Study fails to link chemical brain woes
Wed, 26 Sep 2007 21:01:19 GMTBy ALICIA CHANG, AP Science Writer
LOS ANGELES - A mercury-based preservative once used in many vaccines does not raise the risk of neurological problems in children, concludes a large federal study that researchers say should reassure parents about the safety of shots their kids received a decade or more ago.
However, the study did not examine autism — the developmental disorder that some critics blame on vaccines. A separate study due out in a year will look at that issue, said scientists at the federal Centers for Disease Control and Prevention, who led the latest analysis and published results in Thursday's New England Journal of Medicine.
They found no clear link between early exposure to the preservative thimerosal and problems with brain function and behavior in children age 7 to 10. The results are in line with past research that found no connection between vaccines and neurological problems or autism.
Thimerosal has not been used in childhood vaccines since 2001, although it is still in some flu shots. The new findings apply to children immunized before then, or exposed to the preservative through shots their mothers received while pregnant. Thimerosal was put in vaccines to prevent contamination from bacteria.
Some doctors say the CDC study should reassure parents worried about the safety of vaccines.
"It's good news for families," said Dr. Michael Goldstein, vice president of the American Academy of Neurology who works in private practice in Salt Lake City. "There's no evidence that these vaccines have caused injury."
The study involved 1,047 children who were exposed to varying levels of thimerosal while in the womb or after birth in the 1990s. The children belonged to four health maintenance organizations that are part of a federal project to study the side effects of vaccines. Their mercury exposure was determined through medical and immunization records and interviews with parents.
Each child was tested for speech and language skills, motor coordination and intelligence. Parents, teachers and trained specialists also rated stuttering, attention span and tic disorders such as head shaking, eye blinking and neck jerking. A total of 42 neurological problems were analyzed.
On balance, researchers did not find a consistent pattern between increasing thimerosal exposure and the risk of these problems. However, they said one finding merited further study: Boys exposed to higher mercury levels seemed to have more tic problems — a link seen in previous research.
"The doses of mercury that children were exposed to because of immunization doesn't cause neuropsychological damage," said Dr. Bruce H. Cohen, a Cleveland Clinic pediatric neurology specialist who had no role in the study.
The CDC study was reviewed by an independent panel of scientists and statisticians who oversaw its design, reviewed results and contributed to writing the report.
The panel included one vaccine opponent — Sallie Bernard, executive director of the consumer group SafeMinds. Although she had a role in planning the study, she asked to be listed as a "dissenting member" because she disagreed with the study's conclusions.
The research was led by William Thompson, a CDC epidemiologist who once worked for vaccine maker Merck & Co. Four other researchers have received fees from drug companies and one has served as a consultant to a CDC committee on immunization.
The study was not designed to tease out the effects of mercury exposure on autism. Thompson is completing a separate study examining whether thimerosal exposure before or after birth causes autism. The study recruited 1,000 children including 250 with autism. Results are expected next year.
Autism is a major public health concern, with one in 150 American children diagnosed with the disorder characterized by repetitive behaviors and impaired social interaction.
Although past scientific studies have found no link between autism and thimerosal-containing vaccines, the highly charged issue went on trial this summer.
A court in Washington, D.C., heard from an Arizona mother who blamed vaccines on her 12-year-old daughter's severe autism. The case is being followed by about 5,000 families who filed similar claims to receive compensation from a federal vaccine injury fund. The fund so far has not paid out an autism claim.
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On the Net:
New England Journal: http://www.nejm.org
CDC page on thimerosal: http://www.cdc.gov/od/science/iso/concerns/thimerosal.htm
Dems work to limit diacetyl exposure
Wed, 26 Sep 2007 19:40:03 GMTBy JESSE J. HOLLAND, AP Labor Writer
WASHINGTON - House Democrats on Wednesday ordered federal safety regulators to limit popcorn plant workers' exposure to a flavoring chemical linked to a lung ailment, saying further delay could cost lives.
The lack of an Occupational Safety and Health Administration standard on diacetyl "has endangered the health of families," said Rep. Betty Sutton, D-Ohio. "That is why we have to act today. Workers should never have to choose between their health and feeding their families."
But the Bush administration and House Republicans think the Democrats' bill is premature, and Congress' interference with OSHA's work may cause more harm than good.
"We believe that it's important to give OSHA time to complete a scientific study of diacetyl exposure and to issue a recommended exposure limit for the use of that chemical," said Rep. Lincoln Diaz-Balart, R-Fla. "Without a complete study, Congress may push manufacturers to use different chemicals that could be even more directly responsible for diseases."
Diacetyl occurs naturally in foods such as butter, cheese and fruits, and the Food and Drug Administration has approved its use as a flavor ingredient. The concern is when workers inhale it in manufacturing settings — either in making the flavoring or adding it to food products ranging from popcorn to pound cakes.
In a number of lawsuits, workers who were exposed to diacetyl have linked the chemical to cases of bronchiolitis obliterans, a rare life-threatening disease often called popcorn lung. Workers suffering from the progressive lung disease can be forced to undergo lung transplants to survive.
The Democrats' legislation gives OSHA three months to tell microwave popcorn production and packaging establishments and all flavoring manufacturing locations using diacetyl to limit exposure to the chemical; institute air monitoring, medical surveillance and safety labeling; and require the wearing of protective clothing and equipment for workers exposed to it.
Two years after the legislation is signed, the rules would apply to everywhere diacetyl is processed or used.
"OSHA has not acted, so today we will," said Rep. Robert Andrews, D-N.J.
The House passed the legislation 260-154. The Senate has not yet considered the bill.
A call to OSHA on Wednesday was not immediately returned.
ConAgra Foods Inc., General Mills Inc. and the American Pop Corn Company already have said they would stop using diacetyl. Together those companies accounted for more than 80 percent of the market for microwave popcorn over the past 12 months, according to the research firm Information Resources Inc.
Last year, the National Institute for Occupational Safety and Health, or NIOSH, issued a report that found several employees at a microwave popcorn plant were diagnosed with lung disease.
NIOSH determined that inhaling the butter flavoring put workers at risk for the lung disease. Since then, OSHA has increased inspections in places that make butter-flavor popcorn, and on Monday announced it had started the rulemaking process on diacetyl.
But in unusual criticism of the Republican administration, Rep. Howard "Buck" McKeon, R-Calif., said OSHA was silent on what it would do about diacetyl while House Democrats were working on this bill.
"In fact, if the administration had simply been forthright with Congress about its plans, we might not be here considering this questionable legislation at all," he said.
Republicans, including the White House, argued that Democrats' attempt to circumvent OSHA's decision-making process could hurt more than help.
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The bill number is H.R. 2693.
On the Net:
For bill text: http://thomas.loc.gov
Merck set to donate cancer vaccine doses
Wed, 26 Sep 2007 20:09:15 GMTBy LINDA A. JOHNSON, AP Business Writer
TRENTON, N.J. - Drug maker Merck & Co. plans to donate enough doses of its cervical cancer vaccine, Gardasil, to inoculate 1 million women in some of the world's poorest countries.
Merck announced the gift Wednesday at the third annual Clinton Global Initiative conference in New York.
The Whitehouse Station-based company said at least 3 million doses of Gardasil are to be distributed over the next five years. The vaccine is given in three shots spread over six months.
Cervical cancer, caused by a sexually transmitted virus, is the No. 2 cause of cancer deaths worldwide, with nearly 500,000 new cases and 250,000 deaths each year. Most deaths occur in poor nations, where women rarely get tests to detect cervical cancer early, when it is most curable.
Merck plans to partner with a nongovernment organization to set up programs to distribute the vaccine in countries yet to be chosen.
"Our company is fully committed to making Gardasil available to those who need it," Margaret McGlynn, head of Merck Vaccines and Infections Diseases, said in a statement.
Gardasil is 99 percent effective in preventing infection by two strains of the human papilloma virus that together cause about 70 of cervical cancer cases. It also protects against 10 other strains that cause cancer, plus another two that cause genital warts but not cancer.
In the United States, Gardasil costs about $360 for three doses, plus any fee for a doctor visit.
Merck has the only cervical cancer vaccine approved in the United States, but rival GlaxoSmithKline PLC's vaccine, Cervarix, was approved Monday for sale in the 27 European Union member states and is awaiting U.S. approval.
Study Firms should help unhappy workers
Wed, 26 Sep 2007 03:08:30 GMTBy LINDSEY TANNER, AP Medical Writer
CHICAGO - Investing in depressed employees — quickly getting them treatment and even offering telephone psychotherapy — can cut absenteeism while improving workers' health, a study suggests.
Many employers view mental health coverage as a financial black hole, but the study shows that spending money on depression is a smart business move, said researcher Dr. Philip Wang. Wang works for the National Institute of Mental Health, which funded the study.
Employees who got the aggressive intervention worked on average about two weeks more during the yearlong study than those who got the usual care — advice to see their doctor or seek a mental health specialist.
Also, more workers in the intervention group were still employed by year's end — 93 percent vs. 88 percent — savings that helped employers avoid hiring and training costs, the researchers said.
In addition, intervention employees were almost 40 percent more likely to recover from depression during the yearlong study, which is reported in Wednesday's Journal of the American Medical Association.
The researchers haven't finished a formal cost-benefits analysis but early results suggest savings from more hours worked averaged to about $1,800 per employee. That far exceeds the program's initial $100 to $400 per worker cost. The benefits also likely exceed other costs, including drugs and therapy too, the researchers said.
"We knew before that treating depression makes good medical sense. This suggests that it makes good business sense," said Dr. Thomas Insel, director of the institute.
The percentage of workers who improved substantially — 31 percent — or who recovered — 26 percent — was low even in the intervention group. That was comparable to the rate of improvement in other studies of people with depression.
The results are important because depression takes a hefty toll on the U.S. workplace, affecting about 6 percent of employees each year and costing over $30 billion annually in lost productivity, said study co-author Ronald Kessler, a Harvard Medical School researcher. Kessler has worked as a paid consultant for several drug companies, including makers of antidepressants.
Two other co-authors are employees of United Behavioral Health, the large managed-care company involved in the study, and own stock in UBH's parent company. The research compared UBH's usual mental health coverage with the experimental telephone-based outreach program devised for the research.
Because of the study's results, UBH began offering a similar program after the study ended more than a year ago.
Dr. Ken Duckworth, medical director of the nonprofit National Alliance on Mental Illness, praised the research as "a real advance."
"This study shows employers benefit" from paying attention to depression, Duckworth said. His group supports a bill before Congress that would require employers to offer mental health insurance coverage that is equal to that provided for physical illnesses, when policies cover both.
The study involved 604 white-collar and blue-collar workers at 16 large U.S. companies. Employees included pilots, lawyers, bankers, truckers and janitors.
The study volunteers answered an online screening questionnaire that found signs of depression. Half got the usual care, including a letter suggesting they contact their primary-care doctor or call UBH for referral to a mental health specialist.
The intervention group got repeated telephone calls during non-work hours from UBH case managers trained in mental health treatment. Case managers urged workers to get treatment and called periodically to see how it was going.
When workers resisted seeking help, case managers offered telephone psychotherapy, which many employees viewed as less stigmatizing and more convenient than office visits with a psychiatrist, Kessler said.
About 40 percent of workers in both groups got antidepressants. Intervention group workers were 60 percent more likely to get treatment from a mental health specialist.
More employees in the treatment group stayed employed, a savings for the company.
Among those participating were workers at International Truck and Engine Corp., based in Warrenville, Ill. Dr. William Bunn, the company's medical director, said the results influenced International Truck to enhance its mental health coverage and do more employee depression screening.
"Now we know that purchasing a product such as the intervention is going to be cost-effective," Bunn said. "It's not just the right thing to do, it also saves money for the company."
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On the Net:
JAMA: http://jama.ama-assn.org
Men who smoke risk erectile dysfunction study
Wed, 26 Sep 2007 18:22:14 GMTNEW YORK - Otherwise healthy men who smoke risk developing erectile dysfunction -- and the more cigarettes they smoke, the greater the risk of erectile dysfunction, according to a new study.
Erectile dysfunction is the consistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance. In a study of 4,763 Chinese men aged 35 to 74 years who were free of blood vessel disease and who reported that they had been sexually active within the last 6 months, the researchers found a significant statistical link between the number of cigarettes smoked and the likelihood of erectile dysfunction.
&;The association between cigarette smoking and erectile dysfunction was found in earlier studies,&; said first author Dr. Jiang He of Tulane University School of Public Health, New Orleans. &;However, most of those studies were conducted in patients with hypertension , diabetes and cardiovascular disease. What distinguishes this study is that it is the first to find this association among healthy men.&;
Overall, men who smoked had a 41-percent greater risk of erectile dysfunction than men who did not, the team reports in the American Journal of Epidemiology.
And there was a clear &;dose-response&; relationship, meaning that the more the men smoked, the higher was their risk of erectile dysfunction. Compared with non-smokers, men who smoked up to 10 cigarettes per day had a 27-percent greater likelihood of erectile dysfunction ; those who smoked 11 to 20 butts a day had a 45-percent greater likelihood of erectile dysfunction; and those who smoked more than 20 cigarettes daily had a-65 percent greater chance of suffering erectile dysfunction.
The investigators estimate that 22.7 percent of erectile all dysfunction cases among healthy Chinese men - or 11.8 million cases -- might be caused by cigarette smoking.
And even when cigarette smokers quit, their risk of developing erectile dysfunction did not decrease. The risk of erectile dysfunction was statistically about the same for former cigarette smokers as for current cigarette smokers, the authors found.
&;This study really has a strong message for young men,&; He said. &;It may get their attention if they know that smoking is associated with erectile dysfunction -- even in the healthy population.&;
&;So the message is: Don't start.&;
SOURCE: American Journal of Epidemiology, October 1, 2007.
Maternal weight tied to child39s body composition
Wed, 26 Sep 2007 21:05:34 GMTBy Megan Rauscher
NEW YORK - Investigators have found that children, whose mothers had a larger body mass index prior to pregnancy or a large mid-upper arm circumference in late pregnancy, also had higher levels of body fat at the age of 9 years than other children of the same age. The amount of weight mothers put on during pregnancy, however, had no effect on their child's body fat.
Both BMI, the ratio between height and weight often used to determine whether or not a person is overweight or underweight, and mid-upper arm circumference are indicators of nutritional status. The findings suggest that maternal weigh rather than nutrition during pregnancy may be the factor with the greater effect on a child's predisposition to gain excess body fat.
However, &;it is also possible that our results might be due to genetic factors transmitted from mother to child,&; Dr. Catherine R. Gale, of the University of Southampton, UK, told Reuters Health.
While evidence suggests that babies' fat mass at birth is greater if their mothers were overweight during pregnancy, it's less clear if this association persists into childhood.
To investigate, the UK team studied 216 nine-year-old children whose mothers had participated in a study of nutrition in pregnancy.
In analyses adjusted for the influence of age, birthweight, infant weight gain, duration of breast-feeding, maternal height, smoking and amount of weight gained during pregnancy, a larger maternal mid-upper arm circumference in late pregnancy and a higher pre-pregnancy BMI remained independent predictors of greater BMI at age 9 years in both boys and girls.
As maternal mid-upper arm circumference increased in late pregnancy, an equivalent increase in fat mass was observed in boys and girls
Similar relationship were seen between increases in pre-pregnancy BMI and increases in fat mass in boys and girls, according to the study findings in the report, published online in the Journal of Clinical Endocrinology and Metabolism.
Gale noted that &;more and more women are now overweight or obese at the start of pregnancy, so if being over nourished at this time does have permanent and long-lasting effects on the child's , this has important implications for the current epidemic of childhood obesity.&;
SOURCE&; Journal of Clinical Endocrinology and Metabolism, 2007.
