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.)

Curing Cancer Requires Enabling Serendipity, Not a Centrally Planned War

Happy Accidents is a wonderful book on serendipitous discovery that I ran across serendipitously. I had never heard of the author, but was interested in serendipity, so I started to collect books that Amazon says have something to do with serendipity. I let Happy Accidents sit on my shelf for about four years before starting to read.
The author is a retired, distinguished physician. The book is mainly a compendium of cases where major medical advances resulted from chance discoveries. Of course, the discoveries usually required more than just good luck. They usually required that someone was alert to the unexpected, and was willing to work in order to turn the unexpected into a cure. Their efforts are often made all the harder because of resistance from powerful incumbent “experts” and institutions. Often the discoveries go against the current theory, and are discovered by underfunded marginal outsiders.
Meyers points out that the centrally planned War on Cancer has cost the taxpayer a lot of money, and has largely failed to achieve its intended and predicted results. The reason is that you cannot centrally plan serendipity.
During the next several weeks, I will be quoting some of Meyers’ more revealing examples or thought-provoking comments.

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

Drugs May Rebuild Muscle in Frail Elderly

(p. B1) In 1997, scientist Se-Jin Lee genetically engineered “Mighty Mice” with twice as much muscle as regular rodents. Now, pharmaceutical companies are using his discovery to make drugs that could help elderly patients walk again and rebuild muscle in a range of diseases.
. . .
“I am very optimistic about these new drugs,” says Dr. Lee, a professor of molecular biology at Johns Hopkins University in Baltimore, who isn’t involved in any of the drug trials. “The fact that they’re so far along means to me they must have seen effects.”
Myostatin is a naturally occurring protein that curbs muscle growth. The drugs act by blocking it, or blocking the sites where it is detected in the body, potentially rebuilding muscle.

For the full story, see:
HESTER PLUMRIDGE and MARTA FALCONI. “Drugs Aim to Treat Frailty in Aging.” The Wall Street Journal (Mon., April 28, 2014): B1-B2.
(Note: ellipsis added.)
(Note: the second paragraph quoted above is divided into two mini-paragraphs in the online, but not in the print, version.)
(Note: the online version of the story has the date April 27, 2014, and has the title “Drugs Aim to Help Elderly Rebuild Muscle.”)

3.2 Million Waiting for Care Under England’s Single-Payer Socialized Medicine

(p. A13) . . . even as the single-payer system remains the ideal for many on the left, it’s worth examining how Britain’s NHS, established in 1948, is faring. The answer: badly. NHS England–a government body that receives about £100 billion a year from the Department of Health to run England’s health-care system–reported this month that its hospital waiting lists soared to their highest point since 2006, with 3.2 million patients waiting for treatment after diagnosis. NHS England figures for July 2013 show that 508,555 people in London alone were waiting for operations or other treatments–the highest total for at least five years.
Even cancer patients have to wait: According to a June report by NHS England, more than 15% of patients referred by their general practitioner for “urgent” treatment after being diagnosed with suspected cancer waited more than 62 days–two full months–to begin their first definitive treatment.
. . .
The socialized-medicine model is struggling elsewhere in Europe as well. Even in Sweden, often heralded as the paradigm of a successful welfare state, months-long wait times for treatment routinely available in the U.S. have been widely documented.
To fix the problem, the Swedish government has aggressively introduced private-market forces into health care to improve access, quality and choices. Municipal governments have increased spending on private-care contracts by 50% in the past decade, according to Näringslivets Ekonomifakta, part of the Confederation of Swedish Enterprise, a Swedish employers’ association.

For the commentary, see:
SCOTT W. ATLAS. “OPINION; Where ObamaCare Is Going; The government single-payer model that liberals aspire to for the U.S. is increasingly in trouble around the world.” The Wall Street Journal (Thur., Aug. 14, 2014): A13.
(Note: the online version of the commentary has the date Aug. 13, 2014.)