- Email: [email protected]
Mark Donowitz Reflects on the Future of Clinical Gastroenterology
Gastroenterology and Hepatology News continued
Index (CDAI) score ⬍150. The CDAI is a weighted composite score of 8 clinical factors that evaluate patient wellness, including daily number of liquid or very soft stools, severity of abdominal pain, levels of general well-being, and other relevant measures. The CLASSIC I induction trial evaluated the ability of HUMIRA to induce remission. Of 299 anti– TNF-␣ naive patients, 36% of patients receiving HUMIRA (160 mg at week 0 followed by 80 mg at week 2) achieved clinical remission at week 4
compared with 12% treated with placebo (P ⬍ .001). The CHARM trial studied the ability of HUMIRA to maintain clinical remission. CHARM was a 56-week trial that enrolled 854 patients with moderate to severe Crohn’s disease. During a 4-week open-label induction phase, 58% of patients (n ⫽ 499) demonstrated a clinical response to HUMIRA (a CDAI decrease ⱖ70 from baseline). These patients were randomized to receive either HUMIRA 40 mg every other week, HUMIRA 40 mg weekly, or
placebo. Of those who continued on HUMIRA 40 mg every other week, 40% were in clinical remission at week 26 (P ⬍ .001) and 36% were in remission at week 56 (P ⬍ .001), versus 17% and 12% of patients in the placebo group, respectively. In GAIN, a 4-week induction trial of 325 patients who lost response or were intolerant to infliximab, 3 times as many patients taking HUMIRA achieved clinical remission at week 4 versus patients taking placebo (21% vs 7%, P ⱕ .001).
Mark Donowitz Reflects on the Future of Clinical Gastroenterology
colonography. And we’re trying to make certain that our members begin thinking what their practice might look like a few years from now.” Dr. Donowitz sees a future in which practicing gastroenterologists would hire “midlevel providers” to do some of the standard procedures under their supervision. “And that the gastroenterologist would then begin becoming proficient in how to perform and interpret the newer technologies. “It is in the best interest of the patient with GI disease that the gastroenterologist is in charge. He or she is the captain of the ship, from diagnosis through treatment and patient management.” Pay for performance is another area of concern, according to Dr. Donowitz. He says the AGA sees “both great potential and great risk here. Having already begun this approach, CMS [Center for Medicare and Medicaid Services] does not seem to have any rules as to defining what are Best Practices and have made some decisions without carefully determining what is best for the patient.” Dr. Donowitz points to guidelines for treating patients with gastroesophageal reflux disease as an example, where “the GI community has just begun looking at what could make a difference. But before we could complete
the process, CMS has adopted some of these guidelines without sufficiently determining their impact on patients.” The Johns Hopkins gastroenterologist says he is “very excited about NOTES [non-orifice transendoscopic surgery]. We are interested in finding out its potentials, determining who should and should not use it, and what are its pros and cons.” Given the advent of NOTES, he asks if the basic model of medicine departments might be changed. “If we’re going to be working very closely with surgeons, should we be part of the department of medicine or should we have our real commitment to an ‘Institute of Digestive Diseases,’ where surgeons and gastroenterologists work hand in hand?”
H
aving almost completed his term as AGA President, Dr. Mark Donowitz, LeBoff Professor of Medicine and Director of the Hopkins Center for Epithelial Disorders at The Johns Hopkins University School of Medicine, offers some candid reflections on the future of clinical Gastroenterology. While following new technologies on the horizon, Donowitz says he and the AGA have identified several issues of concern. The first involves the genetic understanding of disease. “Medicine is changing, not just GI but all of medicine,” he says. “The future is now . . . and it is our responsibility, at the very least, to understand our role in the genetic understanding of disease.” Dr. Donowitz says the AGA recognizes that in a few years the reliance on upper endoscopy and colonoscopy— both for income and diagnosis—“is probably going to change, and that the practice of the gastroenterologist may not be as heavily oriented in performing these procedures. “We’ve begun alerting our members that this could be happening, and we are trying to help them recognize what is ahead that is going to replace conventional colonoscopy, for instance, which is likely going to be CT
Mark Donowitz, MD
1645
Index (CDAI) score ⬍150. The CDAI is a weighted composite score of 8 clinical factors that evaluate patient wellness, including daily number of liquid or very soft stools, severity of abdominal pain, levels of general well-being, and other relevant measures. The CLASSIC I induction trial evaluated the ability of HUMIRA to induce remission. Of 299 anti– TNF-␣ naive patients, 36% of patients receiving HUMIRA (160 mg at week 0 followed by 80 mg at week 2) achieved clinical remission at week 4
compared with 12% treated with placebo (P ⬍ .001). The CHARM trial studied the ability of HUMIRA to maintain clinical remission. CHARM was a 56-week trial that enrolled 854 patients with moderate to severe Crohn’s disease. During a 4-week open-label induction phase, 58% of patients (n ⫽ 499) demonstrated a clinical response to HUMIRA (a CDAI decrease ⱖ70 from baseline). These patients were randomized to receive either HUMIRA 40 mg every other week, HUMIRA 40 mg weekly, or
placebo. Of those who continued on HUMIRA 40 mg every other week, 40% were in clinical remission at week 26 (P ⬍ .001) and 36% were in remission at week 56 (P ⬍ .001), versus 17% and 12% of patients in the placebo group, respectively. In GAIN, a 4-week induction trial of 325 patients who lost response or were intolerant to infliximab, 3 times as many patients taking HUMIRA achieved clinical remission at week 4 versus patients taking placebo (21% vs 7%, P ⱕ .001).
Mark Donowitz Reflects on the Future of Clinical Gastroenterology
colonography. And we’re trying to make certain that our members begin thinking what their practice might look like a few years from now.” Dr. Donowitz sees a future in which practicing gastroenterologists would hire “midlevel providers” to do some of the standard procedures under their supervision. “And that the gastroenterologist would then begin becoming proficient in how to perform and interpret the newer technologies. “It is in the best interest of the patient with GI disease that the gastroenterologist is in charge. He or she is the captain of the ship, from diagnosis through treatment and patient management.” Pay for performance is another area of concern, according to Dr. Donowitz. He says the AGA sees “both great potential and great risk here. Having already begun this approach, CMS [Center for Medicare and Medicaid Services] does not seem to have any rules as to defining what are Best Practices and have made some decisions without carefully determining what is best for the patient.” Dr. Donowitz points to guidelines for treating patients with gastroesophageal reflux disease as an example, where “the GI community has just begun looking at what could make a difference. But before we could complete
the process, CMS has adopted some of these guidelines without sufficiently determining their impact on patients.” The Johns Hopkins gastroenterologist says he is “very excited about NOTES [non-orifice transendoscopic surgery]. We are interested in finding out its potentials, determining who should and should not use it, and what are its pros and cons.” Given the advent of NOTES, he asks if the basic model of medicine departments might be changed. “If we’re going to be working very closely with surgeons, should we be part of the department of medicine or should we have our real commitment to an ‘Institute of Digestive Diseases,’ where surgeons and gastroenterologists work hand in hand?”
H
aving almost completed his term as AGA President, Dr. Mark Donowitz, LeBoff Professor of Medicine and Director of the Hopkins Center for Epithelial Disorders at The Johns Hopkins University School of Medicine, offers some candid reflections on the future of clinical Gastroenterology. While following new technologies on the horizon, Donowitz says he and the AGA have identified several issues of concern. The first involves the genetic understanding of disease. “Medicine is changing, not just GI but all of medicine,” he says. “The future is now . . . and it is our responsibility, at the very least, to understand our role in the genetic understanding of disease.” Dr. Donowitz says the AGA recognizes that in a few years the reliance on upper endoscopy and colonoscopy— both for income and diagnosis—“is probably going to change, and that the practice of the gastroenterologist may not be as heavily oriented in performing these procedures. “We’ve begun alerting our members that this could be happening, and we are trying to help them recognize what is ahead that is going to replace conventional colonoscopy, for instance, which is likely going to be CT
Mark Donowitz, MD
1645