Government – Page 136 – artdiamondblog.com

FDA Irrationally Bans Drugs that Would Help Patients Suffering from Deadly Disease

The most welcome news a cancer patient can hear from their doctor is: "Your tumor is regressing." Sadly, the message that the Food and Drug Administration is now delivering to cancer patients is that the fight against tumors is regressing.

Current FDA policies are discouraging the development of groundbreaking treatments for cancer and other killer diseases, turning the clock back on hard-won regulations put in place in response to the AIDS crisis that allow patients faster access to new drugs. Case in point: This week, facing rejection by the Agency, GPC Biotech withdrew its New Drug Application (NDA) for Satraplatin, a drug to treat prostate cancer — despite data from a large controlled clinical trial showing the drug delayed tumor growth in patients where the disease is widespread.

Most of the patients in this study had exhausted all known therapies; many required powerful medication to control bone pain. Time is running out for them, yet results from this statistically significant study were not sufficient for the FDA. Although GPC Biotech’s application for Satraplatin was under consideration for accelerated approval, the Agency indicated it would need to wait for full survival data from this trial, which will delay approval at least one year.

Sadly, far from being an aberration, Satraplatin is the fifth promising cancer treatment set back by the FDA this year.

. . .

For patients with life-threatening diseases and their families, the implications of the FDA’s recent regressive trend are devastating. It may be acceptable for regulators to be risk-averse when considering drugs for routine or nonserious diseases where alternative therapies exist. But this mindset is simply irrational when it comes to drugs intended to treat patients suffering from deadly diseases — people who often have only weeks or months to live.

For the full commentary, see:

RICHARD MILLER. "Cancer Regression." The Wall Street Journal (Weds., August 1, 2007): A15.

Fred Thompson Skewers Michael Moore with Wit and Wisdom

Mr. Moore was back from Cuba, where he made a documentary on the superiority of Castro’s health-care system. Mr. Thompson suggested Mr. Moore is just another lefty who loves dictators. Mr. Moore challenged Mr. Thompson to a health-care debate and accused him of smoking embargoed cigars. Within hours Mr. Thompson and his supposedly nonexistent staff had produced a spirited video response that flew through YouTube and the conservative blogosphere. Sitting at a desk and puffing on a fat cigar, Mr. Thompson announces to Mr. Moore he can’t fit him into his schedule. Then: "The next time you’re down in Cuba . . . you might ask them about another documentary maker. His name was Nicolás Guillén. He did something Castro didn’t like, and they put him in a mental institution for several years, giving him devastating electroshock treatments. A mental institution, Michael. Might be something you ought to think about."

You couldn’t quite tell if Mr. Thompson was telling Mr. Moore he ought to think more about Cuba, or might himself benefit from psychiatric treatment. It seemed almost . . . deliberately unclear.

PEGGY NOONAN. "DECLARATIONS; The Man Who Wasn’t There." The Wall Street Journal (Sat., May 19, 2007): P14.

(Note: ellipsis in original.)

See Fred Thompson’s response to Michael Moore on YouTube at:

http://www.youtube.com/watch?v=Ds_GhRxivOI

Source: screen capture from Fred Thompson’s response to Michael Moore at http://www.youtube.com/watch?v=Ds_GhRxivOI

The Courage of Milton Friedman

The following two paragraphs are from a paper I am currently working on.

Milton Friedman wrote a Newsweek column many years ago that caused a firestorm of anger among his colleagues in the economics profession. Friedman’s argument was that, in general, the government is not going to do a good job of identifying the best and most productively innovative economists. In particular, he argued that economics funding by the National Science Foundation (NSF) had made the economics profession more mathematical than was appropriate.

Even his ‘Chicago’ colleagues, who were otherwise inclined to be sympathetic to his work, were appalled: Robert Lucas wrote against Friedman in the New York Times, and Zvi Griliches spoke against him before Congress.

Not too long after Friedman’s article came out, I praised it during one of the sessions of a Liberty Fund colloquium held in California. After the session, a very distinguished economist came up to me, and started talking about the Friedman article in a very irritated and animated manner. He said that what Friedman wrote in the article, might be true, but he shouldn’t have written it in a public forum.[i] He said that within the NSF, the physicists have always been opposed to funding economics, and that Friedman’s article gave the physicists just the ammunition they needed. I remember distinctly that after this conversation, the distinguished economist got into his very large and very expensive car and drove off. To the cynical, it may also be worth mentioning that this economist had received very substantial funding from the NSF.

I also remember mentioning to George Stigler my disappointment that Lucas had written contra Friedman, and Stigler gave me his cynical smile, and said that I should have expected that Lucas, and the rest of the profession, would defend NSF funding.

[i] Most of the conversation I remember in broad terms, but specifically, I remember he said something very close to: ‘Friedman shouldn’t air the profession’s dirty laundry in public.’

The reference for the Friedman article, is:

Friedman, Milton. "An Open Letter on Grants." Newsweek, May 18 1981, 99.

Private Companies Beat Government in Accessible and Affordable Health Care

A CVS pharmacy MinuteClinic. Source of photo: online version of the WSJ article cited below.

It’s Friday evening and you suspect that your child might have strep throat or a worsening ear infection. Do you bundle him up and wait half the night in an emergency room? Or do you suffer through the weekend and hope that you can get an appointment with your pediatrician on Monday — taking time off your job to drive across town for another wait in the doctor’s office?

Every parent has faced this dilemma. But now there are new options, courtesy of the competitive marketplace. You might instead be able to take a quick trip on Friday night to a RediClinic in the nearby Wal-Mart or a MinuteClinic at CVS, where you will be seen by a nurse practitioner within 15 minutes, most likely getting a prescription that you can have filled right there. Cost of the visit? Generally between $40 and $60.

These new retail health clinics are opening in big box stores and local pharmacies around the country to treat common maladies at prices lower than a typical doctor’s visit and much lower than the emergency room. No appointment necessary. Open daytime, evenings and weekends. Most take insurance.

Much like the response to Hurricane Katrina, private companies are far ahead of the government in answering Americans’ needs, this time for more accessible and more affordable health care. Political leaders across the country seeking to expand government’s role in health care should take note.

For the full commentary, see:

GRACE-MARIE TURNER. "Customer Health Care." The Wall Street Journal (Mon., May 14, 2007): A17.

Brookings Harsh Critics of Bush Iraq Policies, Surprised to See Military Progress in Iraq

Please note that the commentary excerpted below was published on the Op-Ed page of the New York Times, and was written by two policy experts at the Brookings Institute, the leading think-tank of the Democratic party.

Washington. VIEWED from Iraq, where we just spent eight days meeting with American and Iraqi military and civilian personnel, the political debate in Washington is surreal. The Bush administration has over four years lost essentially all credibility. Yet now the administration’s critics, in part as a result, seem unaware of the significant changes taking place.

Here is the most important thing Americans need to understand: We are finally getting somewhere in Iraq, at least in military terms. As two analysts who have harshly criticized the Bush administration’s miserable handling of Iraq, we were surprised by the gains we saw and the potential to produce not necessarily “victory” but a sustainable stability that both we and the Iraqis could live with.

After the furnace-like heat, the first thing you notice when you land in Baghdad is the morale of our troops. In previous trips to Iraq we often found American troops angry and frustrated — many sensed they had the wrong strategy, were using the wrong tactics and were risking their lives in pursuit of an approach that could not work.

Today, morale is high. The soldiers and marines told us they feel that they now have a superb commander in Gen. David Petraeus; they are confident in his strategy, they see real results, and they feel now they have the numbers needed to make a real difference.

Everywhere, Army and Marine units were focused on securing the Iraqi population, working with Iraqi security units, creating new political and economic arrangements at the local level and providing basic services — electricity, fuel, clean water and sanitation — to the people. Yet in each place, operations had been appropriately tailored to the specific needs of the community. As a result, civilian fatality rates are down roughly a third since the surge began — though they remain very high, underscoring how much more still needs to be done.

. . .

In war, sometimes it’s important to pick the right adversary, and in Iraq we seem to have done so. A major factor in the sudden change in American fortunes has been the outpouring of popular animus against Al Qaeda and other Salafist groups, as well as (to a lesser extent) against Moktada al-Sadr’s Mahdi Army.

These groups have tried to impose Shariah law, brutalized average Iraqis to keep them in line, killed important local leaders and seized young women to marry off to their loyalists. The result has been that in the last six months Iraqis have begun to turn on the extremists and turn to the Americans for security and help. The most important and best-known example of this is in Anbar Province, which in less than six months has gone from the worst part of Iraq to the best (outside the Kurdish areas). Today the Sunni sheiks there are close to crippling Al Qaeda and its Salafist allies. Just a few months ago, American marines were fighting for every yard of Ramadi; last week we strolled down its streets without body armor.

For the full commentary, see:

MICHAEL E. O’ HANLON and KENNETH M. POLLACK. "A War We Just Might Win." The New York Times (Mon., July 30, 2007): A19.

(Note: ellipses added.)

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