1000 Islands Region
Alexandria Bay, NY
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1000 Islands Region
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The 2003 OUCH Convention took place on July 18, 19 & 20, 2003 at the Pine Tree Point Resort in Alexandria Bay, New York. It was well attended and very informative. Following is a report of the convention proceedings from Cathy Lind, Convention Chairperson:
O.U.C.H. CONVENTION 2003
SUMMARY AND DISCUSSION
Bio for Lori Choyce RN
Practiced psychiatric nursing in the home environment and in acute care settings, most recently with Yale Hospital.
Specialized in insurance and Medicare issues/related problems in the home care setting.
Working currently for The New England Center for Headache, The Research Institute coordinating research trials for pharmaceutical companies and for the center (which designs several of their own studies)
At the Center she is able to combine her psychiatric skills with her knowledge of regulations to help people.
Bio for Dr. Marcelo Bigal MD, M PhD
Neurologist, Master Degree in Neurological Sciences (1999), PhD Degree in Neurological Sciences (2001)
Research Associate, The New England Center for Headache, Stamford, CT.
Assistant Professor of Neurology, The Albert Einstein College of Medicine, NY.
SUMMARY
1. Quality of life questionnaire. In order to get the data they need to prove that CH requires the pharm co's to work on meds just for us and to get existing meds labeled for CH they have to be able to show the impact of CH on quality of life. Without that information things are going nowhere.
2. IHS has updated the CH criteria and Chronic is now labeled as 1 year of CH medicated or NOT with less than 30 days of remission.
3. The ratio of men to women has changed and is now at 2.1:1 M:F
4. Civamide clinical trials have closed out and the number crunching has begun. What they learned from the earlier trials with civamide is that it works most effectively in a prevention mode. It appears to work on a cumulative effect. The first week does not show much improvement, but by the time they get out to 20 days there is marked improvement. This may be something that can be used to abort a cycle, not just an attack.
5. Glaxo already HAS a 3mg injection and they have decided not to go public with it in the US. It's in use in Europe, or will be shortly, but the dollar here is dictating the release of the 3mg shot. The patent on imitrex runs out in 4 years.
6. Topomax has just finished in a small clinical study and has been found to be an effective preventative treatment with little side effects PROVIDING the doses are titrated slowly. His recommendation is 15mg to start and increase by 15 every week until a dose of 100mg is reached.
7. A small clinical study was conducted on using Amerge as a short term preventative. If an Amerge is taken at night it has been shown to prevent night time attacks.
8. The information clusterbusters provided to them on psilocin had them extremely excited and fascinated. Research will begin on it starting with the chemical compounds and compare to known compounds that treat CH. There is NO legal issue at all for this research and OUCH to be associated with it. Lidocaine came from cocaine, sansert from LSD etc etc and he made it very very clear there is nothing illegal or dangerous to the organization by being a part of the research info on psilocin. Remember, we are not looking into legalizing mushrooms, we want to know what the mechanics are that make it work and isolate the chemical compounds that make it work so that it can go to pharm co's production line to become a medication. There is a great deal more info on this than my little excerpt here but I will get into detail when I do up the full report.
9. Advocacy is what is going to make or break us. Lori talked extensively with us about this, and we need to create an advocacy committee and that is static to get OUCH in the face of everyone out there. Again, more detail to follow, but we now have the inside track on how to get those educational grants. Lori was appalled that we only got $2500 from glaxo last year. She is going to work with us and our education grants will start to come together in dollar figures MUCH larger. She was thinking int he 25k range as she often gets grants in the hundreds of thousands to educate.
10. The Italians doing the stimulation surgery is proving to be extremely effective for chronic refractory CH. The numbers so far are very promising, almost 100%
11. There are trials with zomig nasal spray that are showing it to be nearly as effective for CH as Imitrex injections. It seems to work as quickly and as good.
DISCUSSION
Cluster headaches are not new. The first occurrence of cluster was described by Romberg in 1840. It was described as a recurrent pain in the eye generally confined to one side. Since then it has had multiple names, and the term cluster headache was coined in 1952. CH was first added as a primary headache to the IHS classifications in 1988. Ad Hoc committees accepted it prior to then, but officially it became a primary headache classified by the IHS in 1988.
This year, 2003, the IHS updated their criteria and classifications on cluster headaches, and the criteria for chronic cluster changed. Previously it was cluster attacks that lasted more than one year with less than 14 consecutive days in remission. Chronic is now considered cluster attacks lasting more than one year with less than 30 consecutive days of remission IRREGARDLESS of medication.
The prevalence of CH is 0.4% overall. That is, CH may be 1% in New England, and only 0.1% in Brazil. The reason for this, is, they are now exploring the theory that CH is affected by environmental conditions, to include latitude. CH appears to be much more common in cold climate countries than it is in warm climates. They believe this may be due to hot climate countries being closer to the equator and don't experience the shorter and longer days of the year. This all ties in to the circadian rhythms. This also is only prevalent in CH sufferers, not in migraine, not in tension, not in sinus, etc. They believe that the circadian rhythms and the hypothalamus are triggered into derangement because of the winter and summer solstice.
It has been observed, on an OVERALL plotting of CH sufferers that there is a circannual periodicity in CH. They have shown that overall, sufferers (episodics in cycle, or chronics) will suffer a CH attack 2 weeks after the longest day of the year, and 2 weeks after the shortest day of the year. This was observed by Dr. Kudrow after plotting ALL his patients' attacks. Individuals will vary obviously, but overall, this has been shown to be true.
Overall peak time periods of attacks have shown to be 2:00 a.m., 3:00 p.m., 9:00 p.m., with the average attacks being 3 per day, with individuals suffering anywhere from 1-8 attacks per day. Again, this is plotted overall data, and not individual.
Chronic sufferers can go episodic, and then go chronic, although it is rare for this to occur. Chronic can go episodic and episodic and go chronic and then back to episodic. These are more common, but still rare occurrences within CH sufferers.
They have now determined that there is a genetic influence on cluster headache, however, it appears to be less important than environmental influence (such as daylight exposure, triggers etc) in CH sufferers. Further studies are being done on this, as we heard about from the UK conference. Until more data is available regarding genetics and CH we just don't know for sure the impact it has.
70% of cluster headache sufferers will have migraine symptoms (phonophobia, photophobia, nausea, aura etc) at SOME point during their CH life. These symptoms will not occur in every individual, and will not occur in the same individual all the time.
The current ratio of CH between men and women is 2.1:1 M:F ratio. African American women will have a much more difficult time being diagnosed with CH because of the belief of Doctors that it is a "white male disorder". African American women may take up to three times longer to get a diagnosis than a white female.
The medical community has now confirmed that cluster headaches result from a dysfunction of the hypothalamus. Altered secretory circadian rhythms of hypophyseal hormone systems are at the root. The hormones they know that are involved are melatonin, testosterone, beta-endorphin, beta-lipoprotin cortisol, prolactin) . However, if you have your blood hormone levels tested, these will appear normal unless a 24 hour level is done, and then only while in cycle for episodics. This is not useful for a standard test for diagnosis though. We know that melatonin levels change between day and night, and they have seen that the levels of not just melatonin, but all the above hormones, significantly fluctuate in CH sufferers. These levels are not wrong per se, and will not show up as wrong, but the fluctuation in a sufferer is considerable compared to a non CH sufferer.
Suprachiasmatic nucleus in the hypothalamus affects the circadian rhythms and is HIGHLY sensitive to daylight hours. This region of the hypothalamus is what is responsible for maintaining circadian rhythms as well as the above mentioned hormones. This hypothalamic derangement is only present SOMETIMES. That is to say that if an episodic sufferer were to undergo imaging of the hypothalamus during remission, nothing would show up as being deformed in the hypothalamus. This deformity seems to only be present DURING a cluster cycle. Impaired pain modulation originating from the hypothalamus opens the door for pain and facilitates the trigeminovascular system which is activated by the impairment and the result is the worst pain known to man. When the hypothalamus is fine, the 'pain door' is closed. When it is not fine, the door opens and activates the autonomic and vascular systems and results in pain and autonomic features known to us as cluster headaches.
The tiers of CH are the hypothalamus deformity at the top, followed by impaired pain modulation, and trigeminovascular system. When we treat CH with Imitrex, we treat at the trigeminal level. When we treat CH with verapamil, it is still at the trigeminal level. When we treat CH with O2 it is still at the trigeminal level. Essentially, when we use the current available medications to treat CH, we are only treating the symptoms, not the cause. The cause lies in the hypothalamus and the challenge is to focus on formulating medications and procedures to treat the cause of CH.
The 3 modalities of treatment encompass Acute, Transitional, and Preventative. Imitrex is used as an acute treatment to abort individual attacks. Prednisone is used as a transitional treatment to gain relief while waiting for a preventative treatment to take effect. Verapamil is a preventative treatment that hopefully would allow prevention of the CH cycle.
The current medications that are evidentiary based treatments for CH are Oxygen, Imitrex injections (6mg), Imitrex nasal spray (20mg), IV/IM/SC DHE (0.5-1.0mg).
While other medications may work, these are the only ones that there is evidence for treatment in CH at this time. Oxygen has also been proven to only delay attacks in some sufferers, and has an efficacy of 70% at 15 minutes when it is effective. While it may abort attacks in most, in some people, it will only put the attack off until a later time. Also, Imitrex will NOT increase the frequency of cluster attacks in a cluster only sufferer. That is to say, if you suffer only from CH with no co-existing migraine or other form of headache, taking multiple doses of Imitrex will not increase the frequency of your attacks. If you suffer from migraine and CH, Imitrex may induce rebound headaches, and can cause the frequency and intensity of headaches overall to increase. Imitrex is also shown to maintain its' efficacy. On the whole Imitrex will not lose it's effectiveness. Imitrex will not cause episodics to go chronic. That occurs only as a natural course of CH. If a patient should end up with rebound headaches, then it is the doctors' responsibility to treat that. A doctor should not say that they won't use a specific drug because it will cause rebound headaches. It is their job to then treat the rebound.
Other treatment options being explored are melatonin 10mg each night, gabapentin (Neurontin) at 900-2400mg, Amerge as a preventative 2.5 to 5 mg, Topomax starting at 15mg and titrating the dose by 15mg weekly until a dose of 100mg is reached. Surgical treatments under investigation are radiofrequency or glycerol rhizotomy, gamma knife, trigeminal root section, and hypothalamic stimulation.
The current results are showing that trigeminal surgery is NOT effective overall. It can only treat the pain modality and not the cause of the pain. There have been 9 patients undergo the hypothalamic stimulating electrode implant, (essentially a pacemaker for the hypothalamus), this is a stereotactic procedure, and not like full open brain surgery, but is still an invasive and risky procedure. The method is reversible, and works on highly selective inhibition of hypothalamic grey matter. As of now, 7 of the 9 patients (2 are not fully reported on, but are so far pain free) are all pain free with stimulation or with stimulation and medication.
In active controlled studies of Zomig nasal spray versus Imitrex and Zomig nasal spray versus placebo, they are seeing that the nasal spray is nearly as effective as the Imitrex injections. Out of 7 attacks, 1 is placebo and 6 are drugs, and the results are showing that in individual attacks, not a cycle, Zomig NS is highly effective.
In the studies on Amerge as a preventative, using a dose of 2.5 mg to 5 mg, out of 9 patients studied, each experiencing between 1-6 attacks in a 24 hour period, at 2.5 mg, 5 patients became headache free, 1 patient was getting 1 headache a week, and 2 patients had no response. Another 2.5 mg was added at night, and 4 patients had 100% efficacy, 1 patient was 90% and 2 had substantial improvement.
In the studies on Topomax, side effects were shown to be a problem in the dosages used. However, Dr. Bigal and the other doctors and researchers at The New England Headache Center believe that if the drug is titrated slowly, starting at 15mg and increasing 15mg per week until you reach a dose of 100mg the side effects will be minimal. The study showed results of 5 refractory sufferers with 3 finding relief with no side effects, and 2 that experienced relief but the side effects were present.
It was brought to our attention that the insurance companies not only don't care about the individual, but that each area is concerned only with their bottom line. For example, one representative is told that if they would approve Imitrex, it would save the company a great deal of money, as the patient would no longer be going to the emergency room. The representative said "I don't care I don't pay the emergency room bill". They are only interested in each of their specific department's bottom line. We are not only fighting the overall bottom line, but at each level as well.
Lori Choyce spoke to us about the 3mg Imitrex injection that Glaxo has. This information has not been publicly released, and will not be made public. Lori had permission to share the information with us from the medical journal studies conducted, but did not have permission to hand out the information. The patent on Imitrex runs out in 4 years, and Glaxo is not interested in releasing a 3 mg injection in the US, even though they have studies completed in Europe that prove 3 mg is equally as effective for CH as 6 mg. It has been shown in fact that as little 1mg can be effective, and that on average 2 mg injections will abort an attack.
The civamide clinical trials have just closed out so the data is not yet available for the final trials. What they have noticed in the prior trials is that the civamide, while not effective for individual attacks, seems to have a cumulative effect. After 21 days there was considerable improvement in the number of attacks a sufferer experienced. This drug may prove effective to lessen an entire cycle, rather than individual attacks.
Lori is well versed in advocacy and education. She spent a great deal of time telling us some tactics for gaining educational grant money and how to organize an effective advocacy campaign to gain further funding and education.
Some of the key things she mentioned were to target the pharmaceutical companies that currently have trials going on medications not yet labeled for CH. It would prove far more beneficial to go after the makers of Amerge, Topomax and Zomig and approach them from an advocacy point of view, and say that we have heard great things about your medication in the treatment of CH and what can OUCH do to help. This is one way that OUCH and sufferers can interact and participate in the pharmaceutical trials. It is also a means to gain funding for education. Getting the makers of Amerge to award an educational grant so that OUCH can not only educate physicians, clinicians and the public about CH but also how Amerge works well for prevention of CH. She recommended that we form an advocacy committee with a 'loud mouth' at the head of it and start pestering these companies. She emphasized the fact that quiet and polite won't get you far when you are trying to gain ground and funding for an organization.
One of the key factors that is a road block for cluster headache sufferers, is the fact the pharmaceutical and medical community has no quality of life impact data to substantiate the researchers claims of a need for new medications and labeling of old ones for CH. Marcelo discussed this at length and he is in the process of putting together a quality of life questionnaire for OUCH. We require the data so that the impact CH has can be shown to researchers and pharmaceutical companies to show there is a severe impairment on quality of life for cluster sufferers. This data shows the impact this affliction has on not just our lives, but on society, as sufferers and supporters go through divorce, lost time at work etc and this has a profound effect on the community and economy. Once this data is compiled, OUCH and Marcelo will have much stronger foundations to work from. This data can then be used in conjunction with an advocacy committee to start knocking on doors and producing print, radio and television interviews to get our story out in the public eye.
The pioneers of the psilocin research compiled 2 books of data. The first was the FAQ's on psilocin, and all the technical data. The second was a book entirely of personal stories, successes and failures. This was the first time that Marcelo had heard about this being used as a treatment. Both he and Lori were excited and fascinated by the information. What will happen now is they will take the information back to the research institute, and begin working on the mechanisms that are involved with psilocin. As they break down and compare the compounds that are contained in Psilocybe cubensis each chemical compound will be identified and associated with what they know does or does not affect the hypothalamus. From there, the compounds will be associated to known medications that exist and have the same properties. The idea being that eventually, the compound, or compounds that give the results from using psilocybin can then be transferred into a marketable medication. Marcelo made it very clear that there are no legal issues involved with his research on this substance. Lidocaine was derived from cocaine, and Sansert from LSD, and many other medications that are in common use today have come from uncommon or street drugs. While it is far too early in the process to tell if this will be our magic bullet, Marcelo was very excited about the possibilities this information will bring. There is a belief that this may result in the first medication that actually treats the cause of cluster headaches, and not just the symptoms. All the data from clusterbusters has been made available to Marcelo, Lori and the institute, and they did a brief poll of people in attendance that have had success with this treatment. There is a great deal of work to be done in researching this treatment, but Marcelo was cautiously optimistic. We may get our magic bullet after all.
There was a great deal of off the floor discussions with our speakers as well. Both Marcelo and Lori have tentatively agreed to attend and speak again next year, and Marcelo, knowing the man who created Imitrex, offered to contact him and have us meet him. Many good things came out of these discussions, and unfortunately, I could not be in everyplace at once, and this is not an all encompassing document from the weekend. Both Marcelo and Lori spent a fair amount of time mingling and socializing with us. They were able to witness and experience a small glimpse of the life of sufferers outside of the clinical setting. This is very important as it allows them to take measure of just how difficult our lives are. Both expressed their surprise at how fun and happy the group was, as they expected to meet mostly embittered, depressed suffering people. While they were able to witness the suffering at its worst, they were also able to witness the resilience a CH sufferer has. We have formed a wonderful partnership with The New England Headache Center and Dr. Marcelo Bigal and Lori Choyce RN.
While in the past the conventions have always been done by proposal and vote, it is unlikely that we will be able to keep to this format. Having formed a professional relationship with some top researchers, it is in OUCH's best interest to have the speaking and professional aspects of future conventions controlled by the board. The locations and banquets and the peripheral activities can easily continue to go by the proposal method, but I believe we would do the organization a disservice if we did not stay consistent with the people who arrange for and contact the speakers.
I do not have the video of Lori, so I know I am missing some things in this report, but I will do an addendum after I have that completed.
Cathy Lind, Convention Chair 2003, OUCH Board of Directors.