UK-based consumer-products giant Reckitt Benckiser Group has entered the bedroom by acquiring SSL International, the maker of Durex, for $3.9 billion. Durex is the world’s best-selling condom brand.

Before purchasing the condom-maker, Reckitt had accumulated a ménage of decidedly unsexy products including d-Con mousetraps, Clearasil acne cream, Veet hair remover, Mucinex decongestant, Lysol disinfectants and Harpic toilet-bowl cleaner.

In marketing Durex, SSL had recently moved from a “safe sex” message to “better sex.”  It introduced a line of lubricants and began selling vibrators in supermarkets and pharmacies. It also entered emerging markets like India and China. Durex sales rose nearly 5% last year, to $410 million.

In addition to condoms, the SSL deal allows Reckitt to market Scholl bunion pads outside the US (Merck has rights in the US), where they can enhance Reckitt’s already profitable line of OTC health care products including Gaviscon heartburn elixir and Strepsils cough drops. Even before the deal, health and personal care had been Reckitt’s largest market, accounting for about 40% of its $9.3 billion in sales.

In this market, shoppers will pay a premium for trusted brands, according to Julian Hardwick, a Royal Bank of Scotland analyst. “If you’ve got a sore throat, runny nose or splitting headache,” she explained to the Wall Street Journal, “You want something to sort that out for you. You really don’t care how much you pay for it.”

Reckitt’s offer of £11.71 per share was 45% above SSL’s average share price over the last 6 months. SSL shares traded below £5.50 just 9 months ago, suggesting the acquisition might have come a bit late for Reckitt.

The deal was prompted by pressure from consumer-goods colossus Procter & Gamble, which had been gaining market share vs. Reckitt in several categories in Western Europe over the last year.

In Victorian times, dreams were believed to represent repressed sexual desires or random brain activity. Now scientists believe they reflect an attempt by the unconscious mind to process and store emotion-laced events from the day.

“We take our problems to sleep and work through them during the night,” Rosalind Cartwright, a neuroscience professor at Rush University Medical Center told the Wall Street Journal.

According to Cartwright, during dreams the mind juxtaposes unprocessed emotions encountered during waking hours with older, related memories. “That’s why dreams look so peculiar. You have old memories and new memories Scotch-plaided into each other,” she added. “They are emotional connections rather than logical ones.”

If this theory is true, it may be possible for people to direct their own dreams. For example, people who experience recurring nightmares might learn to substitute happier endings or eliminate them altogether.

A small group of people who practice “lucid dreaming” believe this is indeed possible. According to these people, recurring nightmares are caused when people wake up from the frightening experiences, thereby interrupting the normal process of emotional reconciliation that takes place during dreaming. Without the reconciliation, the dream is left to repeat itself.

“Your brain seems to think that it’s helping you to prepare, but you don’t allow yourself to finish it so it becomes a broken record,” Shelby Freedman Harris, a Behavioral Sleep Medicine expert at Montefiore Medical Center explained to the Journal.

Harris runs a program that tries to help folks either rewrite or delete the script of recurring dreams using a technique known as Image Rehearsal Therapy. In implementing the technique, dreamers recreate the nightmare with better endings or more palatable story-lines (substituting dolphins for sharks, for example), and rehearse the new script several times per day. 

While far from 100% effective, many of Harris’ patients are able to dream the revised script, while others stop having the nightmare completely.

Private health insurance companies have long since required patients to pay higher out-of-pocket fees when they see physicians who are not in the insurers’ contracted physicians network. In a more recent development, they have begun to rank physicians according to quality and cost parameters and offer enrollees lower out-of-pocket charges if they see physicians who fare better on these parameters.

In such programs for example, a doctor shown to order fewer imaging tests that are of questionable value would rank in a higher category.

Physicians have always objected to these practices. A March article in the New England Journal of Medicine brought the issue to a boil by showing that these tiered rating systems misclassified 22% of all doctors.

The study prompted provider organizations to release a letter protesting the payer’s practices. “Physicians’ reputations are being unfairly tarnished using unscientific methodologies and calculations,” the letter claimed.

“There are serious flaws in health insurers’ programs to try to rate individual physicians,” AMA President Cecil Wilson added in an interview with the Wall Street Journal.

The provider organizations implored payers to reevaluate their ranking programs.

Payers’ reactions to the letter were lukewarm. For example, Cigna told the Journal that its doctor-rating program already addressed issues raised in the study by focusing on physician groups rather than individuals. Besides that, “Some physicians do provide higher-quality or more-efficient care, and it makes sense to provide modest incentives for choosing that care,” said Dick Salmon, the company’s VP for network quality.

A spokesperson for WellPoint responded it has “taken a thorough, thoughtful approach in introducing measures of physician quality and cost effectiveness” and that the effort is “collaborative with the physician community.”

An FDA advisory panel has voted to allow ongoing sales of the diabetes drug Avandia despite the fact that Glaxo’s former blockbuster poses a “significant safety” concern by increasing the risk of cardiovascular events.

The FDA is not required to follow the recommendations of its panels, although it usually does.

Nearly one-third of the 33-member panel voted to ban Avandia. Most panelists who voted to keep the drug on the market called for increased restrictions on its use, and said it should be used only as a second- or third-line drug for the treatment of diabetes.

For example, David Oakes, a statistics professor at the University of Rochester, told the Wall Street Journal that his vote for continued sales of Avandia should not be construed a “vote of confidence,” but rather that he was concerned about the quality of studies which link Avandia to heart attack risk.

Janet Woodcock, who heads-up the FDA’s drug division, said her agency will decide on the matter within the next few weeks.

Avandia sales have plummeted since a 2007 article in the New England Journal of Medicine reported a 43% bump in heart attack risk with the drug. Q1, 2010 world-wide sales of Avandia were reported to be $245 million, off 10% year-over-year.

The FDA panel also concluded that Avandia posed a greater heart attack risk than Actos, a rival drug made by Takeda. Both drugs were approved in 1999 for blood-glucose control in patients with Type 2 diabetes.

In the wake of the panel’s announcement, Glaxo’s Chief Medical Officer Ellen Strahlman defended the safety record of Avandia. She said the drug would remain on the market pending the FDA’s decision.

Traditional wisdom holds that children who are picky eaters will outgrow the behavior, so no intervention is required. That holds true for the vast majority of people, but recently scientists have called attention to a small group of adults who are remarkably picky eaters.

One woman featured in a Wall Street Journal article on the subject for example, has lived on the following diet for more than 20 years: French fries, pasta with butter or marinara sauce, vegetarian pizza, cooked broccoli, corn on the cob and cakes and cookies without nuts.

“When I was younger it was cute,” the woman told the Journal. “Now it’s embarrassing.”

Adult picky eaters don’t fit existing definitions for eating disorders, since their behavior is not driven by the need to achieve a certain body weight. In fact, they aren’t necessarily skinny or obsessed with their appearance, at all.

Yet their odd food preferences can interfere with their social and professional relationships, which suggests a true behavioral disorder. For example, some adult picky eaters lie about their diets and avoid parties or business lunches in order to keep their secret. Others refuse to eat with their families. Many feel ashamed or inconvenienced about their dietary preferences.

In an attempt to understand adult picky eating, scientists at Duke University have launched a national public registry that allows people to report on their unusual dietary habits (www.eatingdisorders.mc.duke.edu). Counseling is also available, though no therapeutic strategy has been shown to be effective so far.

Meanwhile, a group of experts that has been tasked to author the Eating Disorders section of the 2013 version of the Diagnostic and Statistical Manual of Mental Disorders may recognize for the first time a condition called “selective eating” that could apply to both adults and children.

Training program directors and patient advocates have voiced concerns for years that residents who toil for long shifts on-the-job could harm patients because fatigue increases the risk they will make errors of one sort or another.

A 6 year-old study by the Accreditation Council for Graduate Medical Education gave credence to their concerns by showing that the fatigued residents  caused more than half of all preventable adverse events.

In response, the ACGME recently proposed strict new guidelines which would, if adopted, curtail the duration of residents’ shifts and increase supervision requirements for those in charge of their care. The plan extends previous initiatives by the ACGME to limit the work hours of residents.

The new guidelines were published in the New England Journal of Medicine and are subject to a 45-day public comment period.

The fundamental components of the ACGME’s proposal are 16-hour shift limits for first-year residents and 24-hour limits for those in later years of training.  Current rules permit residents to work for as many as 30 consecutive hours.

Also included are instructions about the supervision of interns by residents, and beefed-up monitoring and enforcement of the guidelines including annual site visits of each program.

In a replay of what happened the last time ACGME addressed the subject, some physicians and patient advocacy groups said the new guidelines didn’t go far enough. These groups pointed out that the guidelines weren’t as far-reaching as the changes recommended by the Institute of Medicine in 2008.

Meanwhile, some physicians argued the new limitations would impede the educational process and result in more errors…the kind that occur during hand-offs in care at the ends of shifts. Hopefully, some well designed studies of the matter can add value to the debate once (and if) the new guidelines go into effect.

An FDA advisory panel has voted to allow ongoing sales of the diabetes drug Avandia, even though it expressed concern that Glaxo’s former blockbuster increases the risk of cardiovascular events like heart attacks.

The FDA is not required to follow the recommendations of its panels, although it usually does.

Nearly one-third of the 33-member panel voted to ban Avandia. Most panelists who voted to keep the drug on the market called for increased restrictions on its use, saying it should be used only as a second- or third-line drug for the treatment of diabetes.

For example, David Oakes, a statistics professor at the University of Rochester, told the Wall Street Journal that his vote for continued sales of Avandia should not be construed a “vote of confidence,” but rather as reflecting his concerns about the quality of studies which link Avandia to heart attacks.

Janet Woodcock, who heads-up the FDA’s drug division, said her agency will decide on the matter within the next few weeks.

Avandia sales have plummeted since a 2007 article in the New England Journal of Medicine reported a 43% bump in heart attack risk with Avandia. Q1, 2010 world-wide sales of Avandia are reported to have been $245 million, off 10% year-over-year.

The FDA panel also concluded that Avandia posed a greater heart attack risk than Actos, a rival drug made by Takeda. Both drugs were approved in 1999 for blood-glucose control in patients with Type 2 diabetes.

In the wake of the panel’s announcement, Glaxo’s Chief Medical Officer Ellen Strahlman defended the safety record of Avandia. She said the drug would remain on the market pending the FDA’s decision.

Almost 9 years after letters laced with weapons-grade anthrax spores killed 5 people and inflamed fears about bioterrorism, the US still relies on a single anthrax vaccine maker that uses expensive, impractical, decades-old technology.

The company is Emergent BioSolutions, and its BioThrax vaccine is its only product. Emergent has copped $1.4 billion in federal contracts for the vaccine in the last decade alone.

Twice before, the Feds tried to find cheaper anthrax vaccines and increase the number of vaccine suppliers. In 2004, it awarded an $877 million contract to VaxGen, but aggressive lobbying by Emergent and manufacturing problems at VaxGen forced the Feds to void that contract.

A second RFP that was released last year by Barda–the Biomedical Advanced Research and Development Authority–was halted after officials determined that no supplier could produce a vaccine quickly enough.

That was a setback for PharmAthene, a rival to Emergent. PharmAthene claims that heavy lobbying by Emergent scuttled what it thought was a sure win. Emergent spent $4 million in lobbying during 2009 to maintain its monopoly.

BioThrax requires the administration of 5 doses over 18 months, and costs the Feds $120 per person immunized. PharmAthene’s SparVax would cost $45 per person. That vaccine remains in testing, however. In fact, PharmAthene has no products on the market right now.

Barda is also hoping to lure some large consortiums into the field, including one involving Merck, GE and and the University of Pittsburgh, but they remain leery of the risks.

“The country needs an anthrax vaccine that requires fewer injections, produces fewer side effects and is made using modern techniques,” said former Sen. Bob Graham, who co-chaired a federal commission that questioned the nation’s bioterror readiness earlier this year.

UPDATE: At the time this post is being scheduled for publication, the Washington Post is reporting that Emergent BioSolutions will soon announce that it “received a contract worth up to $107 million to ready its anthrax vaccine for large-scale manufacture.

According to Emergent, the contract will pay for the company to develop and obtain regulatory approval for large-scale manufacture of BioThrax.

The award is based on an Emergent proposal that says the company can produce 26 million doses annually, a significant increase from the roughly 7 million to 9 million it generates today.”

Short stature is associated with a 50% greater risk of coronary heart disease, according to Tuula Paajanen and colleagues, who reported their findings in the European Heart Journal.

To reach these conclusions, the scientists performed a meta-analysis on 52 relevant articles on the subject, which were found during a systematic search of MEDLINE, PREMEDLINE and All EBM reviews. Together, the studies included a bit more than 3 million individuals.

For the purposes of their study, the scientists defined “short” as being below 5’5″ in males and below 5’0″ in females. They defined “tall” as being above 5’10″ in men and above 5’6″ in women.

Analysis of the combined studies revealed that individuals in the shortest cohort had a 46% greater likelihood of sustaining a cardiovascular event than those in the tallest cohort.

The scientists concluded that since short children tend to become short adults, their findings might help physicians select shorter kids and teens for early intervention programs designed to reduce cardiovascular risk. 

The study is believed to be the first to confirm the association, which had been debated for at least 50 years. It must be remembered that this study has shown a correlation, but does not prove that short stature actually causes cardiovascular disease. Randomized controlled trials would be required to prove causality, but of course they are impractical in the current instance.

America’s epidemic of overweight and obesity sets back private employers by nearly $45 billion per year in health care costs and diminished productivity. In response, nearly one-third of US companies either offer, or are considering financial incentives that motivate employees to lose weight or otherwise become healthier.

The incentives are quite diverse. Some companies simply reward employees for getting a check-up evaluation or pay the costs of diet classes. Others pay employees that achieve certain exercise targets. Still others cut health-insurance premiums.

IBM has long been considered a leader in such programs. Nearly half of its workforce earns upwards of $150 per year for participating. In one scheme, IBM pays employees for completing 3-month, Web-based health programs.

As another example, OhioHealth, a hospital chain, began paying employees for walking. The provider uses pedometers and pays up to $500 depending on the distance travelled. “We thought that would be a big enough number to help people think twice,” Lisa Meddock, OhioHealth’s benefits manager told the Wall Street Journal.

Nearly half of OhioHealth’s 9,000 employees participated, and the provider has paid out over $377,000 so far.

The literature contains few studies designed to assess the impact of employer-based health incentive programs like this. In one of the largest studies, Cornell University scientists examined 7 such programs and found that the average participant lost just over 1 pound.

The Cornell team did find, however that programs designed to put employees at risk for losing their own money were more effective than those designed to win money. In one such study featuring so-called “refundable bonds,” participants agreed to shed X pounds by Y date or forfeit the money they deposited. In this program, employees lost an average of 4 pounds.

Just one week after first-dietician-in chief Michelle Obama asked the food industry to reduce the marketing of unhealthy foods to kids as part of her campaign against childhood obesity, 16 food makers agreed to cut 1.5 trillion calories from their products by 2015.

The companies, which include Hershey, Kraft Foods, Coca-Cola and Pepsico, announced plans to reach the goal by reducing portion sizes, changing recipes for certain products, and offering more low-cal alternatives to their offerings.

The move represents the food industry’s response to Ms. Obama’s call for a reduction in childhood obesity rates to 5% by 2030. Currently, about a third of US children are overweight or obese.

“This is precisely the kind of real private-sector commitment that we need,” Mrs. Obama told the Wall Street Journal.

Notably absent from the list of participating organizations were restaurant companies. Even so, participating companies account for nearly a quarter of the entire US food supply by volume, according to White House statistics.

To determine whether they meet their target, participating companies will determine the amount of calories they remove from each product and multiply that by the number of units sold. They will also try to account for sales trends. When new products or smaller portions of existing products are sold, the companies will calculate the percent of market share cannibalized by the new (or smaller sized) product, and multiply that by the number of units sold.

Healthy-food advocates were lukewarm to the initiative, noting that people could simply eat more servings of the food items.

“This is where the market is taking these companies anyway. I don’t know that this represents much of a concession,” said Yale’s Kelly Brownell, who studies obesity.

In a truly remarkable scientific breakthrough, researchers at Synthetic Genomics, Inc. have created a living organism that is wholly controlled by man-made genetic instructions.

“We call it the first synthetic cell,” Craig Venter, the company founder who oversaw the project told the Wall Street Journal. “These are very much real cells.”

The unicellular organism can reproduce but has no living ancestors.

The laboratory methods used to create it, which are patented by Synthetic Genomics, appear to be applicable to other bacterial strains with commercial potential. In fact at least 3 companies are using similar methods to create organisms which produce fuels and vaccines and (better late than never) gobble up oil spills.

“This is literally a turning point in the relationship between man and nature,” said molecular biologist Richard Ebright of Rutgers University. “For the first time, someone has generated an entire artificial cell with predetermined properties.”

Synthetic Genomics provided $30 million to fund the work. It owns intellectual-property rights to the entire process.

To create the new life form, Venter and bioengineer Daniel Gibson stripped out the DNA of a bacterium known as Mycoplasma capricolum and replaced it with a genome they built which was a variant of a second species known as Mycoplasma mycoides. The minor variations amount to biochemical signatures of the scientists, essentially proving the creation was theirs.

“We make a genome from four bottles of chemicals; we put that synthetic genome into a cell; that synthetic genome takes over the cell,” Gibson told the Journal. “The cell is entirely controlled by that new genome.”

The incredible work is documented in Science.

Soon after the announcement, the House Energy and Commerce Committee said it would hold public hearings on the matter in the near future.

Obesity is a serious threat to health, but recent research suggests that being 10-15 pounds overweight doesn’t increase health risks and may help in certain circumstances. Here is a summary of these findings:

Mildly overweight people do not have an increased risk of death from cancer or cardiovascular disease-In a study published in JAMA, Katherine Flegal and colleagues from the CDC looked at mortality rates reported in NHANES, an annual health survey. They found that mortality among those classified as overweight was lower than they had estimated. By contrast, those classified as underweight and obese had higher mortality rates than had been predicted.

Another study of 9,000 people conducted in Australia showed a reduced risk of death among septuagenarians who were overweight when compared to those of normal weight. The scientists concluded a little extra weight could protect folks against illness and injury as they age.

A little extra weight appears to protect against osteoporosis in women-Scientists who have reported this suggest that estrogen, produced by subcutaneous fat, helps increase bone mass. “Women should not worry if they are 10 to 15 pounds overweight, particularly if the fat is not concentrated in [the] belly,” Felicia Cosman, director of National Osteoporosis Foundation told the Wall Street Journal.

Slightly overweight women tend to look younger-According to a study in last year’s Archives of Dermatology, older women who were a bit overweight looked younger because the subcutaneous fat combats sagging and wrinkles.

The key is the location of the fat. Subcutaneous fat, common in the mildly overweight, tends to appear on the hips, thighs and butt. It is benign physiologically. Visceral fat attaches to internal organs and causes protruded bellies. It increases the risk of diabetes, cancer and cardiovascular disease.

Rejection of the donor organ is a frequent and sometimes life-threatening complication of heart transplantation. It is best handled if caught early, and since early rejection is typically asymptomatic, physicians had heretofore been required to perform regular biopsies to screen for rejection of the transplanted heart.

The biopsy is expensive and not without risk however, so scientists have long searched for a non-invasive alternative to diagnose rejection.

That search may have yielded results. In a presentation at last month’s meeting of the International Society for Heart & Lung Transplantation, Michael Pham and colleagues from Stanford University showed that a genetic test reduced the need for biopsies in selected patients.

The gene test is known as Allomap. It is marketed by XDx and has been used on 7,000 transplant recipients so far. It costs about $3,000, or 25-40% less than the biopsy.

The study by Pham’s team included 602 transplant recipients. It showed that Allomap was as effective as routine biopsies in preventing serious episodes of transplant rejection like heart failure, the need for a re-transplant or death.

The study was limited to patients who were at low risk for rejection and had undergone the procedure at least 6 months prior to enrollment. Nineteen months after randomization, 14.5% of patients that were followed with the genetic test and 15.3% of those followed with routine biopsies suffered a major complication.

“You’re not going to harm patients by reducing the number of biopsies,” Pham told the Wall Street Journal.

Pham noted that his team’s findings could not be extrapolated to patients that had received a transplant within the last 6 months or to those at high risk for rejection.

The study appears in the New England Journal of Medicine.

Tens of thousands of people use computer-based brain-training exercises to boost memory and mental fitness. These people will be disappointed to learn that a recently published study suggests the tools may not work.

In the 6-week study, Jessica Grahn and colleagues at the Medical and Research Council’s Cognition and Brain Sciences Unit in Cambridge, England randomized 11,430 healthy participants to one of 3 groups. The first engaged in online games designed to improve general intelligence skills like problem-solving and reasoning. The second group performed exercises aimed at increasing attention, short-term memory and mathematical skills—the focus of commercial brain-training programs. The control group browsed the Internet in search of answers to general knowledge questions.

Participants performed these activities for at least 10 minutes, 3-times each day.

Grahn’s team found that participants in the brain-training (second) group improved in the tasks that they practiced, but their improvement was about the same as that made by the control group. No groups showed improved cognitive skills that weren’t specifically targeted in their tasks.

The brain training industry is focused for the moment on software offerings and online programs. It generated $265 million in North American revenues last year, up from $225 in 2008. About 40% of these revenues came from consumers. The remaining came from schools and retirement communities.

Industry spokespeople said the study was flawed. “It’s not brain training,” Alvaro Fernandez, CEO of SharpBrains told the Wall Street Journal. Cognitive improvements can only be expected, he said, “after more than 15 hours of training and where each session lasts at least 30 minutes.”

Steven Aldrich, CEO of Posit Science, a brain-training vendor, added that the “study overreaches in generalizing that since their methods did not work, all methods would not work.”

A congressional investigation into the FDA’s handling of the 2008 outbreak of deaths and anaphylactic reactions caused by contaminated heparin from China has revealed that the agency failed to pursue “specific, credible leads” that could have fingered the culpable organizations.

The FDA never did say who was responsible for the outbreak, which caused at least 80 deaths and several hundred severe reactions, according to Joe Barton, the ranking Republican on the House Energy and Commerce Committee.

Nearly all the world’s heparin comes from Chinese farms, where ingredients for the widely-used blood thinner are derived from pig intestines. China-based pharmaceutical companies process the raw ingredients and export them around the world.

In February 2008, US hospitals and dialysis centers began reporting severe allergic reactions and deaths associated with heparin. Six weeks after the outbreak began, the FDA announced it was caused by a contaminant, chondroitin sulfate, that had been added to the raw product to stretch supplies.

In one instance cited by Barton, a foreign “respectable regulatory government agency” tipped-off the FDA that a Chinese company was producing tainted heparin. The FDA never pursued the lead.

A letter penned by Barton also cites an internal FDA memo from April, 2008 indicating the agency was aware that one company, Chongqing Imperial Bio-Chem, was supplying tainted heparin to the US.

Although the FDA subsequently banned US imports from Chongqing, Barton’s letter accuses the FDA of failing to explore more thoroughly the possibility that the company was centrally involved in the scam. In an inspection of the facility later in the year, the letter said, the FDA relied on the company’s president to translate.

A Chinese embassy spokesperson responded that Chinese officials “provided full cooperation to the US in the whole process.”