Good Health & Wellness for Life

Baxter says trial on new flu shot promising

Baxter International Inc., working to modernize the production of influenza vaccines, this morning said its seasonal flu product is showing "strong antibody responses and good tolerability" in an early stage clinical trial in humans.

Although Baxter is still several years from winning approval of the product, the study shows Baxter's reformulated seasonal flu vaccine is tolerable. In late 2004, Baxter had to suspend final-stage human sudy of its seasonal flu vaccine because it was causing fevers in some patients.

The Deerfield-based medical product giant is trying to develop a flu vaccine produced with cell tissues, which is a method that would allow manufacturers to quickly brew vaccine by the vat and likely eliminate shortages like the one that rattle U.S. consumers and health-care providers from time to time.
The cell-based approach is a sharp contrast to the tedious, 1940s method still used today that involves hand-processing millions of chicken eggs in labs. For each dosers shine a light through the shell of an egg to find the fluid surrounding an embryo, inject a strain of the flu virus and let it incubate for several months.

The current method is a long months-long process fraught with risk, while cell-based vaccines are more consistent and could be produced in as little as nine to 12 weeks.

In the latest clinical trial, Baxter said more than 900 patients were studied. Baxter said the preliminary data show its cell-based seasonal influenza vaccine's "tolerability profile" to be similar to egg-based seasonal flu vaccines on the market. There were, however, some side effects that included headaches and some injection site reactions, Baxter said.

Baxter is building momentum for its vaccines business. The company is also in the final stages of testing for a vaccine against strains of the Avian influenza, also known as the bird flu and is working with governments around the world interested in stockpiling the product in the event of a pandemic outbreak. Chicago Tribune

Yes. Sexual dysfunction — including difficulty achieving and sustaining erections (erectile dysfunction) — is more common in men with epilepsy than in the general population. Several factors likely play a role.

Epilepsy itself may cause sexual dysfunction, especially if seizures are poorly controlled. Disruptions in hormone levels and brain activity may impair sexual desire and performance. In many cases, improved seizure control alleviates sexual dysfunction.

Drugs used to treat epilepsy may also cause sexual dysfunction. Anti-seizure medications, such as phenytoin and carbamazepine, can decrease testosterone levels in men, which in turn reduces sexual desire and impairs sexual function. If a specific anti-seizure medication is the likely culprit of erectile dysfunction, your doctor may recommend an alternative medication.

In addition, psychological factors — such as depression, sexual anxiety or stigma associated with epilepsy — can contribute to sexual dysfunction in men with epilepsy.

If you have epilepsy and erectile dysfunction, consult your doctor. Your doctor may refer you to a urologist to make sure that your erectile dysfunction isn't due to an unrelated urological condition. In any case, a careful assessment is needed to determine the cause and best treatment for erectile dysfunction.

Source: Mayoclinic

In a new study that will be published in the July 17th issue of the journal Circulation, Canadian researchers reveal that the erectile dysfunction drug Viagra (Sildenafil), may likely be effective in the treatment of patients with right-sided heart failure, principally because their study shows that only the hearts of these patients exhibit the target molecules that can be blocked by these types of drugs.

The study was led by Drs. Jayan Nagendran, a cardiac surgery resident and Evangelos Michelakis, professor in the Department of Surgery and the Department of Pharmacology at the University of Alberta in Canada.

The researchers wanted to gain insight into the mechanism of how Viagra may benefit patients with pulmonary hypertension (high blood pressure in the lung vessels). This devastating condition usually leads to right-sided (right ventricle) heart failure.

In their study, the researchers evaluated heart specimens from 9 patients to assess their phosphodiesterase type-5 (PDE-5) activity and their response to specific type-5 PDE inhibitors such as Viagra.

PDE-5 is an enzyme that degrades the activity of cGMP, a chemical that relaxes smooth muscle cells. In the vasculature, relaxation of smooth muscle cells causes vessels to dilate thereby increasing blood flow.

PDE-5 is preponderant in the corpus cavernosum of the penis. When it's inhibited, it leads to higher cGMP levels and less dilation (more constriction) of the blood vessels that let blood escape from the corpus cavernosum and thereby leading to a sustained erection.

The researchers essentially found that PDE-5 was not expressed in heart samples from patients that were healthy. Conversely, they did discover that patients with enlarged right heart ventricles had marked increased PDE-5 activity.

When the research team used Viagra (the PDE-5 inhibitor) in their experiments, they found that it increased the activity of isolated cardiac cells and the strength of heart contractions only in unhealthy samples and patients and not in any of the healthy controls.

In the press release from the University of Alberta, Dr. Nagendran stated that "there are a number of medical conditions in both children and adults for which there is a need to boost the performance of the right ventricle, and this drug can be clinically and immediately relevant to help these patients"

Dr. Michelakis also added that "We have a number of drugs and therapies available to treat the left ventricle of the heart to prevent it from failing or to treat it after it has failed, bet we don't have anything for the right ventricle. The phosphodiesterase type-5 inhibtors, which include Viagra and similar other drugs may offer some important benefits in this case."

Viagra (Sildenafil) has been recently approved in the treatment of pulmonary hypertension.

Source: Associatedcontent

TOKYO: GlaxoSmithKline PLC is ready to work with Japanese pharmaceutical companies if the Japanese government agrees to stockpile the company's pre-pandemic vaccine for bird flu, the head of the company's vaccine business said Wednesday.

"We are in contact with all the local vaccine manufacturers" and the Japanese government to discuss the need to prepare for a possible bird flu outbreak among humans, said Jean Stephenne, president of GlaxoSmithKline Biologicals at a news conference in Tokyo.

Britain-based GlaxoSmithKline is one of the world's largest makers of vaccines and is calling on governments to stockpile pre-pandemic influenza vaccine to deal with outbreaks in their early stages.

If a bird flu pandemic hits, Japanese companies could manufacture vaccines using GlaxoSmithKline technology, while its adjuvant system could be applied to existing vaccines.

GlaxoSmithKline's adjuvant system can reduce the dosage from a vaccine for protection and assists in providing protection against similar strains of a virus, improving the chances of controlling mutated versions of the H5N1 bird flu virus, according to Stephenne.

Japan's vaccine market is tightly closed, and major vaccine makers are government-affiliated organizations that don't have very strong funding or research capabilities.

Japan's vaccine development guidelines also differ from those of other major markets and the World Health Organization, making it difficult to import vaccines made overseas. (The Associated Press)

Veterinarians Could Be First to Get Bird Flu

MONDAY, June 18 (HealthDay News) -- Because veterinarians who work with birds are at increased risk of infection with bird flu viruses, they should be included on lists of people with priority access to pandemic flu vaccines and antiviral drugs, U.S. researchers say.

A team at the University of Iowa College of Public Health analyzed blood samples from a group of American veterinarians who worked with chickens, ducks, turkeys, geese or quail.

They found that their blood had increased levels of antibodies against the H5, H6 and H7 avian influenza viruses. These increased levels indicated that the veterinarians had previously been infected by these viruses.

These mild forms of bird flu occasionally circulate among wild and domestic birds in the United States. But experts fear that the deadly H5N1 bird flu virus that emerged in Asia may mutate into a form that's easily transmitted between humans and trigger a global pandemic.

"Veterinarians and others with frequent and close contact to infected birds may be among the first to be infected with a pandemic strain of influenza," study author Kendall Myers, a doctoral student in occupational and environmental health, said in a prepared statement.

"They have the potential to spread the illness to their families and communities. Because of this, we suggest that veterinarians should be considered for inclusion on priority access lists for pandemic influenza vaccines and antivirals," Myers said.

The study is published in the July 1 issue of the journal Clinical Infectious Diseases.