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.

 

“I Couldn’t Write a Prescription for Antiobiotics, Because There Were None”

 

    "THE DOCTOR MIGHT BE IN Cubans young and old at a Havana clinic in 2004."  Source of caption and photo:  online version of the NYT article cited below. 

 

CUBA works hard to jam American TV signals and keep out decadent Hollywood films. But it’s a good bet that Fidel Castro’s government will turn a blind eye to bootleg copies of “Sicko,” Michael Moore’s newest movie, if they show up on the streets of Havana.

“Sicko,” the talk of the Cannes Film Festival last week, savages the American health care system — and along the way extols Cuba’s system as the neatest thing since the white linen guayabera.

Mr. Moore transports a handful of sick Americans to Cuba for treatment in the course of the film, . . .

. . .

Universal health care has long given the Cuban regime bragging rights, though there is growing concern about the future. In the decades that Cuba drew financial and military support from the Soviet Union, Mr. Castro poured resources into medical education, creating the largest medical school in Latin America and turning out thousands of doctors to practice around the world.

But that changed after the collapse of the Soviets, according to Cuban defectors like Dr. Leonel Cordova. By the time Dr. Cordova started practicing in 1992, equipment and drugs were already becoming scarce. He said he was assigned to a four-block neighborhood in Havana Province where he was supposed to care for about 600 people.

“But even if I diagnosed something simple like bronchitis,” he said, “I couldn’t write a prescription for antibiotics, because there were none.”

He defected in 2000 while on a medical mission in Zimbabwe and made his way to the United States. He is now an urgent-care physician at Baptist Hospital in Miami.

Having practiced medicine in both Cuba and the United States, Dr. Cordova has an unusual perspective for comparison.

“Actually there are three systems,” Dr. Cordova said, because Cuba has two: one is for party officials and foreigners like those Mr. Moore brought to Havana. “It is as good as this one here, with all the resources, the best doctors, the best medicines, and nobody pays a cent,” he said.

But for the 11 million ordinary Cubans, hospitals are often ill equipped and patients “have to bring their own food, soap, sheets — they have to bring everything.”  . . .

. . .

Until he had to have emergency surgery last year, Fidel Castro — who turned 80 this year — was considered a model of vibrant long life in Cuba. But it was only last week that he acknowledged in an open letter that his initial surgery by Cuban doctors had been botched. He did not confirm, however, that a specialist had been flown in from Spain last December to help set things right. 

 

For the full commentary, see: 

ANTHONY DePALMA.  "‘Sicko,’ Castro and the ‘120 Years Club’."  The New York Times, Section 4  (Sun., May 27, 2007):   3. 

(Note:  ellipses added.)

 

Why New York City Needs Wal-Mart

 

(p. 7)  . . .  an enduring mystery of the retail economic world: why don’t people in New York City want a Wal-Mart in Midtown?

Manhattan is the most underserved market I have ever seen for retail customers. There really is nowhere for bargains on ordinary household goods and groceries in the whole borough. Yes, I know unions hate Wal-Mart. But not every New Yorker is in a union, and every New Yorker needs food and paper towels. (I, by the way, am a member of three unions: the Screen Actors Guild, the American Federation of Television and Radio Artists, and the Writers Guild of America, West. How many unions is Mayor Michael Bloomberg in?)

Don’t the consumers deserve a break, too? I know Wal-Mart is not hip, slick and cool. It’s for people who have to live within a budget, not for people who see movies with subtitles and have houses on Martha’s Vineyard (or would like to). But don’t working-class people deserve bargains on their daily bread?

To keep Wal-Mart out of New York — or my home, Los Angeles — is simply to inflict a snobby class prejudice on working people. Why they and their representatives put up with this classist, ”let them eat Whole Foods” nonsense is yet another mystery, and one that could be solved if politicians really cared about consumers.

 

For the full commentary, see: 

BEN STEIN.  "EVERYBODY’S BUSINESS; Assorted Mysteries of Economic Life."  The New York Times, Section 3  (Sun., May 13, 2007):  7.

(Note: ellipsis added.)

 

Total Retirement Assets Will Increase, Even as Baby Boomers Retire

 

RetirementAssetsGraph.jpg   Source of graph:  online version of the NYT article cited below.

 

WILL stocks suffer a multidecade bear market as the baby-boom generation sells its shares to support its retirement? Some have predicted such an outcome, but a new study — which projects huge growth in 401(k) assets in future decades — paints a far more sanguine picture.

The study, “New Estimates of the Future Path of 401(k) Assets,” has been circulating since earlier this month as a working paper from the National Bureau of Economic Research. Its authors are James M. Poterba, chairman of the economics department at the Massachusetts Institute of Technology; Steven F. Venti, an economics professor at Dartmouth; and David A. Wise, a professor of political economy at Harvard. A version is at www.nber.org/papers/w13083.

Despite the baby boomers’ liquidation of retirement assets in coming decades, the study estimates that the total size of 401(k) plans will nevertheless grow markedly. That forecast may come as a surprise to some people, the professors concede, because 401(k)’s now represent only a modest fraction of a typical retiree’s total wealth. But the professors point out that 401(k) plans have existed only since the early 1980s; by the time that today’s younger workers retire, they will have had many more years to contribute to their 401(k)’s than current retirees have had.

 

For the full commentary, see: 

MARK HULBERT.  "STRATEGIES; Baby Boomers Are Cashing In.  So What?"  The New York Times, Section 3  (Sun., May 27, 2007):  5.

 

Professors Have Lost the Skills to Write Lively Prose and Choose Interesting Topics

 

The excerpt below is from a WSJ summary of an article by Maureen Ogle in the March-April 2007 issue of HISTORICALLY SPEAKING.

 

History professors, writes Ms. Ogle in the History Society’s bimonthly bulletin, don’t make enough effort to connect with students who view the world through a lens shaped by iPods and instant messaging. Worse, professors have lost the skills needed to engage a general audience like writing lively prose or choosing interesting topics. Their careers depend on getting articles into tiny journals on abstruse topics, not conveying the importance of that research to the public.  . . .

. . .

She resigned from her university post in 1999 and began a mission to provide nonacademic readers with "well-researched, well-documented, well-reasoned history." On the way, she discovered the perils, and pleasures, of writing for an audience "larger than six."

 

For the full summary, see: 

"Informed Reader; ACADEMIA; Historians Belong on the Street, Not in the Tower."  The Wall Street Journal  (Thurs., May 31, 2007):  B6.

(Note:  ellipsis added.)

 

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

 

Better Measures of Worker Output, Increase Income Inequality

 

Many of us would say that income inequality is not bad, if it reflects differences in worker productivity.  One argument in the article excerpted below, is that information technology has allowed better measurement of worker productivity, and hence is partly responsible for the increase in income inequality.

 

. . . as companies and compensation consultants began using information technology to determine more accurately the contributions of individual employees, employers began to discriminate among employees based on performance. In a working paper, Professor MacLeod, along with Thomas Lemieux of the University of British Columbia and Daniel Parent of McGill University, mined census data and found that the proportion of jobs with a performance-pay component rose to 40 percent in the 1990s from 30 percent in the late 1970s.

”Since companies are better able to measure precisely what an employee contributes, we’ve seen a greater range of incomes among people doing roughly the same jobs,” Professor MacLeod said.

The fact that more Americans are paid less on the basis of a job title and more on their individual output inexorably leads to greater inequality. The authors’ conclusion is that the rise of performance-based pay has accounted for 25 percent of the growth in wage inequality among male workers from 1976 to 1993.

”All the bits of evidence we have tend to say that this trend is continuing,” Professor Lemieux said. In 2003, the authors note, 44.5 percent of workers at Fortune 1000 companies received some form of performance-based pay, up from 34.7 percent in 1996. And think of the growing legions of self-employed — people selling items on eBay, mortgage brokers and real estate brokers, freelance journalists and consultants of all types — for whom all pay is performance-based. Among these growing cadres, the dispersion of incomes is rather large.

”When you look at the self-employed and contractors,” Professor Lemieux said, ”inequality is much higher.”

 

For the full commentary, see: 

DANIEL GROSS.  "ECONOMIC VIEW; Income Inequality, Writ Larger."  The New York Times, Section 3  (Sun., June 10, 2007):  7.

(Note:  ellipsis added.)