Trends: Augmenting Treatment With Medical Foods

Primary care providers spend much of their workday trying to help patients with depression. What many clinicians do not realize, however, is that an estimated two-thirds of patients have a suboptimal response to antidepressants.

These patients—and those with several other conditions, ranging from HIV to Alzheimer’s disease—may benefit from medical foods, a growing trend in medicine. As more companies bring such products to market, health care providers are gradually incorporating them into their day-to-day practice.

These products are not traditional drugs, and yet they are stronger than vitamins and dietary supplements. They are regulated under the FDA’s Orphan Drug program. Consumers can use them only if they have a prescription.

Nurse practitioners and physician assistants can prescribe medical foods, just as they can most drugs. “We clinicians need more and more tools to help our patients,” says Rakesh Jain, MD, MPH, a psychiatrist in Lake Jackson, Texas. “If this will bring someone out of a depression sooner, of course I’m going to use it.”

“It Certainly Can’t Hurt”
Recent research has shown that patients with depression who experience persistent symptoms may have insufficient levels of folate in the brain. For patients who have not achieved sufficient response to antidepressants, Jain, Director of Psychiatric Drug Research at R/D Clinical Research Center in Lake Jackson, often prescribes a product called Deplin^®, made by Louisiana-based Pamlab.

Deplin, described as an augmentation to depression treatment, is a trimonoamine modulator. Its active ingredient, L-methylfolate, is the only active form of folate that can cross the blood-brain barrier, and regulates the synthesis of serotonin, norepinephrine, and dopamine. Deplin essentially helps to boost levels of folate in a patient’s brain; the folate, in turn, helps to activate the neurotransmitters in the brain that are associated with mood.

Studies have demonstrated that when folate levels rise, patients start to feel better within a few weeks or months. That’s because their brain is able to access the benefits of their antidepressant medication more effectively.

“If I’m sitting in front of a patient who is suffering at work and suffering at home, I will try Deplin,” Jain says. “The data do predict they will have a better response.” And since patients have not reported any adverse effects, it certainly can’t hurt to try it, he adds.

Sometimes patients wonder if they can just eat more green vegetables, such as spinach. But Jain says these patients’ folate deficits are so great that they would have to eat bags and bags of spinach every day to make up for it. Instead, Deplin offers a highly concentrated dose of the ingredient.

Details about Deplin and its effect in patients with depression can be found at www.deplin.com.

An “Elegantly Simple” Approach to Alzheimer’s
In the Rocky Mountains of Colorado, a Broomfield-based company, Accera, focuses on medical foods for central nervous system disorders, such as Alzheimer’s disease and Parkinson’s disease. Clinical studies show their new medical food product, Axona™, can significantly improve cognitive functioning and memory in patients with mild to moderate Alzheimer’s disease.

Scientists who developed the product knew that one cause of Alzheimer’s disease is the brain’s reduced ability to properly metabolize glucose. The resulting glucose deficits lead to symptoms such as memory loss.

As the body digests Axona, it causes the liver to produce extra ketones, compounds that occur naturally in the body. In a brain with insufficient glucose, ketones provide an “alternative energy source” that helps the brain continue to function despite the deficit.

Accera CEO Steve Orndorff, PhD, and company cofounder Sam Henderson, PhD, both had a personal interest in finding better therapies for Alzheimer’s disease: They both had seen parents and grandparents develop the condition and try to live with it. “We saw the need firsthand,” Orndorff says.

Henderson, who was conducting research on the genetics of aging at the University of Colorado at Boulder, showed Orndorff data from several NIH studies that showed ketones have a neuroprotective effect. “He thought if we give patients these medium-chain triglycerides, the body will produce ketones and it will basically rescue those cells from the hypometabolism of glucose,” Orndorff explains. “It’s an elegantly simple approach to the disease.”

If the brain is allowed to function with a deficient amount of glucose, Orndorff adds, neurons begin to die—and memory loss begins. That is why the ketones are so essential for prevention of this form of dementia.

The two scientists formed their company in 2001 and brought Axona to the market in March 2009. A clinical trial of their product yielded very positive results. Patients who took Axona (in the form of a sweet drink packet) had a sevenfold improvement on cognitive function tests. By comparison, Orndorff says, patients using Alzheimer’s disease drugs currently on the market tend to experience about a 2.7-fold improvement. “We were more than double the efficacy of those drugs,” he explains.

To put those figures in perspective, Orndorff points out that the typical patient with mild to moderate Alzheimer’s disease will demonstrate a decline of 5 to 10 points a year, on average, on those same cognitive function tests. “So with a seven-point improvement, you’re looking at delaying that disease by a whole year,” he says.

While no specific data are available yet, Axona also appears to prevent other types of early age-related memory loss, Orndorff says.

Accera currently is reaching out to clinicians across the country to educate them about their product. More information is available in the provider section of their Web site, www.accerapharma.com.

“It Really Does Help” Memory Impairment
Meanwhile, clinicians with large populations of elderly patients are seeing good results with another medical food product from Pamlab, called Cerefolin^®. It is designed to help patients combat the forgetfulness typically associated with aging (also known as age-associated memory impairment). Like Deplin, Cerefolin contains high doses of folate, in a form that is easier for the body to metabolize.

Bennett Machanic, MD, a neurologist and associate clinical professor at the University of Colorado, turned to medical foods, in part, because he was not happy with the choice of conventional drugs on the market for patients with premature memory loss. “At best, there is a modest benefit from those medicines, but they are not cures,” he says.

Machanic typically tries Cere-folin for any patient who comes in with an elevated level of homocysteine. “I figure at the very worst, it’s harmless, and at the very best, it may improve memory, cognition, and behavior,” Machanic says. “Families are telling me it really does help.”

Word is spreading slowly through the medical community, Machanic says. But once clinicians learn about medical foods like Cerefolin, they are convinced, he adds. “There are physicians across the country who are taking it themselves” to slow memory loss, he says. “Many of these people feel they can prevent Alzheimer’s by taking this (although there is no shred of evidence to prove it). They just feel they are mentally sharper when they take it.”

For details on Cerefolin dosages and prescribing, visit www.pamlabs.com.

“The Perfect Drugs” for Neuropathy?
Diabetic neuropathy is another area in which medical foods can offer patients some new hope. Studies show they can also cut costs by reducing the need for pricey conventional treatments.

Diabetic neuropathy can be very dangerous for diabetic patients because they lose sensation in their feet and legs. Falls become increasingly common, and if they step on a nail, they might not feel the warning signals of pain and the wound can become infected. Too often, that leads patients to lose a toe or an entire limb.

Like Machanic, Dorothy Merritt, MD, an internal medicine provider in Texas City, Texas, turned to medical foods out of frustration. Merritt says her practice has a high percentage of diabetic patients, many with neuropathy. While most clinicians treat this painful condition with antiseizure drugs, the conventional treatments are not very effective, Merritt says. They also have many troublesome adverse effects. “They cause a lot of sedation,” she adds.

Merritt confesses she was aware of medical foods for two years before she started prescribing them. “I let them sit on the shelf,” she says.

But when she read an NIH article about the gene MTHSR, she realized nearly half of all Americans have a genetic inability to process the folate in the foods they eat. Even if they take vitamins like B12 and folic acid, their bodies cannot convert these substances into a
usable form, Merritt explains. “This gene is easy to test for, and 90% of the people in my practice have it,” she says.

Medical foods like Metanx^® (another product from Pamlab) and Cerefolin offer folate in a more bioavailable form that the body can use, even if the patient has this genetic defect. Metanx, in particular, has been shown to be effective in reducing the pain and numbness associated with diabetic neuropathy. “Metanx restores their nervous system,” Merritt says.

Medical foods have dramatically changed the way Merritt practices medicine. She jokes that her drug reps thought she had retired because she and the two PAs on her staff are now writing about half as many prescriptions for conventional drugs as they once were.

“I like these medical foods because they get down to heal the basis of what is making people ill (instead of masking the symptoms),” Merritt says, adding that these agents seem to have very few adverse effects. “From a clinical point of view, they are the perfect drugs.”

Primary care providers spend much of their workday trying to help patients with depression. What many clinicians do not realize, however, is that an estimated two-thirds of patients have a suboptimal response to antidepressants.

These patients—and those with several other conditions, ranging from HIV to Alzheimer’s disease—may benefit from medical foods, a growing trend in medicine. As more companies bring such products to market, health care providers are gradually incorporating them into their day-to-day practice.

These products are not traditional drugs, and yet they are stronger than vitamins and dietary supplements. They are regulated under the FDA’s Orphan Drug program. Consumers can use them only if they have a prescription.

Nurse practitioners and physician assistants can prescribe medical foods, just as they can most drugs. “We clinicians need more and more tools to help our patients,” says Rakesh Jain, MD, MPH, a psychiatrist in Lake Jackson, Texas. “If this will bring someone out of a depression sooner, of course I’m going to use it.”

“It Certainly Can’t Hurt”
Recent research has shown that patients with depression who experience persistent symptoms may have insufficient levels of folate in the brain. For patients who have not achieved sufficient response to antidepressants, Jain, Director of Psychiatric Drug Research at R/D Clinical Research Center in Lake Jackson, often prescribes a product called Deplin^®, made by Louisiana-based Pamlab.

Deplin, described as an augmentation to depression treatment, is a trimonoamine modulator. Its active ingredient, L-methylfolate, is the only active form of folate that can cross the blood-brain barrier, and regulates the synthesis of serotonin, norepinephrine, and dopamine. Deplin essentially helps to boost levels of folate in a patient’s brain; the folate, in turn, helps to activate the neurotransmitters in the brain that are associated with mood.

Studies have demonstrated that when folate levels rise, patients start to feel better within a few weeks or months. That’s because their brain is able to access the benefits of their antidepressant medication more effectively.

“If I’m sitting in front of a patient who is suffering at work and suffering at home, I will try Deplin,” Jain says. “The data do predict they will have a better response.” And since patients have not reported any adverse effects, it certainly can’t hurt to try it, he adds.

Sometimes patients wonder if they can just eat more green vegetables, such as spinach. But Jain says these patients’ folate deficits are so great that they would have to eat bags and bags of spinach every day to make up for it. Instead, Deplin offers a highly concentrated dose of the ingredient.

Details about Deplin and its effect in patients with depression can be found at www.deplin.com.

An “Elegantly Simple” Approach to Alzheimer’s
In the Rocky Mountains of Colorado, a Broomfield-based company, Accera, focuses on medical foods for central nervous system disorders, such as Alzheimer’s disease and Parkinson’s disease. Clinical studies show their new medical food product, Axona™, can significantly improve cognitive functioning and memory in patients with mild to moderate Alzheimer’s disease.

Scientists who developed the product knew that one cause of Alzheimer’s disease is the brain’s reduced ability to properly metabolize glucose. The resulting glucose deficits lead to symptoms such as memory loss.

As the body digests Axona, it causes the liver to produce extra ketones, compounds that occur naturally in the body. In a brain with insufficient glucose, ketones provide an “alternative energy source” that helps the brain continue to function despite the deficit.

Accera CEO Steve Orndorff, PhD, and company cofounder Sam Henderson, PhD, both had a personal interest in finding better therapies for Alzheimer’s disease: They both had seen parents and grandparents develop the condition and try to live with it. “We saw the need firsthand,” Orndorff says.

Henderson, who was conducting research on the genetics of aging at the University of Colorado at Boulder, showed Orndorff data from several NIH studies that showed ketones have a neuroprotective effect. “He thought if we give patients these medium-chain triglycerides, the body will produce ketones and it will basically rescue those cells from the hypometabolism of glucose,” Orndorff explains. “It’s an elegantly simple approach to the disease.”

If the brain is allowed to function with a deficient amount of glucose, Orndorff adds, neurons begin to die—and memory loss begins. That is why the ketones are so essential for prevention of this form of dementia.

The two scientists formed their company in 2001 and brought Axona to the market in March 2009. A clinical trial of their product yielded very positive results. Patients who took Axona (in the form of a sweet drink packet) had a sevenfold improvement on cognitive function tests. By comparison, Orndorff says, patients using Alzheimer’s disease drugs currently on the market tend to experience about a 2.7-fold improvement. “We were more than double the efficacy of those drugs,” he explains.

To put those figures in perspective, Orndorff points out that the typical patient with mild to moderate Alzheimer’s disease will demonstrate a decline of 5 to 10 points a year, on average, on those same cognitive function tests. “So with a seven-point improvement, you’re looking at delaying that disease by a whole year,” he says.

While no specific data are available yet, Axona also appears to prevent other types of early age-related memory loss, Orndorff says.

Accera currently is reaching out to clinicians across the country to educate them about their product. More information is available in the provider section of their Web site, www.accerapharma.com.

“It Really Does Help” Memory Impairment
Meanwhile, clinicians with large populations of elderly patients are seeing good results with another medical food product from Pamlab, called Cerefolin^®. It is designed to help patients combat the forgetfulness typically associated with aging (also known as age-associated memory impairment). Like Deplin, Cerefolin contains high doses of folate, in a form that is easier for the body to metabolize.

Bennett Machanic, MD, a neurologist and associate clinical professor at the University of Colorado, turned to medical foods, in part, because he was not happy with the choice of conventional drugs on the market for patients with premature memory loss. “At best, there is a modest benefit from those medicines, but they are not cures,” he says.

Machanic typically tries Cere-folin for any patient who comes in with an elevated level of homocysteine. “I figure at the very worst, it’s harmless, and at the very best, it may improve memory, cognition, and behavior,” Machanic says. “Families are telling me it really does help.”

Word is spreading slowly through the medical community, Machanic says. But once clinicians learn about medical foods like Cerefolin, they are convinced, he adds. “There are physicians across the country who are taking it themselves” to slow memory loss, he says. “Many of these people feel they can prevent Alzheimer’s by taking this (although there is no shred of evidence to prove it). They just feel they are mentally sharper when they take it.”

For details on Cerefolin dosages and prescribing, visit www.pamlabs.com.

“The Perfect Drugs” for Neuropathy?
Diabetic neuropathy is another area in which medical foods can offer patients some new hope. Studies show they can also cut costs by reducing the need for pricey conventional treatments.

Diabetic neuropathy can be very dangerous for diabetic patients because they lose sensation in their feet and legs. Falls become increasingly common, and if they step on a nail, they might not feel the warning signals of pain and the wound can become infected. Too often, that leads patients to lose a toe or an entire limb.

Like Machanic, Dorothy Merritt, MD, an internal medicine provider in Texas City, Texas, turned to medical foods out of frustration. Merritt says her practice has a high percentage of diabetic patients, many with neuropathy. While most clinicians treat this painful condition with antiseizure drugs, the conventional treatments are not very effective, Merritt says. They also have many troublesome adverse effects. “They cause a lot of sedation,” she adds.

Merritt confesses she was aware of medical foods for two years before she started prescribing them. “I let them sit on the shelf,” she says.

But when she read an NIH article about the gene MTHSR, she realized nearly half of all Americans have a genetic inability to process the folate in the foods they eat. Even if they take vitamins like B12 and folic acid, their bodies cannot convert these substances into a
usable form, Merritt explains. “This gene is easy to test for, and 90% of the people in my practice have it,” she says.

Medical foods like Metanx^® (another product from Pamlab) and Cerefolin offer folate in a more bioavailable form that the body can use, even if the patient has this genetic defect. Metanx, in particular, has been shown to be effective in reducing the pain and numbness associated with diabetic neuropathy. “Metanx restores their nervous system,” Merritt says.

Medical foods have dramatically changed the way Merritt practices medicine. She jokes that her drug reps thought she had retired because she and the two PAs on her staff are now writing about half as many prescriptions for conventional drugs as they once were.

“I like these medical foods because they get down to heal the basis of what is making people ill (instead of masking the symptoms),” Merritt says, adding that these agents seem to have very few adverse effects. “From a clinical point of view, they are the perfect drugs.”

Primary care providers spend much of their workday trying to help patients with depression. What many clinicians do not realize, however, is that an estimated two-thirds of patients have a suboptimal response to antidepressants.

These patients—and those with several other conditions, ranging from HIV to Alzheimer’s disease—may benefit from medical foods, a growing trend in medicine. As more companies bring such products to market, health care providers are gradually incorporating them into their day-to-day practice.

These products are not traditional drugs, and yet they are stronger than vitamins and dietary supplements. They are regulated under the FDA’s Orphan Drug program. Consumers can use them only if they have a prescription.

Nurse practitioners and physician assistants can prescribe medical foods, just as they can most drugs. “We clinicians need more and more tools to help our patients,” says Rakesh Jain, MD, MPH, a psychiatrist in Lake Jackson, Texas. “If this will bring someone out of a depression sooner, of course I’m going to use it.”

“It Certainly Can’t Hurt”
Recent research has shown that patients with depression who experience persistent symptoms may have insufficient levels of folate in the brain. For patients who have not achieved sufficient response to antidepressants, Jain, Director of Psychiatric Drug Research at R/D Clinical Research Center in Lake Jackson, often prescribes a product called Deplin^®, made by Louisiana-based Pamlab.

Deplin, described as an augmentation to depression treatment, is a trimonoamine modulator. Its active ingredient, L-methylfolate, is the only active form of folate that can cross the blood-brain barrier, and regulates the synthesis of serotonin, norepinephrine, and dopamine. Deplin essentially helps to boost levels of folate in a patient’s brain; the folate, in turn, helps to activate the neurotransmitters in the brain that are associated with mood.

Studies have demonstrated that when folate levels rise, patients start to feel better within a few weeks or months. That’s because their brain is able to access the benefits of their antidepressant medication more effectively.

“If I’m sitting in front of a patient who is suffering at work and suffering at home, I will try Deplin,” Jain says. “The data do predict they will have a better response.” And since patients have not reported any adverse effects, it certainly can’t hurt to try it, he adds.

Sometimes patients wonder if they can just eat more green vegetables, such as spinach. But Jain says these patients’ folate deficits are so great that they would have to eat bags and bags of spinach every day to make up for it. Instead, Deplin offers a highly concentrated dose of the ingredient.

Details about Deplin and its effect in patients with depression can be found at www.deplin.com.

An “Elegantly Simple” Approach to Alzheimer’s
In the Rocky Mountains of Colorado, a Broomfield-based company, Accera, focuses on medical foods for central nervous system disorders, such as Alzheimer’s disease and Parkinson’s disease. Clinical studies show their new medical food product, Axona™, can significantly improve cognitive functioning and memory in patients with mild to moderate Alzheimer’s disease.

Scientists who developed the product knew that one cause of Alzheimer’s disease is the brain’s reduced ability to properly metabolize glucose. The resulting glucose deficits lead to symptoms such as memory loss.

As the body digests Axona, it causes the liver to produce extra ketones, compounds that occur naturally in the body. In a brain with insufficient glucose, ketones provide an “alternative energy source” that helps the brain continue to function despite the deficit.

Accera CEO Steve Orndorff, PhD, and company cofounder Sam Henderson, PhD, both had a personal interest in finding better therapies for Alzheimer’s disease: They both had seen parents and grandparents develop the condition and try to live with it. “We saw the need firsthand,” Orndorff says.

Henderson, who was conducting research on the genetics of aging at the University of Colorado at Boulder, showed Orndorff data from several NIH studies that showed ketones have a neuroprotective effect. “He thought if we give patients these medium-chain triglycerides, the body will produce ketones and it will basically rescue those cells from the hypometabolism of glucose,” Orndorff explains. “It’s an elegantly simple approach to the disease.”

If the brain is allowed to function with a deficient amount of glucose, Orndorff adds, neurons begin to die—and memory loss begins. That is why the ketones are so essential for prevention of this form of dementia.

The two scientists formed their company in 2001 and brought Axona to the market in March 2009. A clinical trial of their product yielded very positive results. Patients who took Axona (in the form of a sweet drink packet) had a sevenfold improvement on cognitive function tests. By comparison, Orndorff says, patients using Alzheimer’s disease drugs currently on the market tend to experience about a 2.7-fold improvement. “We were more than double the efficacy of those drugs,” he explains.

To put those figures in perspective, Orndorff points out that the typical patient with mild to moderate Alzheimer’s disease will demonstrate a decline of 5 to 10 points a year, on average, on those same cognitive function tests. “So with a seven-point improvement, you’re looking at delaying that disease by a whole year,” he says.

While no specific data are available yet, Axona also appears to prevent other types of early age-related memory loss, Orndorff says.

Accera currently is reaching out to clinicians across the country to educate them about their product. More information is available in the provider section of their Web site, www.accerapharma.com.

“It Really Does Help” Memory Impairment
Meanwhile, clinicians with large populations of elderly patients are seeing good results with another medical food product from Pamlab, called Cerefolin^®. It is designed to help patients combat the forgetfulness typically associated with aging (also known as age-associated memory impairment). Like Deplin, Cerefolin contains high doses of folate, in a form that is easier for the body to metabolize.

Bennett Machanic, MD, a neurologist and associate clinical professor at the University of Colorado, turned to medical foods, in part, because he was not happy with the choice of conventional drugs on the market for patients with premature memory loss. “At best, there is a modest benefit from those medicines, but they are not cures,” he says.

Machanic typically tries Cere-folin for any patient who comes in with an elevated level of homocysteine. “I figure at the very worst, it’s harmless, and at the very best, it may improve memory, cognition, and behavior,” Machanic says. “Families are telling me it really does help.”

Word is spreading slowly through the medical community, Machanic says. But once clinicians learn about medical foods like Cerefolin, they are convinced, he adds. “There are physicians across the country who are taking it themselves” to slow memory loss, he says. “Many of these people feel they can prevent Alzheimer’s by taking this (although there is no shred of evidence to prove it). They just feel they are mentally sharper when they take it.”

For details on Cerefolin dosages and prescribing, visit www.pamlabs.com.

“The Perfect Drugs” for Neuropathy?
Diabetic neuropathy is another area in which medical foods can offer patients some new hope. Studies show they can also cut costs by reducing the need for pricey conventional treatments.

Diabetic neuropathy can be very dangerous for diabetic patients because they lose sensation in their feet and legs. Falls become increasingly common, and if they step on a nail, they might not feel the warning signals of pain and the wound can become infected. Too often, that leads patients to lose a toe or an entire limb.

Like Machanic, Dorothy Merritt, MD, an internal medicine provider in Texas City, Texas, turned to medical foods out of frustration. Merritt says her practice has a high percentage of diabetic patients, many with neuropathy. While most clinicians treat this painful condition with antiseizure drugs, the conventional treatments are not very effective, Merritt says. They also have many troublesome adverse effects. “They cause a lot of sedation,” she adds.

Merritt confesses she was aware of medical foods for two years before she started prescribing them. “I let them sit on the shelf,” she says.

But when she read an NIH article about the gene MTHSR, she realized nearly half of all Americans have a genetic inability to process the folate in the foods they eat. Even if they take vitamins like B12 and folic acid, their bodies cannot convert these substances into a
usable form, Merritt explains. “This gene is easy to test for, and 90% of the people in my practice have it,” she says.

Medical foods like Metanx^® (another product from Pamlab) and Cerefolin offer folate in a more bioavailable form that the body can use, even if the patient has this genetic defect. Metanx, in particular, has been shown to be effective in reducing the pain and numbness associated with diabetic neuropathy. “Metanx restores their nervous system,” Merritt says.

Medical foods have dramatically changed the way Merritt practices medicine. She jokes that her drug reps thought she had retired because she and the two PAs on her staff are now writing about half as many prescriptions for conventional drugs as they once were.

“I like these medical foods because they get down to heal the basis of what is making people ill (instead of masking the symptoms),” Merritt says, adding that these agents seem to have very few adverse effects. “From a clinical point of view, they are the perfect drugs.”