Molecules to Medicine: Should pepper spray be put on (clinical) trial?

Pepper spray is all over the news, following the Occupy Wall Street protests, particularly following the widely disseminated images and videos of protestors being sprayed in NY, Portland, andUCDavis.
Before that, I knew and occasionally used its main ingredient, capsaicin, as a treatment for my patients with shingles, an extremely painful Herpes zoster infection. And I knew about the many of the serious side effects of pepper spray, well-described by Deborah Blum.
Recently though, other questions arose, like “How was this learned?”. So off I went, looking for clinical trials to see what, if anything, had been studied, beyond the individual patient, poison control, and toxicology reports. Here’s what I learned:

There are reports of the efficacy of capsaicin in crowd control, but little regarding trials of exposures. Perhaps this is because pepper spray is regulated by the Environmental Protection Agency, as a pesticide and not by the FDA.

The concentration of capsaicin in bear spray is 1-2%; it is 10-30% in “personal defense sprays.”

While the police might feel reassured by the study, “The effect of oleoresin capsicum “pepper” spray inhalation on respiratory function,” I was not. This study met the “gold standard” of clinical trials, in that it was a “randomized, cross-over controlled trial to assess the effect of Oleoresin capsicum (OC) spray inhalation on respiratory function by itself and combined with restraint.” However, while the OC exposure showed no ill effect, only 34 volunteers were exposed to only 1 sec of Cap-Stun 5.5%OC spray by inhalation “from 5 ft away as they might in the field setting (as recommended by both manufacturer and local police policies).”

By contrast, an ACLU report, “Pepper Spray Update: More Fatalities, More Questions” found, in just two years, 26 deaths after OC spraying, noting that death was more likely if the victim was also restrained. This translated to 1 death per 600 times police used spray. (The cause of death was not firmly linked to the OC). According to the ACLU, “an internal memorandum produced by the largest supplier of pepper spray to the California police and civilian markets” concludes that there may be serious risks with more than a 1 sec spray. A subsequent Department of Justice study examined another 63 deaths after pepper spray during arrests; the spray was felt to be a “contributing factor” in several.

A review in 1996 by the Division of Epidemiology of the NC DHHS and OSHA concluded that exposure to OC spray during police training constituted an unacceptable health risk.

Surveillance into crowd control agents examined reports to the British National Poisons Information Service, finding more late (>6 hour) adverse events than had been previously noted, especially skin reactions (blistering, rashes).

Studies have, understandably, more looked at treatment than at systematically exploring toxic effects of pepper spray. An uncontrolled California Poison Control study of 64 patients with exposure to capsaicin (as spray or topically as a cream) showed benefit with topically applied antacids, especially if applied soon after exposure.

In a randomized clinical trial, 47 subjects were assigned to a placebo, a topical nonsteroidal anti-inflammatory agent, or a topical anesthetic. The only group with significant symptomatic improvement in pain received proparacaine hydrochloride 0.5%–and only 55% had decreased pain with treatment.

Another randomized controlled trial looked at 49 volunteers who were treated with one of five treatment groups(aluminum hydroxide–magnesium hydroxide [Maalox], 2% lidocaine gel, baby shampoo, milk, or water). There was a significant difference in pain with more rapid treatment, but not between the groups.

I was most impressed with the efforts of the Black Cross Health Collective in Portland, Oregon. These activists have been thoughtfully approaching studying treatments for pepper spray exposures with published clinical trial protocols, where each volunteer also serves as their own control. Capsaicin is applied to each arm; a “subject-blinded” treatment is applied to one arm, and differences in pain responses are recorded. I love that they are looking for evidenced based solutions.

So far, antacids have been the most effective.

Suggestions for further study

Pepper spray causes inflammation and swelling—particularly a danger for those with underlying asthma or emphysema. In fact, the Department of Justice report notes that in two of 63 clearly documented deaths, the subjects were asthmatic. If they don’t already, police need to have protocols in place to identify and treat “sprayees” who have these pre-existing conditions that predispose them to serious harm from the spray. This particularly holds true for people also at risk for respiratory compromise from being restrained, on other drugs, or with obesity. The study of restrained healthy volunteers exposed to small amounts of capsaicin is simply not applicable to the general population. Also, given that these compounds appear to have delayed effects, there should be legally required medical monitoring of “sprayees” at regular and frequent intervals for at least 24 hours—by someone competent. (Iraq war veteran Kayvan Sabehgi could easily have died from the lacerated spleen sustained in his beating by police. It was 18 hours before he was taken to the hospital, after the jail’s nurse reportedly only offered him a suppository for his abdominal pain. There is also an, as yet unconfirmed report, of a miscarriage after the Portland, Oregon OWS protest last week).

Unfortunately, there is an urgent need for clinical trials in this area—both retrospective assessments of “sprayees” health outcomes, and prospective randomized trials [like the trial done on subjects' arms] to elucidate the effects of various capsaicin concentrations, carrier solvents and propellents and to identify the most effective treatments for each mixture. Until those can be done, there should be a thorough outcomes registry kept, with standardized data being obtained on all those subsequent to being pepper-sprayed.

Sadly, I’m sure the Black Cross and others in the Occupy Wall Street movement will have too many opportunities to test therapies against painful crowd-control chemicals. Studies will be difficult because the settings are largely uncontrolled and because the sprays have different concentrations of capsaicin, carrier solvents, and propellants.

Until then, there should be a moratorium on the use of pepper spray or other “non-lethal” chemicals by police, except in clearly life-threatening confrontations, due to the high number of associated deaths until the risks are better understood?

Perhaps Kamran Loghman, who helped the FBI weaponize pepper spray, will be dismayed enough at the “inappropriate and improper use of chemical agents” to help the Black Cross develop effective antidotes…One can only hope.

Courtesy of Scientific American guest blogger Judy Stone

Beyond Condoms: The Long Quest for a Better Male Contraceptive

A joke among researchers in the field of male contraception is that a clinically approved alternative to condoms or vasectomy has been five to 10 years away for the past 40 years. The so-close-yet-so-far state of male contraceptive development has persisted in large part because of three serious hurdles: the technical challenges of keeping millions of sperm at bay, the stringent safety standards that a drug intended for long-term use in healthy people must meet, and, ultimately, the question of whether men will use it.

Any sex-ed grad can tell you: the only two effective contraceptives for men today are condoms and vasectomy. Condoms have been around for at least 300 years, with early versions made of animal intestines. Today's rubber prophylactics are relatively cheap and widely available, offer bonus protection against sexually transmitted infections, and are 98 percent effective against pregnancy if used properly. On the other hand, surgery to cut the vas deferens (sperm ducts) is nearly foolproof in pregnancy prevention but is usually considered irreversible and tantamount to sterilization. "It's appalling that besides condoms men only have a surgical nonreversible method," says Regine Sitruk-Ware, a reproductive endocrinologist at the Population Council in New York City.

For decades the promise seemed to lie in a hormonal approach—an analogue to the female birth control pill—that would adjust the hormones controlling sperm production. Inconsistent results among men and side effects associated with long-term testosterone use have, however, led some researchers lately to set their sights elsewhere. Newer, nonhormonal methods target various developmental nodes in the formation of sperm, their motility and their egg-penetrating capabilities. There is also work on a form of reversible vasectomy which involves blocking the vas deferens with a polymer gel that may later be dissolved.

Most of the new alternatives under development are geared toward men in long-term relationships who seek a dependable, reversible form of contraception. Increasingly, men want more control over their fertility, and many would like to share the burden of contraception with their female partners. For couples in which the woman cannot handle female birth control for whatever reason—in some women, hormonal contraceptives can cause significant side effects such as bleeding, reduced libido and increased cardiovascular risks; IUDs (intrauterine devices) can cause severe cramps; diaphragms can kill spontaneity and require manual insertion—male contraception may be the best or only option. "It's really an unmet need," Sitruk-Ware says.

About half of pregnancies in the U.S. are unplanned and half of these end in abortion. An effective male contraceptive might have salutary implications for population growth worldwide, but for William Bremner, who leads the Center for Research in Reproduction and Contraception at the University of Washington (U.W.) in Seattle, the goal is providing options to individual couples. "If people had effective methods and real choices, there would be fewer unwanted children and markedly fewer abortions," he says.

Worthy intentions, notwithstanding, the reality is that funding has been a continual challenge for the field. The National Institutes of Health (NIH) currently provides nearly all of the funding for male contraception research in the U.S.—and for some international studies, too. Researchers agree that for a new contraceptive to come to market, support from pharmaceutical companies is a practical necessity, but interest in the industry has been waning in recent years. A major blow came in 2006 when two major companies that had been on board, Schering AG and Organon, shut down their joint hormonal male contraceptive program soon after Schering's acquisition by Bayer. That meant the end of a major funding stream as well as the loss of any research advances that had been made by the project. "Unfortunately, the people who were working on it are under obligation to keep confidential the information, in case they ever go back to it," says Diana Blithe, director of the Male Contraceptive Development Program at the NIH.

Hobbling sperm without hormones
Although none have reached clinical trial stage, nonhormonal methods of male contraception are gaining traction. About three or four years ago, John Amory, a researcher and clinician at U.W. who has been working on hormonal methods for many years, became interested in a nonhormonal target: retinoic acid, a metabolite of vitamin A that is essential for spermatogenesis. In animal models the compound bisdichloroacetyldiamine safely and reversibly induces infertility by inhibiting an enzyme, aldehyde dehydrogenase 1a2, required for retinoic acid synthesis in the testes. Unfortunately, bisdichloroacetyldiamine also inhibits a similar enzyme, aldehyde dehydrogenase 2, required for alcohol metabolism in the liver—meaning that animals on bisdichloroacetyldiamine were unable to process alcohol. "And some would say that if it weren't for alcohol no one would need a contraceptive anyway," jokes Amory, who is working on ways to more specifically inhibit aldehyde dehydrogenase 1a2. In another approach, detailed June 1 in Endocrinology, Debra Wolgemuth's lab at Columbia University used a synthetic retinoid to block retinoid acid receptors, achieving reversible infertility in mice.

Several labs are also looking at ways to thwart sperms' ability to find and swim toward the egg. A group of proteins known as CatSpers controls hyperactivation—the frenzied flagellar beating of sperm tails after ejaculation. Two studies published in March found that progesterone and high-pH, or alkalinity, around an egg act on CatSpers to turn on hyperactivation. Because CatSpers are believed to be found only on sperm, drugs targeted specifically to these proteins would presumably have few side effects elsewhere in the body.

Other agents being investigated, including gamendazole and adjudin, target the Sertoli cells within the testes that provide crucial nourishment to growing sperm. None of these nonhormonal drugs will be tested in humans for at least another two or three years, Sitruk-Ware says. Once a contraceptive target is determined, researchers can use high-throughput screening technology to check thousands of compounds for drug potential.

The dark horse
The most tireless advocate for new male contraceptives may be Elaine Lissner, director of the one-woman operation Male Contraception Information Project, which tries to raise public awareness of nonhormonal male contraceptives. In particular, she has been trumpeting a particular method known as reversible inhibition of sperm under guidance (RISUG). Developed and currently undergoing clinical trials in India, RISUG involves a small incision in the scrotum and injection of a polymer gel into the vas deferens, the same tubes severed in vasectomy. (Vasectomy is reversible in some cases with expensive microsurgery to reconnect the vas deferens. Complications such as anti-sperm antibodies that form when sperm leaks into the body during vasectomy, however, make reversal more than a problem of plumbing.) The porous polymer does not block the flow of sperm but purportedly renders sperm inert by disrupting the chemistry of their cell membranes. Although many researchers appreciate Lissner's advocacy efforts, they do not necessarily share her enthusiasm for RISUG, which is still untested the U.S.

RISUG's fighting chance, touted by its supporters, is its potential reversibility. In nonhuman primates, reversibility has been achieved by dissolving the polymer with an injected solvent. In Amory's view, however, "until they demonstrate reversibility in humans, it's really no different than a vasectomy," although, he adds, "I'd love it if this worked."

Lissner, who is not a scientist herself, bought the international rights to RISUG last year and has created a foundation called Parsemus to develop the procedure in the U.S. That means starting from square one, with toxicology testing and small animal studies. Lissner hopes to eventually get the procedure, now re-branded as Vasalgel, approved as a medical device in the U.S. Before that happens, however, Vasalgel, like all other contenders in the male contraceptive line-up will have to catch the eye of a funding source.

The current status of hormonal methods
The female birth control pill, which went on the market in 1960, increases levels of progesterone to suppress ovulation; similarly, a male hormonal contraceptive would increase levels of testosterone to suppress sperm production. Testosterone inhibits the release of two pituitary hormones, luteinizing hormone (LH) and follicle-stimulating hormone (FSH), which control in the testes testosterone production and spermatogenesis, respectively. Thus, testosterone works in a negative feedback loop with LH and FSH to maintain relatively constant levels of testosterone in the blood. A male contraceptive that delivers extra testosterone into the bloodstream sends a signal to the pituitary to suppress the hormones that promote sperm production.

For women, the birth control pill replicates the body's natural state of infertility—pregnancy—and essentially fools the body into acting as if it were pregnant. "Men don't have an analogous time. After puberty they keep making sperm until they die," Amory explains.

Compared with the one-egg-per-month output of the female reproductive system, the roughly 1,000-sperm-per-heartbeat output of the male reproductive system is "a quantitatively challenging problem" for contraceptive research, Amory says. Thankfully for Amory's cohort, effective male contraception does not require complete obliteration of sperm production. Only about 5 percent of sperm are functional to begin with, Amory estimates, and very few of these high-quality sperm will survive the arduous journey to the egg. Lowering sperm count to less than one million per milliliter of ejaculate from the normal range of 20 million to 30 million per milliliter results in de facto infertility.

Though often referred to as the "male pill," male hormonal contraceptives in development are mostly synthetic testosterone delivered in the form of injections, slow-release implants or rub-on gels that absorb through the skin. (Oral ingestion of testosterone is less effective because much of the hormone is then broken down by the liver.) Adding progesterone (a female sex hormone), which also suppresses spermatogenesis, to a testosterone regimen improves contraceptive outcomes. The testosterone–progesterone combination achieves effective contraception for more than 90 percent of men—but for reasons that are still unclear, there are always some men for whom sperm production is insufficiently suppressed. For comparison, the female pill is about 98 percent effective when taken correctly.

In April a clinical trial of injections of long-acting progestin (synthetic progesterone) and testosterone was ended early due to higher than expected rates of minor side effects such as irritability and acne among the 321 participants. The trial was a collaboration between the World Health Organization and CONRAD, an Arlington, Va.–based nonprofit that supports reproductive health research. Douglas Colvard, deputy director of programs at CONRAD, expressed disappointment at the end of the trial but was optimistic there would be valuable data from the third of participants who had completed 12 months of injections.

A clinical trial of a contraceptive implant, led by the Population Council, the University of California, Los Angeles, and U.W., will begin late this year or early 2012, according to Sitruk-Ware. The implant, which is matchstick-size and placed under the skin of the upper arm, contains a modified synthetic steroid that resembles testosterone but should not have the same effect on prostate growth sometimes associated with testosterone treatments.

"The idea is a good one," Amory says of male hormonal contraception, "and it works most of the time, but not well enough for a pharmaceutical company to jump in and put some money and time into it."

Do men really want it?
When asked whether a new contraceptive will appeal to men, researchers are quick to point out that men are already responsible for 30 percent of contraception in developed countries (and 14 percent in developing countries), split about evenly between condoms and vasectomies. Even if that is the minority of sexual partners, those figures still add up to hundreds of millions of men.

A 2002 survey of 9,000 men in nine countries across four continents found that more than 55 percent of men would be willing to use a hormonal form of contraception. In a 1996 survey of nearly 2,000 women in Scotland, China and South Africa 87 percent thought that a hormonal male contraceptive was "a good idea" and 98 percent of women said they would trust their partners to use a hypothetical "male pill". "Of course, we don't really know for sure what people will do," Amory says. "All surveys have that limitation."

The risk–benefit analysis for male contraceptives is different from that of female contraceptives because at the end of the day, men are not the ones getting pregnant, Colvard says. For that reason, future male contraceptives may come with incentives other than pregnancy prevention: side benefits such as muscle gain, fat loss and even baldness prevention.

(Of course, infertility is a well-known side effect of testosterone doping in athletes. Although testosterone used for contraceptive purposes would show up on a drug test, according to Amory, the levels are far below those needed for significant muscle enhancement.)

Although many men may welcome new contraceptive options, there is not the same momentum that pushed female contraception. "We don't see groups of men going on the streets," Sitruk-Ware says. "On the other hand, when we do clinical trials in various countries the men are very interested."

For now, researchers and consumers can only assume that when presented with a full pipeline of new drugs and better data on the safety, efficacy and public acceptability of male contraceptives, pharmaceutical companies will eventually see an opportunity for their profit margins. The hope is, "If you make it, they will come," NIH's Blithe says.

Source Scientific American

How serious is son preference in China?

Why are female foetuses aborted in China? Does an increase in the number of abortions of female foetuses reflect an increase in son preference? Sociologist Lisa Eklund from Lund University in Sweden has studied why families in China have a preference for sons.

At the time of the census in 2005, almost 121 boys were born for every 100 girls. Last year's census showed that sex ratio at birth (SRB) had improved somewhat. But it is still too early to celebrate, in Eklund's view: the narrowing of the gap does not necessarily mean that girls are valued more highly.

Because of the high SRB, there has been a tendency to picture China as a country where son preference is strong and possibly increasing since the 1980s. However, Eklund argues in her PhD thesis that using SRB as a proxy indicator for son preference is problematic. She has therefore developed a model to estimate what she calls "son compulsion", where data on SRB and total fertility rate are used to estimate the proportion of couples who wants to give birth to at least one son and who take action to achieve that goal. When looking at variation in son compulsion over time and between regions, Eklund finds that new patterns emerge that do not surface when using SRB as a proxy indicator. Contrary to popular belief, son compulsion remained steady in rural China (at around 10 per cent) while it increased in urban China in the 1990s (from 2.8 per cent to 4.5 per cent).

"This doubling concurred in time with cuts in the state welfare system in the cities, which meant that adult sons were given a more important role in providing for the social and financial security of the elderly", she says. Her findings call into question the assumption that son preference is essentially a rural issue. They also have implications for comparative perspectives and her findings suggest that son compulsion may be higher in other countries even though they expose lower SRB.

When it emerged that far more boys than girls were being born in China, the Chinese government launched the Care for Girls Campaign to improve the value of the girl child and to prevent sex-selective abortion. Nonetheless, the imbalance between the sexes continued to increase. Eklund's findings suggest that the campaign may actually have done more harm than good. Families receive extra support if they have girls and in rural areas exceptions are made from the one-child policy if the first child is a girl.
"By compensating parents of girls in various ways, the government reinforces the idea that girls are not as valuable as boys", says Eklund.
Eklund further challenges the notion that families in rural areas want sons because sons are expected to take over the farming.

"That is a weak argument", says Eklund. "Young people, both men and women, are moving away from rural areas. Of those who stay, women provide just as much help as men. In fact, it is the elderly who end up taking greater responsibility for the agriculture."
However, there are also other reasons why sons are seen as more important for families. Traditionally, a girl moves in with her husband's family when she gets married and she thus cannot look after her own parents when they grow old. Boys also play an important role in ancestor worship, and they ensure that the family name lives on.

Eklund further finds that there is a stubbornness in both popular and official discourses to view son preference as a matter of parents and grandparents without looking at structural factors that help underpin the institution of son preference.

Source  EurekaAlert!

Bipolar kids: Victims of the 'madness industry'?

THERE'S a children's picture book in the US called Brandon and the Bipolar Bear. Brandon and his bear sometimes fly into unprovoked rages. Sometimes they're silly and overexcited. A nice doctor tells them they are ill, and gives them medicine that makes them feel much better.

The thing is, if Brandon were a real child, he would have just been misdiagnosed with bipolar disorder.

Also known as manic depression, this serious condition, involving dramatic mood swings, is increasingly being recorded in American children. And a vast number of them are being medicated for it.

 Kids' stuff?

The problem is, this apparent epidemic isn't real. "Bipolar emerges from late adolescence," says Ian Goodyer, a professor in the department of psychiatry at the University of Cambridge who studies child and adolescent depression. "It is very, very unlikely indeed that you'll find it in children under 7 years."

How did this strange, sweeping misdiagnosis come to pass? How did it all start? These were some of the questions I explored when researching The Psychopath Test, my new book about the odder corners of the "madness industry".

Freudian slip

The answer to the second question turned out to be strikingly simple. It was really all because of one man: Robert Spitzer.

I met Spitzer in his large, airy house in Princeton, New Jersey. In his eighties now, he remembered his childhood camping trips to upstate New York. "I'd sit in the tent, looking out, writing notes about the lady campers," he said. "Their attributes." He smiled. "I've always liked to classify people."

The trips were respite from Spitzer's "very unhappy mother". In the 1940s, the only help on offer was psychoanalysis, the Freudian-based approach of exploring the patient's unconscious. "She went from one psychoanalyst to another," said Spitzer. He watched the psychoanalysts flailing uselessly. She never got better.

Spitzer grew up to be a psychiatrist at Columbia University, New York, his dislike of psychoanalysis remaining undimmed. And then, in 1973, an opportunity to change everything presented itself. There was a job going editing the next edition of a little-known spiral-bound booklet called DSM - the Diagnostic and Statistical Manual of Mental Disorders.

DSM is simply a list of all the officially recognised mental illnesses and their symptoms. Back then it was a tiny book that reflected the Freudian thinking predominant in the 1960s. It had very few pages, and very few readers.

What nobody knew when they offered Spitzer the job was that he had a plan: to try to remove human judgement from psychiatry. He would create a whole new DSM that would eradicate all that crass sleuthing around the unconscious; it hadn't helped his mother. Instead it would be all about checklists. Any psychiatrist could pick up the manual, and if the patient's symptoms tallied with the checklist for a particular disorder, that would be the diagnosis.

For six years Spitzer held editorial meetings at Columbia. They were chaos. The psychiatrists would yell out the names of potential new mental disorders and the checklists of their symptoms. There would be a cacophony of voices in assent or dissent - the loudest voices getting listened to the most. If Spitzer agreed with those proposing a new diagnosis, which he almost always did, he'd hammer it out instantly on an old typewriter. And there it would be, set in stone.

That's how practically every disorder you've ever heard of or been diagnosed with came to be defined. "Post-traumatic stress disorder," said Spitzer, "attention-deficit disorder, autism, anorexia nervosa, bulimia, panic disorder..." each with its own checklist of symptoms. Bipolar disorder was another of the newcomers. The previous edition of the DSM had been 134 pages, but when Spitzer's DSM-III appeared in 1980 it ran to 494 pages.

"Were there any proposals for mental disorders you rejected?" I asked Spitzer. "Yes," he said, "atypical child syndrome. The problem came when we tried to find out how to characterise it. I said, 'What are the symptoms?' The man proposing it replied: 'That's hard to say because the children are very atypical'."

He paused. "And we were going to include masochistic personality disorder." He meant battered wives who stayed with their husbands. "But there were some violently opposed feminists who thought it was labelling the victim. We changed the name to self-defeating personality disorder and put it into the appendix."

DSM-III was a sensation. It sold over a million copies - many more copies than there were psychiatrists. Millions of people began using the checklists to diagnose themselves. For many it was a godsend. Something was categorically wrong with them and finally their suffering had a name. It was truly a revolution in psychiatry.

It was also a gold rush for drug companies, which suddenly had 83 new disorders they could invent medications for. "The pharmaceuticals were delighted with DSM," Spitzer told me, and this in turn delighted him: "I love to hear parents who say, 'It was impossible to live with him until we gave him medication and then it was night and day'."

Spitzer's successor, a psychiatrist named Allen Frances, continued the tradition of welcoming new mental disorders, with their corresponding checklists, into the fold. His DSM-IV came in at a mammoth 886 pages, with an extra 32 mental disorders.

Now Frances told me over the phone he felt he had made some terrible mistakes. "Psychiatric diagnoses are getting closer and closer to the boundary of normal," he said.

"Why?" I asked. "There's a societal push for conformity in all ways," he said. "There's less tolerance of difference. Maybe for some people having a label confers a sense of hope - previously I was laughed at but now I can talk to fellow sufferers on the internet."

Part of the problem is the pharmaceutical industry. "It's very easy to set off a false epidemic in psychiatry," said Frances. "The drug companies have tremendous influence."

One condition that Frances considers a mistake is childhood bipolar disorder. "Kids with extreme temper tantrums are being called bipolar," he said. "Childhood bipolar takes the edge of guilt away from parents that maybe they created an oppositional child."

"So maybe the diagnosis is good?"

"No," Frances said. "And there are very good reasons why not." His main concern is that children whose behaviour only superficially matches the bipolar checklist get treated with antipsychotic drugs, which can succeed in calming them down, even if the diagnosis is wrong. These drugs can have unpleasant and sometimes dangerous side effects.

Knife edge

The drug companies aren't the only ones responsible for propagating this false epidemic. Patient advocacy groups can be very fiery too. The author of Brandon and the Bipolar Bear, Tracy Anglada, is head of a childhood bipolar advocacy group called BP Children. She emailed me that she wished me all the best with my project but she didn't want to be interviewed. If, however, I wanted to submit a completed manuscript to her, she added, she'd be happy to consider it for review.

Anglada's friend Bryna Hebert has also written a children's book: My Bipolar, Roller Coaster, Feelings Book. "Matt! Will you take your medicines please?" she called across the kitchen when I visited her at home in Barrington, Rhode Island. The medicines were lined up on the kitchen table. Her son Matt, 14 years old, took them straight away.

The family's nickname for baby Matt had been Mister Manic Depressive. "Because his mood would change so fast. He'd be sitting in his high chair, happy as a clam; 2 seconds later he'd be throwing things across the room. When he was 3 he'd hit and not be sorry that he hit. He was obsessed with vampires. He'd cut out bits of paper and put them into his teeth like vampire teeth and go up to strangers. Hiss hiss hiss. It was a little weird."

"Were you getting nervous?" I asked. "Yeah," said Hebert. "One day he wanted some pretzels before lunch, and I told him no. He grabbed a butcher knife and threatened me."

"How old was he?"

"Four. That was the only time he's ever done anything that extreme," she said. "Oh, he's hit his sister Jessica in the head and kicked her in the stomach."

"She's the one who punched me in the head," called Matt from across the room.

It was after the knife incident, Hebert said, they took him to be tested. As it happened, the paediatric unit at what was then their local hospital, Massachusetts General, was run by Joseph Biederman, the doyen of childhood bipolar disorder. According to a 2008 article in the San Francisco Chronicle, "Biederman's influence is so great that when he merely mentions a drug during a presentation, tens of thousands of children will end up taking it." Biederman has said bipolar disorder can start, "from the moment the child opens his eyes".

"When they were testing Matt he was under the table, he was on top of the table," said Hebert. "We went through all these checklists. One of Dr Biederman's colleagues said, "We really think Matt meets the criteria in the DSM for bipolar disorder."

That was 10 years ago and Matt has been medicated ever since. So has his sister Jessica, who was also diagnosed by Biederman's people as bipolar. "We've been through a million medications," said Hebert. "There's weight gain. Tics. Irritability. Sedation. They work for a couple of years then they stop working."

Hebert was convinced her children were bipolar, and I wasn't going to swoop into a stranger's home for an afternoon and tell her they were normal. That would have been incredibly patronising and offensive. Plus, as the venerable child psychiatrist David Shaffer told me when I met him in New York later that evening, "These kids can be very oppositional, powerful kids who can take years off your happy life. But they aren't bipolar."

"Attention-deficit disorder?" he said. "Often with an ADD kid you think: 'My God, they're just like a manic adult.' But they don't grow up manic. And manic adults weren't ADD when they were children. But they're being labelled bipolar.

"That's an enormous label that's going to stay with you for the rest of your life. You're being told you have a condition which is going to make you unreliable, prone to terrible depressions and suicide."

The debate around childhood bipolar is not going away. In 2008, The New York Times published excerpts from an internal hospital document in which Biederman promised to "move forward the commercial goals of Johnson & Johnson", the firm that funds his hospital unit and sells the antipsychotic drug Risperdal. Biederman has denied the allegations of conflict of interest.

Frances has called for the diagnosis of childhood bipolar to be thrown out of the next edition of DSM, which is now being drawn up by the American Psychiatric Association.

This article shouldn't be read as a polemic against psychiatry. There are a lot of unhappy and damaged people out there whose symptoms manifest themselves in odd ways. I get irritated by critics who seem to think that because psychiatry has elements of irrationality, there is essentially no such thing as mental illness. There is. Childhood bipolar, however, seems to me an example of things having gone palpably wrong.

On the night of 13 December 2006, in Boston, Massachusetts, 4-year-old Rebecca Riley had a cold and couldn't sleep. Her mother, Carolyn Riley, gave her some cold medicine, and some of her bipolar medication, and told her she could sleep on the floor next to the bed. When she tried to wake Rebecca the next morning, she discovered her daughter was dead.

The autopsy revealed that Rebecca's parents had given her an overdose of the antipsychotic drugs she had been prescribed for her bipolar disorder. They had got into the habit of feeding her the medicines to shut her up when she was being annoying. They were both convicted of Rebecca's murder.

Rebecca had been diagnosed as bipolar at 2-and-a-half, and given medication by an upstanding psychiatrist who was a fan of Biederman's research into childhood bipolar. Rebecca had scored high on the DSM checklist, even though like most toddlers she could barely string a sentence together.

Shortly before her trial, Carolyn Riley was interviewed on CBS's 60 Minutes show by Katie Couric:

KC: Do you think Rebecca really had bipolar disorder?

CR: Probably not.             

KC: What do you think was wrong with her now?

CR: I don't know. Maybe she was just hyper for her age.

Jon Ronson is a writer and documentary maker living in London. He is the author of five books, including The Men Who Stare at Goats. His latest book, The Psychopath Test, is about the psychiatry industry

Source New Scientist

Physician participation in lethal injection executions should not be banned, argue 2 ethicists

(Garrison, NY) Should physicians be banned from assisting in a lethal injection execution, or lose professional certification for doing so? A recent ruling by the American Board of Anesthesiology will revoke certification of anesthesiologists who participate in capital punishment, and other medical boards may act similarly. An article in the Hastings Center Report concludes that decertification of physicians participating in lethal injections by a professional certifying organization goes too far—though individual physicians and private medical groups like the AMA are entitled to oppose the practice and may censure or dismiss members who violate it.

Physician participation in execution by lethal injection has always been controversial. All 34 death-penalty states use lethal injections for executions—and 33 of these allow or require physicians to participate. Kentucky is the only state that forbids physicians from participating in lethal injection executions. In 2008, when the Supreme Court upheld, in Baze v Rees, Kentucky's execution process as constitutional, the path seemed clear for lethal injections to proceed without physician involvement. But this didn't happen. As Lawrence Nelson and Brandon Ashby report in their article, "the protocols for almost all states still leave a place for physicians, apparently on grounds that physicians have the special ability to help the prisoner die swiftly and quietly, making the execution more humane for the prisoner, more efficient overall, and (to be frank) less disturbing for everyone who witnesses or has a hand in it."

The authors review the arguments against physician participation, particularly that it is inconsistent with the goals of medicine to help and not harm people—and that the record of botched executions constitutes one of the strongest arguments in favor of participation. "Acknowledging the ability of physicians to reduce needless risk to the condemned," they conclude, "we believe the most that can be fairly said is that physician participation neither fully advances the ethical ideals of medicine nor is strictly anathema to them."
Lawrence Nelson is an associate professor of philosophy at Santa Clara University and a faculty scholar in the Markkula Center for Applied Ethics. Brandon Ashby is a graduate student with the faculty of philosophy at Oxford University, Lady Margaret Hall.

In their report, the authors find that arguments for and against physician participation in executions often get conflated with arguments about the broader question of the ethics of capital punishment. While they acknowledge that "reasonable people of good faith may disagree on the morality and efficacy of capital punishment," the fact is that lethal injection executions continue to occur-- with little prospect of ending soon. Forty such executions took place in the United States in 2010 and eight during the first two months of 2011. Over 20 are scheduled for the remainder of 2011.

The report examines the role that the state expects the physician to play. A newly opened facility in California, for instance, cost over $800,000 and is designed solely for performing executions efficiently, humanely, and in accordance with constitutional requirements. Yet the roles specified for the physicians in the California regulations involve activities expressly barred by the American Medical Association's Code of Ethics.
"As far as we can determine," Nelson and Ashby write, "no physician has lost his or her ability to practice medicine or been dismissed from a professional medical organization as a result of participation in executions." But this may change. In February 2010, the American Board of Anesthesiology ruled that no anesthesiologists may "participate in capital punishment if they wish to be certified by the ABA." And other specialty boards may follow suit.

Such new sanctions go beyond losing membership in a medical society. "Loss of board certification directly affects a physician's ability to practice medicine and attract patients, given that many institutions and patients will not enter into a relationship with a physician lacking this credential of professional competence and accomplishment. . . The ABA's action creates a significant conflict between the important interest of professional certifying boards in enforcing ethical standards and the commitment of the state to the effective, humane, and just administration of the criminal law," the article states.
Will states be able to get physicians into the death chamber if by doing so they lose their practice? The authors cite the states of Washington and Oregon as offering one possible solution. As part of the Death with Dignity laws authorizing physician-assisted suicide, these states have included provisions explicitly forbidding organized medicine from punishing participating physicians.

Nelson and Ashby support the need for medical associations to establish professional guidelines, but they believe that depriving a physician of his or her livelihood is too onerous a penalty. There are other ways for professional associations to achieve their goals: "If a profession's ethical standards ought to emerge out of a dialogue between the profession and the larger community it serves, then organized medicine, individual physicians, and the people in the thirty-four state that allow or require physician participation in executions out to engage in public debate aimed at reaching a practical and principled resolution of this chronic conflict."

Source EurekaAlert!

Moral Responses Change as People Age

Research shows morally laden scenarios get different responses from people of different ages.

Both preschool children and adults distinguish between damage done either intentionally or accidently when assessing whether a perpetrator has done something wrong, but adults are much less likely than children to think someone should be punished if the act was accidental.

Moral responses change as people age says a new study from the University of Chicago.
Both preschool children and adults distinguish between damage done either intentionally or accidently when assessing whether a perpetrator has done something wrong, said study author Jean Decety. But, adults are much less likely than children to think someone should be punished for damaging an object, for example, especially if the action was accidental.

The study, which combined brain scanning, eye-tracking and behavioral measures to understand brain responses, was published in the journal Cerebral Cortex in an article titled "The Contribution of Emotion and Cognition to Moral Sensitivity: A Neurodevelopmental Study."
"This is the first study to examine brain and behavior relationships in response to moral and non-moral situations from a neurodevelopmental perspective," wrote Decety in the article.
Decety is the Irving B. Harris Professor in Psychology and Psychiatry at the University of Chicago and a leading scholar on affective and social neuroscience. The National Science Foundation's (NSF) Division of Behavioral and Cognitive Sciences funds the research.

"Studying moral judgment across the lifespan in terms of brain and behavior is important," said Lynn Bernstein, a program director for Cognitive Neuroscience at NSF. "It will, for example, contribute to the understanding of disorders such as autism spectrum disorder and psychopathology and to understanding how people at various times in the lifespan respond to others' suffering from physical and psychological pain."
The different responses correlate with the various stages of development, Decety said. As the brain becomes better equipped to make reasoned judgments and integrate an understanding of the mental states of others, moral judgments become more tempered.

Negative emotions alert people to the moral nature of a situation by bringing on discomfort that can precede moral judgment, said Decety. Such an emotional response is stronger in young children, he explained.
Decety and colleagues studied 127 participants, aged 4 to 36, who were shown short video clips while undergoing an fMRI scan. The team also measured changes in the dilation of the people's pupils as they watched the clips.
The participants watched a total of 96 clips that portrayed intentional harm, such as someone being shoved, and accidental harm, such as someone being struck accidentally, such as a golf player swinging a club. The clips also showed intentional damage to objects, such as a person kicking a bicycle tire, and accidental damage, such as a person knocking a teapot off the shelf.
Eye tracking revealed that all of the participants, irrespective of their age, paid more attention to people being harmed and to objects being damaged than they did to the perpetrators. Additionally, an analysis of pupil size showed that "pupil dilation was significantly greater for intentional actions than accidental actions, and this difference was constant across age, and correlated with activity in the amygdala and anterior cingulate cortex," Decety said.

The study revealed that the extent of activation in different areas of the brain as participants were exposed to the morally laden videos changed with age. For young children, the amygdala, which is associated the generation of emotional responses to a social situation, was much more activated than it was in adults.
In contrast, adults' responses were highest in the dorsolateral and ventromedial prefrontal cortex areas of the brain that allow people to reflect on the values linked to outcomes and actions.
"Whereas young children had a tendency to consider all perpetrators malicious, irrespective of intention and targets (people and objects), as participants aged, they perceived the perpetrator as clearly less mean when carrying out an accidental action, and even more so when the target was an object," Decety said.
Joining Decety in writing the paper were Kalina Michalska, a postdoctoral scholar, and Katherine Kinzler, an assistant professor, both in the Department of Psychology.

Source National Science Foundation

Changes in brain circuitry play role in moral sensitivity as people grow up

People's moral responses to similar situations change as they age, according to a new study at the University of Chicago that combined brain scanning, eye-tracking and behavioral measures to understand how the brain responds to morally laden scenarios.

Both preschool children and adults distinguish between damage done either intentionally or accidently when assessing whether a perpetrator had done something wrong. Nonetheless, adults are much less likely than children to think someone should be punished for damaging an object, especially if the action was accidental, said study author Jean Decety, the Irving B. Harris Professor in Psychology and Psychiatry at the University of Chicago and a leading scholar on affective and social neuroscience.
The different responses correlate with the various stages of development, Decety said, as the brain becomes better equipped to make reasoned judgments and integrate an understanding of the mental states of others with the outcome of their actions. Negative emotions alert people to the moral nature of a situation by bringing on discomfort that can precede moral judgment, and such an emotional response is stronger in young children, he explained.

"This is the first study to examine brain and behavior relationships in response to moral and non-moral situations from a neurodevelopmental perspective," wrote Decety in the article, "The Contribution of Emotion and Cognition to Moral Sensitivity: A Neurodevelopmental Study," published in the journal Cerebral Cortex. The study provides strong evidence that moral reasoning involves a complex integration between affective and cognitive processes that gradually changes with age.
For the research, Decety and colleagues studied 127 participants, aged 4 to 36, who were shown short video clips while undergoing an fMRI scan. The team also measured changes in the dilation of the people's pupils as they watched the clips.

The participants watched a total of 96 clips that portrayed intentional harm, such as someone being shoved, and accidental harm, such as someone being struck accidentally, such as a golf player swinging a club. The clips also showed intentional damage to objects, such as a person kicking a bicycle tire, and accidental damage, such as a person knocking a teapot off the shelf.
Eye tracking in the scanner revealed that all of the participants, irrespective of their age, paid more attention to people being harmed and to objects being damaged than they did to the perpetrators. Additionally, an analysis of pupil size showed that "pupil dilation was significantly greater for intentional actions than accidental actions, and this difference was constant across age, and correlated with activity in the amygdala and anterior cingulate cortex," Decety said.

The study revealed that the extent of activation in different areas of the brain as participants were exposed to the morally laden videos changed with age. For young children, the amygdala, which is associated the generation of emotional responses to a social situation, was much more activated than it was in adults.
In contrast, adults' responses were highest in the dorsolateral and ventromedial prefrontal cortex — areas of the brain that allow people to reflect on the values linked to outcomes and actions.
In addition to viewing the video clips, participants were asked to determine, for instance, how mean was the perpetrator, and how much punishment should he receive for causing damage or injury. The responses showed a clear connection between moral judgments and the activation the team had observed in the brain.
"Whereas young children had a tendency to consider all the perpetrator malicious, irrespective of intention and targets (people and objects), as participants aged, they perceived the perpetrator as clearly less mean when carrying out an accidental action, and even more so when the target was an object," Decety said.

When recommending punishments, adults were more likely to make allowances for actions that were accidental, he said. The response showed that they had a better developed prefrontal cortex and stronger functional connectivity between this region and the amygdala than children. Adults were better equipped to make moral judgments. "In addition, the ratings of empathic sadness for the victim, which were strongest in young children, decreased gradually with age, and correlated with the activity in the insula and subgenual prefrontal cortex," which area areas associated with emotional behavior and automatic response to stresses, Decety said. Together, the results are consistent with the view that morality is instantiated by functionally integrating several distributed areas/networks.

Source EurekaAlert!

Research study reveals profile for female drink-drivers

Female drink-drivers are more likely to be older, better-educated and divorced, widowed or separated, research has shown.

The study by academics at The University of Nottingham found that emotional factors and mental health problems were common triggers in alcohol-related offences committed by women.

And they also discovered that rehabilitation programmes that force women to face the consequences of their crime can intensify their feelings of guilt and shame, leading them to turn to alcohol and increasing the risk that they will re-offend.

In a paper to be published in Clinical Psychology Review the researchers, led by Professor Mary McMurran of the Institute of Mental Health, have called for more effective treatment programmes to be designed that are specifically tailored for women.

Professor McMurran said: “The profile of women drink-driving offenders is of being divorced, widowed or separated and having fewer previous convictions than their male counterparts. Thus, it may be that these women are distressed by their situation and are turning to drink for solace.

“Treatment programmes that induce negative emotions may actually increase emotional distress, which may increase drinking and, in turn, increase the likelihood of alcohol-related offending.”

The Nottingham researchers carried out a systematic review of 26 previous studies from around the world to gather evidence that could inform the future development of interventions for alcohol-related offending by women and centred on whether there are differences between men and women who break the law after drinking.

They found:

• Overall women were less likely to drink and drive than men and less likely to be repeat offenders
• Fewer women drink-drivers had previously been arrested for public drunkenness and other alcohol-related offences
• Women drink-drivers were older than men, better educated but had a lower income
• Female drink-driving offenders were more likely than men to be separated, divorced or widowed, whereas men were more likely to be married or single
• Women who got behind the wheel drunk were more likely to have parents and partners who abused alcohol and themselves had a greater history of mental health problems.
Only six studies investigated gender differences in other types of offences, demonstrating that while women are overall less likely to offend than men, drinking tends to increase the likelihood of offending in both sexes. Drinking also increases the likelihood of violent offending more than other types of offences and the risk of violence after drinking is higher in both men and women. Again, there is evidence that women offenders with alcohol problems have more psychological problems than men. Using drugs in combination with alcohol may also be an issue for women alcohol abusing offenders.

The researchers found only four studies that evaluated treatments specifically designed for women whose offending was linked to alcohol, meaning there was not enough evidence to answer the question of what treatment works most effectively.

However, there was strong evidence to show which approach did not work. A study in New Mexico showed that putting female drink-driving offenders before a panel of people made up of those who have been seriously injured or whose loved ones have been killed in a crash in a collision with a drink-driver to hear about how it has impacted on their lives actually increased the risk of reoffending.

Another American study documented high-risk female offenders who were given a ‘life activities’ interview as part of their treatment focusing on life adjustment, occupational and financial status. Again, this resulted in a greater rate of offending than those who did not — 44 per cent as opposed to 24 per cent.

Professor McMurran added: “Programmes designed specifically for women whose offences are alcohol related need to be designed and evaluated. While these may draw on those programmes designed for men, greater attention to broader psychological health issues is needed as these may affect the success of the intervention.

“The information contained in this review may help inform the future development and design of treatment programmes for this neglected group of offenders.”

An advance unproofed version of the article Interventions for Alcohol-Related Offending by Women: A Systematic Review is available online at http://tiny.cc/41liw is available on Clinical Psychology’s Online First web pages. 


Source University of Nottingham

Whites Believe They Are Victims of Racism More Often Than Blacks

In Zero Sum Game, "Reverse Racism" Seen as Bigger Problem than Anti-Black Racism.

MEDFORD/SOMERVILLE, Mass. -- Whites believe that they have replaced blacks as the primary victims of racial discrimination in contemporary America, according to a new study from researchers at Tufts University's School of Arts and Sciences and Harvard Business School. The findings, say the authors, show that America has not achieved the "post-racial" society that some predicted in the wake of Barack Obama's election.

Both whites and blacks agree that anti-black racism has decreased over the last 60 years, according to the study. However, whites believe that anti-white racism has increased and is now a bigger problem than anti-black racism.
 "It's a pretty surprising finding when you think of the wide range of disparities that still exist in society, most of which show black Americans with worse outcomes than whites in areas such as income, home ownership, health and employment," said Tufts Associate Professor of Psychology Samuel Sommers, Ph.D., co-author of "Whites See Racism as a Zero-sum Game that They Are Now Losing," which appears in the May 2011 issue of the journal Perspectives on Psychological Science.

Sommers and co-author Michael I. Norton of Harvard asked a nation-wide sample of 208 blacks and 209 whites to indicate the extent to which they felt blacks and whites were the targets of discrimination in each decade from the 1950s to the 2000s.   A scale of 1 to 10 was used, with 1 being "not at all" and 10 being "very much."

White and black estimates of bias in the 1950s were similar. Both groups acknowledged little racism against whites at that time but substantial racism against blacks. Respondents also generally agreed that racism against blacks has decreased over time, although whites believed it has declined faster than blacks do.
However, whites believed that racism against whites has increased significantly as racism against blacks has decreased. On average, whites rated anti-white bias as more prevalent in the 2000s than anti-black bias by more than a full point on the 10-point scale. Moreover, some 11 percent of whites gave anti-white bias the maximum rating of 10 compared to only 2 percent of whites who rated anti-black bias a 10. Blacks, however, reported only a modest increase in their perceptions of "reverse racism."

"These data are the first to demonstrate that not only do whites think more progress has been made toward equality than do blacks, but whites also now believe that this progress is linked to a new inequality – at their expense," note Norton and Sommers. Whites see racial equality as a zero sum game, in which gains for one group mean losses for the other.

The belief that anti-white bias is more prevalent than anti-black bias has clear implications for future public policy debates and behavioral science research, say the authors. They note that claims of so-called reverse racism, while not new, have been at the core of an increasing number of high-profile Supreme Court cases.


Source Tufts University

Abortions generate $95 million a year for Polish doctors as women use illegal private sector

Amsterdam, 17 May, 2011 - New analysis published by the UK journal Reproductive Health Matters shows that the criminalisation of abortion in Poland has led to the development of a vast illegal private sector with no controls on price, quality of care or accountability. Since abortion became illegal in the late 1980s the number of abortions carried out in hospitals has fallen by 99%. The private trade in abortions is, however, flourishing, with abortion providers advertising openly in newspapers.

Women have been the biggest losers during this push of abortion provision into the clandestine private sector. The least privileged have been hardest hit: in 2009 the cost of a surgical abortion in Poland was greater than the average monthly income of a Polish citizen. Low-income groups are less able to protest against discrimination due to lack of political influence. Better-off women can pay for abortions generating millions in unregistered, tax-free income for doctors. Some women seek safe, legal abortions abroad in countries such as the UK and Germany.

"In the private sector, illegal abortion must be cautiously arranged and paid for out of pocket," says Agata Chełstowska, the author of the research and a PhD student at the University of Warsaw. "When a woman enters that sphere, her sin turns into gold. Her private worries become somebody else's private gain". The Catholic Church, highly influential in predominantly Catholic Poland, leads the opposition to legal abortion.
Since illegality has monetised abortion, doctors have incentives to keep it clandestine, "Doctors do not want to perform abortions in public hospitals," says Wanda Nowicka, Executive Director of the Federation for Women and Family Planning. "They are ready, however, to take that risk when a woman comes to their private practice. We are talking about a vast, untaxed source of income. That is why the medical profession is not interested in changing the abortion law."
In several high profile cases, women and girls have been denied legal abortions following rape or because of serious health conditions and have been hounded by the media for seeking them. The 2004 case of a young pregnant woman who died after being denied medical treatment is currently under consideration at the European Court of Human Rights.

Other articles in this issue of Reproductive Health Matters focus on many aspects of health privatisation worldwide and includes studies from Bangladesh, Turkey, Malawi, India, Madagascar and South Africa.

Source  EurekaAlert!