Patients Face Higher Costs and Less Innovation Due to FDA

CongerMartiDiskImplant2011-05-16.jpg“Marti Conger, a business consultant in Benicia, Calif., went to England in October 2009 to get an implant of a new artificial disk for her spine developed by Spinal Kinetics of Sunnyvale, Calif., a short distance from her home.” Source of caption and photo: online version of the NYT article quoted and cited below.

(p. B1) Late last year, Biosensors International, a medical device company, shut down its operation in Southern California, which had once housed 90 people, including the company’s top executives and researchers.

The reason, executives say, was that it would take too long to get its new cardiac stent approved by the Food and Drug Administration.
“It’s available all over the world, including Mexico and Canada, but not in the United States,” said the chief executive, Jeffrey B. Jump, an American who runs the company from Switzerland. “We decided, let’s spend our money in China, Brazil, India, Europe.”
. . .
(p. B7) “Ten years from now, we’ll all get on planes and fly somewhere to get treated,” said Jonathan MacQuitty, a Silicon Valley venture capitalist with Abingworth Management.
Marti Conger, a business consultant in Benicia, Calif., already has. She went to England in October 2009 to get an implant of a new artificial disk for her spine developed by Spinal Kinetics of Sunnyvale, Calif.
“Sunnyvale is 40 miles south of my house,” said Ms. Conger, who has become an advocate for faster device approvals in the United States. “I had to go to England to get my surgery.”
. . .
Device companies have been seeking early approval in Europe for years because it is easier. In Europe, a device must be shown to be safe, while in the United States it must also be shown to be effective in treating a disease or condition. And European approvals are handled by third parties, not a powerful central agency like the F.D.A.
But numerous device executives and venture capitalists said the F.D.A. has tightened regulatory oversight in the last couple of years. Not only does it take longer to get approval but it can take months or years to even begin a clinical trial necessary to gain approval.
Disc Dynamics made seven proposals over three years but could not get clearance from the F.D.A. to conduct a trial of its gel for spine repair, said David Stassen, managing partner of Split Rock Partners, a venture firm that backed the company. “It got to the point where the company just ran out of cash,” Mr. Stassen said. Disc Dynamics was shut down last year after an investment of about $65 million.

For the full story, see:
ANDREW POLLACK. “Medical Treatment, Out of Reach.” The New York Times (Thurs., February 10, 2011): B1 & B7.
(Note: ellipses added.)
(Note: the online version of the story is dated February 9, 2011.)

ArtificialDisk2011-05-16.jpg

“An artificial disk like the one Marti Conger received.”
Source of caption and photo: online version of the NYT article quoted and cited above.

Risking Likely Death for a Tiny Chance to “Dwell in Freedom and Earn $5.15 an Hour”

(p. 281) For all the legitimate problems people experience in the Western nations, we cannot imagine a world which generates such hopelessness that people will hurl themselves toward moving trains, or climb into the wheel wells of jetliners bound for the sky in order to have a tiny chance of getting to a place where they can dwell in freedom and earn $5.15 an hour.

Source:
Easterbrook, Gregg. The Progress Paradox: How Life Gets Better While People Feel Worse. Paperback ed. New York: Random House, 2004.

“A Dart-Throwing Chimpanzee” Predicts as Well as “Experts”

FutureBabble BK.jpg

The image is of the Canadian edition, which has a different subtitle than the American edition cited below. Source of book image: http://3.bp.blogspot.com/_qGSiMLu6NXM/TTWIQkcllmI/AAAAAAAADEI/qD2yo1rxnL0/s1600/Future%2BBabble.jpg

(p. C6) How bad are expert predictions? Almost predictably bad. In 2005, Philip Tetlock, a professor of psychology at the University of Pennsylvania, published the results of a magisterial 20-year analysis of 27,450 judgments about the future from 284 experts. He discovered that the experts, in aggregate, did little better, and sometimes considerably worse, than “a dart-throwing chimpanzee.”

While Mr. Tetlock guaranteed anonymity to get his experts to reveal how useless they were, Mr. Gardner names names. In the late 1960s, he notes, the political scientist Andrew Hacker predicted that race relations in America would soon get so bad that they would lead to the “dynamiting of bridges and water mains” and the “assassinating of public officials and private luminaries.” In the early 1970s, Richard Falk, at Princeton, imagined that by the 1990s we would be living in a world dominated by “the politics of catastrophe.” In the mid-1970s, Daniel Bell and other analysts assumed that high levels of inflation were, as Mr. Gardner puts it, “here to stay.” (In fact, inflation cooled off in the early 1980s and has stayed low for decades.) In the early 1990s, Lester Thurow, the MIT economist, was one of the experts who predicted that Japan would dominate the 21st century, though he noted that Europe had a chance, too.
The high priest of erroneous prediction is, of course, Paul Ehrlich, who, though a respected entomologist, turned into an end-of-the-worlder with “The Population Bomb” (1968) and “The End of Affluence” (1974). In the latter book he wrote: “If I were a gambler, I would take even money that England will not exist in the year 2000.” Now 77, Mr. Ehrlich is “a gregarious and delightful man, a natural performer,” Mr. Gardner reports, thereby tapping into the sources of his success in the face of repeated failure: Never admit mistakes, never sound doubtful. As Mr. Gardner shows in his survey of expert prediction-making, the more you sound like you know what you are talking about, the more people will believe you.

For the full review, see:
TREVOR BUTTERWORTH. “Prophets of Error.” Wall Street Journal (Sat., APRIL 30, 2011): C6.
(Note: the online version of the article is dated APRIL 30, 2011.)

The book being reviewed, is:
Gardner, Dan. Future Babble: Why Expert Predictions Are Next to Worthless, and You Can Do Better. New York: Dutton Adult, 2011.

The important Tetlock book mentioned, is:
Tetlock, Philip E. Expert Political Judgment: How Good Is It? How Can We Know? Princeton, NJ: Princeton University Press, 2005.

Income Inequality Makes People Happy When It Gives Them Hope

(p. A19) If the royal family were to utilize Kate’s background to help encourage and spread this culture of entrepreneurship, the effects in Britain–and possibly much of the world–could be incredible. The people of the United Kingdom would be much richer, and not just in material terms. “Earned success gives people a sense of meaning about their lives,” writes the social scientist Arthur Brooks, who is president of the American Enterprise Institute think tank.

Indeed, studies show that in both the U.S. and U.K., many blue- and white-collar workers prefer to have the opportunity to advance, even if this means a less equal income distribution. A study of thousands of British employees by Andrew Clark, associate chair of the Paris School of Economics, found that measures of these workers’ happiness actually rose as their demographic group’s average income increased relative to their own.

These findings suggests that as people see members of their peer group gain wealth–even surpassing them–it gives them hope that they can improve their lot as well. As Mr. Clark put it in his study of British workers, “income inequality . . . need not be harmful for economic growth” if it “contains an aspect of opportunity.”

For the full story, see:
JOHN BERLAU. “The Entrepreneurs’ Princess; For centuries in Britain, commercial activities were looked down upon by the aristocracy, whose wealth lay in landownership.” Wall Street Journal (Thurs., APRIL 28, 2011): A17.

Data on Race Are Muddled by Melting Pot

LopezMullinsRaceGraph2011-05-09.jpgSource of graph: online version of the NYT article quoted and cited below.

(p. A1) The federal Department of Education would categorize Michelle López-Mullins — a university student who is of Peruvian, Chinese, Irish, Shawnee and Cherokee descent — as “Hispanic.” But the National Center for Health Statistics, the government agency that tracks data on births and deaths, would pronounce her “Asian” and “Hispanic.” And what does Ms. López-Mullins’s birth certificate from the State of Maryland say? It doesn’t mention her race.

Ms. López-Mullins, 20, usually marks “other” on surveys these days, but when she filled out a census form last year, she chose Asian, Hispanic, Native American and white.
The chameleon-like quality of Ms. López-Mullins’s racial and ethnic identification might seem trivial except that statistics on ethnicity and race are used for many important purposes. These include assessing disparities in health, education, employment and housing, enforcing civil rights protections, and deciding who might qualify for special consideration as members of underrepresented minority groups.
But when it comes to keeping racial statistics, the nation is in transition, moving, often without uniformity, from the old “mark one (p. A17) box” limit to allowing citizens to check as many boxes as their backgrounds demand. Changes in how Americans are counted by race and ethnicity are meant to improve the precision with which the nation’s growing diversity is gauged: the number of mixed-race Americans, for example, is rising rapidly, largely because of increases in immigration and intermarriage in the past two decades. (One in seven new marriages is now interracial or interethnic.)
In the process, however, a measurement problem has emerged. Despite the federal government’s setting standards more than a decade ago, data on race and ethnicity are being collected and aggregated in an assortment of ways. The lack of uniformity is making comparison and analysis extremely difficult across fields and across time.

For the full story, see:
SUSAN SAULNY. “Race Remixed; In Multiracial Nation, Many Ways to Tally Can Throw Off Some Numbers.” The New York Times, First Section (Thurs., February 10, 2011): A1 & A17.
(Note: the online version of the story is dated February 9, 2011 and has the title “Race Remixed; Counting by Race Can Throw Off Some Numbers.”)

“The Frozen Body of Someone Desperate to Enter the United States”

(p. 279) In August 2001, as an American Airlines 777 jetliner arriving from overseas descended toward John F. Kennedy International Airport in New York and lowered its landing gear, the frozen body of a man fell into a marsh beneath the field’s approach lanes. The body, believed to be that of a young Nigerian, was buried in a plain wooden casket in City Cemetery, the resting place of New York indigents popularly known as Potter’s Field. No one will ever know for certain, but it appears the young man, who carried no identification, had hidden in the wheel well of the jet, hoping to steal into the United States. If, as police speculated, he was from an African village, he might not have known that the air outside a jetliner at cruise altitude may be minus-80 degrees Fahrenheit, and that wheel wells are unheated; they are also not pressurized, rendering breathing almost impossible at a jetliner’s cruise altitude. Or the victim might have known these things and climbed into the wheel well anyway because he was desperate. The unknown man’s death (p. 280) marked the third time since 1997 that the frozen body of someone desperate to enter the United States had fallen from the wheel wells as a jetliner from overseas lowered its landing gear on descent toward JFK. In the man’s pockets were a few minor personal effects and a street-vendor’s map of Manhattan.

Contemplating this tragedy I thought, first, of the horror the man must have experienced as the plane’s mindless hydraulic mechanisms drew the landing struts and wheels up to crush him. Somehow he avoided being crushed–only to realize as the air craft ascended that it was getting very cold and the air was getting very thin, and he was going to die gasping and shaking. Then I contemplated what the man’s final thoughts might have been. Fear, of course; regret. Perhaps, at the last, dread that his own death might consign the rest of his family in his village to a life of suffering: for the desperation of many trying to reach the West from the developing world is motivated by their desire to work extremely hard and to live on the edge here, sending part of their incomes back home to those even worse off.

Source:
Easterbrook, Gregg. The Progress Paradox: How Life Gets Better While People Feel Worse. Paperback ed. New York: Random House, 2004.

Nearly Half of College Students Learn Nothing in First Two Years

Academically-AdriftBK.jpg

Source of book image: http://ffbsccn.files.wordpress.com/2011/01/academically-adrift.jpg

(p. D9) Andrew Carnegie didn’t think much of college. More than a century ago, he looked around at the men commanding the industries of the day and found that few had wasted their time lollygagging on a campus quad. “The almost total absence of the graduate from high positions in the business world,” he wrote in “The Empire of Business,” “seems to justify the conclusion that college education, as it exists, is fatal to success in that domain.”

. . .
. . . , as the reward for the collegiate credential has been going up, what goes into getting that degree has been going down. So find sociologists Richard Arum and Josipa Roksa in their book “Academically Adrift” (University of Chicago Press). Institutions of higher learning are “focused more on social than academic experiences,” they write. “Students spend very little time studying, and professors rarely demand much from them in terms of reading and writing.” More than a third of students do less than five hours of studying a week–and these shirkers end up, on average, earning B’s.
Ms. Roksa, who teaches at University of Virginia, and Mr. Arum, a professor at New York University, mined data from thousands of sophomores who retook a learning assessment test they had first been given when they arrived at college. Nearly half the students showed no sign of intellectual progress after two years of undergraduate endeavor.
. . .
What would Mr. Carnegie have thought of it? “While the college student has been learning a little about the barbarous and petty squabbles of a far-distant past,” he wrote, “or trying to master languages which are dead…the future captain of industry is hotly engaged in the school of experience, obtaining the very knowledge required for his future triumphs.” Mr. Carnegie may have thought the knowledge gained at college was “adapted for life upon another planet,” but he did expect that the students were gathering some sort of knowledge. Shouldn’t parents footing the massive tab for tuition be able to expect the same?

For the full commentary, see:
ERIC FELTEN. “POSTMODERN TIMES; Now College is the Break.” The Wall Street Journal (Fri., FEBRUARY 11, 2011): D9.
(Note: ellipses added.)

The book under discussion is:
Arum, Richard, and Josipa Roksa. Academically Adrift: Limited Learning on College Campuses. Chicago: University of Chicago Press, 2011.