Posts Tagged ‘clinical trials’

FDA to Liberalize Obesity Drug Process

October 11th, 2012

The Food and Drug Administration  (FDA) may have gotten the word. A report on Bloomberg Businessweek indicates the FDA is considering, for obesity and infectious disease treatments, allowing developers to conduct faster clinical trials with a small group of patients than now required. The proposal evidently would look at a pathway to ensure that the drugs were only used in patients where there was an applicable risk-benefit situation. Bloomberg Businessweek: Faster Process for Obesity Drugs

To my mind, this is the kind of policy which could energize drug developer to start (or restart) obesity drug development programs. “High time”, in my view.

Employer Incentives

September 27th, 2009

Employer Wellness Programs

In recent years, employers, mainly large ones, have developed wellness programs designed to promote healthier lifestyles among their employees while at the same time reducing their health care expenses. Recently, questions have arisen addressing how much of an incentive can an employer provide before it becomes a punitive measure. The National Business Group on Health has proposed as part of health care reform that the tax code be amended so that the expense of the employer-sponsored program is not taxed as income to the employee when provided off-site. Likewise, employees would be able to use their own health spending accounts for fitness and weight management.

Others have sought to change current laws to allow employers to provide significant financial rewards to persons with certain conditions under control or, from the other viewpoint, penalize workers who cannot bring such conditions, under control.

New research from the National Bureau for Economic Research indicates that financial rewards for weight loss simply do not work. Outcomes in a Program that Offers Financial Rewards for Weight Loss

Safeway, for example, has been promoting their plan called Health Measures. This plan gives employees reduction in their insurance premiums if they are, and stay, within certain limits on four medical risk factors: smoking, obesity, blood pressure and cholesterol. Rebates for achieving the goals total nearly $800 for an employee or $1,600 for a family. People who test within the limits get lower health premiums at the outset of the year. An employee who fails the obesity test can get a retroactive payment if he or she loses 10% of his or her body weight by the end of the year. But if the person’s BMI is still over 30 at the beginning of the following year, the payment is withheld until the employee reaches the permanent goal of under a BMI of 30. (See, Bensinger Gail, Corporate Wellness, Safeway style, http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2009/01/02/CM1714IPV8.DTL&type=health, accessed May 24, 2009)

Legally, the Safeway program may be pushing the envelope. Under the Health Insurance Portability and Accountability Act of 1996 (HIPPA), no person can be denied or charged more for coverage than other similarly situated person (e.g. full time, part time) because of health status, genetic history, evidence of insurability, disability or claims experience. HIPPA “makes it easy for health plans to reward members for participating in health-promotion programs but difficult to reward them for achieving a particular health standard, “ according to Mello and Rosenthal. In one allowable category for wellness programs, employee rewards are based solely on participation. The second category allows rewards based on attainment of a specific standard, such as losing a specific amount of weight, but the financial incentive is limited to less that 20% of the cost of the employee’s coverage. If the person cannot meet the standard if it is unreasonably difficult or medically inadvisable, that person must be offered a reasonable alternative standard. Other federal and state laws also apply to this situation. (Mello MM, Rosenthal MB, Wellness Programs and Lifestyle Discrimination – The Legal Limits, NEJM July 10, 2008; 359: 192-199) Wellness programs and lifestyle discrimination–th…[N Engl J Med. 2008] – PubMed Result

Safeway President Steven Burd has called for overturning the HIPPA 20% rule and the provisions of the Americans with Disabilities Act which prevent companies from being more aggressive about pushing employees reaching specific personal targets.

This is a highly sensitive issue for several reasons:

  1. Obesity is caused by a multitude of factors a few of which are under an individual’s control. By the time a person enters the workforce, the number of fat cells (adipose tissue) has been established and will not change no matter what the intervention, including bariatric surgery. Genetic predisposition and an environment overwhelming favoring the easy availability of food are two extremely strong factors for an individual to try to overcome. Eating and exercise habits are ingrained. It is therefore of some concern that the person who designed the Safeway program, Ken Shaclmut, Senior VP for Strategic Initiatives, indicated, “I want to be clear – we were adamant about designing this program to cover only those things for which our employees had control and which were clearly behavioral in nature. We do not differentiate for genetics and we did everything prospectively and transparently so that everyone had equal opportunity to improve their behaviors.” ( Emphasis added. http://www.thehealthcareblog.com/the_health_care_blog/2008/10/safeway-uses-in.html Accessed May 24, 2009).

A few things about this statement. First, obesity has a strong genetic basis. See, Understanding Obesity.

Second, Mr. Shaclmut may overstate the level of individual control over the three other factors – smoking, blood pressure and cholesterol. What makes these risks controllable has little to do with behavior and more to do with a variety of prescription and over-the-counter drugs for their control. Obesity is, unfortunately, lacking the number and variety of such products.

Three, employers already discriminate against persons with obesity in firing, promotion and hiring decisions. A recent paper addressed 32 experimental studies in weight discrimination in employment. The findings demonstrated that overweight and obese individuals are disadvantaged in workplace interactions, evaluations, and employment outcomes as a result of negative weight stereotypes. (Roehling MV, Pilcher S, Oswald F, Bruce T, The effects of weight bias on job-related outcomes: a meta-analysis of experimental studies. Academy of Management Annual Meeting, Anahiem, CA, 2008 )

Fourth, another recent study for the negative association between BMI and wages is larger in occupations requiring interpersonal skills with presumably more social interactions. This wage penalty increases as employees get older. This study demonstrates that being overweight and obese penalizes the probability of employment across all race and gender groups except for black men and women. (Han E, Norton ED, Stearns SC, Weight and Wages: Fat Versus Lean Paychecks, Health Econ 2009; 18:535-548 Weight and wages: fat versus lean paychecks. [Health Econ. 2009] – PubMed Result)

Fifth, obese employees in firms which provide employer paid health care are paid less than their peers for the same work. This indicates that employers are offsetting the higher health care costs of obese employees with lower wages. Bundorf MK, Bhattacharya J. The Incidence of the Health Care Costs of Obesity, Abstr AcademyHealth Meeting 2004;21: No. 1329. Available at www.nber.org/papers/w11303 – 17k – 2005-05-02)

Sixth, the difficulties of weight loss and maintenance of weight loss need to be understood. About 1/3 of American adults are engaged in weight loss efforts at any given time. Yet, obesity increases. Why is that? Some dieters do succeed in weight loss but few, 5-10%, manage to keep the weight off over the long term. (See, Freedman MR, King J, Kennedy E, Popular Diets: A Scientific Review. 2001, Obesity Res. 9 Suppl.1: 1S-40S. Popular diets: a scientific review. [Obes Res. 2001] – PubMed Result Maintaining weight loss is extremely difficult. As soon as weight starts to decrease, energy expenditure also drops in obese individuals. Not only is resting metabolic rate decreased; non-resting energy expenditure is also less because less mass is being moved. Take the situation with persons with type 2 diabetes, a common chronic disease highly correlated with obesity. Weight loss in this population is very difficult. Typically, patients lose weight over 4-6 months then plateau. Patients generally lose about 4-10% of their baseline weight. Hypothalamic signals in defense of body weight increase and intervene to prevent further weight loss. This initiates a regain of the lost weight. Neurotransmitters are activated to such an extent that the signal levels of increased hunger and decreased satiety become extremely difficult to ignore. Also, most diabetic patients are on anti-diabetes medications, many of which, like insulin, actually cause weight gain. (See, Pi-Sunyer, FX, Weight Loss in Type 2 Diabetic Patients, Diabetes Care, June 2005, 28;6:1526-7 Weight loss in type 2 diabetic patients. [Diabetes Care. 2005] – PubMed Result )

Seventh, employer wellness programs, as they apply to obesity, are not precisely defined. At present they encompass a variety of approaches and do not have a standardized format. It does appear that they provide advice on nutrition and physical activity and perhaps the ill effects of obesity. As such, they would be similar to the behavioral format used as standard therapy for control groups in randomized clinical trials, usually of pharmacological compounds. Such interventions have not been particularly effective. (See, Poston WS, Haddock CK, Lifestyle Treatments in Randomized Clinical Trials of Pharmacotherapies for Obesity. Obesity Research 2001 9;9:552-563. Lifestyle treatments in randomized clinical trials…[Obes Res. 2001] – PubMed Result) However structured, it is impossible to think that an employer wellness program would be as intense and well-funded as the Diabetes Prevention Program (DPP). In this study over 3,000 non-diabetic persons with elevated fasting and plasma glucose concentrations ( but not diabetes) were assigned to placebo, metformin (a drug to treat diabetes) or an intensive life-style modification program with the goal of at least a 7% weight loss and at least 150 minutes of physical activity per week. “The lifestyle modification intervention reduced the incidence of diabetes by 58% compared to 31% in the metformin group. The advantage of lifestyle intervention over metformin was greater in older persons and those with a lower body-mass index than in younger persons and those with higher body-mass index.” The weight loss difference between the lifestyle group and the metformin group was barely 4 pounds after 4 years. Only 10 million persons in the United States resemble the participants in the DPP. (Diabetes Prevention Program Research Group, Reduction in the Incidence of Type 2 Diabetes with Lifestyle Intervention or Metformin, New England Journal of Medicine, 2/7/2002 346:393-403. Reduction in the incidence of type 2 diabetes with…[N Engl J Med. 2002] – PubMed Result)

Eight, employer wellness programs do have adequate evidence of their effectiveness at long term weight loss and maintenance. A CDC Report evaluating such programs reported, “The Task Force determined that insufficient evidence existed to determine the effectiveness of single-component worksite interventions focused on nutrition, physical activity, or other behavioral interventions among adults.” (Katz DL, et al, Public Health Strategies for Preventing and Controlling Overweight and Obesity in School and Worksite Settings, A Report on Recommendations of the Task Force on Community Preventive Services, MMWR, Oct. 7, 2005 Public health strategies for preventing and contro…[MMWR Recomm Rep. 2005] – PubMed Result) More recently, Goetzel and Ozminkowski looked at the health and cost benefits of work site health-promotion programs. Commenting on a 2007 systematic literature review they observed, “Health and productivity outcomes from these interventions were reported from 50 studies qualifying for inclusion in the review. The outcomes included a range of health behaviors, physiologic measurements, and productivity indicators linked to changes in health status. Although many of the changes in these outcomes were small when measured at an individual level, such changes when measured at an individual level were considered substantial.” 38 38 (Goetzel RZ, Ozminkowski RJ, The Health and Cost Benefits of Work Site Health-Promotion Programs. Annu. Rev. Public Health 2008;29:303-23 The health and cost benefits of work site health-p…[Annu Rev Public Health. 2008] – PubMed Result)

Ninth, wellnessand prevention programs also may actually be working at cross purposes. It is not uncommon to see programs stress smoking cessation and weight loss. Rarely, however, do they seem to address the perception that smoking cessation will lead to weight gain. A 1991 study by the Centers for Disease Control published in the New England Journal of Medicine found mean weight gain after smoking cessation was 2.8 kg for men and 3.8 for women. Major weight gain of over 13kg occurred in 9.8% of the men and 13.4% of the women. (Williamson DF, Madans J, Anda RF, Smoking Cessation and severity of weight gain in a national cohort. NEJM, 1991 Mar.14;324 (11):739-45. Smoking cessation and severity of weight gain in a…[N Engl J Med. 1991] – PubMed Result) Smoking creates insulin resistance and is associated with central fat accumulation. As a result, smoking increases the risk of the metabolic syndrome and type 2 diabetes. ( Chiolero A, Consequences of smoking for body weight, body fat …[Am J Clin Nutr. 2008] – PubMed Result ) Weight control advice was not associated with reduction in weight gain after cessation. (See, Parsons AC, Shraim M, Inglis J, Interventions for prevention weight gain after smoking cessation. Cochrane Database Syst. Rev. 2009 Jan. 21;(1):CD006219 Interventions for preventing weight gain after smo…[Cochrane Database Syst Rev. 2009] – PubMed Result

Tenth, to the extent that wellness programs which shift costs to employees create stress, they may actually lead to weight gain. We know that chronic stress is a contributor to obesity and the metabolic syndrome. (See, Kyroou I, Tsigos C Chronic stress, visceral obesity and gonadal dysfunction, Hormones 2008 7(4):287-293. Chronic stress, visceral obesity and gonadal dysfu…[Hormones (Athens). 2008 Oct-Dec] – PubMed Result) Overweight women experience more stressful lives events than normal women. Obese and extremely obese men and women are more likely to report several specific stressful life events and more stressful life events overall compared to normal weight individuals. ( See, Gender differences in associations between stressf…[Prev Med. 2008] – PubMed Result

Twelfth, more punitive employer wellness programs are likely to operate like a tax on overweight employees. Compliance with any weight loss regimen involves both time and money. While employers may bear some of this in their programs, the economic burden is likely to fall mainly on overweight/ obese employees, who have already paid a penalty in their wages for their largely inherited status.

Successful maintainers who have lost at least 30 lbs. for an average of five years expended and average of 1.5 hours a day on exercise and consume less that 1,400-1, 500 calories. (See, Klem, ML, Wing RR, McGuire MT, Seagle HM, Hill JO, A descriptive study of individuals successful at long-term maintenance of substantial weight loss. 1997 Am J Clin Nutr 66;239-246 A descriptive study of individuals successful at l…[Am J Clin Nutr. 1997] – PubMed Result))

A recent collaborative position paper explains the issues of money, place and time stated:

The Role of Money

One hypothesis linking SES variables and childhood obesity is the low cost of widely available energy-dense but nutrient-poor foods. Fast foods, snacks, and soft drinks have all been linked to rising obesity prevalence among children and youth. Fast food consumption, in particular, has been associated with energy-dense diets and to higher energy intake overall. Calorie for calorie, refined grains, added sugars and fats provide inexpensive dietary energy, while more nutrient-dense foods cost more, and the price disparity between the low-nutrient, high-calorie foods and healthier food options continues to grow. Whereas fats and sweets cost only 30% more than 20 years ago, the cost of fresh produce has increased more than 100%. More recent studies in Seattle supermarkets showed that the lowest energy density foods (mostly fresh vegetables and fruit) increased in price by almost 20% over 2 years, whereas the price of energy-dense foods high in sugar and fat remained constant.

Lower cost foods make up a greater proportion of the diet of lower income persons. In U.S. Department of Agriculture (USDA) studies, female recipients of food assistance had more energy-dense diets, consumed fewer vegetables and fruit, and were more likely to be obese. Healthy Eating Index scores are inversely associated with body weight and positively associated with education and income .

The Importance of Place

Knowing the child’s place of residence can provide additional insight into the complex relationships between social and economic resources and obesity prevalence. Area-based SES measures, including poverty levels, property taxes and house values, provide a more objective way to assess the wealth or the relative deprivation of a neighborhood. All these factors affect access to healthy foods and opportunities for physical activity.

Living in high-poverty areas has been associated with higher prevalence of obesity and diabetes in adults, even after controlling for individual education, occupation, and income. In the Harvard Geocoding Study, census tract poverty was a more powerful predictor of health outcomes than was race/ethnicity. Childhood obesity prevalence also varies by geographic location. The California Fitnessgram data showed that higher prevalence of childhood obesity was observed in lower income legislative districts. In Los Angeles, obesity in youth was associated with economic hardship level and park area per capita. Thus, the built environment and disadvantaged areas may contribute in significant ways to childhood obesity.

The Poverty of Time

The loss of manufacturing jobs, the growth of a service economy and the increasing number of women in the labor force have been associated with a dramatic shift in family eating habits, from the decline of the family dinner to the emerging importance of snacks and fast foods. The allocation of time resources by individuals and households depends on socioeconomic status.

The concept of “time poverty” addresses the difficult choices faced by lower income households. When it comes to diet selection, the common tradeoff is between money and time. One illustration of the dilemma is provided by the Thrifty Food Plan (TFP), a recommended diet meeting federal nutrition recommendations at the estimated cost of $27 per person per week. While this price is attractive, it has been estimated that TFP menus would require the commitment of 16 hours of food preparation per week. By contrast, a typical working American woman spends only 6 hours per week, whereas a non-working woman spends 11 hours per week preparing meals . Thus, TFP may provide adequate calories at low cost, but requires an unrealistic investment in time. ( See, Caprio S, Daniels SR, Drewnowski A, Kaufman FR, Palinkas LA, Rosenbloom AL, Schwimmer JB Influence of race, ethinicity, and culture on childhood obesity: implications for prevention and treatment: a consensus statement of Shaping America’s Health and the Obesity Society. Diabetes Care 2008 Nov;31(11):2211-21. Influence of race, ethnicity, and culture on child…[Obesity (Silver Spring). 2008] – PubMed Result)

It is useful to consider that weight management is not the only thing people have to do. Time taken for physical activity and nutritional improvement is going to be time taken away from other activities, such as care for self and others, self-improvement, community activities and volunteering, time with children and family members, and recreation (including television viewing and using a computer/Internet)

Intrusive wellness programs have the potential to interfere with the employees’ right to privacy and complicate the doctor-patient relationship. Under the Safeway plan, for example, an employee can request an exception on recommendation of a physician. To whom the employee can request this is not clear. Nor is it clear under what circumstances the exception would be granted. Look at two common scenarios:

1. The employee has a disease like HIV/AIDs or cancer in which weigh loss is common and his or her physician does not want the employee to lose any weight if they can help it. Would the employee have to reveal this condition?

2. The employee has common diseases like type 2 diabetes or depression. The physician has recommended drugs which actually cause weight gain. Does the employee have to disclose this? What if the employer decides that another medication could be used? Does now the doctor, patient and often managed care plan have to discuss medical alternatives with Human Resources? In other words, will the employees health be endangered by the effort to live a healthy lifestyle?

Who is disadvantaged by employer wellness program? Programs such as Safeway’s may have unintended discriminatory effects. The biometrics used in such programs, to the extent they include obesity, elevated triglycerides and blood pressure, are part of what is known as the metabolic syndrome. Approximately 34% of adults meet the National Cholesterol Education Program’s criteria. Older males and females from 40-59 years of age are about 3 times as likely as those 20-39 to meet the criteria for the metabolic syndrome. Males and females over 60 were more than 4 and 6 times respectively to meet the criteria. Overweight and obese males were 6 and 32 times as likely as normal weight males to the meet the criteria and overweight and obese females were 5 and 17 times as likely to meet the criteria. (See, Ervin RB, Prevalence of metabolic syndrome among adults 20 years of age and over, by sex, age, race and ethnicity, and body mass index: United States, 2003-2006. National Health Statistics Reports; No. 13.National Health Statistics metabolic syndrome – PubMed Results )

Therefore, we can expect that such programs deliver little in the way of improvements in individual’s body weight, while having a disproportionate impact on minorities, the elderly and those with serious health conditions. To the extent that these employees see a reduction in their health insurance (possibly to the point of zero if the 20% limitation is totally removed), they will only increase the ranks of the uninsured, thereby frustrating the whole purpose of health care reform.

For further information, see;

Insurance coverage and incentives for weight loss …[Obesity (Silver Spring). 2008] – PubMed Result

Effects of a reimbursement incentive on enrollment…[Obesity (Silver Spring). 2007] – PubMed Result

Worksite Opportunities for Wellness (WOW): Effects…[Prev Med. 2009] – PubMed Result

The Working Healthy Project: a worksite health-pro…[J Occup Environ Med. 1999] – PubMed Result

LEAN Works: About CDC’s LEAN Works | DNPAO | CDC

Public Health Strategies for Preventing and Controlling Overweight and Obesity in School and Worksite Settings </P><P>A Report on Recommendations of the Task Force on Community Preventive Services

Financial incentive-based approaches for weight lo…[JAMA. 2008] – PubMed Result

Federal Government

September 27th, 2009

Federal Programs on Obesity

For an excellent overview, see http://www.stopobesityalliance.org/research-and-policy/research-center/gw-research/ and F as in Fat: How Obesity Policies Are Failing in America 2008 – RWJF

National Institutes of Health

NIH is the preeminent research organization in the United States and the world and have a number of research programs related to obesity.

Weight Information Network has many fact sheets, also available in Spanish Welcome to WIN – The Weight-control Information Network

What is NIH spending on obesity? A projected $664 million. NIH Research Portfolio Online Reporting Tool (RePORT) – Estimates of Funding for Various Research, Condition, and Disease Categories (RCDC)

What are the specific grants now in process? NIH Research Portfolio Online Reporting Tool (RePORT) – RCDC Project Listing by Category

What is their plan to address obesity? Obesity Research at the National Institutes of Health (NIH)

Information on applying for grants. http://grants.nih.gov/favicon.ico

Clinical trials Home – ClinicalTrials.gov

Some particular projects:

Longitudinal Assessment of Bariatric Surgery Longitudinal Assessment of Bariatric Surgery

Clinical Nutrition Research Units WIN – Research – ONRCs and CNRUs

Research Opportunities Obesity Research at NIDDK : NIDDK

Advisory Groups Clinical Obesity Research Panel (CORP) : NIDDK

NIDDK Office on Obesity Research Office of Obesity Research : NIDDK

Look Ahead Trial Action For Health in Diabetes (Look AHEAD) : NIDDK

Food and Drug Administration (FDA)

The FDA has several responsibilities when it comes to obesity, including nutrition labeling and approval of drugs and devices

Calories Count: The 2004 plan of FDA to address obesity FDA/CFSAN – Calories Count: Report of the Working Group on Obesity Q&A Questions and Answers – The FDA’s Obesity Working Group Report

The Keystone Report on Away from Home Foods Calories Count and Keystone Report

Consumer information on reading the nutrition label. Make Your Calories Count

Department of Agriculture

Women Infants Children program of the USDA is a program of providing grants to states for nutrition education and support for low income pregnant, breastfeeding or post partum women WIC

Food and Nutrition Information Center Food and Nutrition Information Center

General Information on obesity General Information and Resources : Weight and Obesity : Food and Nutrition Information Center

Consumer Nutrition Information Weight Management : Nutrition.gov

Internal Revenue Service (IRS)

While the IRS is not considered a health agency, it does provide that taxpayers may use the medical deduction for expenses related to weight loss when a physician makes a recommendation of weight loss. Publication 502 (2008), Medical and Dental Expenses

Surgeon General

Surgeon General Richard Carmona on Obesity The Obesity Crisis in America

Surgeon General’s Report to Prevent and Decrease ObesityThe Surgeon General’s Call to Action to Prevent and Decrease Overweight and Obesity

Transcript of meeting where Surgeon General David Satcher decided to issue Surgeon General’s Report on Preventing and Overcoming Obesity: http://www.health.gov/hpcomments/council4-23-99/focus.htm

Earlier Surgeon General Reports on Nutrition and Health The Surgeon General’s Report on Nutrition and Health (1988) and Physical Activity Physical Activity and Health Executive Summary

Center for Medicare and Medicaid Services (CMS)

In 2004, CMS dropped language from its policies that obesity was not considered a disease. 2004.07.15: HHS Announces Revised Medicare Obesity Coverage Policy. A Deletion Opens Medicare To Coverage for Obesity – The New York Times

Subsequently, it convened an advisory panel to consider expanding or restricting medicare coverage of bariatric surgery which considered a summary of the evidence on the surgery’s safety and effectiveness. http://www.cms.hhs.gov/FACA/downloads/id26c.pdf

The outcome of the advisory panel was very favorable and, in 2006, official coverage policy was changed and expanded. Centers for Medicare & Medicaid Services

Disability

EEOC Policy on obesity EEOC Informal Discussion Letter

EEOC definition of “disability” Section 902 Definition of the Term Disability

6th Circuit Court of Appeals denies ADA claim based on morbid obesity. Read the full decision in EEOC v. Watkins Motors. http://www.ca6.uscourts.gov/opinions.pdf/06a0351p-06.pdf

Through the Social Security Administration, individuals who are morbidly obese and have cardiovascular, respiratory or musculoskeletal problems may quality for disability.

See: Disability Doc – Examining Social Security Disability – Obesity and Disability

Centers for Disease Control and Prevention (CDC)

The CDC has numerous fact sheets and guides. Where appropriate, they are incorporated into more specific sections of the site.

To see all the CDC resources available, go to Obesity and Overweight: Topics | DNPAO | CDC

Agency for Healthcare Research and Quality (AHRQ)

AHRQ funds research, especially on the translation of basic research into clinical practice, improvements to clinical care and a number of evidence-based guidelines. Relevant guidelines are included in the treatment or health effects sections. AHRQ is a leader in Comparative Effectiveness Research and obesity is one of their major conditions of interest.

See Agency for Healthcare Research and Quality (AHRQ) Home Page

Medicaid

Morbidly obese patients often return to work after gastric bypass surgery Return to work after gastric bypass in Medicaid-fu…[Arch Surg. 2007] – PubMed Result

Veterans Administration

Learn about the VA programs in weight management at MOVE! Home

Department of Defense

Information on the military’s Tricare program and weight management can be found at The TRICARE Blog

Research

September 26th, 2009

                                                                                                                                                                                                                                                                              

Research is fundamental to understanding, preventing and treating obesity. And yet research reports are often not accepted by the public or policy-makers. One reason is that almost every adult is their own self-study of weight control. A study might have the most precise protocol, a powerful sample size and control for a variety of factors but if it does not comport with what “I” experience, I am not likely to believe it. But research itself in obesity is not without its difficulties. Many studies are ‘underpowered”, i.e. they have too few subjects to draw a conclusion from. That is why many preliminary studies do not pan out in larger tests. Also, in many cases, especially in drug trials, researchers try to remove “confounders” from the test subjects so they can see if there is an effect of the drug. That means that many patients who are sick, smoke, take other drugs, etc. are excluded from the trial. When the drug, for example, gets used by a more ‘real-world’ sample, the effects sometimes vanish. Studies that rely on self-reported weights or dietary recall or physical activity diaries are sometimes less reliable than studies where a more objective measurement is needed. Self-reported weight and height — Rowland 52 (6): 1125 — American Journal of Clinical Nutrition and COMPARISON OF SELF-REPORTED AND MEASURED HEIGHT AND WEIGHT — PALTA et al. 115 (2): 223 — American Journal of Epidemiology

There also may be a bias from the funding source (See Conflict of Interest in Medical Research, Education, and Practice – Institute of Medicine, Relationship between funding source and conclusion…[PLoS Med. 2007] – PubMed Result, Scope and impact of financial conflicts of interes…[JAMA. 2003 Jan 22-29] – PubMed Result) or a selection of participants which may skew the results one way or another. Currently, there is a lot of concern about ghost written scientific articles. Ghostwriting Widespread in Medical Journals, Study Says – NYTimes.com

What’s a reader to do? The first is to read skeptically. The second is to go to several different papers or research articles. If different authors appear to agree upon key points, chances are that they are on to something. Remember, extraordinary claims require extraordinary evidence. Research is a communications process among researchers and it should be thought of as a dialogue to which we can all listen.

Many readers may find useful this site, The Little Handbook of Statistical Practice. It is a handy guide to understanding some of the statistical issues involved…like association is not causation.

Research is key. If you are interested in furthering research, you should look into participating in a clinical research activity. To see what clinical trials are underway in obesity research, see www.ClinicalTrials.gov/Search of: Open Studies | “Obesity” – List Results – ClinicalTrials.gov

A major NIH initiative is support for Obesity and Nutrition Research Centers. In addition to the research they carry out, these centers are critical training facilities for new investigators exploring obesity. Most have their own websites which can provide additional, valuable information. Their sites may provide you with helpful information. Also included are their annual reports.

  1. University of Alabama Nutrition & Obesity Research Center | Nutrition & Obesity Research Center Annual report at http://www2.niddk.nih.gov/NR/rdonlyres/E6AE7940-23AC-402E-BCAC-D4F11A9213B0/0/Alabama.pdf
  2. University of Colorado at Denver and Health Science Center. No website. Annual report at http://www2.niddk.nih.gov/NR/rdonlyres/061BCC83-261E-4B39-95CC-226C97B03ED2/0/Colorado.pdf
  3. Pennington Biomedical Research Center PBRC – Nutrition Obesity Research Center. Annual report at: http://www2.niddk.nih.gov/NR/rdonlyres/841B5FA5-7AC1-4DDB-AD3F-300B94468560/0/Pennington.pdf
  4. University of Maryland, http://medschool.umaryland.edu/cnru/index.asp. Annual report at http://www2.niddk.nih.gov/NR/rdonlyres/BF6E7D31-948E-450A-AFF5-B863FF427B24/0/Maryland.pdf
  5. Boston, MA  Boston Obesity Nutrition Research Center Annual report at: http://www2.niddk.nih.gov/NR/rdonlyres/83F114DD-E707-4623-BA20-BCE02C33ADF6/0/Boston.pdf
  6. Harvard,MA,  no website. Annual report at: http://www2.niddk.nih.gov/NR/rdonlyres/9AFA2465-42C0-40CB-87DB-35813E80A978/0/Harvard.pdf
  7. University of Minnesota. Minnesota Obesity Center | College of Food, Agricultural and Natural Resource Sciences | University of Minnesota Annual Report at http://www2.niddk.nih.gov/NR/rdonlyres/78A3842A-030C-45F7-856E-5C27BE202C15/0/Minnesota.pdf
  8. Washington University, Missouri http://www2.niddk.nih.gov/NR/rdonlyres/BB5BBA2D-AA63-4B73-99D6-56741BB220B3/0/WashingtonUniversity.pdf
  9. Columbia/Cornell, New York, NY http://www.nyorc.org/favicon.ico Annual Report at: http://www2.niddk.nih.gov/NR/rdonlyres/28E027FF-5212-4F15-960B-4E5C84FF952A/0/NewYork.pdf
  10. University of North Carolina at Chapel Hill. No website. Annual report at: http://www2.niddk.nih.gov/NR/rdonlyres/8836D29C-0AF8-4C6A-914E-9D12828A1A82/0/NorthCarolina.pdf
  11. University of Pittsburgh. No web site. Annual Report at: http://www2.niddk.nih.gov/NR/rdonlyres/C8B65B24-EE7A-495C-B441-05EAD3372283/0/Pittsburgh.pdf
  12. University of Washington. http://depts.washington.edu/favicon.ico. Annual Report at: http://www2.niddk.nih.gov/NR/rdonlyres/739D3F88-98FE-4733-9D31-6BB81A1DA915/0/Washington.pdf

 

New Studies , updated October 16, 2009

Obesity driven GERD drives up health care visits Trends in Gastroesophageal Reflux Disease as Measu…[Dig Dis Sci. 2009] – PubMed Result

Psychiatrists survey on attitudes to obese patients Psychiatrists’ perceptions and practices in treati…[Acad Psychiatry. 2009 Sep-Oct] – PubMed Result

More evidence for role of FTO gene in obesity via loss of control and selecting diet high in fat The FTO gene rs9939609 obesity-risk allele and los…[Am J Clin Nutr. 2009] – PubMed Result

AHRQ summarizes evidence on breast-feeding, finds reduced risk of obesity, type 2 diabetes A Summary of the Agency for Healthcare Research an…[Breastfeed Med. 2009] – PubMed Result

Weight loss after bariatric surgery may be explained by changes in gut hormones controlling appetite. The Gut Hormone Response Following Roux-en-Y Gastr…[Obes Surg. 2009] – PubMed Result