Posts Tagged ‘NIH’

NIH Director Address Gastric Bypass Surgery and Diabetes

July 30th, 2013

Francis Collins, director of the National Institutes of Health, has a new blog out on how gastric bypass surgery affects the development of type 2 diabetes.

Arlen Specter and NIH

October 14th, 2012


Today’s news include the passing of Arlen Specter, former Senator from Pennsylvania. Most of the obituaries will focus on his important role in Supreme Court nomination fights, the impeachment of President Clinton, being one of only 3 Republican votes for the Affordable Care Act and for supporting NIH, including stem cell, breast cancer, Alzheimer disease research. All this is true of course. But when it comes to NIH, his contribution is so much greater.

When Specter came to Congress in 1983, the NIH budget was about $3.6 billion. Now, it is about $30 billion. Much of that increase is due to the year-in-year-out work on the Appropriations Committees of which Senator Specter was a leader…for all areas of research. His staff was always open and interested in how basic biomedical research can be expanded. Specter was part of a cadre of Republicans in the 80s and 90s which included Lowell Weicker, Pete Domenici, and, in the House of Representatives, Silvio Conte, who continually worked with Democratic allies like Senator Tom Harkin, Ted Kennedy, Dave Obey and William Natcher to grow NIH. These Members had a huge respect for NIH, often referring to it as the “crown jewel” of the federal government. They understood that biomedical was an engine not only to improve treatments and cure diseases but to support drug and device developers, the biotech industry, hospitals, the health professions and others grow and prosper. Unfortunately, today, we do not have a similar senior cadre with the same commitment to biomedical research. And, as a result, the NIH budget is stagnant. There are great shoes which other Members of Congress can, and should, fill.

 

The Calorie-Out Math is All Wrong

February 23rd, 2012

Two scientists from the National Institutes of Health (NIH) have presented a new mathematical model to calculate reductions in caloric intake needed to lose weight. The old formula of a reduction of 500 calories/day resulting in a pound a week weight loss is wrong, according the researchers. The reason for the error is that, as weight is lost, metabolism slows down. Therefore, ever greater intake reductions are needed. This is why so many dieters feel like failures. Bottom line: It’s not their fault. The researchers presented at AAAS in Vancouver.  Battling obesity with better mathematical models They have an on-line tool (which is not that easy to use)   http://bwsimulator.niddk.nih.gov/favicon.ico  . Their work was published in Lancet. Quantification of the effect of energy imbalance on bodyweight : The Lancet.

Conflicts of Interest on Obesity Panel

November 3rd, 2011

The New York Times reports on conflicts of interest on three panels writing clinical guidelines for the National Institutes of Health, including cholesterol, hypertension and obesity. The article notes “At least eight of the 19 members of the obesity panel have financial ties to a phalanx of private business interests.” The companies listed include GlaxoSmithKline which makes Alli (over-the-counter version of Xenical), Allergan (maker of Lap-Band), Nestle and Weight Watchers. “One (panel member, not identified), is paid to speak or advise 11 companies with obesity products.” Potential Conflicts on U.S. Health Guideline Panels – NYTimes.com

In my opinion, the latter point here is important. The people picked for these guideline writing groups are often clinical researchers. Usually they are at academic centers with clinical facilities which attract patients who companies need to be included in a valid clinical trial of their product. The fact is that, in the obesity field, there is not a large pool of such clinical researchers. Few can exist on NIH funding alone, or on clinic fees alone, for that matter. So, it is natural that companies with products under development come to these centers for clinical trials. 

Some years ago, a case could have been made that too many researchers on such panels were working for  a few pharmaceutical companies. Now, many pharmaceutical companies have disbanded their research and development activities. The companies left in the market are too small to exert much influence.

As a result, many of these researchers have worked for multiple companies who are competitors. The companies are not monolithic interests. Device companies compete with drug companies who compete with behavioral care providers; medical providers compete with non-medical providers. (Another point is that many also do work for food and beverage companies.) So it would a real surprise if one of these conflicted researchers were to, in effect, burn their reputation and prospects for future research, to shill for one of many companies in a complex market. Might happen, can’t say it won’t. But then again, this would be evident not only to the other 18 members of the panel but the staff of NIH as well. Oh, did I mention the staff are often involved in funding these researchers? It would have been interesting for the writer to ask how many were funded by NIH, CDC, Robert Wood Johnson Foundation and other, non-commercial interests.

As mentioned in an earlier post, the medical device makers looking at the obesity market are taking their research OUS, outside the United States to avoid the extra costs and time in the US regulatory schema.

The public and other health professionals have a right to expect that clinical guidelines are free of undue influence which would change the recommendations from that as indicated by the scientific literature. But they also have a right to expect guidance from leading experts whose range of experience, even in the commercial sector, gives them invaluable information. The NIH and FDA will, no doubt, continue to grapple with this problem.

What’s Up with the FDA – Part 5

September 6th, 2011

My colleagues, Christopher Still of the Geisinger Obesity Institute, and Arya Sharma, of the University of Alberta and I , have just published an article, Is there a path for approval of an anti-obesity drug at the FDA. The article analyzes in some depth the reviews by the FDA of the 3 new drug applications and the review of the approved drug, sibutramine. All the new applications were turned down and sibutramine was withdrawn after a split vote by the advisory committee. The article describes the conceptual quagmire the FDA is in regarding drugs to treat obesity. Rather than depend on the results of studies, conclusions reached by FDA are often based on assumptions and fears.

We conclude that obesity is simply too important to go without drug therapy and recommends that FDA, NIH, industry and researchers must work together to design a methodology to gain approval for obesity pharmacotherapy in the future.

Is there a path for appro… [Curr Opin Endocrinol Diabetes Obes. 2011] – PubMed – NCBI

NIH Releases Ho-Hum Strategic Obesity Research Plan

May 13th, 2011

On March 30, 2011, NIH released a new version of its Strategic Plan for Obesity Research. There isn’t anything particularly new in the plan. It is more or less a signal to researchers what the NIH expects to fund in the next few years.  As with earlier plans, this one lacks any sense of urgency in addressing and views most issues as interesting from a research point of view rather than fitting into a comprehensive strategy for obesity prevention and treatment. There is weak attention to the challenges of developing medicines to treat obesity, to the value of engaging obesity prevention/interventions on an international scale and to attacking obesity in  lower socioeconomic groups  and ethnically diverse communities most in need. In other words, it is largely academics talking to other academics. Nevertheless, it does an insight into the complexity of obesity which the policy-makers who spout the diet-and-exercise line would do well to read. Strategic Plan for NIH Obesity Research

A Diet for the New Administration

September 27th, 2009

December 30, 2008

By Morgan Downey

At this time of year, millions of Americans are hoping the new Administration will solve our seemingly intractable problems at home and abroad. Millions are also hoping to lose weight in the New Year. The two are not unrelated.

Over the past three decades, obesity has increased among all segments of the population, in the United States and abroad. Obesity is now recognized as the fuel behind many major health problems from cancer to diabetes to heart disease, and a significant cause of increasing health care utilization and health care costs.

While this recognition has increased among both Republicans and Democrats (for the first time, both parties recognized obesity in their 2008 party platforms), changing public policy has not caught up with the problem. Under President George W. Bush, Medicare did undo its policy that obesity was not a disease and did expand coverage of surgery for the treatment of obesity. There have been modest increases in the research and prevention budgets at the National Institutes of Health and the Centers for Disease Control and Prevention. But by and large, the efforts of the last eight years have been largely educational: tell people they should lose weight, eat more nutritiously, and exercise more.

Duh! We get it. And it doesn’t work. Frankly, other than bariatric surgery, nothing works very well to lose significant amounts for a long period of time. There simply is not one ‘fix’ that will reverse this disturbing trend.

So here is some advice to the incoming Administration. It should be noted that many appointees named so far have a solid exposure to obesity from a public policy perspective, including former Senator Tom Daschle, nominee for Secretary of Health and Human Services, Peter Orszag, named to head the Office of Management and Budget, Governor Bill Richardson, nominated for Secretary of Commerce, and Melody Barnes, incoming chief of domestic policy at the White House.

Universal health insurance is often put forward as the panacea for all ills. However, Democrats may have to learn that expanding health insurance coverage alone does not translate to a healthier population, especially if obesity continues to increase among children and adolescents. Truth be told, we do not have adequate medical interventions to affect the rates of obesity and its effects. So, if we do not know how to truly prevent obesity or create a long term treatment, what should a new Administration do? Basically, it should focus on how to create the conditions where it is more likely than not that we will find effective strategies for prevention and treatment in the future.

  1. Being a role model is not enough. It’s been noted that George Bush and Barack Obama share a passion for physical activity. Unfortunately, the habits of the chief executive do not translate to population changes. And then there is the smoking thing. Being a role model is not an excuse for inadequate policies.
  2. Make someone responsible for obesity policy development. Right now there is no one tasked at the upper levels of the U.S. Government with dealing with obesity. True, periodically the heads of different agencies give a speech, start a new website or create a new task force but little happens because so many do so little with scant coordination.
  3. Prepare to spend some money. For one of the most significant health problems in the country, the federal government spends vastly less than on obesity than other conditions. Research, prevention and treatment costs for diabetes and heart disease, to name but two, swamp comparable figures for obesity. The federal government is spending more on getting TV converters boxes in US homes than the entire NIH research budget on obesity.
  4. Do not just focus on childhood obesity. While childhood obesity is critical, remember that the population between 7 and 16 spans only 9 years out of a lifetime. Look at obesity over the lifetime and look for relevant interventions. Support childhood prevention programs but require that they have a competent evaluation method so we will know what is working and what is not.
  5. Do focus on research. Perhaps 90% of what we know about obesity has been learned since the discovery of leptin in 1994. Too many people believe that we know everything we need to know about obesity and do not need any more research. That’s not true. A great deal is known but there are many more questions than answers. Scientific credibility on issues around body weight is sorely needed. Every hour on television another weight loss program or product is hyped as being based on doctor’s advice or scientific study. What can help on both fronts is for the Administration to create a National Institute of Obesity Research at the National Institutes of Health. A new entity like this can reenergize researchers on obesity, can more closely coordinate the many disparate programs across NIH, provide leadership to other federal agencies, states and local governments and provide much needed focus on the social and economic impacts of obesity. Furthermore, a director who is articulate can help lead policymakers and the public away from harmful and dangerous products and keep a focus on developing effective interventions. The NIH bureaucracy will oppose “disease specific” research but their interests should not trump the public health needs and the best use of taxpayer dollars.
  6. As part of your health care reform package, remove the bias against drugs for weight loss in the Medicaid statute and change the exclusion of these drugs under Medicare Part D. Then have the Food and Drug Administration revisit its risk/benefit views of drugs to treat obesity. There are few fans of pharmaceutical companies in a Democratic Congress and Administration and there are even fewer who favor drugs to treat obesity. Nonetheless, there is a huge treatment gap. We have more and more effective surgical options, one over-the-counter FDA approved pill, a couple of tried medicines, commercial plans and self-help. What we do not have are the drug treatment options we have for high cholesterol, hypertension or diabetes. Recently, major pharmaceutical companies such as Merck, Pfizer, Solvay and Sanofi-Aventis have dropped or cut back on their programs to develop drugs for obesity. There are two reasons. First, insurance companies will not reimburse for most obesity treatments, including counseling, drugs and surgery. For the pharmaceutical industry, it just did not make economic sense to invest in drugs which were not going to be reimbursed. This is where leadership by Medicaid and Medicare is critical. If these programs support obesity products, private insurance may follow. This is in the government’s long term interest because insurers can avoid treating or preventing obesity knowing that the big effects, like diabetes and heart disease will not be seen until later in life, when Medicare will become the payor. Second, many involved in obesity drug development feel, rightly or wrongly, that the Food and Drug Administration is so risk-averse that they simply cannot afford the long and expensive trials necessary to meet the rising bar of safety. A National Institute of Obesity Research can help shape clinical trials needed by the FDA and speed the process along.
  7. Look to multiply your opportunities. For example, you can use the public works part of the economic stimulus package to construct new gyms in schools, sidewalks, playgrounds, green spaces and biking/walking trails to encourage more physical activity.
  8. Let the states experiment with taxes and proposals like displaying caloric content in restaurants. Vending machines, non-diet soft drinks, high-fat foods have all come under fire in recent years for contributing to the obesity epidemic. The problem is that these products still only contribute a fraction to an individual’s total caloric intake. But no one is sure that they won’t be replaced by other calories. Likewise, there will be voices to restrict food advertising to children through the federal government’s regulatory powers. Use your National Institute of Obesity Research to design evaluation studies so that there is an objective review to see if these policies will work.
  9. Take some leadership internationally. The United States has a long history of involvement in global health issues, such as HIV/AIDs. However, very little is done on the federal level to learn from other countries’ experiences and to help shape global patterns of eating and physical activity.
  10. Avoid the single fix ideas. The obesity field is full of good advice and scant evidence. Focusing on a single fix, such a TV advertising, agricultural subsidies or sweetened beverage may consume a great amount of political resources without producing the outcome you seek.

The obesity epidemic is more likely than not to continue to grow over the next four to eight years. However, the new Administration can position the United States for meaningful change if it takes its time and devotes attention to organizing the effort. With any luck, we can make future New Year’s resolutions more likely to be successful.

Managing Obesity

September 27th, 2009

January 5, 2011

A new paper from the Agency for Healthcare Quality and Research finds limited evidence for long-term changes  in body weight through lifestyle interventions for Type 2 diabetes,  breast cancer, Metabolic Syndrome and Prostate cancer. Comments are being accepted until January 13, 2011. http://www.ahrq.gov/clinic/ta/lifeintrvrev/lifeinterv_draft.pdf

                                                                                                                                                                   

Overall Reviews and Assessements of Treatment Options

Systematic review of the long-term effects and eco…[Health Technol Assess. 2004] – PubMed Result

Effective obesity treatments. [Am Psychol. 2007] – PubMed Result

AHRQ Clinical Aid: http://www.ahrq.gov/clinic/obesaid.pdf

NHLBI Guidelines on the Treatment of Adult Obesity NHLBI, Obesity Guidelines-Home Page

Weight-loss outcomes: a systematic review and meta…[J Am Diet Assoc. 2007] – PubMed Result

Evaluating weight programs IOM report Weighing the options: criteria for evaluating weig…[Obes Res. 1995] – PubMed Result