Month: May 2018

Big Pharma Is Mellow about FDA Obstacles to Innovation

It sometimes appears that big pharma is comfortable with the hugely expensive FDA drug approval process. Perhaps big pharma firms have learned how to navigate the process and have the resources to do so. And perhaps the process discourages disruptive innovations from small medical startups that have not learned how to navigate the process, and do not have the resources to do so. If so, then the puzzling indifference of big pharma indicated in the passages quoted below, becomes easier to understand.
(There’s a wonderful recent TV ad from big pharma supporting innovation by quoting the Dylan Thomas poem saying we should “rage, rage against the dying of the light.” If only they really meant it.)

(p. A13) In recent years, the arrival of breakthrough drugs for everything from cancer to rare diseases has led to a surge in the number of patients wanting early access to treatments. The pleas — sometimes driven by viral social media campaigns — have proved vexing for companies that have invested millions to get a drug to market and are wary of doing anything to jeopardize their chances.

Today, companies’ policies on granting early access to drugs are a confusing patchwork that tends to favor affluent and well-connected patients at leading medical centers, who have the resources and know-how to navigate the system.
“You have to be pretty sophisticated,” said Dr. Arthur L. Caplan, a bioethicist at New York University who has been working with companies, including Johnson & Johnson, to develop better early-access programs. But the bill passed this week, he said, “does somewhere between nothing and absolutely nothing to help you.”
The bill’s passage represented a victory for proponents of “right to try,” a campaign championed by Vice President Mike Pence and initiated by the Goldwater Institute, a libertarian think tank that favors limiting the scope of the F.D.A. At least 38 states have passed local versions of right-to-try laws, which allow patients to sidestep F.D.A. approval once they have received permission from a company.
The right-to-try measures are opposed by a broad coalition of groups, which contend the bill will not help patients and will undermine the authority of the primary regulatory agency, the F.D.A. Four former F.D.A. commissioners, including two each from Democratic and Republican administrations, oppose the bills, as do dozens of patient groups, including the American Cancer Society Cancer Action Network and the American Lung Association.
The pharmaceutical industry, while not taking a position on the issue, has been circumspect. A spokesman for its main lobbying group, the Pharmaceutical Research and Manufacturers of America, said on Friday, “We believe any legislation must truly benefit and protect patients and not disrupt the future of clinical trials, U.S. Food and Drug Administration oversight and the research and approval of new medicines.”
. . .
The F.D.A. already approves 99 percent of such applications, and the agency has streamlined the approval process. Drug companies also have many other reasons to bar access — often, companies do not have enough extra product to give to patients, or they worry that the logistical work of granting access could slow efforts to get the drug approved, when it would become available to any patient who needed it.
There is also the possibility that the drug does not work — many experimental products fail in late-stage trials.
. . .
“In our view, the F.D.A. plays a really important role,” Dr. Joanne Waldstreicher, the chief medical officer of Johnson & Johnson, said in an interview Thursday. Johnson & Johnson initiated a program in 2015 that delegates decisions about early access to a program set up by Dr. Caplan. The F.D.A., Dr. Waldstreicher said, has “information that we don’t have necessarily; they see safety and efficacy information on products that may be similar.”

For the full story, see:
KATIE THOMAS. “For Terminally Ill People, a Convoluted Procedure Just to Give Drugs a Try.” The New York Times (Saturday, March 24, 2018): A13.
(Note: ellipses added.)
(Note: the online version of the story has the date March 23, 2018, and has the title “Why Can’t Dying Patients Get the Drugs They Want?”)

“A Litigious, Protective Culture Has Gone Too Far”

(p. A1) SHOEBURYNESS, England — Educators in Britain, after decades spent in a collective effort to minimize risk, are now, cautiously, getting into the business of providing it.
. . .
Limited risks are increasingly cast by experts as an experience essential to childhood development, useful in building resilience and grit.
Outside the Princess Diana Playground in Kensington Gardens in London, which attracts more than a million visitors a year, a placard informs parents that risks have been “intentionally provided, so that your child can develop an appreciation of risk in a controlled play environment rather than taking similar risks in an uncontrolled and unregulated wider world.”
This view is tinged with nostalgia for an earlier Britain, in which children were tougher and more self-reliant. It resonates both with right-wing tabloids, which see it as a corrective to the cosseting of a liberal nanny state; and with progressives, drawn to a freer and more natural childhood.
. . .
(p. A12) Britain is one of a number of countries where educators and regulators say a litigious, protective culture has gone too far, leaching healthy risks out of childhood. Guidelines on play from the government agency that oversees health and safety issues in Britain state that “the goal is not to eliminate risk.”

For the full story, see:
ELLEN BARRY. “In Britain, Learning to Accept Risk, and the Occasional ‘Owie’.” The New York Times, First Section (Sunday, March 11, 2018): A1 & A12.
(Note: ellipses added.)
(Note: the online version of the story has the date MARCH 10, 2018, and has the title “In Britain’s Playgrounds, ‘Bringing in Risk’ to Build Resilience.”)

“Puttin’ On the Ritz”

(p. C9) The Savoy, which opened in 1889, was glamorous and cosmopolitan, an antidote to Victorian stuffiness. Its owner, Richard D’Oyly Carte, the backer of Gilbert and Sullivan’s comic operas, had a theater next door, and his ambition was to create a modern luxury hotel the likes of which had never been seen. To fulfill his vision, in 1890 he turned to Escoffier and the Swiss hotelier Ritz, a man known for his impeccable taste, and in short order the two men, who’d had a previous success at the Grand Hotel in Monte Carlo, made the Savoy into the most famous and profitable hotel and restaurant in the world.
“Ritz & Escoffier,” Luke Barr’s entertaining narrative history, reads like a novel (complete with cliff hangers and descriptions of the characters’ private thoughts). Both of its subjects had grown up poor, but were opposites temperamentally.
. . .
Neither man had to use the stairs at the Savoy, since the hotel had six elevators, the largest ever seen in Europe, which D’Oyly Carte called “ascending rooms.” There were 400 guestrooms and an unheard-of number of bathrooms–67 all told, many en suite and at no extra charge. (The recently opened Hotel Victoria provided just four for 500 guests.) The Savoy also had electric light that you could switch on or off in your room without getting out of bed, also at no extra charge.
. . .
. . ., D’Oyly Carte gave Escoffier and Ritz free rein from the start. The restaurant became enormously popular, a gathering place open to all who could afford it: aristocrats, the nouveau riche, royalty, Jewish bankers and fur traders (Jews weren’t freely accepted in society at the time), and stars of the theater and opera. Formal evening dress was de rigueur in the dining room and women were admitted–except those of “doubtful reputation and uncertain revenue,” who arrived unaccompanied, wearing makeup and large hats. Mr. Barr writes, “An extravagant hat worn in the evening, Ritz had discovered, was a sign of trouble.” But Ritz not only gave ladies’ banquets, he also successfully campaigned to change the laws against eating out on Sundays. Soon those formerly grim at-home evenings of “cold joint and gloom” became the most fashionable times of the week to dine at the Savoy.
. . .
Ritz had opened the hotel’s doors to anyone with money wearing the right clothes. The old social rules were broken. Mr. Barr comments, “Indeed, there was an element of decadence in the Savoy’s brand of luxury–it was this decadence that made it modern, the sense that pleasure was to be celebrated.”

For the full review, see:
Moira Hodgson. “‘Modern Hospitality.” The Wall Street Journal (Saturday, March 31, 2018): C9.
(Note: ellipses added.)
(Note: the online version of the review has the date March 30, 2018, and has the title “‘Ritz & Escoffier’ Review: Modern Hospitality.”)

The book under review, is:
Barr, Luke. Ritz and Escoffier: The Hotelier, the Chef, and the Rise of the Leisure Class. New York: Clarkson Potter, 2018.

Global Warming Most Affects Coldest Regions

(p. A11) Winters in the United States have gotten warmer in the past 30 years, and some of the coldest parts of the country have warmed up the most.
In Minnesota, winters between 1989 and 2018 were an average of 3 degrees Fahrenheit warmer, compared to a 20th century baseline, according to data from the National Oceanic and Atmospheric Administration analyzed by The New York Times. Florida’s winters were 1.4 degrees warmer, on average, during that time.
For each 30-year period above, the maps show how much warmer or cooler winters were across the contiguous United States, compared to an average winter for that location during the 20th century. Though it might not always feel like it, warmer winters have become more common across most of the country. The most significant temperature increases can be seen in the Northern Great Plains, a region stretching from Montana to Michigan.
The Northern Great Plains have warmed up particularly quickly in part because of the dry winter conditions typical there, said Kenneth Blumenfeld, a senior climatologist at the Minnesota State Climate Office. Cold air moving into the area from Canada and the Arctic is also not as cold as it used to be, he said.
“In Minnesota, we used to get to negative 30 or negative 40 degrees with certain frequency. But no longer. Maybe we’ll now hit negative 30 with the frequency we used to hit negative 40,” Dr. Blumenfeld said. But, he added, this difference in cold extremes can be difficult for people to perceive. When it’s that cold out, after all, people tend to stay inside.
The pattern of warming shown here is largely consistent with global trends, said Jake Crouch, a scientist at NOAA’s climate monitoring branch. “In general, northern latitudes are warming faster than southern latitudes. Interior locations are warming faster than coastal locations.”

For the full story, see:
NADJA POPOVICH and BLACKI MIGLIOZZI. “Where Are America’s Winters Warming the Most? In Cold Places.” The New York Times (Saturday, MARCH 17, 2018): A11.
(Note: the online version of the story has the date MARCH 16, 2018.)

Ode to Physical Film Premieres on Digital Netflix

(p. C6) “Kodachrome” is based on an article that A.G. Sulzberger, who became the publisher of The New York Times this January, wrote in 2010. It concerned the international rush on Dwayne’s Photo in Parsons, Kan., which became the world’s last processor of the discontinued color film Kodachrome.
But in a twist that may make camera buffs’ heads explode, the feature, directed by Mark Raso, arrives courtesy of Netflix, which bought the movie after it was made. Despite a credit noting that the movie was shot (to little effect) on 35-millimeter Kodak film, “Kodachrome” will mostly be seen on the streaming platform, whose current business model hastens the destruction of physical media.

For the full review, see:

BEN KENIGSBERG. “An Ode to Color Film, Now Streaming Near You.” The New York Times (Friday, April 20, 2018): C6.
(Note: the online version of the review has the date APRIL 19, 2018, and has the title “Review: ‘Kodachrome,’ an Ode to Color Film, Now Streaming Near You.”)

Silicon Valley Warms to Trumps Lower Taxes and Deregulation

(p. B1) SAN FRANCISCO — Two days after Donald J. Trump won the 2016 election, executives at Google consoled their employees in an all-staff meeting broadcast around the world.
“There is a lot of fear within Google,” said Sundar Pichai, the company’s chief executive, according to a video of the meeting viewed by The New York Times. When asked by an employee if there was any silver lining to Mr. Trump’s election, the Google co-founder Sergey Brin said, “Boy, that’s a really tough one right now.” Ruth Porat, the finance chief, said Mr. Trump’s victory felt “like a ton of bricks dropped on my chest.” Then she instructed members of the audience to hug the person next to them.
Sixteen months later, Google’s parent company, Alphabet, has most likely saved billions of dollars in taxes on its overseas cash under a new tax law signed by Mr. Trump. Alphabet also stands to benefit from the Trump administration’s looser regulations for self-driving cars and delivery drones, as well as from proposed changes to the trade pact with Mexico and Canada that would limit Google’s liability for user content on its sites.
Once one of Mr. Trump’s most vocal opponents, Silicon Valley’s technology industry has increasingly found common ground with the White House. When Mr. Trump was elected, tech executives were largely up in arms over a leader who espoused policies on immigration and other issues that were antithetical to their companies’ values. Now, many of the industry’s executives are growing more comfortable with the president and how his (p. B5) economic agenda furthers their business interests, even as many of their employees continue to disagree with Mr. Trump on social issues.
. . .
. . . quietly, the tech industry has warmed to the White House, especially as companies including Alphabet, Apple and Intel have benefited from the Trump administration’s policies.
Those include lowering corporate taxes, encouraging development of new wireless technology like 5G and, so far, ignoring calls to break up the tech giants. Mr. Trump’s tougher stance on China may also help ward off industry rivals, with the president squashing a hostile bid to acquire the chip maker Qualcomm this month. And Mr. Trump let die an Obama-era rule that required many tech start-ups to give some workers more overtime pay.
Mr. Trump “has been great for business and really, really good for tech,” said Gary Shapiro, who leads the Consumer Technology Association, the largest American tech trade group, with more than 2,200 members including Apple, Google, Amazon and Facebook.
Mr. Shapiro said that he had voted for Hillary Clinton, Mr. Trump’s opponent, in 2016, but that he and many tech executives had come around on Mr. Trump. While they disagree with him on immigration and the environment, they have found areas where their interests align, like deregulation and investment in internet infrastructure.
“This isn’t Hitler or Mussolini here,” Mr. Shapiro said. And even though the president’s new tariffs on steel and aluminum could hurt American businesses and consumers, “disagreement in one area does not mean we cannot work together in others,” Mr. Shapiro said. “Everyone who is married knows that.”

For the full story, see:

JACK NICAS. “Silicon Valley, Wary of Trump, Warms to Him.” The New York Times (Saturday, March 31, 2018): B1 & B5.
(Note: ellipses added.)
(Note: the online version of the story has the date MARCH 30, 2018, and has the title “Silicon Valley Warms to Trump After a Chilly Start.”)

Brain as Computer “Is a Bad Metaphor”

(p. A13) In “The Biological Mind: How Brain, Body, and Environment Collaborate to Make Us Who We Are,” Mr. Jasanoff, the director of the MIT Center for Neurobiological Engineering, presents a lucid primer on current brain science that takes the form of a passionate warning about its limitations. He argues that the age of popular neurohype has persuaded many of us to identify completely with our brains and to misunderstand the true nature of these marvelous organs.
We hear constantly, for example, that the brain is a computer. This is a bad metaphor, Mr. Jasanoff insists. Computers run on electricity, so we concentrate on the electrical activity within the brain; yet there is also chemical and hormonal signaling, for which there are no good computing analogies.

For the full review, see:
Steven Poole. “”BOOKSHELF; Identify Your Self.” The Wall Street Journal (Friday, April 6, 2018): A13.
(Note: the online version of the review has the date April 5, 2018, and has the title “BOOKSHELF; ‘The Biological Mind’ Review: Identify Your Self.”)

The book under review, is:
Jasanoff, Alan. The Biological Mind: How Brain, Body, and Environment Collaborate to Make Us Who We Are. New York: Basic Books, 2018.

Finding Workers Is Top Restaurant Challenge

(p. D1) WASHINGTON — The owner of Taco Bamba Taqueria peered out from the kitchen at the line of customers snaking around the corner at his latest spot in a suburban Virginia strip mall, and felt terror. Who was going to cook, serve and clean up for all these people?
“The cooks had left,” overwhelmed by the crowds, said Victor Albisu, who owns four Taco Bambas in the region, with a new upscale Mexican place on the horizon. “The wait staff had left. The chef and sous-chef had walked out because of the amount of business. It doesn’t stop.”
A tight labor market and an explosion of new restaurants have made finding and keeping help ever more difficult across the country.
(p. D5) In 2017, the National Restaurant Association reports, 37 percent of its members said labor recruitment was their top challenge, up from 15 percent two years ago. With low profit margins leaving little room to do what most businesses do in tight labor markets — increase wages — restaurant owners are having to find other ways to attract and hold onto workers.

For the full story, see:
JENNIFER STEINHAUER. “Tight Labor Market Squeezes Restaurants.” The New York Times (Wednesday, April 11, 2018): D1 & D5.
(Note: the online version of the story has the date APRIL 5 [sic], 2018, and has the title “A Worker Shortage Is Forcing Restaurants to Get Creative.”)

Labor-Intensive Tinkering Can Advance Science

(p. A24) When John E. Sulston was 5 years old and growing up in Britain, the son of an Anglican priest, his parents sent him to a private school. There, he discovered, sports were his nemesis.
“I absolutely loathed games,” he said. “I was hopeless.”
When it came to schoolwork, he said, he was “not a books person.”
He had only one consuming interest: science. He liked to tinker, to figure out how things were put together.
. . .
The Nobel he received, shared with two other scientists, recognized the good data he amassed in his work on the tiny transparent roundworm C. elegans in an effort to better understand how organisms develop.
. . .
At the time, it was widely believed that the 558 cells the worm had when it hatched were all it would ever have. But Dr. Sulston noticed that, in fact, the worm kept gaining cells as it developed. And by tracing the patterns of divisions that gave rise to those new cells, he found, surprisingly, that the worm also lost cells in a predictable way. Certain cells were destined to die at a specific time, digesting their own DNA.
Dr. Sulston’s next major project was to trace the fate of every single cell in a worm. It was a task so demanding and labor-intensive that other scientists still shake their heads in amazement that he got it done.
Each day, bending over his microscope for eight or more hours, he would start with a worm embryo and choose one of its cells. He would then watch the cell as it divided and follow each of its progeny cells as, together, they grew and formed the organism. This went on for a total of 18 months.
In the end, he had a complete map of every one of the worm’s 959 cells (not counting sperm and egg cells).

For the full obituary, see:
GINA KOLATA. “John Sulston, 75; Tiny Worm Guided Him to Nobel.” The New York Times (Friday, March 16, 2018): A24.
(Note: ellipses added.)
(Note: the online version of the obituary has the date MARCH 15, 2018, and has the title “John E. Sulston, 75, Dies; Found Clues to Genes in a Worm.”)

Amazon Hires Thousands of Low-Tech Workers

(p. B1) TROMEOVILLE, Ill. — Brandon Williams arrived at an Amazon fulfillment center here, about an hour outside of Chicago, around 7:30 a.m. on Wednesday [August 2, 2017], one of thousands across the country who turned up for the company’s first Jobs Day. While he appeared to wilt slightly during the five hours he waited before an M.C. summoned him for a tour, his enthusiasm did not wane.
“What’s not great about a company that keeps building?” he said, seated in a huge tent the company erected in the parking lot as a kind of makeshift waiting room.
The event was a vivid illustration of the ascendance of Amazon, the online retail company that, to a far greater extent than others in the tech industry, has a seemingly insatiable need for human labor to fuel its explosive growth.
Like other tech giants, Amazon is recruiting thousands of people with engineering and business degrees for high-paying jobs. But the vast majority of Amazon’s hiring is for what the company calls its “fulfillment network” — the armies of people who pick and pack orders in warehouses and unload and drive delivery trucks, and who take home considerably smaller incomes.
The event on Wednesday, held at a dozen locations including Romeoville, Ill., was intended to help fill 50,000 of those lower-paying positions, 40,000 of them full-time jobs.
Those high-low distinctions did not seem to bother the attendees of the jobs fair, many of them united in the conviction that Amazon represented untapped opportunity — that a foot in the door could lead to a career of better-compensated, more satisfying work, whether in fulfillment, I.T., marketing or even fashion.
Mr. Williams, a military veteran studying computer network security at a nearby community college, said he hoped to eventually work his way up to an I.T. job with Amazon. But even those whose ambitions were more in line (p. B7) with the vast majority of available jobs could not hide their excitement.
. . .
Arun Sundararajan, a professor of information, operations and management sciences at New York University’s Stern School of Business, said Amazon’s employment needs are unique among tech companies.
. . .
“While the digital disruption is destroying the traditional retail business model,” Dr. Sundararajan said, “the Amazon model that replaces it will continue to live in the physical world and require human labor for the foreseeable future.”

For the full story, see:
NOAM SCHEIBER and NICK WINGFIELD. “Amazon’s Clear Message: Hiring.” The New York Times (Thursday, August 3, 2017): B1 & B7.
(Note: ellipses, and bracketed date, added.)
(Note: the online version of the story has the date AUG. 2, 2017, and has the title “Amazon’s Jobs Fair Sends Clear Message: Now Hiring Thousands.”)