Category: Government

FDA Has No Right to Stop the Terminally Ill from Seeking Cures

(p. C4) Ms. Olsen notes that “today, about 40 percent of cancer patients attempt to enroll in clinical trials, but only about 3 percent end up participating. That means that the vast majority don’t make the cut, whether because they fail to meet the strict criteria, or a trial is thousands of miles from their home.” Many of those who don’t get these experimental drugs are the sickest patients because they are deemed “too sick to be useful for the study.”
Ms. Olsen argues that terminally ill patients should be able to access such drugs–at their own risk and outside the context of FDA-required studies–if the companies are willing to provide them, and the book’s title alludes to her proposed remedy: the state-by-state campaign the Goldwater Institute is leading to pass “Right to Try” legislation. The bills would allow terminally ill patients who have “exhausted all conventional treatment options” to access an experimental treatment if their doctors believe it is “the best medical option to extend or save the patients’ life” and “the treatment has successfully completed basic safety testing and is part of the FDA’s ongoing evaluation and approval process.” Insurers, critically, would not be required to cover the treatment–a significant hurdle, largely unexplored here, since such costs could be significant.
The think tank’s campaign has been incredibly successful, with 24 states passing Right to Try laws to date. Still, Ms. Olsen doesn’t present such laws as a panacea. She doesn’t expect experimental treatments to always–or even often–work for terminally ill patients. But she believes that some chance is better than the alternative. “If you have the Right to Die, you have the Right to Try,” Ms. Olsen writes. “And you don’t have to wait on Washington to secure it.”
Yet therein lies the book’s main shortcoming. Washington, it turns out, has a fair bit of say here. Courts have found that the FDA’s powers to regulate drug development are extraordinarily broad. Many changes Ms. Olsen champions won’t be possible without congressional action to revamp the FDA’s drug development process and find new ways of paying for experimental drugs that would make widespread access sustainable for patients, companies and insurers. These issues, though touched on, are not grappled with in detail.

For the full review, see:
PAUL HOWARD. “BOOKSHELF; Hail Mary Medicine; Patients spend their last days pleading with reluctant drug companies and the FDA to get access to treatments that could save their lives.” The Wall Street Journal (Fri., Nov. 13, 2015): C4.
(Note: ellipses added.)
(Note: the online version of the review has the date Nov. 12, 2015.)

The book under review, is:
Olsen, Darcy. The Right to Try: How the Federal Government Prevents Americans from Getting the Lifesaving Treatments They Need. New York: HarperCollins Publishers, 2015.

Health Care Mandate “Freezes You at a Time When You Need to Be Moving Fast”

(p. B4) When LaRonda Hunter opened a Fantastic Sams hair salon 10 years ago in Saginaw, Tex., a suburb of Fort Worth, she envisioned it as the first of what would eventually be a small regional collection of salons. As her sales grew, so did her business, which now encompasses four locations — but her plans for a fifth salon are frozen, perhaps permanently.

Starting in January, the Affordable Care Act requires businesses with 50 or more full-time-equivalent employees to offer workers health insurance or face penalties that can exceed $2,000 per employee. Ms. Hunter, who has 45 employees, is determined not to cross that threshold. Paying for health insurance would wipe out her company’s profit and the five-figure salary she pays herself from it, she said.
“The margins are not big enough within our industry to support it,” she said. “It’s not that I don’t want to — I love my employees, and I want to do everything I can for them — but the numbers just don’t work.”
. . .
For some business owners on the edge of the cutoff, the mandate is forcing them to weigh very carefully the price of growing bigger.
“There’s kind of a deer-in-headlights moment for those who say, ‘I have this new potential client, but if I bring them on, I have to hire five additional people,'” said Philip P. Noftsinger, the payroll unit president at CBIZ, a financial services provider for businesses. “They’re really trying to assess how much the 50th employee is going to cost.”
. . .
For businesses that use many seasonal, variable-hour or temporary workers, like those in the hospitality industry, simply figuring out how many qualifying employees they have can be a challenge.
“I think companies are going to have to work with their payroll processor for the basic data, and then their accountant or attorney about what certain items mean,” Mr. Prince said.
The expense and distraction of all that paperwork is one of the biggest frustrations for one business owner, Joseph P. Sergio. His industrial cleaning company, Polar Clean, which is based in South Bend, Ind., but dispatches teams nationally, has just under 50 core employees. One of its business lines is disaster restoration, and after a flood or hurricane, its temporary staff balloons.
Mr. Sergio offers health insurance to his permanent staff, but the premiums have risen so quickly that he had to switch to a more restrictive plan, with a higher deductible. He is reluctant to go over the 50-employee line and incur all of the new rules that come with it. That makes bidding for new jobs an arduous and risky exercise.
“I’ve had to pull my controller and a couple of top people to sit and spend days going through this,” he said. “If you ramp up, and it pushes you over 50, there’s all these unknown costs and complicated rules. Are we really going to be able to benefit from going after that opportunity? It freezes you at a time when you need to be moving fast.”

For the full story, see:
STACY COWLEY. “ENTREPRENEURSHIP; Health Care Law Leads Business Owners to Rethink Plans for Growth.” The New York Times (Thurs., NOV. 19, 2015): B4.
(Note: ellipses added.)
(Note: the online version of the story has the date NOV. 18, 2015, and has the title “ENTREPRENEURSHIP; Health Care Law Forces Businesses to Consider Growth’s Costs.”)

How Democratic Operatives Fight Innovation-Crushing Regulations

(p. B1) SAN FRANCISCO — Over the last few years, so-called sharing companies like Airbnb and Uber — online platforms that allow strangers to pay one another for a room or a ride — have established footholds in thousands of communities well before local regulators have figured out how to deal with them.

. . .
Chris Lehane, a Washington political operative who now serves as Airbnb’s head of global policy and public affairs, framed Proposition F (p. B10) as a hotel-industry-led attack on the middle class.
In this city of about 840,000 people, roughly $8 million was raised by groups opposed to Proposition F — about eight times the amount raised by the proposition’s backers, according to records filed with the San Francisco Ethics Commission.
Much of that money was spent mobilizing Airbnb hosts and users, Mr. Lehane said. Still, he repeatedly homed in on one of the company’s most important talking points: Airbnb’s victory was a win for the middle class.
“Cities recognize where the world is going, right, they understand that you’re either going to go forward or you’re going to go backward,” he said. “They understand that in a time of economic inequality, this is a question of whose side are you on: Do you want to be on the side of the middle class, or do you want to be opposed to the middle class?”
. . .
Companies like Airbnb and Uber have become multibillion-dollar companies by employing a kind of guerrilla growth strategy in which they set up a modest team of workers in a city and immediately start providing their services to the public, whether local laws allow them to or not.
. . .
Mr. Lehane, a former political operative in the Clinton administration, was nicknamed the Master of Disaster for his no-holds-barred approach to winning political fights. David Plouffe, a former adviser to President Obama, is now a senior adviser to Uber and a member of its board.
Mr. Lehane and Mr. Plouffe have both tried to frame their companies as middle-class saviors in a moment of economic anxiety and income inequality — themes that are playing out in the presidential election as well. Jeb Bush and other Republicans have bragged about their Uber rides on the campaign trail, praising these companies as the future of self-sufficient employment.

For the full story, see:
CONOR DOUGHERTY and MIKE ISAAC. “Airbnb and Uber Mobilize Vast User Base to Sway Policy.” The New York Times (Thurs., NOV. 5, 2015): B1 & B10.
(Note: ellipses added.)
(Note: the online version of the story has the date NOV. 4, 2015.)

Environmentalists’ Mandatory Green-Bins Succeed at Breeding Smarter Raccoons

(p. A1) TORONTO–Last fall, Suzanne MacDonald spent a week tempting raccoons into her Toronto-area backyard every night with rotisserie chickens locked inside organic-waste bins.
At one point, “I had like 12 raccoons on one bin trying to get in,” said Ms. MacDonald, an animal behavior researcher who was testing bin prototypes for the city. None succeeded, she said, but “they did try mightily.”
. . .
The battle between the city’s residents and its backyard wildlife is increasingly playing out over the disposal of organic waste. Residents’ green bins–which the city collects weekly at the curb–offer a smorgasbord for raccoons and have helped their numbers increase. Torontonians say it is tough to keep the (p. A8) bins sealed and the animals away.
. . .
“The members of Raccoon Nation are smart, they’re hungry and they’re determined,” Mayor John Tory told reporters in April when he unveiled the new green bins. The bins, which feature a turn lock, will cost the city 31 million Canadian dollars ($23.6 million) and are to be rolled out next year.
. . .
Toronto was one of the first North American cities to introduce a mandatory green-bin program, as part of an effort to keep local landfills from overflowing and after years of a highly contentious cross-border garbage-disposal program in Michigan.
. . .
Ms. MacDonald believes the growing intelligence of Toronto’s raccoons may be linked to the efforts people have put into outwitting them.
Her research, which has received financial backing from the National Geographic Society, suggests urban raccoons are smarter than their “country cousins,” driven to new heights of intelligence by the humans working so diligently to outsmart them by creating obstacles.
“We’re creating our environment in such a way that they have to be able to figure them out in order to survive,” she said, “and those that figure them out will be smart and survive and pass on to their offspring.”

For the full story, see:
JANE GERSTER. “Toronto Vows to Outsmart Its Raccoons; Hoping to stymie critters, city will roll out new green bins; ‘Defeat is not an option’.” The Wall Street Journal (Mon., Aug. 24, 2015): A1 & A8.
(Note: ellipses added.)
(Note: the online version of the story was updated on Aug. 23, 2015, and has the title “Toronto Vows to Outsmart Its Raccoons; Hoping to stymie critters, city will roll out new green bins; ‘Defeat is not an option’.”)

The Morality of Denying Hope to 30 Million Guanggun

(p. A4) One wife, many husbands.
That’s the solution to China’s huge surplus of single men, says Xie Zuoshi, an economics professor at the Zhejiang University of Finance and Economics, whose recent proposal to allow polyandry has gone viral.
. . .
By 2020, China will have an estimated 30 million bachelors — called guanggun, or “bare branches.” Birth control policies that since 1979 have limited many families to one child, a cultural preference for boys and the widespread, if illegal, practice of sex-selective abortion have contributed to a gender imbalance that hovers around 117 boys born for every 100 girls.
Though some could perhaps detect a touch of Jonathan Swift in the proposal, Mr. Xie wrote that he was approaching the problem from a purely economic point of view.
Many men, especially poor ones, he noted, are unable to find a wife and have children, and are condemned to living and dying without offspring to support them in old age, as children are required to do by law in China. But he believes there is a solution.
. . .
“With so many guanggun, women are in short supply and their value increases,” he wrote. “But that doesn’t mean the market can’t be adjusted. The guanggun problem is actually a problem of income. High-income men can find a woman because they can pay a higher price. What about low-income men? One solution is to have several take a wife together.”
He added: “That’s not just my weird idea. In some remote, poor places, brothers already marry the same woman, and they have a full and happy life.”
. . .
On Sunday [October 25, 2015], he published an indignant rebuttal on one of his blogs, accusing his critics of being driven by empty notions of traditional morality that are impractical and selfish — even hypocritical.
“Because I promoted the idea that we should allow poor men to marry the same woman to solve the problem of 30 million guanggun, I’ve been endlessly abused,” he wrote. “People have even telephoned my university to harass me. These people have groundlessly accused me of promoting immoral and unethical ideas.
“If you can’t find a solution that doesn’t violate traditional morality,” he continued, “then why do you criticize me for violating traditional morality? You are in favor of a couple made up of one man, one woman. But your morality will lead to 30 million guanggun with no hope of finding a wife. Is that your so-called morality?”

For the full story, see:
DIDI KIRSTEN TATLOW. “Bachelor Glut in China Leads to a Proposal: Share Wives.” The New York Times (Tues., OCTOBER 27, 2015): A4.
(Note: ellipses, and bracketed date, added.)
(Note: the online version of the story has the date OCTOBER 26, 2015, and has the title “Not Enough Women in China? Let Men Share a Wife, an Economist Suggests.”)

“Racist” Woodrow Wilson Adopted “White Supremacy as Government Policy”

(p. A25) In 1882, soon after graduating from high school, the young John Davis secured a job at the Government Printing Office.

Over a long career, he rose through the ranks from laborer to a position in midlevel management. He supervised an office in which many of his employees were white men. He had a farm in Virginia and a home in Washington. By 1908, he was earning the considerable salary — for an African-American — of $1,400 per year.
But only months after Woodrow Wilson was sworn in as president in 1913, my grandfather was demoted. He was shuttled from department to department in various menial jobs, and eventually became a messenger in the War Department, where he made only $720 a year.
By April 1914, the family farm was auctioned off. John Davis, a self-made black man of achievement and stature in his community at the turn of the 20th century, was, by the end of Wilson’s first term, a broken man. He died in 1928.
Many black men and women suffered similar fates under Wilson. As the historian Eric S. Yellin of the University of Richmond documents in his powerful book “Racism in the Nation’s Service,” my grandfather’s demotion was part of a systematic purge of the federal government; with Wilson’s approval, in a few short years virtually all blacks had been removed from management responsibilities, moved to menial jobs or simply dismissed.
My grandfather died before I was born, but I have learned much about his struggle — and that of other black civil servants in the federal government — from his personnel file.
. . .
Consider a letter he wrote on May 16, 1913, barely a month after his demotion. “The reputation which I have been able to acquire and maintain at considerable sacrifice,” he wrote, “is to me (foolish as it may appear to those in higher stations of life) a source of personal pride, a possession of which I am very jealous and which is possessed at a value in my estimation ranking above the loss of salary — though the last, to a man having a family of small children to rear, is serious enough.”
And the reply he received? His supervisor said, simply, that my grandfather was unable to “properly perform the duties required (he is too slow).” Yet there had never been any indication of this in his personnel file.
Wilson was not just a racist. He believed in white supremacy as government policy, so much so that he reversed decades of racial progress. But we would be wrong to see this as a mere policy change; in doing so, he ruined the lives of countless talented African-Americans and their families.

For the full commentary, see:
GORDON J. DAVIS. “Wilson, Princeton and Race.” The New York Times (Tues., NOV. 24, 2015): A25.
(Note: ellipsis added.)
(Note: the online version of the commentary has the title “What Woodrow Wilson Cost My Grandfather.”)

The Yellin book praised in the passage quoted above, is:
Yellin, Eric S. Racism in the Nation’s Service: Government Workers and the Color Line in Woodrow Wilson’s America. Chapel Hill, NC: The University of North Carolina Press, 2013.

See also:
Patler, Nicholas. Jim Crow and the Wilson Administration: Protesting Federal Segregation in the Early Twentieth Century. Boulder, CO: University Press of Colorado, 2004.

While Woodrow Wilson Was President of Princeton, “No Blacks Were Admitted”

(p. A1) PRINCETON, N.J. — Few figures loom as large in the life of an Ivy League university as Woodrow Wilson does at Princeton.

. . .
But until posters started appearing around campus in September, one aspect of Wilson’s legacy was seldom discussed: his racist views, and the ways he acted on them as president of the United States.
The posters, put up by a year-old student group called the Black Justice League, featured some of Wilson’s more offensive quotes, including his comment to an African-American leader that “segregation is not humiliating, but a benefit, and ought to be so regarded by you,” and led to a remarkable two days at this genteel (p. A17) campus last week.
. . .
Perhaps best known for leading the United States during World War I and for trying to start the League of Nations, Wilson as president rolled back gains blacks had made since Reconstruction, removing black officials from the federal government and overseeing the segregation of rank-and-file workers.
Raised in the South, he wrote of “a great Ku Klux Klan” that rose up to rid whites of “the intolerable burden of governments sustained by the votes of ignorant Negroes.”
During Wilson’s tenure as president of Princeton, no blacks were admitted — “The whole temper and tradition of the place are such that no Negro has ever applied,” he wrote — though Harvard and Yale had admitted blacks decades earlier. Princeton admitted its first black student in the 1940s.

For the full story, see:
ANDY NEWMAN. “At Princeton, Woodrow Wilson, a Heralded Alum, Is Recast as an Intolerant One.” The New York Times (Mon., NOV. 23, 2015): A1 & A17.
(Note: ellipses added.)
(Note: the online version of the story has the date NOV. 22, 2015.)

Bike Helmet Regulations Hurt Health

(p. D1) . . . many cycling advocates have taken a surprising position: They are pushing back against mandatory bike-helmet laws in the U.S. and elsewhere. They say mandatory helmet laws, particularly for adults, make cycling less convenient and seem less safe, thus hindering the larger public-health gains of more people riding bikes.
All-ages helmet laws might actually make cycling more dangerous, some cyclists say, by decreasing ridership. Research shows that the more cyclists there are on the road, the fewer crashes there are. Academics theorize that as drivers become used to seeing bikes on a street, they watch more closely for them.
. . .
Piet de Jong, a professor in the department of applied finance and actuarial studies at Sydney’s Macquarie University, actually calculated the trade-off of mandatory helmet laws. In a 2012 paper in the journal Risk Analysis, he weighed the reduction of head injuries against increased morbidity due to foregone exercise from reduced cycling.
Dr. de Jong concluded that mandatory bike-helmet laws “have a net negative health impact.” That is in part because many people cycle to work or for errands, experts say. People tend to replace that type of cycling not with another physical activity such as a trip to the gym, but with a ride in a car.

For the full story, see:
RACHEL BACHMAN. “The Helmet-Law Backlash.” The Wall Street Journal (Tues., Oct. 13, 2015): D1 & D4.
(Note: ellipses added.)
(Note: the online version of the article was dated Oct. 12, 2015, and has the title “Do Bike Helmet Laws Do More Harm Than Good?”)

After Hiding Under Desk, Student Wants Gun to Protect Self and Others

(p. A1) ROSEBURG, Ore. — A week has passed since J. J. Vicari huddled underneath a desk while gunshots exploded in the classroom next door. Now he is thinking about guns. Not about tightening gun laws, as President Obama urged after nine people were killed at the community college here. But about buying one for himself.
“It’s opened my eyes,” said Mr. Vicari, 19. “I want to have a gun in the house to protect myself, to protect the people I’m with. I’m sure I’ll have a normal life and never have to go through anything like this, but I want to be sure.”

For the full story, see:
JACK HEALY and JULIE TURKEWITZ. “Common Response After Killings in Oregon: ‘I Want to Have a Gun’.” The New York Times (Thurs., OCT. 8, 2015): A1 & A18.
(Note: the online version of the article was dated OCT. 7, 2015.)

Chinese Communists Fear the Magna Carta

(p. A5) HONG KONG — China’s leaders have long behaved as if nothing could daunt them. But an 800-year-old document written in Latin on sheepskin may have them running scared.
. . .
It is not clear why the public showing was moved off the Renmin University campus. But Magna Carta is widely considered a cornerstone for constitutional government in Britain and the United States, and such a system is inimical to China’s leaders, who view “constitutionalism” as a threat to Communist Party rule.
In 2013, the party issued its “seven unmentionables” — taboo topics for its members. The first unmentionable is promoting Western-style constitutional democracy. The Chinese characters for “Magna Carta” are censored in web searches on Sina Weibo, the country’s Twitter-like social media site.
Hu Jia, a prominent Chinese dissident, said he was not surprised that the exhibit had been moved off the campus. He said that Renmin University had close ties to the Communist Party’s training academy and that the principles the document stood for were contrary to the party’s. More important, he said, Chinese leaders may have been concerned that the exhibit would be popular and that “many students would flock there.”
“They fear that such ideology and historical material will penetrate deep into the students’ hearts,” Mr. Hu said.
. . .
Magna Carta has been the subject of several academic conferences and lectures in China this year, including two at Renmin University. One doctoral student in history who knows people at the museum said that the school had canceled the exhibit on orders of the Ministry of Education.
“To get kind of wound up about an old document like the Magna Carta? They’re a little bit brittle and fragile, aren’t they, Chinese leaders?” said Kerry Brown, a former British diplomat who was stationed in Beijing and now serves as director of the China Studies Center at the University of Sydney in Australia. “Poor dears.”

For the full story, see:
MICHAEL FORSYTHE. “Magna Carta Visits China, but Venue Abruptly Shifts.” The New York Times (Thurs., OCT. 15, 2015): A5.
(Note: ellipses added.)
(Note: the online version of the article was dated OCT. 14, 2015, and had the title “Magna Carta Exhibition in China Is Abruptly Moved From University.”)