Novel Variables
An Interview with Bradley S. Galer, M.D.
| Each month, Dr. Lynette Menefee tackles pressing issues in pain management with one of the nation's leading practitioners. This month, Dr. Menefee speaks with Bradley S. Galer, M.D., Vice President of Scientific Affairs at Endo Pharmaceuticals Inc., about new trends in analgesia clinical trials. |
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Questions
1: We are focusing on novel study variables that are used in analgesia clinical trials. Which new variables do you think are most interesting?
 2: Those are interesting angles and differ from simple measurment of pain intensity and description. Let’s take them in order. Will you define pain qualities and explain why this variable is so important?
3: You also mentioned the intensity or “bothersomeness” of a drug’s side effects. Will you say more about that?
4: How is the side-effect burden measured?
5: Please say more about analgesic tolerance, especially since there is lively discussion about how great a role analgesic tolerance plays in treating patients with pain.
6: Wow. Many practitioners might find those results surprising.
7: How will these novel variables help practitioners and patients?
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-------------------------------------------------------------------------------------------------------------------------- Dr. Lynette Menefee: Thanks for speaking with us today, Dr. Galer.
We are focusing on novel study variables that are used in analgesia clinical trials. Which new variables do you think are most interesting? Bradley S. Galer, M.D.: Two types of variables stand out. First, pain qualities, such as “burning,” “shooting,” “skin sensitivity,” and “aching,” among others; and second, intensity or “bothersomeness” of side effects. 
LM: Those are interesting angles and differ from simple measurment of pain intensity and description. Let’s take them in order. Will you define pain qualities and explain why this variable is so important? BG: Many patients who respond to analgesics will only report partial relief. Partial relief may actually mean many things. It may mean that the patient is experiencing less overall pain from the treatment but is still having some degree of pain. Or it can mean that the patient’s various pain experiences are being affected differently by the treatment. Many patients will describe their pain using several adjectives, such as “burning,” “shooting,” “aching,” “sensitive,” and many more. A treatment may alleviate or completely abolish one or several of a patient’s pains and perhaps not affect others at all.
Thus, measuring different pain qualities, as with the Neuropathic Pain Scale (NPS), allows the clinician and the clinical researcher to capture this data. The NPS is a validated tool that is often a more sensitive measure of clinical response than an overall pain intensity score. At Endo, we are currently developing a broader pain quality tool, The Pain Quality Assessment Scale (PQAS). We are working with my NPS co-developer, Mark Jensen of the University of Washington.
LM: You also mentioned the intensity or “bothersomeness” of a drug’s side effects. Will you say more about that? BG: Unfortunately, in most clinical trials, especially of analgesics, the accurate burden of side effects on the patient is rarely measured. We all know, both as treating physicians and as patients, that the true value of a medication (or any treatment) is not just its efficacy, but also its burden of side effects.
LM: How is the side-effect burden measured? BG: At Endo, we have been developing specific side-effect burden measures for each drug that we study. Typically, the patient is asked to rate several typical side effects from a drug class on a 0 to 10 scale on a regular basis. This data can be critically important to gain an overall value for a drug and also can be quite helpful in comparing different active treatments.
LM: Please say more about analgesic tolerance, especially since there is lively discussion about how great a role analgesic tolerance plays in treating patients with pain. BG: Well another widely-assumed medical dictum looks as though it may be just another bit of medical folklore. In 2002, we completed three randomized controlled trials assessing analgesic tolerance in association with chronic use of opioids in a three-month treatment period. All three studies failed to demonstrate that chronic pain patients developed any clinically significant tolerance with daily around-the-clock opioid use.
LM: Wow. Many practitioners might find those results surprising. BG: Yes, plus, this lack of tolerance was present in both opioid-naďve and opioid-experienced patients, as well as in all types of pain conditions studied.
LM: How will these novel variables help practitioners and patients? BG: The more scientifically-derived data are in well conducted clinical trials, the better informed the treating physician is and in the end, and most importantly, the better treatment we can offer to all of our patients. Also, I am very hopeful that our new data regarding the lack of opioid analgesic tolerance will help strike down yet another barrier to treating chronic pain patients with chronic opioids, if warranted.
LM: That’s great. Thank you for talking with us today. We greatly appreciate your time and look forward to hearing about studies in which you provide us with even better information about analgesics.
Bradley S. Galer, M.D., joined Endo Pharmaceuticals Inc. in 2000 as Vice President, Scientific Affairs. In this role, he is responsible for the Departments of Clinical Research, Clinical Operations, Medical Affairs, and Clinical Education & Development. He is also Adjunct Assistant Professor of Neurology at the University of Pennsylvania School of Medicine. Prior to joining Endo, he was actively involved in the clinical development of Lidoderm®, a skin patch approved in 1999 for post-herpetic neuralgia.
Dr. Galer is a founding member and former chairman of the Pain Medicine Section of the American Academy of Neurology. He has published more than 100 articles and book chapters about pain management and pain pharmacotherapy. He co-authored a book, “Clinical Guide to Neuropathic Pain,” with Dr. Robert Dworkin and is the author of the CD-ROM “Chronic Pain and Headache.” Since its inception, he has been a Steering Committee member of the annual International Neuropathic Pain Conference. He is the founding Editor-in-Chief of the journal Current Pain and Headache Reports, and was the Associate Editor of The Clinical Journal of Pain, for which he now serves on the Editorial Board. In addition, Dr. Galer is an ad-hoc reviewer of manuscripts for many journals. He was named in the 1998 “Best Doctors in America” list for Pain Management/Neurology.
Dr. Galer earned his M.D. at Albert Einstein College of Medicine in New York City and his B.A. in Biology-Psychology at Wesleyan University in Connecticut.
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