One of my favorite writers on medical subjects is fellow ASCO colleague George W. Sledge, Jr., MD. 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, MD, 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."
Tthese 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 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.
This post by Richard Just, MD, ACP Member, originally appeared at JustOncology.com, a joint publication of Richard Just, MD, aka @chemosabe1 on Twitter and Gregg Masters, MPH, aka @2healthguru on Twitter. Dr. Just has 36 years in clinical practice of hematology and medical oncology.