Gardasil

UWI to expand Clinical Trials CentreSaturday, May 31, 2008

THE University of the West Indies (UWI) is getting ready to expand its Clinical Trials Centre as it prepares to embark on its 10th clinical trial since it started operations two years ago."We are attempting now to expand it (the centre) to increase the number of persons employed because the faculty two years ago decided that in order to enhance our research, gain international visibility and

also as a means of raising funds we should be doing more clinical trials,


" Professor Archibald McDonald, dean of the Faculty of Medical Sciences, told the Observer this week."There are two full-time research scientists with some administrative support and we are about to employ additional researchers and an administrator," he added.Professor McDonald, who spoke with the Observer this week after the 19th annual Nursing Midwifery Research Conference at the University of the West Indies, Mona, said the latest trial will involve a renal failure drug. He said an application for the approval of the trial will be made to the university's ethics committee next month.".There is quite a lot of work in preparing for a trial and conducting a trial and the pharmaceutical companies are very demanding and you absolutely must do everything right in the set time lines and so on," Professor McDonald said.The centre has already successfully completed five trials, including the rota virus vaccine, RotaTeq, created by Merck & Company Incorporated. The trial, which was led by Professor Christie Samuels, was selected as the best piece of medical research that was published in the year 2006 by the New England Journal of Medicine.

The centre also conducted clinical trials for sickle cell and schizophrenia drugs and collaborated with the Ministry of Health's HIV Vaccine Trial Unit (HVTU) in conducting HIV vaccine trials here.


Four other trials are currently taking place.Dr McDonald said pharmaceutical companies normally approach the university to do clinical trials because of its "excellent reputation" in research, in addition to the variety of ethnicities found here."

The difficulties they have in the developed world is to find a suitable population of what they refer to as minorities to conduct the trials because sometimes drugs work differently in Caucasians than it does in black people, than it does in people from Asia and so forth," he said. "Therefore because of our mix of ethnicities within our population we are sort of an ideal.

once they know you have the expertise to do the trial you will get trials."



Gardasil vaccine doubts grow
The safety and effectiveness of the HPV vaccine Gardasil as a preventive cervical cancer treatment for girls are questioned in a report.
By Linda Marsa Special to The Times
August 11, 2008
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Sandra Levy wants to do everything she can to safeguard the health of her 11-year-old daughter -- and that, of course, includes cancer prevention. She has had her child inoculated with one shot of Gardasil, the human papilloma virus vaccine that may prevent cervical cancer. But now, she says, she has serious reservations about going ahead with the next two injections of the course."It's very confusing, and we really don't know if it's 100% safe," says Levy, of Long Beach. "I'm not against vaccines, but I don't want to do anything that would harm my daughter."Though most medical organizations strongly advocate using the HPV vaccine, some doctors and parents, like Levy, are asking whether the vaccine's benefits really outweigh its costs. They say they aren't convinced that the expensive shots offer any more protection than preventive measures already available -- principally, regular screening via the Pap smear test.A handful worry that blanket immunizations of the nation's adolescents could backfire by lulling them into a false sense of security that leads them to neglect regular screening. If that happened, vaccination could eventually boost cervical cancer rates instead of lowering them.
In addition, because Gardasil protects only against the HPV strains linked most strongly to cervical cancer, "we don't know if it will make a difference in the ultimate rates of cancer," says Abby Lippman, an epidemiologist at McGill University in Montreal who has researched the HPV vaccine. "The jury is still out on how much benefit we're actually going to get with this vaccine."A report released in June stirred up more doubts. Although cause and effect were not proved, the report listed serious events -- such as seizures, spontaneous abortions and even deaths -- among teens, preteens and young women who had earlier had Gardasil shots.As a result, the decision -- to vaccinate or not? -- has become controversial. Sorting through the pros and cons can be daunting for many parents.Promoted on TVSince its approval in June 2006, Gardasil has been promoted via TV ads featuring girls jumping rope and chanting "One less, one less," a reference to the promise that they won't be another statistic. The vaccine has been hailed by physicians' groups as a breakthrough that could potentially eradicate cervical cancer in the U.S. within a generation.The American College of Obstetricians and Gynecologists recommended that girls get the required series of three doses (given over a six-month period) at age 9 or older; the American Academy of Pediatrics and the Centers for Disease Control and Prevention recommended the same, with a starting age of 11 or later. (Because HPV is normally spread by intimate contact, the vaccine is considered most effective when given before the beginning of sexual activity. It will not eradicate HPV if someone is already infected.)Since 2006, about 8 million females in the U.S. have received at least one shot of Gardasil, according to the vaccine's maker, Merck & Co. of Whitehouse Station, N.J., which based these estimates on data from government and private insurers. Of the 100 known strains of HPV, about 30 cause cancer or genital warts. Two -- HPV-16 and HPV-18 -- are responsible for 70% of cervical cancers. Pre-market studies showed that the vaccine is 90% to 100% effective in thwarting the transmission of these two strains and two others, which are linked to 90% of genital warts. The vaccine is expensive. It costs $360 for the series of three shots, and administrative fees can add $100 or more. Though insurance companies sometimes cover costs, the overall expense for vaccinating the nations' teenagers could run into billions, a bill that will affect taxpayers as the shots are given to recipients of government health programs and health insurance premiums rise. The price may not be worth it, says Dr. Karen Smith-McCune, an obstetrician and gynecologist at the UC San Francisco School of Medicine. Because it takes years for cervical cancer to develop, it is easily preventable as long as HPV infection is detected early. Though the cancer is common in developing countries and kills more than 280,000 women worldwide every year, it is much less of a health threat in the U.S., she says, where 11,000 women are diagnosed with the disease annually, and about 3,700 will die of it. The comparatively low U.S. incidence of cervical cancer is due to one of the public health system's triumphs: widespread use of Pap smears, which detect abnormal cervical cells so they can be removed before they turn into cancers. Adoption of the Pap test caused a reduction of cervical cancer rates by 74% between 1955 and 1992, according to the American Cancer Society. Rates continue to drop by 4% each year.Smith-McCune and other critics of Gardasil also note that up to 90% of HPV infections in adolescents clear up on their own -- meaning that cervical cancer will not develop even in most women infected with the most aggressive type of HPV. In other words, a woman's risk of developing cervical cancer is already extremely low, and the immune system normally makes short work of HPV without outside help.Even if women get the vaccine, they still need to continue annual Pap screenings because they could contract other cancer-causing HPV strains that the vaccine does not fight. "The crux of it is that we know how to prevent cervical cancer," Smith-McCune says. "One of the key questions is whether this huge outlay of money for the vaccine is a better strategy than reaching out to the women who aren't getting Pap tests and follow-ups."Studies inconclusiveIt is not yet proven that Gardasil actually prevents cervical cancer, which can take a decade to develop after HPV infection, because tests of the vaccine before the FDA greenlighted it didn't run long enough to prove that conclusively. "Even though it guards against two HPV strains, the other HPV types need to be taken into account," Smith-McCune says. "It will take a long time before we know the true efficacy of the vaccine." Even doctors who helped devise the vaccine point out that Pap screening may be more effective in cutting cervical cancer rates. "If we vaccinate every single 12-year-old, it should reduce by half the number of cervical cancers in the next 35 years," says Dr. Diane Harper, director of the Gynecologic Cancer Prevention Research Group at Dartmouth Medical School in Hanover, N.H., and a lead researcher in the development of the HPV vaccine. "With Pap screening, we've reduced it by nearly 75%

Then there is the issue of side effects. When the vaccine was tested in more than 11,000 females age 9 to 26 before its FDA approval, no serious ones emerged, though some subjects felt soreness at the injection site and, in rare instances, fainted after the shot. But an analysis released June 30 by the Washington, D.C.-based public interest group Judicial Watch raised some red flags. Judicial Watch obtained records from the FDA's Vaccine Adverse Event Reporting System (VAERS), a voluntary system used by doctors, patients and drug companies to report side effects with vaccines to the federal agency. The report revealed that since the vaccine's 2006 approval, when girls began getting it, nearly 9,000 had bad health events after receiving Gardasil. The incidents included 10 miscarriages, 78 severe outbreaks of genital warts and six cases of Guillain-Barré syndrome, an autoimmune disorder that can result in paralysis. There were also 18 reported deaths. Since the FDA's VAERS is known to catch perhaps 10% of adverse events at best, according to a 2004 report in the New England Journal of Medicine by the FDA, the actual numbers may be far higher. It is difficult to prove whether the vaccine was the culprit behind these side effects -- just because two events happen, it does not mean that one caused the other, says Dr. Laurie E. Markowitz, an epidemiologist at the CDC who has had her own daughter vaccinated. The deaths, and all the other serious events, could have happened in the absence of the vaccine, she says.
Markowitz remains convinced the vaccine is safe. "The CDC and the FDA checked out these reports very carefully," she says. "And we've done calculations for the number of cases reported and the number of cases that you'd find in the general population, and we have not found an increase." Given these caveats, should girls be getting the shots?Most major medical groups still think Gardasil should be part of routine immunizations for 11- and 12-year-old girls.Shots still strongly urgedThere is more than the matter of cancer prevention, says Dr. Joseph A. Bocchini, chief of pediatric infectious disease at Louisiana State University Health Sciences Center in Shreveport and chairman of the American Academy of Pediatrics committee on infectious diseases. The vaccine could spare hundreds of thousands of women from the psychological trauma and physical pain of a cycle of follow-up tests when they have an abnormal Pap test result and the treatments for pre-cancerous lesions that can cause infertility. "You can actually prevent these infections and the cervical abnormalities that require more invasive interventions," he says.Whether the shots should be mandatory -- a step that has been considered by Texas, Michigan and Virginia -- is another issue. "This decision should be up to parents, and mandates are silly," says Harper of Dartmouth. "While the vaccine will improve the health of American women, its real benefit is in the developing world. And no matter what, Pap screening shouldn't be neglected. That's still our best safety net."
http://www.sun-sentinel.com/features/health/la-he-gardasil11-2008aug11,0,6269685.story


*****Africans as Guinea Pigs: Nigeria vs Pfizer (Der Spiegel)"USING AFRICANS AS GUINEA PIGS" is a three-part report in the German magazine, Der Spiegel, about Pfizer's unethical drug experiment conducted in 1996 in Kano, Nigeria, during a major meningitis epidemic. The subjects were 200 very sick children who, it is alleged, were treated as Guinea Pigs: There are a total of four civil and criminal lawsuits filed against Pfizer: two each in Kano and Abuja.The Nigerian prosecutor exclaimed: "We are not numbers. We are human beings."The difficulty for plaintiffs' legal team has been to match names with the numbers on Pfizer’s patient documents and to give the names faces and real lives. The lawyer representing the Nigerian government, Babatunde Irukera, is a 39 year old Nigerian with dual citizenship, who is a partner in a Chicago law firm. When he moved to Chicago, Irukera says, he admired the US for its self-confidence, for its greatness. But the more he found out about the Trovan test, the smaller the country became in his eyes. "Pfizer treated the Nigerians in Kano as if the life of a black child was worth less than the life of a white child." "Why don't you do these kinds of tests on children from Manhattan?" he asked Pfizer officials. (but perhaps they do [Link] Ed.)The case first came to public attention by The Washington Post (2000). Documents cited in investigative press reports show the tests were conducted in violation of international ethical standards—the Nuremberg Code and the Declaration of Helsinki—and in violation of US federal regulations. There was no informed consent: children's lives were put at risk even though another antibiotic with proven efficacy was available in Kano from Doctors Without Borders. 11 children died while others suffered brain damage. [Link]Pfizer has maintained it conducted the trials for humanitarian reasons. However, as Der Spiegel reports, "When they arrived in Kano, the Americans revealed that they were not on a humanitarian aid mission, but had been sent to administer medical tests. Physicians selected 200 sick children to test Pfizer's new antibiotic, Trovan. They had to be at least three months old and younger than 18, and they could not be HIV-positive or malnourished." The central questions: Who should assume the risks and whose life should be put on the line to test new drugs and vaccines? How do you justify exposing impoverished people to the risks in the knowledge that they will not benefit even if the drugs prove safe and effective? These questions are conspicuously avoided by the American medical research community--all of who have financial stakes in the business of clinical trials--either as shareholders or grant recipients, or their wages are dependent on industry. Physicians, academic medical centers and their ethics committees (Institutional Review Boards). Thoug IRBs are entrusted with reviewing clinical trials prior to approval, their role is hardly independent. Ditto for bioethicists, industy's paid lap dogs. [Link] Worse still, is the compromised role of government agencies--such as, the National Institutes of Health, FDA, Environmental Protection Agency--all dependent on industry fees and grants. Internal documents reveal that these agencies accommodate whatever "ethics" a sponsor chooses to follow. For example, an internal FDA document (Jan 24, 2001) acknowledges that “conduct of a placebo-controlled Surfactant trial in premature infants with RSD [Respiratory Distress Syndrome] is considered unethical in the USA.” The document rationalizes such a trial on infants in South America: “Use of Placebo-Controls in Life-Threatening Diseases: Is the Developing World the Answer?” See: Moral Principles or Expediency? [Link] A recent US Inspector General report (Sept. 2007) confirmed that even when the FDA uncovers gross ethical violations in drug trials, the agency accepts the data from sponsors—thereby encouraging research misconduct that undermines the integrity of the scientific documentation and the justification for exposing human subjects to risks.The IG report found: “The F.D.A. disqualified investigators from conducting further clinical trials 26 times from 2000 to 2005 and disqualified their data just twice even though the agency found serious problems at trial sites 348 times in that period, the inspector general found.” [Link] Inasmuch the primary purpose of conducting clinical trials is to obtain data for gaining FDA approval for marketing FDA’s failure to disqualify unethically obtained data encourages violators to repeat their offenses--and increases the likelihood that unsafe, ineffective drugs / vaccines are brought to market.Pfizer exploited the 1996 meningitis epidemic in Nigeria as an opportunity to test Trovan in children with meningitis so as to provide data to the FDA demonstrating that its new drug was also safe for children. But as Dr. Idris Mohammed, a Nigerian professor of medicine, an eye witness who coordinated the relief work for the government at the time, noted that aside from meningitis, aid workers were fighting measles and cholera. It was, as he put it, less than ideal conditions for testing a new drug. But when business ethics are allowed to prevail, both moral and scientific standards of medical research are swept aside.Because meningitis patients often suffer from nausea, and there is a high risk that they will vomit up the drug before it has a chance to take effect, doctors treating the patients have very little time to prevent brain damage. Thus, only injections can allow them to be sure that the drug works quickly. Why then, did Pfizer give these Nigerian children Trovan orally?Pfizer's team appears to have broken a number of fundamental ethics rules. International guidelines for clinical studies--the Declaration of Helsinki--specify that risks to subjects be minimized and that the best current therapeutic methods be provided to ALL human subjects. Rocephin, a reliable antibiotic was available—yet, the children continued to be given Trovan even as they were dying.Patient 0069, a little girl, received 56 milligrams of Trovan on the first day of treatment. Although her condition rapidly deteriorated, the doctors maintained this dose. On the third day, the girl died. Der Spiegel reports: It takes three, four drops at the most to diagnose meningitis. But according to Dr. Mohammed, he observed that a Pfizer team doctor took more than 50 drops. Cerebrospinal fluid protects the brain from concussions; it works as a shock absorber. An adult has approximately 120 to 200 milliliters of the liquid; a child has significantly less. If too much is removed, there is a risk that the brain stem may be pushed into the opening of the spinal chord. This can damage vital centers in the brain stem, in the worst case leading to paralysis or death.Dr. Mohammed was afraid that the child's life was in danger. "How much brain fluid do you think a child like this has?" he asked "Plenty," said the Pfizer doctor. "How much is 'plenty,' in your opinion?" "More than a liter." An hour later the child died.Pfizer ignored Dr. Mohammed's calls to discontinue the testing. It wasn't until mid-April, after the 200th child had been treated, that the team packed their bags and flew home, says Mohammed. "The 'humanitarian gesture' ended right at the height of the epidemic."A former journalist searched two years before locating participants in the drug test. He finally hit pay dirt in the slums of Kano where the disease took its heavy toll. A crumpled pink card read "Pfizer Meningitis Study" in the upper left-hand corner of what was once a white label, and under that a number: "Pf 0001." Patient 0001.The pink card belongs to a child who was five years old at the time, male, weighing 25 pounds. Only his initials are printed on the card: "A. M." On April 3, 1996, A. M. was admitted to a clinic; three follow-up appointments are marked with a black felt-tip pen on the card. On May 14, the boy was due to come to the hospital one last time for a final examination. Irukera stares at the card. Patient 0001 must be 16 years old now. He would like to know, says Irukera, if the boy is suffering from long-term side effects.This case demonstrates the validity of the ethical principles laid down by the Nuremberg Code whose aim was / is to rein in biomedical researchers who, when given free rein are inclined to exploit the weak and cut ethical corners—for the illusive “greater good” claim, or simply to increase profits. The Nuremberg Code is the most important legal document in the history of medical research ethics, and the first of its kind to focus on the rights of human subjects. Formulated 60 years ago (1947) by American jurists who rendered judgment in the Nazi doctor trial during which the world learned about the nature and magnitude of the experimental atrocities conducted on concentration camp inmates. The judges at Nuremberg recognized the inadequacy of the physicians’ Hippocratic Oath—first, do no harm--to protect human research subjects.The judges at Nuremberg defined a set of 10 ethical principles centered on the research subject. The judges were uncompromising about the fundamental human right to informed consent by the human subject--explicitly adding the subject's right to withdraw. The Nuremberg Code recognizes that research lies outside the context of the physician-patient relationship requiring a physician to provide the best treatment for a particular patient. In research the physician-researcher is motivated by a scientific hypothesis. Implicit in the Nuremberg Code is the recognition— reaffirmed in a landmark decision by the Maryland Court of Appeals (2001)--that the medical research community cannot be entrusted as the sole arbiters of what ethical standards should be applied in the conduct of research. [Link] After 11 long years the Trovan case against Pfizer--for whom the stakes can reach $9 billion-- may finally be brought before a court of law.Babatunde Irukera is fighting for his old homeland and challenging his new one. Der Spiegel reports that he notes with a laugh: "Suddenly the Americans realize that they are dealing with blacks in Nigeria who are intelligent -- niggers with brains."DER SPIEGEL - Using Africans as Guinea Pigs* Part 1: Nigeria Takes On Pfizer over 'Killer Drug' [Link] * Part 2: Whose Life Should Be Put on the Line? [Link]Part 3: White Doctors Offering Help [Link]Before they test a drug on children, pharmaceutical companies have to acquire the parents' consent, even in the developing world. They have to explain to the parents that this is a drug in the test phase, and that its safety and effectiveness have not yet been established. The parents must be made aware that there are alternative medicines available that have already been tried and tested. And they have to know that they have the right to exit the study at any time. They heard on the radio about the white doctors offering help, says Zaharadeen's mother. What did the white doctors tell her? "Nothing," she says. "They wrote down Zaharadeen's name, and then they gave him a pill. Then we went home."Right from the beginning, Zaharadeen suffered from symptoms of paralysis. The muscles in his legs felt hot, he said. Even today, the pain is sometimes so intense that he has to lie on a mattress for weeks on end.Just one street down lives Safiya Sani Isa, whose son did not survive the test. Pfizer is the world's biggest pharmaceutical company with a market value of €200 billion. Did the doctors present themselves as Pfizer employees? "No," she says. "We thought they came to help our children. We didn't know that we had a choice between them and Doctors Without Borders."For a long time, Pfizer refused to comment on the allegations. In 2001, company employees assured a Nigerian committee of inquiry that the test "was totally devoid of any commercial undertone."Over the past few years, Pfizer has become a household name worldwide thanks to its potency drug Viagra. Boosted by the amazing success story of this and other products, within just three years the company's market value soared from €45 billion to over €200 billion. It was not the time to answer awkward questions. But now, with this trial about to open, Pfizer has changed its strategy. The Americans want to regain control of the situation. All contact with the company's headquarters in New York is organized by a woman who only goes by her first name: Sharon. She asks what the caller wants, who he has met in Nigeria, and who he is going to meet. Two days later, Dr. Jack Watters from the New York headquarters calls back. He is the Vice President for International External Medical Affairs, responsible for "corporate responsibility" and "human rights."Watters has a British accent and a pleasant voice. He promises that he will do his best to answer every question. Of course, says Watters, the parents gave their consent, but orally. He says that an authorized nurse then signed the release form in their name. And the side effects? The risks for bones, joints and liver, especially for children?None of this was known at the time, says Watters. "We didn't find out about the side effects until Trovan came out on the market, two years after the clinical test." Watters has been with Pfizer since 1994, so he should know better. He should be aware that the side effects of the drug group that Trovan belongs to were documented no later than 1992. What's more, the Pfizer employees wrote in their own test protocol in 1996 that there was a significantly higher rate of joint problems among the children who were treated with Trovan. Fifteen percent of the test patients complained of pain, noted the Pfizer researchers, three times the rate for the reference drug. And patient 0069? The girl who was subjected to further experiments, although her condition had worsened? What was her cause of death? Watters said that he was not familiar with the details of this particular case, sorry.Even following specific questions submitted to the company, Pfizer refused to comment on individual cases. Recently, Irukera met in London with lawyers from the opposing party. Afterwards, he had the feeling that they had little idea what the trial was about. "I asked them questions, and every answer that they gave to my questions made the next answer even more difficult for them," says Irukera. Now he is waiting at the airport in Abuja. It is late in the afternoon, and he has missed one flight and the next one has been postponed due to a storm over Lagos. But Irukera is totally calm, almost elated. Everything is going according to plan."Pfizer treated the Nigerians in Kano as if the life of a black child was worth less than the life of a white child," says Irukera. When he moved to Chicago, he admired the US for its self-confidence, for its greatness. But the more he found out about the Trovan test, the smaller the country became in his eyes. "Suddenly the Americans realize that they are dealing with blacks in Nigeria who are intelligent -- niggers with brains," he says, and laughs. "Why don't you do these kinds of tests on children from Manhattan?" he asked Pfizer officials.Surviving the 'Humanitarian Gesture' Pfizer denies all the allegations. The company says that it is totally unclear whether the children died because of the tests or the after-effects of the disease. It appears that the corporation would rather make an out-of-court settlement. It would probably amount to a legal sensation if a Nigerian court were to rule that an American company had to pay billions of dollars in compensation.Perhaps all of this is a question of power, not law, and no lawyer can change that, no document and no victim who happened to survive. Mohammed Mustapha's son Anas Mohammed lives in a mud hut in the heart of the Kano slums. He is 16 years old; the house has no electricity or running water. Anas shares this humble abode with his 12 brothers. Anas Mohammed is A. M., Pfizer's patient 0001.Eleven years ago, his father and mother carried him to the hospital. He was five years old and weighed only 25 pounds. Now father and son are sitting on a bench in the shade. There is not a cloud in the sky and it is scorching hot outside.Mohammed Mustapha, at the time did the doctors at the hospital explain anything to you? "No."Did anyone explain anything?"No."Did you have to sign anything?"No."Did you know that the doctors were not from Doctors Without Borders but from Pfizer, a pharmaceuticals company?"No," says Mohammed Mustapha, and gives an unsure smile.He pushes aside a straw curtain and rummages around in a box behind his bed. He is looking for the folder where he has kept Anas' medical documents all these years. Then he reappears with a white binder in his hand; he has saved every official document that he has ever received. He still has stiff knees, says Anas, his son. For a long time, he received treatment for the condition, and things have improved with time. He survived the "humanitarian gesture," but he will never be healthy again. When he walks relatively long distances, the pain immediately returns.Anas goes into his bedroom and after a few minutes returns with a pink plastic syringe in his hand. At the top of the syringe is a wheel, and when the plunger is pushed in, the wheel is supposed to spin and make sparks. The wheel broke a long time ago, but Anas has kept the toy; it is the only one he has. He says that the people from Pfizer gave it to him after the final examination, as a reward.See also: * Part 1: Nigeria Takes On Pfizer over 'Killer Drug' [Link] * Part 2: Whose Life Should Be Put on the Line?



http://www.jamaicaobserver.com/news/html/20070926T230000-0500_127782_OBS_AIDS_TRIAL_TURNS_DEADLY.asp AIDS trial turns deadly11 J'cans participated in failed experimentTANEISHA 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