Novartis's Tekturna shows promise in heart failure

A new type of blood pressure pill from Novartis (NOVN.VX: Quote, Profile, Research) also shows promise as a treatment for heart failure, scientists said on Sunday.

Tekturna, known generically as aliskiren, recently went on sale in the United States and was approved last month in Europe, where is it goes under the name Rasilez.

It is the first of a new type of drug known as a renin inhibitor that experts hope will give extra benefits compared with older medicines.

John McMurray of the University of Glasgow, Scotland, said a 300-patient study of patients with heart failure found Tekturna significantly cut levels of B-type natriuretic peptide (BNP), a biomarker associated with worsening outcomes for patients.

The effect was seen even though patients were already taking other types of blood pressure medications, suggesting Tekturna can offer additional protection to the heart.

"We would hope that a reduction of BNP would translate into a reduction of morbidity and mortality, but that needs to be proved in a large randomised trial, which is the next step," McMurray told reporters at the annual meeting of the European Society of Cardiology.

There was no significant excess of either hypotension -- excessively low blood pressure -- or kidney dysfunction, he added.

Heart failure affects more than 14 million people in Europe alone and is a major killer worldwide, making it a major focus of medical research.

The condition occurs when the heart is unable to maintain adequate circulation of blood in the body's tissues, resulting in shortness of breath, excessive tiredness and fluid build-up.

Tekturna, which was co-developed by Swiss biotech company Speedel (SPPN.S: Quote, Profile, Research), is a key new product for Novartis, which is seeking ways to shore up its hypertension medicine sales.

This business is currently supported by Diovan, Novartis's top-seller with 2006 sales of $4.2 billion, which will lose patent protection in 2012.

Diovan reduces blood pressure by targetting angiotensin receptors, while Tekturna blocks renin, a kidney enzyme that triggers a process in hypertension.
Source :http://www.reuters.com

Acambis up on FDA OK for smallpox vaccine

Acambis was up 9-1/4 pence at 122-3/4 after the US Food and Drug Administration gave the green light to the company's ACAM2000 smallpox vaccine.

Following the approval, Landsbanki reiterated its 'buy' recommendation on the stock, based on its positive outlook for both ACAM2000 and the Japanese Encephalitis vaccine ChimeriVax-JE.

The broker's 164p target price represents an additional 34 pct upside to the current share price. Acambis ACAM2000 and ChimeriVax pipeline contribute 31p and 78p respectively to Landsbanki's aggressively discounted (50 pct premium to cost of capital) sum-of-the-parts based valuation.

Again on the upside, Irvine Energy edged up 0.25 to 3.3750 as the AIM-listed oil and gas exploration company completed the acquisition of the Niobrara oil and gas project in Kansas, US.
Source :http://www.forbes.com/

Medicaid changes assailed

As Washington spends more money to provide health insurance for all its children by 2010, state leaders and child care advocates are blasting the Bush administration over new rules that they say would punish the state for its leadership on the issue.

Dennis Smith, the federal official who oversees state Medicaid programs, recently notified state Medicaid directors that he was setting new standards for states that wanted to increase eligibility for the State Children's Health Insurance Plan, or SCHIP, above 250 percent of the federal poverty level (which is an annual income of $51,625 for a family of four).

The new rules would:

# Require those states to include cost-sharing that includes co-payments and premiums that more closely mirror the cost of private insurance.

# Impose at least a one-year waiting period without insurance for children before receiving coverage.

# Require states to show that they have already insured at least 95 percent of children in families below 200 percent of the poverty level.

# Require states to show that the number of children in the income range covered by Medicaid and SCHIP who are insured through private employers has not decreased by more than 2 percentage points over the past five years.

More than 66,000 children in Washington lack health insurance, according to a Washington State Budget & Policy Center analysis of 2006 data.

Those uninsured children risk their health and incur community costs through treatment of routine medical issues in their aggravated and emergency state, the center's report said.

Under legislation enacted this year, Washington would expand eligibility for children from families with annual incomes of up to 300 percent of the federal poverty level in 2009.

The new federal rules could make the state responsible for providing $5 million more than it had anticipated in federal matching funds.

Last week, Gov. Chris Gregoire said the new federal restrictions would make it harder for Washington to fulfill its commitment to provide all children access to health coverage.

In a letter to Health and Human Services Secretary Mike Leavitt, Gregoire questioned the legality of setting the rules without going through the formal rulemaking process and pointed out that Congress does not support the administration's new policy.

"I, and the vast majority of Americans, expect our government to follow the appropriate process when establishing important new policies," Gregoire wrote.

"We also understand the importance of SCHIP to the well-being of our children and hope that the federal government continues to be a partner, rather than a roadblock, to our children's health."

Jon Gould, deputy director of the Children's Alliance, a state child advocacy group, said that even before the new rules, Washington state had been penalized for expanding coverage to poorer children.

When SCHIP was created, it allowed federal funding only to states that implemented new programs or expansions. Washington already had a program in place and was ineligible for most of the federal funding -- in essence penalized for developing its program before most other states, he said.

Gould said Washington has already missed out on $200 million of federal participation.

"And children will continue to miss out unless Congress and President Bush reauthorize SCHIP with a fix for Washington state in September," he said.

California and New York are among 23 other states that have expanded children's health care coverage and stand to lose federal participation because of those policies.

Govs. Arnold Schwarzenegger of California, a Republican, and Elliot Spitzer of New York, a Democrat, have also objected to the new rules.

This year, the Democratic-controlled Legislature in Washington approved $30 million for a children's health care program that:

# Consolidates several health coverage programs into one program of comprehensive benefits, including medical, dental, vision and mental health.

# Adds all children in families up to 250 percent of the federal poverty level into the state's health care budget.

# Opens up public insurance to all families who need it. Families between 200 percent and 300 percent of the federal poverty level will pay monthly premiums on a sliding scale based on income.

Though Washington still qualifies for federal SCHIP dollars, the expansion planned for 2009 would be in question.

Other children's groups said the new waiting period the federal government has added in hopes of preventing an exodus from private insurance would also be harmful.

"It's irresponsible to ask a child with cancer or a pregnant woman to wait one full year for health coverage, even if a parent dies or loses their job," said Bruce Lesley, president of First Focus, a national child advocacy group.

"To protect the health and well-being of our children, this directive should be put to bed and withdrawn."
Source :http://seattlepi.nwsource.com

Indonesia dismisses human transmission on bird flu

Indonesia confirmed that there has been no human-to-human transmission of avian influenza virus in the country, Health Minister Siti Fadilah Syupari said here Monday.

The minister told a press conference that thousands people had been killed should the transmission occurred already in Indonesia.

" There is no human-to-human transmission in Indonesia," she said.

"There has been no virologist report, and it is still zero epidemiologist," said Fadilah at a office here.

She said that the conclusion of the experts from the Fred Hutchinson Cancer Research Center in Seattle, Washington last week could not be used to say that human-to-human transmission had already happened in Indonesia, as the expert only make their calculation mathematically.

The expert found a statistical confirmation that H5N1 virus spread from human-to-human between a small number of people within a family in North Sumatra, Indonesia, where eight people died in April last year.

"That is only a statistical test," said the minister.

In North Sumatra, the cluster contained a chain of infection that involved a ten-year-old boy who probably caught the virus from his 37-year-old aunt, who had been exposed to dead poultry and chicken feces.

The minister said that Indonesian authorities already declared the cluster in North Sumatra as limited human-to-human.

"For example, the father, who has two children, he died. Why was the mother not infected by her child, why only the father was infected?. This still become a big question until now," said Fadilah.

Experts fear that the highly pathogenic H5N1 virus could mutate in a certain level that can make them transmittable among humans that can cause a pandemic where million people can be killed.

The viruses have killed globally 195 out of 322 infected people, most of them in Indonesia with 84 fatalities and 105 cases.

It is rare that the virus was transmitted by human, most of them are passed by birds.

Cluster was rarely happen. Experts worry of the possibility that the H5N1 virus is transmitted by human.

As the number of victims of the virus keeps slowly rising in the country, the health authorities have decided to use the country's own anti-bird flu vaccine after September to stop the virus spread on human, despite the World Health Organization suggestion to stock pile the vaccines.

Huge territory, traditional way of rising chickens on back yardand lack of obedience of provincial administration in implementing the Jakarta decision to stop the virus spread, are among the obstacles in fighting the bird flu in the country.
Source :http://news.xinhuanet.com

Diabetics benefit from lower blood pressure: study

Australian researchers say reducing blood pressure in people with type 2 diabetes can dramatically reduce the risk of death or serious complications.

The scientists say the findings from what is the largest study of treatments for the disease could potentially save several million lives over the next decade.

More than 600,000 Australians have type 2 diabetes and around 250 million people worldwide suffer from the disease.

Many will eventually die or become disabled by complications resulting from it.

But researchers from the George Institute for International Health say death rates could be cut by around one-fifth if patients took a combination of two blood pressure lowering drugs.

Dr Bruce Neal is senior director at the George Institute and an associate professor of medicine at the University of Sydney.

He says the study shows that patients get benefits from the blood pressure lowering treatment, irrespective whether the patient has got hypertension or not.

"We got a 10 per cent proportional reduction in the risk of having a serious complication and almost double that reduction in the risk of dying from a serious event like a stroke or a heart attack," he said.

He says that while it is obvious that lowering blood pressure has a number of health benefits, what is not obvious is that people who do not have high blood pressure would get the benefit.

"That's the really novel thing about this study - it's that for a long time we believed that you would get these benefits even if you had normal blood pressure but no one's demonstrated it in this way before," he said.

Preventative therapy

That opens up a new preventative therapy to many, many millions or hundreds of millions of people worldwide with diabetes.

The four year study of 11,000 people with type 2 diabetes in 20 countries, is being published in The Lancet.

It was funded to a large extent by the manufacturer of the drug used.

Dr Neal says that does not comprise the findings.

"Absolutely not - the study was funded almost entirely by a large pharmaceutical company, although there was also funding from the Australian Health and Medical Research Council," he said.

"The reason why this funding doesn't impact upon the validity of the result is that the study was done completely independent to the company.

"They gave us the money, we did the study, and we reported the study independent of sponsor."
Source :http://www.abc.net.au

More Children Being Treated for Bipolar Disorder

The number of American children and adolescents treated for bipolar disorder increased 40-fold from 1994 to 2003, researchers are to report on Tuesday, in the most comprehensive study to look at the controversial diagnosis. And experts say the numbers have almost certainly risen further in the years since.

Most experts believe the jump reflects the fact that doctors are more aggressively applying the diagnosis to children, not that the number of new cases has gone up. But the magnitude of the increase is surprising to many experts, who say it is likely to intensify a debate over the validity of the diagnosis that has shaken the field of child psychiatry in recent years.

Bipolar disorder is characterized by extreme mood swings and, until relatively recently, it was thought to emerge only in adulthood. Some psychiatrists say that the disorder is too often missed in children, and that increased awareness — reflected in the increasing use of the diagnosis — is now allowing youngsters who suffer from it to get the treatment they need. But others argue that bipolar disorder is overdiagnosed. The term, they say, has become a diagnosis du jour, a catch-all now applied to almost any explosive, aggressive child. Once children are labeled, these experts add, they are treated with powerful psychiatric drugs that have few proven benefits in children and potentially serious side-effects, like rapid weight gain.

The spread of the diagnosis has been a boon to drug makers, according to these experts, because treatment typically includes medications that can be three to five times more expensive than those prescribed for other disorders, like depression or anxiety.

“I think the increase shows that the field is maturing when it comes to recognizing pediatric bipolar disorder, but the tremendous controversy reflects the fact that we haven’t matured enough,” said Dr. John March, chief of child and adolescent psychiatry at Duke University’s school of medicine, who was not involved in the research.

“From a developmental point of view, we simply don’t know how accurately we can diagnose bipolar disorder, or whether those diagnosed at age 5 or 6 or 7 will grow up to be adults with the illness,” he said. “The label may or may not reflect reality.”

Most children who qualify for the diagnosis do not go on to develop the classic features of adult bipolar disorder, like mania, researchers have found. They are far more likely to become depressed.

But Dr. Mani Pavuluri, director of the pediatric mood disorders program at the University of Illinois, Chicago, said that label is often better than any of the other diagnoses that difficult children often receive. “These are kids that have rage, anger, bubbling emotions that are just intolerable for them, and it is good that this is finally being recognized as part of a single disorder,” to better tailor treatment, she said.

In the study, researchers from New York, Maryland and Madrid analyzed data from a National Center for Health Statistics survey of office visits, which focused on doctors in private or group practices. The researchers calculated the number of visits in which doctors recorded a diagnosis of bipolar disorder, and found that the numbers went up from roughly 20,000 such diagnoses in 1994 to about 800,000 in 2003

“I have been studying trends in mental health services for some time, and this finding really stands out as one of the most striking increases in this short a time,” said Dr. Mark Olfson of the New York State Psychiatric Institute at Columbia University, the senior author of the study, which appears in the September issue of Archives of General Psychiatry, which is to be published Tuesday.

The increase makes bipolar disorder more common among children than clincial depression, the authors said. The study found that psychiatrists made almost 90 percent of the diagnoses, and that two-thirds of the young patients were boys. About half the patients also had been identified as having other mental difficulties, most often attention-deficit disorder.

The treatment given the children almost always included medication. About half received antipsychotic drugs, like Risperdal from Janssen or Seroquel from Astrazeneca, both developed to treat schizophrenia; a third were prescribed so-called mood stabilizers, most often the epilepsy drug Depakote; and antidepressants and stimulants were also common. Most children were on some combination of two or more drugs, and about four in 10 received some psychotherapy.

Their regimens were very similar to those of a group of adults with bipolar diagnoses, the study found. “You get the sense looking at the data that doctors are generalizing from the adult literature and applying the same principles to children,” Dr. Olfson said.

The rise in bipolar diagnoses in children reflects several factors, experts say. Bipolar symptoms do appear earlier in life than previously thought, in teenagers and young children who later develop the full-blown disorder, recent studies suggest. The label also gives doctors and desperate parents a quick way to try to manage children’s rages and outbursts, in an era when long-term psychotherapy and hospital care are less accessible, they say.

In addition, in recent years drug makers and company-sponsored psychiatrists have been encouraging doctors look for the disorder, ever since several drugs were approved to treat the disorder in adults. Last month the Food and Drug Administration approved one of these medications, Risperdal, to treat bipolar in children — which many experts say they expect will escalate the use of Risperdal and similar drugs in young people.

“We are just inundated with stuff from drug companies, publications, throwaways, that tell us six ways from Sunday that, ‘Omigod, we’re missing bipolar,’ ” said Dr. Gabrielle Carlson, a professor of psychiatry and pediatrics at Stony Brook University School of Medicine on Long Island. “And if you’re a parent with a difficult child, you go online, and there’s a Web site for bipolar, and you think, ‘Thank God I’ve found a diagnosis. I’ve found a home.’ ”

Some parents whose children have received the diagnosis say that, with time, the label led to effective treatment. "It’s been a godsend for us," said Kelly Simons, of Montrose, Colo., whose son Brit, 15, was prone to angry outbursts until given a combination of lithium, a mood-stabilizer and Risperdal several years ago. He is now on lithium alone and he is an honor-roll student.

Others say their children have suffered from side effects of drugs given for bipolar disorder, without getting much benefit.

Ashley Ocampo, 40, of Tallahassee, Fla., the mother of an 8-year-old boy, Nicholas Ryan, who is being treated for bipolar disorder, said that he had tried several antipsychotic drugs and mood stabilizers, and that he had been better lately.

But, she said in an interview, “He has gained weight, to the point where we were struggling find clothes for him; he’s had tremors, and still has some fine motor problems that he’s getting therapy for.”

She added, “But he’s a fabulous kid, and I think, I hope, that we’re close to finding the right combination of medications to help him.”
Source :http://www.nytimes.com

Schizophrenia Could Be Treated with Fewer Side Effects

A new drug that addresses schizophrenia symptoms has shown considerably less side effects than the “traditional” medication, promising more efficient treatments in the future.

Schizophrenia is a severe mental disorder that affects around 1% of the general population, with 2 million men and women being diagnosed every year in the United States as having this disease. It is one of the most mysterious mental illnesses, since the brain of the affected patients is organically “intact”, unlike Alzheimer’s disease or Parkinson’s disease, where the brain shows distinctive signs of degradation (like the deposition of beta-amyloid protein that kills neurons and leads to dementia).

Treatments for schizophrenia’s symptoms are numerous and effective at reducing chances of relapse, however they also have numerous and sometimes very visible side effects. Included in the panoply of treatments are prescription of antipsychotics, antidepressants and psychotherapy, although supplements of glycine (an amino acid), Omega-3 fats (found in fish oils) and antioxidants also help alleviate the manifestations of the chronic disease.

Most side effects quoted by medical reports are related to drowsiness and dizziness in patients receiving treatment, but these are the “easy” ones. Violent tremor (similar to Parkinson tremor) and considerable weight gain are among the worse, along with low blood pressure, rigidity in muscles, severe headaches and different symptoms associated with euphoria.

What Dr Sandeep Patil and colleagues, from drug firm Eli Lilly, have tried to do with their new "LY2140023" treatment is to address both the problem of the side effects and the efficiency of the overall medication, by taking a different path. As a side note, Eli Lilly is renowned for its other drug called Zyprexa, introduced in 1996, whose side effects were ironically downplayed by the company from fear that it would hurt sales.

This time, Patil, who continued the breakthrough work of Dr. Darryle D. Schoepp, a toxicologist and pharmacologist who joined Lilly in 1988, worked on the relationship between glutamate receptors in the brain and the symptoms of schizophrenia.

Current anti-psychotic drugs block the uptake of a naturally occurring chemical called dopamine, which is both a hormone and a very important neurotransmitter. Excessive levels of dopamine are thought to trigger psychotic episodes in patients suffering from schizophrenia, which is why anti-psychotics’ main purpose is to inhibit the influence of dopamine.

However, Patil’s team avoided the “dopamine-filled brain” path and concentrated instead on another neurotransmitter, called glutamate, whose involvement in psychotic episodes has been a long debate among scientists. The debate started when psychiatrists noticed that the use of a drug called PCP, also known as angel dust, induced symptoms similar to schizophrenic episodes in consumers, by blocking glutamate’s receptors.

Glutamate is the major excitatory neurotransmitter in the mammalian central nervous system (CNS), including humans of course. Its receptors and associated proteins are likely to be located on every neuron in the brain. Thus, glutamatergic transmission may affect every central neuron and is critical to all mental, sensory, motor, and affective function. For this reason alone, the glutamatergic transmitter system has received attention in examinations of schizophrenia.

In the brains of individuals with schizophrenia, glutamatergic signaling may well contribute to the functional changes in neural networks that account for the progression of the disease through its various stages, as well as for temporal variations in the severity of symptoms at each stage.

Since glutamatergic signaling inside the brain plays such an important role in the development of neural circuitry and in schizophrenia, altered glutamate function, either primarily or as a downstream consequence of some other event, may be part of the pathogenic mechanism leading to psychosis.

Psychotic episodes are characterized by a general loss of contact with reality, involving hallucinations, delusional beliefs, disorganized thinking and an alteration of personality. Because of the fact that these symptoms involve superior cognitive functions, Schoepp and Patil have narrowed their research domain to the study of pre-frontal cortex (PFC), the anterior part of the frontal lobes of the brain, lying in front of the motor and premotor areas.

This part of the brain is mainly involved in the so-called executive function, which gives us the ability to decide between conflicting thoughts, determine good or bad or anticipated different consequences of our current actions. Many authors have indicated an integral link between a person's personality and the functions of the prefrontal cortex.

“This is a system that is so fundamental to the function of your brain that it is quite powerful,” said Dr. Schoepp.

During the evaluation period, which lasted for four weeks, LY2140023 was administered to 97 patients alongside smaller groups given placebos or olanzipine, a commonly prescribed anti-psychotic medication. The results show that Russian olanzipine-treated patients (the experiment took place in Russia between August 2005 to June 2006) and those who received LY2140023 showed roughly the same encouraging effects. LY2140023 matched the effectiveness of olanzipine for both "positive" symptoms such as hallucinations as well as "negative" ones, including withdrawal.

Of course, results need further confirmation, and a new trial, involving 870 patients, is expected to be complete in January 2009. Eli Lilly will re-evaluate the findings from this second phase of the clinical tests, and if things turn out as expected a larger phase III will commence, with more than 2,000 patients.

“We have to confirm safety and efficacy with multiple studies,” Dr. Steven Paul, the president of Lilly Research Laboratories said. “We are very actively working on this target and related targets because we believe that this mechanism is now validated,” he added.
Source :http://www.efluxmedia.com