Government – Page 110 – artdiamondblog.com

FDA Rejects Long-Lasting Disappearance of Disease as a “Theoretical Construct”

Consider the FDA’s handling of Genasense, a new drug for melanoma and chronic lymphocytic leukemia (CLL), two often terminal forms of cancer. The drug is being developed by Genta, a small, innovative company with only one approved drug and limited financial resources. Despite compelling evidence that Genasense is making progress in fighting both diseases, the FDA appears determined to kill the drug.

In the case of the melanoma application, instead of reviewing the clinical-trial data in accordance with usual methods (which showed positive results), the FDA chose a nonstandard statistical approach aimed at discrediting the results. The agency used this analysis in its briefing to its advisory committee, claiming that the drug might not be effective. The committee then relied on that information to vote against approval.

. . .

The FDA’s inane answer to the CLL experts was that the long-lasting disappearance of disease in patients taking Genasense was a "theoretical construct" and not grounds for approval.

The experts explained to the FDA that complete responses in advanced CLL patients are the medical equivalent of the Holy Grail. The FDA finally agreed, but was unimpressed with emerging data showing responders to Genasense living longer than responders in the control group.

The experts were unanimous in advising that Genasense should be approved, but the FDA was unmoved. The agency’s Dr. Pazdur suggested that Genta could make the drug available as an unapproved treatment through an expanded access program — this from a regulator fond of stating that the best way to get a drug to patients in need is through approval! In this case the agency was saying to Genta: We are not going to approve your drug, but any patient who needs it can have it so long as you give it away.

. . .

The FDA’s handling of Genasense lays bare the all too common, aggressive incompetence of the FDA’s cancer-drug division and should lead to an immediate examination of its policies and leadership, followed by swift corrective action.

As for the FDA’s belief that their power to control us and even deny us the pursuit of life itself is unlimited under the Constitution, we can only hope the appeals court disagrees. An agency that blocks progress against deadly diseases — while arguing that its power to do so is above challenge — is in dire need of a court supervised review.

For the full commentary, see:

STEVEN WALKER. "Drug Czars." The Wall Street Journal (Fri., May 4, 2007): A15.

(Note: ellipses added.)

Sweden’s Welfare State Destroys Work Ethic

Source of graphic: online version of the WSJ article cited below.

(p. A1) LULEA, Sweden — Lotta Landström is allergic to electricity — so says her doctor. Along with hundreds of other Swedes diagnosed with the condition in recent years, she came to rely on state-funded sick pay.

But last year, Sweden’s famously generous welfare system cut off Ms. Landström, a 35-year-old former teacher. Electro-hypersensitivity isn’t widely recognized elsewhere in the world as a medical diagnosis. The decision to end her two years of benefits was part of a broad effort to crack down on sickness and disability benefits, according to Swedish welfare officials.

Swedes are among the healthiest people in the world according to the World Health Organization. And yet 13% of working-age Swedes live on some type of disability benefit — the highest proportion on the globe. To explain this, many Swedish policy makers, doctors and economists blame a welfare system that is too lax and does little to verify individual claims.

At a time when low-cost competition from Asia is clobbering Europe’s markets and straining its generous welfare states, governments from Finland to Portugal are trying to cut back and get more people to work. Sweden’s bloated sick bay, which includes (p. A15) roughly 744,000 people on extended leave, has caused soul-searching about whether the system coddles Swedes and encourages them to feel sick.

"If we don’t look out, we will end up with only two-thirds [of the labor force] in work, and one-third out, living on different kinds of subsidies," said Sweden’s new prime minister, Fredrik Reinfeldt, in an interview earlier this year.

At a time when low-cost competition from Asia is clobbering Europe’s markets and straining its generous welfare states, governments from Finland to Portugal are trying to cut back and get more people to work. Sweden’s bloated sick bay, which includes roughly 744,000 people on extended leave, has caused soul-searching about whether the system coddles Swedes and encourages them to feel sick.

"If we don’t look out, we will end up with only two-thirds [of the labor force] in work, and one-third out, living on different kinds of subsidies," said Sweden’s new prime minister, Fredrik Reinfeldt, in an interview earlier this year.

. . .

Most of Sweden’s boom in sickness absenteeism since the late 1990s is about more than simple fraud. Sick leave for psychological conditions such as depression, burnout or panic attacks has rocketed. Over 20% of the population complain of anxiety syndromes. "We are actually the safest country in the world," says David Eberhard, chief psychiatrist at St. Göran’s hospital in Stockholm. But "people are feeling psychologically worse and worse."

Assar Lindbeck, one of Sweden’s best-known economists, says the lenient welfare state has changed the country over the past generation. In place of the old Protestant work ethic, it has become acceptable to feel unable to work and to live on benefits, he says. "I would not call it cheating," Prof. Lindbeck says. "I would call it a drift in attitudes and social norms."

By being so accommodating, the Swedish system has encouraged Swedes to treat life’s tribulations as clinical issues requiring sick leave, posits Anna Hedborg, a former Social Democrat cabinet minister: "As time has passed, we have medicalized all sorts of problems."

For the full story, see:

MARCUS WALKER. "Rx FOR CHANGE; Sweden Clamps Down On Sick and Disability Pay; Once Freely Dispensed, Benefits Face Scrutiny; Ms. Lanström Is Cut Off." The Wall Street Journal (Weds., May 9, 2007): A1 & A15.

(Note: ellipsis added.)

A former Swedish teacher who had been receiving government disability payments for being allergic to electricity. Source of photo: online version of the WSJ article cited above.

Kirkcaldy’s Current Native-Son Would Do Well to Remember Kirkcaldy’s 18th Century Native Son

In Kirckcaldy, Gordon Brown, the man on the right, tries to persuade the natives to vote for the Labor Party. Source of the photo: online version of the NYT article cited below.

Many years ago, we took the train from Edinburgh to spend a few hours in Kirkcaldy, the birthplace of Adam Smith. I was surprised at how little there was to honor Smith in the town where he was born and raised. There was a small cafe/theatre named after Smith. A small crystal shop sold some shot glasses with Smith’s image engraved on them. And there was a small plaque, above a no-parking sign, on the main street, at the spot where Smith’s family home had been.

I remember asking a very polite young father with two or three small children in tow, why there was so little of Smith in Kirckaldy? With a twinge of something like regret, he said that everyone in that part of Scotland supported Labor, and they saw Smith as supporting capitalism, and so did not like him much.

It was a crowded Saturday shopping day when Jeanette took my picture in front of the small plaque. Incredulous passers-by turned and glanced in my direction, probably wondering why the crazy American wanted his picture taken next to a no-parking sign.

For the sake of Kirkcaldy, and Britain, let us hope that Gordon Brown has read a bit of the work of his fellow Kirkcaldy native son:

(p. A10) KIRKCALDY, Scotland, April 30 — Gordon Brown, Britain’s presumed prime minister-to-be, is usually associated with a somewhat dour manner and a mastery of statistics. But here, he displays other skills — a bolt-on smile and a ready handshake to work sparse crowds between the discount stores on the High Street, asking parents with strollers whether their new babies are keeping them awake at night, and inquiring whether the men support the local Raith Rovers soccer team.

. . .

“This is a big choice on Thursday, between those who want to break up Britain and those who want to build up Scotland,” Mr. Brown, currently Britain’s chancellor of the exchequer, told students at Adam Smith College, named for the 18th-century economist who was born here.

. . .

Mr. Brown, who is not standing in these elections, came to town, alongside the choppy waters of the Firth of Forth, to support the Scottish Labor campaign and resist the nationalists.

“I do not think the Scottish people want to see the breakup of the union” that makes up Britain, he said here in Kirkcaldy (pronounced kerr-CUDDY).

But advocates of independence say it would propel Scotland to a bright future, as viable as any other small European state.

For the full story, see:

ALAN COWELL. "Elections in Britain Reveal a Scottish Line in the Sand." The New York Times (Weds., May 2, 2007): A10.

(Note: ellipses added.)

Source of the map: online version of the NYT article cited above.

Art Diamond in Kirkcaldy in 1994 at location (I think on High Street) where Adam Smith’s boyhood home used to be. (Photo by Jeanette Diamond.)

Nonprofits Often Fund Risky, but Useful, Research that is Shunned by Government

The following excerpt from a summary of a May 17th Nature article, has a message that complements what I found in a paper published a couple of years ago (see the reference at the bottom of this entry).

Do charities like the Bill & Melinda Gates Foundation produce better medical research than institutions supported by the government?

. . .

. . . , some scientists believe philanthropies make better use of that $5 billion than corporations or governments, says Nature’s Meredith Wadman. Many researchers have stories about nonprofits who rescued risky but useful projects that had been shunned by government-backed institutions. Charities can make decisions more quickly and can take bigger risks. Philanthropists also tend to closely monitor their investments and want the satisfaction of a mission accomplished.

For the full summary, see:

"Informed Reader; PHILANTHROPY; Do Charities Outdo Research By Federal-Backed Agencies?" The Wall Street Journal (May 18, 2007): B6.

(Note: ellipses added.)

The reference to the Nature article is:

Meredith Wadman. "Biomedical philanthropy: State of the donation." Nature 447, (May 17, 2007): 248 – 250.

My related paper is:

Diamond, Arthur M., Jr. "The Relative Success of Private Funders and Government Funders in Funding Important Science." The European Journal of Law and Economics 21, no. 2 (April 2006): 149-61.

Atlanta Police Killed Innocent Elderly Woman Who Attempted to Defend Her Home

"The victim, Kathryn Johnson, was described as either 88 or 92." Source of caption and photo: online version of the NYT article cited below.

In my 11/23/06 blog entry on Kathryn Johnston’s death at the hands of the Atlanta police, I thought that she was an innocent by-stander in a legal drug bust (though I criticized the drug laws). But it turns out that the situation was even worse than I thought.

In the article excerpted below, it appears that the police lied to get a no-knock warrant, and when no drugs were found anywhere in the home, they planted marijuana that they had obtained from a previous drug bust.

(One more bit of evidence that Milton Friedman was right that we need a serious policy discussion on the economics and ethics of the War on Drugs.)

ATLANTA, April 26 — After the fatal police shooting of an elderly woman in a botched drug raid, the United States attorney here said Thursday that prosecutors were investigating a “culture of misconduct” in the Atlanta Police Department.

In court documents, prosecutors said Atlanta police officers regularly lied to obtain search warrants and fabricated documentation of drug purchases, as they had when they raided the home of the woman, Kathryn Johnston, in November, killing her in a hail of bullets.

Narcotics officers have admitted to planting marijuana in Ms. Johnston’s home after her death and submitting as evidence cocaine they falsely claimed had been bought at her house, according to the court filings.

Two of the three officers indicted in the shooting, Gregg Junnier and Jason R. Smith, pleaded guilty on Thursday to state charges including involuntary manslaughter and federal charges of conspiracy to violate Ms. Johnston’s civil rights.

. . .

The day she was killed, narcotics officers said, they arrested a drug dealer who said he could tell them where to recover a kilogram of cocaine, and pointed out Ms. Johnston’s modest green-trimmed house at 933 Neal Street.

Instead of hiring an informant to try to buy drugs at the house, the officers filed for a search warrant, claiming that drugs had been bought there from a man named Sam. Because they falsely claimed that the house was equipped with surveillance equipment, they got a no-knock warrant that allowed them to break down the front door.

First, according to court papers, they pried off the burglar bars and began to ram open the door. Ms. Johnston, who lived alone, fired a single shot from a .38-caliber revolver through the front door and the officers fired back, killing her.

After the shooting, they handcuffed her and searched the house, finding no drugs.

“She was without question an innocent civilian who was caught in the worst circumstance imaginable,” Mr. Howard, the district attorney, said at a news conference on Thursday. “When we learned of her death, all of us imagined our own mothers and our own grandmothers in her place, and the thought made us shudder.”

When no drugs were found, the cover-up began in earnest, according to court papers.

Officer Smith planted three bags of marijuana, which had been recovered earlier in the day in an unrelated search, in the basement. He called a confidential informant and instructed him to pretend he had made the drug buy described in the affidavit for the search warrant.

For the full story, see:

SHAILA DEWAN and BRENDA GOODMAN. "Officials Investigate Broad Corruption in Atlanta Police Dept." The New York Times (Fri., April 27, 2007): A16.

(Note: ellipsis added. The online title of the article was: "Prosecutors Say Corruption in Atlanta Police Dept. Is Widespread.")

Mugabe Prints More Money and Beats Up Shopkeepers, as Inflation Soars: More on Why Africa is Poor

"Inflation made food cost a fortune in Harare this week. The government imposed controls that required vendors to sell some items below cost." Source of caption and photo: online version of the NYT article cited below.

JOHANNESBURG, July 3 — Zimbabwe’s week-old campaign to quell its rampant inflation by forcing merchants to lower prices is edging the nation close to chaos, some economists and merchants say.

As the police and a pro-government youth militia swept into shops and factories, threatening arrest and worse unless prices were rolled back, staple foods vanished from store shelves and some merchants reported huge losses. News reports said that some shopkeepers who had refused to lower prices had been beaten by the youth militia, known as the Green Bombers for the color of their fatigues.

In interviews, merchants said that crowds of people were following the police and militia from shop to shop to buy goods at the government-ordered prices.

“People are losing millions and millions and millions of dollars,” said one merchant in Bulawayo, referring to the Zimbabwean currency, which is becoming worthless given the nation’s inflation, the world’s highest. “Everyone is now running out of stock, and not being able to replace it.”

. . .

Gasoline was reported to be vanishing from stations as the going price, about 180,000 dollars per liter, was slashed by the government to something closer to the officially approved price of 450 dollars per liter. Mr. Mugabe’s government intends to cope with the shortages by subsidizing producers of basic goods. One of the few newspapers not under government control, The Zimbabwe Independent, reported last week that flour, which is controlled entirely by the state, will be sold to bakers for 10 million dollars a ton, half the market price. Similarly, many suppliers of basic goods have been told by the government that they will be allowed to buy gasoline at one tenth the going price, the newspaper reported. The government apparently plans to make up those losses by printing more money. Zimbabwe’s dollar has lost more than half its value in recent weeks because the government has constantly issued new bills to pay its mounting debts.

For the full story, see:

MICHAEL WINES. "Anti-Inflation Curbs on Prices Create Havoc for Zimbabwe." The New York Times (Weds., July 4, 2007): A8.

(Note: ellipsis added.)

CNN on 7/10/07 broadcast a great clip from ITN, that had been courageously recorded undercover by Martin Geissler. See "Desperation in Zimbabwe":

http://www.cnn.com/video/#/video/offbeat/2007/06/23/vo.mi.ugly.dogs.ap?DPFPR=true

(Note: ITN is sometimes also called ITV. "ITN" stands for the International Television Network.)

Postscript: According to an entry on the ITV web site entitled "Mugabe Battles Economic Crises," Mugabe "has warned he will not be restrained by "bookish economics"." (He makes a great case for cracking open the books, doesn’t he? Or at least for opening the window and looking at what is happening outside?)

For the Mugabe quote on bookish economics, see:

http://itn.co.uk/news/a1d7763de3c4778b619a72cbeab24d6d.html

Dubai Is “Turbo-Charged Free-Market Capitalism”

Dubai skyline. Source of photo: online version of the WSJ commentary quoted and cited below.

(p. A9) Dubai, which is part of the United Arab Emirates, represents turbo-charged free-market capitalism at its purest — sometimes crass, often over-the-top, and always in motion. Home to more than 1.2 million people, more than 80% of whom are resident aliens, Dubai is as much a multicultural melting pot as New York City was in its late 19th century heyday. And like New York then, Dubai teems with winners and losers, the rich and not-so-rich, and immigrants who often find that life in the glittering metropolis is cold, hard and unfair. But the government maintains order, spends billions on infrastructure and is dedicated to establishing the city-state as a global capital of, well, capital.

. . .

Seeing Dubai as an economic model for other parts of the Arab world is admittedly a challenge: Like Singapore, it has the virtues of a small ruling class, a tiny population and not much territory, and that is not something Egypt or Syria could emulate. But as a cultural model, or an attitude, it does offer an alternate vision of the future, one with its own excesses and vices for sure, but still free of the divisiveness and religious conflict that has become the assumed status quo in other parts of the Middle East.

Dubai should not be written off as little more than an Arab Las Vegas. It deeply challenges the assumption that Muslims, Christians and Jews cannot find common ground and work together to construct a shared future. Dubai is proof, not perfect, but real, that they can.

For the full commentary, see:

ZACHARY KARABELL. "City of Dreams." The Wall Street Journal (Sat., March 17, 2007): A9.

(Note: ellipsis added.)

FDA Should Not Restrict Drugs the Terminally Ill Choose to Use

On March 1, a federal appeals court will hear oral arguments in the case of the Abigail Alliance organization’s lawsuit to change systems at the Food and Drug Administration to allow terminally ill patients access to promising drugs that have successfully completed initial stages of human safety testing. Because of my former role in the oncology division at the FDA, and in my eight-year experience as a cancer patient advocate on behalf of my son, I may be able to shed some light on the regulatory policy, medical drug development and patient rights issues surrounding this landmark case.

. . .

Patients have valid arguments in demanding greater access to promising agents under development. Public servants should respect citizens who advocate that they be allowed to have a say in methods of their treatment when terminally ill, and government officials should have very compelling reasons for denying such access. New drug development will not suffer if a small minority of patients fighting for their lives, with no other options and in concert with their physician, gain access to a potentially beneficial agent with an established basic safety profile.

For the full commentary, see:

MARK THORNTON. "The Clinical Trial." The Wall Street Journal (Mon., February 12, 2007): A14.

(Note: ellipsis added.)

According to the online version of USA Today, the court did hear oral arguments on March 1st, and ". . . isn’t likely to rule for several months, . . . "

Source: http://www.usatoday.com/news/nation/2007-04-02-unapproved-drugs_N.htm

Obama Advised By Economists Cutler, Liebman, and Goolsbee

Source of graphic: online version of the WSJ article cited below.

In a previous entry, I expressed guarded optimism in response to an article that identified Austan Goolsbee as an advisor to Obama. The article excerpted below, casts Goolsbee in a less central role, thus giving reason to guard the optimism even more.

While Mr. Obama’s economic platform is still in its formative stages, interviews with his aides and a review of his congressional record and speeches suggest that Obamanomics may place him somewhat to the left of New York Sen. Hillary Rodham Clinton, but to the right of former North Carolina Sen. John Edwards, another rival for the 2008 nomination. Mrs. Clinton seems to be cultivating the centrist mantle her husband won during his presidency, while Mr. Edwards is courting the party’s labor and grassroots activist base.

. . .

As Mr. Obama prepares for his first series of domestic-policy speeches in the coming weeks, he appears to be still shopping for a place on the political spectrum.

One top economic adviser is Jeffrey Liebman, a Harvard economist and former adviser to President Clinton who is focused heavily on the earned income tax credit and its role in moving people from welfare to work.

The candidate is also consulting with University of Chicago economics professor Austan Goolsbee, a taxation expert and centrist Democrat who has advised Mr. Obama since his 2004 Senate campaign.

David Cutler, a Harvard economist specializing in health policy who served in the Clinton administration, is also among Mr. Obama’s advisers.

For the full story, see:

DEBORAH SOLOMON. "Seeking Clues to Obamanomics; Democratic Candidate Is Just Beginning To Fill In the Blanks." The Wall Street Journal (Tues., April 24, 2007): A4.

(Note: ellipsis added.)

Burned Up Over Gas Rationing in Iran

"Protesters burned at least two gas stations in Tehran after the Oil Ministry announced gas rationing would begin Wednesday just after midnight." Source of caption and photo: online version of the NYT article cited below.

TEHRAN, June 27 — Angry drivers set fire to at least two gas stations overnight in Tehran after the government announced that gasoline rationing would begin Wednesday just after midnight.

The state television news said Wednesday that “several gas stations and public places had been attacked by vandals.” While there were some reports that a large number of gas stations had been set on fire, only two fires were confirmed.

. . .

Under the new regulations announced by the Oil Ministry on Tuesday evening, private cars will be able to buy a maximum of 26 gallons of gasoline a month at the subsidized price of 34 cents per gallon. Taxis will be allowed 211 gallons a month. Parliament would have to determine whether individuals would be allowed to buy more at market rates.

There were long lines at gas stations in Tehran on Wednesday, causing traffic jams, and the police moved in to control the lines.

Iran is OPEC’s second-largest exporter of oil. But it needs to import half of its gasoline — at a cost of $5 billion a year — because of high consumption and low refining capabilities.

Inflation in Iran had already been high, as a result of a combination of economic factors and government decisions. The price of dairy products like milk, butter and yogurt increased this week by at least 20 percent.

For the full story, see:

NAZILA FATHI. "2 Iranian Gas Stations Burned Over Rationing." The New York Times (Thurs., June 28, 2007): A8.

(Note: ellipsis added.)