Psoriasis, RA drugs don't raise infection risk

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TNF inhibitors, which include Humira and Enbrel, pose no additional infection risk is a "very new and heretical idea."The research contradicts numerous earlier studies that did find an increased risk Felson, however, says the new findings aren't sufficient to quell the concernsPrevious studies have found that TNF inhibitors as much as double the risk

(Health.com) -- A class of injectable drugs used to treat autoimmune disorders such as rheumatoid arthritis doesn't raise the risk of serious infection when compared with more conventional treatments, according to a new analysis in the Journal of the American Medical Association.

The research, which was funded by the Food and Drug Administration and other federal health agencies, contradicts numerous earlier studies that did find an increased risk of infection associated with the drugs, known as tumor necrosis factor (TNF) inhibitors.

The possibility that TNF inhibitors -- which include popular drugs such as Humira and Enbrel -- pose no additional infection risk is a "very new and heretical idea," says David T. Felson, M.D., a professor of medicine and epidemiology at the Boston University School of Medicine, who cowrote an editorial accompanying the study. "Up until now there has been considerable evidence that anti-TNFs heightened the risk of serious infection compared to other treatments."

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The lead author of the study, Carlos G. Grijalva, M.D., a professor of preventive medicine at Vanderbilt University, in Nashville, Tennessee, says the findings "should be reassuring for patients and providers."

Felson, however, says the new findings aren't sufficient to quell the concerns raised by previous studies. "We still need to be concerned about serious infection risk among patients starting these medicines," he says.

Autoimmune conditions, including rheumatoid arthritis, psoriasis, and inflammatory bowel disease, arise when the body's immune system goes awry and begins attacking healthy cells and tissue. TNF inhibitors -- known as biologic drugs, because they're derived from substances that occur naturally in humans and animals -- work by blocking the action of TNF, an important immune-system molecule.

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This class of drugs drastically improved the treatment of these conditions when first introduced in the late 1990s, but because they suppress the immune system they are believed to open the door to opportunistic infections. Some patients taking the drugs have died from these infections, and the FDA has been closely watching the drugs' safety profile as more and more people use them.

Previous studies have found that TNF inhibitors as much as double the risk of serious infection compared with other treatment options. Those trials tended to be relatively small, however. The new study, which was presented this weekend at an annual meeting of the American College of Rheumatology, sought to address that weakness.

Grijalva and his colleagues combined data on more than 32,000 mostly low-income people from four large health-care databases, including those for Medicaid and Medicare. About half of the people took TNF-inhibitors for their conditions, and the other half took older, non-biologic drugs -- such as leflunomide, hydroxychloroquine, and sulfasalazine.

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The authors identified 1,172 infections requiring hospitalization during the study period. (The most common infections were pneumonia and skin and soft-tissue infections.) After one year of treatment, people taking TNF inhibitors had no higher risk of serious infections than those taking other types of drugs.

The researchers did find, however, that among patients with rheumatoid arthritis, the TNF inhibitor Remicade carried an approximately 25% higher risk of infection than Enbrel or Humira.

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It's not clear why Remicade might be riskier than other TNF inhibitors, but it's possible that the higher initial doses the drug requires might be partly responsible, Grijalva says. The mechanism of action may also be slightly different than that of other TNF inhibitors, he adds.

The study does have an important limitation that detracts from the findings, Felson says. As he notes in his editorial, some 40% of participants taking TNF inhibitors dropped out within the first month, compared with only 15% in the comparison group.

In previous trials and in clinical practice, people who stop taking TNF blockers "tend to be older and at a higher risk of serious infections," Felson says. That pattern, he adds, may have skewed the study results and made TNF inhibitors look safer than they perhaps really are.

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Million-dollar payments to surgeons raise questions

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By Frederik Joelving

NEW YORK | Mon Oct 24, 2011 5:20pm EDT

NEW YORK (Reuters Health) - Orthopedic surgeons have received hundreds of millions of dollars from joint implant manufacturers in recent years, according to a report released Monday.

In 2007, five device makers said they had paid surgeons more than $198 million, with 43 payments exceeding $1 million.

While the number of payments appears to have dropped since 2007, the average dollar amount has gone up, based on data from the three manufacturers that disclosed physician payments made in the last several years.

"There is a lot of money flowing back and forth," said Jason Hockenberry of Emory University, whose findings are published in the Archives of Internal Medicine.

Those financial ties represent anything from consulting fees to royalties to research support. Some argue they are necessary to drive medical innovations, but others fear they could end up harming patients as well.

Doctors getting industry money could be quicker to use implants from the companies paying them, for instance, or downplay the side effects of those products in their research.

The new results come as the U.S. Senate investigates whether surgeons paid by Medtronic, a medical device maker not included in the current study, failed to report sterility and other complications stemming from the company's bone-growth implant Infuse.

"There is evidence from other studies that these relationships drive practice one way or another," said Dr. Seth Leopold, of the University of Washington School of Medicine, who was not involved in the new work.

An orthopedic surgeon himself, Leopold chose to sever all ties to device makers in 2005.

"I felt there was no way I'd be able to convince people that these dollars did not affect my clinical decisions," he told Reuters Health.

After seeing the new report, Leopold added, he realized he was just "a smalltime guy."

Hockenberry's findings are based on data released after the five largest orthopedic implant makers -- Biomet Orthopedics, DePuy Orthopedics, Smith & Nephew, Stryker Orthopedics and Zimmer -- settled a kickback probe with the U.S. Department of Justice in 2007.

That year, the companies made more than 1,000 physician payments. In 2008, after the companies found out they'd have to disclose those relationships, the number fell by almost half.

But the three companies that continue to voluntarily disclose payments increased the amount of money they paid doctors by more than 40 percent between 2008 and 2010.

The mean, or mid-range, amount of individual payments also rose slightly, from $212,740 in 2007 to $233,108 in 2010.

"If you are concerned about your physician's loyalties you should by all means ask them," said Hockenberry, stressing that the majority don't have industry ties.

"The reality is, only four percent of all orthopedic surgeons are receiving funds," he said.

It is currently unclear what impact commercial relationships have on patient care. Hockenberry said he'd like to know more about the doctors who stopped taking industry money after the 2007 settlement and those who continued to do so.

"We would also love to be able to tie this to clinical practice," he said.

One way to do so would be to establish a universal device registry for all the implants patients get, so that it would be possible to look at the link between company payments and physician practice patterns.

According to the Patient Protection and Affordable Care Act passed last year, manufacturers must report payments of more than $10 by 2013, and this information will be freely available online.

But in an editorial on the new study, Dr. Robert Steinbrook of Yale School of Medicine in New Haven, Connecticut, said disclosure alone isn't enough.

"The disclosure of industry payments should not divert attention from the real issues with regard to conflict of interest," he writes.

"These are the minimization or elimination of financial ties between physicians and industry in areas other than research support, bona fide consulting related to basic and clinical research, and legitimate payments related to intellectual property. Although many well-publicized examples with regard to conflict of interest involve physicians in specific fields, such as orthopedics or psychiatry, the issues are similar for all specialties."

SOURCE: bit.ly/uJGWr9 and bit.ly/u0srxV Archives of Internal Medicine, October 24, 2011.

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Free formula samples at hospitals raise concern

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By Genevra Pittman

NEW YORK | Mon Sep 26, 2011 1:19am EDT

NEW YORK (Reuters Health) - Company-sponsored infant formula samples are still the norm at many hospitals, although fewer are giving out the freebies now than in 2007, according to a new report.

Experts worry that giving new moms the free samples could undermine official recommendations that they stick to breastfeeding until their baby is at least six months old.

"If a hospital gives it out... the patient thinks it's the best thing for the baby," said Anne Merewood from Boston Medical Center, who worked on the new study. "The bottom line is that the hospitals are marketing for the formula industry."

The free samples typically come in diaper bags that maternity wards give out to moms when they leave the hospital. Sometimes those bags are funded by the hospital. But as research has shown, more often than not they're provided by formula companies.

"The companies have an incentive to give as much away early on, because it kind of gets hospitals and mothers hooked on that," said Chessa Lutter, regional advisor on food and nutrition for the Pan American Health Organization, part of the World Health Organization.

In 2007, Merewood and her colleagues surveyed hospitals in every state and found that more than 90 percent of them gave company-sponsored formula to mothers.

To see if anything had changed, last year the researchers went back to all hospitals in the 10 states that were most likely to give out free formula and the 10 that were least likely to do so.

Of the more than 1,200 hospitals in those 20 states, 72 percent said they gave out company-sponsored samples to some or all mothers, compared to the 86 percent in 2007.

Merewood said that trend may be due to grassroots movements working to promote breastfeeding. The states least likely to hand out the freebies include California, Massachusetts and Minnesota.

Yet the 10 states most likely to give out samples, including Oklahoma, New Jersey and Texas still distribute them at 93 percent of their hospitals, the researchers reported Monday in Pediatrics.

"Most of them are still giving it out," Merewood told Reuters Health. "It's not too rosy a picture."

The free samples are an ethical issue for hospitals because mothers might think that their doctors endorse the formula, and that they should use it instead of, or in addition to breastfeeding, Merewood said.

She and Lutter said that just about all formula companies sponsor samples, because they're at a competitive disadvantage when moms shop for formula on their own if they don't.

Lutter, who wasn't involved in the new study, said there's no law in the U.S. saying formula companies can't use hospitals to give out samples of their products -- but the WHO has come out strongly against that practice in all countries.

Not accepting free formula, she said, "is essential for assuring that the knee-jerk reaction for hospital (staff) as well as moms is not to go to the formula when there's any question or any concerns" about breastfeeding.

Breastfeeding has a number of health benefits for kids, Lutter pointed out. That includes prevention against infection, and possibly an IQ boost. After six months of exclusive breastfeeding, the WHO recommends at least partial breastfeeding up to two years or longer.

While formula might be helpful when new mothers can't breastfeed for one reason or another, free samples usually do little good, Merewood said.

"Nurses like to give things to people, especially when they're not very wealthy," she told Reuters Health. "It's not really a gift, because it's not good for their health."

Abbott Nutrition, which makes formula, would not comment on the study.

The International Formula Council, which represents formula manufacturers and marketers, told Reuters Health that formula samples serve a valuable purpose.

"The IFC believes mothers should be trusted to make good choices for their babies according to their individual family circumstances," it said in an email to Reuters Health.

"Hospital discharge packs provide key educational materials, which may include an infant formula sample -- directing moms to the right type of formula and to proper use and storage instructions, if needed."

But Lutter and Merewood agreed that there's little room for debate about the right move for hospitals when it comes to company freebies.

"Hospitals should not accept any donations of a formula," Lutter said.

SOURCE: bit.ly/jsoh2P Pediatrics, online September 26, 2011.

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HEALTH MANAGEMENT. Parent sleep advice can raise children shut-eye

Geneva Pittman
NEW YORK | 9. September 2011 4: 08 pm EDT
NEW YORK (Reuters Health) - screening children to the sleep problems and sleep strategies discuss with parents could teenagers at school with better night-time rules, routines help, suggests new research from Australia.
Researchers found that if they had sleep-related consultations have with parents, children, the tend to be less sleep problems and to get better bedtime as children whose parents do not advise habits.
The study was small and not to demonstrate that the sleep improvements to changes in academic achievements of children this year.
Still, the results show that "sleep disorders in school children are treatable using... a short behavioral intervention", said study author Jon QUACH, at the University of Melbourne, Reuters Health in an e-Mail.
"Consult parents should sleep for your child if they are concerned," he added.
In five and six-year-old, that related behavior, most sleeping children on researchers say.
"Some of them have poor sleeping habits, where become too late to bed, they have a good-night routine nor many of them have even parents for them to stay, when they go to sleep at night", said Pediatric sleep specialist Jodi Mindell, St. Joseph's University in Philadelphia, which was not involved in the study.
"In this age group some night, fear" said they, and fear may increase as the children start school.
The current study on this back-to-school timeframe, including children, who were led in their first year of primary school. This is an important window for the treatment of insomnia, Quach said, since children, who sleep well might not more trouble, the transition to the school, that school performance and poorer relations puts it later for worse.
Quach and his colleagues studied about 1,500 parents of children from 22 different elementary schools in Melbourne. These parents 161 said her child had a moderate or severe sleep and 108 were recruited for the study. Children with serious breathing problems sleep-related, for example were excluded.
Half of the participating parents had followed a private consultation in College, by a telephone call of two weeks later behaviour to discuss sleep strategies based on their child problems. The other half were not additional help offered.
Next year, the researchers investigated parents over their children shut-eye again. Six months after the first consultation, they all gave children learn an assessment.
Sleep problems tend to dissolve in both groups, reported researchers in Pediatrics. Yet children, whose parents had sleep-related advice in General, better.
After six months or 26 percent of children in the consultation group and in the no-Consulting Group 47% of moderate or hard sleep disorders. By a year but there was no difference, and about one-third of children in both groups had insomnia.
Children in the consultation group less resistance before going to sleep and less time had to go to bed, parents reportedly. But there was no difference in how well she determined on scientific tests to measure, reading, mathematics and spelling skills have.
Quach and colleagues found that the study was small and a follow up with more children among other things, the students for more than a year tracking needs be-. It may be that improvements translate sleep better in academic abilities would take, she said.
Mindell said: "There is no question" that this type of program with school Advisor or nurses the sleep consultation in the U.S. schools could work. "I think this is a wake up call for teachers and school psychologists, they need to always on the lookout for sleep disorders," said Reuters Health.
For now she had to have some important tips for parents of young children, who sleep problems.
The "really simple changes," she said, are: "for your child to bed goes, before nine - we know that this is the turning point;" including reading as part of the bedtime routine-it helps calm children down, there is a focus on them, it helps with writing, it's all good; "then children encourage to fall asleep on their own."
Finally, make sure that there are no unwanted electronics in the nursery, she said. "The game boys will be go on, the computer Los, mobile phones become los."
Source: bit.ly/pXdFNv Pediatrics, online 2. September 2011.

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