Month: March 2016

After Wife’s Cancer, F.D.A. Regulator Cuts Decision Time from Six to Five Months (Beyond Years Spent Testing)

(p. 1) BETHESDA, Md. — Mary Pazdur had exhausted the usual drugs for ovarian cancer, and with her tumors growing and her condition deteriorating, her last hope seemed to be an experimental compound that had yet to be approved by federal regulators.
So she appealed to the Food and Drug Administration, whose oncology chief for the last 16 years, Dr. Richard Pazdur, has been a man denounced by many cancer patient advocates as a slow, obstructionist bureaucrat.
He was also Mary’s husband.
In her struggle with cancer and ultimately her death in November, Ms. Pazdur had a part, her husband and a number of cancer specialists now say, in a profound change at the F.D.A.: a speeding up of the drug approval process. Ms. Pazdur’s three-year battle with cancer was a factor, they say, in Dr. Pazdur’s willingness to swiftly approve risky new treatments and passion to fight the disease that patient advocates thought he lacked.
. . .
(p. 13) Certainly there has been a change at the powerful agency. Since Ms. Pazdur learned she had ovarian cancer in 2012, approvals for drugs have been faster than at any time in the F.D.A.’s modern history. Although companies go through a yearslong discovery and testing process with new drugs before filing a formal application with the F.D.A., the average decision time on drugs by Dr. Pazdur’s oncology group has come down to five months from six months. That is a major acceleration in a pharmaceutical industry where every month’s delay can mean thousands of lives lost and sometimes hundreds of millions of dollars in sales that, given limited patent times, can never be recovered.
When asked specifically how his wife’s illness had changed his work at the F.D.A., Dr. Pazdur said he was intent on making decisions more quickly.
“I have a much greater sense of urgency these days,” Dr. Pazdur, 63, said in an interview. “I have been on a jihad to streamline the review process and get things out the door faster. I have evolved from regulator to regulator-advocate.”

For the full story, see:
GARDINER HARRIS. “A Wife’s Cancer Prods the F.D.A.” The New York Times, First Section (Sun., JAN. 3, 2016): 1 & 13.
(Note: ellipsis added.)
(Note: the online version of the story has the date JAN. 2, 2016, and has the title “F.D.A. Regulator, Widowed by Cancer, Helps Speed Drug Approval.”)

Slower World of Narrative Leads to Analogies, Comparisons and Understanding

(p. A25) As the neuroscientist Susan Greenfield writes in her book “Mind Change,” expert online gamers have a great capacity for short-term memory, to process multiple objects simultaneously, to switch flexibly between tasks and to quickly process rapidly presented information.
. . .
Research at the University of Oslo and elsewhere suggests that people read a printed page differently than they read off a screen. They are more linear, more intentional, less likely to multitask or browse for keywords.
The slowness of solitary reading or thinking means you are not as concerned with each individual piece of data. You’re more concerned with how different pieces of data fit together. How does this relate to that? You’re concerned with the narrative shape, the synthesizing theory or the overall context. You have time to see how one thing layers onto another, producing mixed emotions, ironies and paradoxes. You have time to lose yourself in another’s complex environment.
As Greenfield puts it, “by observing what happens, by following the linear path of a story, we can convert information into knowledge in a way that emphasizing fast response and constant stimulation cannot. As I see it, the key issue is narrative.”
When people in this slower world gather to try to understand connections and context, they gravitate toward a different set of questions. These questions are less about sensation than about meaning. They argue about how events unfold and how context influences behavior. They are more likely to make moral evaluations. They want to know where it is all headed and what are the ultimate ends.
Crystallized intelligence is the ability to use experience, knowledge and the products of lifelong education that have been stored in long-term memory. It is the ability to make analogies and comparisons about things you have studied before. Crystallized intelligence accumulates over the years and leads ultimately to understanding and wisdom.

For the full commentary, see:
David Brooks. “Building Attention Span.” The New York Times (Fri., JULY 10, 2015): A25.
(Note: ellipsis added.)

The book discussed in the commentary, is:
Greenfield, Susan. Mind Change: How Digital Technologies Are Leaving Their Mark on Our Brains. New York: Random House, 2015.

The “Freedom” of Soviet Cinema

(p. A13) In the world we live in–and the system we’ve created for ourselves, in terms of it’s a big industry–you cannot lose money. So the point is that you’re forced to make a particular kind of movie. And I used to say this all the time, with people, you know, back when Russia was the Union of Soviet Socialist Republics, and they’d say, “Oh, but aren’t you so glad that you’re in America?” And I’d say, well, I know a lot of Russian filmmakers and they have a lot more freedom than I have. All they have to do is be careful about criticizing the government. Otherwise, they can do anything they want.

George Lucas, from an interview with Charlie Rose, as quoted in:
“Notable & Quotable: George Lucas and Soviet Cinema.” The Wall Street Journal (Mon., Jan. 4, 2016): A13.
(Note: the online version of the commentary has the date Jan. 3, 2016.)

Compare what Lucas says, with the following:

(p. 164) Auteur cinema encountered difficulties in the and 1970s, partly because its poetic language remained inaccessible for the masses and made no considerable win at the box office, and partly because its symbolism was often feared to lead (p. 165) astray Soviet cinema’s political agenda. Sometimes international pressure or support could mean that film was released for screenings, while it remained undistributed or in low distribution at home. This applies to films of the leading auteurs of the period: Andrei Tarkovsky, whose Andrei Rublev was delayed for several years; Alexei Gherman, whose Trial on the Roads was banned; Alexander Sokurov, whose films were stopped during production (Anaesthesia Dolorosa); and Kira Muratova, who had two films banned and was prevented from working as director until the 1980s.

Auteur cinema, which emphasized the artistic impulse, in sharp contrast to socialist principle and was condemned, even with hindsight, by Sergei Gerasimov in 1988: ‘They [the auteur filmmakers] want to preach like a genius, a messiah. That is a position that is compatible with our communist ethics.’

Source:
Beumers, Birgit. A History of Russian Cinema. Oxford, UK: Berg, 2009.
(Note: bracketed phrase in original.)

Federal Regulations Restrict Concrete Innovation

(p. B1) Chris Tuan, a professor of civil engineering for the University of Nebraska at the Peter Kiewit Institute, has been perfecting an electrically semiconductive concrete over the past 20 years.
The mixture includes a 20 percent mix of steel fibers, shavings and carbon added to a traditional concrete mix. Steel reinforcing bars serve as the conductor, and once electricity is added, the concrete heats to 35 to 40 degrees — just enough to melt the ice and snow.
. . .
For now, the concrete can’t be used in public spaces. Anything exposed and electrified above 48 volts — much less than the 208 volts used in Tuan’s concrete — is considered high voltage and is not allowed. Federal law will have to be rewritten to change that.
. . .
Tuan said traditional concrete needs to be replaced every five years or so. Without chemical use, the electric concrete lasts much longer, with fewer potholes. His concrete is also maintenance-free, because the power cords and conductive rods are encased in the concrete and not exposed to the elements.
. . .
In 2013 Tuan also implemented his concrete on ramps in China. He recently installed a private driveway in Regency using the legally allowed 48-volt limit, which is less energy efficient.
“If the government or if insurance agencies approve this technology, then everybody can use it,” Tuan said. “But right now, it’s almost cost prohibitive.”

For the full story, see:
Reece Ristau. “In Concrete World, This Is Hot Stuff.” Omaha World-Herald (Tues., JAN. 15, 2016): B1 & B2.
(Note: ellipses added.)
(Note: the online version of the story has the title “Special Concrete Mix Can Melt Snow and Ice All by Itself — Just Add Electricity.”)

The Use of Virtual Reality (VR) in Education and Training

(p. B5) The thing that’s especially difficult to convey about “room-scale” VR–the kind enabled by the HTC Vive, where you can actually walk around with a headset on, exploring a virtual environment in exactly the same way you would experience a real one–is just how compelling it is. “Any VR experience is so much more engrossing than any you’d have on a flat screen,” says Patrick Hackett, senior user interface designer at Google for the Google Cardboard VR headset.
That has potentially huge implications for education.
Amir Rubin, head of VR software company Sixense, is working with a client on a system to train thousands of technicians to decommission nuclear-power plants. “Any application that has high liability, where teaching students has a high cost of insurance, and is high risk, we’re seeing people ask for VR training,” says Mr. Rubin. At Stanford, Dr. Bailenson is taking students on virtual tours of the world’s great works of art–letting them clamber over and deeply experience, for example, Michelangelo’s “David.”

For the full commentary, see:
CHRISTOPHER MIMS. “Virtual Reality Isn’t Just About Games.” The Wall Street Journal (Mon., Aug. 3, 2015): B1 & B5.
(Note: the online version of the commentary has the date Aug. 2, 2015.)

The Value of Longer Life

(p. C6) With the seeker’s restlessness that seems not to have left him until his last breath, . . . [Dr. Paul Kalanthi accrued] two B.A.s and an M.A. in literature at Stanford, then a Master of Philosophy at Cambridge, before graduating cum laude from the Yale School of Medicine. He returned to Stanford for a residency in neurological surgery and a postdoctoral fellowship in neuroscience. His training was almost complete when the bad diagnosis hit.
. . .
And then everything changes. In a single moment of recognition, everything Dr. Kalanithi has imagined for himself and his wife evaporates, and a new future has to be imagined.
. . . A job at Stanford for which he was the prime candidate? Not happening. Another good job that would require the Kalanithis to move to Wisconsin? Too far from his oncologist. Long-term plans of any kind? Well, what does long-term mean now? Does he have a day, a month, a year, six years, what? He’s heard the advice about living one day at a time, but what’s he supposed to do with that day when he doesn’t know how many others remain?

For the full review, see:
JANET MASLIN. “Books of The Times; Singularly Striving Until Life Steps In.”The New York Times (Tues., July 7, 2015): C1 & C6.
(Note: ellipses, and bracketed words, added.)
(Note: the online version of the review has the date July 6, 2015, and has the title “Books of The Times; Review: In ‘When Breath Becomes Air,’ Dr. Paul Kalanithi Confronts an Early Death.”)

The book under review, is:
Kalanithi, Paul. When Breath Becomes Air. New York: Random House, 2016.

Ethanol Adds Carbon Dioxide to Atmosphere

(p. A9) Before long, it may be politically safe to take a wise step and eliminate the Renewable Fuel Standard (RFS).
. . .
Today, ethanol’s downsides have become clear.
First, it increases the cost of driving. Current ethanol blends provide fewer miles per gallon, so drivers pay more to travel the same distance. According to the Institute for Energy Research, American drivers have paid an additional $83 billion since 2007 because of the RFS.
Second, ethanol adds more carbon dioxide to the atmosphere than it eliminates by replacing fossil fuels. The Environmental Working Group says that “corn ethanol is an environmental disaster.” The group explains: “The mandate to blend ethanol into gasoline has driven farmers to plow up land to plant corn–40 percent of the corn now grown in the U.S. is used to make ethanol. When farmers plow up grasslands and wetlands to grow corn, they release the carbon stored in the soil, contributing to climate-warming carbon emissions.” And then there is the carbon emitted in harvesting, transporting and processing the corn into ethanol.

For the full commentary, see:
MERRILL MATTHEWS. “The Corn-Fed Albatross Called Ethanol.” The Wall Street Journal (Weds., Jan. 6, 2016): A9.
(Note: ellipsis added.)
(Note: the online version of the commentary has the date Jan. 5, 2016.)

Locally Sourced Chipotle’s Swift, Severe and Surprising Fall from Grace

(p. B1) Chipotle emphasizes fresh, locally sourced ingredients. It was the first major chain to reject genetically modified food. Chipotle has embodied the notion of doing well by doing good.
So it may not be too surprising that its fall from grace has been swift and severe.
Since July, when five customers became ill with the E. coli bacterium after eating at a Chipotle restaurant in Seattle — the first food-borne illness connected to the chain since 2009 — Chipotle has been confronted by a rash of outbreaks. At least six incidents have occurred over the last six months.
“I’ve been involved in every food-borne illness outbreak, small and large, since 1993,” said Bill Marler, a Seattle-based lawyer who specializes in representing victims of food-borne illnesses and has filed several recent cases against Chipotle. “I can’t think of any chain, restaurant or food manufacturer who’s ever reported that many outbreaks in just six months. Underlying that has to be a lack of controls.”

For the full story, see:
JAMES B. STEWART. “Common Sense; New Chipotle Mantra: Safe (and Fresh) Food.” The New York Times (Fri., JAN. 15, 2016): B1 & B4.
(Note: the online version of the story has the date JAN. 14, 2016, and has the title “Common Sense; Chipotle’s New Mantra: Safe Food, Not Just Fresh.”)

Japan Population Down a Million in Five Year Period

(p. A12) TOKYO — Japan’s population shrank by nearly a million during the last half-decade, official census figures confirmed on Friday [February 26, 2016], an unprecedented drop for a society not ravaged by war or other deadly crisis, and one that helps explain the country’s persistent economic woes.
It was the first time since Japan began collecting census data in 1920 that a nationwide count recorded a decline in the population, though surveys based on smaller samples have shown a downward trend for years.

For the full story, see:
JONATHAN SOBLE. “Japan Lost Nearly a Million People in 5 Years, Census Says.” The New York Times (Sat., FEB. 27, 2016): A12.
(Note: bracketed date added.)
(Note: the online version of the story has the date FEB. 26, 2016.)

Greek Corruption, Fraud, Evasion and Public Worker Job Security

(p. A11) Mr. Angelos, a former Journal correspondent, travels through Greece as a journalist first, and a native son second, to conduct a mostly unpleasant archaeology. By way of background, however, he first tackles the pervasive issues of disability and pension fraud, rampant tax evasion, and public worker job protections. These are the very problems that Greece’s European lenders sought to remedy through a series of supposedly helpful but also punitive and ineptly administered reforms. Mr. Angelos dismantles the facile narrative accepted by many in the eurozone, in which hardworking Germans must clean up a mess made by their lazy and “Oriental” southern neighbors. But he is equally tenacious when it comes to exposing the misconduct of Greek politicians, not to mention the country’s corrupt system of career tenure and its, well, truly Byzantine bureaucracy.
Mr. Angelos’s book allows us to see how these problems play out, sometimes farcically, in the lives of actual people. There’s a cranky grandmother on the island of Zakynthos who receives generous blindness benefits even though she can see perfectly well. There’s the arrogant former prime minister who accepted millions of euros in bribes to buy useless submarines on behalf of the Greek government.
. . .
. . . the book’s single most flattering portrait is of Yiannis Boutaris, the tattooed, wine-making, freethinking mayor of Thessaloniki, who courts Turkish tourism, refuses to kowtow to the church and publicly acknowledges the crucial role of Jews in the city’s history.

For the full review, see:

CHRISTOPHER BAKKEN. “BOOKSHELF; How Greece Got to ‘No’; On the island of Zakynthos, a grandmother receives generous blindness benefits–even though she can see perfectly well.”The Wall Street Journal (Tues., July 7, 2015): A11.
(Note: ellipses added.)
(Note: the online version of the review has the date July 6, 2015.)

The book under review, is:
Angelos, James. The Full Catastrophe: Travels among the New Greek Ruins. New York: Crown Publishers, 2015.