AIDS Trial turns deadly. Scientific Legislation?

Anyone that doubted the validity of Xx theory, well here is an example of why this topic is so critical. The Book will go into details.

The connection:

Opinion Polling and more rigorous research such as pharmaceutical and sociological surveys are 'generally' designed with somewhat 'similar construct research models'. The patois interpretation (local language): "dem cut from de same nable tring/vine"

The people are at risk....here goes the story and without scientific legislation there will be more like the following, unfortunately.


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http://www.jamaicaobserver.com/news/html/20070926T230000-0500_127782_OBS_AIDS_TRIAL_TURNS_DEADLY.asp



"AIDS trial turns deadly11 J'cans participated in failed experiment
TANEISHA LEWIS, Observer staff reporter editorial@jamaicaobserver.comThursday, September 27, 2007
ELEVEN Jamaicans who took part in a worldwide AIDS experiment are to be informed that the trial has failed, raising the possibility that some of them could have contracted the deadly disease.
However, local investigators for the HIV vaccine trial have declined to confirm or deny if any of the Jamaican participants in the trial were among 45 participants who contracted the disease during the experiment.
"Essentially, the vaccine was not effective in protecting the persons when they were exposed to HIV through sexual intercourse," said Dr Jacqueline Duncan, co-investigator in the global programme of the HIV Vaccine Trials Network (HVTN).
Dr Duncan said that the local participants, whose names were not disclosed, along with the relevant authorities, were being notified of the failure.
"We will continue to follow persons in that trial, but it is just that we're not continuing any further vaccination... At the moment we are actually following nine persons... Two aren't being followed up for various reasons," said a sombre Duncan.
She added that the local HIV Vaccine Trials Unit would continue to monitor the participants until the trial, which began last year, came to an end in 2011.
Last week, New Jersey-based Merck & Company suspended worldwide enrolment and vaccination of volunteers in the study, which was partly funded by the United States National Institutes of Health.
According to the Associated Press, Merck's vaccine was the farthest along and was closely watched by experts in the field, anxious to find a cure for one of the world's cruellest killers. A total of 3,000 volunteers worldwide had the vaccine administered to them.
The Merck vaccine, known only as V520, was also being tested in a similar study in South Africa and in two smaller studies, which were also halted.
Officials at the company, based in Whitehouse Station, New Jersey, said 24 of 741 volunteers who got the vaccine in one segment of the experiment later became infected with HIV, the virus that causes AIDS. In a comparison group of volunteers who got dummy shots, 21 of 762 participants also became infected.
"It's very disappointing news," said Keith Gottesdiener, head of Merck's clinical infectious disease and vaccine research group. "A major effort to develop a vaccine for HIV really did not deliver on the promise."
In explaining the experiment, Dr Duncan said investigators sent data on participants daily to the global network and periodically. Additionally, she said a safety monitoring board reviewed all the data from all the participating countries - Australia, Brazil, Canada, the Dominican Republic, Haiti, Jamaica, Peru, Puerto Rico and the United States.
"Similarly when we looked at persons who became HIV infected through sexual exposure in both groups where they looked at the viral load (amount of virus in the blood), they found that there was no difference in terms of the viral load in the vaccine group and those in the placebo group," she said.Nevertheless, Dr Duncan sought to allay fears that the failure of this trial would doom efforts to find a viable vaccine.
"This is just one vaccine that the analysis showed that the vaccine wasn't effective. There are several vaccine trials occurring worldwide," she said. "It doesn't mean that all vaccines and all trials have stopped. That is one particular protocol."
Jamaica, she added, recently started testing another HIV vaccine with at least 24 volunteers which are among 480 worldwide. However, Dr Duncan was confident that recent developments would not discourage those participants.
"In terms of scaring off anybody I don't see why it would because this is a part of clinical trials and it is explained in the informed consent process that it is an experiment vaccine and we don't know if it will protect persons and that is why we emphasise when participants come in that they practise safe sex behaviours," she said. "This is because they don't know if they are receiving placebo and because if they do receive a vaccine you don't know if it will work."
The volunteers in the experiment were all free of HIV at the start. But they were at high risk for getting the virus: most were homosexual men or female sex workers. They were all repeatedly counselled about how to reduce their risk of HIV infections, including use of condoms, according to Merck.
Volunteers had to meet a long list of criteria in order to be accepted for the trial. The key requirements included an age limit of 18 to 45 years and in good health.
According to Dr Duncan, volunteers received three doses over three months after going through an informed consent process"

- Additional reporting by the Associated Press

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http://www.allheadlinenews.com/articles/7008596093
Merck Discontinues HIV Vaccine Trials After Experiment Fails
September 21, 2007 9:24 p.m. EST


Nidhi Sharma - AHN News Writer
Trenton, NJ (AHN) - Pharmaceutical giant Merck and Co. has suspended trials of a new AIDS vaccine after several volunteers who got the vaccine later became infected with HIV. The study, which was partly funded by the National Institutes of Health, did not render effective results and compelled Merck to end clinical trials. However, the company said it would continue working toward a vaccine.
The New Jersey-based company halted the trials after 24 of its 741 vaccinated volunteers became infected with HIV, the virus that causes AIDS. The results of volunteers who received the vaccine and those who received a placebo were similar.
Keith Gottesdiener, head of Merck's clinical infectious disease and vaccine research group said, "It's very disappointing news. A major effort to develop a vaccine for HIV really did not deliver on the promise."
It was the first major clinical trial by any such company of a new strategy to prevent HIV infection. The recent research hoped to find a way for the body produce more of a crucial immune cell, called killer T cells. With the help of the new vaccine, the researchers aim to simultaneously "train" those cells and make them capable of recognizing and destroying the AIDS virus when it enters cells in the bloodstream.
The experiment, called STEP, began in December 2004 and had enrolled 3,000 sex workers as volunteers in Australia, Brazil, Canada, the Dominican Republic, Haiti, Jamaica, Peru and the United States.
President of Merck Research Laboratories Dr. Peter S. Kim said, "We share in the disappointment of the research and HIV communities today. Sadly, developing an effective AIDS vaccine remains one of the most challenging tasks facing modern medicine."
"We are committed to studying the data closely and sharing it with the scientific community to inform the on-going search for an effective HIV vaccine," he added.