Month: July 2005
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July 10, 2005
Will Any Organ Do?
By GRETCHEN REYNOLDS
Last summer at one hospital in Dallas, four people died from rabies, an unheard-of level of incidence of this rare disease. As it turned out, each patient was infected by an organ or tissue — a kidney, a liver, an artery — that he or she received in a transplant several weeks earlier. Their shared donor, William Beed Jr., a young brain-dead man, had rabies, caught apparently through a bite from a rabid bat, something the surgeons never suspected. They all thought he had suffered a fatal crack-cocaine overdose, which can produce symptoms similar to those of rabies. ”We had an explanation for his condition,” says Dr. Goran Klintmalm, a surgeon who oversees transplantation at Baylor University Medical Center, where the transplants occurred. ”He’d recently smoked crack cocaine. He’d hemorrhaged around the brain. He’d died. That was all we needed to know.”
Since the rabies deaths, recriminations have flown, procedural reviews have begun and sorrow and regret have dogged the families of the organ recipients. But the outbreak also exposed a controversy that until then was roiling only the rarefied world of transplant specialists. The issue, although freighted with monetary and bio-ethical complexities, can be boiled down to one deceptively simple question. Should transplant surgeons be using organs from nearly anyone?
Organ transplanting has become, in fundamental ways, a victim of its own success. Not long ago, transplant surgery was a dodgy, last-ditch response to end-stage kidney failure. But with the advent of better antirejection drugs and surgical techniques, transplantation has become the treatment of choice for a growing range of conditions, including chronic kidney failure, end-stage lung or liver disease and some congestive heart failure. Kidneys are implanted routinely, as are increasing numbers of livers, hearts and pancreases.
Fifteen years ago, about 20,000 people in the United States were on waiting lists for organs. Today, about 88,000 are. The number of donors has not come close to keeping pace. There were about 15,000 transplants completed with organs from cadavers in 1993 and about 20,000 last year. Patients used to wait weeks for an organ. Now they wait years. On average, 18 people on organ waiting lists die every day.
Doctors, patients and politicians concerned about transplantation have responded with proposals for increasing donations. In 2002, the American Medical Association voted to endorse pilot projects to give families financial incentives, like cash payments to help cover the costs of funerals, for donating their deceased loved ones’ organs. The next year, Congress held hearings on the topic. Representative James Greenwood, Republican of Pennsylvania, introduced a bill that would have authorized demonstration projects to determine whether offering financial incentives to families of brain-dead patients would increase donation rates. There was a public outcry against ”buying” organs and the bill died. (A few states offer tax incentives to families who donate relatives’ organs.)
Increasingly desperate people in need of transplants have turned to highway billboards and Internet sites to solicit donors. Donations from living people have helped. Today the number of living kidney donors is greater than the number of dead donors. But living donations of other organs are rare because they can be dangerous or are impossible.
All of which has led transplant specialists to quietly begin to relax the standards of who can donate. As a result, according to surgeons I spoke with and reports in medical journals, the transplanting of what doctors refer to as ”marginal” or ”extended criteria” organs, organs that once would have been considered unusable, has increased considerably in the last several years. The definition of a marginal organ differs from transplant center to transplant center and also from one type of organ to another. This makes it difficult to quantify the increase in the use of these organs. But the expansion is undeniable and has become a much-discussed issue in the field, a topic of ethics papers, surgical conferences and soul-searching on the part of many of the surgeons involved.
Fifteen years ago, William Beed Jr. would not have qualified as an organ donor. When he died in May 2004, he was 20, unemployed and had been living with his mother and sister in a bat-infested apartment building in Texarkana, Ark. Throughout his life, Beed had been in and out of trouble, his mother acknowledged when I spoke to her recently. Marijuana and cocaine were found in his urine at the time of his death, according to a report in The New England Journal of Medicine.
Beed’s drug use alone would have disqualified him as a donor. (It still would keep him from giving blood.) ”What people have to understand is that donors now, except for the 75-year-olds who die of intracranial bleeds, are not part of the church choir,” Klintmalm told me when I met with him in Dallas earlier this year. ”The ones who die are the ones you don’t want your daughter or your son to socialize with. They drink. They drive too fast. They use crack cocaine. They get caught up in drive-bys.”
The donor pool was different in the early days of transplantation. Beginning in the 60′s and through the 80′s, a majority of donors were head-trauma victims, people who had been involved in car accidents, botched suicides or tumbles off horses or ladders. These donors were almost all young, between 15 and 45. (In the 80′s, few transplant surgeons would take a 50-year-old organ.) They were of average weight, with no history of diabetes, cancer, infectious disease, imprisonment, high blood pressure, cigarette-smoking habits, tattoos (which have been associated with blood-borne illnesses) or unsafe sexual behaviors. The chosen organs, said Klintmalm, who has been in practice for about 25 years, ”were pristine.”
It was easy to adhere to those standards at first. ”We didn’t perceive any shortage of organs back in the day,” says Dr. Nicholas Tilney, the Francis D. Moore professor of surgery at Harvard Medical School and one of the nation’s premier kidney-transplant surgeons. ”If a patient had to wait a few weeks for a kidney, that seemed long. We never foresaw the kind of situation we have today.”
Conditions began to change in the 90′s. Seat-belt use was more common by then, and fewer Americans were dying of head injuries, depriving transplantation of its most reliable sources of pristine organs. At the same time, the demand for transplants was growing. Surgeons had little choice but to start looking to alternative sources for organs.
On April 28, 2004, William Beed Jr. complained to his mother that he was feeling sick. ”He couldn’t swallow,” his mother, Judy, a practical nurse, recalled when I spoke with her earlier this year. They decided he should go to an emergency room, she said, and the doctors there examined him and sent him home with medication, saying he was dehydrated. By that evening, he was drooling, throwing up, shaking and still having difficulty swallowing. His fever was rising. He started vomiting blood. His father drove him to another E.R.
Diagnosis is often a matter of context. Because of doctor-patient confidentiality rules, doctors involved with this case would not talk about it on the record, but a few did say that had Beed not had cocaine in his blood, the E.R. doctors might have investigated his symptoms more aggressively instead of assuming he had overdosed. (Because no autopsy was done, doctors have not been able to establish whether the rabies or the drugs actually killed him.)
Soon after, Beed fell into a coma and was put on a ventilator. After a few days, his mother said, the doctors told her and her family that their son was brain-dead. Transplant surgeons use organs from brain-dead patients because they still have a heartbeat, and if the patients are placed on a ventilator, their organs continue to get oxygen. Without oxygen, the organs degrade within minutes.
According to Judy Beed, a transplant coordinator approached her and asked whether she would be willing to donate her son’s organs. She agreed, and in the middle of the night on May 4, the parents of Joshua Hightower received a phone call offering them William Beed’s kidney.
Joshua Hightower, who lived in Gilmer, Tex., had had kidney problems since he was 2. They had grown progressively worse over the years. ”When he was 16, things got really bad,” said his mother, Jennifer Hightower, a special education assistant in the public schools, when I met with her in February. ”He was pale and droopy. He weighed 112 pounds. He was sleeping all the time.” His teachers at Gilmer High School walked him up and down the halls between classes to help him stay awake. A doctor urged his parents to get him on the waiting list for a kidney. In the meantime, Joshua began daily dialysis at home. The process, which purified his blood of toxins, required that he be home every evening by 10. Once there, he was tethered to the dialysis machine for between 9 and 16 hours. When the Hightowers received the call from the hospital, they jumped at the opportunity.
It is impossible to know now when the first less-than-pristine organ was retrieved and transplanted. But over the course of the 90′s, according to surgeons I spoke with, many barriers fell. Age was almost certainly the first to go. Instead of accepting donors 45 and younger, some transplant centers began, gradually, to take those who were 48, 49, 50 and then up from there. ”I wrote a paper for The Journal of the American Medical Association back in 1989,” Dr. Lewis Teperman, director of transplantation at New York University Medical Center, told me when I talked to him earlier in the spring. ”It was looking at the outcomes of using older donors. By older donors, we meant someone over 60. That was considered really, really old.” Recently, N.Y.U. transplanted a liver from a deceased 80-year-old. A couple of years ago, a Canadian hospital used a 93-year-old liver from a deceased donor.
Almost imperceptibly, most of the other traditional prohibitions evaporated. Surgeons started accepting lungs from people who had smoked, sometimes for decades. They accepted hearts and kidneys from those who had had high blood pressure or had been obese. They took organs from alcoholics and drug users. (Because cocaine is flushed from the body relatively quickly, it is considered one of the least problematic drugs in donors.) Infectious disease was no longer an automatic disqualifier, either. Most surgeons would have once discarded organs from someone with hepatitis C, for instance, since it destroys the liver. But the virus, often spread by injected drug use, is now so common in urban areas that few transplant surgeons will immediately turn down an organ infected with it. Ideally the surgeons implant these infected organs into patients who already harbor hepatitis C. But lately there have been cases in which doctors, as a last resort, have transplanted infected livers into patients who don’t have hepatitis C. There is little published data yet about the long-term outcomes for these patients.
The expansion into ”marginal” or ”extended criteria” organs has not been systematic. One transplant surgeon will use a marginal organ from, say, a morbidly obese donor or a drug user. His patient survives. Then he will repeat it again and again. At the next big transplant conference, he will talk to his colleagues about his success, and they will go back to their own transplant centers and accept, for the first time, an obese donor or a crack-cocaine user. ”You sometimes have to experiment,” Klintmalm says.
Klintmalm and other surgeons I spoke with who work in urban areas say that marginal organs are well on their way to being the majority of organs they transplant. Klintmalm, though, takes issue with the very definition of marginal. ”Older organs should not be called ‘marginal,”’ Klintmalm maintains, referring to donors over age 55. ”They’re standard for us.” But two years ago, when the United Network for Organ Sharing (UNOS), the private organization that oversees organ transplantation in the United States, published its first definition of extended-criteria organs, age was prominent. The UNOS classification, which applies only to kidneys, defines a marginal kidney as one that comes from a deceased person over 60 or one over 50 with two of three characteristics: stroke, hypertension or abnormal kidney function. The definition does not mention smoking, diabetes, hepatitis, alcoholism, obesity or drug use.
No government agency sets standards for what makes an organ acceptable. The Department of Health and Human Services contracts with UNOS to handle the day-to-day logistics of the transplant system (getting organs to the next person on the list and so on). But the government’s main concerns in policing transplants are that donors and recipients be matched for blood type and that organs be distributed primarily based on medical need, not the wealth, race or celebrity of the recipients. So decisions about whether organs are usable are made on the spot by individual surgeons.
To date, not many peer-reviewed studies have been published that examine the long-term outcomes of using marginal organs. The research that has been done mostly looks at kidneys.
Recent studies of older kidneys (usually defined as over 50), for instance, have shown that they can function almost as well as younger ones. They don’t work for as long, however. In a report presented by UNOS, which adjusted for the health of the recipient, among other things, about a third of extended-criteria kidneys failed within three years. (About 20 percent of non-extended-criteria organs also failed within three years.) Transplantation, even under the best of circumstances, still involves risk. In assessing marginal organs, it is difficult to know whether a bad outcome — the recipient’s death or the organ’s failure — was caused by the organ, the surgery or the fragile health of the recipient.
Except for age-related research, few large-scale studies have yet investigated the effects of other extended-criteria kidneys. Do kidneys from diabetics, the obese, alcoholics, smokers or drug users generally work over the long term? Surgeons and scientists can’t say for sure.
There is even less information about imperfect livers, hearts or lungs. Surgeons do know that livers, for some reason, don’t age at the same rate as their original owners. Sixty- or 70-year-old livers can be in fine shape. Hearts and lungs aren’t as durable and are more likely to fail as they get older. But surgeons are using them. A 2003 report by the UNOS-administered Organ Procurement and Transplantation Network stated: ”The need to more agressively utilize available organs for the candidate population as a whole competes with the expectation of each individual.”
And this is, ultimately, the crux of the matter. The marginality of any given organ is relative. It depends on how sick the waiting recipient is. There is a kind of mad, desperate arithmetic that goes into calculating whether to use a marginal organ and when. ”We’re all trying to quantify the risks,” Lewis Teperman, the N.Y.U. transplant director, says. ”If we know that there’s a 0.7 increase in relative risk of an extended-criteria organ failing, which is about what we’ve seen in kidneys so far, you take that number, look at your patient’s chances for survival, which might be 90 percent with a perfect organ and 80 percent with an extended-criteria one and. . . . ” He trails off. ”It sounds very clinical when I put it like that, which isn’t what I want.” He starts again. ”It’s easy enough to come up with these kinds of calculations. But it’s difficult for any of us to apply them in practice, when we’re dealing with very sick people’s lives.”
Dr. Marlon Levy, a liver-transplant surgeon in Fort Worth and the medical director for the Southwest Transplant Alliance, the group that unwittingly collected and distributed the rabid organs last year, told me: ”You have this immensely complex weighing of benefits and risks in each of these cases. Is the recipient sick enough to justify using any organ, even a really marginal one, to try and save his life and give him a few more years? Or say you have a slightly healthier patient, and you think he’s doing well enough to pass on a marginal organ and wait for a better one. Then, suddenly, he develops complications and dies before another organ becomes available. Were these decisions wrong?”
It is extremely difficult to predict outcomes. ”The best thought-out decision doesn’t work out all the time,” Teperman says. ”I have put in extended-criteria organs that worked perfectly, and the person walked out the door a week later. Other times, a patient has gotten an extended-criteria organ and remained hospitalized for months. I’ve also waited, thinking a better organ would come along, and the patient has died in the meantime.”
To some extent, surgeons’ hands are tied. In general, the current system requires that the most desperately ill patient must get the next organ that comes in, whether it is the best organ for that patient or not. ”Things would work best if we could put the most extended-criteria organs into the less critically ill patients and the healthiest organs into the sickest patients,” Teperman says.
The calculus may be even more complex from the patient’s perspective. Dr. Grant Campbell, an epidemiologist with the Centers for Disease Control and Prevention, had a liver transplant in 1990. At that time, he was chronically ill and knowingly accepted an organ infected with cytomegalovirus, a common and usually mild disease but one that can be serious in immunosuppressed transplant patients. Fortunately, he didn’t become sick.
Even the most rational attempts to weigh the risks and benefits of marginal organs tend to fall apart in the face of truly boundless human despair. ”We would have taken any lungs,” said Harry Littlejohn, 59, of Lewisville, Tex., whose 28-year-old daughter, Carmen, died in 2001 of cystic fibrosis. She had been No. 1 on the state waiting list for new lungs for eight weeks by then. None became available. ”We would have done anything to save her,” he said, ”anything. But there was nothing we could do.”
Joshua Hightower turned 18 on May 10, 2004, in the transplant recovery ward at Baylor University Medical Center. Photos from around that time show him propped up in bed, looking wan, but smiling.
Joshua had been added to the lengthy transplant waiting list the year before. The doctors said they could not estimate how long the wait would be, Jennifer Hightower, his mother, told me.
After the Hightowers received the call from the hospital, his mother recalled, she had wondered about the donor. Anonymity has been crucial to the workings of the organ-transplant system. Donation is supposed to be a blind act of altruism. Donor families aren’t told at the time who will receive the organs, and recipients generally are told only the age and sex of the donor.
”You don’t want people coming in and saying, ‘I’ll only donate to Italians.’ Or ‘I only want them to go to someone in the Ku Klux Klan,”’ says Sheldon Zink, director of the program for transplant policy and ethics at the University of Pennsylvania. You also don’t want recipients turning down organs because of their own biases.
But how much should a surgeon tell a patient who is about to receive a compromised organ? Should he explain that the new kidney comes from a retiree, a drug user or an alcoholic, a chain smoker or a member of a motorcycle gang? Does he have to tell a patient that the organ he is about to receive is considered marginal?
“I wish we had been told more,” Jennifer Hightower says. Her son, she went on to say, would have declined the kidney had they known more about Beed’s background and his death. Joshua, she says, was not so sick that he couldn’t wait. ”I would have made him pass on it.”
Her attitude worries Zink, the ethicist. ”I would question anyone’s motivation in refusing an organ from a drug user,” she told me. ”They aren’t responding to clinical information, because the available clinical data” — the anecdotal reports from doctors — ”indicates that organs from crack-cocaine users are fine, in general. So they must be responding to preconceptions about that person’s lifestyle. That’s only one small step from declining an organ because the donor is black or Hispanic.”
At the moment, no formal national medical standards dictate what transplant surgeons should tell their patients about organs other than kidneys or what they can withhold. Each doctor makes that decision based on how he feels about the ethics of the situation.
”I believe in erring on the side of telling the patient as much as possible,” Teperman says. ”We have a lengthy consent form here at N.Y.U., and it goes into the use of marginal organs. We ask patients if they will accept one. You don’t want to be calling someone at 2 a.m. and saying: ‘You can take this organ we just got in that may not be very good or you can wait and maybe die. What do you want to do?’ That’s an unrealistic burden to put on a patient. We try to have the conversation early on, when patients are a little more clearheaded. That’s not always an easy conversation to have. Some patients would rather not think about it. They’d rather the doctor just make the decision for them.”
Some surgeons insist on making decisions about marginal organs unilaterally. ”There are transplant surgeons who think they absolutely know best,” Zink says. ”They don’t bother asking the patient if he wants a marginal organ because they don’t want the patient having a choice. They make it for him.”
When Zink recently asked surgeons at a major transplant conference how many of them always tell their patients if they are about to implant a marginal organ, ”about half said they tell the patient,” Zink told me. ”Half said they don’t.”
Some surgeons withhold information because they are concerned about litigation (better to say nothing than to say that an organ might be compromised, have your judgment proved right and be sued for it). Others are prodded by compassion. ”There are doctors out there who think that a patient will recover better if he isn’t worrying about the quality of the organ inside of him,” Zink says.
Wry pragmatism also plays a role. ”At some large urban transplant centers, virtually all organs nowadays are extended-criteria organs,” Zink points out. Why discuss the option of accepting or declining an imperfect organ? If a patient says he doesn’t want one, he’ll most likely never get an organ at all. ”I’ve had doctors tell me they don’t even tell their patients that they’re about to get an organ that might be infected with hepatitis C because so many of the donated organs may have it,” Zink says.
On Friday, May 28, 24 days after his transplant, Joshua Hightower, who had been released from the hospital, graduated from high school. He clutched his diploma, climbed up into the stands and threw up, Jennifer Hightower said. He didn’t stop vomiting all through the celebrations that followed. The next day, he was stumbling, and by the evening, he was having convulsions. Spit dribbled down his face. Doctors at the nearest emergency room hurriedly transferred him to the E.R. at Baylor.
Upstairs in the transplant wing, around the same time, three other patients who had received donations from William Beed Jr. lay dying, each with convulsions, delirium or pain. Within two weeks, all but Joshua were dead. Rabies was confirmed as the cause of death a few weeks later.
There is no formal system that tracks the short-term fate of individual organs from a particular donor. Surgeons report raw data about deaths and severe surgical complications to UNOS. Had all of the people who received an organ from William Beed Jr. not come back to the same hospital and died, one after another, their rabies may not have come to light.
In May, three people died who had received organs from the same donor in New England. As it turned out, the donor had passed along lymphocytic choriomeningitis virus, a rare illness transmitted to humans from rodents like hamsters. Two of the recipients, after getting ill, went to the same hospital, which helped doctors there determine that the transplant was the cause.
”I doubt very much that this is the only time” that rabies has killed transplant patients, says Charles Rupprecht, the C.D.C.’s rabies expert about the Beed case. ”And I doubt that it will be the last.” In February, doctors in Germany announced that four patients there had been infected with rabies after receiving organs from a rabid young woman who had died, they had thought, of a heart attack associated with an overdose of cocaine and Ecstasy.
”Rabies is a sentinel disease,” argues Dr. Matthew Kuehnert, the assistant director for blood safety at the C.D.C., who has studied outbreaks of disease in transplant recipients. ”It tells us we should be paying attention, that something needs to change.”
What, though? ”We cannot start testing every donor for rabies or any of the other once-in-a-lifetime diseases that might crop up,” Klintmalm says. ”We don’t have time. It would cost too much. You might as well shut down every transplant center. If another case came in today exactly like that one, a young man who used crack cocaine and died, I would not demand more explanation. Why? We’ll never get the risk of transplants down to zero. It’s stupid to pretend we can. That young man appeared to be a perfect donor. I wish we had more like him.”
The broader question is what, if anything, should change in transplantation as marginal organs become everyday organs? ”We at the C.D.C. wish that there were more formal disease surveillance and follow-up of transplant patients,” Kuehnert said. ”We simply don’t know the risks of using certain types of donors at this point.” The C.D.C. has no authority to require such follow-up and study, though. Only other regulatory agencies within the Department of Health and Human Services or state agencies can set such mandates.
In June 2004, the New York State Department of Health became the first regulatory agency in the country to start formally looking into the growing use of marginal organs and to formulate recommendations about what patients should be told and what kinds of organs should be allowed. Its report is due soon.
In the meantime, the United Network for Organ Sharing has created a designation for patients who say they will accept a marginal kidney. At the end of February, 42 percent of the adults waiting for a kidney in the United States said they would take a marginal organ.
A year ago, while Joshua Hightower lay unconscious but alive, the doctors decided to surgically remove his transplanted kidney. But by then, rabies (not yet identified as the culprit) was everywhere in him. His condition worsened. On June 18, a Friday, doctors tested for brain activity. They found none and declared him brain dead. Stung with grief, Jennifer Hightower and the rest of her family sat with the boy through a wrenching weekend while he remained on a ventilator. On that Monday, his parents agreed to end life support. That afternoon, with his family watching, doctors turned off the ventilator. His mother held him as his heart stopped.
It will not be a simple matter in the years ahead to decide how best to save lives with transplants. At some point this year, the number of people on transplant waiting lists in the United States will very likely top 100,000. Unless there is an enormous effort, probably from the federal government, to increase organ donation, the shortage will only grow. ”All these kids we see with diabetes,” Nicholas Tilney says, ”so many of them will need a new kidney in a few years. Where are those organs going to come from?”
Gretchen Reynolds frequently writes about medical topics. Her last article for the magazine was about epidemiologists tracking the avian flu.
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Mick Jagger, seen during an April 1999 concert at the MGM, and the Rolling Stones will be back in town Nov. 18.
Photo by Clint Karlsen
Stones coming to town
Sources say Mick and company to return to MGM
By MIKE KALIL
© Copyright 2005, REVIEW-JOURNAL
The Rolling Stones have been booked to play the MGM Grand Garden in November during a gap between Northern California shows, sources confirmed Thursday.
Although officials with the MGM Grand declined to comment, three sources with knowledge of the deal verified that the British rock legends are slated to perform Nov. 18 at the hotel’s arena.
“This has been kept pretty quiet, but it’s a done deal,” said one source, who spoke on condition of anonymity. “They’re sandwiching the Vegas dates between the ones in California.”
Ticket prices and an on-sale date remained unclear Thursday.
Attempts to reach Stones tour promoter Michael Cohl in Toronto were unsuccessful.
Singer Mick Jagger, drummer Charlie Watts, and guitarists Keith Richards and Ronnie Wood were holed up with backup musicians Thursday in that Canadian city’s Greenwood College School practicing for the tour, which kicks off Aug. 21 at Boston’s Fenway Park.
The four-day opening between a Nov. 15 appearance in San Francisco and a Nov. 20 gig in Fresno suggests the group could schedule a second Las Vegas date, as it has on its past two tours.
In the late 1990s and in 2002, the Stones played both the 14,800-seat MGM Grand Garden arena and a more intimate show at The Joint, the 2,000-capacity theater at the Hard Rock Hotel.
Hard Rock officials were tight-lipped Thursday.
“We cannot confirm a date,” said Phil Shalala, Hard Rock’s vice president of marketing.
It also remains unclear who will open for the band here. Confirmed acts for early East Coast and Canadian dates include Beck, Black Eyed Peas, Maroon 5, John Mayer, Pearl Jam and Joss Stone.
While ticket prices have not been announced, fans who want to spend the night together with the Stones better make sure they got the silver.
During the past 11 years, Las Vegas has four times been the host city for the Stones to set a new benchmark for ticket prices.
The band’s Las Vegas debut during the Voodoo Lounge tour in October 1994 saw tickets offered for $100 to $300, prices unheard of at the time.
But that was a bargain by the time of the group’s November 2002 appearance at The Joint. Tickets for that gig topped out at $1,000, but several concertgoers reported paying several times that to scalpers -
July 10, 2005
The Seat-Belt Solution
By STEPHEN J. DUBNER and STEVEN D. LEVITT
A Car-Seat Crash Test
On a recent Monday morning, nearly 20 police officers gathered in Clarkstown, N.Y., for a four-day seminar. They had assembled to fight one of modernity’s great scourges: child deaths in motor-vehicle crashes. Each officer was given a 345-page training manual issued by the National Highway Traffic Safety Administration (NHTSA). At seminar’s end, each would be certified as a ”child passenger safety technician,” which primarily means that they would be experts in the installation and use of child car seats.
Why does it take four days to learn about car seats? Because any given seat is a tangle of straps, tethers and harnesses built by one of dozens of manufacturers whose products must be secured by the diverse seat-belt configurations of any passenger vehicle sold in the United States. According to the NHTSA manual, more than 80 percent of car seats are improperly installed.
So over the course of those four days, there were many questions to be answered. But one question about car seats is rarely even asked: How well do they actually work?
They certainly have the hallmarks of an effective piece of safety equipment: big and bulky, federally regulated, hard to install and expensive. (You can easily spend $200 on a car seat.) And NHTSA data seem to show that car seats are indeed a remarkable lifesaver. Although motor-vehicle crashes are still the top killer among children from 2 to 14, fatality rates have fallen steadily in recent decades — a drop that coincides with the rise of car-seat use. Perhaps the single most compelling statistic about car seats in the NHTSA manual was this one: ”They are 54 percent effective in reducing deaths for children ages 1 to 4 in passenger cars.”
But 54 percent effective compared with what? The answer, it turns out, is this: Compared with a child’s riding completely unrestrained. There is another mode of restraint, meanwhile, that doesn’t cost $200 or require a four-day course to master: seat belts.
For children younger than roughly 24 months, seat belts plainly won’t do. For them, a car seat represents the best practical way to ride securely, and it is certainly an improvement over the days of riding shotgun on mom’s lap. But what about older children? Is it possible that seat belts might afford them the same protection as car seats?
The answer can be found in a trove of government data called the Fatality Analysis Reporting System (FARS), which compiles police reports on all fatal crashes in the U.S. since 1975. These data include every imaginable variable in a crash, including whether the occupants were restrained and how.
Even a quick look at the FARS data reveals a striking result: among children 2 and older, the death rate is no lower for those traveling in any kind of car seat than for those wearing seat belts. There are many reasons, of course, that this raw data might be misleading. Perhaps kids in car seats are, on average, in worse wrecks. Or maybe their parents drive smaller cars, which might provide less protection.
But no matter what you control for in the FARS data, the results don’t change. In recent crashes and old ones, in big vehicles and small, in one-car crashes and multiple-vehicle crashes, there is no evidence that car seats do a better job than seat belts in saving the lives of children older than 2. (In certain kinds of crashes — rear-enders, for instance — car seats actually perform worse.) The real answer to why child auto fatalities have been falling seems to be that more and more children are restrained in some way. Many of them happen to be restrained in car seats, since that is what the government mandates, but if the government instead mandated proper seat-belt use for children, they would likely do just as well / without the layers of expense, regulation and anxiety associated with car seats.
NHTSA, however, has been pushing the car-seat movement ever further. The agency now advocates that all older children (usually starting at about age 4) ride in booster seats, which boost a child to a height where the adult lap-and-shoulder belts fit properly. Could this be a step in the wrong direction? In 2001, the Insurance Institute for Highway Safety sent NHTSA a memo warning that its booster-seat recommendations were ”getting ahead of science and regulations” and that certain booster seats ”did not improve belt fit, and some actually worsened the fit.”
If car seats and booster seats are shown in the FARS data to be no more effective than seat belts, might it be because so many of them are improperly installed? To find out, we contacted an independent lab that conducts crash tests. The idea was simple: compare properly installed car seats with properly used standard seat belts. We commissioned two crash tests: a 3-year-old-sized dummy in a car seat versus a 3-year-old dummy in lap-and-shoulder belt; and a 6-year-old-sized dummy in a booster seat versus a 6-year-old dummy in lap-and-shoulder belt.
The conditions of the test ensured that the seats would perform optimally: they were strapped to old-fashioned bench-style seats (which give a flush fit) by an experienced engineer (who is presumably more competent than the average parent). The dummies in the seat belts were also positioned optimally, sitting upright and flush.
The chore was gruesome, from start to finish. Each dummy, dressed in shorts, T-shirt and sneakers, had a skein of wires snaking out of his body to measure head and chest damage. The pneumatic sled was fired backward with a frightening bang, simulating a 30 m.p.h. frontal crash; on impact, the dummy’s head, legs and arms jerked forward, fingers flailing in the air, and then the head recoiled.
Within minutes, we had some data. Though the lap-and-shoulder belts rode too high on the 3-year-old dummy, the head- and chest-impact data were only nominally higher than that for the 3-year-old in the car seat; according to federal standards, most likely neither child would have been injured. In the second test, the 6-year-old in the booster and the 6-year-old in the seat belt produced virtually identical numbers. Again, most likely neither one would have been injured.
These tests don’t actually prove much. The sample was too small, the circumstances were too controlled and the sensors didn’t measure neck or abdominal injuries, which child-safety advocates say are worse with seat belts. What matter are the crash data from the real world, where one 4-year-old in a lap-and-shoulder belt may find the shoulder belt so irritating that he puts it behind his back and another 4-year-old may be in a poorly installed car seat. And when it comes to real-world situations, the FARS data are extremely compelling.
So if car seats and booster seats aren’t the safety miracle that parents have been taught to believe, what should they do? The most important thing, certainly, is to make sure that children always ride with some kind of restraint — and, depending on your state, a car seat or booster seat may be the only legal option. On a broader level, though, it might be worth asking this question: Considering that Americans spend a few hundred million dollars annually on complicated contraptions that may not add much lifesaving value, how much better off might we be if that money was spent to make existing seat belts fit children? Some automakers do in fact make integrated child seats (in which, for example, the car’s seat back flips down for the child to sit on); other solutions might include lap-and-shoulder belts that vertically adjust to fit children, or even a built-in five-point harness.
It may be that the ultimate benefit of car seats and booster seats is that they force children to sit still in the back seat. If so, perhaps there is a different contraption that could help accomplish the same goal for roughly the same price: a back-seat DVD player.
Stephen J. Dubner and Steven D. Levitt are the authors of ”Freakonomics: A Rogue Economist Explores the Hidden Side of Everything.”
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Leaning Tower of Oil
Friday July 15, 2005 4:00AM PT
After Hurricane Dennis raced across the Gulf of Mexico last weekend, a massive oil platform called Thunder Horse was found listing 20 to 30 degrees off-kilter. Now, a 20-degree incline might not be much if you’re talking about your backyard badminton net, but when the world’s largest semi-submersible oil platform leans like that — well, it looks dramatic, and it generates excitement. Owned by British Petroleum and ExxonMobil, the $1 billion platform hasn’t even begun producing oil yet; it was scheduled to start later this year. What’s more, a BP spokesman says that the cause of the alarming tilt has “not been determined.”
Thunder Horse
News of the leaning behemoth — and the astonishing photos that accompanied it — hit the Buzz in a big way. “Thunder Horse” spiked 810%, and “BP Thunder Horse” leapt 717%. BP, now madly at work to right the platform, rose 178%. Any number of queries, ranging from “BP Hurricane Dennis” to “BP Thunder Horse sinks,” also swept through the Search box. Fortunately, experts predict that the next storm gathering strength — Hurricane Emily — will steer clear of the sloping platform.
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July 14, 2005
Botox Plus: New Mixes for Plumping and Padding
By NATASHA SINGER
BABAK AZIZZADEH, a facial plastic surgeon in Beverly Hills, recently concocted a menu of “Cosmetic Cocktails.” Although the frothy title might suggest intoxicating mixed drinks for patients who have just gone under the knife, the doctor’s elixirs are not alcoholic. They are toxins and wrinkle fillers that he injects into patients’ faces to smooth their age lines and puff up their cheeks.
Dr. Azizzadeh employs the bartending analogy to suggest the advantages of mixing his remedies. His typical cocktail might include Botox, a toxin that relaxes frown lines in the forehead; Sculptra, a synthetic filler, to bulk the cheeks; and Radiesse, a gel containing microscopic calcium particles, to fill wrinkles.
Billed as “filler face-lifts” or “tissue tailoring,” multi-injection procedures are not merely the latest gimmick for cosmetic-treatment aficionados who have already tried every kind of laser and acid peel. They represent a kinder, gentler alternative to face-lifts, a way of plumping up rather than cutting away and hoisting sagging tissue. Their growing popularity is part of a trend toward injections and away from surgery.
In 2004 the number of face-lifts dropped by 3 percent from 2002 to about 114,000, according to the American Society of Plastic Surgeons, while the number of Botox injections soared by 166 percent to nearly 3 million. Collagen injections were also up, to more than 500,000, an 18 percent increase, the society said.
Filler face-lifts offer only temporary results – lasting six months to two years, depending on which materials are used – but at $2,500 to $3,500 they are cheaper and less invasive than surgical face-lifts, which can run from $10,000 to $20,000. They also require less recovery time. And though their results are not as dramatic as a face-lift, injection cocktails, say doctors who offer them, are sufficient for patients in their 30′s, 40′s and 50′s who do not have a lot of loose skin to cut away.
“Why go under the knife unnecessarily when you can have these treatments that make you look natural and youthful?” said Barbara Kaminsky, a Manhattan fashion stylist who for two years has been having her face injected with three different substances: Botox in her forehead and neck; Restylane in her cheeks and chin; and collagen in her lips.
“I’m a single woman over 50, but now I’m getting hit on by men who think I’m in my 30′s or 40′s,” she said. “The only drawback is that, just like going to the dentist or the gym, with injectables you have to keep up a maintenance routine.”
Some doctors say it is pointless to use so many different substances. “A wrinkle is a wrinkle, and you just fill it; you don’t have to add whipped cream and chocolate sprinkles on top,” said Marvin Rapaport, a clinical professor of dermatology at the University of California, Los Angeles, and a practicing dermatologist in Beverly Hills.
Others question the safety of cosmetic cocktails. Although the substances have been found to be generally safe when used individually, little research has been done to ascertain whether they might somehow mix together under the skin, potentially diminishing one another’s effects or causing unforeseen problems.
Still, hundreds of early-adopter physicians and their patients are forging ahead. “Combining Botox with one or two injectable agents is becoming widespread,” said Dr. Richard G. Glogau, a clinical professor of dermatology at the University of California, San Francisco. He is a consultant for Allergan, the maker of Botox.
This new approach to cosmetic enhancement is a recent development. Just four years ago only two substances were approved for injections: fat, to add volume, and collagen, to fill in wrinkles and acne scars.
Then in 2002 the arsenal began to expand when the Food and Drug Administration approved the cosmetic use of Botox. In 2003 the agency sanctioned Restylane, a gel that is used to fill wrinkles and folds around the nose and mouth and, off label, to plump cheeks and lips.
Last year the F.D.A. approved three new hyaluronic acids to treat wrinkles and folds: Hylaform, Hylaform Plus and Captique, which doctors also inject to fatten lips and structure cheeks. Doctors are also now using Sculptra (F.D.A. approved to rebuild the hollowed faces of AIDS patients) and Radiesse (approved to strengthen vocal cords) for facial enhancement even though they have not been sanctioned for cosmetic purposes.
“It’s nice to have different products for different situations because each injectable works differently on each person,” said Jeffrey S. Dover, a Boston dermatologist who himself prefers to use only two, Botox and Restylane. “It’s like being a painter. You’d like a variety of colors at your disposal.”
Fredric Brandt, Ms. Kaminsky’s dermatologist, who practices in Manhattan and Miami, said he regularly injects two, three or four agents in one sitting. (He is a consultant for Allergan and for Medicis, Restylane’s distributor.) In extreme cases, like “thin women in their 50′s whose faces are caving in,” Dr. Brandt said, he might use five.
Patricia Wexler, another Manhattan dermatologist, uses up to four substances, often on patients who have recently lost a lot of weight. Each agent serves a purpose, she said. “First you use volumizers to restore the youthful contours of the face, then you use fillers that give definition and structure to wrinkles,” she said.
Doctors do not know whether these agents mix together once they are in the skin, or what would happen if they do.
“There is no hard clinical data right now,” said Nick Teti, the chief executive of Inamed, the manufacturer of the collagen fillers Zyderm, Zyplast, CosmoDerm and CosmoPlast. “We know physicians like to use collagen and Captique at the same time for different purposes, but we do not promote combination therapy.”
In Vancouver, British Columbia, Alastair Carruthers, a dermatologist who is a consultant for Allergan, has begun to experiment with the simultaneous use of Botox and Restylane. In 2003 he published a study of 38 patients who were given this treatment. He found that their results lasted 32 weeks, almost twice as long as those who had been given Restylane alone.
But not all patients do as well. Dr. Carruthers said he is treating a patient whose previous doctor injected her face over a period of years with collagen, Restylane and Artecoll (a filler that is not approved in the United States) with unpleasant results.
“For the last six years I’ve had raised, very prominent blue lines that run from the folds of my nose down to my mouth,” said the patient, 60, who would not disclose her name because she did not want to impugn the doctor who injected her. “But because I had so many injectables put in the same location, we can’t tell what the cause is.”
Side effects like bruising and skin irritation can occur even when only one filler is used. “If something goes wrong and you have injected four or five different foreign agents, how is the doctor going to be able to determine the cause of the problem and how to treat it?” asked Audrey Kunin, a dermatologist in Kansas City, Mo.
Cosmetic treatments sometimes have aesthetic side effects, which is why potential patients are often advised to take care that the doctor they choose shares their sense of how much work is too much.
“I think of an aging face as a sagging sofa which has to be restuffed so the pillows fluff up to their beautiful original shape,” Dr. Brandt said. “But a sofa can be overstuffed by someone overzealous.” He has a nickname for those unfortunate patients who end up on a cosmetic cocktail bender. “I call them the ‘big giant heads.’ “
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Mr. Berinie Ecclestone. British Grand Prix, 2005.
All in all, this season has been gratifying since Fernando Alonso has been so incredibly quick and consistent. For his youth, he seems a very mature driver, and he appears to have the balance of his emotions and ego placed in proper perspective. In short, the guy is super talented and very cool. This is the best thing that could happen to Formula 1.
As far as Indianapolis is concerned, I believe there were unseen forces that may be quite pleased to see Formula 1 fall flat on its face here in America. Of course, when viewed from a strictly fan perspective, the entire episode was one giant farcical disappointment.
Several matters come to mind. Michelin, the internationally known and recognized tire company somehow did not do the necessary research and showed up in America without a tire that was capable of performing on the Indy track surface. Granted, Bridgestone had been at the 500, so they naturally would have had more data on the track surface and so were well advised in what compounds they had chosen prior to arriving at the Brickyard. It is astounding however, when you analyze the sequence of events. That first and foremost, a tire company participating in Motor racing at the highest level of international competition with billions of dollars involved throughout the entire enterprise, would be capable of going in blindly without having at least examined what options they might need to have or what kind of obstacles they might be expected to incur. It was not a secret that the race track had been resurfaced in some way or another which resulted in a grittier more abrasive characteristic.
Michelin shows up and discovers that the tires they have are relatively useless and worse yet they are dangerous. Ralf Schumacher goes off in a high speed shunt, and one other driver whose name escapes me now, goes out as well, and all the while Michel in have no clue. Except they do realize and admit that the safety of the drivers precludes them from simply pressing forward and acting as if everything would be alright. For this I give them a certain degree of respect.
So when the windup ensues you have the race itself, and all that it represents in terms of the perennial desire for Formula 1 to someday, somehow establish itself firmly and loyally in the minds and hearts of American racing fans.
And then you have the internecine intrigue between the intricately drawn factions of the International Grand Prix circus. Here we enter into cultural, financial, philosophical, and not the least, personal conflicts and long standing animosities.
From the Bridgestone perspective, why would they have wished to smooth over a gaffe that exposed their world’s greatest rival as something of a complete incompetent?
From the FISA point of view, I suppose they felt they would open a Pandora’s box of possibilities wherein which rules that are so incredibly complex, must be continuously revised and reformatted to account for so many variables within the sport and the technology that it draws from in large measure. These rules would perhaps then be the constant point of negotiation as other points of departure would come into question.
Finally, Scuderia Ferrari was showing as much compassion as the Italian Expeditionary Tank forces extended to Hailee Sallase and his vastly out numbered, camel bourne , sling shot bearing defense force in Ethiopia. Another less than memorable episode in 20th century Italian history.
FISA was in no way potent enough by way of silent persuasion to effectuate an ultimate compromise. Max Mosley would have been wise, in my opinion, to have made his way to the paddock and the negotiating table, because the entire BRAND of Formula 1 was suffer ring a devastating blow to its credibility, marketability, and general point of popular acceptance.
As it turns out, he remained somewhere in Europe, Paris I suppose, and from that distance felt safe enough while allowing Ecclestone to bear all of the justifiable ire and resentment from those fans who made their weekend around seeing a genuinely competitive International Grand Prix. They deserve, and I believe they eventually will receive, their money for admission refunded.
Furthermore, Mr. Ecclestone is one person who would have, if he were able, in and of his own will, put together a compromise solution so as to have the racing fans enjoy what they had come to see. There is no one that I know, in or out of Formula 1 who is more desirous of establishing a permanent presence and appreciation for Grand Prix racing in the U.S. than Bernie Ecclestone. He has made repeated attempts to educate, if you will, the civic leaders here in Las Vegas about the kind of product that Formula 1 confirms as unique and attended by a very high end marketing segment with disposable income far greater than what is demographically described by the NASCAR and other forms of all American motor racing.
The unfairness in regards to Ecclestone and the vents at the recent American Grand Prix, is that there are limits to what he personally can do without risking the opposite side of the critics corner wherein which he is accused of wielding totalitarian and dictatorial control over every aspect of the entire enterprise.
To my way of thinking, to the extent that in every instance where to a greater or lesser degree, “The Ecclestone as Czar model” is accurate, then the entire Formula 1 world and everyone involved in this endeavor in any way large or small, should be thankful for all of the years of incessant determination and unrelenting focus and vision with which Bernie Ecclestone has dedicated himself towards bringing together the very essence of what is accepted as the world’s premier Motor Racing series.
Most knowledgeable people with even the slightest awareness of Motor racing in general, will acknowledge that Grand Prix Formula 1 exists on a level of technical and physical challenge unlike any other form of entertainment in the world today. The very fact that Ecclestone has traveled from year to year from race to race, from airport to hotel to airplane to helicopter to jet to hotel and back around again is testimony to the superior discipline, motivation, intellect and abounding business genius that mark the achievements of this leader of the world of Grand Prix Motor Sport.
His comment about the women being advised to wear dresses the color of kitchen appliances was simply his “East End” London sense of humor flexing itself as a leit motif to a very stressful situation.
I know from first hand, personal experience that Bernie Ecclestone is a genuine humanitarian and extraordinarily generous to those he loves and cares about. He is unsparingly loyal to those loyal to him, and he is a person who has done innumerable acts of great kindness to help those less fortunate through times of overwhelming adversity.
His financial success should not be held against him, because every pound note Bernie may hold he well deserves because he has worked his butt off and taken many risks, suffered many personal setbacks and disappointments integral to the dangers of Formula 1 and survived it all to stand as the single most influential leader in the world of Motor Sport since the beginning of organized and sanctioned competition.
No one that I can identify comes even close to having been able to accomplish so much from every angle to see that so many people realized so much more as drivers, team owners, promoters, journalists, photographers, and accessory entrepreneurs of every ancillary stripe.
All persons related to this unique form of incredible excitement and test of competitive skill and technical expertise owe an eternal debt of gratitude to Mr. Ecclestone, and those persons who have character and real integrity within the sport itself realize this only too well.
Without him, Grand Prix Motor Racing as we know it today, would not exist. Case Closed
Michael P. Whelan Las Vegas, July 12, 2005.
FIA reverses stance on Michelin teams in U.S. Grand Prix
Paris, France (Sports Network) – The seven Formula One teams that faced penalties stemming from their refusal to race in the United States Grand Prix last month will have guilty verdicts dropped.
FIA, Formula One’s governing body, made its latest decision after hearing new evidence from the seven teams who decided against competing in the Indianapolis race because of faulty tires from Michelin. The organization had found the teams guilty of failing to ensure that they had suitable tires and refusing to start a race.
“The Senate was satisfied that the teams were contractually bound to follow the instructions of their tire supplier and that their tire supplier had expressly prohibited them from racing at the Indianapolis Motor Speedway in its licensed configuration,” the FIA said in a statement.
“Recognizing that for both sporting and legal reasons it was impossible for the FIA to authorize a change to the circuit configuration and that both the FIA and the teams could have faced serious legal difficulties in the United States had they not observed to the letter their respective rules and contractual obligations [particularly had there been any kind of accident], the Senate was of the view that having regard to this new evidence, disciplinary proceedings against the teams had ceased to be appropriate and were no longer in the interest of the sport.”
The statement added that the FIA will send its recommendation to the World Motor Sport Council for a vote to cancel the guilty verdicts.
Teams from BAR-Honda, McLaren-Mercedes, Red Bull, Renault, Sauber, Toyota and Williams-BMW decided against racing in the June 19 U.S. Grand Prix after Michelin decided the track at the Indianapolis Motor Speedway was not safe for their tires.
The controversy began after two accidents during practice for the race indicated that Michelin was having problems with its tires.
Following an investigation into the incidents, Michelin wrote to the seven teams and explained that they could not guarantee the quality of their tires unless the “speeds in turn 13 could be reduced.”
Michelin air-freighted a new compound tire to replace the questionable ones, but F1 officials would not allow them to be used. F1 rules require a team to race on the tires they used during qualifying.
The teams and Michelin then requested a chicane be built to slow the cars through the offending corner. Again, F1 refused their request.
On race day, the seven Michelin teams removed their cars from the grid following the parade lap and the race was run with just six cars, all who used Bridgestone tires.
Michael Schumacher earned his first victory of the year in the race.
Michelin, as a gesture of good faith, offered refunds to fans who attended this year’s race, as well as free tickets to those for next year’s U.S. Grand Prix.
07/14 15:54:31 ET
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