A Publication of the East Bay Headache Support Group
A Member of the American Council for Headache Education
(ACHE) Support Group Network

VOLUME 7, ISSUE 3
MAY 2002

May 14th Meeting:  Headache Meds—What’s Right for you?

The East Bay Headache Support Group is pleased to welcome one of its own planning committee members as guest speaker on May 14, Mr. Richard “Dick” Tomchalk, RPh. Dick is a retired pharmacist and former sales manager for Abbott Laboratories, and a long-time migraineur.

Dick will be talking about the various forms of drugs (medications) used in aborting and preventing headaches, with emphasis on migraine as well as other common types of headache pain. Questions will be answered as to the efficacy of older and new drugs. What are the ingredients in combination products? What action can be taken to increase the time period between migraine attacks? What drugs are currently available, and how do they work?

Dick has been doing lots of research in preparation for his presentation, and will be able to give us up-to-the-minute information on what is coming in the near future to relieve the pain and ill effects of headaches.

Dick promises to double your money back if you do not come away from this meeting with a better understanding and knowledge of migraine headaches and how to treat them. You ask, “How can he make this claim?” 

SIMPLY BECAUSE THE MEETING IS FREE!!

Bring interested friends and family members to the meeting, to be held Tuesday evening, May 14, from 7:30 to 9:00 pm in the Ball Auditorium at John Muir Medical Center. For more information, call 925-228-1084.

Reminder...  Remember to sign in (legibly) at each meeting with your name and complete mailing address, including ZIP code.

Personal Profile - A Glimmer of Hope

For the first time in years, I have more than a glimmer of hope in getting relief from the chronic migraines I have been experiencing since my early teens. I am 51 now, so that is a long time to have my life constantly disrupted by pain. Let me give you some history first before I tell about my “glimmer of hope.”

My earliest memories include headaches. I had them as a very young child while I was still in grammar school. These weren’t migraines, but they were daily, annoying headaches that I was constantly taking aspirin for. I learned to live with them and actually just felt they were a part of my life and didn’t get very concerned about them. I did miss out on occasional sleepovers, parties, etc., but all in all I was able to function pretty well.

When I hit puberty I got my first real migraine, in addition to my daily nagging headaches. These headaches came out of nowhere and just flattened me. After awhile they were completely linked to ovulation and menstruation. I would retire to my darkened bedroom with a heating pad around my neck and an ice bag on my head. I remember crying, but that only made the pain worse. My mother tried to help by rubbing Ben Gay on my head and giving me more aspirin, but nothing really relieved it—I just had to wait it out. We never got very worried about these headaches because my mother, aunt and grandmother had all suffered with migraines.

I don’t remember ever seeing a doctor about them and even if I had, I don’t think much relief was available in the 1960s. These were severe headaches lasting at least one day and sometimes two. I would usually try to continue on with my activities because I didn’t want to miss out on anything, but in reality I did miss out on many fun things, dances, parties, dates. I could never count on being able to go somewhere because I might get a headache.

As I got older, in my twenties and thirties, I decided it was time to do something about these headaches. I went from doctor to doctor in search of help. We tried Cafergot, which made me sick, and a number of other medications that I don’t remember the names of. Finally, Fiorinal seemed to help the most, but all it did was dull the pain— I was still pretty much out of commission until the headache eased up. During an especially bad headache which lasted three days, my husband actually picked me up from my bed and carried me into the Emergency Room where I was given a shot of Demerol. I slept for two days, but that was such a relief. I also tried biofeedback at a headache clinic, but the doctor who was teaching it to me was so hyper he made me nervous!

Wherever I worked it didn’t take long for my coworkers to discover that I was a migraine sufferer. This was so embarrassing to me because I felt like such a sissy and weakling. There was such a stigma attached to it. In fact, I actually had one of my sisters-in-law tell me I was a sickling. I do not like to attract attention to myself in any way, and this is the worst part of having something like migraines. I would try to hide them and have gotten quite good at doing it, but sometimes I just can’t.

When I became pregnant with my son, my headaches flared again and I spent most of the first trimester in bed with the blinds pulled. The worst thing was feeling guilty about taking Tylenol and Codeine while I was pregnant, although the doctors assured me it was safe. It was pretty difficult to take care of an infant and toddler when I would experience a migraine. I really learned to get tough and just plow through them whenever possible, but again, I felt guilty because my son was getting such a cranky, fatigued mom. Fortunately my mother and friends were of tremendous help to me.

In the mid 1990s, while I was going through menopause and getting migraines more frequently again, I went to my primary care physician with a terrible migraine in the hopes of getting a shot of Demerol. Instead of Demerol she gave me a shot of Imitrex.

I thought I was in heaven! I couldn’t believe how quickly and completely it got rid of the pain. Then when the Imitrex pills came out, I thought I was all set, but unfortunately I have taken them so regularly that I seem to be having rebound headaches. Now, instead of just two or three migraines a month, I am having daily ones. I have tried acupuncture, herbs, homeopathy, meditation, everything I could think of, but nothing has helped.

Every time I would see my primary care physician, I’d tell her how debilitating these headaches are and how tired I always am from being in pain so much. She was sympathetic but didn’t have any answers for me and just told me to keep taking the Imitrex. Finally, I went in and asked if there was someone like a headache specialist in the area because I just couldn’t stand living my life like this anymore and I didn’t like taking so much medication. She said, “Oh, sure, Michael Stein.” She gave me a referral and for the first time in years I had a “glimmer of hope.”

As I told Dr. Stein when I first met him, “I haven’t been so excited to see a doctor since I found out I was pregnant with my son!” I was so impressed with all the time Dr. Stein took in taking my history, listening patiently, and helping me remember all the details of my headaches. He didn’t treat me like a whiny, hysterical woman, but really seemed to understand what I had been dealing with all these years. I finally felt listened to and heard. 

Editor’s Note: Ever wonder why it seems to take forever and ever for a new drug to come on the market in the United States? On the Web site of the Pharmaceutical Research and Manufacturers of America, I found this timeline of the lengthy and costly process to develop a drug and get it approved by the FDA.

The Drug Development and Approval Process By Bertram A. Spilker, MD, PhD - Senior Vice President for Scientific and Regulatory Affairs, PhRMA

The U.S. system of new drug approvals is perhaps the most rigorous in the world. On average, it costs a company $500 million to get one new medicine from the laboratory to U.S. patients, according to a January 1996 report by the Boston Consulting Group.

It takes 15 years on average for an experimental drug to travel from lab to U.S. patients, according to the Tufts Center for the Study of Drug Development, Tufts University, based on drugs approval from 1993 through 1995.

Only five in 5,000 compounds that enter preclinical testing make it to human testing, and only one of those five is approved for sale.

Once a new compound has been identified in the laboratory, medicines are developed as follows:

Preclinical Testing

A pharmaceutical company conducts laboratory and animal studies to show biological activity of the compound against the targeted disease, and the compound is evaluated for safety.

Investigational New Drug Application (IND)

After completing preclinical testing, a company files an IND with the U.S. Food and Drug Administration (FDA) to begin to test the drug in people. The IND becomes effective if FDA does not disapprove it within 30 days. The IND shows results of previous experiments; how, where and by whom the new studies will be conducted; the chemical structure of the compound; how it is thought to work in the body; any toxic effects found in the animal studies; and how the compound is manufactured. All clinical trials must be reviewed and approved by the Institutional Review Board (IRB) where the trials will be conducted. Progress reports on clinical trials must be submitted at least annually to FDA and the IRB.

Clinical Trials, Phase I

These tests involve about 20 to 80 normal, healthy volunteers. The tests study a drug’s safety profile, including the safe dosage range. The studies also determine how a drug is absorbed, distributed, metabolized, and excreted as well as the duration of its action.

Clinical Trials, Phase II

In this phase, controlled trials of approximately 100 to 300 volunteer patients (people with the disease) assess a drug’s effectiveness.

Clinical Trials, Phase III

This phase usually involves 1,000 to 3,000 patients in clinics and hospitals. Physicians monitor patients closely to confirm efficacy and identify adverse events.

New Drug Application (NDA)

Following the completion of all three phases of clinical trials, a company analyzes all of the data and files an NDA with FDA if the data successfully demonstrate both safety and effectiveness. The NDA contains all of the scientific information that the company has gathered. NDAs typically run 100,000 pages or more. By law, FDA is allowed six months to review an NDA. The average NDA review time for new molecular entities approved in 1997 was 16.2 months.

Approval Once FDA approves an NDA, the new medicine becomes available for physicians to prescribe. A company must continue to submit periodic reports to FDA, including any cases of adverse reactions and appropriate quality-control records. For some medicines, FDA requires additional trials (Phase IV) to evaluate long-term effects.

Discovering and developing safe and effective new medicines is a long, difficult, and expensive process. The research-based pharmaceutical industry will invest $30 billion in research and development in 2001.

Found on the Web site of Pharmaceutical Research and Manufacturers of America: www.phrma.org

Have your headaches improved to the
point where you can volunteer a little time
to help organize support group meetings?

The time commitment is minimal, and
since we are all headache sufferers
ourselves, we understand when
someone cannot make it to a meeting
because of a headache.

The East Bay Headache Support Group is a nonprofit organization dedicated to providing a forum for headache sufferers. The support group meets the second Tuesday every other month at John Muir Medical Center from 7:30 to 9:00 p.m. It is open to all headache sufferers and their families; the meetings are free (however, donations to cover printing, postage, and Web site expenses are appreciated!). The support group meetings include lectures by guest speakers, question and answer sessions, and informational materials.

The intention of the East Bay Headache Support Group is to provide information and resources. It does not provide medical advice, which should be obtained directly from a physician.

Directions to John Muir Medical Center:  Take Highway 680 to the Ygnacio Valley Road exit in Walnut Creek; go East approximately 1-1/2 miles, and turn right onto La Casa Via. Turn left into the Medical Center parking lot, and enter at the Main Lobby.  Take stairs or elevator to the lower level and follow signs to the meeting room.

We value your input! Call, fax, write, or e-mail us if you have any comments or suggestions, or would like to help. The planning committee meets one evening every other month and welcomes new members. Michael Stein, MD, Advisor; Leslie Davis, Editor; Donna Johnson, Treasurer; Dana Giese, Webmaster; Carol Bartlett, Reg Fong, Joan Kelley, Richard Tomchalk.

Notes... The East Bay Headache Support Group features medical and other professionals as speakers at its meetings.  Notes are taken of each presentation and available for a suggested donation of $2.00 each, or find them on our Web site. Past topics include: Biofeedback therapy, genetics, caregiving, dietary triggers, chiropractic treatment, pharmaceutical remedies, hormonal triggers, reducing stress in the workplace, dealing with holiday stress, acupuncture and Chinese herbal therapy, children’s headaches, temporomandibular joint disease (TMJ), somatic headache relief, compounding medications, allergies, experimental drugs, stress relief, non-traditional therapies, tension headaches, menopause, head injury headaches, environmental medicine, emotional impact of headaches, sleep disorders, pain management, exercise headaches, cluster headaches, 5-HTP, and Emergency Room visits.