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Should we be concerned about 'our' (Jamaican) role as "research subjects"? My answer is an alarming, Yes! However, you must read/research and arrive at your own conclusion.
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Role Of Science In Knowledge Creation:A Philosophy Of Science Perspective
Reference citation for this document is given below:
Malhotra, Yogesh. (1994). Role Of Science In Knowledge Creation: A Philosophy Of Science Perspective [WWW document]. URL http://www.kmbook.com/science.htm
The Scientific Method
The word science has its origins in the Latin verb scire, meaning "to know." Although, one can "know" through tenacity, authority, faith, intuition, or science, the method of science [or the "scientific method"] is distinct in its notion of intersubjective certification. In other words, it should be possible for other investigators to ascertain the truth content of scientific explanation(s). "Scientific knowledge thus rests on the bedrock of empirical testability" (Hunt, 1991: p. 197). Empirical replication depends on a comparison of "objective" observations of different researchers studying the phenomenon.
Science And Objectivity
All observation is potentially contaminated, whether by our theories or our worldview or our past experiences, but we should deny the conclusion that science cannot, therefore, objectively choose from among rival theories on the basis of empirical testing. Obviously, if objectivity requires that the choice between rival theories be made with certainty (no possibility of error), then science is not objective. In science, all knowledge claims are tentative, subject to revision on the basis of new evidence. Although science cannot provide one with hundred percent certainty, yet it is the most, if not the only, objective mode of pursuing knowledge (Hunt, 1991: p, 200-201). This pursuit is dependent upon the imagination as well as critical and analytical skills of the scientist. It is generally believed that the goal of the pursuit is the discovery of truth.
Science And Truth
Two conceptions of science embody two different valuations of scientific life and of the purpose of scientific enquiry. According to the first conception, science is above all else an imaginative and exploratory activity, and the scientist is a person taking part in a great intellectual adventure. The alternative conception suggests that science is above all else a critical and analytical activity and the scientist is pre-eminently a person who requires evidence before he or she delivers an opinion, and when it comes to evidence is hard to please (Medawar, 1991: p. 30-31).
In the first conception, truth takes shape in the mind of the observer: it is his imaginative grasp of what might be true that provides the incentive for finding out, so far as he can, what is true. This viewpoint is supported by other scholars of science. For instance, Greenwald, et al. (1986) argue that: "One's preliminary hypotheses have a decided advantage in the judgement process."
According to the second conception, truth resides in nature and is to be got at only through the evidence of the senses: apprehension leads by a direct pathway to comprehension, and the scientist's task is essentially one of discernment (Medawar, 1991: p. 30-31).
Inasmuch as these two sets of opinions contradict each other flatly in every particular, it seems hardly possible that they should both be true; but anyone who has actually done or reflected deeply upon scientific research knows that there is in fact a great deal of truth in both of them. For a scientist must indeed be freely imaginative and yet skeptical, creative and yet a critic. What are usually thought of as two alternative and indeed competing accounts of the two successive and complementary episodes of thought that occur in every advance of scientific understanding. This general conception of science which reconciles the two sets of contradictory opinions is sometimes called the 'hypothetico-deductive' conception (Medawar, 1991: p. 32-33, p. 231; Popper, 1959).
Besides these two accounts of the purpose of scientific inquiry, there are two other [mutually competing] conceptions that provide direction to the process of scientific inquiry: consensual view of science and the dissension view of science.
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Now that being said lets look at one particular Company as a case of illustration.
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Merck
Research Philosophy
http://www.merck.com/mrl/clinical_trials/
… understanding the science eventually helps us develop better compounds to combat disease, which ultimately will prove good for the patient.
L. Mitnaul, Ph.D.Research Fellow,Cardiovascular Diseases
MRL prides itself on innovation in all areas of drug research and development with programs focused on satisfying unmet medical needs. Our dedication to basic research is a critical component of our mission and overall philosophy. However, providing breakthrough therapies depends on more than discovery. Our scientists also play key roles throughout the development process, from preclinical development and statistics to clinical research and regulatory affairs.
An important part of our strategy for leadership in science and technology is to attract the best, most varied talent available and then provide a work environment that helps them to achieve and encourages them to stay. MRL strives to recruit researchers who are leaders in their scientific and technical disciplines — people with the enthusiasm and drive to help provide medicines that save lives and improve the quality-of-life for our patients.
An unrelenting focus on breakthrough science has helped Merck researchers bring many important medicines to market. Research is the foundation of Merck's success and the heart of our company's overall strategy. Our research is conducted in a broad range of therapeutic categories.
Merck-sponsored Clinical Trials
Merck conducts clinical trials worldwide to evaluate the safety and effectiveness of our products. These trials are fundamental to the development of innovative medicines and vaccines that treat and prevent illness.
We focus our research on areas where there is the greatest need for significant medical advance. Merck’s pipeline, from preclinical development to phase III clinical trials, illustrates the breadth and depth of our research in areas such as cardiovascular disease, cancer, diabetes, obesity, and Alzheimer’s disease. Merck also devotes significant resources to the prevention of disease through vaccines. In addition, Merck continues to study many of our marketed products for new indications and further evaluate their safety.
Basic Biomedical Research
Merck's primary task is to discover, develop, manufacture and market innovative medicines and vaccines that treat and prevent illness in both humans and animals. In accomplishing this goal, Merck is committed to the highest standards of quality, ethics and integrity in all that we do.
Merck conducts clinical trials worldwide to evaluate the safety and effectiveness of our products. These trials are fundamental to the development of innovative medicines and vaccines that treat and prevent illness.
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Informed Consent
It is Merck policy that all investigational studies be carried out consistent with legal statues and regulations for the protection of patients, including protection of patient privacy. Merck requires that all patients involved in clinical trials or their legal representatives understand the procedures, use and disclosure of personal information, uses of biological samples and the risks and benefits involved in a study.
Merck also requires assurances that a person's participation in a study is voluntary. Consent must be obtained before any screening procedures begin; in addition, trial participants must be made aware of any significant new information that may affect their willingness to continue to participate in the trial.
While as many non-animal testing methods as possible are used in research, the development of new medicines is dependent on animal testing for safety and efficacy. Through the use of animals, Merck scientists, physicians and veterinarians are searching for, and discovering, treatments and cures for people who suffer from currently incurable diseases, such as Alzheimer's, cancer, stroke, diabetes and HIV/AIDS.
There is no alternative to this for the development of new, safe and effective medicines and vaccines. Animal research at Merck has also contributed to the development of vaccines and antibiotics; drugs to treat hypertension, high cholesterol, heart failure, osteoporosis, arthritis and pain, and glaucoma; as well as a variety of veterinary anti-parasitic drugs, to name but a few.
We recognize that in our business, ethics and transparency are of critical importance to patients, health care professionals, our employees and investors - and to our business success. We have strong policies and safeguards in place, and a long history of adherence to high ethical standards.
"You do not have a rigorous ethics culture just because you have a code of conduct. It starts with senior management championing ethical behavior and modeling it at every opportunity. It lives on with all Merck people embracing our ethics and applying them to their work, day-in and day-out."
— Jacqueline Brevard, Vice President,Chief Ethics and Compliance Officer
What are the Research 'Safeguards' in place to protect and minimize 'risk' to the poor Jamaican Research subjects? If you cannot answer definitively with specifics, then concerns should logically prevail.
"Vitamins may increase risk of death
Story Highlights
Taking vitamin supplements to prolong life may have the opposite effect
Researchers find no evidence that antioxidants are key to a long life
Health specialists say research is 'flawed' and pills are safe
LONDON, England (CNN) -- Taking antioxidants like vitamins A and E to prolong life may actually have the opposite effect, new research has found.
Taking vitamin supplements in large quanities may actually prove detrimental to your health.
A review of 67 studies involving more than 230,000 people found "no convincing evidence" that the vitamins prolonged life, the Press Association reported.
"Even more, beta-carotene, vitamin A, and vitamin E seem to increase mortality," according to the researchers.
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Researchers Tested AIDS Drugs on Children
By JOHN SOLOMON Associated Press Writer Posted May 4 2005, 3:27 PM EDT
WASHINGTON -- Government-funded researchers tested AIDS drugs on hundreds of foster children over the past two decades, often without providing them a basic protection afforded in federal law and required by some states, an Associated Press review has found. The research funded by the National Institutes of Health spanned the country. It was most widespread in the 1990s as foster care agencies sought treatments for their HIV-infected children that weren't yet available in the marketplace.
The practice ensured that foster children -- mostly poor or minority -- received care from world-class researchers at government expense, slowing their rate of death and extending their lives. But it also exposed a vulnerable population to the risks of medical research and drugs that were known to have serious side effects in adults and for which the safety for children was unknown. The research was conducted in at least seven states -- Illinois, Louisiana, Maryland, New York, North Carolina, Colorado and Texas -- and involved more than four dozen different studies. The foster children ranged from infants to late teens, according to interviews and government records. Several studies that enlisted foster children reported patients suffered side effects such as rashes, vomiting and sharp drops in infection-fighting blood cells as they tested antiretroviral drugs to suppress AIDS or other medicines to treat secondary infections. In one study, researchers reported a "disturbing" higher death rate among children who took higher doses of a drug. That study was unable to determine a safe and effective dosage. The government provided special protections for child wards in 1983. They required researchers and their oversight boards to appoint independent advocates for any foster child enrolled in a narrow class of studies that involved greater than minimal risk and lacked the promise of direct benefit. Some foster agencies required the protection regardless of risks and benefits. Advocates must be independent of the foster care and research agencies, have some understanding of medical issues and "act in the best interests of the child" for the entirety of the research, the law states. However, researchers and foster agencies told AP that foster children in AIDS drug trials often weren't given such advocates even though research institutions many times promised to do so to gain access to the children. Illinois officials believe none of their nearly 200 foster children in AIDS studies got independent monitors even though researchers signed a document guaranteeing "the appointment of an advocate for each individual ward participating in the respective medical research." New York City could find records showing 142 -- less than a third -- of the 465 foster children in AIDS drug trials got such monitors even though city policy required them. The city has asked an outside firm to investigate. Likewise, research facilities including Chicago's Children's Memorial Hospital and Johns Hopkins University in Baltimore said they concluded they didn't provide advocates for foster kids. Some states declined to participate in medical experiments. Tennessee said its foster care rules generally prohibit enlisting children in such trials. California requires a judge's order. And Wisconsin "has absolutely never allowed, nor would we even consider, any clinical experiments with the children in our foster care system," spokeswoman Stephanie Marquis said. Officials estimated that 5 percent to 10 percent of the 13,878 children enrolled in pediatric AIDS studies funded by NIH since the late 1980s were in foster care. More than two dozen Illinois foster children remain in studies today. Some foster children died during studies, but state or city agencies said they could find no records that any deaths were directly caused by experimental treatments. Researchers typically secured permission to enroll foster children through city or state agencies. And they frequently exempted themselves from appointing advocates by concluding the research carried minimal risk and the child would directly benefit because the drugs had already been tried in adults. "Our position is that advocates weren't needed," said Marilyn Castaldi, spokeswoman for Columbia Presbyterian Medical Center in New York. If they decline to appoint advocates under the federal law, researchers and their oversight boards must conclude that the experimental treatment affords the same or better risk-benefit possibilities than alternate treatments already in the marketplace. They also must abide by any additional protections required by state and local authorities. Many of the studies that enrolled foster children occurred after 1990 when the government approved using the drug AZT -- an effective AIDS treatment -- for children. Arthur Caplan, head of medical ethics at the University of Pennsylvania, said advocates should have been appointed for all foster children because researchers felt the pressure of a medical crisis and knew there was great uncertainty as to how children would react to AIDS medications that were often toxic for adults. "It is exactly that set of circumstances that made it absolutely mandatory to get those kids those advocates," Caplan said. "It is inexcusable that they wouldn't have an advocate for each one of those children. "When you have the most vulnerable subjects imaginable -- kids without parents -- you really do have to come in with someone independent, who doesn't have a dog in this fight," he said. Those who made the decisions say the research gave foster kids access to drugs they otherwise couldn't get. And they say they protected the children's interest by carefully explaining risks and benefits to state guardians, foster parents and the children themselves. "I understand the ethical dilemma surrounding the introduction of foster children into trials," said Dr. Mark Kline, a pediatric AIDS expert at Baylor College of Medicine. He enrolled some Texas foster kids in his studies, and doesn't recall appointing advocates for them. "To say as a group that foster children should be excluded from clinical trials would have meant excluding these children from the best available therapies at the time," he said. "From an ethical perspective, I never thought that was a stand I could take." Illinois officials directly credit the decision to enroll HIV-positive foster kids with bringing about a decline in deaths -- from 40 between 1989 and 1995 to only 19 since. NIH, the government health research agency that funded the studies, did not track researchers to determine if they appointed advocates. Instead, the decision was left to medical review boards made up of volunteers at each study site. A recent Institute of Medicine study concluded those Institutional Review Boards (IRBs) were often overwhelmed, dominated by scientists and not focused enough on patient protections. An ethicist who served 22 years on such boards said they lack the resources to ensure the safety of foster children. "Over the last half century, IRBs have basically broken under the strain of some of the structural changes in research," said Gregory E. Pence, a University of Alabama-Birmingham bioethicist. The U.S. Office for Human Research Protections, created to protect research participants after the infamous Tuskegee syphilis studies on black men, is investigating the use of foster children in AIDS research. The office declined to discuss the probe. NIH said it considers patient safety its top priority and awaits the outcome of the investigation. "If we find that patient protections need further strengthening, we will take action to do so," spokesman John Burklow said. AP's review found that if children were old enough -- usually between 5 and 10 -- they also were educated about the risks and asked to consent. Sometimes, foster parents or biological parents were consulted; other times not. "Our policy was to try and contact the (biological) parents because it was fairly common when we got done the foster kid would go back to the parents," said Dr. Ross McKinney, a pediatrics AIDS expert at Duke University. Research and foster agencies declined to make foster parents or children in the drug trials available for interviews, or to provide information about individual drug dosages, side effects or deaths, citing medical privacy laws. Other families who participated in the same drug trials told AP their children mostly benefited but parents needed to carefully monitor potential side effects. Foster children, they said, need the added protection of an independent advocate. "I don't believe a foster care parent can do it," said Vinnie DiPoalo, a New Jersey woman whose 10-year-old adopted son has participated in three AIDS drug trials. "There are informed consents that have to be signed. There are follow-up blood appointments. "I think that's the role the advocate should take, because a foster parent may only have this child for three months and then the child moves on and someone needs to be watching all the time," she said. Many studies that enlisted foster children involved early Phase I and Phase II research -- the riskiest -- to determine side effects and safe dosages so children could begin taking adult "cocktails," the powerful drug combinations that suppress AIDS but can cause bad reactions like rashes and organ damage. Some of those drugs were approved ultimately for children, such as stavudine and zidovudine. Other medicines were not. Illinois officials confirmed two or three foster children were approved to participate in a mid-1990s study of dapsone. Researchers hoped the drug would prevent a pneumonia that afflicts AIDS patients. Researchers reported some children had to be taken off the drug because of "serious toxicity," others developed rashes, and the rates of death and blood toxicity were significantly higher in children who took the medicine daily, rather than weekly. At least 10 children died from a variety of causes, including four from blood poisoning, and researchers said they were unable to determine a safe, useful dosage. They said the deaths didn't appear to be "directly attributable" to dapsone but nonetheless were "disturbing." "An unexpected finding in our study was that overall mortality while receiving the study drug was significantly higher in the daily dapsone group. This finding remains unexplained," the researchers concluded. Another study involving foster children in the 1990s treated children with different combinations of adult antiretroviral drugs. Among 52 children, there were 26 moderate to severe reactions -- nearly all in infants. The side effects included rash, fever and a major drop in infection-fighting white blood cells. New York City officials defend the decision to enlist foster children en masse, saying there was a crisis in the early 1990s and research provided the best treatment possibilities. Nonetheless, they are changing their policy so they no longer give blanket permission to enroll children in preapproved studies. "We learned some things from our experience," said Elizabeth Roberts, assistant commissioner for child and family health at the Administration for Children's Services. "It is a more individualized review we will be conducting." Researchers likewise defend their work, saying they often sat with foster families to explain the risks and benefits, and provided them literature and 24-hour phone numbers. "We talk about it. Then they come the next time. There is no rush," explained Dr. Ram Yogev, the chief pediatric AIDS researcher in Chicago whose patients include a large number of foster children. Kline, the Texas researcher, added: "I never wanted a parent or guardian to ever say 'yes' simply because they thought that it was what I wanted them to do. I wanted it to be the right choice for them. I think there is not any single right answer for any family." * __ Researcher Rachel Landau in Washington and reporter Carla K. Johnson in Chicago contributed to this story. On the Net: Documents associated with this story are available at: http://wid.ap.org/inv/foster.html National Institutes of Health: http://www.nih.gov/
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Journal blasts Merck for 'ghostwriting' medical research on drugs
By LINDSEY TANNER The Associated Press
April 16, 2008
CHICAGO - Two new reports involving the painkiller Vioxx raise fresh concerns about how drug companies influence the interpretation and publication of medical research.The reports claim Merck & Co. frequently paid academic scientists to take credit for research articles prepared by company-hired medical writers, a practice called ghostwriting.They also contend Merck tried to minimize deaths in two studies that showed that the now-withdrawn Vioxx didn't work at treating or preventing Alzheimer's disease.Merck called the reports in today's Journal of the American Medical Association false and misleading.
Five writers of the articles were paid consultants for people who sued Merck over Vioxx's heart and stroke risks; the sixth testified about Merck and Vioxx's heart risks before a Senate panel.Merck says those connections makes the reports themselves biased.While Merck is singled out, the practices are not uncommon, according to JAMA's editors.In an editorial, they urge strict reforms, including a ghostwriting crackdown and requiring all authors to spell out their specific roles.Dr. Catherine DeAngelis, JAMA's editor-in-chief, said those are already policies at JAMA but not at many other journals."The manipulation is disgusting. I just didn't realize the extent," she said.The practices outlined in JAMA can lead editors to publish biased research that can result in doctors giving patients improper and even harmful treatment, she said.DeAngelis said doctors, medical researchers and journal editors bear some responsibility for those harms."We're the ones who have allowed this to happen. Now we've got to make it stop," she said.The articles are based on reviews of company documents from court cases over Vioxx, which was pulled in 2004 because of its heart and stroke risks. Merck agreed to pay $4.85 billion last November to settle thousands of lawsuits.One JAMA report says internal company data showed in 2001 that Vioxx patients in two Alzheimer's studies had a higher death rate than patients on dummy pills.Merck didn't publicize that "in a timely fashion" and provided information to federal regulators that downplayed the deaths, the report said.But Jim Fitzpatrick, a Merck attorney, said "it's completely not true" that Merck tried to minimize those deaths.He said a Merck analysis found the excess deaths were not related to Vioxx.
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AIDS vaccine trials halted; drugs heightened HIV risk
Future of search for prevention may be in doubt
By David Brown The Washington Post
March 21, 2008
WASHINGTON - The two-decade search for an AIDS vaccine is in crisis after two field tests of the most promising contender not only did not protect people from the virus but may actually have put them at increased risk of becoming infected.The results of the trials, which enrolled volunteers on four continents, have spurred intense scientific inquiry and unprecedented soul-searching as researchers try to make sense of what happened and assess whether they should have seen it coming.Both field tests were halted last September, and seven other trials of similarly designed AIDS vaccines have been either stopped or put off indefinitely. Some may be modified and others canceled outright.
Numerous experts are questioning both the scientific premises and the overall strategy of the nearly $500 million in AIDS vaccine research financed annually by the U.S. government."This is on the same level of catastrophe as the Challenger disaster" that destroyed a NASA space shuttle, said Robert Gallo, co-discoverer of the human immunodeficiency virus (HIV), which causes AIDS, and head of the Institute for Human Virology in Baltimore.The recently closed studies, STEP and Phambili, used a vaccine made from a common respiratory virus called adenovirus type 5 that had been crippled and then loaded with fragments of HIV. Both studies were halted when it became clear the STEP study was futile and possibly harmful.The results of the Phambili vaccine trial, which was conducted in South Africa, were revealed last month and only worsened the gloom. Although the number of new HIV infections in that study was far smaller than in STEP — and too few from which to draw firm conclusions — those results, too, hinted at a trend toward harm among vaccine recipients.Many researchers are questioning the scientific premises on which all those studies were based, and wondering, along with AIDS activists, what effect this near-worst-case scenario might have on tests of future vaccines.The working hypothesis for what went wrong is that the vaccine somehow primed the immune system to be more susceptible to HIV infection: a scenario neither foreseen nor suggested by previous studies.The National Institutes of Health, which funded the STEP and Phambili trials, is convening a meeting next week to reassess its AIDS vaccine program. But some respected scientists have already reached a verdict."None of the products currently in the pipeline has any reasonable chance of being effective in field trials," Ronald Desrosiers, a molecular geneticist at Harvard University, declared last month at an AIDS conference in Boston. "We simply do not know at the present time how to design a vaccine that will be effective against HIV."He told a rapt audience that he has reluctantly concluded that the NIH has "lost its way in the vaccine arena" and that he believes it should redirect its AIDS vaccine funds to basic research and away from human trials.In this fiscal year, the NIH's budget for AIDS vaccine research is $497 million. The STEP and Phambili trials were each expected to cost about $32 million. Pharmaceutical giant Merck & Co. has spent an undisclosed amount developing the vaccine and helping to manage the studies."We can't afford to have any more trials like this," said Mark Harrington, head of the activist Treatment Action Group and a longtime observer of AIDS research. "We have to stop and reassess and recommit to basic science, or people will begin to lose faith."At the moment, only two things are certain.The first is that the vaccine, developed by Merck, could not have caused HIV infection because it contains only three proteins from HIV, not the entire virus. The second is there are no obvious villains."I do not think that what happened in this trial is an example of scientists blindly rushing into dangerous things," said John Moore, an AIDS virologist at Weill Cornell Medical College, who has criticized vaccine trials he considered futile. "In the general HIV-research community, I didn't know anyone who said this was going to happen."Both trials recruited people who were at high risk of HIV infection through sexual activity. The STEP subjects included many male homosexuals; the Phambili volunteers were male and female heterosexuals. Half the people in each trial were randomly assigned to get three shots of vaccine, and half to get three shots of a harmless liquid containing no adenovirus or HIV proteins.Each trial was to have 3,000 participants. STEP had finished enrolling subjects in North and South America, the Caribbean and Australia. Phambili (which means "moving forward" in the Xhosa language of South Africa) had signed up 801 by the time it was shut down
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Cervical cancer vaccine being tested on men
TANEISHA LEWIS, Observer staff reporter editorial@jamaicaobserver.comFriday, April 18, 2008
PHARMACEUTICAL company Merck Inc is currently testing its cervical cancer vaccine, Gardasil, on young men to determine if the drug is efficacious in protecting men from the human papillomavirus (HPV) and preventing HPV transmission from men to women.
"It is important to consider boys for vaccination because studies have strongly shown that men transmit human papillomavirus (HPV) to women and so targeting men make sense in order to decrease transmission to women ,but also because men suffer from HPV related disease," Dr Carlos Sattler, director of biologics clinical research at Merck told the Observer during his visit to the island last week to senstise local and regional doctors about the vaccine. "For example, genital warts, which produces HPV types six and 11 occur basically as frequently in men than they do in women overall and men also suffer from cancer related HPV although less common than women. They can have penile cancer they can have head and neck cancer."
Added he: "We feel strongly that there is a good place for the vaccination of men and that it would make sense vaccinating men not only for protection from the disease, but prevention of transition to women."
Dr Sattler said current data from studies in pre-adolescent and young adolescent boys between age nine and 15 have shown that Gardasil is highly immunogenic and safe in that age group.
"The reason it (Gardasil) was not approved in the US for males is because we only have results in children nine to 15. We know the vaccine causes a very strong immune response and it's safe but we don't know if the vaccine prevents disease and for that we have an ongoing study for 16 to 26 year-old men to see if the vaccine actually prevents infection and disease," he said.
At the same time, Dr Sattler said Merck is awaiting the results from the studies by the end of the year, which will be submitted to the FDA and other regulatory agencies for approval in this age group. If the vaccine is determined to be efficacious in this cohort, then Merck will be able to extend its target market to include men.
Currently, Gardasil is for girls and young women ages nine to 26. However, Dr Sattler said a recent study indicated that the vaccine was also effective in older women.
"There is a study called Future Three whose primary analysis is now available. It is an international study of about 3,800 women ages 24 to 45 and the results show that the vaccine is highly efficacious in this age group in the prevention of infection and disease caused by HPV 6, 11, 16, 18," he said.
Meanwhile, Dr Sattler told the Observer that the reason men were not included in the original studies was because studies of HPV epidemiology and men lag behind women. He said it has been widely recognised that HPV causes cervical cancer and cervical cancer is a tremendous burden globally so researchers concentrated on HPV infection and the detection of HPV infection in women.
"It took a lot of studying to see what was the best way to sample women to detect HPV and the field of HPV detection was way ahead of men," he said, adding that there has be a shift towards men in recent years. "Sampling men [and] knowing about the epidemiology of men in order to design clinical studies [provided a challenge]."
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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?
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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 experimentTANEISHA LEWIS, Observer staff reporter editorial@jamaicaobserver.comThursday, September 27, 2007ELEVEN 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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....and our ATTRACTIVENESS as a 'convenient medical trials testing lab' continues....with I am sure the usual clandestine lip service to the term 'Informed Consent'.
http://www.go-localjamaica.com/readarticle.php?ArticleID=10507
A study comparing Crestor and Lipitor- treatment for Atherosclerosis(Mar-05-2008)
AstraZeneca has announced the launch of a new clinical trial, Saturn, designed to assist physicians in the treatment of coronary artery disease.
The study will measure the impact of Crestor (rosuvastatin) 40mg and atorvastatin (Lipitor) 80mg on the progression of atherosclerosis or hardening of the arteries, in high risk patients.
Saturn will compare the effects of these two statins on the ability to decrease progression or induce regression of atherosclerosis, the main cause of cardiovascular disease, following two years of treatment in patients with coronary artery disease. Statins are a class of drugs used to lower cholesterol levels in people with or at risk of cardiovascular disease.
Elizabeth Bjork, Global Medical Director for Crestor said “This study… will provide physicians with important information to better understand how these two statins compare with treating patients with advanced atherosclerosis.”
“Two major studies in the Galaxy programme have already demonstrated the significant impact of Crestor 40mg on atherosclerosis across the disease spectrum".
The Astertoid study was the first to show regression of coronary atherosclerosis in patients with established disease, and the Meteor study showed that Crestor can also slow or delay the progression of carotid atherosclerosis in patients with early signs of the disease.
Crestor has now received regulatory approvals in more than 90 countries, and over 11 million patients have been prescribed worldwide.
Data from clinical trials and real world use shows that the safety profile for Crestor is in line with other marketed statins.
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http://www.douglassreport.com/reports/l_cholesterol_free_report.html?gclid=COmtiOOH9JICFQksswodcSIn5g
Lower Cholesterol Can Kill You!
Forget the myths about cholesterol and animal fat. And forget about trying to lower your cholesterol levels with prescription drugs. In fact, I'd say take most of that so-called health advice and TOSS IT OUT THE WINDOW.
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If you've been paying attention to the news lately, no doubt your faith in cholesterol drugs has taken a hit. Marck and Schering-Plough finally released the results of their study, which showed that the patients taking Vytorin (a combo of Zetia and the traditional statin drug simvastatin) had MORE plaque building at the end of the trial than they did at the beginning!
And as if that wasn't enough, a government study came out almost simultaneously showing that even though statins DO reduce your "bad" cholesterol, they DON'T reduce the number of deaths or of serious illnesses that would require hospitalization. In other words: They have no benefit at all.
When you try to lower your cholesterol levels-either by restricting your diet or taking cholesterol-lowering drugs (which, by the way, have been linked to sexual dysfunction and increased risk of cancer, among other things)-the results can be fatal.
In spite of the vision you may have of hamburger grease and egg yolks glugging through your bloodstream, settling into the walls of your narrow, delicate arteries-fact is, it doesn't work that way. Cholesterol won't clog your arteries unless it has something to attach to, like a ridge or a rip. Eggs and steak do NOT rip your arteries.
No, high cholesterol isn't the problem. There's a much greater "stealth" risk factor you should know about-the one that causes those rips in your artery walls. In this special report, you'll learn all about the REAL cause of heart disease-and best of all, you'll also learn how taking just three low-cost, zero-risk nutrients can effectively wipe out heart disease and help you lead a healthy life.
And if your doctor asks you where you heard such nonsense, tell him Dr. William Campbell Douglass said so.
And just who am I, you may be wondering.
I've long been one of America's most popular mythbusters. I make it my mission to reveal the surprisingly inexpensive and easy road to real health - to the chagrin of pharmaceutical companies and surgeons everywhere.
I've been called "the conscience of modern medicine," and the National Health Federation voted me "Doctor of the Year." But I've also been labeled a "maverick," and several less flattering names, too, by some of the biggest names in government and the health establishment-but hey, that's part of the territory. I've taken more than a few arrows in my time in order to get you the truth-without paying an arm and a leg for Band-aid "solutions" that will only make you sicker and promise to send you to an early grave.
Trust me-I know how confusing it can be to sift through all the baloney you're indundated with by greedy drug companies and ignorant doctors. That's why I'm happy to offer you this free report, The Great Cholesterol Myth Busted.
Simply enter your email address in the space above and click "Get my FREE Report" for instant access to The Great Cholesterol Myth Busted! When you do, you'll also receive-absolutely FREE-a subscription to my Daily Doses, an e-letter written by yours truly that I send out three times a week. The Daily Doses will keep you up to date on health-related news, breakthrough studies, bureaucratic snafus, and revolutionary new products for looking and feeling great.
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My beef is not about if statins work or any myth associated or even quackery in general, but rather research strategies that gets 'us' caught up in its nexus of clinical trial.
Lobby your Politicians to enact meaningful scientific legislation that will protect the Jamaican people, not necessarily from companies that possess inherent 'conflicts' between ethical principles, operational scientific procedures and profit. But rather, the natuural flaws inherent is medical research and the asymmetry (clinical trials are for 'testing' a product-unknowns are a constant) of information when it involves poor people with limited knowledge in these areas who maybe faced with an immediate need to make a few dollars or simply following a trusted Doctor's advice who may themselves possess limited knowledge.
What does the term 'Informed Consent' mean to you?
Is it; Dem sey it good fe mi an may help sou mi jus tek eh an pray? Or does it mean, explaining the nuances and intricacies of scientific observation research model/strategies, the 'common people' nexus, 'risks' and clinical trials?
UWI to expand Clinical Trials Centre
Saturday, 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."
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The following could occur if you choose to be involved in clinincal trials with or without 'informed consent' or consume medication that is 'essentially' being authenticated by the Pharmaceutical companies themselves as they are primarily responsible for 'scientific testing' otherwise called trials.
Arthritis drugs investigated for link to cancer
By MATTHEW PERRONE The Associated Press
June 5, 2008
WASHINGTON - Federal regulators are investigating whether a group of best-selling arthritis drugs made by Abbott Laboratories, Schering-Plough Corp. and other companies heighten the risk of cancer in youngsters.The Food and Drug Administration said Wednesday it has received 30 reports of children and young adults developing cancer while taking the drugs over the past 10 years. About half the cases were lymphomas, a type of immune-system cancer. Others reported were leukemia, melanoma and cancers of various organs.The drugs under review include Abbott Labs' Humira, Schering-Plough's Remicade, and Enbrel, which is marketed by Amgen Inc. and Wyeth. They are prescribed to children with arthritis to block a chemical that causes inflammation. The drugs also are used to treat children with the intestinal disorder Crohn's disease.The safety of Humira was reviewed in February when the FDA first cleared it for use in juvenile arthritis, Abbott said in a statement. The company has not recorded any instances of lymphoma in children.
Representatives from the other companies did not immediately return calls for comment.The FDA said the drugs' labeling already warns of a potential association with cancer, but the agency's investigation will focus on risks to younger patients.
