Buprenorphine: New Medication to Treat Substance Abuse

BY MATTHEW DOUGHERTY
PRESCRIPTION PAIN MEDICATIONS HELP PEOPLE EVERY DAY FOR such common ailments as lower back pain. But for a small percentage of patients, painkillers can develop into a nightmare of drug dependence. As many as 13 million people in America abuse opiates, which include painkillers such as Oxycontin and illegal street drugs such as heroin.
Now Columbia is helping patients and physicians with drug-dependent patients learn about and administer a new treatment, buprenorphine. P&S started the buprenorphine program in October 2003 after the Food and Drug Administration approved the medication for prescription treatment of opiate abuse for patients. Until now, the only other medication option was methadone.
Buprenorphine is a partial agonist that blocks the effects of other opiates and eliminates the major motivation for opiate abuse by preventing withdrawal symptoms. It also produces less stimulation and physical dependence than other opiates such as methadone that are full agonists. It is also difficult to overdose on buprenorphine.
"These qualities make buprenorphine acceptable for office-based therapy as opposed to methadone, which can be abused more easily," says David M. McDowell, M.D., assistant clinical professor of psychiatry and director of the Columbia program. Therefore, methadone is only distributed in single doses at methadone clinics, which can be a burden for patients who need to come in before work to get a daily dose, for example. Once a physician initiates a patient on buprenorphine and is satisfied with the progress, the physician can allow the patient to take the drug at home much like any other prescription medication.
Doctors must complete an eight-hour training session — provided by the American Psychiatric Association, the American Society of Addiction Medicine, and the American Academy of Family Practice — and register with the Secretary of Health and Human Services to be certified to prescribe buprenorphine. Each approved doctor can prescribe the medication to a maximum of 30 patients, a measure to prevent physicians from prescribing the drug to too many patients, says Dr. McDowell.
So far, the program has started more than 150 patients on the medication. Preliminary results from research that has followed program participants for more than six months show a 14 percent relapse rate, which Dr. McDowell characterizes as an "incredible" finding. Besides Dr. McDowell, the staff consists of Herbert D. Kleber, M.D., professor of psychiatry and director of the New York State Psychiatric Institute's Division on Substance Abuse; Erik W. Gunderson, M.D., assistant clinical professor of psychiatry and medical director of the buprenorphine program; Roberta P. Sales, director of nursing and communications; and Margaret M. Rombone, Ph.D., a clinical psychologist.
Aside from treating patients, the staff has worked diligently to tell physicians and, by extension, patients in the New York area about the Columbia program and the treatment. Dr. McDowell, who is vice chairman of the American Psychiatric Association, has made presentations to substance abuse programs in the community and participated in the association's April forum on buprenorphine that 100 metropolitan-area physicians attended.
The Columbia program staff arranges for doctors and residents to observe how simple it is to start people on the medication and to conduct follow-up visits with patients. Third-year residents in psychiatry visit the program and one fourth-year resident will do a rotation in the program next year.
Dr. McDowell would like the program to participate more in both the psychiatric and medicine residency training programs. Dr. McDowell says that spreading the news about the benefits of buprenorphine has been a frustratingly slow process. "The two things that patients on the medicine say the most are 'Thank you, I feel like I got my life back,' and, 'How come I didn't know about this before?'" Dr. McDowell is committed to eliminating the last question. "We're working to get the word out."
For more information, contact the Columbia Buprenorphine Program at 212-342-1496 or 212-342-1512 or by email: info@BupProgram.com.

Cystic Fibrosis: Steady Progress

BY SUSAN CONOVA
THE SUE AND JOHN L. WEINBERG CYSTIC FIBROSIS CENTER MAY not be the biggest cystic fibrosis center in the nation, but its kids are. Children cared for at the center are among  the "fattest" in  the nation's 117 cystic fibrosis centers. "Fat" in CF patients is a good thing.
"Numerous studies show that people with CF have improved outcomes when they are well nourished," says Lynne Quittell, M.D., associate clinical professor of pediatrics and medicine and director of the center. "Our goal is for our patients to meet their genetic potential in both weight and height and that may be an important factor in our success."
In the most recent assessment by the Cystic Fibrosis Foundation, children at the center had not only good nutritional outcomes, but also excellent lung function. Both factors are among the best predictors of survival.
Adults now comprise about half of the nation's cystic fibrosis patients. The CF Foundation has recognized the adult center at Columbia — directed by Emily DiMango, M.D., assistant professor of clinical medicine — for having patients who have fared well.
What's the key to Columbia's success? The CF Foundation is now analyzing data from Columbia and several other successful centers to pinpoint the best practices for cystic fibrosis so the practices can become standardized across the nation.
"If we systemize how we provide health care so each practitioner isn't doing things differently, we could increase survival by seven years, even without any new therapies," says Dr. Quittell.
The CF Foundation has embarked on a collaborative quality improvement project and the Columbia CF center is contributing to this endeavor by collecting data on how it prescribes medications. This project may help define practice patterns and how they impact on clinical outcomes.
Along with the center's responsibility in improving the lives of its own patients, the center is also involved in improving the lives of patients everywhere through research and clinical services. Columbia's CF Referral Center for Susceptibility and Synergy Studies, the only such center in the country, helps clinicians from around the country find the best antibiotics for patients who have become resistant to multiple drugs. The lab performs susceptibility and synergy studies on samples of resistant organisms sent by clinicians. Tests are performed within three days of receiving the shipment of samples. Since early this year, clinicians can access the results online as soon as the tests are finished, instead of waiting for the paper report to arrive.
Information about the referral center can be found online at synergy.columbia.edu or by calling 212-305-1991.
Columbia has been involved in clinical trials for three of the newest cystic fibrosis medications, including the newest one, azithromycin, led by Lisa Saiman, M.D., professor of clinical pediatrics. Last year she published results in JAMA showing that this common antibiotic can dramatically improve lung function in cystic fibrosis patients.
"Researchers and clinicians communicate and collaborate very closely here," says Dr. Quittell. "That interface helps us provide the most comprehensive care possible for this difficult disease."
Columbia has been a leader in the cystic fibrosis field since Dorothy Andersen, M.D., a pediatrician and pathologist, published the first clinical description of the disease in 1938 and built the world center for its study. Columbia's Paul di Sant'Agnese and Robert Darling developed the famous "sweat test" to diagnose CF.
The Sue and John L. Weinberg Cystic Fibrosis Center can be reached at 212-305-5122.

Endovascular Surgical Neuroradiology: A Blend of Imaging, Surgery, and Catheters

AS SIX VIDEO SCREENS SHOW HIS PROGRESS, A COLUMBIA University Medical Center physician gently guides a catheter along a brain artery to treat a brain aneurysm, using X-ray images for guidance. The device deposits tiny, soft platinum coils precisely within the aneurysm. The coils placed in the aneurysm cause it to thrombose, which is the first step in healing.
It is fitting that physicians at CUMC's Neuroendovascular Services are leaders in this field. Elements of the sophisticated procedures they commonly perform were tested here first by Dr. Sadek Hilal, a Columbia radiologist, in the late 1960s. Dr. Hilal was a pioneer in the use of catheters and iodinated contrast agents to diagnose and treat problems in the brain's vasculature.
Through a tiny incision in the femoral artery of the leg, Dr. Hilal passed a catheter into the arteries and navigated it from the leg to the brain's circulation. X-ray images acquired during passage of the contrast agent through the vessels were used to aid in vascular catheterization, diagnosis of disease, and early efforts at treatment.
Beginning in the early 1990s, Dr. John Pile-Spellman, professor of radiology and neurological surgery in neurology, was recruited from Harvard to continue Dr. Hilal's tradition of excellence. Dr. Pile-Spellman organized and directed the Center for Neuroradiology, consisting of a multidisciplinary team of physicians and nurses who developed new and better ways to treat a variety of complex cerebral vascular diseases, including arteriovenous malformations, aneurysms, atherosclerotic diseases, tumors, and embolic or clotting diseases.
With the increased clinical application of these interventional techniques, the program has undergone a major transformation to put it in a position to lead the nation in defining the future of neuroendovascular therapy. The center was initially in the Department of Radiology, and Dr. Pile-Spellman, who had a joint appointment in radiology and neurological surgery, was the director. Now Dr. Pile-Spellman is academic director of interventional neuroradiology, director of interventional MRI, and vice chairman of radiology for research.
The service has been reorganized under the co-direction of Dr. Sean D. Lavine and Dr. Philip M. Meyers, both assistant professors of neurological surgery and radiology, into a collaborative program in the Department of Neurological Surgery and the Department of Radiology.
Bringing together the unique skills and talents of both groups, Columbia physicians routinely treat aneurysms, tumors, strokes, and arteriovenous malformations using catheters to repair damaged or malfunctioning blood vessels in the brain. The field is making huge strides, and Columbia's program is part of the movement to restructure the entire field into a new discipline that brings clinicians from multiple specialties together for collaborative disease-specific treatment of cerebrovascular disorders.
"This field has been growing and developing for a long time, and now it's really taking off," Dr. Meyers says. "Endovascular procedures were once reserved for patients who were not good candidates for surgery, but these procedures are potentially going to replace some open surgical procedures. Columbia's program is strong in its integration of the endovascular and open neurosurgical programs to provide comprehensive patient care."
Traditionally, patients would receive either surgery or the less invasive catheterization depending largely on which doctor they saw first. The neurological surgery and radiology partnership now means patients receive the best treatment option for their particular circumstances. "The lines between the two disciplines are blurring," Dr. Meyers says.
Aneurysm treatment, for example, can involve either endovascular techniques such as the platinum-coil procedure or open-brain surgery, in which surgeons block the aneurysm with a metal clip. Doctors weigh the options based on factors such as the patient's age, clinical presentation, and the stage of the aneurysm. "Depending on the complexity of the situation, some patients require combined therapy," Dr. Meyers says. "In this area, Columbia excels."
Advances are being made every year in endovascular surgical neuroradiology, says Dr. Lavine, and Columbia's program participates in clinical trials of new procedures and use of new microtechnology.
Some of the more advanced treatments are not available anywhere else in the Northeast. The endovascular treatment of brain aneurysms using the platinum coil procedure is still uncommon in the United States, although it is more commonly performed in Europe. The U.S. medical community has been slow to accept it despite growing evidence of its safety and effectiveness, documented in a study published in October 2002.
The study, published in Lancet Oct. 16, 2002, followed endovascular treatment for ruptured brain aneurysms at 44 major medical institutions throughout the world. Patients who underwent endovascular treatment were 25 percent more likely to have a good outcome than those who underwent standard surgery with craniotomy and clipping of the aneurysm. With studies like these, the table is rapidly turning, say Drs. Meyers and Lavine.
Physicians at the Columbia center also have been among the first to use a technique designed to prevent strokes that can occur during procedures to unclog brain arteries. When surgeons or radiologists use a stent to widen an artery, fatty deposits clogging the vessel can break loose and lead to a blockage elsewhere, causing stroke.
"Now, there are revolutionary new filtering devices —attached to the treatment catheters — that catch any loose debris before it reaches the brain," making the procedure much safer, says Dr. Meyers. This, in turn, makes catheterization a more viable option compared with surgery.
Columbia faculty, working with colleagues at Weill Cornell, also are assessing a new glue to treat arteriovenous malformations and studying blood flow to create a new model for drug testing. Columbia's collaboration with Cornell's medical school, also affiliated with New York-Presbyterian Hospital, covers training and research and provides 24-hour physician coverage for emergencies.
Like other areas of high-risk surgery, the volume of cerebrovascular procedures correlates with better outcomes. Centers conducting higher volumes of procedures to treat cerebrovascular disease have better outcomes than smaller centers. Together, the Columbia and Cornell cerebrovascular centers have among the highest volumes in the world.
Columbia is also taking aim at improved stroke imaging, applying MRI technology to stroke treatment for the first time. Dr. Pile-Spellman is working with GE Medical Systems to re-engineer stroke treatment to enable physicians to assess a stroke's location, the extent of tissue death, and the nature of the tissue damage. "We're going to develop the first dedicated, neurointerventional MRI machine," says Dr. Pile-Spellman, who has received a $2.5 million, two-year grant from General Electric.
Acute ischemic stroke affects more than 700,000 patients annually, but most patients do not reach the hospital early enough to receive the best treatments. Physicians must find better ways to help the majority of patients who reach the hospital more than six hours after the stroke. "So far, only one patient in 100 is effectively treated for ischemic stroke," Dr. Pile Spellman says. "I want to increase that to 20 in 100."

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