New FDA research center rife with risks
Sun, 14 Oct 2007 20:13:04 GMTBy MATTHEW PERRONE, AP Business Writer
WASHINGTON - The Food and Drug Administration is moving with unprecedented speed to launch a drug research center to be paid for by companies it regulates.
The goal of the Reagan-Udall Foundation, approved by Congress and signed into law late last month, is to streamline and improve the development of drugs and medical devices, a goal long sought by regulators and the biggest players in the industry, such as Merck & Co., Pfizer Inc., Wyeth, GlaxoSmithKline PLC, and Johnson & Johnson.
At a time when the FDA's reputation has been battered by perceptions that it is lax on some safety issues and too cozy with drug makers, consumer advocates say the loosely defined partnership increases the agency's vulnerability to industry clout despite its promise of groundbreaking success. It's an ambitious undertaking that puts regulators and companies in a relationship unlike that of any other industry.
Congress required fast-track creation of the foundation. The FDA filed a public notice Oct. 3 that it was accepting board nominations and will name board members Oct. 27. Drug industry executives likely will hold four seats on the center's 14-member board. The rest will be academics, consumer advocates and physicians, with no voting seats for FDA commissioners or staff.
The board's makeup could allow drugs to be developed more cheaply, improving pharmaceutical industry profits, but not necessarily result in safer and less expensive drugs for consumers, critics worry.
"Given FDA's track record in the past, I'm not confident in their ability to create something that is free of influence from industry," said Francesca Grifo, a director at the Union of Concerned Scientists. Her group and others have argued that the agency has become too accommodating to drug companies the past 25 years, after they began paying FDA user fees for the review of drug applications.
"Time and again we've seen that people within FDA behave as if industry is their primary client," Grifo said.
Sen. Edward M. Kennedy, D-Mass., a co-sponsor of the bill to create the foundation, says the bill requires "effective safeguards to ensure that the foundation is independent of both the FDA and its donors, whether those donors are from industry or are charitable organizations."
Reagan-Udall "will make new research tools and techniques available to the entire research community, shortening the time it takes to develop new drugs and reducing costs for patients," Kennedy added in an e-mailed response.
However, the law creating the center leaves crucial decisions to the appointed board — from where the center will be located to how funds will be collected from companies and distributed for research. And there are many unanswered ethical questions, such as who will own patents obtained from the foundation's research and how any potential profits would be shared or distributed.
One crucial issue, though, seems to have been decided, according to FDA Deputy Commissioner Janet Woodcock: "The FDA intends to put forward a variety of research projects that we think are important, but as with any foundation, the donors will have the primary say over how the funds are used."
Company executives say it's premature to comment on questions about Reagan-Udall, but they do say, as do FDA officials, that they hope the foundation reverses an alarming imbalance between how much companies spend on drug research and the number of drugs making it to market. Drug R&D spending hit $43 billion in 2006, a 150 percent increase the past decade compared with a 2.5 percent rise in the number of new FDA drug applications during that period.
The problem is time and money. Companies on average spend almost 15 years and $1 billion to get a new drug to market, according to the Pharmaceutical Research and Manufacturers of America. The drug development process can involve tracking up to 15,000 patients taking a drug for as long as five years.
At Reagan-Udall, FDA scientists, with private-sector funding, are hoping to do world-class research not being done elsewhere, while giving pharmaceutical companies a role in developing more effective drug approval methods and standards.
It's part of the FDA's Critical Path Initiative, unveiled in 2004, which calls for the agency to work with industry and academia to speed the "critical path" a drug travels from discovery to market. But critics question the potential trade-offs.
"FDA's primary role is regulating drugs and protecting the public health," said David Ross, a former FDA safety reviewer at the Department of Veterans Affairs. "If you start blurring that line between regulation and collaboration, you have real problems."
For example, Ross, who left the FDA last year over a drug safety dispute, is concerned, as are others, that the FDA might be persuaded to quickly adopt a controversial drug-testing process that uses biological indicators, such as blood pressure and cholesterol levels, to determine a drug's safety.
Drug companies have taken the unusual step of sharing research data on these indicators, called biomarkers, to see if the size and duration of patient drug trails can be reduced. Some critics call their use a high-risk gamble.
"Biomarkers are a bit like dynamite in that they can be extremely useful but they can cause a lot of damage," said Ross.
He cites a biomarker that suggested irregular heart rhythms were a key predictor of fatal heart attacks. Using the assumption, doctors prescribed heart-regulating drugs to millions of patients in the 1980s but abruptly halted the practice in 1989 when a long-term study revealed patients were actually more than twice as likely to die of sudden heart failure.
FDA officials counter that HIV biomarkers have turned out be a reliable predictor of survival for patients susceptible to AIDS, a disease that can fatally damage the body's ability to fight off serious illness.
Rachel Behrman, who heads FDA's Office of Critical Path Programs, says it's too early to know whether biomarker research would be an initial project. She wants to focus on the opportunities the center will offer.
"This has to do with being smarter," Behrman said. "That's what this initiative is about."
Report ranks jobs by rates of depression
Sun, 14 Oct 2007 11:42:14 GMTBy KEVIN FREKING, Associated Press Writer
WASHINGTON - People who tend to the elderly, change diapers and serve up food and drinks have the highest rates of depression among U.S. workers.
Overall, 7 percent of full-time workers battled depression in the past year, according to a government report available Saturday.
Women were more likely than men to have had a major bout of depression, and younger workers had higher rates of depression than their older colleagues.
Almost 11 percent of personal care workers — which includes child care and helping the elderly and severely disabled with their daily needs — reported depression lasting two weeks or longer.
During such episodes there is loss of interest and pleasure, and at least four other symptoms surface, including problems with sleep, eating, energy, concentration and self-image.
Workers who prepare and serve food — cooks, bartenders, waiters and waitresses — had the second highest rate of depression among full-time employees at 10.3 percent.
In a tie for third were health care workers and social workers at 9.6 percent.
The lowest rate of depression, 4.3 percent, occurred in the job category that covers engineers, architects and surveyors.
Government officials tracked depression within 21 major occupational categories. They combined data from 2004 through 2006 to estimate episodes of depression within the past year. That information came from the National Survey on Drug Use and Health, which registers lifetime and past-year depression bouts.
Depression leads to $30 billion to $44 billion in lost productivity annually, said the report from the Substance Abuse and Mental Health Services Administration. The report was available Saturday on the agency's Web site at http://oas.samhsa.gov
The various job categories tracked could be quite broad, with employees grouped in the same category seemingly having little in common.
For example, one category included workers in the arts, media, entertainment and sports. In the personal care category, a worker caring for toddlers at a daycare center would have quite a different job from a nursing aide who helps an older person live at home rather than in a nursing home.
Just working full-time would appear to be beneficial in preventing depression. The overall rate of depression for full-time workers, 7 percent, compares with the 12.7 percent rate registered by those who are unemployed.
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On the Net:
Read the report at: http://tinyurl.com/2ft37p
Report Childbirth deaths down slightly
Sat, 13 Oct 2007 09:49:47 GMTBy EDITH M. LEDERER, Associated Press Writer
UNITED NATIONS - Women are dying from complicated pregnancies and childbirth at almost the same rate they were in 1990, and the vast majority of deaths are occurring in sub-Saharan Africa and south Asia, a report said Friday.
The report by three U.N. agencies and the World Bank estimated that 536,000 women died due to complications in pregnancy or childbirth in 2005, compared to 576,000 in 1990. That represents an average annual decline of less than 1 percent — far below the 5.5 percent needed to achieve a U.N. goal of reducing the ratio by 75 percent by 2015, it said.
Ninety-nine percent of the deaths occurred in developing countries, according to the report.
"In this 21st century no woman should die giving life. Millions of lives are at stake and we must act now," said Thoraya Ahmed Obaid, executive director of the U.N. Population Fund, one of the agencies behind the report.
The report called for the prevention of unplanned pregnancies and unsafe abortions to achieve the Millennium Development Goal set by world leaders at a U.N. summit in 2000. It also called for high-quality pregnancy and delivery care.
Obaid said "three simple interventions" are needed — skilled birth attendants, emergency obstetric care, and family planning.
In Africa, less than 50 percent of births are attended by a skilled health worker, the report said. That's far below the global target of ensuring that at least 90 percent of births worldwide are attended by skilled health personnel by 2015, it said.
According to the report, 270,000 maternal deaths in 2005 occurred in sub-Saharan Africa, followed by South Asia with 188,000. The two regions accounted for 86 percent of the total.
The report gave the estimated number of maternal deaths per 100,000 live births in 171 countries in 2005.
The highest estimated rate was in Sierra Leone at 2,100 deaths per 100,000 live births, followed by Afghanistan and Niger at 1,800.
The United States had an estimated rate of 11 deaths for every 100,000 births — higher than most European countries and Japan. The lowest rate was in Ireland at 1 death per 100,000 births.
The report was based on estimates by the World Health Organization, the U.N. Children's Fund, the U.N. Population Fund and the World Bank.
Advocates fight Segway ban at Fla. parks
Sat, 13 Oct 2007 20:41:11 GMTORLANDO, Fla. - Advocates for the disabled want two theme parks to lift a ban on Segways, saying the scooters give people who can't walk a degree of freedom not afforded by wheelchairs.
Some employees at Walt Disney World use Segways, but officials at that park and SeaWorld Orlando said the two-wheeled scooters could be dangerous if used by visitors.
"We're not turning people away," said Disney World spokeswoman Kim Prunty. "We're turning away a particular form of transportation."
Disability Rights Advocates for Technology, which raises money to donate Segways to disabled U.S. military veterans and pushes for their acceptance, is asking the parks to lift the ban.
Many people who use prosthetics, and people who can stand but can't easily walk — such as many people with multiple sclerosis — find Segways offer more mobility and dignity than wheelchairs, said group co-founder Jerry Kerr, 52.
Disney has put many of its employees on Segways, but officials said they see serious safety concerns if untrained visitors ride the scooters on the same crowded walkways as toddlers, the elderly and other people with disabilities.
They also worry because Segways can go faster than 12 mph, they say.
SeaWorld spokeswoman Becca Bides said the park had similar concerns.
Messages left for Segway, based in Bedford, N.H., were not immediately returned Saturday.
Universal Orlando permits disabled riders on Segways on a case-by-case basis, park officials said.
Overweight kids at risk for asthma hospitalization
Sat, 13 Oct 2007 00:37:16 GMTBy Anthony J. Brown, MD
NEW YORK - Overweight children seen in the ER for an asthma flare-up are more likely to be admitted to the hospital than their non-overweight peers, according to a report in the journal Pediatrics. Moreover, this finding holds true regardless of illness severity.
&;This is the first study in children to examine the relationship between overweight and hospital admission during asthma exacerbations,&; lead author Dr. Christopher L. Carroll, from Connecticut Children's Hospital in Hartford, told Reuters Health.
Carroll said his team was &;somewhat surprised&; by the main finding. &;It suggests that obese children respond more slowly to therapy for acute exacerbations.&;
The findings are based on a review of all children, older than 2 years of age, who were seen for an asthma flare-up at the researchers' ER in 2005. Only children without other chronic medical conditions were included in the analysis. Overweight children were defined as being in the 95th or higher percentile of weight-for-age.
Overall, 813 children made 884 ER visits for asthma flare-ups during the study period, the authors report. Of these visits, 27 percent resulted in a hospital admission, including 4 percent that involved an intensive care unit admission.
Increasing asthma severity was associated with hospital admission, but age, gender, and poverty were not, the report indicates.
Of the ER visits made during the study, 77 percent involved a normal weight child and 23 percent involved an overweight child. On average, overweight children were older and were more likely to come from an impoverished area.
No major differences in asthma severity or in the ER treatment received were noted between overweight and normal-weight children. Nonetheless, 34 percent of ER visits involving an overweight child resulted in hospital admission compared with 25 percent of visits made by a normal weight child.
The main message is that &;overweight children with asthma have significant health-related consequences as a result of their being overweight,&; Carroll said.
Still, further research is needed to better understand the relationship between body weight and asthma and the possible treatment implications, he said.
Asthma is a diverse disease, &;with different subtypes that may require different treatment approaches. Accurate characterization of these subtypes may allow us to tailor therapies on a more individual basis. Overweight children with asthma may have a better response to different first-line therapies. Currently, we are conducting research to explore these areas.&;
SOURCE: Pediatrics, October 2007.
Vatican bars cleric who spoke of gay sex
Sat, 13 Oct 2007 19:22:23 GMTBy FRANCES D'EMILIO, Associated Press Writer
VATICAN CITY - The Vatican said Saturday it has suspended a monsignor from a senior post at the Holy See after an Italian TV program using a hidden camera recorded him making advances to a young man and asserting that gay sex was not sinful.
The Vatican did not identify the monsignor by name. But Monsignor Tommaso Stenico confirmed in a telephone interview with The Associated Press that he had been suspended from his post at the Vatican's Congregation for Clergy, an office which aims to ensure proper conduct by priests.
"Don't condemn me," Stenico said, adding that the program "was done fraudulently" because it used a hidden camera.
In the program on private Italian network La7, a man identified as a priest is heard saying that he "didn't feel he was sinning" by having sex with gay men.
Rome daily La Repubblica reported Saturday that Vatican officials recognized the monsignor's office in the background of the program, which aired Oct. 1.
The Rev. Federico Lombardi, a Vatican spokesman, said the Italian monsignor was suspended while the case was under investigation.
"Higher-ups are evaluating the situation with the necessary reserve and with the obligatory respect for the person involved, even if this person has erred," Lombardi said.
Vatican officials "had to intervene decisively and with the severity required by conduct not compatible with priestly service and with the mission of the Holy See," he added.
While the Vatican rarely comments on individual sex scandals, this case directly touched the Holy See, apparently prompting the confirmation of the report.
Vatican teaching holds that homosexual activity is a sin.
Stenico said to call back later in the day when he would have more to say, but later attempts to reach him were not successful.
The Italian news agency ANSA ed him as saying he had sent his superiors "a dutiful memo" about the case.
Milan daily Corriere della Sera had previously reported that a young man had contacted La7 and said he had been in contact with several priests on chat lines popular with gay men. Corriere said La7 then filmed encounters between the man and priests with a hidden camera.
A woman identifying herself as a producer for La7's "Exit" program declined to comment about the case, saying only that the program could be viewed on the network's Web site.
In the program, the faces of those speaking with the young man are obscured and their voices altered so they would not be recognized.
The man La Repubblica identified as the Vatican official can be heard saying that "he didn't feel he was sinning" by having sex with gay men and asking his visitor if he liked him.
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On the Net:
La7's "Exit" program: http://www.la7.it/blog/post_dettaglio.asp?idblog15&ID1065
U.S. maternal death rate higher than Europe39s report
Sat, 13 Oct 2007 23:04:08 GMTWASHINGTON - The United States has a sharply higher rate of women dying during or just after pregnancy than European countries, even some relatively poor countries such as Macedonia and Bosnia, according to the first estimates in five years on maternal deaths worldwide.
The report released by various United Nations agencies and the World Bank on Friday shows that Ireland has the lowest rate of deaths, while several African countries have the worst.
The United States has a far higher death rate than the European average, the report shows, with one in 4,800 U.S. women dying from complications of pregnancy or childbirth, the same as Belarus and just slightly better than Serbia's rate of one in 4,500.
Just one out of 47,600 women in Ireland die during or just after childbirth, the report found. Bosnia had the second-lowest rate, with 1 in 29,000 women dying during pregnancy and childbirth.
&;Among the ten top-ranked European and other industrialized countries, where women are guaranteed good-quality health and family planning services that minimize their lifetime risk, fewer than one in 16,400 will die from complications of pregnancy and childbirth,&; the United Nations, which issued the report along with the World Bank, said in a statement.
&;At the other end of the scale are ten countries where high fertility and shattered health care systems raise women's lifetime risk so that more than one in every 15 women will die of pregnancy-related causes,&; it said.
The report, published in the Lancet medical journal, places the United States 41st among 171 countries.
The four lowest-ranked countries in the report are Chad, with 1 in 11 women dying in pregnancy or childbirth, Afghanistan and Sierra Leone with one in eight, and Niger losing one in seven mothers.
&;Americans tend to be complacent about pregnancy and childbirth. Most believe it is now more or less routine and no longer the deadly risk it was for their grandmothers. This is true for most U.S. women, but by no means for all,&; the U.N.-led group said in a statement.
The group includes U.N. agencies such as the World Health Organization and UNICEF, the World Bank and Family Care International.
According to the U.S. National center for Health Statistics, about 6 million U.S. women get pregnant every year. Four million children are born, about 1 million pregnancies end in miscarriages and another 1 million in induced abortion.
The major direct causes of U.S. pregnancy-related deaths are blood clots, hemorrhage, complications of medical conditions, and eclampsia and pre-eclampsia, which are marked by dangerously high blood pressure.
The death rate among U.S. black women was nearly four times the rate found among non-Hispanic white women -- 34.7 deaths per 100,000 live births for blacks versus 9.3 per 100,000 live births for whites, the report said.
Genes found that slow both aging and cancer
Sun, 14 Oct 2007 20:48:45 GMTBy Maggie Fox, Health and Science Editor
WASHINGTON - Researchers have identified a batch of genes that not only prevent cancer but slow the aging process in worms, and say they are now looking to see if the genes have the same properties in humans.
Many of the genes in the worms are already known to have counterparts in humans, and the team at the University of California, San Francisco, say they hope to better understand some of the processes that cause both aging and cancer.
Drugs that mimic the effects of these genes might help people both avoid cancer and also live longer, they wrote in Sunday's issue of the journal Nature Genetics.
Biologist Cynthia Kenyon is perhaps best known for discovering that a change in just one gene, called daf-2, could double the life span of small roundworms called Caenorhabditis elegans.
She and graduate student Julie Pinkston-Gosse screened as many genes as they could that were affected by daf-2. They looked at 734 in total, and found that 29 of them either stimulated tumor growth or suppressed it.
Some caused cell proliferation -- which goes haywire to help a tumor grow and spread -- while others initiated a programmed suicide process called apoptosis, used by the body to destroy faulty cells, including tumor cells.
&;About half of these genes also affected normal aging, thereby linking these two processes mechanistically,&; the two researchers wrote.
&;There is a widely held view that any mechanism that slows aging would probably stimulate tumor growth,&; Kenyon said in a statement.
&;But we found many genes that increase life span, but slow tumor growth. Humans have versions of many of these genes, so this work may lead to treatments that keep us youthful and cancer-free much longer than normal.&;
The genes that stimulated tumor growth also accelerated aging, Kenyon found. The genes that prevented tumor growth slowed down the aging process and extended life span in the worms.
Kenyon said the findings strengthen theories that the controls of life span and cancer have deep, common roots.
Small creatures that researchers work on, such as the C. elegans roundworm, often share genes with humans, and these genes often underlie key biological processes.
