Big Data, Government and Cancer Research: A Benefit for Patients?

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big data, cancer, clinicaltrials, dan munro, evidence based medicine, genomics, innovation, medicine, oncology, social media

By Gregg A. Masters, MPH

On the Wednesday, July 24th, 2013 broadcast of This Week in Oncology at 2PM Pacific/5PM Eastern our special guest is entrepreneur, social media thought leader and Forbes Contributor Dan Munro aka @danmunro.

Dan recently penned a piece for Forbes titled: ‘Big Government Opens Big Database For Cancer Research‘

This catchy headline caught my attention since part of our mission at This Week In Oncology is to eliminate the esoterica from ‘oncology-speak’ and to present the significance of the discoveries, trends and developments in the cancer care and dignostics in plain english for more general consumption.

Much progress has been realized in medica oncology of late with a fair amount of the promisesd upside of ‘personalized [or individualized] medicine’ often pointing to better outcomes via more targeted treatment of specific tumors based on their unique genetic signature.

So called ‘big data’ is in the news as ubiquitous technology, connectivity, the declining costs of massive data dragnets and disease specific mashups affords insights previously inaccessible to reseachers, clinicians and others interested in the diagnosis and/or treatment of oncology.

We’ll get Dan’s takes on his piece and see how he sees the confluence of these trends coming together for the benefits of patients.

To listen live or via archived replay, click here.

The Advent of Cancer Immunotherapy: Addressing Unmet Needs Part 1

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cancer, evidence based medicine, health, immunotherapy, innovation, integrative oncology, managed care, medical education, wellness

By Gregg A. Masters, MPH

The following is provided via the video series at the American Journal of Managed Care on ‘The Advent of Cancer Immunotherapy’, part 1 of a 3 part series:

 

In a discussion moderated by Dr. Peter Salgo, Drs. Jeffrey Weber, Michael Kolodziej, and Daniel J. George share their insights and perspectives on the rise of cancer immunotherapy, and its significance during a time in which cancer is recognized as the “new global pandemic” that has killed more than 600,000 US persons in 2012 alone.

 

For original source link, click here.

Tumor Board: Is There Value in Multidisciplinary Case Consideration?

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digital health, evidence based medicine, health, innovation, oncology, participatory medicine, tumor board

By Gregg A. Masters, MPH

When the American College of Surgeons Commission on Cancer picked up the accreditation football and in the spirit of the then Joint Commission on Accreditation of Hospitals ‘Joint Commission‘ began the promulgation of specific standards for the accreditation of aspiring ‘cancer programs’, at the center of this consideration was the multidisciplinary cancer conference also known as ‘tumor board.’

Via these standards there were both structural and certain process considerations to meet, but the underlying assumption or zeitgeist of the value proposition – better cancer care – was that ‘multidisciplinary’ engagement of cancer specialists in the diagnosis and treatment of cancer patients would produce superior outcomes.

Then in October of 2012 Keating et al published a study titled: ‘Tumor Boards and the Quality of Cancer Care’. While somewhat dated (interval 2001-2004), and not generally representative of community oncology practices per se (the sample was sourced in the Veteran’s Health System), the conclusions are none-the-less a compelling call to objectively demonstrate long held assumptions of the benefits of tumor board ‘collaboration’.

The background context for the study was noted as follows:

Despite the widespread use of tumor boards, few data on their effects on cancer care exist. We assessed whether the presence of a tumor board, either general or cancer specific, was associated with recommended cancer care, outcomes, or use in the Veterans Affairs (VA) health system.

While Keating et al concluded as follows:

We observed little association of multidisciplinary tumor boards with measures of use, quality, or survival. This may reflect no effect or an effect that varies by structural and functional components and participants’ expertise.

Following publication a series of pieces appeared in the professional press with eye catching headlines such as:

‘Tumor Boards May Not Really Impact Cancer Care‘, and ‘Little association of multidisciplinary tumor boards with effects on cancer care‘, but the title that grabbed our attention was an opinion piece in response to the Keating study offered by Douglas W. Blayney, MD, Stanford Cancer Institute, Stanford School of Medicine, titled: ‘Tumor Boards (team Huddles) Aren’t Enough to Reach the Goal‘.

Blayney details his reasoning and observation while cautioning against the potential ‘knee jerk’ over reaction by some to the Keating conclusions and ‘market aftermath’ as follows:

Tumor boards have too long a history for them to be easily
abandoned. Much like the “hurry-up” offense changed the conduct of huddles in football, tumor boards should also adapt to the changing times and technology. In the system studied by Keating et al. (1), there are only huddles and no feedback loop. Their measurement work provides a reason to change tumor board conduct.

On ‘This Week in Oncology‘, May 22nd, 2013 at 2PM Pacific/5PM Eastern Dr. Blayney is our very special guest. We’ll dive deeper into his thought process, rationale and recommendations to tweak the tumor board formula via technology and other process adds, to perhaps better align this important multi-disciplinary experience with improved patient outcomes.

‘You Don’t Know Jack’ by Morgan Spurlock

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cancer, clinical trials, digital media, evidence based medicine, health, innovation, Intel Science Fair, jack andraka, oncology, participatory medicine

By Gregg A. Masters, MPH

But you should! Get to know him here:

Earlier today we just finished chatting with Jack Andraka on This Week In Oncology. One of my favorite lines from the conversation is quoted below, Jack refers to the high school biology class as the:

absolute stifler of innovation

From which he none-the-less associates inspiration for his scientific inquiry. Suffice it to say, Jack was neither encouraged nor challenged by the curriculum, and found other ways to engage his mind and curiousity.

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.

Get to Know ‘Chemotopia’

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cancer, chemotherapy, chemotopia, evidence based medicine, integrative oncology, Just Oncology, medical education, oncology, social media, startUp health, twitter

By Gregg A. Masters, MPH

On the Wednesday, November 7th 2012 broadcast of
‘This Week in Oncology‘ we chatted with medical oncologist, integrative cancer care specialist, and ‘serial entrepreneur’ Steven Eisenberg, D.O., co-founder of StartUp Health Academy’s transformer entry ‘chemotopia‘aka @chemotopia on Twitter.

Disclosure: Dr. Eisenberg is a partner with Dr. Just in Cancer Care Associates for Research and Education (CCARE).

We spoke with Dr. Eisenberg about his most recent entrepreneurial interest known as ‘chemotopia’, where the tagline is:

getting through chemotherapy, together

To listen to the broadcast, click on the show logo below:

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.

Why Cancer Research Requires Constant Vigilance

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cancer care, clinical research, conflict of interest, evidence based medicine, oncology, publish or perish, scientific fiasco

By Richard Just, MD

One of my favorite writers on medical subjects is fellow ASCO colleague George W. Sledge, Jr., M.D.  I make it a point to read his essays in Oncology Times as they are always informative and well written.  One that caught my eye appeared on May 25, 2012 entitled “Fraud, Poor Ingredients, and Shortcuts in Cancer Research.”  Also in that issue is an article by Wendy S. Harpham, M.D. called “Scientific Fiasco.”  Whoa!!  Worth a second look. 

The three examples of fraud cited by Dr. Sledge all involved deliberate falsification of data and elaborate attempts to cover up deceit.  In fact, they could have been the basis for episodes of “Law and Order.”  Interestingly, these examples all occurred at respected academic institutions:  the University of Montreal in Canada, the University of Witwatersrand in Johannesburg, South Africa, and Duke University in North Carolina.  The most severe consequences to patients occurred in the South African example.  A toxic and sometimes lethal treatment (high dose chemotherapy + bone marrow or stem cell infusion) was given to women with breast cancer who should have received less toxic standard chemotherapy.  The toll in injuries and deaths that resulted was enormous.  The other two cases also impacted highly respected research institutions: the National Surgical Adjuvant Breast Project or NSABP was closed down for two years pending audit of all their trials, and Duke had to repay all grant money given to the researcher and suffered severe damage to its reputation.  Sad, but fraud and greed are an international phenomena, even in the field of cancer research.

As Dr. Sledge states:

My major concern with fraud is how long it takes us to catch on.

How can we prevent these atrocities from occurring? One would think that our peer-review process would be a good place to start. But as Dario Maestripieri explains in his work,  Games Primates Play, as cited in Dr. Harpham’s article, academic politics get in the way. Because of the need to “publish or perish”, some reviewers will review anonymously in order to trash the competition to give themselves an inside track. Obviously, when there is transparency and all reviewers are named, the review is less likely to be slanted and more likely to be honest and fair. Even more insidious and dangerous is when researchers and others in the industry of cancer research take shortcuts.  Basic sloppiness is responsible for the epidemic of retractions of published papers when initial reports cannot be validated in different labs or institutions.  The system encourages “getting published first rather than getting the science right.”  This type of behavior is unfortunately common. Again, it is sad that this takes place in an area that is supposed to be concentrating on the health and safety of human beings.

The issue of faulty cell cultures and contamination of tissue samples, which I’ve written about in previous blogs, result in poor ingredients.  An extensive article in Wired Magazine a few years back documents how antiquated our tissue storage techniques are, and that a high percentage of specimens are no longer suitable for research purposes when needed.  The entire field of Individualized or Personalized Oncology (indeed Medicine in general) depends on viable tissue specimens that may require storage for long periods of time in tissue banks.  A related issue is actual contamination of cell cultures by HeLa cells, highly malignant and rapidly growing cervical cancer cells.   All this leads to inaccurate results and slows progress in the field.

The committee at each institution responsible for overseeing the conduct of clinical and laboratory research is the Investigational Review Board (IRB) or Committee (IRC). This is where the peer review process for research occurs.  I have been Chairman of our IRC for the last 24 years.  Clinical Research has become a complex industry, both scientifically and administratively, during this time period.  As a result, our IRC’s workload and responsibilities have increased dramatically.  It’s easy to see where items can “fall through the cracks.”  Since our charge is to protect the safety of research patients, eternal vigilance is mandatory.

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.