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She called the problem “moral distress.”

Since that discussion, I have not been able to stop noticing moral distress.

Recently, for instance, I visited one of my closest friends, a brilliant and articulate nurse whom I’ll call Mary. During the years that we worked together, I learned that Mary’s assessments of different clinical situations were nearly always correct. But I also noticed that over time, she would often resort to enigmatic and noncommittal statements when expressing her opinions to doctors and supervisors.

Soon after we met, for example, Mary began taking care of a transplant patient admitted with an infected abdominal hernia repair. By the time I became one of the residents on this patient’s surgical team, he had lived in the I.C.U. for a month and his abdominal wall, or what was left of it, had become a beehive of festering bacterial pockets.

One morning, after yet another attempt in the operating room to clear the infected pockets, Mary pulled me aside. “How much can a person take?” she asked. Over the next few days, Mary posed the same question to the rest of the surgical team.

When it finally became clear that no one on the team was acknowledging her concerns, Mary’s question changed. If a doctor asked her to prepare the patient for yet another trip to the O.R., she would ask back, “What do you want me to do?”

Or she would reply, “Say that again?”

Or she would walk away, her response trailing behind. “O – kay.”

Eventually, Mary stopped answering at all. She simply went about her job in the most perfunctory of ways, and her usually bright patter turned flat.

I finally asked her what was wrong.

“If I say something, I get into trouble,” she explained, looking up from her charting work. “Doctors think I am out of line, and I get warnings from my superiors about being unprofessional. But if I don’t say anything, I’m afraid that the patient might suffer.”

Her gaze drifted over to our patient. “What can I do?” she asked.

Moral distress – knowing what is ethically appropriate but being unable to act on it because of obstacles inherent in a situation – was first described in 1984 in a book on nursing ethics. Subsequent researchers focused primarily on the experiences of nurses and found that those who suffered from moral distress often became reluctant to interact with patients and other providers. In one recent study, 15 percent of nurses left their jobs because of moral distress.

It now appears that doctors – caught between obligations to patients and the demands of insurance companies, administrators and even, occasionally, patients’ families – are feeling increasingly “trapped” and unable to do what they believe is ethically right. Researchers from the University of Virginia recently studied I.C.U. physicians and nurses and found that while doctors on average are less frustrated than nurses, they can also suffer from intense moral distress.

This finding doesn’t surprise me. It is profoundly disheartening to haggle with disembodied voices over the phone over insurance approval for operations to remove cancers, to struggle to do everything that should be done for the rising numbers of patients a single doctor must see, and to follow the wishes of estranged relatives who swoop into the hospital during the last days of life and demand aggressive treatment.

What can we do?

I spoke with Ann B. Hamric, a registered nurse and the lead author of the study on I.C.U. physicians and nurses.

“There are many different reasons why a clinician may feel that he or she is not able to do the ethically appropriate thing,” Dr. Hamric said over the phone. “A lot of the reasons for moral distress come from the environments where we work. Are we working as respectful partners or are we afraid? Doctors feel that the risk managers or the lawyers are telling them what they can and cannot do for patients, and that affects physicians.”

We discussed the implications of moral distress for the current nursing shortage and the impending primary care shortage. I asked her if there might be some way to change the work environment.

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Those are the marching orders that Smith & Nephew, a leading maker of artificial hips and knees, has given executives and sales representatives attending a big meeting of orthopedic surgeons next month.

The company has told them to limit their interactions with doctors to 9 a.m. to 5 p.m., the “business” hours of the convention of the American Academy of Orthopaedic Surgeons.

It remains to be seen whether such seeming magnets as doctors and sales executives can resist each other. But Smith & Nephew’s convention curfew is a sign of an ethical makeover under way within the medical device industry, a field that has been troubled by federal investigations and bad publicity over the volatile issue of frequently undisclosed financial ties between companies and physicians.

On Thursday, two senators increased the pressure further by reintroducing legislation that would require device and drug makers to report all financial links with doctors on a federal Web site.

That bill is known as the Physician Payments Sunshine Act, and a parallel effort is in the House.

“The public is clamoring for transparency,” one of the Senate sponsors, Herb Kohl, a Wisconsin Democrat, said. The co-sponsor is Charles E. Grassley, Republican of Iowa.

The nation’s biggest hip and knee makers, including Smith & Nephew, Zimmer Holdings, DePuy and Biomet, are operating under Justice Department oversight as part of a deal to resolve allegations they gave doctors illegal inducements to use their products.

Other sectors of the device industry face continuing federal inquiries or are voluntarily taking house-cleaning measures. Much of it involves the public disclosure of information that would be mandated under the Senate proposal – the names of the doctors who work for device manufacturers as consultants, lecturers, researchers or trainers, and how much each one is paid for those services.

Under their Justice Department settlements, the hip and knee makers are already disclosing such payments on their corporate Web sites. And seeing the writing on the wall, several other large device companies, including Boston Scientific and Edwards Lifesciences, recently announced they would do so voluntarily.

Meanwhile, the device industry’s main trade group, the Advanced Medical Technology Association, said it had supported the Senate measure when it was introduced two years ago.

There is little question that battles over how much companies, doctors and medical institutions disclose about their financial ties will continue. But some experts on medical conflicts of interest, seeing the rapid fall of resistance by most major companies, say that a turning point has arrived.

“We are definitely moving toward more disclosure and disclosure of information that is useful to people,” said Lisa Bero, a pharmacy professor at the University of California, San Francisco.

Recently, several big pharmaceutical companies have also said they plan to release the names of doctors they use as consultants. But the ties between medical device makers and physicians are often more entangled and can have a bigger impact on both patient care and product sales.

For one, doctors may be involved in the design of a medical device and can hold a patent on it. Further, device makers also hire surgeons to train other doctors on how to implant their products. And hospitals often give doctors a large say in determining the suppliers of products like artificial hips or heart defibrillators – companies with which those same doctors may have financial relationships.

Some hospital systems, including the big Kaiser Permanente network, bar physicians from taking industry money and now require device suppliers to compete on the same basis on which most medical products are purchased – price.

In recent months, the ground has shifted so rapidly under device makers that companies find themselves scrambling to keep up.

Take Edwards Lifesciences, a producer of heart valves and other devices. Last year, the company’s chief executive, Michael A. Mussallem, decided that Edwards would voluntarily disclose all its payments to doctors.

Mr. Mussallem said that the decision came from the push for federal legislation and the passage in Massachusetts last summer of a state law requiring drug and device companies to disclose all payments to doctors in excess of $50.

Edwards, like other device makers, has also been the subject of media articles raising questions about the motives of physicians with financial ties to the company.

“We make our living on innovation,” said Mr. Mussallem, who is also the current president of the Advanced Medical Technology Association. “But every time we turned around there was a story that made this seem negative rather than positive.”

But gathering that physician data is proving easier said than done. For instance, Edwards officials soon discovered that each company division had used a different process to account for its doctor payments, and technological havoc resulted when they tried to pull the data together.

“You couldn’t tell if Dr. Jones and Dr. Jones were the same guy,” or different ones, said Dirksen Lehman, the company’s vice president for government affairs.

Edwards hopes to resolve those issues in time to meet its self-imposed deadline of making physician disclosures public by December, he said.

For years, both device makers and their consulting doctors insisted that money did not affect how the physicians treated patients. And device makers rebuffed efforts to disclose such ties.

But the Justice Department changed all that through its investigation of orthopedics companies, which was headed by the United States attorney in Newark. Although federal prosecutors said they found that most financial ties between companies and doctors were legitimate, there was enough evidence of illegal sales inducements and sham consulting contracts to warrant filing charges.

To avoid prosecution, the companies, without acknowledging wrongdoing, entered settlements in 2007 under which they agreed, among other things, to submit all their doctor ties to an outside monitor for review. They also agreed as a group to limit daily consulting payments to most doctors to $500, and to justify such expenses.

More recently, two companies involved in the Justice Department action, Zimmer Holdings and Biomet, said separately that they would no longer give educational funds directly to medical schools, but instead would give them to professional organizations, which would decide how they should be distributed.

The federal inquiry has also had an impact on surgeons who specialize in hip and knee replacements. Company-sponsored work on new products has largely been at a standstill since 2007, several doctors said. And other types of consulting relationships are just starting to resume under the new disclosure rules.

For instance, Dr. Michael C. Raklewicz, an orthopedic surgeon in Kingston, Pa., said he was notified just a few weeks ago by Zimmer Holdings, the biggest orthopedic implant maker, that it would again retain him to train other surgeons on the use of its products.

“All I knew was that I had a few teaching sessions left and they were canceled” back in late 2007, said Dr. Raklewicz. “Then, it was like, ‘Hold on, hold on, we’ll get back to you’ and finally they did.”

The possibility of similar Justice Department action may also be facing other companies that have declared themselves converts to the concept of disclosure.

Since 2005, for example, the Justice Department has been investigating ties between doctors and makers of heart pacemakers and defibrillators. The companies involved deny any wrongdoing. But two of them – Medtronic and St. Jude Medical – have said they support federal disclosure legislation.

A third big producer, Boston Scientific, has gone a step further. The company, which acquired the heart device business of the Guidant Corporation in 2006, recently said that it planned this year to publicly release data about its financial links to doctors among all its business units.

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Of 33 new drugs approved by the Food and Drug Administration in 2001 and 2002, one-fifth of supporting clinical trials were not published in medical journals, according to a new study. And those results that were published were often more positive than what companies presented to the FDA in their applications. As a result, potentially unreliable data is being used to promote drugs on which billions of dollars and thousands of lives may ride.

“Some studies aren’t published at all. Then, when they are, there are little changes that make the papers look more favorable towards the product,” said review co-author Lisa Bero, a University of California, San Francisco health policy expert.

If new — and typically more expensive — drugs are only slightly better than existing drugs, but otherwise are comparable, this is largely an ethical and financial problem. But if the drugs later prove harmful, the damage can be profound.

In 2004, Merck’s blockbuster anti-inflammatory drug Vioxx was pulled from the market after killing an FDA-estimated 27,000 people. The drug doubled heart attack risk — a side effect that critics say was glossed over in the company’s studies, which in retrospect were partly marketing propaganda. Another Merck blockbuster, the cholesterol-lowering drug Vytorin, has proven ineffective. GlaxoSmithKline’s best-selling diabetes drug Avandia was allowed to remain on the market, but only with a label stating its apparent cardiovascular risks.

Keep reading at Drug Companies Cook Books, Misleading Doctors | Wired Science from Wired.com#more#more

Yet everywhere, anxious Democrats wring their hands. They’ve seen this Lucy-and-the-football routine before, and they’re just waiting for their ball to be snatched away, the foiled Charlie Browns again. Remember how the exit polls in 2004 predicted President Kerry?

The anxiety is more acute this year, because Senator Obama is the first African-American major-party presidential nominee. And even pollsters say they can’t be sure how accurately polls capture people’s feelings about race, or how forthcoming Americans are in talking about a black candidate.

In recent days, nervous Obama supporters have traded worry about a survey — widely disputed by pollsters yet voraciously consumed by the politically obsessed — that concluded racial bias would cost Mr. Obama six percentage points in the final outcome. He is, of course, about six points ahead in current polls. See? He’s going to lose.

If he does, it wouldn’t be the first time that polls have overstated support for an African-American candidate. Since 1982, people have talked about the Bradley effect, where even last-minute polls predict a wide margin of victory, yet the black candidate goes on to lose, or win in a squeaker. (In the case that lent the phenomenon its name, Tom Bradley, the mayor of Los Angeles, lost his race for governor, the assumption being that voters lied to pollsters about their support for an African-American.)

But pollsters and political scientists say concern about a Bradley effect — some call it a Wilder effect or a Dinkins effect, and plenty call it a theory in search of data — is misplaced. It obscures what they argue is the more important point: there are plenty of ways that race complicates polling. Considered alone or in combination, these factors could produce an unforeseen Obama landslide with surprise victories in the South, a stunningly large Obama loss, or a recount-thin margin. In a year that has already turned expectations upside down, it is hard to completely reassure the fretters.

Among the non-Bradley factors at the intersection of race and polling is something called the reverse Bradley (perhaps more prevalent than the Bradley), in which polls understate support for a black candidate, particularly in regions where it is socially acceptable to express distrust of blacks. Then there are the voters not captured by polls. Research shows that those who refuse to participate in surveys tend to be less likely to vote for a black candidate. The race of the questioner, too, affects a poll — but no one is sure whether people give more or less accurate answers when they’re interviewed by someone of their own race.

“How much we are under-representing people who are intolerant and therefore unlikely to vote for Obama is an open question,” said Andrew Kohut, the president of Pew Research Center. “I suspect not a great deal, but maybe some. And ‘maybe some’ could be crucial in a tight election.”

In 1982, exit polls had Mayor Bradley so likely to win that newspaper headlines called him the victor. Yet he lost, narrowly. There emerged what seemed like a pattern: a number of polls found more support than there actually was for Harold Washington in the 1983 Chicago mayoral race; for David N. Dinkins in the 1989 New York mayoral race; and for L. Douglas Wilder in the 1989 Virginia governor’s race.

Were people so afraid to appear bigoted that they lied to pollsters, thinking it more socially acceptable to support a black candidate? Pollsters and political scientists have long questioned that assumption because they do not believe people have an incentive to deceive unless they are explicitly asked, “Do you support the white guy or the black guy?”

“We have no evidence that people lie to us,” said Joe Lenski, executive vice president of Edison Media Research, which conducts the exit polls the television networks use. He and others say that discrepancy in the polls has more to do with which people decline to participate, or say they are undecided.

Adam Berinsky, a political scientist at M.I.T. who has written about the “I don’t know” voters, points out that while polls overpredicted Mr. Dinkins’s support in 1989, they got it right in 1993, when he was running against the same opponent, Rudolph Giuliani. In 1989, Mr. Berinsky argues, people who feared being thought racist said “I don’t know.” By 1993, they could find things in Mr. Dinkins’s mayoral record to object to and so felt more free to express their opposition without fear of seeming racist.

Mr. Kohut conducted a study in 1997 looking at differences between people who readily agreed to be polled and those who agreed only after one or more callbacks. Reluctant participants were significantly more likely to have negative attitudes toward blacks — 15 percent said they had a “very favorable” attitude toward them, as opposed to 24 percent of the ready respondents. “The kinds of people suspicious of surveys are also more intolerant,” Mr. Kohut said.

Scott Keeter, Pew’s director of survey research, said pollsters had a harder time reaching voters with lower levels of education. Less-educated whites are the kind Mr. Obama has had trouble winning over. Conversely, young people are more likely to answer surveys, and they tend to favor Mr. Obama.

There may be several factors at work: Michael Traugott, a University of Michigan professor who studies polling, argues that the Bradley effect was misnamed from the start; the problem with the polls in the 1982 race was not that they failed to capture latent racism but that they failed to account for the absentee ballots, which ultimately handed the election to the white Republican, George Deukmejian.

Whatever its causes, the Bradley gap seems to be disappearing.

In a new study, Daniel J. Hopkins, a postdoctoral fellow at Harvard, considered 133 elections between 1989 and 2006 and found that blacks running for office before 1996 suffered a median Bradley effect of 3 percentage points. Blacks running after 1996, however, performed about 3 percentage points better than their polls predicted. Mr. Hopkins argues that the changes in the welfare laws in 1996 and the decline of violent crime took off the table issues that had aggravated racial animosity.

The Bradley effect in the 2006 vote was largely absent (and in some stances a reverse effect was seen by some pollsters). In Tennessee, Harold Ford Jr., a black congressman, lost by six points. His pollster, Pete Brodnitz, said the campaign had been watching for a Bradley effect and screened carefully to make sure its own polls looked only at the people most likely to vote. Internal polls were largely correct, but some public polls, relying on a more general population, were wildly off. Mr. Brodnitz blamed bad polling, not lying.

In this year’s Democratic primaries, University of Washington researchers found a Bradley effect in three states, but a reverse Bradley effect in 12 (in the other 17, polls were within a seven-point margin of error).

The results tended to correlate with the black population in a state: blacks made up 15 percent or more of the population in almost all the states where the polls showed less support for Mr. Obama than there actually was; in the three states where polls showed more support than there was, less than 10 percent of the population is black.

The differences are too great to be explained by just high black turnout, said Anthony Greenwald, one of the researchers. Nor were people necessarily lying. Instead, he sees a cultural dynamic at work: the states where polls underpredicted support for Mr. Obama were generally in the Southeast, where the culture has more stubbornly favored whites, so the “right” answer there was to choose the white candidate. In the three states where polls in the study overpredicted support for Mr. Obama — Rhode Island, California and New Hampshire — “the desirable thing is to appear unbiased and unprejudiced,” Mr. Greenwald said. (Many polling experts also believe that Mr. Obama was benefiting from an Iowa bounce in the late New Hampshire polls, as Senator Hillary Rodham Clinton had been ahead for months, and that therefore Mr. Obama’s loss there was not a true Bradley effect.)

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The drop was the result of growth in government-sponsored health insurance programs, officials said, most of them focused on children. At the same time, the number of people covered by private insurance continued to decline.

Experts cautioned that the report, which also included data on income and poverty, did not take into account the economic downturn that began late last year, and therefore it probably presents a rosier picture than the current economic reality.

According to the report, the nation’s median household income rose by 1.3 percent in 2007, to $50,233, the third consecutive annual increase. The nation’s poverty rate remained flat at 12.5 percent, the report said.

“The data in this report refer to last year, when everything was different,” said Jared Bernstein, a senior economist at the Economic Policy Institute, a liberal policy group in Washington. “This year, we’re losing jobs on a monthly basis, inflation is running well over 5 percent, and unemployment was last seen at 5.7 percent and rising.”

Health-care experts and advocates for the poor said the report also presented an outdated picture regarding health insurance. The rate of people without health insurance declined to 15.3 percent in 2007, from 15.8 percent a year earlier.

“In 2007, at least 26 states made efforts to expand coverage, but as the economy has turned downward so have state efforts,” said Diane Rowland, executive vice president of the Kaiser Family Foundation.

Ms. Rowland added that insurance premiums had risen faster than wages and inflation, causing more people to seek insurance from public programs.

The census report, she said, highlights the importance of expanding government health-care plans like the State Children’s Health Insurance Program.

In December, President Bush signed legislation that extends federal financing for the program through the end of March 2009. That action came after he vetoed two Congressional attempts to expand the program.

David Johnson, chief of the Housing and Household Economic Statistics Division at the Census Bureau, said that the number of people covered by private insurance declined in 2007, but that the overall number of people who were uninsured went down because of federal and state programs.

“The fall in private insurance was similar to recent years,” Mr. Johnson said. “That fall was offset by the rise in government insurance.”

The number of people under 18 without insurance dropped to 11 percent, or 8.1 million, in 2007, from 11.7 percent, or 8.7 million, a year earlier.

Over all, the percentage of people covered by government programs rose to 27.8 percent in 2007 from 27 percent the year before. The percentage and number of people on Medicaid, the government health insurance program for low-income people, rose to 13.2 percent, or 39.6 million, in 2007, up from 12.9 percent, or 38.3 million, in 2006.

Private health insurance fell, covering 67.5 percent of Americans in 2007, down from 67.9 percent in 2006. Employment-based coverage also continued its long decline in 2007, dropping to 59.3 percent from 59.7 percent.

“States such as Massachusetts have also played an important role in stemming the rising tide of uninsured, and thanks to their health reform law they now have one of the lowest uninsured rates,” said Karen Davis, president of the Commonwealth Fund, a private foundation supporting independent health policy and health care research. “But 45.7 million uninsured people are far too many, and we need a national solution to this crisis.”

Changes in economic circumstances varied regionally and by race and age.

Douglas J. Besharov, a resident scholar at the American Enterprise Institute, a conservative research group, said one of the most noteworthy statistics in the report concerned foreign-born residents.

While households led by someone who was native-born had an increase of 1 percent in median income, the income of households headed by foreign-born persons who are noncitizens dropped 7.3 percent in 2007, according to the report.

Real median income (adjusted for inflation) for black and non-Hispanic white households rose between 2006 and 2007, representing the first measured real increase in annual household income for each group since 1999, according to the report. Real median household income remained statistically unchanged for Asians and Hispanics.

Mr. Besharov said an increase in poverty among Hispanics in the construction trade stemmed largely from the bursting of the housing bubble and the ensuing mortgage crisis.

“With more current data, we would see that the type of the poverty that we see among Latinos has actually already spread to the general population,” Mr. Besharov said.

Mr. Bernstein, from the Economic Policy Institute, agreed and said that while comparisons to 2006 showed some improvement, in order to understand the difficulties facing middle- and low-income families, it was important to consider these results in the context of the economic expansion since 2000.

For the first time on record, real household income is no higher at the end of an economic expansion than it was when the cycle began, Mr. Bernstein said.

The median income of working-age households — with household heads under age 65 — rose insignificantly in 2007, when adjusted for inflation, and was $2,010 below its 2000 level.

“Working households helped bake a bigger economic pie but ended up with thinner slices,” Mr. Bernstein said.

The report also found other disparities.

Women earned 78 cents for every $1 earned by men. But that is the highest percentage ever reported for women, when compared with men.

Texas led the nation with the highest percentage of uninsured residents, 24.4 percent, while Massachusetts and Hawaii, at 8.3 percent, had the lowest.

Read the full report here…

However, this is incorrect. Employers do not bear the cost of employment-based insurance; workers and households pay for health insurance through lower wages and higher prices. Moreover, government has no source of funds other than taxes or borrowing to pay for health care.

Failure to understand that individuals and households actually foot the entire health care bill perpetuates the idea that people can get great health benefits paid for by someone else. It leads to perverse and counterproductive ideas regarding health care reform.

Continue reading at JAMA site…

While justices don’t give reasons for deciding not to take part in cases, it appears to be the third time that Roberts’ financial holdings have played a role in his participation or absence from cases.

With Roberts on the sidelines and the other justices evenly split, the court left intact a lower court ruling favorable to people who sued pharmaceutical company Warner-Lambert.

The company is owned by Pfizer Inc., a company in which Roberts owns $15,000 to $50,000 worth of stock. The holdings were listed on the financial disclosure form the chief justice filed last May.

In a lawsuit, a number of Michigan residents alleged they were harmed by Rezulin, a drug to combat diabetes. Federal regulators approved it despite risks to the liver and cardiovascular system.

In their suit, users of the drug are relying on a Michigan law to allege that the pharmaceutical company engaged in fraud by misleading federal regulators to get the drug approved. The Michigan law shields pharmaceutical companies from product liability lawsuits, unless they committed fraud.

At issue in the case is whether that fraud exception, which allows lawsuits to proceed, is pre-empted by federal regulation of the pharmaceutical industry.

The 2nd U.S. Circuit Court of Appeals in New York ruled that the exception to the Michigan law was not pre-empted by federal regulations, enabling the Michigan plaintiffs to pursue the case.

Last year, Roberts initially removed himself from an important securities fraud lawsuit, apparently because he owned stock in Cisco Systems Inc., the parent company of a defendant in the case. But Roberts later got back in the case, an indication he had sold the stock. Roberts was in the majority in that case.

Similarly, Roberts returned to a case last year in which the court sided with Wall Street banks accused by investors of conspiring to manipulate stock prices during the dot-com bubble of the late 1990s. Again, he sided with the majority.

The chief justice was not the deciding vote in either of the two cases to which he returned.

Copyright 2008 Associated Press. All rights reserved.
This material may not be published, broadcast, rewritten, or redistributed.© 2008 Michigan Live. All Rights Reserved.
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“A new study by a professor at the University of Texas at Austin suggests that home plate umpires call balls and strikes more favorably when the pitcher is their same race, Time magazine reported.

The research team led Daniel Hamermesh, professor of economics, found that umpires call strikes more for pitchers of their race and balls more when the pitcher is of another race, Time said.

The study found that the disparity occurred in 1 percent of pitches. The researchers analyzed 2.1 million umpire calls between the 2004 and 2006 seasons, Time said.

“One pitch called the other way affects things a lot,” Hamermesh said. “Baseball is a very closely played game.”

Hamermesh added that even a slight bias by umpires will affect the kinds of pitches that pitchers make if they believe they are getting squeezed by the umps. Pitchers who are getting balls called too much might start throwing over the middle of the plate more, thus resulting in batters getting fat pitches to hit, Time said.

Seventy-one percent of major-league pitchers and 87 percent of umpires are white. ” more…