Mary Ellen Schneider

WASHINGTON — Clinical genetic testing for the BRCA1 and BRCA2 genes allows physicians to more precisely identify who is at high risk for certain cancers, Dr. Karen H. Lu said at the annual meeting of the American College of Obstetricians and Gynecologists.

Armed with this knowledge, physicians can recommend risk-reducing strategies including prophylactic surgery, said Dr. Lu, associate professor of gynecologic oncology and co-clinical medical director of the Clinical Cancer Genetics program at the MD Anderson Cancer Center in Houston.

For example, performing a bilateral salpingo-oophorectomy in someone who is a BRCA mutation carrier decreases their risk for ovarian cancer by 85%–95%, she said.

“In someone who is at such high risk for developing a disease for which we have no current effective screening, performing this surgery effectively saves their lives,” Dr. Lu said.

In terms of breast cancer management, a 35-year-old woman with breast cancer and a strong family history might otherwise be advised to undergo a lumpectomy, radiation, and chemotherapy.

However, if she knew she carried either a BRCA1 or BRCA2 mutation, she might choose to undergo a bilateral mastectomy with reconstruction upfront to decrease her risk of developing a second cancer, Dr. Lu said.

Physicians can identify women who may be good candidates for genetic testing by asking a few targeted questions during the annual visit, Dr. Lu said.

The hallmarks of hereditary cancers are generally a younger age of onset, more than one cancer in a single family member, and multiple individuals in a family who have developed cancer, she said.

Consider asking these three questions:

▸ Do you have multiple members of your family who have had breast, ovarian, colon, or uterine cancer?

▸ Is there anyone in your family who has had both breast and ovarian cancer?

▸ Is there anyone in your family who has had these cancers under the age of 50?

Keep in mind that these cancers can be inherited through both maternal and paternal relatives, so ask about cancer on the father's side as well, Dr. Lu said.

Also consider ethnicity, she said. The prevalence of BRCA genes in the general population is about 1 per 500, or 0.2%.

However, some populations have “founder” mutations in the BRCA1 and BRCA2 genes that increase their risk. For example, the Ashkenazi Jewish population has three founder mutations that put them at about a 10-fold increased risk for having a BRCA1 or BRCA2 gene mutation. So instead of a 0.2% risk of having the mutation, there is a 2%–3% frequency of the mutation among this population.

Overall, about 5%–10% of all cancers are hereditary. For breast cancer, that translates into about 10,000 to 20,000 cases a year in the United States and about 2,000 cases each year of ovarian cancer.

The frequency of BRCA1 or BRCA2 carriers in the United States is about 1 in 500 in the general U.S. population. “Individuals who carry these mutations have staggering risks of cancer,” Dr. Lu said.

The BRCA1 mutation carries a lifetime risk of 50% to 85% for breast cancer and a 40% to 60% risk of developing a second breast cancer. And there is a 20%–50% lifetime risk for ovarian cancer with the BRCA1 gene. This is significantly higher than the lifetime risk in the general population of about 11% for breast cancer and 1.7% for ovarian cancer.

In addition, the BRCA2 gene carries a lifetime risk of 50%–85% for breast cancer and a 10%–25% risk for ovarian cancer.

Genetic testing can be useful both for cancer patients who want to find out if they face an increased risk of a second cancer and for women unaffected by cancer but with a strong family history.

The ideal person to test in a family is someone who has had ovarian or breast cancer, Dr. Lu said. In the case of a patient unaffected by cancer with a strong family history, advise them to be tested with someone in their family who has had cancer. The person who has had cancer must be tested first.

Pretest counseling is critical, Dr. Lu commented. Patients need to be aware of the range of possible results and the limitations of the test. They may also have questions about genetic discrimination, she said.

The test itself is a simple blood test and does not require fasting. It generally costs about $3,000 to do a full analysis with complete sequencing of both the BRCA1 and BRCA2 genes. The cost of predictive tests on a previously identified familial mutation is about $200–$400.

Insurance companies have generally been covering these tests. An analysis of MD Anderson data in 2004 showed that 87% of insurance preauthorization requests for genetic testing were covered. Of those covered, about 90% were covered at 80% or more.

“The bottom line is that insurance companies are paying for this test,” Dr. Lu said. “The access to this genetic testing is much wider now than it was in the past.”

WASHINGTON — Clinical genetic testing for the BRCA1 and BRCA2 genes allows physicians to more precisely identify who is at high risk for certain cancers, Dr. Karen H. Lu said at the annual meeting of the American College of Obstetricians and Gynecologists.

Armed with this knowledge, physicians can recommend risk-reducing strategies including prophylactic surgery, said Dr. Lu, associate professor of gynecologic oncology and co-clinical medical director of the Clinical Cancer Genetics program at the MD Anderson Cancer Center in Houston.

For example, performing a bilateral salpingo-oophorectomy in someone who is a BRCA mutation carrier decreases their risk for ovarian cancer by 85%–95%, she said.

“In someone who is at such high risk for developing a disease for which we have no current effective screening, performing this surgery effectively saves their lives,” Dr. Lu said.

In terms of breast cancer management, a 35-year-old woman with breast cancer and a strong family history might otherwise be advised to undergo a lumpectomy, radiation, and chemotherapy.

However, if she knew she carried either a BRCA1 or BRCA2 mutation, she might choose to undergo a bilateral mastectomy with reconstruction upfront to decrease her risk of developing a second cancer, Dr. Lu said.

Physicians can identify women who may be good candidates for genetic testing by asking a few targeted questions during the annual visit, Dr. Lu said.

The hallmarks of hereditary cancers are generally a younger age of onset, more than one cancer in a single family member, and multiple individuals in a family who have developed cancer, she said.

Consider asking these three questions:

▸ Do you have multiple members of your family who have had breast, ovarian, colon, or uterine cancer?

▸ Is there anyone in your family who has had both breast and ovarian cancer?

▸ Is there anyone in your family who has had these cancers under the age of 50?

Keep in mind that these cancers can be inherited through both maternal and paternal relatives, so ask about cancer on the father's side as well, Dr. Lu said.

Also consider ethnicity, she said. The prevalence of BRCA genes in the general population is about 1 per 500, or 0.2%.

However, some populations have “founder” mutations in the BRCA1 and BRCA2 genes that increase their risk. For example, the Ashkenazi Jewish population has three founder mutations that put them at about a 10-fold increased risk for having a BRCA1 or BRCA2 gene mutation. So instead of a 0.2% risk of having the mutation, there is a 2%–3% frequency of the mutation among this population.

Overall, about 5%–10% of all cancers are hereditary. For breast cancer, that translates into about 10,000 to 20,000 cases a year in the United States and about 2,000 cases each year of ovarian cancer.

The frequency of BRCA1 or BRCA2 carriers in the United States is about 1 in 500 in the general U.S. population. “Individuals who carry these mutations have staggering risks of cancer,” Dr. Lu said.

The BRCA1 mutation carries a lifetime risk of 50% to 85% for breast cancer and a 40% to 60% risk of developing a second breast cancer. And there is a 20%–50% lifetime risk for ovarian cancer with the BRCA1 gene. This is significantly higher than the lifetime risk in the general population of about 11% for breast cancer and 1.7% for ovarian cancer.

In addition, the BRCA2 gene carries a lifetime risk of 50%–85% for breast cancer and a 10%–25% risk for ovarian cancer.

Genetic testing can be useful both for cancer patients who want to find out if they face an increased risk of a second cancer and for women unaffected by cancer but with a strong family history.

The ideal person to test in a family is someone who has had ovarian or breast cancer, Dr. Lu said. In the case of a patient unaffected by cancer with a strong family history, advise them to be tested with someone in their family who has had cancer. The person who has had cancer must be tested first.

Pretest counseling is critical, Dr. Lu commented. Patients need to be aware of the range of possible results and the limitations of the test. They may also have questions about genetic discrimination, she said.

The test itself is a simple blood test and does not require fasting. It generally costs about $3,000 to do a full analysis with complete sequencing of both the BRCA1 and BRCA2 genes. The cost of predictive tests on a previously identified familial mutation is about $200–$400.

Insurance companies have generally been covering these tests. An analysis of MD Anderson data in 2004 showed that 87% of insurance preauthorization requests for genetic testing were covered. Of those covered, about 90% were covered at 80% or more.

“The bottom line is that insurance companies are paying for this test,” Dr. Lu said. “The access to this genetic testing is much wider now than it was in the past.”

WASHINGTON — Clinical genetic testing for the BRCA1 and BRCA2 genes allows physicians to more precisely identify who is at high risk for certain cancers, Dr. Karen H. Lu said at the annual meeting of the American College of Obstetricians and Gynecologists.

Armed with this knowledge, physicians can recommend risk-reducing strategies including prophylactic surgery, said Dr. Lu, associate professor of gynecologic oncology and co-clinical medical director of the Clinical Cancer Genetics program at the MD Anderson Cancer Center in Houston.

For example, performing a bilateral salpingo-oophorectomy in someone who is a BRCA mutation carrier decreases their risk for ovarian cancer by 85%–95%, she said.

“In someone who is at such high risk for developing a disease for which we have no current effective screening, performing this surgery effectively saves their lives,” Dr. Lu said.

In terms of breast cancer management, a 35-year-old woman with breast cancer and a strong family history might otherwise be advised to undergo a lumpectomy, radiation, and chemotherapy.

However, if she knew she carried either a BRCA1 or BRCA2 mutation, she might choose to undergo a bilateral mastectomy with reconstruction upfront to decrease her risk of developing a second cancer, Dr. Lu said.

Physicians can identify women who may be good candidates for genetic testing by asking a few targeted questions during the annual visit, Dr. Lu said.

The hallmarks of hereditary cancers are generally a younger age of onset, more than one cancer in a single family member, and multiple individuals in a family who have developed cancer, she said.

Consider asking these three questions:

▸ Do you have multiple members of your family who have had breast, ovarian, colon, or uterine cancer?

▸ Is there anyone in your family who has had both breast and ovarian cancer?

▸ Is there anyone in your family who has had these cancers under the age of 50?

Keep in mind that these cancers can be inherited through both maternal and paternal relatives, so ask about cancer on the father's side as well, Dr. Lu said.

Also consider ethnicity, she said. The prevalence of BRCA genes in the general population is about 1 per 500, or 0.2%.

However, some populations have “founder” mutations in the BRCA1 and BRCA2 genes that increase their risk. For example, the Ashkenazi Jewish population has three founder mutations that put them at about a 10-fold increased risk for having a BRCA1 or BRCA2 gene mutation. So instead of a 0.2% risk of having the mutation, there is a 2%–3% frequency of the mutation among this population.

Overall, about 5%–10% of all cancers are hereditary. For breast cancer, that translates into about 10,000 to 20,000 cases a year in the United States and about 2,000 cases each year of ovarian cancer.

The frequency of BRCA1 or BRCA2 carriers in the United States is about 1 in 500 in the general U.S. population. “Individuals who carry these mutations have staggering risks of cancer,” Dr. Lu said.

The BRCA1 mutation carries a lifetime risk of 50% to 85% for breast cancer and a 40% to 60% risk of developing a second breast cancer. And there is a 20%–50% lifetime risk for ovarian cancer with the BRCA1 gene. This is significantly higher than the lifetime risk in the general population of about 11% for breast cancer and 1.7% for ovarian cancer.

In addition, the BRCA2 gene carries a lifetime risk of 50%–85% for breast cancer and a 10%–25% risk for ovarian cancer.

Genetic testing can be useful both for cancer patients who want to find out if they face an increased risk of a second cancer and for women unaffected by cancer but with a strong family history.

The ideal person to test in a family is someone who has had ovarian or breast cancer, Dr. Lu said. In the case of a patient unaffected by cancer with a strong family history, advise them to be tested with someone in their family who has had cancer. The person who has had cancer must be tested first.

Pretest counseling is critical, Dr. Lu commented. Patients need to be aware of the range of possible results and the limitations of the test. They may also have questions about genetic discrimination, she said.

The test itself is a simple blood test and does not require fasting. It generally costs about $3,000 to do a full analysis with complete sequencing of both the BRCA1 and BRCA2 genes. The cost of predictive tests on a previously identified familial mutation is about $200–$400.

Insurance companies have generally been covering these tests. An analysis of MD Anderson data in 2004 showed that 87% of insurance preauthorization requests for genetic testing were covered. Of those covered, about 90% were covered at 80% or more.

“The bottom line is that insurance companies are paying for this test,” Dr. Lu said. “The access to this genetic testing is much wider now than it was in the past.”

WASHINGTON — Performing a routine CT scan before staging laparotomy in patients with endometrial cancer may be an unnecessary expense, regardless of the histology, grade, or stage of the cancer, researchers reported in a poster presented at the annual meeting of the American College of Obstetricians and Gynecologists.

Dr. Sean Rosenbaum and his colleagues at the John Peter Smith Hospital in Fort Worth, Texas, conducted a retrospective review of 103 patients with endometrial cancer who were being managed by a gynecologic oncologist.

They compared the normal, abnormal, and incidental findings from the CT scan to surgical findings, histology, and grade.

Of the 64 patients who had a preoperative CT scan of the abdomen and pelvis, the histology included 46 adenocarcinomas, 2 adenosquamous carcinomas, 3 adenosarcomas, 11 papillary squamous or clear cell carcinomas, and 2 squamous cell carcinomas. In addition, 45 patients had grade 2 or grade 3 disease and 15 patients had disease outside the uterus. But none of the decisions made at the staging laparotomy were affected by the preoperative CT scan results even in cases where high-risk cancer was identified, Dr. Rosenbaum said.

Among the 39 patients who did not receive a preoperative CT scan because of suspected low stage or grade, or patient preference, no pathology was found during surgery that would have altered the surgical approach if it had been detected earlier, the researchers wrote.

Because the CT scan did not affect the surgical decision making, Dr. Rosenbaum and his colleagues estimated that their hospital could have saved about $44,000 just by eliminating the 64 CT scans performed.

And if they had performed CT scans on all 103 of the endometrial cancer patients, the unnecessary expense would have reached nearly $71,000.

WASHINGTON — Performing a routine CT scan before staging laparotomy in patients with endometrial cancer may be an unnecessary expense, regardless of the histology, grade, or stage of the cancer, researchers reported in a poster presented at the annual meeting of the American College of Obstetricians and Gynecologists.

Dr. Sean Rosenbaum and his colleagues at the John Peter Smith Hospital in Fort Worth, Texas, conducted a retrospective review of 103 patients with endometrial cancer who were being managed by a gynecologic oncologist.

They compared the normal, abnormal, and incidental findings from the CT scan to surgical findings, histology, and grade.

Of the 64 patients who had a preoperative CT scan of the abdomen and pelvis, the histology included 46 adenocarcinomas, 2 adenosquamous carcinomas, 3 adenosarcomas, 11 papillary squamous or clear cell carcinomas, and 2 squamous cell carcinomas. In addition, 45 patients had grade 2 or grade 3 disease and 15 patients had disease outside the uterus. But none of the decisions made at the staging laparotomy were affected by the preoperative CT scan results even in cases where high-risk cancer was identified, Dr. Rosenbaum said.

Among the 39 patients who did not receive a preoperative CT scan because of suspected low stage or grade, or patient preference, no pathology was found during surgery that would have altered the surgical approach if it had been detected earlier, the researchers wrote.

Because the CT scan did not affect the surgical decision making, Dr. Rosenbaum and his colleagues estimated that their hospital could have saved about $44,000 just by eliminating the 64 CT scans performed.

And if they had performed CT scans on all 103 of the endometrial cancer patients, the unnecessary expense would have reached nearly $71,000.

WASHINGTON — Performing a routine CT scan before staging laparotomy in patients with endometrial cancer may be an unnecessary expense, regardless of the histology, grade, or stage of the cancer, researchers reported in a poster presented at the annual meeting of the American College of Obstetricians and Gynecologists.

Dr. Sean Rosenbaum and his colleagues at the John Peter Smith Hospital in Fort Worth, Texas, conducted a retrospective review of 103 patients with endometrial cancer who were being managed by a gynecologic oncologist.

They compared the normal, abnormal, and incidental findings from the CT scan to surgical findings, histology, and grade.

Of the 64 patients who had a preoperative CT scan of the abdomen and pelvis, the histology included 46 adenocarcinomas, 2 adenosquamous carcinomas, 3 adenosarcomas, 11 papillary squamous or clear cell carcinomas, and 2 squamous cell carcinomas. In addition, 45 patients had grade 2 or grade 3 disease and 15 patients had disease outside the uterus. But none of the decisions made at the staging laparotomy were affected by the preoperative CT scan results even in cases where high-risk cancer was identified, Dr. Rosenbaum said.

Among the 39 patients who did not receive a preoperative CT scan because of suspected low stage or grade, or patient preference, no pathology was found during surgery that would have altered the surgical approach if it had been detected earlier, the researchers wrote.

Because the CT scan did not affect the surgical decision making, Dr. Rosenbaum and his colleagues estimated that their hospital could have saved about $44,000 just by eliminating the 64 CT scans performed.

And if they had performed CT scans on all 103 of the endometrial cancer patients, the unnecessary expense would have reached nearly $71,000.

The Food and Drug Administration is once again under fire for its evaluation of the proposed over-the-counter use of the emergency contraceptive Plan B, with advocates for approval accusing the agency of putting politics first.

Fueling the accusations are recently released depositions from a lawsuit filed against the FDA by the Center for Reproductive Rights along with the Association of Reproductive Health Professionals, the National Latina Institute for Reproductive Health, and individual members of the Morning-After Pill Conspiracy, an advocacy group.

The plaintiffs are asking a U.S. District Court in New York to order the FDA to make Plan B (levonorgestrel) available without a prescription to women of all ages.

In a deposition taken in April as part of the lawsuit and released in late May, Dr. Steven Galson, director of the Center for Drug Evaluation and Research, testified that he had been leaning toward approval of over-the-counter use of Plan B for older teens and women in early 2005 when Lester Crawford, Ph.D., who was then acting FDA commissioner, took over decision making on the application.

“Dr. Crawford … told me that he was concerned about where we were heading because he knew that I was heading towards [supporting an over-the-counter approval for Plan B], and he told me that he was going to make the decision on what to do with the application,” Dr. Galson said in his deposition.

Dr. Galson added that this was the first time that the FDA commissioner had ever removed authority over a drug application from him and he did not know of it happening to anyone else in his position.

In May 2004, the FDA rejected an application from Barr Pharmaceuticals Inc. to make Plan B available without a prescription.

In August 2005, Dr. Crawford announced that the agency was issued an advance notice of proposed rule making to solicit comments about the regulatory issues involved in split approval of the drug—with over-the-counter availability for women aged 17 and older and prescription-only access for those under 17.

The agency has yet to issue a decision on this proposed dual marketing approach to Plan B.

In his deposition, Dr. Galson said that he supported the approval of Plan B for over-the-counter use among certain women based on public health considerations.

However, he testified that he was not pressured into issuing the May 2004 not-approvable letter for making Plan B available over the counter for women of all ages.

In his deposition, Dr. Galson also expressed concerns about the lack of data on the effect of OTC access among younger girls.

The Center for Reproductive Rights also released a deposition taken in April from FDA Deputy Commissioner Dr. Janet Woodcock. She testified that Dr. Crawford had assumed the authority for the Plan B decision.

Dr. Crawford gave testimony in late May, but a transcript was not available at press time.

Dr. Mark McClellan, former FDA commissioner and current administrator of the Centers for Medicare and Medicaid Services, is expected to give a deposition in June. Officials with the Center for Reproductive Rights have requested that five other FDA officials give depositions as part of the lawsuit.

Officials at the FDA had no comment on the lawsuit or the recently released depositions.

Jodie Curtis, assistant director of government relations for the Planned Parenthood Federation of America, said that the information coming out of the depositions continues to raise concerns about the role politics played in FDA decision making on Plan B. She said she hopes that the lawsuit will “shine a light” on what is going on within the FDA and that Congress will also use its oversight authority to start asking questions.

But despite irregularities in the way Plan B has been handled, in most instances the drug approval process works well, she said. “The system is broken in this case,” Ms. Curtis said. “I don't know that the system is broken overall.”

Susan F. Wood, Ph.D., a consultant with the Reproductive Health Technologies Project and the former head of the FDA's Office of Women's Health, said that from what she has read in media reports, the information from the depositions is “consistent” with her impressions that the FDA's professional staff was cut out of the decision making on Plan B.

Dr. Wood resigned from the FDA in 2005 in protest of the agency's delay in approving Plan B for OTC use. The handling of the Plan B application has damaged the FDA's credibility and in the long-term could make it difficult to recruit and retain talented scientists, Dr. Wood said. If the FDA had relied on its normal process for evaluating Plan B, it would already have been approved, she said.

But David Christensen, director of congressional affairs for the Family Research Council, said Dr. Crawford acted properly in taking time to consider the legal and regulatory issues that go along with this type of dual marketing approval. The implications go beyond Plan B and beyond just scientific considerations, he said. “This wasn't politics,” he said. “This was just prudence.”

The Food and Drug Administration is once again under fire for its evaluation of the proposed over-the-counter use of the emergency contraceptive Plan B, with advocates for approval accusing the agency of putting politics first.

Fueling the accusations are recently released depositions from a lawsuit filed against the FDA by the Center for Reproductive Rights along with the Association of Reproductive Health Professionals, the National Latina Institute for Reproductive Health, and individual members of the Morning-After Pill Conspiracy, an advocacy group.

The plaintiffs are asking a U.S. District Court in New York to order the FDA to make Plan B (levonorgestrel) available without a prescription to women of all ages.

In a deposition taken in April as part of the lawsuit and released in late May, Dr. Steven Galson, director of the Center for Drug Evaluation and Research, testified that he had been leaning toward approval of over-the-counter use of Plan B for older teens and women in early 2005 when Lester Crawford, Ph.D., who was then acting FDA commissioner, took over decision making on the application.

“Dr. Crawford … told me that he was concerned about where we were heading because he knew that I was heading towards [supporting an over-the-counter approval for Plan B], and he told me that he was going to make the decision on what to do with the application,” Dr. Galson said in his deposition.

Dr. Galson added that this was the first time that the FDA commissioner had ever removed authority over a drug application from him and he did not know of it happening to anyone else in his position.

In May 2004, the FDA rejected an application from Barr Pharmaceuticals Inc. to make Plan B available without a prescription.

In August 2005, Dr. Crawford announced that the agency was issued an advance notice of proposed rule making to solicit comments about the regulatory issues involved in split approval of the drug—with over-the-counter availability for women aged 17 and older and prescription-only access for those under 17.

The agency has yet to issue a decision on this proposed dual marketing approach to Plan B.

In his deposition, Dr. Galson said that he supported the approval of Plan B for over-the-counter use among certain women based on public health considerations.

However, he testified that he was not pressured into issuing the May 2004 not-approvable letter for making Plan B available over the counter for women of all ages.

In his deposition, Dr. Galson also expressed concerns about the lack of data on the effect of OTC access among younger girls.

The Center for Reproductive Rights also released a deposition taken in April from FDA Deputy Commissioner Dr. Janet Woodcock. She testified that Dr. Crawford had assumed the authority for the Plan B decision.

Dr. Crawford gave testimony in late May, but a transcript was not available at press time.

Dr. Mark McClellan, former FDA commissioner and current administrator of the Centers for Medicare and Medicaid Services, is expected to give a deposition in June. Officials with the Center for Reproductive Rights have requested that five other FDA officials give depositions as part of the lawsuit.

Officials at the FDA had no comment on the lawsuit or the recently released depositions.

Jodie Curtis, assistant director of government relations for the Planned Parenthood Federation of America, said that the information coming out of the depositions continues to raise concerns about the role politics played in FDA decision making on Plan B. She said she hopes that the lawsuit will “shine a light” on what is going on within the FDA and that Congress will also use its oversight authority to start asking questions.

But despite irregularities in the way Plan B has been handled, in most instances the drug approval process works well, she said. “The system is broken in this case,” Ms. Curtis said. “I don't know that the system is broken overall.”

Susan F. Wood, Ph.D., a consultant with the Reproductive Health Technologies Project and the former head of the FDA's Office of Women's Health, said that from what she has read in media reports, the information from the depositions is “consistent” with her impressions that the FDA's professional staff was cut out of the decision making on Plan B.

Dr. Wood resigned from the FDA in 2005 in protest of the agency's delay in approving Plan B for OTC use. The handling of the Plan B application has damaged the FDA's credibility and in the long-term could make it difficult to recruit and retain talented scientists, Dr. Wood said. If the FDA had relied on its normal process for evaluating Plan B, it would already have been approved, she said.

But David Christensen, director of congressional affairs for the Family Research Council, said Dr. Crawford acted properly in taking time to consider the legal and regulatory issues that go along with this type of dual marketing approval. The implications go beyond Plan B and beyond just scientific considerations, he said. “This wasn't politics,” he said. “This was just prudence.”

The Food and Drug Administration is once again under fire for its evaluation of the proposed over-the-counter use of the emergency contraceptive Plan B, with advocates for approval accusing the agency of putting politics first.

Fueling the accusations are recently released depositions from a lawsuit filed against the FDA by the Center for Reproductive Rights along with the Association of Reproductive Health Professionals, the National Latina Institute for Reproductive Health, and individual members of the Morning-After Pill Conspiracy, an advocacy group.

The plaintiffs are asking a U.S. District Court in New York to order the FDA to make Plan B (levonorgestrel) available without a prescription to women of all ages.

In a deposition taken in April as part of the lawsuit and released in late May, Dr. Steven Galson, director of the Center for Drug Evaluation and Research, testified that he had been leaning toward approval of over-the-counter use of Plan B for older teens and women in early 2005 when Lester Crawford, Ph.D., who was then acting FDA commissioner, took over decision making on the application.

“Dr. Crawford … told me that he was concerned about where we were heading because he knew that I was heading towards [supporting an over-the-counter approval for Plan B], and he told me that he was going to make the decision on what to do with the application,” Dr. Galson said in his deposition.

Dr. Galson added that this was the first time that the FDA commissioner had ever removed authority over a drug application from him and he did not know of it happening to anyone else in his position.

In May 2004, the FDA rejected an application from Barr Pharmaceuticals Inc. to make Plan B available without a prescription.

In August 2005, Dr. Crawford announced that the agency was issued an advance notice of proposed rule making to solicit comments about the regulatory issues involved in split approval of the drug—with over-the-counter availability for women aged 17 and older and prescription-only access for those under 17.

The agency has yet to issue a decision on this proposed dual marketing approach to Plan B.

In his deposition, Dr. Galson said that he supported the approval of Plan B for over-the-counter use among certain women based on public health considerations.

However, he testified that he was not pressured into issuing the May 2004 not-approvable letter for making Plan B available over the counter for women of all ages.

In his deposition, Dr. Galson also expressed concerns about the lack of data on the effect of OTC access among younger girls.

The Center for Reproductive Rights also released a deposition taken in April from FDA Deputy Commissioner Dr. Janet Woodcock. She testified that Dr. Crawford had assumed the authority for the Plan B decision.

Dr. Crawford gave testimony in late May, but a transcript was not available at press time.

Dr. Mark McClellan, former FDA commissioner and current administrator of the Centers for Medicare and Medicaid Services, is expected to give a deposition in June. Officials with the Center for Reproductive Rights have requested that five other FDA officials give depositions as part of the lawsuit.

Officials at the FDA had no comment on the lawsuit or the recently released depositions.

Jodie Curtis, assistant director of government relations for the Planned Parenthood Federation of America, said that the information coming out of the depositions continues to raise concerns about the role politics played in FDA decision making on Plan B. She said she hopes that the lawsuit will “shine a light” on what is going on within the FDA and that Congress will also use its oversight authority to start asking questions.

But despite irregularities in the way Plan B has been handled, in most instances the drug approval process works well, she said. “The system is broken in this case,” Ms. Curtis said. “I don't know that the system is broken overall.”

Susan F. Wood, Ph.D., a consultant with the Reproductive Health Technologies Project and the former head of the FDA's Office of Women's Health, said that from what she has read in media reports, the information from the depositions is “consistent” with her impressions that the FDA's professional staff was cut out of the decision making on Plan B.

Dr. Wood resigned from the FDA in 2005 in protest of the agency's delay in approving Plan B for OTC use. The handling of the Plan B application has damaged the FDA's credibility and in the long-term could make it difficult to recruit and retain talented scientists, Dr. Wood said. If the FDA had relied on its normal process for evaluating Plan B, it would already have been approved, she said.

But David Christensen, director of congressional affairs for the Family Research Council, said Dr. Crawford acted properly in taking time to consider the legal and regulatory issues that go along with this type of dual marketing approval. The implications go beyond Plan B and beyond just scientific considerations, he said. “This wasn't politics,” he said. “This was just prudence.”

LOS ANGELES — Both seniors and adolescents can be good candidates for Roux-en-Y gastric bypass surgery, according to new research presented at the annual Digestive Disease Week.

In a review of 167 surgical cases at the Mayo Clinic in Rochester, Minn., involving patients aged 60 or older and adolescents aged 12–18 years, researchers found a significant decrease in obesity-related mortality after gastric bypass surgery, and limited morbidity and mortality overall.

The researchers reviewed the Mayo Clinic's 20-year bariatric surgery database and obtained morbidity and mortality rates from medical records. They also sent a questionnaire to surviving patients.

The older patients had higher rates of adverse events and saw less dramatic results both in decreases in body mass index (BMI) and self-reported declines in obesity-related health conditions. The 155 older patients—aged 60–76 years—had a 6% mortality after 5 years of follow-up, and 14% had had serious morbidities that delayed hospital discharge such as wound infections and bowel obstructions.

Patients reported about a 50% reversal in obesity-related comorbidities, and the mean BMI fell from 46 to 33 kg/m

Mortality for older patients (0.7%) was significantly lower than that in a previous report about Medicare patients, Dr. Sarr said. That study reported a 30-day mortality of nearly 5% in patients aged 65 and older (JAMA 2005;294:1903–8). “That is not our experience at the Mayo Clinic,” he said. But he added that mortality and morbidity post surgery can be high at centers that perform a low volume of these operations, while high-volume centers carry a much lower risk.

Among 12 adolescents aged 12–18 years, there were no serious adverse events and no deaths after 3 years of follow-up. The overall morbidity was about 10%, Dr. Sarr said. The adolescent patients had an average drop in BMI of 55 to 36, and patients reported experiencing an 82% reduction in obesity-related diseases.

LOS ANGELES — Both seniors and adolescents can be good candidates for Roux-en-Y gastric bypass surgery, according to new research presented at the annual Digestive Disease Week.

In a review of 167 surgical cases at the Mayo Clinic in Rochester, Minn., involving patients aged 60 or older and adolescents aged 12–18 years, researchers found a significant decrease in obesity-related mortality after gastric bypass surgery, and limited morbidity and mortality overall.

The researchers reviewed the Mayo Clinic's 20-year bariatric surgery database and obtained morbidity and mortality rates from medical records. They also sent a questionnaire to surviving patients.

The older patients had higher rates of adverse events and saw less dramatic results both in decreases in body mass index (BMI) and self-reported declines in obesity-related health conditions. The 155 older patients—aged 60–76 years—had a 6% mortality after 5 years of follow-up, and 14% had had serious morbidities that delayed hospital discharge such as wound infections and bowel obstructions.

Patients reported about a 50% reversal in obesity-related comorbidities, and the mean BMI fell from 46 to 33 kg/m

Mortality for older patients (0.7%) was significantly lower than that in a previous report about Medicare patients, Dr. Sarr said. That study reported a 30-day mortality of nearly 5% in patients aged 65 and older (JAMA 2005;294:1903–8). “That is not our experience at the Mayo Clinic,” he said. But he added that mortality and morbidity post surgery can be high at centers that perform a low volume of these operations, while high-volume centers carry a much lower risk.

Among 12 adolescents aged 12–18 years, there were no serious adverse events and no deaths after 3 years of follow-up. The overall morbidity was about 10%, Dr. Sarr said. The adolescent patients had an average drop in BMI of 55 to 36, and patients reported experiencing an 82% reduction in obesity-related diseases.

LOS ANGELES — Both seniors and adolescents can be good candidates for Roux-en-Y gastric bypass surgery, according to new research presented at the annual Digestive Disease Week.

In a review of 167 surgical cases at the Mayo Clinic in Rochester, Minn., involving patients aged 60 or older and adolescents aged 12–18 years, researchers found a significant decrease in obesity-related mortality after gastric bypass surgery, and limited morbidity and mortality overall.

The researchers reviewed the Mayo Clinic's 20-year bariatric surgery database and obtained morbidity and mortality rates from medical records. They also sent a questionnaire to surviving patients.

The older patients had higher rates of adverse events and saw less dramatic results both in decreases in body mass index (BMI) and self-reported declines in obesity-related health conditions. The 155 older patients—aged 60–76 years—had a 6% mortality after 5 years of follow-up, and 14% had had serious morbidities that delayed hospital discharge such as wound infections and bowel obstructions.

Patients reported about a 50% reversal in obesity-related comorbidities, and the mean BMI fell from 46 to 33 kg/m

Mortality for older patients (0.7%) was significantly lower than that in a previous report about Medicare patients, Dr. Sarr said. That study reported a 30-day mortality of nearly 5% in patients aged 65 and older (JAMA 2005;294:1903–8). “That is not our experience at the Mayo Clinic,” he said. But he added that mortality and morbidity post surgery can be high at centers that perform a low volume of these operations, while high-volume centers carry a much lower risk.

Among 12 adolescents aged 12–18 years, there were no serious adverse events and no deaths after 3 years of follow-up. The overall morbidity was about 10%, Dr. Sarr said. The adolescent patients had an average drop in BMI of 55 to 36, and patients reported experiencing an 82% reduction in obesity-related diseases.

LOS ANGELES — Laparoscopic Nissen fundoplication is superior to medication for overall symptom control in patients with gastroesophageal reflux disease, according to preliminary research results presented at the annual Digestive Disease Week.

Even patients who do well on medication may be candidates for surgery, said Dr. Mehran Anvari, director of the center for minimal access surgery at McMaster University in Hamilton, Ontario, the study's lead author. He presented the 1-year results of the study, in which patients whose symptoms were controlled by long-term use of proton pump inhibitors (PPIs) were randomized to either continued PPI therapy or laparoscopic Nissen fundoplication.

Of more than 200 patients with GERD who were eligible for the study, 104 gave informed consent. Four surgeons performed the surgery, using a previously published technique. Investigators assessed symptoms every 3 months using a validated instrument and conducted 24-hour pH testing at 1 year.

Of the 104 randomized patients, 98 were available for follow-up after 1 year. Patients in both arms of the study showed improvement in 24-hour pH and in GERD symptoms. However, overall patient satisfaction with symptom control in the surgical group increased from 73.3 to 90.2 on a 100-point global rating scale, whereas results from the medication group stayed the same, compared with baseline.

Laparoscopic Nissen fundoplication may be an alternative for patients who don't want to be on long-term therapy with medication, Dr. Anvari said. While this trial showed surgery to be an effective option, particularly in terms of overall symptom control, surgery is operator dependent, he said.

LOS ANGELES — Laparoscopic Nissen fundoplication is superior to medication for overall symptom control in patients with gastroesophageal reflux disease, according to preliminary research results presented at the annual Digestive Disease Week.

Even patients who do well on medication may be candidates for surgery, said Dr. Mehran Anvari, director of the center for minimal access surgery at McMaster University in Hamilton, Ontario, the study's lead author. He presented the 1-year results of the study, in which patients whose symptoms were controlled by long-term use of proton pump inhibitors (PPIs) were randomized to either continued PPI therapy or laparoscopic Nissen fundoplication.

Of more than 200 patients with GERD who were eligible for the study, 104 gave informed consent. Four surgeons performed the surgery, using a previously published technique. Investigators assessed symptoms every 3 months using a validated instrument and conducted 24-hour pH testing at 1 year.

Of the 104 randomized patients, 98 were available for follow-up after 1 year. Patients in both arms of the study showed improvement in 24-hour pH and in GERD symptoms. However, overall patient satisfaction with symptom control in the surgical group increased from 73.3 to 90.2 on a 100-point global rating scale, whereas results from the medication group stayed the same, compared with baseline.

Laparoscopic Nissen fundoplication may be an alternative for patients who don't want to be on long-term therapy with medication, Dr. Anvari said. While this trial showed surgery to be an effective option, particularly in terms of overall symptom control, surgery is operator dependent, he said.

LOS ANGELES — Laparoscopic Nissen fundoplication is superior to medication for overall symptom control in patients with gastroesophageal reflux disease, according to preliminary research results presented at the annual Digestive Disease Week.

Even patients who do well on medication may be candidates for surgery, said Dr. Mehran Anvari, director of the center for minimal access surgery at McMaster University in Hamilton, Ontario, the study's lead author. He presented the 1-year results of the study, in which patients whose symptoms were controlled by long-term use of proton pump inhibitors (PPIs) were randomized to either continued PPI therapy or laparoscopic Nissen fundoplication.

Of more than 200 patients with GERD who were eligible for the study, 104 gave informed consent. Four surgeons performed the surgery, using a previously published technique. Investigators assessed symptoms every 3 months using a validated instrument and conducted 24-hour pH testing at 1 year.

Of the 104 randomized patients, 98 were available for follow-up after 1 year. Patients in both arms of the study showed improvement in 24-hour pH and in GERD symptoms. However, overall patient satisfaction with symptom control in the surgical group increased from 73.3 to 90.2 on a 100-point global rating scale, whereas results from the medication group stayed the same, compared with baseline.

Laparoscopic Nissen fundoplication may be an alternative for patients who don't want to be on long-term therapy with medication, Dr. Anvari said. While this trial showed surgery to be an effective option, particularly in terms of overall symptom control, surgery is operator dependent, he said.

WASHINGTON — Teenage girls should have their first visit with an ob.gyn. between the ages of 13 and 15, according to a recommendation from the American College of Obstetricians and Gynecologists.

This initial visit should be focused on preventive services and education, and may include a discussion on topics such as adolescent development, normal menses, sexual orientation, healthy eating, injury prevention, and prevention of pregnancy and sexually transmitted diseases, according to an opinion from the ACOG Committee on Adolescent Health Care (Obstet. Gynecol. 2006;107:1215).

“The goal of this key visit is to help teens identify an ob.gyn. and then get acquainted with their ob.gyn. before they need to seek care for a specific health issue,” Dr. Marc R. Laufer, chief of gynecology at Children's Hospital Boston, said at the annual meeting of the American College of Obstetricians and Gynecologists. Dr. Laufer is the immediate past chair of the ACOG Committee on Adolescent Health Care.

Officials at ACOG have been advocating for an initial reproductive health visit around age 13–15 years for a number of years, but the new committee opinion provides details on what topics should be included in the visit and coding suggestions for payment of the visit.

The initial visit does not need to include an internal pelvic exam and may not even include a physical exam, Dr. Laufer said. An “age-appropriate pelvic examination” can be performed if problems are identified during the medical history such as abnormal menstrual bleeding or pelvic pain, according to the committee opinion. In cases where a speculum or bimanual exam is needed, physicians should first give the patient a full explantation of the exam and obtain consent.

The initial visit is generally more of an “information session,” Dr. Laufer said. For example, the visit is a chance for teens to get a better understanding of normal development and menstruation. It also is an opportunity to talk about issues that may need early intervention such as weight and body image, blood pressure problems, mental health problems, and physical and sexual abuse.

This initial visit opens discussion about family history with teens. For example, physicians can provide information about the impact of a family history of polycystic ovarian syndrome, endometriosis, or familial gynecologic malignancies, Dr. Laufer said.

The widespread acceptance of this routine health visit will give teens a way to get answers to questions that they may be too embarrassed to bring up with parents, friends, or a primary care physician, Dr. Laufer said.

But the initial visit to the ob.gyn. is not meant to replace the role of the primary care physician. It is meant to be a complement to that care, said Dr. Laufer.

But how this care is provided will be physician dependent, he said. In many cases, the primary care physician and the ob.gyn. each would be handling somewhat different aspects of preventive health.

However, some gynecologists are taking on the full role of preventative health care and vaccination, and some family physicians are more active in counseling on reproductive issues.

WASHINGTON — Teenage girls should have their first visit with an ob.gyn. between the ages of 13 and 15, according to a recommendation from the American College of Obstetricians and Gynecologists.

This initial visit should be focused on preventive services and education, and may include a discussion on topics such as adolescent development, normal menses, sexual orientation, healthy eating, injury prevention, and prevention of pregnancy and sexually transmitted diseases, according to an opinion from the ACOG Committee on Adolescent Health Care (Obstet. Gynecol. 2006;107:1215).

“The goal of this key visit is to help teens identify an ob.gyn. and then get acquainted with their ob.gyn. before they need to seek care for a specific health issue,” Dr. Marc R. Laufer, chief of gynecology at Children's Hospital Boston, said at the annual meeting of the American College of Obstetricians and Gynecologists. Dr. Laufer is the immediate past chair of the ACOG Committee on Adolescent Health Care.

Officials at ACOG have been advocating for an initial reproductive health visit around age 13–15 years for a number of years, but the new committee opinion provides details on what topics should be included in the visit and coding suggestions for payment of the visit.

The initial visit does not need to include an internal pelvic exam and may not even include a physical exam, Dr. Laufer said. An “age-appropriate pelvic examination” can be performed if problems are identified during the medical history such as abnormal menstrual bleeding or pelvic pain, according to the committee opinion. In cases where a speculum or bimanual exam is needed, physicians should first give the patient a full explantation of the exam and obtain consent.

The initial visit is generally more of an “information session,” Dr. Laufer said. For example, the visit is a chance for teens to get a better understanding of normal development and menstruation. It also is an opportunity to talk about issues that may need early intervention such as weight and body image, blood pressure problems, mental health problems, and physical and sexual abuse.

This initial visit opens discussion about family history with teens. For example, physicians can provide information about the impact of a family history of polycystic ovarian syndrome, endometriosis, or familial gynecologic malignancies, Dr. Laufer said.

The widespread acceptance of this routine health visit will give teens a way to get answers to questions that they may be too embarrassed to bring up with parents, friends, or a primary care physician, Dr. Laufer said.

But the initial visit to the ob.gyn. is not meant to replace the role of the primary care physician. It is meant to be a complement to that care, said Dr. Laufer.

But how this care is provided will be physician dependent, he said. In many cases, the primary care physician and the ob.gyn. each would be handling somewhat different aspects of preventive health.

However, some gynecologists are taking on the full role of preventative health care and vaccination, and some family physicians are more active in counseling on reproductive issues.

WASHINGTON — Teenage girls should have their first visit with an ob.gyn. between the ages of 13 and 15, according to a recommendation from the American College of Obstetricians and Gynecologists.

This initial visit should be focused on preventive services and education, and may include a discussion on topics such as adolescent development, normal menses, sexual orientation, healthy eating, injury prevention, and prevention of pregnancy and sexually transmitted diseases, according to an opinion from the ACOG Committee on Adolescent Health Care (Obstet. Gynecol. 2006;107:1215).

“The goal of this key visit is to help teens identify an ob.gyn. and then get acquainted with their ob.gyn. before they need to seek care for a specific health issue,” Dr. Marc R. Laufer, chief of gynecology at Children's Hospital Boston, said at the annual meeting of the American College of Obstetricians and Gynecologists. Dr. Laufer is the immediate past chair of the ACOG Committee on Adolescent Health Care.

Officials at ACOG have been advocating for an initial reproductive health visit around age 13–15 years for a number of years, but the new committee opinion provides details on what topics should be included in the visit and coding suggestions for payment of the visit.

The initial visit does not need to include an internal pelvic exam and may not even include a physical exam, Dr. Laufer said. An “age-appropriate pelvic examination” can be performed if problems are identified during the medical history such as abnormal menstrual bleeding or pelvic pain, according to the committee opinion. In cases where a speculum or bimanual exam is needed, physicians should first give the patient a full explantation of the exam and obtain consent.

The initial visit is generally more of an “information session,” Dr. Laufer said. For example, the visit is a chance for teens to get a better understanding of normal development and menstruation. It also is an opportunity to talk about issues that may need early intervention such as weight and body image, blood pressure problems, mental health problems, and physical and sexual abuse.

This initial visit opens discussion about family history with teens. For example, physicians can provide information about the impact of a family history of polycystic ovarian syndrome, endometriosis, or familial gynecologic malignancies, Dr. Laufer said.

The widespread acceptance of this routine health visit will give teens a way to get answers to questions that they may be too embarrassed to bring up with parents, friends, or a primary care physician, Dr. Laufer said.

But the initial visit to the ob.gyn. is not meant to replace the role of the primary care physician. It is meant to be a complement to that care, said Dr. Laufer.

But how this care is provided will be physician dependent, he said. In many cases, the primary care physician and the ob.gyn. each would be handling somewhat different aspects of preventive health.

However, some gynecologists are taking on the full role of preventative health care and vaccination, and some family physicians are more active in counseling on reproductive issues.

LOS ANGELES — Extended combination therapy with consensus interferon for 72 weeks appears to help improve the viral response of patients with chronic hepatitis C who have previously relapsed after a 48-week course of treatment, according to a study presented at the annual Digestive Disease Week.

The investigator-initiated study, conducted by researchers from the University of Tübingen in Germany, showed that at the end of 72 weeks of daily therapy, the majority of patients treated with a combination of either consensus interferon plus ribavirin or pegylated interferon alfa-2a plus ribavirin had a reduction in hepatitis RNA. However, the drop was not statistically significant, said the lead study author, Dr. Stephan Kaiser, a professor of medicine at the university.

The investigators compared the two interferon combinations in 81 patients who had experienced a previous relapse after a standard 48 weeks of pegylated interferon plus ribavirin. At the end of week 72, 89% of patients taking the consensus interferon combination were in remission, compared with 76% of the pegylated alfa-2a interferon group.

But relapse rates remained high in the study, Dr. Kaiser said. The pegylated alfa-2a interferon combination had significantly higher rates of relapse than the consensus interferon combination. About 44% of patients in the pegylated alfa-2a interferon combination group had a sustained viral response after completing treatment, compared with 69% of the consensus interferon group.

Overall, the study indicated that treatment for relapse can be successful using consensus therapy for an extended period, but more research is needed in multicenter trials, Dr. Kaiser said.

Researchers also presented new data on treatments for another difficult-to-treat population: nonresponders. Interim results from an ongoing phase II multicenter trial show that a combination of valopicitabine (NM283) at high doses plus pegylated interferon can reduce hepatitis RNA at 24 weeks of treatment, reported Dr. Paul Pockros of Scripps Clinic in California and his colleagues.

The five-arm study compares valopicitabine alone to three different doses of valopicitabine (400 mg/day, 800 mg/day, and dose-ramping from 400 to 800 mg/day) with pegylated interferon, and pegylated interferon plus ribavirin as a control.

Valopicitabine, manufactured by Idenix Pharmaceuticals, is the first nucleotide-type HCV polymerase inhibitor to advance to phase II trials. The study is funded by the drug maker.

The best results—about a 3-log decrease in hepatitis RNA—were achieved with the 800-mg dose of valopicitabine plus pegylated interferon. However, some patients experienced vomiting and nausea at initiation of treatment, and three patients were hospitalized with dehydration, so researchers stopped using the 800-mg dose and are continuing with 200-mg and 400-mg doses of the drug.

The results with the combination of 400 mg of valopicitabine and pegylated interferon were less promising in the nonresponder study population, with about a 2.5-log decrease, Dr. Pockros said.

Continued treatment is needed to find out if there will be a sustained response with the new drug combination, Dr. Pockros said, and to find out if the drug will be more effective for preventing relapse than are current therapies.

LOS ANGELES — Extended combination therapy with consensus interferon for 72 weeks appears to help improve the viral response of patients with chronic hepatitis C who have previously relapsed after a 48-week course of treatment, according to a study presented at the annual Digestive Disease Week.

The investigator-initiated study, conducted by researchers from the University of Tübingen in Germany, showed that at the end of 72 weeks of daily therapy, the majority of patients treated with a combination of either consensus interferon plus ribavirin or pegylated interferon alfa-2a plus ribavirin had a reduction in hepatitis RNA. However, the drop was not statistically significant, said the lead study author, Dr. Stephan Kaiser, a professor of medicine at the university.

The investigators compared the two interferon combinations in 81 patients who had experienced a previous relapse after a standard 48 weeks of pegylated interferon plus ribavirin. At the end of week 72, 89% of patients taking the consensus interferon combination were in remission, compared with 76% of the pegylated alfa-2a interferon group.

But relapse rates remained high in the study, Dr. Kaiser said. The pegylated alfa-2a interferon combination had significantly higher rates of relapse than the consensus interferon combination. About 44% of patients in the pegylated alfa-2a interferon combination group had a sustained viral response after completing treatment, compared with 69% of the consensus interferon group.

Overall, the study indicated that treatment for relapse can be successful using consensus therapy for an extended period, but more research is needed in multicenter trials, Dr. Kaiser said.

Researchers also presented new data on treatments for another difficult-to-treat population: nonresponders. Interim results from an ongoing phase II multicenter trial show that a combination of valopicitabine (NM283) at high doses plus pegylated interferon can reduce hepatitis RNA at 24 weeks of treatment, reported Dr. Paul Pockros of Scripps Clinic in California and his colleagues.

The five-arm study compares valopicitabine alone to three different doses of valopicitabine (400 mg/day, 800 mg/day, and dose-ramping from 400 to 800 mg/day) with pegylated interferon, and pegylated interferon plus ribavirin as a control.

Valopicitabine, manufactured by Idenix Pharmaceuticals, is the first nucleotide-type HCV polymerase inhibitor to advance to phase II trials. The study is funded by the drug maker.

The best results—about a 3-log decrease in hepatitis RNA—were achieved with the 800-mg dose of valopicitabine plus pegylated interferon. However, some patients experienced vomiting and nausea at initiation of treatment, and three patients were hospitalized with dehydration, so researchers stopped using the 800-mg dose and are continuing with 200-mg and 400-mg doses of the drug.

The results with the combination of 400 mg of valopicitabine and pegylated interferon were less promising in the nonresponder study population, with about a 2.5-log decrease, Dr. Pockros said.

Continued treatment is needed to find out if there will be a sustained response with the new drug combination, Dr. Pockros said, and to find out if the drug will be more effective for preventing relapse than are current therapies.

LOS ANGELES — Extended combination therapy with consensus interferon for 72 weeks appears to help improve the viral response of patients with chronic hepatitis C who have previously relapsed after a 48-week course of treatment, according to a study presented at the annual Digestive Disease Week.

The investigator-initiated study, conducted by researchers from the University of Tübingen in Germany, showed that at the end of 72 weeks of daily therapy, the majority of patients treated with a combination of either consensus interferon plus ribavirin or pegylated interferon alfa-2a plus ribavirin had a reduction in hepatitis RNA. However, the drop was not statistically significant, said the lead study author, Dr. Stephan Kaiser, a professor of medicine at the university.

The investigators compared the two interferon combinations in 81 patients who had experienced a previous relapse after a standard 48 weeks of pegylated interferon plus ribavirin. At the end of week 72, 89% of patients taking the consensus interferon combination were in remission, compared with 76% of the pegylated alfa-2a interferon group.

But relapse rates remained high in the study, Dr. Kaiser said. The pegylated alfa-2a interferon combination had significantly higher rates of relapse than the consensus interferon combination. About 44% of patients in the pegylated alfa-2a interferon combination group had a sustained viral response after completing treatment, compared with 69% of the consensus interferon group.

Overall, the study indicated that treatment for relapse can be successful using consensus therapy for an extended period, but more research is needed in multicenter trials, Dr. Kaiser said.

Researchers also presented new data on treatments for another difficult-to-treat population: nonresponders. Interim results from an ongoing phase II multicenter trial show that a combination of valopicitabine (NM283) at high doses plus pegylated interferon can reduce hepatitis RNA at 24 weeks of treatment, reported Dr. Paul Pockros of Scripps Clinic in California and his colleagues.

The five-arm study compares valopicitabine alone to three different doses of valopicitabine (400 mg/day, 800 mg/day, and dose-ramping from 400 to 800 mg/day) with pegylated interferon, and pegylated interferon plus ribavirin as a control.

Valopicitabine, manufactured by Idenix Pharmaceuticals, is the first nucleotide-type HCV polymerase inhibitor to advance to phase II trials. The study is funded by the drug maker.

The best results—about a 3-log decrease in hepatitis RNA—were achieved with the 800-mg dose of valopicitabine plus pegylated interferon. However, some patients experienced vomiting and nausea at initiation of treatment, and three patients were hospitalized with dehydration, so researchers stopped using the 800-mg dose and are continuing with 200-mg and 400-mg doses of the drug.

The results with the combination of 400 mg of valopicitabine and pegylated interferon were less promising in the nonresponder study population, with about a 2.5-log decrease, Dr. Pockros said.

Continued treatment is needed to find out if there will be a sustained response with the new drug combination, Dr. Pockros said, and to find out if the drug will be more effective for preventing relapse than are current therapies.

More than 2 years after President Bush issued his call to action on the adoption of electronic health records, experts say there is growing pressure on physicians to heed that call.

Although physician adoption of EHRs remains low—especially in small practices—the movement toward pay for performance could start to drive adoption, said Mureen Allen, senior associate for informatics and practice improvement at the American College of Physicians. And the certification of electronic health records by an independent body, which is slated to begin this summer, should help too. “The paradigm to some extent is changing.”

This month, many of the biggest players in health information technology will gather in Washington for National Health IT Week. More than 40 groups are slated to participate in this first-ever event, including medical professional societies such the American Academy of Family Physicians, government agencies, a regional health information organization, and other public and private organizations.

The series of events follows on the heels of more than 2 years' major actions in the health IT landscape starting with President Bush's State of the Union address in January 2004 in which he called for the widespread adoption of interoperable EHRs within the decade.

A few months later, the Health and Human Services secretary appointed Dr. David J. Brailer as the first National Health Information Technology Coordinator. Dr. Brailer resigned from the post last month saying that he only planned to stay in the job for 2 years. Dr. Brailer said there is still a lot work to be done in closing the adoption gap between large and small physician practices. His office has been focused on three strategies to close the gap—lowering costs, raising the benefits, and lowering the risks involved in purchasing an EHR system, he said during a teleconference announcing his resignation.

Last fall, HHS Secretary Mike Leavitt established the American Health Information Community, a federally chartered commission to advise the secretary on interoperability issues. HHS proposed allowing hospitals and other entities to give physicians health IT hardware, software, and training. HHS also awarded three contracts to public and private groups to create processes for harmonizing information standards, certifying health IT products, and addressing variations in state laws on privacy and security practices.

And starting in January, prescription drug plans participating in the Medicare Part D program were required to begin supporting electronic prescribing. The regulation is optional for physicians and pharmacies.

Most recently, the Food and Drug Administration adopted the Systematized Nomenclature of Medicine (SNOMED) standard as the format for the highlights section of prescription drug labeling. The format will be required starting on June 30 for all new drugs and drugs approved within the last 5 years. The use of the SNOMED standards will make it easier for electronic systems to exchange FDA-approved labeling information, according to the agency.

One of the most significant developments has been the establishment of the Certification Commission on Health Information Technology (CCHIT). This group was formed in 2004 by the American Health Information Management Association, the Healthcare Information and Management Systems Society (HIMSS), and the National Alliance for Health Information Technology to develop criteria for the certification of EHRs.

CCHIT received a 3-year grant from HHS last fall to certify products in the ambulatory and inpatient settings, and to certify the systems' networks. The announcement of the first certified products in the ambulatory setting is expected in late June or early July.

The means for objectively comparing EHR systems is “about to become a reality,” said CCHIT Chair Mark Leavitt.

Current estimates put physician adoption of EHRs at around 14%. Dr. Leavitt said he hopes that by taking some of the risk out of buying an EHR product it will boost those adoption figures.

“I think we are on track,” said Dave Roberts, vice president of government relations at HIMSS. While physicians still need to be educated about the value of EHRs, there are some other encouraging signs. For example, many states are becoming more interested in health IT and are helping to form regional health information organizations, he said.

These groups, called RHIOs, help to standardize the various regulations and business policies surrounding health information exchange. The federal government has funded more than 100 of these regional projects, and more efforts, supported by private industry or state governments, are underway, according to HHS.

“The states are really buying into this whole initiative,” Mr. Roberts said.

For the majority of physicians, it just hasn't made financial sense to purchase an EHR system, Dr. Allen said. However, some physicians are beginning to see a strategic advantage in the adoption of technology. One advantage stems from regulations that encourage electronic prescribing.

EHR adoption is inevitable, Dr. Allen said, if only because so many younger physicians were trained on EHRs and it is not acceptable to them to go back to a paper system once they enter practice. And older physicians recognize that the change is coming, she said.

But Dr. Allen advised physicians that they don't need to jump into a full-blown EHR system. Electronic prescribing systems and electronic patient registries may be easier to adopt than a full EHR system. Physicians can also purchase EHRs in a modular fashion so that they can ramp up over time, she said.

More than 2 years after President Bush issued his call to action on the adoption of electronic health records, experts say there is growing pressure on physicians to heed that call.

Although physician adoption of EHRs remains low—especially in small practices—the movement toward pay for performance could start to drive adoption, said Mureen Allen, senior associate for informatics and practice improvement at the American College of Physicians. And the certification of electronic health records by an independent body, which is slated to begin this summer, should help too. “The paradigm to some extent is changing.”

This month, many of the biggest players in health information technology will gather in Washington for National Health IT Week. More than 40 groups are slated to participate in this first-ever event, including medical professional societies such the American Academy of Family Physicians, government agencies, a regional health information organization, and other public and private organizations.

The series of events follows on the heels of more than 2 years' major actions in the health IT landscape starting with President Bush's State of the Union address in January 2004 in which he called for the widespread adoption of interoperable EHRs within the decade.

A few months later, the Health and Human Services secretary appointed Dr. David J. Brailer as the first National Health Information Technology Coordinator. Dr. Brailer resigned from the post last month saying that he only planned to stay in the job for 2 years. Dr. Brailer said there is still a lot work to be done in closing the adoption gap between large and small physician practices. His office has been focused on three strategies to close the gap—lowering costs, raising the benefits, and lowering the risks involved in purchasing an EHR system, he said during a teleconference announcing his resignation.

Last fall, HHS Secretary Mike Leavitt established the American Health Information Community, a federally chartered commission to advise the secretary on interoperability issues. HHS proposed allowing hospitals and other entities to give physicians health IT hardware, software, and training. HHS also awarded three contracts to public and private groups to create processes for harmonizing information standards, certifying health IT products, and addressing variations in state laws on privacy and security practices.

And starting in January, prescription drug plans participating in the Medicare Part D program were required to begin supporting electronic prescribing. The regulation is optional for physicians and pharmacies.

Most recently, the Food and Drug Administration adopted the Systematized Nomenclature of Medicine (SNOMED) standard as the format for the highlights section of prescription drug labeling. The format will be required starting on June 30 for all new drugs and drugs approved within the last 5 years. The use of the SNOMED standards will make it easier for electronic systems to exchange FDA-approved labeling information, according to the agency.

One of the most significant developments has been the establishment of the Certification Commission on Health Information Technology (CCHIT). This group was formed in 2004 by the American Health Information Management Association, the Healthcare Information and Management Systems Society (HIMSS), and the National Alliance for Health Information Technology to develop criteria for the certification of EHRs.

CCHIT received a 3-year grant from HHS last fall to certify products in the ambulatory and inpatient settings, and to certify the systems' networks. The announcement of the first certified products in the ambulatory setting is expected in late June or early July.

The means for objectively comparing EHR systems is “about to become a reality,” said CCHIT Chair Mark Leavitt.

Current estimates put physician adoption of EHRs at around 14%. Dr. Leavitt said he hopes that by taking some of the risk out of buying an EHR product it will boost those adoption figures.

“I think we are on track,” said Dave Roberts, vice president of government relations at HIMSS. While physicians still need to be educated about the value of EHRs, there are some other encouraging signs. For example, many states are becoming more interested in health IT and are helping to form regional health information organizations, he said.

These groups, called RHIOs, help to standardize the various regulations and business policies surrounding health information exchange. The federal government has funded more than 100 of these regional projects, and more efforts, supported by private industry or state governments, are underway, according to HHS.

“The states are really buying into this whole initiative,” Mr. Roberts said.

For the majority of physicians, it just hasn't made financial sense to purchase an EHR system, Dr. Allen said. However, some physicians are beginning to see a strategic advantage in the adoption of technology. One advantage stems from regulations that encourage electronic prescribing.

EHR adoption is inevitable, Dr. Allen said, if only because so many younger physicians were trained on EHRs and it is not acceptable to them to go back to a paper system once they enter practice. And older physicians recognize that the change is coming, she said.

But Dr. Allen advised physicians that they don't need to jump into a full-blown EHR system. Electronic prescribing systems and electronic patient registries may be easier to adopt than a full EHR system. Physicians can also purchase EHRs in a modular fashion so that they can ramp up over time, she said.

More than 2 years after President Bush issued his call to action on the adoption of electronic health records, experts say there is growing pressure on physicians to heed that call.

Although physician adoption of EHRs remains low—especially in small practices—the movement toward pay for performance could start to drive adoption, said Mureen Allen, senior associate for informatics and practice improvement at the American College of Physicians. And the certification of electronic health records by an independent body, which is slated to begin this summer, should help too. “The paradigm to some extent is changing.”

This month, many of the biggest players in health information technology will gather in Washington for National Health IT Week. More than 40 groups are slated to participate in this first-ever event, including medical professional societies such the American Academy of Family Physicians, government agencies, a regional health information organization, and other public and private organizations.

The series of events follows on the heels of more than 2 years' major actions in the health IT landscape starting with President Bush's State of the Union address in January 2004 in which he called for the widespread adoption of interoperable EHRs within the decade.

A few months later, the Health and Human Services secretary appointed Dr. David J. Brailer as the first National Health Information Technology Coordinator. Dr. Brailer resigned from the post last month saying that he only planned to stay in the job for 2 years. Dr. Brailer said there is still a lot work to be done in closing the adoption gap between large and small physician practices. His office has been focused on three strategies to close the gap—lowering costs, raising the benefits, and lowering the risks involved in purchasing an EHR system, he said during a teleconference announcing his resignation.

Last fall, HHS Secretary Mike Leavitt established the American Health Information Community, a federally chartered commission to advise the secretary on interoperability issues. HHS proposed allowing hospitals and other entities to give physicians health IT hardware, software, and training. HHS also awarded three contracts to public and private groups to create processes for harmonizing information standards, certifying health IT products, and addressing variations in state laws on privacy and security practices.

And starting in January, prescription drug plans participating in the Medicare Part D program were required to begin supporting electronic prescribing. The regulation is optional for physicians and pharmacies.

Most recently, the Food and Drug Administration adopted the Systematized Nomenclature of Medicine (SNOMED) standard as the format for the highlights section of prescription drug labeling. The format will be required starting on June 30 for all new drugs and drugs approved within the last 5 years. The use of the SNOMED standards will make it easier for electronic systems to exchange FDA-approved labeling information, according to the agency.

One of the most significant developments has been the establishment of the Certification Commission on Health Information Technology (CCHIT). This group was formed in 2004 by the American Health Information Management Association, the Healthcare Information and Management Systems Society (HIMSS), and the National Alliance for Health Information Technology to develop criteria for the certification of EHRs.

CCHIT received a 3-year grant from HHS last fall to certify products in the ambulatory and inpatient settings, and to certify the systems' networks. The announcement of the first certified products in the ambulatory setting is expected in late June or early July.

The means for objectively comparing EHR systems is “about to become a reality,” said CCHIT Chair Mark Leavitt.

Current estimates put physician adoption of EHRs at around 14%. Dr. Leavitt said he hopes that by taking some of the risk out of buying an EHR product it will boost those adoption figures.

“I think we are on track,” said Dave Roberts, vice president of government relations at HIMSS. While physicians still need to be educated about the value of EHRs, there are some other encouraging signs. For example, many states are becoming more interested in health IT and are helping to form regional health information organizations, he said.

These groups, called RHIOs, help to standardize the various regulations and business policies surrounding health information exchange. The federal government has funded more than 100 of these regional projects, and more efforts, supported by private industry or state governments, are underway, according to HHS.

“The states are really buying into this whole initiative,” Mr. Roberts said.

For the majority of physicians, it just hasn't made financial sense to purchase an EHR system, Dr. Allen said. However, some physicians are beginning to see a strategic advantage in the adoption of technology. One advantage stems from regulations that encourage electronic prescribing.

EHR adoption is inevitable, Dr. Allen said, if only because so many younger physicians were trained on EHRs and it is not acceptable to them to go back to a paper system once they enter practice. And older physicians recognize that the change is coming, she said.

But Dr. Allen advised physicians that they don't need to jump into a full-blown EHR system. Electronic prescribing systems and electronic patient registries may be easier to adopt than a full EHR system. Physicians can also purchase EHRs in a modular fashion so that they can ramp up over time, she said.

LOS ANGELES — Individuals who consume moderate amounts of alcohol have a lower risk of developing colorectal adenomas compared with heavy drinkers, according to research presented at the annual Digestive Disease Week.

Also, moderate alcohol consumption—between two and seven drinks per week—may actually protect against the disease, compared with teetotalism, said lead investigator Dr. Greg Austin of the University of North Carolina at Chapel Hill.

He and his colleagues performed a case-control analysis of 203 patients and 522 controls; all underwent a full colonoscopy and completed the National Cancer Institute's food frequency questionnaire.

Individuals who reported consuming an average of less than two drinks a week or between two and seven drinks per week had the lowest probability of developing colorectal adenoma. Moderate drinkers—those who reported consuming between two and seven drinks—were used as a reference group in the study. The researchers controlled for potential confounding factors including sex, age, body mass index, race, smoking, and the use of nonsteroidal anti-inflammatory medications.

Those who abstained from alcohol use, the largest group in the study, had about a 40% increased risk, compared with moderate drinkers.

Heavier drinkers had the highest risk. Individuals who consumed between 7 and 14 drinks per week had about a 60% increased risk of developing adenoma compared with moderate drinkers, and those who consumed 14 drinks or more had a 150% increased risk.

“A moderate level of alcohol consumption certainly isn't harmful,” and it may be protective, Dr. Austin said.

The preliminary results lack statistical power to show that limited alcohol intake is better than abstention, commented Dr. Lee Kaplan, director of the Massachusetts General Hospital Weight Center, Boston.

But the findings clearly show that moderate alcohol consumption is better than heavy consumption, said Dr. Kaplan, who was not involved in the study.

LOS ANGELES — Individuals who consume moderate amounts of alcohol have a lower risk of developing colorectal adenomas compared with heavy drinkers, according to research presented at the annual Digestive Disease Week.

Also, moderate alcohol consumption—between two and seven drinks per week—may actually protect against the disease, compared with teetotalism, said lead investigator Dr. Greg Austin of the University of North Carolina at Chapel Hill.

He and his colleagues performed a case-control analysis of 203 patients and 522 controls; all underwent a full colonoscopy and completed the National Cancer Institute's food frequency questionnaire.

Individuals who reported consuming an average of less than two drinks a week or between two and seven drinks per week had the lowest probability of developing colorectal adenoma. Moderate drinkers—those who reported consuming between two and seven drinks—were used as a reference group in the study. The researchers controlled for potential confounding factors including sex, age, body mass index, race, smoking, and the use of nonsteroidal anti-inflammatory medications.

Those who abstained from alcohol use, the largest group in the study, had about a 40% increased risk, compared with moderate drinkers.

Heavier drinkers had the highest risk. Individuals who consumed between 7 and 14 drinks per week had about a 60% increased risk of developing adenoma compared with moderate drinkers, and those who consumed 14 drinks or more had a 150% increased risk.

“A moderate level of alcohol consumption certainly isn't harmful,” and it may be protective, Dr. Austin said.

The preliminary results lack statistical power to show that limited alcohol intake is better than abstention, commented Dr. Lee Kaplan, director of the Massachusetts General Hospital Weight Center, Boston.

But the findings clearly show that moderate alcohol consumption is better than heavy consumption, said Dr. Kaplan, who was not involved in the study.

LOS ANGELES — Individuals who consume moderate amounts of alcohol have a lower risk of developing colorectal adenomas compared with heavy drinkers, according to research presented at the annual Digestive Disease Week.

Also, moderate alcohol consumption—between two and seven drinks per week—may actually protect against the disease, compared with teetotalism, said lead investigator Dr. Greg Austin of the University of North Carolina at Chapel Hill.

He and his colleagues performed a case-control analysis of 203 patients and 522 controls; all underwent a full colonoscopy and completed the National Cancer Institute's food frequency questionnaire.

Individuals who reported consuming an average of less than two drinks a week or between two and seven drinks per week had the lowest probability of developing colorectal adenoma. Moderate drinkers—those who reported consuming between two and seven drinks—were used as a reference group in the study. The researchers controlled for potential confounding factors including sex, age, body mass index, race, smoking, and the use of nonsteroidal anti-inflammatory medications.

Those who abstained from alcohol use, the largest group in the study, had about a 40% increased risk, compared with moderate drinkers.

Heavier drinkers had the highest risk. Individuals who consumed between 7 and 14 drinks per week had about a 60% increased risk of developing adenoma compared with moderate drinkers, and those who consumed 14 drinks or more had a 150% increased risk.

“A moderate level of alcohol consumption certainly isn't harmful,” and it may be protective, Dr. Austin said.

The preliminary results lack statistical power to show that limited alcohol intake is better than abstention, commented Dr. Lee Kaplan, director of the Massachusetts General Hospital Weight Center, Boston.

But the findings clearly show that moderate alcohol consumption is better than heavy consumption, said Dr. Kaplan, who was not involved in the study.

LOS ANGELES — The use of angiotensin-converting enzyme inhibitors is associated with a significantly lower risk of developing esophageal, pancreatic, and colon cancers, according to research presented at the annual Digestive Disease Week.

Three case-control analyses of more than 480,000 veterans living in eight states in the south-central United States showed that patients who used ACE inhibitors were less likely to develop certain cancers. Patients taking ACE inhibitors were 53% less likely to develop colon cancer, 52% less likely to develop pancreatic cancer, and 46% less likely to develop esophageal cancer than patients who did not take the drugs.

ACE inhibitors may exert this risk-reduction effect by suppressing vascular endothelial growth factor (VEGF), which many researchers believe plays a significant role in the angiogenesis of human tumors, said lead study author Dr. Vikas Khurana of the Overton Brooks VA Medical Center in Shreveport, La. Dr. Khurana is on the speakers' bureau for AstraZeneca.

Dr. Khurana and his colleagues performed three retrospective analyses of the Veterans Integrated Service Network 16 database, looking at 483,733 patients who made regular visits to a VA medical center clinic from October 1998 to June 2004.

Of those patients, 184,743 (38%) were using ACE inhibitors. A total of 6,697 patients in the VA database (1.5%) had colon cancer, 475 patients (0.1%) had pancreatic cancer, and 659 patients (0.14%) had esophageal cancer.

The data were adjusted for age, race, gender, body mass index, smoking, alcohol use, diabetes, and statin use. The protective effect of ACE inhibitor use was independent of statin use for all three cancers, Dr. Khurana said. However, the investigators did not factor the dose, duration, or type of ACE inhibitor into their analysis.

But Dr. Khurana does not recommend a change in prescribing patterns based on the results of this study, since it was a case-control analysis. “We need to have randomized controlled trials before we use these agents as chemopreventive agents,” he said.

LOS ANGELES — The use of angiotensin-converting enzyme inhibitors is associated with a significantly lower risk of developing esophageal, pancreatic, and colon cancers, according to research presented at the annual Digestive Disease Week.

Three case-control analyses of more than 480,000 veterans living in eight states in the south-central United States showed that patients who used ACE inhibitors were less likely to develop certain cancers. Patients taking ACE inhibitors were 53% less likely to develop colon cancer, 52% less likely to develop pancreatic cancer, and 46% less likely to develop esophageal cancer than patients who did not take the drugs.

ACE inhibitors may exert this risk-reduction effect by suppressing vascular endothelial growth factor (VEGF), which many researchers believe plays a significant role in the angiogenesis of human tumors, said lead study author Dr. Vikas Khurana of the Overton Brooks VA Medical Center in Shreveport, La. Dr. Khurana is on the speakers' bureau for AstraZeneca.

Dr. Khurana and his colleagues performed three retrospective analyses of the Veterans Integrated Service Network 16 database, looking at 483,733 patients who made regular visits to a VA medical center clinic from October 1998 to June 2004.

Of those patients, 184,743 (38%) were using ACE inhibitors. A total of 6,697 patients in the VA database (1.5%) had colon cancer, 475 patients (0.1%) had pancreatic cancer, and 659 patients (0.14%) had esophageal cancer.

The data were adjusted for age, race, gender, body mass index, smoking, alcohol use, diabetes, and statin use. The protective effect of ACE inhibitor use was independent of statin use for all three cancers, Dr. Khurana said. However, the investigators did not factor the dose, duration, or type of ACE inhibitor into their analysis.

But Dr. Khurana does not recommend a change in prescribing patterns based on the results of this study, since it was a case-control analysis. “We need to have randomized controlled trials before we use these agents as chemopreventive agents,” he said.

LOS ANGELES — The use of angiotensin-converting enzyme inhibitors is associated with a significantly lower risk of developing esophageal, pancreatic, and colon cancers, according to research presented at the annual Digestive Disease Week.

Three case-control analyses of more than 480,000 veterans living in eight states in the south-central United States showed that patients who used ACE inhibitors were less likely to develop certain cancers. Patients taking ACE inhibitors were 53% less likely to develop colon cancer, 52% less likely to develop pancreatic cancer, and 46% less likely to develop esophageal cancer than patients who did not take the drugs.

ACE inhibitors may exert this risk-reduction effect by suppressing vascular endothelial growth factor (VEGF), which many researchers believe plays a significant role in the angiogenesis of human tumors, said lead study author Dr. Vikas Khurana of the Overton Brooks VA Medical Center in Shreveport, La. Dr. Khurana is on the speakers' bureau for AstraZeneca.

Dr. Khurana and his colleagues performed three retrospective analyses of the Veterans Integrated Service Network 16 database, looking at 483,733 patients who made regular visits to a VA medical center clinic from October 1998 to June 2004.

Of those patients, 184,743 (38%) were using ACE inhibitors. A total of 6,697 patients in the VA database (1.5%) had colon cancer, 475 patients (0.1%) had pancreatic cancer, and 659 patients (0.14%) had esophageal cancer.

The data were adjusted for age, race, gender, body mass index, smoking, alcohol use, diabetes, and statin use. The protective effect of ACE inhibitor use was independent of statin use for all three cancers, Dr. Khurana said. However, the investigators did not factor the dose, duration, or type of ACE inhibitor into their analysis.

But Dr. Khurana does not recommend a change in prescribing patterns based on the results of this study, since it was a case-control analysis. “We need to have randomized controlled trials before we use these agents as chemopreventive agents,” he said.