FDA weighs approval of adult psychiatric drugs for children

Officials have concerns about exposing younger patients to the drugs’ side effects.

AP | Jun 5, 2009

By MATTHEW PERRONE

WASHINGTON (AP) — Three blockbuster psychiatric drugs currently approved for adults also appear to work in adolescents, though federal health officials have concerns about exposing younger patients to the drugs’ side effects.

The Food and Drug Administration is reviewing drugs from AstraZeneca PLC, Eli Lilly & Co. and Pfizer Inc. for use in patients between the ages of 10 and 17. The drugs — already approved to treat schizophrenia and bipolar mania in adults — had combined sales of more than $7.4 billion last year, according to IMS Health.

FDA reviewers on Friday said they were wary of exposing youngsters to the drugs’ side effects, including weight gain and high blood sugar, “because they may be exposed for many decades.”

“These risks are of particular concern in pediatric patients because of the lifelong nature of these disorders,” FDA director for psychiatric products, Dr. Thomas Laughren, wrote in documents posted online.

The FDA released its review of the drugs ahead of a meeting Tuesday where outside experts will weigh in on the drugs’ risks and benefits. The agency is not required to follow the group’s advice, though it usually does.

Many doctors already prescribe the medications to children and adolescents, although regulators have not officially cleared that use. Physicians are free to prescribe medicines as they see fit, though companies can only promote them for FDA-approved indications.

AstraZeneca and Lilly are seeking permission to market their drugs for adolescents with schizophrenia and bipolar mania, also called manic depressive disorder. Pfizer is seeking a pediatric bipolar disorder indication for its drug.

FDA drug reviewers noted that the “safety profile of the pediatric population is very similar compared to that of the adult population.” And while there were no side effects unique to younger patients, there were differences in the frequency of the effects compared with adults.

In schizophrenia studies of Lilly’s Zyprexa, more than 30 percent of adolescents gained weight, compared with just 6 percent of adults. On average, adolescents gained nearly 10 pounds, compared with 6 pounds for adults.

Lilly is seeking FDA approval to market the drug as a second-line treatment, or a second option after other drugs have been tried.

Adolescent patients taking Pfizer’s Geodon were more likely to report sleepiness and dystonia, a movement disorder that causes muscle spasms. AstraZeneca noted higher rates of increased appetite and blood pressure among children and adolescents taking Seroquel compared with adults.

Despite concerns over the side effects, Laughren and other FDA officials acknowledged the need for additional drugs to treat schizophrenia and bipolar disorder in teenagers and older children.

“Schizophrenia and bipolar disorder are serious illnesses in pediatric patients and represent substantial burden for both patients and their families,” Laughren said.

Currently only two drugs are cleared for those uses: Bristol-Myers Squibb’s Abilify and Johnson & Johnson’s Risperdal. Abilify was the second best-selling anti-psychotic drug in the U.S. last year with sales of $3 billion. Risperdal was fourth with $1.6 billion in sales.

Schizophrenia affects about 2.4 million Americans and is characterized by hallucinations, delusions and social withdrawal, according to the National Institute of Mental Health. About 5.7 million Americans experience bipolar disorder, which causes rapid mood swings and shifts in energy.

U.S. military: Heavily medicated and armed

Prescription pill dependency among American troops is on the rise

MSNBC | May 19, 2009

U.S. military: Heavily armed and medicated

By Melody Petersen

Marine Corporal Michael Cataldi woke as he heard the truck rumble past.

He opened his eyes, but saw nothing. It was the middle of the night, and he was facedown in the sands of western Iraq. His loaded M16 was pinned beneath him.

Cataldi had no idea how he’d gotten to where he now lay, some 200 meters from the dilapidated building where his buddies slept. But he suspected what had caused this nightmare: His Klonopin prescription had run out.

His ordeal was not all that remarkable for a person on that anti-anxiety medication. In the lengthy labeling that accompanies each prescription, Klonopin users are warned against abruptly stopping the medicine, since doing so can cause psychosis, hallucinations, and other symptoms. What makes Cataldi’s story extraordinary is that he was a U. S. Marine at war, and that the drug’s adverse effects endangered lives — his own, his fellow Marines’, and the lives of any civilians unfortunate enough to cross his path.

“It put everyone within rifle distance at risk,” he says.

In deploying an all-volunteer army to fight two ongoing wars, in Iraq and Afghanistan, the Pentagon has increasingly relied on prescription drugs to keep its warriors on the front lines. In recent years, the number of military prescriptions for antidepressants, sleeping pills, and painkillers has risen as soldiers come home with battered bodies and troubled minds. And many of those service members are then sent back to war theaters in distant lands with bottles of medication to fortify them.

According to data from a U. S. Army mental-health survey released last year, about 12 percent of soldiers in Iraq and 15 percent of those in Afghanistan reported taking antidepressants, anti-anxiety medications, or sleeping pills. Prescriptions for painkillers have also skyrocketed. Data from the Department of Defense last fall showed that as of September 2007, prescriptions for narcotics for active-duty troops had risen to almost 50,000 a month, compared with about 33,000 a month in October 2003, not long after the Iraq war began.

In other words, thousands of American fighters armed with the latest killing technology are taking prescription drugs that the Federal Aviation Administration considers too dangerous for commercial pilots.

Military officials say they believe many medications can be safely used on the battlefield. They say they have policies to ensure that drugs they consider inappropriate for soldiers on the front lines are rarely used. And they say they are not using the drugs in order to send unstable warriors back to war.

Yet the experience of soldiers and Marines like Cataldi show the dangers of drugging our warriors. It also worries some physicians and veterans’ advocates. “There are risks in putting people back to battle with medicines in their bodies,” says psychiatrist Judith Broder, M. D., founder of the Soldiers Project, a group that helps service members suffering from mental illness.

Prescription drugs can help patients, Dr. Broder says, but they can also cause drowsiness and impair judgment. Those side effects can be dealt with by patients who are at home, she says, but they can put active-duty soldiers in great danger. She worries that some soldiers are being medicated and then sent back to fight before they’re ready.

“The military is under great pressure to have enough people ready for combat,” she says. “I don’t think they’re as cautious as they would be if they weren’t under this kind of pressure.”

Brought more than memories back

When Cataldi talks about what happened to him in Iraq, he begins with an in incident that took place on a cold January night in 2005, when he and five other Marines received a radio call informing them that a helicopter had disappeared. The men roared across the desert of western Iraq and found what was left of the chopper. Flames roared from the pile of metal. Cataldi, 20, was ordered to do a body count.

The pilot’s body was still on fire, so he shoveled dirt on it to douse the acrid flames. He picked up a man’s left boot in order to find the dog tag every Marine keeps there. A foot fell to the ground. “People were missing heads,” Cataldi remembers. “They were wearing the same uniform I was wearing.”

The final death toll from that crash of a CH-53E Super Stallion was 30 Marines and one sailor.

For days, Cataldi couldn’t escape the odor of burning flesh. “I had the smell all over my equipment,” he says. “I couldn’t get it off .”

When he returned to his stateside base at Twentynine Palms, California, he knew he’d brought more than memories back from Iraq. He would cry for no reason. He flew into fits of rage. One night he woke up with his hands around the throat of his wife, Monica, choking her.

“It scared the crap out of me,” he says.

He went to see a psychiatrist on base. “He said, ‘Here’s some medication,’ ” Cataldi recalls. The prescribed drugs were Klonopin, for anxiety; Zoloft, for depression; and Ambien, to help him sleep.

Later, other military doctors added narcotic painkillers for the excruciating pain in his leg, which he’d injured during a training exercise. He was also self-medicating with heavy doses of alcohol.
Those prescriptions didn’t stop the Marine Corps from sending Cataldi back to Iraq. In 2006, he returned to the same part of the Iraqi desert to do the same job: performing maintenance on armored personnel carriers known as LAVs. He also took his turn driving the 14-ton tanklike vehicles, one of which was armed with a 25 mm cannon and two machine guns and loaded with more than 1,000 rounds of ammunition.

Marine Major Carl B. Redding says he can’t talk about the medical history of any Marine because of privacy laws. He says the Corps has procedures to ensure that service members taking medications for psychiatric conditions are deployed only if their symptoms are in remission. Those Marines, he says, must be able to meet the demands of a mission.

But it’s difficult to square those regulations with Cataldi’s experience. His medications came with written warnings about the dangers of driving and operating heavy machinery. The labels don’t lie.

One night, Cataldi took his pills after his commander told him he was done for the day. Five minutes later, however, plans changed, and he was told to drive the LAV. He asked the Marine sitting behind him to help keep him awake. “I said, ‘Kick the back of my seat every 5 minutes,’ and that’s what he did.”

Cataldi says he managed on the medications — until his Klonopin ran out. The medical officer told him there was no Klonopin anywhere in Iraq. So the officer gave him a drug called Seroquel. That’s when Cataldi says he started to become “loopy.”

“I’d go to pick up a wrench and come back with a hammer,” he says. “I wasn’t able to do my job. I wasn’t able to fight.”

Soldiers on medication

Soldiers have doped up in order to sustain combat since ancient times. Often their chosen drug was alcohol. And Iraq isn’t the first place U. S. military doctors have prescribed medications to troops on the front. During the Vietnam war, military psychiatrists spoke enthusiastically about some newly psychiatric medicines, including Thorazine, an anti-psychotic, and Valium, for anxiety. According to an army textbook, doctors frequently prescribed those drugs to soldiers with psychiatric symptoms. Anxiety-ridden soldiers with upset bowels were sometimes given the antidiarrheal Compazine, a potent tranquilizer.

But the use of those drugs in Vietnam became controversial. Critics said it was dangerous to give soldiers medications that slowed their reflexes, a side effect that could raise their risk of being injured, captured, or killed. That risk was real. In a report supported by the U. S. Navy 14 years after the United States withdrew from Vietnam, researchers looked at the records of all Marines wounded there between 1965 and 1972. Marines who’d been hospitalized for psychiatric reasons before being sent back to battle were more likely to have been injured in combat than those who hadn’t been hospitalized.

Critics of medication use in Vietnam also said that a soldier traumatized by battle may not be coherent enough to give his consent to take the drugs in the first place. Plus, a soldier would risk court-martial if he refused to follow orders, they said, making it unlikely he could make a reasoned decision about taking the medications.

After the war, the practice of liberally giving psychiatric drugs to warriors fell out of favor. In War Psychiatry, a 1995 military medical textbook, a U. S. Air Force flight surgeon warned about the use of psychiatric drugs, saying they should be used sparingly.

“Sending a person back to combat duty still under the influence of psychoactive drugs may be dangerous,” he wrote. “Even in peacetime, people in the many combat-support positions… would not be allowed to take such medications and continue to work in their sensitive, demanding jobs.”

Colonel Elspeth Cameron Ritchie, M. D., M. P. H., a psychiatrist and the medical director of the strategic communication directorate in the Office of the Army Surgeon General, acknowledges that writing more prescriptions for frontline troops was a change in direction for the Pentagon. “Twenty years ago,” she says, “we weren’t deploying soldiers on medications.”

Today it’s not uncommon for a soldier to arrive in Iraq while taking a host of prescription drugs. The Pentagon explained its new practice in late 2006, stating that there are “few medications that are inherently disqualifying for deployment.”

According to Colonel Ritchie, military officials have concluded that many medicines introduced since the Vietnam War can be used safely on the front lines. Military physicians consider antidepressants and sleeping pills to be especially helpful, she says. Doctors have also found that small doses of Seroquel, an anti-psychotic, can help treat nightmares, she says, even though the drug is not approved for that use.

Full Story

Government Experiments on U.S. Soldiers: Shocking Claims Come to Light in New Court Case

They say government scientists messed with their minds. Now, veterans who were the subject of top-secret experiments want answers.

Mother Jones | May 23, 2009

By Bruce Falconer

Their stories are a staple of conspiracy culture: broken men, suffering hallucinations and near-total amnesia, who say they are victims of secret government mind-control experiments. Think Liev Schreiber in The Manchurian Candidate or Mel Gibson in Conspiracy Theory. Journalists are a favorite target for the paranoid delusions of this population. So is Gordon Erspamer—and the San Francisco lawyer’s latest case isn’t helping him to fend off the tinfoil-hat crowd. He has filed suit against the CIA and the US Army on behalf of the Vietnam Veterans of America and six former American soldiers who claim they are the real thing: survivors of classified government tests conducted at the Army’s Edgewood Arsenal in Maryland between 1950 and 1975. “I get a lot of calls,” he says. “There are a lot of crazy people out there who think that somebody from Mars is controlling their behavior via radio waves.” But when it comes to Edgewood, “I’m finding that more and more of those stories are true!”

That government scientists conducted human experiments at Edgewood is not in question. “The program involved testing of nerve agents, nerve agent antidotes, psychochemicals, and irritants,” according to a 1994 General Accounting Office (now the Government Accountability Office) report (PDF). At least 7,800 US servicemen served “as laboratory rats or guinea pigs” at Edgewood, alleges Erspamer’s complaint, filed in January in a federal district court in California. The Department of Veterans Affairs has reported that military scientists tested hundreds of chemical and biological substances on them, including VX, tabun, soman, sarin, cyanide, LSD, PCP, and World War I-era blister agents like phosgene and mustard. The full scope of the tests, however, may never be known. As a CIA official explained to the GAO, referring to the agency’s infamous MKULTRA mind-control experiments, “The names of those involved in the tests are not available because names were not recorded or the records were subsequently destroyed.” Besides, said the official, some of the tests involving LSD and other psychochemical drugs “were administered to an undetermined number of people without their knowledge.”

Erspamer’s plaintiffs claim that, although they volunteered for the Edgewood program, they were never adequately informed of the potential risks and continue to suffer debilitating health effects as a result of the experiments. They hope to force the CIA and the Army to admit wrongdoing, inform them of the specific substances they were exposed to, and provide access to subsidized health care to treat their Edgewood-related ailments. Despite what they describe as decades of suffering resulting from their Edgewood experiences, the former soldiers are not seeking monetary damages; a 1950 Supreme Court decision, the Feres case, precludes military personnel from suing the federal government for personal injuries sustained in the line of duty. The CIA’s decision to use military personnel as test subjects followed the court’s decision and is an issue Erspamer plans to raise at trial. “Suddenly, they stopped using civilian subjects and said, ‘Oh, we can get these military guys for free,’” he says. “The government could do whatever it wanted to them without liability. We want to bring that to the attention of the public, because I don’t think most people understand that.” (Asked about Erspamer’s suit, CIA spokeswoman Marie Harf would say only that the agency’s human testing program has “been thoroughly investigated, and the CIA fully cooperated with each of the investigations.”)

Erspamer’s involvement in the case is deeply personal. His father was a government scientist during Operation Crossroads, a series of nuclear tests conducted at Bikini Atoll in the Pacific in the summer of 1946; he was present aboard a research vessel for the “Baker” test, during which a 21-kiloton thermonuclear bomb was detonated 90 feet below water. The blast resulted in massive radioactive contamination. Erspamer’s father and the rest of the ship’s crew, he says, all died in middle age from radiogenic diseases. Erspamer makes his living in the field of energy litigation, but has twice before argued class action suits for veterans—one for soldiers who, like his father, were exposed to radiation during nuclear tests (a case he ultimately lost in a 1992 appellate decision) and more recently one on behalf of Iraq and Afghanistan veterans denied treatment for post-traumatic stress disorder. The case is on appeal in California’s 9th Circuit. “Nobody out there is doing these types of cases,” he says. “It’s really sad because the veterans are left holding the bag, and it’s not a very pretty bag.”

One of those vets is Frank Rochelle. Unlike those of other test veterans, portions of his heavily redacted medical records have survived, providing a rare, if incomplete, account of his experiences. In 1968, while posted at Virginia’s Fort Lee as a 20-year-old Army draftee, he saw a notice calling for volunteers for the Edgewood program. Among the promised incentives were relief from guard duty, the freedom to wear civilian clothes, three-day weekends, and, upon completion, a medal of commendation—all for participation in experiments that, according to the notice, would help the military test a new generation of equipment, clothing, and gas masks. Upon his arrival at the testing facility in Maryland, he says he was asked to sign a series of documents, including a release form and a secrecy agreement. The tests would be risk free, he says he was told, and any drugs given would not exceed normal dosage. Over the next two months, however, he was subjected to three rounds of experiments that, Rochelle says, left him permanently damaged. His medical records indicate that he was exposed to nonlethal incapacitating agents like DHMP and glycolate, both of which act as sedatives that produce hallucinations. In the latter case, Rochelle says he was taken into a gas chamber and strapped to a chair by two men in white lab coats, who affixed a mask to his face and told him to breathe normally. He quickly lost consciousness. According to Erspamer’s complaint, “Over the next two to three days, Frank was hallucinating and high: he thought he was three feet tall, saw animals on the walls, thought he was being pursued by a 6-foot-tall white rabbit, heard people calling his name, thought that all his freckles were bugs under his skin, and used a razor to try to cut these bugs out. No one from the clinical staff intervened on his behalf…”

Medical records indicate that Rochelle went through a third round of testing, but he has no memory of it. For years he’s been having nightmares about the Edgewood tests and now suffers from anxiety, memory loss, sleep apnea, tinnitus, and loss of vision, all of which he claims are direct results of the experiments. Still, he didn’t inform his doctor of the tests until 2006, believing that he was still bound by the oath of secrecy he swore in 1968. (The government finally released human test subjects to speak to their physicians about the tests in June 2006, under the condition that they not “discuss anything that relates to operational information that might reveal chemical or biological warfare vulnerabilities or capabilities.”)

Rochelle’s story is similar to those of Erspamer’s other plaintiffs, all of whom claim to be suffering debilitating health effects stemming from the experiments. Of course, substantiating these claims is a challenge, given that most of the medical records were destroyed upon completion of the program. Rochelle’s records remain intact, but for “others we have less information,” says Erspamer. “We spent a great deal of time on that topic, and we are confident that the plaintiffs are who they say they are, were where they said they were, and got what they said they got,” in terms of exposure to experimental chemicals. “Who bears the burden on that issue when the defendants destroyed the evidence?” Erspamer asks. “They’ve put all that stuff through the shredder.”

Compensation for injuries sustained during human testing of chemical and biological agents is not unprecedented. Last year, more than 350 servicemen who served as test subjects at Porton Down, a secret military research facility where the British government conducted its own series of mind-control experiments, were granted nearly $6 million in compensation in an out-of-court settlement with the UK’s Ministry of Defence. Likewise, in 2004, the Canadian government began offering $18,000 payments to eligible veterans of experiments at its testing facilities. Nevertheless, says Erspamer, “No American soldiers have ever been compensated.” The CIA and the Army “just hope they’re all gonna die off, and they will unless somebody does something.”

After suicide of 7-year-old, agency finds serious shortcomings in monitoring of foster children on psychotropic drugs

Review finds shortfalls in monitoring of foster children on psychiatric drugs

13.19 percent, are taking one or more psychotropic medications

St. Petersburg Times | May 29, 2009

By Kris Hundley

Spurred by the shocking suicide of a 7-year-old on psychiatric drugs, the agency in charge of Florida’s foster children has discovered serious shortcomings in its monitoring of kids on such powerful prescriptions.

After reviewing its files, the Department of Children and Families determined it had undercounted the number of foster kids on such medications as Risperdal and Adderall, overlooking hundreds of cases.

It also has failed to meet its legal requirement that such prescriptions be given only after parental consent or court order.

On Thursday, DCF said a review of the files of more than 20,000 children currently in the state’s foster care showed 2,669, or 13.19 percent, are taking one or more psychotropic medications.

That compares with about 4 or 5 percent of children in the general population who are on such prescriptions.

Of those foster children taking drugs, DCF discovered 16 percent had no proof either a parent or judge had signed off on the prescription, as required by a 2005 Florida law.

“That is unacceptable,” said DCF Secretary George Sheldon. “We’re going to bring every single case of a foster child on drugs into compliance with the law.”

Concerns about pediatric use of antipsychotic and antidepressants such as Adderall and Risperdal have been growing along with increased warnings of such side effects as suicide, diabetes and weight gain. Few of the drugs have been tested or approved by the FDA for children, though physicians can prescribe them for this age group.

Robin Rosenberg, a Tampa lawyer and deputy director of Florida’s Children First, said advocacy groups like hers have been fighting for oversight of psychotropic drugs for years. “We’re not as far along as we should have been if the state had followed up on serious concerns starting in the late 1990s,” she said. “It’s a shame we’re in this place today.”

Sheldon, who was named to the top job at DCF in October, left no doubt that he had been deeply affected by Gabriel Myers, the 7-year-old who hanged himself on a shower hose in South Florida in mid April. The boy was in his third foster home and on Vyvanse, a medication for ADHD, as well as Symbyax, a combination antipsychotic and antidepressant.

Though his caseworker repeatedly said Gabriel’s mother had agreed to the medications, that was not true. The boy’s psychotropic medications also had not been entered in the state’s tracking system.

To correct ongoing problems, Sheldon set a deadline of June 5 for action on cases without consent. This could include scheduling new doctors’ appointments, gaining informed consent from parents or expediting a judge’s review of the prescription.

Sheldon said he also was going to focus on the cases of 73 children under age 6 found to be on psychotropic drugs.

“I want a sense of urgency, but I also want to get it right,” he said. “I want to move forward, but I think it’s important for the agency to apologize for misinformation it may have put out in the past.”

Flaws in DCF’s record-keeping became clear in the immediate aftermath of Gabriel’s death. An initial review of the state’s database showed only 1,950 kids on psychotropic prescriptions. After a thorough review of individual records, however, that number grew by more than 700.

Preliminary data released in mid May also showed some questionable dates on judicial consent. Though it’s not inconceivable a judge might sign an order on a Saturday or Sunday, early returns showed weekend consent orders on 129 occasions.

The final database, including information on types of drugs and diagnoses, was not available Thursday. Sheldon said a summary of the drug data would be posted on the DCF Web site and updated weekly.

“I’ve got a lot more confidence in these numbers than I had two weeks ago,” he said. “But any database is only as good as the quality of the information being put into it.”

One ongoing area of concern, Sheldon said, is the validity of any consent given by parents whose kids are in the state’s custody.

“A parent whose child is taken into our care is going to sign virtually anything and that’s not informed consent,” he said. “My preference is that the biological parent have a dialogue with the psychiatrist.”

Now that DCF has a handle on the number of foster children on psychotropic drugs, Sheldon said the department can begin to address the bigger issue of the efficacy of such drugs.

He has asked an independent panel investigating Gabriel Myers’ death to make recommendations on improving DCF’s oversight of these medications. Sheldon said a second-party review of all such prescriptions might be necessary; currently, only prescriptions for kids under age 6 require such review.

DCF has set up a page on its Web site that tracks the progress of the panel investigation into the boy’s suicide. The page includes a photo of the smiling boy.

“We have his face on the screen watching us to see how well we learned from his life and death,” Sheldon said. “We cannot let him down.”

ADHD treatment causes young boys to develop female breasts

3news.co.nz | May 26, 2009

In Janssen's own clinical trials, 43 children developed the abnormal breasts

A drug used to treat ADHD children is causing concern in the United States.

It is called Risperdal and it is supposed to be used primarily for adults with sever psychological problems.

But last year it was prescribed more than 6.5 million times.

The side effects include young males developing female sex organs.

Nineteen-year-old John was just seven when he began taking Risperdal for ADD.

Even though the FDA approved the drug only for adult patients who were psychotic, John’s doctor and others widely prescribed it to kids for less severe behaviour problems.

Once taking Risperdal, John’s mum says he became aggressive, sleepy, and developed bowel problems. But the biggest shock came when he was 14 and started developing women’s breasts.

“He asked me if he was a girl,” she says.

It turns out Risperdal can increase production of a hormone called prolactin, which stimulates breast growth. It is called gynecomastia – and it is irreversible.

Risperdal and other so-called “atypical anti-psychotics” have exploded in use.

Hundreds of thousands of kids have been prescribed Risperdal in the 14 years it has been on sale – long before the FDA approved it for very limited pediatric use in 2006.

John and most of the other children were not psychotic at all, but were given Risperdal for behaviour disorders including autism and ADD.

Attorney Stephen Sheller is suing Janssen, which makes Risperdal. He claims Janssen marketed Risperdal for unapproved uses in children, downplayed serious risks like diabetes and seizures.

Janssen would not agree to an interview but told us the breast growth risk is “clearly stated in the FDA-approved” labelling, and “we only promote our products for their FDA-approved indications.”

Nobody knows how often it happens. But in Janssen’s own clinical trials with fewer than 2,000 children (1,885), 43 developed the abnormal breasts.

Mr Sheller represents John and nine other boys – one of whom was only four when he developed a breast on one side and began producing milk.

The treatment for the unbridled breast growth is as unthinkable as the disorder: painful removal of the breasts.
Eventually, the boys can appear normal again.

The family’s lawsuit is still in court.

But John’s mother says surgery did not fix all of the problems from the medicine.

When asked if John still thinks he’s a girl his mother wells up and cries before answering, “yes.”

As for Risperdal – it’s still on the market.  And families say putting even more children at risk.

With recent police activity, anti-terror adverts and CCTV everywhere no wonder we’re all scared stiff

Big Brother state? Britain has more CCTV cameras than the rest of Europe put together

Daily Mail | April 15, 2009

By Eamonn Butler

So it has now become one of the main causes of anxiety. Among all the other worries that people face  -  the recession, crime, hospital superbugs and terrorism  -  a new fear has emerged: that of the Big Brother state.

According to a survey by the Mental Health Foundation, we are a pretty fearful lot. In fact, more than seven million of us are living with some sort of anxiety problem.

And the proliferation of surveillance equipment such as CCTV cameras (of which we have more than the rest of Europe put together) only makes people more worried of the very things the cameras are designed to tackle: crime and terrorism.

It is ironic that something which is supposed to put our minds at rest has exactly the opposite effect.

But there is also a darker side to the proliferation of monitoring equipment which should also be a cause of great concern to us all.

The evidence can no longer be ignored that after a decade of New Labour, Britain has become a far worse place for honest citizens to live their lives as they please, away from the eyes and ears of the state.

In the name of ‘efficiency’ and ‘national security’, our civil liberties have been systematically eroded.

We have calmly allowed our rulers to grab enormous and unprecedented power. They claim it is needed to protect us from criminals, but in fact they are using it to bully and enslave us with a litany of regulation and red tape.

Police and other state officials have turned from our servants into our masters.

We have granted these sweeping powers to our rulers on the understanding they would only be used against the most determined and brutal terrorists.

But, in fact, they have been used to browbeat ordinary, honest, tax-paying citizens  -  particularly when they oppose the Government’s point of view.

Now they can be used to check on your rubbish bins, an extension to your home, or even that you do actually live where you claim to live when applying to a local school.

If Taliban extremists ever did bring Britain under their control, you might imagine that the first thing they would abolish would be our right to free speech. But they wouldn’t need to. We’ve already done it for them.

It’s already a crime to demonstrate your views peacefully, or heckle a politician, or even wear a T-shirt making fun of one.

Meanwhile, the Freedom of Information Act, which is meant to allow us access to what is happening, is under threat of being watered down to the point of being pointless.

The 7/7 bombings showed that terrorism is a real threat; so is organised crime.

But as Dame Stella Rimington, head of MI5 from 1992 to 1996, has made clear, it is far better to deal with those risks rather than frighten people into accepting new laws that actually enslave us.

Typically, the Home Office has defended its approach as ‘proportionate’  -  which simply shows that it has no concept of how authoritarian it has become.

Home Secretary Jacqui Smith is behind the plans for the new ’super database’ to record all our emails, internet searches and phone calls, just in case one of us might be a wrong ‘un.

If the police do pick us up, she wants to keep us under interrogation for up to six weeks without trial.

That’s worrying, because now the police can arrest us, not just for serious crimes, but for even the most trivial reasons. And with the hundreds of sweeping laws New Labour has brought in, or the 3,609 new offences that it has created since 1997, there’s quite a choice.

The police  -  plus 1,407 other official bodies  -  can now impose on-the-spot fines for things as trivial as dropping an apple core. Refuse to pay up and you’ll be arrested and tried.

Now, even photographing a policeman could land you with a ten-year jail sentence.

Under Section 76 of the 2008 Counter-Terrorism Act, any picture ‘likely to be useful to a person committing or preparing an act of terrorism’ is strictly banned.

A new series of ominous TV adverts certainly does nothing to allay people’s fears, but rather increases them. The sound of a normal street scene is described as ‘the sound of a bomb not going off’ because someone had reported some suspicious activity.

While being alert to threat is commendable, there is the danger of making people afraid of just about anything.

And if you do fall foul of these sweeping new powers, once arrested, your DNA will be swabbed and added to the largest DNA database in the world, with 4.8 million samples.

Youth is no defence. Of the 722,464 swabs taken in 2006-7, some 350,000 were taken from children under 15.

It took a six-month legal battle to get the DNA of one 13-year-old boy, falsely accused of writing graffiti, removed from the database.

In fact, the police are incentivised to make criminals of us, rather than prevent crime.

In London last year, three officers wasted half the night by holding a 19-year-old student for five hours before cautioning him for holding open the door of a lift in an Underground station.

But then police chiefs can get up to £15,000 in annual performance bonuses depending on how many people they spot-fine, caution or charge.

So be careful near the end of the month when they are trying to fill their monthly quotas.

The whole system encourages the police to go after the easy targets  -  the peaceful, unthreatening, decent majority  -  rather than the criminals and terrorists they should focus on.

The TV licensing advertisements sum up this nightmare as eloquently as anything.

We’re told in no uncertain terms: ‘Your town, your street, your home. It’s all in our database. It’s impossible to hide.’

Well, I agree that people should pay their taxes. But these bullyboy tactics wouldn’t look out of place in Stalin’s Russia.

It is impossible to hide. Britain has more CCTV cameras than any other country. The number of speed cameras alone has trebled in the past six years.

Some 800 organisations can have our phones tapped, including, of course, all those local councils who suspect you might be leaving your wheeliebins out too early.

There is something dark in New Labour’s psychology that makes it regard such oppression as ‘proportionate’. Its need to keep control of a perpetually wayward party mutated into a desire to control a bloodyminded public.

And New Labour really believed it knew what was best for us. If our traditional rights and institutions  -  trial by jury, habeas corpus, Parliament and the judiciary  -  got in the way, they could quite legitimately be swept aside.

This week, more than 100 climate change protesters were arrested before they protested about anything, but just because of what they might do.

So now we are defenceless against even more oppression. And that’s not just my view.

In a speech at Exeter University recently, David Blunkett  -  the former Home Secretary  -  warned that a planned government ’super-database’, storing people’s emails, internet traffic and other personal data, would be a threat to individual rights.

And Sir David Ormand  -  Whitehall’s former security and intelligence co-ordinator  -  has warned that the Government’s plans to gather ever-increasing amounts of data on citizens ‘will involve breaking everyday moral rules’.

The International Commission of Jurists has suggested that countries like Britain were doing the terrorists’ jobs for them, enacting laws that undermine the very values and freedoms they claim to be protecting. Even at the highest levels, there is clearly unease at the extent of ‘Big Brother Britain’.

Let’s hope these alarms are loud enough to wake us up to the full horror of what we’ve created. No wonder we’re all so worried.

Millions of Britons racked with worry over recession, crime, health and the Big Brother surveillance state

Stress is causing a generation of anxious Brits worrying about everything from money to bird flu

The report, In the Face of Fear, calls for a campaign to cut ‘institutionally-driven fear’

Daily Mail | Apr 14, 2009

By Jenny Hope

More than seven million Britons are living with anxiety problems, almost a million more than a decade ago, a report reveals.

Two in three say the financial downturn has caused them to be anxious, fuelled by 24-hour news and ‘worst case’ images used by politicians.

Mental health experts believe that fear and anxiety could actually make the economic crisis worse and result in a longer recession.

Knife crime, MRSA, bird flu and terrorism are among other issues contributing to a ‘culture of fear’, says a report from the Mental Health Foundation (MHF) charity.

Even measures to tackle crime such as CCTV cameras may be counter-productive because they intensify fears.

The report, In the Face of Fear, calls for a campaign to cut ‘institutionally-driven fear’ and raise awareness of mental health problems.

It says: ‘The more fearful people feel in the general population, the more will be tipped over into diagnosable anxiety disorders.’

A poll of 2,246 adults for the MHF report found 77 per cent believed the world had become a more frightening place in the last ten years.

Asked specifically about the economic crisis, 49 per cent said they were anxious about money, with 66 per cent experiencing fear or anxiety about the current economic situation.

The MHF says fear is partly driving the economic crisis because emotion overrides logical thinking and this could hinder efforts to escape it.

It says: ‘Individuals and institutions – keen to protect themselves – are now too afraid to lend, spend and invest, despite the fact that these actions could assist in ending the recession.’

Research shows people with anxiety are at increased risk of heart disease and high blood pressure.

Anxiety has also been linked to increased incidence of gastrointestinal problems, arthritis, migraine, allergies, thyroid disease and chronic respiratory disorders such as asthma.

Dr Andrew McCulloch, chief executive of the Mental Health Foundation, said: ‘This report shows that fear is having a serious negative impact on the mental and physical health of the nation.

‘The modern world will test our resilience again and again, and people need to know how to process their emotions better to prevent harm to their mental and physical health.

‘Prevention campaigns about physical illnesses like heart disease and cancer are often mounted, but less than 0.1 per cent of adult mental health investment is allocated to mental health promotion.’

Care services minister Phil Hope said: ‘During the last ten years, we’ve seen major improvements in the mental health services available, but now we need to develop a dynamic new approach, which actively helps create more mentally healthy and resilient communities.’

Suicide-Linked Cymbalta Promoted for Minor Conditions

Epoch Times | Mar 17, 2009

By Martha Rosenberg

Many are outraged that Eli Lilly gave nonprofits $3.9 million in grants last year for medical courses to “educate” doctors about the pain-and-fatigue ailment fibromyalgia—more than it spent for diabetes and Alzheimer’s, which people already know they have.

But finding new diseases to justify a drug’s existence is the normal way pharma operates, especially Lilly, which agreed to pay $1.42 billion for illegal marketing of its anti-psychotic Zyprexa in January—$615 million for criminally promoting it for dementia—another $62 million to 32 states for illegal pediatric marketing, and agreed to resolve Medicaid fraud investigations into “rebates” at the same time. Lilly—whose diabetes treatment Byetta is tanking since reports last summer of six deaths, at least two from pancreatitis.

But Lilly’s fibromyalgia-fighting drug, Cymbalta (duloxetine)—its second-best seller after Zyprexa—is anything but normal.

Starting with the death of 19-year-old Cymbalta test subject Traci Johnson, who hanged herself in the Lilly Clinic in Indianapolis in 2004 and had no history of mental problems—it has been beset by reports of baffling, rapid, unprovoked, and out-of-character suicides and suicide attempts.

A 37-year-old man described in the February 2008 Journal of Clinical Psychopharmacology with a stable marriage and employment and no history of mental problems tried to kill himself with carbon monoxide two months after taking Cymbalta for back pain.

“The patient was unable to state exactly why he wanted to commit suicide,” write the four physician authors of the Department of Psychiatry and Behavioral Sciences at the University of Kansas Medical Center, who note he returned to normal when the drug was stopped.

A 63-year-old man with no history of suicide attempts or ideation was similarly “unable to explain why he was having thoughts of wanting to die,” say the authors after becoming suicidal two weeks after being put on Cymbalta for fatigue, insomnia, and sadness.

Last January, a Texas man prescribed Cymbalta for peripheral neuropathy because of a job that required him to be on his feet all day, a man with no history of mental problems “had a normal day at work, drove home, said he was going to grab a sandwich for his wife, went and shot himself,” his family wrote a reporter.

In February 2007, a 19-year-old Wisconsin college student recently put on Cymbalta “checked out books for a paper he was to write over the weekend,” emailed his résumé “to see if he could get a spot on Obama’s team for the summer,” and “then hung himself from his loft bed in his dorm,” writes his family. One month earlier, a 21-year-old Midwest college student, recently put on Cymbalta, took his own life three minutes after speaking to his family while driving home and sounding fine, the family wrote a reporter.

Approved as an antidepressant and for diabetic nerve pain in 2004—soon after the Johnson suicide, thanks to an unfazed FDA—Cymbalta soon proved to be the “Swiss Army Knife” of Lilly drugs, says its hometown paper the Indianapolis Star. It was approved for general anxiety disorder and maintenance treatment of depression in 2007, for fibromyalgia in 2008, and with approvals for chronic knee and low-back pain expected shortly.

In Europe, it is in use for stress urinary incontinence, but in the United States, its side effect of urinary retention landed Cymbalta on the FDA’s first Potential Signals of Serious Risks danger list in 2008. (FDA won’t release suicidal rates from stress urinary incontinence trials says reporter Jeanne Lenzer on Slate.com. She estimates the suicidal rates as 400 per 100,000 person-years for middle-aged women.)

But some, like Shannon Brownlee, author of “Overtreated: Why Too Much Medicine Is Making Us Sicker and Poorer,” question the revenue-driven prescribathon. Should drugs  “that may have a really serious side effect called suicide,” be used for simple knee or back pain, she asks in the Star.

Cymbalta is also being studied for binge eating, social phobia, chronic fatigue, restless legs disorder, seasonal affective disorder, migraines, attention deficit disorder, and childhood depression (despite known pediatric risks), PMS, menopause, alcoholism, panic disorder, obsessive compulsive disorder, kleptomania, and the important medical condition: tennis elbow.

At the American Academy of Pain Medicine Annual Meeting in January, Lilly presented a study by its own doctors finding Cymbalta was superior to placebo in knee pain—in keeping with its penchant to publish studies by Lilly-funded and Lilly-employed doctors who say Cymbalta is safe.

Cymbalta is also a good use of state and third-party-payer dollars, say Lilly-funded doctors in “Differences in Medication Adherence and Healthcare Resource Utilization Patterns: Older Versus Newer Antidepressant Agents in Patients With Depression and/or Anxiety Disorders” in the 2008-22 CNS Drugs. These doctors are fighting the “restrictive reimbursement policies for newer antidepressants,” in which pharmacy benefits managers are saying, “You want us to spend WHAT”?

Getting benefits managers to cover the $200-a-month cost for Cymbalta prescriptions for fibromyalgia may also be tough since the ailment has no clear cause, blood test, or cure.

Maybe Lilly will offer pointers in the medical courses it is funding.

Martha Rosenberg is a freelance writer.

Army responds to record number of suicides

In 2004, the U.S. Army reported 12 suicides; last year, 143.

Minnesota Public Radio | Mar 18, 2009

by Nikki Tundel

The U.S. Army recently made suicide prevention training mandatory for every single person in the service. This initiative comes on the heels of news that the Army suicide rate has reached its highest level since the Pentagon began keeping records in 1980.

Minneapolis, Minn. — It’s 0800 hours and the 88th Regional Readiness Command has reported for duty.

“Turn to the person next to you and say, ‘Are you thinking of killing yourself?’”

On this morning, there are no push-ups or jumping jacks. No one’s learning how to disable a roadside bomb or survive a chemical attack. Instead, the focus is on suicide awareness and prevention.

In 2004, the U.S. Army reported 12 suicides; last year, 143. At this point in 2009, more soldiers have lost their lives to suicide than have been killed in combat.

In light of these numbers, the Army ordered what it calls ‘a service-wide stand down’, giving suicide prevention training priority over everything else.

“Typically in the military, commanders took care of their soldiers. If somebody got a broken leg, we fixed it. Now we’re realizing all of the other things we have to do to help take care of our soldiers,” said Lt. Col. Cynthia Rasmussen, a combat stress officer for the U.S. Army Reserve at Fort Snelling.

For years, Rasmussen has been the one soldiers have turned to when they feel like life just isn’t worth living.

It’s not hard to see how the horrors of war can affect one’s well being. What is difficult, says Rasmussen, is getting soldiers to reach out for help when they need it.

“In the military you’re trained to be tough. You can’t let nobody know you’re weak,” said Staff Sgt. Charlotte Dubois, who spent a year in Iraq.

When the native of Trinidad and Tobago returned to Minnesota, she struggled to fit back in.

“I felt alone,” Dubois said. “When I looked at everybody, I felt more or less like, ‘Ok you guys have no idea what we’ve been through over there.’ Everybody is laughing and having a good time. But at the same time you don’t want to deal with nobody. There were times I couldn’t sleep at night. I would have dreams. I would wake up sweating, just feeling hopeless.”

Still, she was afraid that asking for help would ruin her military career.

“I thought they were going to look at my medical records and it was going to make me look like I’m a mental case,” Dubois said.

Eventually Dubois sought help at a V.A. hospital, where she was diagnosed with post-traumatic stress syndrome and severe depression. Today the staff sergeant says she’s “back to normal.” But overcoming the stigma attached with seeking psychological help wasn’t easy.

Letting soldiers know it’s OK to talk about their traumatic experiences in battle is important, said Lt. Col. Rasmussen, but that only addresses one portion of the problem.

One third of soldiers who kill themselves have yet to be deployed; they’ve never seen combat.

That statistic has surprised many — but not Rasmussen.

“What I’m seeing is a lot of the young kids coming in now are missing some of the basic coping skills that you need just to deal with life,” she said. “They come from abusive families, chaotic families, that kind of thing. They go to basic training. Then they come home and it’s all confusing because what’s the most important thing in your life when you’re 18? Your friends. You leave for six months, what happens with your friends? They all find new friends.”

Trying to deal with the loss of your support system isn’t easy when you don’t have any coping skills to start with.

This isn’t the Army’s first attempt at suicide prevention training. But what’s different this time around is that preventing suicide is now a compulsory part of the military mission – just like protecting security points and fighting insurgents.

All soldiers are required to ask others in their unit how they’re doing and it’s their responsibility to alert leaders when they think something is wrong with a fellow soldier.

This kind of systematic tactic of caring for others may seem forced to the average civilian. But Rasmussen is convinced it’s the only approach that will work in an organization she describes as “paternalistic”. “If you think about it, we’re used to being told what to do. We pretty much look the same, we think the same, we act the same because we are told to. It sounds kind of weird, but unless you’re in the military or wear the uniform, (you) don’t understand that that’s how we function. So we really do need from the top down, permission to change the way we interact and care for each other,” Rasmussen said.

The way Rasmussen puts it, the Army may not be able to stop war. But it can certainly do a better job of helping soldiers move on from it. She’s hopeful this new initiative will do that.

Psychiatrist hails GPS tracking for dementia patients as ‘major breakthrough’

Psychiatrist hails GPS devices for dementia patients as ‘major breakthrough’

A psychiatrist at the first NHS trust to trial tracking devices for dementia patients said the new technology could provide patients with more freedom to go out safely.

Telegraph | Mar 18, 2009

Dr Rupert McShane is running a two-year trial at the Oxfordshire and Buckinghamshire Mental Health Trust which has become the first in the country to fit dementia patients with the pocket GPS devices.

A total of 20 patients from the Thames Valley and Somerset areas are taking part in the trial which enables their movements to be monitored on a map via a secure website.

Dr McShane, a consultant in old age psychiatry at the trust, told BBC Radio Five Live: “About 30 per cent of people with dementia get lost at some point, and about 25 per cent of them are locked into their houses by worried relatives.

“With the development of GPS technology, we think people with dementia might have more freedom to go out and they might be safer if they do go out, if it’s possible to know where they are if they get lost.”

Sue Fulford-Dobson, whose partner Ian is taking part in the trial, said: “He is fascinated by sunsets. So suddenly at eight o’clock at night he will say, ‘There’s a lovely sunset; I think I’ll just go and see if I can see it better’. And that’s when he will disappear.

“I mentioned to our GP this was becoming a problem. We’d had a couple of really bad incidents where we’d had to call the police out and he’d been missing for more than 24 hours, overnight.”

But she said it was difficult to persuade Ian to carry the tracker with him at first.

“I wouldn’t say he’s happy but provided I put it in his pouch every morning he will leave it there, which is all he has to do,” she said.

“At least it means that if he has vanished, even if I can’t find him, it helps the police to find him.

“I think if somebody is really, really unhappy about it then you can’t do it – because people do have human rights.”

A carer can also be alerted by a phone call or text if the wearer goes outside a specific area.

In April 2007, the then Science Minister Malcolm Wicks was criticised for suggesting dementia patients could be monitored with the use of GPS devices, but the Alzheimer’s Society gave the technology its backing later that year.

Its chief executive Neil Hunt said the technology “could offer benefits to people with dementia and their carers”.