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Study: Homicidal poisoning increasing

From United Press International, Inc.:

Homicidal poisoning -- an often overlooked crime -- is rare but on the rise, with infants the most common victims, University of Georgia researchers say.

Greene Shepherd of the University of Georgia College of Pharmacy and recent graduate Brian Ferslew examined seven years of recent federal mortality data and identified 523 deaths due to homicidal poisoning -- a figure that corresponds to a rate of 0.26 poisonings per million people.

The study, published in the journal Clinical Toxicology, finds poisonings appear to be on the rise -- although they account for less than 1 percent of all homicides.

The study documented a low of 0.20 cases per million in 2000 and a high of 0.35 in 2004.

"Homicidal poisoning is rare relative to a lot of other causes of death, but the numbers are trending higher," Shepherd said in a statement. "We may never know the true incidence because some cases undoubtedly evade detection and classification."

Children younger than age 1 are approximately nine times more likely than the general population to be victims, the study finds.

Shepherd says that rather than being premeditated acts, the majority of these poisonings are likely negligent homicides committed by parents or caretakers due to long hours, stress and sometimes bad decisions to try to sedate a child with medication or alcohol.

Posted: 5/29/2009 10:45:00 AM

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Zinc and Selenium are the Minerals that Fight Breast Cancer

From Natural News:

Any woman wanting to avoid breast cancer or its recurrence needs to be aware of the risk factors.  Imbalances in the body are the risk factors that explain why women get breast cancer. Two minerals, zinc and selenium, are key in maintaining balance in the body and keeping cancer away. Recent research has added to the pile of data underscoring the importance of these minerals in keeping women cancer-free.

Researchers at Pennsylvania State University have reported that glands in the breast have unique zinc requirements resulting from their need to transfer extraordinary amounts of zinc into milk during lactation. When nursing women's breasts are deficient in zinc, the result can be severe zinc deficiency in the infant, resulting in impaired growth and development. When zinc is deficient or not properly metabolized, breast cancer is often an additional outcome. Lack of zinc has been implicated not only in the initiation of breast cancer, but also in the transition, progression, and metastasis of the disease. When zinc is deficient, cellular functioning in the breast is compromised.

In France, scientists report that estrogen receptor expression in breast cancers is associated with differentiated tumors and a more favorable prognosis. The greater the resemblance of cancerous breast cells to non-cancerous breast cells, the less threatening is the disease. Although the exact mechanism underlying the protection ERs play against cancer progression remains to be researched, these scientists studied the actions of ER alpha, and documented that one of the ways this ER inhibits invasion is though its first zinc finger. A zinc finger is a group of proteins organized around a zinc ion that can bind to DNA and influence gene regulation

In other research, Dr. David Watts reviewed the hair trace mineral reports of thousands of women and found that a pattern of elevated boron, copper and calcium levels with lower levels of zinc occurred in women with breast cancer. According to Dr. Watts, boron and copper appear to make the body more sensitive to the stimulatory effects of estrogen, and less responsive to the quieting effects of progesterone. Zinc is the mineral that aids in the production and utilization of progesterone, so this pattern of mineralization makes women less progesterone responsive and more estrogen sensitive. Raising zinc levels and lowering boron, copper and calcium levels can bring these women into mineral balance and help in the creation of hormonal balance.

The primary gene protecting women from breast cancer, p53, is thought to be the most frequently mutated or altered gene in the development of cancer. This gene requires zinc, and if it is missing, the gene becomes mutated, resulting in it becoming inactivated or suppressed. Dysfunction of p53 is well documented in the development of breast cancer, indicating that a zinc deficiency is a risk factor for breast cancer independent of the levels of boron, copper and calcium.

The relationship between selenium status and intake among breast cancer patients was studied by scientists in Kuala Lumpur. 64 women with breast cancer and 127 matched controls were interviewed to obtain information on their habitual dietary intakes, demographic data, and medical history. Selenium status was determined from toenail and hair analysis. The researchers found that total energy and protein intake was significantly higher among controls than among the breast cancer cases. The selenium intake among the women with breast cancer was significantly lower than the controls. Breast cancer risk decreased with the increasing quartiles of selenium intake. Selenium in hair did not differ among breast cancer cases and controls, but selenium status in the nails of controls was significantly higher compared to the breast cancer cases.

In a recent study done at the University of Washington, scientists investigated the signaling pathways modulated by selenium. They compared global gene expression profiles in mammary tissues from pubescent female rats maintained on a selenium (3ppm) diet with those on a standardized diet. The selenium-enriched diet altered the steady-state levels of genes involved in various cellular functioning, the most dramatic of which was the changes in the expression of multiple genes that regulate circadian rhythm.

The normal mammary tissue of rats fed the standardized diet showed little circadian oscillation relative to liver tissue. However, the mammary tissue of the selenium fed rats showed a progressive, time-dependent increase in the expression of circadian gene Per2, and a circadian regulated transcription factor. Further, the results showed that the expression of Per2 and transcription mitigated RNA was significantly decreased in mammary tumors arising in selenium fed rate, but not in tumors of rats on the control diet. This suggests that selenium-induced elevation in the expression of circadian genes was incompatible with mammary cancer. The researchers concluded that the Per 2 gene is an important target of selenium for cancer prevention.

Posted: 5/26/2009 11:31:00 AM

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U.S. military: Heavily armed and medicated


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.

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.

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.

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.

The U. S. Army's suicide rate is now at an all-time high. Colonel Ritchie says officials are studying the reasons for the increase, including the possible role of medications. Soldiers taking antidepressants have killed themselves, she says, but so far there is no evidence that the risk is higher for those taking the drugs.

Instead, the army has found, soldiers who committed suicide often had personal problems, such as troubled marriages or financial difficulties. Repeated deployments can strain family relationships. "The army has been at war for a long time," Colonel Ritchie says, "and everyone is kind of tired."

Pentagon policy requires that service members with psychiatric conditions be stable for at least 3 months before they can be deployed. Colonel Ritchie says she can't comment specifically on any soldier's medical history, but agrees that sending someone to Iraq just hours after leaving a psychiatric hospital would violate the policy.

Military physicians can be swayed by the aggressive promotional efforts of the pharmaceutical industry just like civilian doctors often are. The military has rules that limit the handouts doctors can take from drug companies. A doctor can go to a dinner paid for by a drug company, but the meal's value can't be more than $20, and the value of all gifts received from a company over the course of a year can't exceed $50.

The drug companies have devised ways of working around those limits.

When thousands of military and federal health-care professionals met in November for the annual meeting of the Association of Military Surgeons of the United States (AMSUS), more than 80 pharmaceutical companies and other health-care firms were on hand. The companies helped pay for that San Antonio event in exchange for the opportunity to set up booths in the convention hall, where sales reps pressed doctors to prescribe their products or to use their medical equipment and devices.

Aggressive corporate promotion is one reason behind the army's fast-rising use of narcotic painkillers. Manufacturers of narcotics like OxyContin and Actiq have spent millions in recent years to convince doctors that the drugs aren't as addictive or as dangerous as most people believe. Before such corporate marketing campaigns, many doctors hesitated to prescribe narcotics unless a patient was suffering from a serious, pain-inflicting condition — terminal cancer, for instance. Drugmakers expanded the market by encouraging docs to prescribe narcotics to people suffering from more moderate pain, and by downplaying the drugs' addictive potential.

These same manufacturers fund organizations like the American Pain Society. The society's noble goal of eliminating pain has made it the perfect conduit for drug marketing.

Military doctors agreed with the American Pain Society that pain treatment should be more accessible. In 1999, the Department of Defense and the Veterans Health Administration began a campaign called "Pain as the Fifth Vital Sign," a motto that had been created and trademarked by the society. Doctors treating active-duty service members and vets were urged to test and treat pain just as they would blood pressure and body temperature.

The Defense Department and the Department of Veterans Affairs also issued a guideline in 2003 that directed doctors on how to prescribe narcotic painkillers for chronic pain. Chronic pain can be related to conditions ranging from arthritis to the phantom-limb pain experienced by amputees. "Repeated exposure to opioids in the context of pain treatment only rarely causes addiction," the guideline noted.

That statement is controversial. In a study at Brigham and Women's Hospital, in Boston, 22 percent of patients taking narcotics for long-term treatment showed signs of abusing the drugs. The army has plenty of firsthand evidence of how addictive the painkillers can be. At Fort Leonard Wood, in Missouri, officials charged more than a dozen soldiers with illegally using and distributing narcotics, including drugs they'd reported picking up at the base's pharmacy for little or no cost. Many of the soldiers had suffered injuries in Iraq or in training but had later begun abusing the painkillers reportedly prescribed by army doctors.

One problem is that injured soldiers in pain are often also suffering from posttraumatic stress disorder (PTSD), which makes them vulnerable to abusing alcohol or drugs. A soldier taking a narcotic can start using it to escape more than his pain.

According to Colonel Ritchie, painkillers can help soldiers do their jobs by reducing pain, which allows them to concentrate. "But these medications are lethal in overdose and can't be used carelessly," she says, adding that if side effects interfere with a soldier's ability to perform, he or she is moved to another job or sent back to a home base.

The army is adding safeguards to reduce the chance that soldiers will become addicted to painkillers, she notes. And the guideline informing doctors that the drugs rarely cause addiction is being rewritten.

Posted: 5/20/2009 9:08:00 AM

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Fake cigarettes, fake smoke, real nicotine

From the Baltimore Sun:

From a distance, it looks like Tal Broustin is lighting up a cigarette, right in the middle of Arundel Mills, a clear no-no. And he is trying to get others to take drags, too, luring passersby to his kiosk by asking if they are trying to quit smoking.

Up close, it is clear that Broustin is taking puffs not from an actual cigarette, but from a battery-powered gadget designed to look like the real thing. Called an "e-cigarette," or electronic cigarette, it contains no tobacco, gives off no smoke but instead is a nicotine delivery device that gives off heated water vapor. Some companies are pitching e-cigarettes simply as less harmful alternatives to smoking, saying that smokers who can't quit might be better off "vaping" one of their products. Other companies, though, are selling their e-cigarettes as smoking cessation tools, claims that have not been backed up by any science.

Regardless, the relatively new devices - available online, at truck stops and at mall kiosks like the one where Broustin works - are drawing fire, mostly from groups such as the American Cancer Society and the American Lung Association, and from scientists who say they fear the products may pose unknown dangers, even if they're not from the known carcinogens in cigarette smoke.

Some have called on the Food and Drug Administration to ban them immediately. The FDA says e-cigarettes are "unapproved drug-device combinations," and, in the past two months, has detained 17 shipments from China at the border and sent them back. "We don't know its safety profile," said spokeswoman Karen Riley.

Despite the recent FDA actions, the industry says more than 100,000 e-cigarettes have been sold in the United States, and the number grows every day.

"Relatively little is known about how they're used, how much nicotine gets into people, what other chemicals are coming along for the ride," said Dr. Jonathan Samet, director of the Institute for Global Health at the University of Southern California and a former department chairman at the Johns Hopkins School of Public Health in Baltimore. "To make a therapeutic claim, you need to do the proper testing."

One selling point of e-cigarettes is that they can be used where smoking is banned - in bars, in restaurants, at the mall. Samet said he thinks people who use them could get even more nicotine than before because they will be able to "light up" in more places. One consequence of smoking bans, he said, has been that more people have quit smoking.

A starter e-cigarette kit typically goes for about $100. When the user inhales through the cigarette-like tube, a heating element is activated and it vaporizes a nicotine solution stored in the mouthpiece. A red light will glow on the end, simulating the burning of tobacco. The mouthpiece contains about the same amount of nicotine in a pack of cigarettes and is flavored to taste like tobacco or menthol (though some offer mint, vanilla or other flavors). The nicotine needs to be replenished at an additional charge.

William T. Godschall, executive director of Smokefree Pennsylvania, said he finds the debate about e-cigarettes to be counterproductive. He agreed that clinical trials have not been conducted, but he finds it odd that a government that can't seem to regulate cigarettes - which are known to cause cancer - is upset over a much less hazardous product.

Posted: 5/18/2009 11:02:00 AM

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Cocaine Spurs Long-Term Change in Brain Chemistry

From HealthDay:

Many remember those fried-egg "this is your brain on drugs" public service announcements. Now, a new study offers insight into how addictive drugs such as cocaine "cook" the brain.

"The study's findings enable us to glimpse for the first time exactly how cocaine modifies the activity of genes in regions of the brain that that mediate reward," explained Nora Volkow, the director of the U.S. National Institute on Drug Abuse, the organization that supported the study. "These genes represent promising new targets for the development of medications to treat cocaine addiction," she said.

Scientists led by Dr. Eric Nestler, of New York's Mount Sinai School of Medicine, used a new molecular analysis technique to watch changes in the gene activity of mice that were injected with cocaine. The changes involve a shift in proteins called histones and transcription factors, which bind to DNA and regulate how the genetic information in a DNA strand is read to make a complementary sequence of RNA. A cell uses the information in the RNA to make final protein products.

Using these genetic markers, scientists mapped the effects of drug use in a critical part of the brain's "reward circuitry."

The process showed, for the first time, that a family of genes called the sirtuins are activated by chronic cocaine use and fuel addiction-related behaviors in lab animals.

The research was published May 14 in the journal Neuron.

"This analysis provides fundamentally new information about the range of genes that are altered by cocaine in this brain region," Nestler said. "We showed that blocking the activity of the sirtuins reduced both cocaine's rewarding effects and the motivation to self-administer the drug."

In other words, scientists may someday be able to take away the desire for cocaine as well as the pleasure a person gets from using it, the researchers said.

Posted: 5/15/2009 3:38:00 PM

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Warmer weather raises risks associated with TVA ash spill


A Duke University scientist has published the first academic scholarly research on the TVA ash spill, citing several health concerns regarding airborne ash. Dr. Avner Vengosh said hotter and drier summer conditions increase the odds of ash going airborne.

Vengosh's findings were published last week in the Environmental Science and Technology scholarly journal. The paper said the smallest particulate matter poses the most danger in terms of going airborne and toxicity.

The study said, "Fine fractions of fly ash are typically 4 - 10 times enriched in metals... affecting human health directly... through inhalation and indirectly through the food chains (agricultural products)."

The research cites previous studies that say exposure to coal ash is associated with an increased risk of skin, lung, and bladder cancers.

"We agree with him that those are valid concerns that need to be worried about," said Joe Hoagland, TVA Vice President Environmental Science and Policy. "We've done a great deal to monitor airborne particulates and suppress dust."

"The state and EPA have required extensive monitoring and extensive dust suppression measures," said Tisha Calabrese-Benton, spokesperson for the Tennessee Department of Environment and Conservation. "We have not seen dust exceed safe levels in our monitoring, but certainly recommend that people go inside if they see dust outside. And if they are experiencing symptoms to see their primary care physician."

Hoagland said much of Vengosh's data is in line with samples gathered by TVA. However, he disagrees with Vengosh's conclusions regarding Mercury levels in the river sediment. Vengosh took samples both upstream and downstream from the ash spill.

The paper said "sediments from the downstream Clinch River have higher [Mercury] content, which suggests a significant contribution of [Mercury] from the coal ash to the river sediments. We therefore conclude that ash transport and deposition in the Clinch River has increased the [Mercury] content in the river sediments.

Hoagland said Vengosh's upstream sample showed unusually low Mercury levels compared to historical samples from the Department of Energy. Hoagland said the elevated mercury levels came from Oak Ridge.

"That is legacy material that's in there. I think there's more analysis and research would need to be done related to his [Vengosh's] ideas," said Hoagland.

Calabrese-Benton said TDEC supports Vengosh's scientific efforts and has endorsed his application for a national grant to continue researching the ash spill.

Posted: 5/13/2009 11:52:00 AM

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'Miracle drug' has high success rate for treating opiate addiction

From the Lancaster Eagle-Gazette:

Rampant opiate use in Fairfield County has local recovery officials wondering what they can do to help more addicted individuals.

Pressed with time and a growing number of patients, many doctors are forced to turn away people hooked on opiates such as heroin, OxyContin, Vicodin, morphine and other pain relievers.

Some even die on waiting lists for a widely used medication called Suboxone: A touted "miracle drug" that suppresses symptoms of withdrawal, reduces cravings, reduces drug use and helps patients stay in treatment.

"With all the deaths and what's happening because of opiates, I just feel like we need more programs in Ohio for that," said Dr. Robert C. Polite, medical director at the Recovery Center in Lancaster. "That's on my wish list to get an opilaoid-treatment license for the Recovery Center where we do specifically Suboxone."

Polite founded the Recovery Center's opiate-addiction recovery program that uses the drug Suboxone. His goal is to one day have a clinic devoted solely to helping those addicted to opiates.

The center chalks up much of its success to the drug, which is helping many Fairfield County residents kick their opiate dependency. The center boasts a success rate of more than 60 percent.

The medication blocks the ability for patients to get high off other drugs, but it still gives the patient a lower feeling of being high, said Recovery Center Clinical Director Sharon Shultz.

Patients typically stay on the medication 10 to 18 months, and more than half refrain from opiate use after treatment. That's a drastically higher success rate than any other type of addiction treatment, Shultz said.

The center has a 30- to 40-person waiting list for the Suboxone program, with more than 50 being treated right now. It's the fact others are waiting their turn - often in critical stages of dependency - that makes the Recovery Center strict on its Suboxone patients, Shultz said.

A lot of patients understand the severity of their situations and stick to the rules, she said.

The number of patients treated in the program has more than doubled in the past two years, since the Recovery Center started offering the treatment program.

But, Polite said the program still is fairly new and malleable.  He said one of the challenges with the program is getting more patients in the door for help.

The problem lies in the number of patients doctors are prohibited to see, Polite said. On top of that, only specially-licensed doctors may prescribe Suboxone.

Posted: 5/11/2009 3:30:00 PM

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Bar-shooter convicted of 4 murders; killed uncle by mistake

From the Philadelphia Daily News:

A judge yesterday convicted a 28-year-old man of four counts of first-degree murder for shooting numerous times into a narrow Southwest Philly bar two years ago and killing four people, including his own uncle.

Common Pleas Judge Benjamin Lerner then sentenced Vonzell "Pooh" Roundtree to four mandatory terms of life in prison, to be served concurrently.

The prosecution had decided not to proceed with the death penalty after Roundtree agreed to a nonjury trial.

Evidence at the trial showed that Roundtree fired a 9 mm Beretta at least eight times in Abay Wheelers Bar, on 62nd Street near Wheeler, about 12:30 a.m. July 22, 2007, shortly after a televised boxing match ended.

Roundtree told police that he saw a couple of men punching his uncle in the bar, and that he pulled out his gun in an attempt to protect his uncle, Jamar Thompson.

"I fired until the gun was empty," he said.

But Roundtree ended up killing his uncle, 31, and shooting his uncle's friend, Gallmon, 36, who was not part of the fight that Thompson had with others. Gallmon died about a month later, on Aug. 24.

Roundtree also shot dead the two men whom he said he saw punching his uncle - Claude Snelling, 30, and Arthur Jennings, 20.

Defense attorney David Nenner contended in his closing argument yesterday that Roundtree was "substantially intoxicated" that night from having smoked PCP and marijuana and drinking alcohol, and was unable to form a specific intent to kill.

Nenner called to the stand two witnesses yesterday. Edward Barbieri, of NMS Labs, in Willow Grove, testified that hair samples collected from Roundtree 16 days after the shooting tested positive for PCP and Ecstasy.

He said that the drugs could have been taken about two weeks before the samples were collected.

Psychologist Steven Samuel testified that based on interviews he had with Roundtree, and on Roundtree's statement to police, he did not think that Roundtree formed a specific intent to kill because of the amount of drugs and alcohol that the defendant allegedly ingested before the shooting.

Assistant District Attorney Jennifer Selber yesterday agreed in her closing argument that Roundtree was under the influence of PCP, marijuana and alcohol that night. But she pointed out that the intoxication did not rise to the level where Roundtree could not form decisions, including a specific intent to kill.

Posted: 5/11/2009 12:25:00 PM

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Why Antidepressants Don't Live Up to the Hype

From TIME:

In the '90s, Americans grew fond of the idea that you can fix depression simply by taking a pill — most famously fluoxetine (better known as Prozac), although fluoxetine is just one of at least seven selective serotonin reuptake inhibitors (SSRIs) that have been prescribed to treat hundreds of millions of people around the world.

But in the past few years, researchers have challenged the effectiveness of Prozac and other SSRIs in several studies. For instance, a review published in the Journal of Affective Disorders in February attributed 68% of the benefit from antidepressants to the placebo effect. Likewise, another paper published in PLoS Medicine a year earlier suggested that widely used SSRIs, including Prozac, Effexor and Paxil, offer no clinically significant benefit over placebos for patients with moderate or severe depression. Meanwhile, pharmaceutical companies maintain that their own research shows that SSRIs are powerful weapons against depression.

Now a major new study suggests that both critics and proponents might be right about SSRIs: the drugs can work, but they appear to work best only for a subset of depressed patients, those with a limited range of psychological problems. People whose depression is compounded with, say, substance abuse or a personality disorder may not get much help from SSRIs — unfortunately for the 45% to 60% of patients in the U.S. who have been diagnosed with a common mental disorder like depression and also meet the criteria for at least one other disorder, such as substance abuse.

The new study, published online in April by the American Journal of Psychiatry, was conducted using data from a large, government-funded trial called Sequenced Treatment Alternatives to Relieve Depression, which usually goes by the moniker STAR*D. The STAR*D project, which collected data from 2001 to 2004 at 41 U.S. psychiatric facilities, was one of the most ambitious efforts ever to understand how best to treat people with major depression. STAR*D participants comprise a powerful research sample because they are highly representative of all depressed Americans. Very few depressed people were excluded from STAR*D; only women who were pregnant, those with seizure disorders and a few others with acute conditions were kept out. All other psychiatric and medical comorbidities were allowed.

The authors of the new paper, a team of 11 researchers led by University of Pittsburgh professor of epidemiology Stephen Wisniewski, were curious how the STAR*D group would compare to a typical group of patients selected for a run-of-the-mill drug-company trial for a new antidepressant — the very trials on which the Food and Drug Administration bases its decisions regarding new drug approval. Drawing on their own experiences helping to conduct such clinical trials, which have far more stringent inclusion criteria than the STAR*D group, Wisniewski and his team divided the STAR*D patients into two groups — an "efficacy" sample of patients who would normally be included in a typical Phase III clinical trial for a new antidepressant and a "nonefficacy" sample of patients who would normally be rejected.

All the STAR*D patients were taking citalopram, an SSRI marketed in North America as Celexa. Not surprisingly, those who met standard inclusion criteria for a clinical trial had significantly better outcomes on the drug. In the efficacy group, 52% responded to Celexa versus 40% of the nonefficacy group. Patients in the latter group also took longer to respond and had to be readmitted to psychiatric settings more often. "Thus," the authors conclude, "current efficacy trials suggest a more optimistic outcome than is likely in practice, and the duration of adequate treatment suggested by data from efficacy trials may be too short."

To bolster their findings, the authors cite a smaller 2002 study that arrived at similar results: in that paper, published in the American Journal of Psychiatry, Dr. Mark Zimmerman of Brown University and his colleagues found that of 315 patients with major depressive disorder who sought care, only 29, or 9.2%, met typical criteria for an efficacy trial. Similarly, psychologist Ronald Kessler of Harvard coauthored a 2003 paper in the Journal of the American Medical Association that concluded that most "real world" patients with major depression would be excluded from clinical trials because of comorbidities.

Such findings help explain why antidepressants haven't quite lived up to their promise.

Conducting clinical trials with representative samples would undoubtedly be more complex — and expensive — since patients with multiple risk factors would have to be monitored more carefully. But for a future generation of antidepressants to be truly effective for most patients, more inclusive trials may be the best answer.

Posted: 5/6/2009 3:46:00 PM

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One Step Closer to Birth Control Shot for Men

From ABC news:

A large study published Monday in the Journal of Clinical Endocrinology and Metabolism indicates that science may be bringing us closer to a male "pill," although the idea of hormones for male birth control still stokes a heated debate among doctors.

Researchers recruited more than 1,000 Chinese men who had fathered at least one child two years before the study with their partners to receive injections of testosterone undecanoate (TU) in tea seed oil every month.

After two years, the injections had 95 percent effectiveness for preventing pregnancy overall, and about 98 percent effectiveness for men whose sperm levels dropped off at expected levels within the first few months of the trial.

Male contraceptive researcher Dr. John K. Amory was impressed by the ability of the injections to drop sperm counts.

"The goal is to try to get to 99 percent effectiveness [for pregnancy prevention]," said Amory, who is an associate professor of medicine at the University of Washington in Seattle

Although testosterone usually triggers sperm production, Amory said too much testosterone can shut down the testes.

The authors write that more long-term studies of testosterone injections are needed for safety, but "that these promising findings provide encouragement that male hormonal-contraceptive regimens may offer a novel and workable alternative to existing family planning options."

But not everyone agrees that hormones for male birth control are novel, or a workable alternative.

It's really not new and it's been abandoned for a number of reasons," said Dr. Larry Ross, past president of the American Urological Association.

The first reason, Ross said, is that testosterone injections proved to be unreliable in the past.

"Failure rates as high as 20 percent have been reported," said Ross, who is also professor of urology at the University of Illinois at Chicago.

On the other hand, Ross said testosterone injections can be too effective and, over time, can sterilize a man.

But researchers of male birth control in the United States say they have to kindly disagree with the notion that the effects of abuse rule out any future for testosterone as birth control.

"I'm not sure I agree that it can lead to sterility," said Armory, who added that in the 35 male hormonal-contraception studies using testosterone he has seen, there has never been a case of irreversible sterility.

Dr. Ronald Swerdloff, a veteran male contraceptive researcher, believes there are issues other than safety or effectiveness that are keeping male hormone contraception research from reaching its goal.

"This as been known for 15 and 20 years that [testosterone injections] are quite effective and that there is a limitation that it didn't work on everybody," Swerdloff said. "But there's another problem and the other problem is that it doesn't work right away," he said.

Unlike the condom, which works immediately, or the pill which works within one month's cycle, a man on testosterone may have to wait three months before sperm production shuts down.

Swerdloff thinks the lack of interest by pharmaceutical companies may be another contributor to barriers for male hormone contraception research.

Swerdloff believes that -- unlike a new cancer drug that people need and would pay big money for -- pharmaceutical companies don't see the profits in male contraception investments when healthy people already have relatively cheap, safe options for women's birth control or other methods.

"There would be a considerable up-front cost," Swerdloff said.

But at least all doctors can agree that one thing male contraception research isn't missing is interest by the public.

Posted: 5/5/2009 11:36:00 AM

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