a publication OF THE east bay headache support group

a member of the American Council for Headache Education (ACHE) support group network

Volume 9, Issue 4

July, 2004

July 13^th Meeting:  “Mr. Health Search”

The East Bay Headache Support Group welcomes Cliff Kalibjian as its guest speaker on July 13.  Cliff’s presentation will cover a variety of self-empowering topics, including self-advocacy, living well with a chronic health problem, and tips on how to find the latest information and research on treatments for headaches.

Cliff Kalibjian is the owner of Mr. Health Search, a medical information research company that specializes in customized research on any medical condition or health topic for consumers and professionals.  He is also the author of Straight from the Gut:  Living With Crohn’s Disease & Ulcerative Colitis (O’Reilly & Associates, 2003).  This book is a comprehensive guide for people touched by ulcerative colitis and Crohn’s disease, two serious illnesses that cause inflammation in the digestive tract.  As someone who developed Crohn’s at the age of 13, Cliff’s mission now is to help those with chronic illnesses improve the quality of their lives through education and self-advocacy.

Meet in the Hanson Room, downstairs at John Muir Medical Center, from 7:30 to 9:00 pm on Tuesday, July 13.  For more information, call Leslie at 925-685-8775.

Future Meetings:

September 14, 2004:  Talk It Over Night with Michael Stein, MD

November 9, 2004:  To be determined

E-Patients Deserve Medical Community’s Recognition and Appreciation

People who seek online health information report better health information and services, and “different” relationships with their doctors, according to a report in the May issue of the British Medical Journal.  The report, written by senior research fellow Tom Ferguson, offers “five tentative conclusions regarding the emerging world of the e-patient.”

1.)  Over the last several years, doctors have questioned the usefulness of online health information, underestimating the benefits and overestimating the risk.  Instead of embracing the new technology, medical researchers have become so “distracted by focusing on the negative aspects of the Internet that they have overlooked the benefits it provides.”   There are, however, very few reports of patients suffering the consequences of online advice, whereas it is common for patients to obtain better care, avoid medical mistakes, or even save their own lives due to online health sites.  Many “e-patients” even say that the medical information and guidance they can find online is more complete and useful than what they receive from their clinicians.

2.)  As well as online information, medical online support groups have become an important healthcare resource, providing emotional support, guidance, health information, and medical referrals for most medical conditions, around the clock, for free.  According to two reports by Tom Ferguson, “they encourage self education and self responsibility, encourage patients’ initiative and assertiveness, and provide members with an opportunity to help others.”

3.)  Doctors who are willing to discuss health information on the Internet with their patients may enhance the doctor-patient relationship by being open to new information and revealing confidence in their own abilities as doctors.  On the other hand, doctors who respond negatively may act as if they feel their authority is being challenged, and may damage or disrupt the doctor-patient relationship.

4.)  It is important to realize that we are in the midst of one of the most important “technocultural” medical revolutions of the past century, and it is important to give e-health the attention it deserves.  As well, researchers should work towards finding the best models for helping patients using the technology that is emerging.

5.)  No one in the 20^th century had quite envisioned the ability of patients to develop such an incredibly useful and powerful forum for healthcare information, and as a result, the medical world still lags behind in legitimizing the new technology.  It will take time, but it is necessary for a change of thinking to occur “for e-patients to be recognized as a valuable new type of renewable resource-managing much of their own care, providing care for others, helping professionals improve the quality of their services, and participating in collaborations between patients and professionals.

Found on the Web site of The World Headache Alliance:  www.w-h-a.org.

“Our Drug’s Better Than Theirs” -- Understanding Comparative Claims
By David W. Dodick, MD

The 1990s have seen a virtual explosion of knowledge regarding the biological basis of migraine.  Fortunately for migraine sufferers, this scientific knowledge has led to the emergence of a new class of drugs that have transformed the acute treatment of migraine.  In 1991, sumatriptan (Imitrex) became the first drug in this new class of specific migraine medications, ushering in the “triptan era.”  Over the past two years, the Food and Drug Administration (FDA) has approved three additional triptans, zolmitriptan (Zomig), naratriptan (Amerge), and rizatriptan (Maxalt), for the acute treatment of migraine, while two others are pending approval and a seventh is in the late development phase.

Editor’s Note:  This article was written in 1999.  There are now 7 triptans-the 3 latest ones are almotriptan (Axert), frovatriptan (Frova), and eletriptan (Relpax).

A Race to be the No. 1 Triptan

The obvious question to ask is:  Why did we need several drugs from the same class with the same mechanism of action?  Researchers speculated that patients could receive quicker, more consistent, and lasting pain relief if new compounds could be developed that were more rapidly and consistently absorbed, that penetrated the barrier separating the blood from brain, and that lasted longer in the bloodstream.  Based upon these goals, the race to develop the “ultimate” triptan began.

In “Triptan Updates,” my colleagues have outlined the results of clinical trials that were designed to prove not only that the second generation triptans are superior to placebo, but that in one or more respects, they are superior to sumatriptan tablets as well.  The drug companies cite these studies to claim that their triptan possesses one or more attributes (rapid onset, consistent relief, tolerability, low recurrence) that makes it distinct and unique among the competition in this class of medications.  The incentive to be distinct from the competition is very great.  From the perspective of the drug companies, the cost of bringing a medication from the lab to the patient is enormous.  However, the potential for a significant return on this investment is also enormous.  The worldwide market for migraine medications exceeds $1.2 billion a year and is estimated to triple over the next decade as more patients are recognized, diagnosed and appropriately treated.  With so much to win or to lose, it’s not surprising to find that the companies are marketing their products aggressively.  Indeed, the rivalry between these triptans and the respective drug companies has been called the “triptan war.”

In such a high-stakes market, competitive claims are made to try to distinguish one drug as superior to another in one regard or another.  However, the evidence for these claims is derived from studies that are different in many respects.  These differences make direct comparisons between the drugs very difficult, if not in many instances impossible.

Comparing Apples and Oranges

First, the clinical trials involving the triptans are conducted by researchers across several continents, including Australia, North America, and Europe, and involve different patient populations.  This is not a trivial matter, because significant cultural differences may be seen in the percentage of patients responding to placebo, as well as with the number of patients who report side effects from the study medication.  These cultural differences can skew results more or less in favor of the study medication.

Also, people who chose (and are chosen) to participate in clinical trials may not be a representative sample of the migraine population at large.  For example, people who have other significant health problems or whose headaches don’t match strict diagnostic criteria for migraine are generally excluded from clinical trials.  Finally, the average response rate of a large study population is not much help in predicting how an individual migraine sufferer will respond in real life.

To make matters more difficult, the designs of the studies are often dissimilar and the primary objectives or the endpoints used to determine the effectiveness of the drug may be completely different.  For example, one study may evaluate the percentage of headache attacks that respond to the drug, while another may analyze the percentage of patients who respond.  Some studies may evaluate the percentage of patients reporting headache relief 2 hours after taking the medication, while another may look at the same endpoint but at a 4-hour time point.  Direct comparisons between these studies and between the individual drugs become difficult and akin to comparing apples to oranges.

The definitions of various endpoints including headache recurrence sometimes differ between studies, and the statistical methods used to arrive at various conclusions are complex and may change from study to study.  The data from a particular study may be analyzed in such a way as to show marginal statistical superiority over a competitor, and the consumer (physician and patient) may interpret this as “actual” superiority, which may or may not be true for an individual patient.  As the saying goes, “statistics prove you can prove anything by statistics.”

You may occasionally see or hear advertisements that say studies have shown drug x produces “significant improvement” or “significant results.”  In discussing the results of studies, the word “significant” is shorthand for “statistically significant,” meaning a difference that is unlikely to occur by accident.  The difference doesn’t need to be big or important to be statistically significant.  In fact, if a study includes a very large number of participants, an “insignificant” difference can be “statistically significant.”

Finally, the comparative claims made by drug companies are based upon studies that have been published and are in the public domain.  Companies are under no obligation to publish negative studies that do not present their particular drug in a favorable light.

Small Differences Can Still Make a Difference

When the results of the clinical trials are integrated with our experience in treating many migraine patients with these medications, these drugs are far more similar than they are distinct, as Dr. Cady points out in “Triptan Updates.”  They are members of a class of medication that all terminate a migraine attack by the same mechanism of action, and as such, they have similar response rates, side effect profiles and contraindications.

However, differences in the way they are absorbed and processed in the body do create some differences in the way individual patients may respond to one and not the other.  In general, physicians try to pick the triptan and the formulation (tablet, nasal spray, subcutaneous injection) with properties that are best suited for an individual patient based on features of her or his attack, such as severity, the rapidity with which the pain peaks, the severity of nausea and vomiting accompanying each attack, the person’s sensitivity to side effects, and the frequency of headache recurrence.

Even when considerable effort is spent to figure out the “perfect match,” the drug might not be effective of the individual may have significant side effects.  Because the response to any given triptan can be idiosyncratic (unique to the individual), both patient and doctor should be prepared to try another if the first one fails, since a negative response to one does not predict the same response to another.  This is precisely why it is advantageous to have several different options even amongst drugs within the same class.

Without question, the clear victor in the “war of the triptans” is the migraine patient, for in their effort to develop the ultimate triptan, the pharmaceutical industry has provided patients and physicians with a formidable arsenal with many options for migraine relief.

David W. Dodick, MD, FRCP©.  Mayo Clinic.  Scottsdale, Arizona

Found in Headache, Volume 10, Issue 1, Spring 1999-the quarterly newsletter of the American Council for Headache Education (ACHE).  www.achenet.org.

Excessive Consumption of Cola Drinks Can Cause Daily Chronic Headache in Otherwise Healthy Children and Teens

Children and adolescents who regularly consume cola drinks may be at risk of caffeine-induced daily headache.  Excessive caffeine consumption is a well-recognized cause of headache and migraine, and withdrawal can cause headache.

Lead researcher Dr. Hering-Hanit of the Sapir Medical Center in Kfar Saba, Israel says that “caffeine abuse is probably the most common of all ‘substance’ abuses…[it is an] excellent candidate for producing physical dependency as manifested by biochemical, physiological, or behavioral changes when discontinued.”

Historically, caffeine has been compared to opioids, in terms of an abused substance.  While drug-induced headache has been recognized as a major cause of chronic daily or almost daily headaches in adults, it has only recently been reported in children.  This study looks at caffeine as a substance of abuse in children and adolescents.

To study the effects of excessive caffeine consumption in children and adolescents, the researchers enrolled 19 boys and 17 girls who had been suffering from chronic headache occurring daily or at least four days a week.  The average age of the patients was 9.2 years (ranging from 6-18).  They had suffered from chronic headache for an average of 1.8 years.  The headaches were described as constant, dull, pressure like, and on both sides of the head.  No patients had a history of migraine, and all physical and neurological tests were normal.

All of the patients were heavy cola drink consumers, drinking at least 1.5 liters of cola a day.  Caffeine consumption averaged 192.88 mg/day, which compares to 2.33 small cups of ground coffee.  The weekly average was 11 liters, with average caffeine consumption equaling 17.14 cups of coffee.  Very few patients consumed tea, and none drank coffee.  The patients were encouraged to gradually stop consuming cola drinks over 1-2 weeks to prevent possible abrupt caffeine withdrawal headaches.  This resulted in a complete end of all headaches in 33 out of the 36 patients at the end of the two weeks, and headache cessation persisted through the 24-week follow-up period.  The three patients who continued to have headaches experienced intermittent episodic migraine without aura instead of daily headache.

The researchers conclude by saying that their study “justifies taking a detailed history of caffeine intake…in youngsters with chronic daily headache.  If this is found excessive, the diagnosis of caffeine-induced headache should be strongly considered.”  They go on to say that pediatricians and health providers should be alerted to these findings “as approximately 55% of caffeine intake in young American schoolchildren is in the form of soft drinks.”

Source:  Hering-Hanit R, Gadoth N.  Caffeine-induced Headache in Children and Adolescents.  Cephalalgia 2003;23:332-335.

Found on the Web site of The World Headache Alliance:  www.w-h-a.org