Consumer News & Warnings
Wednesday, November 29, 2006
  Women's Health

That Prenatal Visit May Be Months Too Late

Published: November 28, 2006

For years, women have had it drummed into them that prenatal care is the key to having a healthy baby, and that they should see a doctor as soon as they know they are pregnant.

But by then, it may already be too late. Public health officials are now encouraging women to make sure they are in optimal health well in advance of a pregnancy to reduce the risk of preventable birth defects and complications. They have recast the message to emphasize not only prenatal care, as they did in the past, but also what they are calling “preconception care.”

The problem, doctors say, is that by the first prenatal visit, a woman is usually 10 to 12 weeks pregnant. “If a birth defect is going to happen, it’s already happened,” said Dr. Peter S. Bernstein, a maternal fetal medicine specialist at Montefiore Medical Center in New York who helped write new government guidelines on preconception care.

For many women, Dr. Bernstein said, “The most important doctor’s visit may be the one that takes place before a pregnancy is conceived.”

The new guidelines, issued by the Centers for Disease Control and Prevention last spring, include 10 specific health care recommendations and advise prepregnancy checkups that include screening for diabetes, H.I.V. and obesity; managing chronic medical conditions; reviewing medications that may harm a fetus; and making sure vaccinations are up to date.

Much of the advice directed to women is fairly standard: they should abstain from smoking, alcohol and drugs, and should take prenatal vitamins, including folic acid.

For Diane Jackey, a mother of five from Hempstead, N.Y., maintaining preconception health meant continuing prenatal vitamins between pregnancies, snatching exercise whenever she could and maintaining a balanced diet. “I don’t smoke, and I don’t drink at all,” Ms. Jackey said.

What is new and somewhat controversial about the guidelines is the suggestion that they should apply to women throughout their reproductive years, even when they are not planning pregnancies. (Men should be wary of exposures to toxins that cause birth defects and should avoid sexually transmitted diseases, experts say.)

But while the report was criticized in some quarters for treating all women as though they were eternally “prepregnant,” it also discusses the importance of family planning and child spacing and encourages young people to develop a “reproductive life plan.” Half of all pregnancies in the United States are unplanned, experts say, and preparing for a healthy pregnancy can require behavioral changes that may take months. Even daily supplements of folic acid should ideally be taken for three months before conception.

“It’s not like we have an injection we can give someone” to prepare her for pregnancy, said Dr. Hani Atrash, associate director for program development at the National Center on Birth Defects and Developmental Disabilities at the disease centers. “Some of the interventions, like weight management, need time to happen. You cannot quit smoking in one day.”

The issue of preconception health has taken on added urgency in recent years because while infant mortality rates were on the decline from 1980 to 2000, the proportion of small and preterm babies increased significantly. And low birth weight, which has been linked to maternal smoking and multiple births, is a leading cause of death and disability for infants.

In 2002, the infant mortality rate in the United States increased for the first time in more than 40 years, to 7.0 deaths per 1,000 live births in 2002 from 6.8 deaths per 1,000 live births in 2001. The rate dropped back to 6.8 per 1,000 in 2003. Blacks are at the highest risk for preterm birth and low birth weights, and their infant mortality rates are more than double that of whites.

Meanwhile, rising obesity rates and the tendency to postpone motherhood mean far more women are overweight when they become pregnant and thus are more likely to have high blood pressure, diabetes or prediabetes, which complicate pregnancy.

“There is no question the No. 1 issue for women in America is their weight,” said Dr. Gary Hankins, who leads the committee on obstetrics practice of the American College of Obstetricians and Gynecologists.

Pre-existing diabetes significantly increases the risk of birth defects, but the risk is virtually eliminated if the disease is controlled before conception, Dr. Hankins said. Obese women who become pregnant face a higher risk of developing gestational diabetes and of having a large baby and a difficult delivery.

While doctors have been recommending preconception care for many years, it has never really caught on. Only one in six health care providers said they had provided preconception care to patients, one study found, and most health plans do not cover it. Medicaid, the government health plan for the poor, often only covers women after they are pregnant.

Rochelle Carr, 31, a Bronx mother, sought preconception counseling because she worried that her asthma medications might harm a developing fetus. Ms. Carr was also concerned because she had suffered a life-threatening pulmonary embolism, or blood clot to the lung, when she was 29.

Ms. Carr’s doctor referred her to a maternal fetal medicine specialist at Montefiore Medical Center. Dr. Ashlesha Dayal reviewed Ms. Carr’s medications and advised her to stop taking an asthma drug linked to birth defects and to start taking folic acid daily.

Once Ms. Carr became pregnant, Dr. Dayal prescribed an anticoagulant because Ms. Carr was at high risk for developing another blood clot. The doctor also explained the risks of taking the anticoagulant. “She really put my mind at ease,” said Ms. Carr, who delivered a healthy baby, Joshua, on Nov. 29, 2005.

Doctors say that planning pregnancies and using reliable contraception are part and parcel of preconception care, and they are encouraging all health providers — not just obstetricians but emergency room doctors, primary care physicians, cardiologists and endocrinologists — to counsel women of childbearing age about the possibility of pregnancy. “What we’re actually talking about,” Dr. Atrash said, “is women’s health.”



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Monday, November 27, 2006
  Too Good to be True?

The High Cost of Too Good to Be True

Published: November 26, 2006

AS the red-hot California real estate market sizzled in recent years, National Consumer Mortgage looked like just another residential mortgage company successfully riding the boom. It had lush offices in downtown Orange; the former baseball great Steve Garvey promoted its products in radio spots; and its founder, Salvatore Favata, a former local baseball hero himself, lived in a $1.7 million mansion in tony Yorba Linda and zipped around in a Mercedes roadster. An annual “Favata Fest” at the founder’s home featured live music and photo ops with Mr. Garvey.

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Tom Keene/LAdigital Photo

Salvatore Favata, right, who recently agreed to a plea deal involving mortgage investments, with the former baseball star Steve Garvey. Mr. Garvey, who helped promote the Favata firm, was not implicated.

Steve Goldstein for The New York Times

Bryan Downey at home in Canyon Country, Calif., with his sons Cade, 3, left, and Bryce, 6. He lost an inheritance of $125,000 when he was persuaded to invest the money with National Consumer Mortgage.

Matthew Staver for The New York Times

Melissa Miller and her father, Dennly Becker, with her son, Jetton, in Parker, Colo. Both lost hundreds of thousands in the N.C.M. fraud.

The little mortgage company was also ambitious. N.C.M. ran an investment arm that offered high-yielding notes to preferred clients, promising to use customers’ funds to make short-term, high-interest loans to individuals and companies that needed money quickly. For customers like Bryan F. Downey, a 41-year-old father of three, it was a tantalizing pitch. Mr. Downey had a $125,000 inheritance that he wanted to put to work, and his younger brother had already invested his inheritance with N.C.M.

In April 2005, Mr. Downey invested the entire $125,000 in N.C.M. notes guaranteeing annual interest payments of 12.5 percent for two years. After the contracts were signed, Mr. Downey recalls, Mr. Favata, 46, tan and trim, glided into the conference room, which had a view of Angel Stadium, nearby in Anaheim. Mr. Favata greeted him like an old friend and shook his hand, saying, “Welcome to the family.” It’s a relationship Mr. Downey now wishes he could disown.

Earlier this spring, Mr. Downey, along with more than 200 others living mostly in California and Colorado, found out they were victims of a long-running Ponzi scheme that pulled in about $30 million before N.C.M. sought bankruptcy this spring, according to a Securities and Exchange Commission civil complaint and filings in a federal criminal case, both filed in United States District Court for the Central District of California in Santa Ana. Rather than using the money to make loans, authorities say, Mr. Favata wagered away about $10 million of it in Las Vegas and plowed through much of the rest in his business dealings and lavish lifestyle.

The N.C.M. scheme, of course, is hardly novel. It is not even all that big by recent standards. But it bears all the hallmarks that have made financial scams possible for generations: naïve trust, a speculative market offering seemingly easy riches, and gilded lures hitched to people’s unending desire to keep up with the Joneses. So why is it that year after year, century after century, certain people fall for financial dodges, regardless of their provenance?

“You would think living in an information age it would be easier for people to sort out the fact that these schemes exist,” says James H. Burrus, assistant director with the Federal Bureau of Investigation in Washington. “But so much information is available and coming at people at different ways that the fraudsters are much better at adapting to the environment to defraud the victims out their money.

“People believe their next-door neighbor is investing in property, flipping it and getting rich quick,” Mr. Burrus added. “Everybody seems to be doing it. Fraudsters take advantage of those types of cycles.”

But con artists don’t use greed alone. Analysts say a variety of factors come into play when scams are afoot, many of which revolve around a fear of financial and emotional vulnerability — concerns about not having saved enough to send your children to college; the isolation and loneliness of the elderly; the stress that accompanies career changes; or the loss of a loved one.

MONEY, especially fast money, offers a buffer of sorts in an uncertain world. And con artists are only too happy to wear the guise of the market sage or guardian angel.

“The best scams start with a kernel of truth that are ripped right out of the headlines,” explained Joseph P. Borg, director of the Alabama Securities Commission and president of the North American Securities Administrators Association. “Oil prices are up. There’s a war in Afghanistan and Iraq. Tainted spinach. All of these can spawn frauds.”

Faced with the opportunity to invest on the ground floor of something completely plausible and, better yet, exclusive, some jump in with both feet. “It’s a combination of greed and a feeling of, ‘If somebody is going to make money, why not me?’ ” Mr. Borg said.

The inner workings of the N.C.M. scheme, which snared wealthy professionals as well as retirees on fixed incomes, suggest that the common perception that only the elderly, less sophisticated or less well-off investors can be duped may be flawed — that a large cross-section of society can be swindled out of large sums.

Mr. Favata used existing investors, to whom he was faithfully making interest payments, to recruit their friends and family members. The promised returns were not so outsize as to raise the suspicions of more sophisticated investors. Payments, which came monthly or quarterly, lulled many into believing that their investments were safe and solid — at least for a while.

“They were really slick in how they presented themselves, how they looked, even where the building was located,” recalled Mr. Downey, who attended college for two years and now licenses consumer products for a private company. “They looked like they were making lots of money and that they had lots of good investors.”

Mr. Favata, who struck a plea deal with prosecutors in the federal district court in Santa Ana, declined to comment. “Mr. Favata has fully accepted responsibility for his actions,” said his lawyer, Nathan J. Hochman, from Beverly Hills. “He is completely cooperating with federal and state authorities and will devote the rest of his life toward paying back the people he has taken money from.”

Regulators have not accused Mr. Garvey of wrongdoing, and he does not appear to have invested in the scheme. Messages left for him with his agent were not returned.

Experts say that for those caught up in financial scams, especially schemes similar to the one Mr. Favata has acknowledged engineering at N.C.M., the early stages are exhilarating and therefore magnetic. Indeed, until the moment investors finally absorb the fact that they may have been duped and their money gone forever, speculating on a “sure thing” has all of the warm and fuzzy benefits of a freewheeling joy ride.

In its purest form, being involved in a bogus get-rich-quick scheme is like a trip to Disneyland, says Anthony Pratkanis, a psychology professor at the University of California, Santa Cruz, and co-author of “Weapons of Fraud: A Source Book for Fraud Fighters.” Professor Pratkanis equates being taken in by a fraud to riding the Pirates of the Caribbean attraction.

“You’re experiencing the ride, singing, ‘Yo ho ho! It’s a pirate’s life for me,’ but you never see any of the trappings of the ride itself,” he said. “Criminals call it, ‘putting the victim under the ether.’ ”

In other words, once they have taken the bait, victims typically stop asking questions. While there are various estimates of how many people are taken in by cons and how much money they lose, experts and law enforcement authorities acknowledge that their best guesses are just that. The F.B.I., for instance, believes that more than $1 billion was lost to mortgage fraud last year. While that number seems substantial, experts note that it represents a minute fraction of the $3 trillion in mortgages issued last year.

There may never be a comprehensive tally of fraud, in large part because it is one of the most underreported crimes, authorities say. Some victims deny, even to themselves, that they have been defrauded, while others are simply too embarrassed to tell anyone. No demographic group is immune to fraud, and sophisticated con artists tailor their pitches to their audience.

A younger victim may be motivated by a rich payday, while the elderly appear to fall for schemes that claim to involve the government or a charity, said Sid Kirchheimer, author of “Scam-Proof Your Life,” a book published by AARP.

“None of them say they wanted to get rich,” Mr. Kirchheimer said of the elderly he counsels through his work at AARP. “They tell me that their grandson wants to go to college and they wanted to help him — at least that’s what they tell me.”

Fraud operators are also deft at using middlemen to become associated with a community group or religious organization. The authorities label these schemes “affinity frauds,” because they take in people who have a common interest.

“Whether in a religious group or any other community-based organization, all you may need to do is scam one person very aggressively, in hope that this ‘centerpoint’ will start peddling the scheme to other members,” said John Reed Stark, chief of the office of Internet enforcement at the S.E.C. “The centerpoint may not even profit or be at all complicit in the scheme, but he or she nonetheless becomes an important part of the overall con.”

ONE investment pitch under investigation occurred in Indianapolis and involved Robert Penn, who owned several property management and real estate businesses and cut a charming figure in the community. Mr. Penn has been accused in a lawsuit — filed in Marion County Circuit Court in Indianapolis by the mortgage giant Countrywide Financial and other lenders — of orchestrating a scheme to use straw buyers to file hundreds of fraudulent mortgages worth upwards of $40 million.

In a response filed in court, Mr. Penn denied the allegations; he and his lawyers did not return phone calls seeking comment. Countrywide is contending that Mr. Penn and his associates sold it overpriced mortgages they took out in the names of his investors. Federal prosecutors are looking into the allegations.

Mr. Penn came across as savvy and self-assured, yet always concerned for the well-being of those around him, recall people who worked and invested with him. One of those people was Cynthia K. Hancock, who met Mr. Penn through her former colleagues in 2003.

Ms. Hancock, then an aide at an animal research lab at the Indiana University School of Medicine, describes herself as unsophisticated about finance and real estate. “I don’t carry a Coach handbag; I have never had a manicure,” she said. “I have just worked all my life and paid my bills. That’s why I had such a great credit score. I thought for once my credit score could help me get a little ahead.”

Ms. Hancock said Mr. Penn told her — as well as many individuals in rural Virginia, where his sister lived and his mother served as a lay minister to a small congregation — that their credit scores could help them make money the way rich people do: in real estate.

To Ms. Hancock and the others who heard the stories of easy money in real estate or read them in newspapers, it was a credible pitch. All they had to do was put their names on multiple mortgage applications, thereby “investing” their credit scores, they said Mr. Penn told them. The borrowers saw little downside; they were not asked to put any money down. They said Mr. Penn told them that he and his business associates would do that on each borrower’s behalf.

When some received a check for several thousand dollars, it seemed that the investment was paying off as it was billed. Then, they said, they discovered that they were on the hook for hundreds of thousands of dollars in inflated mortgages taken out on homes in Indiana, some of them in rundown neighborhoods. Ms. Hancock, who worked at Mr. Penn’s property management company for a year and a half, owned five homes. Her daughter — a law student — was named as the buyer for four homes. All of the homes have been foreclosed on, and Ms. Hancock and her daughter are considering filing for bankruptcy protection.

IN hindsight, it is easy to see where Mr. Penn’s investors made their mistakes: they were hurried through paperwork and did not read what they were signing. No one asked to see the properties they were buying or pressed for confirmation that rents were being collected and mortgages were being paid. And the investors said Mr. Penn also tapped into key vulnerabilities, particularly those among the largely African-American, working-class investor group in Virginia. By investing in real estate, they said he told them, they could start to close the financial gap between them and white middle-class investors.

Many investors also dropped their guards because Mr. Penn’s family, and his mother in particular, were viewed as religious leaders in the area. Spirituality and predatory practices never intermingle, investors believed.

“The whole basis of church affiliation is a sense of morality,” Mr. Kirchheimer said. “Your natural resistance, your armor will probably be a little less because you are assuming people there are more moral.”

Establishing — and ultimately violating — a bond of trust is at the heart of many frauds, whether it comes through a religious affiliation or a longstanding business relationship.

If there was one person whom Melissa A. Miller of Parker, Colo., thought she could trust, it was Robert O. Bryant, a friend and her insurance agent for 10 years. When Ms. Miller sold her dental practice in 2005, she said, she was not sure what to do with her money.

A fairly conservative investor, she said she was skeptical when Mr. Bryant first told her about Mr. Favata’s private notes. She talked with her friends in the real estate business as well as her father, who owned rental property and had experience with similar instruments, eventually concluding that the notes were a safe bet because the properties served as collateral.

Ms. Miller, 39, and her husband, Sam, an airline pilot, who have three daughters and a son, invested $575,000 in N.C.M. notes. She recruited her father, Dennly R. Becker, and he invested $250,000. Aside from the few interest payments they received, the father and daughter believe that most of that money is lost.

“Yes, I am embarrassed,” Ms. Miller said. “I am ashamed that I got my family involved in this. But it could absolutely happen to everybody.

“They seemed so trustworthy,” Ms. Miller said of Mr. Favata and Mr. Bryant, “which is what got everybody.

“They were knowledgeable,” she added. “They had every answer to every question you could ask about this scheme.”

OR almost every answer. John P. Brincko, a management consultant advising the creditors committee in N.C.M.’s bankruptcy, said that none of the investors, to his knowledge, asked to see the deeds of trust that ostensibly backed their investments. Ms. Miller said that she asked to see them several times, but that Mr. Bryant rebuffed her with excuses: the deeds would be available after the loans had been made; he would pick up the deeds when he visited Mr. Favata next; and, just before the scheme collapsed, he said he had forgotten to bring them back from California.

Mr. Bryant has not been charged with any crime. He did not respond to an interview request and is listed in N.C.M.’s bankruptcy filing as having lost close to $1 million of his own money.

In October, Mr. Favata agreed to plead guilty to one count of mail fraud in exchange for a five-year sentence, a $250,000 fine and repayment of more than $20 million to the victims, all of which is still to be approved by a judge. But it is unclear whether the victims will receive much beyond pennies on the dollar. His mansion in Yorba Linda will be sold to pay victims, but he appears to have few other hard assets, the authorities say. The Mercedes roadster and a Lincoln Town Car that he drove, for instance, were leased by N.C.M.

Brent G. Tabacchi, an assistant United States attorney based in Santa Ana, said the investigation was continuing but that the prosecutors had decided to settle with Mr. Favata because, among other reasons, he turned himself in, gave up his assets and agreed to a restitution plan.

But for the victims of fraud, there are some losses that can never be repaid.

“I lost a lot of faith in human beings — I will really not trust someone with my money now,” said Mr. Downey, who regrets losing his father’s money. “He worked hard to become middle class, he left us a nice home that we sold, and we all got taken in by a clown in Orange County.

“I foolishly fell for this because I went into their beautiful building that was overlooking Angel Stadium,” he added. “They even promised me box seats.”



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Thursday, November 23, 2006
  Slow Food Nation

Watch What You Eat, if You Dare

First Run/Icarus Films

Modern Meals A scene from “Our Daily Bread,” a new documentary on the food processing industry.

Published: November 22, 2006

THREE years ago the Austrian filmmaker Nikolaus Geyrhalter grew curious about what lay behind the sunny images of food in advertisements and packages. He had read that Europeans were spending 8 percent of their income on food. In the 1950s the figure was 30 percent, and Mr. Geyrhalter wondered what, apart from an increase in affluence, made modern meals so cheap.

Mr. Geyrhalter channeled his curiosity into a documentary, “Our Daily Bread,” which opens in New York on Friday at Anthology Film Archives. “Fast Food Nation,” the book that inspired countless Americans to stop asking for “fries with that,” has been made into a feature film by Richard Linklater, complete with stars and an indie soundtrack. But “Our Daily Bread” could do much more to catalyze the move toward Slow Food nation.

The film depicts the mechanical monotony of industrialized food production, where the difference between a cow and an apple is a matter of equipment, and where humans are employed only when there isn’t yet a machine efficient enough to replace them. Each section of the 92-minute film is composed with attention to the scale and symmetry of these food factories, making it as much an art film as a political statement.

In Mr. Geyrhalter’s long, static shots, chicks shoot from a tube into baskets on a conveyor belt in an endless peeping blur. Pigs are processed in a ghoulish mechanical ballet. “Vine ripened” vegetables grow in neat rows inside a vast greenhouse complex, planted in plastic-wrapped pallets of nutrient-soaked matter and suspended by strings from a network of cables. Salmon sucked from a fjord are sawed open, eviscerated and vacuumed clean in seconds.

“ ‘Our Daily Bread’ is a documentary that could probably find a place in a course on science fiction films,” said Richard Peña, the chairman of the selection committee of the New York Film Festival, where the movie was shown to acclaim this fall. “Geyrhalter presents a world that looks like ours but seems one step removed from it. Of course the conceit is that indeed what he’s showing us is our world, whether we know it or not. And whether we like it or not.”

At 34, Mr. Geyrhalter has directed six documentaries on such subjects as the first year of peace in Bosnia and life in the restricted zone near Chernobyl. He made “Our Daily Bread” in Europe. Getting permission to film wasn’t always easy, but he said that when he wasn’t allowed to enter a poultry plant in, say, Germany, he would simply find another, nearly identical, place in Spain or Poland.

During editing, Mr. Geyrhalter removed all the interviews. Even the workers who are seen eating alone on lunch breaks — effectively marking the end of the conveyor belt — do not speak.

“I had the feeling that as soon as somebody starts talking, even if it’s interviews, the audience expects explanations and somebody to be blamed,” the director said last month from a hilltop near his weekend home in the Austrian countryside, where he had driven to find a cellphone signal.

“And since food has to do with everybody, I just didn’t want to give the audience any chance to escape because they all have the responsibility for what they buy.”

Since completing the film, Mr. Geyrhalter said, he eats less meat and buys organic food when he can. While he said that the recent spate of books and films that take on agribusiness could have some impact on certain consumers, he is not optimistic about more sweeping changes.

“You will never reach the majority,” he said. “Whatever we see in the movie is just part of our reality, and it will always stay part of our reality.”

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Wednesday, November 22, 2006
  Back Surgery

For Spinal Disks, Surgery Appears Equal to Waiting

Published: November 21, 2006

People with ruptured disks in their lower backs usually recover whether or not they have surgery, researchers are reporting. The study, a large trial, found that surgery appeared to relieve pain more quickly but that most people recovered eventually and that there was no harm in waiting.

And that, surgeons said, is likely to change medical practice.

The study, published Wednesday in The Journal of the American Medical Association, is the only large and rigorous randomized trial to compare surgery with waiting for sciatica.

The study was controversial from the start, with many surgeons saying they knew that the operation worked and that it would be unethical for their patients to participate.

In the end, though, neither waiting nor surgery was a clear winner, and most patients could safely decide what do based on personal preference and level of pain. Although many patients did not stay with their assigned treatment, with whatever treatment they had, most fared well.

Patients who had surgery often reported immediate relief. But by three to six months, patients in the two groups reported marked improvement.

After two years, about 70 percent of the patients in the two groups said they had a “major improvement” in their symptoms. No one who waited had serious consequences, and no one who had surgery had a disastrous result.

Many surgeons had long feared that waiting would cause severe harm, but those fears were proved unfounded.

“I think this will have an impact,” said Dr. Steven R. Garfin, chairman of the department of orthopedic surgery at the University of California, San Diego. “It says you don’t have to rush in for surgery.”

“Time is usually your ally, not your enemy,” Dr. Garfin added.

As many as a million Americans suffer from sciatica, said Dr. James Weinstein, a professor of orthopedic surgery at Dartmouth who led the study. The condition is characterized by an often agonizing pain in the buttocks or a leg or weakness in a leg.

It is caused when a ruptured disk impinges on the root of the sciatic nerve, which runs down the back of the leg. And an estimated 300,000 Americans a year have surgery to relieve the symptoms, Dr. Weinstein added. Patients often are told that if they delay surgery they may risk permanent nerve damage, perhaps a weakened leg or even losing bowel or bladder control. But nothing like that occurred in the two-year study comparing surgery with waiting in nearly 2,000 patients.

The patients did not include people who had just lower back pain, which can have a variety of causes. Nor did they include patients with conditions that would require immediate surgery like losing bowel or bladder control or significant or sudden leg weakness. Instead, they were typical of a vast majority of people with sciatica who are made miserable by searing pain. For such patients, fear that delaying an operation could be dangerous “was the 800-pound gorilla in the room,” said Dr. Eugene J. Carragee, professor of orthopedic surgery at Stanford.

Dr. Carragee never believed it himself, he said, but the concern was there and it was widespread among patients and doctors.

“The worry was not knowing,” he added. “If someone had a big herniated disk, can you just say, ‘Well, if it’s not bothering you that much, you can wait?’ It’s kind of like walking on eggshells. What if something terrible did happen?”

With the new results, it is clear that the risk of waiting “is, if not extraordinarily small, at least off the radar screen,” Dr. Carragee said.

The study involved 13 spine clinics in 11 states. All the participants had pain from a herniated disk and leg pain. The patients were asked whether they would allow the researchers to decide their treatment at random, surgery or waiting. Those who did not have surgery generally received physical therapy, counseling and anti-inflammatory drugs.

In the end, though, the study could not provide definitive results on the best course of treatment because so many patients chose not to have the treatment they were assigned to at random.

About 40 percent of those assigned to surgery decided not to have it, often because their conditions improved while they awaited the operations. A third of patients assigned to wait decided to have operations, often because their pain was so bad that they could not stand it any longer.

Others asked not to be randomized and were followed to see what treatment they chose and how they fared.

The researchers also are conducting a separate analysis on the cost effectiveness of surgery compared with waiting. Although that analysis has not been published, Dr. Anna N. A. Tosteson of Dartmouth, an author of the study, said that Medicare paid a total of $5,425 for the operation and that private insurers might pay three to four times that.

Although the results answered one question, about the safety of waiting, they were also, in a sense, disappointing, said Dr. David R. Flum, a contributing editor at The Journal of the American Medical Association and an associate professor of surgery at the University of Washington.

“Everyone was hoping the study would show which was better,” surgery or waiting, Dr. Flum said.

“And everyone was surprised by the tremendous number of crossovers in both directions,” he added, referring to the large number of participants who changed from surgery to waiting and vice versa.

That muddied the data.

“You can’t say which is better,” he concluded.

Sciatica tends to run in families and occurs when the soft gel-like material in a spinal disk protrudes through the outer lining of the disk like a bubble on a bicycle tire. That compresses and inflames a nerve root that forms the sciatic nerve.

The resulting pain can feel like a burning fork in the buttocks, Dr. Weinstein said. Or it can be a searing pain down the back of a leg. The pain can be so intense that some people cannot walk. Some cannot sit. Some, Dr. Weinstein said, “can barely crawl.”

The operation is quick and generally effective, Dr. Garfin said.

“This isn’t where the spine-surgery horror stories come from,” he said, at least in properly selected patients.

It involves gently pushing the compressed nerve root away from the herniated disk. Then the surgeon makes an incision in the disk and deflates it. The nerve returns to its normal position, the inflammation goes away, and the pain often disappears.

Despite the fact that the study could not tell for sure whether it was better to have the operation or to wait, The Journal of the American Medical Association published two papers on the study anyway, one reporting on the randomized trial and the other on the patients who chose not to be randomized. And it published editorials by Dr. Carragee and Dr. Flum.

The reason for all the attention, Dr. Flum explained, was that the study was large and well designed, that its authors had no conflicts of interest, and, “we can learn a lot.” The message, in the end, Dr. Weinstein said, was that no matter which treatment a patient received, “nobody got worse.”

He added, “We never knew that until we did the study.”



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Friday, November 10, 2006
  Alcohol Hangover Ratings
Really?

The Claim: Some Types of Alcohol Cause Worse Hangovers Than Others

Published: November 7, 2006

THE FACTS Too much alcohol of any kind can cause sickness and regret the morning after. But it’s often said that some kinds of drinks are worse than others.

Experts say that the type of alcohol you drink does make a difference, but for various reasons. Among the most important is the amount of congeners (pronounced CON-juh-nurz) — complex organic molecules — in a particular drink. Impurities in poorly refined spirits like cheap vodka can also play a role, but congeners, which are common in darker liquors, seem to have the greatest effect.

According to one report in The British Medical Journal, which looked at the effects of different types of alcohol, the drink that produced the most hangover symptoms was brandy, followed by red wine, rum, whiskey, white wine, gin and vodka. Another study showed that bourbon was twice as likely to cause sickness as the same amount of vodka.

There is also wide variation within certain categories, like wine. Wines that come from countries where a small change in climate can greatly affect their quality, some experts say, can contain significantly more hangover-inducing compounds in a bad season. Inexpensive red wines, in particular, have a reputation for causing sickness. But that may be because some people suffer from a syndrome called red wine headache, whose cause is unknown. What scientists do know is that the wines that cause it vary from person to person, and across brands, grapes and price.

THE BOTTOM LINE Certain types of alcohol can make a hangover worse.

scitimes@nytimes.com



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Tuesday, November 07, 2006
  Migraine Treatment

It May Come as a Shock

Published: November 7, 2006

In ancient Rome, patients with unbearable head pain were sometimes treated with jolts from the electricity-producing black torpedo fish, or electric ray.

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Top, Corbis; Bottom, Tony Cenicola/The New York Times

A.D. 41 In ancient Rome doctors treated the throbbing pain of migraine headaches by applying an electric fish like the black torpedo, top, directly to the head. 2006 It doesn't smell and its shocks are more predictable, but the occipital nerve stimulator, implanted in the head and buttocks, operates on the same principle, bottom.

From Top, Lawrence Konig; Kevin Fitzsimons for The New York Times; Richard L. Weiner

One of the two kinds of electrical stimulatory treatment of migraines now in widespread clinical trials is occipital nerve stimulation. (The other uses electromagnetic impulses.) Top, a surgeon implanting an occipital nerve stimulator into a patient. Center, Cheryl Myers shows where hers is implanted. Bottom, an X-ray of an implant.

Scribonius Largus, physician to Emperor Claudius, was a staunch advocate of the remedy. “To immediately remove and permanently cure a headache, however long-lasting and intolerable, a live black torpedo is put on the place which is in pain, until the pain ceases and the part grows numb,” he wrote in the first century.

Electric fish have long disappeared from the medical armamentarium. And patients with headaches are most frequently treated with pharmaceuticals.

But recently, electrical or electromagnetic devices that hark back to the head-zapping torpedo fish have come into vogue among the country’s most prominent migraine researchers. Two different kinds of stimulatory devices are now in large-scale clinical trials for possible use in patients with the most severe migraine cases. Many researchers believe that such devices are likely to play a greater role in migraine treatment in the future.

Roughly 30 million Americans suffer from migraines, an inherited neurological disorder characterized in part by painful, throbbing headaches.

Dr. Richard B. Lipton, a professor of neurology at the Albert Einstein College of Medicine and director of the Montefiore Headache Center, says that while there are many drugs to treat the disorder or ward off the pain of an attack, some people do not respond or cannot tolerate the side effects.

“There is still a lot of unmet need,” Dr. Lipton said. “So the idea of having stimulatory devices that can be used to prevent headaches or to treat them acutely is very attractive to me, and I think very attractive to patients as well.”

The two kinds of stimulatory approaches now in large-scale clinical trials are occipital nerve stimulation, or O.N.S., and transcranial magnetic stimulation, or T.M.S.

In occipital nerve stimulation, a pacemakerlike device is connected to electrodes placed at the back of the head just under the skin. Electrical current is delivered through these electrodes, with the goal of inhibiting or preventing migraine pain.

In transcranial magnetic stimulation, a magnetic device is pressed to the back of the head, and brief pulses are delivered, altering electrical activity inside the brain in hopes of halting the migraine before it progresses. This approach is being studied only for patients whose migraines begin with an aura, or premonitory phase, that is typically characterized by flashing lights or other visual disturbances.

Experts say approaches like these represent a powerful new trend in migraine research.

“Since 1990, there have been well over 100 clinical trials for migraine drugs,” said Dr. Lipton, who added that by comparison virtually every stimulatory-device study that has been started is still going.

Some patients who have undergone the treatments say that they have helped.

Cheryl Myers, a mother of two who lives near Columbus, Ohio, said that for 9 or 10 years she suffered from chronic and disabling migraines that forced her to stop working and often confined her to bed.

“The only thing that helped was narcotics,” said Ms. Myers, 49. “But I couldn’t be taking them three or four times a week.”

In 2004, Ms. Myers enrolled in a clinical trial at the Michigan Head-Pain and Neurological Institute, where she had an occipital nerve stimulator surgically implanted.

The pacemakerlike device was placed in her upper buttocks and connected, by way of wires tunneled under the skin, to electrodes at the base of her neck, on either side.

Soon after the device was turned on, Ms. Myers said, she began having fewer migraines, and those she did have were less severe. Within a few months, she was also able to return to work several days a week. “I am not headache-free,” she said, adding that she still has “one or two headaches a week” and takes Percocet, a pain-relieving narcotic.

“However, I am enjoying a much more normal life,” she said.

Dr. Joel R. Saper, director of the neurological institute, said that in the treatment, electrodes are positioned to stimulate the greater occipital nerve, which runs along the back of the head on either side. The occipital nerve converges in the upper or cervical spinal cord with the trigeminal system, which includes neurons and neural pathways responsible for conveying much of the throbbing pain associated with migraine, he said.

Dr. Saper says it is not clear precisely how occipital nerve stimulation works. But one possibility is that it effectively inhibits activity in the trigeminal system, dampening the patient’s pain.

Three companies are conducting large-scale clinical trials of three different occipital nerve stimulators for use in migraine patients. The companies are Advanced Neuromodulation Systems, a division of St. Jude Medical; Advanced Bionics, a Boston Scientific company; and Medtronic.

Though the studies are not done, Dr. Saper, who has served as an advisory board member for all three companies, said that outside of the trials, “it is clear that some people get better but some people don’t.”

Dr. Saper said the treatment was appropriate only for patients who did not respond to less invasive approaches.

In 2003, Kerrie Smyres of Seattle was implanted with an occipital nerve stimulator that was not part of a clinical trial. In 2005 the leads from the electrodes began slipping out of position. When the leads moved, they caused a sharp pinching pain and sometimes set off another migraine.

The device meant that some kinds of activity that had helped her maintain a positive state of mind were off limits, including yoga and kayaking.

“Over time, I realized that it caused more pain and was more limiting than it was helping,” she said of the device.

So in September, Ms. Smyres had her stimulator removed.

“More than anything, I worry about patients who act on desperation like I did and then have their hearts broken, like I did,” said Ms. Smyres, who in 2005 began a blog about migraines called The Daily Headache.

Transcranial magnetic stimulation, the other type of stimulation being tested for migraines in large trials, does not require a surgical procedure. Rather, it uses magnetic pulses, delivered through the skin, to induce electrical changes in a particular brain area.

Dr. Yousef M. Mohammad, a neurologist at Ohio State University Medical Center, said preliminary research, conducted by his group and others, indicated that this approach might prove helpful to migraine patients who experience an aura before developing a pounding headache.

In a study of 43 patients conducted by Dr. Mohammad and his colleagues in 2004 and 2005, participants came to the medical center’s emergency room when they began to experience an aura, and were then given either transcranial magnetic stimulation or a sham treatment.

Two hours after being treated, 74 percent of the patients who received magnetic stimulation said they had no headache or a mild headache, compared with 45 percent of the patients in the control group.

Dr. Mohammad presented the results at the annual conference of the American Headache Society in June.

Christina Sidebottom, a retired technical writer who participated in the study, said that after stimulation, she would still get a mild headache, but never the intense throbbing pain she had before. “It was like having discovered Aladdin’s cave,” she said.

Initially, the study participants were required to come to the emergency room for treatment because the magnetic stimulation devices were cumbersome (weighing roughly 80 pounds, they are modified versions of machines used for brain mapping).

The California-based company Neuralieve has since developed smaller, portable devices that resemble ray guns and weigh just under three pounds. It is these devices that are being tested in the current trial, which involves several medical centers (Dr. Lipton heads the Neuralieve medical advisory board).

Gary H. Stroy, president and chief executive of Neuralieve, said that depending on the result of the trials and whether the Food and Drug Administration approves the device, a portable stimulator could be on the market in about 18 months. The stimulator is available now only to migraine patients participating in the research study.

Dr. Mohammad, who is on Neuralieve’s medical advisory board, said the idea of using electrical or electromagnetic stimulation to treat migraines resulted partly from a shift in how neurologists understood the disorder. Modern medicine has viewed migraines primarily as a vascular problem. Blood vessels in the brain constricted, then subsequently dilated, irritating the nerve endings around them and causing pulsating pain.

More recently, however, scientists have come to view these vascular changes as secondary to underlying neural events. For some patients who experience an aura, a wave of electrical excitation appears to spread through an area of the brain called the occipital cortex. Because this area governs vision, patients may see flashing lights, dancing bright spots or wavy lines, or they may experience a blind spot in their vision. If the excitation spreads to other areas, other neurological symptoms — like numbness, tingling or difficulty speaking — may occur.

Intense excitation is soon followed by exhaustion or depression of the affected brain cells, Dr. Mohammad said. The end result of this process, known technically as “cortical-spreading depression,” is irritation of trigeminal nerve fibers — and a throbbing, pounding headache.

The goal of transcranial magnetic stimulation is to interfere with the initial wave of excitation, thereby preventing the migraine from proceeding to the headache phase.

Dr. Mohammad offered an analogy of a forest fire. “If you cut some trees in the middle then the fire will not spread,” he said. “That is what we’re doing with T.M.S.”

The treatment is noninvasive and does not appear to have side effects, he added. So for some patients, it might be a first or second approach, rather than a treatment of last resort. “We are treating electricity with electricity rather than treating electricity with chemicals,” Dr. Mohammad said.

Roughly 20 percent of migraine patients experience an aura, according to the National Headache Foundation. But for those who do not, it is not clear whether cortical-spreading depression occurs in some other area of the brain or whether an entirely different mechanism is at play. It is also unclear whether transcranial magnetic stimulation would be useful in these cases.

Dr. David W. Dodick, a professor of neurology at the Mayo Clinic Arizona, said that while the biology and treatment of migraine have come a long way in the last 20 years, scientists needed to develop a better understanding of the mechanisms that initiate an attack, as well as the mechanisms by which some patients develop frequent and sometimes daily headaches.

Genetics are thought to play a major role in predisposing people to migraines. And in those who are predisposed, migraine attacks can occur spontaneously or be set off by a host of environmental factors, including stress, noise, bright lights, changes in sleep patterns and certain foods, as well as fluctuating estrogen levels, which may be why the disorder is about three times more common in women than in men.

But how these factors interact and the specific ways in which they exert an influence on neural processes are not well understood, said Dr. Dodick, who is involved in experimental work on occipital nerve stimulation and has served as a science adviser to Neuralieve.

Neurologists also do not know where in the brain a migraine begins and how additional areas are involved as the attack progresses, the details of which may be different for different patients.

Cortical-spreading depression may occur in some people, Dr. Dodick said. But other neural mechanisms are almost certainly at play, as well, and may turn out to be even more fundamental. Dysfunctional pain control centers in the brain stem may prove to be a root cause of the disorder, at least for some.

Nonetheless, he said, once the basic science of migraine is better understood, it will be possible to develop pharmaceuticals that aim to prevent attacks without untoward side effects. “That’s where I believe the future is.”

J. Steven Poceta, a neurologist at the Scripps Clinic in La Jolla, Calif., who is not involved in the current trials, also focused on the importance of new drug discoveries. Dr. Poceta emphasized that migraines are a progressive disorder, with headaches often becoming more frequent and less amenable to treatment. The goal, he said, is to develop drugs that can stop the progression before it gets to the point where nothing works.

“The brain is an organ that learns,” he said. “That’s its basic job. So the more it does something, the more it tends to do that same thing.”



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