Saturday, August 9, 2008

Family planning groups against abortion proposal


Family planning groups said on Friday they were still planning to lobby against a proposed new regulation aimed at countering state laws that require certain health care workers to provide contraception to women.

A widely circulated version of the draft regulation would have cut off federal funds to hospitals and states that attempt to compel medical providers to offer legal abortion and contraception services to women.

Health and Human Services Secretary Mike Leavitt said a version of the regulation is still under consideration.

"Not only are there clear provisions in three separate laws protecting federally funded health care providers' right of conscience, but doing otherwise undermines the most fundamental moral underpinning of freedom of expression and action," Leavitt wrote in his blog.

Leavitt said the part that many groups objected to most strongly, which defined abortion to include most birth control pills and intrauterine devices, would not be included.

But Nancy Northup of the Center for Reproductive Rights said her group objected to other parts of the proposal.

"It broadly defines everyone who works at a healthcare establishment as being involved in doing procedures," Northup said in a telephone interview.

"It allows everybody, whether you are a receptionist or a maintenance person ... to object to doing their jobs because they object to abortion or sterilization," she added. "It puts women in the position of not knowing when they go to get healthcare if someone is going to say, 'I am not going to help you here.'"

The National Family Planning & Reproductive Health Association said it was concerned the proposed regulation would target 37 state laws.

"These laws mandate the availability of EC (emergency contraception) in emergency rooms, bar pharmacies from flatly refusing to fill prescriptions and mandate coverage of contraception when other prescriptions are covered," the group said in a statement.

"Given that at least 17.5 million women in America are in need of publicly funded contraceptive services ... we believe the department should be working to increase access to these crucial health care services, rather than working to limit them."

New York Sen. Hillary Clinton also expressed doubts after reading Levitt's comments.

"It is crucial that science, not ideology, be the basis of any rules released by the Department of Health and Human Services," she said in a statement. "It is unconscionable that this administration would even consider putting women's health and prevention in jeopardy."



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Heart drugs combination can cause muscle damage

U.S. health officials warned the public on Friday about the risk of a rare type of muscle injury seen when the cholesterol drug simvastatin is combined with the anti-arrhythmia medicine amiodarone.

The Food and Drug Administration said it continued to receive reports of rhabdomyolysis, a type of muscle injury that can lead to kidney failure or death, despite a 2002 warning about combining the drugs.

Simvastatin is an ingredient in Merck & Co's Zocor and Abbott Laboratories Inc's Simcor, and is sold generically. It also is one of two components in Merck and Schering-Plough Corp's Vytorin.

Amiodarone is an ingredient in Wyeth's Cordarone and is also sold generically. Upsher-Smith sells a version under the name Pacerone. The drug is used to control a life-threatening type of abnormal heart beat.

All drugs in the statin class of medicines, which include simvastatin, Pfizer Inc's Lipitor and others, carry a potential risk of rhabdomyolysis.

But compared with other statins, the risk is "more pronounced" when simvastatin is given with amiodarone, the FDA said. The risk increased with simvastatin doses greater than 20 milligrams per day.

"Prescribers should be aware of the increased risk of rhabdomyolysis when simvastatin is prescribed with amiodarone, and they should avoid doses of simvastatin greater than 20 mg per day in patients taking amiodarone," the FDA said in a notice on its website.

The FDA has confirmed 52 U.S. reports of rhabdomyolysis associated with use of amiodarone and simvastatin since the 2002 warning, agency spokeswoman Susan Cruzan said. During the same period, there were six cases linked with use of other statins and amiodarone, she said.

Patients should contact a doctor immediately if they develop unexplained muscle cramps, pain, tenderness, stiffness or spasms, the FDA said.

The muscle injury risk has been "very clearly stated" on Zocor's label since 2002, Merck spokesman Ron Rogers said.

Schering-Plough spokesman Lee Davies also said the risk was noted in Vytorin's prescribing instructions for years, and Abbott spokeswoman Elizabeth Hoff said the "prescribing information for Simcor already contains this information."

Wyeth noted a possible interaction specifically with simvastatin on Cordarone's label about six months ago, company spokesman Doug Petkus said. Earlier information mentioned a risk when combining Cordarone with Lipitor and implied it would apply to other statins, he said.



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Longterm smoking linked to gene


For most people, the first experimental drags on a cigarette bring on nausea, coughing and other signals from the brain that say, "Turn back. This is a bad idea." But for some, they bring a wave of pleasure.

Those in the second group likely bear a gene type that not only increases their addiction risk, but has been implicated in the development of lung cancer, researchers said on Friday.

"If you have this variant, you are going to like your earliest experiences with smoking," said Ovide Pomerleau of the University of Michigan Medical School, whose research appears in the journal Addiction.

Pomerleau said the finding suggests that for some, smoking even one cigarette is a bad idea. "It's a trap," he said in a telephone interview.

"What they don't realize is if they have this kind of genetic make-up, they are on their way to dependency," he said, and that raises their risk for lung cancer.

The research is part of a growing understanding of genetic factors involved in nicotine addiction and lung cancer.

Teams of scientists reported earlier this year that smokers who had certain changes in three nicotine receptor genes -- which control entry of nicotine into brain cells -- were more likely to develop lung cancer than other smokers.

This week, Canadian researchers said that, by manipulating receptors for the chemical dopamine, they were able to control which rats in a study enjoyed their first exposure to nicotine and which were repelled by it.

Pomerleau said the field may soon lead to new treatments for nicotine addiction and tests to assess addiction risks.

Smoking causes nine out of 10 cases of lung cancer, the leading cause of cancer death in men worldwide and the second-leading cause of cancer death among women.

Pomerleau and colleagues studied data from 435 people. Some had tried a cigarette but never developed a habit; others smoked at least five cigarettes a day for the past five years.

Regular smokers in the study were far more likely than those who had never smoked to have a change in the CHRNA5 nicotine receptor gene. Smokers were eight times more likely to report liking cigarettes from the start.

Pomerleau said work has begun to develop a genetic screen for the CHRNA5 variant. Two other researchers on the team, Laura Bierut and John Rice at Washington University, hold a patent on the gene variant, which has been licensed by privately held Perlegen Sciences Inc.

Pfizer Inc, maker of the smoking cessation drug Chantix owns a $50 million stake in Perlegen.

Pomerleau, who has served on Pfizer's scientific advisory board, said he favors development of diagnostic tests, as long as people understand it is not the only risk factor for nicotine addiction.

"What we don't know is far greater than what we do know," he said.



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Thursday, August 7, 2008

Weight loss can affect bones longterm

When people lose weight, they often lose some bone mass as well. Now a new study suggests that changes in bone metabolism may persist even after the weight loss stops.

In a study of obese adults who followed a very low-calorie diet, researchers found that even after the dieters stopped shedding pounds and entered the "weight maintenance" phase, changes in their bone turnover remained.

Bone turnover, or "remodeling," refers to the normal process by which the body constantly breaks down old bone and builds up new tissue to replace it. It's known that even moderate weight loss can cause an imbalance in this process, leading to a dip in bone mass, but it has been unclear whether changes in bone turnover persist after a person's weight stabilizes.

Among dieters in the current study, researchers found that the balance between bone breakdown and bone formation was restored after they stopped losing weight. However, the overall rate of bone turnover increased during weight loss, and it stayed higher once their weight stabilized.

This is a potential concern, says lead researcher Dr. Pamela Hinton, because increased bone turnover can make bones more fragile, even when bone breakdown and formation are balanced.

"Accelerated bone remodeling is thought to be an independent risk factor for bone fracture," explained Hinton, an associate professor of nutritional sciences at the University of Missouri in Columbia.

However, she told Reuters Health, long-term studies are still needed to see how weight loss ultimately affects people's actual bone density and fracture risk.

Bone mass changes slowly, Hinton noted, and it takes six months to a year to see a shift. Moreover, bone fractures may not occur for many years after the weight loss, she said.

Her team's findings, which are to be published in the Journal of the American College of Nutrition, come from a weight-loss study of 37 obese adults age 50 and older.

For three months, the men and women followed a liquid-based diet that provided just 500 calories per day; in the end, they lost an average of 20 percent of their initial weight.

Hinton and her colleagues then followed the dieters through a nine- month maintenance phase where they increased their calorie intake to a level designed to maintain their weight or to continue a slower, gradual weight loss.

Periodically, the researchers measured the study participants' blood levels of certain proteins that serve as markers of bone breakdown and formation. Based on those markers, the average rate of bone remodeling sped up during weight loss and remained higher during the weight-maintenance phase.

It's not clear what people can do to alter their bone turnover rate after weight loss. Hinton said there is some evidence that a high calcium intake -- 1,500 to 1,800 milligrams per day -- lessens bone loss and adverse effects on bone turnover as people are losing weight.

Weight-bearing exercise -- such as jogging, stair-climbing and weightlifting -- helps build bone in people who are not shedding pounds, Hinton noted. However, she said, research has been inconclusive as to whether it can prevent bone loss in people who are losing weight.



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Diabetes risk can be prevented by high vitamin C intake

An abundance of vitamin C in the diet may help lower a person's risk of developing type 2 diabetes, new research suggests.

In a study of middle-aged and older men and women, those with the highest blood levels of vitamin C were significantly less likely to develop diabetes over 12 years than those with the lowest levels, researchers found.

Fruits and vegetables are the main source of vitamin C in Western diets, and blood levels of vitamin C are good markers of fruit and vegetable intake, Dr. Nita G. Forouhi, at the Institute of Metabolic Science at Addenbrooke's Hospital, Cambridge, England, and colleagues note.

The current findings "re-endorse the public health message of the beneficial effect of increasing total fruit and vegetable intake," the investigators wrote in Archives of Internal Medicine.

Forouhi's team followed 21,831 healthy men and women who were 40 to 75 years old for the development of type 2 diabetes. At study entry, all participants provided detailed health and lifestyle information, as well as blood samples, which investigators used to determine vitamin C levels.

Over the course of the study, 423 men and 312 women developed type 2 diabetes, an overall rate of 3.2 percent.

According to the investigators, the likelihood of developing diabetes was 62 percent lower in men and women with the highest circulating vitamin C levels, relative to men and women with the lowest vitamin C levels.

Factoring out other characteristics associated with diabetes risk, such as older age, gender, family history, alcohol intake, physical activity, smoking status and body weight did not significantly alter these associations.

These data offer "persuasive evidence of a beneficial effect of vitamin C and fruit and vegetable intake on diabetes risk," Forouhi and colleagues conclude.



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Diabetes worries parents

Parents of children with type 1 diabetes are particularly concerned about the complications of the disease, new research shows.

Initially, most of the concern is centered on daily management tasks, but over time it shifts to concerns about long-term complications, such as kidney disease, blindness, and amputation, according to the report in the journal Diabetes Care.

Dr. Lisa M. Buckloh, from Nemours Children's Clinic in Jacksonville, Florida, and colleagues studied 30 mothers, 14 fathers, and 3 other relatives of 33 children with type 1 diabetes who participated in focus-group discussions of diabetes complications.

In general, the parents said they preferred a flexible, collaborative approach with their child's healthcare provider in discussing complications. Moreover, they wanted the information to be tailored to the child's age and duration of diabetes.

A number of participants desired more sensitive communications and improved emotional support from their healthcare professional.

Motivating children to care for their disease was cited as being particularly challenging, the report indicates. Family burnout with diabetes care over time was also observed.

Misinformation about diabetes complications was uncommon.

"Amount, depth, and timing of presentation of information about complications to youth should be tailored to the child's developmental maturity, the family's prior exposure to diabetes, and parental preferences," Buckloh and colleagues conclude.

"Parents should receive emotional support and guidance in talking with their children about complications in a positive, constructive, and motivating manner rather than using negative methods such as scare tactics."



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Cognitive problems cause heart disease

Results of a study in the European Heart Journal indicate an association between heart disease and lower thinking or "cognitive" performance in middle-aged adults.

Using data from the Whitehall II study, Dr. Archana Singh-Manoux, of INSERM, Cedex, France, and colleagues examined the association between heart disease and cognition in 10,308 subjects who were 35 to 55 years of age when the study began in the late 1980s. Heart attacks and other related heart problems were recorded up to 2004, at which point 5837 subjects had completed six cognitive tests.

Men and women who developed heart disease scored lower on a number of cognitive tests, particularly those involving reasoning and vocabulary, than did their peers without heart disease. Moreover, there was evidence, at least in men, that the longer the heart disease was present, the greater the impairment in thinking.

"Our results suggest that even among middle-aged individuals, heart disease is associated with poor cognitive performance with some evidence to suggest a stronger effect among those with longest standing (disease)," Singh-Manoux and colleagues conclude.

However, these findings are unable to answer the question of whether heart disease leads to impaired cognition or vice versa, the authors note.



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Early Screening Not Related To Family Breast Cancer

New research suggests that just because a woman has family members with breast cancer, it does not mean that she should undergo early screening for the cancer. According to the report, there are certain factors doctors can look for to determine whether early screening is advisable.

"Breast cancer is very common. Familial clustering is also rather common," Dr. Geertruida H. de Bock, the study's first author, told Reuters Health. "About 25 to 30 percent of breast cancer is family clustered, but the (rate) of breast cancer in the family is not very useful in predicting if you will get breast cancer yourself."

At present, having a first-degree relative (mother, sister, or daughter) diagnosed with breast cancer before age 40 is considered to be an indication for starting breast cancer screening before age 50, de Bock and her team note in the journal BMC Cancer. However, this practice is based on estimates from families with risky gene mutations or who are otherwise cancer-prone.

To better understand the risk in the general population, the researchers looked at 1,987 women, all of whom had sisters who had been diagnosed with breast cancer. Some of the study participants had breast cancer while others didn't.

The researchers identified four familial factors that were related to developing breast cancer at a younger age:

--at least two cases of breast cancer in a first-degree relative;

--at least two cases of breast cancer in first or second-degree (grandparent, grandchild, uncle, aunt, nephew, niece, half-sibling) relatives younger than 50;

--at least one case of breast cancer in a first or second-degree relative younger than 40;

--or any case of cancer affecting both breasts

Women who had at least two of these risk factors were roughly eleven times more likely than those with no risk factors to develop breast cancer by age 30. For cancers occurring before ages 40 and 50, the presence of two or more factors raised the risks by five-fold and two-fold, respectively.

However, because breast cancer is so uncommon in younger women, even with two or more of the above factors, the odds of breast cancer by age 30 is just 1 percent. By ages 50 and 70, the risks of breast cancer increased to 13 and 11 percent, respectively. Given that these risks are already pretty low, women with just one factor are likely to have a very low risk and may not require early screening at all.

The authors believe that by looking for the factors they identified, doctors can better inform patients of their true risk of breast cancer and whether early screening is warranted.

"There is a tendency to screen everyone and I think screening has disadvantages as well as advantages," de Bock said. Doctors "should be critical about it and really think about it if there isn't really an increased risk."



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Friday, August 1, 2008

Chemotherapy information not given to terminally ill cancer patients

Patients with incurable cancer are often not clearly informed of what they stand to gain from palliative chemotherapy, according to the study results published in BMJ Online First. As a result, British investigators say, patients may lack sufficient knowledge make a decision based on informed consent.

Palliative chemotherapy is not intended to cure patients of cancer, only to make their lives more tolerable. Nonetheless, this treatment may slightly improve survival.

Dr. Suzanne Audrey, at the University of Bristol, and colleagues observed and recorded 9 oncologists and 37 patients during consultations in which palliative chemotherapy for advanced lung, pancreas, or colon cancer was first discussed.

In all cases, patients were informed that their cancer could not be cured, and the purpose of palliative chemotherapy was explained. They were also informed about treatment options, common side effects and associated risks.

In 8 cases, survival was not discussed at all. In 18 cases, information was "vague," involving comments such as "about 4 weeks, a few months extra, and buy you some time." Only 6 patients were given numerical data about how much longer they would probably live if palliative chemotherapy were used.

"If the oncologist focuses on the benefits of palliative chemotherapy in terms of control of symptoms and quality of life, but omits information about survival benefit, the patient might assume much greater potential to prolong life than is likely to be the case," Audrey and colleagues suggest.

"Perhaps most difficult of all is when a patient, or their partner or carer, makes it clear that they do not want to receive any more bad news. Talking about life expectancy can seem cruel at this point," they continue. "But... supplying basic information about the survival benefit of treatment need not entail giving 'intrusive' data about prognosis."

Instead of evading the subject, the authors recommend that oncologists receive coaching on how to inform patients without taking away hope.

In a related editorial, Dr. Daniel F. Munday at Myton Hamlet Hospice in Warwick and Dr. E. Jane Maher at Mount Vernon Hospital in Middlesex urge researchers to investigate the dynamics of end-of-life consultations and to develop "decision aids" to help patients fully understand and interpret the information they are given.




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Bowel Disease and Hygiene Hypothesis

Children who grow up in a spick-and-span home may have a higher risk of developing inflammatory bowel disease, a study suggests.

Inflammatory bowel disease, or IBD, refers to a group of conditions marked by chronic inflammation in the intestines, leading to symptoms like abdominal pain and diarrhea. It's thought that the conditions arise from an immune system overreaction that injures the body's own intestinal tissue.

In the new study, published in the American Journal of Gastroenterology, researchers looked at whether the so-called "hygiene hypothesis" might be involved in young people's risk of developing IBD.

The hygiene hypothesis was first advanced in the late 1980s as one explanation for the rise in allergic diseases in developed nations.

The theory is that when children are exposed to few viruses, bacteria and other microorganisms early in life, their immune system development is affected in a way that raises the risk of abnormal immune reactions.

For example, studies have found that young children who spend time in daycare, where they are likely to be exposed to viruses and other microorganisms, are less likely to develop allergies than their peers who spend little time around other children early in life.

For the current study, Dr. Eran Israeli and colleagues looked at the relationship between IBD risk and certain markers of how "hygienic" a child's upbringing was -- including how many siblings a child had, his or her spot in the family birth order, and whether the family lived in an urban or rural area. A rural environment is considered generally less hygienic than an urban one.

The researchers found that among the nearly 400,000 Israeli teenagers included in the study, 768 -- or 0.2 percent -- had been diagnosed with IBD. Those with one sibling were between two and three times more likely to have IBD than teens with five or more siblings.

Similarly, teenagers who lived in an urban setting were 38 percent more likely to suffer from IBD than their rural counterparts.

The findings do not prove that the hygiene hypothesis is at work in IBD, according to Israeli, of Hadassah Medical Center-Hebrew University in Jerusalem.

The study, he told Reuters Health, looked only at "surrogate markers" of childhood hygiene and showed an association between those markers and IBD.

But if the extra-clean surroundings of modern life do indeed contribute to IBD development in certain susceptible individuals, what are the implications?

"It would of course be impractical to suggest living in a less 'hygienic' environment or changing living conditions in order to afford possible protection (from) future development of IBD," Israeli said.

However, he added, it might be possible to lower IBD risk in people who are at higher-than-normal risk -- such as those with family members with the disease -- by exposing them to harmless microbes to help regulate their immune responses.

Researchers have already begun studying whether exposure to harmless parasitic worms might help treat Crohn's or colitis. Studies have not yet investigated such tactics for preventing IBD in healthy, high-risk people, Israeli noted.




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