Lab fined for testing with children

[Tonka]

http://www.correiodoestado.com.br/noticias/laboratorio-e-multado-por-testes-com-criancas_137388/
Portuguese-English translation

Lab fined for testing with children
FOLHA.COM 04/01/2012 7:00 a.m.

The Argentine court rejected the appeal of the U.S. laboratory and ordered GlaxoSmithKline to pay a fine of approximately $ 230 thousand for irregularities during testing of a vaccine in children from poor families, said on Tuesday a judicial authority.

The penalty also hits two doctors and is related to failures in clinical trials performed during the years 2007 to 2008 in the provinces of Santiago del Estero (north), Mendoza and San Juan (northeast), to monitor the development of a vaccine pneumonia and ear infections.

The laboratory and the two researchers "did not comply with basic legal requirements to carry out tests on nearly 14 000 children," according to research conducted by ANMAT (National Administration of Drugs, Food and Medical Technology).

The office launched a fine, which the U.S. company appealed, but was finally confirmed by Judge Marcelo Aguinsky, according to a spokesman for the Argentine courts.

The laboratory today expressed its disagreement with the sanction and anticipated it would appeal again as an official of the company.

In research carried out by way ANMAT detected flaws in the procedures for obtaining consent, which affected the rights of patients, it said in a report released today.

 

[Tonka]

Re: Lab fined for testing with children

http://www.gacetamercantil.com.ar/notas/11663/abogado-damnificados-glaxo-apunta-medicos.html
Spanish-English translation

Glaxo lawyer says victims against doctors

He charged that it charged for each vaccinated and that the company was engaged "in a commercial" to vaccinate children.


The lawyer for two families affected by the laboratory tests conducted by Glaxo, Bernardo Jos? Herrera, blamed today (Tuesday, 3) doctors, nurses and social workers who participated in experimental vaccine trials in infants by the death of 14 of them .

"Charged for vaccinating everyone who" denounced Herrera, Justice representative to the two families of Santiago del Estero, referring to professionals who have collaborated with the British laboratory in the application of vaccines.

"This company (Glaxo) was engaged in a trade to vaccinate children. It was a network that carried out this whole mechanism," the lawyer shot in front of television cameras.

"Deceives the parents and the kids had had to put them telling them that a vaccine, but were not told what it was that vaccine," remarked the lawyer.

In relation to the case of the Medina family, one of its customers, Herrera reported that the baby received medication at the time he suffered pneumonia, causing serious health complications.

To counsel, the number of cases of homeless families would be higher than currently known, as "there are cases of babies who died for the implementation of the vaccine and were not reported."

Glaxo, the world's third laboratory, was fined for committing irregularities to seek the consent of the parents of at least 14 babies died after being subjected to the test of an experimental vaccine

 

[Tonka]

Re: Lab fined for testing with children

http://www.infobae.com/notas/625002...allecidos-esten-vinculados-con-la-vacuna.html
Spanish-English translation

The laboratory denied that the dead children are linked to the vaccine

So said Rosana Felice , medical director of Glaxo, in dialogue with Radio 10 . He anticipated that the extent of Judge Marcelo Aguinsky be appealed. also denied paying bribes to conduct clinical trials

Following allegations that point to the U.S. medical laboratory Glaxosmithkline for the deaths of 14 babies under the application of a vaccine in the context of clinical research, medical director of the company, Roxana Felice denied "absolutely" the possibility of bribes and irregularities related to the study.

"None of the 14 deaths were linked to the vaccine," he said on Radio 10 . He added: "There is no possibility of bribery, fraud or corruption associated with the conduct of this study or any study that Glaxo do not in Argentina or elsewhere in the world."

According to the doctor, "at no time are paid to people who participate in research. If paid, of course, an honorary doctor researcher," he said.

He also explained that the study, called Compas, was approved by the health authority in our country through a provision in 2007, after having exhausted all of the research protocol, and "was approved by the ethics committees of the provinces of Santiago del Estero, Mendoza and San Juan, "said Felice.

According to the representative of the laboratory, the research "is approved by the health authorities of Argentina and the world. In fact, other countries have included it in their vaccination schedule."

Rejecting the allegations of the families who lost their babies and complained of having been deceived, Felice said he was invited to participate under the rules of clinical research.

Finally, with respect to the fine of $ 400 thousand that applied the ANMAT for signature by the judge Marcelo Aguinsky by false permits parents to allow their children to test, the doctor said that the punishment "not applicable" because it was the same body control which "approved the protocol." Therefore, subsequently appealed to the measure.

Official statement on the position of the company GlaxoSmithKline for the resolution of the ANMAT and Justice:

"The COMPAS survey began in Argentina in June after all appropriate approvals (available ANMAT No. 3166, dated 07.06.2007) and the same was monitored regularly. The study was successfully completed June 30, 2011 and provided health benefits to the population and in the localities where it took place, because pneumococcal disease prevention and health checks were carried out in the study population.

Due to strict medical monitoring was carried out with patients in this study, since its inception in mid 2007, there has been an improvement in health conditions of children involved, resulting in a significant reduction in mortality rates compared with estimated rates in our country. Physicians, researchers, health authorities, and a committee of independent international experts have studied and analyzed each death and demonstrated that none of the deaths are related to the vaccine. The final diagnosis indicates that died of the common causes that indicate national statistics. According to the Pan American Health Organization (PAHO), the common causes are infections, congenital anomalies, perinatal conditions, sudden infant death syndrome and other causes such as accidents and malnutrition.

GlaxoSmithKline respect for justice, but wishes to express its disagreement with the fine imposed on the laboratory and investigators who participated in the trials, for this, GSK initiated the process for appeals.

It is important to note that at no time ANMAT questioned the safety of the vaccine or the study, which concluded in Argentina dated June 30, 2011, in the three provinces (Santiago del Estero, Mendoza and San Juan) . The study is in closing stage and was carried out according to the protocol established by respecting and complying with the standards of Good Clinical Practice.

The vaccine used in this study has been approved for marketing by regulatory agencies in over 85 countries, based on data from more than 40 clinical studies conducted in different countries, including studies in Europe (Denmark, Finland, France, Germany, Norway, Spain, etc..). The countries that have already approved this vaccine include: European Union, Canada, Australia, Argentina, Chile, Bolivia, Uruguay, Peru, Ecuador, Venezuela, Colombia, Brazil and Mexico, among others, and has been chosen as a vaccine Expanded Immunization Plan in Chile, Ecuador, Peru, Bogota (Colombia), Mexico (IMSS), Brazil (part of technology transfer agreement), Australia (Northern Territory), Finland, Bulgaria, Hong Kong, Taiwan (Taipei ), New Zealand, Holland and Sweden, to prevent pneumococcal disease in children. In 2010 this vaccine was awarded the prize for best technological innovation. "

 

[Tonka]

Re: Lab fined for testing with children

http://www.perfil.com/contenidos/2012/01/03/noticia_0024.html
Spanish-English translation

EXCLUSIVE PERFIL.COM
A father says his baby was killed by a Glaxo vaccine
Gabriel, 4 months, died after an injection. "They would not give me the body," he said.


By Ramon Indart (*) | 03.01.2012 | 17:27

When Alvaro Shepherd learned the fine imposed on laboratory GlaxoSmithKline could not help but unleash their anger. Is that in 2007 his son Gabriel, 4 months, was one of the 14 000 babies throughout Argentina who received a vaccine from the same laboratory which has now been sanctioned by the Justice for clinical trials with infants in three provinces. Soon after the Shepherd's son received the vaccine against pneumonia and otitis, has died. And no one explained the reasons. "My wife, Claude (Hoyos), took our son to a control and a health worker in the area made ​​him speak with a medical protocol. There he was offered the vaccine," he told Profile. com . Before vaccination your child had been hospitalized twice with pneumonia and bronchitis and had low defenses . "The doctor told us that the vaccine would improve and protect against disease. After he was given the vaccine made ​​him sign a contract and give him consent. Never was explained that, "he said. The baby Gabriel was a single dose of experimental vaccine in August 2007. He died on October 2. Suspicions were raised when family medical staff refused to give the body of her dead son. "We went to remove the body and did not want to deliver. After a while a doctor offered us money to fix. It was Henry Smith, "he said. The doctor Smith was one of the leading researchers of the laboratory in the province. He who gave the authorization was his brother Juan Carlos Smith when he was provincial health minister with the approval of Governor Gerardo Zamora. At the time one of the principal investigators of the study. "I am absolutely convinced he made ​​the right decision , although some research Taliban have wanted to bastardize the procedure, "said the former official at the newspaper review .

 

[Tonka]

Re: Lab fined for testing with children

http://www.perfil.com/contenidos/2012/01/05/noticia_0003.html
Spanish-English translation

LAXO IMPACT CASE
Complaint asserts that "it was found dead children" should not have been vaccinated"
According to the lawyer of the families in Santiago del Estero who lost their children, the boys set ANMAT should not have been inoculated.


05.01.2012 | 8:30


According to the resolution of ANMAT, children should not have been vaccinated. | Photo: Cedoc.
Extend

The children who died in the north of the country "should not have been vaccinated," the study of GlaxoSmithKline and so "found" ANMAT resolution, while the lab was a "lucrative collection system was unethical" and abused impoverished condition of these people, said the lawyer of two affected families.

The representative of the families in Santiago del Estero, Bernardo Jos? Herrera, said the research protocol, "says young children should not be vaccinated with immunosuppressive diseases because, with low defenses with such vaccines are enhanced disease. "

Herrera referred to the study conducted by the British drugmaker GlaxoSmithKline in Santiago del Estero, San Juan and Mendoza in children to test a vaccine against pneumococcus, fined by the Court as a result of irregularities in the selection of patients for clinical trials between 2007 and 2008.

The lawyer said that the lab "vitiated the consent of parents" of victims to have used deadly "extremely vulnerable sectors, excluding the health system, illiterate," the agency DyN . In this regard, said the company had a "lucrative collection system was unethical" and reiterated that "there were subsequent control or the pre-vaccine" .

"The resolution is very clear ANMAT, it was found that babies who died were babies should not have been vaccinated. They should have been excluded from the protocol (IP)," said Herrera told Radio Mitre.

The lawyer said that in the case of the baby of the family Medina, one of its representations, "to have fulfilled the protocol had not vaccinated ever, because he was hospitalized for pneumonia." Herrera insisted that "the laboratory vitiated the consent" of parents of children.

"They resorted to particularly vulnerable sectors, excluding the health system, illiterate. The collection system was unethical. The vehicle carrying babies and parents without vaccination sites was informal and telling an experimental vaccine that was within the official calendar "he said.

The representative of the affected families said that "it was so lucrative that a system did not control nor the subsequent pre-vaccine" and that "the laboratory wanted to get to 2,500 vaccinated, so they paid a per capita vaccinated."

The laboratory will rule on complaints which accounted for the deaths of 14 babies following the implementation of immunization.

"Physicians, researchers, health authorities, and a committee of independent international experts have studied and analyzed every death and demonstrated that none of the deaths are related to the vaccine," the laboratory said in a statement. The Health Ministry, meanwhile, said at the time that "none of the deaths mentioned in the news stories related to the administration of the vaccine given as part of the COMPASS study."

The health portfolio said, in that sense, that these patients had received placebo, "is a simile of the vaccine but without any active substance. The vaccine is safe."

The economic criminal judge Marcelo Aguinsky confirmed the sanction of 400 000 pesos against GlaxoSmithKline and 300 thousand dollars for each of the doctors H?ctor Miguel Tregnaghi Abate , rejecting an appeal from the laboratory to the penalty provided in 2009 by the National Drug, Food and Medical Technology.