treated during my training years.  I’m sure our cancer patients experience similar anxiety and fear when faced our current dilemma.

Causes of shortages are multifactorial.  In Doxil’s case, the manufacturing plant in Alabama was struck by lightning during the tornado earlier this year.  Hard to believe but that’s the story.  Obviously an unpredictable Serious Adverse Event (SAE).  However, most of the chemotherapy drugs in short supply are older agents, e.g., bleomycin, cisplatin, cytarabine, daunorubicin, doxorubicin, etoposide, leucovorin/levoleucovorin, mechlorethamine, thiotepa, and vincristine.  Many are now off patent and therefore priced lower as generics; so not as profitable.  In some cases manufacturing of the drug was stopped in anticipation of newer and, of course, more expensive replacements.  One of the predictable side effects replacing old, cheaper drugs with newer, more expensive agents is pushback from payors who deny coverage/payment.  We then get on the authorization-denial-authorization-denial merry go round many times leading to a teleconference with the medical director of the health plan.  All this takes time and can delay treatment for quite a while, adversely effecting results.  Especially when used with curative intent and when there are no good substitutes, this is unacceptable.  Another complication is the emergence of a “gray market” where drugs from questionable sources pass through unknown hands to our offices at up to 10 times the usual price.  In the ‘90’s we called this brown-bagging.  Trying to keep inventory straight as to which drug from what source belonged to whom was an added challenge.

From the above, it is obvious that health care is big business.  An invaluable source of health care information is, therefore, the Wall Street Journal.  In last weekend’s edition I learned that “Roche Holding AG has stopped delivering its drugs for cancer and other diseases to some state-funded hospitals in Greece that haven’t paid their bills.”  This policy may extend to Spain, Portugal and Italy.  Patients had to purchase chemotherapy from private pharmacies and bring them back to hospitals for administration.  In the US, we find ourselves in a similar situation in that we can’t afford to purchase some drugs for our patients.  So drug shortages are a global issue involving different causes requiring different approaches directed to specific problems.

I found two articles helpful in defining the problem and proposing possible solutions:

1. Link, M., et. al.:  Drug Shortages Threaten Patient Health and Safety; HemOnc today, vol 12 no 15, August 10, 2011, pg 1, 10-12.
2. Johnson, P.E.:  Drug Shortages:  Impact and Strategies; JNCCN, vol 9 no 8, August, 2011, pp 815-819.

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Surprise!!!

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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.

Victims No More

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It was 1967.  I was an intern in the UCLA-Wadsworth VA Rotating Internship Program when I reported for my physical as part of the Berry Plan deferment.  For the younger set, physicians and dentists could elect to delay military service until completion of their first year of residency training, and we could elect our branch of service we preferred to serve in.  I chose the Air Force.  On the History portion, I stated that I suffered with asthma since childhood.  Within short order, I was notified of disqualification by the Air Force, my Draft Board reclassified my status to IA, and I was drafted into the U.S. Army, losing my deferment!  I sought legal advice, pronto.

After one year of legal maneuvering, during which time an independent physician certified I should be disqualified from military service altogether, my attorney informed me that all appeals had been exhausted.  I had two options:  go in as a captain or be drafted as a private.  I elected the former.  His parting words were:  “At least you won’t go to Viet Nam.  Not with all the documentation”.  My orders read “Saigon”.  Modifying the Sinatra song:  “It Was” NOT “A Very Good Year”.

I resigned myself to serving my time in Viet Nam.  My wife and one year old daughter would live in Hawaii near her father during my tour.  But, my wife admonished me to try one more time to appeal what was obviously unfair.  So, before we left for Ft. Sam Houston, I humored her and called the Pentagon.  I explained the situation to a Major Baker who was new at his post.  He discovered that all of my records had been shredded!  I sent more copies of my documents to a panel of physicians for its review with no guarantee that their decision would change my orders.

On reporting to Ft. Sam, the entire new group was addressed by the commanding officer.  Sighting his rank (a bird colonel), we greeted him with the loudest groan I’ve ever heard.  But I’ll never forget his advice to us:  “Let’s face it, we gotcha.  You can be miserable all this time.  Or you can make the best of it”.  He went on to say that we would have one year (I had two) at a stateside base during which time we should avail ourselves of all the opportunities to do something other than practice medicine 24/7.  Two weeks later, I was called into the same bird colonel’s office and advised Major Baker had called.  I was not going to Viet Nam!  I’ve said a prayer for Major Baker every night since.  And I did everything reasonable to appeal the decision and then let it go.  No longer a victim.

My two years at the Rock island Arsenal were terrific.  One Sunday I was rounding at a local hospital when a general practitioner (that’s what the terminology was in those days) commented about the then recently enacted Medicare legislation:  “Mark my words.  This is the beginning of Socialized Medicine”.  From that point on, any proposal to organize our practices was met with suspicion.  We were victims of external pressures and resisted most changes to the status quo.

Over time, this attitude has shifted to a more proactive position, dealing with the situation at hand (i.e., making the best of it) and trusting in an outcome that can be managed.  I was impressed by an article entitled:  “Oncology patient-centered medical home and accountable cancer care” by John D. Sprandio, M.D. in the December 2010 issue of Community Oncology, Volume 7/Number 12, pp. 565-572.  This medical home model has been adapted to oncology from primary care as both are assuming more responsibilities for patient care and are under severe financial restraints.  For oncologists, the situation is complicated by “by the perverse methodology of paying physician practices for the drugs they administer after discounts from pharmaceutical companies-a model that has eroded over the past several years”.  A detailed description of the model is provided and successes to date listed, giving hope that we can deal with proposed healthcare reform in a positive manner.  Current and future challenges are discussed.  These include:

1. Assessing and improving value in cancer care.
2. Enhancing physician accountability.
3. Standardizing and integrating clinical care.
4. Encouraging payer collaboration.

The author concludes by stating:  “None of the other efforts that payers are considering provides a sustainable business model for community oncologists”.  It was refreshing to read a well thought out plan addressing present issues rather than the old whining and complaining of the past.  Rather than victims, we become survivors.

A ‘moment of clarity’ (and then some)

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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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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.