Latest Entries »

American True Man Health Incorporated is expanding it’s voluntary recall of dietary supplement product sold under the name and identified as True Man’s Sexual Energy Nutriment Men’s Formula with the expiration date up to and including December 2010 to also include the dietary supplement product sold under the name and identified as Energy Max, Energy Supplement Men’s Formula (the products) with the expiration date up to and including December 2010.

Finished products from several lots of these products were tested and were found to contain an analog of an ingredient in an FDA-approved drug. The analog resembles the active pharmaceutical ingredients in Tadalafil, Vardenafil, and Sildenefil, FDA-approved drugs used to treat erectile dysfunction (ED).

Consequently, the products may possess a similar pharmacological and adverse event profile, posing a threat to consumers because of interaction with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, who may seek products to enhance sexual performance. Additionally, the product may cause side effects, such as headaches and flushing.

The recall is being done notwithstanding that the Company is unaware of any adverse effects having been reported or associated with the product.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

The Company is advising consumers to return any unused product, for a full refund of the purchase price, to the retail location from which it was purchased, or to the Company directly if it was purchased from the Company.

To understand how reproductive hazards affect a man’s ability to have healthy children, it is important to understand how the male reproductive system works.

The testicles have two important functions: they produce the hormone testosterone, which produces the deep male voice, beard, and sex drive; and they produce sperm.

After the sperm are made (in about 72 days), they are stored in the epididymis, the outer structure of the testicles. The sperm remain in the epididymis for about 15 to 25 days. While there, they mature and develop the ability to swim. If the sperm are not ejaculated, they eventually die and are absorbed by the body.

When a man ejaculates, the mature sperm cells move through the vas deferens (the tube cut in a vasectomy) and past the seminal vesicles and prostate gland. The seminal vesicles and the prostate provide most of the liquid in semen.

The semen is deposited in the vagina and the sperm must then swim through the cervix into the uterus and up into the fallopian tubes. If an egg is present, it is fertilized in the fallopian tubes. The fertilized egg then moves down to the uterus, where it attaches to the wall and continues to grow. If no egg is present, the sperm may live within the uterus for up to 2 days.

How Do Reproductive Hazards Affect the Male Reproductive System?

Number of Sperm
Some reproductive hazards can stop or slow the actual production of sperm. This means that there will be fewer sperm present to fertilize an egg; if no sperm are produced, the man is sterile. If the hazard prevents sperm from being made, sterility is permanent.

Sperm Shape
Reproductive hazards may cause the shape of sperm cells to be different. These sperm often have trouble swimming or lack the ability to fertilize the egg.

Sperm Transfer
Hazardous chemicals may collect in the epididymis, seminal vesicles, or prostate. These chemicals may kill the sperm, change the way in which they swim, or attach to the sperm and be carried to the egg or the unborn child.

Sexual Performance
Changes in amounts of hormones can affect sexual performance. Some chemicals, like alcohol, may also affect the ability to achieve erections, whereas others may affect the sex drive. Several drugs (both legal and illegal) have effects on sexual performance, but little is known about the effects of workplace hazards.

Sperm Chromosomes
Reproductive hazards can affect the chromosomes found in sperm. The sperm and egg each contribute 23 chromosomes at fertilization. The DNA stored in these chromosomes determines what we will look like and how our bodies will function. Radiation or chemicals may cause changes or breaks in the DNA. If the sperm’s DNA is damaged, it may not be able to fertilize an egg; or if it does fertilize an egg, it may affect the development of the fetus. Some cancer treatment drugs are known to cause such damage. However, little is known about the effects of workplace hazards on sperm chromosomes.

Pregnancy
If a damaged sperm does fertilize an egg, the egg might not develop properly, causing a miscarriage or a possible health problem in the baby. If a reproductive hazard is carried in the semen, the fetus might be exposed within the uterus, possibly leading to problems with the pregnancy or with the health of the baby after it is born.

Erectile dysfunction

Erectile dysfunction may provide a warning sign of significant coronary heart disease, researchers from the University of Chicago report in the January 23, 2006, issue of the Archives of Internal Medicine. Although recent studies suggest an association between erectile dysfunction and atherosclerotic vascular disease, this is the first study to link� � Erectile dysfunction with abnormal results on cardiac stress testing, including evidence for severe coronary artery blockages and markers of a poor cardiovascular prognosis.

In this study,� � Erectile dysfunction was a stronger predictor of significant coronary heart disease than any of the traditional office-based risk factors, such as family history, cholesterol levels, or blood pressure.� � Erectile dysfunction was also associated with reduced exercise endurance and decreased ejection fraction – a measure of the heart’s pumping capacity.

“This suggests we may need to ask male patients a new set of sensitive questions as part of the evaluation for heart disease,” said cardiologist and study director Parker Ward, MD, assistant professor of medicine and director of the cardiology clinic at the University of Chicago. “The good news is that a decrease in sexual function could provide an additional warning sign for the presence of heart disease.”

The study focused on 221 men who had been referred to cardiologists at the University of Chicago for nuclear stress testing, a widely used non-invasive way to detect the extent, severity, and reversibility of coronary heart disease. Before cardiac testing began, the men filled out a questionnaire that assessed erectile function.

Almost 55 percent of the men (121 out of 221) suffered from erectile dysfunction. Those men, on average, scored less well on exercise tests and measures of coronary heart disease. They had shorter exercise times, lower treadmill scores, and more frequently had a low ejection fraction.

They also had greater evidence for significant coronary artery blockages during myocardial perfusion imaging – the portion of the test that measures blood flow to the heart. Forty-three percent of men with Erectile dysfunction, compared to 17 percent of tested men without Erectile dysfunction, had a myocardial perfusion summed stress score greater than eight, which is “strongly associated with clinically significant obstructive coronary artery disease and a high risk of both cardiac death and nonfatal myocardial infarction,” note the authors.

Erectile dysfunction does not cause heart disease, they caution, but it may indicate that the process of arterial damage is well under way.

The risk factors for� � Erectile dysfunction and coronary artery disease are similar, including obesity, diabetes, hypertension, smoking, and hyperlipidemia. “As the penile arteries are relatively small in comparison with the coronary arteries,” the authors write, “they may be more prone to cause� � Erectile dysfunction with even comparatively small amounts of atherosclerosis.”

They caution that there are a number of potential causes for erectile dysfunction, including emotional or psychological components, which may not be associated with heart disease. Nonetheless, “the fact that heart disease and� � Erectile dysfunction are linked biologically should come as no surprise,” Ward said.

This paper has two important clinical implications, Ward said.

“First, our study identifies a group with a high prevalence of Erectile dysfunction, and thus increased communication about this sensitive topic between patients and physicians may lead to increased treatments and improved quality of life for these patients.”

“Second, asking patients about their sexual function may help identify those at risk for significant heart disease, allowing physicians to stratify that risk with further testing, and get them engaged in an aggressive program of risk-factor modification or treatment.”

Erectile dysfunction medications and youth

A new study indicates a high prevalence of erectile dysfunction (ED) and evidence of recreational use of erectile dysfunction medications (EDM) among adolescents and young men.

Researchers at Children’s Memorial Hospital and Northwestern University’s Feinberg School of Medicine conducted an anonymous survey of 234 sexually active males between the ages of 18-25 on the campuses of three national universities in Chicago. This survey � � � � � � � �” the first of its kind � � � � � � � �” found that a significant number of surveyed young men had used erectile dysfunction medications (EDM) such as Viagra� � � � � � � � � – many in conjunction with other recreational drugs, and most without consulting their physician.

Often associated with sexual dissatisfaction, decreased quality of life, depression and anxiety,� � erectile dysfunction has rarely been studied in adolescent males. This first study to gauge ED occurring with condom use (EDwC) indicates that men who have experienced ED while putting on a condom are four times more likely to use condoms inconsistently.

13%� � of the respondents reported erectile dysfunction, defined as “ever had difficulty getting or keeping an erection,” but rarely discussed this with their medical providers.� � 25% reported� � erectile dysfunction occurring with condom use. “Our exploratory study examines the prevalence and correlates of ED, EDwC and EDM use in a community-based sample of college-age males,” said Najah Musacchio, MD, fellow in General Academic Pediatrics and lead investigator. “Participants with EDwC were 4 times more likely to use condoms inconsistently, and 5 times more likely to have multiple sex partners in the last year, suggesting that EDwC may represent a barrier to safer sex and play a role in STI transmission,” said Robert Garofalo, Director of Adolescent HIV Services.

A total of 302 college-age males completed a self-administered survey. Oral consent was obtained before survey administration. Sixty-eight participants (23%) reported no anal/vaginal sex in the past year and were excluded from analysis. Participants were predominantly white (66%), ages 18-20 (64%) and heterosexual (95%). Most (83%) had one to five sexual partners in the past year and 47% reported 100% condom use for anal/vaginal sex. Six participants (3%) had a prior STI, five of whom were men who have sex with men (MSM).

6%� � of surveyed men used erectile dysfunction medications.� � 57% of participants who took EDM used them to treat erectile dysfunction; 29% used them to enhance sexual performance.� � 64% percent of� � erectile dysfunction medications users mixed EDM with alcohol or illicit drugs; 36% with multiple other drugs. “Particularly concerning is mixing Viagra� � � � � � � and other EDM with alcohol and drugs, such as ecstasy or methamphetamine,” said Musacchio. “Such drugs boost sex drive and reduce inhibitions, yet impair sexual performance.� � erectile dysfunction medication use may permit men in altered mental and physical states to engage in unsafe sexual behaviors, creating concern for unwanted pregnancy and sexually transmitted infections (STI).”

Survey participants rarely obtained their� � erectile dysfunction medication from a medical provider: most (54%) got EDM from their friends or other non-medical sources (39%) such as the Internet.

In studies with adult men who have sex with men (MSM), Viagra� � � � � � � use has similarly been associated with risky sex (increased number of sex partners, higher rates of STIs, and unprotected sex with HIV-positive partners). “Although small in number, the young MSM in our sample reported disproportionate� � erectile dysfunction medication use and STIs, possibly warranting exploration of these issues in this adolescent subpopulation,” said Musacchio.

Survey findings suggest that� � erectile dysfunction and EDwC occur with some frequency in adolescents, and that these issues are rarely discussed with medical providers. Given the association between ED and negative health outcomes such as depression and sexual dissatisfaction, medical providers should ask adolescent males about ED and counsel them on potential health risks of� � erectile dysfunction medication and substance use, they advised. Providers should specifically inquire about EDwC, stressing the importance of using condoms with all sexual encounters.

“The topic must be addressed,” Musacchio said. “Data indicates that ED and� � erectile dysfunction medications use is not uncommon in young males. It should be openly discussed in the medical community and between provider and patient � � � � � � � �” especially since it can lead to unsafe sex and other health risks.”

The first human study using gene transfer to treat erectile dysfunction (ED) shows promising results and suggests the potential for using the technology to treat overactive bladder, irritable bowel syndrome and asthma, according to the researchers.

“In the small pilot study, this new therapy was well tolerated and safe,” said George Christ, Ph.D., senior researcher and a professor at the Institute for Regenerative Medicine at Wake Forest University School of Medicine. “It provides evidence that gene transfer is a viable approach to treating ED and other diseases involving smooth muscle cells.”

The results of the study, which included 11 men with erectile dysfunction, are reported online today in Human Gene Therapy. The technology was developed by Christ and Arnold Melman, M.D., when they worked together at Albert Einstein College of Medicine in the Bronx, New York.

Unlike traditional gene therapy, the gene transfer approach being pioneered by Christ and Melman does not change the DNA or genetic code of cells. Instead, small pieces of DNA reach the nuclei of cells and this causes them to increase production of particular proteins. These proteins help relax smooth muscle cells, the type of muscle found in the penis as well as in hollow organs such as the bladder. Relaxing the tissue allows the penis to fill with blood and become erect.

Previous research has shown that more than 50 percent of men between 40 and 70 years old and 70 percent over age 70 may have erectile dysfunction. The new therapy is a potential alternative to oral medications, such as Viagra, which are not effective for an estimated 30 to 40 percent of men with ED.

A possible advantage of gene transfer is that a single treatment could last for months. In the current study, improvements were maintained through the 24 weeks of study.

The study was conducted from May 2004 to May 2006 at Mount Sinai School of Medicine and New York University School of Medicine. Men ranged from 42 to 80 years old with a mean age of 59. Six subjects were white, four were black and one was Hispanic. In half of the subjects, the cause of� � erectile dysfunction was diabetes or cardiovascular disease � � � � � � � �” both of which can interfere with the ability of smooth muscle cells to relax.

The primary goal of the study was to determine the safety and tolerability of the new therapy. However, the results also showed that at the highest doses, men reported highly significant improvements in erectile function.

The DNA segments � � � � � � � �” mixed into plasma � � � � � � � �” were injected into the corpus cavernosum, expandable tissue along the length of the penis that fills with blood during erection. A variety of clinical and laboratory tests were used to assess safety. In addition, effectiveness was measured using the International Index of Erectile Function scale, a questionnaire that is commonly used to measure erectile dysfunction. Patient responses were validated by their partners.

Researchers identified no safety issues with the treatment. Participants who received the highest two doses had apparent sustained improvements in� � erectile dysfunction� � as measured by the questionnaire. The researchers said that a larger study that includes a “control” group treated with a placebo is needed to confirm the safety and effectiveness of the treatment.

The technology is being developed by Ion Channel Innovations (ICI), a development stage biotechnology company, in which Christ and Melman are co-founders and directing members. The therapy is known as ion channel therapy because the proteins it targets are potassium channels, “gates” within cells critical for contraction and relaxation of smooth muscle.

At the Wake Forest Institute for Regenerative Medicine, Christ is continuing to pursue the therapy in collaboration with ICI, and is also exploring the potential of combining gene transfer with traditional oral medications to further increase the clinical utility of the technology. The Albert Einstein College of Medicine at Yeshiva University owns the ICT patents and has granted the company exclusive, worldwide rights.