Paternalistic FDA Violates Patients’ Freedom to Choose

The notion that the FDA should “err on the side of safety” sounds like a tautology but is an affront to patients with incurable or poorly treatable diseases: For them, there is no safety in the status quo, and we only damage them further with paternalistic public policy that prevents individuals from exercising their own judgment about risks and benefits. If the FDA must err, it should be on the side of patients’ freedom to choose.

For the full commentary, see:
HENRY I. MILLER. “Paternalism Costs Lives.” The Wall Street Journal (Thurs., March 2, 2006): A14.

In Canada: Dog Health Care Better than Human Health Care?

VANCOUVER, British Columbia, Feb. 23 – The Cambie Surgery Center, Canada’s most prominent private hospital, may be considered a rogue enterprise.
Accepting money from patients for operations they would otherwise receive free of charge in a public hospital is technically prohibited in this country, even in cases where patients would wait months or even years before receiving treatment.
But no one is about to arrest Dr. Brian Day, who is president and medical director of the center, or any of the 120 doctors who work there. Public hospitals are sending him growing numbers of patients they are too busy to treat, and his center is advertising that patients do not have to wait to replace their aching knees.
The country’s publicly financed health insurance system — frequently described as the third rail of its political system and a core value of its national identity — is gradually breaking down. Private clinics are opening around the country by an estimated one a week, and private insurance companies are about to find a gold mine.
Dr. Day, for instance, is planning to open more private hospitals, first in Toronto and Ottawa, then in Montreal, Calgary and Edmonton. Ontario provincial officials are already threatening stiff fines. Dr. Day says he is eager to see them in court.
”We’ve taken the position that the law is illegal,” Dr. Day, 59, says. ”This is a country in which dogs can get a hip replacement in under a week and in which humans can wait two to three years.”
. . .
The median wait time between a referral by a family doctor and an appointment with a specialist has increased to 8.3 weeks last year from 3.7 weeks in 1993, according to a recent study by The Fraser Institute, a conservative research group. Meanwhile the median wait between an appointment with a specialist and treatment has increased to 9.4 weeks from 5.6 weeks over the same period.
Average wait times between referral by a family doctor and treatment range from 5.5 weeks for oncology to 40 weeks for orthopedic surgery, according to the study.

For the full article, see:
CLIFFORD KRAUSS. ” Canada’s Private Clinics Surge as Public System Falters.” The New York Times (Tuesday, February 28, 2006): A3.

“Unlike Pilots, Doctors Don’t Go Down with Their Planes”


(p. C1) With all the tools available to modern medicine — the blood tests and M.R.I.’s and endoscopes — you might think that misdiagnosis has become a rare thing. But you would be wrong. Studies of autopsies have shown that doctors seriously misdiagnose fatal illnesses about 20 percent of the time. So millions of patients are being treated for the wrong disease.
As shocking as that is, the more astonishing fact may be that the rate has not really changed since the 1930’s. “No improvement!” was how an article in the normally exclamation-free Journal of the American Medical Association summarized the situation.
. . .
But we still could be doing a lot better. Under the current medical system, doctors, nurses, lab technicians and hospital executives are not actually paid to come up with the right diagnosis. They are paid to perform tests and to do surgery and to dispense drugs.
There is no bonus for curing someone and no penalty for failing, except when the mistakes rise to the level of malpractice. So even though doctors can have the best intentions, they have little economic incentive to spend time double-checking their instincts, and hospitals have little incentive to give them the tools to do so.
. . .
(p. C4) Joseph Britto, a former intensive-care doctor, likes to compare medicine’s attitude toward mistakes with the airline industry’s. At the insistence of pilots, who have the ultimate incentive not to mess up, airlines have studied their errors and nearly eliminated crashes.
“Unlike pilots,” Dr. Britto said, “doctors don’t go down with their planes.”

For the full story, see:
DAVID LEONHARDT. “Why Doctors So Often Get It Wrong.” The New York Times (Weds., February 22, 2006): C1 & C4.

Who Decides Treatment When Medicine is Socialized?

Ann Marie Rogers at High Court in London on Wed., Feb. 15, 2006. Image source: online version of NYT article quoted and cited below.

(p. A6) LONDON, Feb. 15 — When her local health service refused to treat her breast cancer with the drug Herceptin, 54-year-old Ann Marie Rogers sued. But on Wednesday, a High Court judge ruled against her.
In his decision the judge, David Bean, said that although he sympathized with Ms. Rogers’s predicament, the health service in Swindon, where she lives, had been justified in withholding the drug.
“The question for me is whether Swindon’s policy is irrational and thus unlawful,” Justice Bean wrote. “I cannot say it is.”
The ruling has potentially serious implications for patients across the taxpayer-financed National Health Service.
Despite health officials’ contention that decisions about treatment are based solely on clinical effectiveness, critics contend that with drugs growing ever more expensive, cost has become an increasingly important factor. They also say patients are at the mercy of the so-called postcode lottery, in which treatments are available in some postal zones but not others.

For the full story, see:
SARAH LYALL. “British Clinic Is Allowed to Deny Medicine; Decision on Cost Has Broad Impact.” The New York Times (Thurs., February 16, 2006): A6.

Protecting the “Dots”

Is it the free market, or big government, that is most likely to treat individual human beings as expendible “dots”?

One of the best conspiracy movies ever made is the perfect British classic, “The Third Man.” In the most haunting scene, the villain, played adroitly by Orson Welles, takes Joseph Cotten, the good guy, up in a Ferris wheel. The villain, named Harry Lime, has been selling adulterated penicillin in postwar Vienna, making a fortune and causing children to become paralyzed and die.
Mr. Cotten’s character, a pulp fiction writer named Holly Martins, asks him how he could do such an evil thing for money. The two men are at the top of the Ferris wheel, and the people below them look like tiny dots. Mr. Welles’s villain looks down and says, “Tell me, would you really feel any pity if one of those dots stopped moving forever? If I offered you £20,000 for every dot that stopped, would you really, old man, tell me to keep my money, or would you calculate how many dots you could afford to spare?”

BEN STEIN. “Everybody’s Business; When You Fly in First Class, It’s Easy to Forget the Dots.” The New York Times, Section 3 (Sunday, January 29, 2006): 3.

Unintended Consequences of Making My Cold Medicine Hard to Get

SudafedColdCcough.jpg
Source of image: http://www.sudafed.com/products/cold_and_cough.html

When I get a cold, nothing keeps me functioning as well as Sudafed Cold and Cough. Unfortunately, the pills contain pseudoephedrine, which apparently is an ingredient that can be used in the process of making meth. So in their zeal to protect people from their own bad choices, governments across the country, including my own Nebraska, have put increasingly severe restrictions on the sale and purchase of medicines like Sudafed Cold and Cough. Many stores that used to carry the medicine, have dropped it, and those that still carry it, have significantly increased the price.
So the government has made life harder for me. But at least they’ve benefitted the meth addicts, right? Read on:

(p. 1A) Restrictions on the sale of cold medicine appear to be reducing seizures of homemade methamphetamine labs in Nebraska and Iowa.
Both states passed laws last year restricting over-the-counter purchases of cold medicines used to make meth – and both report fewer lab discoveries.
But officials in the two states – and others with similar restrictions – now have a new problem: The drop in home-cooked methamphetamine has been met by a flood of crystal methamphetamine coming largely from Mexico.
Sometimes called ice, crystal meth is far purer, and therefore even more highly addictive, than powdered home-cooked meth.
And because crystal meth costs more, the police say thefts are increasing, as people who once cooked at home now have to buy it.
The University of Iowa Burn Center, which in 2004 spent $2.8 million treating people whose skin had been scorched off by the toxic chemicals used to make meth at home, says it now sees hardly any cases of that sort. Drug treatment cen- (p. 3A) ters, on the other hand, say they are treating just as many or more meth addicts.
And although Iowa child welfare officials say they are removing fewer children from homes where parents are cooking the drug, the number of children being removed from homes where parents are using it has more than made up the difference.

For the full story, see:
“Meth labs decline, but ‘ice’ fills gap.” Omaha World-Herald (Sunrise Edition, Mon., January 30, 2006): 1A & 3A.

Apparently the only current substitute for pseudoephedrine in cold medicines is phenylephrine. But it has several drawbacks. Consider:

. . . pharmacologists, who specialize in the properties of medications, say oral phenylephrine has several disadvantages. First, the effects of the current formulations wear off faster than pseudoephedrine — meaning users will need to take a pill after four hours instead of up to six for the shorter-acting pseudoephedrine. Pseudoephedrine also comes in long-acting 12- and 24-hour pills, an option not currently available for over-the-counter phenylephrine.
Another question is whether oral phenylephrine is as effective as pseudoephedrine. There have been no major published head-to-head trials comparing the two, and neither Pfizer nor Germany’s Boehringer Ingelheim GmbH, a major supplier of powder phenylephrine for pills, has studied the matter. In 2003, Pfizer conducted a consumer survey in which 400 mall-goers with stuffy noses were given either standard Sudafed or Sudafed PE. In a telephone survey a week later, about 70% of each group reported “good” or “excellent” results, the company says.
But pharmacologists say there are reasons for caution. For one, oral phenylephrine is heavily absorbed by the intestine and broken down in the liver — so only 6% to 40% of the actual medicine makes it into the blood stream, compared with nearly all of pseudoephedrine, scientists say. Moreover, its use as a decongestant has been far less heavily studied than pseudoephedrine’s. The FDA review cited more than six studies, primarily unpublished work from a single laboratory, which found it effective. The review also cited a nearly equal number of studies from a variety of laboratories that found phenylephrine no better than a placebo — but the agency concluded overall that it does work. Little has been published since then.
The American Heart Association warns that both drugs can raise blood pressure, so people with high blood pressure or heart disease should consult their doctor before taking them. It isn’t known whether phenylephrine poses more or less of a risk than pseudoephedrine, though some experts say phenylephrine has been less tested so may merit more caution.
If a stuffy nose is making you miserable and only the most proven remedy will do, you may want to take the time to look for pseudoephedrine — even if it means you have to wait at the counter.

For the full story, see:
LAURA JOHANNES. ” ACHES & CLAIMS; Choosing a Pill for That Cold.” THE WALL STREET JOURNAL (Tues., December 27, 2005): D4.

Wal-Mart Is Front-line Soldier in Real War on Poverty

 

BALTIMORE — In Big Labor’s war against Wal-Mart, "collateral damage" — in the form of lost jobs and income for the poor — is starting to add up. Of course, since the unions and their legislative allies claim that their motive is to liberate people from exploitation by Wal-Mart, these unintended effects are often ignored.

Here in Maryland, however, that’s getting hard to do. The consequences of our legislature’s override of Republican Gov. Robert Ehrlich’s veto of their "Fair Share Health Care Act" on Jan. 12 will be tragic for some of the state’s neediest residents. The law will force companies that employ over 10,000 to spend at least 8% of their payroll on health care or kick any shortfall into a special state fund. Wal-Mart would be the only employer in the state to be affected.

Almost surely, therefore, the company will pull the plug on plans to build a distribution center that would have employed 800 in Somerset County, on Maryland’s picturesque Eastern Shore. As a Wal-Mart spokesman has put it, "you have to take a step back and call into question how business-friendly is a state like Maryland when they pass a bill that . . . takes a swipe at one company that provides 15,000 jobs."

 . . .

. . . , legislators should be mindful that companies like Wal-Mart are not the enemy but rather front-line soldiers in a real war on poverty. The profit motive leads them to seek out areas where there is much idle labor and put it to work. Where they are prevented or discouraged from doing so, the alternative job prospect is rarely a cushy spot in the bureaucracy. Rather, it is continued idleness and hardship.

 

For the full commentary, see:

STEVE H. HANKE and STEPHEN J.K. WALTERS. "Cross Country; Hard Line State." The Wall Street Journal (Thurs., January 26, 2006): A11.

 

Thanks to DDT Ban and Recycling: Bedbugs Are Back

Bedbug.jpg Image source: http://www.suburbanchicagonews.com/heraldnews/top/4_1_JO02_BEDBUGS_S1.htm

(p. 1) . . . bedbugs, stealthy and fast-moving nocturnal creatures that were all but eradicated by DDT after World War II, have recently been found in hospital maternity wards, private schools and even a plastic surgeon’s waiting room.
Bedbugs are back and spreading through New York City like a swarm of locusts on a lush field of wheat.
. . .
In the bedbug resurgence, entomologists and exterminators blame increased immigration from the developing world, the advent of cheap international travel and the recent banning of powerful pesticides. Other culprits include the recycled mattress industry and those thrifty New Yorkers who revel in the discovery of a free sofa on the sidewalk.

For the full story, see:
ANDREW JACOBS . “Just Try to Sleep Tight. The Bedbugs Are Back.” The New York Times Section 1 (Sun., November 27, 2005): 1 & 31.
(Note: ellipses added.)

Industrial Giants Succeeded in Philanthropy in the Same Way They Succeeded in Business

(p. 3) . . . the Gateses were not the first to see that money could sometimes move mountains in public health. They are following in the footsteps of the industrial giants of the late-19th century, said Dr. Howard Markel, director of the University of Michigan’s Center for the History of Medicine.

These men also brought their fortunes to bear on social problems, and believed that they could succeed in philanthropy in much the way they had succeeded in business.
The donors of the robber-baron years started their philanthropy while still alive – a novel idea then. Andrew Carnegie, for example, gave away hundreds of millions of dollars to build libraries long before his death.
The largest bequest in American history prior to Carnegie’s time was from Johns Hopkins, a Baltimore merchant, who left $7 million to found the eponymous university and hospital in 1873 – after he died.
But the closest parallel to the Gates approach to philanthropy is that of John D. Rockefeller, said Dr. Markel and Robert E. Kohler, a medical historian from the University of Pennsylvania.
Rockefeller built Standard Oil. Like Mr. Gates, he was the richest man of his time, and like him he was reviled as a greedy monopolist.
Rockefeller, like Mr. Gates, hired a professional to run his charities. And he, like Mr. Gates, used his money systematically to identify and attack important public health problems.
Rockefeller hired Frederick T. Gates, a former minister (and no relation to the Microsoft co-founder) as his philanthropic executive. Mr. Gates read an 1892 medical textbook that convinced him that diseases had causes, like germs and worms, that could be fought by science – not a universally accepted idea at the time.
The most famous health campaign he started with Rockefeller money was the drive, begun in 1907, to rid the rural American South of hookworm. Called “the germ of laziness” because it caused anemia and made victims lethargic and dull-witted, hookworm afflicted up to a third of Southerners.
The foundation set up clinics that administered purgatives and – because the worm is shed in feces and picked up by bare feet – taught people to dig deep privies and wear shoes. More Rockefeller money underwrote some of the 20th century’s great public health drives, many using research done at Rockefeller University. Clinics were built in 50 other countries to eliminate hookworm worldwide. The effort failed because the worm can survive in soil and reinfect people; but the problem diminished, especially in parts of Asia.
In 1915, the foundation declared war on yellow fever; by 1932, scientists had realized that monkeys were also a reservoir for the virus, making eradication impossible, but by then Rockefeller scientists had invented the vaccine still used today.
Patty Stonesifer, chief executive of the Gates foundation, said she and William H. Gates Sr., the father of the software pioneer and co-chair of the foundation, consider the Rockefeller campaigns especially instructive. “We stood on their shoulders,” she said.
. . .
As Ms. Stonesifer said admiringly of the Rockefeller campaign against hookworm: “A lot of people would say, ‘you’ve got to reduce poverty to get rid of hookworm.’ But the Rockefellers said, ‘You don’t need a 20-year intervention. You can use shoes.’ “

For the full article, see:

DONALD G. McNEIL Jr. “The Rich, Sometimes, Are the Best Medicine.” The New York Times, Section 4 (Sun., December 11, 2005): 3.

(Note: ellipses added.)

Dear Feds: Stop Bugging US!

15bugs.1842.jpg Asian lady beetles (Photo source: online version of article cited below, downloaded from: http://www.nytimes.com/2005/11/15/national/15bugs.html?pagewanted=1)

(p. A18) This Asian cousin of the benign, beloved ladybug has transformed domestic life in rural and suburban regions from Louisiana to Canada, intruding on the peace – and the attics, curtains and nostrils – of a significant swath of the nation.

Some years, the beetle problem is terrible. Some years, like this one, there are fewer beetles. But even so, in the 12 years that the beetle has spread from the South through the East and Midwest, irritation has given way to fury in its favorite wooded haunts.
“Please help us get rid of these bugs!” one Kentuckian commented on an anonymous survey by the University of Kentucky’s entomology department. “It’s so bad you can’t eat safely. They are falling into the food and drinks.”
A second person wrote, “A huge swarm enveloped my house last fall, causing me to fall off the porch and break my shoulder.” From a third came a cri de coeur: “Get rid of these pests. They are making me crazy. They have ruined my life.”
Unlike domestic ladybugs, the multicolored Asian variety likes to keep its polka dots indoors in the winter. In older rural neighborhoods, where houses are not knit tight, only insecticide can hope to keep them out. They swarm by the tens of thousands. Unlike the domestic ladybug, the Asian variety leaves a yellow stain. It can bite. Worst of all, it stinks.
. . .
It was for the benefit of farmers like the pecan growers that the Department of Agriculture released Asian lady beetles in the 1980’s in Georgia and elsewhere. The promise of aphid-free fruit trees and crops had prompted the department to try to import the bugs repeatedly, from 1916 on. But they never seemed to survive, until the early 1990’s.
A 1995 article in the journal Agricultural Research quoted William H. Day, a federal entomologist with the Agricultural Research Service, saying, “U.S.D.A. scientists have gone overseas for more than 100 years to search for, test, import, rear, release and evaluate exotic beneficial lady beetles, parasitic wasps, other insects and microorganisms.”

FELICITY BARRINGER. “Asian Cousin of Ladybug Is a Most Unwelcome Guest.” The New York Times (Tuesday, November 15, 2005): A18.
(Note: ellipsis added.)

Even Medical Experts Can’t Understand Their Medical Bills

Medical paperwork is a world of co-payments and co-insurers, deductibles, exclusions and contracted fees. Nothing is as it seems: patients receive statements that often do not reflect what is actually owed; telephone calls to customer service agents are at best time-consuming and at worst fruitless. The explanations of benefits that insurers send out — known as E.O.B.’s — are filled with unintelligible codes.
The system is so impenetrable that it mystifies even the most knowledgeable.
”I’m the president’s senior adviser on health information technology, and when I get an E.O.B. for my 4-year-old’s care, I can’t figure out what happened, or what I’m supposed to do,” said Dr. David Brailer, National Coordinator for Health Information Technology, whose office is in the Department of Health and Human Services. ”I can’t figure out what care it was related to or who did what.”
Dr. Blackford Middleton, a professor at Harvard Medical School with special training in health services research, said he did not fare much better than Dr. Brailer.
”I understand the words of diagnoses and procedures,” he said. ”But codes? No. Or how things are paid or not paid? I don’t understand that.”
Dr. Brailer said he often used an analogy to describe the current state of medical billing.
”Suppose you walk into a restaurant,” he said, ”and you don’t get a menu, you don’t get any choice of what food you’ll eat, they don’t tell you what it is when they’re serving it to you, they don’t tell you what it’s going to cost.”
”Then, weeks or months later, you get a bill that tells you all the food you ate and the drinks you had, some of which you remember and some you don’t, and although you get the bill, you still can’t figure out what you really owe,” Dr. Brailer said.
Some people make valiant efforts to sort through bills and claims, but end up throwing up their hands; others ignore them, until they are pursued by collection agencies; still others, basically healthy but weary at the prospect of a paperwork fusillade, stop going to the doctor altogether.

KATIE HAFNER. “Treated for Illness, Then Lost in Labyrinth of Bills.” The New York Times (October 13, 2005): A1.