Showing posts with label Health. Show all posts
Showing posts with label Health. Show all posts

EU drug regulator OKs Novartis' meningitis B shot

LONDON (AP) — Europe's top drug regulator has recommended approval for the first vaccine against meningitis B, made by Novartis AG.

There are five types of bacterial meningitis. While vaccines exist to protect against the other four, none has previously been licensed for type B meningitis. In Europe, type B is the most common, causing 3,000 to 5,000 cases every year.

Meningitis mainly affects infants and children. It kills about 8 percent of patients and leaves others with lifelong consequences such as brain damage.

In a statement on Friday, Andrin Oswald of Novartis said he is "proud of the major advance" the company has made in developing its vaccine Bexsero. It is aimed at children over two months of age, and Novartis is hoping countries will include the shot among the routine ones for childhood diseases such as measles.

Novartis said the immunization has had side effects such as fever and redness at the injection site.

Recommendations from the European Medicines Agency are usually adopted by the European Commission. Novartis also is seeking to test the vaccine in the U.S.

Read More..

EU drug regulator OKs Novartis' meningitis B shot

LONDON (AP) — Europe's top drug regulator has recommended approval for the first vaccine against meningitis B, made by Novartis AG.

There are five types of bacterial meningitis. While vaccines exist to protect against the other four, none has previously been licensed for type B meningitis. In Europe, type B is the most common, causing 3,000 to 5,000 cases every year.

Meningitis mainly affects infants and children. It kills about 8 percent of patients and leaves others with lifelong consequences such as brain damage.

In a statement on Friday, Andrin Oswald of Novartis said he is "proud of the major advance" the company has made in developing its vaccine Bexsero. It is aimed at children over two months of age, and Novartis is hoping countries will include the shot among the routine ones for childhood diseases such as measles.

Novartis said the immunization has had side effects such as fever and redness at the injection site.

Recommendations from the European Medicines Agency are usually adopted by the European Commission. Novartis also is seeking to test the vaccine in the U.S.

Read More..

EU drug regulator OKs Novartis' meningitis B shot

LONDON (AP) — Europe's top drug regulator has recommended approval for the first vaccine against meningitis B, made by Novartis AG.

There are five types of bacterial meningitis. While vaccines exist to protect against the other four, none has previously been licensed for type B meningitis. In Europe, type B is the most common, causing 3,000 to 5,000 cases every year.

Meningitis mainly affects infants and children. It kills about 8 percent of patients and leaves others with lifelong consequences such as brain damage.

In a statement on Friday, Andrin Oswald of Novartis said he is "proud of the major advance" the company has made in developing its vaccine Bexsero. It is aimed at children over two months of age, and Novartis is hoping countries will include the shot among the routine ones for childhood diseases such as measles.

Novartis said the immunization has had side effects such as fever and redness at the injection site.

Recommendations from the European Medicines Agency are usually adopted by the European Commission. Novartis also is seeking to test the vaccine in the U.S.

Read More..

EU drug regulator OKs Novartis' meningitis B shot

LONDON (AP) — Europe's top drug regulator has recommended approval for the first vaccine against meningitis B, made by Novartis AG.

There are five types of bacterial meningitis. While vaccines exist to protect against the other four, none has previously been licensed for type B meningitis. In Europe, type B is the most common, causing 3,000 to 5,000 cases every year.

Meningitis mainly affects infants and children. It kills about 8 percent of patients and leaves others with lifelong consequences such as brain damage.

In a statement on Friday, Andrin Oswald of Novartis said he is "proud of the major advance" the company has made in developing its vaccine Bexsero. It is aimed at children over two months of age, and Novartis is hoping countries will include the shot among the routine ones for childhood diseases such as measles.

Novartis said the immunization has had side effects such as fever and redness at the injection site.

Recommendations from the European Medicines Agency are usually adopted by the European Commission. Novartis also is seeking to test the vaccine in the U.S.

Read More..

Diabetes rates rocket in Oklahoma, South

NEW YORK (AP) — The nation's diabetes problem is getting worse, and health officials say the biggest changes have been in Oklahoma and a number of Southern states.

The diabetes rate in Oklahoma more than tripled over 15 years, and also boomed in Southern states like Kentucky, Georgia and Alabama.

Most cases are the kind of diabetes linked to obesity. Health officials believe extra weight explains the increases in the South and Southwest. They also say the rates overall are up because people with diabetes are living longer.

The Centers for Disease Control and Prevention issued the state report Thursday.

The diabetes rate more than doubled in several Northern states, too, including Washington, Idaho, Montana, Wyoming, South Dakota, Minnesota, Missouri, Ohio and Maine.

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Online:

CDC report: http://www.cdc.gov/mmwr

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Ireland probes death of ill abortion-seeker

DUBLIN (AP) — The debate over legalizing abortion in Ireland flared Wednesday after the government confirmed that a miscarrying woman suffering from blood poisoning was refused a quick termination of her pregnancy and died in an Irish hospital.

Prime Minister Enda Kenny said he was awaiting findings from three investigations into the death of Savita Halappanavar, a 31-year-old Indian who was 17 weeks pregnant. Her case highlights the bizarre legal limbo in which pregnant women facing severe health problems can find themselves in predominantly Catholic Ireland.

Ireland's constitution officially bans abortion, but a 1992 Supreme Court ruling found the procedure should be legalized for situations when the woman's life is at risk from continued pregnancy. Five governments since have refused to pass a law resolving the confusion, leaving Irish hospitals reluctant to terminate pregnancies except in the most obviously life-threatening circumstances.

In practice the vast bulk of Irish women wanting abortions, an estimated 4,000 per year, simply travel next door to England, where abortion has been legal on demand since 1967. But that option is difficult, if not impossible, for women in failing health.

University Hospital Galway in western Ireland declined to say whether doctors believed Halappanavar's blood poisoning could have been reversed had she received an abortion rather than wait for the fetus to die on its own. In a statement, it described its own investigation into the death, and a parallel probe by the national government's Health Service Executive, as "standard practice" whenever a pregnant woman dies in a hospital. The Galway coroner also planned a public inquest.

Savita Halappanavar's husband, Praveen, said doctors determined she was miscarrying within hours of her hospitalization for severe pain on Sunday, Oct. 21. He said that over the next three days doctors refused their requests for an abortion to combat her surging pain and fading health.

"Savita was really in agony. She was very upset, but she accepted she was losing the baby," he told The Irish Times in a telephone interview from Belgaum, southwest India. "When the consultant came on the ward rounds on Monday morning, Savita asked if they could not save the baby, could they induce to end the pregnancy? The consultant said: 'As long as there is a fetal heartbeat, we can't do anything.'

"Again on Tuesday morning ... the consultant said it was the law, that this is a Catholic country. Savita said: 'I am neither Irish nor Catholic,' but they said there was nothing they could do," Praveen Halappanavar said.

He said his wife vomited repeatedly and collapsed in a restroom that night, but doctors wouldn't terminate the fetus because its heart was still beating.

The fetus died the following day and its remains were surgically removed. Within hours, Praveen Halappanavar said, his wife was placed under sedation in intensive care with blood poisoning and he was never able to speak with her again. By Saturday her heart, kidneys and liver had stopped working and she was pronounced dead early Sunday, Oct. 28.

The couple had settled in 2008 in Galway, where Praveen Halappanavar works as an engineer at the medical devices manufacturer Boston Scientific. His wife qualified as a dentist but had taken time off for her pregnancy. Her parents in India had just visited them in Galway and left the day before her hospitalization.

Praveen Halappanavar said he took his wife's remains back to India for a Hindu funeral and cremation Nov. 3. News of the circumstances that led to her death emerged Tuesday in Galway after the Indian community canceled the city's annual Diwali festival. Savita Halappanavar had been one of the festival's main organizers.

Opposition politicians appealed Wednesday for Kenny's government to introduce legislation immediately to make the 1992 Supreme Court judgment part of statutory law. Barring any such bill, the only legislation defining the illegality of abortion in Ireland dates to 1861 when the entire island was part of the United Kingdom. That British law, still valid here due to Irish inaction on the matter, states it is a crime punishable by life imprisonment to "procure a miscarriage."

In the 1992 case, a 14-year-old girl identified in court only as "X'' successfully sued the government for the right to have an abortion in England. She had been raped by a neighbor. When her parents reported the crime to police, the attorney general ordered her not to travel abroad for an abortion, arguing this would violate Ireland's constitution.

The Supreme Court ruled she should be permitted an abortion in Ireland, never mind England, because she was making credible threats to commit suicide if refused one. During the case, the girl reportedly suffered a miscarriage.

Since then, Irish governments twice have sought public approval to legalize abortion in life-threatening circumstances — but excluding a suicide threat as acceptable grounds. Both times voters rejected the proposed amendments.

Legal and political analysts broadly agree that no Irish government since 1992 has required public approval to pass a law that backs the Supreme Court ruling. They say governments have been reluctant to be seen legalizing even limited access to abortion in a country that is more than 80 percent Catholic.

Coincidentally, the government said it received a long-awaited expert report Tuesday night proposing possible changes to Irish abortion law shortly before news of Savita Halappanavar's death broke. The government commissioned the report two years ago after the European Court of Human Rights ruled that Ireland's inadequate access to abortions for life-threatening pregnancies violated European Union law.

An abortions right group, Choice Ireland, said Halappanavar might not have died had any previous government legislated in line with the X judgment. Earlier this year, the government rejected an opposition bill to do this.

"Today, some 20 years after the X case, we find ourselves asking the same question: If a woman is pregnant, her life in jeopardy, can she even establish whether she has a right to a termination here in Ireland?" said Choice Ireland spokeswoman Stephanie Lord.

Yet the World Health Organization identifies Ireland as an unusually safe place to be pregnant. Its most recent report on global maternal death rates found that only three out of every 100,000 women die in childbirth in Ireland, compared with an average of 14 in Europe and North America, 190 in Asia and 590 in Africa.

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British medical journal slams Roche on Tamiflu

LONDON (AP) — A leading British medical journal is asking the drug maker Roche to release all its data on Tamiflu, claiming there is no evidence the drug can actually stop the flu.

The drug has been stockpiled by dozens of governments worldwide in case of a global flu outbreak and was widely used during the 2009 swine flu pandemic.

On Monday, one of the researchers linked to the BMJ journal called for European governments to sue Roche.

"I suggest we boycott Roche's products until they publish missing Tamiflu data," wrote Peter Gotzsche, leader of the Nordic Cochrane Centre in Copenhagen. He said governments should take legal action against Roche to get the money back that was "needlessly" spent on stockpiling Tamiflu.

Last year, Tamiflu was included in a list of "essential medicines" by the World Health Organization, a list that often prompts governments or donor agencies to buy the drug.

Tamiflu is used to treat both seasonal flu and new flu viruses like bird flu or swine flu. WHO spokesman Gregory Hartl said the agency had enough proof to warrant its use for unusual influenza viruses, like bird flu.

"We do have substantive evidence it can stop or hinder progression to severe disease like pneumonia," he said.

In the U.S., the Centers for Disease Control and Prevention recommends Tamiflu as one of two medications for treating regular flu. The other is GlaxoSmithKline's Relenza. The CDC says such antivirals can shorten the duration of symptoms and reduce the risk of complications and hospitalization.

In 2009, the BMJ and researchers at the Nordic Cochrane Centre asked Roche to make all its Tamiflu data available. At the time, Cochrane Centre scientists were commissioned by Britain to evaluate flu drugs. They found no proof that Tamiflu reduced the number of complications in people with influenza.

"Despite a public promise to release (internal company reports) for each (Tamiflu) trial...Roche has stonewalled," BMJ editor Fiona Godlee wrote in an editorial last month.

In a statement, Roche said it had complied with all legal requirements on publishing data and provided Gotzsche and his colleagues with 3,200 pages of information to answer their questions.

"Roche has made full clinical study data ... available to national health authorities according to their various requirements, so they can conduct their own analyses," the company said.

Roche says it doesn't usually release patient-level data available due to legal or confidentiality constraints. It said it did not provide the requested data to the scientists because they refused to sign a confidentiality agreement.

Roche is also being investigated by the European Medicines Agency for not properly reporting side effects, including possible deaths, for 19 drugs including Tamiflu that were used in about 80,000 patients in the U.S.

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Online:

www.bmj.com.tamiflu/

Read More..

British medical journal slams Roche on Tamiflu

LONDON (AP) — A leading British medical journal is asking the drug maker Roche to release all its data on Tamiflu, claiming there is no evidence the drug can actually stop the flu.

The drug has been stockpiled by dozens of governments worldwide in case of a global flu outbreak and was widely used during the 2009 swine flu pandemic.

On Monday, one of the researchers linked to the BMJ journal called for European governments to sue Roche.

"I suggest we boycott Roche's products until they publish missing Tamiflu data," wrote Peter Gotzsche, leader of the Nordic Cochrane Centre in Copenhagen. He said governments should take legal action against Roche to get the money back that was "needlessly" spent on stockpiling Tamiflu.

Last year, Tamiflu was included in a list of "essential medicines" by the World Health Organization, a list that often prompts governments or donor agencies to buy the drug.

Tamiflu is used to treat both seasonal flu and new flu viruses like bird flu or swine flu. WHO spokesman Gregory Hartl said the agency had enough proof to warrant its use for unusual influenza viruses, like bird flu.

"We do have substantive evidence it can stop or hinder progression to severe disease like pneumonia," he said.

In the U.S., the Centers for Disease Control and Prevention recommends Tamiflu as one of two medications for treating regular flu. The other is GlaxoSmithKline's Relenza. The CDC says such antivirals can shorten the duration of symptoms and reduce the risk of complications and hospitalization.

In 2009, the BMJ and researchers at the Nordic Cochrane Centre asked Roche to make all its Tamiflu data available. At the time, Cochrane Centre scientists were commissioned by Britain to evaluate flu drugs. They found no proof that Tamiflu reduced the number of complications in people with influenza.

"Despite a public promise to release (internal company reports) for each (Tamiflu) trial...Roche has stonewalled," BMJ editor Fiona Godlee wrote in an editorial last month.

In a statement, Roche said it had complied with all legal requirements on publishing data and provided Gotzsche and his colleagues with 3,200 pages of information to answer their questions.

"Roche has made full clinical study data ... available to national health authorities according to their various requirements, so they can conduct their own analyses," the company said.

Roche says it doesn't usually release patient-level data available due to legal or confidentiality constraints. It said it did not provide the requested data to the scientists because they refused to sign a confidentiality agreement.

Roche is also being investigated by the European Medicines Agency for not properly reporting side effects, including possible deaths, for 19 drugs including Tamiflu that were used in about 80,000 patients in the U.S.

____

Online:

www.bmj.com.tamiflu/

Read More..