Dearth of Drugs Leaves Few Options for Obesity

As studies documenting the toll that obesity and excess weight have on health and mortality continue to be reported, access to multidisciplinary weight-loss programs remain poor – and the approved weight-loss drugs have dwindled to just orlistat and phentermine.

With the absence of effective pharmaceutical options and inconsistent insurance coverage of multidisciplinary weight-loss programs, the options that clinicians have available to address the treatment gap between basic lifestyle changes and referral for surgical treatment of obesity now include improved in-office counseling, setting modest weight-loss goals, the use of medications with weight loss as a side effect for indicated conditions, and online weight-loss programs.

Photo courtesy Cedar-Sinai Medical Center, Los Angeles.

A recent study of national health survey data suggests that frank conversations are far more motivating than previously thought. Researchers found that fewer than half of overweight people surveyed and fewer than two-thirds of the obese people surveyed had been told by their physicians that they were overweight. The study also found that if their physicians had told them they were overweight, the odds that the patient would see themselves as overweight and would try to lose weight would increase considerably.

Dr. Adrienne Youdim, medical director of the center for weight loss at Cedars-Sinai Medical Center, Los Angeles, said in an interview that the study shows that "physician advice goes a long way towards patients recognizing the condition [and] is a first step in addressing the condition." Although there are multiple barriers to effective weight-loss treatment that are often cited (including lack of resources, lack of reimbursement, personal physician bias, or lack of comfort in addressing this disease), "from a preventive medicine standpoint [and] as internists and primary care physicians, we need to take this challenge not only in identification and diagnosis but also [in] providing guidance and counseling on how to address the problem," said Dr. Youdim, who was not involved in the study. Without intervening at the front lines, "we cannot sway the tide of what has become the No. 1 public health crisis in the United States."

She also recommended helping patients keep modest weight-loss goals that are achievable with lifestyle changes. "When you’re talking about disease burden, a lot can be gained from modest weight loss and small lifestyle changes – an important point that is often understated," she said, referring to a study indicating that patients would reach their desired weight if they lost more than 100 pounds, and that they would be disappointed if they lost 17% of their body weight. But that is a substantial amount of weight, she pointed out, particularly because a 5%-10% weight loss results in significant cardiometabolic improvements.

Many studies show "that physician-guided advice goes a long way, and that it doesn’t have to be intensive," Dr. Youdim said. Physicians can use outside resources for behavioral modification if they don’t have a dietician on staff. She recommends programs like Weight Watchers, Overeaters Anonymous, and TOPS Club, which can be augmented with in-office counseling and even applications that are available for smart phones and can used by a motivated patient to help monitor food intake, she added.

"Be forceful, direct, and blunt in your discussions with patients about the need for the interventions in terms of diet and exercise," as advocated by the American Heart Association, the American College of Cardiology, the American Diabetes Association, the American Association of Clinical Endocrinologists, and other organizations, said Dr. Helena Rodbard, an endocrinologist in Gaithersburg, Md. She recommended that clinicians calculate the body mass index of their overweight and obese patients "and let people know where they stand in terms of the percentiles of their body weight compared to the norms set before the current epidemic." She advises clinicians to screen patients for metabolic syndrome, prediabetes, and diabetes, and to inform them about their risk factors, using calculations from available programs about patients’ risks of developing heart disease or diabetes within the next 5-10 years. She emphasized paying special attention to obesity in youth and adolescents, who "will be obese for life and have diabetes early and diabetic complications early."

In an interview, Dr. Rodbard said that because of logistical issues and costs, she rarely refers patients to a weight-loss program; instead, she counsels them and arranges for them to see a dietician in her office 1 or 2 days a week. "Frequent return visits and motivational sessions within those visits are helpful," she said, advising clinicians to use the services of a dietician when possible, and to "fight for better reimbursement for those kinds of services."

The prospects for any new obesity drugs’ becoming available in the near future dimmed considerably after the majority of the Food and Drug Administration’s Endocrinologic Drugs Advisory Panel recommended against approval of the phentermine-topiramate (Qnexa) combination and the serotonergic drug lorcaserin (Lorqess) at meetings last summer and fall. Then in February, the FDA put its decision on another drug combination – the antidepressant bupropion and the opioid antagonist naltrexone (Contrave) – on hold when it requested a large cardiovascular safety trial in overweight and obese people before the agency would consider approval.

Dr. Rodbard, who is past president of the American Association of Clinical Endocrinologists and the American College of Endocrinology, said that although these drugs had potential side effects, she considers their side effects to be lower than the risk of remaining obese, adding that "it is a tragedy that we do not have more and better drugs available for treatment of obesity, and that there has not been a larger and more effective and sustained program to change the lifestyle habits of Americans with regard to diet and exercise."

Although Dr. Youdim acknowledged that concerns over the safety of the drugs are legitimate, "there is a lot of bias around drugs for obesity, because the thought is that if patients would just stop eating, they’d lose weight. ... The rigor placed on these drugs is a lot greater because of that bias." But obesity is a disease, she added, "and there should be treatment options available to us," just as there are options available for other diseases.

Although weight-loss drugs have not been effective on their own, they have been useful adjuncts to lifestyle modification, and "the cornerstone of treatment in a select group of patients who are having trouble adhering to lifestyle recommendations."

Dr. Youdim said that certain drugs are associated with some weight loss and can be used – not "completely without indication" – to help patients lose weight. For example, a patient who is both overweight and clinically depressed could be prescribed bupropion, someone with insulin resistance can benefit from metformin, and a patient with type 2 diabetes who requires insulin may benefit from exenatide (Byetta). All three of these drugs are associated with weight loss.

Dr. Rodbard said that in patients with diabetes in whom exenatide is indicated, about a third of those receiving it "have very dramatic weight loss ... especially in some patients with a very massive degree of obesity to begin with," and that this loss is "very nicely sustained." Published data support the notion that the combination of the glucagonlike peptide–1 receptor agonists with insulin will help to reduce the weight gain associated with insulin therapy, she added.

Metformin has a very small effect on weight, but appears to have beneficial effects on the risk of heart disease and cancer; "hence, it is one of the backbones of therapy for type 2 diabetes and used in combination with nearly all other medications," she added.

As for the FDA-approved weight-loss drugs, Dr. Rodbard said that she rarely uses phentermine, and – when it was available – she rarely used sibutramine, which was used mainly because there were not many other options available. The side effects of orlistat, she said, are unacceptable "to all but a very few patients."

Dr. Louis Aronne, director of the comprehensive weight control program at New York–Presbyterian Hospital, said that there clearly is a need for more medical treatments for obesity – as well as improved access to comprehensive weight-loss programs that are affordable and effective – before the clinicians opt for surgery. "Right now, a patient can go from Weight Watchers to the operating room" for bariatric surgery because of the gap in treatment and dearth of medical options, he said.

Dr. Aronne is a developer of an online program designed to address the treatment gap and poor access to comprehensive weight-loss programs. The "BMIQ" program is a 16-session, online, comprehensive program run by a dietician in a group setting. It includes dietary and exercise counseling that is aimed at helping obese people with type 2 diabetes to lose weight and manage their diabetes by using a "weight-centric approach" efficiently and without extra costs. Primary care physicians refer their patients to the program; after the patient fills out an evaluation form, the physician receives information on the patient along with recommendations on how to manage that patient. For example, the clinician is alerted if the patient is taking over-the-counter sleep medications that contain strong antihistamines, which can both cause weight gain and make it difficult to lose weight; eliminating them is "like giving someone an appetite suppressant," he said.

In a pilot program, a large New York State health insurer is providing the BMIQ program to 2,000 of its beneficiaries who are overweight and have type 2 diabetes. Data indicate that programs like this help patients lose weight, reduce medication costs, and can save over $1,000 per person, and "we’re hopeful that we will be able to show the insurer that they can save money," said Dr. Aronne, who believes that insurers and employers will pay for the program once they see that it’s an efficient model of delivering this service. The program is available to people now, at a cost of $300, at BMIQ.com.

Dr. Youdim had no disclosures. Dr. Aronne said he has been involved in studies of more than 20 weight-loss drugs, including the three reviewed by the FDA panel last year, and has served as a consultant to Vivus and Orexigen; he also developed the BMIQ program. Dr. Rodbard has received research grants and served as a consultant to, adviser to, and/or speaker for Amylin, Astra-Zeneca, Biodel, Bristol-Myers Squibb, Eli Lilly, Mannkind, Merck, Roche, and Sanofi-Aventis.

As studies documenting the toll that obesity and excess weight have on health and mortality continue to be reported, access to multidisciplinary weight-loss programs remain poor – and the approved weight-loss drugs have dwindled to just orlistat and phentermine.

With the absence of effective pharmaceutical options and inconsistent insurance coverage of multidisciplinary weight-loss programs, the options that clinicians have available to address the treatment gap between basic lifestyle changes and referral for surgical treatment of obesity now include improved in-office counseling, setting modest weight-loss goals, the use of medications with weight loss as a side effect for indicated conditions, and online weight-loss programs.

Photo courtesy Cedar-Sinai Medical Center, Los Angeles.

A recent study of national health survey data suggests that frank conversations are far more motivating than previously thought. Researchers found that fewer than half of overweight people surveyed and fewer than two-thirds of the obese people surveyed had been told by their physicians that they were overweight. The study also found that if their physicians had told them they were overweight, the odds that the patient would see themselves as overweight and would try to lose weight would increase considerably.

Dr. Adrienne Youdim, medical director of the center for weight loss at Cedars-Sinai Medical Center, Los Angeles, said in an interview that the study shows that "physician advice goes a long way towards patients recognizing the condition [and] is a first step in addressing the condition." Although there are multiple barriers to effective weight-loss treatment that are often cited (including lack of resources, lack of reimbursement, personal physician bias, or lack of comfort in addressing this disease), "from a preventive medicine standpoint [and] as internists and primary care physicians, we need to take this challenge not only in identification and diagnosis but also [in] providing guidance and counseling on how to address the problem," said Dr. Youdim, who was not involved in the study. Without intervening at the front lines, "we cannot sway the tide of what has become the No. 1 public health crisis in the United States."

She also recommended helping patients keep modest weight-loss goals that are achievable with lifestyle changes. "When you’re talking about disease burden, a lot can be gained from modest weight loss and small lifestyle changes – an important point that is often understated," she said, referring to a study indicating that patients would reach their desired weight if they lost more than 100 pounds, and that they would be disappointed if they lost 17% of their body weight. But that is a substantial amount of weight, she pointed out, particularly because a 5%-10% weight loss results in significant cardiometabolic improvements.

Many studies show "that physician-guided advice goes a long way, and that it doesn’t have to be intensive," Dr. Youdim said. Physicians can use outside resources for behavioral modification if they don’t have a dietician on staff. She recommends programs like Weight Watchers, Overeaters Anonymous, and TOPS Club, which can be augmented with in-office counseling and even applications that are available for smart phones and can used by a motivated patient to help monitor food intake, she added.

"Be forceful, direct, and blunt in your discussions with patients about the need for the interventions in terms of diet and exercise," as advocated by the American Heart Association, the American College of Cardiology, the American Diabetes Association, the American Association of Clinical Endocrinologists, and other organizations, said Dr. Helena Rodbard, an endocrinologist in Gaithersburg, Md. She recommended that clinicians calculate the body mass index of their overweight and obese patients "and let people know where they stand in terms of the percentiles of their body weight compared to the norms set before the current epidemic." She advises clinicians to screen patients for metabolic syndrome, prediabetes, and diabetes, and to inform them about their risk factors, using calculations from available programs about patients’ risks of developing heart disease or diabetes within the next 5-10 years. She emphasized paying special attention to obesity in youth and adolescents, who "will be obese for life and have diabetes early and diabetic complications early."

In an interview, Dr. Rodbard said that because of logistical issues and costs, she rarely refers patients to a weight-loss program; instead, she counsels them and arranges for them to see a dietician in her office 1 or 2 days a week. "Frequent return visits and motivational sessions within those visits are helpful," she said, advising clinicians to use the services of a dietician when possible, and to "fight for better reimbursement for those kinds of services."

The prospects for any new obesity drugs’ becoming available in the near future dimmed considerably after the majority of the Food and Drug Administration’s Endocrinologic Drugs Advisory Panel recommended against approval of the phentermine-topiramate (Qnexa) combination and the serotonergic drug lorcaserin (Lorqess) at meetings last summer and fall. Then in February, the FDA put its decision on another drug combination – the antidepressant bupropion and the opioid antagonist naltrexone (Contrave) – on hold when it requested a large cardiovascular safety trial in overweight and obese people before the agency would consider approval.

Dr. Rodbard, who is past president of the American Association of Clinical Endocrinologists and the American College of Endocrinology, said that although these drugs had potential side effects, she considers their side effects to be lower than the risk of remaining obese, adding that "it is a tragedy that we do not have more and better drugs available for treatment of obesity, and that there has not been a larger and more effective and sustained program to change the lifestyle habits of Americans with regard to diet and exercise."

Although Dr. Youdim acknowledged that concerns over the safety of the drugs are legitimate, "there is a lot of bias around drugs for obesity, because the thought is that if patients would just stop eating, they’d lose weight. ... The rigor placed on these drugs is a lot greater because of that bias." But obesity is a disease, she added, "and there should be treatment options available to us," just as there are options available for other diseases.

Although weight-loss drugs have not been effective on their own, they have been useful adjuncts to lifestyle modification, and "the cornerstone of treatment in a select group of patients who are having trouble adhering to lifestyle recommendations."

Dr. Youdim said that certain drugs are associated with some weight loss and can be used – not "completely without indication" – to help patients lose weight. For example, a patient who is both overweight and clinically depressed could be prescribed bupropion, someone with insulin resistance can benefit from metformin, and a patient with type 2 diabetes who requires insulin may benefit from exenatide (Byetta). All three of these drugs are associated with weight loss.

Dr. Rodbard said that in patients with diabetes in whom exenatide is indicated, about a third of those receiving it "have very dramatic weight loss ... especially in some patients with a very massive degree of obesity to begin with," and that this loss is "very nicely sustained." Published data support the notion that the combination of the glucagonlike peptide–1 receptor agonists with insulin will help to reduce the weight gain associated with insulin therapy, she added.

Metformin has a very small effect on weight, but appears to have beneficial effects on the risk of heart disease and cancer; "hence, it is one of the backbones of therapy for type 2 diabetes and used in combination with nearly all other medications," she added.

As for the FDA-approved weight-loss drugs, Dr. Rodbard said that she rarely uses phentermine, and – when it was available – she rarely used sibutramine, which was used mainly because there were not many other options available. The side effects of orlistat, she said, are unacceptable "to all but a very few patients."

Dr. Louis Aronne, director of the comprehensive weight control program at New York–Presbyterian Hospital, said that there clearly is a need for more medical treatments for obesity – as well as improved access to comprehensive weight-loss programs that are affordable and effective – before the clinicians opt for surgery. "Right now, a patient can go from Weight Watchers to the operating room" for bariatric surgery because of the gap in treatment and dearth of medical options, he said.

Dr. Aronne is a developer of an online program designed to address the treatment gap and poor access to comprehensive weight-loss programs. The "BMIQ" program is a 16-session, online, comprehensive program run by a dietician in a group setting. It includes dietary and exercise counseling that is aimed at helping obese people with type 2 diabetes to lose weight and manage their diabetes by using a "weight-centric approach" efficiently and without extra costs. Primary care physicians refer their patients to the program; after the patient fills out an evaluation form, the physician receives information on the patient along with recommendations on how to manage that patient. For example, the clinician is alerted if the patient is taking over-the-counter sleep medications that contain strong antihistamines, which can both cause weight gain and make it difficult to lose weight; eliminating them is "like giving someone an appetite suppressant," he said.

In a pilot program, a large New York State health insurer is providing the BMIQ program to 2,000 of its beneficiaries who are overweight and have type 2 diabetes. Data indicate that programs like this help patients lose weight, reduce medication costs, and can save over $1,000 per person, and "we’re hopeful that we will be able to show the insurer that they can save money," said Dr. Aronne, who believes that insurers and employers will pay for the program once they see that it’s an efficient model of delivering this service. The program is available to people now, at a cost of $300, at BMIQ.com.

Dr. Youdim had no disclosures. Dr. Aronne said he has been involved in studies of more than 20 weight-loss drugs, including the three reviewed by the FDA panel last year, and has served as a consultant to Vivus and Orexigen; he also developed the BMIQ program. Dr. Rodbard has received research grants and served as a consultant to, adviser to, and/or speaker for Amylin, Astra-Zeneca, Biodel, Bristol-Myers Squibb, Eli Lilly, Mannkind, Merck, Roche, and Sanofi-Aventis.

As studies documenting the toll that obesity and excess weight have on health and mortality continue to be reported, access to multidisciplinary weight-loss programs remain poor – and the approved weight-loss drugs have dwindled to just orlistat and phentermine.

With the absence of effective pharmaceutical options and inconsistent insurance coverage of multidisciplinary weight-loss programs, the options that clinicians have available to address the treatment gap between basic lifestyle changes and referral for surgical treatment of obesity now include improved in-office counseling, setting modest weight-loss goals, the use of medications with weight loss as a side effect for indicated conditions, and online weight-loss programs.

Photo courtesy Cedar-Sinai Medical Center, Los Angeles.

A recent study of national health survey data suggests that frank conversations are far more motivating than previously thought. Researchers found that fewer than half of overweight people surveyed and fewer than two-thirds of the obese people surveyed had been told by their physicians that they were overweight. The study also found that if their physicians had told them they were overweight, the odds that the patient would see themselves as overweight and would try to lose weight would increase considerably.

Dr. Adrienne Youdim, medical director of the center for weight loss at Cedars-Sinai Medical Center, Los Angeles, said in an interview that the study shows that "physician advice goes a long way towards patients recognizing the condition [and] is a first step in addressing the condition." Although there are multiple barriers to effective weight-loss treatment that are often cited (including lack of resources, lack of reimbursement, personal physician bias, or lack of comfort in addressing this disease), "from a preventive medicine standpoint [and] as internists and primary care physicians, we need to take this challenge not only in identification and diagnosis but also [in] providing guidance and counseling on how to address the problem," said Dr. Youdim, who was not involved in the study. Without intervening at the front lines, "we cannot sway the tide of what has become the No. 1 public health crisis in the United States."

She also recommended helping patients keep modest weight-loss goals that are achievable with lifestyle changes. "When you’re talking about disease burden, a lot can be gained from modest weight loss and small lifestyle changes – an important point that is often understated," she said, referring to a study indicating that patients would reach their desired weight if they lost more than 100 pounds, and that they would be disappointed if they lost 17% of their body weight. But that is a substantial amount of weight, she pointed out, particularly because a 5%-10% weight loss results in significant cardiometabolic improvements.

Many studies show "that physician-guided advice goes a long way, and that it doesn’t have to be intensive," Dr. Youdim said. Physicians can use outside resources for behavioral modification if they don’t have a dietician on staff. She recommends programs like Weight Watchers, Overeaters Anonymous, and TOPS Club, which can be augmented with in-office counseling and even applications that are available for smart phones and can used by a motivated patient to help monitor food intake, she added.

"Be forceful, direct, and blunt in your discussions with patients about the need for the interventions in terms of diet and exercise," as advocated by the American Heart Association, the American College of Cardiology, the American Diabetes Association, the American Association of Clinical Endocrinologists, and other organizations, said Dr. Helena Rodbard, an endocrinologist in Gaithersburg, Md. She recommended that clinicians calculate the body mass index of their overweight and obese patients "and let people know where they stand in terms of the percentiles of their body weight compared to the norms set before the current epidemic." She advises clinicians to screen patients for metabolic syndrome, prediabetes, and diabetes, and to inform them about their risk factors, using calculations from available programs about patients’ risks of developing heart disease or diabetes within the next 5-10 years. She emphasized paying special attention to obesity in youth and adolescents, who "will be obese for life and have diabetes early and diabetic complications early."

In an interview, Dr. Rodbard said that because of logistical issues and costs, she rarely refers patients to a weight-loss program; instead, she counsels them and arranges for them to see a dietician in her office 1 or 2 days a week. "Frequent return visits and motivational sessions within those visits are helpful," she said, advising clinicians to use the services of a dietician when possible, and to "fight for better reimbursement for those kinds of services."

The prospects for any new obesity drugs’ becoming available in the near future dimmed considerably after the majority of the Food and Drug Administration’s Endocrinologic Drugs Advisory Panel recommended against approval of the phentermine-topiramate (Qnexa) combination and the serotonergic drug lorcaserin (Lorqess) at meetings last summer and fall. Then in February, the FDA put its decision on another drug combination – the antidepressant bupropion and the opioid antagonist naltrexone (Contrave) – on hold when it requested a large cardiovascular safety trial in overweight and obese people before the agency would consider approval.

Dr. Rodbard, who is past president of the American Association of Clinical Endocrinologists and the American College of Endocrinology, said that although these drugs had potential side effects, she considers their side effects to be lower than the risk of remaining obese, adding that "it is a tragedy that we do not have more and better drugs available for treatment of obesity, and that there has not been a larger and more effective and sustained program to change the lifestyle habits of Americans with regard to diet and exercise."

Although Dr. Youdim acknowledged that concerns over the safety of the drugs are legitimate, "there is a lot of bias around drugs for obesity, because the thought is that if patients would just stop eating, they’d lose weight. ... The rigor placed on these drugs is a lot greater because of that bias." But obesity is a disease, she added, "and there should be treatment options available to us," just as there are options available for other diseases.

Although weight-loss drugs have not been effective on their own, they have been useful adjuncts to lifestyle modification, and "the cornerstone of treatment in a select group of patients who are having trouble adhering to lifestyle recommendations."

Dr. Youdim said that certain drugs are associated with some weight loss and can be used – not "completely without indication" – to help patients lose weight. For example, a patient who is both overweight and clinically depressed could be prescribed bupropion, someone with insulin resistance can benefit from metformin, and a patient with type 2 diabetes who requires insulin may benefit from exenatide (Byetta). All three of these drugs are associated with weight loss.

Dr. Rodbard said that in patients with diabetes in whom exenatide is indicated, about a third of those receiving it "have very dramatic weight loss ... especially in some patients with a very massive degree of obesity to begin with," and that this loss is "very nicely sustained." Published data support the notion that the combination of the glucagonlike peptide–1 receptor agonists with insulin will help to reduce the weight gain associated with insulin therapy, she added.

Metformin has a very small effect on weight, but appears to have beneficial effects on the risk of heart disease and cancer; "hence, it is one of the backbones of therapy for type 2 diabetes and used in combination with nearly all other medications," she added.

As for the FDA-approved weight-loss drugs, Dr. Rodbard said that she rarely uses phentermine, and – when it was available – she rarely used sibutramine, which was used mainly because there were not many other options available. The side effects of orlistat, she said, are unacceptable "to all but a very few patients."

Dr. Louis Aronne, director of the comprehensive weight control program at New York–Presbyterian Hospital, said that there clearly is a need for more medical treatments for obesity – as well as improved access to comprehensive weight-loss programs that are affordable and effective – before the clinicians opt for surgery. "Right now, a patient can go from Weight Watchers to the operating room" for bariatric surgery because of the gap in treatment and dearth of medical options, he said.

Dr. Aronne is a developer of an online program designed to address the treatment gap and poor access to comprehensive weight-loss programs. The "BMIQ" program is a 16-session, online, comprehensive program run by a dietician in a group setting. It includes dietary and exercise counseling that is aimed at helping obese people with type 2 diabetes to lose weight and manage their diabetes by using a "weight-centric approach" efficiently and without extra costs. Primary care physicians refer their patients to the program; after the patient fills out an evaluation form, the physician receives information on the patient along with recommendations on how to manage that patient. For example, the clinician is alerted if the patient is taking over-the-counter sleep medications that contain strong antihistamines, which can both cause weight gain and make it difficult to lose weight; eliminating them is "like giving someone an appetite suppressant," he said.

In a pilot program, a large New York State health insurer is providing the BMIQ program to 2,000 of its beneficiaries who are overweight and have type 2 diabetes. Data indicate that programs like this help patients lose weight, reduce medication costs, and can save over $1,000 per person, and "we’re hopeful that we will be able to show the insurer that they can save money," said Dr. Aronne, who believes that insurers and employers will pay for the program once they see that it’s an efficient model of delivering this service. The program is available to people now, at a cost of $300, at BMIQ.com.

Dr. Youdim had no disclosures. Dr. Aronne said he has been involved in studies of more than 20 weight-loss drugs, including the three reviewed by the FDA panel last year, and has served as a consultant to Vivus and Orexigen; he also developed the BMIQ program. Dr. Rodbard has received research grants and served as a consultant to, adviser to, and/or speaker for Amylin, Astra-Zeneca, Biodel, Bristol-Myers Squibb, Eli Lilly, Mannkind, Merck, Roche, and Sanofi-Aventis.