Results

As of February 21, 2011, a total of 39 HIV-1 transmissions were observed (incidence rate, 1.2 per 100 person-years; 95% confidence interval [CI], 0.9 to 1.7); of these, 28 were virologically linked to the infected partner (incidence rate, 0.9 per 100 person-years, 95% CI, 0.6 to 1.3). Of the 28 linked transmissions, only 1 occurred in the early-therapy group (hazard ratio, 0.04; 95% CI, 0.01 to 0.27; P<0.001). Subjects receiving early therapy had fewer treatment end points (hazard ratio, 0.59; 95% CI, 0.40 to 0.88; P=0.01).

Full Text of Results…

The draft guidance covers not only nonpublic unsolicited requests — that is, requests “directed to firms privately through one-on-one communications” — but also public unsolicited requests. According to the FDA, this latter category of request has proliferated in recent years because of the communication revolution brought about by the Internet. But as consumers move increasingly online for publicly available answers to their medical questions, they don’t always access sites and electronic forums controlled by makers and distributors, which the FDA says it trusts to respond in “a truthful, non-misleading, and accurate manner.”

Instead, says the agency, consumers sometimes access Web sites, discussion boards, and chat rooms that are created and maintained by people other than the manufacturer or intellectual property owner who don’t always publish online content that’s accurate.

In response to each type of request for off-label information — nonpublic and public — the FDA has set out a separate list of recommendations. For firms’ response to nonpublic unsolicited requests, the agency has made the following 7 recommendations:

• Response information should be limited to the requestor and treated as private, one-on-one communication.
• Information should be limited to the scope of the initial question.
• Information should be “truthful, non-misleading, accurate, and balanced.”
• Information should be scientific in nature.
• Information should be generated “by medical or scientific personnel independent from sales or marketing departments.”
• Information should be accompanied by several documents, including a statement notifying the recipient that FDA has not approved the product for the specific off-label use.
• The responding firm should maintain required records, including any follow-up questions from the requestor.

For firms responding in public to public unsolicited requests, FDA makes the following 4 recommendations:

• A firm should respond only to a request about its own named product and is not solely about a competitor’s product.
• The firm’s response “should be limited to providing [its] contact information and should not include any off-label information.”
• Those responding on behalf of the firm should clearly disclose their specific involvement with that firm.
• Responses “should not be promotional in nature or tone.”

FDA has given those wishing to comment on the draft guidance 90 days from the date of its publication to do so

The research shows:

* More than half (53%) of smokers underestimate the number of people who die annually from smoking related diseases by at least 70,000 (the actual figure is over 80,000 deaths a year in England as a result of smoking)

* More than half (58%) of smokers underestimate how many long term smokers die early from smoking related disease (the actual figure is that 1 in 2 of all long-term smokers will die early from smoking related disease)

* More than a third (35%) of smokers underestimate the number of cancer deaths caused by smoking (the actual figure is that smoking is estimated to be responsible for almost a third of all cancer deaths in the England
* And surprisingly, 8% of smokers still do not believe that smoking can seriously damage their health and lead to premature death.

Smokers also underestimate the financial costs of smoking – on average smokers estimate that smoking 20-a-day habit is costing them £1,800 per year. With a packet of 20 cigarettes now costing on average £6.59, smokers are underestimating this by more than £600. In reality, a 20-a-day smoker could save £2,405 a year if they quit.

The research also suggested that many smokers are not stopping smoking because of misconceptions they have about quitting: over a third said that they feel too stressed to try to quit (33%), the same amount are not quitting because they don’t feel they have the willpower required (33%) or are not quitting because they tried before and failed (35%)
In reality, research shows that smoking causes more stress and anxiety than not smoking and that quitting can help to reduce stress. Evidence also shows that you can increase your chances of quitting successfully by using NHS support and that your willpower can be boosted with simple exercises available in the new and improved Quit Kit.

Help is at hand for the thousands of smokers who want to quit in the New Year. The Department of Health is launching an advertising campaign aimed at giving people the right tools to quit smoking by encouraging them to get a new and improved NHS Quit Kit from a participating pharmacy in England from 1 January. To find your nearest stockist text SEARCH and your postcode to 88088 or search online at www.nhs.uk/smokefree.

The NHS Quit Kit has been developed by experts together with smokers and ex-smokers and contains practical tools and advice to help smokers quit smoking for good. Items include a health/wealth wheel which helps quitters calculate how much they are saving and the improvements they’ll see to their health; MP3 downloads which are scientifically proven to reduce cravings and a ‘tangle’ toy to help keep hands busy. The Quit Kit also contains information on other free quitting help such as local Stop Smoking Services, plus smokers can sign up to get new motivational text messages straight to their mobile.

To find your nearest Quit Kit pharmacy stockist text SEARCH and your p

In a cohort study of more than 100 elderly patients with mild cognitive impairment (MCI), investigators found that those who progressed to AD less than 4 years later had a molecular signature suggesting a state of increased hypoxia.

“The study is important, as it identifies molecular changes associated with AD progression years in advance,” lead author Matej Orešič, PhD, research professor of systems biology and bioinformatics at the VTT Technical Research Center of Finland in Espoo, told Medscape Medical News.

“The study therefore suggests that a blood test may eventually be available to identify the patients at risk of AD who could then be followed-up more tightly,” said Dr. Orešič.

The investigators note that the application of a simple biochemical assay from these blood tests could complement neurocognitive assessments given to elderly patients.

“Establishment of pathogenic relevance of predictive biomarkers such as ours may not only facilitate early diagnosis, but may also help identify new therapeutic avenues,” they write.

The study was published online December 13 in Translational Psychiatry.

Small Molecules as Predictors?

MCI is considered a transitional phase between normal aging and AD.

“MCI confers an increased risk of developing AD, although the state is heterogeneous with several possible outcomes, including even improvement back to normal cognition,” the investigators write.

Dr. Orešič reported that he has been investigating metabolome (the complete set of small-molecule metabolites) in relation to health and disease for nearly 10 years, with lipids being one of his main areas of study.

“Lipids are known to play an important role in AD pathogenesis, but it has not yet been known whether lipids or any other small molecules can also be good predictive markers of AD,” he explained.

For this study, the investigators used metabolomics, a method of detecting small metabolites, to produce blood profiles associated with the progression of AD.

They evaluated information on 143 patients diagnosed with MCI from longitudinal databases and then compared their findings to data from 46 healthy control volunteers and 37 patients with AD.

Blood samples were collected at baseline (time of diagnosis or upon identification as healthy control participants) and during a follow-up period, the average of which was 27 months (±18 months).

Hypoxia May “Kick Off” AD

Results showed that 52 of the patients with MCI progressed to AD by the end of the follow-up period.

“At baseline, AD patients were characterized by diminished ether phospholipids, phosphatidylcholines, sphingomyelins, and sterols,” write the investigators.

Although 3 metabolites were identified in the molecular signature of the MCI patients who progressed to AD, “the main contributor to the predictive model” was 2,4-dihydroxybutanoic acid (P = .0048). This indicated the potential involvement of hypoxia.

Analysis of metabolic pathways showed that upregulation of the pentose phosphate pathway was associated with AD progression; this also implicated hypoxia, along with oxidative stress, as having a role in early disease process.

Dr. Orešič noted that there were two surprising aspects to the study. First, although past research has shown that several membrane phospholipids, as measured in blood, were diminished in patients with AD, “these lipids were not early predictors of AD in our study.”

Instead, “the lipid-specific changes may be a later event in AD pathogenesis,” he said.

“Second, instead of lipids, we observed metabolic changes associated with hypoxia as early predictor of AD, suggesting that hypoxia may be an early event kicking off the AD.”

Dr. Orešič reported that the investigators are now “aiming to validate our findings” in a large prospective cohort. In addition, they are striving to better understand the physiological origin of the molecular changes observed in the blood.

“For this reason, we are currently undergoing detailed metabolomics analyses of cerebrospinal fluid samples from the same patients. Further related studies in this direction are also being considered.”

The study was supported under the 7th Framework Program by the European Commission and by grants from the Health Research Council of The Academy of Finland and from Kuopio University Hospital. Dr. Orešič has disclosed no relevant financial relationships.

Transl Psychiatry. Published online December 13, 2011. Full article

In 1987, the ADA established the New Dentist Conference on the idea that dentists starting out in practice could benefit from leadership development and education tailored specifically to their unique needs.

Twenty-five years later, it’s still getting the job done.

Award winning: Dr. Rob Leland (center), chair of the ADA New Dentist Committee, presents the NDC Outstanding Program Award of Excellence to Dr. Ashish Vashi (left) of California’s San Gabriel Valley Dental Society, and the Golden Apple Award for New Dentist Leadership to Dr. Paul Kennedy III, president of Texas’ Nueces Valley District Dental Society.

More than 325 attended the ADA 25th New Dentist Conference in Chicago June 16-18, a networking and CE event for dentists in practice for less than 10 years. It’s an all-inclusive conference that is planned and put on by the 17 members of the ADA New Dentist Committee. A full day of pre-conference leadership programming encourages information sharing among new dentist volunteers across the country, and helps those who want to get more involved do so.

With an emphasis on networking and social events as well as clinical, practice, and professional issues CE, the event is one way the ADA builds community for new dentists.

“This conference is geared to what new dentists want to learn,” said Dr. Jennifer Fong of Las Vegas, who started attending the New Dentist Conference while still in dental school. “I love Annual Session, too, but this meeting has a more intimate feel and is more focused on our needs.”

“It’s nice to meet people in the same generation as you,” said Dr. Joseph DiBernardo of Smithtown, N.Y. “We’re starting families. We’re starting practices. We have debt. We can talk about those things and say, ‘This is how I dealt with it.’ ”

“I like the smaller environment of the conference and getting to meet people,” said Dr. Katrina K. Foster of Chicago. “This has been a lot of fun.”

“We’re in a smaller setting and it’s a relaxed atmosphere, so you have more opportunities to share information,” said Dr. Rob Leland, chair of the ADA New Dentist Committee, which hosted the conference.

This year’s conference presented a unique opportunity for mentoring. On the occasion of its 25th anniversary, 15 committee alumni were in attendance. Several alums led small group discussion sections during the conference leadership day, on topics ranging from advocacy and PAC involvement to starting a study club.

“It’s amazing how similar the concerns are today,” said Dr. Charlene Berkman from Port Washington, N.Y., who was in the first class for the Commission on the Young Professional, which later transitioned to the ADA New Dentist Committee. She said issues like student debt load and mobility in the licensure process still dominate conversations among new dentists.

Information sharing: Dr. Justine Kelley, chair of the Massachusetts Dental Society Council on Membership, asks for advice on starting a mentoring program during the New Dentist Committee Network Idea Exchange.

Dr. Patsy Fujimoto of Hilo, Hawaii, who chaired the commission, is the current president of the Hawaii Dental Association. She reminisced about planning the first New Dentist Conference in 1987.

“People asked, ‘Who were these newly minted dentists and what could they possibly tell us about the profession?’ ” said Dr. Fujimoto. But new dentists’ commitment to making contributions to their profession “still remains, manifested in your conference and dedication,” she told the crowd in opening remarks.

Events such as the New Dentist Conference were designed to support new dentists as they make decisions that will affect them throughout their professional lives, said Dr. Jim Cantwil of Flushing, Mich., another alumnus of the committee. Dr. Cantwil worries that economic pressures may have a negative impact on new dentists with higher debt loads.

“Will they be more likely to look at managed care contracts without understanding the long-term repercussions?” said Dr. Cantwil.  Both short- and long-term practice goals are important to keep in mind, he says. In his tenure on the New Dentist Committee (1992-96), Dr. Cantwil spent time getting new dentists and graduate students involved “with the goal of making them know they had a voice” in organized dentistry, and that’s still a priority for the ADA.

The number varies from year to year, but this year’s conference drew 18 members and officers of the ADA Board of Trustees to get to know the young professionals in their own districts, hear about state and local new dentist committee activities across the country, and find out what issues are “top of mind” for new dentists.  During the annual “Hot Topic” question-and-answer session with ADA leaders, issues such as midlevel providers, mobility in the licensure process, the importance of peer-reviewed evidence in clinical care, new dental schools and corporate dentistry were brought up.

“The topics discussed were issues that new dentists care about, and people came in with questions prepared,” said Dr. Leland. “It also gave the ADA a chance to show how it works every day for new dentists. For example, if you work for a corporate practice and many of your needs are taken care of by your employer, how does the ADA stay relevant to you?”

Keeping new dentists involved in organized dentistry was emphasized during the conference’s New Dentist Committee Network Idea Exchange where success stories were shared. State and local new dentist committee representatives talked about how they’ve built networks for new dentists to seek employment opportunities, social events, continuing education, mentoring programs and more.

Speaking out: Dr. Chris Salierno, a member of the ADA New Dentist Committee, leads a workshop on Public Speaking—Conquer Your Fears, Master Your Words during the conference.

The 25th New Dentist Conference also marked the second year with a full day of leadership programming, which had a strong turnout, said Dr. Leland, indicating the appetite new dentists have for topics like the use of social media marketing, public speaking, how to get involved and stay involved, and effective communication for all generations.

“People loved the leadership day, and there were people who had never been part of tripartite dental society activities before,” said Dr. Leland. “The best feedback I heard was from a participant who said he walked away with a bagful of ideas.”

Some came to the conference with interests in mind. Dr. Katrina Foster, a public health dentist who graduated from Meharry Medical College School of Dentistry six years ago, attended a session on public speaking.

“This is valuable to me not only for the public speaking portion but also because it will help me develop thoughts and effective communication skills that will be useful in research proposals,” she said.

“I wanted to tell the Board of Trustees that I’m interested in evidence-based dentistry,” said Dr. DiBernardo, a member of the board of directors for New York’s Suffolk County Dental Society. He completed his endodontic training at New York University College of Dentistry in 2007, where he learned to find evidence to make a positional statement and defend it, as well as rate the strengths of various clinical studies. “When you’re in dental school, you’re so busy digesting information that you really can’t recognize when it’s low quality,” said Dr. DiBernardo, who added that online discussion boards are not enough. He is planning to attend the ADA Evidence-Based Dentistry Champions Conference later this month.

Dr. Fong, a Veterans Affairs dentist, said she’s interested in learning more about how to get dentists from the federal services involved in ADA activities. “One thing I rely on the ADA for is information about infection control,” said Dr. Fong. “That’s a big issue right now, and we’re under more scrutiny with disease outbreaks in some centers. It’s reassuring to have ADA guidelines on this topic.”

Next year’s conference, the ADA 26th New Dentist Conference: A Monumental Experience, will be held June 22-24, 2012, in Washington, D.C.  Member new dentists and dental students interested in attending are encouraged find the conference community on Facebook by searching for “ADA New Dentist Conference” and requesting to join.

He said: ‘I appreciate that it is useful for all of us to have a “snapshot” of the market at any one time. However, consider four sales that we made in the last three months of 2011:

• Cornwall – 68%
• Devon – 61%
• Cambridgeshire – 133%
• North London – 122%

He said: ‘This gives an average of 96%. This figure is a clear distortion of the market as none of these practices are worth anywhere near 96%.’

Andy also feels that the perception of the ‘corporate takeover’ of dentistry, is someway wide of the mark.

He added: ‘Of the last 75 sales we have completed, only four have been to corporates – just 5%. The rest have been sold to independent dentists and so the myth that the corporates are “taking over” is not valid in our experience.’

He is advising dentists to be wary about handing over their affairs to anyone without extensive experience of working with the dental profession.

The impact of the recession on many professional firms makes acting for dentists an attractive prospect, he says.

Unlike many other businesses which are struggling as a result of the economic climate, dentists working in the NHS, in particular, have a steady predictable income.

He said: ‘What’s happening is that many firms of accountants and lawyers in fields such as construction and the retail trade are losing clients and they are then attempting to begin acting for dentists in order to replace that lost income.

‘In many cases, in order to break into the dental market they are offering to undertake work at less than cost price.’

He urges UK dentists not to be tempted to put their faith in someone new to the market.

They may be very good at what they do, he says, but without the in depth knowledge and experience that NASDAL members have of dentists, their advice may not be sound.

As examples of the complexities of dental business he mentions:

• The NHS pension Scheme
• The risks of incorporation for NHS principals and associates
• The NHS contract, which is constantly evolving
• Dental practice goodwill
• Associate/performer contracts

Ray Goodman, chairman of the NASDAL Lawyers Group, said that on a regular basis, specialist lawyers were having to unravel the mistakes made by lawyers with no experience in the dental market place.

‘Dentists should be very cautious if a non-specialist lawyer is dramatically undercutting a specialist. If they are planning to complete the job in less time at a lower cost, without fully understanding the technicalities of the work they are doing, it’s almost certainly not in the best interests of the client,’ he said.

Entitled ‘Amazing Mouths Thank Amazing Mums’, it launched last month and mums must buy a special pack of Aquafresh and visit the campaign’s site – www.aquafresh.co.uk/amazingmums – to enter the code found on the inside flap of their Aquafresh ‘Win Mum’s Wish List’ pack.

A walk-in video booth will be placed at supermarkets, shopping centres and cinemas and people can record a personalised message about what makes their mum so amazing.

Selected video messages will then be uploaded onto the campaign site where registered users can vote for their favourite video.

The video with the most votes will win a family holiday worth £5,000.

The roadshow began at Essex’s Lakeside Shopping Centre last month and will finish on July 1.

Entries can be made online at www.aquafresh.co.uk/amazingmums – a special site set up to support the promotion.

Families are also invited to take part in a separate promotion by uploading a video to the site explaining why they think mum is amazing.

According to an accompanying poll, mothers most wanted their children to enter traditional professions, with lawyer or architect topping the survey on 19%, followed by doctor or dentist on 17%.

Other popular choices included being a teacher, lecturer or academic, a scientist or engineer, and a plumber, builder or electrician.Teaching was the top career choice for children with 11%, followed by footballer, doctor, scientist and pop star.

Entrepreneur Sir Richard Branson and author JK Rowling topped the poll of famous faces who mums felt was the best role model for their kids.

The Virgin boss scooped 15% of the vote while Harry Potter creator Rowling secured 11%. Chef Jamie Oliver came third with 10%, with US president Barack Obama in fourth on 8%.

Sarah E. Anderson, PhD, from the Division of Epidemiology at the Ohio State University College of Public Health in Columbus, and colleagues reported their findings in an article published online December 26 in Pediatrics.

According to the researchers, attachment security to the mother influences the development of children’s emotion regulation and stress response and “could influence adiposity through their effects on appetite, sleep, and activity.” However, no studies have measured the association with respect to adolescent obesity.

The researchers analyzed data from 977 of 1364 participants in the Study of Early Child Care and Youth Development, a prospective cohort study of children born in 1991 that was designed to examine the effect of nonmaternal care on children’s developmental outcomes.

The maternal–child relationship of participants was scored on the basis of 2 measures. One measure was the extent of “secure attachment.” This evaluated the child’s awareness that the mother can be used as a “secure base” from which to explore, and that returning to the mother after a stressful experience will be comforting. For this, the researchers evaluated the child’s behavior during a standardized separation from and reunion in a laboratory setting (at 15 and 36 months), as well as observation in the home (at 24 months).

The other measure was maternal sensitivity, which assessed the mother’s capacity to recognize the child’s emotional state and to respond warmly and consistently. This quality was measured during a 15-minute play session between mother and child conducted either in the home (at 15 months) or a child development laboratory (24 and 36 months). Trained coders scored aspects such as sensitivity to nondistress, intrusiveness, and positive regard.

Child attachment security and maternal sensitivity scores were then correlated with the presence of adolescent obesity, defined as a body mass index of the 95th percentile or higher at age 15 years.

A poor-quality maternal–child relationship, as indicated by a maternal–child relationship quality score of at least 3, was assigned to 24.7% of children, whereas a score of 0 (highest-quality relationship) was given to 22.0% of the children. Adolescent obesity was present in 26.1%, 15.5%, 12.1%, and 13.0% of those participants with risk scores of 3 or higher, 2, 1, and 0, respectively.

After adjusting for sex and birth weight, the risk for adolescent obesity was found to be 2.45 (95% confidence interval, 1.49 – 4.04) times higher in those with the worst relationship (score, ≥3) compared with those considered to have the highest-quality relationship (score, 0). Compared with insecure attachment, low maternal sensitivity was more strongly associated with obesity, the researchers found.

“Our results are suggestive of a cumulative effect of the poor quality of the early maternal–child relationship on a child’s obesity risk,” the authors suggest. “Although maternal sensitivity was a stronger predictor than insecure attachment, the combination of both seemed to be a greater risk than either alone.”

The researchers suggest that maternal sensitivity could protect against obesity by “improving children’s ability to modulate their physiologic and behavioral responses to stress.” Those with a well-regulated response, they add, may eat less in response to emotional distress and may sleep more, which would reduce their risk for obesity.

“If future research confirms these mechanisms, obesity prevention interventions could incorporate more emphasis on the quality of maternal–child relationships,” Dr. Anderson and colleagues conclude.

The study was funded by the National Institutes of Health. The authors have disclosed no relevant financial relationships.

Pediatrics. Published online . Abstract