Directions: Go north on 680 past Walnut Creek, and take 242 to Concord. Take the Grant Street exit, turn right and follow it to the medical center (1/2 mile). (Grant Street curves to the left and then right and becomes East Street). Turn left onto Almond Avenue and into the medical center parking lot. The Concord 1/Board Room is the first room on the left after you go in the main entrance.

Dr. Sankary graduated from the University of California, Berkeley with a degree in biophysics, and earned his medical degree from Harvard Medical School in Boston, MA.

He established and oversees the Sleep Disorders Center at Doctors Hospital in Pinole, maintains a full-time practice as a member of the Greater Pinole Physicians Group, and is an instructor in medicine at UCSF.

Are you one of the more than 23 million Americans suffering from migraine headaches? Or perhaps you aren’t sure what type of headache you have, you just know it hurts and it is adversely affecting your life. On June 8th, we are back in the Ball Auditorium at John Muir Medical Center, for a special two-hour meeting sponsored by Glaxo Wellcome Inc. This is a patient information program entitled, "Take Charge!" A migraine sufferer will speak about her experiences, and Michael Stein, M.D., will outline specific steps a migraineur can take to defend her/his lifestyle against the often devastating effects of migraine headaches. There will also be a question and answer session, and brochures with helpful information

The drug development and approval process is also expensive. It costs a company, on average, $359 million to get one new medicine from the lab to the pharmacist.

Once new drug entities have been identified and designed in the laboratory, they undergo numerous pre-clinical screens. Pharmaceutical companies conduct these laboratory and animal studies to show that the drug is effective against a targeted disease and to evaluate the compound for safety. Finally, the compound is formulated in an appropriate dosage form.

Before a drug can be tested in humans, an Investigational New Drug application (IND) must be filed with the Food and Drug Administration (FDA). This IND provides information about the chemistry of the drug’s active ingredient and how the finished drug product is made. One of the most important sections of the IND contains results of the animal tests to determine whether the drug is safe for study in people. In general, the IND establishes the drug’s purity, stability and toxicology (a science that deals with poisons and their effects) profile and demonstrates that the formulation delivers the drug against the targeted disease in a predictable manner.

Once IND approval has been granted, a pharmaceutical company can then begin studying the drug’s effects in people. Reaching this threshold typically takes years of work and generates bookshelves full of literature reviews, regulatory documents, and analytical, pharmacological and toxicological reports.

The first stage of clinical testing, called Clinical Trials, Phase I, is to evaluate the drug in about 20 to 80 healthy volunteers for its overall safety and to see what doses can be safely tolerated. During these studies, other factors are examined,

including how a drug is absorbed, distributed, metabolized and excreted, and its duration of action.

After tolerance levels have been established, Phase II studies are conducted on approximately 100 to 300 people with the disease. These studies determine the drug’s effectiveness.

With the information gathered from Phase II studies, clinical researchers establish the protocols for large-scale Phase III testing. Protocols establish the type of patients (for example, age, disease state) to be enrolled in the studies, dosage schedules and time points for evaluation, pregnancy risk, if any, and other criteria for inclusion or exclusion. These protocols are designed to assure the scientific validity of the studies and to protect the participants.

Phase III studies, which usually involve between 1,000 to 3,000 patients in clinics and hospitals, are well-controlled studies that must make the case for the drug’s effectiveness and safety in the targeted disease state. Physicians monitor volunteer patients closely in these studies.

With the completion and statistical evaluation of Phase I, II and III studies, the pharmaceutical company is ready to being to prepare the New Drug Application (NDA). In order for a drug to be sold in the United States, the FDA must find the product safe and effective. The NDA, which can easily consist of 20 volumes of information, contains all the data that have been generated during the years of work on the compound. It includes all the preclinical and clinical studies, information on how the drug is produced and manufacturing specifications. The law allows the FDA six months to review an NDA.

Once the FDA approves the NDA, the new drug becomes available for physicians to prescribe to their patients. Even after receiving approval, many drugs are required to undergo postmarketing studies (Phase IV) to continuously evaluate long-term effectiveness and safety. Pharmaceutical companies must submit regular reports on all new drugs to the FDA, including information such as any instances of adverse reactions.

A trigger can be either an external factor or an internal factor that may lead to headache onset. Whatever it may be, the trigger is not the cause of the headache. Examples of external triggers include changes in weather, bright lights, or certain foods. Triggers that occur internally include exhaustion, hunger, or the relaxation period following stress.

Avoiding your triggers is not always easy, and susceptibility to triggers will vary from person to person. Factors such as age and sex can also influence how a trigger will affect each individual. For instance, younger people may have a higher tolerance of certain triggers and women may be affected more often by weather changes or certain odors than men. With women, susceptibility to triggers often increases during the pre- or postmenstrual period and decreases after menopause.

The following list contains many, but not all, of the triggers that may bring on migraines in some susceptible people:

Doctors often ask headache patients to keep a diary in which they record the time their headaches began, how long they lasted, what may have triggered them, where the pain was located, and what the character of the pain was. Several triggers may be involved in the onset of your headaches, so it’s important to identify as many as possible. Keeping a headache diary can be helpful for both you and your doctor. Not only does it provide valuable information that can help your doctor determine which treatment is appropriate, but it can help give you direction amid the confusion of recurring pain.

Excerpted from the first issue of HeadsUp!, a quarterly newsletter published by Merck & Company, Inc.

A: People who are not headache prone do not usually get headaches under stressful conditions. Those who are prone to headache, however, may experience headache when under stress or after a stressful period has passed, during the so-called letdown period.

Re: Tension-type headache: These headaches are sometimes associated with muscle tension and sometimes emotional tension. Emotional stress may, of course, result in tense muscles about the head and neck.

Re: Migraine headache: Some people with migraine headache have attacks while under stress; others are fine until the stressful events have passed and get into trouble during the letdown, such as after things have returned to normal or during a vacation that follows a stressful period. Surprisingly, they may get a migraine attack while relaxing on a beach, even though they are free of responsibility.

Q: How often can I take pain medicine for headache?