Damian McNamara

MIAMI BEACH — The perioperative risk of thromboembolism is small but real for warfarin patients who discontinue anticoagulation to undergo noncardiac surgery or other procedures. Bridging therapy can reduce this risk, but it increases the likelihood of postoperative bleeding, so clinical judgment, guideline recommendations, and individual patient and surgical factors remain paramount, Dr. Amir K. Jaffer said.

“This whole area lacks randomized, controlled trials, and management is guided by observational data and consensus,” Dr. Jaffer said at a meeting on perioperative medicine sponsored by the University of Miami. “You have to balance risk of bleeding against the risk of clotting.”

Patients often require an individualized approach. For example, the population of patients with older-generation mechanical heart valves or mechanical valves in the mitral position are at higher risk for thromboembolic events, according to the most recent guidelines on perioperative management of antithrombotic therapy from the American College of Chest Physicians (Chest 2008;133[suppl 6]:299S-339S). The valve type and its position are two important factors to consider, Dr. Jaffer said. Risk is generally greater among patients with a mitral valve or older device (for example, ball-in-cage type), compared with patients with an atrial bileaflet valve (Circulation 1994;89:635–41).

“Warfarin is a tricky drug,” said Dr. Jaffer, chief of the division of hospital medicine at the University of Miami, and a coauthor of the ACCP guidelines. “It is a highly litigated area of perioperative medicine. Every week or so I have an attorney calling me to serve as an expert; the plaintiffs' attorneys are always going after these types of cases.” One reason warfarin is big business for lawyers is that an estimated 3 million patients are taking the drug in North America, and 400,000 of these are evaluated for bridging therapy each year, according to the American Heart Association 2002 Heart and Stroke Statistical Update.

Although the dangers are clinically significant, they affect only a minority of patients. “The risk of thromboembolism is low. It's not zero; it is about 1%,” Dr. Jaffer said. For example, 2 of 224 (0.9%) of warfarin patients experienced a cardiac thromboembolism in one study (Circulation 2004;110:1658–63).

The risk of major bleeding in this series was 6.9%. However, the average risk of major bleeding is 3%–3.5% across studies in the literature for patients with a valve or other indication who have warfarin discontinued and receive low-molecular-weight heparin (LMWH) as a bridge. For example, major bleeding occurred in 3.5% of 260 patients in one study (J. Thromb. Haemost. 2007;5:2211–8) and 3.3% of 721 patients in another (J. Thromb. Haemost. 2006;4:1246–52).

There can be increased bleeding immediately postoperatively with full-dose LMWH or unfractionated heparin, “but this can likely be minimized by delaying reinitiation of full-dose heparin … for up to 48 hours, depending on the type of surgery,” Dr. Jaffer said. In the interim, lower prophylactic doses may be warranted. “Those centers who dose everyone with full doses were at [six times] higher risk for major bleeding than those who did not give full doses,” according to unpublished data on 500 patients.

Guidelines support bridging patients with therapeutic doses of subcutaneous LMWH, rather than intravenous unfractionated heparin, as there is a paucity of data for intravenous unfractionated heparin, said Dr. Jaffer, who is also associate professor of medicine at the University of Miami. Dr. Jaffer is a consultant for Sanofi-Aventis, AstraZeneca, Bristol-Myers Squibb, and Boehringer Ingelheim. He receives research and grant support from AstraZeneca and is on the speakers bureau for Sanofi-Aventis and Roche Diagnostics.

Although both thromboembolic events and major bleeding can be fatal, mortality and morbidity rates differ for the two conditions. “With bleeding, patients can be resuscitated; with a thromboembolic event, they can have long-lasting disability,” Dr. Jaffer said. Major bleeding events rarely result in permanent disability, but 9%-13% are fatal (Ann. Intern. Med. 2003;139:893–900). In contrast, an estimated 20% of arterial thromboembolic events are fatal, and more than 50% result in permanent disability (Arch. Intern. Med. 1994;154:1449–57).

Ultimately, the decision on how to manage warfarin patients perioperatively relies on individual risk factors. The patients' indication for anticoagulation, their risk profile for thromboembolism, the type of surgery, and the likely amount of time they will be off warfarin therapy are important considerations, Dr. Jaffer said. “Weigh the consequences of thromboembolism and bleeding and then determine the need for bridging therapy.

'Weigh the consequences of thromboembolism and bleeding and then determine the need for bridging therapy.' DR. JAFFER

MIAMI BEACH — The perioperative risk of thromboembolism is small but real for warfarin patients who discontinue anticoagulation to undergo noncardiac surgery or other procedures. Bridging therapy can reduce this risk, but it increases the likelihood of postoperative bleeding, so clinical judgment, guideline recommendations, and individual patient and surgical factors remain paramount, Dr. Amir K. Jaffer said.

“This whole area lacks randomized, controlled trials, and management is guided by observational data and consensus,” Dr. Jaffer said at a meeting on perioperative medicine sponsored by the University of Miami. “You have to balance risk of bleeding against the risk of clotting.”

Patients often require an individualized approach. For example, the population of patients with older-generation mechanical heart valves or mechanical valves in the mitral position are at higher risk for thromboembolic events, according to the most recent guidelines on perioperative management of antithrombotic therapy from the American College of Chest Physicians (Chest 2008;133[suppl 6]:299S-339S). The valve type and its position are two important factors to consider, Dr. Jaffer said. Risk is generally greater among patients with a mitral valve or older device (for example, ball-in-cage type), compared with patients with an atrial bileaflet valve (Circulation 1994;89:635–41).

“Warfarin is a tricky drug,” said Dr. Jaffer, chief of the division of hospital medicine at the University of Miami, and a coauthor of the ACCP guidelines. “It is a highly litigated area of perioperative medicine. Every week or so I have an attorney calling me to serve as an expert; the plaintiffs' attorneys are always going after these types of cases.” One reason warfarin is big business for lawyers is that an estimated 3 million patients are taking the drug in North America, and 400,000 of these are evaluated for bridging therapy each year, according to the American Heart Association 2002 Heart and Stroke Statistical Update.

Although the dangers are clinically significant, they affect only a minority of patients. “The risk of thromboembolism is low. It's not zero; it is about 1%,” Dr. Jaffer said. For example, 2 of 224 (0.9%) of warfarin patients experienced a cardiac thromboembolism in one study (Circulation 2004;110:1658–63).

The risk of major bleeding in this series was 6.9%. However, the average risk of major bleeding is 3%–3.5% across studies in the literature for patients with a valve or other indication who have warfarin discontinued and receive low-molecular-weight heparin (LMWH) as a bridge. For example, major bleeding occurred in 3.5% of 260 patients in one study (J. Thromb. Haemost. 2007;5:2211–8) and 3.3% of 721 patients in another (J. Thromb. Haemost. 2006;4:1246–52).

There can be increased bleeding immediately postoperatively with full-dose LMWH or unfractionated heparin, “but this can likely be minimized by delaying reinitiation of full-dose heparin … for up to 48 hours, depending on the type of surgery,” Dr. Jaffer said. In the interim, lower prophylactic doses may be warranted. “Those centers who dose everyone with full doses were at [six times] higher risk for major bleeding than those who did not give full doses,” according to unpublished data on 500 patients.

Guidelines support bridging patients with therapeutic doses of subcutaneous LMWH, rather than intravenous unfractionated heparin, as there is a paucity of data for intravenous unfractionated heparin, said Dr. Jaffer, who is also associate professor of medicine at the University of Miami. Dr. Jaffer is a consultant for Sanofi-Aventis, AstraZeneca, Bristol-Myers Squibb, and Boehringer Ingelheim. He receives research and grant support from AstraZeneca and is on the speakers bureau for Sanofi-Aventis and Roche Diagnostics.

Although both thromboembolic events and major bleeding can be fatal, mortality and morbidity rates differ for the two conditions. “With bleeding, patients can be resuscitated; with a thromboembolic event, they can have long-lasting disability,” Dr. Jaffer said. Major bleeding events rarely result in permanent disability, but 9%-13% are fatal (Ann. Intern. Med. 2003;139:893–900). In contrast, an estimated 20% of arterial thromboembolic events are fatal, and more than 50% result in permanent disability (Arch. Intern. Med. 1994;154:1449–57).

Ultimately, the decision on how to manage warfarin patients perioperatively relies on individual risk factors. The patients' indication for anticoagulation, their risk profile for thromboembolism, the type of surgery, and the likely amount of time they will be off warfarin therapy are important considerations, Dr. Jaffer said. “Weigh the consequences of thromboembolism and bleeding and then determine the need for bridging therapy.

'Weigh the consequences of thromboembolism and bleeding and then determine the need for bridging therapy.' DR. JAFFER

MIAMI BEACH — The perioperative risk of thromboembolism is small but real for warfarin patients who discontinue anticoagulation to undergo noncardiac surgery or other procedures. Bridging therapy can reduce this risk, but it increases the likelihood of postoperative bleeding, so clinical judgment, guideline recommendations, and individual patient and surgical factors remain paramount, Dr. Amir K. Jaffer said.

“This whole area lacks randomized, controlled trials, and management is guided by observational data and consensus,” Dr. Jaffer said at a meeting on perioperative medicine sponsored by the University of Miami. “You have to balance risk of bleeding against the risk of clotting.”

Patients often require an individualized approach. For example, the population of patients with older-generation mechanical heart valves or mechanical valves in the mitral position are at higher risk for thromboembolic events, according to the most recent guidelines on perioperative management of antithrombotic therapy from the American College of Chest Physicians (Chest 2008;133[suppl 6]:299S-339S). The valve type and its position are two important factors to consider, Dr. Jaffer said. Risk is generally greater among patients with a mitral valve or older device (for example, ball-in-cage type), compared with patients with an atrial bileaflet valve (Circulation 1994;89:635–41).

“Warfarin is a tricky drug,” said Dr. Jaffer, chief of the division of hospital medicine at the University of Miami, and a coauthor of the ACCP guidelines. “It is a highly litigated area of perioperative medicine. Every week or so I have an attorney calling me to serve as an expert; the plaintiffs' attorneys are always going after these types of cases.” One reason warfarin is big business for lawyers is that an estimated 3 million patients are taking the drug in North America, and 400,000 of these are evaluated for bridging therapy each year, according to the American Heart Association 2002 Heart and Stroke Statistical Update.

Although the dangers are clinically significant, they affect only a minority of patients. “The risk of thromboembolism is low. It's not zero; it is about 1%,” Dr. Jaffer said. For example, 2 of 224 (0.9%) of warfarin patients experienced a cardiac thromboembolism in one study (Circulation 2004;110:1658–63).

The risk of major bleeding in this series was 6.9%. However, the average risk of major bleeding is 3%–3.5% across studies in the literature for patients with a valve or other indication who have warfarin discontinued and receive low-molecular-weight heparin (LMWH) as a bridge. For example, major bleeding occurred in 3.5% of 260 patients in one study (J. Thromb. Haemost. 2007;5:2211–8) and 3.3% of 721 patients in another (J. Thromb. Haemost. 2006;4:1246–52).

There can be increased bleeding immediately postoperatively with full-dose LMWH or unfractionated heparin, “but this can likely be minimized by delaying reinitiation of full-dose heparin … for up to 48 hours, depending on the type of surgery,” Dr. Jaffer said. In the interim, lower prophylactic doses may be warranted. “Those centers who dose everyone with full doses were at [six times] higher risk for major bleeding than those who did not give full doses,” according to unpublished data on 500 patients.

Guidelines support bridging patients with therapeutic doses of subcutaneous LMWH, rather than intravenous unfractionated heparin, as there is a paucity of data for intravenous unfractionated heparin, said Dr. Jaffer, who is also associate professor of medicine at the University of Miami. Dr. Jaffer is a consultant for Sanofi-Aventis, AstraZeneca, Bristol-Myers Squibb, and Boehringer Ingelheim. He receives research and grant support from AstraZeneca and is on the speakers bureau for Sanofi-Aventis and Roche Diagnostics.

Although both thromboembolic events and major bleeding can be fatal, mortality and morbidity rates differ for the two conditions. “With bleeding, patients can be resuscitated; with a thromboembolic event, they can have long-lasting disability,” Dr. Jaffer said. Major bleeding events rarely result in permanent disability, but 9%-13% are fatal (Ann. Intern. Med. 2003;139:893–900). In contrast, an estimated 20% of arterial thromboembolic events are fatal, and more than 50% result in permanent disability (Arch. Intern. Med. 1994;154:1449–57).

Ultimately, the decision on how to manage warfarin patients perioperatively relies on individual risk factors. The patients' indication for anticoagulation, their risk profile for thromboembolism, the type of surgery, and the likely amount of time they will be off warfarin therapy are important considerations, Dr. Jaffer said. “Weigh the consequences of thromboembolism and bleeding and then determine the need for bridging therapy.

'Weigh the consequences of thromboembolism and bleeding and then determine the need for bridging therapy.' DR. JAFFER

HOLLYWOOD, FLA. — Many people experience fear, anxiety, and depression during the transition from cancer patient to survivor, according to a panel of oncologists, survivors, patient advocates, and others at the annual conference of the National Comprehensive Cancer Network.

Patients should be screened at the very least for anxiety and depression after the acute treatment period, said Mary S. McCabe, R.N., who runs a program for adult cancer survivors at Memorial Sloan-Kettering Cancer Center in New York City. In her experience, many patients can handle their initial treatment psychologically, “but they then run out of gas, and face both anxiety and depression. … They tell us that this is often the scariest time after the diagnosis. Up until then, there has been a plan.”

Oncologists need to start addressing the gamut of patients' concerns before they transition back to their primary care provider, said Elizabeth Edwards, patient advocate, attorney, and wife of former North Carolina Senator and vice presidential candidate John Edwards. She noted that oncologists are the ideal providers to discuss end-of-life concerns with survivors.

“I have developed trust with this person, I have placed my life in their hands, and I want to hear information from them, even if they refer me,” said Ms. Edwards, who has breast cancer.

It helps when oncologists address end-of-life issues early in the course of treatment, said Dr. Douglas W. Blayney, medical director at the University of Michigan Comprehensive Cancer Center, Ann Arbor. He typically tells patients: “We will only talk about the end now, once, and you can bring it up any time you want.” Having that conversation proactively and “letting the patient know you're open, that you're not going to talk doom and gloom all the time,” helps people feel comfortable talking about their biggest worry. “Working that into your conversation at the second or third visit saves time down the road, and it's the polite thing to do.”

Quality-of-life issues are also important, said Dr. Blayney, who urged oncologists to be open to a discussion of sexual health issues. “Many of us at large institutions have a team who can explore these things … but we as doctors need to introduce that to patients,” said Dr. Blayney, who is incoming president of the American Society of Clinical Oncology.

“Patients assume we only want to know what happens to them physically, but [sexuality] is a huge area of recovery for patients,” agreed Ms. McCabe.

Oncologists need to be proactive about asking survivors about all aspects of their lives, said Dr. Kenneth Miller, medical director, Lance Armstrong Foundation Adult Cancer Survivorship Clinic at the Dana Farber Cancer Institute in Boston. “Often, we ask cancer survivors how they are doing and they say 'fine.' But there is a family member there nodding their heads no.”

An automated system that screens survivors for various issues would be ideal, said Catherine M. Alfano, Ph.D., program director, National Cancer Institute Office of Cancer Survivorship. The Institute of Medicine outlined such a systematic process in an October 2007 report called “Cancer Care for the Whole Patient: Meeting Psychosocial Health Needs.” The number of issues that some patients want to discuss can be “overwhelming,” she said. Addressing these issues in a systematic way is key.

Patients have a tough time transitioning to primary care. “People want to cling to their cancer treatment providers. But clearly the doctors and nurses have to move on to take care of other people,” said Sam Donaldson, former ABC News anchor and a survivor of melanoma from a diagnosis in 1995.

Oncologists have a significant role to play in easing that transition. New guidelines from NCCN address Cancer Survivorship Care, and are aimed at guiding this process.

The transition time is also a period of opportunity, when doctors can teach patients how to optimize their time as survivors, and emphasize the importance of healthy nutrition, exercise, bone health, and smoking cessation.

Acute care and long-term survivorship “are both teachable moments,” said Dr. Miller.

HOLLYWOOD, FLA. — Many people experience fear, anxiety, and depression during the transition from cancer patient to survivor, according to a panel of oncologists, survivors, patient advocates, and others at the annual conference of the National Comprehensive Cancer Network.

Patients should be screened at the very least for anxiety and depression after the acute treatment period, said Mary S. McCabe, R.N., who runs a program for adult cancer survivors at Memorial Sloan-Kettering Cancer Center in New York City. In her experience, many patients can handle their initial treatment psychologically, “but they then run out of gas, and face both anxiety and depression. … They tell us that this is often the scariest time after the diagnosis. Up until then, there has been a plan.”

Oncologists need to start addressing the gamut of patients' concerns before they transition back to their primary care provider, said Elizabeth Edwards, patient advocate, attorney, and wife of former North Carolina Senator and vice presidential candidate John Edwards. She noted that oncologists are the ideal providers to discuss end-of-life concerns with survivors.

“I have developed trust with this person, I have placed my life in their hands, and I want to hear information from them, even if they refer me,” said Ms. Edwards, who has breast cancer.

It helps when oncologists address end-of-life issues early in the course of treatment, said Dr. Douglas W. Blayney, medical director at the University of Michigan Comprehensive Cancer Center, Ann Arbor. He typically tells patients: “We will only talk about the end now, once, and you can bring it up any time you want.” Having that conversation proactively and “letting the patient know you're open, that you're not going to talk doom and gloom all the time,” helps people feel comfortable talking about their biggest worry. “Working that into your conversation at the second or third visit saves time down the road, and it's the polite thing to do.”

Quality-of-life issues are also important, said Dr. Blayney, who urged oncologists to be open to a discussion of sexual health issues. “Many of us at large institutions have a team who can explore these things … but we as doctors need to introduce that to patients,” said Dr. Blayney, who is incoming president of the American Society of Clinical Oncology.

“Patients assume we only want to know what happens to them physically, but [sexuality] is a huge area of recovery for patients,” agreed Ms. McCabe.

Oncologists need to be proactive about asking survivors about all aspects of their lives, said Dr. Kenneth Miller, medical director, Lance Armstrong Foundation Adult Cancer Survivorship Clinic at the Dana Farber Cancer Institute in Boston. “Often, we ask cancer survivors how they are doing and they say 'fine.' But there is a family member there nodding their heads no.”

An automated system that screens survivors for various issues would be ideal, said Catherine M. Alfano, Ph.D., program director, National Cancer Institute Office of Cancer Survivorship. The Institute of Medicine outlined such a systematic process in an October 2007 report called “Cancer Care for the Whole Patient: Meeting Psychosocial Health Needs.” The number of issues that some patients want to discuss can be “overwhelming,” she said. Addressing these issues in a systematic way is key.

Patients have a tough time transitioning to primary care. “People want to cling to their cancer treatment providers. But clearly the doctors and nurses have to move on to take care of other people,” said Sam Donaldson, former ABC News anchor and a survivor of melanoma from a diagnosis in 1995.

Oncologists have a significant role to play in easing that transition. New guidelines from NCCN address Cancer Survivorship Care, and are aimed at guiding this process.

The transition time is also a period of opportunity, when doctors can teach patients how to optimize their time as survivors, and emphasize the importance of healthy nutrition, exercise, bone health, and smoking cessation.

Acute care and long-term survivorship “are both teachable moments,” said Dr. Miller.

HOLLYWOOD, FLA. — Many people experience fear, anxiety, and depression during the transition from cancer patient to survivor, according to a panel of oncologists, survivors, patient advocates, and others at the annual conference of the National Comprehensive Cancer Network.

Patients should be screened at the very least for anxiety and depression after the acute treatment period, said Mary S. McCabe, R.N., who runs a program for adult cancer survivors at Memorial Sloan-Kettering Cancer Center in New York City. In her experience, many patients can handle their initial treatment psychologically, “but they then run out of gas, and face both anxiety and depression. … They tell us that this is often the scariest time after the diagnosis. Up until then, there has been a plan.”

Oncologists need to start addressing the gamut of patients' concerns before they transition back to their primary care provider, said Elizabeth Edwards, patient advocate, attorney, and wife of former North Carolina Senator and vice presidential candidate John Edwards. She noted that oncologists are the ideal providers to discuss end-of-life concerns with survivors.

“I have developed trust with this person, I have placed my life in their hands, and I want to hear information from them, even if they refer me,” said Ms. Edwards, who has breast cancer.

It helps when oncologists address end-of-life issues early in the course of treatment, said Dr. Douglas W. Blayney, medical director at the University of Michigan Comprehensive Cancer Center, Ann Arbor. He typically tells patients: “We will only talk about the end now, once, and you can bring it up any time you want.” Having that conversation proactively and “letting the patient know you're open, that you're not going to talk doom and gloom all the time,” helps people feel comfortable talking about their biggest worry. “Working that into your conversation at the second or third visit saves time down the road, and it's the polite thing to do.”

Quality-of-life issues are also important, said Dr. Blayney, who urged oncologists to be open to a discussion of sexual health issues. “Many of us at large institutions have a team who can explore these things … but we as doctors need to introduce that to patients,” said Dr. Blayney, who is incoming president of the American Society of Clinical Oncology.

“Patients assume we only want to know what happens to them physically, but [sexuality] is a huge area of recovery for patients,” agreed Ms. McCabe.

Oncologists need to be proactive about asking survivors about all aspects of their lives, said Dr. Kenneth Miller, medical director, Lance Armstrong Foundation Adult Cancer Survivorship Clinic at the Dana Farber Cancer Institute in Boston. “Often, we ask cancer survivors how they are doing and they say 'fine.' But there is a family member there nodding their heads no.”

An automated system that screens survivors for various issues would be ideal, said Catherine M. Alfano, Ph.D., program director, National Cancer Institute Office of Cancer Survivorship. The Institute of Medicine outlined such a systematic process in an October 2007 report called “Cancer Care for the Whole Patient: Meeting Psychosocial Health Needs.” The number of issues that some patients want to discuss can be “overwhelming,” she said. Addressing these issues in a systematic way is key.

Patients have a tough time transitioning to primary care. “People want to cling to their cancer treatment providers. But clearly the doctors and nurses have to move on to take care of other people,” said Sam Donaldson, former ABC News anchor and a survivor of melanoma from a diagnosis in 1995.

Oncologists have a significant role to play in easing that transition. New guidelines from NCCN address Cancer Survivorship Care, and are aimed at guiding this process.

The transition time is also a period of opportunity, when doctors can teach patients how to optimize their time as survivors, and emphasize the importance of healthy nutrition, exercise, bone health, and smoking cessation.

Acute care and long-term survivorship “are both teachable moments,” said Dr. Miller.

The first head lice treatment with benzyl alcohol as the active ingredient has received Food and Drug Administration approval for use in adults and children aged 6 months and older.

The newly approved agent (not yet named) is the first prescription product to kill head lice by suffocation. While the agent lacks pesticides contained in other FDA-approved products, the approval carries a strongly worded warning not to use the agent in premature infants, citing the risk of serious respiratory and heart- or brain-related adverse events such as seizure, coma, or death.

The gestational age of the participants was not known when the clinical study data were submitted to the FDA, Jesse Fishman, Pharm.D., medical information officer for Sciele Pharma Inc. (manufacturer of benzyl alcohol lotion, 5%), said in an interview.

The company recommends only using the product on babies of normal gestation age plus 6 months. Therefore, based on an average full gestation of 40 weeks, a baby born prematurely at 35 weeks could be treated when they reach 6 months plus 5 weeks of age, for example.

The April 9 approval was based on data from two safety and efficacy trials with a total of 628 children with active infestations of Pediculosis capitis; the children's average age was 7 years in one trial and 10 years in the other. The study participants underwent two 10-minute applications (1 week apart) of benzyl alcohol lotion, 5% or topical placebo. Scalp examination conducted 14 days after completion of treatment showed that active infestation was resolved in 75% of the participants on active treatment and 26% of those on placebo.

"The warning about not using [the drug] in premature infants is strong," Dr. Seth J. Orlow said in an interview. "Parents and prescribers will want to know how premature an infant must be to fall under the warning, and when an ex-preemie is no longer considered 'a premature infant,'" he said.

The potential for treatment resistance, however, might be lower with benzyl alcohol lotion, 5%, compared with traditional pediculocides, said Dr. Orlow, chairman of dermatology and professor of pediatric dermatology at New York University, New York. He had no relevant disclosures.

The official indication to treat children as young as 6 months with benzyl alcohol lotion, 5% is a plus, Dr. Orlow said. "In addition to other potential benefits, it will no doubt be attractive to some parents who wish to use a 'non-pesticide' type agent. On the other hand, benzyl alcohol is, of course, still a chemical."

The product should be applied only to the scalp or the hair attached to the scalp. Irritation of the skin, scalp, and eyes were commonly reported adverse events in the studies, as was application-site numbness.

Parents who have grown cautious of putting pesticides on their children's heads to treat lice infestations have long ago embraced home remedies. The Internet has thousands of Web sites devoted to alternative treatments for smothering head lice. Many involve coating the child's head with mayonnaise, Vaseline, margarine, olive oil, or some other relatively thick and occlusive, yet washable agent. It is still necessary to comb out the eggs.

The first head lice treatment with benzyl alcohol as the active ingredient has received Food and Drug Administration approval for use in adults and children aged 6 months and older.

The newly approved agent (not yet named) is the first prescription product to kill head lice by suffocation. While the agent lacks pesticides contained in other FDA-approved products, the approval carries a strongly worded warning not to use the agent in premature infants, citing the risk of serious respiratory and heart- or brain-related adverse events such as seizure, coma, or death.

The gestational age of the participants was not known when the clinical study data were submitted to the FDA, Jesse Fishman, Pharm.D., medical information officer for Sciele Pharma Inc. (manufacturer of benzyl alcohol lotion, 5%), said in an interview.

The company recommends only using the product on babies of normal gestation age plus 6 months. Therefore, based on an average full gestation of 40 weeks, a baby born prematurely at 35 weeks could be treated when they reach 6 months plus 5 weeks of age, for example.

The April 9 approval was based on data from two safety and efficacy trials with a total of 628 children with active infestations of Pediculosis capitis; the children's average age was 7 years in one trial and 10 years in the other. The study participants underwent two 10-minute applications (1 week apart) of benzyl alcohol lotion, 5% or topical placebo. Scalp examination conducted 14 days after completion of treatment showed that active infestation was resolved in 75% of the participants on active treatment and 26% of those on placebo.

"The warning about not using [the drug] in premature infants is strong," Dr. Seth J. Orlow said in an interview. "Parents and prescribers will want to know how premature an infant must be to fall under the warning, and when an ex-preemie is no longer considered 'a premature infant,'" he said.

The potential for treatment resistance, however, might be lower with benzyl alcohol lotion, 5%, compared with traditional pediculocides, said Dr. Orlow, chairman of dermatology and professor of pediatric dermatology at New York University, New York. He had no relevant disclosures.

The official indication to treat children as young as 6 months with benzyl alcohol lotion, 5% is a plus, Dr. Orlow said. "In addition to other potential benefits, it will no doubt be attractive to some parents who wish to use a 'non-pesticide' type agent. On the other hand, benzyl alcohol is, of course, still a chemical."

The product should be applied only to the scalp or the hair attached to the scalp. Irritation of the skin, scalp, and eyes were commonly reported adverse events in the studies, as was application-site numbness.

Parents who have grown cautious of putting pesticides on their children's heads to treat lice infestations have long ago embraced home remedies. The Internet has thousands of Web sites devoted to alternative treatments for smothering head lice. Many involve coating the child's head with mayonnaise, Vaseline, margarine, olive oil, or some other relatively thick and occlusive, yet washable agent. It is still necessary to comb out the eggs.

The first head lice treatment with benzyl alcohol as the active ingredient has received Food and Drug Administration approval for use in adults and children aged 6 months and older.

The newly approved agent (not yet named) is the first prescription product to kill head lice by suffocation. While the agent lacks pesticides contained in other FDA-approved products, the approval carries a strongly worded warning not to use the agent in premature infants, citing the risk of serious respiratory and heart- or brain-related adverse events such as seizure, coma, or death.

The gestational age of the participants was not known when the clinical study data were submitted to the FDA, Jesse Fishman, Pharm.D., medical information officer for Sciele Pharma Inc. (manufacturer of benzyl alcohol lotion, 5%), said in an interview.

The company recommends only using the product on babies of normal gestation age plus 6 months. Therefore, based on an average full gestation of 40 weeks, a baby born prematurely at 35 weeks could be treated when they reach 6 months plus 5 weeks of age, for example.

The April 9 approval was based on data from two safety and efficacy trials with a total of 628 children with active infestations of Pediculosis capitis; the children's average age was 7 years in one trial and 10 years in the other. The study participants underwent two 10-minute applications (1 week apart) of benzyl alcohol lotion, 5% or topical placebo. Scalp examination conducted 14 days after completion of treatment showed that active infestation was resolved in 75% of the participants on active treatment and 26% of those on placebo.

"The warning about not using [the drug] in premature infants is strong," Dr. Seth J. Orlow said in an interview. "Parents and prescribers will want to know how premature an infant must be to fall under the warning, and when an ex-preemie is no longer considered 'a premature infant,'" he said.

The potential for treatment resistance, however, might be lower with benzyl alcohol lotion, 5%, compared with traditional pediculocides, said Dr. Orlow, chairman of dermatology and professor of pediatric dermatology at New York University, New York. He had no relevant disclosures.

The official indication to treat children as young as 6 months with benzyl alcohol lotion, 5% is a plus, Dr. Orlow said. "In addition to other potential benefits, it will no doubt be attractive to some parents who wish to use a 'non-pesticide' type agent. On the other hand, benzyl alcohol is, of course, still a chemical."

The product should be applied only to the scalp or the hair attached to the scalp. Irritation of the skin, scalp, and eyes were commonly reported adverse events in the studies, as was application-site numbness.

Parents who have grown cautious of putting pesticides on their children's heads to treat lice infestations have long ago embraced home remedies. The Internet has thousands of Web sites devoted to alternative treatments for smothering head lice. Many involve coating the child's head with mayonnaise, Vaseline, margarine, olive oil, or some other relatively thick and occlusive, yet washable agent. It is still necessary to comb out the eggs.

MIAMI BEACH — Dosing, speed of onset, and extent of spread are among differences to anticipate with a second botulinum toxin expected to reach the U.S. market soon, according to physicians who evaluated its safety and efficacy in preclinical trials.

The Food and Drug Administration is reviewing data for Reloxin (botulinum toxin, Ipsen). "This is really exciting—the first new toxin in the market since Botox," Dr. Mark Nestor said at the South Beach Symposium. "We are hoping it will be approved in the next few months."

"The starting out point for us, especially if it comes in a 300-unit vial, is to do the same thing you do now with Botox," said Dr. Nestor, a dermatologist in private practice in Aventura, Fla., and clinical associate professor of dermatology and cutaneous surgery at the University of Miami. "Start out conservatively, and you will finesse this over time." Dr. Nestor is a speaker and consultant for and has received research grants from Medicis. He is also an advisory board member and speaker for Allergan.

There are four important studies that demonstrate its safety and efficacy, said Dr. Joel L. Cohen, principal investigator of one and assistant clinical professor of dermatology at the University of Colorado, Denver. Two studies assessed patient response to a single 50-U treatment and two others to repeat injections over time. Dr. Cohen is a consultant for Medicis and Allergan.

Median time to onset of effect was 2 days in a study of 300 patients who received Reloxin or placebo to treat the glabellar area. At 3 days, about half of patients felt an effect, and by 7 days, cumulative response was 90%, according to patient diaries. Investigators reported median response duration of 117 days. Nine patients had eye problems, including ptosis. A total of five patients experienced serious adverse events, but none were considered related to treatment, said Dr. Cohen, who is also in private practice in Englewood, Colo. Incidence of headache and injection site bleeding were similar to placebo.

A 90% response was also reported in another single treatment trial with 158 patients receiving either the toxin or placebo. There were some slight differences in efficacy compared to the other single treatment trial. Patient diaries indicated median time to effect of 3 days. Researchers found an 85-day median duration of effect. Reloxin also was well tolerated in this study, Dr. Cohen said.

Up to five repeat treatment sessions were allowed in an open-label, multicenter study. Researchers found a greater proportion of responders at each follow-up evaluation. They reported an overall 93% response and 73% of participants had at least a two-grade improvement. Patients older than 65 years were less likely to respond to Reloxin, as were those with severe ratings at baseline. In addition, the toxin appeared to work better in women, compared with men. Repeat injections were well tolerated, Dr. Cohen said.

The majority of treatment-emergent adverse events were mild. Injection site events, ocular events, and headaches were the most common. There were 72 severe adverse events during the study, including 1 death by gunshot, all unrelated to treatment.

Dr. Cohen and his colleagues also conducted a repeat injection study that found no difference between toxin and placebo patients in terms of vital signs or serum assays (no patient developed antibodies). This study included 768 patients allowed up to eight repeat treatments over 2 years. The multiple cycles were well-tolerated and effective, he said. Injection site pain and nasopharyngitis were the most common adverse events. A total of 37 participants had at least one treatment-emergent adverse event, 2% of which were severe.

The injection technique and pattern will be similar because the mechanism of action is the same for Reloxin and Botox (Allergan), Dr. Michael A.C. Kane said. He has served as an adviser and consultant to Medicis and Allergan.

"The dose-response curves are not parallel, so there is no simple conversion between Reloxin and Botox. "It cannot be a simple number multiplier, period," according to Dr. Kane, attending plastic surgeon at the Manhattan Eye, Ear and Throat Hospital in New York City.

Patients who have had both Botox and Reloxin say Botox is a gradual change over days, Dr. Kane said. "The biggest difference [with Reloxin is] patients say it's almost like a sledgehammer hits them—a much more abrupt feeling—they really feel it kick in."

"Migration is probably the biggest issue we will hear," Dr. Kane said. Tissue migration may be related to complex size, and Botox is a larger 900 kd, compared with 500-600 kd for Reloxin. "We know bigger things move more slowly in muscle. But they would have you believe the smaller molecules of Reloxin will spread all over the place."

To put the differences in perspective, Dr. Kane said, "The hyaluronic acid fillers will vary by a greater degree than the differences between the different toxins."

MIAMI BEACH — Dosing, speed of onset, and extent of spread are among differences to anticipate with a second botulinum toxin expected to reach the U.S. market soon, according to physicians who evaluated its safety and efficacy in preclinical trials.

The Food and Drug Administration is reviewing data for Reloxin (botulinum toxin, Ipsen). "This is really exciting—the first new toxin in the market since Botox," Dr. Mark Nestor said at the South Beach Symposium. "We are hoping it will be approved in the next few months."

"The starting out point for us, especially if it comes in a 300-unit vial, is to do the same thing you do now with Botox," said Dr. Nestor, a dermatologist in private practice in Aventura, Fla., and clinical associate professor of dermatology and cutaneous surgery at the University of Miami. "Start out conservatively, and you will finesse this over time." Dr. Nestor is a speaker and consultant for and has received research grants from Medicis. He is also an advisory board member and speaker for Allergan.

There are four important studies that demonstrate its safety and efficacy, said Dr. Joel L. Cohen, principal investigator of one and assistant clinical professor of dermatology at the University of Colorado, Denver. Two studies assessed patient response to a single 50-U treatment and two others to repeat injections over time. Dr. Cohen is a consultant for Medicis and Allergan.

Median time to onset of effect was 2 days in a study of 300 patients who received Reloxin or placebo to treat the glabellar area. At 3 days, about half of patients felt an effect, and by 7 days, cumulative response was 90%, according to patient diaries. Investigators reported median response duration of 117 days. Nine patients had eye problems, including ptosis. A total of five patients experienced serious adverse events, but none were considered related to treatment, said Dr. Cohen, who is also in private practice in Englewood, Colo. Incidence of headache and injection site bleeding were similar to placebo.

A 90% response was also reported in another single treatment trial with 158 patients receiving either the toxin or placebo. There were some slight differences in efficacy compared to the other single treatment trial. Patient diaries indicated median time to effect of 3 days. Researchers found an 85-day median duration of effect. Reloxin also was well tolerated in this study, Dr. Cohen said.

Up to five repeat treatment sessions were allowed in an open-label, multicenter study. Researchers found a greater proportion of responders at each follow-up evaluation. They reported an overall 93% response and 73% of participants had at least a two-grade improvement. Patients older than 65 years were less likely to respond to Reloxin, as were those with severe ratings at baseline. In addition, the toxin appeared to work better in women, compared with men. Repeat injections were well tolerated, Dr. Cohen said.

The majority of treatment-emergent adverse events were mild. Injection site events, ocular events, and headaches were the most common. There were 72 severe adverse events during the study, including 1 death by gunshot, all unrelated to treatment.

Dr. Cohen and his colleagues also conducted a repeat injection study that found no difference between toxin and placebo patients in terms of vital signs or serum assays (no patient developed antibodies). This study included 768 patients allowed up to eight repeat treatments over 2 years. The multiple cycles were well-tolerated and effective, he said. Injection site pain and nasopharyngitis were the most common adverse events. A total of 37 participants had at least one treatment-emergent adverse event, 2% of which were severe.

The injection technique and pattern will be similar because the mechanism of action is the same for Reloxin and Botox (Allergan), Dr. Michael A.C. Kane said. He has served as an adviser and consultant to Medicis and Allergan.

"The dose-response curves are not parallel, so there is no simple conversion between Reloxin and Botox. "It cannot be a simple number multiplier, period," according to Dr. Kane, attending plastic surgeon at the Manhattan Eye, Ear and Throat Hospital in New York City.

Patients who have had both Botox and Reloxin say Botox is a gradual change over days, Dr. Kane said. "The biggest difference [with Reloxin is] patients say it's almost like a sledgehammer hits them—a much more abrupt feeling—they really feel it kick in."

"Migration is probably the biggest issue we will hear," Dr. Kane said. Tissue migration may be related to complex size, and Botox is a larger 900 kd, compared with 500-600 kd for Reloxin. "We know bigger things move more slowly in muscle. But they would have you believe the smaller molecules of Reloxin will spread all over the place."

To put the differences in perspective, Dr. Kane said, "The hyaluronic acid fillers will vary by a greater degree than the differences between the different toxins."

MIAMI BEACH — Dosing, speed of onset, and extent of spread are among differences to anticipate with a second botulinum toxin expected to reach the U.S. market soon, according to physicians who evaluated its safety and efficacy in preclinical trials.

The Food and Drug Administration is reviewing data for Reloxin (botulinum toxin, Ipsen). "This is really exciting—the first new toxin in the market since Botox," Dr. Mark Nestor said at the South Beach Symposium. "We are hoping it will be approved in the next few months."

"The starting out point for us, especially if it comes in a 300-unit vial, is to do the same thing you do now with Botox," said Dr. Nestor, a dermatologist in private practice in Aventura, Fla., and clinical associate professor of dermatology and cutaneous surgery at the University of Miami. "Start out conservatively, and you will finesse this over time." Dr. Nestor is a speaker and consultant for and has received research grants from Medicis. He is also an advisory board member and speaker for Allergan.

There are four important studies that demonstrate its safety and efficacy, said Dr. Joel L. Cohen, principal investigator of one and assistant clinical professor of dermatology at the University of Colorado, Denver. Two studies assessed patient response to a single 50-U treatment and two others to repeat injections over time. Dr. Cohen is a consultant for Medicis and Allergan.

Median time to onset of effect was 2 days in a study of 300 patients who received Reloxin or placebo to treat the glabellar area. At 3 days, about half of patients felt an effect, and by 7 days, cumulative response was 90%, according to patient diaries. Investigators reported median response duration of 117 days. Nine patients had eye problems, including ptosis. A total of five patients experienced serious adverse events, but none were considered related to treatment, said Dr. Cohen, who is also in private practice in Englewood, Colo. Incidence of headache and injection site bleeding were similar to placebo.

A 90% response was also reported in another single treatment trial with 158 patients receiving either the toxin or placebo. There were some slight differences in efficacy compared to the other single treatment trial. Patient diaries indicated median time to effect of 3 days. Researchers found an 85-day median duration of effect. Reloxin also was well tolerated in this study, Dr. Cohen said.

Up to five repeat treatment sessions were allowed in an open-label, multicenter study. Researchers found a greater proportion of responders at each follow-up evaluation. They reported an overall 93% response and 73% of participants had at least a two-grade improvement. Patients older than 65 years were less likely to respond to Reloxin, as were those with severe ratings at baseline. In addition, the toxin appeared to work better in women, compared with men. Repeat injections were well tolerated, Dr. Cohen said.

The majority of treatment-emergent adverse events were mild. Injection site events, ocular events, and headaches were the most common. There were 72 severe adverse events during the study, including 1 death by gunshot, all unrelated to treatment.

Dr. Cohen and his colleagues also conducted a repeat injection study that found no difference between toxin and placebo patients in terms of vital signs or serum assays (no patient developed antibodies). This study included 768 patients allowed up to eight repeat treatments over 2 years. The multiple cycles were well-tolerated and effective, he said. Injection site pain and nasopharyngitis were the most common adverse events. A total of 37 participants had at least one treatment-emergent adverse event, 2% of which were severe.

The injection technique and pattern will be similar because the mechanism of action is the same for Reloxin and Botox (Allergan), Dr. Michael A.C. Kane said. He has served as an adviser and consultant to Medicis and Allergan.

"The dose-response curves are not parallel, so there is no simple conversion between Reloxin and Botox. "It cannot be a simple number multiplier, period," according to Dr. Kane, attending plastic surgeon at the Manhattan Eye, Ear and Throat Hospital in New York City.

Patients who have had both Botox and Reloxin say Botox is a gradual change over days, Dr. Kane said. "The biggest difference [with Reloxin is] patients say it's almost like a sledgehammer hits them—a much more abrupt feeling—they really feel it kick in."

"Migration is probably the biggest issue we will hear," Dr. Kane said. Tissue migration may be related to complex size, and Botox is a larger 900 kd, compared with 500-600 kd for Reloxin. "We know bigger things move more slowly in muscle. But they would have you believe the smaller molecules of Reloxin will spread all over the place."

To put the differences in perspective, Dr. Kane said, "The hyaluronic acid fillers will vary by a greater degree than the differences between the different toxins."

The discovery of a genotype associated with a higher risk for cutaneous melanoma in young women could lead to development of an early screening test, according to findings from a pilot study.

Incidence of melanoma is higher among women than men younger than age 40, generally equivalent between men and women aged 40-50, and affects more men than women in people older than 50, according to data from the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) database.

Investigators proposed that modulation of estrogen levels through a MDM2 single nucleotide polymorphism (SNP) 309 might explain these epidemiologic differences. Dr. Elnaz F. Firoz, of New York University, and his associates assessed MDM2 SNP309 from DNA samples in a prospective study of 227 patients newly diagnosed with melanoma at New York University Medical Center (Clin. Cancer Res. 2009;15:2573-80).

They chose to evaluate this specific genetic polymorphism because, among other research findings, the presence of a specific G allele of MDM2 SNP309 was associated with earlier onset of colorectal cancer, non-small cell lung cancer, and squamous cell carcinoma of the head and neck, compared with patients lacking this allele (Int. J. Cancer 2006;119:718-21; J. Med. Genet. 2005;42:694-8).

Participants were enrolled between August 2002 and November 2006. The study patients were 98% white, a typical percentage for the melanoma population. In addition, the gender distribution in the study—59% men and 41% women—was representative of the melanoma population in the United States (SEER Cancer Statistics Review, 1975-2005).

Of the patients, 75% had stage I disease, 17% had stage II, and 8% had stage III. Median overall age at time of diagnosis was 58 years. However, women with the GG genotype MDM2 SNP309 were diagnosed a median 13 years younger, at 46 years, compared with women with either the TG or TT genotype (diagnosed at a median of 59 years). Median age at diagnosis for men was approximately equal regardless of genotype (60 years for GG, compared with 58 years for TG or TT).

Put another way, women with a GG genotype had a 3.9 times greater chance of being diagnosed before age 50, compared with women with TG or TT genotypes. The greatest likelihood of a diagnosis for women with the GG genotype was before age 40 (odds ratio, 4.6).

"The decrease in the odds ratio from 4.6 to 3.9 as the age cut point increased from age 40 to age 50 may reflect the fact that it is not uncommon for women to undergo menopause prior to the age of 50, but it is rare for this to occur prior to the age of 40," the authors wrote. "These findings, combined with the SEER epidemiologic observation that prior to the age of 40 melanoma is more common among women than men (but not after the age of 50), support the hypothesis that active estrogen signaling in combination with the GG genotype may contribute to melanoma onset in women."

The researchers also assessed histopathologic features of the melanoma tumors and found no associations between MDM2 or p53 genotypes and tumor thickness, histopathologic subtype, anatomic site, or tumor ulceration. In addition, they found no associations between these polymorphisms and recurrence or overall survival.

The lack of a control group of patients who were unaffected by melanoma and patient ancestry data were limitations of the study, as was not having information on patients' menopausal status at the time of diagnosis.

The discovery of a genotype associated with a higher risk for cutaneous melanoma in young women could lead to development of an early screening test, according to findings from a pilot study.

Incidence of melanoma is higher among women than men younger than age 40, generally equivalent between men and women aged 40-50, and affects more men than women in people older than 50, according to data from the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) database.

Investigators proposed that modulation of estrogen levels through a MDM2 single nucleotide polymorphism (SNP) 309 might explain these epidemiologic differences. Dr. Elnaz F. Firoz, of New York University, and his associates assessed MDM2 SNP309 from DNA samples in a prospective study of 227 patients newly diagnosed with melanoma at New York University Medical Center (Clin. Cancer Res. 2009;15:2573-80).

They chose to evaluate this specific genetic polymorphism because, among other research findings, the presence of a specific G allele of MDM2 SNP309 was associated with earlier onset of colorectal cancer, non-small cell lung cancer, and squamous cell carcinoma of the head and neck, compared with patients lacking this allele (Int. J. Cancer 2006;119:718-21; J. Med. Genet. 2005;42:694-8).

Participants were enrolled between August 2002 and November 2006. The study patients were 98% white, a typical percentage for the melanoma population. In addition, the gender distribution in the study—59% men and 41% women—was representative of the melanoma population in the United States (SEER Cancer Statistics Review, 1975-2005).

Of the patients, 75% had stage I disease, 17% had stage II, and 8% had stage III. Median overall age at time of diagnosis was 58 years. However, women with the GG genotype MDM2 SNP309 were diagnosed a median 13 years younger, at 46 years, compared with women with either the TG or TT genotype (diagnosed at a median of 59 years). Median age at diagnosis for men was approximately equal regardless of genotype (60 years for GG, compared with 58 years for TG or TT).

Put another way, women with a GG genotype had a 3.9 times greater chance of being diagnosed before age 50, compared with women with TG or TT genotypes. The greatest likelihood of a diagnosis for women with the GG genotype was before age 40 (odds ratio, 4.6).

"The decrease in the odds ratio from 4.6 to 3.9 as the age cut point increased from age 40 to age 50 may reflect the fact that it is not uncommon for women to undergo menopause prior to the age of 50, but it is rare for this to occur prior to the age of 40," the authors wrote. "These findings, combined with the SEER epidemiologic observation that prior to the age of 40 melanoma is more common among women than men (but not after the age of 50), support the hypothesis that active estrogen signaling in combination with the GG genotype may contribute to melanoma onset in women."

The researchers also assessed histopathologic features of the melanoma tumors and found no associations between MDM2 or p53 genotypes and tumor thickness, histopathologic subtype, anatomic site, or tumor ulceration. In addition, they found no associations between these polymorphisms and recurrence or overall survival.

The lack of a control group of patients who were unaffected by melanoma and patient ancestry data were limitations of the study, as was not having information on patients' menopausal status at the time of diagnosis.

The discovery of a genotype associated with a higher risk for cutaneous melanoma in young women could lead to development of an early screening test, according to findings from a pilot study.

Incidence of melanoma is higher among women than men younger than age 40, generally equivalent between men and women aged 40-50, and affects more men than women in people older than 50, according to data from the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) database.

Investigators proposed that modulation of estrogen levels through a MDM2 single nucleotide polymorphism (SNP) 309 might explain these epidemiologic differences. Dr. Elnaz F. Firoz, of New York University, and his associates assessed MDM2 SNP309 from DNA samples in a prospective study of 227 patients newly diagnosed with melanoma at New York University Medical Center (Clin. Cancer Res. 2009;15:2573-80).

They chose to evaluate this specific genetic polymorphism because, among other research findings, the presence of a specific G allele of MDM2 SNP309 was associated with earlier onset of colorectal cancer, non-small cell lung cancer, and squamous cell carcinoma of the head and neck, compared with patients lacking this allele (Int. J. Cancer 2006;119:718-21; J. Med. Genet. 2005;42:694-8).

Participants were enrolled between August 2002 and November 2006. The study patients were 98% white, a typical percentage for the melanoma population. In addition, the gender distribution in the study—59% men and 41% women—was representative of the melanoma population in the United States (SEER Cancer Statistics Review, 1975-2005).

Of the patients, 75% had stage I disease, 17% had stage II, and 8% had stage III. Median overall age at time of diagnosis was 58 years. However, women with the GG genotype MDM2 SNP309 were diagnosed a median 13 years younger, at 46 years, compared with women with either the TG or TT genotype (diagnosed at a median of 59 years). Median age at diagnosis for men was approximately equal regardless of genotype (60 years for GG, compared with 58 years for TG or TT).

Put another way, women with a GG genotype had a 3.9 times greater chance of being diagnosed before age 50, compared with women with TG or TT genotypes. The greatest likelihood of a diagnosis for women with the GG genotype was before age 40 (odds ratio, 4.6).

"The decrease in the odds ratio from 4.6 to 3.9 as the age cut point increased from age 40 to age 50 may reflect the fact that it is not uncommon for women to undergo menopause prior to the age of 50, but it is rare for this to occur prior to the age of 40," the authors wrote. "These findings, combined with the SEER epidemiologic observation that prior to the age of 40 melanoma is more common among women than men (but not after the age of 50), support the hypothesis that active estrogen signaling in combination with the GG genotype may contribute to melanoma onset in women."

The researchers also assessed histopathologic features of the melanoma tumors and found no associations between MDM2 or p53 genotypes and tumor thickness, histopathologic subtype, anatomic site, or tumor ulceration. In addition, they found no associations between these polymorphisms and recurrence or overall survival.

The lack of a control group of patients who were unaffected by melanoma and patient ancestry data were limitations of the study, as was not having information on patients' menopausal status at the time of diagnosis.

HOLLYWOOD, FLA. — For the first time, the National Comprehensive Cancer Network has added cancer survivorship care recommendations to its non-small cell lung cancer and colorectal cancer guidelines.

The recommendations are aimed at smoothing the transition of patients to primary care once acute treatment for their cancer is completed. Oncologists are advised to develop a long-term treatment plan with specific duties for themselves and a primary care physician.

The goal is to give the primary care provider a summary of surgical, radiation, and chemotherapy treatment. Information should be provided about the expected time to resolution of acute toxicities, potential late adverse effects, and possible long-term effects of treatment.

A significant number of people could benefit. According to the American Cancer Society, there are nearly 150,000 new cases of colorectal cancer and 215,000 new cases of lung cancer (small and non-small cell) diagnosed each year.

Regarding surveillance of colorectal cancer survivors, NCCN recommends that they have a history and physical examination every 3-6 months for 2 years, and then every 6 months for 3 years. Carcinoembryonic antigen (CEA) testing also is recommended with the same frequency.

Colonoscopy should be performed at 1 year, and then as clinically indicated. The guideline authors also recommend a CT scan of the abdomen and pelvis annually for 3 years.

Surveillance for non-small cell lung cancer survivors requires a history and physical examination with a contrast-enhanced chest CT scan every 4-6 months for 2 years. Thereafter, an annual history, physical exam, and a non-contrast-enhanced chest CT scan is recommended. Smoking status should be assessed at each visit, with counseling and referral as warranted. In addition, the NCCN recommends annual trivalent inactivated influenza vaccinations and pneumococcal vaccination, with repeat vaccinations as necessary.

Survivors of colorectal cancer or non-small cell lung cancer should be routinely screened for breast cancer, cervical cancer, and prostate cancer. Non-small cell lung cancer survivors should be screened regularly for colorectal cancer.

“The main reason for surveillance is to make certain there is no recurrence, to make certain they don't develop a second neoplasm,” said Dr. Paul F. Engstrom, senior vice president of extramural research programs at Fox Chase Cancer Center in Philadelphia.

General health monitoring such as routine blood pressure, cholesterol, and glucose testing is recommended. “I have patients 15-20 years out now who have coronary artery disease and need to be stented. So other conditions arise as they age,” Dr. David S. Ettinger said during the meeting at an update on non-small cell lung cancer guidelines.

“Just because you have cancer” does not mean one is exempt from all other diseases, said Dr. Ettinger, professor of oncology and medicine, otolaryngology-head and neck surgery, obstetrics and gynecology, and radiation oncology at The Johns Hopkins University School of Medicine in Baltimore.

Guidelines to manage the late sequelae of colorectal cancer and its treatment address chronic diarrhea and incontinence; oxaliplatin-induced neuropathy; and bone health and sexual dysfunction after pelvic radiation. “Chronic diarrhea can be disabling for some patients, and neuropathy is an issue with the use of our main agent, oxaliplatin,” Dr. Engstrom said.

The guidelines recommend physicians counsel survivors to maintain a healthy weight, limit alcohol consumption, and adopt a healthy diet and physically active lifestyle. “By and large medical oncologists are not up on what kind of diet and healthy lifestyle is most appropriate,” Dr. Engstrom said. “We need to learn more.”

The optimal diet is unknown for survivors, Dr. Engstrom said, but the guidelines recommend an emphasis on plant sources of food. Exercise has been associated with increased survival with colorectal cancer. “Tell [patients] exercise matters.

HOLLYWOOD, FLA. — For the first time, the National Comprehensive Cancer Network has added cancer survivorship care recommendations to its non-small cell lung cancer and colorectal cancer guidelines.

The recommendations are aimed at smoothing the transition of patients to primary care once acute treatment for their cancer is completed. Oncologists are advised to develop a long-term treatment plan with specific duties for themselves and a primary care physician.

The goal is to give the primary care provider a summary of surgical, radiation, and chemotherapy treatment. Information should be provided about the expected time to resolution of acute toxicities, potential late adverse effects, and possible long-term effects of treatment.

A significant number of people could benefit. According to the American Cancer Society, there are nearly 150,000 new cases of colorectal cancer and 215,000 new cases of lung cancer (small and non-small cell) diagnosed each year.

Regarding surveillance of colorectal cancer survivors, NCCN recommends that they have a history and physical examination every 3-6 months for 2 years, and then every 6 months for 3 years. Carcinoembryonic antigen (CEA) testing also is recommended with the same frequency.

Colonoscopy should be performed at 1 year, and then as clinically indicated. The guideline authors also recommend a CT scan of the abdomen and pelvis annually for 3 years.

Surveillance for non-small cell lung cancer survivors requires a history and physical examination with a contrast-enhanced chest CT scan every 4-6 months for 2 years. Thereafter, an annual history, physical exam, and a non-contrast-enhanced chest CT scan is recommended. Smoking status should be assessed at each visit, with counseling and referral as warranted. In addition, the NCCN recommends annual trivalent inactivated influenza vaccinations and pneumococcal vaccination, with repeat vaccinations as necessary.

Survivors of colorectal cancer or non-small cell lung cancer should be routinely screened for breast cancer, cervical cancer, and prostate cancer. Non-small cell lung cancer survivors should be screened regularly for colorectal cancer.

“The main reason for surveillance is to make certain there is no recurrence, to make certain they don't develop a second neoplasm,” said Dr. Paul F. Engstrom, senior vice president of extramural research programs at Fox Chase Cancer Center in Philadelphia.

General health monitoring such as routine blood pressure, cholesterol, and glucose testing is recommended. “I have patients 15-20 years out now who have coronary artery disease and need to be stented. So other conditions arise as they age,” Dr. David S. Ettinger said during the meeting at an update on non-small cell lung cancer guidelines.

“Just because you have cancer” does not mean one is exempt from all other diseases, said Dr. Ettinger, professor of oncology and medicine, otolaryngology-head and neck surgery, obstetrics and gynecology, and radiation oncology at The Johns Hopkins University School of Medicine in Baltimore.

Guidelines to manage the late sequelae of colorectal cancer and its treatment address chronic diarrhea and incontinence; oxaliplatin-induced neuropathy; and bone health and sexual dysfunction after pelvic radiation. “Chronic diarrhea can be disabling for some patients, and neuropathy is an issue with the use of our main agent, oxaliplatin,” Dr. Engstrom said.

The guidelines recommend physicians counsel survivors to maintain a healthy weight, limit alcohol consumption, and adopt a healthy diet and physically active lifestyle. “By and large medical oncologists are not up on what kind of diet and healthy lifestyle is most appropriate,” Dr. Engstrom said. “We need to learn more.”

The optimal diet is unknown for survivors, Dr. Engstrom said, but the guidelines recommend an emphasis on plant sources of food. Exercise has been associated with increased survival with colorectal cancer. “Tell [patients] exercise matters.

HOLLYWOOD, FLA. — For the first time, the National Comprehensive Cancer Network has added cancer survivorship care recommendations to its non-small cell lung cancer and colorectal cancer guidelines.

The recommendations are aimed at smoothing the transition of patients to primary care once acute treatment for their cancer is completed. Oncologists are advised to develop a long-term treatment plan with specific duties for themselves and a primary care physician.

The goal is to give the primary care provider a summary of surgical, radiation, and chemotherapy treatment. Information should be provided about the expected time to resolution of acute toxicities, potential late adverse effects, and possible long-term effects of treatment.

A significant number of people could benefit. According to the American Cancer Society, there are nearly 150,000 new cases of colorectal cancer and 215,000 new cases of lung cancer (small and non-small cell) diagnosed each year.

Regarding surveillance of colorectal cancer survivors, NCCN recommends that they have a history and physical examination every 3-6 months for 2 years, and then every 6 months for 3 years. Carcinoembryonic antigen (CEA) testing also is recommended with the same frequency.

Colonoscopy should be performed at 1 year, and then as clinically indicated. The guideline authors also recommend a CT scan of the abdomen and pelvis annually for 3 years.

Surveillance for non-small cell lung cancer survivors requires a history and physical examination with a contrast-enhanced chest CT scan every 4-6 months for 2 years. Thereafter, an annual history, physical exam, and a non-contrast-enhanced chest CT scan is recommended. Smoking status should be assessed at each visit, with counseling and referral as warranted. In addition, the NCCN recommends annual trivalent inactivated influenza vaccinations and pneumococcal vaccination, with repeat vaccinations as necessary.

Survivors of colorectal cancer or non-small cell lung cancer should be routinely screened for breast cancer, cervical cancer, and prostate cancer. Non-small cell lung cancer survivors should be screened regularly for colorectal cancer.

“The main reason for surveillance is to make certain there is no recurrence, to make certain they don't develop a second neoplasm,” said Dr. Paul F. Engstrom, senior vice president of extramural research programs at Fox Chase Cancer Center in Philadelphia.

General health monitoring such as routine blood pressure, cholesterol, and glucose testing is recommended. “I have patients 15-20 years out now who have coronary artery disease and need to be stented. So other conditions arise as they age,” Dr. David S. Ettinger said during the meeting at an update on non-small cell lung cancer guidelines.

“Just because you have cancer” does not mean one is exempt from all other diseases, said Dr. Ettinger, professor of oncology and medicine, otolaryngology-head and neck surgery, obstetrics and gynecology, and radiation oncology at The Johns Hopkins University School of Medicine in Baltimore.

Guidelines to manage the late sequelae of colorectal cancer and its treatment address chronic diarrhea and incontinence; oxaliplatin-induced neuropathy; and bone health and sexual dysfunction after pelvic radiation. “Chronic diarrhea can be disabling for some patients, and neuropathy is an issue with the use of our main agent, oxaliplatin,” Dr. Engstrom said.

The guidelines recommend physicians counsel survivors to maintain a healthy weight, limit alcohol consumption, and adopt a healthy diet and physically active lifestyle. “By and large medical oncologists are not up on what kind of diet and healthy lifestyle is most appropriate,” Dr. Engstrom said. “We need to learn more.”

The optimal diet is unknown for survivors, Dr. Engstrom said, but the guidelines recommend an emphasis on plant sources of food. Exercise has been associated with increased survival with colorectal cancer. “Tell [patients] exercise matters.

ORLANDO — CT colonography continues to show promise as an adjunct to colonoscopy for colorectal cancer screening, according to study findings.

Dr. Ruben D. Acosta and his associates assessed 170 average-risk patients at the National Naval Medical Center in Bethesda, Md. All patients had computed tomographic colonography (CTC) followed by a colonoscopy. Polyp histology was used to compare results from 92 participants with a positive CTC and another 60 randomly selected patients with a negative CTC. Mean age was 56 years, 32% were women, and 82% were white.

In previous studies, the researchers had demonstrated that CTC could detect polyps 6 mm or larger as accurately as colonoscopy on a per-patient basis (Gastroenterology 2006;130:A46).

In the current study, the histology showed that 6 of the 60 patients with a negative CTC had adenoma and 2 had advanced adenoma. In addition, 58% of patients with a normal CTC had at least one polyp detected on colonoscopy, Dr. Acosta said at the annual meeting of the American College of Gastroenterology.

“This underscores the complementary relationship between CTC and colonoscopy programs,” said Dr. Acosta, a gastroenterologist at the center.

Of the 348 polyps detected by colonoscopy, 59% were smaller than 6 mm, 26% were 7–9 mm, and 15% were 10 mm or larger. Histology suggested that 167 of these polyps were adenomas (48%). A total of 76, or 46%, of these polyps were noted on the initial CTC report.

However, CTC missed 222 polyps detected by colonoscopy, including 87 hyperplastic polyps and 84 adenomas. In addition, CTC missed seven advanced adenomas (an overall 3% miss rate).

Two of the seven advanced adenomas missed by CTC were smaller than 10 mm (a 0.9% miss rate).

The miss rate for CTC was inversely associated with polyp size, Dr. Acosta said. As expected, 79% of the 222 polyps missed by CTC, but detected by follow-up colonoscopy, were smaller than 6 mm.

Among the 16% of missed polyps in the 7-mm to 9-mm range, 15 polyps were hyperplastic and 17 were adenomas. The remaining polyps that were missed by CTC were 10 mm or larger and included five hyperplastic polyps and five adenomas.

The CTC miss rate for polyps greater than 10 mm was 4.5%. Dr. Acosta said this miss rate is comparable to the rate of large polyps missed with tandem colonoscopy (Am. J. Gastroenterol. 2006;101:343–50). In this systematic review of six studies with 465 patients, researchers found a 2.1% miss rate for polyps 10 mm or larger.

Dr. Acosta reported having no disclosures related to his presentation.

ORLANDO — CT colonography continues to show promise as an adjunct to colonoscopy for colorectal cancer screening, according to study findings.

Dr. Ruben D. Acosta and his associates assessed 170 average-risk patients at the National Naval Medical Center in Bethesda, Md. All patients had computed tomographic colonography (CTC) followed by a colonoscopy. Polyp histology was used to compare results from 92 participants with a positive CTC and another 60 randomly selected patients with a negative CTC. Mean age was 56 years, 32% were women, and 82% were white.

In previous studies, the researchers had demonstrated that CTC could detect polyps 6 mm or larger as accurately as colonoscopy on a per-patient basis (Gastroenterology 2006;130:A46).

In the current study, the histology showed that 6 of the 60 patients with a negative CTC had adenoma and 2 had advanced adenoma. In addition, 58% of patients with a normal CTC had at least one polyp detected on colonoscopy, Dr. Acosta said at the annual meeting of the American College of Gastroenterology.

“This underscores the complementary relationship between CTC and colonoscopy programs,” said Dr. Acosta, a gastroenterologist at the center.

Of the 348 polyps detected by colonoscopy, 59% were smaller than 6 mm, 26% were 7–9 mm, and 15% were 10 mm or larger. Histology suggested that 167 of these polyps were adenomas (48%). A total of 76, or 46%, of these polyps were noted on the initial CTC report.

However, CTC missed 222 polyps detected by colonoscopy, including 87 hyperplastic polyps and 84 adenomas. In addition, CTC missed seven advanced adenomas (an overall 3% miss rate).

Two of the seven advanced adenomas missed by CTC were smaller than 10 mm (a 0.9% miss rate).

The miss rate for CTC was inversely associated with polyp size, Dr. Acosta said. As expected, 79% of the 222 polyps missed by CTC, but detected by follow-up colonoscopy, were smaller than 6 mm.

Among the 16% of missed polyps in the 7-mm to 9-mm range, 15 polyps were hyperplastic and 17 were adenomas. The remaining polyps that were missed by CTC were 10 mm or larger and included five hyperplastic polyps and five adenomas.

The CTC miss rate for polyps greater than 10 mm was 4.5%. Dr. Acosta said this miss rate is comparable to the rate of large polyps missed with tandem colonoscopy (Am. J. Gastroenterol. 2006;101:343–50). In this systematic review of six studies with 465 patients, researchers found a 2.1% miss rate for polyps 10 mm or larger.

Dr. Acosta reported having no disclosures related to his presentation.

ORLANDO — CT colonography continues to show promise as an adjunct to colonoscopy for colorectal cancer screening, according to study findings.

Dr. Ruben D. Acosta and his associates assessed 170 average-risk patients at the National Naval Medical Center in Bethesda, Md. All patients had computed tomographic colonography (CTC) followed by a colonoscopy. Polyp histology was used to compare results from 92 participants with a positive CTC and another 60 randomly selected patients with a negative CTC. Mean age was 56 years, 32% were women, and 82% were white.

In previous studies, the researchers had demonstrated that CTC could detect polyps 6 mm or larger as accurately as colonoscopy on a per-patient basis (Gastroenterology 2006;130:A46).

In the current study, the histology showed that 6 of the 60 patients with a negative CTC had adenoma and 2 had advanced adenoma. In addition, 58% of patients with a normal CTC had at least one polyp detected on colonoscopy, Dr. Acosta said at the annual meeting of the American College of Gastroenterology.

“This underscores the complementary relationship between CTC and colonoscopy programs,” said Dr. Acosta, a gastroenterologist at the center.

Of the 348 polyps detected by colonoscopy, 59% were smaller than 6 mm, 26% were 7–9 mm, and 15% were 10 mm or larger. Histology suggested that 167 of these polyps were adenomas (48%). A total of 76, or 46%, of these polyps were noted on the initial CTC report.

However, CTC missed 222 polyps detected by colonoscopy, including 87 hyperplastic polyps and 84 adenomas. In addition, CTC missed seven advanced adenomas (an overall 3% miss rate).

Two of the seven advanced adenomas missed by CTC were smaller than 10 mm (a 0.9% miss rate).

The miss rate for CTC was inversely associated with polyp size, Dr. Acosta said. As expected, 79% of the 222 polyps missed by CTC, but detected by follow-up colonoscopy, were smaller than 6 mm.

Among the 16% of missed polyps in the 7-mm to 9-mm range, 15 polyps were hyperplastic and 17 were adenomas. The remaining polyps that were missed by CTC were 10 mm or larger and included five hyperplastic polyps and five adenomas.

The CTC miss rate for polyps greater than 10 mm was 4.5%. Dr. Acosta said this miss rate is comparable to the rate of large polyps missed with tandem colonoscopy (Am. J. Gastroenterol. 2006;101:343–50). In this systematic review of six studies with 465 patients, researchers found a 2.1% miss rate for polyps 10 mm or larger.

Dr. Acosta reported having no disclosures related to his presentation.

PALM BEACH, FLA. — Neoadjuvant aromatase inhibitor therapy allows some breast cancer patients to be downstaged to breast-conserving surgery rather than being considered inoperable or as candidates for mastectomy, according to results of a multicenter phase II trial.

The treatment shrank tumors from a median 4.9 cm to 3.0 cm for a “highly significant difference preoperatively versus after therapy,” said Dr. George S. Leight Jr., a general surgeon at Duke University Medical Center, Durham, N.C.

Because experience with neoadjuvant aromatase inhibitor therapy is limited in the United States, Dr. Leight said, he and his associates studied 106 postmenopausal women who either had inoperable breast cancer or had been recommended for mastectomy. The women had estrogen receptor-positive, stage II/III breast cancer and palpable tumors of 2 cm or larger.

Seven women chose neoadjuvant chemotherapy and three declined surgery, so researchers assessed surgical outcomes for the remaining 96 women. Participants were treated with the aromatase inhibitor letrozole (Femara) for 16–24 weeks.

In all, 48 of the women had successful breast-conserving operations. Women in this arm included 30 of 46 patients who were initially identified as likely to require a mastectomy, as well as 15 of 39 patients who were initially judged to definitely require a mastectomy. Results were presented at the annual meeting of the Southern Surgical Association.

“This is an excellent study,” said Dr. Kelly K. Hunt, chief of the surgical breast section in the department of surgical oncology at the University of Texas M.D. Anderson Cancer Center, Houston. “The fact that they could downstage patients to more surgical options, especially breast-conserving surgery, is important.”

The 11 women who had been deemed inoperable at baseline were converted to operable status, including 3 who had successful breast-conserving surgery.

Dr. Leight, lead author John A. Olson Jr., and their associates gauged clinical response with ultrasound and/or mammography. In all, 13% of women had a complete response to aromatase inhibitor therapy, 49% had a partial response, 26% had stable disease, and the remaining 12% had progressive breast cancer.

“Do you think other imaging studies, such as MRI or PET scan, would be more appropriate than ultrasound?” Dr. Hunt asked.

“Regarding imaging, the inadequacy of mammograms and ultrasound is clear,” said Dr. Olson, chief of endocrine, breast, and oncologic surgery at Duke. “MRI and PET are options, but [are] full of limitations that are not addressed in this trial.”

The remaining 48 women still had mastectomy. “The decision between mastectomy and breast-conserving surgery is complex, and we were sobered by the number of patients who had very small tumors yet still had mastectomy,” Dr. Olson said.

Pretreatment T stages were T2 in 53% of patients, T3 in 37%, and T4 in 10%. Following treatment with letrozole, T stages changed to T0 in 1%, T1 in 41%, T2 in 41%, T3 in 13%, and T4 in 4%.

“This suggests that a significant number of patients who had mastectomy could have had breast-conserving surgery,” Dr. Leight said.

“I assume most of these patients with median tumor size of 5 cm are going to get chemotherapy anyway. What is the rationale for giving endocrine therapy up front instead of chemotherapy?” asked Dr. Kelly M. McMasters, chair of the surgery department at the University of Louisville (Ky.).

“Regarding a 5-cm tumor being treated with endocrine therapy versus chemotherapy—that is the point—it is appropriate to treat large, estrogen receptor-rich tumors with endocrine therapy,” Dr. Olson said.

Neither Dr. Leight nor Dr. Olson had any relevant financial disclosures.

The trial was sponsored by the National Cancer Institute.

PALM BEACH, FLA. — Neoadjuvant aromatase inhibitor therapy allows some breast cancer patients to be downstaged to breast-conserving surgery rather than being considered inoperable or as candidates for mastectomy, according to results of a multicenter phase II trial.

The treatment shrank tumors from a median 4.9 cm to 3.0 cm for a “highly significant difference preoperatively versus after therapy,” said Dr. George S. Leight Jr., a general surgeon at Duke University Medical Center, Durham, N.C.

Because experience with neoadjuvant aromatase inhibitor therapy is limited in the United States, Dr. Leight said, he and his associates studied 106 postmenopausal women who either had inoperable breast cancer or had been recommended for mastectomy. The women had estrogen receptor-positive, stage II/III breast cancer and palpable tumors of 2 cm or larger.

Seven women chose neoadjuvant chemotherapy and three declined surgery, so researchers assessed surgical outcomes for the remaining 96 women. Participants were treated with the aromatase inhibitor letrozole (Femara) for 16–24 weeks.

In all, 48 of the women had successful breast-conserving operations. Women in this arm included 30 of 46 patients who were initially identified as likely to require a mastectomy, as well as 15 of 39 patients who were initially judged to definitely require a mastectomy. Results were presented at the annual meeting of the Southern Surgical Association.

“This is an excellent study,” said Dr. Kelly K. Hunt, chief of the surgical breast section in the department of surgical oncology at the University of Texas M.D. Anderson Cancer Center, Houston. “The fact that they could downstage patients to more surgical options, especially breast-conserving surgery, is important.”

The 11 women who had been deemed inoperable at baseline were converted to operable status, including 3 who had successful breast-conserving surgery.

Dr. Leight, lead author John A. Olson Jr., and their associates gauged clinical response with ultrasound and/or mammography. In all, 13% of women had a complete response to aromatase inhibitor therapy, 49% had a partial response, 26% had stable disease, and the remaining 12% had progressive breast cancer.

“Do you think other imaging studies, such as MRI or PET scan, would be more appropriate than ultrasound?” Dr. Hunt asked.

“Regarding imaging, the inadequacy of mammograms and ultrasound is clear,” said Dr. Olson, chief of endocrine, breast, and oncologic surgery at Duke. “MRI and PET are options, but [are] full of limitations that are not addressed in this trial.”

The remaining 48 women still had mastectomy. “The decision between mastectomy and breast-conserving surgery is complex, and we were sobered by the number of patients who had very small tumors yet still had mastectomy,” Dr. Olson said.

Pretreatment T stages were T2 in 53% of patients, T3 in 37%, and T4 in 10%. Following treatment with letrozole, T stages changed to T0 in 1%, T1 in 41%, T2 in 41%, T3 in 13%, and T4 in 4%.

“This suggests that a significant number of patients who had mastectomy could have had breast-conserving surgery,” Dr. Leight said.

“I assume most of these patients with median tumor size of 5 cm are going to get chemotherapy anyway. What is the rationale for giving endocrine therapy up front instead of chemotherapy?” asked Dr. Kelly M. McMasters, chair of the surgery department at the University of Louisville (Ky.).

“Regarding a 5-cm tumor being treated with endocrine therapy versus chemotherapy—that is the point—it is appropriate to treat large, estrogen receptor-rich tumors with endocrine therapy,” Dr. Olson said.

Neither Dr. Leight nor Dr. Olson had any relevant financial disclosures.

The trial was sponsored by the National Cancer Institute.

PALM BEACH, FLA. — Neoadjuvant aromatase inhibitor therapy allows some breast cancer patients to be downstaged to breast-conserving surgery rather than being considered inoperable or as candidates for mastectomy, according to results of a multicenter phase II trial.

The treatment shrank tumors from a median 4.9 cm to 3.0 cm for a “highly significant difference preoperatively versus after therapy,” said Dr. George S. Leight Jr., a general surgeon at Duke University Medical Center, Durham, N.C.

Because experience with neoadjuvant aromatase inhibitor therapy is limited in the United States, Dr. Leight said, he and his associates studied 106 postmenopausal women who either had inoperable breast cancer or had been recommended for mastectomy. The women had estrogen receptor-positive, stage II/III breast cancer and palpable tumors of 2 cm or larger.

Seven women chose neoadjuvant chemotherapy and three declined surgery, so researchers assessed surgical outcomes for the remaining 96 women. Participants were treated with the aromatase inhibitor letrozole (Femara) for 16–24 weeks.

In all, 48 of the women had successful breast-conserving operations. Women in this arm included 30 of 46 patients who were initially identified as likely to require a mastectomy, as well as 15 of 39 patients who were initially judged to definitely require a mastectomy. Results were presented at the annual meeting of the Southern Surgical Association.

“This is an excellent study,” said Dr. Kelly K. Hunt, chief of the surgical breast section in the department of surgical oncology at the University of Texas M.D. Anderson Cancer Center, Houston. “The fact that they could downstage patients to more surgical options, especially breast-conserving surgery, is important.”

The 11 women who had been deemed inoperable at baseline were converted to operable status, including 3 who had successful breast-conserving surgery.

Dr. Leight, lead author John A. Olson Jr., and their associates gauged clinical response with ultrasound and/or mammography. In all, 13% of women had a complete response to aromatase inhibitor therapy, 49% had a partial response, 26% had stable disease, and the remaining 12% had progressive breast cancer.

“Do you think other imaging studies, such as MRI or PET scan, would be more appropriate than ultrasound?” Dr. Hunt asked.

“Regarding imaging, the inadequacy of mammograms and ultrasound is clear,” said Dr. Olson, chief of endocrine, breast, and oncologic surgery at Duke. “MRI and PET are options, but [are] full of limitations that are not addressed in this trial.”

The remaining 48 women still had mastectomy. “The decision between mastectomy and breast-conserving surgery is complex, and we were sobered by the number of patients who had very small tumors yet still had mastectomy,” Dr. Olson said.

Pretreatment T stages were T2 in 53% of patients, T3 in 37%, and T4 in 10%. Following treatment with letrozole, T stages changed to T0 in 1%, T1 in 41%, T2 in 41%, T3 in 13%, and T4 in 4%.

“This suggests that a significant number of patients who had mastectomy could have had breast-conserving surgery,” Dr. Leight said.

“I assume most of these patients with median tumor size of 5 cm are going to get chemotherapy anyway. What is the rationale for giving endocrine therapy up front instead of chemotherapy?” asked Dr. Kelly M. McMasters, chair of the surgery department at the University of Louisville (Ky.).

“Regarding a 5-cm tumor being treated with endocrine therapy versus chemotherapy—that is the point—it is appropriate to treat large, estrogen receptor-rich tumors with endocrine therapy,” Dr. Olson said.

Neither Dr. Leight nor Dr. Olson had any relevant financial disclosures.

The trial was sponsored by the National Cancer Institute.

MIAMI BEACH — A hospitalist who is asked to perform a perioperative consultation can optimize reimbursement by getting the request in writing, making sure that it outlines a specific reason or concern, and documenting that a written report has been submitted.

Do not agree to evaluate a patient based only on a spoken request or in response to being paged within the hospital, advised Gail Pfeiffer, director of coding compliance at the Cleveland Clinic. “You need to nicely remind the doctor that you need a written order.

“The biggest challenge is getting back to those folks requesting your services and getting them to use the proper language,” Ms. Pfeiffer said at a meeting on perioperative medicine sponsored by the University of Miami.

The requesting physician must document the purpose of the consultation. “Our carrier really stressed that writing 'consult' is not enough. They need a reason,” Ms. Pfeiffer said. Terminology is important; words such as “consult,” “evaluation,” and “opinion” are good to include in a request, provided that they are supported with specifics. “If it appears to be a co-evaluation, the consultant is at higher medicolegal risk.”

A hospitalist also must document properly. “You have to document 'consult received for Dr. X for evaluation of Y.' You have to make a statement that you received that order,” she said.

Consultation codes are common sources of error, according to the Comprehensive Error Rate Testing (CERT) program. For example, in Ohio, CERT data revealed a 20% error rate for consultation codes.

Along with coding, proper supporting documentation is essential to optimize reimbursement. Documentation that supports a lower level of service or that lacks “the 3Rs” (a request in writing, a rendered opinion, and a report with recommendations) are the most common consultation errors, she said. “The more you can be explicit, the better,” Ms. Pfeiffer said.

Documentation may differ based on whether you work in a shared-record versus separate-record environment. Inpatient stays are almost always a shared-record situation. “I recommend a note in your record that states 'this record will be shared with requesting physician via e-mail, fax, or whatever,'” she said. In contrast, if the consultation request came from a physician outside your institution or health system, “you have to demonstrate in your record that you sent a report to the requesting physician.”

When requesting reimbursement for a preoperative consultation, for example, the first listed ICD-9 code should be V72.8x, Ms. Pfeiffer said. The preoperative diagnosis or reason for surgery dictates the second code, and the third through eighth codes identify comorbid and underlying conditions, as well as appropriate personal and family history codes. Keep in mind that some payers recognize only the first four codes, so it is important to prioritize, she advised.

“Most payers will pay for preoperative consultations as long as you meet all the requirements,” she said. “Medicare will pay as long as it is medically necessary—in other words, [it is] not routine screening.” If you are concerned that a payer might consider the consultation routine, cite a patient's comorbid conditions, risk factors, and chronic medication use. “Most of the patients you see I would think have underlying conditions.”

Medicare does not consider a postoperative evaluation a consultation if you or someone in your group performed the preoperative consultation on the same patient. “It's follow-up care for that same visit,” she said. Instead, use subsequent coding when the same patient is seen again postoperatively.

A meeting attendee asked how to bill when a consultation service is split between a physician and a midlevel provider. Most payers “don't want you to split the consult at all,” Ms. Pfeiffer replied. “We tend not to use midlevels to do consults.”

MIAMI BEACH — A hospitalist who is asked to perform a perioperative consultation can optimize reimbursement by getting the request in writing, making sure that it outlines a specific reason or concern, and documenting that a written report has been submitted.

Do not agree to evaluate a patient based only on a spoken request or in response to being paged within the hospital, advised Gail Pfeiffer, director of coding compliance at the Cleveland Clinic. “You need to nicely remind the doctor that you need a written order.

“The biggest challenge is getting back to those folks requesting your services and getting them to use the proper language,” Ms. Pfeiffer said at a meeting on perioperative medicine sponsored by the University of Miami.

The requesting physician must document the purpose of the consultation. “Our carrier really stressed that writing 'consult' is not enough. They need a reason,” Ms. Pfeiffer said. Terminology is important; words such as “consult,” “evaluation,” and “opinion” are good to include in a request, provided that they are supported with specifics. “If it appears to be a co-evaluation, the consultant is at higher medicolegal risk.”

A hospitalist also must document properly. “You have to document 'consult received for Dr. X for evaluation of Y.' You have to make a statement that you received that order,” she said.

Consultation codes are common sources of error, according to the Comprehensive Error Rate Testing (CERT) program. For example, in Ohio, CERT data revealed a 20% error rate for consultation codes.

Along with coding, proper supporting documentation is essential to optimize reimbursement. Documentation that supports a lower level of service or that lacks “the 3Rs” (a request in writing, a rendered opinion, and a report with recommendations) are the most common consultation errors, she said. “The more you can be explicit, the better,” Ms. Pfeiffer said.

Documentation may differ based on whether you work in a shared-record versus separate-record environment. Inpatient stays are almost always a shared-record situation. “I recommend a note in your record that states 'this record will be shared with requesting physician via e-mail, fax, or whatever,'” she said. In contrast, if the consultation request came from a physician outside your institution or health system, “you have to demonstrate in your record that you sent a report to the requesting physician.”

When requesting reimbursement for a preoperative consultation, for example, the first listed ICD-9 code should be V72.8x, Ms. Pfeiffer said. The preoperative diagnosis or reason for surgery dictates the second code, and the third through eighth codes identify comorbid and underlying conditions, as well as appropriate personal and family history codes. Keep in mind that some payers recognize only the first four codes, so it is important to prioritize, she advised.

“Most payers will pay for preoperative consultations as long as you meet all the requirements,” she said. “Medicare will pay as long as it is medically necessary—in other words, [it is] not routine screening.” If you are concerned that a payer might consider the consultation routine, cite a patient's comorbid conditions, risk factors, and chronic medication use. “Most of the patients you see I would think have underlying conditions.”

Medicare does not consider a postoperative evaluation a consultation if you or someone in your group performed the preoperative consultation on the same patient. “It's follow-up care for that same visit,” she said. Instead, use subsequent coding when the same patient is seen again postoperatively.

A meeting attendee asked how to bill when a consultation service is split between a physician and a midlevel provider. Most payers “don't want you to split the consult at all,” Ms. Pfeiffer replied. “We tend not to use midlevels to do consults.”

MIAMI BEACH — A hospitalist who is asked to perform a perioperative consultation can optimize reimbursement by getting the request in writing, making sure that it outlines a specific reason or concern, and documenting that a written report has been submitted.

Do not agree to evaluate a patient based only on a spoken request or in response to being paged within the hospital, advised Gail Pfeiffer, director of coding compliance at the Cleveland Clinic. “You need to nicely remind the doctor that you need a written order.

“The biggest challenge is getting back to those folks requesting your services and getting them to use the proper language,” Ms. Pfeiffer said at a meeting on perioperative medicine sponsored by the University of Miami.

The requesting physician must document the purpose of the consultation. “Our carrier really stressed that writing 'consult' is not enough. They need a reason,” Ms. Pfeiffer said. Terminology is important; words such as “consult,” “evaluation,” and “opinion” are good to include in a request, provided that they are supported with specifics. “If it appears to be a co-evaluation, the consultant is at higher medicolegal risk.”

A hospitalist also must document properly. “You have to document 'consult received for Dr. X for evaluation of Y.' You have to make a statement that you received that order,” she said.

Consultation codes are common sources of error, according to the Comprehensive Error Rate Testing (CERT) program. For example, in Ohio, CERT data revealed a 20% error rate for consultation codes.

Along with coding, proper supporting documentation is essential to optimize reimbursement. Documentation that supports a lower level of service or that lacks “the 3Rs” (a request in writing, a rendered opinion, and a report with recommendations) are the most common consultation errors, she said. “The more you can be explicit, the better,” Ms. Pfeiffer said.

Documentation may differ based on whether you work in a shared-record versus separate-record environment. Inpatient stays are almost always a shared-record situation. “I recommend a note in your record that states 'this record will be shared with requesting physician via e-mail, fax, or whatever,'” she said. In contrast, if the consultation request came from a physician outside your institution or health system, “you have to demonstrate in your record that you sent a report to the requesting physician.”

When requesting reimbursement for a preoperative consultation, for example, the first listed ICD-9 code should be V72.8x, Ms. Pfeiffer said. The preoperative diagnosis or reason for surgery dictates the second code, and the third through eighth codes identify comorbid and underlying conditions, as well as appropriate personal and family history codes. Keep in mind that some payers recognize only the first four codes, so it is important to prioritize, she advised.

“Most payers will pay for preoperative consultations as long as you meet all the requirements,” she said. “Medicare will pay as long as it is medically necessary—in other words, [it is] not routine screening.” If you are concerned that a payer might consider the consultation routine, cite a patient's comorbid conditions, risk factors, and chronic medication use. “Most of the patients you see I would think have underlying conditions.”

Medicare does not consider a postoperative evaluation a consultation if you or someone in your group performed the preoperative consultation on the same patient. “It's follow-up care for that same visit,” she said. Instead, use subsequent coding when the same patient is seen again postoperatively.

A meeting attendee asked how to bill when a consultation service is split between a physician and a midlevel provider. Most payers “don't want you to split the consult at all,” Ms. Pfeiffer replied. “We tend not to use midlevels to do consults.”

MIAMI BEACH — Hospitalists are most likely to be targeted by malpractice claims that involve alleged informed consent issues, standard of care, or errors resulting from poor communication.

Physicians still win more than half of malpractice cases, Dr. Franklin A. Michota Jr. said at a meeting on perioperative medicine sponsored by the University of Miami.

Lawsuits are inevitable, he said. “I am estimating that 30%–40% of you in the audience have been sued.” In general, surgeons are sued about once every 4 years, anesthesiologists once every 5 years, and internists once every 7–10 years. Hospitalists, as part of the perioperative team, are sued at about the same frequency as surgeons, said Dr. Michota, director of academic affairs for the department of hospital medicine at the Cleveland Clinic.

Poor communication is the leading reason physicians get sued, Dr. Michota said. “Sometimes it doesn't matter if you do everything right. If you don't talk to the patient, you are going to get sued.”

Hospitalists can reduce their risk by paying attention to the top reasons for lawsuits, as illustrated by three actual malpractice cases presented by Dr. Michota and Matt Donnelly, chief counsel at the Cleveland Clinic.

Informed consent was the key issue in the case of a 65-year-old man referred for preoperative stress testing prior to total knee arthroplasty. He had a history of coronary artery disease and had marked limitation of activity as assessed by the Duke Activity Status Index; he also had chronic obstructive pulmonary disease, hypertension, and prior abdominal aortic aneurysm repair. Dobutamine stress echocardiography was performed with a target heart rate of 132 bpm. Sporadic premature ventricular contractions occurred, the man complained of shortness of breath and chest pain, and the test was stopped. He went into ventral tachycardia, then ventral fibrillation, and died despite resuscitative efforts.

Mr. Donnelly noted that the manner in which informed consent was obtained was central to this case. Was it obtained by the referring physician a few weeks before the stress test, or by the personnel who performed it? Was death as a potential outcome discussed with the patient or family as part of the informed consent process? Also, was there appropriate monitoring during the test?

“I've worked in perioperative care for 5 or 6 years now,” Dr. Michota said. “I don't ever remember a time when I referred someone to a stress test where I told them they could die. I do now.”

A lawsuit can be filed even if the patient signed a consent form in the stress testing laboratory, Mr. Donnelly said. A plaintiff's attorney might question whether the patient understood the risks, for example.

Standard of care issues are illustrated by a case involving a 75-year-old man with rectal cancer. He had a remote cardiac history but presented for surgery with good functional capacity on the Duke Activity Status Index and no symptoms. Surgery was uneventful, but he developed hypotension in the postanesthesia care unit. He improved the next morning. Bleeding occurred on postoperative day 2 and he was returned to the operating room, where he experienced cardiac arrest. He was revived but died 2 weeks later. An autopsy showed that myocardial infarction was the cause of death.

“The complaint was he did not have a proper cardiac workup,” Dr. Michota said. Mr. Donnelly commented that the patient's cardiac condition was well controlled and “was way in the past.” One of the main issues in the case was the question of whether an ECG should have been performed, Mr. Donnelly said. “You have to remind the jury that they have to think about what the physician was facing at the time, not retrospectively.”

Hospitalists could be involved in such a case if they do a preoperative evaluation and do not order an ECG, even though it is not recommended in this scenario by the American College of Cardiology or American Heart Association, Dr. Michota said.

In response to a meeting attendee's question about what defines standard of care, Dr. Michota replied, “Often it gets down to a battle of the experts. If you work at a community hospital that orders stress testing for everyone and that seems like standard of care, a plaintiff attorney can still argue it was risky and never should have been ordered. Or you work at an institution that never orders stress testing, and the attorney will ask why you did not order it when it is available.”

A third case shows the importance of documentation and communication. A 67-year-old man was seen for a consultation after developing shortness of breath following a laminectomy. He was started on full-dose low-molecular-weight heparin (LMWH), his symptoms resolved, and his workup was negative. The consultants signed off without stopping the LMWH. Discharged to a rehabilitation unit, the man did well until postoperative day 7, when he developed urinary retention and could not move his legs. The LMWH was stopped, and he underwent emergency surgery to evacuate a spinal hematoma. He never fully recovered neurologic function.

“This case was interesting because once the docs involved realized what happened, they got nervous and started finger-pointing,” Dr. Michota said. The surgeons thought someone else was going to stop the LMWH. “Interestingly, the hospitalist in the case made a notation in the chart after the neurological injury occurred, but dated the entry as before the fact. Doctoring the medical record never plays well to the jury—it is a clear sign of guilt!”

'Sometimes it doesn't matter if you do everything right. If you don't talk to the patient, you are going to get sued.' DR. MICHOTA

MIAMI BEACH — Hospitalists are most likely to be targeted by malpractice claims that involve alleged informed consent issues, standard of care, or errors resulting from poor communication.

Physicians still win more than half of malpractice cases, Dr. Franklin A. Michota Jr. said at a meeting on perioperative medicine sponsored by the University of Miami.

Lawsuits are inevitable, he said. “I am estimating that 30%–40% of you in the audience have been sued.” In general, surgeons are sued about once every 4 years, anesthesiologists once every 5 years, and internists once every 7–10 years. Hospitalists, as part of the perioperative team, are sued at about the same frequency as surgeons, said Dr. Michota, director of academic affairs for the department of hospital medicine at the Cleveland Clinic.

Poor communication is the leading reason physicians get sued, Dr. Michota said. “Sometimes it doesn't matter if you do everything right. If you don't talk to the patient, you are going to get sued.”

Hospitalists can reduce their risk by paying attention to the top reasons for lawsuits, as illustrated by three actual malpractice cases presented by Dr. Michota and Matt Donnelly, chief counsel at the Cleveland Clinic.

Informed consent was the key issue in the case of a 65-year-old man referred for preoperative stress testing prior to total knee arthroplasty. He had a history of coronary artery disease and had marked limitation of activity as assessed by the Duke Activity Status Index; he also had chronic obstructive pulmonary disease, hypertension, and prior abdominal aortic aneurysm repair. Dobutamine stress echocardiography was performed with a target heart rate of 132 bpm. Sporadic premature ventricular contractions occurred, the man complained of shortness of breath and chest pain, and the test was stopped. He went into ventral tachycardia, then ventral fibrillation, and died despite resuscitative efforts.

Mr. Donnelly noted that the manner in which informed consent was obtained was central to this case. Was it obtained by the referring physician a few weeks before the stress test, or by the personnel who performed it? Was death as a potential outcome discussed with the patient or family as part of the informed consent process? Also, was there appropriate monitoring during the test?

“I've worked in perioperative care for 5 or 6 years now,” Dr. Michota said. “I don't ever remember a time when I referred someone to a stress test where I told them they could die. I do now.”

A lawsuit can be filed even if the patient signed a consent form in the stress testing laboratory, Mr. Donnelly said. A plaintiff's attorney might question whether the patient understood the risks, for example.

Standard of care issues are illustrated by a case involving a 75-year-old man with rectal cancer. He had a remote cardiac history but presented for surgery with good functional capacity on the Duke Activity Status Index and no symptoms. Surgery was uneventful, but he developed hypotension in the postanesthesia care unit. He improved the next morning. Bleeding occurred on postoperative day 2 and he was returned to the operating room, where he experienced cardiac arrest. He was revived but died 2 weeks later. An autopsy showed that myocardial infarction was the cause of death.

“The complaint was he did not have a proper cardiac workup,” Dr. Michota said. Mr. Donnelly commented that the patient's cardiac condition was well controlled and “was way in the past.” One of the main issues in the case was the question of whether an ECG should have been performed, Mr. Donnelly said. “You have to remind the jury that they have to think about what the physician was facing at the time, not retrospectively.”

Hospitalists could be involved in such a case if they do a preoperative evaluation and do not order an ECG, even though it is not recommended in this scenario by the American College of Cardiology or American Heart Association, Dr. Michota said.

In response to a meeting attendee's question about what defines standard of care, Dr. Michota replied, “Often it gets down to a battle of the experts. If you work at a community hospital that orders stress testing for everyone and that seems like standard of care, a plaintiff attorney can still argue it was risky and never should have been ordered. Or you work at an institution that never orders stress testing, and the attorney will ask why you did not order it when it is available.”

A third case shows the importance of documentation and communication. A 67-year-old man was seen for a consultation after developing shortness of breath following a laminectomy. He was started on full-dose low-molecular-weight heparin (LMWH), his symptoms resolved, and his workup was negative. The consultants signed off without stopping the LMWH. Discharged to a rehabilitation unit, the man did well until postoperative day 7, when he developed urinary retention and could not move his legs. The LMWH was stopped, and he underwent emergency surgery to evacuate a spinal hematoma. He never fully recovered neurologic function.

“This case was interesting because once the docs involved realized what happened, they got nervous and started finger-pointing,” Dr. Michota said. The surgeons thought someone else was going to stop the LMWH. “Interestingly, the hospitalist in the case made a notation in the chart after the neurological injury occurred, but dated the entry as before the fact. Doctoring the medical record never plays well to the jury—it is a clear sign of guilt!”

'Sometimes it doesn't matter if you do everything right. If you don't talk to the patient, you are going to get sued.' DR. MICHOTA

MIAMI BEACH — Hospitalists are most likely to be targeted by malpractice claims that involve alleged informed consent issues, standard of care, or errors resulting from poor communication.

Physicians still win more than half of malpractice cases, Dr. Franklin A. Michota Jr. said at a meeting on perioperative medicine sponsored by the University of Miami.

Lawsuits are inevitable, he said. “I am estimating that 30%–40% of you in the audience have been sued.” In general, surgeons are sued about once every 4 years, anesthesiologists once every 5 years, and internists once every 7–10 years. Hospitalists, as part of the perioperative team, are sued at about the same frequency as surgeons, said Dr. Michota, director of academic affairs for the department of hospital medicine at the Cleveland Clinic.

Poor communication is the leading reason physicians get sued, Dr. Michota said. “Sometimes it doesn't matter if you do everything right. If you don't talk to the patient, you are going to get sued.”

Hospitalists can reduce their risk by paying attention to the top reasons for lawsuits, as illustrated by three actual malpractice cases presented by Dr. Michota and Matt Donnelly, chief counsel at the Cleveland Clinic.

Informed consent was the key issue in the case of a 65-year-old man referred for preoperative stress testing prior to total knee arthroplasty. He had a history of coronary artery disease and had marked limitation of activity as assessed by the Duke Activity Status Index; he also had chronic obstructive pulmonary disease, hypertension, and prior abdominal aortic aneurysm repair. Dobutamine stress echocardiography was performed with a target heart rate of 132 bpm. Sporadic premature ventricular contractions occurred, the man complained of shortness of breath and chest pain, and the test was stopped. He went into ventral tachycardia, then ventral fibrillation, and died despite resuscitative efforts.

Mr. Donnelly noted that the manner in which informed consent was obtained was central to this case. Was it obtained by the referring physician a few weeks before the stress test, or by the personnel who performed it? Was death as a potential outcome discussed with the patient or family as part of the informed consent process? Also, was there appropriate monitoring during the test?

“I've worked in perioperative care for 5 or 6 years now,” Dr. Michota said. “I don't ever remember a time when I referred someone to a stress test where I told them they could die. I do now.”

A lawsuit can be filed even if the patient signed a consent form in the stress testing laboratory, Mr. Donnelly said. A plaintiff's attorney might question whether the patient understood the risks, for example.

Standard of care issues are illustrated by a case involving a 75-year-old man with rectal cancer. He had a remote cardiac history but presented for surgery with good functional capacity on the Duke Activity Status Index and no symptoms. Surgery was uneventful, but he developed hypotension in the postanesthesia care unit. He improved the next morning. Bleeding occurred on postoperative day 2 and he was returned to the operating room, where he experienced cardiac arrest. He was revived but died 2 weeks later. An autopsy showed that myocardial infarction was the cause of death.

“The complaint was he did not have a proper cardiac workup,” Dr. Michota said. Mr. Donnelly commented that the patient's cardiac condition was well controlled and “was way in the past.” One of the main issues in the case was the question of whether an ECG should have been performed, Mr. Donnelly said. “You have to remind the jury that they have to think about what the physician was facing at the time, not retrospectively.”

Hospitalists could be involved in such a case if they do a preoperative evaluation and do not order an ECG, even though it is not recommended in this scenario by the American College of Cardiology or American Heart Association, Dr. Michota said.

In response to a meeting attendee's question about what defines standard of care, Dr. Michota replied, “Often it gets down to a battle of the experts. If you work at a community hospital that orders stress testing for everyone and that seems like standard of care, a plaintiff attorney can still argue it was risky and never should have been ordered. Or you work at an institution that never orders stress testing, and the attorney will ask why you did not order it when it is available.”

A third case shows the importance of documentation and communication. A 67-year-old man was seen for a consultation after developing shortness of breath following a laminectomy. He was started on full-dose low-molecular-weight heparin (LMWH), his symptoms resolved, and his workup was negative. The consultants signed off without stopping the LMWH. Discharged to a rehabilitation unit, the man did well until postoperative day 7, when he developed urinary retention and could not move his legs. The LMWH was stopped, and he underwent emergency surgery to evacuate a spinal hematoma. He never fully recovered neurologic function.

“This case was interesting because once the docs involved realized what happened, they got nervous and started finger-pointing,” Dr. Michota said. The surgeons thought someone else was going to stop the LMWH. “Interestingly, the hospitalist in the case made a notation in the chart after the neurological injury occurred, but dated the entry as before the fact. Doctoring the medical record never plays well to the jury—it is a clear sign of guilt!”

'Sometimes it doesn't matter if you do everything right. If you don't talk to the patient, you are going to get sued.' DR. MICHOTA