GSK fined after over vaccine trials 14 babies reported dead

“Laboratories can’t experiment in Europe or the United States, so they come to do it in third-world countries.”

GlaxoSmithKline Argentina Laboratories Company was fined 400,000 pesos by Judge Marcelo Aguinsky following a report issued by the National Administration of Medicine, Food and Technology (ANMAT in Spanish) for irregularities during lab vaccine trials conducted between 2007 and 2008 that allegedly killed 14 babies.
Likewise, two doctors -Héctor Abate, and Miguel Tregnaghi- were fined with 300,000 pesos each for irregularities during the studies.
The charges included experimenting with human beings as well falsifying parental authorizations so babies could participate in vaccine-trials conducted by the laboratory from 2007 to 2008.
Since 2007, 15,000 children under the age of one from Mendoza, San Juan and Santiago del Estero have been included in the research protocol, a statement of what the study is trying to achieve. Babies were recruited from poor families that attended to public hospitals.
A total of seven babies died in Santiago del Estero; five in Mendoza; and twoo in San Juan.
Pediatrician Ana Marchese, who reported the case through the Argentine Federation of Health Professionals (FESPROSA in Spanish), and was working at the Eva Perón children’s public hospital in Santiago del Estero when the studies wee being conducted, said this morning in conversations with Continental AM radio that “GSK Argentina set an protocol at the hospital, and recruited several doctors working there.”
“These doctors took advantage of many illiterate parents whom take their children for treatment by pressuring and forcing them into signing these 28-page consent forms and getting them involved in the trials.”
“Laboratories can’t experiment in Europe or the United States, so they come to do it in third-world countries.”
Colombian and Panama were also chosen by GSK as staging grounds for trials of the vaccine against the pneumococcal bacteria.
Likewise, Marchese, explained the modus operandi: “Once a picked patient arrived, it would automatically disappear to be taken somewhere else in order to be treated by those doctors specially recruited by GSK. These kind of practices are not legal and occurred without any type of state control, plus they don’t comply with minimum ethical requirements.”
Marchese also remembered that “laboratory trials on human beings are not legalized in Argentina.”
Furthermore, the pediatrician explained that “it is also known that in various particular cases, the doctors who had conducted the trials did not answer the calls made by the worried parents after witnessing their babies’ reactions to the vaccines.”
According to Marchese, “there already exist very good vaccines for the same diseases, but we all know how laboratories work, they only care for their own business.”
To end, Doctor Marchese aimed to Santiago del Estero Governor, Gerardo Zamora, who “never ever came out to stage to comment on the case, and same happened with national deputies and senators that didn’t even bother into discussing a hot topic that was echoed worldwide. I’m also ashamed of the scientific community that also kept its mouth shut.”
Julieta Ovejero, great aunt of one of the six babies who died in Santiago del Estero, said that “A lot of people wanted to leave the protocol but they weren’t allowed; they forced them to continue under the threat that if they leave they won’t receive any other vaccine.”
During 2008, the vaccine trial was still ongoing despite the reports issued by FESPROSA, and those in charge of the study told reporters that the procedures were being carried out in a lawful manner.
On the contrary, the ruling states that the laboratory as well the involved doctors broke all legal requirements for conducting clinical tests on babies.
Surprisingly, during same year pediatrician Enrique Smith, one of the lead investigators told reporters: “Only 12 have died throughout the country, which is a very low figure if we compare it with the deaths produced by respiratory illnesses caused by the pneumococcal bacteria.”
In Santiago del Estero, one of the country’s poorest provinces, the trials were authorized when Enrique’s brother, Juan Carlos Smith, was provincial health minister.
According to Fesprosa, “the laboratory paid $8,000 pesos for each child included in the study, but none (of that money) remained in the province that lends the public facilities and the health personnel for the private research.”

From: ping.fm/G0A13$1m

4D ultrasound provides insights in delivery

Published 03 January 2012 | Article by Ultrasound in Obstetrics and Gynecology 2011

During vaginal delivery, injury to the puborectal fascicle of the levator ani muscle may occur. This condition may be an etiological factor for pelvic floor pathologies such as uterine prolapse, cystocele and rectocele. During delivery, distension of the levator ani, by about 25–245%, allows the…

Abstract

Objective To determine the frequency of avulsion of the levator ani muscle in primiparous women according to delivery mode, using introital four-dimensional ultrasonography.

Methods We performed a prospective observational study at a tertiary obstetric unit. One hundred and eighty primiparous women were included and divided into three groups: normal vaginal delivery without episiotomy, forceps delivery and Cesarean section groups. Between 40 and 120 days after delivery, four-dimensional ultrasonography was performed in order to evaluate the integrity of the levator ani muscle. The operator was blinded to all clinical data and was not aware of delivery mode. The influence of other variables associated with delivery such as birth weight, body mass index, maternal age and use of epidural anesthesia was also studied.
Results Avulsion of the puborectalis component of the levator ani muscle was detected on ultrasonography in 61.7% of women who had undergone a forceps delivery, compared with 13.3% of those who had had a normal vaginal delivery and 0% of those who had had a Cesarean section. Bilateral avulsion was observed in 12/60 (20.0%) of the forceps group and in 2/60 (3.3%) of the normal vaginal delivery group (P < 0.001). Other variables did not seem to influence prevalence.
Conclusions Forceps delivery is associated with an increased rate of avulsion of the puborectalis component of the levator ani muscle. The effect of forceps use is independent of other delivery-related variables.

From: Ping.fm

Southwest Airlines drops 15 Cities

Image by Getty Images via @daylife

DALLAS — Southwest Airlines Co. said Friday that it would keep flying to 22 cities served by AirTran Airways but end flights to six others — raising the final cut list to 15 AirTran locations — as it combines the two airlines.

The dropped cities are smaller than typical Southwest markets and include Allentown, Pa., and Sarasota, Fla. Southwest said it couldn’t afford to serve such markets with today’s high jet fuel prices.

The decision ended months of suspense after Southwest bought AirTran in May. AirTran served 69 cities, including many also served by Southwest.

Besides the overlapping cities, the 22 non-Southwest destinations that the company will keep include airports in Mexico, the Caribbean and the Midwest and eastern half of the United States. Among them: Charlotte, N.C.; Memphis, Tenn., and Richmond, Va.

Outside the U.S., the airline will serve Cancun, Mexico; San Juan, Puerto Rico; Punta Cana, Dominican Republic; Montego Bay, Jamaica; Aruba; Bermuda; and Nassau, Bahamas. It will also keep Mexico City, where AirTran plans to begin flying in May, and San Jose del Cabo, Mexico, where AirTran has set a June launch.

From: http://ping.fm/Xa9IW

Sport Cycling Mathematics Matematicas Deportivas

ENGLISH: This type of mathematics is the kind I like.
SPANISH: Este es el tipo de matemáticas que me gusta!

Eng

Advances in Immunology and AIDS Research

Just over a month ago, the medical world marked the 20th anniversary of the report that first identified the strange and apparently fatal disease that we now know as AIDS (for acquired immunodeficiency syndrome). During the 1980s the worldwide scientific and medical community struggled to understand the nature of the disease, to track down the human immunodeficiency virus (HIV) responsible for it, and to develop rudimentary treatments — an effort that continued throughout the 1990s.

In the meantime, AIDS has continued to destroy lives. The Joint United Nations Programme on HIV/AIDS (UNAIDS) estimates that 36.1 million individuals around the world were living with HIV infections or full-blown AIDS at the end of last year.
In 2000 alone HIV/AIDS caused the deaths of approximately 3 million individuals, making a cumulative death toll of 21.8 million by year’s end. UNAIDS’ figures also indicate that roughly one in every 100 adults between the ages of 15 and 49 is now infected with HIV. More than 80 percent of all adult HIV infections have resulted from heterosexual intercourse.

Throughout the past decade the scientific and medical communities have sought better understanding of the HIV virus in hopes of developing more effective therapies, possibly including vaccines for individuals not exposed to the virus and for AIDS patients. Policy makers realize that they have a long road to travel before they begin to think about having this disease in check. “You not only have the effect of the virus infecting the cell,” says Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID). “The HIV envelope itself is an extraordinary entity in its ability to have an aberrant effect on the immune system. In addition to being a disease of immune deficiency, it is a disease of aberrant immune system activations. These effects are really quite profound. Unfortunately for the human species HIV/AIDS is proving to be an extraordinary experiment of nature with regard to its effects on the immune system.”

Marie Chow, professor of microbiology and immunology at the University of Arkansas, expands that thought. “Certainly other viruses have had some effects on immune systems before, but we never saw anything as devastating as the HIV,” she explains. That devastation is amplified by HIV’s ability to destroy the immune system. “The virus has been very difficult to pin down. HIV is making a precision surgical hit, knocking out the cells that direct and regulate the immune response,” Chow continues. “AIDS victims succumb to diseases caused by other fungal, parasitic, bacterial, and viral infections owing to the loss of T cell function from the underlying HIV infection. On the one hand we’re still learning so much about the immune system and how it works. But at the same time we can’t defer research on HIV therapeutics and vaccine development until we understand how to help the immune system combat infections. It is really guerilla warfare at several levels, developing treatments and therapies for the variety of different infections seen in AIDS patients that are symptoms of the HIV infection itself.”

Multidisciplinary approaches, involving collaborations between basic researchers and clinicians and among research scientists with different skills, have become mandatory for that effort and for treating the conditions that the virus causes. “HIV has forced us to deal with this disease on multiple fronts with individuals who have different backgrounds,” says Chow.

From: http://ping.fm/P9PkF

Salvation Army starts cutting budget when kettle drive falls short

CHAMPAIGN — The Salvation Army of Champaign County has started making some budget cuts, after falling just over $46,000 short of its holiday fund drive.

After word was out last week that the organization was $59,000 short of its fund-raising goal with just days remaining before the close of the campaign, last-minute donations brought in another $12,800, Envoy Mike Fuqua said.
But ultimately, donations fell short of the $430,000 goal the Salvation Army hoped to bring in from its red kettle collections at stores and appeals through the mail during the 2011 holiday season.
Now, Fuqua is tweaking the budget to accommodate the lower donor funding.

He says no layoffs are planned among the organization’s 13 full- and part-time employees — though there will be some minimal reductions in hours.

He also said he plans to delay maintenance and equipment expenses, and will try to squeeze more money — hopefully about $20,000 — out of the Salvation Army’s two thrift stores at 2212 N. Market St. and 109 W. John St. in Champaign.

But he can’t do that alone. That will require more advertising, more donated items from the public and more people willing to do their shopping at those stores, Fuqua said.

“We’ll also have to reduce our food budget, hopefully not by much,” he said.

Recipients of food from the Salvation Army include men staying in its Stepping Stone emergency shelter and needy families whose food budgets won’t quite stretch far enough, Fuqua said.

Donors who couldn’t afford to give dollars can help in other ways by donating unused, non-perishable canned and packaged food items. If it’s something you buy for your family, the Salvation Army could probably use it, Fuqua said.

“What is really helpful are canned stews that can sit on our food shelves,” he said.

From: http://ping.fm/DsmSC