After reading this advertisement on the Jamaican Gleaner Webpage I wonder how the clinical trial subjects turned out? Does anyone really knows or do they just die from 'Obeah' with an unknown Cause of Death?
CAVEAT EMPTOR BUYER BEWARE
http://www.invegasustenna.com/invegasustenna/index.html?utm_source=Google&utm_medium=web&utm_campaign=Numbers
IMPORTANT SAFETY INFORMATION FOR INVEGA® SUSTENNA®
INVEGA® SUSTENNA® (paliperidone palmitate) is used for the treatment of schizophrenia.
INVEGA® SUSTENNA® is not approved for the treatment of dementia-related psychosis in elderly patients. Elderly patients who were given oral antipsychotics like INVEGA® SUSTENNA® in clinical studies for psychosis caused by dementia (memory problems) had a higher risk of death.
Neuroleptic Malignant Syndrome (NMS) is a rare, but serious side effect that could be fatal and has been reported with INVEGA® SUSTENNA® and similar medicines. Call the doctor right away if you develop symptoms such as a high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness. Treatment should be stopped if you are being treated for NMS.
Tardive Dyskinesia (TD) is a rare, but serious and sometimes permanent side effect reported with INVEGA® SUSTENNA® and similar medicines. Call your doctor right away if you start to develop twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the total dose received. This condition can also develop after a short period of treatment at low doses but this is less common. There is no known treatment for TD but it may go away partially or completely if the medicine is stopped.
One risk of INVEGA® SUSTENNA® is that it may change your heart rhythm. This effect is potentially serious. You should talk to your doctor about any current or past heart problems. Because these problems could mean you're having a heart rhythm abnormality, contact your doctor IMMEDIATELY if you feel faint or feel a change in the way that your heart beats (palpitations).
High blood sugar and diabetes have been reported with INVEGA® SUSTENNA® and similar medicines. If you already have diabetes or have risk factors such as being overweight or a family history of diabetes, blood sugar testing should be done at the beginning and during the treatment. The complications of diabetes can be serious and even life-threatening. Call your doctor if you develop signs of high blood sugar or diabetes, such as being thirsty all the time, having to urinate or "pass urine" more often than usual, or feeling weak or hungry.
Weight gain has been observed with INVEGA® SUSTENNA® and other atypical antipsychotic medications. If you notice that you are gaining weight, please notify your doctor.
Some people may feel faint, dizzy, or may pass out when they stand up or sit up suddenly. Be careful not to get up too quickly. It may help if you get up slowly and sit on the edge of the bed or chair for a few minutes before you stand up. These symptoms may decrease or go away after your body becomes used to the medicine.
INVEGA® SUSTENNA® and similar medicines have been associated with decreases in the counts of white cells in circulating blood. If you have a history of low white blood cell counts or have unexplained fever or infection, then please contact your doctor right away.
INVEGA® SUSTENNA® and similar medicines can raise the blood levels of a hormone called prolactin and blood levels of prolactin remain high with continued use. This may result in some side effects including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection.
If you have a prolonged or painful erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.
Call your doctor right away if you start thinking about suicide or wanting to hurt yourself.
INVEGA® SUSTENNA® can make some people feel dizzy, sleepy, or less alert. Until you know how you are going to respond to INVEGA® SUSTENNA®, be careful driving a car, operating machines, or doing things that require you to be alert.
This medicine may make you more sensitive to heat. You may have trouble cooling off or be more likely to become dehydrated. Be careful when you exercise or spend time doing things that make you warm.
Some medications interact with INVEGA® SUSTENNA®. Please inform your healthcare professional of any medications or supplements that you are taking.
INVEGA® SUSTENNA® should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.
Inform your healthcare professional if you become pregnant or intend to become pregnant during therapy with INVEGA® SUSTENNA®.
Do not drink alcohol while you are taking INVEGA® SUSTENNA®.
In a study of people taking INVEGA® SUSTENNA®, common side effects in the treatment of schizophrenia were reactions at the injection site, sleepiness, dizziness, feeling of inner restlessness, and abnormal muscle movements, including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of the eyes.
This is not a complete list of all possible side effects. Ask your doctor or treatment team if you have any questions or want more information.
If you have any questions about INVEGA® SUSTENNA® or your therapy, talk with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088
Saturday, October 16, 2010
Drug Trial Guinea Pigs
July 11, 2010
Inside the Risky World of Drug-Trial 'Guinea Pigs
Human volunteers in university research may not realize the dangers they face, an anthropologist has found
Sarah Bones for The Chronicle
Roberto Abadie, an anthropologist who studies human volunteers in drug research, at Thomas Jefferson University Hospital, in Philadelphia, where some of his subjects volunteer.
By David Glenn
http://chronicle.com/article/Inside-the-Risky-World-of/66225/
New York
Frank Little (not his real name) is a 33-year-old political activist in Philadelphia. To help subsidize an itinerant life of rallies, food cooperatives, and independent publishing, Mr. Little volunteers a few times a year to participate in safety trials of new drugs. In exchange for two weeks of blood draws, boredom, and occasional side effects during these "Phase 1" trials, Mr. Little can pocket $3,000 or more.
"I try to mix it up," Mr. Little says. "I sometimes do MRI studies and other psychology experiments, which only pay a hundred dollars or so. But two or three times a year I'll do a Phase 1 trial, and there the payments are much higher." (Mr. Little insisted on a pseudonym because he worries about compromising his ability to volunteer for future trials.)
Since 1980, when Phase 1 drug tests on prisoners were banned in the United States, university medical schools and pharmaceutical companies have depended on volunteers like Mr. Little to test the safety of new drugs. Bioethicists have devoted thousands of pages to debates about the system. Some fear that high payments for volunteers are an "undue inducement" that might tempt them to take risks against their better judgment. Others say that people like Mr. Little are consenting adults who are reasonably capable of assessing danger.
Enlarge Image Getty Images
Getty Images
Most of those debates have been conducted in the abstract. But now an anthropologist has produced a study of several dozen medical volunteers, including Mr. Little. Roberto L. Abadie, a visiting scholar in the health-sciences program at the Graduate Center of the City University of New York, spent a year living in youth hostels and group houses in Philadelphia, trying to get a sense of why volunteers do what they do and how they understand their risks.
He offers his findings in The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects (Duke University Press, August). The book's primary purpose is to offer a detailed description of medical volunteering and its contexts, not to weigh in on the ethics of clinical trials. But after his year in the field, Mr. Abadie does have opinions about policy: Volunteers underestimate their long-term risks, he says, and universities should do more to protect them.
"Philosophers and bioethicists are very logical, and they can construct strong arguments," Mr. Abadie says. "But what they can't do is to go in there and do what I did—to do an in-depth ethnographic analysis, spending weeks and months with volunteers. Knowing who they are, what their neighborhoods look like, how they go through the trials, how they think and talk about the risks they're taking."
A Mix of Motives
Mr. Abadie spent time with anarchist activists who are attracted to guinea-pigging because of the flexibility it offers. Between 1996 and 2002, that milieu was documented in Guinea Pig Zero, a Philadelphia zine published by and for activist medical volunteers.
But Mr. Abadie's book also examines two other types of medical volunteer. First, he describes transient, economically struggling people who travel from place to place in search of lucrative trials. These volunteers are often less educated and more socially isolated than the anarchists.
Second, Mr. Abadie spent months at an HIV clinic where patients were participating in long-term trials to determine the effectiveness of new drug combinations. That environment is very different from the Phase 1 trials described elsewhere in the book. At the clinic, the HIV patients knew they had a personal stake in the development of new drugs, and the financial compensation they received was much smaller. Even though they were taking risks by participating in the drug studies, Mr. Abadie says, those volunteers seemed to reap psychological gains.
"They see the trials as an opportunity to empower themselves in their fight against the disease, a way to take control of their bodies and their lives," he writes.
Mr. Abadie is more ambivalent about the wisdom of participating in Phase 1 trials. Most of the volunteers he spent time with tend to say—naïvely, in his view—that the drugs will "wash out" of their systems within a week after the experiments. That may be true in most cases, but some drugs can accumulate in the liver. There may also be unknown risks associated with participating in many trials over a lifetime.
"Almost my entire time there, volunteers said to me, 'No, risk isn't a problem,'" Mr. Abadie says. "It wasn't until the end of the year that someone finally said, 'OK, we don't like to talk about it. Maybe it's a coping mechanism.'"
A New Angle on Risk
People who use drugs are familiar territory to Mr. Abadie. He was born and raised in Uruguay, and he spent several years there working with heroin users at an HIV clinic before moving to Canada to study anthropology. "Throughout my life, I had been studying drug users and how they understand risk," he says. "That's what I thought I would do as a medical anthropologist."
But when he entered the doctoral program at CUNY in 2001, Mr. Abadie became fascinated by the story of Ellen Roche, a staff member at the Johns Hopkins University who died while volunteering for a trial of a new asthma medication.
"When I first found this topic, I was so engaged with it that I couldn't sleep," he says.
Through an extended network of friends, Mr. Abadie made contact with Robert P. Helms, a self-taught historian and serial medical volunteer who was the editor of Guinea Pig Zero.
"When Roberto first came to Philadelphia, it was clear that he didn't know very much," Mr. Helms says. "But he's a quick learner. He hung around, and he asked the right questions."
Mr. Abadie would like to see Phase 1 volunteers be recognized legally as workers, bringing them under the umbrella of labor law. (Mr. Helms, an anarchist and a former labor organizer, is skeptical. "Roberto hasn't had the horrible experiences I've had with American labor law," he says.)
Mr. Abadie would also like to see the creation of a national registry of Phase 1-trial participants. A central database, he says, would prevent people from participating in too many trials, and might also help researchers identify long-term adverse effects associated with certain experiments.
Glen N. Gaulton, executive vice dean for research at the University of Pennsylvania School of Medicine, says he is open to such an idea, if it can be done efficiently and with enough privacy protections.
"Conceptually, it's absolutely the right thing to do," Mr. Gaulton says. "Especially in a city like Philadelphia, where there are so many medical centers. We ask subjects to disclose if they're participating in other trials—but if someone wants to lie, I won't necessarily know if they're simultaneously doing a trial across town."
But Mr. Gaulton disputes any suggestion that his university does a poor job of protecting research participants. After the death of Jesse Gelsinger, an 18-year-old patient who died during a gene-therapy experiment at Penn in 1999, the university created new systems for auditing clinical trials. "Our auditing office randomly visits trials to make sure that protocols are being followed," he says. "Any institution that doesn't do that is asking for trouble. The single biggest risk associated with clinical trials does not have to do with payments or volunteer recruitment, but with making sure that the experiment is actually being carried out in the way that the IRB was told it would be carried out."
Is that really the single biggest risk? Mr. Abadie is not so sure. "I think the biggest way to reduce risks is to look at financial conflicts of interest," he says. "When researchers have financial stakes in the outcome of a trial, that compromises safety, ethics, and the legitimacy of the entire thing."
Inside the Risky World of Drug-Trial 'Guinea Pigs
Human volunteers in university research may not realize the dangers they face, an anthropologist has found
Sarah Bones for The Chronicle
Roberto Abadie, an anthropologist who studies human volunteers in drug research, at Thomas Jefferson University Hospital, in Philadelphia, where some of his subjects volunteer.
By David Glenn
http://chronicle.com/article/Inside-the-Risky-World-of/66225/
New York
Frank Little (not his real name) is a 33-year-old political activist in Philadelphia. To help subsidize an itinerant life of rallies, food cooperatives, and independent publishing, Mr. Little volunteers a few times a year to participate in safety trials of new drugs. In exchange for two weeks of blood draws, boredom, and occasional side effects during these "Phase 1" trials, Mr. Little can pocket $3,000 or more.
"I try to mix it up," Mr. Little says. "I sometimes do MRI studies and other psychology experiments, which only pay a hundred dollars or so. But two or three times a year I'll do a Phase 1 trial, and there the payments are much higher." (Mr. Little insisted on a pseudonym because he worries about compromising his ability to volunteer for future trials.)
Since 1980, when Phase 1 drug tests on prisoners were banned in the United States, university medical schools and pharmaceutical companies have depended on volunteers like Mr. Little to test the safety of new drugs. Bioethicists have devoted thousands of pages to debates about the system. Some fear that high payments for volunteers are an "undue inducement" that might tempt them to take risks against their better judgment. Others say that people like Mr. Little are consenting adults who are reasonably capable of assessing danger.
Enlarge Image Getty Images
Getty Images
Most of those debates have been conducted in the abstract. But now an anthropologist has produced a study of several dozen medical volunteers, including Mr. Little. Roberto L. Abadie, a visiting scholar in the health-sciences program at the Graduate Center of the City University of New York, spent a year living in youth hostels and group houses in Philadelphia, trying to get a sense of why volunteers do what they do and how they understand their risks.
He offers his findings in The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects (Duke University Press, August). The book's primary purpose is to offer a detailed description of medical volunteering and its contexts, not to weigh in on the ethics of clinical trials. But after his year in the field, Mr. Abadie does have opinions about policy: Volunteers underestimate their long-term risks, he says, and universities should do more to protect them.
"Philosophers and bioethicists are very logical, and they can construct strong arguments," Mr. Abadie says. "But what they can't do is to go in there and do what I did—to do an in-depth ethnographic analysis, spending weeks and months with volunteers. Knowing who they are, what their neighborhoods look like, how they go through the trials, how they think and talk about the risks they're taking."
A Mix of Motives
Mr. Abadie spent time with anarchist activists who are attracted to guinea-pigging because of the flexibility it offers. Between 1996 and 2002, that milieu was documented in Guinea Pig Zero, a Philadelphia zine published by and for activist medical volunteers.
But Mr. Abadie's book also examines two other types of medical volunteer. First, he describes transient, economically struggling people who travel from place to place in search of lucrative trials. These volunteers are often less educated and more socially isolated than the anarchists.
Second, Mr. Abadie spent months at an HIV clinic where patients were participating in long-term trials to determine the effectiveness of new drug combinations. That environment is very different from the Phase 1 trials described elsewhere in the book. At the clinic, the HIV patients knew they had a personal stake in the development of new drugs, and the financial compensation they received was much smaller. Even though they were taking risks by participating in the drug studies, Mr. Abadie says, those volunteers seemed to reap psychological gains.
"They see the trials as an opportunity to empower themselves in their fight against the disease, a way to take control of their bodies and their lives," he writes.
Mr. Abadie is more ambivalent about the wisdom of participating in Phase 1 trials. Most of the volunteers he spent time with tend to say—naïvely, in his view—that the drugs will "wash out" of their systems within a week after the experiments. That may be true in most cases, but some drugs can accumulate in the liver. There may also be unknown risks associated with participating in many trials over a lifetime.
"Almost my entire time there, volunteers said to me, 'No, risk isn't a problem,'" Mr. Abadie says. "It wasn't until the end of the year that someone finally said, 'OK, we don't like to talk about it. Maybe it's a coping mechanism.'"
A New Angle on Risk
People who use drugs are familiar territory to Mr. Abadie. He was born and raised in Uruguay, and he spent several years there working with heroin users at an HIV clinic before moving to Canada to study anthropology. "Throughout my life, I had been studying drug users and how they understand risk," he says. "That's what I thought I would do as a medical anthropologist."
But when he entered the doctoral program at CUNY in 2001, Mr. Abadie became fascinated by the story of Ellen Roche, a staff member at the Johns Hopkins University who died while volunteering for a trial of a new asthma medication.
"When I first found this topic, I was so engaged with it that I couldn't sleep," he says.
Through an extended network of friends, Mr. Abadie made contact with Robert P. Helms, a self-taught historian and serial medical volunteer who was the editor of Guinea Pig Zero.
"When Roberto first came to Philadelphia, it was clear that he didn't know very much," Mr. Helms says. "But he's a quick learner. He hung around, and he asked the right questions."
Mr. Abadie would like to see Phase 1 volunteers be recognized legally as workers, bringing them under the umbrella of labor law. (Mr. Helms, an anarchist and a former labor organizer, is skeptical. "Roberto hasn't had the horrible experiences I've had with American labor law," he says.)
Mr. Abadie would also like to see the creation of a national registry of Phase 1-trial participants. A central database, he says, would prevent people from participating in too many trials, and might also help researchers identify long-term adverse effects associated with certain experiments.
Glen N. Gaulton, executive vice dean for research at the University of Pennsylvania School of Medicine, says he is open to such an idea, if it can be done efficiently and with enough privacy protections.
"Conceptually, it's absolutely the right thing to do," Mr. Gaulton says. "Especially in a city like Philadelphia, where there are so many medical centers. We ask subjects to disclose if they're participating in other trials—but if someone wants to lie, I won't necessarily know if they're simultaneously doing a trial across town."
But Mr. Gaulton disputes any suggestion that his university does a poor job of protecting research participants. After the death of Jesse Gelsinger, an 18-year-old patient who died during a gene-therapy experiment at Penn in 1999, the university created new systems for auditing clinical trials. "Our auditing office randomly visits trials to make sure that protocols are being followed," he says. "Any institution that doesn't do that is asking for trouble. The single biggest risk associated with clinical trials does not have to do with payments or volunteer recruitment, but with making sure that the experiment is actually being carried out in the way that the IRB was told it would be carried out."
Is that really the single biggest risk? Mr. Abadie is not so sure. "I think the biggest way to reduce risks is to look at financial conflicts of interest," he says. "When researchers have financial stakes in the outcome of a trial, that compromises safety, ethics, and the legitimacy of the entire thing."
Saturday, October 9, 2010
Medical Apartheid
Medical Apartheid
From Wikipedia, the free encyclopedia
Jump to: navigation, search
This article is written like an advertisement. Please help rewrite this article from a neutral point of view. For blatant advertising that would require a fundamental rewrite to become encyclopedic, use {{db-spam}} to mark for speedy deletion.
Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present is a 2007 book by Harriet A. Washington. It is a comprehensive history of medical experimentation on African Americans. From the era of slavery to the present day, this book presents the first full account of black America's mistreatment as unwitting subjects of medical experimentation. Medical Apartheid won the 2007 National Book Critics Circle Award for Nonfiction.[1][2]
[edit] See also
From Wikipedia, the free encyclopedia
Jump to: navigation, search
This article is written like an advertisement. Please help rewrite this article from a neutral point of view. For blatant advertising that would require a fundamental rewrite to become encyclopedic, use {{db-spam}} to mark for speedy deletion.
Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present is a 2007 book by Harriet A. Washington. It is a comprehensive history of medical experimentation on African Americans. From the era of slavery to the present day, this book presents the first full account of black America's mistreatment as unwitting subjects of medical experimentation. Medical Apartheid won the 2007 National Book Critics Circle Award for Nonfiction.[1][2]
[edit] See also
Abbott to withdraw diet drug Meridia
Abbott to withdraw diet drug Meridia
By Bruce Japsen and Andrew Zajac
5:22 p.m. EDT, October 8, 2010
E-mail Print Share Text Size la-fi-1009-meridia-20101008
Abbott Laboratories said Friday that it would withdraw the diet drug Meridia at the request of the U.S. Food and Drug Administration, less than a month after it failed to win over one of the federal agency's safety advisory panels.
The FDA confirmed the Chicago drug giant's decision, saying Abbott withdrew the drug because of "clinical trial data indicating an increased risk of heart attack and stroke."
The withdrawal of Meridia, also known by its scientific name sibutramine, leaves just one U.S.-approved diet drug on the market: the prescription Xenical.
"Meridia's continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke," said Dr. John Jenkins, director of the FDA's Office of New Drugs in the agency's Center for Drug Evaluation and Research. "Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their healthcare provider about alternative weight loss and weight loss maintenance programs."
Drug safety has been the subject of intense criticism from consumer groups and mounting scrutiny by the Obama administration and members of Congress from both political parties. Though Meridia remains available in 40 other countries around the world, regulatory agencies abroad have the drug under scrutiny as well.
Last month, eight of 16 members of an FDA advisory panel said Meridia should be withdrawn from the U.S. market. Six of the panelists said the drug should be prescribed only by "specially trained physicians" and should include a strict FDA black box warning noting the new limits.
The other two panelists said a new boxed warning should be added to alert consumers of increased risks of heart attacks and a need for closer monitoring of patients by clinicians. None of the members of the Endocrinologic and Metabolic Drugs Advisory Committee panel said the drug should remain on the market with the labeling in its current form.
Sidney Wolfe — head of Public Citizen, a not-for-profit health research group — criticized the FDA for waiting too long to pressure Abbott to pull the drug. Wolfe noted that in January, the European Medicines Agency recommended halting the use of Meridia based on the same evidence cited by the FDA.
"The FDA's decision to ask Abbott to withdraw the drug is commendable but dangerously too late for all of the victims of its unacceptable risks," said Wolfe, whose group asked the agency to ban Meridia in 2002.
In a statement, Abbott said it "believes [Meridia] has a positive risk/benefit profile in the approved patient population but will comply with the FDA's request."
Meridia was approved by the FDA in November 1997 for "weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease," the FDA said. At the time, the agency said the approval "was based on clinical data showing that more people receiving sibutramine lost at least 5% of their body weight than people on placebo who relied on diet and exercise alone."
Meridia has not been a big seller. Revenue from the pill has deteriorated amid criticism of its heart risks. Abbott has said it no longer promotes the drug in the U.S., where its sales are projected this year to be $30 million.
Prescription diet pills have had trouble winning respect with consumers and doctors because of safety issues and side effects. In 1997, a diet drug combination known as fen-phen was yanked from pharmacy shelves after it was linked to heart valve damage.
Late last month, the FDA sharply limited the use of the diabetes drug Avandia because it was associated with an increased risk of heart problems. In that case, the FDA decided there was a possible benefit to patients for whom no other treatment worked, so it permitted the drug to remain on the market subject to numerous restrictions.
With Meridia, regulators thought weight loss would lead to cardiovascular benefits that would outweigh worrisome, but readily monitored, side effects such as spikes in blood pressure and heart rate. But instead, studies showed an increased risk of heart attacks and strokes.
FDA officials estimated that about 100,000 people use Meridia and said they were not aware of any risks associated with halting use of the drug.
Also on Friday, the FDA warned consumers against using Slimming Beauty Bitter Orange Slimming Capsules because they contain sibutramine — which is the active ingredient in Meridia.
bjapsen@tribune.com
azajac@tribune.com
By Bruce Japsen and Andrew Zajac
5:22 p.m. EDT, October 8, 2010
E-mail Print Share Text Size la-fi-1009-meridia-20101008
Abbott Laboratories said Friday that it would withdraw the diet drug Meridia at the request of the U.S. Food and Drug Administration, less than a month after it failed to win over one of the federal agency's safety advisory panels.
The FDA confirmed the Chicago drug giant's decision, saying Abbott withdrew the drug because of "clinical trial data indicating an increased risk of heart attack and stroke."
The withdrawal of Meridia, also known by its scientific name sibutramine, leaves just one U.S.-approved diet drug on the market: the prescription Xenical.
"Meridia's continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke," said Dr. John Jenkins, director of the FDA's Office of New Drugs in the agency's Center for Drug Evaluation and Research. "Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their healthcare provider about alternative weight loss and weight loss maintenance programs."
Drug safety has been the subject of intense criticism from consumer groups and mounting scrutiny by the Obama administration and members of Congress from both political parties. Though Meridia remains available in 40 other countries around the world, regulatory agencies abroad have the drug under scrutiny as well.
Last month, eight of 16 members of an FDA advisory panel said Meridia should be withdrawn from the U.S. market. Six of the panelists said the drug should be prescribed only by "specially trained physicians" and should include a strict FDA black box warning noting the new limits.
The other two panelists said a new boxed warning should be added to alert consumers of increased risks of heart attacks and a need for closer monitoring of patients by clinicians. None of the members of the Endocrinologic and Metabolic Drugs Advisory Committee panel said the drug should remain on the market with the labeling in its current form.
Sidney Wolfe — head of Public Citizen, a not-for-profit health research group — criticized the FDA for waiting too long to pressure Abbott to pull the drug. Wolfe noted that in January, the European Medicines Agency recommended halting the use of Meridia based on the same evidence cited by the FDA.
"The FDA's decision to ask Abbott to withdraw the drug is commendable but dangerously too late for all of the victims of its unacceptable risks," said Wolfe, whose group asked the agency to ban Meridia in 2002.
In a statement, Abbott said it "believes [Meridia] has a positive risk/benefit profile in the approved patient population but will comply with the FDA's request."
Meridia was approved by the FDA in November 1997 for "weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease," the FDA said. At the time, the agency said the approval "was based on clinical data showing that more people receiving sibutramine lost at least 5% of their body weight than people on placebo who relied on diet and exercise alone."
Meridia has not been a big seller. Revenue from the pill has deteriorated amid criticism of its heart risks. Abbott has said it no longer promotes the drug in the U.S., where its sales are projected this year to be $30 million.
Prescription diet pills have had trouble winning respect with consumers and doctors because of safety issues and side effects. In 1997, a diet drug combination known as fen-phen was yanked from pharmacy shelves after it was linked to heart valve damage.
Late last month, the FDA sharply limited the use of the diabetes drug Avandia because it was associated with an increased risk of heart problems. In that case, the FDA decided there was a possible benefit to patients for whom no other treatment worked, so it permitted the drug to remain on the market subject to numerous restrictions.
With Meridia, regulators thought weight loss would lead to cardiovascular benefits that would outweigh worrisome, but readily monitored, side effects such as spikes in blood pressure and heart rate. But instead, studies showed an increased risk of heart attacks and strokes.
FDA officials estimated that about 100,000 people use Meridia and said they were not aware of any risks associated with halting use of the drug.
Also on Friday, the FDA warned consumers against using Slimming Beauty Bitter Orange Slimming Capsules because they contain sibutramine — which is the active ingredient in Meridia.
bjapsen@tribune.com
azajac@tribune.com
Saturday, October 2, 2010
STD's Clinical Research-US apologise
http://www.cnn.com/2010/WORLD/americas/10/01/us.guatemala.apology/index.html?hpt=T2
US apologizes for infecting Guatemalans with STDs in the 1940sBy the CNN Wire Staff
October 1, 2010 10:18 p.m. EDT
President Obama offers "profound apologies" to the Guatemalan president for the tests.STORY HIGHLIGHTS
Obama offers "profound apologies"
Guatemala accepts the apology, the presidential spokesman said
The United States is launching an investigation
The research was "reprehensible," the U.S. statement said
Washington (CNN) -- The United States apologized Friday for a 1946-1948 research study in which people in Guatemala were intentionally infected with sexually transmitted diseases.
A statement by Secretary of State Hillary Clinton and Secretary of Health and Human Services Secretary Kathleen Sebelius called the action "reprehensible."
"We deeply regret that it happened, and we apologize to all the individuals who were affected by such abhorrent research practices," the joint statement said. "The conduct exhibited during the study does not represent the values of the United States, or our commitment to human dignity and great respect for the people of Guatemala."
President Barack Obama called his Guatemalan counterpart Friday "offering profound apologies and asking pardon for the deeds of the 1940s," President Alvaro Colom told CNN en Espanol in a telephone interview from Guatemala City.
"Though it happened 64 years ago, it really is a profound violation of human rights," said Colom, who said the report took him by surprise.
Clinton called him on Thursday, he said. "She too offered her apologies," he said, adding that she told him she was ashamed the United States had been involved in the matter.
Video: U.S. gave STDs to Guatemalans
RELATED TOPICS
Guatemala
Sexually Transmitted Diseases
Contagious and Infectious Diseases
Asked whether Guatemala was planning to take legal action, Colom said, "That's part of the work of the commission."
"We reject these types of actions, obviously," said Guatemala presidential spokesman Ronaldo Robles. "We know that this took place some time ago, but this is unacceptable and we recognize the apology from Secretary Clinton."
The scientific investigation, called the U.S. Public Health Service Sexually Transmitted Disease Inoculation Study of 1946-1948, aimed at determining the effectiveness of penicillin in treating or preventing syphilis after subjects were exposed to the disease. Gonorrhea and chancres were also studied. Penicillin was a relatively new drug at the time.
The tests were carried out on female commercial sex workers, prisoners in the national penitentiary, patients in the national mental hospital and soldiers. According to the study, more than 1,600 people were infected: 696 with syphilis, 772 with gonorrhea and 142 with chancres.
The study came to light recently when Wellesley College researcher Susan Reverby found the archived but unpublished notes from the project as she was researching a similar study that was conducted between 1932 and 1972 in Tuskegee, Alabama. That study included nearly 400 poor African-American men with preexisting syphilis whose disease was allowed to progress without treatment. Researchers did not infect the subjects, but they did not tell them they had the disease either.
The Tuskegee study was done under the direction of Dr. John C. Cutler, a U.S. Public Health Service medical officer who died in 2003.
"I was doing what historians do," said Reverby, a professor of the history of ideas and women and gender issues, who has written a book on the Tuskegee study. She went to the University of Pittsburgh, where Cutler had taught, and searched through an archive of his papers.
"There was nothing on Tuskeegee in the papers, but there was this report of the Guatemala study," she told CNN in a telephone interview. "I started to read, and I almost fell off my chair."
She found that Cutler also led the research in Guatemala. It was carried out there, in part, she said, because prostitution was legal and prisoners were allowed to bring prostitutes in for sex.
Dr. Francis Collins, director of the U.S. National Institutes for Health, told reporters that the Guatemala study represented "a dark chapter in the history of medicine."
The study "appears to have been funded" by the U.S. National Institutes of Health, he said, citing four primary ethical violations: 1) study subjects "were members of one or more vulnerable populations;" 2) there is no evidence they gave informed consent; 3) they were often deceived about what was being done to them; 4) they were intentionally infected with pathogens that could cause serious illness without their understanding or consent.
U.S. officials said Friday that ethical safeguards would prevent such abuses from occurring today.
An Institute of Medicine task force will look at what happened in the study, and a group of ethics experts will convene to review the matter and report on how best to ensure such abuses do not recur, Collins said.
"The study is a sad reminder that adequate human subject safeguards did not exist a half-century ago," the U.S. statement said. "Today, the regulations that govern U.S.-funded human medical research prohibit these kinds of appalling violations."
Collins said the published literature contains more than 40 other U.S.-based studies "where intentional infection was carried out with what we could now consider to be completely inadequate consent in the United States."
Many of those studies were funded by the Public Health Service, he said.
But at least some people believed at the time that the experiment was flawed, according to Wellesley's Reverby, who cited this reaction to Cutler's work from his supervisor, PHS physician R.C. Arnold: "I am a bit, in fact more than a bit, leery of the experiment with insane people," Arnold said. "They can not give consent, do not know what is going on, and if some good organization got wind of the work, they would raise a lot of smoke. I think the soldiers would be best or the prisoners for they can give consent. Maybe I'm too conservative ... In the report, I see no reason to say where the work was done and the type of volunteer."
"The vast majority" of study subjects were adequately treated for their illness, Collins said. One subject died during an epileptic seizure, though it was not clear that the death was related to the study, he added.
Cutler's work helped refine testing procedures and suggested a better means of prevention, but "made little impact on syphilis research," Reverby concluded.
Clinton and Sebelius said the United States is launching an investigation and also convening a group of international experts to review and report on the most effective methods to make sure all human medical research worldwide meets rigorous ethical standards.
"As we move forward to better understand this appalling event, we reaffirm the importance of our relationship with Guatemala, and our respect for the Guatemalan people, as well as our commitment to the highest standards of ethics in medical research," the U.S. statement said.
CNN's Arthur Brice, Nick Valencia and Tom Watkins and CNNRadio's Shelby Lin Erdman contributed to this report.
_______________
Studies show 'dark chapter' of medical researchBy Elizabeth Landau, CNN
October 1, 2010 6:08 p.m. EDT
The Public Health Service took photographs during the Tuskegee syphilis study, but no captions remain. This is one of them.STORY HIGHLIGHTS
The Tuskegee study, which began in the early 1930s, consisted of 399 African-American men
The Guatemala-based research involved 696 subjects
Both studies were sponsored by U.S. government health agencies
(CNN) -- The Tuskegee syphilis experiment of the 20th century is often cited as the most famous example of unethical medical research. Now, evidence has emerged that it overlapped with a shorter study, also sponsored by U.S. government health agencies, in which human subjects were unknowingly being harmed by participating in an experiment.
Research from Wellesley College professor Susan Reverby has uncovered evidence of an experiment in Guatemala that infected people with sexually transmitted diseases in an effort to explore treatments.
The U.S. government apologized for the research project on Friday, more than 60 years after the experiments ended. Officials said an investigation will be launched into the matter.
The Tuskegee and the Guatemala studies show what National Institutes of Health Director Francis Collins called a "a dark chapter in the history of medicine."
As unethical as the methods were, the basic research questions behind both studies were highly relevant at the time, said Peter Brown, medical anthropologist at Emory University. Research in Guatemala focused on the powers of penicillin; in Tuskegee, researchers wanted to know the natural history of syphilis.
"In a racist context, they thought [syphilis] might be different in African-Americans; the real unethical part in my mind had to do with denial of treatment and, most importantly, the denial of information about the study to the men involved," he said.
In 1926, syphilis was seen as a major health problem, according to the Centers for Disease Control and Prevention; in 1928, about 25 percent of black employees at the Delta Pine and Land Company of Mississippi had tested positive for syphilis, according to Tuskegee University. A charity called the Julius Rosenwald Fund came to the U.S. Public Health Service to start a project to improve the health of African-Americans in the South.
But in 1929, the Great Depression began, and the Rosenwald Fund had to cut its funds for the treatment program.
The director of the U.S. Public Health Service, Dr. Taliaferro Clark, proposed salvaging the project by investigating the course of untreated syphilis.
Getting African-Americans to participate was not a challenge; most African-Americans did not have access to medical care at that time and the study provided free health exams, food and transportation, according to Tuskegee University.
Video: U.S. gave STDs to Guatemalans
RELATED TOPICS
African-American Issues
Centers for Disease Control and Prevention
Sexually Transmitted Diseases
Tuskegee
But none of the patients who had syphilis was told that he carried the condition, and doctors did not give the patients sufficient treatment. Instead they were told they would get treatment for "bad blood," a phrase that connoted a variety of illnesses including syphilis, anemia and fatigue, the CDC said.
The Tuskegee study, which began in the early 1930s, consisted of 399 African-American men with syphilis and 201 without, according to the CDC. The Tuskegee Institute partnered with the Public Health Service for an experiment that was supposed to last 6 months. Instead it lasted about 40 years.
While the Tuskegee study was still going in the 1940s, other efforts that would never meet today's medical ethics standards were going on elsewhere. The Public Health Service did research at a U.S. prison in 1944 that involved injecting inmates with gonorrhea, Reverby said. That project was abandoned, and the Public Health Service turned to Guatemala to more closely examine syphilis and in what ways penicillin could treat or prevent it, Reverby said in documents posted on her website.
"The whole fact that the Public Health Service was very aware about the ethical problems is very characteristic of American international health policy at the time, which was very condescending to other countries," Brown said.
It turns out that a physician at the Public Health Service, Dr. John C. Cutler, participated in both the Guatemala and the Tuskegee experiments. Cutler came to the Tuskegee project in the 1960s, according to Reverby, and continued to defend it even in the 1990s, long after it ended. Cutler died in 2003 at age 87.
The Guatemala syphilis research involved 696 subjects who came from the Guatemala National Penitentiary, army barracks and the National Mental Health Hospital, according to Reverby's research. These subjects did not give direct permission to participate. Instead, the authorities signed them up. There were also 772 patients exposed to gonorrhea and 142 subjects exposed to chancres, according to a CDC report.
Unlike the Tuskegee project, these participants were given the diseases as part of the experiment.
"The doctors used prostitutes with the disease to pass it to the prisoners (sexual visits were allowed by law in Guatemalan prisons) and then did direct inoculations made from syphilis bacteria poured onto the men's penises or on forearms and faces that were slightly abraded when the 'normal exposure' produced little disease, or in a few cases through spinal punctures," Reverby wrote.
Many people wrongly believe that the Tuskegee study involved injecting subjects with syphilis, according to a 2008 study led by Ralph Katz of the NYU College of Dentistry. His survey found that more than 60 percent of both whites and blacks said they believed study subjects were injected with syphilis.
Another important difference between the studies is that the subjects in Guatemala received penicillin after getting the sexually transmitted disease, Reverby wrote, although it's not clear whether everyone was cured.
In Tuskegee, on the other hand, the Public Health Service made sure that the subjects with syphilis did not get treatment from elsewhere. During World War II, draft boards agreed to lift the requirement of syphilis treatment for study participants, according to Tuskegee University.
Tuskegee study subjects continued to be excluded when the Public Health Service began giving other patients penicillin to treat syphilis in 1943. The agency set up Rapid Treatment Centers to treat the disease in 1947, helping to lower the overall syphilis rate; study subjects were still not treated, according to the CDC.
The Guatemalan study ended when "it proved difficult to transfer the disease and other priorities at home seemed more important," according to Reverby's paper. Cutler was told go back to the United States, she said. There he went on to work on an inoculation study at Sing Sing Prison in Ossining, New York, from 1953 to 1956, and later to Tuskegee. As for the participants in the Guatemalan study, there was some follow-up laboratory testing and observation until the early 1950s, the CDC said.
Tuskegee experiments stopped on a more dramatic note: in 1972 when Peter Buxton, who also worked for the Public Health Service, relayed information about the experiment to a reporter. By that time, 28 men had died of syphilis and 100 others had died of related complications. As a result of the experiment, at least 40 wives contracted syphilis and 19 children had it from birth.
The exposure of the study sparked congressional hearings in 1973 that led to a total overhaul of the Health, Education and Welfare rules concerning work with human subjects. A class-action lawsuit resulted in an out-of-court settlement of $10 million, with the U.S. government promising lifetime medical benefits and burial services to all study subjects still living. This program later expanded to include wives, widows and children.
President Bill Clinton publicly apologized to the victims of the Tuskegee experiments in an emotional speech in 1997, in which he said the study was shameful and racist.
"The people who ran the study at Tuskegee diminished the stature of man by abandoning the most basic ethical precepts. They forgot their pledge to heal and repair. They had the power to heal the survivors and all the others and they did not. Today, all we can do is apologize," he said at a ceremony at the White House.
Because of the ethical guidelines that all research institutions must follow, these kinds of studies would not happen in the United States today, Brown said.
http://www.cnn.com/2010/HEALTH/10/01/guatemala.syphilis.tuskegee/index.html?hpt=Sbin
US apologizes for infecting Guatemalans with STDs in the 1940sBy the CNN Wire Staff
October 1, 2010 10:18 p.m. EDT
President Obama offers "profound apologies" to the Guatemalan president for the tests.STORY HIGHLIGHTS
Obama offers "profound apologies"
Guatemala accepts the apology, the presidential spokesman said
The United States is launching an investigation
The research was "reprehensible," the U.S. statement said
Washington (CNN) -- The United States apologized Friday for a 1946-1948 research study in which people in Guatemala were intentionally infected with sexually transmitted diseases.
A statement by Secretary of State Hillary Clinton and Secretary of Health and Human Services Secretary Kathleen Sebelius called the action "reprehensible."
"We deeply regret that it happened, and we apologize to all the individuals who were affected by such abhorrent research practices," the joint statement said. "The conduct exhibited during the study does not represent the values of the United States, or our commitment to human dignity and great respect for the people of Guatemala."
President Barack Obama called his Guatemalan counterpart Friday "offering profound apologies and asking pardon for the deeds of the 1940s," President Alvaro Colom told CNN en Espanol in a telephone interview from Guatemala City.
"Though it happened 64 years ago, it really is a profound violation of human rights," said Colom, who said the report took him by surprise.
Clinton called him on Thursday, he said. "She too offered her apologies," he said, adding that she told him she was ashamed the United States had been involved in the matter.
Video: U.S. gave STDs to Guatemalans
RELATED TOPICS
Guatemala
Sexually Transmitted Diseases
Contagious and Infectious Diseases
Asked whether Guatemala was planning to take legal action, Colom said, "That's part of the work of the commission."
"We reject these types of actions, obviously," said Guatemala presidential spokesman Ronaldo Robles. "We know that this took place some time ago, but this is unacceptable and we recognize the apology from Secretary Clinton."
The scientific investigation, called the U.S. Public Health Service Sexually Transmitted Disease Inoculation Study of 1946-1948, aimed at determining the effectiveness of penicillin in treating or preventing syphilis after subjects were exposed to the disease. Gonorrhea and chancres were also studied. Penicillin was a relatively new drug at the time.
The tests were carried out on female commercial sex workers, prisoners in the national penitentiary, patients in the national mental hospital and soldiers. According to the study, more than 1,600 people were infected: 696 with syphilis, 772 with gonorrhea and 142 with chancres.
The study came to light recently when Wellesley College researcher Susan Reverby found the archived but unpublished notes from the project as she was researching a similar study that was conducted between 1932 and 1972 in Tuskegee, Alabama. That study included nearly 400 poor African-American men with preexisting syphilis whose disease was allowed to progress without treatment. Researchers did not infect the subjects, but they did not tell them they had the disease either.
The Tuskegee study was done under the direction of Dr. John C. Cutler, a U.S. Public Health Service medical officer who died in 2003.
"I was doing what historians do," said Reverby, a professor of the history of ideas and women and gender issues, who has written a book on the Tuskegee study. She went to the University of Pittsburgh, where Cutler had taught, and searched through an archive of his papers.
"There was nothing on Tuskeegee in the papers, but there was this report of the Guatemala study," she told CNN in a telephone interview. "I started to read, and I almost fell off my chair."
She found that Cutler also led the research in Guatemala. It was carried out there, in part, she said, because prostitution was legal and prisoners were allowed to bring prostitutes in for sex.
Dr. Francis Collins, director of the U.S. National Institutes for Health, told reporters that the Guatemala study represented "a dark chapter in the history of medicine."
The study "appears to have been funded" by the U.S. National Institutes of Health, he said, citing four primary ethical violations: 1) study subjects "were members of one or more vulnerable populations;" 2) there is no evidence they gave informed consent; 3) they were often deceived about what was being done to them; 4) they were intentionally infected with pathogens that could cause serious illness without their understanding or consent.
U.S. officials said Friday that ethical safeguards would prevent such abuses from occurring today.
An Institute of Medicine task force will look at what happened in the study, and a group of ethics experts will convene to review the matter and report on how best to ensure such abuses do not recur, Collins said.
"The study is a sad reminder that adequate human subject safeguards did not exist a half-century ago," the U.S. statement said. "Today, the regulations that govern U.S.-funded human medical research prohibit these kinds of appalling violations."
Collins said the published literature contains more than 40 other U.S.-based studies "where intentional infection was carried out with what we could now consider to be completely inadequate consent in the United States."
Many of those studies were funded by the Public Health Service, he said.
But at least some people believed at the time that the experiment was flawed, according to Wellesley's Reverby, who cited this reaction to Cutler's work from his supervisor, PHS physician R.C. Arnold: "I am a bit, in fact more than a bit, leery of the experiment with insane people," Arnold said. "They can not give consent, do not know what is going on, and if some good organization got wind of the work, they would raise a lot of smoke. I think the soldiers would be best or the prisoners for they can give consent. Maybe I'm too conservative ... In the report, I see no reason to say where the work was done and the type of volunteer."
"The vast majority" of study subjects were adequately treated for their illness, Collins said. One subject died during an epileptic seizure, though it was not clear that the death was related to the study, he added.
Cutler's work helped refine testing procedures and suggested a better means of prevention, but "made little impact on syphilis research," Reverby concluded.
Clinton and Sebelius said the United States is launching an investigation and also convening a group of international experts to review and report on the most effective methods to make sure all human medical research worldwide meets rigorous ethical standards.
"As we move forward to better understand this appalling event, we reaffirm the importance of our relationship with Guatemala, and our respect for the Guatemalan people, as well as our commitment to the highest standards of ethics in medical research," the U.S. statement said.
CNN's Arthur Brice, Nick Valencia and Tom Watkins and CNNRadio's Shelby Lin Erdman contributed to this report.
_______________
Studies show 'dark chapter' of medical researchBy Elizabeth Landau, CNN
October 1, 2010 6:08 p.m. EDT
The Public Health Service took photographs during the Tuskegee syphilis study, but no captions remain. This is one of them.STORY HIGHLIGHTS
The Tuskegee study, which began in the early 1930s, consisted of 399 African-American men
The Guatemala-based research involved 696 subjects
Both studies were sponsored by U.S. government health agencies
(CNN) -- The Tuskegee syphilis experiment of the 20th century is often cited as the most famous example of unethical medical research. Now, evidence has emerged that it overlapped with a shorter study, also sponsored by U.S. government health agencies, in which human subjects were unknowingly being harmed by participating in an experiment.
Research from Wellesley College professor Susan Reverby has uncovered evidence of an experiment in Guatemala that infected people with sexually transmitted diseases in an effort to explore treatments.
The U.S. government apologized for the research project on Friday, more than 60 years after the experiments ended. Officials said an investigation will be launched into the matter.
The Tuskegee and the Guatemala studies show what National Institutes of Health Director Francis Collins called a "a dark chapter in the history of medicine."
As unethical as the methods were, the basic research questions behind both studies were highly relevant at the time, said Peter Brown, medical anthropologist at Emory University. Research in Guatemala focused on the powers of penicillin; in Tuskegee, researchers wanted to know the natural history of syphilis.
"In a racist context, they thought [syphilis] might be different in African-Americans; the real unethical part in my mind had to do with denial of treatment and, most importantly, the denial of information about the study to the men involved," he said.
In 1926, syphilis was seen as a major health problem, according to the Centers for Disease Control and Prevention; in 1928, about 25 percent of black employees at the Delta Pine and Land Company of Mississippi had tested positive for syphilis, according to Tuskegee University. A charity called the Julius Rosenwald Fund came to the U.S. Public Health Service to start a project to improve the health of African-Americans in the South.
But in 1929, the Great Depression began, and the Rosenwald Fund had to cut its funds for the treatment program.
The director of the U.S. Public Health Service, Dr. Taliaferro Clark, proposed salvaging the project by investigating the course of untreated syphilis.
Getting African-Americans to participate was not a challenge; most African-Americans did not have access to medical care at that time and the study provided free health exams, food and transportation, according to Tuskegee University.
Video: U.S. gave STDs to Guatemalans
RELATED TOPICS
African-American Issues
Centers for Disease Control and Prevention
Sexually Transmitted Diseases
Tuskegee
But none of the patients who had syphilis was told that he carried the condition, and doctors did not give the patients sufficient treatment. Instead they were told they would get treatment for "bad blood," a phrase that connoted a variety of illnesses including syphilis, anemia and fatigue, the CDC said.
The Tuskegee study, which began in the early 1930s, consisted of 399 African-American men with syphilis and 201 without, according to the CDC. The Tuskegee Institute partnered with the Public Health Service for an experiment that was supposed to last 6 months. Instead it lasted about 40 years.
While the Tuskegee study was still going in the 1940s, other efforts that would never meet today's medical ethics standards were going on elsewhere. The Public Health Service did research at a U.S. prison in 1944 that involved injecting inmates with gonorrhea, Reverby said. That project was abandoned, and the Public Health Service turned to Guatemala to more closely examine syphilis and in what ways penicillin could treat or prevent it, Reverby said in documents posted on her website.
"The whole fact that the Public Health Service was very aware about the ethical problems is very characteristic of American international health policy at the time, which was very condescending to other countries," Brown said.
It turns out that a physician at the Public Health Service, Dr. John C. Cutler, participated in both the Guatemala and the Tuskegee experiments. Cutler came to the Tuskegee project in the 1960s, according to Reverby, and continued to defend it even in the 1990s, long after it ended. Cutler died in 2003 at age 87.
The Guatemala syphilis research involved 696 subjects who came from the Guatemala National Penitentiary, army barracks and the National Mental Health Hospital, according to Reverby's research. These subjects did not give direct permission to participate. Instead, the authorities signed them up. There were also 772 patients exposed to gonorrhea and 142 subjects exposed to chancres, according to a CDC report.
Unlike the Tuskegee project, these participants were given the diseases as part of the experiment.
"The doctors used prostitutes with the disease to pass it to the prisoners (sexual visits were allowed by law in Guatemalan prisons) and then did direct inoculations made from syphilis bacteria poured onto the men's penises or on forearms and faces that were slightly abraded when the 'normal exposure' produced little disease, or in a few cases through spinal punctures," Reverby wrote.
Many people wrongly believe that the Tuskegee study involved injecting subjects with syphilis, according to a 2008 study led by Ralph Katz of the NYU College of Dentistry. His survey found that more than 60 percent of both whites and blacks said they believed study subjects were injected with syphilis.
Another important difference between the studies is that the subjects in Guatemala received penicillin after getting the sexually transmitted disease, Reverby wrote, although it's not clear whether everyone was cured.
In Tuskegee, on the other hand, the Public Health Service made sure that the subjects with syphilis did not get treatment from elsewhere. During World War II, draft boards agreed to lift the requirement of syphilis treatment for study participants, according to Tuskegee University.
Tuskegee study subjects continued to be excluded when the Public Health Service began giving other patients penicillin to treat syphilis in 1943. The agency set up Rapid Treatment Centers to treat the disease in 1947, helping to lower the overall syphilis rate; study subjects were still not treated, according to the CDC.
The Guatemalan study ended when "it proved difficult to transfer the disease and other priorities at home seemed more important," according to Reverby's paper. Cutler was told go back to the United States, she said. There he went on to work on an inoculation study at Sing Sing Prison in Ossining, New York, from 1953 to 1956, and later to Tuskegee. As for the participants in the Guatemalan study, there was some follow-up laboratory testing and observation until the early 1950s, the CDC said.
Tuskegee experiments stopped on a more dramatic note: in 1972 when Peter Buxton, who also worked for the Public Health Service, relayed information about the experiment to a reporter. By that time, 28 men had died of syphilis and 100 others had died of related complications. As a result of the experiment, at least 40 wives contracted syphilis and 19 children had it from birth.
The exposure of the study sparked congressional hearings in 1973 that led to a total overhaul of the Health, Education and Welfare rules concerning work with human subjects. A class-action lawsuit resulted in an out-of-court settlement of $10 million, with the U.S. government promising lifetime medical benefits and burial services to all study subjects still living. This program later expanded to include wives, widows and children.
President Bill Clinton publicly apologized to the victims of the Tuskegee experiments in an emotional speech in 1997, in which he said the study was shameful and racist.
"The people who ran the study at Tuskegee diminished the stature of man by abandoning the most basic ethical precepts. They forgot their pledge to heal and repair. They had the power to heal the survivors and all the others and they did not. Today, all we can do is apologize," he said at a ceremony at the White House.
Because of the ethical guidelines that all research institutions must follow, these kinds of studies would not happen in the United States today, Brown said.
http://www.cnn.com/2010/HEALTH/10/01/guatemala.syphilis.tuskegee/index.html?hpt=Sbin
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