Clinical Cancer Advances 2012 via @ASCO

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cancer, evidence based medicine, innovation, medical education, oncology, participatory medicine, physician, social media, twitter

Now in its eighth year, Clinical Cancer Advances 2012 was developed under the guidance of an 21-person editorial board of leading oncologists, overseen by Executive Editors Nicholas J. Vogelzang, MD and Bruce J. Roth, MD.
Each year, the American Society of Clinical Oncology conducts an independent review of advances in clinical cancer research that have the greatest potential impact on patients’ lives.

This year’s report, Clinical Cancer Advances 2012: ASCO’s Annual Report on Progress Against Cancer, features 87 studies, 17 of which were designated as “major” advances by the report’s 21-person editorial board.

The large number of advances featured in this year’s Report affirms the remarkable payoff of national investments in clinical research on cancer prevention, screening, treatment and quality of life for patients with cancer.

For complete report, click here.

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Western Meets Eastern Medicine: Or Ying Meets Yang?

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cancer, clinical trials, CME, digital media, epatients, evidence based medicine, innovation, integrative oncology, medicine, pharma, physician, research, Traditional Chinese medicine

By Richard Just, MD

In today’s China, both eastern and western medical philosophies and practices exist relatively harmoniously.  Patients with minor, usually self limited problems are treated initially with a seven day course of seven liquid herbal preparations taken each day.  If symptoms subside, usually treatment is discontinued.  If improved but not resolved, formula may be modified.  If worse, regimen can be changed and/or referral to specialists arranged.  There are hospitals that practice purely eastern or only western medicine.  But it is becoming more frequent to find hospitals that integrate both disciplines.  Chronic conditions, like cancer, tend to be treated with western techniques, with Traditional Chinese Medicine (TCM) used in a supportive or complementary role.

I was somewhat surprised to hear that the 2 largest cancer problems are breast cancer and liver cancer (mainly the former but not the latter).  Before I left, one of my patients had brought an article to my attention about a low incidence of breast cancer in China  compared to the West.  This may not be the case.  Primary liver cancer, hepatocellular carcinoma), has long been the number one cancer in frequency in the world due to a high incidence of hepatitis, especially in Asia.  This results in chronic active hepatitis, cirrhosis and, finally, cancer.  Even though we stayed at 5 star hotels, we didn’t brush our teeth or rinse our toothbrushes with tap water, and avoided ice.  Sanitation, or lack of it, is an issue.

Everywhere in China, especially big cities, there are forests of skyscrapers.  Private homes are essentially nonexistent as the government owns all the land.  New construction is ubiquitous, so cranes are numerous.  Many of these apartment spaces are empty due to high prices, and those that are bought or rented are shared by several families.  Same with kitchens and bathrooms.  Public bathrooms may lack toilets and simply be holes in the ground.  In some buildings, one bathroom per floor exists.  We saw the interiors of 3 residences.  First, the home of one of four of the farmers that first discovered the terra-cotta warriors outside Xi’an.  Clean.  Very little furniture as you buy empty spaces which you have to furnish yourselves.  But several generations of the family lives there.  Second, a more modest quarters of a woman in the old section of Beijing.  Bathrooms were down the road apiece.  The last was a tiny, single room in what used to be the French Concession section of Shanghai.  Five people slept on one cot.  No mystery why hepatitis and liver cancers are still issues.

Another surprise is lack of mention of lung cancer.  Cars everywhere.  Their gridlock is continuous and called “rush days”.  Mist or fog (mostly pollution) gives a surreal appearance to the landscape of high rises.  Seemingly everyone coughs.  Lots of spitting.  A perfect setup for respiratory problems including lung cancer.  There are several hospitals in major cities devoted to respiratory diseases, however.

An excellent article appeared in the Wall Street Journal, Tuesday, April 3, 2012, pg D4, entitled “Chinese Medicine Goes Under the Microscope” by Shirley S. Wang.  The main topic is a clinical trial studying a four herb combination, called huang qin tang in China and PHY906 in this trial, in combination with chemotherapy to see if effective in reducing side effects of chemo (nausea, vomiting, and diarrhea).  If so, patients might be able to tolerate higher doses of chemo with better results.  Trial design and quality control are issues when doing studies such as these:

One challenge with using herbal medicines is that the ratio of the chemicals they contain isn’t consistent when plants are grown under different conditions.  After testing various suppliers, Dr. (Yung-Chi) Cheng ended up creating a biotechnology company sponsored by Yale called PhytoCeutica to carefully monitor growing conditions to ensure plants from different batches were pharmacologically consistent and to continue clinical development of the compound.

Finally, an article that appeared in the China Daily entitled “There’s More to Life Than Money” by Cai Hong, a senior writer for the paper, cites the first World Happiness Report   released by the Earth Institute last month.  Not surprisingly, the top 4 rated are northern European welfare states:  Denmark, Finland, Norway and the Netherlands.  China doesn’t make the top 100.  One of the benchmarks evaluated is health:

……Increased insurance coverage has not yet been effective in reducing patients’ financial risks, as both health expenditure and out-of-pocket payments continue to rise rapidly.  And there are many reports of disgruntled patients and their relatives attacking the medical staff in hospitals.  Reform of public hospitals is essential to control health expenditure because such institutes deliver more than 90% of the country’s health services.  But Health Minister Chen Zhu said the cost of improving care remains an obstacle, and China is looking to other nations for cost-effective solutions.

While this notice appeared in the WSJ this last weekend:

U.S.-China Pharma: Some big pharmaceutical firms are partnering with Chinese companies in trying to discover the next blockbuster drug.  This Philadelphia conference will include venture capitalists and such Western firms as Novartis and Abbott Labs. Wednesday-Thursday, Hub Cira Centre.  Regular admission:  $1,799.00.

I find it interesting that both the U.S. and Chinese governments are investigating hospitals for price gouging in the sale of drugs. Further, given the emerging cost and access pressures they’re witnessing, might mainland China by eying the health system reform experiment underway in Taiwan?

China: A report from the journey

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cancer, digital media, evidence based medicine, integrative oncology, medical education, oncology, participatory medicine, physician, social media, Traditional Chinese medicine, wellness

By Richard Just, MD

China is nothing like I imagined! The evolution of healthcare mirrors major events in Chinese history.  Traditional Chinese Medicine (TCM) dates back 5,000 years when the first documentation appears.  What is currently called TCM goes back 3,000 years, and was essentially passed from one generation to the next.  Another factor that resulted in fragmentation of medical practices was that China was a feudal society whose states were constantly at war with each other.  The emergence of the Qin state resulted in a single state system with a single script and standardized weights and measures.  But their reign was so oppressive it lasted only 15 years, overthrown by the Han Dynasty in 210 BC.  During this time fragments of the Great Wall were fused into one continuous structure, and the underground mausoleum of the terra-cotta warriors was constructed near modern day Xi’an which was China’s capitol at that time.

In my mind, China was still a monolithic society under a Communist regime and TCM was available to the masses while western medicine was for the ruling class.  Well that’s not exactly the case.  Prior to 1949, there had been a widening chasm between those who had access to healthcare and most everyone else who didn’t.  When the Party came to power, most workers were employed by the government and had access to healthcare.  All through the Cold War era, the only major leader who never left his country was Mao.  He was mainly concerned with unification of the country and building a strong infrastructure.  Many lesser officials did interface with the West, and when they returned with different ideas, the Cultural Revolution (1966-1976) ensued.

We all know that intellectuals, including doctors, suffered.  But Mao realized he needed some physicians to treat the population.  He also realized that TCM needed to be standardized so it could be disseminated to as many doctors as possible.  In this process, much of the practice of TCM was changed in China, but it continued as it had been practiced for 3,000 years in Japan.  In 1980, with the end of the Cultural Revolution, two policies were instituted that have resulted in major changes in society:

1. One child per family rule:  There are certain exceptions to this rule.  But, in general, if a family has more than one child they are fined, heavily.  And, if the practice continues, a sterilization procedure results.
2. Opening up China to western ideas and businesses:  One of the first businesses allowed into China was health insurance.  Hard  to believe but true.  What has resulted is a system resembling ours.  Government employees and  officials  have  government insurance, which is essentially free.  They have access to everything necessary for their care, and it is funded by taxing the entire population.  Non-governmental employees buy private health insurance which generally covers 70% of  costs, leaving 30% out-of-pocket.  These policies consume a  good  chunk of income, and are renewed for 25 years after which all costs are covered by Social Security and the government.  Again these funds derive from taxes.  Parents pay for healthcare of their children, and rural farmers who can’t afford insurance are eligible for something like Medicaid/MediCal with “bare-bones” coverage.  This latter situation is also not free.  Obviously, most young people prefer a government job.  These are hard to come by unless you know someone, and contribute to his “Red Pack.”  This is the local phrase for payola or bribe.

Does this sound familiar?  I found no one who felt the system was fair.  But I didn’t speak with a government official.

Meanwhile, my wife and I had a personal experience with TCM.  Prior to our trip, Dee Dee fractured two metatarsals in her left foot.  This was healing when we left.  But, I’ve dubbed China as the country of stairs.  Lots of walking and climbing.  This time both feet and ankles were extremely painful and swollen when we boarded the Yangtze River cruise.  Fortunately, there was a doctor on board who saw her the next day.  Her treatment consisted of acupuncture, acupressure, placement of antifungal patches on the tops of her feet and cupping.  Not what I learned in training.  It was recommended that she soak her feet and legs up to mid-calf level each night in very warm to hot water for 20-30 minutes.  The whole process lasted one hour and cost 550 yuan, equating to roughly 90 USD.  She was much improved by the following morning.  That afternoon, Dee Dee had a second treatment.  Both treatments were very painful, especially when the needles were inserted.  It turns out Chinese needles have a much larger bore than those used in the U.S.

We listened to a lecture on TCM given by the same doctor.  TCM involves not only acupuncture, acupressure and cupping, but also herbal medicine, Qigong, and Tai chi.  He discussed the use of TCM modalities in treatment of migraine and other headaches, motion sickness and back pain.  Every morning, the same Dr. John Lee gave Tai chi lessons on board, which we both attended.  The only excursion Dee Dee has missed was to the temples at Fengdu which involved over 500 stairs and inclined walkways.

Now for the big question:  “Is there any role for TCM in the treatment of cancer?”  He said that TCM is of little benefit in treating or preventing cancer, but may have some benefit as an adjunct to surgery or other conventional treatments.  More on this when we reach Shanghai.

More To The Henrietta Lacks Story

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cancer, clinical trials, elder wisdom, epatients, evidence based medicine, health, Henrietta lack, medical education, medicine, physician, physicians, research, social media, twitter, wellness

By Richard Just, MD

A few weeks ago, my wife and I attended “A Conversation With David ‘Sonny’ Lacks” at the California Center for the Arts, Escondido.  The event was a sellout with 900 attendees.  As it turns out, most of the colleges and universities in San Diego County designated “The Immortal Life of Henrietta Lacks” as the book discussed by students and faculty this past academic year.  The conversation was sponsored by California State University, San Marcos.  As an added bonus, Mr. Lacks’ daughter appeared with him on the podium.  I had previously attended a similar lecture with the author, Rebecca Skloot, at UCSD.

The story of Henrietta Lacks can be viewed from several vantage points.  As a medical oncologist, and Chairman of the Investigational Review Committee as well as Medical Director of the Research Institute at Palomar- Pomerado Health, ethics in medical research certainly occupies a position of paramount importance to me.  In fact, the book is being discussed locally primarily from this perspective.  Ms. Skloot points out that obtaining ‘Informed Consent’ from patients to do research on their tissue was not required, nor was it considered, in 1951 when Mrs. Lacks’ biopsy was obtained for research purposes.  Mr. Lacks stated he did not feel the family should receive financial compensation for using her tissue for research purposes.  But, Henrietta and the family should have been told that her cells were going to be used for research purposes, what the research involved, and knowledge of the results.  In other words, essentially informed consent as we now require in all patients undergoing clinical trials.

On the other hand, he did feel that the family should receive financial remuneration from the companies that commercialized his mother’s cells by selling them to labs around the world.  This proposal seems fair.  To date, no financial restitution has occurred.

But despite all this, Mr. Lacks maintains an air of dignity that engenders respect.  Throughout the evening, there was no expression of anger or hostility; no complaining.  When asked if he thought that racial discrimination played a role in how they were treated, Mr. Lacks said no, people of all races were treated the same at that time.  Sonny said that although no one from Johns Hopkins has ever formally apologized, they have honored his mother in other ways.

Sonny Lacks was 3 years old when his mother died.  So, he has no direct recollection of her.  In fact, the picture on the front of the book is the only picture of Henrietta in existence.  All that he and his daughter know about her they learned from his older siblings and Ms. Skloot’s research for the book.  When Henrietta was treated, Johns Hopkins was the only hospital in the state of Maryland that treated the uninsured.  Fast forward to the present and this sore is still festering in our country.  Mr. Lacks stated that he recently required stents placed in his coronary arteries on an urgent basis and he, like all the members of his family, is uninsured.  This brought an audible gasp from the audience.  He said he had $100,000.00 in unpaid bills, and he opined that health care should be a right as it is in other countries, not a privilege for only those who can afford it.  This elicited a vigorous round of applause from the audience .  I would add that the number of people in the U.S. who can afford access to healthcare is dwindling also. [Editor’s Note: For specific discussion on the impact in the Black community, see: ‘Blacks See Largest Decline in Health Insurance Coverage.’]

The closest we have to universal healthcare provided by government is Medicare and Medicaid (MediCal in California), see: ‘Medicare: The Basics.’  I recently crunched the numbers in my own situation at age 70 to decide whether or not to convert from my medical group’s health plan (since I’m still working to full Medicare coverage.  Plan A is free and mandatory at age 65.  But I needed Plan B, a Medicare Supplement Plan and Medicare Part D for prescription drugs.  Part B involves an annual fee of $140.00 + monthly premiums of $99.00 + something called “Modified Adjusted Gross Income” (MAGI).  The IRS now sends Medicare a report of my income and a graduated monthly charge is added to my premium.  The monthly total amounted to $259.70.  Added to that is the cost of the Supplement and Medicare Part D.  Then the out of pocket expenses including cost of drugs in the donut hole and now you’re talking “real money.”  Of course, you can opt for a Medicare HMO but choices are limited. So for effect, I will quote myself (drum roll please!):

My conclusion was that being insured does not equate to being covered, and I needed to be a CPA to figure this out.  So, I stayed with my group health plan.

The most poignant moment of the evening occurred when Henrietta’s granddaughter was asked how she felt her grandmother should be remembered.  Her answer:

The gift that keeps on giving.

Not a dry eye in the room.

@JustOncology Acquires Top Level Domain ‘TumorBoard.com’

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cancer, cancer program, clinical trials, CME, digital media, evidence based medicine, innovation, medical education, medicine, oncology, physician, social media, tumor board

By Gregg A. Masters, MPH

Since the beginning of this blog, including @Chemosabe1 and @JustOncology Twitter participation, and the launch of ‘This Week in Oncology‘ on the BlogTalk Radio Network we’ve been developing the concept of @TumorBoard. The idea is to ‘up-level’ the traditional hospital based ‘bricks and sticks’ tumor board to the web for real time consultative access to peer sourced and evidenced based best practices.

Once the center piece of any community hospital with ‘cancer center’ aspirations, and a value added incentive for staff physicians to journey from the office to the hospital for either breakfast, lunch, or dinner as the case may be, for peer networking, education, including Category 1 accredited CME, and periodic guidance and support on difficult cases, the popularity of tumor board had waned somewhat. We believe this is due in part to the increasing complexity and demands on physician time particularly in community based practices.

Yet we reasoned, with the introduction of smart phones and devices such as iPads or their tablet derivatives, to the near universal prevalence of desktops and laptops in medical practices, plus a small but steadily growing interest and participation of physicians in social media applications, why not attempt to bridge the either/or ‘workflow divide’ via these ubiquitous devices and secured web based access?

We thought the experimentation to be well worthwhile, and that the technology, people and macro-economic trends were on our side. As a result, we met with several ‘infrastructure’ partners and vendors to evaluate the state of the art so to speak, and were pleasantly surprised. We have certain specifications and needs lined up but remain open as to our preferred relationship at this time.

To date, we’ve opened the Twitter account @TumorBoard, acquired the domain names TumorBoard.co and TumorBoard.tv, since TumorBoard.com was owned by someone else, though only in a ‘parked’ and passive status. But the ‘gold standard’ from a branding perspective remained the outside our reach dot com version. After some preliminary domain brokering exchanges, we finally settled on a price, and are now pleased to announce the acquisition of TumorBoard.com. We will be activating the site shortly.

There is lots more to come. So stay tuned!

The Avastin Story: It Ain’t Over ‘Til the Fat Lady Sings

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Avastin, cancer, CME, digital media, epatients, innovation, participatory medicine, pharma, physician, social media, twitter, wellness

After 5 months of deliberation, FDA Commissioner Margaret Hamburg, the final arbiter in the Avastin hearings, decided to revoke approval of the drug in patients with metastatic breast cancer.  At first blush, this event would seem to end the story.  But not so fast!  Even though Avastin cannot be marketed for this indication, it still can be prescribed “off label” as oncologists have done in the past for many agents.  And, this ruling doesn’t affect its use for other indications including colon, lung, kidney and brain cancers.  Medicare will continue to reimburse for Avastin use in breast cancer patients.  But response of private insurers has been variable so far.  All of the above has a familiar ring to it.  The situation is almost exactly the same as it was when hearings ended in June.

We have extensively covered these hearings and the articles on which this decision is based in prior blogs and radio broadcasts.  The data clearly documented that no complete remissions were achieved and, therefore, there were no cures.  In the Wall Street Journal report (WSJ; Saturday/Sunday, November 19-20, 2011, pp. B1-B2), Rep. Sue Myrick (R., N.C.) is quoted as saying:  “When a drug can help save patients’ lives, they should be able to do that affordably.”  Her point was that this decision may result in denial of coverage.  But stating that Avastin saves the lives of breast cancer patients implies a cure, giving thousands of women false hope.  Yes, I’ve personally treated many breast cancer patients with Avastin.  Some have lived months longer than they would have without it.  Rarely years.  But none have been cured.

Coverage of the FDA’s decision has been rapid and extensive.  This morning’s AMA Morning Rounds provides an excellent compendium of what’s been published or aired so far.  I found the last 2 cited sources especially interesting, providing a “point-counterpoint” perspective:

“WSJournal critical of FDA move.  The Wall Street Journal (11/19, Subscription Publication) argued that the FDA’s requiring credible, objective evidence is a subjective standard and criticized the government for interfering with patients’ choices.  The Journal argued that the FDA and medical journals dislike the accelerated approval process for medicines and that its decision isn’t based on Avastin’s side effects but an effort to convey a message that the agency is in charge of pharmaceutical development.  The Journal asserted that the FDA was ignoring the real world and should have allowed Avastin to remain on the market while more was learned about it.”

“FDA decision applauded.  On a blog in Forbes (11/19), Matthew Harper wrote, ‘the FDA decision is the right one, and, more than that, it’s actually good for the drug industry.’  According to Harper, the opposite decision ‘would have made scientists who work at the regulator or who advise it on expert advisory committees more reluctant to give accelerated approvals at all.’  Furthermore, ‘we’re not going to beat cancer by lowering the bar.’  Harper notes, ‘that Avastin costs $80,000 for the average breast cancer patient, and Roche pockets the money whether it works or not,’ adding, ‘we can’t afford to fight cancer with weapons that don’t both shrink tumors and prolong patients’ lives.”

Recognizing these divergent opinions are being read and heard by our patients and their families and friends, how do we advise them about Avastin’s appropriate role in breast cancer, if there are any?    Thoughts of two respected breast cancer researchers, Joyce A. O’Shaughnessy, M.D. and Hope S. Rugo, M.D., are reasonable.  They are stated in the OncLive issue; Vol 12 No 9, 9.11, pg 18:  “Insights on Avastin:  Patient Selection Is Key.”  This selection process should obviously identify both those patients most likely to benefit and those most likely to suffer adverse reactions:

1. At this point in time, we haven’t identified biomarker(s) predictive for response.  Preliminary data suggesting that levels of VEGF-A may identify a subset of patients potentially responsive to Avastin is apparently being investigated.  Until such a marker is identified, it is reasonable to recommend weekly, low dose Taxol + Avastin 10 mg/kg IV q2wks. for aggressive tumors, e.g., triple negative disease.  We have the option of hormonal therapy in addition to chemotherapy for ER+/PgR+ patients, and Heceptin and chemotherapy for HER-2+ patients.
2. By avoiding Avastin in patients at increased risk for complications (recent surgery, planned surgery in the near future, diverticulitis, active body wounds, or uncontrolled hypertension at baseline), safety of administration can be improved.

Don’t blink.  We probably haven’t heard the last of this evolving story.  But that’s as it should be.  Nothing in medicine is exempt from testing to see if it can be done better.

When Less Is More – Part III

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cancer, health, innovation, medical education, medicine, oncology, physician, Siddhartha Mukherjee MD, twitter, wellness

In addition to screening PSA testing for prostate cancer and screening mammography for breast cancer, the U.S. Preventive Services Task Force (USPSTF) also recommended changes in routine screening for cervical cancer.  Again, their recommendation was for less screening, prolonging annual PAP smears to every three years for low to average risk women.  Predictably, controversy ensued.  All three tests were proven to diagnose potentially lethal cancers before symptoms appeared, and therefore, with early treatment, reduce the chances of these cancers from ever appearing (secondary prevention).  So what’s not to like?

For reference, I turned to “The Emperor of All Maladies; A Biography of Cancer” by Siddhartha Mukherjee, M.D., published by Scribner, 2010.  Part Four in this remarkable book is entitled:  “Prevention is the Cure”.  The saga of George Papanicolaou is chronicled and is worth reading (pp 286-291).  Mukherjee then turns his attention to issues involving screening trials in general.  “Screening trials in cancer are among the most slippery of all clinical trials-notoriously difficult to run, and notoriously susceptible to errors.”  There are two main performance errors to consider:

1. Overdiagnosis (false positives) meaning you test positive for cancer but you don’t have it.  Not good for your emotional and physical wellbeing.  Can lead to tests and treatments that are unnecessary and possibly harmful.
2. Underdiagnosis (false negatives) meaning you test negative but really have cancer.  Again, not nice.  Over the years, I’ve had a not insignificant number of women state that their cancers were not detected on mammography initially and they, therefore, request an alternative screening modality.

Unfortunately, when researchers try to reduce the likelihood of false positives, the test in question can become too insensitive and result in more false negatives, and vice versa.  The goal is to design a test with the highest sensitivity and specificity as possible, but achieving this can be difficult.

The USPSTF is currently examining these tests from another perspective, i.e., whether or not the test improves mortality.  This criterion has to be distinguished from increased survival that can be flawed by lead time bias.  If we are using increased survival as the endpoint of the study, some in the group screened by PAP smears when they are asymptomatic may develop cervical cancer a decade later and survive 5 more years.  Some patients in the unscreened group develop their cancers ten years later, and also survive 5 years.  Thus, the screened patients may appear to survive longer if lead time bias is not taken into account.

Certainly, we’re able to diagnose cancers when they are smaller and possibly curable with modern day treatments.  But these screening tests give very little information about the biology of an individual patient’s cancer.  When the topic of PAP smears and cervical cancers comes up, my mind focuses on “the Immortal Life of Henrietta Lacks” and her HeLa cells.  I wrote a ‘Hela Cells’ blog post on this fascinating story several months ago.  So when the author, Rebecca Skloot, was in San Diego two weeks ago, I made it a point to hear her speak.  Would events have transpired differently now?

1. “What if” no socioeconomic barriers to healthcare existed?  No racism, poverty and lack of education.  Regular PAP smears may have given her a better chance.
2. “What if” it was recognized initially how aggressive her cancer was?  She had a rare variant cervical cancer, an adenocarcinoma, which is known to be more aggressive than the more common squamous cell type.  When she initially presented she was found to have a small tumor.  Her physicians were surprised to see how rapidly Henrietta”s cancer recurred and spread after extensive surgery and radiation therapy.
3. “What if” we knew more about her risk factors?  We know the histology of her cancer indicated a more aggressive malignancy.  We know that it is a sexually transmitted disease in “sexually active” young women, and that she had other STD’s.
4. Then, maybe her disease could have been prevented with the HPV vaccine.  When her cancer cells were analyzed for the human papilloma virus, they tested positive.

Hindsight is 20-20.  But it is interesting to go back in time to see how much progress we’ve made and paths we need to pursue now.

Quality

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cancer, clinical trials, evidence based medicine, medicine, oncology, physician, social media, twitter, VBP, wellness

Twenty-five years ago, my daughter was applying for admission to various colleges and universities.  One that she was accepted to was The University of Redlands.  Prior to starting her freshman year, students and their parents were invited to participate in a discussion of a book with faculty members.  The book was Robert M. Pirsig’s Zen and The Art of Motorcycle Maintenance.  Even though she ultimately didn’t attend Redlands, I read the book anyway and found it very thought provoking and inspirational.

One of the central themes is the author’s struggle with the concept of Quality.  In this process he resurrects the word “gumption”, an old Scottish word which he likes “because it describes exactly what happens to someone who connects with Quality.  He gets filled with gumption.”  The word implies what the Greeks called enthousiasmos, our “enthusiasm,” meaning “filled with theos,” or God, or Quality.  “If you’re going to repair a motorcycle, an adequate supply of gumption is the first and most important tool.”

Seems to me the word Quality is used so routinely in Healthcare that it has become part of the wallpaper.  Everyone is providing Quality care.  I saw a notice recently that an insurance company had purchased a large medical group for the purpose of providing (you guessed it) Quality care.  So how do we identify quality?  The old response was:  “I know it when I see it.”  Obviously too subjective.  The most reasonable definition I saw in Merriam-Webster online was “grade” or “degree of excellence.”  Better, but still subjective.  When I poll my partners, the usual response is that by practicing Evidence-Based Oncology, usually defined by NCCN Guidelines, we are, therefore, a quality group.  Also, payors base authorization and reimbursement decisions on adherence to these guidelines.  Since recommendations are ranked by level of evidence cited in literature reviews, quantitative data is provided.

Now that we have a working definition of Quality Cancer Care, how to demonstrate that, in fact, we are providing such care is the next challenge.  I think all agree we can’t provide supportive data without an EHR.  It would be very difficult to collect all necessary information and abstract appropriate data points from paper charts.  Not impossible, but tedious and error-prone.  Recognizing that this is a necessity, the number of oncology practices that are computerized, even including those who are actively considering it, is still pretty low.  According to a recent article entitled “Impact of EHR’s on Oncology Practice:  Enhancing the Value of Cancer Care” (Value-Based Cancer Care, vol 21 no 5, August, 2011, pp 32-33), that number is 25% of 12,000 US oncologists.  So why, with all the advantages mentioned in this article, haven’t more oncologists signed up?  In my experience the answer is the systems require a lot of work, they are not intuitive, and cost is prohibitive.  Focusing in on one obstacle, “the leading oncology-specific EHR’s implemented in the marketplace today” are client-server applications.  Responsibility  for upgrades and maintenance fall to the practice.  “But only the oncologists who are on a web-based platform are on a HITECH-certified version today” and thus eligible for incentives to digitize. These systems have to be upgraded at more cost.  Catch-22.

In conclusion, “Oncology practices need to continue on this path, sharing best practices with each other, and steadily improve leveraging information systems whenever possible to provide the highest-quality cancer care for their patients.”  There’s that word again.  Pirsig uses the motorcycle as an example of technology.  When fixing machines, things always come up that “drain off gumption, destroy enthusiasm and leave you so discouraged you want to forget the whole business.”  The trick is to avoid these “gumption traps.”

Drug Shortages: A View From The Trenches

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cancer, clinical trials, clinicaltrials, CME, digital media, Dr Just, drug shortgages, elder wisdom, epatients, FDA, health, health 2.0, innovation, Just Oncology, kris ghosh md, medical education, medicine, oncology, Pacific Oncology, participatory medicine, pharma, physician, research, San Diego, social media, twitter, wellness

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.

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.