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We hear a lot about zombies these days – in films, in music and even in philosophy – but many are unaware that in 1997 The Lancet published a medical study of three genuine Haitian zombies.

The cases studies were reported by British anthropologist Roland Littlewood and Haitian doctor Chavannes Douyon and concerned three individuals identified as zombies after they had apparently passed away.

The Haitian explanation for how zombies are created involves the distinction between different elements of the human being – including the body, the gwobon anj (the animating principle) and the ti-bon anj, which represents something akin to agency, awareness, and memory.

In line with these beliefs is the fact that awareness and agency can be split off from the human being – and can be captured and stored in a bottle by abòkò, a type of magician and spirit worker who can be paid to send curses or help individuals achieve their aims.

This purportedly leaves a passive easily-controlled animated body – the zombie – believed to be created to provide free labour on plantations.

Anthropologist Wade Davis claimed to have identified the ingredients of thebòkò’s zombification powder which supposedly included tetrodotoxin – a naturally occurring neurotoxin found in some animals, like the pufferfish, which can cause temporary coma-like states.

I won’t say much more about the ‘neurotoxin’ theory of zombification, not least because it was brilliantly covered by science writer Mo Costandi and I couldn’t improve on his fantastic article which will tell you everything you need to know.

But on the cultural level, zombies are identified by specific characteristics – they cannot lift up their heads, have a nasal intonation, a fixed staring expression, they carry repeated purposeless actions and have limited and repetitive speech.

This means that they are easily identified by the community and Littlewood and Douyon’s study was a medical investigation into three ‘returned zombies’ – each of which was identified as a member of the family who had died and who had returned with the characteristic features.

FI was a 30-year-old woman who had died after a short illness and was buried next to the house, only for her to be recognised in a zombified state three years later by her family, wandering near to her village.

WD died at the age of 18 shortly after his “eyes turned yellow” and his body “swelled up” and was buried in a family tomb. He was identified as a zombie at a cockfight eight years after he had been buried.

MM was a young woman who also died at 18 after a short illness, but who was identified 13 years later in the town market, walking around in the characteristic detached shambling way.

While the families put their fate down to sorcery, a full medical examination was carried out by the two doctors, including the use of EEG and CT brain scans.

FI showed no neurological damage but was diagnosed with catatonic schizophrenia, a very withdrawn form of psychosis. WD was found to have brain damage, probably from lack of oxygen, and epilepsy, which could be treated with drugs. MM was found to a developmental learning disability, probably caused by her alcoholism when her mother was pregnant with her.

The fact that doctors gave medical explanations for people identified as zombies is, perhaps, no big surprise, but most interesting was that DNA and fingerprinting tests that showed that two of the zombies were cases of mistaken identity. They weren’t the dead relatives that the families thought they were.

The authors of the study noted that it is unlikely that there is a single explanation for all people identified as zombies and there was a hint that the ‘neurotoxin’ theory could explain some cases. Two types of ‘zombification’ powder from local bòkòs were tested, and, in line with Wade Davis’s ideas, tetrodotoxin was found.

But more probable is that most cases are mistaken identification of wandering mentally ill or neurologically impaired strangers by bereaved relatives.

They noted “People with a chronic schizophrenic illness, brain damage, or learning disability are not uncommonly met with wandering in Haiti, and they would be particularly likely to be identified as lacking volition and memory which are characteristics of a zombi.”

Interestingly, the first known photograph of a zombie, shown above, was taken by anthropologist Zora Neale Hurston and reproduced in her 1938 book Voodoo Gods where it notes that the subject was photographed in a psychiatric hospital, which makes more sense in light of this more recent medical examination.

It’s worth making a final point that while zombies are a particularly well-known aspect of Haitian culture, thanks to the stereotypes and Hollywood hijacking, traditional Haitian psychology and related concepts of illness are hugely fascinating topics in themselves.

If you want to lose yourself in another understanding of ourselves and the world, you could do much worse than reading the World Health Organisation’s short report ‘Culture and Mental Health in Haiti’ which is available online as a pdf. The whole report is fascinating but start at the section on ‘Religion’ from page 6 if you want to get straight to the psychology.

Link to locked case study in The Lancet.
Link to Mo Costandi’s “The ethnobiology of voodoo zombification”.
pdf of WHO report on ‘Culture and Mental Health in Haiti’.

Source: Mind Hacks

 

Several companies are raking in the dough selling plastic bracelets. Power Balance one of the most popular of the so called performance bands is manufactured in China and sells for more than $30.

After a little testing it is easy to figure out that the only this the plastic jewelry is doing for you is making you poorer.

Maybe it helps by balancing your wallet by removing all of your hard earned cash.

 

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For this year’s “World Homeopathy Awareness Week,” the James Randi Educational Foundation (JREF) issued a strong statement against the misleading advertising of homeopathic medicines and called on Congress to close the loophole exempting these quack products from certain FDA regulations.

“So-called homeopathic remedies may be the only products given a free pass to say they’re intended to treat disease, without any proof at all that they work.” JREF President D.J. Grothe said.

“Drugs have to be tested for safety and potency before they can be sold. Supplements have to carry disclaimers, telling consumers that their claims have not been evaluated by the FDA. Homeopathy is exempt from these requirements because of a law passed more than 70 years ago. It’s time to close the loophole and make manufactures of these quack medications play by the same rules as everyone else.”

On Feb. 5, the JREF put $1 million on the table for any manufacturer or homeopath who could demonstrate that their homeopathic products were effective under fair observing conditions. In the months since, none have come forward to claim the prize.

The JREF invites consumers to send a message to members of the Senate Health, Education, Labor, and Pensions Committee, which oversees the FDA, and ask them to close the loophole that allows misleading claims by manufacturers of quack medicine:

Click here to sign the petition to Congress asking them to: Close the quack medicine loophole for homeopathic remedies

The facts about homeopathic remedies:

• No Ingredients: Homeopathic remedies are so extremely dilute that most do not contain a single atom of their claimed active ingredient. The most popular homeopathic remedy, oscillococcinum, is based on a dilution of one part duck liver to 10^{^400} parts of water. 10^{^400} is the number 1 with 400 zeroes after it. To make such a dilution, you’d have to mix a single molecule of duck liver with more matter than exists in the entire known universe.
• No Testing: Homeopathic remedies are exempted from regulations requiring drugs to prove they’re effective and accurately labeled with respect to dosage and potency. What’s more, homeopathic remedies were never even tested by their inventors to make sure they work. Homeopathic remedies are invented by a process homeopaths call “proving”: they give a substance to a healthy person, observe the symptoms it causes, and then take it on faith that homeopathic doses of the same substance will cure those symptoms. For example, coffee causes sleeplessness—that’s all homeopaths need to know in order to prescribe homeopathically-diluted coffee as sleeping pills, called “coffea cruda.” According to homeopathic principles, there’s no need to test whether it actually helps anyone sleep.
• No Facts: Major pharmacy chains like CVS, Walgreens, and Rite Aid sell useless homeopathic products right alongside real medicine, with no warning to consumers. Manufacturers and retailers profit by denying customers the facts they need to make up their minds. U.S. law exempts homeopathy from certain rules that govern drugs and nutritional supplements, so manufacturers can market homeopathic remedies for the treatment of illnesses despite the fact that reputable studies show homeopathy to work no better than dummy pills made of plain sugar.

Source: Randi.org

 

If you thought that scene in Sucker Punch where the doctor gave lobotomies with an ice pick was artistic exaggeration – well, it wasn’t. That’s exactly how Walter Freeman, a popularizer of lobotomies in the 1940s, performed thousands of operations.

In the mid-twentieth century, the lobotomy was such a popular “cure” for mental illness that Freeman’s colleague António Egas Moniz was awarded the 1949 Nobel Prize for Medicine for his role in perfecting the operation. While Moniz was treating patients in Europe, Freeman started using an ice pick-shaped instrument in America to perform up to 25 lobotomies a day, without anaesthesia, while reporters looked on. Freeman’s crazy antics didn’t scare off potential patients, though: John F. Kennedy’s sister Rosemary got a lobotomy from Freeman, which left her a vegetable for the rest of her life. And she was one of many people whose “cure” was more like zombification than freedom from mental anguish.

How did the lobotomy ever become accepted medical practice? And why are people still getting them today, under the less-disturbing name “lobectomy”?

Invention of the lobotomy

Moniz and Freeman are usually credited with inventing the lobotomy in the 1930s, though in truth their work was based on many other people’s research going back to the mid-nineteenth century. They had read about the work of a European doctor named Gottlieb Burckhardt, who in the 1880s performed some of the first psychosurgeries on patients’ frontal lobes as well as other parts of their brains. Though Burckhardt was derided by his colleagues, some of whom thought his work was barbarous, Moniz and Freeman were intrigued by the idea that the frontal lobe could be somehow separated from the rest of the brain. This would leave incurably schizophrenic patients relieved of their emotional distress, they believed. In experiments with dogs, they determined that cutting nerves between the brain and its frontal lobe – the so-called “seat of reason” – left the animals quiet.

And so Moniz, later followed by Freeman, began experimenting on patients. His first surgery, on a mentally ill woman, involved drilling two holes in her skull and pumping alcohol into her frontal cortex. Later surgeries involved “coring” several regions in the frontal cortex with hollow needles – literally sucking out parts of the brain to sever neural connections. All these surgeries were done blind, which is to say they rarely opened up a person’s skull to see where they were cutting. Moniz just drilled into the skull and guesstimated where he should core or cut.

They published articles about their work in prestigious scientific journals, reporting that patients who had been horrific burdens on their families, violent or suicidal, were calmed down immeasurably by the surgery. In a 1942 presentation at the New York Academy of Medicine, Freeman and his research partner James Watts reported that after lobotomy, patients did sometimes become “indolent” or “outspoken.” They were like “children,” and loving families could simply dismiss their lack of social graces because now they were so much happier.

Moniz, in a 1937 article on the procedure, describes curing a woman from Lisbon whose husband took her to the Congo, where she was unhappy and became “incapable of running her household.” So her husband forced her to go back to Lisbon alone, against her wishes, and she gradually became deeply upset because she was always “expecting horrible events” and believed people were out to kill her. In retrospect, it seems clear why she might have felt that way, but Moniz reports that after a frontal lobotomy she was cured, “though possibly a little reticent.” Though many of Moniz and Freeman’s patients became essentially catatonic, while others were unaffected, enough seemed “cured” that the lobotomy became standard practice in mental institutions in the 1940s and early 50s.

The icepick cure

Freeman apparently found Moniz’s techniques a bit stodgy, and he began experimenting with an outpatient procedure, where he would drive an icepick into his patients’ brains near the top of their eye sockets. Once the pick was inside the brain, he would literally wiggle it around, cutting through the white and gray matter. It was not a precision surgery. Using a hammer and his pick, he boasted that he could do a lobotomy in 10 minutes and didn’t even need anaesthesia (though usually he gave the patient shock treatment first, so they were unaware of what was happening). The icepick method was too much for Watts, who distanced himself from his former partner.

But Freeman became a big hit in America, where he toured hospitals performing the procedure and training psychologists to do it too. He even prescribed it for headaches. So many people wrote about Freeman’s work – he was a showman who invited press coverage – that he managed to popularize the surgery further. Of course, the lobotomy always had its critics. Doctors, as well as the families of patients, protested that the surgery did nothing more than turn people into vegetables. Sure, they might be easier to take care of, but were they really being helped? Or just snuffed out?

In 2005 NPR did an interesting profile of a man who was given a lobotomy by Freeman in the 1950s, because his stepmother felt that he was “savage” and refused to go to bed. The man was traumatized by the experience, but seemed to have suffered no ill effects – though of course, it’s impossible to know who he might have become if nobody had driven an icepick into his brain.

Rise of the lobectomy

These days, lobotomies are no longer performed on the mentally ill. The rise of drugs like thorazine make it easier to chemically lobotomize patients – no more messy ice picks. Though many doctors protest that these anti-psychotic drugs are just as bad as lobotomies once were, the justification for their use continues for the same reasons lobotomies were embraced 70 years ago. The patients often seem happier and more calm. Plus, they are less trouble to their families and caretakers.

A lobotomy-like procedure called the lobectomy, however, is on the rise. That’s because it’s actually an excellent way to treat extreme cases of epilepsy as well as other seizure disorders. Over time, epileptic seizures can cause irreparable brain damage, so it’s often considered better to remove the anterior temporal lobe of the brain so that seizures simply can’t happen. This is what lobectomies usually are, and ten years ago an article in the New England Journal of Medicine reported a that a randomized, controlled trial of epilepsy patients getting the surgery revealed that indeed it is probably the best treatment we have in these difficult cases.

Unlike Freeman’s “go in through the eyes” technique, these surgeries are performed in a very precise way. They may leave patients with a slightly different personality, but they are able to return to normal life. They are also far more likely to survive without suffering from brain-damaging seizures.

And so, from a terrifying medical practice we’ve gotten at least one good form of therapy. And a reminder that one generation’s Nobel Prize-winning cure is another generation’s worst nightmare.

Watch an overview of Freeman’s lobotomy procedure:

Although acupuncture is commonly used for pain control, doubts about its effectiveness and safety remain. Investigators from the Universities of Exeter & Plymouth (Exeter, UK) and the Korea Institute of Oriental Medicine (Daejeon, South Korea) critically evaluated systematic reviews of acupuncture as a treatment of pain in order to explore this question. Reporting in the April 2011 issue of PAIN®, they conclude that numerous systematic reviews have generated little truly convincing evidence that acupuncture is effective in reducing pain, and serious adverse effects continue to be reported.

“Many systematic reviews of acupuncture for pain management are available, yet they only support few indications, and contradictions abound,” commented lead investigator Professor Edzard Ernst, MD, PhD, Laing Chair in Complementary Medicine, Peninsula Medical School, Universities of Exeter & Plymouth, UK. “Acupuncture remains associated with serious adverse effects. One might argue that, in view of the popularity of acupuncture, the number of serious adverse effects is minute. We would counter, however, that even one avoidable adverse event is one too many. The key to making progress would be to train all acupuncturists to a high level of competency.”

Researchers carefully identified and critically examined systematic reviews of acupuncture studies for pain relief and case reviews reporting adverse effects. Reviews were defined as systematic if they included an explicit Methods section describing the search strategy and inclusion/exclusion criteria. Systematic reviews had to focus on the effectiveness of any type of acupuncture for pain. Of the 266 articles found, 56 were categorized as acceptable systematic reviews.

The authors observe that recent results from high-quality randomized controlled trials have shown that various forms of acupuncture, including so-called “sham acupuncture,” during which no needles actually penetrate the skin, are equally effective for chronic low back pain, and more effective than standard care. In these and other studies, the effects were attributed to such factors as therapist conviction, patient enthusiasm or the acupuncturist’s communication style.

If even sham acupuncture is as good as or better than standard care, then what is the harm? The answer lies in the adverse effect case studies. These studies were grouped into three categories: Infection (38 cases), trauma (42 cases) and other adverse effects (13 cases). Many of these adverse side effects are not intrinsic to acupuncture, but rather result from malpractice of acupuncturists. The most frequently reported complications included pneumothorax, (penetration of the thorax) and bacterial and viral infections. Five patients died after their treatment.

In an accompanying commentary, Harriet Hall, MD, states her position forcefully:

“Importantly, when a treatment is truly effective, studies tend to produce more convincing results as time passes and the weight of evidence accumulates. When a treatment is extensively studied for decades and the evidence continues to be inconsistent, it becomes more and more likely that the treatment is not truly effective. This appears to be the case for acupuncture. In fact, taken as a whole, the published (and scientifically rigorous) evidence leads to the conclusion that acupuncture is no more effective than placebo.”

Source: Science Daily

 

Henry Langlois was one of 38 soldiers who were told in 1955 that they were serving their country when they volunteered to inhale a biological agent that the government was testing.

A year later, inmates at the Ohio Penitentiary were told they were serving society when they volunteered to let researchers inject them with live cancer cells.

In the 1960s and 1970s, 15,000 Marines were told the same thing when Ohio State University scientists tested a pneumonia vaccine on them.

These and other government-funded experiments on military personnel, prisoners and mental patients are driving an investigation into the rules that are meant to protect people who volunteer for scientific studies.

The Presidential Commission for the Study of Bioethical Issues met last week to discuss “human subjects protection” after the government apologized in October for a 1940s-era experiment. In the research, Guatemalan soldiers, prisoners and mental patients were infected with syphilis to test penicillin treatments.

As the commission prepares a report it is to deliver to President Barack Obama in September, its work is stirring up memories.

Langlois, a 74-year-old Hilliard retiree, calls the summer that he participated in Q-fever tests at the Army’s Dugway Proving Grounds in Utah a mistake. He blames the government test for two leaky heart valves that a surgeon replaced in 2003.

Q fever is a disease caused by the bacterium Coxiella burnetii, which usually affects animals.

“They could not explain what caused it. I never smoked in my life,” Langlois said of his damaged heart. “When you are 18 years old, you do dumb things.”

At the time, such experiments were not unusual.

“It was kind of a free-for-all. It seemed like it was unregulated and uncontrolled,” said Karla Zadnik, chairwoman of one of three OSU committees that review proposals for research involving human subjects. Each year, OSU researchers conduct as many as 5,000 studies that involve human subjects.

“There are people here who work really, really hard every day to prevent anything even close to those events of the past from ever happening,” she said.

A review of Dispatch archives revealed several studies in the 1950s and 1960s that used prisoners at the old Ohio Pen. They included a vaccine test in which inmates were infected with tularemia, or rabbit fever, and a test of fluoride pills to determine their effect on human blood.

In 1958, tranquilizers were tested on 90 prisoners.

Perhaps the most famous was the cancer-vaccine test. As many as 160 prisoners were injected with live cancer cells.

The study, co-sponsored by Ohio State and the Sloan-Kettering Research Institute, ran from 1956 until 1961. Eventually, researchers said they lost track of most of the prisoners and thus had no results.

Zadnik said experiments such as that would not be approved today. There would be too many concerns about scientific value, risks and whether inmates and troops were pushed to volunteer.

“That’s a vulnerable population you could take advantage of,” she said.

Today, researchers must assure review boards that test subjects are fully aware of potential risks and benefits. That’s called “informed consent.”

Arthur Caplan, director of the University of Pennsylvania’s Bioethics Center in Philadelphia, said even tougher protections are needed. He said U.S. research increasingly involves human test subjects in other countries, and it’s not always clear whether the same rules are applied there.

And as industries such as pharmaceutical companies increasingly fund research efforts, there are growing concerns about whether finances are influencing the studies.

“Research itself is changing,” Caplan said. “You don’t want to (oversee) a 21st-century research enterprise with a 1970s guidance system.”

Source: Columbus Dispatch

 

 

Shocking as it may seem, U.S. government doctors once thought it was fine to experiment on disabled people and prison inmates. Such experiments included giving hepatitis to mental patients in Connecticut, squirting a pandemic flu virus up the noses of prisoners in Maryland, and injecting cancer cells into chronically ill people at a New York hospital.

Much of this horrific history is 40 to 80 years old, but it is the backdrop for a meeting in Washington this week by a presidential bioethics commission. The meeting was triggered by the government’s apology last fall for federal doctors infecting prisoners and mental patients in Guatemala with syphilis 65 years ago.

U.S. officials also acknowledged there had been dozens of similar experiments in the United States – studies that often involved making healthy people sick.

An exhaustive review by The Associated Press of medical journal reports and decades-old press clippings found more than 40 such studies. At best, these were a search for lifesaving treatments; at worst, some amounted to curiosity-satisfying experiments that hurt people but provided no useful results.

Inevitably, they will be compared to the well-known Tuskegee syphilis study. In that episode, U.S. health officials tracked 600 black men in Alabama who already had syphilis but didn’t give them adequate treatment even after penicillin became available.

These studies were worse in at least one respect – they violated the concept of “first do no harm,” a fundamental medical principle that stretches back centuries.

“When you give somebody a disease – even by the standards of their time – you really cross the key ethical norm of the profession,” said Arthur Caplan, director of the University of Pennsylvania’s Center for Bioethics.

Some of these studies, mostly from the 1940s to the ’60s, apparently were never covered by news media. Others were reported at the time, but the focus was on the promise of enduring new cures, while glossing over how test subjects were treated.

Attitudes about medical research were different then. Infectious diseases killed many more people years ago, and doctors worked urgently to invent and test cures. Many prominent researchers felt it was legitimate to experiment on people who did not have full rights in society – people like prisoners, mental patients, poor blacks. It was an attitude in some ways similar to that of Nazi doctors experimenting on Jews.

“There was definitely a sense – that we don’t have today – that sacrifice for the nation was important,” said Laura Stark, a Wesleyan University assistant professor of science in society, who is writing a book about past federal medical experiments.

The AP review of past research found:

-A federally funded study begun in 1942 injected experimental flu vaccine in male patients at a state insane asylum in Ypsilanti, Mich., then exposed them to flu several months later. It was co-authored by Dr. Jonas Salk, who a decade later would become famous as inventor of the polio vaccine.

Some of the men weren’t able to describe their symptoms, raising serious questions about how well they understood what was being done to them. One newspaper account mentioned the test subjects were “senile and debilitated.” Then it quickly moved on to the promising results.

-In federally funded studies in the 1940s, noted researcher Dr. W. Paul Havens Jr. exposed men to hepatitis in a series of experiments, including one using patients from mental institutions in Middletown and Norwich, Conn. Havens, a World Health Organization expert on viral diseases, was one of the first scientists to differentiate types of hepatitis and their causes.

A search of various news archives found no mention of the mental patients study, which made eight healthy men ill but broke no new ground in understanding the disease.

-Researchers in the mid-1940s studied the transmission of a deadly stomach bug by having young men swallow unfiltered stool suspension. The study was conducted at the New York State Vocational Institution, a reformatory prison in West Coxsackie. The point was to see how well the disease spread that way as compared to spraying the germs and having test subjects breathe it. Swallowing it was a more effective way to spread the disease, the researchers concluded. The study doesn’t explain if the men were rewarded for this awful task.

-A University of Minnesota study in the late 1940s injected 11 public service employee volunteers with malaria, then starved them for five days. Some were also subjected to hard labor, and those men lost an average of 14 pounds. They were treated for malarial fevers with quinine sulfate. One of the authors was Ancel Keys, a noted dietary scientist who developed K-rations for the military and the Mediterranean diet for the public. But a search of various news archives found no mention of the study.

-For a study in 1957, when the Asian flu pandemic was spreading, federal researchers sprayed the virus in the noses of 23 inmates at Patuxent prison in Jessup, Md., to compare their reactions to those of 32 virus-exposed inmates who had been given a new vaccine.

-Government researchers in the 1950s tried to infect about two dozen volunteering prison inmates with gonorrhea using two different methods in an experiment at a federal penitentiary in Atlanta. The bacteria was pumped directly into the urinary tract through the penis, according to their paper.

The men quickly developed the disease, but the researchers noted this method wasn’t comparable to how men normally got infected – by having sex with an infected partner. The men were later treated with antibiotics. The study was published in the Journal of the American Medical Association, but there was no mention of it in various news archives.

Though people in the studies were usually described as volunteers, historians and ethicists have questioned how well these people understood what was to be done to them and why, or whether they were coerced.

Prisoners have long been victimized for the sake of science. In 1915, the U.S. government’s Dr. Joseph Goldberger – today remembered as a public health hero – recruited Mississippi inmates to go on special rations to prove his theory that the painful illness pellagra was caused by a dietary deficiency. (The men were offered pardons for their participation.)

But studies using prisoners were uncommon in the first few decades of the 20th century, and usually performed by researchers considered eccentric even by the standards of the day. One was Dr. L.L. Stanley, resident physician at San Quentin prison in California, who around 1920 attempted to treat older, “devitalized men” by implanting in them testicles from livestock and from recently executed convicts.

Newspapers wrote about Stanley’s experiments, but the lack of outrage is striking.

“Enter San Quentin penitentiary in the role of the Fountain of Youth – an institution where the years are made to roll back for men of failing mentality and vitality and where the spring is restored to the step, wit to the brain, vigor to the muscles and ambition to the spirit. All this has been done, is being done … by a surgeon with a scalpel,” began one rosy report published in November 1919 in The Washington Post.

Around the time of World War II, prisoners were enlisted to help the war effort by taking part in studies that could help the troops. For example, a series of malaria studies at Stateville Penitentiary in Illinois and two other prisons was designed to test antimalarial drugs that could help soldiers fighting in the Pacific.

It was at about this time that prosecution of Nazi doctors in 1947 led to the “Nuremberg Code,” a set of international rules to protect human test subjects. Many U.S. doctors essentially ignored them, arguing that they applied to Nazi atrocities – not to American medicine.

The late 1940s and 1950s saw huge growth in the U.S. pharmaceutical and health care industries, accompanied by a boom in prisoner experiments funded by both the government and corporations. By the 1960s, at least half the states allowed prisoners to be used as medical guinea pigs.

But two studies in the 1960s proved to be turning points in the public’s attitude toward the way test subjects were treated.

The first came to light in 1963. Researchers injected cancer cells into 19 old and debilitated patients at a Jewish Chronic Disease Hospital in the New York borough of Brooklyn to see if their bodies would reject them.

The hospital director said the patients were not told they were being injected with cancer cells because there was no need – the cells were deemed harmless. But the experiment upset a lawyer named William Hyman who sat on the hospital’s board of directors. The state investigated, and the hospital ultimately said any such experiments would require the patient’s written consent.

At nearby Staten Island, from 1963 to 1966, a controversial medical study was conducted at the Willowbrook State School for children with mental retardation. The children were intentionally given hepatitis orally and by injection to see if they could then be cured with gamma globulin.

Those two studies – along with the Tuskegee experiment revealed in 1972 – proved to be a “holy trinity” that sparked extensive and critical media coverage and public disgust, said Susan Reverby, the Wellesley College historian who first discovered records of the syphilis study in Guatemala.

By the early 1970s, even experiments involving prisoners were considered scandalous. In widely covered congressional hearings in 1973, pharmaceutical industry officials acknowledged they were using prisoners for testing because they were cheaper than chimpanzees.

Holmesburg Prison in Philadelphia made extensive use of inmates for medical experiments. Some of the victims are still around to talk about it. Edward “Yusef” Anthony, featured in a book about the studies, says he agreed to have a layer of skin peeled off his back, which was coated with searing chemicals to test a drug. He did that for money to buy cigarettes in prison.

“I said ‘Oh my God, my back is on fire! Take this … off me!’” Anthony said in an interview with The Associated Press, as he recalled the beginning of weeks of intense itching and agonizing pain.

The government responded with reforms. Among them: The U.S. Bureau of Prisons in the mid-1970s effectively excluded all research by drug companies and other outside agencies within federal prisons.

As the supply of prisoners and mental patients dried up, researchers looked to other countries.

It made sense. Clinical trials could be done more cheaply and with fewer rules. And it was easy to find patients who were taking no medication, a factor that can complicate tests of other drugs.

Additional sets of ethical guidelines have been enacted, and few believe that another Guatemala study could happen today. “It’s not that we’re out infecting anybody with things,” Caplan said.

Still, in the last 15 years, two international studies sparked outrage.

One was likened to Tuskegee. U.S.-funded doctors failed to give the AIDS drug AZT to all the HIV-infected pregnant women in a study in Uganda even though it would have protected their newborns. U.S. health officials argued the study would answer questions about AZT’s use in the developing world.

The other study, by Pfizer Inc., gave an antibiotic named Trovan to children with meningitis in Nigeria, although there were doubts about its effectiveness for that disease. Critics blamed the experiment for the deaths of 11 children and the disabling of scores of others. Pfizer settled a lawsuit with Nigerian officials for $75 million but admitted no wrongdoing.

Last year, the U.S. Department of Health and Human Services’ inspector general reported that between 40 and 65 percent of clinical studies of federally regulated medical products were done in other countries in 2008, and that proportion probably has grown. The report also noted that U.S. regulators inspected fewer than 1 percent of foreign clinical trial sites.

Monitoring research is complicated, and rules that are too rigid could slow new drug development. But it’s often hard to get information on international trials, sometimes because of missing records and a paucity of audits, said Dr. Kevin Schulman, a Duke University professor of medicine who has written on the ethics of international studies.

These issues were still being debated when, last October, the Guatemala study came to light.

In the 1946-48 study, American scientists infected prisoners and patients in a mental hospital in Guatemala with syphilis, apparently to test whether penicillin could prevent some sexually transmitted disease. The study came up with no useful information and was hidden for decades.

The Guatemala study nauseated ethicists on multiple levels. Beyond infecting patients with a terrible illness, it was clear that people in the study did not understand what was being done to them or were not able to give their consent. Indeed, though it happened at a time when scientists were quick to publish research that showed frank disinterest in the rights of study participants, this study was buried in file drawers.

“It was unusually unethical, even at the time,” said Stark, the Wesleyan researcher.

“When the president was briefed on the details of the Guatemalan episode, one of his first questions was whether this sort of thing could still happen today,” said Rick Weiss, a spokesman for the White House Office of Science and Technology Policy.

That it occurred overseas was an opening for the Obama administration to have the bioethics panel seek a new evaluation of international medical studies. The president also asked the Institute of Medicine to further probe the Guatemala study, but the IOM relinquished the assignment in November, after reporting its own conflict of interest: In the 1940s, five members of one of the IOM’s sister organizations played prominent roles in federal syphilis research and had links to the Guatemala study.

So the bioethics commission gets both tasks. To focus on federally funded international studies, the commission has formed an international panel of about a dozen experts in ethics, science and clinical research. Regarding the look at the Guatemala study, the commission has hired 15 staff investigators and is working with additional historians and other consulting experts.

The panel is to send a report to Obama by September. Any further steps would be up to the administration.

Some experts say that given such a tight deadline, it would be a surprise if the commission produced substantive new information about past studies. “They face a really tough challenge,” Caplan said.

Source: Associated Press

 

 

James Randi launched a bold challenge Saturday that aims to debunk so-called homeopathic drugs. The fraud-busting magician even offered $1 million to any manufacturer who could prove they work as directed.

Finding science and medicine experts to defend homeopathy isn’t easy. The National Center for Complementary and Alternative Medicine offers a primer complete with an explanation of homeopathy regulation, the status of research and more.

The first two “key points” are especially notable, the first for the explanation, the second for the context.

“The principle of similars [or 'like cures like'] is a central homeopathic principle. The principle states that a disease can be cured by a substance that produces similar symptoms in healthy people.

“Most analyses have concluded that there is little evidence to support homeopathy as an effective treatment for any specific condition; although, some studies have reported positive findings.”

Respected skeptic Steven Barrett is more blunt. He says this about homeopathy: “Homeopathic ‘remedies’ enjoy a unique status in the health marketplace: They are the only category of quack products legally marketable as drugs.” That’s just the beginning of his essay. Read the full post on Barrett’s site,Quackwatch.

The National Center for Homeopathy would disagree, of course. And it helpfully distinguishes between “homeopathic” and “herbal” for those who consider all nonprescription or “alternative” products virtually the same. “Homeopathy is a system of medical therapy that uses very small doses of medicines, or remedies. These remedies are prepared from substances found in nature. Nevertheless, homeopathy should not be confused with herbal medicine. These two systems of medicine are very different. Herbal medicine uses tinctures of botanical substances, whereas homeopaths use ultradilute ‘micro’ doses made from not only plants, but minerals or any other substance found in nature.”

In the meantime, we’ll wait to see whether anyone takes Randi up on his challenge.

Source: LA Times

AUSTRALIAN medical students are carrying out intrusive procedures on unconscious and anaesthetised patients without gaining the patient’s consent.

The unauthorised examinations include genital, rectal and breast exams, and raise serious questions about the ethics of up-and-coming doctors, Madison reports.

The research, soon to be published in international medical journal, Medical Education, describes – among others – a student with “no qualms” about performing an anal examination on a female patient because she didn’t think the woman’s consent was relevant.

Another case outlined in the research describes a man who was subjected to rectal examinations from a “queue” of medical students after he was anaesthetised for surgery.

“I was in theatre, the patient was under a spinal (anaesthetic) as well and there was a screen up and they just had a queue of medical students doing a rectal examination,” a student confessed.

“[H]e wasn’t consented but because … you’re in that situation, you don’t have the confidence to say ‘no’ you just do it.”

The author of the study, Professor Charlotte Rees, voiced concerns about senior medical staff ordering students to perform unauthorised procedures, leaving the students torn between the strong ethics of consent in society and the weak ethics of medical staff.

Of students who were put in this position during the research, 82 per cent obeyed orders.

“We think that it is weakness in the ethical climate of the clinical workplace that ultimately serves to legitimise and reinforce unethical practices in the context of students learning intimate examinations,” writes Prof Rees.

The study consists of 200 students across three unnamed medical schools in Britain and Australia. Not all participants agreed to carry out the intimate examinations without permission from the patient.

One student refused to take part in an examination of a woman who was “part spread-eagled on the bed and the nurse is (sic) pulling down her jeans at the same time and it was all very complicated and you could see her, she was about seventeen”.

Carol Bennett, the CEO of the Consumer Health Forum, said the report was a “poor reflection on these medical schools that they are setting these examples”.

“Most people would not be pleased about having medical procedures performed on them without it even being mentioned to them,” she told news.com.au.

“Patients should never be examined without consent, particularly by a third party.”

Comment is being sought from the Australian Medical Association.

Source: News.com.au