Edmund's Newsletter
April 29, 2008
Issue: #18 Volume 8
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In This Issue
Common Vitamin And Other Micronutrient Supplements Reduce Risks Of TB Recurrence
Teams Unravel Heparin Death Mystery
FDA Takes Closer Look at Whose Eyes Fare Badly With Lasik
Benefits of Omega-3s Still Unclear for Bipolar Disorder
Children With ADHD Should Get Heart Tests Before Treatment With Stimulant Drugs
Anticholinergic Drugs May Increase Cognitive Decline
Researchers Detail Chemotherapy's Damage to the Brain
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Common Vitamin And Other Micronutrient Supplements Reduce Risks Of TB Recurrence
Common Vitamin And Other Micronutrient Supplements Reduce Risks Of TB Recurrence, Study Suggests

New findings show a link between micronutrient supplementation and reduced risk of recurrence during tuberculosis chemotherapy, according to a new study.

Nutritional assessment and support in tuberculosis therapy, once common before the advent of anti-TB drugs, is no longer an integral part of clinical therapy in most low-income countries even though poor nutrition impairs the immune system and leads to risk of further infection and relapse.

In Tanzania, Eduardo Villamor, MD, DrPH, of the Harvard School of Public Health, and a team of researchers conducted a randomized trial of micronutrients using doses of vitamins A, B-complex, C, E, and selenium or placebo in 887 patients receiving tuberculosis therapy, who were then followed for a medium of 43 months; 471 were HIV-coinfected and not receiving antiretroviral therapy and 416 were HIV-uninfected.

The study showed that micronutrient supplementation was associated with reduced rates of TB recurrence. In the study, both HIV-infected and uninfected patients with pulmonary TB who were receiving the supplements had a decreased risk of TB recurrence during the next few months after the TB culture had become negative: 45 percent overall and 63 percent in HIV-infected patients. Supplementation also reduced the incidence of peripheral neuropathy by 57 percent, irrespective of HIV status, and increased the levels of certain cells (CD3 and CD4) important in immune response in HIV-uninfected patients.

Teams Unravel Heparin Death Mystery
An international team of researchers led by MIT has explained how contaminated batches of the blood-thinner heparin were able to slip past traditional safety screens and kill dozens of patients recently in the United States and Germany.

The team, led by Professor Ram Sasisekharan of MIT, identified the chemical structure of the contaminant, known as oversulfated chondroitin sulfate (OSCS). The researchers present their findings and offer new approaches to detecting the contaminant in a report appearing today in the online edition of Nature Biotechnology.

Another team led by Sasisekharan has shown exactly how OSCS can kill--specifically by setting off an allergy-like reaction. The biological effects of the contaminant are outlined in a report also being published online today in the New England Journal of Medicine.

FDA Takes Closer Look at Whose Eyes Fare Badly With Lasik
In fury and despair, people harmed by Lasik eye surgery told of severe eye pain, blurred vision and even a son's suicide, as the government began considering if the public needs more warning about the risks of the hugely popular operations.

About 700,000 Americans a year undergo the elective laser surgery. Like golf star and famed Lasik recipient Tiger Woods, they're hoping to throw away their glasses, just as the ads say.

And while the vast majority benefit - most see 20-20 or even better - about one in four people who seeks Lasik is not a good candidate, and a small fraction suffer serious, life-changing side effects: worse vision, severe dry eye, glare, inability to drive at night.

"Too many Americans have been harmed by this procedure and it's about time this message was heard," David Shell of Washington told the Food and Drug Administration's scientific advisers Friday.

Shell held up large photographs that he said depict his blurred world, showing halos around objects and double vision, since his 1998 Lasik.

Benefits of Omega-3s Still Unclear for Bipolar Disorder
Despite intriguing findings that omega-3 fatty acid supplements could alleviate depression symptoms, there is still not enough evidence to say whether omega-3s are useful treatments for people with bipolar disorder, according to a review of recent studies.

Nevertheless, omega-3s deserve further study, since they seem to have no serious side effects and most experts recommend the supplements for people with heart disease and some immune disorders, said authors Paul Montgomery, Ph.D., and Alex Richardson, Ph.D., of the University of Oxford.

Montgomery and Richardson found five studies on the effects of omega-3 supplements for bipolar disorder, but only one study of 75 patients provided enough data on the therapy's outcomes for the researchers to analyze. Patients in the study had less severe depression symptoms while taking the supplements, but omega-3s did not affect their mania symptoms. Patients with bipolar disorder can cycle between periods of mania - elevated mood and energy - and depression.

The review of studies appears in the latest issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews like this one draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.

Children With ADHD Should Get Heart Tests Before Treatment With Stimulant Drugs
Children with attention deficit hyperactivity disorder (ADHD) should get careful cardiac evaluation and monitoring -- including an electrocardiogram (ECG) -- before treatment with stimulant drugs, a new American Heart Association statement recommends.

The scientific statement on Cardiovascular Monitoring of Children and Adolescents with Heart Disease Receiving Stimulant Drugs is published online in Circulation: Journal of the American Heart Association.

In 1999, concerns over potential cardiovascular effects of psychotropic drugs, especially tricyclic antidepressants, but including stimulants, prompted an American Heart Association Scientific Statement: Cardiovascular Monitoring of Children and Adolescents Receiving Psychotropic Drugs. However, no specific cardiovascular monitoring was recommended for the use of stimulant medications. Warnings from the U. S. Food and Drug Administration (FDA) about stimulant medications and public concern for the safety of using them have prompted the current statement.
Anticholinergic Drugs May Increase Cognitive Declines
A new study finds that the use of drugs with anticholinergic activity is associated with a more rapid decline in cognitive performance in older individuals.

The findings suggest that physicians should take this possible effect into account when prescribing anticholinergic medication or drugs that have anticholinergic properties, said lead author Jack Tsao, MD, DPhil, associate professor of neurology at Uniformed Services University, in Bethesda, Maryland.

Dr. Tsao presented the results here at the American Academy of Neurology 60th Annual Meeting.

Their study arose from experience with a patient seen by study coauthor Kenneth Heilman, MD, from the University of Florida at Gainesville, Dr. Tsao told Medscape Neurology & Neurosurgery. The woman had come in with memory complaints and hallucinations. However, Dr. Tsao said, "Her cognitive testing was essentially normal except for the memory issues, so she didn't fit the diagnosis of Alzheimer's-type dementia."

This patient had just begun treatment with tolterodine (Detrol, Pfizer) a drug to treat overactive-bladder problems. "Because Dr. Heilman had seen a previous case of another woman who had memory complaints that reversed after stopping her bladder medicine, we did the same for this lady, and her memory improved," he said. "This prompted us to ask the question of whether anticholinergic medicines or medicines that have anticholinergic properties actually can impair thinking in normal individuals."


Researchers Detail Chemotherapy's Damage to the Brain
A commonly used chemotherapy drug causes healthy brain cells to die off long after treatment has ended and may be one of the underlying biological causes of the cognitive side effects - or "chemo brain" - that many cancer patients experience. That is the conclusion of a study published today in the Journal of Biology.

A team of researchers at the University of Rochester Medical Center (URMC) and Harvard Medical School have linked the widely used chemotherapy drug 5-fluorouracil (5-FU) to a progressing collapse of populations of stem cells and their progeny in the central nervous system.

"This study is the first model of a delayed degeneration syndrome that involves a global disruption of the myelin-forming cells that are essential for normal neuronal function," said Mark Noble, Ph.D., director of the University of Rochester Stem Cell and Regenerative Medicine Institute and senior author of the study. "Because of our growing knowledge of stem cells and their biology, we can now begin to understand and define the molecular mechanisms behind the cognitive difficulties that linger and worsen in a significant number of cancer patients."

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Study Finds That Frequent Masturbation Leads to Higher Risk of Testicular Cancer

In an astounding new study done by the University of Western Sydney, Australia, men who masturbate frequently may have a higher risk of developing Testicular Cancer. The study, conducted by the universities elite scientists, started in 2004 when a student brought up the question of how testicular cancer is caused.

The study, conducted at a local cancer treatment center, was given to men who were diagnosed with testicular cancer or who were receiving treatment. The names of the men were anonymous, and they were given a survey which was done voluntarily. In order to get a good range of information, such questions such as age, weight, how often you have intercourse, family history, and how often you masturbate were given. Of the surveys that were given out, 85% of them were voluntarily filled out and returned.

When the University was done conducting the study, and punching the numbers, they found that frequent masturbation and testicular cancer may be linked. When asking Dr. Tim Roberts if he had any response to this, he responded by saying that "We've put a lot of time and effort into this. Our team was very dedicated in this survey and we were all very enthused in wanting to find out if there were any leads to testicular cancer." It turns out that there were leads. For men who masturbate three times a day or more, they have a 35% higher risk in developing testicular cancer. Of the men that filled out and returned the surveys, 27% of them masturbate 21 or more times a week. "We cannot explain this, other then that masturbating can be an addiction and there can be a lot of strain," said Dr. Tim Roberts.

The team of scientists vowed that they are not done, and they want to go more in-depth with this. While they believe they have found a major breakthrough, they know that there are many other reasons that men develop testicular cancer. "We want to make men aware of what the causes of testicular cancer are. Testicular cancer has been on the rise over the last 10 years, and we want that number to start going down," said Dr. Roberts.
News From MedWatch
Keep up-to-date on all of the recent MedWatch reports that gives you timely safety information on the drugs and other medical products regulated by the U.S. Food and Drug Administration by  CLICKING HERE
 
Recently Approved Drugs/Indications
Keep up-to-date on all of the recently approved drugs and/or approved new indications on already FDA approved drugs by CLICKING HERE
 
FDA Recalls and Safety Alerts in the Past 60 Days:
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Drug Shortages:
As many of you are aware, many drugs in the US are either unavailable or in short supply.  To view a list of these drugs CLICK HERE
 
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