Hallucinations Are Rare Side Effects of ADHD Medications

(HealthDay News) -- Children who take medications for attention-deficit hyperactivity disorder (ADHD) may rarely experience some disturbing side effects, such as hallucinations.

U.S. government experts reviewed clinical trials and post-marketing reports of side effects from the commonly prescribed ADHD stimulant medications, such as Concerta, Ritalin and Strattera. They found that out of every 100 "person-years" of treatment, one or two children will experience serious side effects, such as hallucinations of bugs or snakes.

"Patients and physicians should be aware that psychosis or mania arising during drug treatment of attention-deficit hyperactivity disorder may represent adverse drug reactions, the study's authors wrote in the February issue Pediatrics.

"These reactions are very rare," said Dr. Roy Boorady, director of the psychopharmacology service at the New York University Child Study Center in New York City.

"We see a lot of children on medications here, and I would say maybe one a year or once every two years, we might hear about a child with tactile hallucinations, where kids feel like they have bugs on them. It's usually really young kids who are on medications, and once they back off or stop the medications, the sensation is gone," he said.

Almost 8 percent of children in the Unite States -- about 4.5 million -- have ever received a diagnosis of ADHD, according to background information in the article. And, it's estimated that 4.3 percent of American children are taking medications to treat ADHD. The main signs of ADHD are inattention, hyperactivity, and impulsiveness.

Concern about potential psychiatric side effects from these medications led to the current study.

The FDA experts reviewed the results of 49 randomized, placebo-controlled trials and asked drug manufacturers to analyze their post-marketing surveillance databases.

They found that 11 psychosis or mania episodes occurred for every 743 person-years of treatment. No episodes of psychosis or mania occurred in children taking placebo treatments. For every 100 person-years, the rate of psychosis or mania was 1.48, according to the study.

The post-marketing reports found more than 800 incidences of psychosis or mania. In about 90 percent of cases, there was no previous history of a similar psychiatric condition, the study found.

The most common hallucinations were visual or tactile sensations of insects, snakes or worms.

"Any medication has side effects, some of which are very, very rare," said Dr. William Cohen, a developmental-behavioral pediatrician in the Child Development Unit at Children's Hospital of Pittsburgh. "Whenever your child is taking any new medication, if something new starts, consider it a side effect and call your doctor. With these medications, it's safe to stop them and call your doctor."

Boorady said that sleep problems and a loss of appetite tend to be more common side effects of these types of medications. And he doesn't think parents should be overly concerned about the possibility of psychiatric symptoms, because they are so uncommon.

More information
The Nemours Foundation has more on ADHD medications and their side effects.

Multiple Doses of Steroids Don't Help Preemies

(HealthDay News) -- Pregnant women at risk of preterm delivery who are given multiple doses of steroids to help their fetus tend to give birth to low birth-weight babies with smaller head circumference, a new study found.

A single dose of corticosteroids had been the standard of care for many years to reduce the chances of infant mortality, respiratory distress syndrome, and bleeding in the brain. And, it was thought that women who remained at risk of preterm birth after an initial dose would benefit from repeated doses.

"A single course of steroids is given to all women at risk of preterm birth, and that still holds," said study lead author Dr. Kellie E. Murphy, who's with Mount Sinai Hospital's Department of Obstetrics and Gynaecology, in Toronto, Canada.

"The results of this trial will change clinical practice worldwide," she said. "It will conclusively stop practitioners from giving multiple courses of antenatal corticosteroids."




The report was published in the Dec. 20/27 issue of The Lancet.

Dr. William F. Walsh, chief of nurseries and a specialist in the care of high-risk newborn babies at Vanderbilt University Medical Center in Nashville, said clinical practice has already changed, and most doctors only give a single dose of steroids.

"Every research has shown an overwhelming benefit from one course of steroids for premature babies," he said, adding that multiple doses are no better than one.

"It's an important question to answer, but I thought it had already been answered," Walsh said.

For the new research, Murphy and her colleagues studied 1,858 women at 25 to 32 weeks of gestation who had not delivered their babies within 14 to 21 days after receiving one dose of corticosteroids.

The women were randomly assigned to corticosteroids every 14 days until 33 weeks of gestation or until they delivered, or a placebo. The researchers looked for cases of death before or after delivery and other conditions, such as severe respiratory distress syndrome and bleeding in the brain.

Murphy's team found that women given multiple doses of corticosteroids had babies that weighed less, were shorter and had smaller head circumference than babies of mothers given a placebo.

Also, there was no difference in other results, such as death, respiratory problems and bleeding in the brain between the babies of women given more than one dose of steroids and women given a placebo, the researchers reported.

More information
For more on premature infants, visit the U.S. National Library of Medicine.

Osteoporosis Drug Seems to Shrink Breast Tumors

(HealthDay News) -- Researchers continue to test the mettle of breakthrough breast cancer cancer drugs, three decades after tamoxifen changed the medical landscape by drastically reducing the risk of recurrences in women with estrogen receptor-positive tumors.

Encouraging findings on several different drugs were presented Thursday at the CTRC-AACR San Antonio Breast Cancer Symposium in Texas.

First in the line-up, the osteoporosis drug zoledronic acid (Zometa) appears to shrink breast tumors in patients who undergo chemotherapy.

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The drug is already approved to treat breast cancer that has spread to the bone and, earlier this year, was reported to lower the risk of breast cancer recurrence in pre-menopausal women with early estrogen- or progesterone-positive tumors.

In an analysis of slightly more than 200 women, those who received Zometa in addition to chemotherapy had better results than those receiving chemotherapy alone. After compensating for variables such as estrogen receptor status and treatment duration, residual invasive tumor size was 42.4 millimeters in the chemotherapy alone group, and 28.2 millimeters in the combination group.

"This data suggests that zoledronic acid is doing something more than protecting bone," said study senior author Dr. Robert Coleman, a professor of medical oncology at the University of Sheffield in England. "It's not practice-changing. It's hypothesis-generating, which will lead to the design of new trials to look at this in detail. But this is the first patient-related evidence."

Coleman spoke, along with researchers involved with other trials, at a Thursday teleconference. Other studies showing promise included:

Postmenopausal women with estrogen receptor- and/or progesterone receptor-positive breast cancer who took the aromatase inhibitor exemestane (Aromasin) had a 15 percent relative reduction in recurrences and a 19 percent reduction in the risk of distant metastasis, compared with those taking tamoxifen alone. "Exemestane is very effective at preventing recurrences," said Dr. Stephen Jones, medical director of U.S. Oncology Research in Houston. Exemestane, like other aromatase inhibitors, blocks production of estrogen, while tamoxifen, long the gold standard in breast cancer therapy, inhibits the hormone's effects in the body.
Seventy percent of women receiving Herceptin (trastuzumab), a drug used to treat HER2-positive breast cancer, plus chemotherapy before surgery survived three years without a recurrence. Only slightly more than half of women receiving chemotherapy alone survived that long. The incidence of major heart problems was low. "Herceptin given before surgery with chemotherapy significantly [reduces the likelihood] of a recurrence in patients with advanced HER2-positive cancer, and most likely will translate into a benefit in terms of survival," said Dr. Luca Gianni, director of medical oncology at the National Cancer Institute in Milan, Italy. "We think that this data establishes preoperative Herceptin with chemotherapy as a standard treatment option for women with advanced HER2-positive breast cancer."
Combining lapatinib (Tykerb), another HER2 inhibitor, with an aromatase inhibitor (in this case, letrozole) prolonged progression-free survival from three months among those taking letrozole (Femara) alone to 8.2 months in women taking both drugs. These patients had HER-2-positive metastatic breast cancer. "The combination shows benefits in controlling the disease and controlling it for longer than using endocrine therapy alone," said Stephen Johnston, a consultant in medical oncology and reader in breast cancer medicine at Royal Marsden Hospital and Foundation in the United Kingdom. "The suggestion is that combined therapy may be the best approach."
Finally, aromatase inhibitors may be poised to replace tamoxifen as standard treatment to prevent breast cancer recurrence in women who have already undergone conventional therapy, according to a new meta-analysis. The analysis looked at two groups: women with postmenopausal estrogen receptor-positive breast cancer who took tamoxifen for five years after standard treatment and women who took tamoxifen but then switched to an aromatase inhibitor after initial treatment. "The data are still early but it does show a statistically significant advantage in [women who were switched from tamoxifen to an aromatase inhibitor] but not in [women who took tamoxifen for the full five years]," said Dr. James Ingle, director of the breast cancer program at the Mayo Clinic, in Rochester, Minn. "But you have to remember our experience with tamoxifen. It took 10 to 15 years to see the full effect of tamoxifen."

More information
Visit the U.S. National Cancer Institute for more on breast cancer treatment.

Drugs Show Potential for Weight Loss, But Hands Off Unless You’re Diabetic

By Sean Kelley

A few years ago, when a new injectable drug—Byetta—showed promise helping type 2 diabetics control their blood sugar and lose weight, a funny thing happened: Non-diabetics began trying the drug (off-label) as a weight-loss solution.

This week, the press is trumpeting the weight-loss potential of another injectable diabetes drug, Symlin (pramlintide acetate). There’s nothing new about the drug’s ability to help diabetics manage their blood sugar and lose weight; past studies have already illustrated the potential. Read More

Antidepressants Help HIV-Infected Patients Stick to Treatment

(HealthDay News) -- People with HIV who suffer from depression are much less likely to stick with their treatment regimens, new research shows.

However, treating their depression with widely used selective serotonin reuptake inhibitor (SSRI) antidepressants can get them back on track, the researchers said.

A team from Kaiser Permanente in Oakland, Calif., analyzed the mental health, disease progression and treatment data of almost 3,400 HIV-infected patients nationwide between 2000 and 2003. All patients were starting a new, highly active antiretroviral therapy (HAART).

Reporting in the current online issue of the Journal of Acquired Immune Deficiency Syndromes, they found that almost half of the study participants (42 percent) had depression during the 12-month study. Those who were depressed were less likely to take their medications and had worse viral response than people who were not depressed. However, when depressed people took prescribed SSRIs -- which include drugs such as Celexa, Paxil, Prozac and Zoloft -- they had the same health outcomes as patients who were not depressed.

"The take-home point of this study is that depression carries a worse prognosis for HAART in HIV patients. However, we also found that SSRIs can reverse this and improve outcomes for HIV-depressed patients," lead author Dr. Michael A. Horberg, director of HIV/AIDS for Kaiser Permanente, said in a prepared statement. "HIV and depression often go hand in hand. If you are HIV-infected, you should be screened regularly for depression, and if you are depressed, and you are going to go on HAART, it's very worthwhile to treat your depression."

More information
To learn more about depression, visit the American Academy of Family Physicians.

Morphine Painkillers Won't Impair Driving

(HealthDay News) -- Moderate, long-term use of opioid pain medications such as morphine does not impair a person's driving ability, U.S. researchers report.

A team at Rush University Medical Center in Chicago compared two groups of people -- 51 long-term users of oral morphine and 49 who weren't taking any pain medication. All the participants spent about 12 minutes in a driving simulator that measured deviation from the center of the road, weaving, number of accidents, and reaction time to unexpected events.

The average amount of weaving for both groups was 3.83 feet, and the morphine group had 5.33 collisions, compared with 5.04 collisions for the control group. Average reaction time for the morphine group was 0.67 seconds, compared with 0.69 seconds for the control group.

The findings suggest that patients who require long-term pain medication may "become tolerant" to side effects that could potentially impair function, said researcher Dr. Asokumar Buvanendran, an associate professor in the anesthesiology department at Rush.

The study was expected to be presented Oct. 13 at the annual meeting of the American Society of Anesthesiologists, in San Francisco.

Opioid pain relievers carry warning labels urging patients not to drive or operate heavy machinery while taking the medications, and drivers under the influence of pain drugs are typically subject to the same laws and penalties as people who drink and drive.

According to Buvanendran, this study's findings suggest that patients on long-term pain medication may be able to live "like normal functioning people, without the stigma and limitations now associated with long-term pain medication use."

More information
The American Academy of Family Physicians has more about chronic pain medicines.

Rattlesnake Capsules Linked to Salmonella Poisoning

(HealthDay News) -- Capsules of dried rattlesnake meat -- a Hispanic folk remedy purported to cure a host of health problems including acne, impotence, AIDS and cancer -- can be contaminated with a potentially lethal strain of salmonella bacteria, a U.S. infection control expert warns.

John James, a microbial epidemiologist at Children's Hospital in Denver, said the life-threatening strain of bacteria -- Salmonella arizonae -- in capsules of dried rattlesnake meat caused a child to become seriously ill. The child survived.

James talked about that case and the overall issue on Saturday at the annual scientific sessions of the Society for Healthcare Epidemiology of America in Baltimore.

"Anecdotal evidence linking capsules of dried rattlesnake meat to salmonella poisoning has been reported for years. For the first time, however, we've used DNA molecular testing to prove definitively that the salmonella bacteria found in the dried meat was the cause of a life-threatening case of salmonella blood poisoning in a patient treated at our hospital," James said in a prepared statement.

Salmonella arizonae is commonly found in snakes and lizards.

"Unfortunately, the rattlesnake capsules -- believed by some to treat many types of diseases -- are often given to people whose immune systems already are compromised," James said. The child in this case had systemic lupus.

"These capsules should be removed from the market, or the manufacturers should be required by the U.S. Food and Drug Administration to irradiate the product before it is sold," James said.

Drug Cuts 'Off' Time for Parkinson's Patients

(HealthDay News) -- Taking 24-hour prolonged release ropinirole significantly reduced daily "off" time that Parkinson's disease patients experience due to the return of symptoms such as tremors, slowness, stiffness and difficulty walking as drugs wear off, a U.S. study says.

The study, published in the April 3 issue of the journal Neurology, included 393 Parkinson's patients who weren't fully responding to the widely-used Parkinson's drug levodopa. Half the patients took 24-hour prolonged release ropinirole and levodopa for six months, while the other half took a placebo and levodopa. None of the patients' other Parkinson medications were changed during the study.

The average daily "off" time in the ropinirole group was reduced 2.1 hours, compared to 0.3 hours in the placebo group. The study also found that more than half the patients in the ropinirole group were "much improved" or "very much improved," compared to 14 percent of patients in the placebo group. In addition, patients taking ropinirole were able to reduce their dosage of levodopa.

The study was supported by GlaxoSmithKline and Skye Pharma, makers of prolonged release ropinirole.

Involuntary movements, nausea, dizziness, drowsiness, hallucinations, and sudden drops in blood pressure were common side effects among patients taking prolonged release ropinirole.
"Ropinirole 24-hour prolonged release, when taken with levodopa, is effective in reducing daily 'off' time for Parkinson patients who aren't getting the best results from levodopa. We also found the drug helped improve quality of life and motor function," study author Dr. Rajesh Pahwa, of the University of Kansas Medical Center, said in a prepared statement.

More information
We Move has more about Parkinson's disease.

FDA Panel to Weigh Value of Drug-Coated Stents

(HealthDay News) -- When a U.S. Food and Drug Administration advisory committee begins a two-day session Thursday to examine the safety of drug-coated stents, thousands of cardiologists and millions of patients will be paying close attention.

Coated stents have dominated cardiovascular surgery since their introduction several years ago. Some 2 million to 3 million people in the United States now carry one of these devices in an artery, according to the latest FDA estimates, with implantations topping 900,000 per year.

But a number of studies have now suggested that these coated stents, which can cost thousands of dollars each, have long-term dangers -- most specifically, the risk of thrombotic artery blockages that can cause heart attacks. So, cardiologists are trying to assess the risk vs. benefit equation for coated stents.

That means that this week's meeting "will be a very closely watched panel," said Dr. Deepak Bhatt, an interventional cardiologist at the Cleveland Clinic. "Cardiologists are looking for guidance and will be very receptive to whatever comes out of that meeting."

But the controversy is already affecting medical practice, Bhatt said. His team published a study that found a slight increase in thrombotic events -- about 0.5 percent -- in patients getting coated rather than bare-metal stents.

So, Bhatt has cut back on his use of coated stents, "probably from 90 percent to 80 percent of my patients." And, he said, other cardiologists are being "a little more cautious about the implants or are extending the duration of anti-clotting medications."

Anti-clotting medications such as Plavix (clopidogrel) and aspirin are important because doctors often prescribe them after stent implantation. And research published earlier this week linked the increased risk of thrombosis to discontinuation of one such drug, Plavix.

"This raises the question of whether these drug-eluting stents should be anticoagulated for a long period of time," noted Dr. John Kao, assistant professor of medicine at the University of Illinois at Chicago. "What that time period is, is at this moment unclear."

The American Heart Association released a cautious statement saying that "there is conflicting data regarding the magnitude and significance" of the increased risk of late thrombosis in patients getting coated stents.

What is clear is that "it is very important that patients do not discontinue their anti-platelet therapy within a year after stenting without consulting their treating cardiologist," the heart association statement said. The risk of discontinuing Plavix therapy is less clear, it said.

"Additional studies probably will be required to define the risk of late blood clots in patients with drug-eluting stents and the appropriate therapy to prevent them," the association statement said.

There are other angles to the drug-coated stent issue. Stenting and its follow-up treatment is now a very big business. Two brands of drug-coated stents are sold in the United States -- one, brand-named Taxus, is marketed by Boston Scientific Corp., while another, Cypher, is made by Cordis Corp., a subsidiary of Johnson & Johnson. And a number of physicians invited to participate in the FDA advisory committee have ties to one or another of these companies.
For example, one panel member is Dr. Robert A. Harrington, who heads a research unit at Duke University that gets funding from Boston Scientific and Johnson & Johnson.

In all, six of the experts summoned by the FDA have such ties to heart device manufacturers.
However, Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, defended the composition of the group during a news conference Tuesday.

"Whether or not waivers were granted or not granted, it was important that we had a panel of individuals who were able to give us objective, non-biased information," Schultz said. "Looking at the entire panel, if you look at that objectively, you will see that we have done a pretty good job of achieving that goal."

Another issue: the cost to patients of Plavix, which can total $120 or more a month. Current guidelines recommend that Plavix be taken (along with aspirin) for three months if a Boston Scientific coated stent is implanted and for six months with a Cordis stent. Because the drug can be so expensive, Kao said he sometimes makes his decisions on implanting a bare-metal or coated stent on the basis of a patient's income.

"When I evaluate someone who needs intervention who is on a fixed income and cannot afford to take Plavix for six to 12 months, I put in a bare-metal stent," Kao said.

For patients who can afford the drug, "my recommendation now is to take it for one year, indefinitely if they can afford it," he said.

But there are medical considerations in prescribing Plavix, Bhatt said. The medication can cause dangerous bleeding, he said, so he evaluates patients for bleeding risk before prescribing the drug.

Cardiologists in Europe now are "a little more cautious about extending the duration of anti-clotting medications," and the same is becoming true in the United States, Bhatt said.

The issue of possible clots is not the only consideration when weighing the need for drug-coated stents, said Dr. Joseph B. Muhlestein, a professor of medicine at the University of Utah. His group has followed patients receiving stents very carefully and has found "something we don't understand," he said.

As expected, the drug-coated stents did reduce the incidence of artery closure at the site where they were implanted, Muhlestein said. But the incidence of artery problems at other sites occurred "significantly more often than when we used bare-metal stents," he said. So, the overall incidence of artery problems ended up being the same, regardless of stent type, Muhlestein said.

It is possible that the problem occurred because coated stents were used on more high-risk patients, he said. But it's also possible that the coated stents interfered with the endothelium, the delicate tissue that lines the arteries -- something also reported in a Dutch study.

These doubts about the value of coated stents have caused Muhlestein to cut back on their use. "We used to use them in 90 percent of cases," he said. "Now, it's about 40 percent."

What does all of this mean for someone facing a stent implant? "At this point, in the absence of more information, the kind of stent should be the subject of discussion between patients and cardiologists," advised Dr. David F. Kong, an assistant professor of medicine at Duke University.

More information
To learn more on stents, head to the American Heart Association.

Hydergine: Desire Better Brain-Power?

Q: Hydergine: Desire Better Brain-Power? What do you think of hydergine to boost mental powers?

A: Hydergine has been touted for some time as a "smart" drug for use in enhancing mental abilities and improving intelligence.

It has been around for more than 20 years and is marketed today as a nonspecific cerebral stimulant and prescribed to help relieve symptoms of age-related mental decline. Hydergine has been studied but found ineffective for the treatment of Alzheimer's disease.

Originally developed for the treatment of hypertension, hydergine didn't really help lower blood pressure and is no longer used for that purpose. However, some people who took it soon after its introduction noticed improvements in memory and mood, which they associated with use of the drug. At first, these changes were attributed to increased blood flow to the brain, but later research suggested that hydergine improved brain cell metabolism.

Today, hydergine is FDA approved only for the treatment of people over the age of 60 who show signs of mental decline. I'm told it is more widely used in Europe, and I understand that some in the anti-aging community advocate taking more than the 3 mg daily dose recommended by the FDA.

Frankly, I wouldn't bother. I tried hydergine myself some years ago to see what it could do, but I detected no benefits. While the drug seems safe enough, I don't see the point of using it - especially since it's expensive. I'm unconvinced that it makes good on the promises made for it by its Internet promoters.

Andrew Weil, M.D.

Antibiotics in Poultry May Pose Risk to Humans

(HealthDay News) -- Could a turkey sandwich or a bowl of chicken soup be hazardous to your health?

Poultry has that potential, according to research that suggests people who eat drug-treated poultry may be at increased risk of developing antibiotic resistance.

Still, the findings are preliminary and shouldn't make anyone stop eating chicken or turkey, the study's lead investigator said.

"We don't want to suggest to anyone that they should alter their diet based on this," said Dr. Edward Belongia, director of the Marshfield Clinic Research Foundation's Epidemiology Research Center in Wisconsin.

But federal regulators should consider the results as they make rules about the kinds of drugs given to poultry, the investigator added.

At issue is the use of virginiamycin, an antibiotic used in farm animals to boost their growth.
The drug is banned in Europe, but farmers are allowed to use it in the United States.
Some studies have suggested that virginiamycin can cause germs in poultry to become super-powered, much as overuse of antibiotics in humans has made some people immune to certain drugs.

This phenomenon, known as drug resistance, happens when an antibiotic is used so often that germs mutate around it.

It's possible for drug resistance to be spread through food. "When we consume food with organisms that have resistance genes, these genes can be transferred to our natural organisms, causing them to become drug-resistant," explained Molly Marten, a clinical epidemiologist at Scripps Mercy Hospital in San Diego who's familiar with the study findings.

Belongia and colleagues launched their study to see if people who ate chicken or turkey treated with antibiotics would themselves become resistant to an antibiotic known as quinupristin-dalfopristin, or Synercid.

Synercid treats disease caused by Enterococcus faecium, germs that are normally found in the gut and can cause disease in some cases.

The illnesses caused by these germs are especially common in hospitals among patients whose immune systems are weakened.

The study authors looked for signs of drug resistance by looking at enterococcus bacteria found in stool samples from 105 newly hospitalized patients and 65 healthy vegetarians, all living in the Midwest.

They also looked for signs of drug-resistance in enterococcus bacteria found in 77 samples of ordinary poultry from retail stores and 23 samples of poultry raised without antibiotics.
The findings of the study, which was funded by the federal government, are published in the Nov. 1 issue of the Journal of Infectious Diseases.

The researchers said they did not find any sign that the humans had developed resistance to Synercid from eating poultry. However, they said that "plenty" of drug-resistant enterococcus was found in poultry treated with antibiotics, Belongia said.

Furthermore, 38 percent of the hospitalized patients had a genetic trait that might make it easier for them to develop resistance to Synercid; none of the vegetarians had the trait.
Patients who ate the most chicken seemed most susceptible to developing immunity to the drug, as did those who touched poultry.

Right now, this isn't a major problem because Synercid isn't used a great deal, Belongia said. That means germs haven't had a chance to become immune to it.

"But that could change," he said.

Belongia believes that the U.S. Food and Drug Administration should take the findings into account. In a written statement, Belongia said that antibiotics should not be used to promote growth in animals.

"This research makes a strong case for limiting the use of antibiotics in food-producing animals," added Marten, the epidemiologist. "By using antibiotics for strictly therapeutic purposes (such as treating an infection), rather than as a growth promoter, we will slow the emergence of drug-resistant organisms in human populations."

More information:
Learn more about drug resistance from the World Health Organization.

New Drug Treats Premature Ejaculation

(HealthDay News) -- A new antidepressant drug designed specifically to treat premature ejaculation proved safe and effective in two large trials, researchers report.

However, it's not likely that dapoxetine, a short-acting selective serotonin reuptake inhibitor (SSRI), will win U.S. approval anytime soon because it can produce side effects, one expert said.
SSRIs, which are used to treat depression and other psychiatric disorders, are now also used "off-label" as a treatment for premature ejaculation. They work because one of their side effects is to delay ejaculation. But, continued SSRI use can have some negative side effects, such as psychiatric problems, skin reactions, weight gain, and loss of libido, experts said.

"This is the first drug specifically developed for premature ejaculation," said lead researcher Dr. Jon L. Pryor, a professor and chairman of urologic surgery at the University of Minnesota. "It worked both in lengthening ejaculation time and in patients' feeling control over ejaculation and both subjects' and partners' feelings of satisfaction with intercourse," he said.

The findings are published in the Sept. 9 issue of The Lancet.
Premature ejaculation is the most common male sexual problem, even more common than erectile dysfunction, affecting 21 percent to 33 percent of American men.

In the study, Pryor and his colleagues looked at the combined results of two trials that tested dapoxetine. The trials included 2,614 men who had moderate to severe premature ejaculation.
The men were randomly assigned to receive a placebo or different doses of dapoxetine. They were told to take the drug one to three hours before having sex. At the start of the study, the men ejaculated, on average, in less than a minute after penetration.

However, after 12 weeks, men taking dapoxetine increased their time to ejaculation to 2.78 minutes for those receiving a 30-milligram dose, and to 3.32 minutes for those receiving a 60-milligram dose, the researchers found. For men taking a placebo, the time to ejaculation averaged 1.75 minutes.

Pryor thinks this study will get people talking more about the problem of premature ejaculation. "I hope this paper brings premature ejaculation out of the closet," he said. "I hope it allows for mature discussion about it, and that people realize that there is hope."

One expert familiar with dapoxetine thinks the drug has promise but will not be available in the United States.

"The problem is that dapoxetine was presented to the U.S. Food and Drug Administration last year, and they rejected it out-of-hand as a treatment for premature ejaculation," said Dr. James Barada, director of the Center for Sexual Health in Albany, N.Y.

The drug can produce side effects such as nausea, headache, upset stomach and weakness. It is being released in Europe, Barada said.

"Premature ejaculation is a real clinical condition that causes distress for the man, his partner and especially the relationship," he added. "Because we have no approved therapy, we are at somewhat of a loss to treat it. For many years, we have been using off-label therapies -- SSRIs -- because of the side effect they have of delaying ejaculation."

Doctors can still use SSRIs, Viagra, and psychotherapy to treat the problem, Barada said. "We need to get better research to understand the mechanisms of premature ejaculation and hopefully design a medicine that has good efficacy and safety that is not an SSRI," he said.

More information
The U.S. National Library of Medicine can tell you more about premature ejaculation.



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Health Highlights: Aug. 18, 2006

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Maker of 'Morning-After' Pill Reapplies to FDA

The maker of the controversial Plan B "morning-after" pill has resubmitted an application to the U.S. Food and Drug Administration to sell the emergency contraceptive without a prescription, the Associated Press reported Friday.

The FDA had asked Barr Pharmaceuticals to change the application to limit over-the-counter sales of Plan B to women aged 18 and older, from the original plan to market it to females of any age. Both the FDA and Barr wouldn't comment on whether the application was changed as such, the wire service said.

Plan B is now available in most states only by prescription. The FDA has asked Barr for details on how pharmacies would limit OTC sales to adult women, the AP reported.

"Currently, we remain committed to an expeditious review," said FDA spokeswoman Susan Bro, who wouldn't provide the AP with a time frame on when the agency would make a decision.
Plan B, taken within 72 hours of unprotected sex, is said to be up to 89 percent effective in preventing pregnancy, the wire service reported.
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Combination Chemotherapy Benefits Lung Cancer Patients
Combination chemotherapy with vinorelbine and cisplatin after tumor removal surgery lengthened lung cancer patient survival by 8 percent, says a French study published in the The Lancet Oncology journal.

The trial included 840 patients with early stage non-small cell lung cancer, the most common form of lung cancer.
"Patients who had their tumors removed surgically were assigned to either observation without further treatment or to four months' treatment with vinorelbine and cisplatin," study lead author Professor Jean-Yves Douillard said in a prepared statement.

"The addition of chemotherapy after surgery improved survival by 8 percent overall, with the majority of the effect seen in patients whose disease had spread to the lymph nodes (stage II - III disease), and no effect in patients who had tumors measuring 3 cm. or larger that had not spread to the lymph nodes," he said.
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Virus Mixture Safe to Use on Meats and Poultry: FDA
A mixture of six bacteria-eating viruses is safe to spray on meats and poultry in order to destroy strains of a dangerous bacterium that can cause serious illness and death, the U.S. Food and Drug Administration ruled Friday.

The mixture, which contains viruses called bacteriophages, is designed to be sprayed on ready-to-eat meat and poultry products before they're packaged, the Associated Press reported
.
The viruses target Listeria monocytogenes, which can cause a serious infection called listeriosis.

Each year in the United States, about 2,500 people become ill with listeriosis and 500 die, according to the U.S. Centers for Disease Control and Prevention.

Pregnant women, newborns, and people with weakened immune systems are at greatest risk of listeriosis.

The virus mixture is made by Intralytix Inc. of Baltimore. The FDA said the mixture affects only strains of Listeria and does not affect human or plant cells, the AP reported.
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U.S. Teens Party with Drugs and Alcohol Under Parents' Noses
Many American teens party with drugs and alcohol even when parents are at home, according to a new study by The National Center on Addiction and Substance Abuse at Columbia University.

The survey included 1,297 young people, aged 12 to 17. Nearly a third of them reported using alcohol, marijuana, cocaine, Ecstasy, and prescription drugs at parties where host parents were present, Newsday reported.

Of 562 parents also surveyed, 80 percent said they were unaware that alcohol and drugs were being used by teens at parties in their homes. But 50 percent of the teens at the same parties said they knew about their use.

"That shows just how out of touch the parents are," Joseph A. Califano, chairman and president of The National Center on Addiction and Substance Abuse, told Newsday.

The amount of drug and alcohol use apparently was much higher when parents weren't home, the survey found. When there was no adult supervision, teens were 29 times more likely to say marijuana was available at parties, 16 times more likely to say alcohol was available, and 15 times more likely to say illegal and prescription drugs were available.

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Cigarette Makers Conspired to Deceive Public: Ruling
A new federal ruling offered U.S. cigarette makers a mix of bad news and good news.
Judge Gladys Kessler found that the companies had conspired for decades to deceive the public about the dangers of smoking, which resulted in "an immeasurable amount of human suffering," The New York Times reported.

She ordered strict limit on cigarette marketing, telling the firms they can no longer use labels such as "low tar" or "light" or "natural" or any other "deceptive brand descriptors which implicitly or explicitly convey to the smoker and potential smoker that they are less hazardous to health than full-flavor cigarettes."

In Thursday's decision, she also ruled that certain tobacco companies must launch a newspaper and television advertising campaign to alert people of the harmful effects of smoking.

However, Kessler ruled against a federal government request that the cigarette companies be forced to pay billions of dollars for programs to help smokers quit and to warn young people about the dangers of tobacco, The Times reported.

Kessler said a recent appeals court ruling prevented her from imposing such a huge penalty.
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Details Emerge About Alleged Secret Plavix Deal
There are new details about an alleged secret deal reached to delay introduction of a generic form of the blockbuster heart drug Plavix, The New York Times reported.

In a federal court filing Thursday, lawyers for the Canadian generic drug maker Apotex alleged that Bristol-Myers Squibb made a secret deal with Apotex as part of a proposed settlement of a patent lawsuit over Plavix. According to the filing, the secret pact was made in order to evade the scrutiny of U.S. regulators reviewing the settlement, the Times reported.

The U.S. Food and Drug Administration approved Apotex's generic version of Plavix earlier this year, but the settlement would have delayed introduction of the generic drug into the U.S. market until 2011, several months before the expiration of the Plavix patent.

Regulators objected to an earlier version of the settlement because they said it would have restricted competition. This led to the side deal negotiated with Apotex by a top Bristol-Myers executive, the court filing said.

Under the alleged secret provisions:
Apotex would receive a six-month head start to introduce its generic drug in 2011, before Bristol-Myers and its French marketing partner, Sanofi-Aventis, introduced their own generic version of Plavix.

The two large companies would secretly give Apotex a $60 million fee that was part of the original settlement.

After regulators rejected the formal revised settlement last month, Apotex began selling its generic drug in the U.S. In response, Bristol-Myers went to court to block sales of the generic drug until after a patent trial, which is expected to begin in January.

Novel Immune System Enhancer Strengthens Microbial and Mutagenic Defense

Immunity is one of our body's most important resources. Yet, some of the most devastating diseases can affect this aspect of our health including HIV, cancer, and autoimmune diseases such as rheumatoid arthritis, lupus and multiple sclerosis. Even if we're not subject to any of these chronic conditions, we can become vulnerable to a host of influenza viruses or bacterial infections. It's therefore integrally important to reinforce our immune systems.

Over the last three years some of the top laboratories in the nation have been researching a substance that appears to modulate the immune system in such a way as to make it resistant to pathogenic organisms. After personally communicating with the director of the research team responsible for investigating this new substance, I have concluded that it is one of the most promising agents I've seen. However, before I describe its discovery and how it supports the immune system, I must describe several key aspects of our bodies' immune defenses. One of the ways we can nurture this aspect of health is to enhance the activity of natural killer cells, key players in immunity.

Natural killer cells are lymphocytes, cells present in the blood and lymphatic tissue that are integral to immunity. Natural killer cells bond to viral-invaded cells and release cytotoxins that kill the infected cells. They act similarly on many types of tumor cells. While natural killer cells are an important aspect of immunity, they are not the only aspect. The immune system is a complex tapestry that also relies upon the proper functioning of T-cells.

These cells emerge from the bone marrow in an immature state and must migrate to the thymus gland, where they are programmed to transform into:

1) CD4 helper cells, which orchestrate the immune response by activating other immune cells and stimulating the production of antibodies by the B- cells.

2) CD8 suppressor cells, which suppress killer cells by signaling the termination of an attack. Therefore, if we could find a natural substance that decreases the number of CD8 suppressor cells in relation to the number of CD4 helper cells, we would improve the CD4/CD8 ratio, strengthening the immune system's ability to defend against viral, bacterial, and parasitical invaders. A third aspect of immunity involves immunoglobulin A (IgA).

IgA is the principal immunoglobulin in exocrine secretions. It is important in protecting mucosal surfaces from invasion by pathogenic bacteria and viruses. Its presence in colostrum is thought to be the main reason behind colostrum's anti-infective properties in newborns. While the aforementioned aspects of immunity are important, they are, in a sense, oversimplifying how the immune system works, as it is a complex interplay of many different factors. However, understanding each of the factors I mention above will help explain how the new discovery discussed below has a novel and fascinating effect on the immune system.

Accidental Discovery
The discovery of a unique yeast-derived product called EpiCor™ began when insurance adjusters noticed that employees of a leading manufacturer of animal nutrition products, experienced unusually low sick leave rates and filed significantly fewer claims than employees of similarly sized companies. In fact, while 2004 annual insurance premiums increased an average of 11.2 percent nationally, this company's 2004 premiums didn't increase at all. The owners suspected this low illness rate was due to a fermented yeast culture the company manufactured for production animals since the workers who came in contact with this fermented yeast culture experienced an unusual lack of illnesses.

Consequently, the company commissioned a research group to perform a series of studies investigating EpiCor's effects, its safety and whether it was the agent responsible for the enhanced immunity at the company's production facility plant. Prior to conducting these studies, the research group visited the manufacturing facility and interviewed the employees. They began with the plant manager, who had previously worked at another company for more than 20 years. His wife was an emergency room nurse and often caught viral infections while on the job. While working at the other company, the plant manager and his children contracted 3 to 5 colds or flus per year. However, he had now worked with the fermented yeast product for 9 years and had not had a cold or flu for at least the last 7 years.

His wife and children continued to contract a number of illnesses every year. After hearing similar stories from other members of the production facility staff, the researchers were intrigued. Among the production facility workers, there had been no admissions for any emergency room visits, no incidence of any chronic diseases. In the administrative building, where employees rarely came in contact with the fermented yeast product, there was a greater incidence of colds and flu. There definitely seemed to be a reason to investigate this product.

Background on EpiCor
The ingredient to be investigated was an end product of fermentation of baker's yeast (Saccharomyces cerevisiae). The company has produced this product for 63 years as an additive to animal feed products and they distribute it worldwide. The process used to manufacture the product, while not patented, is a trade secret that other large companies have failed to replicate. Consequently, EpiCor's producer has dominated in the feed marketplace for many years, especially since it wasn't uncommon for animals consuming the animal feed version of EpiCor to have an increased litter size compared to what would normally be expected.

Antioxidant Powerhouse
First, the team of researchers broke down EpiCor's composition to help determine why it might have an immunomodulating effect. In doing this, it was noted that EpiCor had an excellent profile of mono unsaturated and polyunsaturated fatty acids and a small amount of saturated fat. In addition, all of the essential vitamins and minerals were in the product as well as trace elements. Interestingly, they also found it contained compounds known to exert free radical fighting activity such as phytosterols and phenolics including catechins and trans resveratrol. The researchers were surprised to find compounds such as squalene, which is found in sharks and only a very few plant species. Given this profile of substances known to exert antioxidant activity, they decided to subject EpiCor to studies investigating its antioxidant potential.

The first study conducted was designed to determine whether EpiCor could inhibit the formation of radical oxygen species (ROS) in freshly purified human neutrophil cells. They exposed the cells to hydrogen peroxide to induce severe oxidative stress then compared the EpiCor-treated cells to the cells left untreated. They discovered significant reduction of all ROS formation at EpiCor concentrations as low as 1 part per trillion compared to control cells challenged with only hydrogen peroxide. They continued to observe inhibition of ROS formation at concentrations even lower than one part per trillion. This effect didn't stop until they reached a concentration of 0.01 part per trillion. The antioxidant activity of EpiCor (or ORAC activity, as its called in the industry) was actually significantly greater than that of blueberries.

Microbial Studies
Next, the researchers found that EpiCor dramatically reduced the growth of E. Coli bacteria and Candida Tropicalis. At concentrations that continued all the way down to 1 part per billion they noted total inhibition of E. Coli and Candida Tropicalis. It did not, however, inhibit Staphylococcus aureus.

After conducting this study, they concluded that EpiCor may provide protection against infection with coliform bacteria (a common cause of food poisoning) and candida. The study also indicated that EpiCor may support the growth of desirable mucosal flora in the intestinal tract.

Stability and Toxicity Studies
The research team also decided to conduct a study to determine if EpiCor had a sufficient shelf life, an important consideration if it were to be consumed by humans. They first determined that when the product sat at 77 degrees Fahrenheit for 28 days, levels of mold, Salmonella, and Staphylococcus aureus stayed below the acceptable limit. Other tests have shown that it is extremely stable for at least 22 months.

In another study, they asked a leading lab to check for 139 different pesticides. EpiCor was found free of all 139 compounds tested for at the detection limits. They also performed oral toxicity studies in rats. They gave 2,000 mg of EpiCor per kg of body weight to 20 rats—the equivalent to 140 grams administered orally in humans. After 14 days, the animals treated with EpiCor had normal body weights and no deaths occurred during the treatment period. In addition, no gross pathological changes were observed.

In a 90-day toxicity study, they treated 4 groups of rats (40 animals per group) with either 30, 200 or 1,500 mg of EpiCor per kg of body weight. A fourth group served as the control. EpiCor-treated rats did not have an increased rate of mortality, there were no treatment-related clinical symptoms, no significant differences in body weight, nor any pathological changes in any areas examined. In addition, there were no gross pathological lesions found in any organs.

The researchers concluded that EpiCor was well tolerated in daily oral doses up to 1,500 mg for 90 days. (A 90-day rodent study is equivalent to 1.5 years of human consumption in a 70 kg adult male or a 50 kg adult female).

Other tests have shown that EpiCor is not mutagenic and does not have the potential to cause gene mutation. Before delving into human studies they also investigated whether EpiCor is contraindicated in people taking any type of pharmaceutical drug. So they looked at whether it would affect drug-metabolizing enzymes such as Cytochrome P450. They conducted a test called the immortalized human hepatocyte assay, considered the gold standard for inducing drug-metabolizing enzymes. Through this test, they found that EpiCor is not toxic, does not induce the expression or enzymatic activity of cytochrome P450 or other drug metabolizing enzymes and therefore does not interfere in drug metabolism.

Human Studies
They were almost ready to conduct human studies on EpiCor's immunomodulating potential. However, first, they wanted to ensure its safety. For one month, 15 men and women ages 15 – 40 consumed 500 mg of EpiCor in a single daily dose. They measured baseline values 3 days preceding the study's start. Multiple blood samples were taken on day 2 and 28 and additional blood and saliva samples on days 0, 14, 21, 28. EpiCor was well tolerated with no evidence of adverse effects on the immune system nor any clinically relevant changes to any vital signs.

Now that they had determined that EpiCor is safe, non-toxic, non-mutagenic, is not harmful to cells, and is pesticide free, they were ready to begin studying if and how it affects immunity in humans. They compared one group of 10 production employees who are exposed to EpiCor on the job at the facility with another group of 10 gender and aged matched non-production facility employees not exposed to EpiCor.

They analyzed blood samples and what they found was fascinating. The group exposed to EpiCor showed a significant decrease in CD8 suppressor cells, resulting in an improvement in the CD4/CD8 ratio. The CD4/CD8 ratio suggested that these EpiCor-exposed individuals had at least 2 to 3 times the natural killing activity against viruses, bacteria and cancer cells than would normally be expected! This was quite striking to the laboratory. The director called one of the researchers and said, “I've never seen anything like these results before. These people seem virtually immune from contracting almost anything.” The researcher then asked him to go through the results and highlight the ones he thought were significant while the researcher did the same. They did not hold the code as to whose blood samples they were observing. The code was still kept by a scientist at the facility. But when they broke the code they had both 100 percent successfully separated the production from the non-production employees based on their immune profile. One of the other interesting aspects is that natural killer cells in EpiCor-exposed subjects had a much higher killing efficiency of pathogen-infected and abnormal cells despite a significant decrease in the natural killer cells' number. To use an analogy, if we sent out soldiers, we could send out less soldiers because they had become more efficient at doing battle. At the same time, EpiCor-exposed subjects experienced a significant inhibition of interferon gamma production, which indicates that EpiCor has anti-inflammatory abilities. They also found significantly higher levels of total salivary secretory IgA in the EpiCor subjects. The IgA levels were surprisingly high—more than 300 mg per ml. This indicated that the EpiCor subjects had the equivalent of an immunological envelope protecting all the membranes in the eyes, nasal passages, and all the places where pathogenic organisms enter into the system. They also found significantly lower levels of immune complexes and higher levels of glutathione in erythrocytes (red blood cells). Higher levels of immune complexes are responsible for inflammation, and lowering their levels would result in less inflammation and tissue damage. These same immune-modulating effects were seen in the study mentioned earlier in this article, in the 15 subjects treated with EpiCor for 28 days.

Calcium
Signaling Another aspect of the EpiCor studies worth mentioning is known as calcium signaling. Calcium signaling between cells is pivotal to the coordinated response of cells in tissues and organs within the whole body. It is now well established that cells do not behave as selfish entities but rather tend to form "micro-societies" whose proper functioning requires a precise coordination of signals that the cells emit and receive. When these signals are not working properly, this can result in pathological situations that can range from abnormal cell proliferation to cell death. The research has shown that EpiCor can influence calcium signaling, thereby offering a potential explanation for how EpiCor supports immunity and defends against invading pathogens. Additionally, it was determined that EpiCor affects the activity of Nuclear Factor Kappa B (NFK-B). NFK-B plays an important role in inflammation, immunity, autoimmune responses, cell adhesion, cell proliferation, cell development and cell death (apoptosis) because it regulates the expression of genes involved in all these processes. GRAS Status After conducting these studies, an expert panel of toxicologists was assembled to review the data. The panel was chaired by the former director of the division of drugs and environmental toxicology and the human food safety program at the FDA. Other panelists included EPA scientists and the editor of the journal Food and Chemical Toxicology. As a result of the panel review, EpiCor has now received FDA's Generally Recognized as Safe (GRAS) classification.

Conclusion
I have never been so impressed by the effects of a compound as I have been with EpiCor. At this writing, there is one published study depicting the immune modulating aspects of EpiCor (Schauss AG, Vodjani A. Discovery of an edible fermentation product with unusual immune enhancing properties in humans.
FASEB J. 2006;20(4):A143).

Because this information is so new, a majority of studies mentioned in this article are still unpublished. The researchers expect to submit 5 manuscripts to peer reviewed journals within the next six months. Meanwhile, the confirmed safety of EpiCor and its effects on various immune parameters indicate that it is an immune modulating substance par excellence.

Chris Meletis, ND
Dr. Chris D. Meletis is an educator, international author and lecturer. Dr. Meletis has authored 14 books and was awarded the 2003 naturopathic physician of the year by the American Association of Naturopathic Physicians. He has also written over 200 nationally published health and wellness articles. He served as Chief Medical Officer and Dean of Naturopathic Medicine for the National College of Naturopathic Medicine and has participated in starting 16 clinics providing care for uninsured families. His personal mission is "Changing America's Health One Person at a Time." He believes that when people become educated about their health that this is when true wellness is achieved.
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Magic Mushrooms Gave People Full Mystical Experience

Over 60% of volunteers in a rigorous trial funded by the American government said that one magic mushroom session gave them a full mystical experience and several months of happiness. Magic mushrooms are also known as psychedelic mushrooms.

The researchers, from John Hopkins University, Baltimore, wanted to find out what the neurological mechanisms and effects of psilocybin were. They were exploring psilocybin as a possible therapeutic compound. Psilocybin is the hallucinogenic agent found in magic mushrooms. The research was funded by the U.S. National Institute of Drug Abuse and the Council on Spiritual Practices.

Trials have rarely been carried out on psilocybin. Mainly because magic mushrooms have been viewed as products used by people who take illegal narcotics for recreational use. Lead researcher, Prof. Roland Griffiths, said "More than 60 percent of the volunteers reported effects of their psilocybin session that met the criteria for a full mystical experience as measured by well-established psychological scales.”Most of the volunteers described their experience of taking the mushrooms as one of the most meaningful and spiritually significant of their lives. There were 36 volunteers, all of them college educated, averaging 46 years of age.

The trial was randomized and double-blinded. None of them had a history of drug abuse or mental illness.Most of them claim they became better people after the experience. Relatives and friends said they noticed that many of the participants were happier and kinder for several weeks. No brain damage or negative long-term side effects were detected among any of the volunteers. You can read about this study in the journal Psychopharmacology, 11 July issue.

On being asked whether these mushrooms may get us any nearer to God, Griffiths said "We know that there were brain changes that corresponded to a primary mystical experience. But that finding, as precise as it may get, will in no way inform us about the metaphysical question of the existence of a higher power."

It is important to bear in mind that the volunteers were supervised at all times, they were in a controlled environment and had people at hand to help them in case they experienced a ‘bad trip'. “Psilocybin can occasion mystical-type experiences having substantial and sustained personal meaning and spiritual significance”R. R. Griffiths,
Contact Information, W. A. Richards, U. McCann and R. Jesse
Psychopharmacology
Publisher: Springer Berlin / Heidelberg
ISSN: 0033-3158 (Paper) 1432-2072 (Online) DOI: 10.1007/s00213-006-0457-5
Link to Abstract
Written by: Christian Nordqvist
Editor: Medical News Today