Advanced Cardiac Devices Assist Sickest Patients
Better Schizophrenia Drugs Urgently Needed
THE LIST OF DRUGS TO TREAT SCHIZOPHRENIA HAS GROWN IN recent years, seemingly good news for psychiatrists and their patients. But until last fall, psychiatrists went without the long-term empirical data needed to compare the efficacy, side effects, and cost-effectiveness of the new and old drugs. The informational void now is starting to be filled, thanks to a landmark NIH-funded study the NIMH Clinical Antipsychotic Trial of Intervention Effectiveness, dubbed “CATIE” headed by Jeffrey Lieberman, M.D., chairman of the Department of Psychiatry at P&S and director of the New York State Psychiatric Institute.
“It is the art of medicine to match a particular medication to the response characteristics of the individual patient, and this was previously based more on trial and error,” Dr. Lieberman says. “CATIE provides an empirical basis for determining which medicines are better for which individual patients. Now a psychiatrist can consider a patient’s history of response to medications and overall health then look at the CATIE data and make a more informed choice about which medication to prescribe.”
In the $42.6 million CATIE study, Dr. Lieberman and colleagues throughout the United States examined the effectiveness of most marketed antipsychotic medications in almost 1,500 patients for 18 months. They found that the existing treatments work better than no treatment at all but still leave room for improvement. Almost three-quarters of the patients wanted to switch to a different medication after 18 months, which usually was attributed to one of three issues: the medication’s lack of control over symptoms; side effects (the newest, seemingly most effective drug caused the most effects); or the patients’ perception of their need for treatment.
The next part of the study addresses the second phase of treatment when the patients were switched to a different antipsychotic drug. A third piece, expected to be published in six to nine months, will focus on the cost-effectiveness of various drug options. The implications of the study are far-reaching for the approximately 3.2 million Americans with schizophrenia and for the pharmaceutical and health care industries.
The CATIE study has not been without controversy. Initial media reports about the results of the first leg of the study, published in September 2005, grossly oversimplified the study’s conclusions, Dr. Lieberman says, with major newspapers stating just that the new antipsychotic drugs weren’t much more effective than the old ones. Some of the drug companies who donated their drugs free of charge for the study published press releases and statements “agreeing with whatever was most favorable to their medication,” Dr. Lieberman says. Then the New York Times published an editorial claiming that the study “compared five drugs used to treat schizophrenia and found that most of the newest, most heavily prescribed drugs were no better than an older drug that is far cheaper.” Dr. Lieberman countered with his own editorial in Psychiatric News in January 2006 to set the record straight.
“There was a rush to judgment in the media to take a large and complex study and turn it into a policy decision,” Dr. Lieberman says, adding that the psychiatric community and schizophrenic patients should reap the benefits of CATIE despite media inaccuracies. “There needs to be as wide a range of options for patients as possible.”
TECHNOLOGICAL ADVANCES, THE DEVELOPMENT AND PERFECTION of new surgical techniques, and a growing partnership with the catheterization lab at the Center for Interventional Vascular Therapy are keeping CUMC on the cutting edge of cardiac care.
Among the new developments is the use of the third generation of left ventricular assist devices (LVADs), mechanical pumps that augment the function of the heart’s most critical pumping chamber. The VentrAssist used in a CUMC feasibility study is made of light, durable materials and is less likely to cause blood clots than previous LVADs, says Yoshifumi Naka, M.D., Ph.D., the Herbert Irving Assistant Professor of Surgery and director of CUMC’s cardiac transplantation program and mechanical circulatory support program. The VentrAssist was first used at CUMC in February 2005, and surgeons plan to use it as a bridge to transplant but may eventually implant it in patients ineligible for transplant. According to its manufacturer, VentrAssist can be used for both children and adults.
CUMC also is one of six U.S. medical centers participating in a feasibility study to gain approval by the FDA for the use of fenestrated stent grafts to manage abdominal aortic aneurysms and thoracic aortic aneurysms. Patients who require surgical aneurysm repair typically require an incision in the chest and face risks such as blood loss and lung dysfunction and have a lengthy recovery.
Now surgeons can use a catheter to insert fenestrated stent grafts that can be positioned within the aorta to align the fenestrations, or windows, with the openings in the renal artery. Smaller stents are then threaded into the renal arteries to fix the position of the aortic stent graft. The technique has been used in Europe and Australia, and James McKinsey, M.D., associate professor of clinical surgery and site chief of the vascular surgery division, is optimistic about its potential.
“This is one of the greatest advancements for treating aneurysms since the original surgical procedure was developed,” Dr. McKinsey says. “This is a dramatic move toward a minimally invasive procedure.”
CUMC surgeons also are participating in a Phase I clinical trial to implant aortic valves without heart surgery and putting a patient on bypass. Instead, they thread a cardiac catheter through a patient’s leg to insert percutaneous valves through the groin artery.
“The use of percutaneous valves is a significant advance for patients who can’t tolerate heart surgery,” says Allan Stewart, M.D., assistant professor of surgery and director of the aortic surgery program at CUMC. “We’ve had excellent success with this so far, and our hope is that it will be offered to a greater spectrum of patients and possibly replace open heart surgery for high-risk patients in the future.”
Dr. Stewart also is performing valve-sparing aortic root replacement. The technique involves resection of the aortic root, followed by re-implanting the patient’s own valve within a special graft that contains aortic sinuses. This allows for a curative resection of the aneurysm, while allowing the patient to retain his own valve. The benefit to the patient is the avoidance of a lifetime of Coumadin (required with a mechanical valve) or the necessity of a re-operation (required with a tissue valve). Fewer than 10 U.S. medical centers are performing the FDA-approved procedure; Dr. Stewart has performed more than 40.
“We believe that this is a reproducible operation with excellent results. It can be used in a much wider scope of patients to cure ascending aortic aneurysms and use the patient’s own valve.”
Center Strives to Raise Awareness of Celiac Disease
AN ACCURATE DIAGNOSIS OF CELIAC DISEASE CAN TAKE MORE than a decade, researchers at Columbia’s Celiac Disease Center have found. Medical schools in the United States teach that the disease is rare, so doctors are not looking for it, and the disease can be confused with other medical problems.
For patients suffering from both celiac disease and other intestinal disorders, such as lactose intolerance, bacterial overgrowth, fructose intolerance (a manifestation of other things rather than a disease), getting a diagnosis can be challenging. These patients won’t be helped by the only treatment available to celiac patients a gluten-free diet. That’s why the center is testing for disorders that can accompany celiac disease, an autoimmune disease in which the small intestine is damaged because of an immune response to gluten, a protein found in wheat, rye and barley.
“We know that these other intestinal disorders, such as bacterial overgrowth, lactose intolerance, or even Crohn’s disease, can go hand-in-hand with celiac disease, or they can exist alone,” says Peter Green, M.D., professor of clinical medicine and director of the center. “The tests to exclude these conditions are for the small fraction of celiac sufferers who don’t respond to the gluten-free diet.”
If a patient is thought to have celiac disease, he or she is given a blood test and if the test indicates an antibody marker for the disease, an endoscopy for biopsy of the upper small intestine is performed. If positive, the patient is put on a strict gluten-free diet. But the condition for some patients does not improve on the diet, so the center now administers breath tests to look for food intolerances and bacterial overgrowth. These patients may require additional changes in their diets.
In addition to administering tests for a more accurate diagnosis and aiding recently diagnosed patients with their diet, the center is expanding its reach through educational programs. A patient education day sponsored by the center drew about 500 people, and a family screening day tested about 200 people for celiac disease.
“There were some people who hadn’t heard of celiac, but they came to be tested when they learned that a family member was diagnosed with it, and they had similar symptoms,” Dr. Green says, adding that the disease has a genetic component.
In addition to the center’s programs and Dr. Green’s new book, “Celiac Disease: A Hidden Epidemic” (Harper Collins, February 2006), the center plans to host an international conference on the disease in November 2006 in New York City. Dr. Green points to a successful 2004 conference as a positive turning point in awareness about the disease.
The NIH organized a consensus development conference, which concluded, among other things, that one in 100 Americans not one in 5,000, as previously thought has celiac disease. A federal law also took effect in January calling for clear food labeling for major allergens, including wheat. The packaging labels should help patients, but the labels will not identify the presence of gluten, barley, and rye.
“It’s not the fault of physicians, because they’re taught that the disease is rare,” Dr. Green says, adding that the awareness of the disease in the United States lags behind that of England, Australia, Argentina, Brazil, and Scandinavia. “In Argentina you can have gluten-free ice cream, and gluten-free products are part of the national healthcare program in the U.K. Hopefully, we’ll reach that point in the United States as well.”