The Shell Answer Man

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cancer, clinical trials, clinicaltrials, CME, digital media, evidence based medicine, health, Just Oncology, oncology, participatory medicine, social media, twitter

By Richard Just, MD

Over the past 37 years in practice, I’ve received thousands of requests from patients, family and friends to interpret results of clinical trials.  These requests have increased dramatically with the advent of the Internet.   Many of these reports involve poor trial design or are inappropriate for the patient under consideration.  Sometimes I’ve mumbled to myself “I feel like the Shell Answer Man”.  For those too young to remember, I’m referring to a Shell Oil Co. ad beginning in the 1960’s in which the ‘Shell Answer Man”, replete in his Shell gas station uniform, answered common questions about driving and the uses of gas and oil. He just memorized a script; sometimes I wish I had one.   

Over Labor Day weekend, while in Chicago for a family event, we turned on TV to catch up on the day’s news. As fate would have it, we stumbled upon a healthcare segment on the NBC affiliate.  The reporter was listing items individuals should consider in evaluating results of clinical trials.  It seemed to me that knowledge of these items would be very helpful to people who are not healthcare professionals; people who need some way to filter trials worth pursuing with their physicians.  The following are those questions:

1. Are the patients in the trial separated into groups, with one receiving the drug or regimen being tested (“Experimental Group”) while the other is treated with the agent(s) considered standard treatment (“Controls”)?  These groups are many times labeled “arms.”  The Control Arm may be a placebo if there is no known standard treatment.  This does not mean the patient receives no treatment at all.  These types of studies are considered the “gold standard” of clinical trials in that they involve large numbers of patients who are followed for long periods of time.  This increases the likelihood that resultant findings are valid.  The downside is they take a long time to complete and are very expensive (about $1 billion from start to finish).
2. What is the total number of patients entered into the trial?  As alluded to above, the more the better.  If one study includes 50 patients while another 350 (all other factors being equal), place more trust in the larger trial.
3. What is the length of the study? In other words, how long are the patients followed? Again, the longer the better.
4. Were the patients included in the trial representative of the proposed population to be studied?  For example, if the population to be studied involves pediatric patients, someone over 18 years of age should not be entered into the trial.
5. Who is funding the study? Pay attention here. If the study is paid for by the company who developed the experimental agent, how likely are they to give a completely unbiased report? Of course we want to assume that they will, but unfortunately, some won’t.  A government supported trial is more likely to report balanced findings than an industry funded one. The reporter added that patients should note what the authors say about their study, i.e., do they make overly optimistic claims for their treatments?  Most investigators add some type of cautionary note, like “the proposed treatment looks promising pending further studies.”  This disclaimer recognizes that no study is perfect.  In fact, there has been a marked increase in the number of studies initially reporting positive results that were retracted when similarly designed trials were subsequently negative.  The end result has been a delay in patients receiving appropriate treatments and a horrible waste of money.
6. I’m adding this one on my own. I’ve noticed that one of the most common mistakes people make is to search for clinical trials involving the wrong cancer, not realizing that we identify cancers by their organ-of-origin, not the organ where they spread (metastasize).  An example would be to collect articles about liver cancer instead of colon cancer that metastasized to liver.

As chairman of our hospital’s Investigational Review Committee, I and our members are in charge of reviewing proposed clinical trials conducted in our hospital district.  The above factors, as well as many others, are considered before studies are approved, denied or amendments recommended.  Consideration of the items discussed above could save everyone a lot of wasted time, and even lead to the retirement of the Shell Answer Man.

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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?

More On Screening: Barrett’s Esophagus

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Barrett’s Esophagus, cancer, CME, epatients, GERD, medical education, medicine, oncology, participatory medicine, patients, physicians, research

By Richard Just, MD

Recently, a friend of mine asked me for medical advice concerning his condition, Barrett’s esophagus.  When the diagnosis was initially made, he was advised he would require annual screening endoscopies with random biopsies.  But, on his last visit, my friend was told he didn’t need another procedure for 5 years, with no explanation.  “What’s up?”  Since he had a copy of the biopsy report (not with him, but at home), I advised he read it and look for the word dysplasia.  Wikipedia defines dysplasia as

maturation abnormality.

So far, I haven’t heard back.  But this stimulated me to review current recommendations on the subject.

Between 2-3 decades ago, there was a sudden increase of adenocarcinomas (“glandular cancers”) of the lower esophagus usually in Caucasian males.  This event was noticeable in that the usual esophageal cancers were a different cell type, squamous cell carcinomas, that tended to occur in Black males.  Adenocarcinomas appeared to be correlated with gastroesophageal reflux disease (GERD), while squamous cell carcinomas (SCC) are associated with smoking and alcohol consumption.  These are tends, not absolutes.  GERD causes irritation of the cells of the lower esophagus resulting in conversion of the cell type (metaplasia) from squamous cells to columnar cells, the definition of Barrett’s esophagus.  Barrett’s, in turn, can progress to low grade dysplasia, high grade dysplasia, and adenocarcinoma.  Thus, it has been proposed that patients with at least weekly GERD symptoms (heartburn, regurgitation, and dysphagia, meaning difficulty swallowing) that have been present for at least 5 years, and who have multiple risk factors for esophageal adenocarcinoma including white ethnicity, male sex, older age, obesity and long duration of GERD undergo screening for Barrett’s esophagus.

Management of Barrett’s esophagus involves 3 major components:

1. Treatment of GERD:  Recommended to be initiated prior to surveillance endoscopies to minimize confusion caused by inflammation in diagnosing dysplasia.  Not thought to reduce incidence of esophageal adenocarcinomas.
2. Endoscopic surveillance:  If no dysplasia found, next scope in 3-5 years.  Follow up for low grade dysplasia is 6-12 months  For intensive endoscopic surveillance of high grade dysplasia, scope every 3 months.
3. Treatment of high-grade dysplasia:  Recommendations can include esophagectomy, endoscopic ablative therapies, and endoscopic mucosal resection in addition to intensive endoscopic surveillance.

Since the above recommendations were updated in 2011, my assumption is that no dysplasia was discovered on any of the 3 studies and risk of progression to cancer is low.  For the general population of patients with Barrett’s esophagus, the risk of esophageal adenocarcinoma is 0.5% per year.  Contrast this with 5-8% per year in patients with high grade dysplasia.  The risk for low grade dysplasia falls somewhere between these 2 extremes.

I’ve written previously about the limitations and risks of mass screening techniques, e.g., mammography for breast cancer, PSA testing for prostate cancer and PAP smears for cervical cancer.  The same applies to screening endoscopies for Barrett’s esophagus.  The procedure carries with it risks, including perforation and bleeding.  It’s also not very comfortable to have a hose snaked down your throat so that pre-anesthetics are sometimes necessary, creating more risk.  Random biopsies are performed because it’s sometimes difficult for the endoscopist to identify areas of dysplasia from just metaplastic cells, leading to falsely negative results.  In his new book “The Creative Destruction of Medicine”, Dr. Eric Topal opines “We’re not very good at detecting and fighting cancer.  The mass screening model, as with mammography or prostate specific antigen (PSA) testing……..is enormously expensive and leads to an untold number of false positive results and more unnecessary biopsy procedures.  Doing serial sensitive scans like PET or CT would likely make this problem worse, both by increasing the false positives and incidental findings and by exposing individuals to ionizing radiation that itself causes cancer.”  The use of innovative technologies such as circulating tumor cells (CTC), genomics (circulating DNA and RNA) and wireless sensors including implanted nanosensors are described.  Obviously, hope runs high that at least some of these techniques will be validated so that the ultimate goal, prevention, is achieved.

@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!

Trials and Errors

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cancer, clinical trials, clinicaltrials, CME, digital media, medical education, medicine, oncology, participatory medicine, pharma

By Richard Just, MD

The explosion of information in molecular oncology has identified a seemingly infinite number of targets for novel therapeutic agents.  This has spawned the concept of personalized oncology, which has “gone viral.”  However, a disconnect between the very large number of possible targets and the very small number of treatments is now apparent.  In addition, most (85%) of drugs thought to be beneficial in Phase II clinical trials cannot be validated when other labs and institutions attempt to reproduce these results.  And it is still taking up to 10 years and costing over $1 billion to bring a single new agent from the bench to the bedside.  A postulated major roadblock is that Clinical Trial design has not adapted to these new developments.

Maitland and Schilsky addressed this topic in a comprehensive article entitled:  Clinical Trials in the Era of Personalized Oncology; CA, A Cancer Journal for Clinicians; vol 61 no 6, Nov/Dec 2011:  pp 365-381.  Table 1, pg 366 summarizes “Oncology Care and Clinical Trials in the Eras of Population Oncology, Transition, and Personalized Oncology.”  In the areas of Screening, Diagnosis, Staging, Treatment determination, and Assessment intervals, we are headed for molecular-based and individual-based decision making, but we’re still in the transition phase.  As far as early phase clinical trials are concerned, the Population Oncology Era was oriented to maximum tolerated dose (MTD); the Transition Phase is oriented to “optimum biologic dose” and the Personalized Oncology Era to determine the range of tolerable and active doses.   Mid-phase clinical trials use histology and prior treatment-based eligibility in typically single-arm, non-comparator trials in the Population Oncology Era; the addition of some marker-based screening and some randomized controlled trials in the Transition Phase and some trials, histology, and prior treatment-based eligibility with rapid, serial assessments in the Personalized Oncology Era, many with eligibility restricted to tumor marker subsets.  Obviously, the trend is to stratify patients according to their biomarkers and to serially assess for response or lack of it at more frequent intervals to accelerate the conduct of trials.

Another issue is the complexity of the diseases we’re dealing with.  Weinberg and Hanahan proposed 6 “rules” that define the behavior of cancers, the so-called hallmarks of cancer:

1. Self-sufficiency in growth signals:  cancer cells acquire an autonomous drive to proliferate, so-called pathological mitosis, by virtue of the activation of oncogenes
2. Insensitivity to growth-inhibitory (antigrowth) signals:  cancer cells inactivate tumor suppressor genes that normally inhibit growth.
3. Evasion of programmed cell death (apoptosis):  cancer cells suppress and inactivate genes and pathways that normally enable cells to die.
4. Limitless replicative potential:  cancer cells activate specific gene pathways that render them immortal even after generations of growth.
5. Sustained angiogenesis:  cancer cells acquire the capacity to draw out their own supply of blood and blood vessels-tumor angiogenesis.
6. Tissue invasion and metastasis:  cancer cells acquire the capacity to migrate to other organs, invade other tissues, and colonize these organs, resulting in their spread throughout the body.

A Cancer Genome Atlas is currently in process of development for the major cancers to map all these mutations and pathways to hopefully identify targets important in the causation of these cancers.

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.

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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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.

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.