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& Temporomadibular Joint
aka
TMJ  Eventually Cancer.
Click Slide Show Draft for New TN Patients.
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 Page 6 of 7  Bilateral Facial Pain and Bitter Taste in the Mouth. http://www.briannelsonconsulting.com/trigeminal-neuralgia-tn/bilateral-facial-pain.html 

 Page 7 of 7 Patient Painful Stories  You are at: http://www.BrianNelsonConsulting.com/trigeminal-neuralgia-tn/patient-painful-stories.html

 

You can find this site again  by typing  the word "neuralgia1" backwards, ie.  OR "1aiglaruen"in Google. Brian "

 

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Today's  special sale: Business is slow. Call me right now while this include page is up and get a 23% discount off any www.PartyTentCity.com  order.  No charge for shipping if picked up at  31 Gessner Rd.  in Houston, TX  77024 Use PayPal to Brian@NelsonIdeas.com or Call Brian 713-467-3025. http://www.NelsonIdeas.com/Directory-All-Websites/Alphabetical.html
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Contact information for this Website:
 
Brian Nelson

 31 Gessner Rd. Houston, TX  08/25/2009 09:31 PM -0500
713-467-3025  Fax 713-467-3192  
Click: E-mail me
 
Trigeminal Neuralgia, aka Tic douloreaux  or  TN
&
Temporomandibular  Joint aka TMJ  Eventually Cancer.This website is about Brian Nelson's fight with a parotid (salivary) gland tumor. It started out with the symptoms of  Trigeminal Neuralgia, aka Tic douloreaux  or  TN & Temporomadibular Joint aka TMJ Click Here to see my other record file at IAmFightingCancer.com  Bookmark this page now!  
 
Scan down to read my very lengthy and detailed web journal. Call me if I can help you. 713-467-3025 Brian
Signature Card For:                 Brian Nelson    31 Gessner Rd. , Houston, TX  77024
Tel. 713-467-3025 (Refers to my cell)      Fax 713-467-3192        
Click here to e-mail me.

www.NelsonIdeas.com
       Make a difference in the world!  "Idea Possibility Consulting"
www.BrianNelsonConsulting.com    There are so many new ways to make more profit. 
www.PartyTentCity.com 
                                The best modular party tent you can buy!
www.IamFightingCancer.com   Brian's story on Cancer and TN.  Post your Cancer story!

Bookmark this page now!

Trigeminal Neuralgia, aka Tic douloreaux  or  TN
& Temporomadibular Joint
aka
TMJ  Eventually Cancer.
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Dear Trigeminal Neuralgia Suffer,

I hope you can learn something from these 4 very large compendium pages.   I will add any information you may want me to submit to these pages or created a hyperlink to the page or create a new page for that information.    IT is unfortunate that much is yet unknown about TN (Trigeminal Neuralgia ). Because it basically is not a fatal disorder the amount of research being done is very small. Every tidbit of new learning is most valuable and well received by the TN community. 

A lot of information can be obtain by simply learning from those who have the disorder. Compiling those facts is encouraged.  You can contact the Trigeminal Neuralgia Association and complete a survey form. _______

In addition I am compiling a different form of data. You can help with that by sending me your full story about your bout with TN and how it has affected your life. You  would send this to me at bnelson@PartyTentCity.com  .  You  can  attach your name or leave it anonymous. I encourage you to provide your contact information so the data can be verified. I can also send you updates on new things I am finding.  When everyone collates their data together we can learn significant things. The smallest common tidbit can be extremely valuable to a suffering soul. We can significantly help each other but we have to be willing to share.

Please let me hear from you. I  will respond to you personally as one of my "Pain Pals"

Painfully Yours.

Brian Nelson
31 Gessner Rd.
Houston, TX  77024
Click here to e-mail me.
713-467-3025

[an error occurred while processing this directive]
 2  Treatments for TN and related facial pain

        There are multiple ways to treat TN, including medications and surgical treatments. Initially  the  treatment option is  through medications. Surgical procedures are used for  patients unable to tolerate the medications, exhibit serious side effects from the medications  or if the medications do not control the problem.  but over a period of time their effectiveness may diminish and a surgical procedure required.
 During all phases of medical treatment, patients need good communication with their physician and nurse to monitor their medication and response. The patient must understand the need to maintain a therapeutic blood level of medication for effective pain relief. Taking the medications irregularly is not effective.
        Abrupt withdrawal of medications can cause serious side effects. Analgesics (i.e. aspirin, Tylenol, etc.) are not effective in addressing the pain of TN as it is of lightning-like intensity and the attacks are of brief duration. In general, narcotics have not been recommended as first line therapy for TN, as they have not been found to be effective for the characteristics of TN pain. While there are no controlled studies in TN, there is recent information that narcotics may be helpful in other painful conditions that have similar pain characteristics.
        The primary drug used to treat TN is carbamazepine. It is also used to treat seizures. Initial relief is so readily achieved that many physicians consider its use as a means to confirm the diagnosis of TN. The drug is introduced slowly and increased to a level where the patient is pain-free or side effects occur.
        Carbamazepine is available as Tegretol. A newer medication is oxcarbazepine, available as Trileptal. Extended release carbamazepine is available as Carbatrol and Tegretol XR.
        In the last several years, oxcarbazepine (Trileptal) has been used more frequently as a first line drug for TN. It is structurally related to carbamazepine, and may be preferable due to a more favorable side effect profile.
        Other medications used in the treatment of TN may include baclofen (Lioresal), gabapentin (Neurontin), clonazepam (Klonopin), sodium valporate (Depakote), lamotrigine (Lamictal), and topiramate (Topamax).

TN In the News:   Dr. Donohue: Medicines can control many facial tics

4 Information about Neurontin Drug

The drug Neurontin was FDA approved only as a supplementary treatment for partial seizures when no other treatment options were working. Now, Pfizer, the world’s largest drug company, is the target of lawsuits that are in part due to its drug Neurontin and the improper promotion of it. The FDA sent multiple letters to Pfizer because the agency found the drug Neurontin to be improperly represented. Both in 2001 and 2002, the drug Neurontin raised eyebrows, leading the FDA to warn Pfizer about its’ marketing materials.

In May 2002, the Public Citizen consumer group posted an article on the drug Neurontin titled, “The Illegal Corporate Creation of a Blockbuster Drug”. The article exposed evidence of Pfizer’s illegal promotion of unapproved uses for the drug Neurontin. The company was able to use a loophole in FDA policy to come up with more ways to use the drug Neurontin, greatly expanding a previously small corner of the market in order to turn the drug Neurontin into a blockbuster.

Estimates as high as 90% of the drug Neurontin’s sales are from off-label uses that have fueled it to become an over $1.3 billion per year force. Critics of the FDA point to the drug Neurontin as an example of the seemingly little degree of caution that the agency is able to enforce. The FDA had sent Pfizer warning letters because the agency believed the drug Neurontin was being improperly represented.

Civil suits are currently against Pfizer for the drug Neurontin. Consumers and consumer groups are unhappy with large drug companies that over push their products, such as the drug Neurontin, as government regulators appear to enforce little punishment against powerful firms. Various watchdog groups have been critical of the FDA’s lack of aggressive action to protect consumers and the drug Neurontin is one of the most documented cases of the growing power pharmaceutical companies have to manipulate the market.  

For more information on Neurontin, please contact us.

More Neurontin Breaking News:

June 7, 2004 - "Pfizer Sued Again Over Improper Marketing of Neurontin"

June 1, 2004 - "Pfizer to Settle Neurontin Marketing Suit"

May 20, 2004 - "A petition is asking the Food and Drug Administration to act on claims that it may be tied to suicidal behavior."

May 18, 2004 - "Law Firm of Finkelstein and Partners files formal objection to the
proposed criminal plea agreement. It disregards hundreds of American deaths
and injuries attributable to their admitted criminal acts"

May 17, 2004 - "Law Firm of Finkelstein and Partners files Citizen Petition with
FDA to include suicide warnings on Neurontin labeling"

May 13, 2004 - "Pfizer pleads guilty to U.S. criminal charges of misbranding Neurontin"

March 11, 2004 - "Parke-Davis unit of Pfizer faces Neurontin lawsuit"

January 22, 2004 - "Pfizer's profits fall following personal injury claims and government investigation"

 

Trigeminal Neuralgia, aka Tic douloreaux  or  TN
&
Temporomandibular  Joint aka TMJ  Eventually Cancer.This website is about Brian Nelson's fight with a parotid (salivary) gland tumor. It started out with the symptoms of  Trigeminal Neuralgia, aka Tic douloreaux  or  TN & Temporomadibular Joint aka TMJ Click Here to see my other record file at IAmFightingCancer.com  Bookmark this page now!  
 
Scan down to read my very lengthy and detailed web journal. Call me if I can help you. 713-467-3025 Brian
Signature Card For:                 Brian Nelson    31 Gessner Rd. , Houston, TX  77024
Tel. 713-467-3025 (Refers to my cell)      Fax 713-467-3192        
Click here to e-mail me.

www.NelsonIdeas.com
       Make a difference in the world!  "Idea Possibility Consulting"
www.BrianNelsonConsulting.com    There are so many new ways to make more profit. 
www.PartyTentCity.com 
                                The best modular party tent you can buy!
www.IamFightingCancer.com   Brian's story on Cancer and TN.  Post your Cancer story!

 5          What Is Trigeminal Neuralgia?

TN (Trigeminal Neuralgia / tic douloureux) is a disorder of the fifth cranial (trigeminal) nerve that causes episodes of intense, stabbing, electric shock-like pain in the areas of the face where the branches of the nerve are distributed - lips, eyes, nose, scalp, forehead, upper jaw, and lower jaw.  By many, it's called the "suicide disease".  A less common form of the disorder called "Atypical Trigeminal Neuralgia" may cause less intense, constant, dull burning or aching pain, sometimes with occasional electric shock-like stabs.   Both forms of the disorder most often affect one side of the face, but some patients experience pain at different times on both sides.  Onset of symptoms occurs most often after age 50, but cases are known in children and even infants. Something as simple and routine as brushing the teeth, putting on makeup or even a slight breeze can trigger an attack, resulting in sheer agony for the  individual. Trigeminal neuralgia (TN) is not fatal, but it is universally considered to be the most painful affliction known to medical practice.  Initial treatment of TN is usually by means of anti-convulsant drugs, such as Tegretol or  Neurontin.  Some anti-depressant drugs also have significant pain relieving effects.  Should medication be ineffective or if it produces undesirable side effects, neurosurgical procedures are available to relieve pressure on the nerve or to reduce nerve sensitivity.  Some patients report having reduced or relieved pain by means of alternative medical therapies such as acupuncture, chiropractic adjustment, self-hypnosis or meditation.

6  Important Subjects found on this site
 
Trigeminal Neuralgia aka tic douloreau, Information Page,TN,  Pain Management, Neurontin.   anti-depressant drugs  pain relieving effects.    medication   undesirable side effects, neurosurgical procedures relieve pressure  nerve sensitivity.   reduced or relieved pain   alternative medical therapies such as acupuncture, chiropractic adjustment, self-hypnosis or meditation.Trigeminal Neuralgia, tic doloreaux, tic douloureux, Trigeminal disorder, what is Trigeminal Neuralgia, Carbamazepine is available as Tegretol. A newer medication is oxcarbazepine, available as Trileptal. Extended release carbamazepine is available as Carbatrol and Tegretol XR. TN, trigeminal neuralgia surgery, trigeminal neuralgia treatment, tic dolorue, trigeminal neurolgia, trigeminal, trigeminal neuropathy, trigeminal neuralgia cure, trigeminal nerve surgery, trigeminal neualgia, trigeminal neuralga, trigeminal nueralgia, mri of trigeminal nerve, trigeminal neuralgias, Trigeminal Neuralgia symptom, Trigeminal Neuralgia research, information on Trigeminal Neuralgia, trigeminal nerve injury, trigeminal nerve damage, trigeminal cranial nerve, trigeminal neralgia, tic douloureaux, symptom of tic douloureux,   Trigeminal Neuralgia (tic doloreaux) information Trigeminal Neuralgia - Trigeminal neuralgia (TN), also known as tic douloureux, is a pain syndrome recognizable by patient history alone. The condition is characterized by pain often accompanied by a brief facial spasm or tic. Pain distribution is unilateral and follows the sensory distribution of cranial nerve V, typically radiating to the maxillary (V2) or mandibular (V3) area. Physical examination eliminates alternative diagnoses. Signs of cranial nerve dysfunction or other neurologic abnormality excludes the diagnosis of idiopathic,glossopharyngeal, face pain, atypical face pain, atypical trigeminal neuralgia, TN, ATN, ATFP, AFP, GN, orofacial, cranio-facial, gum pain, gingival pain, cheek pain, orofacial, cranio-facial,facial neuralgia, face neuralgia, trigeminal neuralgia, tic douloureux, glossopharygeal neuralgia, face pain, facial pain, atypical face pain, atypical trigeminal neuralgia, TN, ATN, ATFP, AFP, GN, Trigeminal Neuralgia Resources, myofascial, orofacial, cranio-facial, gum pain, gingival pain, cheek painTrigeminal neuralgia, also called ticdouloureux, the most frequent of all neuralgias, causes severe, stabbing, paroxysmal pain on one side of the face. It is characterized by a sudden, severe, electric shock-like or stabbing pain typically felt on one side of the jaw or cheek. The cause of trigeminal neuralgia is unknown, but the disorder occurs most frequently in middle or old age (more common in women than in men,trigeminal neuralgia, face, facial pain, nerve, forehead, eye, cheek, jaw, tumor, arteriovenous malformation, multiple sclerosis, anticonvulsants, Tegretol, carbamezapine, Dilantin, phenytoin Neurontin, gabapenti, Baclofen, lioresal, microvascular decompression, MVD, Gamma knife, radiosurgery, percutaneous, glycerol rhizotomy, alternative surgery, glossopharyngeal neuralgia, cranial nerve, trigeminal, facial pain, face, cheek, jaw, stabbing, electricTrigeminal Neuralgia - Aretaeus of Cappadocia, known for one of the earliest descriptions of migraine, is credited with the first indication of trigeminal neuralgia (TN). headache "spasms and distortions of the countenance took place." John Fothergill was the first to give a full and accurate description of TN in a paper titled "On a Painful Affliction of the Face,"  presented to the medical society of London in 1773. Nicholaus Andre coined the term  trigeminal neuralgia, fothergill syndrome, fothergill's syndrome, tic douloureux, tn,

 7
Treating Trigeminal Neuralgia

   There is a growing arsenal of ways to treat TN, including medications and surgical treatments. The first universally accepted treatment option is usually through medications. Surgical procedures are used for those patients who are unable to tolerate the medications, exhibit serious side effects, or if the medications do not control the problem. Medications are initially effective for many patients, but over a period of time their effectiveness may diminish and a surgical procedure required.
        During all phases of medical treatment, patients need good communication with their physician and nurse to monitor their medication and response. The patient must understand the need to maintain a therapeutic blood level of medication for effective pain relief. Taking the medications irregularly is not effective.
        Abrupt withdrawal of medications can cause serious side effects. Analgesics (i.e. aspirin, Tylenol, etc.) are not effective in addressing the pain of TN as it is of lightning-like intensity and the attacks are of brief duration. In general, narcotics have not been recommended as first line therapy for TN, as they have not been found to be effective for the characteristics of TN pain. While there are no controlled studies in TN, there is recent information that narcotics may be helpful in other painful conditions that have similar pain characteristics.
        The primary drug used to treat TN is carbamazepine. It is also used to treat seizures. Initial relief is so readily achieved that many physicians consider its use as a means to confirm the diagnosis of TN. The drug is introduced slowly and increased to a level where the patient is pain-free or side effects occur.
        Carbamazepine is available as Tegretol. A newer medication is oxcarbazepine, available as Trileptal. Extended release carbamazepine is available as Carbatrol and Tegretol XR.


        In the last several years, oxcarbazepine (Trileptal) has been used more frequently as a first line drug for TN. It is structurally related to carbamazepine, and may be preferable due to a more favorable side effect profile.  Other medications used in the treatment of TN may include baclofen (Lioresal), gabapentin (Neurontin), clonazepam (Klonopin), sodium valporate (Depakote), lamotrigine (Lamictal), and topiramate (Topamax).
      

 

















 

 

 

 

9  the agency to add a warning to the labeling for Neurontin and to send a letter to doctors and other health-care professionals.

[FDA]According to the petition, the number of suicides reported by Pfizer to the FDA jumped to 17 in the first six months of 2003, the latest information available, compared with a total of eight from 1998 through 2002. Drug companies are required by law to file such reports.

Mr. Finkelstein said he filed the petition because the "sudden uptick in reports" meant that FDA officials "have enough in their own data set to take action without any delay."

In a statement, Pfizer said it remains "confident of the safety and effectiveness of this product" and it would be "extremely irresponsible if the petition or accompanying publicity were used to promote the false impression that there is a causal link between Neurontin and suicide." The company said it hasn't seen the petition, but is aware that law firms are soliciting as clients current and former Neurontin patients.

Neurontin brought Pfizer revenue of $2.7 billion in 2003. The drug is sold in more than 100 countries and has been prescribed to about 10 million patients since it was launched in 1994.

Last week, Pfizer unit Warner-Lambert pleaded guilty to illegally promoting the drug for a variety of uses not approved by the FDA, and agreed to pay a total of $430 million in fines and damages. Neurontin originally was approved as a supplemental antiseizure treatment for epilepsy, but it is widely used "off label" for a variety of other conditions, including migraines, bipolar disorder and pain.

An FDA spokesman said the agency "looks forward to reviewing and responding" to the petition.

The agency frequently doesn't regard information from its own adverse-event reporting system as a definitive measure of risk. In addition, it often is tough for regulators and drug companies to clearly tie suicidal behavior to a specific medication, particularly in patients suffering from psychiatric disorders.

In the early 1990s the FDA rejected a petition from a group funded by the Church of Scientology to ban the antidepressant Prozac because of concerns it could lead to suicidal behavior and other bad effects, and an agency advisory committee voted against a label warning. That issue has re-emerged recently because of concerns that some antidepressants may somehow be tied to suicidal tendencies in young people. The FDA recently asked drug makers to add a new, generally worded warning to their labels urging doctors and others to closely monitor all patients on antidepressants.

10 Neurontin News

May 20, 2004 Pfizer Inc.'s drug Neurontin, at the heart of a controversy over an illegal marketing scheme, is facing a new challenge: a petition asking the Food and Drug Administration to act on claims that it may be tied to suicidal behavior.

The petition to the FDA came from Finkelstein & Partners, a personal-injury law firm in Newburgh, N.Y., that has filed three suits against Pfizer on behalf of people who committed suicide or attempted it. The suits allege that Neurontin played a role in the suicidal behavior.

Andrew Finkelstein, the managing partner at the firm, says he plans to file hundreds of more suits. Largely by running television ads raising questions about the drug, he has accumulated a list of 160 suicides and 2,000 attempts by people who were taking Neurontin for a variety of ailments, he says.

The petition to the FDA, however, is based on the FDA's own adverse-event reporting database, not Mr. Finkelstein's list of clients. It asks the agency to add a warning to the labeling for Neurontin and to send a letter to doctors and other health-care professionals.

[FDA]According to the petition, the number of suicides reported by Pfizer to the FDA jumped to 17 in the first six months of 2003, the latest information available, compared with a total of eight from 1998 through 2002. Drug companies are required by law to file such reports.

Mr. Finkelstein said he filed the petition because the "sudden uptick in reports" meant that FDA officials "have enough in their own data set to take action without any delay."

In a statement, Pfizer said it remains "confident of the safety and effectiveness of this product" and it would be "extremely irresponsible if the petition or accompanying publicity were used to promote the false impression that there is a causal link between Neurontin and suicide." The company said it hasn't seen the petition, but is aware that law firms are soliciting as clients current and former Neurontin patients.

Neurontin brought Pfizer revenue of $2.7 billion in 2003. The drug is sold in more than 100 countries and has been prescribed to about 10 million patients since it was launched in 1994.

Last week, Pfizer unit Warner-Lambert pleaded guilty to illegally promoting the drug for a variety of uses not approved by the FDA, and agreed to pay a total of $430 million in fines and damages. Neurontin originally was approved as a supplemental antiseizure treatment for epilepsy, but it is widely used "off label" for a variety of other conditions, including migraines, bipolar disorder and pain.

An FDA spokesman said the agency "looks forward to reviewing and responding" to the petition.

The agency frequently doesn't regard information from its own adverse-event reporting system as a definitive measure of risk. In addition, it often is tough for regulators and drug companies to clearly tie suicidal behavior to a specific medication, particularly in patients suffering from psychiatric disorders.

In the early 1990s the FDA rejected a petition from a group funded by the Church of Scientology to ban the antidepressant Prozac because of concerns it could lead to suicidal behavior and other bad effects, and an agency advisory committee voted against a label warning. That issue has re-emerged recently because of concerns that some antidepressants may somehow be tied to suicidal tendencies in young people. The FDA recently asked drug makers to add a new, generally worded warning to their labels urging doctors and others to closely monitor all patients on antidepressants.

Neurontin News

June 7, 2004

"Pfizer Sued Again Over Improper Marketing of Neurontin"

Just weeks after Pfizer and its Warner-Lambert Co. unit were penalized $430 million in federal and state courts for selling Neurontin for purposes that have not yet been FDA approved, the company is again under fire for fraudulent marketing practices. The company pleaded guilty in May to two felony counts of violating the Food, Drug and Cosmetic Act.

This week, the Alaska State Employees Association health benefits trust filed a lawsuit mirroring that of federal and state prosecutors, claiming the pharmaceutical company reaped billions of dollars in profits by marketing its drug for unapproved, or "off-label," uses. According to the suit, Neurontin, which received FDA approval in 1993 for the partial treatment of epilepsy, was "aggressively marketed by Warner-Lambert" for bipolar mental disorders, Lou Gehrig's disease, attention deficit disorder, migraines and various pain disorders.


The suit also claims that the company's revenue for Neurontin jumped from $97.5 million in 1995 to $2.5 billion in 2003, and that by 2003, 90 percent of the drug's prescriptions were for "off-label" uses. The company is accused of falsifying clinical trials and illegally paying physicians to prescribe Neurontin and conceal the off-label use on claim forms.

 

Trigeminal Neuralgia, aka Tic douloreaux  or  TN
&
Temporomandibular Joint aka TMJ  Eventually Cancer.This website is about Brian Nelson's fight with a parotid (salivary) gland tumor. It started out with the symptoms of  Trigeminal Neuralgia, aka Tic douloreaux  or  TN & Temporomadibular Joint aka TMJ Click Here to see my other record file at IAmFightingCancer.com  Bookmark this page now!  
 
Scan down to read my very lengthy and detailed web journal. Call me if I can help you. 713-467-3025 Brian
Signature Card For:                 Brian Nelson    31 Gessner Rd. , Houston, TX  77024
Tel. 713-467-3025 (Refers to my cell)      Fax 713-467-3192        
Click here to e-mail me.

www.NelsonIdeas.com
       Make a difference in the world!  "Idea Possibility Consulting"
www.BrianNelsonConsulting.com    There are so many new ways to make more profit. 
www.PartyTentCity.com 
                                The best modular party tent you can buy!
www.IamFightingCancer.com   Brian's story on Cancer and TN.  Post your Cancer story!
12 Trigeminal Neuralgia  from http://www.neurosurgery.ucsd.edu/cnd/trigeminal_neuralgia.htm

Introduction

Trigeminal Neuralgia (TN), or "Tic Douloureux" is characterized by intermittent, shooting pain in the face. TN is diagnosed by clinical symptoms, but all patients should have an MRI scan of the head to evaluate for any intracranial abnormality. The most common cause of Trigeminal Neuralgia is an enlarged looping artery or vein pressing on the Trigeminal nerve at the base of the brain. Other less frequent causes are multiple sclerosis or a brain tumor, both of which can usually be identified by MRI scan when they exist. Tumors require immediate surgical attention, whereas face pain caused by multiple sclerosis can be treated the same as Trigeminal Neuralgia except that microvascular decompression is not feasible. Face pain which is secondary to a dental procedure, or which is classified as "atypical facial pain," is different from Trigeminal Neuralgia and the following comments may not be applicable.

The initial treatment for Trigeminal Neuralgia should be medical. The most effective drugs are carbamazepine (Tegretol®) and gabapentin (Neurontin®). They should be started at a low dose and gradually increased with the ideal dosage being that which controls the pain but does not cause side effects. If during therapy the pain subsides completely for four weeks, it is reasonable to gradually reduce the dosage and see if the Trigeminal Neuralgia has gone into remission. If the pain recurs the drug can be re-instituted.

Once the initial pain is controlled it is important to consider the natural history of Trigeminal Neuralgia in order to understand long term management. (see below)

For those patients whose symptoms cannot be controlled medically without side effects such as nausea, ataxia, or mental dulling, or who desire long term relief without medication, it is wise to consider surgical options. The surgical options can be divided into two categories: non-destructive procedures and destructive procedures. (see below)

Natural History

Trigeminal Neuralgia can occur at any age, but usually has its onset in individuals over fifty. It is common for the pain of Trigeminal Neuralgia to come and go spontaneously (frequently referred to as waxing and waning), which often makes it difficult to know whether any specific treatment is beneficial.

Unfortunately, over time the pain of Trigeminal Neuralgia usually becomes more severe and more frequent, requiring higher dosage and more continuous use of medications. As a result, many patients whose pain was initially well controlled with medication find over time that they must increase to toxic levels in order to control their pain. At this point, unless they are willing to exist with the pain or in a toxic state, they require surgical intervention.

An Alternate Strategy

Instead of waiting for the pain to become intractable or the medications toxic, an individual with trigeminal neuralgia has the option to request early surgery. This has a number of potential advantages:

· Avoid years of medication and intermittent pain

· Avoid facing surgery when old or infirm

· If the person has a vascular loop, early microvascular decompression will increase the possibility of a successful operation with decreased risk of recurrence (evidence suggests better outcomes and lower recurrence rate the shorter the interval between onset of symptoms and nerve decompression)

How To Find Out If You Have a Vascular Loop

The conventional MRI scans used to rule out the presence of a brain tumor or multiple sclerosis as a cause of a patients face pain are not adequate to visualize the trigeminal nerve or an associated blood vessel. Fortunately, the continued improvement in MRI neuro-imaging now makes it possible to visualize both. The technique, which is called 3-D volume acquisition, is performed with contrast injection and utilizes thin cuts (0.8mm), without gaps similar to what was developed for MRI angiography and venography. The trigeminal nerve is easily visualized in the axial plane when the MRI series is centered at the midpoint of the fourth ventricle. To ensure an adequate evaluation, the nerve should be seen on three adjacent cuts. Early studies indicate that when an offending vessel is present it will be detected 80% of the of the time. With continued imaging improvements this percentage will definitely increase.

Surgical Options: Non-Destructive Procedures

The only non-destructive procedure which reliably relieves the symptoms of Trigeminal Neuralgia is Microvascular Decompression (MVD). This involves surgical exploration with the operating microscope and visualization of the junction where the Trigeminal nerve enters the base of the brain, followed by coagulation or moving and padding away any compressing blood vessels. The advantage is pain relief without numbness in the majority of patients, which usually lasts indefinitely. If the pain recurs after a MVD, which it does in 10-15% of patients, it can usually be controlled with low dose Tegretol® or Neurontin®. If the pain continues, it will require a repeat MVD or one of the destructive procedures.

Surgical Options: Destructive Procedures

There are multiple destructive procedures which are beneficial in the treatment of Trigeminal Neuralgia. The most common of which are glycerol injections, gamma knife radiation, electrocoagulation, and balloon compression. These procedures are all based on interrupting the pain by partial damage to Trigeminal nerve fibers. Generally the more numbness they produce, the longer they last. The specific advantages and disadvantages need to be discussed with the surgeon performing the procedure. These procedures are recommended for patients who have failed MVD or are not candidates for major surgery.

Comments

Treatment is always individualized.  All of the options above should be considered in consultation with a neurosurgeon familiar in their use.

Recommendations

Based on the data currently available, and in an effort to maximize quality of life, we recommend the following:

Patients with less than 10 year life expectancy

Refer for destructive procedure if pain not controlled medically without significant side effects

Patients with more than 10 but less than 20 year life expectancy

Consider destructive procedure

May abolish need for continued increasing medications

Will make medical therapy easier even if fails

Patients with more than 20 year life expectancy

Perform thin cut MRI with 3-D Volume Acquisition

If vessel present recommend MVD

Consideration needs to be given to current life expectancy charts at time of implementation. At this time life expectancy is shown below:

Current Age Life Expectancy
50 30 years
55 28 years
60 24 years
65 20 years
70 16 years
75 12 years
80 9 years
85 6 years
90 5 years

(data from IRS Publication 590, Appendix E, Table 1, December 12, 1999)

When a destructive procedure is required, Gamma Knife stereotactic radiosurgery is the procedure of choice because it is least invasive and has the lowest risk of numbness or other side effects, while producing excellent pain relief in most patients with a low incidence of recurrence.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
14   http://www.askapatient.com/viewrating.asp?drug=20235&name=NEURONTIN   Click here for  78 ratings for the drug: neurontin

Another drug sometimes described for Trigeminal Neuralgia (tic douloreau)
Gabapentin
(ga' ba pen tin)  Below information is from:  http://www.safemedication.com/displaydrug.cfm?id=694007 

15   From : http://www.safemedication.com/displaydrug.cfm?id=682237

Another drug sometimes described for Trigeminal Neuralgia (tic douloreau)
Carbamazepine
(kar ba maz' e peen)

Other Names:Carbatrol, Tegretol, Tegretol-XR
Important Warning

Carbamazepine may cause a decrease in the number of blood cells. Tell your doctor if you have ever had a decrease in the number of blood cells caused by another medication. If you experience any of the following symptoms, call your doctor immediately: sore throat, unusual bleeding or bruising, fever, or mouth sores.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during treatment to check your body's response to carbamazepine.

Why is this medication prescribed?

Carbamazepine is used alone or in combination with other medications to treat certain types of seizures in patients with epilepsy. It is also used to treat trigeminal neuralgia, a condition that causes facial nerve pain. Carbamazepine is in a class of medications called anticonvulsants. It works by reducing abnormal excitement in the brain.

How should this medicine be used?

Carbamazepine comes as a tablet, a chewable tablet, an extended-release (long-acting) tablet, an extended-release capsule, and a suspension (liquid) to take by mouth. The regular tablet, chewable tablet, and liquid are usually taken two to four times a day with meals. The extended-release tablet is usually taken twice a day with meals. The extended-release capsule is usually taken twice a day with or without meals. To help you remember to take carbamazepine, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take carbamazepine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the extended-release tablets whole; do not split, chew, or crush them. The extended-release capsules may be opened and the beads inside sprinkled over food, such as a teaspoon of applesauce or similar food. Do not crush or chew the extended-release capsules or the beads inside them. Shake the liquid well before each use to mix the medication evenly.

Your doctor will start you on a low dose of carbamazepine and gradually increase your dose.

It may take a few weeks or longer before you feel the full benefit of carbamazepine. Continue to take carbamazepine even if you feel well. Do not stop taking carbamazepine without talking to your doctor. Stopping carbamazepine suddenly may cause your seizures to become worse. Your doctor will probably decrease your dose gradually.

What special precautions should I follow?

Before taking carbamazepine,

  • tell your doctor and pharmacist if you are allergic to carbamazepine, amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), phenobarbital (Luminal, Solfoton), phenytoin (Dilantin), protriptyline (Vivactil), trimipramine (Surmontil), or any other medications.
  • do not take carbamazepine if you are taking monoamine oxidase (MAO) inhibitors, including phenelzine (Nardil) and tranylcypromine (Parnate), or have stopped taking them within the past 2 weeks.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: acetaminophen (Tylenol); alprazolam (Xanax); anticoagulants ('blood thinners') such as warfarin (Coumadin); antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral); cimetidine (Tagamet); cisplatin (Platinol); clarithromycin (Biaxin); clomipramine (Anafranil); clonazepam (Klonopin); clozapine (Clozaril); danazol (Danocrine); diltiazem (Cardizem, Dilacor, Tiazac); doxorubicin (Adriamycin, Rubex); doxycycline (Vibramycin); erythromycin (E.E.S., E-Mycin, Erythrocin); fluoxetine (Prozac, Sarafem); haloperidol (Haldol); isoniazid (INH, Nydrazid); lithium (Lithobid); loratadine (Claritin); niacinamide (nicotinamide, Vitamin B3); other anticonvulsants such as ethosuximide (Zarontin), felbamate (Felbatol), lamotrigine (Lamictal), methsuximide (Celontin), phenobarbital (Luminal, Solfoton), phensuximide (Milontin), phenytoin (Dilantin), primidone (Mysoline), tiagabine (Gabitril), and topiramate (Topamax); propoxyphene (Darvon); rifampin (Rifadin, Rimactane); terfenadine (Seldane); theophylline (Theobid, Theo-Dur); troleandomycin (TAO); verapamil (Calan, Covera, Isoptin, Verelan); and valproic acid (Depakene, Depakote). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • if you are taking any other liquid medications, do not take them at the same time as carbamazepine liquid.
  • tell your doctor if you have or have ever had glaucoma; mental illness; or heart, kidney, or liver disease.
  • you should know that carbamazepine may decrease the effectiveness of oral contraceptives (birth control pills) and other hormonal birth control methods (such as implants or injections). Use another form of birth control while taking carbamazepine.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking carbamazepine, call your doctor immediately. Carbamazepine may harm the fetus.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking carbamazepine.
  • you should know that carbamazepine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
  • remember that alcohol can add to the drowsiness caused by this medication.

What special dietary instructions should I follow?
Talk to your doctor about drinking grapefruit juice while taking this medicine.

What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?
Carbamazepine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • drowsiness
  • dizziness
  • unsteadiness
  • upset stomach
  • vomiting

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately:

  • skin rash
  • yellowing of the skin or eyes
  • loss of appetite
  • confusion
  • excitement
  • vision problems

Carbamazepine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

What storage conditions are needed for this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What other information should I know?
Call your doctor if you continue to have seizures or convulsions while taking this medication.

Wear identification (Medic Alert) indicating medication use and epilepsy. Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking carbamazepine.

The extended-release tablet does not dissolve in the stomach after swallowing. It slowly releases the medicine as it passes through your digestive system. You may notice the tablet coating in the stool.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Selected Revisions July 2003

18  Neurontin Lawsuit News

March 11, 2004

"Parke-Davis unit of Pfizer faces Neurontin lawsuit"

Pfizer's Parke-Davis unit sells Neurontin, a large selling epilepsy drug. The company is currently facing a lawsuit over the marketing of Neurontin after a former employee has accused the company of giving doctors misleading information and kickbacks to promote the drug for uses not FDA approved. Pfizer announced March 10, 2004 that the U.S. Department of Justice is investigating its marketing of a growth hormone treatment called Genotropin and a painkiller called Bextra as well. A grand jury has also inquired about the company's diabetes drug Rezulin that was acquired when Pfizer bought Warner-Lambert.

 19  There is a growing arsenal of ways to treat TN, including medications and surgical treatments. The first universally accepted treatment option is usually through medications. Surgical procedures are used for those patients who are unable to tolerate the medications, exhibit serious side effects, or if the medications do not control the problem. Medications are initially effective for many patients, but over a period of time their effectiveness may diminish and a surgical procedure required.
        During all phases of medical treatment, patients need good communication with their physician and nurse to monitor their medication and response. The patient must understand the need to maintain a therapeutic blood level of medication for effective pain relief. Taking the medications irregularly is not effective.
        Abrupt withdrawal of medications can cause serious side effects. Analgesics (i.e. aspirin, Tylenol, etc.) are not effective in addressing the pain of TN as it is of lightning-like intensity and the attacks are of brief duration. In general, narcotics have not been recommended as first line therapy for TN, as they have not been found to be effective for the characteristics of TN pain. While there are no controlled studies in TN, there is recent information that narcotics may be helpful in other painful conditions that have similar pain characteristics.
        The primary drug used to treat TN is carbamazepine. It is also used to treat seizures. Initial relief is so readily achieved that many physicians consider its use as a means to confirm the diagnosis of TN. The drug is introduced slowly and increased to a level where the patient is pain-free or side effects occur.
        Carbamazepine is available as Tegretol. A newer medication is oxcarbazepine, available as Trileptal. Extended release carbamazepine is available as Carbatrol and Tegretol XR.
        In the last several years, oxcarbazepine (Trileptal) has been used more frequently as a first line drug for TN. It is structurally related to carbamazepine, and may be preferable due to a more favorable side effect profile.
        Other medications used in the treatment of TN may include baclofen (Lioresal), gabapentin (Neurontin), clonazepam (Klonopin), sodium valporate (Depakote), lamotrigine (Lamictal), and topiramate (Topamax).

§         Radiofrequency Rhizotomy (RF) - Percutaneous Stereotactic Radiofrequency Rhizotomy (or Electrocoagulation). This outpatient procedure is done under local anesthesia and sedation. A needle is placed through the cheek through which an electrode is inserted to heat the nerve and destroy the pain fibers.

§         Glycerol Rhizotomy - Glycerol Injection or Installation. Using a surgical technique similar to the RF (above) the surgeon injects glycerol into the cavity where the trigeminal ganglion (the central part of the nerve from which the nerve impulses are transmitted) lies. The nerve is bathed with the glycerol to damage the pain fibers.

§         Balloon Compression - Percutaneous Trigeminal Ganglion Compression. Also a "through the cheek" procedure, the surgeon first inserts a catheter up to the trigeminal ganglion and then inflates a tiny balloon to compress the nerve and damage the pain fibers.

§         Microvascular Decompression - (MVD). The operation is performed under general anesthesia where a small opening is made in the back of the skull on the side with the pain. The trigeminal nerve is viewed with a microscope and compressing blood vessels are removed and the nerve is padded with a soft pad (typically shredded Teflon).

§         Stereotactic Radiosurgery - Gamma Knife. - This procedure requires no incision. Using highly focused beams of radiation, a lesion (an area of controlled damage) is created in the root of the trigeminal nerve. The nerve isn't burned as in a laser treatment, but the radiation causes the slow formation of a lesion in the nerve over a period of time to interrupt the pain transmission.

        All these procedures show varying degrees of immediate success and periods of long-term relief from pain. Generally, the average overall rate of success is 85% with about 25% of this group having some level of recurrence in 1-5 years. Many patients respond quite well when additional measures are pursued if the initial procedure is not successful or if the pain returns. There is no one procedure that is 100% effective in all cases. Therefore, it is imperative that the TN patient becomes as informed as possible about the surgical options available and understands fully the potential benefits and outcome possibilities of the procedures being considered.

Trigeminal Neuralgia, aka Tic douloreaux  or  TN
&
Temporomandibular  Joint aka TMJ  Eventually Cancer.This website is about Brian Nelson's fight with a parotid (salivary) gland tumor. It started out with the symptoms of  Trigeminal Neuralgia, aka Tic douloreaux  or  TN & Temporomadibular Joint aka TMJ Click Here to see my other record file at IAmFightingCancer.com  Bookmark this page now!  
 
Scan down to read my very lengthy and detailed web journal. Call me if I can help you. 713-467-3025 Brian

20  Neurontin Lawsuit News

June 1, 2004

"Pfizer to Settle Neurontin Marketing Suit"

The world's largest drug manufacturer, Pfizer, Inc., agreed to pay at least $400 million in order to settle civil charges regarding kickbacks to encourage doctors to prescribe the anti-epileptic drug Neurontin for other purposes.

The settlement is rooted in a US investigation regarding collaboration between drug companies and physicians, wherein government health programs are billed for the free samples given to doctors for promotional purposes. AstraZeneca Plc and Tap Pharmaceuticals Inc. have already pled guilty to criminal charges and agreed to settlements that total over $1 billion.

The lawsuit was originally filled by a former employee of Parke-Davis, a company acquired by Pfizer in June 2000. In its annual report, Pfizer claimed that the alleged misconduct occurred before the acquisition, while Parke-Davis owned Neurontin. Whistleblower Thomas Franklin claims that the company treated doctors to lavish dinners, trips to the Olympics and resort getaways in an attempt to influence physicians to market Neurontin for ailments such as migraines, and that the company sought reimbursement from Medicaid, the government health insurance program for low income individuals.

"It does not appear that there will be any harsh penalties on Pfizer doing business with the government," stated Scott Henry, a stock analyst at Oppenheimer & Co. in Boston. "That's always a concern with Medicaid."

Two other Pfizer drugs, Genotropin growth hormone and Bextra painkiller, are also investigation by the Justice Department. Those drugs were obtained last year when Pfizer acquired Pharmacia Corp. Pfizer and a dozen other drug companies are also named in a lawsuit by Pennsylvania Attorney General Jerry Pappert of inflating drug prices with marketing costs. The government has also scrutinized the marketing practices of other drug makers, including Bristol-Myers Squibb Co, Eli Lilly & Co., Schering-Plough Corp, and Barr Laboratories, Inc.

21 Complementary and Alternative Treatments for TN and related facial pain conditions

        Over the years, TNA has accumulated anecdotal data concerning non-traditional remedies that patients have found helpful in treating their pain. TNA welcomes these reports and always responds. Some reports come from patients who have failed surgeries in their past, some from those who have found medication to be ineffective or bothersome and some from those with a simple desire to find a non-medical or a non-surgical response to their pain.  The volume of this data has increased since TNA expanded its Mission to include conditions related to TN, such as atypical TN and atypical facial pain, where medical and surgical treatments have seemed to be less effective.  Patients with such conditions, like patients with other forms of chronic pain, typically develop increasing interest in non-traditional remedies as they search for relief.

        TNA has always been open to the use of complementary and alternative medicine (CAM).  Sessions at national conferences have been devoted to the subject with speakers on chiropractic, acupuncture, healing hands, hypnosis and nutrition, to name a few.  Editions of our newsletter, the TNAlert, have also addressed these issues.  Currently, we are assembling a task force to establish both guidelines for patients to follow in their use of such therapies and an informed basis for TNA to share with patients the anecdotal data we are collecting.

        In pursuing this effort, TNA believes that one needs to treat the patient, not just the condition.  So, we need to take care of the mind and body as well as our specific facial pain condition.  CAM therapies are legion; some address the mind and spirit, some address the body.  Whichever therapy you intend to use, TNA advocates that you consider the following:

§         Little clinical testing with respect to CAM has been performed according to accepted scientific standards;

§         Anecdotal evidence suggests that some CAM works for some people but not for others;

§         Failures in the use of CAM tend to go under-reported; 

     Also, before resorting to CAM, patients should perform some due diligence:

§         Always research the safety and effectiveness of a product or treatment before use;

§         Determine the expertise of the provider;

§         Establish the cost and the time-frame in which treatment may be expected to be successful;

§         Discuss the proposed treatment with your doctor; and

§         Ask your local TNA support group or the TNA national office to put you in touch with patients who may have experience of the product or treatment you have selected.

22Upper Cervical Chiropractic Care

 

"The Double-Blind Bind" - Excerpt from Spring 2004 TNAlert

        I’d like to comment on the common demand made by conventional medicine for double-blind studies on alternative approaches. Unfortunately, double-blind research is not appropriate for all scientific questions. For example, nobody has ever proposed that coronary bypass surgery be validated in double-blind research.
        A double-blind study is one in which neither the treatment provider nor the recipient knows whether a placebo or an active agent is being administered. This design is excellent for comparing a drug against an identically packaged placebo, for example. However, the problem becomes much trickier when one is studying something like an EEG biofeedback treatment, which is not so easily packaged. How does one set up circumstances where neither the therapist nor the patient knows whether accurate feedback is being given?
        Some researchers have sought to find their way around this problem by providing the members of the control group with pseudo-feedback signals that are unrelated to the subjects’ actual performance. In general, biofeedback trainees in the false-feedback condition either become aware that their feedback is inaccurate and just quit trying, or they make a prolonged effort to modify a pseudo-feedback system that is actually beyond their control, and as a result their symptoms sometimes get worse. This possibility of harming some of the research subjects obviously produces a serious ethical problem. Thus there is no really good biofeedback-based equivalent to the placebo conditions.
        Is it not enough to test whether people who receive the test treatment get better and stay better in comparison to those who do not? Or to test whether those receiving the experimental treatment do as well as those receiving drugs?

From http://www.ahrp.org/infomail/04/05/16.html

23Alliance for Human Research Protection

AHRP is a national network of lay people and professionals dedicated to advancing responsible and ethical medical research practices, to ensure that the human rights, dignity and welfare of human subjects are protected, and to minimize the risks associated with such endeavors.

Pfizer Admits Guilt in Promotion of Neurontin--Agrees to Pay $430 Million

Sun, 16 May 2004

A lawsuit initiated by Dr. David Franklin, a whistleblower, has been settled: Pfizer pleaded guilty to criminal fraud in the promotion of Neurontin, and agreed to pay $430 million. This case is but an example of contemporary drug marketing, demonstrating that the current system--as overseen under the stewardship of the FDA--encourages rather than discourages fraudulent marketing of ineffective, even dangerous drugs.

Neurontin was approved for limited use as a supplemental anti-seizure treatment for epilepsy, but was promoted by Lambert-Warner (now Pfizer) and a consortium of paid physicians who promoted and prescribed the drug for everything from ADHD, mental illnesses to a variety of pain conditions, including migraine headaches. The Wall Street Journal reports (below): "use of Neurontin for unapproved uses - estimated to account for 90% of the $2.7 billion in sales last year - continues to rise despite stepped up prosecutorial efforts aimed at curbing the practice. At the same time, studies show that much of the unapproved use of Neurontin isn't even effective."

The commercially successful marketing "miracle" of Nuerontin was achieved through a collaborative effort of the company and leading physicians who were given financial incentives to encourage their colleagues--under the pretext of providing "continuing medical education"--to prescribe a largely ineffective drug for unapproved, diverse and unrelated conditions. Essentially physicians were "educated" to use their prescribing license to increase profits rather than to improve their patients' health. The Wall Street Journal reports that studies have found off-label use accounted for 40% to 50% of all prescriptions.

In much the same way that Neurontin was promoted, manufacturers of SSRI antidepressant drugs have promoted these drugs for an array of loosely defined "disorders" and off-label uses. The promotional tactics that made Pfizer's drug, Zoloft (and the other antidepressants) commercial blockbusters are not very different from the tactics used to promote Neurontin. The commercial success of antidepressants was achieved through the collaborative effort of the manufacturers and a consortium of leading psychiatrists, academic institutions (including the National Institute of Mental Health), and professional associations--such as, the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry, among others.

The leading opinion shapers in psychiatry all have substantial financial conflicts of interest. They receive grants, stipends (which are sometimes disguised as post-marketing research grants), and perks (honorariums) from drug manufacturers--and some psychiatrists own stocks in the companies. Furthermore, academic institutions that conduct industry-sponsored drug trials, as well as the NIMH, collaborate with industry on "public awareness" campaigns that are disguised marketing campaigns.

See: Emory University, GlaxoSmithKline, and National Institute of Mental Health. Create Partnership To Develop New Treatments for Depression Monday, 1 December 2003. http://www.eurekalert.org/pub_releases/2003-12/euhs-egn120103.php

See: APA Allies and National Campaigns, http://www.psych.org/public_info/allies2.cfm

Opinion leaders in psychiatry have promoted SSRIs for children--even as the evidence from company controlled trials demonstrates, the drugs are neither safe nor effective. See: Koplewicz, H. "Misguided Resistance to Appropriate Treatment for Adolescent Depression" Editorial, Journal of Child & Adolescent Psychopharmacology, 2004.

*See: Peter R. Breggin. Suicidality, violence and mania caused by SSRIs: A review and analysis. International Journal of Risk & Safety in Medicine 16 (2003/2004)

Leading child psychiatrists have, in large part, debased the scientific literature by penning their name to ghostwritten reports that promote unsupportable, off-label prescribing of antidepressants for children.

*See: Jon N Jureidini, Christopher J Doecke, Peter R Mansfield, Michelle M Haby, David B Menkes, Anne L Tonkin, Efficacy and safety of antidepressants for children and Adolescents, British Medical Journal, online free at: http://bmj.bmjjournals.com/cgi/content/full/328/7444/879?

*See: Craig J Whittington, Tim Kendall, Peter Fonagy, David Cottrell, Andrew Cotgrove, Ellen Boddington. Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data. The Lancet. Volume 363, Number 9418, April 24, 2004, online free at: http://www.thelancet.com/journal/journal.isa

Pfizer agreed to pay a fine of $430 million for its Neurontin marketing tactics. The doctors, however, have not been charged with a crime. The punishment is unlikely to discourage corrupt practices in an industry with annual sales of $216 billion. The New York Times reports: "Companies continue to underwrite physician education seminars where unapproved uses of their drugs are discussed. They continue to hire advertising agencies to conduct clinical trials and ghostwriters to write up the studies for experts listed as authors. And they often hire physicians as consultants, arrangements that call into question a physician's independence in deciding what drugs to prescribe for patients." See: Harris, G. Pfizer to Pay $430 Million Over Promotion of Drug by Gardiner Harris, NYT, May 14, 2004, C-1. Indeed, The Wall Street Journal reports that studies have found off-label use accounted for 40% to 50% of all prescriptions.

The New York Times reports: "Companies continue to underwrite physician education seminars where unapproved uses of their drugs are discussed. They continue to hire advertising agencies to conduct clinical trials and ghostwriters to write up the studies for experts listed as authors. And they often hire physicians as consultants, arrangements that call into question a physician's independence in deciding what drugs to prescribe for patients." See: Harris, G. Pfizer to Pay $430 Million Over Promotion of Drug by Gardiner Harris, NYT, May 14, 2004, C-1.

The FDA has failed to use its authority to enforce the law to protect the public health. Instead the FDA has supported drug companies in cases involving false advertising and failure to disclose hazardous risks. In September 2002, the Chief Counsel of the FDA filed an Amicus Curiae brief in support of Pfizer in a case charging Pfizer with failure to warn that the antidepressant, Zoloft, poses a suicide risk. The FDA brief asserted that Pfizer did not have to warn physicians about the suicide risk because there was no evidence of a causal relationship. The law does not require proof of a causal relationship. The law requires prominent warnings whenever there is "reasonable evidence of a possible association of the drug with a serious health hazard." See: 21 C.F.R. §§201.57(e).

The FDA brief also misrepresented the purpose of federal regulations, stating: "FDA's regulation of prescription drugs is designed to ensure each drug's optimal use" claiming that "under-utilization of a drug… could well frustrate the purposes of federal regulation." (p. 23) This statement in a document submitted by the FDA to a court of law contradicts the legal parameters of legitimate vs. fraudulent drug promotion. The purpose of FDA's regulation is to protect the public from undisclosed drug hazards, not to maximize profits--i.e, "ensure the drug's optimal use." See: Motus v Pfizer. 2002. U.S. Court of Appeals, 9th Dist. FDA Amicus Curiae brief in support of Defendant (Pfizer), in favor of reversal of the District Court.

If the promotional claims about the efficacy and safety of Neurontin were backed up by scientific evidence, Pfizer would not have pled guilty of fraud. Similarly, the promotional claims for antidepressants are not backed by evidence. Indeed, since the Motus suit, the FDA acknowledged the suicidal risk of the drug. See: http://www.fda.gov/cder/drug/antidepressants/AntidepressanstPHA.htm

Under the current system, nothing prevents pharmaceutical companies from offering financial incentives to physicians; nothing prevents physicians from misusing their prescribing licenses to increase drug sales. As a result, healthy children have been exposed to harmful drugs, and the cost of drugs has skyrocketed. Unless Congress creates an oversight agency for the biomedical and healthcare industry, with legislative authority equivalent to the Securities and Exchange Commission, fraudulently promoted drugs will undermine public health and deplete public budgets.

Contact: Vera Hassner Sharav
Tel: 212-595-8974
e-mail: veracare@ahrp.org

Pfizer Case Signals Tougher Action On Off-Label Drug Use

By DAVID ARMSTRONG and ANNA WILDE MATHEWS
THE WALL STREET JOURNAL
May 14, 2004; Page B1

Although a unit of Pfizer Inc. agreed to plead guilty and pay hundreds of millions of dollars in fines to settle charges of illegal marketing of its drug Neurontin, lawyers in the case doubt it will curb such "off-label" use of the drug.

Indeed, use of Neurontin for unapproved uses -- estimated to account for 90% of the drug's $2.7 billion in sales last year -- continues to rise despite stepped-up prosecutorial efforts aimed at curbing the practice. At the same time, studies show that much of the unapproved use of Neurontin isn't even effective.

The Pfizer case -- and others in the works -- signal federal regulators' heightened interest in cracking down on overt promotion of off-label drug use.

Other agencies investigating off-label use include the inspector general for the Office of Personnel Management, the agency that oversees benefits for federal employees. The agency has subpoenaed records from Johnson & Johnson's Janssen unit related to sales and marketing of the drug Risperdal; from Wyeth, of Madison, N.J., from and Bristol-Myers Squibb Co., New York, according to disclosures made by the companies.

Meanwhile, the U.S. attorney's offices in Boston and Philadelphia are conducting several off-label investigations. Schering-Plough Corp., Kenilworth, N.J., has indicated it expects to be indicted on federal charges stemming from an investigation by the Boston office into billing and marketing practices.

A big reason health experts and regulators want to curb off-label drug use is that so often such treatment doesn't work and only adds to health-care inflation. "Every taxpayer in the country has been paying for these prescriptions for minimal benefit to a huge majority of patients," says Thomas Greene, lawyer for the drug industry whistleblower who brought the Neurontin case to regulators' attention.

David Franklin, the former drug company employee who first exposed the Neurontin marketing campaign in a 1996 whistleblower lawsuit, said much of the off-label use is to treat conditions in which Neurontin has little or no effect. He said he continues to worry about people who take the drug for unapproved uses.

"Even to this day, the huge majority of people are taking Neurontin" for off-label uses, he said. As for whether the settlement will change the prescribing patterns for Neurontin, Mr. Franklin said it was too early to know.

"People say congratulations, but that is premature," he said. "A couple of years from now if we see some real change that is when we can deem that this case is truly successful."

While doctors are free to treat patients with off-label prescriptions, drug companies are restricted in how they promote their products for such unapproved uses. Last year, when total U.S. prescription-drug spending was about $216 billion, studies found off-label use accounted for 40% to 50% of all prescriptions.

ANOTHER PURPOSE

Some drugs that are prescribed for uses not approved by the FDA:

Drug Indicated Use Off-label Use

Abilify Antipsychotic Bipolar disease Beta-blockers Hypertension Performance anxiety, migraine prevention

Prozac Antidepressant Premature ejaculation

Risperdal Antipsychotic Agitation in elderly

Topamax Antiepileptic Weight loss

Zoloft Antidepressant Bulimia

Source: Decision Resources Inc.

But doctors also maintain that in some cases, off-label prescribing is good medical practice. For instance, many medications approved to treat specific cancers have proved effective when prescribed for other forms of cancer.

In the case of Neurontin, originally approved as a supplemental antiseizure treatment for epilepsy, doctors have embraced the drug to treat migraines, mental illness and a variety of pain conditions. Many of the doctors originally were persuaded to try the drug for these uses between 1996 and 2000 by sales people from Warner-Lambert, a company that Pfizer took over.

Now that doctors are in the habit of issuing such prescriptions, no one expects them to change their practices. A small part of yesterday's $430 million settlement -- $38 million -- will go toward educating consumers and doctors about the potential hazards of off-label usage, but that's only a fraction of what drug companies spend on marketing.

The settlement, announced in Washington yesterday, punishes Pfizer and its Warner-Lambert unit for off-label sales of the drug to Medicaid, the federal insurance program for the poor.

Asked about the widespread off-label use of Neurontin, Pfizer spokesman Paul Fitzhenry said, "I don't see where that would change." Pfizer has declined to give an estimate of how much of the drug's use is off-label.

The U.S. Attorney in Boston, Michael Sullivan, said he didn't know if Neurontin sales would be curbed by the settlement, but acknowledged the drug "has a pretty significant base." The settlement also contains a corporate responsibility agreement dictating how Pfizer should market and promote its products, but the company said it already adheres to those guidelines.

Pfizer said all of the activities in question occurred before it acquired Warner-Lambert in 2000. It said none of its sales people promote off-label drug use.

The Neurontin case was closely watched because drug companies, long accustomed to Food and Drug Administration scrutiny over advertising practices, have seen the Justice Department becoming far more aggressive in cracking down on off-label promotion. In the past year, at least seven drug companies have been served with subpoenas related to off-label marketing.

Earlier FDA efforts to crack down on off-label advertising were hamstrung by court decisions holding that certain types of drug promotions were protected by the First Amendment. As a result, companies believe they have a "safe harbor" from the FDA for some forms of off-label promotion, including providing doctors with medical-journal articles and textbooks that support use of their drugs in ways not authorized on the labels. In addition, the FDA's current leadership is widely seen as taking a cautious approach to enforcement that could run afoul of courts' interpretation of constitutional protection for free speech. A spokesman says the FDA helped with the Neurontin case and continues to go after companies that violate its off-label advertising rules.

The recent stepped-up activity by U.S. attorneys "sent alarm bells through" the drug industry, says Peter Barton Hutt, a lawyer and former top FDA official who now has drug companies as clients. Before the Justice Department's recent series of investigations, "we all thought we knew where the lines were at FDA, and they had become more flexible."

Warner-Lambert agreed to plead guilty to two counts of violating the Food, Drug and Cosmetic Act and pay a $240 million criminal fine. It will also pay $83.6 million in civil damages for losses suffered by Medicaid, and $68.4 million to settle civil liabilities for the losses to state Medicaid programs, according to Justice Department officials.

Warner-Lambert also will pay $38 million in civil penalties for harm caused to consumers and fund a remediation program to address the effect of its improper marketing. Mr. Franklin, the whistleblower, will be paid $26.6 million from the federal settlement amount.

24The History of TNA . . .

    TNA (The Trigeminal Neuralgia Association) was founded in Barnegat Light, NJ in 1990 by TN patients and their families.  Prior to its formation, most TN patients suffered in isolation and knew very little about the disorder and its treatment.  TNA’s founding mission was to improve the quality of life of TN patients through programs that empower patients to become knowledgeable about their condition and treatment options, that aid patients with chronic pain, that educate non-specialists on matters of diagnosis and treatment, and that encourage appropriate medical research.  To achieve those goals, TNA established the following objectives: 

  • Provide information, support and encouragement to TN patients and their families and reduce the isolation of those affected by the disorder;
  • Act as a liaison between patients and qualified medical and dental practitioners, physicians, and treatment centers that diagnose and treat TN;
  • Facilitate a network of support groups in regions throughout the country;
  • Promote greater visibility, awareness and understanding of the disorder within the medical profession and broader public arena;
  • Coordinate a centralized database of TN patients and other information about medical advancements in the treatment of this disorder; and
  • Advocate for medical research needed to determine the cause, treatment options, and cure for TN.

    In 2002 TNA expanded its mission because more and more TNA patients had neuropathic facial pain conditions other than TN.  For the most part, these were patients diagnosed with atypical TN or atypical facial pain, a wastebasket definition for those presenting neuropathic facial pain without the symptoms of classic TN and for whom standard medical or surgical treatments are, for the most part, ineffective.  Such patients needed answers to help their condition.  They attended support group meetings and national conferences looking for 15answers but, for the most part, there was no good news to give them.  Many practitioners, even those well versed in the treatment of TN, believed that the pain of such patients “is in their head”.  TNA believed that a 15better response should be developed for such patients and that TNA was the most appropriate patient-centered organization to address the issue.  Accordingly, after consultation with the MAB, representatives of NIH, researchers and other practitioners, the Board of Directors of TNA adopted a resolution at its March 2002 Board Meeting to expand its Mission Statement to include patients with TN as well as patients with other related facial pain conditions.  This occurred at a time when the mechanisms of neuropathic pain in general were becoming better understood.  

    In recent years a dramatic increase in research on the physiology of neuropathic pain has been undertaken and the advent of functional neuroimaging has demonstrated alterations in brain activity associated with neuropathic pain.  TNA believes that it is time for a patient-centered organization to focus on neuropathic facial pain and the plight of those who suffer from it.  This will yield important dividends for those with classic TN as well as those with other related conditions.

    The new mission also changes the way in which TNA looks at pain itself.  For the most part, practitioners regard TN as an acute pain syndrome because they believe that through medication or surgery they can treat the pain.  Whether or not this is the correct view of the nature of TN is debatable but by embracing other forms of neuropathic facial pain, for which no adequate medical or surgical response presently exists, TNA has gone squarely into the chronic pain management business.

    Key principles in chronic pain management are that to treat chronic pain, one must understand chronic pain; that pain is a lonely and subjective experience; and that those concerned with the plight of chronic pain sufferers must provide understanding and hope.  TNA believes that these principles are poorly understood by those who treat facial pain and by the patients themselves.  Accordingly, these principles must be woven into TNA’s goals and objectives, if it is to meet the challenge of its expanded mission. 

    To address the needs prompted by an expanded mission, TNA determined that it must implement the following measures, focusing on increased research and outreach:

1.   Establish a TN and Related Pain Research Fund.  TNA will appoint a Scientific Advisory Committee, composed of key research investigators, to facilitate research in areas of key importance – epidemiology, heredity, ethnic factors, dental implications and utilization of the TNA Patient Registry information.

2.   Establish appropriate classifications for those neuropathic pain conditions said to affect or arise within the trigeminal system.  Currently, conditions not falling within the definition of classic TN are designated as Atypical TN or Atypical Facial Pain.  These wastebasket definitions give rise to two stereotypical responses:  that no medical or surgical option is available to treat such conditions and that such conditions exist solely in the mind of the patient.

3.    Identify new treatments for neuropathic facial pain conditions, once classified.

4.   Recognize the chronic nature of neuropathic facial pain, including classic TN and how that impacts TNA’s constituencies.  If TN is a progressive disease, for those who decline or are unsuitable for surgery, a lifetime of pain is likely.  The same may be true for those with failed surgeries.  Recognizing the chronic nature of neuropathic facial pain suggests the need for evaluation of lifestyle, behavioral pattersn, and of the role of alternative and complementary therapies.  Those who provide medical and surgical treatment for TN need to be sensitized to its chronic nature.

5.   Encourage pharmaceutical companies to participate in a dialogue with TNA, MAB members, NIH and the Comprehensive Pain Research Department at the University of Florida in order to stimulate expanded research in the use of existing medications for treating neuropathic facial pain.

6.   Using similar techniques, stimulate research in the relationship between neuropathic facial pain and conditions susceptible to treatment by those drugs that impact neuropathic facial pain, e.g., epilepsy.

7.   Encourage pharmaceutical companies with off-label use of their products for treating TN and other neuropathic facial pain conditions to seek FDA approval for these indications.  TNA must redouble its efforts to obtain anecdotal evidence of such use by encouraging patients to complete questionnaires for inclusion in TNA’s Patient Registry.

8.   Expand the Medical Advisory Board to include representatives of other disciplines concerned with the treatment of pain.  For example, the role of the anesthesiologist should be evaluated. 

9.   Explore opportunities for cooperation with other non-profits and institutions concerned with the treatment of pain.  This would include the Chronic Pain Association, the Neuropathy Association, the TMJ Association, the Acoustic Neuroma Association and VZV Foundation.10. Produce new materials to inform patients of new pain classifications, treatment options, the nature of chronic pain and the skills to live a productive and fulfilled life.    In January 2002 TNA moved from Barnegat Light, NJ into new headquarters in Gainesville, Florida.  Gainesville is in a university setting, has access to a young, well-trained workforce and is a low cost environment.  This location also allows TNA easy access to the McKnight Brain Institute, the Parker E. Mahan Facial Pain Center and the Comprehensive Pain Research Department, all located at the University of Florida.  TNA can now play an even more active role in promoting research, and has the opportunity to co-sponsor lectures, forums, and conferences with these institutions to further educate the scientific community.  With a professional staff, TNA is prepared to reach the goals set by the Board.

25 Support:  Support Groups.  Our support groups (SG’s) are an important source of information, encouragement and support for over 7,000 TN patients and others with related facial pain conditions and their families. They provide support and information that empowers patients to make informed decisions about their treatment of TN and related facial pain conditions. TNA is committed to extend SG’s benefits to underserved communities.

  • At the end of 2002, TNA had 65 support groups operating in the U.S. and Canada TNA has since expanded our roster to 75 support groups in these areas, and will increase these by an additional 20 during this year. In addition, we have 12 “sister” international groups.
  • TNA SG’s are predominantly located in communities on the east and west coasts of the U.S. During 2003, we expanded their presence in the heartland, and now have interest in 16 different states and also in 3 countries. This focus will continue.

Plans for 2004 also include developing a stronger leadership component for the SG system, and to enhance their capacity to be a vital, effective link to resources and information for our patients. TNA will implement strategic improvements in the quality of SG leadership through two new specific initiatives:

  • The Support Group Advisory Committee (SGAC) has recently been established, to help provide leadership for a network of key SG volunteer leaders. During 2004, the SGAC will serve as a forum for discussion of important issues and facilitate communication between an expanded network of SG’s and TNA. The SGAC will meet at least quarterly.
  • To better accommodate the nationwide growth of SG’s and assure their continuing responsiveness to patient’s needs, TNA is now creating a Support Group Leader (SGL) Mentor Program. This initiative involves experienced SGL volunteers, working one-on-one with new SGL’s, to create and maintain new support groups and enhance the skills of new leaders to serve their groups. The desired results are reduced burnout and increased capability to reach out to their communities to support patients. These volunteers will enable TNA staff to focus on development of new training materials. Efforts will be made 7during 2004 to implement this program.
Trigeminal Neuralgia, aka Tic douloreaux  or  TN
& Temporomandibular Joint aka TMJ  Eventually Cancer.
This website is about Brian Nelson's fight with a parotid (salivary) gland tumor. It started out with the symptoms of  Trigeminal Neuralgia, aka Tic douloreaux  or  TN & Temporomadibular Joint aka TMJ Click Here to see my other record file at IAmFightingCancer.com  Bookmark this page now!  
 
Scan down to read my very lengthy and detailed web journal. Call me if I can help you. 713-467-3025 Brian

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