Medical food product provides nutritional management for patients with symptomatic diabetic neuropathy in contrast to current pain masking therapies

NEW ORLEANS–(BUSINESS WIRE)–PamLab L.L.C., developer and marketer of Metanx^®, announced today that the results of a study to determine if nutritional management with Metanx^® improves numbness in the feet of patients with Diabetic Neuropathy (DN) was published in the fourth quarter 2010 issue of Reviews in Neurological Diseases. The study demonstrated that Metanx^®, a medical food available by prescription, promotes restoration of lost cutaneous sensation in DN patients.

Diabetic Neuropathy, nerve damage caused by diabetes, is a chronic condition characterized by tingling, burning pain, and numbness in the feet and/or hands. It is estimated that 60-70 percent of the 23.6 million people with diabetes in the U.S. have some form neuropathy. Numbness in the feet is the most common symptom associated with diabetic neuropathy and is the most frequent cause of ulceration and amputation. Additionally, burning pain occurs in 10 to 25 percent of DN patients. Current therapies mask the painful symptoms of DN but do not address the numbness or underlying progression of the condition, a challenge currently facing health care providers.

Mackie J. Walker Jr., DPM, of the Podiatry Division of the Carolina Musculoskeletal Institute in Aiken South Carolina acted as lead study investigator. “There is considerable need for a therapy like Metanx^®, as it has demonstrated to improve sensory loss with a favorable safety profile,” stated Dr. Walker.

“Diabetic Neuropathy is an under-recognized and significantly underserved result of type 2 diabetes,” said Harold O. Koch, Jr., Senior Vice President of Business & Scientific Affairs, and Chief Scientific Officer of Pamlab.

“Unlike the current standards of care, which only mask the painful symptoms, Metanx^® manages the nutritional needs of the patient with Diabetic Neuropathy, maintaining blood flow and creating an environment for increased nerve fiber density; thus, enhancing the patient’s quality of life.”

The efficacy of nutritional management with Metanx^® in restoring sensitivity in patients with type 2 diabetes was measured in three follow-up periods: baseline to 6 months, baseline to 1 year, and 6 months to 1 year. After 6 months and 1 year of Metanx^® compared to baseline, a statistically significant improvement was observed in both tactile and discriminatory testing at the right and left great toe and medial heel of patients. The results of this study were originally presented in 2008 at the New Cardiovascular Horizons Meeting in New Orleans.

About Medical Foods and Metanx^®
As regulated by the FDA, medical foods are specially formulated to manage a specific disease or condition for which medical evaluation, based on recognized scientific principles, has established distinct nutritional requirements. All components of a medical food must have GRAS status (Generally Recognized as Safe) as designated by the FDA or independent review.

Metanx^® is a medical food available by prescription and indicated for the distinct nutritional requirements of patients with endothelial dysfunction who present with loss of protective sensation and neuropathic pain associated with diabetic neuropathy. Metanx^® contains the active forms of folate and Vitamins B12 and B6 (L-methylfolate, methylcobalamin, and pyridoxal 5’-phosphate, respectively). Metanx^® offers a nutritional benefit by improving endothelial function and maintaining blood flow in the vessels that carry important nutrients and oxygen to the peripheral nerves.

About Pamlab, L.L.C.
Pamlab, L.L.C., founded in 1957, is a fully integrated pharmaceutical company specializing in medical foods indicated for specific disease states including diabetic neuropathy, depression and early memory loss.

It has come to our attention that in recent weeks many prescriptions for Metanx® have been switched to an alternative product called Neurpath-B. We believe these products have been linked in error. You should understand that the samples of Neurpath-B that Pamlab has examined are not equivalent to Metanx®.

Acella Pharmacueticals began production of Neurpath-B earlier this year. Tested samples of this product contained a Chinese source of folate rather than the active form of folate (used in Metanx®). Unfortunately, the pharmaceutical listing services and major U.S. wholesalers have linked the Neurpath-B product to Metanx® as “generic”. In turn, many pharmacies began to stock Neurpath-B and to substitute that product when filling Metanx® prescriptions.

We believe such substitutions are not based on sound pharmaceutical principles and are not in the best interests of Metanx® patients.

Acella has presented no information to show that Neurpath-B is bioequivalent to, and thereby substitutable for, Metanx®. On the contrary, the Neurpath-B label states that it is not included in the Orange Book (official FDA listing of approved generic drugs), and specifically disclaims therapeutic equivalence to any other product. (see pdf photos)

Pamlab has taken several steps to correct this situation.
• A false advertising lawsuit has been filed against Acella in Federal Court.
• Informational letters have been sent directly to retail pharmacists.
• The news media has been alerted.
• Full updates on product testing have been posted to www.readitfirst.info

We regret the confusion this situation may have caused. To this point, Acella has done nothing to dissuade the listing services from linking Neurpath-B as a generic for Metanx®. Even the pricing is set to mimic Metanx® – the cost of Neurpath-B to monthly cash patients is approximately 10% less than the typical price of Metanx®.

We seek to clarify and inform. Physicians prescribing Metanx® should know that their patients may not be getting the product as prescribed. Patients should be cautious if told that a “generic” is available – no true generic has yet been introduced in the U.S. marketplace.

Thank you for your attention to this matter.

Sincerely,

Eric Wingerter
President and CEO, Pamlab LLC

Allen Jacobs, a foot doctor in Clayton, Mo., noticed that some of his patients with nerve damage were no longer improving.

Their condition, diabetic neuropathy, had been responding to a prescription product called Metanx. When Jacobs investigated he was dismayed to find that they were no longer taking it. Pharmacists had substituted a much less expensive competing product that used a key ingredient from China and was supposed to be as good.

But Metanx and the substitute are part of a little-known but growing category called prescription medical foods, which exist in a regulatory netherworld between prescription pharmaceuticals and over-the-counter vitamins and supplements. As a result, the substitute didn’t have to be tested to ensure that its main ingredients and their effectiveness were equivalent to Metanx.

That left Jacobs’ patients — and thousands of others — vulnerable to a condition that causes pain and numbness and can lead to amputation.

“It’s not a minor issue,” said Jacobs, a nationally known speaker on health care issues. “The major risk is they’re not being treated.”

Metanx is dispensed to an estimated 500,000 patients across the country, and physicians in Kansas City and elsewhere have been blindsided by the substitute product, Neurpath-B.

The substitute, with its Chinese-produced ingredient, is often less effective than its counterpart in Metanx and somehow made its way into national databases used by pharmacies to dispense equivalents.

The company marketing Neurpath defends the product but also said it was making no claims that it was a “bioequivalent” to Metanx.

Neurpath is another example of how products made in China can undercut the competition on price but, often because of lax U.S. regulation, offer no assurance of providing the same level of safety or effectiveness.

The situation also brings to light the phenomenon of prescription medical foods, which use specially formulated nutrients that can be tailored for people with difficulties absorbing regular nutrients.

Less than three dozen medical foods were available in 1974, but the number is now in the hundreds, and many are widely prescribed. The category is “completely exploding,” said Richard Isaacson, an associate professor of medicine for the University of Miami’s Miller School of Medicine.

Medical foods, often sold as pills or capsules, have a mixed reputation in the medical community. Isaacson , a board certified neurologist, was initially a skeptic. But he now prescribes them to help with disease symptoms and believes they have a place as long as they’re safe and backed by scientific evidence.

“We’re seeing the emergence of a new science,” he said.

Medical foods are subject to some federal regulations, specifying manufacturing practices and calling for claims to be backed by scientific evidence. But unlike prescription drugs, they aren’t required to undergo full-blown clinical trials for efficacy.

FDA spokeswoman Siobhan DeLancey said “there’s no basis for determining whether one product is identical or substantially similar to another” because “medical foods don’t have to be approved or registered with the FDA.”

That information vacuum on equivalency, at least regarding Neurpath, is being filled by private companies that provide information to pharmacists. Neurpath was rated as equivalent to Metanx by the two major companies in the field: First DataBank, owned by the Hearst Corp., which also publishes 15 newspapers, and Medi-Span, owned by Wolters Kluwer, a global information services company.

“We were stunned” by the equivalency ratings, said Jim Currie, a spokesman for Pamlab, which developed Metanx and has been marketing it for six years.

Metanx aims to improve blood flow to help nerves affected by neuropathy. Studies, including one with Tulane University, show that although Metanx is not a cure for neuropathy, it can help reduce the severity of its symptoms.

Pamlab has filed a complaint with the FDA and sued the company behind Neurpath. But the court case was recently continued until January, and Neurpath is being sold as an equivalent for Metanx.

“It’s time to take this to the court of public opinion,” Currie said.

Metanx is basically a combination of B vitamins, and one of its ingredients, L-methylfolate, is at the center of the dispute. It’s a naturally occurring substance that is biologically active, which makes it easier to absorb for some people, including many diabetics. That’s an important advantage over D-methylfolate, a biologically inactive substance, which needs enzymes in the body to turn it into a useful nutrient.

Pamlab buys its L-methylfolate from a German company, but two years ago it heard of a Chinese company supposedly selling the ingredient at a much cheaper price. It turned out to be a mixture that included D-methylfolate, which Pamlab said it and other companies rejected over concerns about its effectiveness.

The Chinese ingredient surfaced in the U.S. in the past year when Brookstone Pharmaceuticals began selling the substitute under the name Folast. Brookstone has since changed its name to Acella Pharmaceuticals and renamed Folast to Neurpath.

Acella declined a request for an interview, but in court papers it said there was no evidence that its ingredients don’t perform. Acella also rejected allegations that it was misleading consumers and noted that its package inserts and other materials clearly state that Neurpath doesn’t claim to be equivalent to Metanx and has not been tested for equivalency.

So how did Neurpath get linked to Metanx in those national databases used by pharmacists?

That’s something Gordon Johnston, a vice president at the Generic Pharmaceuticals Association., wonders about as well.

Brand-name drugs approved by the FDA are put in the agency’s “Orange Book,” and generic drug manufacturers know they have to demonstrate that their products are a bioequivalent — having essentially the same active ingredients and producing the same effects. But that’s not the case for prescription medical foods.

Pamlab is alleging in court documents that the companies providing the databases to pharmacists were convinced by Brookstone and Acella to treat Folast and Neurpath as an equivalent. Acella rejects the allegation and said the databsse companies decided independently to link the two prescription products.

First DataBank and Medi-Span are not parties in the lawsuit, and they declined to answer questions about how they decided to list Neurpath as equivalent to Metanx. The listings have put pharmacists in a difficult position because with hundreds of medical foods being produced they rely on the databases.

Meanwhile, health care professionals treating patients with neuropathy are scrambling to decide what to do.
Akilis Theoharidis, a podiatrist in St. Joseph and the Kansas City area, prescribes Metanx and prefers his patients use it. He has seen some patients use Neurpath and fail to improve.

But he also recognizes that cost is a consideration. His patients can pay $50 or more for Metanx — or about $20 for a comparable amount of Neurpath. So he tells patients on a tight budget that they can try the cheaper product but should be prepared to switch if it doesn’t work.

Steve Simon, a physician in Leawood, is more firmly in the Metanx camp. He said if Neurpath can’t claim to be an equivalent, then he doesn’t want his patients taking it.

“I say, ‘Do not substitute,’ ” he said.

Chinese connections
Prescription medical foods and their substitutes are an example of how products made in China are making inroads in the U.S. market but don’t offer assurances of being safe or effective.

For example, a recent Government Accountability Office report said that only a fraction of China’s factories making pharmaceuticals for U.S. consumption had been inspected by the Food and Drug Administration. And overseas plants now produce nearly 80 percent of the pharmaceutical ingredients and nearly 40 percent of the finished prescription drugs consumed in the U.S.

An investigation by The Kansas City Star found that Chinese imports have taken over 20 percent of the U.S. market for fish oil capsules, the No. 3 dietary supplement here, but they aren’t labeled with their country of origin despite laws and regulations requiring that.

Chinese officials and companies defend the quality and safety of their products and said defect rates have declined. But problems with ineffective or contaminated drugs have raised questions about the need for U.S. regulators to increase inspections.

To reach Steve Everly, call 816-234-4455 or send e-mail to severly@kcstar.com.

“I kept thinking ‘I ought to lose weight,’” he shared.

Returning home from a baseball game one day, PJ experienced tingling in his hands and feet. “I thought that was odd. So the next day, I checked my blood glucose and my jaw dropped because it was so high. I checked the next day in disbelief, and it was still elevated.”

“Right then and there, I thought ‘My toes at 60. There is NO WAY I was going to lose my toes at 60.’

“

Once PJ was diagnosed with type 2 diabetes, the tight belt became the focus of his attention. “I sucked it up, started to exercise and eat right and lost 30 pounds over 4 months. My glucose dropped and has remained low for 5 years. I even had to put a new hole in my belt!”

“Now I watch my diet and exercise 4 days a week. Keeping my 30 pounds off is challenging. I hate it, but it works! I do it for my toes. I do it for my brain, heart, kidneys, eyes and ultimately, my family. I thank God for the kick in the butt to check my blood glucose that day.”

Developing and maintaining a healthy lifestyle can be a challenge any time of the year, but especially during the holidays. During American Diabetes Month^® this November, join the movement to Stop Diabetes^® and download your very own Celebrations Survival Guide. Get tips to handle the holidays and avoid tight belts this Thanksgiving season.

From American Diabetes Association