Category: Regulations

Fewer Regulations Allow Faster Chinese Cancer Innovation

(p. A1) HANGZHOU, China–In a hospital west of Shanghai, Wu Shixiu since March has been trying to treat cancer patients using a promising new gene-editing tool.
U.S. scientists helped devise the tool, known as Crispr-Cas9, which has captured global attention since a 2012 report said it can be used to edit DNA. Doctors haven’t been allowed to use it in human trials in America. That isn’t the case for Dr. Wu and others in China.
In a quirk of the globalized technology arena, Dr. Wu can forge ahead with the tool because he faces few regulatory hurdles to testing it on humans. His hospital’s review board took just an afternoon to sign off on his trial. He didn’t need national regulators’ approval and has few reporting requirements.
Dr. Wu’s team at Hangzhou Cancer Hospital has been drawing blood from esophageal-cancer patients, shipping it by high-speed rail to a lab that modifies disease-fighting cells using Crispr-Cas9 by deleting a gene that interferes with the immune system’s ability to fight cancer. His team then infuses the cells (p. A10) back into the patients, hoping the reprogrammed DNA will destroy the disease.
In contrast, what’s expected to be the first human Crispr trial outside China has yet to begin. The University of Pennsylvania has spent nearly two years addressing federal and other requirements, including numerous safety checks designed to minimize risks to patients. While Penn hasn’t received final federal clearance to proceed, “we hope to get clearance soon,” a Penn spokeswoman said.
“China shouldn’t have been the first one to do it,” says Dr. Wu, 53, an oncologist and president of Hangzhou Cancer Hospital. “But there are fewer restrictions.”

For the full story, see:
Rana, Preetika, Amy Dockser Marcus and Wenxin Fan. “China Races Ahead In Gene Editing.” The Wall Street Journal (Monday, January 22, 2018): A1 & A10.
(Note: the online version of the story has the date Jan. 21, 2018, and has the title “China, Unhampered by Rules, Races Ahead in Gene-Editing Trials.”)

Canada’s Single-Payer System Causes “Suffering and Deaths of People on Wait Lists”

(p. A17) Canada’s single-payer health-care system, known as Medicare, is notoriously sluggish. But private clinics like Cambie are prohibited from charging most patients for operations that public hospitals provide free. Dr. Day is challenging that prohibition before the provincial Supreme Court.
. . .
People stuck on Medicare waiting lists can only dream of timely care. Last year, the median wait between referral from a general practitioner and treatment from a specialist was 21.2 weeks, or about five months–more than double the wait a quarter-century ago. Worse, the provincial governments lie about the extent of the problem. The official clock starts only when a surgeon books the patient, not when a general practitioner makes the referral. That adds months and sometimes much longer. In November [2017] an Ontario woman learned she’d have to wait 4½ years to see a neurologist.
. . .
Dr. Day’s lawsuit aims to overturn these provisions. It alleges that the government’s legal restrictions on private care are to blame for the needless “suffering and deaths of people on wait lists.” Dr. Day argues that the current system violates citizens’ rights to “life, liberty, and security of the person,” as guaranteed by the Canadian Charter of Rights and Freedoms, the equivalent of the U.S. Bill of Rights.

For the full commentary, see:
Sally C. Pipes. “Single-Payer Health Care Isn’t Worth Waiting For; An orthopedic surgeon challenges Canada’s ban on most privately funded procedures.” The Wall Street Journal (Monday, January 22, 2018): A17.
(Note: ellipses, and bracketed year, added.)
(Note: the online version of the commentary has the date Jan. 21, 2018.)

Trump’s Judges Constrain the Administrative State

(p. A1) WASHINGTON — It has been practically a given that anyone nominated for a federal judgeship by a Republican president had to pass an unspoken litmus test — usually on abortion but often on any number of divisive social issues.
The Trump administration has a new litmus test: reining in what conservatives call “the administrative state.”
With surprising frankness, the White House has laid out a plan to fill the courts with judges devoted to a legal doctrine that challenges the broad power federal agencies have to interpret laws and enforce regulations, often without being subject to judicial oversight. Those not on board with this agenda, the White House has said, are unlikely to be nominated by President Trump.
. . .
(p. A13) That the concept of “the administrative state” has become so central to politics today shows how successful the Trump administration has been in elevating to the mainstream ideas that once thrived mainly on the edges of conservative and libertarian thought.
A year ago it was a term known mostly among academics to describe the vast array of federal departments and the unelected functionaries who run them. It entered the mainstream political lexicon last year after the president’s former chief strategist, Stephen K. Bannon, pledged a “deconstruction of the administrative state” under Mr. Trump.
. . .
But this thinking has been advanced by many libertarian-minded conservatives who have long doubted whether the founders envisioned the creation of many New Deal and Great Society programs and the abundance of regulations that flowed from them.
“A lot of this, if you unpack it, I think it will get back to fundamental fairness,” said Mark Holden, general counsel for Koch Industries, which is led by Charles G. and David H. Koch, two of the biggest financial backers of the effort to elect office holders committed to deregulation and free-market enterprise.
The Trump judicial selection process, Mr. Holden added, was ultimately focused on “the size and scope of government and scaling it back, to the extent that it’s counterproductive and contrary to due process.”

For the full story, see:
Jeremy W. Peters. “New Litmus Test for Trump’s Court Picks: Taming the Bureaucracy.” The New York Times (Wednesday, March 28, 2018): A1 & A13.
(Note: ellipses added.)
(Note: the online version of the story has the date March 26, 2018, and has the title “Trump’s New Judicial Litmus Test: Shrinking ‘the Administrative State’.”)

Fewer Summer Jobs Filled by Teenagers

(p. D8) You can still find high school and college students boiling hot dogs and cleaning the fryer at the clam shacks, country clubs and state fairs that spring to life when the weather turns hot. But the food that fuels a summer vacation is now more likely being prepared by temporary workers from other countries or local adults trying to make the gig economy work for them.
. . .
Although youth employment in the United States still spikes in the warmer months, the number of teenagers in the summer labor force fell to 43 percent in 2016, from almost 72 percent at its peak in 1978, according to the most recent figures from the federal Bureau of Labor Statistics.
Pressure has come from several directions. School started stretching into summer. Employment laws became more restrictive. Scooping cones or running a dough-filled Hobart were no longer considered worthy résumé builders.
At the same time, demand for summer workers rose.

For the full story, see:
Kim Severson. “Where Have All the Teenagers Gone?” The New York Times (Wednesday, May 23, 2018): D8.
(Note: ellipsis added.)
(Note: the online version of the story has the date May 22, 2018, and has the title “That Summer Food-Stand Job Is No Longer Just for Teenagers.”)

Firms Transship to Avoid Tariffs

(p. B1) SHANGHAI — Want to avoid American tariffs? In China, a company called Settle Logistics says it knows a way.
Specifically, that way goes through Malaysia — a 4,600-mile diversion compared with sending a shipping container from China straight across the Pacific to the United States. But when those Chinese products arrive at an American port, they will look as if they had come from Malaysia, according to the company, and will be spared tariffs aimed at Chinese goods.
“For those unfair trade barriers targeting our industries from certain countries,” Settle Logistics says on its website, “we can adopt other approaches to bypass those trade tariffs in order to expand markets.”
Such zigzagging routes are called transshipments, and President Trump has used them to justify the trade fight he has picked with a number of countries. They could also take on new relevance should the United States and China carry out their threats to levy a total of more than $200 billion in tariffs against each other.
. . .
(p. B6) Stamping out such transshipments could prove difficult. The United States made a big effort in the late 1990s to address the relabeling in Hong Kong of garments that had been made in mainland China, said Patrick Conway, a textiles trade specialist.
But after American officials gathered enough evidence to put companies on a watch list, the companies quickly disappeared, said Mr. Conway, who is the chairman of the economics department at the University of North Carolina at Chapel Hill. Some of the same people involved emerged later, but at other companies.
“We can anticipate a game of Whac-a-Mole,” Mr. Conway said.

For the full story, see:
Keith Bradsher. “Dodging Tariffs With a Handy Detour.” The New York Times (Monday, April 23, 2018): B1 & B6.
(Note: ellipsis added.)
(Note: the online version of the story has the date April 22, 2018, and has the title “Tariff Dodgers Stand to Profit Off U.S.-China Trade Dispute.”)

Government Uses Cruel Painful Snare Traps to Kill Gorgeous Respectful Foxes

(p. A18) BRIGANTINE, N.J. — Red foxes can be found all over New Jersey, wandering out of the woods and poking through garbage at dusk in search of a meal. In many places, they might be overlooked, if not seen as a disease-carrying nuisance. But not in Brigantine, an island community where the fox has become an unofficial ambassador.
Many residents warmly share stories of their encounters, like the fox that would routinely come up to a back door or the time a children’s soccer game had to pause so one could cross the field. A fox makes an appearance on the cover of the city’s tourism guide, as much of an attraction as its golf course and pristine beaches. A real estate company regularly sends its mascot, Briggy the Fox, to community events.
Yet the island is also the seasonal home to piping plovers, a small bird that returns every year to dig its nests on the beach. The bird is an endangered species in New Jersey that state wildlife officials closely watch and fiercely protect, including from foxes, creating a bitter conflict that has caused an uproar as residents protest the trapping and killing of the animals.
Some are challenging the use of snare traps, a contraption that they describe as cruel and painful. The contretemps has also stirred a wider debate: Is it fair to kill one animal for the sake of protecting another?
“It disgusts me,” said Donna Vanzant, who owns a marina. “Why go after these gorgeous animals? Just let nature take its course.”
State lawmakers recently wrote a letter to wildlife officials expressing their “deep concern,” and the City Council passed a resolution condemning the “inhumane and indiscriminate killing of red foxes.” Briggy the Fox attended the meeting and held a sign: “Please stop killing my friends.”
“Everyone on the island cherishes the foxes and does not want them killed,” said Donna Grazioli DeAngelis, a retired teacher who started a petition online, which about 90,000 people have signed. “They have been so respectful, so perfect in every way,” she said of the foxes. “People paint them, photograph them. They haven’t been a nuisance in any way.”
. . .
“It’s an overreach and overreaction,” Philip J. Guenther, Brigantine’s longtime mayor, said of the fox trapping. “It just doesn’t seem to make any sense from a protection standpoint.”

For the full story, see:
Rick Rojas. “To Save One Precious Animal, a Town Must Sacrifice Another.” The New York Times (Monday, May 7, 2018: A18.
(Note: ellipsis added.)
(Note: the online version of the story has the date May 6, 2018, and has the title “Trapping Foxes to Save Plovers Sets Off Showdown at Jersey Shore.” The online version says the print version appeared on May 6 on p. A17 of the New York Edition. My print version, as usual, was the National Edition.)

San Francisco Suffers Net Loss of People as Tech Booms

(p. A3) San Francisco is such a boomtown that people are leaving in droves.
In 2016 and 2017, more people moved out of the San Francisco-Oakland-Hayward metropolitan area–an urban core of 4.7 million people in a broader region known as the Bay Area–than moved into it from other parts of California or the U.S., according to U.S. census data.
In the year that ended July 1, the region showed a net loss of nearly 24,000 residents to the rest of the country, roughly double the loss of the previous year and a sharp reversal from net annual gains of about 15,000 as recently as 2013-14.
Economists said the outflow is being driven by the high cost of housing in the area, where the average home value in several counties surpasses $1 million.

For the full story, see:
Nour Malas and Paul Overberg. “‘San Francisco’s Boom Leads to an Exodus.” The Wall Street Journal (Friday, March 23, 2018): A3.
(Note: the online version of the story has the date March 22, 2018, and has the title “San Francisco Has a People Problem.”)

California Regulation Adds $9,500 to Average Home Cost

(p. A1) The California Energy Commission voted 5-0 to approve a mandate that residential buildings up to three stories high, including single-family homes and condos, be built with solar installations starting in 2020.
The commission estimates that the move, along with other (p. A2) energy-efficiency requirements, would add $9,500 to the average cost of building a home in California. The state is already one of the most expensive housing markets in the country, with a median price of nearly $565,000 for a single-family home, according to the California Association of Realtors.

For the full story, see:
Erin Ailworth. “Solar Panel Mandate Jolts Housing Industry.” The Wall Street Journal (Thursday, May 10, 2018): A1-A2.

(Note: the online version of the story was updated May 9, 2018, and has the title “California Takes Big Step to Require Solar on New Homes.”)

Clues to How Macron Achieves Major Free Market Reforms in France

(p. A9) PARIS — The plush red velvet seats of France’s National Assembly are filled with lawmakers who owe just about everything to President Emmanuel Macron.
Three-quarters of the 577 members are brand new, swept into power in the wake of his election last year. More than 60 percent are in his camp. Nearly one-third have never held public office, and 38 were under the age of 31 when they entered office.
. . .
On Thursday [March 22, 2018], tens of thousands of railway workers, teachers and air traffic controllers went on strike across France to protest salary freezes for civil servants and Mr. Macron’s pledge to cut 120,000 public-sector jobs and introduce merit-based pay and use more private contractors.
. . .
The assembly has become a showcase of Mr. Macron’s forceful powers of persuasion and the ways he wants to reshape and update all of France.
“There’s been a complete cultural shock,” said Jean-Paul Delevoye, a senior official in Mr. Macron’s government who helped pick his candidates for Parliament.
“We’ve completely overturned the sociology of the assembly,” he added.
Diet Coke replaced wine as the most popular item at the assembly’s bar. Wine sales had plummeted, stunning the barmen, though they are creeping back up under the influence of long days. Mr. Macron’s acolytes sit through them, unlike their predecessors.
Before the rule for a deputy was, arrive Tuesday morning and go home Wednesday evening. Now, many say, Mr. Macron’s deputies come for the whole week.
So assiduous are they that “now, it’s hard to find a spot at the restaurant, that’s what strikes me,” said Brigitte Bourguignon, another ex-Socialist who joined Mr. Macron.
Among the youthful deputies, common positions are worked out in advance on applications like Telegram, befuddling the old-timers. There is little patience for them in any case.
. . .
Parliament was barely to be seen last year when Mr. Macron forced through changes to France’s rigid labor code to allow companies more flexibility in negotiating directly with workers, and to limit payouts after layoffs.
Instead, the president proceeded by special decree, using a rarely used procedure that allowed the National Assembly merely to vote thumbs up or down on the labor reforms — it voted up — but without the power to change or even discuss them.
Then, Mr. Macron rammed through the lifting of a tax on wealth, insisting that it was necessary to free capital for investment. Many economists agreed. But apart from a few opposition whimpers there was hardly any debate.
In coming weeks he proposes to take on the railway workers — the bête noir of many a French government — again by special decree. Mr. Macron wants to end the hiring-for-life, early retirement and enhanced medical insurance that have contributed to a whopping deficit. But he doesn’t necessarily want Parliament debating it.
. . .
For his dedicated supporters in Parliament, subordination is not an issue. Asked whether he had been in disagreement with the government, Mr. Potterie replied: “Ah, no. No. At the margins maybe. But for the moment, no.”
In the National Assembly, “it’s true that we don’t challenge the government,” he added. “It’s because we were elected to carry out their program.”
That sense of purpose runs deep.
“It’s not true that we are simply puppets,” insisted Ms. Bourguignon, the former Socialist. “We’ve got a government that reforms, and we’ve got to follow the government.”

For the full story, see:
ADAM NOSSITER. “Macron Fills the Role Of French Strongman.” The New York Times (Friday, March 23, 2018): A9.
(Note: ellipses, and bracketed date, added.)
(Note: the online version of the story has the date MARCH 22, 2018, and has the title “Emmanuel Macron Becomes France’s Answer to Strongman Populism.” The online version says that the article appeared on p. A13 of the New York edition. It appeared on p. A9 of my National edition.)

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.”)