Category: Health

In Finding Cure for Ulcers, Marshall Was Not Constrained by the Need to Obtain Approval or Funding

(p. 113) Marshall was a youthful maverick, not bound by traditional theory and not professionally invested in a widely held set of beliefs. There is such a thing as being too much of an insider. Marshall viewed the problem with fresh eyes and was not constrained by the requirement to obtain approval or funding for his pursuits. It is also noteworthy that his work was accomplished not at a high-powered academic ivory tower with teams of investigators but instead far from the prestigious research centers in the Western Hemisphere.
The delay in acceptance of Marshall’s revolutionary hypothesis reflects the tenacity with which long-held concepts are maintained. Vested interests–intellectual, financial, commercial, status–keep these entrenched. Dogmatic believers find themselves under siege by a new set of explanations.

Source:
Meyers, Morton A. Happy Accidents: Serendipity in Modern Medical Breakthroughs. New York: Arcade Publishing, 2007.

Ideas Should Not Be Rejected Just Because They Disagree with Reigning Theory

(p. 107) . . . Claude Bernard, the nineteenth-century founder of experimental medicine, . . . famously said, “If an idea presents itself to us, we must not reject it simply because it does not agree with the logical deductions of a reigning theory.”

Source:
Meyers, Morton A. Happy Accidents: Serendipity in Modern Medical Breakthroughs. New York: Arcade Publishing, 2007.
(Note: ellipses added.)

Fleck Made Two Versions of His Typhus Vaccine: A Worthless Version for the SS Troops and an Effective Version for His Fellow Buchenwald Inmates

(p. C7) Ludwik Fleck (1896-1961), who earned a doctorate at Lwów University while studying under Weigl, also became interested in typhus during World War I, when he too was drafted by Austria-Hungary. Fleck’s specialty was immunology, and in 1919 he joined Weigl’s institute. Somewhere between 1921 and 1923 he crafted a way to diagnose typhus, but despite this achievement, Polish anti-Semitism denied him the academic recognition that his talent merited. During this period, he would occupy government posts (until 1935, when anti-Semitic policies made it impossible for Jews to hold such positions) and, with his wife’s dowry, opened his own laboratory.
By August 1942, Fleck, though confined to Lwów’s Jewish ghetto, managed to create a vaccine from the urine of typhus patients. (Fleck’s vaccine may have been easier to produce than Weigl’s.) Six months later, he was sent to Auschwitz, where he worked in a bacteriological research unit and where he was treated somewhat better than most camp inmates. In December 1943, Fleck was dispatched to the Buchenwald concentration camp to work on a typhus vaccine.
The Germans wanted the Buchenwald typhus-vaccine prisoner unit–some were physicians and scientists, some weren’t–to follow instructions for making a vaccine that had originated at the Pasteur Institute in Paris. It was a convoluted process that involved rabbit lungs and the organs of other animals. The unit’s inmates, including Fleck, who understood immunology better than anyone else at Buchenwald, conspired to produce two kinds of vaccine: large quantities of worthless serum that were shipped to SS troops at the front; and much smaller doses of effective vaccine that were used to secretly immunize prisoners. Their daring sabotage could have led to their execution, of course, but their Nazi overseers in the camp were too medically ignorant to understand what was transpiring. If senior SS officials elsewhere became suspicious, the prisoners would supply the real vaccine for testing by the skeptical parties.

For the full review, see:
HOWARD SCHNEIDER. “The Fever that Gripped Europe.” The Wall Street Journal (Sat., July 19, 2014): C7.
(Note: the online version of the review has the date July 18, 2014, and has the title “Book Review: ‘The Fantastic Laboratory of Dr. Weigl’ by Arthur Allen; Two scientists who worked to beat typhus and sabotage the Nazis.”)

The book being reviewed:
Allen, Arthur. The Fantastic Laboratory of Dr. Weigl: How Two Brave Scientists Battled Typhus and Sabotaged the Nazis. New York: W. W. Norton & Company, 2014.

My dissertation adviser, Stephen Toulmin, recommended a philosophy of science book by Ludwig Fleck that I have owned for several decades, but never gotten around to reading. It is said to anticipate some of the issues discussed by Thomas Kuhn in his classic The Structure of Scientific Revolutions. The Fleck book is:
Fleck, Ludwik. Genesis and Development of a Scientific Fact. pb ed. Chicago, IL: University of Chicago Press, 1981 [first published in German in 1935].

Medical Innovator “Maintained a Healthy Skepticism Toward Accepted Wisdom”

(p. 103) Barry Marshall, a lanky twenty-nine-year-old resident in internal medicine at Warren’s hospital, was assigned to was assigned to gastroenterology for six months as part of his training and was looking for a research project. The eldest son of a welder and a nurse, Marshall grew up in a remote area of Western Australia where self-sufficiency and common sense were essential characteristics. His personal qualities of intelligence, tenacity, open-mindedness, and self-confidence would serve him and Warren well in bringing about a conceptual revolution. Relatively new to gastroenterology, he did not hold a set of well-entrenched beliefs. Marshall could maintain a healthy skepticism toward accepted wisdom. Indeed, the concept that bacteria caused stomach inflammation, and even ulcers, was less alien to him than to most gastroenterologists.

Source:
Meyers, Morton A. Happy Accidents: Serendipity in Modern Medical Breakthroughs. New York: Arcade Publishing, 2007.

“It Is Often Essential to Spot the Exceptions to the Rule”

Baruch Blumberg was awarded the Nobel Prize in 1976:

(p. 98) . . ., Blumberg learned an invaluable lesson: “In research, it is often essential to spot the exceptions to the rule–those cases that do not fit what you perceive as the emerging picture…. Frequently the most interesting findings grow out of the ‘chance’ or unanticipated results.”

Source:
Meyers, Morton A. Happy Accidents: Serendipity in Modern Medical Breakthroughs. New York: Arcade Publishing, 2007.
(Note: ellipsis added.)

Variable Gene Expression Gives Us “Surprising Resilience”

(p. 11) As a physician who researches and treats rare genetic disorders, Sharon Moalem, the author of “Inheritance,” sees firsthand how sharply DNA can constrain our lives. Yet “our genes aren’t as fixed and rigid as most of us have been led to believe,” he says, for while genetic defects often create havoc, variable gene expression (our genes’ capacity to respond to the environment with a flexibility only now being fully recognized) can give our bodies and minds surprising resilience. In his new book, Moalem describes riveting dramas emerging from both defective genes and reparative epigenetics.
. . .
Moalem’s earthy, patient-focused account reminds us that whatever its promise, genetics yet stands at a humble place.

For the full review, see:
DAVID DOBBS. “The Fault in Our DNA.” The New York Times Book Review (Sun., July 13, 2014): 11.
(Note: ellipsis added.)
(Note: the online version of the review has the date July 10, 2014.)

Book under review:
Moalem, Sharon. Inheritance: How Our Genes Change Our Lives–and Our Lives Change Our Genes. New York: Grand Central Publishing, 2014.

Why Did Waksman Not Pursue the Streptomycin Antibiotic?

What did Waksman lack to pursue the streptomycin antibiotic sooner? Enough independent funding? Alertness? Enough desire to make a ding in the universe? Enough unhappiness about unnecessary death? Willingness to embrace the hard work of embracing dissonant facts?

(p. 83) Waksman missed several opportunities to make the great discovery earlier in his career, but his single-mindedness did not allow for, in Salvador Luria’s phrase, “the chance observation falling on the receptive eye.” In 1975 Waksman recalled that he first brushed past an antibiotic as early as 1923 when he observed that “certain actinomycetes produce substances toxic to bacteria” since it can be noted at times that “around an actinomycetes colony upon a plate a zone is formed free from fungous and bacterial growth.” In 1935 Chester Rhines, a graduate student of Waksman’s, noticed that tubercle bacilli would not grow in the presence of a soil organism, but Waksman did not think that this lead was worth pursuing: “In the scientific climate of the time, the result did not suggest any practical application for treatment of tuberculosis.” The same year, Waksman’s friend Fred Beau-dette, the poultry pathologist at Rutgers, brought him an agar tube with a culture of tubercle bacilli killed by a contaminant fungus growing on top of them. Again, Waksman was not interested: “I was not moved to jump to the logical conclusion and direct my efforts accordingly…. My major interest at that time was the subject of organic matter decomposition and the interrelationships among soil micro-organisms responsible for this process.”

Source:
Meyers, Morton A. Happy Accidents: Serendipity in Modern Medical Breakthroughs. New York: Arcade Publishing, 2007.
(Note: ellipsis in original.)

Feds Protect Us from Baby Photos

(p. 1) Pictures of smiling babies crowd a bulletin board in a doctor’s office in Midtown Manhattan, in a collage familiar to anyone who has given birth. But the women coming in to have babies of their own cannot see them. They have been moved to a private part of the office, replaced in the corridors with abstract art.
“I’ve had patients ask me, ‘Where’s your baby board?’ ” said Dr. Mark V. Sauer, the director of the office, which is affiliated with Columbia University Medical Center. “We just tell them the truth, which is that we no longer post them because of concerns over privacy.”
For generations, obstetricians and midwives across America have proudly posted photographs of the babies they have delivered on their office walls. But this pre-digital form of social media is gradually going the way of cigars in the waiting room, because of the federal patient privacy law known as Hipaa.
Under the law, the Health Insurance Portability and Accountability Act, baby photos are a type of protected health information, no less than a medical chart, birth date or Social Security number, according to the Department of Health and Human Services. Even if a parent sends in the photo, it is considered private unless the parent also sends written authorization for its posting, which almost no one does.

For the full story, see:
ANEMONA HARTOCOLLIS. “Baby Pictures at the Doctor’s? Cute, Sure, but Illegal.” The New York Times, First Section (Sun., AUG. 10, 2014): 1 & 19.
(Note: the online version of the story has the date AUG. 9, 2014.)

Cancer Will Likely Be Cured by “Lone Wolves, Awkward Individualists, Nonconformists”

Morton Meyers quotes Ernst Chain, who received the Nobel Prize in 1945, along with Fleming and Florey, for developing penicillin:

(p. 81) But do not let us fall victims of the naive illusion that problems like cancer, mental illness, degeneration or old age… can be solved by bulldozer organizational methods, such as were used in the Manhattan Project. In the latter, we had the geniuses whose basic discoveries made its development possible, the Curies, the Rutherfords, the Einsteins, the Niels Bohrs and many others; in the biologic field… these geniuses have not yet appeared…. No mass attack will replace them…. When they do appear, it is our job to recognize them and give them the opportunities to develop their talents, which is not an easy task, for they are bound to be lone wolves, awkward individualists, nonconformists, and they will not very well fit into any established organization.

Source:
Meyers, Morton A. Happy Accidents: Serendipity in Modern Medical Breakthroughs. New York: Arcade Publishing, 2007.
(Note: ellipses in original.)

For Health Entrepreneurs “the Regulatory Burden in the U.S. Is So High”

(p. A11) Yo is a smartphone app. MelaFind is a medical device. Yo sends one meaningless message: “Yo!” MelaFind tells you: “biopsy this and don’t biopsy that.” MelaFind saves lives. Yo does not. Guess which firm found it easier to put their product in consumers hands?
. . .
In January 2010, Jeffrey Shuren, a veteran FDA official, was appointed director of the FDA’s Center for Devices and Radiological Health, the division responsible for evaluating MelaFind. Dr. Shuren, Dr. Gulfo writes, had “a reputation for being somewhat anti-industry” and “an aggressive agenda to completely revamp the device approval process.” Thus in March MELA Sciences was issued something called a “Not Approvable letter” raising various questions about MelaFind.
. . .
The letter sent the author into survival mode. He battled the FDA, calmed investors, and defended against the lawsuit all while trying to keep the company afloat. Under stress, Dr. Gulfo’s health began to decline: He lost 29 pounds, his hair began to fall out, and the pain in his gut became so intense he needed an endoscopy.
. . .
The climax to this medical thriller comes when, in “the greatest 15 minutes of [his] life,” Dr. Gulfo delivers an impassioned speech, à la “Twelve Angry Men,” to the FDA’s advisory committee. The committee voted for approval, 8 to 7, and, perhaps with the congressional hearing in mind, the FDA approved MelaFind in September 2011.
It was a major triumph for the company, but Dr. Gulfo was beat. He retired from the company in June 2013– . . .
. . .
Google’s Sergey Brin recently said that he didn’t want to be a health entrepreneur because “It’s just a painful business to be in . . . the regulatory burden in the U.S. is so high that I think it would dissuade a lot of entrepreneurs.” Mr. Brin won’t find anything in Dr. Gulfo’s book to persuade him otherwise. Until we get our regulatory system in order, expect a lot more Yo’s and not enough life-saving innovations.

For the full review, see:
ALEX TABARROK. “BOOKSHELF; It’s Broke. Fix It. MelaFind’s breakthrough optical technology promised earlier, more accurate detection of melanoma. Then the FDA got involved.” The Wall Street Journal (Tues., Aug. 12, 2014): A11.
(Note: ellipses added, except for the one internal to the final paragraph, which is in the original.)
(Note: the online version of the review has the date Aug. 11, 2014, and has the title “BOOKSHELF; Book Review: ‘Innovation Breakdown’ by Joseph V. Gulfo; MelaFind’s breakthrough optical technology promised earlier, more accurate detection of melanoma. Then the FDA got involved.”)

The book under review is:
Gulfo, Joseph V. Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances. Franklin, TN: Post Hill Press, 2014.

Funding Policies Constrain or Enable Serendipitous Discoveries

(p. xiv) Casting a critical eye on the way in which our society spends its research dollars, Happy Accidents offers new benchmarks for deciding how to spend future research funds. We as a society need to take steps to foster the kind of creative, curiosity-driven research that will certainly result in more lifesaving medical breakthroughs. Fostering an openness to serendipity has the potential to accelerate medical discovery as never before.

Source:
Meyers, Morton A. Happy Accidents: Serendipity in Modern Medical Breakthroughs. New York: Arcade Publishing, 2007.
(Note: italics in original.)