One of the best books I have read in recent times is The Emperor of All Maladies by the talented Siddhartha Mukherjee. Mukherjee won the 2011 Pulitzer Prize for this book. The book is a detailed history of Cancer and humanity’s battle with it. Amongst many things that piqued my interest, was one of the quotes I had heard attributed to Dr. Deming – In God we trust, all others must bring data.
To tell this story, I must first talk about William S. Halsted. Halsted was a very famous surgeon from John Hopkins who came up with the surgical procedure known as the “Radical Mastectomy” in the 1880’s. This is a procedure to remove the breast, the underlying muscles and attached lymph nodes to treat breast cancer. He hypothesized that the breast cancer spreads centrifugally from the breast to other areas. Thus, the removal of the breast, underlying muscles and lymph nodes would prevent the spread of cancer. He called this the “centrifugal theory”. Halsted called this procedure as “radical” to notate that the roots of the cancer are removed. Mukherjee wrote in his book that the intent of radical mastectomy was to arrest the centrifugal spread by cutting every piece of it out of the body. Physicians all across America identified the Radical Mastectomy as the best way to treat breast cancer. The centrifugal theory became the paradigm for breast cancer treatment for almost a century.
There were skeptics of this theory. The strongest critics of this theory were Geoffrey Keynes, a London based surgeon in the 1920s, and George Barney Crile, an American surgeon who started his career in the 1950s. They noted that even with the procedures that Halsted had performed, many patients died within four or five years from metastasis (cancer spreading to different organs). The surgeons overlooked these flaws, as they were firm believers in the Radical Mastectomy. Daniel Dennett, the famous American Philosopher, talks about the concept of Occam’s Broom, which might explain the thinking process for ignoring the flaws in a hypothesis. When there is a strong acceptance of a hypothesis, any contradicting information may get swept under the rug with Occam’s Broom. The contradictory information gets ignored and not confronted.
Keynes was even able to perform a local surgery of the breast and together with radiation treatment achieve some success. But Halsted’s followers in America ridiculed this approach, and came up with the name “lumpectomy” to call the local surgery. In their minds, the surgeon was simply removing “just” a lump, and this did not make much sense. They were aligning themselves with the paradigm of Radical Mastectomy. In fact, some of the surgeons even went further to come up with “superradical” and “ultraradical” procedures that were morbidly disfiguring procedures where the breast, underlying muscles, axillary nodes, the chest wall, and occasionally the ribs, part of the sternum, the clavicle and the lymph nodes inside the chest were removed. The idea of “more was better” became prevalent.
Another paradigm with clinical studies during that time was trying to look only for positive results – is treatment A better than treatment B? However, this approach did not show that treatment A was no better than treatment B. Two statisticians, Jerry Neyman and Egon Pearson, changed the approach with their idea of using the statistical concept of power. The sample size for a study should be based on the power calculated. Loosely stated, more independent samples mean higher power. Thus, with a large sample size of randomized trials, one can make a claim of “lack of benefit” from a treatment. The Halsted procedure did not get challenged for a long time because the surgeons were not willing to take part in a large sample size study.
A Philadelphia surgeon named Dr. Bernard Fisher was finally able to shift this paradigm in the 1980s. Fisher found no reason to believe in the centrifugal theory. He studied the cases put forth by Keynes and Crile. He concluded that he needed to perform a controlled clinical trial to test the Radical Mastectomy against Simple Mastectomy and Lumpectomy with radiation. The opposition from the surgeons slowly shifted with the strong advocacy from the women who wanted a less invasive treatment. Mukherjee cites the Thalidomide tragedy, the Roe vs Wade case, along with the strong exhortation from Crile to women to refuse to submit to a Radical Mastectomy, and the public attention swirling around breast cancer for the slow shift in the paradigm. Fisher was finally able to complete the study, after ten long years. Fisher stated that he was willing to have faith in divine wisdom but not in Halsted as divine wisdom. Fisher brusquely told a journalist – “In God we trust. All other must have data.”
The results of the study proved that all three cases were statistically identical. The group treated with Radical Mastectomy however paid heavily from the procedure but had no real benefits in survival, recurrence or mortality. The paradigm of Radical Mastectomy shifted and made way to better approaches and theories.
While I was researching this further, I found that the quote “In God we trust…” was attributed to another Dr. Fisher. Dr. Edwin Fisher, brother of Dr. Bernard Fisher, when he appeared before the Subcommittee on Tobacco of the Committee on Agriculture, House of Representatives, Ninety-fifth Congress, Second Session, on September 7, 1978. As part of presentation Dr. Fisher said – “I should like to close by citing a well-recognized cliche in scientific circles. The cliche is, “In God we trust, others must provide data.“ This is recorded in “Effect of Smoking on Nonsmokers. Hearing Before the Subcommittee on Tobacco of the Committee on Agriculture House of Representatives. Ninety-fifth Congress, Second Session, September 7, 1978. Serial Number 95-000”. Dr. Edwin Fisher unfortunately was not a supporter of the hypothesis that smoking is bad for a non-smoker. He even cited that people traveling on an airplane are more bothered by crying babies than the smoke from the smokers.
This past year, I was personally affected by a family member suffering from the scourge of breast cancer. During this period of Thanksgiving in America, I am thankful for the doctors and staff who facilitated her recovery. I am thankful for the doctors and experts in the medical field who were courageous to challenge the “norms” of the day for treating breast cancer. I am thankful for the paradigm shift(s) that brought better and effective treatments for breast cancer. More is not always better! I am thankful for them for not accepting a hypothesis based on just rationalism, an intuition on how things might be working. I am thankful for all the wonderful doctors and staff out there who take great care in treating all cancer patients.
I am also intrigued to find the quote of “In God we trust…” used with the statement that smoking may not have a negative impact on non-smokers.
I will finish with a story of another paradigm shift from Joel Barker in The Business of Paradigms.
A couple of Swiss watchmakers in Centre Electronique Horloger (CEH) in Neuchâtel, Switzerland, developed the first Quartz based watch. They went to different Swiss watchmakers with the technology that would later revolutionize the watch industry. However, the paradigm at that time was the intricate Swiss watch making process with gears and springs. No Swiss Watch company was interested in this new technology which did not rely on gears or springs for keeping time. The Swiss watchmakers with the new idea then went to a Clock convention and set up a booth to demonstrate their new idea. Again, no Swiss watch company was interested in what they had to offer. Two representatives, one from the Japanese company Seiko, and the other from Texas Instruments took notice of the new technology. They purchased the patents and as they say – the rest is history. The new paradigm then became Quartz watches. The Swiss, who were on the top of watch making with over 50% of the watch market in the 1970s, stepped aside for the Quartz watch revolution marking the decline of their industry. This was later termed as the Quartz Revolution.
Always keep on learning…
In case you missed it, my last post was The Best Attribute to Have at the Gemba: