MULTIPLE SCLEROSIS -
PROKARIN FREQUENTLY ASKED QUESTIONS

What is Prokarin®?                                                                 
Prokarin® is a transdermal gel - that means that the active ingredients are applied to the skin with a patch.  There are two natural chemicals in Prokarin® and both have been FDA approved for many years.   The active ingredients enter the blood stream through the skin.  It is a therapy discovered and presented to the MS community by Elaine DeLack.  She bases Prokarin® on a study of scientific literature spanning nearly 10 years.  It was when she applied for a ‘use patent’ on Prokarin® that she discovered the work of Dr. Jonez.  Dr. Jonez based his work on Dr. Horton’s from the Mayo Clinic in the 1930’s and 1940’s.

Prokarin® is a compounded (specialty medication) which replenishes an important natural biochemical which most MS patients are deficient in. Our nerve cells communicate by the transmission of certain chemicals, and our body also utilizes these chemicals in times of stress. Prokarin® gives MS patients a chemical that the majority of patients are very deficient in.  Most MS patients are very short of intrinsic factor (IF) which is necessary to absorb vitamin B12 from food.   One of the many functions of Prokarin® seems to be the capability to stimulate the production of (IF) from the parietal cells in the intestine.

The (B12\if) complex travels to the liver where it is coupled with a carrier molecule to transport into the brain.  It is theorized that once through the blood brain barrier, the B12, in the presence of Prokarin® acts as a switch to stimulate the oligodendrocytes to produce myelin, the sheath covering the nerves.  When the nerves have their sheath ‘intact’, then faster nerve transmission occurs.  It is also theorized that “speeded up” nerve transmission to different muscle groups is responsible for reducing the severity of the many symptoms MS patients suffer from.  Patients who replenish with Prokarin® are able to improve the function and control symptoms such as heat sensitivity, decreased balance, muscle spasms, urinary incontinence, fatigue, etc. . . . This is by no means an herbal remedy, it is based on both scientific and observational facts.

Does it work?                                                                       
Prokarin® has been available since August 1999 and there are many people using it.  Elaine DeLack has used it herself for about 3 years.   When she wears consistently, twice daily for 2 consecutive 8 hours intervals her symptoms of fatigue, lack of balance, neuropathy of the legs and feet are controlled.  If she doesn’t use it her original symptoms begin returning within 36 hours.  When she returns to her schedule of 2 patches daily her symptoms are nearly controlled in 48 hours.   Approximately 75% of those who try the therapy find that some of their symptoms are relieved.  Unfortunately, not every MS sufferer experiences improvement.  However, of those who do have a positive experience, many show significant improvement in 1 - 3 of their most troublesome symptoms.

How can it be obtained?                                                       
Prokarin® is available by prescription from pharmacies that are a member of the PCCA (Professional Compounding Centers of America) and who have signed a licensing agreement with EDMS, LLC (a company formed by Marvin and Elaine DeLack).

How can I find a licensed compounding pharmacy?       
You may call the International Academy of Compounding Pharmacists in Texas at 800-927-4227. Many doctors are licensed in a variety of fields and they may write prescriptions.  Standard medical practice demands that a prescribing doctor be fully informed about the medicines he or she prescribes.  Information about Prokarin® can be obtained from the compounding pharmacy or by contacting EDMS.

How do I find a Doctor?                                                            
Call the International Academy of Compounding Pharmacists in Texas at 800-927-4227. The Academy will provide you with names of the nearest Compounding Pharmacist.  When you call the Pharmacy ask them for Doctors that are prescribing Prokarin® near you.  Many doctors are licensed in a variety of fields and they may write prescriptions.  Standard medical practice demands that a prescribing doctor be fully informed about the medicines he or she prescribes.  In order to receive a full packet of information, doctors are asked to submit a one-page “Confidential Disclosure Agreement”.  These can be obtained from any of the licensed compounding pharmacies that are dispensing the Prokarin® system.  A doctor need only request the form, sign it and fax it to the pharmacy that sent it.  The pharmacist will send the packet of information.

How is it used?                                                                           
Prokarin® is dispensed to the patient in a special syringe (it cannot be used for injections so it can be disposed of in regular trash).  Prokarin’s® two main chemicals are combined in a transdermal cream which is then placed within the syringes.  Each syringe is amber, to protect it from light, and is metered, marked in tenths of a ml.  Thus the correct dose of 0.2ml is easily duplicated each time it is applied.   The dose is 0.2ml and it is applied to the skin and covered with an occlusive dressing.  The patch is changed twice daily.  The patch provides an air occlusive dressing which prevents the Prokarin® from drying out.  It must remain moist the entire time it is covered with the patch.

How long do I have to use it before I see improvement?   
Some users report that they experience changes in their condition within just a few days.  Most, however, “patch” for a few weeks before they notice improvements.  Keep in mind that NOT EVERYONE will benefit from the Prokarin® system.  Of those that have positive results, some are more pronounced than others.  It is important to give enough time for the initial trial.  One patient had used the Prokarin® faithfully for almost 6 weeks.  He reported that he felt nothing so he discontinued his Prokarin®.  A week later he contacted his pharmacist and reported that his legs felt encased in concrete.  He had forgotten that this was how he felt prior to beginning Prokarin®.  He refilled his prescription.

How long do I have to use it?                                                   
Prokarin® is NOT a cure for MS.  Its use is similar to insulin.  When it is successful it will probably need to be used for life - or until something better comes along.  The experience with Prokarin® is very short, but in that time there have been great advancements and renewed hope that someone, somewhere will find the path to treatment and cure.  We know that all the results documented by the physicians prescribing Prokarin® so far are anecdotal because their patients are not enrolled in any accredited studies.  Nevertheless, all the reports from patients and compounding pharmacists are certainly very encouraging at this time.

How do I store it?                                                                       
The Prokarin® syringes should be kept under refrigeration (approximately 38 - 45 degrees F).  Some people have recommended keeping the doses in the butter compartment of the refrigerator.  When it gets too cold it freezes and no longer has any activity.  There is evidence that there is also some degree of inactivation when the gel is exposed to warm temperatures.  Elaine DeLack has found that if Prokarin® is left unrefrigerated for 8-12 hours it looses the majority of its 70 day potency.  Prokarin® is made fresh in the compounding pharmacy and it bears a “use before” date of  70 days.

Are there side effects?                                                               
A variety of side effects are “possible”, primarily as a result of the active ingredients.  However, only very minor problems have been reported.  When a person gets their first prescription filled for Prokarin® they will receive a written description of the possible side effects.  The most common problem reported so far is some minor skin irritation that is easily cleared up and prevented by using a mild hydrocortisone cream (the dispensing pharmacists provide this with the prescription when you request it).

Should I avoid certain medicines or foods?                           
Prokarin® presumably exerts its effects by acting with certain H2 receptors in the body.  These receptors are blocked by certain medicines commonly sold to ease stomach discomfort.  Prokarin® users are warned to avoid Tagamet and Zantac, and any variations that claim to be H2 histamine blockers.  However, there is no evidence so far that using antihistamines (for colds, sniffles, allergies, or itching) has any bad effect.  Many people have used common antihistamines without problems (diphenhydramine, Benadryl, etc.).  Many would be users are hesitant to try it for fear of initiating an asthma attack.  Medical books state that asthma is triggered by h1 receptors, not h2.  So far we have not heard of any adverse reactions for patients with asthma.

Will it damage my skin?                                                               
Some users experience irritation and redness at the place where they place their patches.  This is easily treated with hydrocortisone and it can be avoided by using the hydrocortisone cream prior to applying the patch.  It is important to rotate patch sites.   The information that is supplied with the original prescription shows some 28 acceptable sites so everyone should be able to find 4 to 6 sites to use on their body.

Is it FDA approved?                                                                       
Prokarin® is compounded from FDA approved chemicals.  Like every compounded medication, it does not have FDA approval itself and it does not bear a National Drug Code (NDC number), nor is an NDC number required.  Prokarin® is not made of herbs or some type of “mystical” ingredients.  There is solid scientific evidence supporting the formulation and experience supports the science for many users.

Will my insurance pay for it?
If your insurance pays for ANY compounded prescription product then it OUGHT to pay for Prokarin®.  Pharmacists do not generally “accept assignment” for compounded prescriptions.  They will, however, provide you with sufficient information for you to submit a claim for reimbursement.  Be sure to ask your compounding pharmacist to help by giving you a Universal Claim Form.  Prokarin® does not differ in any way from other prescriptions that your compounding pharmacist prepares.  As mentioned above, it does not have an NDC number.  It cannot have one because compounding pharmacists operate under a pharmacy license, not a manufacturing license.  The FDA reserves the use of NDC numbers only for licensed manufacturers for an approved finished drug product.

All chemicals or bulk drugs that compounding pharmacists use are FDA approved, but do not nor are they required by the FDA to have an ‘NDC’ number. To apply a dummy or made-up number would violate Federal code. That should NOT interfere with your ability to be reimbursed by your insurance company.  At the present, however, neither Medicare nor State Medicaid programs reimburse for Prokarin® or other compounded prescriptions.  Many insurance companies have started to reimburse the patients who are using the new patch therapy.

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