Category: Government

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.”)

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.”)

“Science Didn’t Lie”

(p. 22) In the words of The Saturday Evening Post: “If America doesn’t keep out the queer, alien, mongrelized people of Southern and Eastern Europe, her crop of citizens will eventually be dwarfed and mongrelized in turn.”
According to Thomas C. Leonard, who teaches at Princeton, the driving force behind this and other such laws came from progressives in the halls of academia — people who combined “extravagant faith in science and the state with an outsized confidence in their own expertise.” “Illiberal Reformers” is the perfect title for this slim but vital account of the perils of intellectual arrogance in dealing with explosive social issues. Put simply, Leonard says, elite progressives gave respectable cover to the worst prejudices of the era — not to rabble-rouse, but because they believed them to be true. Science didn’t lie.
But barring undesirables was only half the battle; the herd also had to be culled from within. In 1907, Indiana became the first state to legalize forced sterilization, starting a landslide endorsed by progressive icons like Theodore Roosevelt and the birth control champion Margaret Sanger.

For the full review, see:
DAVID OSHINSKY. “No Justice for the Weak.” The New York Times Book Review (Sunday, March 20, 2018): 1 & 22-23.
(Note: the online version of the review has the date March 14, 2018, and has the title “‘Imbeciles’ and ‘Illiberal Reformers’.”)

The book under review, is:
Leonard, Thomas C. Illiberal Reformers: Race, Eugenics, and American Economics in the Progressive Era. Princeton, NJ: Princeton University Press, 2016.

The Role of Progressives in the Forced Sterilization of Thousands

(p. 22) Progressivism was always more than a single cause, however. Attracting reformers of all stripes, it aimed to fix the ills of society through increased government action — the “administrative state.” Progressives pushed measures ranging from immigration restriction to eugenics in a grotesque attempt to protect the nation’s gene pool by keeping the “lesser classes” from reproducing. If one part of progressivism emphasized fairness and compassion, the other reeked of bigotry and coercion.
“Imbeciles,” by Adam Cohen, the author of “Nothing to Fear: FDR’s Inner Circle and the Hundred Days That Created Modern America,” examines one of the darkest chapters of progressive reform: the case of Buck v. Bell. It’s the story of an assault upon thousands of defenseless people seen through the lens of a young woman, Carrie Buck, locked away in a Virginia state asylum. In meticulously tracing her ordeal, Cohen provides a superb history of eugenics in America, from its beginnings as an offshoot of social Darwinism — ­human survival of the fittest — to its rise as a popular movement, advocating the state-sponsored sterilization of “feeble­minded, insane, epileptic, inebriate, criminalistic and other degenerate persons.”

For the full review, see:
DAVID OSHINSKY. “No Justice for the Weak.” The New York Times Book Review (Sunday, March 20, 2018): 1 & 22-23.
(Note: the online version of the review has the date March 14, 2018, and has the title “‘Imbeciles’ and ‘Illiberal Reformers’.”)

The book under review, is:
Cohen, Adam. Imbeciles: The Supreme Court, American Eugenics, and the Sterilization of Carrie Buck. New York: Penguin Press, 2016.

Blockchain Tested to Speed Property Transfers

(p. B8) The blockchain technology that underpins cryptocurrencies such as bitcoin could change the way property deals are done and recorded more than any other new technology, real-estate and technology experts say.
And Sweden’s nearly 400-year-old land mapping and registration authority is likely to become one of the first government agencies to test using blockchain technology for conducting property sales.
The Lantmäteriet expects to conduct the first such transaction in the next few months and is shortlisting volunteers who want to buy or sell a property using the blockchain system. “From the technology point of view, we are quite ready,” said Mats Snäll, Lantmäteriet’s chief digital officer.
Proponents of blockchain say the technology would make recording and transferring titles faster and much more efficient. Transactions that today take months to complete could take days or even hours, they say.
Blockchain technology also is practically bulletproof when it comes to fraudulent transactions, experts say.

For the full story, see:
Shefali Anand. “Test of Blockchain for Real Estate Is Readied.” The Wall Street Journal (Wednesday, March 7, 2018): B8.
(Note: the online version of the story has the date March 6, 2018, and has the title “A Pioneer in Real Estate Blockchain Emerges in Europe.”)

Government Obstacles Slow 5G Innovation

(p. A13) . . . , governmental obstacles threaten to block a new wave of wireless innovation, known as fifth generation or “5G.” It will multiply download speeds by at least 10 times, allowing wireless carriers to compete with cable companies for high-speed internet access. With superfast speeds and low lag times, 5G will enable advances in everything from driverless cars to the “tactile internet,” in which surgeons can perform operations and builders operate construction equipment remotely, and entertainment can include sensations beyond the audiovisual.
. . .
In some places, outdated local requirements prohibit carriers from placing small cells in local rights-of-way and on government-owned utility poles. Zoning ordinances designed for much larger towers often require local zoning boards to approve small cells. Some localities refuse altogether to negotiate right-of-way access, while others impose prohibitive fees and other unreasonable conditions.

For the full story, see:
Robert McDowell. “Local Laws Imperil 5G Innovation; Misapplied zoning rules and huge fees block antennas the size of pizza boxes.” The Wall Street Journal (Tuesday, April 3, 2018): A13.
(Note: ellipses added.)
(Note: the online version of the story has the date APRIL 2, 2018.)

FDA Regulations Stop Vape Shop Innovations

(p. A19) After Kimberly Manor lost her husband to lung cancer, she was inspired to make a dramatic career change. Kimberly now owns and operates Moose Jooce in Lake, Mich., a “vape shop” that sells various electronic nicotine devices. These products use battery-powered coils to vaporize liquids, with differing levels of nicotine or none at all. Thus, vapers may inhale nicotine without the tar or other harmful chemicals in tobacco smoke, since there is no tobacco and no combustion. Scientific evidence suggests this is a much safer alternative to smoking.
Ms. Manor estimates that her business has helped more than 500 people quit smoking, most of them longtime smokers in their 50s or older. Yet the Food and Drug Administration is discouraging more such enterprises. In a regulation issued in 2016 known as the “deeming rule,” the agency ordered that vaping products would be subject to the same regulations developed for the cigarette industry under the Tobacco Control Act of 2009.
The deeming rule has been devastating to businesses like Ms. Manor’s. To give just one example, vape shop owners frequently experiment by mixing new flavors for the liquid “juice.” Now, each separate creation requires its own prohibitively expensive application for FDA approval, which means that vape shops have been forced to stop innovating.

For the full commentary, see:
Todd Gaziano and Tommy Berry, “Career Civil Servants Illegitimately Rule America; Leslie Kux has never been elected or confirmed by the Senate. She’s issued nearly 200 regulations.” The Wall Street Journal (Thursday, March 1, 2018): A19.
(Note: the online version of the commentary has the date Feb. 28, 2018.)

Art Diamond Predicts a 40% Chance that Elon Musk Will Make It to Mars

(p. A1) What are the chances that readers will make it to the end of this article? About 40%.
If you do make it, that prediction will look smart. If you don’t, well, we said the odds were against it.
Such is the nature of the 40% rule, a favorite forecasting tactic of Wall Street analysts and other prognosticators trying to make a bold call without being too bold.
Former British Prime Minister Tony Blair said last month there’s a 40% chance that Brexit will be reversed; Citigroup Inc. analyst Jim Suva wrote that there’s a 40% chance Apple Inc. buys Netflix Inc.; and Nomura Holdings Inc. economist Lewis Alexander said there’s a 40% chance Nafta gets ripped up.
The nice thing about 40% is that you never have to say you were wrong, says Peter Tchir, a market strategist at Academy Securities. Say you predict the Dow Jones Industrial Average has a 40% chance of hitting 30000 before year-end.
“Get it right and you can say ‘See, I was telling everyone it could happen,’ ” he says. “Get it wrong and you can weasel your way out: ‘I didn’t say it was likely, I just said it was a strong possibility.’ “

For the full story, see:
Winkler, Rolfe and Justin Lahart, “How Pundits Never Get It Wrong: Call a 40% Chance.” The Wall Street Journal (Tuesday, Feb. 27, 2018): A1 & A10.
(Note: the online version of the article has the date Feb. 26, 2018, and has the title “How Do Pundits Never Get It Wrong? Call a 40% Chance.”)

Occupational Licensing Hurts Military Spouses

(p. A15) Heather Kokesch Del Castillo launched a dietary advice business in Monterey, Calif., in 2014. The business grew and Ms. Del Castillo eventually established a nationwide client base as a “health coach.” But when her husband, who is in the Air Force, was transferred to a base in Florida, her business hit a roadblock. A Florida Department of Health investigator showed up at the door of their new home with a cease-and-desist letter and a $750 fine.
After nearly two years of operating her business in Florida, Ms. Del Castillo learned that she had run afoul of a law requiring any person offering dietary advice to possess a state-issued license. Qualifying for that permit requires a bachelor’s degree in dietetics, a 900-hour internship, a passing grade on an exam administered by the state Commission on Dietetic Registration, and a $355 fee. A licensed dietitian had tipped off the Health Department that Ms. Del Castillo was giving unauthorized advice. She retained the Institute for Justice, a public-interest law firm, to fight the law that stripped her of her livelihood.
State licensing laws pose a particular burden on military spouses like Ms. Del Castillo. About 1 in 4 Americans need licenses to perform their occupations. In some states, florists, taxidermists and even fortune-tellers need licenses to operate. Far too often, these licenses serve less as safeguards of public health and safety than as barriers to entry. In many cases, the state-appointed boards that issue licenses are stocked with industry insiders seeking to restrict competition.
. . .
Military spouses were 10 times as likely to have moved to a new state in the past year than the average American, according to a combined 2012 study by the Treasury and Defense departments. Surveys suggest that anywhere from 35% to 50% of military spouses work in professions that require licensure, and nearly 75% of them would need to be relicensed upon transferring to a new state. Perhaps as a result, the unemployment rate for military spouses is 16%, while the national unemployment rate is only 4.1%

For the full commentary, see:
Shoshana Weissmann and C. Jarrett Dieterle. “Why Do You Need a College Degree to Give Diet Advice?; State licensing laws overly burden military spouses, who move frequently only to find they can’t work.” The Wall Street Journal (Thursday, February 1, 2018): A15.
(Note: ellipsis added.)
(Note: the online version of the obituary has the date Jan. 31, 2018.)

New York City Mayoral Health Regulator Shook Salt onto His Saltine Crackers

(p. A17) Purring in the mild winter day, a small armada of S.U.V.s was parked Thursday morning along 42nd Street outside the New York Public Library. Inside was Mayor Bill de Blasio, at an interfaith prayer breakfast that went on for quite a while.
By divine right of mayoralty, or someone, 13 vehicles waited at the curb in a no-standing zone, among them four black S.U.V.s (three Chevy Suburbans and one Yukon XL) an ambulance, a huge E.M.S. vehicle and a police school safety van. The engines on those big boys were running while the mayor was inside, for about two hours.
At least one of the S.U.V.s had Taxi and Limousine Commission plates. It may not have been part of the official mayoral entourage, but its dashboard was anointed with the holiest of government oils: a police placard giving it license to park where unblessed mortals cannot.
One day earlier, Mr. de Blasio announced that the city would sue five big oil companies for the hardships and costs inflicted on New York by climate change.
. . .
Hypocrisy is more widely practiced by humans than any creed. Mr. Bloomberg’s health department wanted restaurants to cut sodium from their recipes but he was known to shake salt on slices of pizza and saltine crackers.

For the full commentary, see:
JIM DWYER. “Battling Climate Change From the S.U.V. Back Seat.” The New York Times (Friday, January 12, 2018): A17.
(Note: ellipsis added.)
(Note: the online version of the commentary has the date JAN. 11, 2018, and has the title “About New York; Battling Climate Change from the Back Seat of an S.U.V.”)