Alicia Ault

Despite widely reported results on the safety of Vioxx and now Celebrex and Bextra, there is still a paucity of information on the true long-term effects these drugs as a class, and all of it will take months –if not years– to sort out.

The future of celecoxib (Celebrex) was uncertain at press time. Pfizer Inc., its maker, has announced that an increased risk of heart problems was found in one of two trials examining celecoxib for the prevention of colon cancer. The National Cancer Institute, which was conducting the study for Pfizer, suspended use of the drug after finding a 3.4 times greater risk of cardiovascular events in those taking 400 mg of celecoxib twice daily and a 2.5 times greater risk in those taking 200 mg of the drug twice daily, compared with placebo patients. The average duration of treatment in the trial was 33 months.

Soon thereafter, research investigators suspended the Alzheimer's Disease Anti-Inflammatory Prevention Trial after preliminary data indicated a 50% increased risk for cardiovascular events in participants assigned to take 220 mg twice daily of the nonselective NSAID naproxen (Aleve, Naprosyn). Yet no significant increase in cardiovascular risk was seen in participants taking 200 mg twice daily of celecoxib.

In separate press releases, the Food and Drug Administration and the National Institutes of Health announced that only preliminary data had been reviewed. The agencies are in the process of obtaining and reviewing all of the available data.

John M. Flack, M.D., director of the cardiovascular epidemiology and clinical applications program at Wayne State University, Detroit, said, “I don't think there's enough evidence at all to say this is a class effect, but I also don't think you can quite shut the door on it yet.”

Leading up to the results of the adenoma prevention trial, the preponderance of evidence supported the notion that celecoxib (Celebrex) does not increase the risk of MI, but that rofecoxib (Vioxx), now removed from the market, does.

That view is supported by a study from Stephen E. Kimmel, M.D, and his associates at the University of Pennsylvania, Philadelphia. They reviewed records on 1,718 patients with a first, nonfatal MI who were admitted to 36 hospitals, and compared them with records on 6,800 randomly selected controls from the same five-county area in Pennsylvania (Ann. Intern. Med. 2005;142:157-64).

Patients were asked about their medication use through phone interviews (although only half responded), and were divided into nonusers of NSAIDs, rofecoxib users, celecoxib users, and nonselective NSAID users.

The investigators found that there was no link between COX-2 use and nonfatal MI, but the use of rofecoxib was associated with “significantly higher odds of MI,” when compared with celecoxib (adjusted odds ratio 2.72).

“The study supports the hypothesis that different COX-2 inhibitors differ in their cardiovascular effects,” the authors wrote. Though the reason for the differences–and the potential clinical effect–still isn't clear, rofecoxib has been shown to cause greater increases in blood pressure and more peripheral edema, they noted. The study was supported by the National Institutes of Health, Searle Pharmaceuticals (now Pfizer), and Merck & Co.

In an accompanying editorial, Axel Finckh, M.D., of Brigham and Women's Hospital, Boston, and Mark D. Aronson, M.D., of Beth Israel Deaconess Medical Center, Boston, said, “Overall, these studies suggest that not all COX-2 inhibitors share the same cardiovascular risk as rofecoxib, but the evidence is currently too limited to exclude the possibility of a COX-2 inhibitor class effect” (Ann. Intern. Med. 2005;142:212-4).

Noting that the drugs work by slightly different mechanisms and that there's still much that is not known, Dr. Flack said, “I think there are some bad actors in this class,” and some that haven't been studied enough.

Even so, prior to the adenoma prevention trial, Dr. Flack said that he felt comfortable prescribing celecoxib, especially because those who took the drug in Dr. Kimmel's study were more likely to have cardiovascular risk factors, and yet still had a lower rate of MI.

“In the face of conflicting evidence, when Celebrex is used it can be used most safely at dosages of under 400 mg/day. This new data will undoubtedly turn up the scrutiny of this class of drugs for cardiovascular safety,” Dr. Flack noted.

At the same time, scrutiny of valdecoxib (Bextra) led the Food and Drug Administration to require a label revision warning against the drug's use in patients with coronary artery bypass grafts (CABG).

In early December, Pfizer added the warning on the basis of results of a Pfizer study of 1,500 patients who were treated after CABG. These results showed an increased risk of cardiovascular events, including heart attack, stroke, deep vein thrombosis, and pulmonary embolism.

At the same time, a black box warning was added to valdecoxib's label noting that the drug can cause potentially fatal skin reactions, most likely in the first 2 weeks of therapy. Because the drug contains a sulfa moiety, patients who are allergic to sulfonamides are more likely to have the skin reactions, according to the FDA.

The CABG warning came on the heels of a report by Garret A. FitzGerald, M.D., director of the center for experimental therapeutics at the University of Pennsylvania, of a metaanalysis of surgical patients in two studies in which patients taking valdecoxib had more than twice the risk of stroke and MI, compared with placebo patients.

Despite widely reported results on the safety of Vioxx and now Celebrex and Bextra, there is still a paucity of information on the true long-term effects these drugs as a class, and all of it will take months –if not years– to sort out.

The future of celecoxib (Celebrex) was uncertain at press time. Pfizer Inc., its maker, has announced that an increased risk of heart problems was found in one of two trials examining celecoxib for the prevention of colon cancer. The National Cancer Institute, which was conducting the study for Pfizer, suspended use of the drug after finding a 3.4 times greater risk of cardiovascular events in those taking 400 mg of celecoxib twice daily and a 2.5 times greater risk in those taking 200 mg of the drug twice daily, compared with placebo patients. The average duration of treatment in the trial was 33 months.

Soon thereafter, research investigators suspended the Alzheimer's Disease Anti-Inflammatory Prevention Trial after preliminary data indicated a 50% increased risk for cardiovascular events in participants assigned to take 220 mg twice daily of the nonselective NSAID naproxen (Aleve, Naprosyn). Yet no significant increase in cardiovascular risk was seen in participants taking 200 mg twice daily of celecoxib.

In separate press releases, the Food and Drug Administration and the National Institutes of Health announced that only preliminary data had been reviewed. The agencies are in the process of obtaining and reviewing all of the available data.

John M. Flack, M.D., director of the cardiovascular epidemiology and clinical applications program at Wayne State University, Detroit, said, “I don't think there's enough evidence at all to say this is a class effect, but I also don't think you can quite shut the door on it yet.”

Leading up to the results of the adenoma prevention trial, the preponderance of evidence supported the notion that celecoxib (Celebrex) does not increase the risk of MI, but that rofecoxib (Vioxx), now removed from the market, does.

That view is supported by a study from Stephen E. Kimmel, M.D, and his associates at the University of Pennsylvania, Philadelphia. They reviewed records on 1,718 patients with a first, nonfatal MI who were admitted to 36 hospitals, and compared them with records on 6,800 randomly selected controls from the same five-county area in Pennsylvania (Ann. Intern. Med. 2005;142:157-64).

Patients were asked about their medication use through phone interviews (although only half responded), and were divided into nonusers of NSAIDs, rofecoxib users, celecoxib users, and nonselective NSAID users.

The investigators found that there was no link between COX-2 use and nonfatal MI, but the use of rofecoxib was associated with “significantly higher odds of MI,” when compared with celecoxib (adjusted odds ratio 2.72).

“The study supports the hypothesis that different COX-2 inhibitors differ in their cardiovascular effects,” the authors wrote. Though the reason for the differences–and the potential clinical effect–still isn't clear, rofecoxib has been shown to cause greater increases in blood pressure and more peripheral edema, they noted. The study was supported by the National Institutes of Health, Searle Pharmaceuticals (now Pfizer), and Merck & Co.

In an accompanying editorial, Axel Finckh, M.D., of Brigham and Women's Hospital, Boston, and Mark D. Aronson, M.D., of Beth Israel Deaconess Medical Center, Boston, said, “Overall, these studies suggest that not all COX-2 inhibitors share the same cardiovascular risk as rofecoxib, but the evidence is currently too limited to exclude the possibility of a COX-2 inhibitor class effect” (Ann. Intern. Med. 2005;142:212-4).

Noting that the drugs work by slightly different mechanisms and that there's still much that is not known, Dr. Flack said, “I think there are some bad actors in this class,” and some that haven't been studied enough.

Even so, prior to the adenoma prevention trial, Dr. Flack said that he felt comfortable prescribing celecoxib, especially because those who took the drug in Dr. Kimmel's study were more likely to have cardiovascular risk factors, and yet still had a lower rate of MI.

“In the face of conflicting evidence, when Celebrex is used it can be used most safely at dosages of under 400 mg/day. This new data will undoubtedly turn up the scrutiny of this class of drugs for cardiovascular safety,” Dr. Flack noted.

At the same time, scrutiny of valdecoxib (Bextra) led the Food and Drug Administration to require a label revision warning against the drug's use in patients with coronary artery bypass grafts (CABG).

In early December, Pfizer added the warning on the basis of results of a Pfizer study of 1,500 patients who were treated after CABG. These results showed an increased risk of cardiovascular events, including heart attack, stroke, deep vein thrombosis, and pulmonary embolism.

At the same time, a black box warning was added to valdecoxib's label noting that the drug can cause potentially fatal skin reactions, most likely in the first 2 weeks of therapy. Because the drug contains a sulfa moiety, patients who are allergic to sulfonamides are more likely to have the skin reactions, according to the FDA.

The CABG warning came on the heels of a report by Garret A. FitzGerald, M.D., director of the center for experimental therapeutics at the University of Pennsylvania, of a metaanalysis of surgical patients in two studies in which patients taking valdecoxib had more than twice the risk of stroke and MI, compared with placebo patients.

Despite widely reported results on the safety of Vioxx and now Celebrex and Bextra, there is still a paucity of information on the true long-term effects these drugs as a class, and all of it will take months –if not years– to sort out.

The future of celecoxib (Celebrex) was uncertain at press time. Pfizer Inc., its maker, has announced that an increased risk of heart problems was found in one of two trials examining celecoxib for the prevention of colon cancer. The National Cancer Institute, which was conducting the study for Pfizer, suspended use of the drug after finding a 3.4 times greater risk of cardiovascular events in those taking 400 mg of celecoxib twice daily and a 2.5 times greater risk in those taking 200 mg of the drug twice daily, compared with placebo patients. The average duration of treatment in the trial was 33 months.

Soon thereafter, research investigators suspended the Alzheimer's Disease Anti-Inflammatory Prevention Trial after preliminary data indicated a 50% increased risk for cardiovascular events in participants assigned to take 220 mg twice daily of the nonselective NSAID naproxen (Aleve, Naprosyn). Yet no significant increase in cardiovascular risk was seen in participants taking 200 mg twice daily of celecoxib.

In separate press releases, the Food and Drug Administration and the National Institutes of Health announced that only preliminary data had been reviewed. The agencies are in the process of obtaining and reviewing all of the available data.

John M. Flack, M.D., director of the cardiovascular epidemiology and clinical applications program at Wayne State University, Detroit, said, “I don't think there's enough evidence at all to say this is a class effect, but I also don't think you can quite shut the door on it yet.”

Leading up to the results of the adenoma prevention trial, the preponderance of evidence supported the notion that celecoxib (Celebrex) does not increase the risk of MI, but that rofecoxib (Vioxx), now removed from the market, does.

That view is supported by a study from Stephen E. Kimmel, M.D, and his associates at the University of Pennsylvania, Philadelphia. They reviewed records on 1,718 patients with a first, nonfatal MI who were admitted to 36 hospitals, and compared them with records on 6,800 randomly selected controls from the same five-county area in Pennsylvania (Ann. Intern. Med. 2005;142:157-64).

Patients were asked about their medication use through phone interviews (although only half responded), and were divided into nonusers of NSAIDs, rofecoxib users, celecoxib users, and nonselective NSAID users.

The investigators found that there was no link between COX-2 use and nonfatal MI, but the use of rofecoxib was associated with “significantly higher odds of MI,” when compared with celecoxib (adjusted odds ratio 2.72).

“The study supports the hypothesis that different COX-2 inhibitors differ in their cardiovascular effects,” the authors wrote. Though the reason for the differences–and the potential clinical effect–still isn't clear, rofecoxib has been shown to cause greater increases in blood pressure and more peripheral edema, they noted. The study was supported by the National Institutes of Health, Searle Pharmaceuticals (now Pfizer), and Merck & Co.

In an accompanying editorial, Axel Finckh, M.D., of Brigham and Women's Hospital, Boston, and Mark D. Aronson, M.D., of Beth Israel Deaconess Medical Center, Boston, said, “Overall, these studies suggest that not all COX-2 inhibitors share the same cardiovascular risk as rofecoxib, but the evidence is currently too limited to exclude the possibility of a COX-2 inhibitor class effect” (Ann. Intern. Med. 2005;142:212-4).

Noting that the drugs work by slightly different mechanisms and that there's still much that is not known, Dr. Flack said, “I think there are some bad actors in this class,” and some that haven't been studied enough.

Even so, prior to the adenoma prevention trial, Dr. Flack said that he felt comfortable prescribing celecoxib, especially because those who took the drug in Dr. Kimmel's study were more likely to have cardiovascular risk factors, and yet still had a lower rate of MI.

“In the face of conflicting evidence, when Celebrex is used it can be used most safely at dosages of under 400 mg/day. This new data will undoubtedly turn up the scrutiny of this class of drugs for cardiovascular safety,” Dr. Flack noted.

At the same time, scrutiny of valdecoxib (Bextra) led the Food and Drug Administration to require a label revision warning against the drug's use in patients with coronary artery bypass grafts (CABG).

In early December, Pfizer added the warning on the basis of results of a Pfizer study of 1,500 patients who were treated after CABG. These results showed an increased risk of cardiovascular events, including heart attack, stroke, deep vein thrombosis, and pulmonary embolism.

At the same time, a black box warning was added to valdecoxib's label noting that the drug can cause potentially fatal skin reactions, most likely in the first 2 weeks of therapy. Because the drug contains a sulfa moiety, patients who are allergic to sulfonamides are more likely to have the skin reactions, according to the FDA.

The CABG warning came on the heels of a report by Garret A. FitzGerald, M.D., director of the center for experimental therapeutics at the University of Pennsylvania, of a metaanalysis of surgical patients in two studies in which patients taking valdecoxib had more than twice the risk of stroke and MI, compared with placebo patients.

NEW ORLEANS — Using a robot to perform a minimally invasive radical prostatectomy resulted in less blood loss, faster recovery, and better surgical outcomes in a case series of 300 men, Vipul Patel, M.D., reported at the annual clinical congress of the American College of Surgeons.

The procedure has been available since 2001, when the U.S. Food and Drug Administration approved the prostatectomy application of the robot, the da Vinci Surgical System, made by Intuitive Surgical Inc. But it's not widely available, due to the machine's cost (about $1.3 million), the specialized training needed by surgeons, and the fact that hospitals and surgical centers lose money on every operation, said Dr. Patel, director of minimally invasive surgery at Urology Centers of Alabama, a private clinic in Birmingham. His case series consisted of the first 300 men who had the procedure at the clinic.

Detroit's Henry Ford Hospital has been a leader in prostatectomies with the da Vinci, reaching a total of 1,000 procedures in August. That center has reported less blood loss, better cancer control, and much lower rates of incontinence and impotence with the da Vinci, compared with standard open prostatectomy. Dr. Patel predicted that patients will increasingly demand the less-invasive procedure.

In Dr. Patel's case series, the average blood loss was less than 50 mL, which he said is 300–2,000 mL less than what is typically lost during open surgery. Fewer than 0.5% of patients required a transfusion.

The average age in his group was 63 years, and 70% had stage T1c disease. The average prostate specific antigen (PSA) level was 8.5 ng/mL. The patients generally required 1 day of hospitalization, compared with 2–3 days for the conventional procedure, and they returned to activities of daily living in 7–10 days, compared with 4–6 weeks for open procedures.

Dr. Patel said 95% of the patients were continent at 3 months. Potency rates are not yet available for his group, but he said he expects good results because “nerve sparing is technically much easier to perform robotically since we operate in a bloodless field with magnification and three-dimensional vision.”

During an average follow-up of 10 months, 95% of patients had no rise in PSA levels. The positive margin rate was 10% for all stages, and less than 3% for stage T2 tumors. It will, however, take at least 10 years to know if cancer outcomes are better with the minimally invasive approach, Dr. Patel added.

Dr. Patel also said that his patients are recovering more quickly with the use of a pain-management device that almost eliminates the need for narcotics. This device, the On-Q System, is approved by the FDA and is made by I-Flow Corp.

A subset of 250 men was treated with the On-Q, a ball that holds 300 cubic centimeters of 0.5% bupivacaine (Marcaine) and is worn on a belt around the waist. It pumps the drug into the wound continuously through a catheter over 2–3 days. The patient can remove the On-Q at home.

For those getting the On-Q, there were no narcotics on the initial orders; patients did receive ketorolac (Toradol) 15 mg every 6 hours, and 20 mg daily of valdecoxib (Bextra) starting 2 days after surgery. Overall, 85% of patients with the On-Q went without narcotics, compared with only 35% of those who did not receive the device.

NEW ORLEANS — Using a robot to perform a minimally invasive radical prostatectomy resulted in less blood loss, faster recovery, and better surgical outcomes in a case series of 300 men, Vipul Patel, M.D., reported at the annual clinical congress of the American College of Surgeons.

The procedure has been available since 2001, when the U.S. Food and Drug Administration approved the prostatectomy application of the robot, the da Vinci Surgical System, made by Intuitive Surgical Inc. But it's not widely available, due to the machine's cost (about $1.3 million), the specialized training needed by surgeons, and the fact that hospitals and surgical centers lose money on every operation, said Dr. Patel, director of minimally invasive surgery at Urology Centers of Alabama, a private clinic in Birmingham. His case series consisted of the first 300 men who had the procedure at the clinic.

Detroit's Henry Ford Hospital has been a leader in prostatectomies with the da Vinci, reaching a total of 1,000 procedures in August. That center has reported less blood loss, better cancer control, and much lower rates of incontinence and impotence with the da Vinci, compared with standard open prostatectomy. Dr. Patel predicted that patients will increasingly demand the less-invasive procedure.

In Dr. Patel's case series, the average blood loss was less than 50 mL, which he said is 300–2,000 mL less than what is typically lost during open surgery. Fewer than 0.5% of patients required a transfusion.

The average age in his group was 63 years, and 70% had stage T1c disease. The average prostate specific antigen (PSA) level was 8.5 ng/mL. The patients generally required 1 day of hospitalization, compared with 2–3 days for the conventional procedure, and they returned to activities of daily living in 7–10 days, compared with 4–6 weeks for open procedures.

Dr. Patel said 95% of the patients were continent at 3 months. Potency rates are not yet available for his group, but he said he expects good results because “nerve sparing is technically much easier to perform robotically since we operate in a bloodless field with magnification and three-dimensional vision.”

During an average follow-up of 10 months, 95% of patients had no rise in PSA levels. The positive margin rate was 10% for all stages, and less than 3% for stage T2 tumors. It will, however, take at least 10 years to know if cancer outcomes are better with the minimally invasive approach, Dr. Patel added.

Dr. Patel also said that his patients are recovering more quickly with the use of a pain-management device that almost eliminates the need for narcotics. This device, the On-Q System, is approved by the FDA and is made by I-Flow Corp.

A subset of 250 men was treated with the On-Q, a ball that holds 300 cubic centimeters of 0.5% bupivacaine (Marcaine) and is worn on a belt around the waist. It pumps the drug into the wound continuously through a catheter over 2–3 days. The patient can remove the On-Q at home.

For those getting the On-Q, there were no narcotics on the initial orders; patients did receive ketorolac (Toradol) 15 mg every 6 hours, and 20 mg daily of valdecoxib (Bextra) starting 2 days after surgery. Overall, 85% of patients with the On-Q went without narcotics, compared with only 35% of those who did not receive the device.

NEW ORLEANS — Using a robot to perform a minimally invasive radical prostatectomy resulted in less blood loss, faster recovery, and better surgical outcomes in a case series of 300 men, Vipul Patel, M.D., reported at the annual clinical congress of the American College of Surgeons.

The procedure has been available since 2001, when the U.S. Food and Drug Administration approved the prostatectomy application of the robot, the da Vinci Surgical System, made by Intuitive Surgical Inc. But it's not widely available, due to the machine's cost (about $1.3 million), the specialized training needed by surgeons, and the fact that hospitals and surgical centers lose money on every operation, said Dr. Patel, director of minimally invasive surgery at Urology Centers of Alabama, a private clinic in Birmingham. His case series consisted of the first 300 men who had the procedure at the clinic.

Detroit's Henry Ford Hospital has been a leader in prostatectomies with the da Vinci, reaching a total of 1,000 procedures in August. That center has reported less blood loss, better cancer control, and much lower rates of incontinence and impotence with the da Vinci, compared with standard open prostatectomy. Dr. Patel predicted that patients will increasingly demand the less-invasive procedure.

In Dr. Patel's case series, the average blood loss was less than 50 mL, which he said is 300–2,000 mL less than what is typically lost during open surgery. Fewer than 0.5% of patients required a transfusion.

The average age in his group was 63 years, and 70% had stage T1c disease. The average prostate specific antigen (PSA) level was 8.5 ng/mL. The patients generally required 1 day of hospitalization, compared with 2–3 days for the conventional procedure, and they returned to activities of daily living in 7–10 days, compared with 4–6 weeks for open procedures.

Dr. Patel said 95% of the patients were continent at 3 months. Potency rates are not yet available for his group, but he said he expects good results because “nerve sparing is technically much easier to perform robotically since we operate in a bloodless field with magnification and three-dimensional vision.”

During an average follow-up of 10 months, 95% of patients had no rise in PSA levels. The positive margin rate was 10% for all stages, and less than 3% for stage T2 tumors. It will, however, take at least 10 years to know if cancer outcomes are better with the minimally invasive approach, Dr. Patel added.

Dr. Patel also said that his patients are recovering more quickly with the use of a pain-management device that almost eliminates the need for narcotics. This device, the On-Q System, is approved by the FDA and is made by I-Flow Corp.

A subset of 250 men was treated with the On-Q, a ball that holds 300 cubic centimeters of 0.5% bupivacaine (Marcaine) and is worn on a belt around the waist. It pumps the drug into the wound continuously through a catheter over 2–3 days. The patient can remove the On-Q at home.

For those getting the On-Q, there were no narcotics on the initial orders; patients did receive ketorolac (Toradol) 15 mg every 6 hours, and 20 mg daily of valdecoxib (Bextra) starting 2 days after surgery. Overall, 85% of patients with the On-Q went without narcotics, compared with only 35% of those who did not receive the device.

One of the nation's largest professional societies for plastic surgeons has issued a statement recommending that its members be more cautious in performing cosmetic breast augmentation in women under age 18.

The statement, issued in late December by the American Society of Plastic Surgeons, is meant to clarify previous policy guidelines that also recommended against implanting the devices in young women, with exceptions, said Philip Haeck, M.D., a member of the ASPS board of directors and a plastic surgeon in private practice in Seattle, Wash.

“This policy had one intent: to clarify a gray area for our members and put into writing what was already issued in previous policies,” Dr. Haeck said.

It also serves as a reminder that saline breast implants are not approved by the Food and Drug Administration for women under 18.

The ASPS acknowledged that there has been an increase in the number of media reports of women younger than 18 getting breast implants for cosmetic reasons. But, said ASPS President Scott Spear, M.D., in a statement, “Contrary to popular belief, people 18 and younger make up only 4% of all cosmetic plastic surgery procedures. Although the numbers have increased over the years, teens continue to be a small percentage of the plastic surgery population.”

According to ASPS statistics, 3,841 women aged 18 or younger had breast augmentation in 2003, a 4% increase over 2000 but a 24% increase over 2002. Another professional group, the American Society for Aesthetic Plastic Surgery, reported that 11,326 women under age 18 had breast augmentation in 2003, accounting for 4% of the 280,401 breast augmentation procedures that year.

Diana Zuckerman, Ph.D., said her Washington, D.C.-based advocacy group, the National Center for Policy Research for Women & Families, asked the ASPS to condemn the procedure in women under 18 in mid-2004, primarily because those women aren't mature enough to make such a decision. A long-time critic of cosmetic breast augmentation, Dr. Zuckerman applauded the new policy statement but questioned whether it gave plastic surgeons a “loophole” by saying implants were acceptable in cases of asymmetry.

Dr. Haeck strongly disagreed with that characterization, noting that asymmetric breasts can be socially and psychologically devastating for young women. “This is a private matter between a surgeon and the patient behind the closed door of an exam room, and it is, just like apple pie, the American way,” he said.

He emphasized, however, that in most instances, cosmetic enhancement would not be acceptable.

“Most of us feel that breast implants for your 16th birthday are inappropriate,” Dr. Haeck said. He did acknowledge that the recommendations were just that—advice. “We can't sit in our members' offices and tell them they can't do it,” he said.

The policy urged a delay in implants for these young women, until they have “sufficient emotional and physical maturity to make an informed decision based on an understanding of the factors involved in this procedure.”

With years of experience, a plastic surgeon can determine whether a young woman has this maturity, Dr. Haeck said, adding that in some cases, it is more obvious when implants would be inappropriate—such as when a boyfriend accompanies the patient and is paying for the surgery.

Michael Olding, M.D., chief of plastic surgery at George Washington University, Washington, and a member of the ASPS's public education committee, said he has never performed cosmetic breast augmentation in a woman under age 18. Some women might be mature at that age, he noted, “but those people are, in my opinion, a very small percentage of the women who would want to have breast augmentation at that age.”

One of the nation's largest professional societies for plastic surgeons has issued a statement recommending that its members be more cautious in performing cosmetic breast augmentation in women under age 18.

The statement, issued in late December by the American Society of Plastic Surgeons, is meant to clarify previous policy guidelines that also recommended against implanting the devices in young women, with exceptions, said Philip Haeck, M.D., a member of the ASPS board of directors and a plastic surgeon in private practice in Seattle, Wash.

“This policy had one intent: to clarify a gray area for our members and put into writing what was already issued in previous policies,” Dr. Haeck said.

It also serves as a reminder that saline breast implants are not approved by the Food and Drug Administration for women under 18.

The ASPS acknowledged that there has been an increase in the number of media reports of women younger than 18 getting breast implants for cosmetic reasons. But, said ASPS President Scott Spear, M.D., in a statement, “Contrary to popular belief, people 18 and younger make up only 4% of all cosmetic plastic surgery procedures. Although the numbers have increased over the years, teens continue to be a small percentage of the plastic surgery population.”

According to ASPS statistics, 3,841 women aged 18 or younger had breast augmentation in 2003, a 4% increase over 2000 but a 24% increase over 2002. Another professional group, the American Society for Aesthetic Plastic Surgery, reported that 11,326 women under age 18 had breast augmentation in 2003, accounting for 4% of the 280,401 breast augmentation procedures that year.

Diana Zuckerman, Ph.D., said her Washington, D.C.-based advocacy group, the National Center for Policy Research for Women & Families, asked the ASPS to condemn the procedure in women under 18 in mid-2004, primarily because those women aren't mature enough to make such a decision. A long-time critic of cosmetic breast augmentation, Dr. Zuckerman applauded the new policy statement but questioned whether it gave plastic surgeons a “loophole” by saying implants were acceptable in cases of asymmetry.

Dr. Haeck strongly disagreed with that characterization, noting that asymmetric breasts can be socially and psychologically devastating for young women. “This is a private matter between a surgeon and the patient behind the closed door of an exam room, and it is, just like apple pie, the American way,” he said.

He emphasized, however, that in most instances, cosmetic enhancement would not be acceptable.

“Most of us feel that breast implants for your 16th birthday are inappropriate,” Dr. Haeck said. He did acknowledge that the recommendations were just that—advice. “We can't sit in our members' offices and tell them they can't do it,” he said.

The policy urged a delay in implants for these young women, until they have “sufficient emotional and physical maturity to make an informed decision based on an understanding of the factors involved in this procedure.”

With years of experience, a plastic surgeon can determine whether a young woman has this maturity, Dr. Haeck said, adding that in some cases, it is more obvious when implants would be inappropriate—such as when a boyfriend accompanies the patient and is paying for the surgery.

Michael Olding, M.D., chief of plastic surgery at George Washington University, Washington, and a member of the ASPS's public education committee, said he has never performed cosmetic breast augmentation in a woman under age 18. Some women might be mature at that age, he noted, “but those people are, in my opinion, a very small percentage of the women who would want to have breast augmentation at that age.”

One of the nation's largest professional societies for plastic surgeons has issued a statement recommending that its members be more cautious in performing cosmetic breast augmentation in women under age 18.

The statement, issued in late December by the American Society of Plastic Surgeons, is meant to clarify previous policy guidelines that also recommended against implanting the devices in young women, with exceptions, said Philip Haeck, M.D., a member of the ASPS board of directors and a plastic surgeon in private practice in Seattle, Wash.

“This policy had one intent: to clarify a gray area for our members and put into writing what was already issued in previous policies,” Dr. Haeck said.

It also serves as a reminder that saline breast implants are not approved by the Food and Drug Administration for women under 18.

The ASPS acknowledged that there has been an increase in the number of media reports of women younger than 18 getting breast implants for cosmetic reasons. But, said ASPS President Scott Spear, M.D., in a statement, “Contrary to popular belief, people 18 and younger make up only 4% of all cosmetic plastic surgery procedures. Although the numbers have increased over the years, teens continue to be a small percentage of the plastic surgery population.”

According to ASPS statistics, 3,841 women aged 18 or younger had breast augmentation in 2003, a 4% increase over 2000 but a 24% increase over 2002. Another professional group, the American Society for Aesthetic Plastic Surgery, reported that 11,326 women under age 18 had breast augmentation in 2003, accounting for 4% of the 280,401 breast augmentation procedures that year.

Diana Zuckerman, Ph.D., said her Washington, D.C.-based advocacy group, the National Center for Policy Research for Women & Families, asked the ASPS to condemn the procedure in women under 18 in mid-2004, primarily because those women aren't mature enough to make such a decision. A long-time critic of cosmetic breast augmentation, Dr. Zuckerman applauded the new policy statement but questioned whether it gave plastic surgeons a “loophole” by saying implants were acceptable in cases of asymmetry.

Dr. Haeck strongly disagreed with that characterization, noting that asymmetric breasts can be socially and psychologically devastating for young women. “This is a private matter between a surgeon and the patient behind the closed door of an exam room, and it is, just like apple pie, the American way,” he said.

He emphasized, however, that in most instances, cosmetic enhancement would not be acceptable.

“Most of us feel that breast implants for your 16th birthday are inappropriate,” Dr. Haeck said. He did acknowledge that the recommendations were just that—advice. “We can't sit in our members' offices and tell them they can't do it,” he said.

The policy urged a delay in implants for these young women, until they have “sufficient emotional and physical maturity to make an informed decision based on an understanding of the factors involved in this procedure.”

With years of experience, a plastic surgeon can determine whether a young woman has this maturity, Dr. Haeck said, adding that in some cases, it is more obvious when implants would be inappropriate—such as when a boyfriend accompanies the patient and is paying for the surgery.

Michael Olding, M.D., chief of plastic surgery at George Washington University, Washington, and a member of the ASPS's public education committee, said he has never performed cosmetic breast augmentation in a woman under age 18. Some women might be mature at that age, he noted, “but those people are, in my opinion, a very small percentage of the women who would want to have breast augmentation at that age.”

Since the discovery 3 years ago that adipose tissue contains a rich amount of stem cells, researchers have been trying to coax those cells into potential therapeutics for a variety of conditions. So far, one such therapy has made it into early human trials, to help close fistulas in patients with Crohn's disease.

Damian Garcia-Olmo, M.D., of La Paz University Hospital, Madrid, shared results from a phase I study with researchers and reporters at a recent teleconference on potential uses for fat-derived stem cells.

In 2001, researchers from the University of California, Los Angeles, and the University of Pittsburgh first reported that stem cells could be isolated from fat removed during liposuction. That led to a rush to make use of the 150,000 gallons of fat that is discarded each year from some 300,000 liposuction procedures, said J. Peter Rubin, M.D., president of the International Fat Applied Technology Society and assistant professor of plastic and reconstructive surgery at the University of Pittsburgh.

Unlike stem cells derived from human embryos, there is no anticipated funding difficulty or dearth of sources with adipose tissue. “We have plenty of fat in this country,” Dr. Rubin said.

So far, researchers have determined that there is a huge density of stem cells in fat tissue, and that those cells can grow into new fat tissue, bone, cartilage, nerve, muscle, and endothelial cells.

Dr. Garcia-Olmo, a colorectal surgeon, said that after the first reports in 2001, he and his colleagues wondered if it would be possible to use the fat-derived cells to help Crohn's patients. They designed a phase I study, and enrolled five patients with fistulas who had failed to respond to all previous medical treatments.

All had fat removed through a minimally invasive process akin to liposuction, and the cells were cultured for injection back into the patient. One patient was discontinued due to contamination of the cell culture, Dr. Garcia-Olmo said.

He and his colleagues injected the stem cell mixture into the internal openings of nine fistulas in the four remaining patients. Eight of those fistulas were followed weekly for 8 weeks. By that time, external openings of six were covered with epithelium and considered cured. There was incomplete closure in the two other fistulas. With at least 6 months of follow-up, there have been no adverse events, he said.

The researchers, with support from a Madrid-based company, Genetrix, began a phase II study in 50 patients in September. That trial should take 2 years to complete, Dr. Garcia-Olmo said.

Though the therapy would not be a true cure because fistulas tend to recur with Crohn's disease, it could eliminate the need for multiple surgeries, he said.

Since the discovery 3 years ago that adipose tissue contains a rich amount of stem cells, researchers have been trying to coax those cells into potential therapeutics for a variety of conditions. So far, one such therapy has made it into early human trials, to help close fistulas in patients with Crohn's disease.

Damian Garcia-Olmo, M.D., of La Paz University Hospital, Madrid, shared results from a phase I study with researchers and reporters at a recent teleconference on potential uses for fat-derived stem cells.

In 2001, researchers from the University of California, Los Angeles, and the University of Pittsburgh first reported that stem cells could be isolated from fat removed during liposuction. That led to a rush to make use of the 150,000 gallons of fat that is discarded each year from some 300,000 liposuction procedures, said J. Peter Rubin, M.D., president of the International Fat Applied Technology Society and assistant professor of plastic and reconstructive surgery at the University of Pittsburgh.

Unlike stem cells derived from human embryos, there is no anticipated funding difficulty or dearth of sources with adipose tissue. “We have plenty of fat in this country,” Dr. Rubin said.

So far, researchers have determined that there is a huge density of stem cells in fat tissue, and that those cells can grow into new fat tissue, bone, cartilage, nerve, muscle, and endothelial cells.

Dr. Garcia-Olmo, a colorectal surgeon, said that after the first reports in 2001, he and his colleagues wondered if it would be possible to use the fat-derived cells to help Crohn's patients. They designed a phase I study, and enrolled five patients with fistulas who had failed to respond to all previous medical treatments.

All had fat removed through a minimally invasive process akin to liposuction, and the cells were cultured for injection back into the patient. One patient was discontinued due to contamination of the cell culture, Dr. Garcia-Olmo said.

He and his colleagues injected the stem cell mixture into the internal openings of nine fistulas in the four remaining patients. Eight of those fistulas were followed weekly for 8 weeks. By that time, external openings of six were covered with epithelium and considered cured. There was incomplete closure in the two other fistulas. With at least 6 months of follow-up, there have been no adverse events, he said.

The researchers, with support from a Madrid-based company, Genetrix, began a phase II study in 50 patients in September. That trial should take 2 years to complete, Dr. Garcia-Olmo said.

Though the therapy would not be a true cure because fistulas tend to recur with Crohn's disease, it could eliminate the need for multiple surgeries, he said.

Since the discovery 3 years ago that adipose tissue contains a rich amount of stem cells, researchers have been trying to coax those cells into potential therapeutics for a variety of conditions. So far, one such therapy has made it into early human trials, to help close fistulas in patients with Crohn's disease.

Damian Garcia-Olmo, M.D., of La Paz University Hospital, Madrid, shared results from a phase I study with researchers and reporters at a recent teleconference on potential uses for fat-derived stem cells.

In 2001, researchers from the University of California, Los Angeles, and the University of Pittsburgh first reported that stem cells could be isolated from fat removed during liposuction. That led to a rush to make use of the 150,000 gallons of fat that is discarded each year from some 300,000 liposuction procedures, said J. Peter Rubin, M.D., president of the International Fat Applied Technology Society and assistant professor of plastic and reconstructive surgery at the University of Pittsburgh.

Unlike stem cells derived from human embryos, there is no anticipated funding difficulty or dearth of sources with adipose tissue. “We have plenty of fat in this country,” Dr. Rubin said.

So far, researchers have determined that there is a huge density of stem cells in fat tissue, and that those cells can grow into new fat tissue, bone, cartilage, nerve, muscle, and endothelial cells.

Dr. Garcia-Olmo, a colorectal surgeon, said that after the first reports in 2001, he and his colleagues wondered if it would be possible to use the fat-derived cells to help Crohn's patients. They designed a phase I study, and enrolled five patients with fistulas who had failed to respond to all previous medical treatments.

All had fat removed through a minimally invasive process akin to liposuction, and the cells were cultured for injection back into the patient. One patient was discontinued due to contamination of the cell culture, Dr. Garcia-Olmo said.

He and his colleagues injected the stem cell mixture into the internal openings of nine fistulas in the four remaining patients. Eight of those fistulas were followed weekly for 8 weeks. By that time, external openings of six were covered with epithelium and considered cured. There was incomplete closure in the two other fistulas. With at least 6 months of follow-up, there have been no adverse events, he said.

The researchers, with support from a Madrid-based company, Genetrix, began a phase II study in 50 patients in September. That trial should take 2 years to complete, Dr. Garcia-Olmo said.

Though the therapy would not be a true cure because fistulas tend to recur with Crohn's disease, it could eliminate the need for multiple surgeries, he said.

NEW ORLEANS — Over the past decade, there has been a sixfold decline in open common bile duct explorations, said Edward Livingston, M.D., FACS, at the annual clinical congress of the American College of Surgeons.

This decrease may signal a loss of skill and experience in doing all open procedures, said Dr. Livingston. After learning that one of his residents had never performed an open procedure, Dr. Livingston investigated common bile duct explorations (CBDEs) to see whether the resident's situation was unusual.

Bile duct exploration typically is performed when there's a suspected blockage or obstruction. It requires general anesthesia, the injection of contrast dye and use of x-ray to highlight obstructions, and a 1- to 4-day hospital stay. Increasingly, however, patients with gallstones or other suspected blockages are undergoing endoscopic retrograde cholangiopancreatography (ERCP), a less invasive procedure that also allows imaging of stones.

Dr. Livingston, chair of the gastrointestinal and endocrine surgery division at the University of Texas, Dallas, wanted to see whether ERCP was supplanting CBDE and whether healthier patients were being referred to the endoscopic procedure while sicker patients were undergoing the open procedure. Using the federal government's National Hospital Discharge Summary, he flagged procedures performed in the biliary tract from 1979 to 2001, the most recent year for which information was available.

There were 47,000 CBDEs in 1979, but by 2001, only 7,700 were performed. The number of ERCPs rose steeply in 1989, when a billing code was added, and continued to increase throughout the 1990s, Dr. Livingston said.

He found that as the number of open explorations declined, complication rates increased. Most occurred in the operating room and usually involved technical errors by the surgeon, such as accidental lacerations, he said.

“There are probably too few common bile duct explorations now to [ensure] adequate training and experience,” said Dr. Livingston, adding that CBDEs should perhaps be done only by more experienced surgeons.

“As bad as these results are for CBDE now, the worse may be yet to come,” said Keith Lillimoe, M.D., FACS. He said the trends seen with CBDEs could be viewed as a harbinger for all surgeries. “Imagine what it will be like in 10 years, when few residents are trained in open procedures,” said Dr. Lillimoe, chair of the department of surgery at Indiana University.

Citing data from the American Council of Graduate Medical Education, Dr. Lillimoe said that in 1989–1990, chief surgical residents performed an average of 57 open cholecystectomies. In 2002–2003, that number dropped to 12.8. Chief residents performed 9.8 open CBDEs on average in 1989–1990 and only 3 by 2002–2003.

Dr. Lillimoe also said he's concerned that a growing number of patients may become ineligible for ERCP—in particular, those who have had the Roux-en-Y gastric bypass.

NEW ORLEANS — Over the past decade, there has been a sixfold decline in open common bile duct explorations, said Edward Livingston, M.D., FACS, at the annual clinical congress of the American College of Surgeons.

This decrease may signal a loss of skill and experience in doing all open procedures, said Dr. Livingston. After learning that one of his residents had never performed an open procedure, Dr. Livingston investigated common bile duct explorations (CBDEs) to see whether the resident's situation was unusual.

Bile duct exploration typically is performed when there's a suspected blockage or obstruction. It requires general anesthesia, the injection of contrast dye and use of x-ray to highlight obstructions, and a 1- to 4-day hospital stay. Increasingly, however, patients with gallstones or other suspected blockages are undergoing endoscopic retrograde cholangiopancreatography (ERCP), a less invasive procedure that also allows imaging of stones.

Dr. Livingston, chair of the gastrointestinal and endocrine surgery division at the University of Texas, Dallas, wanted to see whether ERCP was supplanting CBDE and whether healthier patients were being referred to the endoscopic procedure while sicker patients were undergoing the open procedure. Using the federal government's National Hospital Discharge Summary, he flagged procedures performed in the biliary tract from 1979 to 2001, the most recent year for which information was available.

There were 47,000 CBDEs in 1979, but by 2001, only 7,700 were performed. The number of ERCPs rose steeply in 1989, when a billing code was added, and continued to increase throughout the 1990s, Dr. Livingston said.

He found that as the number of open explorations declined, complication rates increased. Most occurred in the operating room and usually involved technical errors by the surgeon, such as accidental lacerations, he said.

“There are probably too few common bile duct explorations now to [ensure] adequate training and experience,” said Dr. Livingston, adding that CBDEs should perhaps be done only by more experienced surgeons.

“As bad as these results are for CBDE now, the worse may be yet to come,” said Keith Lillimoe, M.D., FACS. He said the trends seen with CBDEs could be viewed as a harbinger for all surgeries. “Imagine what it will be like in 10 years, when few residents are trained in open procedures,” said Dr. Lillimoe, chair of the department of surgery at Indiana University.

Citing data from the American Council of Graduate Medical Education, Dr. Lillimoe said that in 1989–1990, chief surgical residents performed an average of 57 open cholecystectomies. In 2002–2003, that number dropped to 12.8. Chief residents performed 9.8 open CBDEs on average in 1989–1990 and only 3 by 2002–2003.

Dr. Lillimoe also said he's concerned that a growing number of patients may become ineligible for ERCP—in particular, those who have had the Roux-en-Y gastric bypass.

NEW ORLEANS — Over the past decade, there has been a sixfold decline in open common bile duct explorations, said Edward Livingston, M.D., FACS, at the annual clinical congress of the American College of Surgeons.

This decrease may signal a loss of skill and experience in doing all open procedures, said Dr. Livingston. After learning that one of his residents had never performed an open procedure, Dr. Livingston investigated common bile duct explorations (CBDEs) to see whether the resident's situation was unusual.

Bile duct exploration typically is performed when there's a suspected blockage or obstruction. It requires general anesthesia, the injection of contrast dye and use of x-ray to highlight obstructions, and a 1- to 4-day hospital stay. Increasingly, however, patients with gallstones or other suspected blockages are undergoing endoscopic retrograde cholangiopancreatography (ERCP), a less invasive procedure that also allows imaging of stones.

Dr. Livingston, chair of the gastrointestinal and endocrine surgery division at the University of Texas, Dallas, wanted to see whether ERCP was supplanting CBDE and whether healthier patients were being referred to the endoscopic procedure while sicker patients were undergoing the open procedure. Using the federal government's National Hospital Discharge Summary, he flagged procedures performed in the biliary tract from 1979 to 2001, the most recent year for which information was available.

There were 47,000 CBDEs in 1979, but by 2001, only 7,700 were performed. The number of ERCPs rose steeply in 1989, when a billing code was added, and continued to increase throughout the 1990s, Dr. Livingston said.

He found that as the number of open explorations declined, complication rates increased. Most occurred in the operating room and usually involved technical errors by the surgeon, such as accidental lacerations, he said.

“There are probably too few common bile duct explorations now to [ensure] adequate training and experience,” said Dr. Livingston, adding that CBDEs should perhaps be done only by more experienced surgeons.

“As bad as these results are for CBDE now, the worse may be yet to come,” said Keith Lillimoe, M.D., FACS. He said the trends seen with CBDEs could be viewed as a harbinger for all surgeries. “Imagine what it will be like in 10 years, when few residents are trained in open procedures,” said Dr. Lillimoe, chair of the department of surgery at Indiana University.

Citing data from the American Council of Graduate Medical Education, Dr. Lillimoe said that in 1989–1990, chief surgical residents performed an average of 57 open cholecystectomies. In 2002–2003, that number dropped to 12.8. Chief residents performed 9.8 open CBDEs on average in 1989–1990 and only 3 by 2002–2003.

Dr. Lillimoe also said he's concerned that a growing number of patients may become ineligible for ERCP—in particular, those who have had the Roux-en-Y gastric bypass.

The Food and Drug Administration has approved a new, nonnarcotic therapy for insomnia, eszopiclone. Most sleep aids are approved for only short-term use of a week to 10 days, but eszopiclone can be safely prescribed for longer, according to the FDA.

Formerly known as Estorra and now called Lunesta, eszopiclone is a nonbenzodiazepine hypnotic that is a pyrrolopyrazine derivative of the cyclopyrrolone class. It is manufactured and sold by Sepracor Inc. of Marlborough, Mass. The drug is expected to be available this month.

Eszopiclone was studied in six phase III randomized, double-blind placebo trials, three of which were included in Sepracor's FDA approval package. The drug was superior to placebo in sleep latency and sleep maintenance for transient insomnia and superior in sleep latency and total sleep time in five 6-month studies in chronic insomnia. In two 2-week studies of patients aged 65-86, eszopiclone was also superior to placebo.

There was no major impact on memory or cognitive function in any of the studies, and only about 1% of patients on the highest dose—3 mg—experienced withdrawal signs. In addition, there was very little rebound insomnia.

Patients who do not respond after 7-10 days of treatment may have an underlying psychiatric disorder, warns the label, which adds that the lowest possible effective dose should be used. Eszopiclone will be available in 1-mg, 2-mg, and 3-mg tablets, and it will likely sell for $3.70 a pill, according to Sepracor. The recommended dose is 2-3 mg for adults up to 65 years old and 2 mg for adults over age 65.

Eszopiclone is also in trials as an insomnia therapy for patients with depression, rheumatoid arthritis, perimenopause, and chronic insomnia.

The Food and Drug Administration has approved a new, nonnarcotic therapy for insomnia, eszopiclone. Most sleep aids are approved for only short-term use of a week to 10 days, but eszopiclone can be safely prescribed for longer, according to the FDA.

Formerly known as Estorra and now called Lunesta, eszopiclone is a nonbenzodiazepine hypnotic that is a pyrrolopyrazine derivative of the cyclopyrrolone class. It is manufactured and sold by Sepracor Inc. of Marlborough, Mass. The drug is expected to be available this month.

Eszopiclone was studied in six phase III randomized, double-blind placebo trials, three of which were included in Sepracor's FDA approval package. The drug was superior to placebo in sleep latency and sleep maintenance for transient insomnia and superior in sleep latency and total sleep time in five 6-month studies in chronic insomnia. In two 2-week studies of patients aged 65-86, eszopiclone was also superior to placebo.

There was no major impact on memory or cognitive function in any of the studies, and only about 1% of patients on the highest dose—3 mg—experienced withdrawal signs. In addition, there was very little rebound insomnia.

Patients who do not respond after 7-10 days of treatment may have an underlying psychiatric disorder, warns the label, which adds that the lowest possible effective dose should be used. Eszopiclone will be available in 1-mg, 2-mg, and 3-mg tablets, and it will likely sell for $3.70 a pill, according to Sepracor. The recommended dose is 2-3 mg for adults up to 65 years old and 2 mg for adults over age 65.

Eszopiclone is also in trials as an insomnia therapy for patients with depression, rheumatoid arthritis, perimenopause, and chronic insomnia.

The Food and Drug Administration has approved a new, nonnarcotic therapy for insomnia, eszopiclone. Most sleep aids are approved for only short-term use of a week to 10 days, but eszopiclone can be safely prescribed for longer, according to the FDA.

Formerly known as Estorra and now called Lunesta, eszopiclone is a nonbenzodiazepine hypnotic that is a pyrrolopyrazine derivative of the cyclopyrrolone class. It is manufactured and sold by Sepracor Inc. of Marlborough, Mass. The drug is expected to be available this month.

Eszopiclone was studied in six phase III randomized, double-blind placebo trials, three of which were included in Sepracor's FDA approval package. The drug was superior to placebo in sleep latency and sleep maintenance for transient insomnia and superior in sleep latency and total sleep time in five 6-month studies in chronic insomnia. In two 2-week studies of patients aged 65-86, eszopiclone was also superior to placebo.

There was no major impact on memory or cognitive function in any of the studies, and only about 1% of patients on the highest dose—3 mg—experienced withdrawal signs. In addition, there was very little rebound insomnia.

Patients who do not respond after 7-10 days of treatment may have an underlying psychiatric disorder, warns the label, which adds that the lowest possible effective dose should be used. Eszopiclone will be available in 1-mg, 2-mg, and 3-mg tablets, and it will likely sell for $3.70 a pill, according to Sepracor. The recommended dose is 2-3 mg for adults up to 65 years old and 2 mg for adults over age 65.

Eszopiclone is also in trials as an insomnia therapy for patients with depression, rheumatoid arthritis, perimenopause, and chronic insomnia.

WASHINGTON — The nonprofit Consumers Union has issued the first in a series of evidence-based, patient-friendly reports listing what it calls the most cost-effective drugs, organization officials announced at a press conference.

The initial guides cover nonsteroidal anti-inflammatory agents (NSAIDs), statins, and proton pump inhibitors (PPIs).

The publisher of Consumer Reports said it hopes that patients—especially those with little or no drug benefit coverage—will use these reports to make informed choices in conjunction with their physicians.

The reports are designed to cut through the clutter of drug company advertising and scattered Internet searches. But drug makers won't be allowed to use the “Best Buy Drugs” designation in marketing or ads: Consumers Union prohibits manufacturers from commercializing any of its recommendations.

The guides should be familiar to anyone who has used Consumer Reports' ratings to buy a car, appliance, or bicycle. But unlike the group's analyses on other consumer goods, the Best Buy Drugs reports are free of charge.

“In each category, based on all the evidence, we've identified Best Buy Drugs—the drugs that are likely to be the best, most affordable choices for most people,” said Joel Gurin, executive vice president of Consumers Union.

The Best Buy Drugs are not selected based on Consumers Union's own tests, however, but rather on systematic reviews conducted by the Drug Effectiveness Review Project (DERP), and on further peer review from medical experts like Mark Helfand, M.D., director of the Oregon evidence-based practice center at Oregon Health and Science University, Portland, which initiated DERP in 2003.

DERP follows the literature review and analysis methods pioneered by the Cochrane Collaboration. That lends the Consumers Union's reports credibility, said Peter Toth, M.D., director of cardiovascular disease prevention at Sterling Rock Falls Clinic in Sterling, Ill.

“I believe patients will find it to be a valuable resource when trying to balance cost with clinical efficacy,” Dr. Toth said.

Funded by 12 states, DERP has completed reports on 12 therapeutic categories. Consumers Union is making the first three available on a new Web site (www.CRBestBuyDrugs.org

The organization has said that it will add three more categories over the next few months—selective serotonin reuptake inhibitors, β-blockers, and ACE inhibitors—and will continue to do so on a monthly basis.

Each report, which is also available in print form, offers a chart comparing the average monthly price for every drug—brand-name, generic, and over-the-counter—available in the class, at each dosage.

Price data are purchased from NDCHealth, a company that processes pharmacy transactions, and those data reflect national retail averages. Consumers may be able to find even better prices by shopping around, said Gail Shearer, director of health policy analysis for Consumers Union.

In the statin category, the report recommends generic lovastatin as its Best Buy Drug for reducing low-density lipoprotein (LDL) by less than 40%. Lovastatin costs an average $28 per month for 10 mg and $40 for 20 mg, according to Consumers Union. Lipitor (atorvastatin), at an average $117 per month, is the Best Buy Drug for LDL reduction of more than 40%.

Although Crestor (rosuvastatin) offers better LDL reduction for the price, it is not recommended because it has not been proved to reduce heart attacks or death, and safety studies are still being conducted, the report said.

Consumers Union rates the over-the-counter version of Prilosec (omeprazole) as the Best Buy Drug among the proton pump inhibitors. The 20 mg/day dosage costs $24 a month—one-fifth the cost of the next least-expensive drug in the class. And, it “is just as likely to relieve symptoms for most people with GERD [gastroesophageal reflux disease],” the report said. But the report also counsels people with drug coverage to talk with their physician about which medication has the lowest out-of-pocket cost under the patient's plan.

Dr. Toth said that if patients use an over-the-counter drug to treat GERD, they might skip seeing a physician—a potentially troubling issue.

“In the case of PPIs, there is concern because among a significant percentage of patients who suffer from chronic GERD, you do have to make sure that they're not developing Barrett's esophagus and that they don't have something more significant than simple reflux,” he said.

Consumers Union reviewers were initially worried about self-medication, but added a caveat to increase the dose or see a physician if symptoms did not improve, said Steve Findlay, a health care analyst with Consumers Union.

Reviewers were more concerned about highlighting over-the-counter medications in the NSAID category because of those drugs' potential to cause ulcers with chronic use, he said. The Best Buy Drugs in that category were generic ibuprofen at an average cost of $24–$30 per month, depending on dosage, and generic aspirin at a cost of $24–$32 a month. By taking these older, generic medicines, patients could save up to $2,160 a year, Consumers Union said.

Patients without drug coverage could consider over-the-counter NSAIDs, but only for periodic—not chronic—use, the report said. The evidence shows that the COX-2 inhibitors Celebrex (celecoxib) and Bextra (valdexocib) may cause fewer stomach ulcers, but it's not clear yet whether they lower the risk of dangerous ulcers or serious gastrointestinal bleeding, and physicians may be more cautious about prescribing these therapies in the wake of Vioxx's recall, the report said.

With issues like the worldwide recall of Vioxx popping up periodically, the Consumers Union aims to constantly monitor safety, effectiveness, and pricing changes, said Ms. Shearer.

DERP plans 25 reports in all, and will update its reports every 6 months.

The Best Buy Drugs project is funded partly by grants from the Engelberg Foundation, and from the National Library of Medicine.

WASHINGTON — The nonprofit Consumers Union has issued the first in a series of evidence-based, patient-friendly reports listing what it calls the most cost-effective drugs, organization officials announced at a press conference.

The initial guides cover nonsteroidal anti-inflammatory agents (NSAIDs), statins, and proton pump inhibitors (PPIs).

The publisher of Consumer Reports said it hopes that patients—especially those with little or no drug benefit coverage—will use these reports to make informed choices in conjunction with their physicians.

The reports are designed to cut through the clutter of drug company advertising and scattered Internet searches. But drug makers won't be allowed to use the “Best Buy Drugs” designation in marketing or ads: Consumers Union prohibits manufacturers from commercializing any of its recommendations.

The guides should be familiar to anyone who has used Consumer Reports' ratings to buy a car, appliance, or bicycle. But unlike the group's analyses on other consumer goods, the Best Buy Drugs reports are free of charge.

“In each category, based on all the evidence, we've identified Best Buy Drugs—the drugs that are likely to be the best, most affordable choices for most people,” said Joel Gurin, executive vice president of Consumers Union.

The Best Buy Drugs are not selected based on Consumers Union's own tests, however, but rather on systematic reviews conducted by the Drug Effectiveness Review Project (DERP), and on further peer review from medical experts like Mark Helfand, M.D., director of the Oregon evidence-based practice center at Oregon Health and Science University, Portland, which initiated DERP in 2003.

DERP follows the literature review and analysis methods pioneered by the Cochrane Collaboration. That lends the Consumers Union's reports credibility, said Peter Toth, M.D., director of cardiovascular disease prevention at Sterling Rock Falls Clinic in Sterling, Ill.

“I believe patients will find it to be a valuable resource when trying to balance cost with clinical efficacy,” Dr. Toth said.

Funded by 12 states, DERP has completed reports on 12 therapeutic categories. Consumers Union is making the first three available on a new Web site (www.CRBestBuyDrugs.org

The organization has said that it will add three more categories over the next few months—selective serotonin reuptake inhibitors, β-blockers, and ACE inhibitors—and will continue to do so on a monthly basis.

Each report, which is also available in print form, offers a chart comparing the average monthly price for every drug—brand-name, generic, and over-the-counter—available in the class, at each dosage.

Price data are purchased from NDCHealth, a company that processes pharmacy transactions, and those data reflect national retail averages. Consumers may be able to find even better prices by shopping around, said Gail Shearer, director of health policy analysis for Consumers Union.

In the statin category, the report recommends generic lovastatin as its Best Buy Drug for reducing low-density lipoprotein (LDL) by less than 40%. Lovastatin costs an average $28 per month for 10 mg and $40 for 20 mg, according to Consumers Union. Lipitor (atorvastatin), at an average $117 per month, is the Best Buy Drug for LDL reduction of more than 40%.

Although Crestor (rosuvastatin) offers better LDL reduction for the price, it is not recommended because it has not been proved to reduce heart attacks or death, and safety studies are still being conducted, the report said.

Consumers Union rates the over-the-counter version of Prilosec (omeprazole) as the Best Buy Drug among the proton pump inhibitors. The 20 mg/day dosage costs $24 a month—one-fifth the cost of the next least-expensive drug in the class. And, it “is just as likely to relieve symptoms for most people with GERD [gastroesophageal reflux disease],” the report said. But the report also counsels people with drug coverage to talk with their physician about which medication has the lowest out-of-pocket cost under the patient's plan.

Dr. Toth said that if patients use an over-the-counter drug to treat GERD, they might skip seeing a physician—a potentially troubling issue.

“In the case of PPIs, there is concern because among a significant percentage of patients who suffer from chronic GERD, you do have to make sure that they're not developing Barrett's esophagus and that they don't have something more significant than simple reflux,” he said.

Consumers Union reviewers were initially worried about self-medication, but added a caveat to increase the dose or see a physician if symptoms did not improve, said Steve Findlay, a health care analyst with Consumers Union.

Reviewers were more concerned about highlighting over-the-counter medications in the NSAID category because of those drugs' potential to cause ulcers with chronic use, he said. The Best Buy Drugs in that category were generic ibuprofen at an average cost of $24–$30 per month, depending on dosage, and generic aspirin at a cost of $24–$32 a month. By taking these older, generic medicines, patients could save up to $2,160 a year, Consumers Union said.

Patients without drug coverage could consider over-the-counter NSAIDs, but only for periodic—not chronic—use, the report said. The evidence shows that the COX-2 inhibitors Celebrex (celecoxib) and Bextra (valdexocib) may cause fewer stomach ulcers, but it's not clear yet whether they lower the risk of dangerous ulcers or serious gastrointestinal bleeding, and physicians may be more cautious about prescribing these therapies in the wake of Vioxx's recall, the report said.

With issues like the worldwide recall of Vioxx popping up periodically, the Consumers Union aims to constantly monitor safety, effectiveness, and pricing changes, said Ms. Shearer.

DERP plans 25 reports in all, and will update its reports every 6 months.

The Best Buy Drugs project is funded partly by grants from the Engelberg Foundation, and from the National Library of Medicine.

WASHINGTON — The nonprofit Consumers Union has issued the first in a series of evidence-based, patient-friendly reports listing what it calls the most cost-effective drugs, organization officials announced at a press conference.

The initial guides cover nonsteroidal anti-inflammatory agents (NSAIDs), statins, and proton pump inhibitors (PPIs).

The publisher of Consumer Reports said it hopes that patients—especially those with little or no drug benefit coverage—will use these reports to make informed choices in conjunction with their physicians.

The reports are designed to cut through the clutter of drug company advertising and scattered Internet searches. But drug makers won't be allowed to use the “Best Buy Drugs” designation in marketing or ads: Consumers Union prohibits manufacturers from commercializing any of its recommendations.

The guides should be familiar to anyone who has used Consumer Reports' ratings to buy a car, appliance, or bicycle. But unlike the group's analyses on other consumer goods, the Best Buy Drugs reports are free of charge.

“In each category, based on all the evidence, we've identified Best Buy Drugs—the drugs that are likely to be the best, most affordable choices for most people,” said Joel Gurin, executive vice president of Consumers Union.

The Best Buy Drugs are not selected based on Consumers Union's own tests, however, but rather on systematic reviews conducted by the Drug Effectiveness Review Project (DERP), and on further peer review from medical experts like Mark Helfand, M.D., director of the Oregon evidence-based practice center at Oregon Health and Science University, Portland, which initiated DERP in 2003.

DERP follows the literature review and analysis methods pioneered by the Cochrane Collaboration. That lends the Consumers Union's reports credibility, said Peter Toth, M.D., director of cardiovascular disease prevention at Sterling Rock Falls Clinic in Sterling, Ill.

“I believe patients will find it to be a valuable resource when trying to balance cost with clinical efficacy,” Dr. Toth said.

Funded by 12 states, DERP has completed reports on 12 therapeutic categories. Consumers Union is making the first three available on a new Web site (www.CRBestBuyDrugs.org

The organization has said that it will add three more categories over the next few months—selective serotonin reuptake inhibitors, β-blockers, and ACE inhibitors—and will continue to do so on a monthly basis.

Each report, which is also available in print form, offers a chart comparing the average monthly price for every drug—brand-name, generic, and over-the-counter—available in the class, at each dosage.

Price data are purchased from NDCHealth, a company that processes pharmacy transactions, and those data reflect national retail averages. Consumers may be able to find even better prices by shopping around, said Gail Shearer, director of health policy analysis for Consumers Union.

In the statin category, the report recommends generic lovastatin as its Best Buy Drug for reducing low-density lipoprotein (LDL) by less than 40%. Lovastatin costs an average $28 per month for 10 mg and $40 for 20 mg, according to Consumers Union. Lipitor (atorvastatin), at an average $117 per month, is the Best Buy Drug for LDL reduction of more than 40%.

Although Crestor (rosuvastatin) offers better LDL reduction for the price, it is not recommended because it has not been proved to reduce heart attacks or death, and safety studies are still being conducted, the report said.

Consumers Union rates the over-the-counter version of Prilosec (omeprazole) as the Best Buy Drug among the proton pump inhibitors. The 20 mg/day dosage costs $24 a month—one-fifth the cost of the next least-expensive drug in the class. And, it “is just as likely to relieve symptoms for most people with GERD [gastroesophageal reflux disease],” the report said. But the report also counsels people with drug coverage to talk with their physician about which medication has the lowest out-of-pocket cost under the patient's plan.

Dr. Toth said that if patients use an over-the-counter drug to treat GERD, they might skip seeing a physician—a potentially troubling issue.

“In the case of PPIs, there is concern because among a significant percentage of patients who suffer from chronic GERD, you do have to make sure that they're not developing Barrett's esophagus and that they don't have something more significant than simple reflux,” he said.

Consumers Union reviewers were initially worried about self-medication, but added a caveat to increase the dose or see a physician if symptoms did not improve, said Steve Findlay, a health care analyst with Consumers Union.

Reviewers were more concerned about highlighting over-the-counter medications in the NSAID category because of those drugs' potential to cause ulcers with chronic use, he said. The Best Buy Drugs in that category were generic ibuprofen at an average cost of $24–$30 per month, depending on dosage, and generic aspirin at a cost of $24–$32 a month. By taking these older, generic medicines, patients could save up to $2,160 a year, Consumers Union said.

Patients without drug coverage could consider over-the-counter NSAIDs, but only for periodic—not chronic—use, the report said. The evidence shows that the COX-2 inhibitors Celebrex (celecoxib) and Bextra (valdexocib) may cause fewer stomach ulcers, but it's not clear yet whether they lower the risk of dangerous ulcers or serious gastrointestinal bleeding, and physicians may be more cautious about prescribing these therapies in the wake of Vioxx's recall, the report said.

With issues like the worldwide recall of Vioxx popping up periodically, the Consumers Union aims to constantly monitor safety, effectiveness, and pricing changes, said Ms. Shearer.

DERP plans 25 reports in all, and will update its reports every 6 months.

The Best Buy Drugs project is funded partly by grants from the Engelberg Foundation, and from the National Library of Medicine.

WASHINGTON – The nonprofit Consumers Union has issued the first in a series of evidence-based, patient-friendly reports listing what it calls the most cost-effective drugs, organization officials announced at a press conference.

The initial guides cover nonsteroidal anti-inflammatory agents (NSAIDs), statins, and proton pump inhibitors (PPIs).

The publisher of Consumer Reports said it hopes that patients–especially those who have little or no drug benefit coverage–will use these reports to make informed choices with their physicians.

The reports are designed to cut through the clutter of drug company advertising and scattered Internet searches.

But drug makers will not be allowed to use the “Best Buy Drugs” designation in marketing or ads: Consumers Union prohibits manufacturers from commercializing any of its recommendations.

The guides should be familiar to anyone who has used Consumer Reports' ratings to buy a car, appliance, or bicycle. But unlike the group's analyses on other consumer goods, the Best Buy Drugs reports are free of charge.

“In each category, based on all the evidence, we've identified Best Buy Drugs–the drugs that are likely to be the best, most affordable choices for most people,” said Joel Gurin, executive vice president of Consumers Union.

The Best Buy Drugs are not selected based on Consumers Union's own tests, however, but rather on systematic reviews conducted by the Drug Effectiveness Review Project (DERP), and on further peer review from medical experts like Mark Helfand, M.D., who serves as director of the Oregon evidence-based practice center at Oregon Health and Science University, Portland, which initiated DERP in 2003.

DERP follows the literature review and analysis methods pioneered by the Cochrane Collaboration.

That lends the Consumers Union's reports credibility, said Peter Toth, M.D., who is director of cardiovascular disease prevention at Sterling Rock Falls Clinic in Sterling, Ill.

“I believe patients will find it to be a valuable resource when trying to balance cost with clinical efficacy,” Dr. Toth said.

Funded by 12 states, DERP has completed reports on 12 therapeutic categories. Consumers Union is making the first three available on a new Web site (www.CRBestBuyDrugs.org

The organization has said that it will add three more categories over the next few months–selective serotonin reuptake inhibitors, β-blockers, and ACE inhibitors–and will continue to do so on a monthly basis.

Each report, which is also available in print form, offers a chart comparing the average monthly price for every drug–brand-name, generic, and over-the-counter–available in the class, at each dosage.

Price data are purchased from NDCHealth, a company that processes pharmacy transactions, and those data reflect national retail averages. Consumers may be able to find even better prices by shopping around, said Gail Shearer, director of health policy analysis for Consumers Union.

In the statin category, the report recommends generic lovastatin as its Best Buy Drug for reducing low-density lipoprotein (LDL) by less than 40%.

Lovastatin costs an average $28 per month for 10 mg and $40 for 20 mg, according to Consumers Union. Lipitor (atorvastatin), at an average $117 per month, is the Best Buy Drug for LDL reduction of more than 40%.

Although Crestor (rosuvastatin) offers better LDL reduction for the price, it is not recommended because it has not been proved to reduce heart attacks or death, and safety studies are still being conducted, the report said.

Consumers Union rates the over-the-counter version of Prilosec (omeprazole) as the Best Buy Drug among the proton pump inhibitors. The 20 mg/day dosage costs $24 a month–one-fifth the cost of the next least-expensive drug in the class. And, it “is just as likely to relieve symptoms for most people with GERD [gastroesophageal reflux disease],” the report said.

But the report also counsels people with drug coverage to talk with their physician about which medication has the lowest out-of-pocket cost under the patient's plan.

Dr. Toth expressed concern that if patients use an over-the-counter drug to treat GERD, they might skip seeing a physician–a potentially troubling issue.

“In the case of PPIs, there is concern because among a significant percentage of patients who suffer from chronic GERD, you do have to make sure that they're not developing Barrett's esophagus and that they don't have something more significant than simple reflux,” according to Dr. Toth.

Consumers Union reviewers were initially worried about self-medication, but added a caveat to increase the dose or see a physician if symptoms did not improve, said Steve Findlay, a health care analyst with Consumers Union.

Reviewers were more concerned about highlighting over-the-counter medications in the NSAID category because of those drugs' potential to cause ulcers with chronic use, he said.

The Best Buy Drugs in that category were generic ibuprofen at an average cost of $24–$30 per month, depending on dosage, and generic aspirin at a cost of $24–$32 a month. By taking these older, generic medicines, patients could save up to $2,160 a year, Consumers Union said.

Patients without drug coverage could consider over-the-counter NSAIDs, but only for periodic–not chronic–use, the report said.

The evidence shows that the COX-2 inhibitors Celebrex (celecoxib) and Bextra (valdexocib) may cause fewer stomach ulcers, but it's not clear yet whether they lower the risk of dangerous ulcers or serious gastrointestinal bleeding, and physicians may be more cautious about prescribing these therapies in the wake of Vioxx's recall, the report said.

With issues such as the worldwide recall of Vioxx popping up periodically, the Consumers Union aims to constantly monitor safety, effectiveness, and pricing changes, Ms. Shearer said.

DERP plans 25 reports in all, and will update its reports every 6 months.

The Best Buy Drugs project is funded partly by grants from the Engelberg Foundation, and from the National Library of Medicine.

WASHINGTON – The nonprofit Consumers Union has issued the first in a series of evidence-based, patient-friendly reports listing what it calls the most cost-effective drugs, organization officials announced at a press conference.

The initial guides cover nonsteroidal anti-inflammatory agents (NSAIDs), statins, and proton pump inhibitors (PPIs).

The publisher of Consumer Reports said it hopes that patients–especially those who have little or no drug benefit coverage–will use these reports to make informed choices with their physicians.

The reports are designed to cut through the clutter of drug company advertising and scattered Internet searches.

But drug makers will not be allowed to use the “Best Buy Drugs” designation in marketing or ads: Consumers Union prohibits manufacturers from commercializing any of its recommendations.

The guides should be familiar to anyone who has used Consumer Reports' ratings to buy a car, appliance, or bicycle. But unlike the group's analyses on other consumer goods, the Best Buy Drugs reports are free of charge.

“In each category, based on all the evidence, we've identified Best Buy Drugs–the drugs that are likely to be the best, most affordable choices for most people,” said Joel Gurin, executive vice president of Consumers Union.

The Best Buy Drugs are not selected based on Consumers Union's own tests, however, but rather on systematic reviews conducted by the Drug Effectiveness Review Project (DERP), and on further peer review from medical experts like Mark Helfand, M.D., who serves as director of the Oregon evidence-based practice center at Oregon Health and Science University, Portland, which initiated DERP in 2003.

DERP follows the literature review and analysis methods pioneered by the Cochrane Collaboration.

That lends the Consumers Union's reports credibility, said Peter Toth, M.D., who is director of cardiovascular disease prevention at Sterling Rock Falls Clinic in Sterling, Ill.

“I believe patients will find it to be a valuable resource when trying to balance cost with clinical efficacy,” Dr. Toth said.

Funded by 12 states, DERP has completed reports on 12 therapeutic categories. Consumers Union is making the first three available on a new Web site (www.CRBestBuyDrugs.org

The organization has said that it will add three more categories over the next few months–selective serotonin reuptake inhibitors, β-blockers, and ACE inhibitors–and will continue to do so on a monthly basis.

Each report, which is also available in print form, offers a chart comparing the average monthly price for every drug–brand-name, generic, and over-the-counter–available in the class, at each dosage.

Price data are purchased from NDCHealth, a company that processes pharmacy transactions, and those data reflect national retail averages. Consumers may be able to find even better prices by shopping around, said Gail Shearer, director of health policy analysis for Consumers Union.

In the statin category, the report recommends generic lovastatin as its Best Buy Drug for reducing low-density lipoprotein (LDL) by less than 40%.

Lovastatin costs an average $28 per month for 10 mg and $40 for 20 mg, according to Consumers Union. Lipitor (atorvastatin), at an average $117 per month, is the Best Buy Drug for LDL reduction of more than 40%.

Although Crestor (rosuvastatin) offers better LDL reduction for the price, it is not recommended because it has not been proved to reduce heart attacks or death, and safety studies are still being conducted, the report said.

Consumers Union rates the over-the-counter version of Prilosec (omeprazole) as the Best Buy Drug among the proton pump inhibitors. The 20 mg/day dosage costs $24 a month–one-fifth the cost of the next least-expensive drug in the class. And, it “is just as likely to relieve symptoms for most people with GERD [gastroesophageal reflux disease],” the report said.

But the report also counsels people with drug coverage to talk with their physician about which medication has the lowest out-of-pocket cost under the patient's plan.

Dr. Toth expressed concern that if patients use an over-the-counter drug to treat GERD, they might skip seeing a physician–a potentially troubling issue.

“In the case of PPIs, there is concern because among a significant percentage of patients who suffer from chronic GERD, you do have to make sure that they're not developing Barrett's esophagus and that they don't have something more significant than simple reflux,” according to Dr. Toth.

Consumers Union reviewers were initially worried about self-medication, but added a caveat to increase the dose or see a physician if symptoms did not improve, said Steve Findlay, a health care analyst with Consumers Union.

Reviewers were more concerned about highlighting over-the-counter medications in the NSAID category because of those drugs' potential to cause ulcers with chronic use, he said.

The Best Buy Drugs in that category were generic ibuprofen at an average cost of $24–$30 per month, depending on dosage, and generic aspirin at a cost of $24–$32 a month. By taking these older, generic medicines, patients could save up to $2,160 a year, Consumers Union said.

Patients without drug coverage could consider over-the-counter NSAIDs, but only for periodic–not chronic–use, the report said.

The evidence shows that the COX-2 inhibitors Celebrex (celecoxib) and Bextra (valdexocib) may cause fewer stomach ulcers, but it's not clear yet whether they lower the risk of dangerous ulcers or serious gastrointestinal bleeding, and physicians may be more cautious about prescribing these therapies in the wake of Vioxx's recall, the report said.

With issues such as the worldwide recall of Vioxx popping up periodically, the Consumers Union aims to constantly monitor safety, effectiveness, and pricing changes, Ms. Shearer said.

DERP plans 25 reports in all, and will update its reports every 6 months.

The Best Buy Drugs project is funded partly by grants from the Engelberg Foundation, and from the National Library of Medicine.

WASHINGTON – The nonprofit Consumers Union has issued the first in a series of evidence-based, patient-friendly reports listing what it calls the most cost-effective drugs, organization officials announced at a press conference.

The initial guides cover nonsteroidal anti-inflammatory agents (NSAIDs), statins, and proton pump inhibitors (PPIs).

The publisher of Consumer Reports said it hopes that patients–especially those who have little or no drug benefit coverage–will use these reports to make informed choices with their physicians.

The reports are designed to cut through the clutter of drug company advertising and scattered Internet searches.

But drug makers will not be allowed to use the “Best Buy Drugs” designation in marketing or ads: Consumers Union prohibits manufacturers from commercializing any of its recommendations.

The guides should be familiar to anyone who has used Consumer Reports' ratings to buy a car, appliance, or bicycle. But unlike the group's analyses on other consumer goods, the Best Buy Drugs reports are free of charge.

“In each category, based on all the evidence, we've identified Best Buy Drugs–the drugs that are likely to be the best, most affordable choices for most people,” said Joel Gurin, executive vice president of Consumers Union.

The Best Buy Drugs are not selected based on Consumers Union's own tests, however, but rather on systematic reviews conducted by the Drug Effectiveness Review Project (DERP), and on further peer review from medical experts like Mark Helfand, M.D., who serves as director of the Oregon evidence-based practice center at Oregon Health and Science University, Portland, which initiated DERP in 2003.

DERP follows the literature review and analysis methods pioneered by the Cochrane Collaboration.

That lends the Consumers Union's reports credibility, said Peter Toth, M.D., who is director of cardiovascular disease prevention at Sterling Rock Falls Clinic in Sterling, Ill.

“I believe patients will find it to be a valuable resource when trying to balance cost with clinical efficacy,” Dr. Toth said.

Funded by 12 states, DERP has completed reports on 12 therapeutic categories. Consumers Union is making the first three available on a new Web site (www.CRBestBuyDrugs.org

The organization has said that it will add three more categories over the next few months–selective serotonin reuptake inhibitors, β-blockers, and ACE inhibitors–and will continue to do so on a monthly basis.

Each report, which is also available in print form, offers a chart comparing the average monthly price for every drug–brand-name, generic, and over-the-counter–available in the class, at each dosage.

Price data are purchased from NDCHealth, a company that processes pharmacy transactions, and those data reflect national retail averages. Consumers may be able to find even better prices by shopping around, said Gail Shearer, director of health policy analysis for Consumers Union.

In the statin category, the report recommends generic lovastatin as its Best Buy Drug for reducing low-density lipoprotein (LDL) by less than 40%.

Lovastatin costs an average $28 per month for 10 mg and $40 for 20 mg, according to Consumers Union. Lipitor (atorvastatin), at an average $117 per month, is the Best Buy Drug for LDL reduction of more than 40%.

Although Crestor (rosuvastatin) offers better LDL reduction for the price, it is not recommended because it has not been proved to reduce heart attacks or death, and safety studies are still being conducted, the report said.

Consumers Union rates the over-the-counter version of Prilosec (omeprazole) as the Best Buy Drug among the proton pump inhibitors. The 20 mg/day dosage costs $24 a month–one-fifth the cost of the next least-expensive drug in the class. And, it “is just as likely to relieve symptoms for most people with GERD [gastroesophageal reflux disease],” the report said.

But the report also counsels people with drug coverage to talk with their physician about which medication has the lowest out-of-pocket cost under the patient's plan.

Dr. Toth expressed concern that if patients use an over-the-counter drug to treat GERD, they might skip seeing a physician–a potentially troubling issue.

“In the case of PPIs, there is concern because among a significant percentage of patients who suffer from chronic GERD, you do have to make sure that they're not developing Barrett's esophagus and that they don't have something more significant than simple reflux,” according to Dr. Toth.

Consumers Union reviewers were initially worried about self-medication, but added a caveat to increase the dose or see a physician if symptoms did not improve, said Steve Findlay, a health care analyst with Consumers Union.

Reviewers were more concerned about highlighting over-the-counter medications in the NSAID category because of those drugs' potential to cause ulcers with chronic use, he said.

The Best Buy Drugs in that category were generic ibuprofen at an average cost of $24–$30 per month, depending on dosage, and generic aspirin at a cost of $24–$32 a month. By taking these older, generic medicines, patients could save up to $2,160 a year, Consumers Union said.

Patients without drug coverage could consider over-the-counter NSAIDs, but only for periodic–not chronic–use, the report said.

The evidence shows that the COX-2 inhibitors Celebrex (celecoxib) and Bextra (valdexocib) may cause fewer stomach ulcers, but it's not clear yet whether they lower the risk of dangerous ulcers or serious gastrointestinal bleeding, and physicians may be more cautious about prescribing these therapies in the wake of Vioxx's recall, the report said.

With issues such as the worldwide recall of Vioxx popping up periodically, the Consumers Union aims to constantly monitor safety, effectiveness, and pricing changes, Ms. Shearer said.

DERP plans 25 reports in all, and will update its reports every 6 months.

The Best Buy Drugs project is funded partly by grants from the Engelberg Foundation, and from the National Library of Medicine.

WASHINGTON — New data suggest that gatifloxacin (Tequin) may be associated with a much higher rate of glucose homeostasis abnormalities than has been observed for quinolone antibiotics in general, Richard Frothingham, M.D., reported at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Gatifloxacin is responsible for many more adverse drug event reports than are other quinolones, and should not be used in patients with diabetes, said Dr. Frothingham of Duke University, Durham, N.C., and a physician at the Durham VA Medical Center.

In preclinical and early clinical studies, there was some suggestion that gatifloxacin might cause some problems with glucose homeostasis, but in the pivotal studies, the drug was equal to other drugs with which it was compared, Dr. Frothingham said at the meeting, sponsored by the American Society for Microbiology.

When gatifloxacin was approved in 1999, the Food and Drug Administration did not add any warnings about glucose metabolism.

Since that time, there have been reports of adverse effects, including severe hypoglycemia in patients with type 2 diabetes treated with oral medications. Hyperglycemia in diabetic patients, usually occurring 4–10 days after starting gatifloxacin, has also been reported.

These episodes are described in the warnings section of the drug's label. Physicians are urged to closely monitor glucose levels in diabetic patients taking the drug and to adjust the dosage based on underlying renal function.

But Dr. Frothingham said he thinks physicians aren't heeding the warnings, and also that problems with glucose homeostasis are underreported. In a Freedom of Information Act request, he queried the FDA's adverse event reports database to compare reports for gatifloxacin and several other marketed quinolones, including ciprofloxacin (Cipro), levofloxacin (Levaquin), and moxifloxacin (Avelox).

He evaluated adverse drug event reports filed for the four drugs from November 1997 until September 2003 and found that gatifloxacin had the largest number of reports related to glucose homeostasis abnormalities per number of prescriptions: 477 per 10 million prescriptions, compared with 39 for moxifloxacin, 11 for levofloxacin, and 4 for ciprofloxacin.

The FDA's database—because it is made up of data collected passively—cannot establish a direct link between a drug and a side effect, Dr. Frothingham noted.

He said he believes “this is a compelling association” between gatifloxacin and glucose homeostasis problems. Dr. Frothingham called it “a rare side effect,” but suggested that physicians never exceed the recommended dosage. He added that gatifloxacin should not be prescribed for diabetics at all. The dosage should be reduced to 200 mg daily in patients who are over age 65 or who have a creatinine clearance of less than 60 mL/min.

In a separate presentation at the meeting, Ben Lomaestro, Pharm.D., of Albany (N.Y.) Medical Center Hospital presented data on the use of gatifloxacin in his facility that suggested there was no difference in glucose levels when gatifloxacin was compared with piperacillin/tazobactam in elderly patients; however, the study had some important limitations, he said.

It was a small study, with 134 patients in the gatifloxacin arm and 82 in the piperacillin arm, and their glucose levels were checked only in the morning.

Despite these limitations, the study demonstrated that glucose intolerance is relatively common in elderly hospitalized patients.

In another presentation, Paul Iannini, M.D., chairman of the department of medicine at Danbury (Conn.) Hospital, evaluated glucose intolerance during treatment with gemifloxacin, compared with other drugs in the class. He said that it was probably not a class-wide problem.

WASHINGTON — New data suggest that gatifloxacin (Tequin) may be associated with a much higher rate of glucose homeostasis abnormalities than has been observed for quinolone antibiotics in general, Richard Frothingham, M.D., reported at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Gatifloxacin is responsible for many more adverse drug event reports than are other quinolones, and should not be used in patients with diabetes, said Dr. Frothingham of Duke University, Durham, N.C., and a physician at the Durham VA Medical Center.

In preclinical and early clinical studies, there was some suggestion that gatifloxacin might cause some problems with glucose homeostasis, but in the pivotal studies, the drug was equal to other drugs with which it was compared, Dr. Frothingham said at the meeting, sponsored by the American Society for Microbiology.

When gatifloxacin was approved in 1999, the Food and Drug Administration did not add any warnings about glucose metabolism.

Since that time, there have been reports of adverse effects, including severe hypoglycemia in patients with type 2 diabetes treated with oral medications. Hyperglycemia in diabetic patients, usually occurring 4–10 days after starting gatifloxacin, has also been reported.

These episodes are described in the warnings section of the drug's label. Physicians are urged to closely monitor glucose levels in diabetic patients taking the drug and to adjust the dosage based on underlying renal function.

But Dr. Frothingham said he thinks physicians aren't heeding the warnings, and also that problems with glucose homeostasis are underreported. In a Freedom of Information Act request, he queried the FDA's adverse event reports database to compare reports for gatifloxacin and several other marketed quinolones, including ciprofloxacin (Cipro), levofloxacin (Levaquin), and moxifloxacin (Avelox).

He evaluated adverse drug event reports filed for the four drugs from November 1997 until September 2003 and found that gatifloxacin had the largest number of reports related to glucose homeostasis abnormalities per number of prescriptions: 477 per 10 million prescriptions, compared with 39 for moxifloxacin, 11 for levofloxacin, and 4 for ciprofloxacin.

The FDA's database—because it is made up of data collected passively—cannot establish a direct link between a drug and a side effect, Dr. Frothingham noted.

He said he believes “this is a compelling association” between gatifloxacin and glucose homeostasis problems. Dr. Frothingham called it “a rare side effect,” but suggested that physicians never exceed the recommended dosage. He added that gatifloxacin should not be prescribed for diabetics at all. The dosage should be reduced to 200 mg daily in patients who are over age 65 or who have a creatinine clearance of less than 60 mL/min.

In a separate presentation at the meeting, Ben Lomaestro, Pharm.D., of Albany (N.Y.) Medical Center Hospital presented data on the use of gatifloxacin in his facility that suggested there was no difference in glucose levels when gatifloxacin was compared with piperacillin/tazobactam in elderly patients; however, the study had some important limitations, he said.

It was a small study, with 134 patients in the gatifloxacin arm and 82 in the piperacillin arm, and their glucose levels were checked only in the morning.

Despite these limitations, the study demonstrated that glucose intolerance is relatively common in elderly hospitalized patients.

In another presentation, Paul Iannini, M.D., chairman of the department of medicine at Danbury (Conn.) Hospital, evaluated glucose intolerance during treatment with gemifloxacin, compared with other drugs in the class. He said that it was probably not a class-wide problem.

WASHINGTON — New data suggest that gatifloxacin (Tequin) may be associated with a much higher rate of glucose homeostasis abnormalities than has been observed for quinolone antibiotics in general, Richard Frothingham, M.D., reported at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Gatifloxacin is responsible for many more adverse drug event reports than are other quinolones, and should not be used in patients with diabetes, said Dr. Frothingham of Duke University, Durham, N.C., and a physician at the Durham VA Medical Center.

In preclinical and early clinical studies, there was some suggestion that gatifloxacin might cause some problems with glucose homeostasis, but in the pivotal studies, the drug was equal to other drugs with which it was compared, Dr. Frothingham said at the meeting, sponsored by the American Society for Microbiology.

When gatifloxacin was approved in 1999, the Food and Drug Administration did not add any warnings about glucose metabolism.

Since that time, there have been reports of adverse effects, including severe hypoglycemia in patients with type 2 diabetes treated with oral medications. Hyperglycemia in diabetic patients, usually occurring 4–10 days after starting gatifloxacin, has also been reported.

These episodes are described in the warnings section of the drug's label. Physicians are urged to closely monitor glucose levels in diabetic patients taking the drug and to adjust the dosage based on underlying renal function.

But Dr. Frothingham said he thinks physicians aren't heeding the warnings, and also that problems with glucose homeostasis are underreported. In a Freedom of Information Act request, he queried the FDA's adverse event reports database to compare reports for gatifloxacin and several other marketed quinolones, including ciprofloxacin (Cipro), levofloxacin (Levaquin), and moxifloxacin (Avelox).

He evaluated adverse drug event reports filed for the four drugs from November 1997 until September 2003 and found that gatifloxacin had the largest number of reports related to glucose homeostasis abnormalities per number of prescriptions: 477 per 10 million prescriptions, compared with 39 for moxifloxacin, 11 for levofloxacin, and 4 for ciprofloxacin.

The FDA's database—because it is made up of data collected passively—cannot establish a direct link between a drug and a side effect, Dr. Frothingham noted.

He said he believes “this is a compelling association” between gatifloxacin and glucose homeostasis problems. Dr. Frothingham called it “a rare side effect,” but suggested that physicians never exceed the recommended dosage. He added that gatifloxacin should not be prescribed for diabetics at all. The dosage should be reduced to 200 mg daily in patients who are over age 65 or who have a creatinine clearance of less than 60 mL/min.

In a separate presentation at the meeting, Ben Lomaestro, Pharm.D., of Albany (N.Y.) Medical Center Hospital presented data on the use of gatifloxacin in his facility that suggested there was no difference in glucose levels when gatifloxacin was compared with piperacillin/tazobactam in elderly patients; however, the study had some important limitations, he said.

It was a small study, with 134 patients in the gatifloxacin arm and 82 in the piperacillin arm, and their glucose levels were checked only in the morning.

Despite these limitations, the study demonstrated that glucose intolerance is relatively common in elderly hospitalized patients.

In another presentation, Paul Iannini, M.D., chairman of the department of medicine at Danbury (Conn.) Hospital, evaluated glucose intolerance during treatment with gemifloxacin, compared with other drugs in the class. He said that it was probably not a class-wide problem.

WASHINGTON — The nonprofit Consumers Union has issued the first in a series of evidence-based, patient-friendly reports listing what it calls the most cost-effective drugs, organization officials announced at a press conference.

The initial guides cover nonsteroidal anti-inflammatory agents (NSAIDs), statins, and proton pump inhibitors (PPIs).

The publisher of Consumer Reports said it hopes that patients—especially those with little or no drug benefit coverage—will use these reports to make informed choices in conjunction with their physicians.

The reports are designed to cut through the clutter of drug company advertising and scattered Internet searches. But drug makers won't be allowed to use the "Best Buy Drugs" designation in marketing or ads: Consumers Union prohibits manufacturers from commercializing any of its recommendations.

The guides should be familiar to anyone who has used Consumer Reports' ratings to buy a car, appliance, or bicycle. But unlike the group's analyses on other consumer goods, the Best Buy Drugs reports are free of charge.

"In each category, based on all the evidence, we've identified Best Buy Drugs—the drugs that are likely to be the best, most affordable choices for most people," said Joel Gurin, executive vice president of Consumers Union.

The Best Buy Drugs are not selected based on Consumers Union's own tests, however, but rather on systematic reviews conducted by the Drug Effectiveness Review Project (DERP), and on further peer review from medical experts like Mark Helfand, M.D., director of the Oregon evidence-based practice center at Oregon Health and Science University, Portland, which initiated DERP in 2003.

DERP follows the literature review and analysis methods pioneered by the Cochrane Collaboration. That lends the Consumers Union's reports credibility, said Peter Toth, M.D., director of cardiovascular disease prevention at Sterling Rock Falls Clinic in Sterling, Ill.

"I believe patients will find it to be a valuable resource when trying to balance cost with clinical efficacy," Dr. Toth commented.

Funded by 12 states, DERP has completed reports on 12 therapeutic categories. Consumers Union is making the first three available on a new Web site (www.CRBestBuyDrugs.org

The organization has said that it will add three more categories over the next few months—selective serotonin reuptake inhibitors, β-blockers, and ACE inhibitors—and will continue to do so on a monthly basis. Each report, which is also available in print form, offers a chart comparing the average monthly price for every drug—brand-name, generic, and over-the-counter—available in the class, at each dosage.

Price data are purchased from NDCHealth, a company that processes pharmacy transactions, and those data reflect national retail averages. Consumers may be able to find even better prices by shopping around, said Gail Shearer, director of health policy analysis for Consumers Union.

In the statin category, the report recommends generic lovastatin as its Best Buy Drug for reducing low-density lipoprotein (LDL) by less than 40%. Lovastatin costs an average $28 per month for 10 mg and $40 for 20 mg, according to Consumers Union. Lipitor (atorvastatin), at an average $117 per month, is the Best Buy Drug for LDL reduction of more than 40%.

Although Crestor (rosuvastatin) offers better LDL reduction for the price, it is not recommended because it has not been proved to reduce heart attacks or death, and safety studies are still being conducted, the report said.

Consumers Union rates the over-the-counter version of Prilosec (omeprazole) as the Best Buy Drug among the proton pump inhibitors.

The 20 mg/day dosage of Prilosec costs $24 a month—one-fifth the cost of the next least-expensive drug in the class. And, it "is just as likely to relieve symptoms for most people with GERD [gastroesophageal reflux disease]," the report said. But the report also counsels people with drug coverage to talk with their physician about which medication has the lowest out-of-pocket cost under the patient's plan.

Dr. Toth said that if patients use an over-the-counter drug to treat GERD, they might skip seeing a physician—a potentially troubling issue.

"In the case of PPIs, there is concern because among a significant percentage of patients who suffer from chronic GERD, you do have to make sure that they're not developing Barrett's esophagus and that they don't have something more significant than simple reflux," Dr. Toth noted.

Consumers Union reviewers were initially worried about self-medication, but added a caveat to increase the dose or see a physician if symptoms did not improve, said Steve Findlay, a health care analyst with Consumers Union.

Reviewers were more concerned about highlighting over-the-counter medications in the NSAID category because of those drugs' potential to cause ulcers with chronic use, he said. The Best Buy Drugs in that category were generic ibuprofen at an average cost of $24–$30 per month, depending on dosage, and generic aspirin at a cost of $24–$32 a month. By taking these older, generic medicines, patients could save up to $2,160 a year, Consumers Union said.

Patients without drug coverage could consider over-the-counter NSAIDs, but only for periodic—not chronic—use, the report said.

The evidence shows that the COX-2 inhibitors Celebrex (celecoxib) and Bextra (valdexocib) may cause fewer stomach ulcers, but it's not clear yet whether they lower the risk of dangerous ulcers or serious gastrointestinal bleeding, and physicians may be more cautious about prescribing these therapies in the wake of Vioxx's recall by the Food and Drug Administration, the report said.

With issues like the worldwide recall of Vioxx popping up periodically, the Consumers Union aims to constantly monitor safety, effectiveness, and pricing changes, said Ms. Shearer.

DERP plans to issue 25 reports in all, and will update its reports every 6 months.

The Best Buy Drugs project is funded partly by grants from the Engelberg Foundation, and from the National Library of Medicine.

WASHINGTON — The nonprofit Consumers Union has issued the first in a series of evidence-based, patient-friendly reports listing what it calls the most cost-effective drugs, organization officials announced at a press conference.

The initial guides cover nonsteroidal anti-inflammatory agents (NSAIDs), statins, and proton pump inhibitors (PPIs).

The publisher of Consumer Reports said it hopes that patients—especially those with little or no drug benefit coverage—will use these reports to make informed choices in conjunction with their physicians.

The reports are designed to cut through the clutter of drug company advertising and scattered Internet searches. But drug makers won't be allowed to use the "Best Buy Drugs" designation in marketing or ads: Consumers Union prohibits manufacturers from commercializing any of its recommendations.

The guides should be familiar to anyone who has used Consumer Reports' ratings to buy a car, appliance, or bicycle. But unlike the group's analyses on other consumer goods, the Best Buy Drugs reports are free of charge.

"In each category, based on all the evidence, we've identified Best Buy Drugs—the drugs that are likely to be the best, most affordable choices for most people," said Joel Gurin, executive vice president of Consumers Union.

The Best Buy Drugs are not selected based on Consumers Union's own tests, however, but rather on systematic reviews conducted by the Drug Effectiveness Review Project (DERP), and on further peer review from medical experts like Mark Helfand, M.D., director of the Oregon evidence-based practice center at Oregon Health and Science University, Portland, which initiated DERP in 2003.

DERP follows the literature review and analysis methods pioneered by the Cochrane Collaboration. That lends the Consumers Union's reports credibility, said Peter Toth, M.D., director of cardiovascular disease prevention at Sterling Rock Falls Clinic in Sterling, Ill.

"I believe patients will find it to be a valuable resource when trying to balance cost with clinical efficacy," Dr. Toth commented.

Funded by 12 states, DERP has completed reports on 12 therapeutic categories. Consumers Union is making the first three available on a new Web site (www.CRBestBuyDrugs.org

The organization has said that it will add three more categories over the next few months—selective serotonin reuptake inhibitors, β-blockers, and ACE inhibitors—and will continue to do so on a monthly basis. Each report, which is also available in print form, offers a chart comparing the average monthly price for every drug—brand-name, generic, and over-the-counter—available in the class, at each dosage.

Price data are purchased from NDCHealth, a company that processes pharmacy transactions, and those data reflect national retail averages. Consumers may be able to find even better prices by shopping around, said Gail Shearer, director of health policy analysis for Consumers Union.

In the statin category, the report recommends generic lovastatin as its Best Buy Drug for reducing low-density lipoprotein (LDL) by less than 40%. Lovastatin costs an average $28 per month for 10 mg and $40 for 20 mg, according to Consumers Union. Lipitor (atorvastatin), at an average $117 per month, is the Best Buy Drug for LDL reduction of more than 40%.

Although Crestor (rosuvastatin) offers better LDL reduction for the price, it is not recommended because it has not been proved to reduce heart attacks or death, and safety studies are still being conducted, the report said.

Consumers Union rates the over-the-counter version of Prilosec (omeprazole) as the Best Buy Drug among the proton pump inhibitors.

The 20 mg/day dosage of Prilosec costs $24 a month—one-fifth the cost of the next least-expensive drug in the class. And, it "is just as likely to relieve symptoms for most people with GERD [gastroesophageal reflux disease]," the report said. But the report also counsels people with drug coverage to talk with their physician about which medication has the lowest out-of-pocket cost under the patient's plan.

Dr. Toth said that if patients use an over-the-counter drug to treat GERD, they might skip seeing a physician—a potentially troubling issue.

"In the case of PPIs, there is concern because among a significant percentage of patients who suffer from chronic GERD, you do have to make sure that they're not developing Barrett's esophagus and that they don't have something more significant than simple reflux," Dr. Toth noted.

Consumers Union reviewers were initially worried about self-medication, but added a caveat to increase the dose or see a physician if symptoms did not improve, said Steve Findlay, a health care analyst with Consumers Union.

Reviewers were more concerned about highlighting over-the-counter medications in the NSAID category because of those drugs' potential to cause ulcers with chronic use, he said. The Best Buy Drugs in that category were generic ibuprofen at an average cost of $24–$30 per month, depending on dosage, and generic aspirin at a cost of $24–$32 a month. By taking these older, generic medicines, patients could save up to $2,160 a year, Consumers Union said.

Patients without drug coverage could consider over-the-counter NSAIDs, but only for periodic—not chronic—use, the report said.

The evidence shows that the COX-2 inhibitors Celebrex (celecoxib) and Bextra (valdexocib) may cause fewer stomach ulcers, but it's not clear yet whether they lower the risk of dangerous ulcers or serious gastrointestinal bleeding, and physicians may be more cautious about prescribing these therapies in the wake of Vioxx's recall by the Food and Drug Administration, the report said.

With issues like the worldwide recall of Vioxx popping up periodically, the Consumers Union aims to constantly monitor safety, effectiveness, and pricing changes, said Ms. Shearer.

DERP plans to issue 25 reports in all, and will update its reports every 6 months.

The Best Buy Drugs project is funded partly by grants from the Engelberg Foundation, and from the National Library of Medicine.

WASHINGTON — The nonprofit Consumers Union has issued the first in a series of evidence-based, patient-friendly reports listing what it calls the most cost-effective drugs, organization officials announced at a press conference.

The initial guides cover nonsteroidal anti-inflammatory agents (NSAIDs), statins, and proton pump inhibitors (PPIs).

The publisher of Consumer Reports said it hopes that patients—especially those with little or no drug benefit coverage—will use these reports to make informed choices in conjunction with their physicians.

The reports are designed to cut through the clutter of drug company advertising and scattered Internet searches. But drug makers won't be allowed to use the "Best Buy Drugs" designation in marketing or ads: Consumers Union prohibits manufacturers from commercializing any of its recommendations.

The guides should be familiar to anyone who has used Consumer Reports' ratings to buy a car, appliance, or bicycle. But unlike the group's analyses on other consumer goods, the Best Buy Drugs reports are free of charge.

"In each category, based on all the evidence, we've identified Best Buy Drugs—the drugs that are likely to be the best, most affordable choices for most people," said Joel Gurin, executive vice president of Consumers Union.

The Best Buy Drugs are not selected based on Consumers Union's own tests, however, but rather on systematic reviews conducted by the Drug Effectiveness Review Project (DERP), and on further peer review from medical experts like Mark Helfand, M.D., director of the Oregon evidence-based practice center at Oregon Health and Science University, Portland, which initiated DERP in 2003.

DERP follows the literature review and analysis methods pioneered by the Cochrane Collaboration. That lends the Consumers Union's reports credibility, said Peter Toth, M.D., director of cardiovascular disease prevention at Sterling Rock Falls Clinic in Sterling, Ill.

"I believe patients will find it to be a valuable resource when trying to balance cost with clinical efficacy," Dr. Toth commented.

Funded by 12 states, DERP has completed reports on 12 therapeutic categories. Consumers Union is making the first three available on a new Web site (www.CRBestBuyDrugs.org

The organization has said that it will add three more categories over the next few months—selective serotonin reuptake inhibitors, β-blockers, and ACE inhibitors—and will continue to do so on a monthly basis. Each report, which is also available in print form, offers a chart comparing the average monthly price for every drug—brand-name, generic, and over-the-counter—available in the class, at each dosage.

Price data are purchased from NDCHealth, a company that processes pharmacy transactions, and those data reflect national retail averages. Consumers may be able to find even better prices by shopping around, said Gail Shearer, director of health policy analysis for Consumers Union.

In the statin category, the report recommends generic lovastatin as its Best Buy Drug for reducing low-density lipoprotein (LDL) by less than 40%. Lovastatin costs an average $28 per month for 10 mg and $40 for 20 mg, according to Consumers Union. Lipitor (atorvastatin), at an average $117 per month, is the Best Buy Drug for LDL reduction of more than 40%.

Although Crestor (rosuvastatin) offers better LDL reduction for the price, it is not recommended because it has not been proved to reduce heart attacks or death, and safety studies are still being conducted, the report said.

Consumers Union rates the over-the-counter version of Prilosec (omeprazole) as the Best Buy Drug among the proton pump inhibitors.

The 20 mg/day dosage of Prilosec costs $24 a month—one-fifth the cost of the next least-expensive drug in the class. And, it "is just as likely to relieve symptoms for most people with GERD [gastroesophageal reflux disease]," the report said. But the report also counsels people with drug coverage to talk with their physician about which medication has the lowest out-of-pocket cost under the patient's plan.

Dr. Toth said that if patients use an over-the-counter drug to treat GERD, they might skip seeing a physician—a potentially troubling issue.

"In the case of PPIs, there is concern because among a significant percentage of patients who suffer from chronic GERD, you do have to make sure that they're not developing Barrett's esophagus and that they don't have something more significant than simple reflux," Dr. Toth noted.

Consumers Union reviewers were initially worried about self-medication, but added a caveat to increase the dose or see a physician if symptoms did not improve, said Steve Findlay, a health care analyst with Consumers Union.

Reviewers were more concerned about highlighting over-the-counter medications in the NSAID category because of those drugs' potential to cause ulcers with chronic use, he said. The Best Buy Drugs in that category were generic ibuprofen at an average cost of $24–$30 per month, depending on dosage, and generic aspirin at a cost of $24–$32 a month. By taking these older, generic medicines, patients could save up to $2,160 a year, Consumers Union said.

Patients without drug coverage could consider over-the-counter NSAIDs, but only for periodic—not chronic—use, the report said.

The evidence shows that the COX-2 inhibitors Celebrex (celecoxib) and Bextra (valdexocib) may cause fewer stomach ulcers, but it's not clear yet whether they lower the risk of dangerous ulcers or serious gastrointestinal bleeding, and physicians may be more cautious about prescribing these therapies in the wake of Vioxx's recall by the Food and Drug Administration, the report said.

With issues like the worldwide recall of Vioxx popping up periodically, the Consumers Union aims to constantly monitor safety, effectiveness, and pricing changes, said Ms. Shearer.

DERP plans to issue 25 reports in all, and will update its reports every 6 months.

The Best Buy Drugs project is funded partly by grants from the Engelberg Foundation, and from the National Library of Medicine.