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Abbott to license drug for nervous system disorders

ABBOTT PARK, Ill., Jan 27 (Reuters) - Health care products company Abbott Laboratories ABT.N said Thursday it agreed to license a compound to treat central nervous system disorders from drug developer American Biogenetic Sciences Inc.

The agreement gives Abbott the exclusive rights to develop and market the compound, ABS-103, worldwide. As a result of the agreement, Abbott will make upfront investments including taking an equity position in ABS as well as making additional milestone payments.

Studies are expected to start in February 2000.

Terms of the agreement were not disclosed. Corpse transmits tuberculosis - US researchers

BOSTON, Jan 26 (Reuters) - Investigators have uncovered a new way in which the lung disease tuberculosis is spread -- through aerosol particles given off when a corpse is embalmed.

Researchers at the Johns Hopkins School of Medicine report in Thursday's New England Journal of Medicine that they have documented a case of tuberculosis that was spread to an embalmer by the corpse on which he was working.

The case may explain why embalmers are twice as likely to show evidence of exposure to TB than funeral home workers who are not involved in embalming, said Dr. Timothy Sterling, an assistant professor of infectious diseases and the chief author of the study.

The tuberculosis bacterium is usually carried from one person to another via tiny water droplets that are exhaled, particularly during coughing.

The Johns Hopkins team had to find another explanation for the fact that the 35-year-old corpse and the 45-year-old embalmer developed an identical variety of TB, even though the two never met in life.

Sterling said aerosols could have been generated when embalming fluids that had passed through the body were dumped down the drain. "In addition, the cadaver can spasm during the embalming process, which can cause the release of respiratory secretions," he said.

Doctors stumbled onto the link when routine testing showed that the TB bacteria from the two men had identical DNA fingerprints. Investigators then noted that the 45-year-old patient had signed the 35-year-old's death certificate.

TB "has been transmitted from cadavers to persons working in autopsy rooms," said Sterling and his colleagues, "but to our knowledge, there have been no reports of transmission to embalmers." U.S. court allows buffer outside abortion clinics

BOSTON, Jan 26 (Reuters) - The Massachusetts Supreme Judicial Court ruled on Wednesday that a pending law that would impose a 25-foot (7.6 metres) buffer zone around abortion clinics does not violate the First Amendment right to assemble peaceably.

The ruling, made five years after John Salvi killed two workers and injured five in a shooting attack at two womens' health care clinics in Brookline, which borders Boston, sets the stage for the Massachusetts legislature to consider a bill to establish buffer zones outside reproductive health clinics.

Would-be demonstrators would still be permitted to protest outside the 25-foot (7.6 metres) boundary, which the court ruled did not impose a "severe" burden on a protester's right to assemble.

The seven-judge panel found that "the governmental interests underlying (the Senate bill) are sufficiently weighty to justify a buffer zone of twenty-five feet."

The Planned Parenthood League of Massachusetts, which supports the proposed buffer zone, lauded the ruling.

"It tones down the climate of violence and fear and intimidation that happens right at the doors," said Planned Parenthood spokeswoman Michelle Ringuette. U.S. woman to proceed with septuplet pregnancy

NEPTUNE, N.J., Jan 26 (Reuters) - A New Jersey woman who is expecting septuplets will proceed with her high-risk pregnancy after deciding to rely on religious faith rather than medical advice to abort some of the foetuses, her doctor said on Wednesday.

Ivette Zapata-Smalls, 31, whose 21-month-old daughter Anisa died of complications from rheumatoid arthritis in 1998, would be one of only a handful of women worldwide to give birth to septuplets.

Physicians plan to deliver the children by Caesarean section in March at the Jersey Shore Medical Centre where Zapata-Smalls, of Lakewood, was admitted for complete bed rest three weeks ago.

"She's at 18 or 19 weeks now and already the size of a woman ready to deliver. She will grow to two or three times that size if we can get her to 27 weeks," said Dr. Charles Hux, her obstetrician.

After failing to get pregnant because of irregular menstrual cycles, she took a fertility drug.

"It is a big test for me, I know that," Zapata-Smalls, a former Army intelligence specialist, told the Asbury Park Press. "But I want to be a mom so bad again. I think it's the greatest gift God could give a woman."

Hux said he warned Zapata-Smalls and her husband, Fred Smalls, a former All-American linebacker from the University of West Virginia, that their best chance for a safe pregnancy would be to reduce the number of foetuses to four at most.

"They decided not to, really for religious reasons. Having lost a child in 1998, they didn't want to reduce. Whatever was going to be, was going to be," he said.

Another reason given was the experience of Bobbie and Kenny McCaughey, the Iowa couple who made history in November 1997 by becoming parents of the only known set of septuplets to survive for more than a few days.

Experts could not say how many septuplet births have taken place. A handful have been reported in the Middle East, and late in 1998 Nigerian-born Nkem Chukwu gave birth in Texas to eight children, one of whom later died of heart and lung failure.

Like Zapata-Smalls, Chukwu had rejected her doctor's recommendation to abort some of the foetuses for reasons of safety. Searle starts global trial on heart drug

SKOKIE, Ill., Jan 26 (Reuters) - Searle, the pharmaceutical group owned by Monsanto Co., said on Wednesday it will launch a global study to determine whether a drug can reduce the mortality rate in patients who have recently had a heart attack that resulted in a diagnosis of heart failure.

The Phase III trial, which will be conducted in the United States and about 30 other countries, will evaluate the agent eplerenone, the first and only entry in a proposed new drug class known as Selective Aldosterone Receptor Antagonists (SARAs).

Eplerenone is the only compound of this type in clinical trials.

Searle has named the new study EPHESUS, or EPlerenone neuroHormonal Efficacy and Survival Study, which will involve about 6,200 patients at more than 600 clinical sites on five continents.

EPHESUS investigators will study if eplerenone can provide additional cardiac and vascular protective benefits in post-MI (myocardial infarction) heart failure patients treated with the current standard of care.

Searle said it is conducting the trial to address a major public health concern.

According to the World Health Organisation, more than 30 percent of total deaths worldwide are due to diseases of the heart and circulation. An estimated 20 million people suffer from heart failure worldwide.

For people with heart failure, the five-year mortality rate is estimated at 50-60 percent. More than half of patients with heart failure have had a prior heart attack.

In yet another indication of the impact of this illness, heart failure patients experience sudden death at six to 9 times the rate expected in the general population.

Until 1999, the hormone aldosterone was not generally considered to be a major factor in the development or progression of heart disease. The first definitive evidence of the detrimental role of aldosterone in heart failure came from a recent study published in the New England Journal of Medicine.

Medical researchers now believe that aldosterone is a major villain in the onset and progression of heart failure. Clinical investigations are under way to assess the role of aldosterone in cardiac hypertrophy, kidney disease and the vascular system. Scientists identify protein linked to nerve repair

By Patricia Reaney

LONDON, Jan 26 (Reuters) - Scientists have identified a protein that prevents damaged cells in the brain and spinal cord from regenerating in a discovery that could offer new hope for people paralysed by stroke or spinal cord injuries.

Unlike tissue in many parts of the body that can repair itself, nerve cells survive injury but the axons or wires that connect them and transmit nerve impulses are severed and do not grow back.

But in three reports in the science journal Nature, scientists in Britain, the United States and Switzerland said an inhibitory protein called Nogo is one of the reasons why.

"It is very likely that Nogo is one reason why but it might be one of several reasons why," Stephen Strittmatter, a neurologist at Yale School of Medicine, said in a telephone interview.

Although new experimental therapies for stroke victims and people with spinal cord injuries are still years away, the researchers believe the discovery of the Nogo protein marks a huge advance in the study of neurological disorders.

"It opens up the possibility of allowing axon regeneration to happen in the brain and spinal cord. That is the promise of it. There are many things to be done before that promise is realised," he added.

Strittmatter and his Yale colleagues and scientists at Harvard Institutes of Medicine in Boston showed that the Nogo protein generated in the laboratory stops axon growth.

Martin Schwab and scientists at the University of Zurich and the Swiss Federal Institute of Technology and Dr Frank Walsh, who led the team at British drugs giant Smithkline Beecham SB.L, reported similar findings about Nogo.

"Now that we have the structure of the Nogo protein we can move on and hopefully identify more specific and more effective ways of neutralising or inhibiting the effects of Nogo," Walsh told Reuters.

The researchers are not sure how the protein works nor how to block its function. That's the next step.

The SmithKline Beecham team have produced Nogo protein in the laboratory to assess its importance. They will also screen Nogo against libraries of genes to try to find receptors to which the protein binds.

In a commentary on the research papers in Nature, J.L. Goldberg and B.A. Barnes of Stanford University School of Medicine in California described the Nogo findings as "a landmark step on a long road towards treatments for patients suffering from neurological conditions, including spinal-cord injury and stroke." Cut back doctors' hours, expert urges Congress

WASHINGTON, Jan 26 (Reuters) - An expert on medical mistakes, which kill as many as 98,000 Americans every year, called Wednesday for limiting the notoriously long hours medical personnel work.

Health care should have safeguards similar to those that make sure airlines, nuclear plants and other industries are safe, Dr. Lucian Leape, a member of the Institute of Medicine panel that reported the surprisingly high rate of deaths due to medical errors last year, told a Senate subcommittee.

"We have a centre for aviation safety," Leape, a pediatrician at the Harvard School of Public Health, said.

"I think health safety is as important as aviation safety. ... What's more important than taking care of sick people? Why do we have tired, overworked people doing it?"

The Senate Committee on Health, Education, Labour and Pensions is examining ways to help reduce medical errors, which kill more people in the United States than AIDS, automobile accidents or breast cancer.

Leape, as well as other experts who have spoken out since the report was issued last November, have pointed out that doctors and nurses fear being blamed and punished for their mistakes, and that everyone in the health care system is afraid of being sued, so mistakes go unreported.

This means little can be done to correct them.

LONG SHIFTS TARGETED

One first step will be fixing a system that leads to mistakes, Leape said. A main target is the long shifts that doctors, nurses and other health workers are forced to put in.

"To people outside health care, this is a no-brainer," Leape said. "We all know you make more mistakes when you are tired. We don't allow a pilot to fly more than eight hours."

Many interns work 24-hour shifts and longer. The argument is that this allows them continuous contact with patients, and it also acts as an unofficial rite of passage for doctors. But Leape said it is counterproductive .

"There is not much question that when you double up the work for a nurse you more than double the chance she'll make a mistake," he said. "My own position is that you shouldn't be required to work more than 12 hours."

The Institute of Medicine, part of the National Academy of Sciences, called for the establishment of a Centre for Patient Safety that would set goals for improving safety, research ways to improve the situation, and help states set up mandatory reporting systems.

CULTURE OF BLAME

Dr. Nancy Dickey, immediate past president of the American Medical Association, warned that any new system would have to address the culture of blame that makes health care workers afraid to admit to mistakes.

"If the fear of litigation continues to pervade efforts to improve patient safety and quality, our transformation into a culture of safety on behalf of our patients may never be fully realised," she told the committee hearing.

Leape recommends that the federal government set standards, which the states implement in whatever way they see fit.

"We feel it is essential that we have this kind of system so that we have accountability and the public perceives us as having accountability," he said.

Patients also need to take some responsibility for their own care, Gail Devers, who won a gold medal in the 100 meter dash at the 1992 Olympics, told the committee.

She had a thyroid condition that went undiagnosed for months, forcing her to drop out of the 1988 Seoul Olympics. Doctors assumed she was overtraining and prescribed rest.

"I do not blame the medical community. I know that every doctor I visited tried to help me. Unfortunately, I did not have all the information I should have had, either. I should have been a better educated patient," she said.

She also said doctors need to share more information so they can more easily recognise rare conditions. Japan seeks to prevent deaths from overwork

TOKYO, Jan 26 (Reuters) - Japan said on Wednesday it would introduce a new medical insurance scheme to help prevent "karoshi" or death from overwork.

Under the plan prepared by the Labour Ministry, people who show "critical" symptoms in four categories -- obesity, high blood pressure, high blood sugar and high blood lipids -- will be able to have medical examinations free of charge.

Those with all four symptoms are about 35 times more at risk of dying from overwork than those without, a ministry official said, adding the ministry hoped the new system would encourage people to get medical exams that would help prevent "karoshi."

Some 90 people died from overwork in 1998, the last year for which data was available, up from 32 in 1994.

Such deaths are often covered by workers' compensation paid to the deceased's family.

The ministry plans to seek parliamentary approval for the plan during the current session and implement the legislation in April 2001. More clues found to molecule's role in asthma

WASHINGTON, Jan 25 (Reuters) - A new study has found additional evidence that a chemical involved in inflammation may play a role in asthma, researchers said on Tuesday.

The study found more of the chemical, known as interleukin-9 (IL-9), in tissue taken from the lungs of people with asthma than in tissue from healthy lungs, they said.

Writing in the Journal of Allergy and Clinical Immunology, the team at McGill University in Montreal, Canada, and the Institut Pasteur in Lille, France, said they believed drugs that cancel out the effects of IL-9 might work to help treat asthma.

"Based on these results, the previous genetic mapping studies and the biology of IL-9, it is our view that an antibody to IL-9 has significant promise as a therapy for asthma," Dr. Qutayba Hamid, a professor of medicine at McGill who led the study, said in a statement.

The results were released by Magainin Pharmaceuticals, which is developing IL-9 antibodies as an asthma treatment, along with Genentech Inc.

Asthma affects nearly 15 million people in the United States, including about 5 million children.

Interleukins have long been known to play a role in regulating the immune system and, in particular, to be responsible for causing the early stages of the inflammation in the lungs that leads to asthma attacks.

They belong to a family of signalling chemicals known as chemokines. Chemokines are especially common in the immune system, where they can provoke inflammation.

Other researchers have found a role for related chemokines, such as IL-4 and IL-13, in asthma. One more risk for Alzheimer's - lots of siblings

WASHINGTON, Jan 25 (Reuters) - People who come from large families seem to have a higher risk of developing Alzheimer's disease, researchers said on Tuesday.

The study, done by a team at the University of Washington, found that people who had five or more siblings have a 39 percent greater risk of developing the disease than those with fewer brothers and sisters.

Victoria Moceri, who led the study, said big families tend to be poorer, which could explain a range of health problems.

"The early-life environment and its effect on the growth and maturation of children is linked to many adult diseases, such as heart disease, stroke and diabetes," Moceri, an epidemiologist, said in a statement.

"A poor-quality childhood environment could prevent the brain from reaching a complete level of maturation," she added. "The effects of impaired development could produce a brain that is normal, but functions less efficiently."

Writing in the journal Neurology, she said the areas of the brain that show the earliest signs of Alzheimer's also take the longest time to mature during childhood and adolescence.

The study also found that people who grew up in the suburbs were less likely to develop Alzheimer's than people whose childhood was spent in the inner city. Both statistics -- being from a large family and being from the city -- could reflect a family's financial situation, the researchers said.

"Families with five or more children were more likely to be from the lower socioeconomic levels, and therefore more likely to have poor growth rates," Moceri said.

The researchers looked at 770 people aged 60 and older who were members of a large health maintenance organisation in Seattle. About half had Alzheimer's disease. Hormones create more risk of breast cancer-US study

CHICAGO, Jan 25 (Reuters) - Women undergoing hormone replacement therapy with both oestrogen and progestin are at higher risk of developing breast cancer than those taking oestrogen alone, a study said on Tuesday.

Progestin, a synthetic version of the hormone progesterone, is taken in combination with oestrogen by post-menopausal women because it reduces the risk of cancer of the uterus by inducing the monthly shedding of the uterine lining.

Hormone replacement therapy is commonly used by post-menopausal women to ward off osteoporosis and bone fractures, and symptoms of menopause such as vaginal dryness. The therapy also reduces the risk of heart disease.

Those who were using or had recently used the combination progestin-oestrogen therapy had a 40 percent higher risk of developing breast cancer than women who did not take any hormones, the study found. The breast cancer risk was 20 percent higher among women who used oestrogen alone compared to nonusers.

"Assessing the comparative risk of oestrogen alone versus oestrogen-progestin was complicated by the fact that use of oestrogen alone was associated with increased risk in lean but not heavy women. We found differences between the two regimens among lean women but were unable to draw conclusions among heavier women," wrote study author Catherine Schairer of the U.S. National Cancer Institute in Rockville, Maryland.

The report, which appeared in the Journal of the American Medical Association, said women's risk of being diagnosed with breast cancer increased with each year of hormone treatment.

The risk rose by 8 percent for each year of oestrogen-progestin use, and by 1 percent for each year of oestrogen use alone.

The researchers examined 15 years of data on 46,355 women participating in a study on breast cancer screening, 2,082 of whom first developed the disease between 1980 and 1995.

In an editorial accompanying the study, doctors from Harvard Medical School and Brigham and Women's Hospital in Boston noted the findings reinforced previous evidence of breast cancer risk associated with recent use of hormone therapy for long periods.

"This has major implications for risk-benefit considerations because the risks of hip fracture and coronary heart disease -- primary targets of preventive use of hormone therapy -- do not become large until a decade or more after menopause," editorial writer Walter Willett wrote.

"Although post-menopausal hormone use has important benefits, the study ... highlights the potential hazards and uncertainties that accompany such use," he wrote.

"The commonly held belief that ageing routinely requires pharmacological management has unfortunately led to neglect of diet and lifestyle as the primary means to achieve healthy ageing," he added.