The importance of facts in science: the Black Swan Research Initiative search for the cure moves ahead
The IMF’s Black Swan Research Initiative® took a major step forward this week in its mission to achieve a cure for myeloma. A study published in the journal Leukemia definitively establishes Next Generation Flow (NGF) as a highly sensitive, fully standardized approach for Minimal Residual Disease (MRD) detection in myeloma. This method, the study’s authors write, “overcomes the major limitations of conventional flow-MRD methods and is ready for implementation in routine diagnostics.”
Why is the establishment of NGF, one of the dozens of BSRI-funded projects around the world, a critical tool in the Black Swan approach to finding a cure?
The ability to precisely measure remaining myeloma cells after treatment allows us to accomplish several important things as never before: evaluate the effectiveness of myeloma therapy; prescribe better therapies, and avoid over-treatment of patients. And, importantly, NGF will be available at medical centers around the world and provide same-day results.
All of this is good news for patients!
The importance of facts
The success of this key BSRI project beautifully illustrates the urgency for scientific rigor and fact—not only in attempting to cure myeloma but also for keeping our planet and all of humanity safe and healthy.
The renowned philosopher and scientist Karl R. Popper used black and white swans to illustrate his proposed “Logic of Scientific Discovery.” He suggested testing the fact or theory that “all swans are white.” Until the end of the 1600s, Europeans were pretty convinced that all swans were white. Then in 1697, the Dutch explorer, Willem de Vlamingh, reported the discovery of black swans in Australia. With this single observation, this fact or theory that “all swans are white” was disproved: what was called by Popper “falsifiable.” Using this technique, it is possible to achieve rapid, definitive research results.
The Black Swan approach
In the BSRI project, we ask questions that are answerable in this fashion and, using the Black Swan investment strategy, we test multiple ideas at the same time to further speed up progress. For MRD testing, the first question was “Can we develop a bone-marrow test to detect very low levels of myeloma cells: one in a million cells?” The answer to that question is yes.
This leads us to the next key questions in our global, collaborative research:
· If MRD is negative, that is, no myeloma cells are detected at a level of one in a million, is this a cure?
The answer is no. Some patients, especially with higher-risk disease, can develop relapse/recurrence/progression. In which case, we need to apply an alternate approach.
· What if a good-risk patient is MRD negative (no myeloma detected)?
The answer is that if the test remains negative at 1, 3 and 5 years, excellent outcomes are expected.
· Are patients with excellent outcomes always MRD negative?
No. Some patients studied at 5, 10, 20 years and beyond clearly have residual disease, and yet are doing well.
· If an MRD test is positive, is it possible to tell if the outcome will nonetheless be excellent or not?
We think the answer to this question will be yes—but this is a currently active “theory” to establish a fact. A BSRI project is studying MRD-positive patients to identify those patients who have stable, benign disease (MGUS-like) as opposed to active myeloma.
The value of evidence
The relative truth of “facts” and “alternative facts” is so much in the news of late, how is one to judge? The example I gave last week was:
· Is real food safe and healthy?
Answer: Yes. There are no reports of negative impacts of eating real food.
· “Is processed food safe and healthy?”
Answer: No. There are innumerable reports of safety and health issues.
This technique can be used to ask other questions, such as:
· Are outcomes affected by access to healthcare coverage and needed drugs?
Yes. The Washington Post estimates the number of people who would be adversely affected by loss of healthcare coverage, citing a study in the New England Journal of Medicine.
· Does water and air pollution affect health outcomes?
Yes. Case in point: the tragedy of the contaminated water supply in Flint, Michigan.
· Are highly drug-resistant, potentially deadly bacteria something for myeloma patients to be concerned about?
Yes. A recent report from the Harvard T.H. Chan School of Public Health and the Broad Institute of MIT and Harvard found a wide variety of resistant bacteria causing disease in four U.S. hospitals. Myeloma patients need to be especially alert about possible infection complications.
Scientists in the U.S. are very keen to stick to the facts. Scientific research moves us forward. To emphasize this point, scientists are planning their own march in Washington. If scientific facts influence the health and wellbeing of citizens, it is essential to support such scientific realities. If you find a black swan, all swans are not white! That is just the way it is! No manner of excuses can change this.
As we strive to move forward to achieve a cure, we are thrilled to have step-wise progress and success moving us ever closer to our goals. We will keep you posted along the road!
Dr. Brian G.M. Durie serves as Chairman of the International Myeloma Foundation and serves on its Scientific Advisory Board. Additionally, he is Chairman of the IMF's International Myeloma Working Group, a consortium of nearly 200 myeloma experts from around the world. Dr. Durie also leads the IMF’s Black Swan Research Initiative®.