Government – Page 89 – artdiamondblog.com

To Cure Fatal Diseases We Need More Financial Incentives and Fewer F.D.A. Restrictions

“JOSHUA THOMPSON with his sons, Wyatt and Jordan, after his diagnosis, top, and before, with his wife, Joy, and Wyatt.” Source of the photos and caption: online version of the NYT article quoted and cited below.

(p. 1) VIRGINIA BEACH — As Lou Gehrig’s disease sapped Joshua Thompson of his ability to move and speak last fall, he consistently summoned one question from within the prison of his own body. “Iplex,” he asked, in a whisper that pierced his mother’s heart. “When?”

Iplex had never been tested in people with amyotrophic lateral sclerosis, the formal name for the fatal disease that had struck Joshua, 34, in late 2006. Developed for a different condition and banished from the market by a patent dispute, it was not for sale to the public anywhere in the world.
But Kathy Thompson had vowed to get it for her son. On the Internet, she had found enthusiastic reviews from A.L.S. patients who had finagled a prescription for Iplex when it was available, along with speculation by leading researchers as to why it might slow the progressive paralysis that marks the disease. And for months, as she begged and bullied biotechnology companies, members of Congress, Italian doctors and federal drug regulators, she answered Joshua the same way:
“Soon,” she said. “Soon.”
At a time when terminally ill patients have more access to medical research than ever before, and perhaps a deeper conviction in its ability to cure them, many are campaigning for the chance to be treated with drugs whose safety and effectiveness is not yet known.
. . .
(p. 19) “Josh’s sadness is unbearable,” his mother wrote one night in her journal, nearly a year after her son’s diagnosis.
Unexpected encouragement came in a Mother’s Day note from her ex-husband. “You have given me some peace of mind that all potential options for Josh are being researched and acted upon,” Bruce wrote. “Thank you.”
Kathy’s boyfriend accompanied her to Insmed’s headquarters in Richmond, Va., offering to raise several million dollars to underwrite a compassionate use program for Iplex in the United States with A.L.S. patients. But the couple came away with a new understanding: F.D.A. regulations, they were told, prohibit any company from profiting on compassionate use. Even if Insmed could wriggle free of restrictions in the patent agreement, there was little financial incentive for it to invest in making the drug solely for compassionate use by A.L.S. patients.
. . .
On Jan. 16, when Dr. Werwath called to tell her the application had been rejected, she stood up in disbelief.
“How could that be?” she asked, dazed.
Kathy’s friend Mrs. Reimers had received a call with the same news.
“He said they had safety concerns,” Mrs. Reimers said. “This for a drug that was approved for children!”
“Safety,” Kathy repeated. “And what, exactly, is safe about A.L.S.?”

Appealing an F.D.A. Denial
Before the F.D.A.’s decision, Kathy had spared little thought for any broader meaning of her quest for Joshua. But when she met with Richard A. Samp, a lawyer with the Washington Legal Foundation a week later, her outrage went beyond her son, and beyond Iplex.
“The F.D.A. is supposed to protect American citizens,” Kathy fumed over an iced tea in Williamsburg, Va. “How does denying dying patients access to this drug serve the common good?”
Mr. Samp had handled a lawsuit by a patient advocacy group, the Abigail Alliance, that had sought to establish a constitutional right for terminally ill patients to use experimental drugs. In the case, which the group had lost on appeal in 2007, the F.D.A. claimed that it granted “nearly all” requests for compassionate use.
They would first make an administrative appeal, Mr. Samp told Kathy, asserting that the F.D.A. had violated its own guidelines. If that failed, they could pursue litigation that might allow them to raise the constitutional question again in a federal court in Virginia.
. . .
Kathy was pouring milk for her cereal on the morning of March 10 when Dr. Werwath’s number flashed on her phone. The F.D.A. had just reversed itself, he said.
Before she could take a breath, Senator Mark Warner’s office called. E-mail bleeped in as the news seeped out.
In the weeks after the appeal, Kathy learned, the F.D.A. had reached out to Insmed. The agency had persuaded the company to run a clinical trial for Iplex with several dozen A.L.S. patients, and permitted it to recoup the hefty costs directly from participants. In the trial, some of the participants would get a placebo. That way, the F.D.A. wrote on its Web site, the next wave of A.L.S. patients would learn whether the drug was in fact beneficial or harmful.
But for now, the agency had ruled, Joshua and 12 other patients would be given Iplex outside of the trial, on a compassionate use basis, if they agreed to read all the data about the risks.

For the full version of a very long story, see:
AMY HARMON. “Months to Live; Fighting for a Last Chance at Life; One Family’s Tenacious Campaign for Access to an Unproven Drug.” The New York Times, First Section (Sun., May 17, 2009): 1, 18-19.
(Note: ellipses added.)

“IN MARCH, Joshua Thompson received his first Iplex injection, from Dr. David L. Werwath. Thereafter Joshua’s wife, Joy, left, and mother, Kathy, took over the daily duties.” Source of the photo and caption: online version of the NYT article quoted and cited above.

“Don’t Kill the Goose”

(p. A11) I think there are two major but not fully formed or fully articulated fears among thinking Americans right now, and the deliberate obscurity of official language only intensifies those fears.

The first is that Mr. Obama’s government, in all its flurry of activism, may kill the goose that laid the golden egg. This is as dreadful and obvious a cliché as they come, but too bad, it’s what people fear. They see the spending plans and tax plans, the regulation and reform hunger, the energy proposals and health-care ambitions, and they–we–wonder if the men and women doing all this, working in their separate and discrete areas, are being overseen by anyone saying, “By the way, don’t kill the goose.”
The goose of course is the big, messy, spirited, inspiring, and sometimes in some respects damaging but on the whole brilliant and productive wealth-generator known as the free-market capitalist system. People do want things cleaned up and needed regulations instituted, and they don’t mind at all if the very wealthy are more heavily taxed, but they greatly fear a goose killing. Economic freedom in all its chaos and disorder has kept us rich for 200 years, and allowed us as a nation to be generous and strong at home and in the world. But the goose can be killed–by carelessness, hostility, incrementalism, paralysis, and by no one saying, “Don’t kill the goose.”

For the full commentary, see:
PEGGY NOONAN. “What’s Elevated, Health-Care Provider? Economy of language would be good for the economy.” Wall Street Journal (Sat., MAY 15, 2009): A11.

French People Sleep More Than Those in Other Industrialized Countries

My hypothesis is not that the French are lazier than others, but that their labor policies give them less incentive to work.

(p. A8) PARIS — When he won the presidential election two years ago, Nicolas Sarkozy urged the French to get up early and work more to earn more.

A study released Monday suggests they missed the wake-up call.
France is the industrialized country where people spend the longest periods sleeping, according to a series of surveys on social habits conducted by the Paris-based Organization for Economic Cooperation & Development.
The French sleep a daily average of 530 minutes, compared with 518 for Americans and 469 for Koreans — the OECD’s “most awake” nation, according to the study.

For the full story, see:
DAVID GAUTHIER-VILLARS. “France Wrests Title of Sleeping Giant.” Wall Street Journal (Tues., MAY 5, 2009): A8.

Powerful Rail Unions Defend Specious Disability Claims

“LAX REGULATIONS; One examination in 1997 found that 97 percent of workers who applied for disability benefits from the Railroad Retirement Board were approved. Despite decades of efforts to re-evaluate the standards, the rate is as high or higher today.” Source of photo and caption: online version of the NYT article quoted and cited below.

(p. A1) After learning that most of her career employees were retiring early and getting disability payments, the Long Island Rail Road’s president, Helena E. Williams, set out in October to learn more about the obscure federal agency in Chicago that was dispensing the money, a quarter of a billion dollars since 2000.

But when Ms. Williams asked to attend the next meeting of the agency — the federal Railroad Retirement Board, rail workers’ version of Social Security — she got a surprise.
The board, with about $34 billion in assets, had not met formally in nearly two years, and no new meeting was scheduled. The three board members, all full-time presidential appointees, rarely met even in private, employees of the agency say.
Operating out of public view, with little scrutiny from Congress and even from its former inspector general, the retirement board has become the agency that cannot say no, last year approving virtually every single disability application it received — almost 98 percent. It did not matter where rail employees lived or where they worked.
An examination of the board by The New York Times, including dozens of interviews and a review of government records, found a disability program plagued by labor-management infighting, weak standards and a failure to use tests that could better weed out specious disability claims.
. . .
(p. A25) More than a half-dozen state and federal agencies are now investigating the retirement board’s disability payments to former L.I.R.R. employees. In September, two days after The Times published the results of an eight-month investigation that documented those disability payments, federal agents raided the board’s Long Island office.
The L.I.R.R.’s disability rate, which since 2000 has ranged between 93 percent and 97 percent for retired career employees, is three to four times that of the average railroad. Workers at other railroads get disabilities just as easily, but they file for them less often because, unlike L.I.R.R. employees, they cannot retire early with a private pension plan to supplement their disability pay.
. . .
The rail unions, which have remained powerful even as the nation’s labor movement has ebbed, have aggressively defended their interests at the retirement board. Management has largely avoided a showdown, choosing to spend its political capital in other areas, including contract issues, according to current and former board officials.
“The unions have been successful not only in getting a separate system, but keeping it,” said Robert S. Kaufman, a former director of retirement claims for the board.

For the full story, see:
WALT BOGDANICH and NICHOLAS PHILLIPS. “The Railroad Disability Board That Couldn’t Say No.” The New York Times (Mon., December 15, 2008): A1 & A25.
(Note: ellipses added; the online version of the title leaves out the word “Railroad.”)

Source of time-line graphic: online version of the NYT article quoted and cited above.

Taiwan Government’s Industrial Policy Ruins Economy

Source of graphic: online version of the NYT article quoted and cited below.

(p. A8) Taiwan, where for years the government encouraged information technology companies with tax breaks, cheap land, loans and more, is probably the most endangered of the small Asian economies. The result of that government largess is an economy extremely dependent on a single industrial sector that has been devastated by plunging worldwide sales of electronics. “Half of the industries just got a bad cold, they probably can recover quickly — the other 50 percent, they’ve got, not cancer, but close,” said Preston W. Chen, a chemicals tycoon who is also the chairman of Taiwan’s Chinese National Federation of Industries.

For the full article, see:
KEITH BRADSHER. “Memo From Singapore – East Asia’s Small Edens of Trade Wilt as Need for Exports Dries Up.” The New York Times (Thurs., March 5, 2009): A8.

The Ascent of Science Led to Belief that the World Could Improve

I believe the following paragraph expresses the central message of Steven Johnson’s book The Invention of Air:

(p. 211) In the popular folklore of American History, there is a sense in which the founders’ various achievements in natural philosophy—Franklin’s electrical experiments, Jefferson’s botany—serve as a (p. 212) kind of sanctified extracurricular activity. They were statesmen and political visionaries who just happened to be hobbyists in science, albeit amazingly successful ones. Their great passions were liberty and freedom and democracy; the experiments were a side project. But the Priestley view suggests that the story has it backward. Yes, they were hobbyists and amateurs at natural philosophy, but so were all the great minds of Enlightenment-era science. What they shared was a fundamental belief that the world could change—that it could improve— if the light of reason was allowed to shine upon it. And that believe emanated from the great ascent of science over the past century, the upward trajectory that Priestley had s powerfully conveyed in his History and Present State of Electricity. The political possibilities for change were modeled after the change they had all experience through the advancements in natural philosophy. With Priestley, they grasped the political power of the air pump and the electrical machine.

Source:
Johnson, Steven. The Invention of Air: A Story of Science, Faith, Revolution, and the Birth of America. New York: Riverhead Books, 2008.
(Note: italics in original.)

Adams, as a Point of Honor, Defended the Innovations of Science

(p. 211) It is no accident that, despite the long litany of injuries Adams felt had been dealt him in Jefferson’s letters to Priestley, he chose to begin his counterassault by denying, as a point of honor, that he had ever publicly taken a position as president that was resistant to the innovations of science. Remember that Jefferson had also insinuated that Adams had betrayed the Constitution with his “libel on legislation.” But Adams lashed out first at the accusation that he was anti-science. That alone tells us something about the gap that separates the current political climate from that of the founders.

Source:
Johnson, Steven. The Invention of Air: A Story of Science, Faith, Revolution, and the Birth of America. New York: Riverhead Books, 2008.

“Infinitely Smart” Physicist and Futurist Expresses Global Warming Doubts

Dyson says that the “climate-studies people” have “. . . come to believe models are real and forget they are only models.” Source of photo and caption: online version of the NYT article quoted and cited below. (The caption used here is adapted from the body of the article, and is not the caption used under the photo in the article.)

The cover story of the March 29, 2009 Sunday New York Times Magazine section was a breath of fresh air on an old hot topic. Here is a small sample of a large article:

(p. 32) FOR MORE THAN HALF A CENTURY the eminent physicist Freeman Dyson has quietly resided in Princeton, N.J., on the wooded former farmland that is home to his employer, the Institute for Advanced Study, this country’s most rarefied community of scholars. Lately, however, since coming “out of the closet as far as global warming is concerned,” as Dyson sometimes puts it, there has been noise all around him. Chat rooms, Web threads, editors’ letter boxes and Dyson’s own e-mail queue resonate with a thermal current of invective in which Dyson has discovered himself variously described as “a pompous twit,” “a blowhard,” “a cesspool of misinformation,” “an old coot riding into the sunset” and, perhaps inevitably, “a mad scientist.” Dyson had proposed that whatever inflammations the climate was experiencing might be a (p. 34 sic) good thing because carbon dioxide helps plants of all kinds grow. Then he added the caveat that if CO2 levels soared too high, they could be soothed by the mass cultivation of specially bred “carbon-eating trees,” whereupon the University of Chicago law professor Eric Posner looked through the thick grove of honorary degrees Dyson has been awarded — there are 21 from universities like Georgetown, Princeton and Oxford — and suggested that “perhaps trees can also be designed so that they can give directions to lost hikers.” Dyson’s son, George, a technology historian, says his father’s views have cooled friendships, while many others have concluded that time has cost Dyson something else. There is the suspicion that, at age 85, a great scientist of the 20th century is no longer just far out, he is far gone — out of his beautiful mind.

But in the considered opinion of the neurologist Oliver Sacks, Dyson’s friend and fellow English expatriate, this is far from the case. “His mind is still so open and flexible,” Sacks says. Which makes Dyson something far more formidable than just the latest peevish right-wing climate-change denier. Dyson is a scientist whose intelligence is revered by other scientists — William Press, former deputy director of the Los Alamos National Laboratory and now a professor of computer science at the University of Texas, calls him “infinitely smart.” Dyson — a mathematics prodigy who came to this country at 23 and right away contributed seminal work to physics by unifying quantum and electrodynamic theory — not only did path-breaking science of his own; he also witnessed the development of modern physics, thinking alongside most of the luminous figures of the age, including Einstein, Richard Feynman, Niels Bohr, Enrico Fermi, Hans Bethe, Edward Teller, J. Robert Oppenheimer and Edward Witten, the “high priest of string theory” whose office at the institute is just across the hall from Dyson’s. Yet instead of hewing to that fundamental field, Dyson chose to pursue broader and more unusual pursuits than most physicists — and has lived a more original life.
. . .
(p. 36) Not long ago Dyson sat in his institute office, a chamber so neat it reminds Dyson’s friend, the writer John McPhee, of a Japanese living room. On shelves beside Dyson were books about stellar evolution, viruses, thermodynamics and terrorism. “The climate-studies people who work with models always tend to overestimate their models,” Dyson was saying. “They come to believe models are real and forget they are only models.” Dyson speaks in calm, clear tones that carry simultaneous evidence of his English childhood, the move to the United States after completing his university studies at Cambridge and more than 50 years of marriage to the German-born Imme, but his opinions can be barbed, especially when a conversation turns to climate change. Climate models, he says, take into account atmospheric motion and water levels but have no feeling for the chemistry and biology of sky, soil and trees. “The biologists have essentially been pushed aside,” he continues. “Al Gore’s just an opportunist. The person who is really responsible for this overestimate of global warming is Jim Hansen. He consistently exaggerates all the dangers.”
Dyson agrees with the prevailing view that there are rapidly rising carbon-dioxide levels in the atmosphere caused by human activity. To the planet, he suggests, the rising carbon may well be a MacGuffin, a striking yet ultimately benign occurrence in what Dyson says is still “a relatively cool period in the earth’s history.” The warming, he says, is not global but local, “making cold places warmer rather than making hot places hotter.” Far from expecting any drastic harmful consequences from these increased temperatures, he says the carbon may well be salubrious — a sign that “the climate is actually improving rather than getting worse,” because carbon acts as an ideal fertilizer promoting forest growth and crop yields. “Most of the evolution of life occurred on a planet substantially warmer than it is now,” he contends, “and substantially richer in carbon dioxide.” Dyson calls ocean acidification, which many scientists say is destroying the saltwater food chain, a genuine but probably exaggerated problem. Sea levels, he says, are rising steadily, but why this is and what dangers it might portend “cannot be predicted until we know much more about its causes.”

For the full article, see:

NICHOLAS DAWIDOFF. “The Civil Heretic.” The New York Times Magazine (Sun., March 29, 2009): 32-39, 54, 57-59.
(Note: ellipses in top photo caption, and in article quotes, are added.)

“Freeman Dyson.” Source of photo and caption: online version of the NYT article quoted and cited above.

Entrepreneurs, Not MITI, Decided Japan Outcomes in ’60s, ’70s and ’80s

(p. 164) Ishibashi’s regime was followed in the early 1960s by the “income-doubling campaign” of his associate Hayato Ikeda, who assumed power in 1961 and continued the supply-side thrust. The result was a steady upsurge of domestic growth, with firms and industries rapidly gaining experience in intense rivalries at home before entering the global arena as low-cost producers, and with government cutting taxes and increasing revenues and savings.

It is from this domestic crucible of intense competition with normal rates of bankruptcy far above those in the United States, with scores of rivals in every field, that the great Japanese companies have emerged. At various times during the last three decades, for example, there have been 58 integrated steel firms, 50 motorbike companies, 12 auto firms, 42 makers of hand-held calculators, 13 makers of facsimile machines, and 250 producers of robots. Overlooking this welter are always the crested bureaucrats of MITI, sometimes offering useful aid and guidance–but at the center, deciding outcomes, have always been the entrepreneurs.

Source:
Gilder, George. Recapturing the Spirit of Enterprise: Updated for the 1990s. updated ed. New York: ICS Press, 1992.

Honest Indian Economist Wins (Charisma is Not Always What Matters Most)

“India’s Prime Minister Manmohan Singh, left, and Rahul Gandhi wave to supporters during an election campaign rally in the northern Indian city of Amritsar May 11.” Source of photo and caption: online version of the WSJ article quoted and cited below.

(p. A12) “Manmohan Singh will be our prime minister,” said Sonia Gandhi, president of the Congress party, at a televised news conference with Mr. Singh. Mr. Singh, in typically low-key fashion, spoke at the same conference in such a quiet voice that his two minutes of remarks were inaudible over the din of the press corps, and he was forced to return to the microphone to repeat them. “The public has expressed faith in Congress,” he mumbled.
. . .
Mr. Singh, who earned honors from Cambridge University in economics and a doctorate from Oxford, was an architect of India’s economic reforms in 1991 that are credited with setting the nation on course for the economic boom it has had over the past few years but that is now slowing. He is widely seen as honest in a system where bribery of politicians and voters is commonplace and more than 1,000 political candidates in the national elections faced various criminal charges.
The election “is an endorsement of the programs and policies initiated by Manmohan Singh,” said Sanjay Kumar, fellow at the Centre for the Study of Developing Societies in New Delhi.

For the full commentary, see:
PAUL BECKETT and VIBHUTI AGARWAL. “Voters Give Singh New Political Life — and a Mandate; Decisive Re-Election Presents New Opportunity to Indian Prime Minister; Reaching Out to Rahul Gandhi, and Youth.” Wall Street Journal (Mon., MAY 18, 2009): A12.
(Note: ellipsis added.)
(Note: the second and third paragraphs quoted above were somewhat different in the print and online versions; the online version is quoted here. The first paragraph is the same in both versions.)