Most Obese People Will Never Reach Normal Weight: Study

Weight loss is considered a major health goal for people who are obese, but the reality is that few reach a normal weight or keep any lost pounds off, a new study shows.

In any given year, obese men had a 1-in-210 chance of dropping to a normal weight, according to the study, which tracked over 176,000 obese British adults.Women fared a bit better: Their odds were 1 in 124, the study found.On the brighter side, people were far more likely to shed 5 percent of their body weight — which is considered enough to bring health benefits like lower blood pressure and blood sugar.Unfortunately, more than three-quarters gained the weight back within five years, the researchers reported online July 16 in theAmerican Journal of Public Health.

It all paints a bleak picture, the study authors acknowledged. And the findings underscore the importance of preventing obesity in the first place, said lead researcher Alison Fildes, a research psychologist at University College London.However, the study does not suggest that weight-loss efforts are futile, stressed Dr. Caroline Apovian, a spokeswoman for the Obesity Society who was not involved in the research.

“We already realize that it’s almost impossible for an obese person to attain a normal body weight,” said Apovian, who directs the Nutrition and Weight Management Center at Boston Medical Center.

She said the “stark” numbers in this study give a clearer idea of just how difficult it is.However, she added, the study was based on medical records, and there is no information on how people tried to lose weight. They might have tried a formal weight-loss program, or they might have tried a fad diet.”So this has no relevance to how effective weight-loss programs are,” Apovian said.Fildes agreed. On the other hand, she said, the results do reflect the real-world experience of obese people who are trying to shed weight.

“What our findings suggest is that current strategies used to tackle obesity are not helping the majority of obese patients to lose weight and maintain that weight loss,” Fildes said. “This might be because people are unable to access weight-loss interventions or because the interventions being offered are ineffective — or both.”For the study, Fildes and her team used electronic medical records to track weight changes among more than 176,000 obese adults between 2004 and 2014. The researchers excluded people who underwent weight-loss surgery, which is an option for severely obese people.

Overall, obese men and women had a low annual probability of achieving a normal weight — especially if they were severely obese. The odds were as high as 1 in 1,290 for morbidly obese men.People did stand a much better chance of losing 5 percent of their body weight: The yearly odds were 1 in 12 for men and 1 in 10 for women.The success, however, was usually short-lived: 78 percent gained that weight back within five years.

Apovian said that because dramatic weight loss is so difficult, obesity specialists do generally advise patients to set a goal of losing 5 percent to 10 percent of their starting weight.But as the current findings show, even that can be tough to maintain, she added.Part of the problem, according to Apovian, is that few obese Americans who are eligible for weight-loss medications or surgery actually do get those therapies.In the United Kingdom, the study authors said, people trying to tackle obesity usually get a referral from their doctor to a weight-management program, which would typically focus on calorie-cutting and exercise.

The new findings suggest that’s insufficient, according to Fildes and her team.For people who are already substantially overweight, Fildes said, staving off further weight gain is vital.”We would recommend obesity treatment programs prioritize preventing further weight gain and maintaining weight loss when it is achieved,” she said.But given the battle most obese people face, Fildes said, public health efforts to prevent obesity will be even more important.

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First Clinical Research Stock Index (FCRI)

Market Activity

FCRI gained 7% last month, while pharmas gained 3%, biotechs gained 3%, and the   general market gained 2%. Seven FCRI stocks gained and two declined. There were two   significant gainers: INC Research Holdings (+25%) and ICON (+20%). There were no   significant decliners.

Notes on Indices    First Clinical Research Index (FCRI). Calculated as the mean average percentage   change from baseline, dividends excluded, adjusted for stock splits. In other words, the   indices are not weighted for stock price or market capitalization. Prices are in local   currencies. Index components may change from time to time based on new listings,   mergers and other factors. Components include eight publicly traded clinical research   stocks: CMIC (2309:JP), EPS Co., Ltd. (4282:JP), Hangzhou Tigermed Consulting Co Ltd   (300347:CH), ICON (ICLR:US), INC Research Holdings (INCR:US), Medidata   (MDSO:US), PAREXEL International (PRXL:US), PRA Health Sciences (PRAH:US), and   Quintiles Transnational Holdings (Q).    S&P 500 Index (SPX). Capitalization-weighted representative sample of 500 mostly   large-capitalization companies in leading industries of the U.S. economy.    S&P 500 Pharmaceutical Index (S5PHARX). Capitalization-weighted S&P 500   companies engaged in research, development or production of pharmaceuticals.    S&P 500 Biotechnology Index (S5BIOTX). Capitalization-weighted S&P 500   companies primarily involved in development, manufacturing or marketing of products   based on advanced biotechnology research.

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Why an HIV Vax Only Works for Some

The only HIV vaccine to show promising efficacy in clinical trials stimulated an antibody-based defence in some individuals but not in others. Analysing patients’ samples from a large trial that took place in Thailand between 2003 and 2005, researchers have now identified a subgroup of study participants who express a human leukocyte antigen (HLA) allele linked to reduced risk of HIV infection after vaccination. The results of this latest analysis were published today (July 15) in Science Translational Medicine.

The highly mutable nature of HIV makes vaccine design particularly challenging. (See “Defeating the Virus,” The Scientist, May 2015.) Individual variation in immune response adds another layer of difficulty. The present study provides additional information on the range of possible immune responses to an HIV vaccine.

“Understanding why [the vaccine] appeared to work in some individuals and may not have worked in others is really paramount to moving the field closer to an effective [HIV] vaccine,” said Bruce Walker, director at the Ragon Institute of Massachusetts General Hospital, MIT, and Harvard, who was not involved in the work. “We don’t yet know enough about how to turn vaccine non-responders into responders, but this is an important first step.”

Rasmi Thomas of the Walter Reed Army Institute of Research in Silver Spring, Maryland, led the international team—including investigators from Thailand’s Ministry of Public Health—that analyzed the HLA class II alleles and HIV antibodies present after immunization in 760 trial participants.

The US Army-sponsored RV144 trial randomized more than 16,000 people in Thailand at risk for HIV infection to either the vaccine or placebo. The efficacy rate, reported in 2009, was 31.2 percent, yet those who expressed the DPB1*13 HLA allele appeared to be better protected from HIV infection, according to this latest analysis. Individuals with the DPB1*13 variant who also had high levels of immunoglobulin G (IgG) antibodies against a portion of the HIV envelope had the lowest rate of HIV infection following immunization in the trial. The efficacy rate in this subgroup was 71 percent. In other words, those individuals who received the placebo were three times more likely to become infected with HIV compared to those immunized individuals who expressed the apparently protective HLA allele.

“We already knew vaccine recipients that showed a certain type of IgG antibody response against a region of the HIV envelope were less likely to become infected with HIV,” Thomas wrote in an e-mail to The Scientist. “We now see that not everyone who produced this good type of antibody response was protected, but only those who had the DPB1*13 HLA variant.”

Specifically, higher levels of IgG antibodies against a 25 amino acid N-terminus portion of the HIV gp120 protein—encoded by the Env gene—conferred more effective immunity in those with the DPB1*13 allele. This portion of the highly variable protein, part of the virus’s outer envelope, is relatively conserved among the most common substrains of HIV.

A previous analysis of trial participants identified anti-Env IgA antibodies associated with reduced vaccine efficacy. This latest analysis further refined this non-responder subgroup, pinpointing individuals who not only generated these IgA antibodies but also expressed the DQB1*06 HLA allele.

Not everyone is so sure that lessons learned from the RV144 trial will advance HIV vaccine strategies. John Moore, who studies HIV-1 Env proteins at Weill Cornell Medical College in New York City is “not convinced that this kind of analysis helps in Env vaccine design.” Moore toldThe Scientist in an e-mail that he questions how antibodies of interest to the RV144 researchers might interact with Env to impede infection.

Walker, too, noted that immune responses may be specific to this vaccine. “This is one of the frustrations in the field,” he said. “We really don’t know if the correlates of risk for one vaccine are the same for another vaccine.”

But Thomas remains optimistic. “The task now is to work out what was different about the protective antibody response, in specifically people with DPB1*13, that could have caused the protection from HIV,” she said. “If this difference could be identified, it may be possible to design a vaccine that could induce an effective response in all individuals.”

Lessons on HIV vaccine efficacy based on genetic differences among individuals may also be extended to vaccine design for other diseases including dengue fever, malaria, and Ebola, added Thomas.

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Clinical Research Word Puzzle

Find 40 words used commonly in clinical research!

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NCI’s Clinical Trials Programs and Initiatives

• Why Clinical Trials Are Critical to Progress against Cancer
• How New Knowledge about Cancer Is Changing Clinical Trials
• How NCI Programs Make a Difference
• Early-Phase Clinical Trials: Building on Basic and Preclinical Advances
• Phase II and Phase III Trials: Testing Effectiveness
• Correlative and Quality of Life Studies: Improving Standard Clinical Practice
• How NCI Is Supporting Cutting-Edge Clinical Trials

WHY CLINICAL TRIALS ARE CRITICAL TO PROGRESS AGAINST CANCER

Clinical trials are essential for moving new methods of preventing, diagnosing, and treating cancer from the laboratory to physicians’ offices and other clinical settings.In clinical trials, researchers carefully and methodically test drugs, medical devices, screening approaches, behavioral modifications, and other interventions. Trials are used to answer many different clinical questions relevant to all aspects of health care, such as whether a treatment can prevent cancer in people at increased risk, whether a new drug can extend the lives of patients with advanced cancer, or whether specific treatment approaches can improve patients’ quality of life. The Food and Drug Administration (FDA) typically requires proof of safety and effectiveness of a new anticancer drug in a large clinical trial before it can be used broadly in patient care.

In addition to testing new interventions, clinical trials can help determine the best use of existing interventions, test new approaches for increasing the number of people who seek follow-up care after a positive cancer screening test, and test ways to improve end-of-life care for patients.

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Clinical trail Broadcast series……. part I

  1-The Power of Clinical Partnerships Zaher El-Assi, President of Merge eClinical, shares lessons learned and the core practices his company uses to forge long-term partnerships that produce value for both companies that goes beyond the traditional buy-sell relationship.
 

   

 2-How Information Technology is Leveling the Clinical Research Playing Field Zaher El-Assi, President of Merge eClinical, discusses the development and application of current and emerging technologies in clinical research. Advances in information technology are revolutionizing how CROs, sponsors and academic institutions can design and manage clinical studies. The growth of affordable, secure cloud-based software services, mobile communications and the digitization of clinical data is helping researchers worldwide conduct studies more quickly, efficiently and cost-effectively. In short, the impact of an organization’s size, budget or existing technology infrastructure on its ability to conduct or compete for trials is decreasing. This trend will accelerate in the next few years, offering a range of benefits for sites, sponsors and CROs as well as patients and medical professionals. Using the eClinicalOS platform from Merge eClinical as a case study, this podcast explores the development and application of current and emerging technologies in clinical research.

   

 3- Challenges with Oncology Trials in Ontario Karen Arts, is the Director of Business Development, High Impact Clinical Trials Program at the Ontario Institute for Cancer Research in Toronto, Canada discusses challenges in oncology trials in Ontario with Roberto Lara, Director of Business Development for Scimega Research.

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Tramadol: Drug Safety Communication – FDA Evaluating Risks of Using in Children Aged 17 and Younger

ISSUE:  FDA is investigating the use of the tramadol in children aged 17 years and younger, because of the rare but serious risk of slowed or difficult breathing. This risk may be increased in children treated with tramadol for pain after surgery to remove their tonsils and/or adenoids. FDA is evaluating all available information and will communicate final conclusions and recommendations to the public when the review is complete.

Tramadol is not FDA-approved for use in children; however, data show it is being used “off-label” in the pediatric population. professionals should be aware of this and consider prescribing alternative FDA-approved for children.

BACKGROUND: In the body, tramadol is converted in the liver to the active form of the opioid, called O-desmethyltramadol. Some people have genetic variations that cause tramadol to be converted to the active form of the opioid faster and more completely than usual. These people, called ultra-rapid metabolizers, are more likely to have higher-than-normal amounts of the active form of the opioid in their blood after taking tramadol, which can result in breathing difficulty that may lead to death. Recently, a 5-year-old child in France experienced severely slowed and difficult breathing requiring emergency intervention and hospitalization after taking a single prescribed dose of tramadol oral solution for pain relief  following surgery to remove his tonsils and adenoids. The child was later found to be an ultra-rapid metabolizer and had high levels of O-desmethyltramadol in his body.

RECOMMENDATION: Parents  and caregivers of children taking tramadol who notice any signs of slow or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness should stop tramadol and seek medical attention immediately by taking their child to the emergency room or calling 911. Parents and caregivers should talk with their child’s health care professional if they have any questions or concerns about tramadol or other pain medicines their child is taking.Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

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• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[09/21/2015 – Drug Safety Communication – FDA]

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