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Saturday, November 28, 2015

CGRP Antagonists: Treatment of Migraine Can we prevent release of CGRP rather than treat with Antagonists

There is big money in the treatment of migraines.

 According to the Tevapharm.com website Teva and Hepartes entered in an agreement to discover and develop novel, small-molecule CGRP Antagonists for treatment of migraine.  Hepartes may receive potential payments of $400 million.  This is excellent news because much of the current drug regimens have safety and effectiveness issues.

Is there a better alternative to CGRP Antagonists for migrane.
Calcitonin gene-related peptide is a vaso-active neuropeptide released by branches of the Trigemino-vascular system of the Trigeminal Nerve.  CGRP and other neurotransmitters released at nerve synapses have been implicated in migraine headaches. 
Drug therapy for migraines are big business worldwide.  The question is there a better method of preventing and eliminating migraines available.
It is unlikely that funding to evaluate neuromuscular dentistry as migraine prevention will ever materialize.  This is in spite of the fact that it is well established that almost 100% of all headaches and migraines (including Trigeminal Autonomic cephalgias) are Trigeminally controlled.
The Trigeminal Nerve is often called the Dentist's nerve because it innervates the teeth (ie. dental pulp), the Periodontal Ligaments, the Jaw Muscles, the Jaw Joints, the anterior two thirds of the tongue, the tensor of the ear drum, the tensor of soft palate (opens and closes eustacian tubes).
The Trigemino-Cervical Complex descends cervically and connects to the sympathetic chain and is responsible for neck and occipital headaches.
The TrigeminoVascular System controls blood flow to the anterior two thirds of the meninges of the brai.  It is in this location that CGRP are released causing vaso dilation asociated with migraines.
The question is not can these drugs work but rather is it possible to prevent the release of the vasoactive neuropeptides by changing input to the trigeminal nervous system?
After accounting for amplification in the Reticular Activating System the Trigeminal Nervous System accounts for more that half of all input to the brain.
If we think of the brain as our central computer we can discuss the computer concept
GARBAGE IN- GARBAGE OUT  as a cause of all migraines and headaches.
Noxious input to the Trigeminal Nervous System causes release of neurotransmitters and vaso-active neuropeptides to the meninges of the brain  that are trigeminally innervated.
Can changing input correct migraine physiology.  The Sphenopalatine Ganglion (SPG) is the Largest Parasympathetic Ganglion of the head.  The SPG Block is extremely effective is stopping and preventing migraines and since it is generally done with lidocaine it is very safe.
Trigeminal fibers pass thru the Ganglion but do not have cell bodies there.  There are currently numerous implantable devices being studied that can change neural input to the Sphenopalatine Ganglion and treat Migraines, Cluster Headaches, Anxiety, Depression and many other disorders.  The block turns of the sympathetic overload of the fight or flight response.  In the parasympathetic mode we feel relaxation, safety, satiety, sexual,  loving, etc
This is proof of fact that changing neural input can treat, prevent and eliminate migraines and other headaches.
Neuromuscular Dentistry also has been shown to be very effective in treating patients with chronic headaches and migraines.  Unfortunately thousands of individual case studies do not carry the same evidence based medicine weight of double blind drug studies.  By its nature it is not possible to do double blind studies with neuromuscular Dentistry.......
There is a situation that clearly showed  the effectiveness of a Neuromuscular TMJ treatment program at Chicago HMO in the 1980's until 1993.
In the 1980's until 1993 I worked closely with Dr Mitchell Trubitt the Medical Director of Chicago HMO.  What started as a fight for insurance coverage for a single patient moved on to a test with six patients to see if Neuromuscular Dentistry could lead to cost savings for insurance compaines.  The initial test was six patients who were treated with neuromuscular orthotics for their TMJ and Headache problems.   All six patients had two surgical opinions stating TMJoint surgery was needed.  All six patients were treated without surgery.  The patients all reported being very happy with results that included relief of headaches and migraines.
The results were that we demonstrated estimated massive savings $250,000 on  just those six patients.  Because of the positive results of that test Chicago HMO began to cove 100% of the cost of Phase one Neuromuscular TMJ treatment .  These savings reflected hospitalization and surgery costs, surgical fees, anaesthesia and physical therapy.  Chicago HMO did not cover phase two treatment so all patients were fitted with appliances made on vitallium frameworks to prevent breakage.  Patients desiring orthodontics or crowns were not reimbursed by medical insurance.
Chicago HMO did not decide to cover  TMJ, disorders, in fact contract language specifically stated non-surgical treatment of TMJ problems were not covered.  In spite of that language Dr Trubitt authorized coverage due to cost savings.  Chicago HMO doctors who referred patients for non-surgical treatment actually were charged less for out of network referrals.  TMJ was given the same cost for referring physicians as Cancer and Heart Disease.
Patients not only experienced improvements in TMJ disorders but also reduction and elimination of headaches and migraines.  TMJ has been called "The Great Imposter" because so many diverse ymptoms are associated with it.  At the time Chicago HMO had no means of tracking drug savings nor did they consider costs of other related disorders.
When insurance coverage and out of pocket costs were taken out of the picture with a guarantee payment we were no longer in a pay per procedure mode but a global fee.  Trigger point injections, SPG Blocks and other procedures were used without additional costs leading to rapid patient improvement.
While there were no patient complaints during the program there were several complaints from oral surgeons objecting to a general dentist seeing patients for non-surgical treatment on patients they deemed surgery necessary.
In 1993 United Health Care bought out Chicago HMO (parent HMO America) and the program ended abruptly even though it had demonstrated significant savings over several years.
I met with the new medical director along with Dr Trubitt in an attempt to keep this very successful treatment and cost containment program going but was told that since United Health Care didn't pay for surgery they would save money treating TMJ non-surgically.
Four years after this experience The Shimshak article was  published that showed that patients carrying a TMJD diagnosis had a 200% increase in total medical expenses.  Shimshak stated "The majority of these differences were attributed to conditions that were not usually considered related to TMJ disorders. These utilization and cost differences extended, in varying degrees, over a wide range of diagnostic and healthcare provider categories."  (Pubmed abstract below)
One year later a follow-up study showed that the increased costs were actually 300% over patients not carrying TMJ diagnosis.  Shimshak stated "For some of the major diagnostic categories, such as nervous, respiratory, circulatory, and digestive, the inpatient and outpatient claims differences in utilization and costs were as large as 3 to 1. For only one diagnostic category, pregnancy and childbirth, were utilization and costs greater for non-TMJ subjects than TMJ patients. The psychiatric claims for TMJ patients exhibited differences that were at least twice as large as those for the non-TMJ subjects." (pubmed abstract below)

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 1997 Apr;15(2):150-8.

Medical claims profiles of subjects with temporomandibular joint disorders.

Abstract

The primary goal of this study was to evaluate the claims profiles of subjects with TMJ disorders relative to a control group without the disorders and to provide a characterization of the type of healthcare services received and the associated costs of healthcare for patients with TMJ disorders. The administrative data base of a major medical insurer was used to compare the claims history of 1,819 patients diagnosed with TMJ disorders to matched controls. The analysis was based only on medical claims. The study found that total medical claim payments for the patients with TMJ disorders were double that of the subjects without TMJ disorders, and similarly, the utilization of institutional and professional care services was found to be approximately twice as high, though not uniformly distributed across all Major Diagnostic Categories, physician specialties or types of service. The level and nature of the differences in the quantity and costs of healthcare between subjects with and without TMJ disorders were unexpectedly large. The majority of these differences were attributed to conditions that were not usually considered related to TMJ disorders. These utilization and cost differences extended, in varying degrees, over a wide range of diagnostic and healthcare provider categories.

 1998 Jul;16(3):185-93.

Health care utilization by patients with temporomandibular joint disorders.

Abstract

The claims data base of a large New England managed care organization was used to compare the health care utilization patterns of patients with TMJ disorders to non-TMJ subjects. Inpatient, outpatient and psychiatric claims data were examined over a wide range of diagnostic categories. Age and sex adjusted results showed that, overall, patients with TMJ disorders were greater utilizers of health care services and had higher associated costs than non-TMJ subjects. For some of the major diagnostic categories, such as nervous, respiratory, circulatory, and digestive, the inpatient and outpatient claims differences in utilization and costs were as large as 3 to 1. For only one diagnostic category, pregnancy and childbirth, were utilization and costs greater for non-TMJ subjects than TMJ patients. The psychiatric claims for TMJ patients exhibited differences that were at least twice as large as those for the non-TMJ subjects.

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posted by Dr Shapira at 9:03 AM

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