Tobacco cash in lung study stirs flap
Wed, 26 Mar 2008 22:40:50 GMTBy MARILYNN MARCHIONE and STEPHANIE NANO, Associated Press Writers
The disclosure of hidden tobacco money behind a big study suggesting that lung scans might help save smokers from cancer has shocked the research community and raised fresh concern about industry influence in important science.
Two medical journals that published studies by Weill Cornell Medical College researchers in 2006 are looking into tobacco cash and other financial ties that weren't revealed. The studies reported benefits from lung scans, which the Cornell team has long touted.
It's a crucial public health issue: Dozens of groups, including such anti-smoking crusaders as the American Cancer Society, have given the Cornell team money to see if routinely screening smokers with CT scans can spot the world's most lethal cancer in time to prevent deaths.
The federal government also has given money even though scientists have criticized the Cornell study's design and the government has its own more rigorous study under way.
Many were stunned to learn that a foundation Cornell set up and listed in the New England Journal of Medicine in October 2006 as a sponsor of the study actually got $3.6 million from a parent company of cigarette maker Liggett Group Inc. The tobacco source was reported in a New York Times story Wednesday.
Liggett, whose owner was the first to break with other tobacco companies and say that tobacco was addictive and deadly, announced its donation to the Cornell foundation in 2000 in a press release. But the foundation's funding source wasn't disclosed to the journal.
On Wednesday, company spokeswoman Carrie Bloom noted in a statement that the company "had no control or influence over the research."
Scientists must maintain the trust of patients in research studies, and "any breach of that trust is not simply disappointing but, I believe, unacceptable," Dr. John Niederhuber, director of the National Cancer Institute, said in a statement.
Any findings from a study tainted by hidden industry ties "will be much less believable," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. The problem is avoidable, he added. "There are plenty of people around who are bright and knowledgeable and don't have conflicts of interest. We need to look harder to find these people."
The cancer society's chief medical officer, Dr. Otis Brawley, said the society would not have contributed to the study if it knew "Big Tobacco" was co-funding the work. Still, there is no sign that the study's findings are tainted, and "it is my belief that something can be learned that can be useful," he said.
The chief Cornell researcher, Dr. Claudia Henschke, did not respond to an e-mail requesting comment. Cornell's dean, Dr. Antonio Gotto, said: "The claim that we set this foundation up in order to cover up the money just isn't true. We made a public announcement that we were taking the money from the tobacco company."
In retrospect, Gotto said perhaps the tobacco cash and patents that Cornell researchers hold on related technology should have been disclosed in Henschke's journal articles. Instead, one listed only the Cornell foundation.
Dr. Catherine DeAngelis, editor in chief of JAMA, the Journal of the American Medical Association, said she contacted Henschke months ago after others pointed out patents not disclosed in a July 2006 study. DeAngelis said Henschke didn't believe the patents were relevant to the research and resisted disclosing them.
"We'd been working with Dr. Henschke trying to get her to write a letter of apology — which is our policy — and to take responsibility," DeAngelis said. "It was not easy to get her to do anything."
Asked whether she would have published the research if the tobacco funding had been known, DeAngelis said: Absolutely not. I would have turned down the paper."
A spokeswoman for the New England Journal, which published the Henschke paper listing the Cornell foundation as a sponsor, one of about 30, said only that the journal was investigating the matter.
Smokers are in dire need of good science on the risk and benefits of lung scans, which are being marketed directly to the public in shopping centers and similar settings. About 1 million people worldwide will be diagnosed with lung cancer this year, and most will die because it is found too late for treatment to do much good.
Advanced X-rays called spiral CT scans have been touted as a way to find tumors earlier. But doctors fear that screening could lead to too many false alarms and unnecessary biopsies without saving lives. The cancer society does not currently recommend them, and most insurers don't pay for them.
Interest in the scans soared after Henschke published a key study in 1999 saying they found more tumors than conventional X-rays. Her ongoing study aims to prove the value of these scans but has been criticized because it lacks a comparison group.
The National Cancer Institute's study now under way has several comparison groups. It, too, has been criticized because two of its leaders were paid by tobacco companies as expert witnesses in lawsuits. Brawley says these were small amounts and one researcher gave the money back. Results of the federal study are expected in 2009 or 2010.
Laurie Fenton Ambrose, president of the patient advocacy group, the Lung Cancer Alliance, has complained about the government study conflicts, and says attacks on Henschke are "mudslinging."
"There is a difference between money that is provided independent of any tobacco control that would help fund research that would advance better patient outcomes and money that tobacco pay researchers for their testimony against screening in class action lawsuits," she said.
However, her group has taken industry money, too — from a maker of CT scanning equipment.
Niederhuber said the government "takes conflict of interest very seriously" and is committed to finishing its study with integrity.
An independent safety monitoring board is in place, and "investigators involved in the study do not have access to the data collected and cannot influence the data in any way that might affect the outcome of the trial," he added.
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Medical Writer Marilynn Marchione reported from Milwaukee; AP writer Stephanie Nano reported from New York.
FDA deadlines may impact drug safety
Wed, 26 Mar 2008 22:40:01 GMTBy LAURAN NEERGAARD, AP Medical Writer
WASHINGTON - Vioxx, Bextra, Rezulin, Baycol. Looking at drugs yanked off the market, Harvard researchers found a disturbing pattern: Medicines approved right on deadline by the Food and Drug Administration are more likely to cause safety problems later than those cleared with more time to spare.
Congress set strict deadlines for FDA to speed the arrival of new medications, but critics have long complained that the ticking clock spurred a dangerous rush to judgment.
The Harvard analysis of decades of drug approvals, published in Thursday's New England Journal of Medicine, provides the first scientific evidence supporting some of those complaints.
The FDA challenged the findings with its own statistics. Still, the study sparked calls to re-examine the balance between speed and safety.
"The article is a wake-up call," said Dr. Steven Nissen, the Cleveland Clinic's influential cardiology chief who helped sound the alarm on the risks of some of those ultimately doomed drugs
"It puts the FDA in a very difficult situation when they're trying to make complex decisions under these very, very tight deadlines," he added. "We've got to reevaluate now whether that's good public policy."
Deadlines were first imposed on FDA by a 1992 law that allowed drug makers to pay millions of dollars in fees directly to the cash-strapped agency so it could hire more reviewers and clear a backlog of pending drug applications. In return, FDA had to make a decision — either approve or reject — on 90 percent of all drug candidates within 12 months of their application, or lose money. The deadline was 6 months for drugs so novel or potentially lifesaving to be classified high-priority.
Congress tightened the deadline for most drugs to 10 months in 1997.
Amid concern about risky drugs, Harvard professor Daniel Carpenter took a closer look at the impact. First, he found approval is 3.4 times as likely in the two months leading up to the user-fee deadline as at any other time.
Drugs approved in that just-before-deadline period had a four- to five-fold higher rate of later being withdrawn or requiring serious safety warnings, compared with drugs approved faster — presumably slam-dunks — or those that miss the deadline, Carpenter concluded.
The FDA argued the findings weren't accurate, rushing out its own statistics that showed somewhat more withdrawals among drugs approved just before the deadline but not enough to be statistically significant.
"FDA won't approve a drug if we are not ready," said drug chief Dr. Janet Woodcock. "And we have the option of denying approval altogether if there is any question about safety."
But the Harvard researchers in turn rechecked their statistics, which had passed review by the medical journal, and informed FDA they were standing by the findings.
Among on-the-brink approvals that later caused problems: The painkiller Vioxx, pulled off the market in 2004 for increasing the risk of heart attacks and strokes; its competitor Bextra, gone in 2005; the diabetes drug Rezulin, withdrawn in 2000 for liver problems; and cholesterol-lowering Baycol pulled in 2001 for muscle damage.
More recently, the diabetes blockbuster Avandia was linked to heart risks last year, getting a strict new warning label.
Carpenter acknowledged that everybody works under deadlines.
For FDA, "these deadlines are kind of stand-ins for pressure" to approve, he contended.
"FDA staffers by their own admission feel very much under the gun as these deadlines loom," added Dr. Jerry Avorn of Brigham and Women's Hospital in Boston, who co-authored the study. "If they're forced to make decisions prematurely, they may not make the right decisions. That needs to be debated openly."
In today's tight budget climate, industry user fees are unlikely to be replaced with taxpayer dollars. Congress reaffirmed the user-fee provisions last year, and it's unclear if lawmakers would revisit the deadline issue.
"It clearly is critical that FDA has the time it needs to do a thorough and complete review of new drugs before consumers are exposed to them," said Rep. Henry Waxman, D-Calif., who chairs the House Government Reform and Oversight Committee. If the user-fee law "is causing undue pressure, we need to fix that."
Nursing homes cut back on restraints
Thu, 27 Mar 2008 03:07:44 GMTBy KEVIN FREKING, Associated Press Writer
WASHINGTON - The use of physical restraints on nursing home patients declined nearly 40 percent nationally in recent years as the federal government, states and the nursing home industry placed greater emphasis on eliminating what once was a common practice.
Overall, about 5.9 percent of 1.5 million long-term patients were physically restrained repeatedly in 2006. That's a drop from 9.7 percent in 2002.
Physical restraints, such as bed rails or wheelchair belts, were once regarded as necessary to improve safety, to keep patients from falling or wandering off, but that mind-set has changed during the past two decades.
States where physical restraints for nursing home patients were most frequently used in 2006 were: California, 13.4 percent; Arkansas, 13.2 percent; and Oklahoma, 11.5 percent.
States where restraints were least frequently used were Nebraska, 1.3 percent; and Iowa, Kansas and Maine, 2 percent. The nursing home data was part of an Agency for Healthcare Research and Quality report that compares states on numerous health issues.
Mary Jean Koren, assistant vice president at The Commonwealth Fund, a research group, said that changes to federal law in 1987 made it illegal for nursing homes to use restraints to discipline residents or as a matter of convenience. The restraints can only be used for medical reasons, such as to prevent a resident from tearing out an IV. Until the change in law, restraints were standard procedure in many homes.
"We didn't know better," Koren said. "We didn't understand what it did to people both physically and psychologically."
Those effects typically include depression, pressure sores and dehydration, she said. Research has also shown that restraints even increased the likelihood of injury as the restrained residents lost strength due to inactivity, making it harder for them to walk once they were allowed to move around.
Heather Thompson, director of nursing at Oakview Terrace, a nursing home in Freeman, S.D., said that about 21 percent of the home's residents were physically restrained in the fourth quarter of 2003. However, since May 2006, the home's policy has been that no restraints can be used on residents.
"It was kind of a scary deal for staff and for family," Thompson said. "In the past, restraints were always seen as something that was keeping the person safe. We thought that by restraining the frail, elderly person, they wouldn't fall and that we were helping them."
Family members have even reported the nursing home to South Dakota authorities because staff refused to allow any restraints, Thompson said.
"It's gotten to be quite heated at times," she said.
Thompson said that technology and greater anticipation of a patient's needs are good substitutes for restraints. For example, the unit for patients with Alzheimer's disease has doors that require a code before they will open. That way patients can't wander away. Beds can be lowered all the way to the ground, eliminating the need for rails for those patients susceptible to rolling out of bed.
Thompson said the nursing home also emphasizes increasing the patients' physical activities to improve their strength. Most importantly, she said, staff members are trained to work exclusively with certain patients.
"They have to have the same staff working with the same group of residents, to get to know their habits, their routines, their behavior," she said.
She said that nursing home workers that used restraints on patients had good intentions.
"The people working in nursing homes weren't bad people. They were just looking at it differently," she said.
Nursing homes, consumer groups and other organizations have pooled their resources through a program called Advancing Excellence in America's Nursing Homes. The organization's goal is to reduce by 30,000 the number of nursing home patients who are physically restrained. The timeline for that goal is September.
"We're seeing this very rapid decline because all the interested parties are coming together around this issue," Koren said. "Everyone is putting their best thinking to it to see how we can reduce the use of these restraints."
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On the Net:
Agency for Healthcare Research and Quality: http://www.ahrq.gov
Commonwealth Fund: http://commonwealthfund.org
Famed Ky. eatery suspected in illnesses
Thu, 27 Mar 2008 03:03:02 GMTSHELBYVILLE, Ky. - Health officials are investigating whether a Kentucky restaurant named for the widow of KFC's founder is responsible for dozens of illnesses.
Officials say that as of Wednesday, about 70 people have complained of getting sick after eating at Claudia Sanders Dinner House outside Shelbyville. She was married to Col. Harland Sanders.
The family of a man who died Tuesday claimed he ate at the restaurant Sunday. But Regional Public Health Director Renee Blair says there's no conclusive evidence linking his death to the restaurant.
Health officials have temporarily closed the restaurant. General manager Louise Riley says it is expecting a preliminary report Thursday from the health department.
Cops Texas boy was slain not crushed
Thu, 27 Mar 2008 03:36:44 GMTLA JOYA, Texas - A morbidly obese woman who authorities originally thought might have crushed her 2-year-old nephew to death was arraigned in her bedroom Wednesday on a capital murder charge, accused of striking him in the head.
Mayra Lizbeth Rosales, who weighs at least 800 pounds, had told police that she slipped and hit the boy's head with her hand and that he fell from a chair. But investigators said the boy died of two blows to the head. The autopsy also found skull fractures that were estimated to be about a month old.
The 27-year-old bedridden woman was photographed and fingerprinted at her La Joya home before being released on a personal recognizance bond, Hidalgo County Sheriff Lupe Trevino said.
Rosales' sister and the boy's mother, Jamie Lee Rosales, was arrested on a charge of injury to a child, accused of failing to protect the boy. She was being held on $50,000 bond. A capital murder conviction could carry a possible sentence of life in prison or the death penalty.
The 20-year-old mother had signed a safety plan in April with Child Protective Services that advised her not to leave her children with her sister because of the woman's disability, according to charging documents.
A woman who answered the phone at Mayra Rosales' home and wouldn't give her name said the family would have no comment. Authorities had no attorney contact information for the sisters.
Eliseo Gonzalez Jr. and his two younger siblings had been left in the sole supervision of Mayra Rosales, authorities say.
Less than two hours later, Mayra Rosales phoned her sister to say that Eliseo had gotten stuck under her bed and his head was swollen, according to the charging documents. Eliseo was removed from life support and declared dead that afternoon.
Bobby Contreras, Hidalgo County justice of the peace, said last week that investigators believed the woman had fallen on the child.
UKOdd Summary
Thu, 27 Mar 2008 05:48:07 GMTExtra bite -- Texan faces charges over snake vodka
SAN ANTONIO - A Texas man is facing charges for selling liquor without a license after he was found peddling bottles of vodka containing dead baby rattlesnakes. Bob Popplewell, who runs "Bayou Bob's Brazos River Rattlesnake Ranch" tourist attraction west of Fort Worth, was believed to be selling the vodka in the Asian community, where snakes are seen having aphrodisiac properties, state authorities said.
Dinosaur fossil found on bus in Peru
AREQUIPA, Peru - Officials found the fossil of a giant dinosaur jawbone while investigating a suspicious package on a bus in the mountains of Peru on Tuesday. The fossil, weighing some 19 pounds, was found in the cargo hold of the bus, which was headed for the capital of Lima, and had been sent on the bus company's package service.
Baseball star gets marriage tips from Japan government
TOKYO - Japanese baseball star Hideki Matsui got some advice on the secrets of a happy marriage from an unexpected source on Thursday -- the government's top spokesman. Matsui, 33, a player for the New York Yankees and a hero for baseball fans at home, is to marry a 25-year-old former office worker, he told Japanese media in a letter.
Man flees home half naked to evade mouse
BERLIN - A man in Germany fled his home half naked for cold, snow-swept streets to escape a mouse in his living room, authorities said on Thursday. "He said there was nothing he was more afraid of," police in Goettingen said in a statement.
Study finds Clinton related to Jolie and Obama to Pitt
LOS ANGELES - The U.S. presidential candidates may have star qualities -- and they also have stars in their families, according to a genealogical study linking Hillary Clinton to Angelina Jolie and Barack Obama to Brad Pitt. The New England Historic Genealogical Society in Boston on Wednesday released a study in which it traced the family trees of all three presidential candidates to find they all had famous relatives, both dead and alive.
Peru's Fujimori pleads to take off socks at trial
LIMA - Former Peruvian President Alberto Fujimori apologized for not wearing socks to his trial on Wednesday and for falling asleep in the previous court session, when a frustrated judge rang a bell to wake him. Fujimori, 69, said medication he takes to improve his circulation and marathon court sessions three times a week have left him exhausted, with a bad back and aching legs.
Russian farmer sues space agency for falling rocket
BARNAUL, Russia - A shepherd is suing Russia's space agency for compensation after he said a 3-metre-long chunk of metal from a space rocket fell into his yard, just missing his outdoor toilet. Boris Urmatov, who is asking for 1 million roubles from the Roskosmos agency, lives in a small village that lies underneath the flight path of rockets taking off from the Baikonur launchpad Russia leases in nearby Kazakhstan.
Ryanair boss fails to back own horse in 33-1 win
DUBLIN - Ryanair boss Michael O'Leary's famed acumen and self-confidence briefly deserted him when he failed to back his own horse Hear The Echo to win the Irish Grand National at odds of 33-1. The outsider ridden by Paddy Flood and trained by Michael 'Mouse' Morris easily knocked 6-1 favourite Royal County Star into second place at Ireland's top steeplechase on Monday.
Dubai restaurant gives discount for bugs
DUBAI - A group celebrating a birthday at a Dubai diner were cheered by a 25 percent discount but not necessarily the reason: "Bug on food". The restaurant cut the bill for seven customers at a birthday dinner after they found four insects crawling around their meals, the Gulf News reported on Tuesday.
South Koreans can afford to lose trousers... maybe
SEOUL - South Koreans may find they can afford to lose their trousers but not their shirts; drink a bit more soju, the cheap national liquor, but not beer; and wash their hair and clothes more often but not their hands. The newly inaugurated government released a list of 52 consumer goods whose prices it wants to control to help ease rising costs in the face of soaring energy prices and the falling Korean won.
Too Little Vitamin D May Soften Baby39s Skull
Thu, 27 Mar 2008 03:47:19 GMTWEDNESDAY, March 26 -- Vitamin D deficiency during pregnancy may be linked to a softening of bones in a baby's skull, Japanese researchers report.
They also found that breast-feeding without vitamin D supplementation could prolong the deficiency, which might lead to a risk of serious health problems later in life, including decreased bone density and type 1 diabetes.
"Craniotabes, the softening of skull bones, in otherwise normal newborns has largely been regarded as a physiological condition without the need for treatment. Our findings, however, show that this untreated condition may be the result of a potentially dangerous vitamin D deficiency," Dr. Tohru Yorifuji, of Kyoto University Hospital, said in a prepared statement.
The researchers evaluated 1,120 newborns and found that, at five to seven days of age, 246 of the babies had craniotabes. The researchers also found strong seasonal variations in the incidence of craniotabes. This suggests that the condition is associated with prenatal vitamin D deficiency, and is likely influenced by the amount of sunlight exposure a woman gets during pregnancy. The body produces vitamin D when the skin is exposed to sunlight.
This vitamin D deficiency in newborns may persist into later life, especially in breast-fed infants who don't receive a formula with vitamin D supplementation, the researchers said. More than half the breast-fed infants with craniotabes showed statistically significant low levels of serum 25-OH vitamin D, the storage form of the vitamin. Some of these infants had symptoms of an overactive parathyroid gland, which is also consistent with vitamin D deficiency.
The study appears in the Journal of Clinical Endocrinology & Metabolism.
"Until more research is done on the effects of perinatal vitamin D deficiency, we suggest treating breast-fed infants with craniotabes with vitamin D, or preferably, treating all pregnant women with vitamin D," Yorifuji said.
Several recent studies have reported a resurgence of vitamin D deficiency, even in developed countries, according to background information in a news release about the study. Skeletal problems, such as rickets in childhood or softening of bones in adults, are common consequences of vitamin D deficiency, which can also increase the risk of multiple sclerosis, type 1 diabetes and colorectal cancer in adults.
More information
The MedlinePlus Medical Encyclopedia has more about craniotabes.
Big belly in 40s raises Alzheimer39s risk in 70s
Wed, 26 Mar 2008 20:04:43 GMTBy Will Dunham
WASHINGTON - Having a big belly in middle age appears to greatly increase one's risk of developing Alzheimer's disease or another form of dementia decades later, researchers said on Wednesday.
Their study tracked 6,583 people in northern California for an average of 36 years starting when they were ages 40 to 45. Their abdominal size was measured at the outset of the study.
A total of 1,049 of them -- nearly 16 percent -- went on to develop Alzheimer's disease or some other form of dementia by the time they reached their 70s. Those in the upper 20 percent in terms of belly size in middle age were almost three times more likely to develop dementia than those in the bottom 20 percent of belly size, the researchers found.
Alzheimer's disease is the most common form of dementia among older people, and researchers have been working to understand the causes and risk factors for the brain disease.
Belly size in middle age was a much better predictor of later development of dementia than looking merely at obesity as shown by a person's body mass index, a measure of body fat based on height and weight, the researchers said.
"It's not just weight, it's where you carry your weight that is a very important risk factor," said Rachel Whitmer, a research scientist at the Kaiser Permanente Division of Research in Oakland, California, who led the study.
"If you have two people who are both 10 pounds overweight, one carries it around the middle and one carries it around the hips, that person who carries it around the middle needs to know they are at greater risk," Whitmer said in a telephone interview.
Previous research has shown that having a large abdomen in middle age elevates one's risk for diabetes, stroke and heart disease, but the researchers said this was the first study linking belly fat in middle age to increased risk of dementia.
Having a large belly raised one's risk of dementia regardless of whether the person was of normal weight overall, overweight or obese, and regardless of health conditions such as diabetes, stroke and cardiovascular disease, according to the study published in the journal Neurology.
Whitmer said research is needed to reveal the underlying mechanisms linking abdominal size to eventual dementia risk.
"We're sort of at the beginning of understanding the clinical effects of these byproducts of fat," Whitmer said. "But there is evidence from the molecular level, from animal models, and from population studies that it could have a negative effect on the brain."
Measuring abdomen size in the elderly may not be as valuable an indicator of dementia risk because people as they age naturally are apt to lose muscle and bone mass and gain belly size, Whitmer said.
