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~ Musings on health, illness & evidence based medicine

@justOncology

Tag Archives: cancer care

Why Cancer Research Requires Constant Vigilance

14 Tuesday Aug 2012

Posted by @JustOncology in Uncategorized

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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.

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The ‘incident’

My life was essentially on autopilot. My oncology practice was very successful; in fact, too successful. All my time and energy was devoted to keeping pace with the increasing demands of the profession. Other pursuits, be they personal or professional, always seemed to take a back seat. My main unfulfilled passion was writing.

On January 7, 2011, everything changed. I had a new bovine aortic valve and three new coronary artery grafts. A life altering event, to say the least. Fortunately my recovery has been uneventful, and I had no evidence of muscle injury. So I’m extremely grateful for the pre-emptive surgery, and since I’m back to work on a part time basis, I now can devote some of my attention to writing.

For the past several years, a colleague, trusted advisor and friend of mine, Gregg Masters, had been prodding me to “just do it”, i.e., just start blogging, podcasting and life streaming my experiences in Medicine. He pointed out the value of my 36 years in clinical practice of hematology and medical oncology as 'elder wisdom' currency in relative short supply. In truth, there is certainly a lot to write about as the clinical knowledge base has grown enormously, to the point where management of all this information requires computers. Fortunately, technology has developed at a rapid rate also so that we can not only mine all this data to obtain meaningful information, but better disseminate it to each other, health plans (including government) and especially our patients. With the advent of social media including Twitter, Facebook and You Tube, this flow of information becomes a two way street allowing physicians to listen as well as talk. On a personal note, my wife published daily status updates during my surgery and through the post-operative period on a website called Caringbridge. She posted pictures as well as narrative. Colleagues, relatives, friends and patients had a window opened to them as to how I was doing, and they in turn wrote back notes of encouragement that touched me deeply.

When Gregg and I thought about it, his background not only in 'web 2.0' (social media) but perhaps more significantly his considerable experience in the business aspects of medicine brings value into the conversation as well. In today’s environment, physicians are constantly reminded that we not only are responsible for all aspects of caring for patients, but we are running a business as well. Years ago, I remember reading an excellent book called “The E-Myth Physician” by Michael Gerber. One of the chapters was devoted to the subject of “Money”. So Gregg’s knowledge complements my clinical background resulting in the birth of JustOncology.com.

Certainly there is no shortage of topics to discuss. Utilizing a variety of media: blogging (which addresses my passion for writing), audio and visual interviews with as many of the stakeholders in cancer care as possible, we hope to provide a forum for discussion of problems facing us. From these interactions, the desired outcome is to identify solutions that can only come from a collaborative effort.

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About

JustOncology.com is a joint publication of Richard Just, MD, aka @chemosabe1 on Twitter and Gregg Masters, MPH, aka @2healthguru on Twitter.

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